Showing papers in "Health and Quality of Life Outcomes in 2005"
TL;DR: An updated review of the literature is provided and a precept governing the application of pediatric HRQOL measurement in pediatric clinical practice is proposed, which can facilitate patient-physician communication, improve patient/parent satisfaction, identify hidden morbidities, and assist in clinical decision-making.
Abstract: Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. HRQOL measures are also increasingly proposed for use in clinical practice settings to inform treatment decisions. In settings where HRQOL measures have been utilized with adults, physicians report such measures as useful, some physicians alter their treatment based on patient reports on such instruments, and patients themselves generally feel the instruments to be helpful. However, there is a dearth of studies evaluating the clinical utility of HRQOL measurement in pediatric clinical practice. This paper provides an updated review of the literature and proposes a precept governing the application of pediatric HRQOL measurement in pediatric clinical practice. Utilizing HRQOL measurement in pediatric healthcare settings can facilitate patient-physician communication, improve patient/parent satisfaction, identify hidden morbidities, and assist in clinical decision-making. Demonstrating the utility of pediatric HRQOL measurement in identifying children with the greatest needs, while simultaneously demonstrating the cost advantages of providing timely, targeted interventions to address those needs, may ultimately provide the driving force for incorporating HRQOL measurement in pediatric clinical practice.
442 citations
TL;DR: There is a need for additional targeted therapies for menopause-associated vasomotor symptoms, validated by results from controlled clinical trials that are safe, efficacious, cost-effective, and well tolerated by symptomatic menopausal women.
Abstract: Many women experience vasomotor symptoms at or around the time of menopause. Hot flushes and night sweats are considered primary menopausal symptoms that may also be associated with sleep and mood disturbances, as well as decreased cognitive function. All of these symptoms may lead to social impairment and work-related difficulties that significantly decrease overall quality of life. Hot flushes have shown a great deal of variability in their frequency and severity in women. In some women, hot flushes persist for several months; in others, they may last for more than 10 years. Traditionally vasomotor symptoms were reported to begin 5 to 10 years prior to the cessation of the final menstrual cycle, corresponding with the initial decline in circulating gonadal hormones; however, night sweats in particular most often begin in perimenopause. The pathogenesis of hot flushes has not yet been fully elucidated, but the circuitry involving estrogen and neurotransmitters, norepinephrine and serotonin specifically, are hypothesized to play a major role in the altered homeostatic thermoregulatory mechanisms underlying these events. Menopause-associated vasomotor symptoms are associated with significant direct and indirect costs. Overall costs of traditional pharmacotherapy or complementary and alternative medicine modalities, including over-the-counter treatments and dietary supplements, for managing menopause-related vasomotor symptoms are substantial and include initial and follow-up physician visits and telephone calls. Additional costs include laboratory testing, management of adverse events, loss of productivity at work, and personal and miscellaneous costs. Pharmacoeconomic analyses, including those that consider risks identified by the Women's Health Initiative, generally support the cost-effectiveness of hormonal therapy for menopause-associated vasomotor symptoms, which have been the mainstay for the management of these symptoms for more than 50 years. However, because many women now want to avoid hormone therapy, there is a need for additional targeted therapies, validated by results from controlled clinical trials that are safe, efficacious, cost-effective, and well tolerated by symptomatic menopausal women.
354 citations
TL;DR: The results show that HRQL in COPD deteriorates with disease severity and with age, and a relationship between HRQL and disease severity obtained by lung function is shown.
Abstract: The aim of this study was to evaluate the association between health-related quality of life (HRQL) and disease severity using lung function measures. A survey was performed in subjects with COPD in Sweden. 168 subjects (70 women, mean age 64.3 years) completed the generic HRQL questionnaire, the Short Form 36 (SF-36), the disease-specific HRQL questionnaire; the St George's Respiratory Questionnaire (SGRQ), and the utility measure, the EQ-5D. The subjects were divided into four severity groups according to FEV1 per cent of predicted normal using two clinical guidelines: GOLD and BTS. Age, gender, smoking status and socio-economic group were regarded as confounders. The COPD severity grades affected the SGRQ Total scores, varying from 25 to 53 (GOLD p = 0.0005) and from 25 to 45 (BTS p = 0.0023). The scores for SF-36 Physical were significantly associated with COPD severity (GOLD p = 0.0059, BTS p = 0.032). No significant association were noticed for the SF-36, Mental Component Summary scores and COPD severity. Scores for EQ-5D VAS varied from 73 to 37 (GOLD I-IV p = 0.0001) and from 73 to 50 (BTS 0-III p = 0.0007). The SGRQ Total score was significant between age groups (p = 0.0047). No significant differences in HRQL with regard to gender, smoking status or socio-economic group were noticed. The results show that HRQL in COPD deteriorates with disease severity and with age. These data show a relationship between HRQL and disease severity obtained by lung function.
324 citations
TL;DR: de Leval's theoretical model linking depression and QoL with a time perspective was largely confirmed and the analysis of a temporal horizon was helpful in understanding the link between depression andQoL.
Abstract: Little is understood about the conceptual relationship of depression and quality of life (QoL). Judgments concerning both, implicitly or explicitly, involve a time perspective. The aim of this study was to test de Leval's theoretical model linking depression and QoL with a time perspective. The model predicts that changes in cognitions about one's past, present and future QoL, will be associated with changes in depressive symptomatology. Eighteen psychiatric in-patients with a clinically confirmed diagnosis of depression were assessed on commencing treatment and 12 weeks later. QoL was assessed by the Schedule for Evaluation of Individual Quality of Life (SEIQoL), depression by the Beck Depression Inventory (BDI-II) and hopelessness by the Beck Hopelessness Scale (BHS). Time perspective was incorporated by asking QoL questions about the past, present and future. Depression and hopelessness were associated with a poorer present QoL. Depression lowered present QoL but did not alter future QoL, as these remained consistently high whether participants were depressed or recovering. However, depressed individuals had a larger gap between their actual present QoL and future (aspired to) QoL. Changes in QoL were influenced by depression and hopelessness. Contrary to the model, perception of "past" QoL was not affected by depression or hopelessness. de Leval's model was largely confirmed. Thus depression and hopelessness influence a person's present and future QoL. The analysis of a temporal horizon was helpful in understanding the link between depression and QoL.
304 citations
TL;DR: Health related quality of life among adults with sickle cell disease is worse than the general population, and in general, their scores were most similar to patients undergoing hemodialysis.
Abstract: Sickle cell disease (SCD) is a chronic disease associated with high degrees of morbidity and increased mortality. Health-related quality of life (HRQOL) among adults with sickle cell disease has not been widely reported. We administered the Medical Outcomes Study 36-item Short-Form to 308 patients in the Pain in Sickle Cell Epidemiology Study (PiSCES) to assess HRQOL. Scales included physical function, physical and emotional role function, bodily pain, vitality, social function, mental health, and general health. We compared scores with national norms using t-tests, and with three chronic disease cohorts: asthma, cystic fibrosis and hemodialysis patients using analysis of variance and Dunnett's test for comparison with a control. We also assessed whether SCD specific variables (genotype, pain, crisis and utilization) were independently predictive of SF-36 subscales, controlling for socio-demographic variables using regression. Patients with SCD scored significantly worse than national norms on all subscales except mental health. Patients with SCD had lower HRQOL than cystic fibrosis patients except for mental health. Scores were similar for physical function, role function and mental health as compared to asthma patients, but worse for bodily pain, vitality, social function and general health subscales. Compared to dialysis patients, sickle cell disease patients scored similarly on physical role and emotional role function, social functioning and mental health, worse on bodily pain, general health and vitality and better on physical functioning. Surprisingly, genotype did not influence HRQOL except for vitality. However, scores significantly decreased as pain levels increased. SCD patients experience health related quality of life worse than the general population, and in general, their scores were most similar to patients undergoing hemodialysis. Practitioners should regard their HRQOL as severely compromised. Interventions in SCD should consider improvements in health related quality of life as important outcomes.
268 citations
TL;DR: Collectively, the Health of the Nation Outcome Scales family of measures can assess outcomes for different groups on a range of mental health-related constructs, and can be regarded as appropriate for routinely monitoring outcomes.
Abstract: The Health of the Nation Outcome Scales was developed to routinely measure outcomes for adults with mental illness. Comparable instruments were also developed for children and adolescents (the Health of the Nation Outcome Scales for Children and Adolescents) and older people (the Health of the Nation Outcome Scales 65+). All three are being widely used as outcome measures in the United Kingdom, Australia and New Zealand. There is, however, no comprehensive review of these instruments. This paper fills this gap by reviewing the psychometric properties of each. Articles and reports relating to the instruments were retrieved, and their findings synthesised to assess the instruments' validity (content, construct, concurrent, predictive), reliability (test-retest, inter-rater), sensitivity to change, and feasibility/utility. Mostly, the instruments perform adequately or better on most dimensions, although some of their psychometric properties warrant closer examination. Collectively, the Health of the Nation Outcome Scales family of measures can assess outcomes for different groups on a range of mental health-related constructs, and can be regarded as appropriate for routinely monitoring outcomes.
249 citations
TL;DR: For certain QOL assessments, self-reported disease burden may provide a more accurate estimate of comorbidity than existing measures that use different methodologies, and that were originally validated against other outcomes.
Abstract: Background
Interventions to improve care for persons with chronic medical conditions often use quality of life (QOL) outcomes. These outcomes may be affected by coexisting (comorbid) chronic conditions as well as the index condition of interest. A subjective measure of comorbidity that incorporates an assessment of disease severity may be particularly useful for assessing comorbidity for these investigations.
245 citations
TL;DR: A review of studies addressing the assessment of generic and health-related quality of life (QoL) in patients with bipolar disorder is presented in this paper. But, the majority of the studies indicated that QoL is markedly impaired, even when they are considered to be clinically euthymic.
Abstract: A sizable body of research has now examined the complex relationship between quality of life (QoL) and depressive disorder. Uptake of QoL research in relation to bipolar disorder (BD) has been comparatively slow, although increasing numbers of QoL studies are now being conducted in bipolar populations. We aimed to perform a review of studies addressing the assessment of generic and health-related QoL in patients with bipolar disorder. A literature search was conducted in a comprehensive selection of databases including MEDLINE up to November 2004. Key words included: bipolar disorder or manic-depression, mania, bipolar depression, bipolar spectrum and variants AND quality of life, health-related QoL, functional status, well-being and variants. Articles were included if they were published in English and reported on an assessment of generic or health-related QoL in patients with BD. Articles were not included if they had assessed fewer than 10 patients with BD, were only published in abstract form or only assessed single dimensions of functioning. The literature search initially yielded 790 articles or abstracts. Of these, 762 did not meet our inclusion criteria, leaving a final total of 28 articles. These were sub-divided into four categories (assessment of QoL in patients with BD at different stages of the disorder, comparisons of QoL in Patients with BD with that of other patient populations, QoL instrument evaluation in patients with BD and treatment studies using QoL instruments to assess outcome in Patients with BD) and described in detail. The review indicated that there is growing interest in QoL research in bipolar populations. Although the scientific quality of the research identified was variable, increasing numbers of studies of good design are being conducted. The majority of the studies we identified indicated that QoL is markedly impaired in patients with BD, even when they are considered to be clinically euthymic. We identified several important avenues for future research, including a need for more assessment of QoL in hypo/manic patients, more longitudinal research and the development of a disease-specific measure of QoL for patients with BD.
231 citations
TL;DR: The condition-specific modules of the DISABKIDS instrument were developed through a step-by-step process including cognitive interview, clinical expertise, factor analysis, correlations and internal consistency to serve as a useful tool with which to assess HRQoL in children and adolescents with a chronic condition.
Abstract: The European DISABKIDS project aims to enhance the Health Related Quality of Life (HRQoL) of children and adolescents with chronic medical conditions and their families. We describe the development of the seven cross-nationally tested condition-specific modules of the European DISABKIDS HRQoL instrument in a population of children and adolescents. The condition-specific modules are intended for use in conjunction with the DISABKIDS chronic generic module. Focus groups were used to construct the pilot version of the DISABKIDS condition-specific HRQoL modules for asthma, juvenile idiopathic arthritis, atopic dermatitis, cerebral palsy, cystic fibrosis, diabetes and epilepsy. Analyses were conducted on pilot test data in order to construct field test versions of the modules. A series of factor analyses were run, first, to determine potential structures for each condition-specific module, and, secondly, to select a reduced number of items from the pilot test to be included in the field test. Post-field test analyses were conducted to retest the domain structure for the final DISABKIDS condition-specific modules. The DISABKIDS condition-specific modules were tested in a pilot study of 360 respondents, and subsequently in a field test of 1152 respondents in 7 European countries. The final condition-specific modules consist of an 'Impact' domain and an additional domain (e.g. worry, stigma, treatment) with between 10 to 12 items in total. The Cronbach's alpha of the final domains was found to vary from 0.71 to 0.90. The condition-specific modules of the DISABKIDS instrument were developed through a step-by-step process including cognitive interview, clinical expertise, factor analysis, correlations and internal consistency. A cross-national pilot and field test were necessary to collect these data. In general, the internal consistency of the domains was satisfactory to high. In future, the DISABKIDS instrument may serve as a useful tool with which to assess HRQoL in children and adolescents with a chronic condition. The condition-specific modules can be used in conjunction with the DISABKIDS chronic generic module.
215 citations
TL;DR: The UK-English version of PedsQL™ performed as well as the original Pedsql™ and is recommended for assessment of paediatric HRQL in the UK.
Abstract: Background: Health related quality of life (HRQL) has been recognised as an important paediatric outcome measurement. One of the more promising measures to emerge in recent years is the Pediatric Quality Of Life Inventory (PedsQL™), developed in the US. Advantages of the PedsQL™ include brevity, availability of age appropriate versions and parallel forms for child and parent. This study developed a UK-English version of PedsQL™ generic module and assessed its performance in a group of UK children and their parents. Methods: PedsQL™ was translated to UK-English. The psychometric properties of the UK version were then tested following administration to 1399 children and 970 of their parents. The sample included healthy children, children diagnosed with asthma, diabetes or inflammatory bowel disease and children in remission from cancer. Results: Psychometric properties were similar to those reported for the original PedsQL™. Internal reliability exceeded 0.70 for all proxy and self-report sub-scales. Discriminant validity was established for proxy and self-report with higher HRQL being reported for healthy children than those with health problems. Sex differences were noted on the emotional functioning subscale, with females reporting lower HRQL than males. Proxy and self-report correlation was higher for children with health problems than for healthy children. Conclusion: The UK-English version of PedsQL™ performed as well as the original PedsQL™ and is recommended for assessment of paediatric HRQL in the UK.
210 citations
TL;DR: The MHI-5 andMHI-3 scores were correlated with the ZSDS score, and can be used to identify people with depressive symptoms in the general population of Japan.
Abstract: The five-question Mental Health Inventory (MHI-5) is a brief questionnaire that can be used to screen for depressive symptoms. Removing the 2 anxiety-related items from the MHI-5 yields the MHI-3. We assessed the performance of the Japanese versions of the MHI-5 and MHI-3 in detecting depressive symptoms in the general population of Japan. From the population of Japan, 4500 people 16 years old or older were selected by stratified-random sampling. The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36, which includes the MHI-5) and the Zung Self-rating Depression Scale (ZSDS) were included in a self-administered questionnaire. ZSDS scores of 48 and above were taken to indicate the presence of moderate or severe depressive symptoms, and scores of 56 and above were taken to indicate the presence of severe depressive symptoms. We computed the correlation coefficient between the ZSDS score and the scores on the MHI-5 and MHI-3. We also computed the sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve. Of the 3107 subjects (69% of the 4500 initially selected), 14.0% had moderate or severe depressive symptoms, and 2.0% had severe depressive symptoms as measured with the ZSDS. The correlations of ZSDS scores with MHI-5 scores and with MHI-3 scores were similar: -0.63 and -0.61, respectively. These correlation coefficients were almost the same whether or not the data were stratified by age and sex. For detecting severe depressive symptoms with the MHI-5, the area under the ROC curve was 0.942 (95%CI: 0.919 – 0.965); for the MHI-3, it was 0.933 (95%CI: 0.904 – 0.962). The MHI-5 and MHI-3 scores were correlated with the ZSDS score, and can be used to identify people with depressive symptoms in the general population of Japan.
TL;DR: Both children and their mothers experience significantly compromised QOL in the months following diagnosis, and caution is required where mothers rate their child's QOL.
Abstract: Background: With current treatments, approximately 75% of children diagnosed with cancer can expect to achieve disease-free survival. However, treatments are complex and aggressive, potentially compromising QOL for children and their parents. Although previous work has shown increased anxiety and depression among parents after diagnosis, the recent development of standardised measures of QOL enables us to look more directly at the impact of diagnosis on mothers' and children's QOL. The aims of this study are to i) describe QOL for children and their mothers after diagnosis by comparing their scores with population norms, ii) explore the relationship between mothers' worries about the illness and their QOL, and iii) determine the relationship between mothers ratings of their own QOL and their child. Method: A total of 87 families took part, constituting 60% of those eligible. The children included 58 males and 29 females aged between 2 years 6 months to 16 years 3 months (mean = 7 years, median = 5 years 8 months). Diagnoses were acute lymphoblastic leukaemia (ALL, n = 57), brain tumours (n = 11), bone tumours (n = 17) and 2 rare cancers. Mothers completed questionnaires about their own and the child's QOL. Results: Mothers' reported their own and the child's QOL to be significantly lower than population norms. There were significant correlations between mothers' worries and their own and their ratings of the child's QOL and mothers' ratings of their own QOL correlated with their ratings of the child's QOL. Conclusion: Both children and their mothers experience significantly compromised QOL in the months following diagnosis. Mothers who rated their own QOL to be poor also rate their child's QOL to be low. These results suggest caution is required where mothers rate their child's QOL. Efforts must continue to be made to improve QOL of children especially in the period immediately following diagnosis.
TL;DR: With minor modifications from the English version, the Japanese NEI VFQ-25 can give reliable, valid, responsive data on vision-related quality of life, for group-level comparisons or for tracking therapeutic outcomes.
Abstract: The importance of evaluating the outcomes of health care from the standpoint of the patient is now widely recognized. The purpose of this study is to develop and test a Japanese version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). A Japanese version was developed with a previously standardized method. The questionnaire and optional items were completed by 245 patients with cataracts, glaucoma, or age-related macular degeneration, by 110 others before and after cataract surgery, and by a reference group (n = 31). We computed rates of missing data, measured reproducibility and internal consistency reliability, and tested for convergent and discriminant validity, concurrent validity, known-groups validity, factor structure, and responsiveness to change. Based on information from the participants, some items were changed to 2-step items (asking if an activity was done, and if it was done, then asking how difficult it was). The near-vision and distance-vision subscales each had 1 item that was endorsed by very few participants, so these items were replaced with items that were optional in the English version. For example, more than 60% of participants did not drive, so the driving question was excluded. Reliability and validity were adequate for all subscales except driving, ocular pain, color vision, and peripheral vision. With cataract surgery, most scores improved by at least 20 points. With minor modifications from the English version, the Japanese NEI VFQ-25 can give reliable, valid, responsive data on vision-related quality of life, for group-level comparisons or for tracking therapeutic outcomes.
TL;DR: In this paper, the authors compare the strength of the association of health-related quality of life (HRQOL) with three multimorbidity indices: the Cumulative Illness Rating Scale (CIRS), the Charlson index (Charlson), and the Functional Comorbidities Index (FCI).
Abstract: Background
Measures of multimorbidity are often applied to source data, populations or outcomes outside the scope of their original developmental work. As the development of a multimorbidity measure is influenced by the population and outcome used, these influences should be taken into account when selecting a multimorbidity index. The aim of this study was to compare the strength of the association of health-related quality of life (HRQOL) with three multimorbidity indices: the Cumulative Illness Rating Scale (CIRS), the Charlson index (Charlson) and the Functional Comorbidity Index (FCI). The first two indices were not developed in light of HRQOL.
TL;DR: Collecting patients' perspectives and developing an organized inventory of the relevant effects of IPF on patients' lives provides valuable information for improving the understanding of the impact of this disease on patients and their loved ones.
Abstract: Idiopathic pulmonary fibrosis (IPF) is a debilitating lung disease with a survival of only three to five years from the time of diagnosis. Due to a paucity of studies, large gaps remain in our understanding of how IPF affects the quality of patients' lives. In only one other study did investigators ask patients directly for their perspectives on this topic. Further, currently there is no disease-specific instrument to measure health-related quality of life (HRQL) in patients with IPF. A carefully constructed measurement instrument, sensitive to underlying change, is needed for use in clinical trials and longitudinal studies of patients with IPF. Before developing such an instrument, researchers must improve their understanding of the relevant effects of IPF on patients' lives. On a broader scale, to provide the best care for people with IPF, clinicians must appreciate – from patients' perspectives – how this disease affects various aspects of their lives. We used focus groups and individual in-depth interviews with 20 IPF patients to collect their perspectives on how IPF affects their lives (with a focus on the quality of their lives). We then analyzed these perspectives and organized them into a conceptual framework for describing HRQL in patients with IPF. Next, we examined how well certain existing measurement instruments – which have been administered to IPF patients in prior studies – covered the domains and topics our patients identified. In our framework, we identified 12 primary domains: symptoms, IPF therapy, sleep, exhaustion, forethought, employment and finances, dependence, family, sexual relations, social participation, mental and spiritual well-being, mortality. Each domain is composed of several topics, which describe how IPF affects patients' lives. When we compared the content of our conceptual framework with the existing instruments, we found the coverage of the existing instruments to be inadequate for several reasons, including they may tap general areas of QOL or HRQL but not some areas that appear to be most directly affected by IPF, and they include items that are relevant to symptoms and effects of other respiratory diseases but not IPF. Collecting patients' perspectives and developing an organized inventory of the relevant effects of IPF on patients' lives provides valuable information for improving our understanding of the impact of this disease on patients and their loved ones. We believe our findings will help alert clinicians and researchers to IPF patients' experiences and concerns. Based on the comparison or our conceptual framework with the content of four existing instruments, it would appear that developing an IPF-specific measurement instrument is justified. Our conceptual framework for describing health-related quality of life in patients with IPF lays a solid foundation for constructing such an instrument.
TL;DR: The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration, and this indicated a degree of re-conceptualisation and reprioritisation.
Abstract: Quality of life (QoL) is now established as an important outcome for evaluating the impact of disease, and for assessing the efficacy of treatments. However, individuals change with time and the basis on which they make a QoL judgement may also change, a phenomenon increasingly referred to as response shift. Here, the individual may change his or her internal standards, values, and/or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status. This has important implications for assessing the effects of treatments as a change in QoL may reflect a response shift, a treatment effect, or a complex combination of both. In this study, we used an individualised quality of life (IQoL) measure, the SEIQoL, together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients. Data are reported here for the first phase of a randomised controlled clinical trial designed to assess the impact, on IQoL, of implant supported dentures compared with high quality conventional dentures. IQoL was measured using the SEIQoL-DW in 117 patients (mean age 64.8; 32% male) at baseline (T1) and 3 months (T2) after receiving high quality conventional dentures. The work was carried out in dental teaching hospitals in Dublin and Belfast. Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months (baseline: 75.0; 3 months: 73.2, p = .33, n.s.). However, the then-test at 3 months revealed that patients retrospectively rated their baseline IQoL as significantly lower (P < .001) than they had rated it at the time (then-test baseline: 69.2). Comparison of the 3 month scores with this readjusted baseline indicated a significant treatment effect (then-test baseline: 69.2; 3 months: 73.2, p = 0.016). 81% of patients nominated at least one different IQoL domain at 3 months. The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration. The nature of the response shifts was highly complex but the data indicated a degree of re-conceptualisation and reprioritisation. Assessment of the impact of treatments using patient-generated reports must take account of the adaptive nature of patients.
TL;DR: DM and chronic medical conditions generally reduced HRQoL in this multiethnic general population in an additive, rather than synergistic or subtractive fashion.
Abstract: Diabetes mellitus (DM) is an important public health concern, the impact of which is increased by the high prevalence of co-existing chronic medical conditions among subjects with DM. The aims of this study were therefore to (1) evaluate the impact of DM and co-existing chronic medical conditions on health-related quality of life (HRQoL) (which could be additive, synergistic or subtractive); (2) to determine the extent to which the SF-6D (a single-index preference measure) captures the multidimensional information provided by the SF-36 (a profile measure). Using data from a cross-sectional, population-based survey of Chinese, Malay and Indians in Singapore, we developed 9 separate multiple linear regression models, with each SF-36 scale or SF-6D index score being the dependent variable for one model. The influence of DM and a second chronic medical condition (hypertension (HTN), heart disease (HD), musculoskeletal illnesses (MS)) and their interactions were studied after adjusting for the influence of potential confounding variables. Among 5,224 subjects, the prevalence of DM, HTN, HD and MS were 5.9%, 10.7%, 2.4% and 26.6% respectively. DM lowered SF-36 scores by more than 2 points on 3 SF-36 scales and lowered SF-6D scores by 0.03 points. Subjects with DM and HTN, DM and HD or DM and MS experienced further lowering of SF-36 scores exceeding 2 points on at least 6 scales and further lowering of SF-6D scores by 0.05, 0.08 and 0.10 points respectively. Generally, DM and co-existing medical conditions exerted additive effects on HRQoL, with the exception of DM and heart disease, where a subtractive effect was noted. SF-6D index scores generally reflected the patterns of influence of DM and chronic medical conditions on SF-36 scores. DM and chronic medical conditions generally reduced HRQoL in this multiethnic general population in an additive, rather than synergistic or subtractive fashion. In this study, the SF-6D was a reasonably good summary measure for the SF-36.
TL;DR: The current re-evaluation of the SpREUK 1.1 questionnaire indicates that it is a reliable, valid measure of distinct topics of SpR that may be especially useful of assessing the role of Spr in health related research.
Abstract: Spirituality has become a subject of interest in health care as it is was recognized to have the potential to prevent, heal or cope with illness. There is less doubt that values and goals are important contributors to life satisfaction, physical and psychological health, and that goals are what gives meaning and purpose to people's lives. However, there is as yet but limited understanding of how patients themselves view the impact of spirituality on their health and well-being, and whether they are convinced that their illness may have "meaning" to them. To raise these questions and to more precisely survey the basic attitudes of patients with severe diseases towards spirituality/religiosity (SpR) and their adjustment to their illness, we developed the SpREUK questionnaire. In order to re-validate our previously described SpREUK instrument, reliability and factor analysis of the new inventory (Version 1.1) were performed according to the standard procedures. The test sample contained 257 German subjects (53.3 ± 13.4 years) with cancer (51%), multiple sclerosis (24%), other chronic diseases (16%) and patients with acute diseases (7%). As some items of the SpREUK construct require a positive attitude towards SpR, these items (item pool 2) were separated from the others (item pool 1). The reliability of the 15-item the construct derived from the item pool 1 respectively the 14-item construct which refers to the item pool 2 both had a good quality (Cronbach's alpha = 0.9065 resp. 0.9525). Factor analysis of item pool 1 resulted in a 3-factor solution (i.e. the 6-item sub-scale 1: "Search for meaningful support"; the 6-item sub-scale 2: "Positive interpretation of disease"; and the 3-item sub-scale 3: "Trust in external guidance") which explains 53.8% of variance. Factor analysis of item pool 2 pointed to a 2-factor solution (i.e. the 10-item sub-scale 4: "Support in relations with the External life through SpR" and the 4-item sub-scale 5: "Support of the Internality through SpR") which explains 58.8% of variance. Generally, women had significantly higher SpREUK scores than male patients. Univariate variance analyses revealed significant associations between the sub-scales and SpR attitude and the educational level. The current re-evaluation of the SpREUK 1.1 questionnaire indicates that it is a reliable, valid measure of distinct topics of SpR that may be especially useful of assessing the role of SpR in health related research. The instrument appears to be a good choice for assessing a patients interest in spiritual concerns which is not biased for or against a particular religious commitment. Moreover it addresses the topic of "positive reinterpretation of disease" which seems to be of outstanding importance for patients with life-changing diseases.
TL;DR: The high levels of anxiety and depression detected in this sample suggests that screening for psychological comorbidity is important in musculoskeletal rehabilitation settings and that item 7 should be removed from the anxiety subscale.
Abstract: Research suggests there is a high prevalence of anxiety and depression amongst patients with chronic musculoskeletal pain, which can influence the effectiveness of rehabilitation programs. It is therefore important for clinicians involved in musculoskeletal rehabilitation programs to consider screening patients for elevated levels of anxiety and depression and to provide appropriate counselling or treatment where necessary. The HADS has been used as a screening tool for assessment of anxiety and depression in a wide variety of clinical groups. Recent research however has questioned its suitability for use with some patient groups due to problems with dimensionality and the behaviour of individual items. The aim of this study is to assess the underlying structure and psychometric properties of the HADS among patients attending musculoskeletal rehabilitation. Data was obtained from 296 patients attending an outpatient musculoskeletal pain clinic. The total sample was used to identify the proportion of patients with elevated levels of anxiety and depression. Half the sample (n = 142) was used for exploratory factor analysis (EFA), with the holdout sample (n = 154) used for confirmatory factor analysis (CFA) to explore the underlying structure of the scale. A substantial proportion of patients were classified as probable cases on the HADS Anxiety subscale (38.2%) and HADS Depression subscale (30.1%), with the sample recording higher mean HADS subscales scores than many other patient groups (breast cancer, end-stage renal disease, heart disease) reported in the literature. EFA supported a two factor structure (representing anxiety and depression) as proposed by the scale's authors, however item 7 (an anxiety item) failed to load appropriately. Removing Item 7 resulted in a clear two factor solution in both EFA and CFA. The high levels of anxiety and depression detected in this sample suggests that screening for psychological comorbidity is important in musculoskeletal rehabilitation settings. It is necessary for clinicians who are considering using the HADS as a screening tool to first assess its suitability with their particular patient group. Although EFA and CFA supported the presence of two subscales representing anxiety and depression, the results with this musculoskeletal sample suggest that item 7 should be removed from the anxiety subscale.
TL;DR: The purpose of this report is to identify the conflict that arises when multiple change coefficients are applied to the same patient sample, and speculate that this dilemma occurs as a result of insufficient preparatory work such as pilot studies to establish the likely change characteristic of the patient population of interest.
Abstract: The past 20-years have seen the development and evaluation of many health status measures. Unlike the high standards demanded of those who conduct and report clinical intervention trials, the methodological rigor for studies examining the sensitivity to change of health status measures are less demanding. It is likely that the absence of a criterion standard for change in health status contributes to this shortcoming. To increase confidence in the results of these types of studies investigators have often calculated multiple change coefficients for the same patient sample. The purpose of this report is to identify the conflict that arises when multiple change coefficients are applied to the same patient sample. Three families of change coefficients based on different assumptions concerning the sample composition are identified: (1) the sample is homogeneous with respect to change; (2) subgroups of patients who truly change by different amounts exist; (3) individual patients, many of whom truly change by different amounts exist. We present several analyses which illustrate a major conceptual conflict: the signal (a measure's true ability to detect change) for some of these coefficients appears in the noise term (measurement error) of the others. We speculate that this dilemma occurs as a result of insufficient preparatory work such as pilot studies to establish the likely change characteristic of the patient population of interest. Uncertainty in the choice of change coefficient could be overcome by conducting pilot studies to ascertain the likely change characteristic of the population of interest. Once the population's change characteristic is identified, the choice of change coefficient should be clear.
TL;DR: Given the adequacy of the metric properties of the Stoma-QOL suggested by the psychometric analyses, this study confirms the suitability of the instrument in clinical practice and in clinical research.
Abstract: Quality of life of stoma patients is increasingly being addressed in clinical trials. However, the instruments used in the majority of these studies have not been validated specifically for stoma patients. The aim of this paper is to describe the development and validation of a quality-of-life instrument, "Stoma-QOL", specifically for patients with colostomy or ileostomy. Potential items were formulated in English on the basis of the results of a series of semi-structured interviews with 169 adult stoma patients. The process resulted in a preliminary 37-item version, which was translated into French, German, Spanish and Danish, and administered repeatedly to 182 patients with colostomy or ileostomy. A psychometric selection of items was performed through Rasch Analysis. The measurement properties of the final questionnaire version were subsequently tested. The 20 items in the final questionnaire covered four domains – sleep, sexual activity, relations to family and close friends, and social relations to other than family and close friends. These items were found to define a unidimensional variable according to Rasch specifications (Infit MNSQ 0.88 (p < 0.01), indicating a high test-retest reliability. Item calibrations by country calculated as ICC were 0.81 (0.67–0.91 95% CI), confirming cross-cultural comparability across the European countries included in the study. Given the adequacy of the metric properties of the Stoma-QOL suggested by the psychometric analyses, this study confirms the suitability of the instrument in clinical practice and in clinical research.
TL;DR: The quality of life of osteoporotic patients should be investigated even before fractures, in order to develop appropriate counselling, support and care interventions to help patients develop efficient strategies for accepting the disease and coping with it.
Abstract: Background
To evaluate the impact of osteoporosis on the patients' quality of life, particularly in the absence of fractures.
TL;DR: The reliability of the ICF codes when measured with the current ICF qualifiers is relatively low, and the result in increase in reliability according to evaluators' experience suggests proper education will have positive effects to raise the reliability.
Abstract: Background
The International Classification of Functioning, Disability and Health (ICF) was published by the World Health Organization (WHO) to standardize descriptions of health and disability. Little is known about the reliability and clinical relevance of measurements using the ICF and its qualifiers. This study examines the test-retest reliability of ICF codes, and the rate of immeasurability in long-term care settings of the elderly to evaluate the clinical applicability of the ICF and its qualifiers, and the ICF checklist.
TL;DR: The current re-evaluation of the SpREUK-P questionnaire indicates that it is a reliable, valid measure of five distinct forms of spiritual, religious and philosophical practice that may be especially useful for assessing the role of spirituality and religiosity in health related research.
Abstract: Background
Quality of life is a multidimensional construct composed of functional, physical, emotional, social and spiritual well-being. In order to examine how patients with severe diseases view the impact of spirituality and religiosity on their health and how they cope with illness, we have developed the SpREUK questionnaire. We deliberately avoided the intermingling of attitudes, convictions and practices, and thus addressed the distinct forms and frequencies of spiritual/religious practices in an additional manual, the SpREUK-P questionnaire.
TL;DR: The clinical utility of the HADS in screening for anxiety and depression in breast cancer patients may be enhanced by using a modified scoring procedure based on a three-factor model of psychological distress.
Abstract: To determine the psychometric properties of the Hospital Anxiety and Depression Scale (HADS) in patients with breast cancer and determine the suitability of the instrument for use with this clinical group. A cross-sectional design was used. The study used a pooled data set from three breast cancer clinical groups. The dependent variables were HADS anxiety and depression sub-scale scores. Exploratory and confirmatory factor analyses were conducted on the HADS to determine its psychometric properties in 110 patients with breast cancer. Seven models were tested to determine model fit to the data. Both factor analysis methods indicated that three-factor models provided a better fit to the data compared to two-factor (anxiety and depression) models for breast cancer patients. Clark and Watson's three factor tripartite and three factor hierarchical models provided the best fit. The underlying factor structure of the HADS in breast cancer patients comprises three distinct, but correlated factors, negative affectivity, autonomic anxiety and anhedonic depression. The clinical utility of the HADS in screening for anxiety and depression in breast cancer patients may be enhanced by using a modified scoring procedure based on a three-factor model of psychological distress. This proposed alternate scoring method involving regressing autonomic anxiety and anhedonic depression factors onto the third factor (negative affectivity) requires further investigation in order to establish its efficacy.
TL;DR: This study estimates the minimal important difference (MID) on the DLQI for patients with chronic idiopathic urticaria (CIU) in the range of 2.24 to 3.10, recommended in interpreting results for Patients with CIU.
Abstract: Background
The Dermatology Quality Life Index (DLQI) has seen widespread use as a health-related quality of life measure for a variety of dermatological diseases. The purpose of this study was to estimate the minimal important difference (MID) on the DLQI for patients with chronic idiopathic urticaria (CIU).
TL;DR: All of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis.
Abstract: The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database), the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet.PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at http://www.proqolid.org. The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.). The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually.Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database.
TL;DR: Preliminary work suggests that the women in this study who experienced widespread pain after breast cancer surgery had significantly more severity of pain, pain impact and lower physical health status than those with regional pain.
Abstract: Most research and treatment of post-breast cancer chronic pain has focused on local or regional pain problems in the operated area. The purpose of this pilot study was to compare and contrast the pain characteristics, symptom impact, health status, and quality of life of post-breast cancer surgery women with regional chronic pain versus those with widespread chronic pain. A cross-sectional, descriptive design compared two groups of women with chronic pain that began after surgery: regional pain (n = 11) and widespread pain (n = 12). Demographics, characteristics of the surgery, as well as standardized questionnaires that measured pain (Brief Pain Inventory (BPI), Short Form McGill Pain Questionnaire (MPQ-SF)), disease impact (Fibromyalgia Impact Questionnaire (FIQ), Functional Assessment of Cancer Therapy-Breast (FACT-B)), health status (Medical Outcomes Short Form (SF-36)) and quality of life (Quality of Life Scale (QOLS)) were gathered. There were no significant differences between the groups on any demographic or type of surgery variable. A majority of both groups described their pain as aching, tender, and sharp on the MPQ-SF. On the BPI, intensity of pain and pain interference were significantly higher in the widespread pain group. Differences between the two groups reached statistical significance on the FIQ total score as well as the FACT-B physical well-being, emotional well-being and breast concerns subscales. The SF-36 physical function, physical role, and body pain subscales were significantly lower in the widespread pain group. QOLS scores were lower in the widespread pain group, but did not reach statistical significance. This preliminary work suggests that the women in this study who experienced widespread pain after breast cancer surgery had significantly more severity of pain, pain impact and lower physical health status than those with regional pain.
TL;DR: These results suggest adolescents are rating two distinct constructs, and that self-rated health and QOL should not be used interchangeably, which is contrary to observations with adults.
Abstract: Background
In adult quality of life (QOL) research, the QOL construct appears to differ from self-rated health status. Although increased QOL continues to be recognized as an important outcome in health promotion and medical intervention, little research has attempted to explore adolescent perceptual differences between self-rated health and QOL.
TL;DR: Despite of clinical usefulness in screening for mental disturbances the construct validity of the HADS is not clear and the resulting scores of the tri-dimensional model can be interpreted as psychomotor agitation, psychic anxiety, and depression in individual patient data or clinical investigations.
Abstract: Depression and anxiety in patients with coronary heart disease (CHD) are associated with a poorer prognosis. Therefore the screening for psychological distress is strongly recommended in cardiac rehabilitation. The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool that has demonstrated good sensitivity and specificity for mental disorders. We assessed mental distress in in-patient cardiac rehabilitation in Germany. The factor structure of the German language version of the HADS was investigated in 1320 patients with CHD. Exploratory factor analysis and confirmatory factor analysis were used to determine the underlying factor structure of the instrument. Three-factor models were found to offer a superior fit to the data compared to two-factor (anxiety and depression) models. The German language HADS performs similarly to the English language version of the instrument in CHD patients. The German language HADS fundamentally comprises a tri-dimensional underlying factor structure (labelled by Friedman et al. as psychomotor agitation, psychic anxiety and depression). Despite of clinical usefulness in screening for mental disturbances the construct validity of the HADS is not clear. The resulting scores of the tri-dimensional model can be interpreted as psychomotor agitation, psychic anxiety, and depression in individual patient data or clinical investigations.