Showing papers in "Health and Quality of Life Outcomes in 2010"
TL;DR: This study provides fairly strong evidence that tooth loss is associated with impairment of OHRQoL and location and distribution of tooth loss affect the severity of the impairment.
Abstract: It is increasingly recognized that the impact of disease on quality of life should be taken into account when assessing health status. It is likely that tooth loss, in most cases being a consequence of oral diseases, affects Oral Health-Related Quality of Life (OHRQoL). The aim of the present study is to systematically review the literature and to analyse the relationship between the number and location of missing teeth and oral health-related quality of life (OHRQoL). It was hypothesized that tooth loss is associated with an impairment of OHRQoL. Secondly, it was hypothesized that location and distribution of remaining teeth play an important role in this. Relevant databases were searched for papers in English, published from 1990 to July 2009 following a broad search strategy. Relevant papers were selected by two independent readers using predefined exclusion criteria, firstly on the basis of abstracts, secondly by assessing full-text papers. Selected studies were grouped on the basis of OHRQoL instruments used and assessed for feasibility for quantitative synthesis. Comparable outcomes were subjected to meta-analysis; remaining outcomes were subjected to a qualitative synthesis only. From a total of 924 references, 35 were eligible for synthesis (inter-reader agreement abstracts κ = 0.84 ± 0.03; full-texts: κ = 0.68 ± 0.06). Meta-analysis was feasible for 10 studies reporting on 13 different samples, resulting in 6 separate analyses. All studies showed that tooth loss is associated with unfavourable OHRQoL scores, independent of study location and OHRQoL instrument used. Qualitative synthesis showed that all 9 studies investigating a possible relationship between number of occluding pairs of teeth present and OHRQoL reported significant positive correlations. Five studies presented separate data regarding OHRQoL and location of tooth loss (anterior tooth loss vs. posterior tooth loss). Four of these reported highest impact for anterior tooth loss; one study indicated a similar impact for both locations of tooth loss. This study provides fairly strong evidence that tooth loss is associated with impairment of OHRQoL and location and distribution of tooth loss affect the severity of the impairment. This association seems to be independent from the OHRQoL instrument used and context of the included samples.
669 citations
TL;DR: The cultural adaptation into Spanish of the 7-item self-administered GAD-7 scale, which is used to identify probable patients with GAD, was carried out and the validity of its content and the relevance and adequacy of items in the Spanish cultural context were confirmed.
Abstract: Generalized anxiety disorder (GAD) is a prevalent mental health condition which is underestimated worldwide. This study carried out the cultural adaptation into Spanish of the 7-item self-administered GAD-7 scale, which is used to identify probable patients with GAD. The adaptation was performed by an expert panel using a conceptual equivalence process, including forward and backward translations in duplicate. Content validity was assessed by interrater agreement. Criteria validity was explored using ROC curve analysis, and sensitivity, specificity, predictive positive value and negative value for different cut-off values were determined. Concurrent validity was also explored using the HAM-A, HADS, and WHO-DAS-II scales. The study sample consisted of 212 subjects (106 patients with GAD) with a mean age of 50.38 years (SD = 16.76). Average completion time was 2'30''. No items of the scale were left blank. Floor and ceiling effects were negligible. No patients with GAD had to be assisted to fill in the questionnaire. The scale was shown to be one-dimensional through factor analysis (explained variance = 72%). A cut-off point of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%), with AUC being statistically significant [AUC = 0.957-0.985); p 0.001). Elderly people, particularly those very old, may need some help to complete the scale. After the cultural adaptation process, a Spanish version of the GAD-7 scale was obtained. The validity of its content and the relevance and adequacy of items in the Spanish cultural context were confirmed.
380 citations
TL;DR: The latent structure originally designed by WHODAS-2 developers has been confirmed for the first time, and it has shown good metric properties in clinic and rehabilitation samples, and considerable support is provided to the WHODas-2 utilization as an international instrument to measure disability based on the ICF model.
Abstract: The WHODAS-2 is a disability assessment instrument based on the conceptual framework of the International Classification of Functioning, Disability, and Health (ICF). It provides a global measure of disability and 7 domain-specific scores. The aim of this study was to assess WHODAS-2 conceptual model and metric properties in a set of chronic and prevalent clinical conditions accounting for a wide scope of disability in Europe. 1,119 patients with one of 13 chronic conditions were recruited in 7 European centres. Participants were clinically evaluated and administered the WHODAS-2 and the SF-36 at baseline, 6 weeks and 3 months of follow-up. The latent structure was explored and confirmed by factor analysis (FA). Reliability was assessed in terms of internal consistency (Cronbach's alpha) and reproducibility (intra-class correlation coefficients, ICC). Construct validity was evaluated by correlating the WHODAS-2 and SF-36 domains, and comparing known groups based on the clinical-severity and work status. Effect size (ES) coefficient was used to assess responsiveness. To assess reproducibility and responsiveness, subsamples of stable (at 6 weeks) and improved (after 3 moths) patients were defined, respectively, according to changes in their clinical-severity. The satisfactory FA goodness of fit indexes confirmed a second order factor structure with 7 dimensions, and a global score for the WHODAS-2. Cronbach's alpha ranged from 0.77 (self care) to 0.98 (life activities: work or school), and the ICC was lower, but achieved the recommended standard of 0.7 for four domains. Correlations between global WHODAS-2 score and the different domains of the SF-36 ranged from -0.29 to -0.65. Most of the WHODAS-2 scores showed statistically significant differences among clinical-severity groups for all pathologies, and between working patients and those not working due to ill health (p < 0.001). Among the subsample of patients who had improved, responsiveness coefficients were small to moderate (ES = 0.3-0.7), but higher than those of the SF-36. The latent structure originally designed by WHODAS-2 developers has been confirmed for the first time, and it has shown good metric properties in clinic and rehabilitation samples. Therefore, considerable support is provided to the WHODAS-2 utilization as an international instrument to measure disability based on the ICF model.
352 citations
TL;DR: The published evidence generally supports the validity and reliability of the EQ-5D as an outcome measure within the cardiovascular area and provides utility estimates across a range of cardiovascular subgroups and treatments that may be useful for future modelling of utilities and QALYs in economic evaluations within theiovascular area.
Abstract: The EQ-5D has been extensively used to assess patient utility in trials of new treatments within the cardiovascular field. The aims of this study were to review evidence of the validity and reliability of the EQ-5D, and to summarise utility scores based on the use of the EQ-5D in clinical trials and in studies of patients with cardiovascular disease. A structured literature search was conducted using keywords related to cardiovascular disease and EQ-5D. Original research studies of patients with cardiovascular disease that reported EQ-5D results and its measurement properties were included. Of 147 identified papers, 66 met the selection criteria, with 10 studies reporting evidence on validity or reliability and 60 reporting EQ-5D responses (VAS or self-classification). Mean EQ-5D index-based scores ranged from 0.24 (SD 0.39) to 0.90 (SD 0.16), while VAS scores ranged from 37 (SD 21) to 89 (no SD reported). Stratification of EQ-5D index scores by disease severity revealed that scores decreased from a mean of 0.78 (SD 0.18) to 0.51 (SD 0.21) for mild to severe disease in heart failure patients and from 0.80 (SD 0.05) to 0.45 (SD 0.22) for mild to severe disease in angina patients. The published evidence generally supports the validity and reliability of the EQ-5D as an outcome measure within the cardiovascular area. This review provides utility estimates across a range of cardiovascular subgroups and treatments that may be useful for future modelling of utilities and QALYs in economic evaluations within the cardiovascular area.
333 citations
TL;DR: The EQ- 5D dimensions and the EQ-5D seem capable of capturing the consequences of diabetes-related complications, and such complications may have substantial impact on several dimensions of health-related quality of life (HRQoL).
Abstract: The aim of this study was to describe how diabetes complications influence the health-related quality of life of individuals with diabetes using the individual EQ-5D dimensions and the EQ-5D index. We mailed a questionnaire to 1,000 individuals with diabetes type 1 and 2 in Norway. The questionnaire had questions about socio-demographic characteristics, use of health care, diabetes complications and finally the EQ-5D descriptive system. Logistic regressions were used to explore determinants of responses in the EQ-5D dimensions, and robust linear regression was used to explore determinants of the EQ-5D index. In multivariate analyses the strongest determinants of reduced MOBILITY were neuropathy and ischemic heart disease. In the ANXIETY/DEPRESSION dimension of the EQ-5D, "fear of hypoglycaemia" was a strong determinant. For those without complications, the EQ-5D index was 0.90 (type 1 diabetes) and 0.85 (type 2 diabetes). For those with complications, the EQ-5D index was 0.68 (type 1 diabetes) and 0.73 (type 2 diabetes). In the linear regression the factors with the greatest negative impact on the EQ-5D index were ischemic heart disease (type 1 diabetes), stroke (both diabetes types), neuropathy (both diabetes types), and fear of hypoglycaemia (type 2 diabetes). The EQ-5D dimensions and the EQ-5D seem capable of capturing the consequences of diabetes-related complications, and such complications may have substantial impact on several dimensions of health-related quality of life (HRQoL). The strongest determinants of reduced HRQoL in people with diabetes were ischemic heart disease, stroke and neuropathy.
297 citations
TL;DR: Patients with low Karnofsky Performance Status, high Mini Mental State-score, hospitalized, recently diagnosed or undergoing opioid titration were at increased risk of symptom underestimation by providers and Clinicians in cancer care should be aware of the factors characterizing patients at risk of symptoms underestimation.
Abstract: Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined. This cross-sectional study included 1933 patient-health care provider dyads, from 11 European countries. Patients reported symptoms by using the four-point scales of the European Organization of Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) version 3, and providers used corresponding four-point categorical scales. Level of agreement was addressed at the group level (Wilcoxon Signed-Rank test), by difference scores (provider score minus patient score), at the individual level (Intraclass Correlation Coefficients, ICCs) and visually by Bland-Altman plots. Absolute numbers and chi-square tests were used to investigate the relationship between agreement and demographic-, as well as disease-related factors. The prevalence of symptoms assessed as moderate or severe by patients and providers, respectively, were for pain (67 vs.47%), fatigue (71 vs. 54%), generalized weakness (65 vs. 47%), anorexia (47 vs. 25%), depression (31 vs. 17%), constipation (45 vs. 30%), poor sleep (32 vs. 21%), dyspnea (30 vs. 16%), nausea (27 vs. 14%), vomiting (14 vs. 6%) and diarrhea (14 vs. 6%). Symptom scores were identical or differed by only one response category in the majority of patient-provider assessment pairs (79-93%). Providers underestimated the symptom in approximately one of ten patients and overestimated in 1% of patients. Agreement at the individual level was moderate (ICC 0.38 to 0.59). Patients with low Karnofsky Performance Status, high Mini Mental State-score, hospitalized, recently diagnosed or undergoing opioid titration were at increased risk of symptom underestimation by providers (all p < 0.001). Also, the agreement was significantly associated with drug abuse (p = 0.024), provider profession (p < 0.001), cancer diagnosis (p < 0.001) and country (p < 0.001). Considerable numbers of health care providers underestimated symptom intensities. Clinicians in cancer care should be aware of the factors characterizing patients at risk of symptom underestimation.
271 citations
TL;DR: Tentative evidence that pain and depression impacted differently on the mental and physical aspect of QoL is offered.
Abstract: The impact of pain and depression on health-related quality of life (QoL) is widely investigated, yet the pain-depression interactions on QoL remain unclear. This study aims to examine the pain-depression-QoL mediation link. Pain severity were assessed in a sample of Chinese professional teachers (n = 385). The subjects were also assessed on depressive symptoms and QoL. Regression models were fitted to evaluate the pain-depression-QoL relationships. About 44% of the sample had 3-5 painful areas in the past 3 months. Shoulder pain (60%) and headache (53%) were common painful areas. The results of regression analyses showed that pain mediated the effects of depression on the mental aspect of QoL (standardized β = -0.111; Sobel test: z = -3.124, p < 0.005) whereas depression mediated the effects of pain on the physical aspect of QoL (standardized β = -0.026; Sobel test: z = -4.045, p < 0.001). Our study offered tentative evidence that pain and depression impacted differently on the mental and physical aspect of QoL. As these findings were based on a Chinese teacher sample, future studies should employ more representative samples across cultures to verify the present data.
249 citations
TL;DR: Type D personality is a vulnerability factor for general psychological distress that affects mental and physical health status and is associated with disease-promoting mechanisms and work-related problems in apparently healthy individuals.
Abstract: The objective was to review all available literature concerning Type D (distressed) personality among the general population and to discuss its implications for research on health status, disease-promoting mechanisms and work-related problems in non-clinical populations. A computerized search of the literature was performed independently and in duplicate by both investigators on December 21st, 2009. Published research reports were included if they studied Type D personality among the general population. Nineteen articles were selected and they were subjected to an 11-item standardised quality checklist by both investigators. The methodological quality of the selected studies was adequate to high. The studies included in this review showed that the presence of Type D characteristics had a negative impact on mental health status (more symptoms of depression, anxiety, post-traumatic stress disorder, mental distress, passive coping, and less social support) and physical health status (more somatic complaints, lower health status, more influenza-like illness reporting). Other studies reported on behavioral and biological mechanisms of disease in apparently healthy individuals with a Type D personality. Finally, some studies also showed a negative effect of Type D personality on work-related problems (higher absence-leave, higher levels of vital exhaustion and burnout, and more work-related stress). Type D personality is a vulnerability factor for general psychological distress that affects mental and physical health status and is associated with disease-promoting mechanisms and work-related problems in apparently healthy individuals.
222 citations
TL;DR: Wang et al. as discussed by the authors described the prevalence of chronic complications among urban Chinese type 2 diabetic outpatients; and analyzed the associations between chronic complications and patients' demographics, diabetic related clinical characteristics.
Abstract: Chronic complications are the major outcome of type 2 diabetes mellitus progress, which reduce the quality of life of patients, incur heavy burdens to the health care system, and increase diabetic mortality. The aims of this study were to describe the prevalence of chronic complications among urban Chinese type 2 diabetic outpatients; and to analyze the associations between chronic complications and patients' demographics, diabetic related clinical characteristics. This cross-sectional hospital-based study was carried out in 4 major Chinese cities: - Shanghai, Chengdu, Beijing and Guangzhou. The survey was conducted from March to July in 2007 among 1,524 type 2 diabetic outpatients. The subjects were interviewed face-to-face by trained interviewers using a questionnaire to capture information on demographics, disease presentations and complications. All the subjects were invited to have a HbA1c test free of charge by the standardized method with Bio-Rad Variant II. Of the 1,524 study subjects, 637 (41.8%) were male, and the mean age was 63.3 ± 10.2 years. At least one chronic complication was diagnosed in 792 individuals (52.0%) of the study subjects; 509 (33.4%) presented with macrovascular complications and 528 (34.7%) with microvascular complications. The prevalence of cardiovascular and cerebrovascular conditions, neuropathy, nephropathy, ocular lesions and foot disease were 30.1%, 6.8%, 17.8%, 10.7%, 14.8% and 0.8%, respectively. The prevalence of chronic complications varied between cities, and significantly increased with age and duration of diagnosed diabetes. The mean of HbA1c in diabetic patients with chronic complications was 8.2% ± 1.6% and 63.0% of the subjects with type 2 diabetes related complications had a poor glycemic control with the HbA1c > 7.5%. Chronic complications are highly prevalent among type 2 diabetic outpatients, the glycemic control of diabetic patients with chronic complications was poor, and future efforts should be directed at intensive blood glucose control, strengthening early diagnosis and improving case management to prevent and minimize the occurrence of complications.
211 citations
TL;DR: The GA-VAS is capable of validly and effectively capturing a reduction in anxiety as quickly as 24 hours post-dose, and much lower with the SF-36 physical functioning subscales.
Abstract: Fast-acting medications for the management of anxiety are important to patients and society. Measuring early onset, however, requires a sensitive and clinically responsive tool. This study evaluates the psychometric properties of a patient-reported Global Anxiety - Visual Analog Scale (GA-VAS). Data from a double-blind, randomized, placebo-controlled study of lorazepam and paroxetine in patients with Generalized Anxiety Disorder were analyzed to assess the reliability, validity, responsiveness, and utility of the GA-VAS. The GA-VAS was completed at clinic visits and at home during the first week of treatment. Targeted psychometric analyses—test-retest reliabilities, validity correlations, responsiveness statistics, and minimum important differences—were conducted. The GA-VAS correlates well with other anxiety measures, at Week 4, r = 0.60 (p < 0.0001) with the Hamilton Rating Scale for Anxiety and r = 0.74 (p < 0.0001) with the Hospital Anxiety and Depression Scale - Anxiety subscale. In terms of convergent and divergent validity, the GA-VAS correlated -0.54 (p < 0.0001), -0.48 (p < 0.0001), and -0.68 (p < 0.0001) with the SF-36 Emotional Role, Social Function, and Mental Health subscales, respectively, but correlated much lower with the SF-36 physical functioning subscales. Preliminary minimum important difference estimates cluster between 10 and 15 mm. The GA-VAS is capable of validly and effectively capturing a reduction in anxiety as quickly as 24 hours post-dose.
196 citations
Abstract: Purpose
It is vital to understand the associations between the medication event monitoring systems (MEMS) and self-reported questionnaires (SRQs) because both are often used to measure medication adherence and can produce different results. In addition, the economic implication of using alternative measures is important as the cost of electronic monitoring devices is not covered by insurance, while self-reports are the most practical and cost-effective method in the clinical settings. This meta-analysis examined the correlations of two measurements of medication adherence: MEMS and SRQs.
TL;DR: The APCA African Palliative Outcome Scale has sound psychometric properties, is well comprehended and brief to use and offers the opportunity to at last address the omissions of palliative care research in Africa.
Abstract: Despite the burden of progressive incurable disease in Africa, there is almost no evidence on patient care or outcomes. A primary reason has been the lack of appropriate locally-validated outcome tools. This study aimed to validate a multidimensional scale (the APCA African Palliative Outcome Scale) in a multi-centred international study. Validation was conducted across 5 African services and in 3 phases: Phase 1. Face validity: content analysis of qualitative interviews and cognitive interviewing of POS; Phase 2. Construct validity: correlation of POS with Missoula-Vitas Quality of Life Index (Spearman's rank tests); Phase 3. Internal consistency (Cronbach's alpha calculated twice using 2 datasets), test-retest reliability (intraclass correlation coefficients calculated for 2 time points) and time to complete (calculated twice using 2 datasets). The validation involved 682 patients and 437 family carers, interviewed in 8 different languages. Phase 1. Qualitative interviews (N = 90 patients; N = 38 carers) showed POS items mapped well onto identified needs; cognitive interviews (N = 73 patients; N = 29 carers) demonstrated good interpretation; Phase 2. POS-MVQoLI Spearman's rank correlations were low-moderate as expected (N = 285); Phase 3. (N = 307, 2nd assessment mean 21.2 hours after first, SD 7.2) Cronbach's Alpha was 0.6 on both datasets, indicating expected moderate internal consistency; test-retest found high intra-class correlation coefficients for all items (0.78-0.89); median time to complete 7 mins, reducing to 5 mins at second visit. The APCA African POS has sound psychometric properties, is well comprehended and brief to use. Application of this tool offers the opportunity to at last address the omissions of palliative care research in Africa.
TL;DR: In this article, the authors investigated dimensions and correlates of quality of life (QOL) associated with frailty status among community-dwelling older outpatients, and found that a negative trend of QOL was associated with health, independence, home and neighbourhood, psychological and emotional well-being, and leisure, activities and religion.
Abstract: There is a lack of knowledge concerning the relationship between two closely-linked multidimensional variables: frailty and quality of life (QOL). The aim of this study was to investigate dimensions and correlates of QOL associated with frailty status among community-dwelling older outpatients. We conducted a cross-sectional survey of 239 community-dwelling outpatients aged 65+ (mean age 81.5 years) consecutively referred to a geriatric medicine clinic in Italy between June and November 2009. Participants underwent a comprehensive geriatric assessment, including assessment of their frailty status according to the Study of Osteoporotic Fractures (SOF) criteria, and QOL, which was evaluated by using the Older People's QOL (OPQOL) questionnaire. One-way ANOVA and chi-squared tests were used to find correlates of frailty, including QOL dimensions, after stratification of participants in the "robust" (n = 72), "pre-frail" (n = 89) and "frail" (n = 78) groups. Multiple linear regression analyses were performed to find correlates of QOL in the overall sample and among "frail" and "robust" participants. A negative trend of QOL with frailty status was found for almost all dimensions of QOL (health, independence, home and neighbourhood, psychological and emotional well-being, and leisure, activities and religion) except for social relationships and participation and financial circumstances. Independent correlates of a poor QOL in the total sample were "reduced energy level" (SOF criterion for frailty), depressive status, dependence in transferring and bathing abilities and money management (adjusted R squared 0.39); among "frail" participants the associations were with depressive status and younger age, and among "robust" participants the association was with lower body mass index. Five out of seven dimensions of QOL were negatively affected by frailty, but only one SOF criterion for frailty was independently related to QOL, after correction for age, functional status and depression. A more advanced age as well as a better affective status were correlates of a better QOL among frail elders. Interventions targeting the QOL in frail community-dwelling older outpatients should consider as outcomes, not only health-related QOL, but also other domains of the QOL.
TL;DR: The results suggest that, in the measurement of cancer pain exacerbations, patients use NRS more appropriately than VRS and as such NRS should be preferred to VRS in this patient's population.
Abstract: Numerical rating scales (NRS), and verbal rating scales (VRS) showed to be reliable and valid tools for subjective cancer pain measurement, but no one of them consistently proved to be superior to the other. Aim of the present study is to compare NRS and VRS performance in assessing breakthrough or episodic pain (BP-EP) exacerbations. In a cross sectional multicentre study carried out on a sample of 240 advanced cancer patients with pain, background pain and BP-EP intensity in the last 24 hours were measured using both a 6-point VRS and a 0-10 NRS. In order to evaluate the reproducibility of the two scales, a subsample of 60 patients was randomly selected and the questionnaire was administered for a second time three to four hours later. The proportion of "inconsistent" (background pain intensity higher than or equal to peak pain intensity) evaluations was calculated to compare the two scales capability in discriminating between background and peak pain intensity and Cohen's K was calculated to compare their reproducibility. NRS revealed higher discriminatory capability than VRS in distinguishing between background and peak pain intensity with a lower proportion of patients giving inconsistent evaluations (14% vs. 25%). NRS also showed higher reproducibility when measuring pain exacerbations (Cohen's K of 0.86 for NRS vs. 0.53 for VRS) while the reproducibility of the two scales in evaluating background pain was similar (Cohen's K of 0.80 vs. 0.77). Our results suggest that, in the measurement of cancer pain exacerbations, patients use NRS more appropriately than VRS and as such NRS should be preferred to VRS in this patient's population.
TL;DR: The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.
Abstract: The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.
TL;DR: This work suggests an alternative approach: reporting results in minimal important difference units (the smallest difference patients experience as important), which provides a potential solution to both the statistical and interpretational problems of existing methods.
Abstract: Systematic reviews of randomized trials that include measurements of health-related quality of life potentially provide critical information for patient and clinicians facing challenging health care decisions. When, as is most often the case, individual randomized trials use different measurement instruments for the same construct (such as physical or emotional function), authors typically report differences between intervention and control in standard deviation units (so-called "standardized mean difference" or "effect size"). This approach has statistical limitations (it is influenced by the heterogeneity of the population) and is non-intuitive for decision makers. We suggest an alternative approach: reporting results in minimal important difference units (the smallest difference patients experience as important). This approach provides a potential solution to both the statistical and interpretational problems of existing methods.
TL;DR: Higher number of behavioural and psychological symptoms, low-community involvement social networks, having a younger carer and higher carer's anxiety were found to be predictors of higher unmet needs in people with dementia living at home.
Abstract: There is lack of evidence about the unmet needs of people with dementia (PWD) living at home and the predictors of high levels of unmet needs. The main aim of this study was to identify the relationship between unmet needs, social networks and quality of life of PWD living at home. One hundred and fifty two community dwelling PWD and 128 carers were interviewed about PWD's needs, social networks, quality of life and other functional and psychological factors. All the interviews with PWD were carried out at their homes. Interviews with carers were undertaken either at PWD's home, their own home or at the health centre. Whenever possible, PWD and carers were interviewed separately. The data collection took place between November 2005 and July 2007. The majority of participants (129, 84.9%) were recruited from National Health Services (NHS) and the rest (23, 15.1%) were recruited from other organisations such as social services and voluntary organizations in the UK. The most frequent unmet needs for PWD were daytime activities (77, 50.7%), company (60, 39.5%), and help with psychological distress (47, 30.9%). Higher number of behavioural and psychological symptoms, low-community involvement social networks, having a younger carer and higher carer's anxiety were found to be predictors of higher unmet needs in PWD. Social networks and behavioural and psychological symptoms had an indirect effect on PWD's self-rated quality of life through unmet needs. Interventions aiming to reduce unmet needs, through the treatment of behavioural and psychological symptoms and the involvement of PWD in the community, would potentially improve PWD's quality of life.
TL;DR: The relationship between arm morbidity and quality of life (QoL) remains unclear as mentioned in this paper, however, the relationship between upper-body function (UBF) and QoL remains unclear.
Abstract: Impairments in upper-body function (UBF) are common following breast cancer. However, the relationship between arm morbidity and quality of life (QoL) remains unclear. This investigation uses longitudinal data to describe UBF in a population-based sample of women with breast cancer and examines its relationship with QoL. Australian women (n = 287) with unilateral breast cancer were assessed at three-monthly intervals, from six- to 18-months post-surgery (PS). Strength, endurance and flexibility were used to assess objective UBF, while the Disability of the Arm, Shoulder and Hand questionnaire and the Functional Assessment of Cancer Therapy-Breast questionnaire were used to assess self-reported UBF and QoL, respectively. Although mean UBF improved over time, up to 41% of women revealed declines in UBF between six- and 18-months PS. Older age, lower socioeconomic position, treatment on the dominant side, mastectomy, more extensive lymph node removal and having lymphoedema each increased odds of declines in UBF by at least two-fold (p < 0.05). Lower baseline and declines in perceived UBF between six- and 18-months PS were each associated with poorer QoL at 18-months PS (p < 0.05). Significant upper-body morbidity is experienced by many following breast cancer treatment, persisting longer term, and adversely influencing the QoL of breast cancer survivors.
TL;DR: Impairment increases rapidly with age but differs considerably between countries, and in all countries, health status is significantly associated with socio-demographic variables.
Abstract: Due to demographic change, the advanced elderly represent the fastest growing population group in Europe. Health problems tend to be frequent and increasing with age within this cohort. To describe and compare health status of the elderly population in six European countries and to analyze the impact of socio-demographic variables on health. In the European Study of the Epidemiology of Mental Disorders (ESEMeD), representative non-institutionalized population samples completed the EQ-5D and Short Form-12 (SF-12) questionnaires as part of personal computer-based home interviews in 2001-2003. This study is based on a subsample of 1659 respondents aged ≥ 75 years from Belgium (n = 194), France (n = 168), Germany (n = 244), Italy (n = 317), the Netherlands (n = 164) and Spain (n = 572). Descriptive statistics, bivariate- (chi-square tests) and multivariate methods (linear regressions) were used to examine differences in population health. 68.8% of respondents reported problems in one or more EQ-5D dimensions, most frequently pain/discomfort (55.2%), followed by mobility (50.0%), usual activities (36.6%), self-care (18.1%) and anxiety/depression (11.6%). The proportion of respondents reporting any problems increased significantly with age in bivariate analyses (age 75-79: 65.4%; age 80-84: 69.2%; age ≥ 85: 81.1%) and differed between countries, ranging from 58.7% in the Netherlands to 72.3% in Italy. The mean EQ VAS score was 61.9, decreasing with age (age 75-79: 64.1; age 80-84: 59.8; age ≥ 85: 56.7) and ranging from 60.0 in Italy to 72.9 in the Netherlands. SF-12 derived Physical Component Summary (PCS) and Mental Component Summary (MCS) scores varied little by age and country. Age and low educational level were associated with lower EQ VAS and PCS scores. After controlling for socio-demographic variables and reported EQ-5D health states, mean EQ VAS scores were significantly higher in the Netherlands and Belgium, and lower in Germany than the grand mean. More than two thirds of the advanced elderly report impairment of health status. Impairment increases rapidly with age but differs considerably between countries. In all countries, health status is significantly associated with socio-demographic variables.
TL;DR: In this paper, the authors examined whether older adults' perception of change is in agreement with conventional longitudinal evaluation of change in their health-related quality of life (HRQoL) over the duration of their hospital stay.
Abstract: Assessments of change in subjective patient reported outcomes such as health-related quality of life (HRQoL) are a key component of many clinical and research evaluations. However, conventional longitudinal evaluation of change may not agree with patient perceived change if patients' understanding of the subjective construct under evaluation changes over time (response shift) or if patients' have inaccurate recollection (recall bias). This study examined whether older adults' perception of change is in agreement with conventional longitudinal evaluation of change in their HRQoL over the duration of their hospital stay. It also investigated this level of agreement after adjusting patient perceived change for recall bias that patients may have experienced. A prospective longitudinal cohort design nested within a larger randomised controlled trial was implemented. 103 hospitalised older adults participated in this investigation at a tertiary hospital facility. The EQ-5D utility and Visual Analogue Scale (VAS) scores were used to evaluate HRQoL. Participants completed EQ-5D reports as soon as they were medically stable (within three days of admission) then again immediately prior to discharge. Three methods of change score calculation were used (conventional change, patient perceived change and patient perceived change adjusted for recall bias). Agreement was primarily investigated using intraclass correlation coefficients (ICC) and limits of agreement. Overall 101 (98%) participants completed both admission and discharge assessments. The mean (SD) age was 73.3 (11.2). The median (IQR) length of stay was 38 (20-60) days. For agreement between conventional longitudinal change and patient perceived change: ICCs were 0.34 and 0.40 for EQ-5D utility and VAS respectively. For agreement between conventional longitudinal change and patient perceived change adjusted for recall bias: ICCs were 0.98 and 0.90 respectively. Discrepancy between conventional longitudinal change and patient perceived change was considered clinically meaningful for 84 (83.2%) of participants, after adjusting for recall bias this reduced to 8 (7.9%). Agreement between conventional change and patient perceived change was not strong. A large proportion of this disagreement could be attributed to recall bias. To overcome the invalidating effect of response shift (on conventional change) and recall bias (on patient perceived change) a method of adjusting patient perceived change for recall bias has been described.
TL;DR: Because of the strong decrease in HRQOL in the general population during adolescence, compared to age-specific norms, adolescents were less impaired than were children, and inpatients had significantly lower scores than did outpatients, even after adjusting for age, gender and zBMI.
Abstract: Background
We examined treatment-seeking overweight and obese youths to better understand the gender, age, and treatment modality differences in generic and disease-specific health-related quality of life (HRQOL).
University of Aberdeen1, Norwegian University of Science and Technology2, Netherlands Cancer Institute3, European Organisation for Research and Treatment of Cancer4, University Medical Center Utrecht5, University of Copenhagen6, Bispebjerg Hospital7, University Hospital Regensburg8, University of Amsterdam9
TL;DR: Issues that arise when testing for DIF in HRQoL instruments are reviewed, and many of the results should be applicable to DIF analyses in general.
Abstract: Background: Differential item functioning (DIF) methods can be used to determine whether different subgroups respond differently to particular items within a health-related quality of life (HRQoL) subscale, after allowing for overall subgroup differences in that scale. This article reviews issues that arise when testing for DIF in HRQoL instruments. We focus on logistic regression methods, which are often used because of their efficiency, simplicity and ease of application. Methods: A review of logistic regression DIF analyses in HRQoL was undertaken. Methodological articles from other fields and using other DIF methods were also included if considered relevant. Results: There are many competing approaches for the conduct of DIF analyses and many criteria for determining what constitutes significant DIF. DIF in short scales, as commonly found in HRQL instruments, may be more difficult to interpret. Qualitative methods may aid interpretation of such DIF analyses. Conclusions: A number of methodological choices must be made when applying logistic regression for DIF analyses, and many of these affect the results. We provide recommendations based on reviewing the current evidence. Although the focus is on logistic regression, many of our results should be applicable to DIF analyses in general. There is a need for more empirical and theoretical work in this area.
TL;DR: Patients with TMD pain less than one year score better than compared to the population norm, and mental health scores and role limitations due to emotional problems do not appear to be seriously affected by reduced physical health, while social functioning appears to be considerably affected.
Abstract: As impact of literature concerning this subject is scarce, the objectives of this study were to assess whether the Health Related Quality of Life (HRQoL) is decreased in patients with painful temporomandibular disorders as compared to the HRQoL in the general population, and to evaluate to what extent pain duration affects HRQoL. Data concerning physical and mental health were retrieved from patients with painful temporomandibular disorders. Assessment tools used were: the Mandibular Function Impairment Questionnaire (MFIQ), the Short-Form-36 (SF-36), the Hospital Anxiety and Depression Schedule (HADS), and the General Health Questionnaire (GHQ). In order to examine the influence of the duration of pain on HRQoL, the total sample was divided into three different subgroups. Subgroup 1 consisted of patients with complaints existing less than one year. Patients with complaints from 1 to 3 years were allocated to the second group. The 3rd subgroup included patients with complaints longer than 3 years. The total sample consisted of 95 patients (90 females and 5 males). On most physical and social functioning items, groups 2 and 3 scored significantly worse than the general population. On the other hand, none of the groups differed from the general population when comparing the mental items. Duration of pain was significantly correlated with SF-36 subscale physical functioning and the mandibular impairment. Patients with TMD pain less than one year score better than compared to the population norm. With a longer duration of pain, mental health scores and role limitations due to emotional problems do not appear to be seriously affected by reduced physical health, while social functioning appears to be considerably affected.
TL;DR: Daily PA is associated with better HRQL (as assessed by the Physical composite score of the SF-36) for people living with stroke, and daily PA should be encouraged to potentially increase HRQL.
Abstract: Participation in daily physical activity (PA) post-stroke has not previously been investigated as a possible explanatory variable of health-related quality of life (HRQL). The aims were 1) to determine the contribution of daily PA to the HRQL of individuals with chronic stroke and 2) to assess the relationship between the functional ability of these individuals to the amount of daily PA. The amount of daily PA of forty adults with chronic stroke (mean age 66.5 ± 9.6 years) was monitored using two measures. Accelerometers (Actical) were worn on the hip for three consecutive days in conjunction with a self-report questionnaire [the PA Scale for Individuals with Physical Disabilities (PASIPD)]. The daily physical activity was measured as the mean total accelerometer activity counts/day and the PASIPD scores as the metabolic equivalent (MET) hr/day. HRQL was assessed by the Physical and Mental composite scores of the Medical Outcomes Study Short-Form 36 (SF-36) in addition to the functional ability of the participants. Correlation and regression analyses were performed. After controlling for the severity of the motor impairment, the amount of daily PA, as assessed by the PASIPD and accelerometers, was found to independently contribute to 10-12% of the variance of the Physical Composite Score of the SF-36. No significant relationship was found between PA and the Mental Composite Score of the SF-36.The functional ability of the participants was found to be correlated to the amount of daily PA (r = 0.33 - 0.67, p < 0.01). The results suggest that daily PA is associated with better HRQL (as assessed by the Physical composite score of the SF-36) for people living with stroke. Daily PA should be encouraged to potentially increase HRQL. Accelerometers in conjunction with a self-report questionnaire may provide important measures of PA which can be monitored and modified, and potentially influence HRQL.
TL;DR: The Arabic version of the Child-OIDP was applicable for use among schoolchildren in Khartoum and showed acceptable psychometric properties and is considered as a valid, reliable and practical inventory for use in this population.
Abstract: Information on oral health-related quality of life, in addition to clinical measures, is essential for healthcare policy makers to promote oral health resources and address oral health needs. This paper aimed at evaluating the psychometric properties of the Arabic version of Child-OIDP, estimating the prevalence, severity and causes of oral impacts on daily performances in 12-year-old public and private school attendees in Khartoum State and to identify socio-demographic and clinical correlates of oral impacts as assessed by the Child-OIDP inventory. The Child-OIDP questionnaire was translated into Arabic was administered to a representative sample of 1109 schoolchildren in Khartoum state. Clinical measures employed in this study included DMFT index, Gingival index, Plaque index and Dean's index. A food frequency questionnaire was used to study the sugar-sweetened snack consumption. The instrument showed acceptable psychometric properties and is considered as a valid, reliable (Cronbach's alpha 0.73) and practical inventory for use in this population. An impact was reported by 54.6% of the schoolchildren. The highest impact was reported on eating (35.5%) followed by cleaning (28.3%) and the lowest impacts were on speaking (8.6%) and social contact (8.7%). Problems which contributed to all eight impacts were toothache, sensitive teeth, exfoliating teeth, swollen gums and bad breath. Toothache was the most frequently associated cause of almost all impacts in both private and public school attendees. After adjusting for confounders in the 3 multiple variable regression models (whole sample, public and private school attendees), active caries maintained a significant association with the whole sample (OR 2.0 95% CI 1.4-2.6) and public school attendees (OR 3.5 95% CI 2.1-5.6), and higher SES was associated with only public school attendees' Child-OIDP (OR 1.9 95% 1.1-3.1). This study showed that the Arabic version of the Child-OIDP was applicable for use among schoolchildren in Khartoum. Despite the low prevalence of the dental caries pathology (24%), a significant relationship, with an average moderate intensity was found with OHRQoL. Focus in this population should be on oral health education, improving knowledge of the prospective treatment opportunities and provision of such services.
TL;DR: Neither treated nor untreated TDI was associated with oral symptoms, functional limitations or emotional wellbeing, however, children with a TDI in the anterior teeth experienced a negative impact on social wellbeing, mainly with regard to avoiding smiling or laughing and being concerned about what other people may think or say.
Abstract: Background
Traumatic dental injury (TDI) could have physical and psychosocial consequences for children. Thus, it is important to measure the impact of TDI on the quality of life of children (QoL). The aim of the present study was to investigate the association between treated/untreated TDI and the impact on the quality of life of 11-to-14-year-old Brazilian schoolchildren.
TL;DR: A simple 10-item Summary scale, together with scales measuring the physical and cognitive components of fatigue, were validated for MS fatigue.
Abstract: Fatigue is a common and debilitating symptom in multiple sclerosis (MS). Best-practice guidelines suggest that health services should repeatedly assess fatigue in persons with MS. Several fatigue scales are available but concern has been expressed about their validity. The objective of this study was to examine the reliability and validity of a new scale for MS fatigue, the Neurological Fatigue Index (NFI-MS). Qualitative analysis of 40 MS patient interviews had previously contributed to a coherent definition of fatigue, and a potential 52 item set representing the salient themes. A draft questionnaire was mailed out to 1223 people with MS, and the resulting data subjected to both factor and Rasch analysis. Data from 635 (51.9% response) respondents were split randomly into an 'evaluation' and 'validation' sample. Exploratory factor analysis identified four potential subscales: 'physical', 'cognitive', 'relief by diurnal sleep or rest' and 'abnormal nocturnal sleep and sleepiness'. Rasch analysis led to further item reduction and the generation of a Summary scale comprising items from the Physical and Cognitive subscales. The scales were shown to fit Rasch model expectations, across both the evaluation and validation samples. A simple 10-item Summary scale, together with scales measuring the physical and cognitive components of fatigue, were validated for MS fatigue.
TL;DR: Although disease-free survivors of DTC are expected to have disease-specific survival comparable to the general population, they experience a significantly decreased HRQOL.
Abstract: Concern regarding the health-related quality of life (HRQOL) of long-term survivors of thyroid cancer has risen due to the rapid increase in the incidence of thyroid cancer, which generally has an excellent prognosis. The aim of this study was to evaluate the status of HRQOL in disease-free survivors of differentiated thyroid carcinoma (DTC) and to evaluate the important determinants of HRQOL. This was a cross-sectional study in which we interviewed consecutive disease-free survivors of DTC. Three different validated questionnaires ("EORTC QLQ-C30" for various functional domains, the "brief fatigue inventory (BFI)" and the "hospital anxiety and depression scale" (HADS)) were used. Data from a large, population based survey of 1,000 people were used as a control. The response rate for the questionnaires was 78.9% (316/401). Disease-free survivors of DTC showed a decreased HRQOL in all five functional domains (physical, role, cognitive, emotional, and social) on the EORTC QLQ-C30 compared with controls (P < 0.01). BFI and HADS-anxiety scores also showed greater distress in disease-free survivors of DTC than in controls (P < 0.05). A multiple regression analysis for the determinants of HRQOL showed that the HADS-anxiety, HADS-depression, and BFI scores were the most significant components of decreased HRQOL. Although disease-free survivors of DTC are expected to have disease-specific survival comparable to the general population, they experience a significantly decreased HRQOL. Anxiety, depression, and fatigue were the major determinants of the decreased HRQOL. Supportive psychological care should be integrated into the management of long-term survivors of DTC.
TL;DR: In this article, the impact of measured cardiovascular and musculoskeletal physical fitness level on health-related quality of life (HRQoL) in Finnish young men was investigated.
Abstract: Currently, there is insufficient evidence available regarding the relationship between level of physical fitness and health-related quality of life (HRQoL) in younger adults. Therefore, the aim of the present study was to investigate the impact of measured cardiovascular and musculoskeletal physical fitness level on HRQoL in Finnish young men. In a cross-sectional study, we collected data regarding the physical fitness index, including aerobic endurance and muscle fitness, leisure-time physical activity (LTPA), body composition, health, and HRQoL (RAND 36) for 727 men [mean (SD) age 25 (5) years]. Associations between HRQoL and the explanatory parameters were analyzed using the logistic regression analysis model. Of the 727 participants who took part in the study, 45% were in the poor category of the physical fitness, while 37% and 18% were in the satisfactory and good fitness categories, respectively. A higher frequency of LTPA was associated with higher fitness (p < 0.001). Better HRQoL in terms of general health, physical functioning, mental health, and vitality were associated with better physical fitness. When the HRQoL of the study participants were compared with that of the age- and gender-weighted Finnish general population, both the good and satisfactory fitness groups had higher HRQoL in all areas other than bodily pain. In a regression analysis, higher LTPA was associated with three dimensions of HRQoL, higher physical fitness with two, and lower number of morbidities with all dimensions, while the effect of age was contradictory. Our study of Finnish young men indicates that higher physical fitness and leisure-time physical activity level promotes certain dimensions of HRQoL, while morbidities impair them all. The results highlight the importance of health related physical fitness while promoting HRQoL.