Economic evaluations to inform decisions about allocation of health resources are scarce in Low and Middle Income Countries, including in Sri Lanka. This is in part due to a lack of country-specific utility weights, which are necessary to derive appropriate Quality Adjusted Life Years. The EQ-5D-3L, a generic multi-attribute instrument (MAUI), is most widely used to measure and value health states in high income countries; nevertheless, the sensitivity of generic MAUIs has been criticised in some conditions such as cancer. This article describes a protocol to produce both a generic EQ-5D-3L and cancer specific EORTC-8D utility index in Sri Lanka.
EQ-5D-3L and EORTC-8D health states will be valued using the Time Trade-Off technique, by a representative population sample (n = 780 invited) identified using stratified multi-stage cluster sampling with probability proportionate to size method. Households will be randomly selected within 30 clusters across four districts; one adult (≥18 years) within each household will be selected using the Kish grid method.
Data will be collected via face-to-face interview, with a Time Trade-Off board employed as a visual aid. Of the 243 EQ-5D-3L and 81,290 EORTC-8D health states, 196 and 84 respectively will be directly valued. In EQ-5D-3L, all health states that combine level 3 on mobility with either level 1 on usual activities or self-care were excluded. Each participant will first complete the EQ-5D-3L, rank and value 14 EQ-5D-3L states (plus the worst health state and “immediate death”), and then rank and value seven EORTC-8D states (plus “immediate death”). Participant demographic and health characteristics will be also collected.
Regression models will be fitted to estimate utility indices for EQ-5D-3L and EORTC-8D health states for Sri Lanka. The dependent variable will be the utility value. Different specifications of independent variables will be derived from the ordinal EQ-5D-3L to test for the best-fitting model.
In Sri Lanka, a LMIC health state valuation will have to be carried out using face to face interview instead of online methods. The proposed study will provide the first country-specific health state valuations for Sri Lanka, and one of the first valuations to be completed in a South Asian Country.
Low and middle income countries; Utilities; Health state valuation; EQ-5D; EORTC-8D; Time trade-off; QALY
End stage renal disease (ESRD) profoundly impacts the lives of patients. Kidney transplantation provides the greatest health-related quality of life (HRQOL) improvement. Its measurement has become an important outcome parameter and a very important criterion in the evaluation of any type of medical treatment, especially in the field of renal transplantation.
In 2007, a specific self-administered questionnaire for renal transplant recipients was developed in the French language: the ReTransQol (RTQ).
After 5 years of use, the properties of the RTQ needed to be re-evaluated in a larger sample.
This paper describes the analysis of the ReTransQol and its adaptation to achieve an improved and revised version.
The study design included three analysis phases for two samples of adult renal transplant recipients which came from two cross-sectional multicenter studies carried out in France in 2007 and 2012. Psychometrics properties like construct validity, acceptability and feasibility, reliability and convergent validity were evaluated and every analysis resulted in a new version of the questionnaire: the RTQ V2. The construct validity of the new RTQ was assessed with a Confirmatory Factor Analysis on a large sample of patients.
The study samples included 1,059 patients and 1,591 patients, respectively.
After a principal component analysis, item reduction was performed and a total of 13 items were deleted. A final version of the RTQ V2 was created and comprised of 32 items describing 5 domains: Physical Health, Social Functioning, Medical Care, Treatment and Fear of Losing Graft.
The explained variance between the first and second RTQ versions improved from 46.3% to 53.1%. All psychometric properties of RTQ V2 were satisfactory: IIC >0.4, IDV (%) of 100% and Cronbach’s Alpha >0.7 in every dimension. The confirmatory analysis showed that the overall scalability of the RTQ V2 was satisfactory; all items showed a good fit to the Rasch model within each dimension, and showed INFIT statistics inside the acceptable range.
Psychometric properties allow this new version of the questionnaire to be used to assess different specific dimensions for the renal transplant population, more effectively than previously possible.
Quality of life; Medical outcomes; Specific questionnaire; Renal transplantation; RETRANSQOL
COPD exacerbations have a negative impact on lung function, decrease quality of life (QoL) and increase the risk of death. The objective of this study was to assess the course of health status after an outpatient or inpatient exacerbation in patients with COPD.
This is an epidemiological, prospective, multicentre study that was conducted in 79 hospitals and primary care centres in Spain. Four hundred seventy-six COPD patients completed COPD assessment test (CAT) and Clinical COPD Questionnaire (CCQ) questionnaires during the 24 hours after presenting at hospital or primary care centres with symptoms of an exacerbation, and also at weeks 4–6. The scores from the CAT and CCQ were evaluated and compared at baseline and after recovery from the exacerbation.
A total of 164 outpatients (33.7%) and 322 inpatients (66.3%) were included in the study. The majority were men (88.2%), the mean age was 69.4 years (SD = 9.5) and the mean FEV1 (%) was 47.7% (17.4%). During the exacerbation, patients presented high scores in the CAT: [mean: 22.0 (SD = 7.0)] and the CCQ: [mean: 4.4 (SD = 1.2)]. After recovery there was a significant reduction in the scores of both questionnaires [CAT: mean: -9.9 (SD = 5.1) and CCQ: mean: -3.1 (SD = 1.1)]. Both questionnaires showed a strong correlation during and after the exacerbation and the best predictor of the magnitude of improvement in the scores was the severity of each score at onset.
Due to their good correlation, CAT and CCQ can be useful tools to measure health status during an exacerbation and to evaluate recovery. However, new studies are necessary in order to identify which factors are influencing the course of the recovery of health status after a COPD exacerbation.
COPD; Health status; CAT; CCQ; Exacerbations
With ever-increasing life expectancy globally, it is imperative to build knowledge of how older peoples’ views of their own aging, considering their health-related circumstances, affect quality of life for practitioners and policy-makers alike. Based on our literature review, we wanted to determine whether older adults’ attitudes toward their own aging would partly mediate the effect of their health satisfaction ratings upon their quality of life. Furthermore, would these attitudes mediate the relationship between health satisfaction and quality of life in the same way when we account for older adults’ country of origin, and their age and gender?
This was a secondary analysis of cross-sectional survey data collected in 20 countries taking part in the 2003 WHOQOL-OLD Field study. The study sample consisted of 4593 adults whom were, on average, 72.10 years of age (range = 60 to 100 years of age); 42.8% were female. The WHOQOL-BREF measured quality of life and health satisfaction. The Attitudes to Aging Questionnaire measured participants’ attitudes toward physical change, psychosocial loss, and psychological growth. All items in both questionnaires were measured on a 5-point Likert scale. Questionnaire responses were analyzed using multilevel modeling and path analysis.
All three attitudes to aging partly mediated the relationship between health satisfaction and physical, psychological, social, environmental, and global quality of life. These partial mediations manifested in the same way across all 20 country samples, regardless of age or gender. Attitudes toward physical change were the strongest mediator of health satisfaction upon global and domain-specific quality of life, followed by psychosocial loss and psychosocial growth.
Our study is the first cross-cultural study with a large sample to show that quality of life judgements, between 60 to 100 years of age, are a product of older men’s and women’s perceptions of health-related circumstances, and attitudes toward physical and psychosocial aspects of the aging self. A prospective study of the linkages between older peoples’ subjective views of health and attitudes toward the aging self over time using multiple subjective measures of health is warranted. Understanding these linkages may help practitioners and policy makers consider strategies to enhance quality of life.
Attitudes to aging; Subjective health; Quality of life; Statistical models
Patient self reported measures for Health Related Quality of Life (HRQOL) and mental distress are frequently used to evaluate outcome of therapeutic strategies in cardiac patients.
Our study aims to describe changes in HRQOL and mental distress after percutaneous coronary intervention (PCI) focusing on temporal pattern of change and interdependences between both outcome measures.
163 PCI patients recruited at 7 cardiovascular care units in Austria answered MacNew Health Related Quality of Life and Hospital Anxiety and Depression Scale (HADS) questionnaires during hospital stay after intervention and at 1, 6, 12 and 24 months.
Improvement of MacNew HRQOL was found up to 6 month after PCI. Mental distress declined during the first month of the follow-up period. MacNew HRQOL is negatively correlated to mental distress. The relationship could be well described by a linear regression with MacNew HRQOL as dependent and HADS Total score as independent variable. The explained variance (R2) of the regression equation increases drastically from 45% at the baseline to a level between 67% and 77% in the follow up.
Our data suggest that the regression equation describing the relation between MacNew HRQOL and HADS-Total score six month after PCI defines a state of equilibrium: In absence of actual symptoms of coronary artery disease (CAD) both measures reflect the general health status and the general attitude underlying the self-assessment of health. At the baseline this equilibrium is imbalanced because the symptoms of CAD have a more pronounced impact on the disease specific MacNew HRQOL measure than on the non-disease specific HADS measure for mental distress. In order to use the MacNew questionnaire as a monitoring and/or prognostic tool it seems promising to refer to the state of equilibrium to define expectancy values for successful treatment.
Health related quality of life; Mental distress; Coronary artery disease; Percutaneous coronary intervention; MacNew; Hospital anxiety and Depression scale
The European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module has been translated into Korean, but to date, its reliability and validity have been evaluated in a pilot study alone. The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire is, overall, a valid instrument to assess the health-related quality of life in Korean cancer patients, although its reliability and validity have not yet been evaluated in patients with brain tumors. This study aimed at evaluating the psychometric properties of these instruments in patients with brain tumors.
The 2 instruments were used for 307 Korean patients with brain tumors. Multi-trait scaling confirmed the scale structure of the instruments with good item convergent and discriminant validity. The reliability was acceptable for all scales except for cognitive functioning and nausea and vomiting. The instruments could be used to distinguish between clinically distinct groups of patients.
The study findings indicate that the instruments are valid and suitable for the assessment of the health-related quality of life in patients with brain tumors as well as in those with primary brain cancer.
Brain tumor; Health-related quality of life; QLQ-BN20; QLQ-C30; Validation; Korea
Epilepsy, a chronic disorder of brain characterised by a predisposition to generate epileptic seizures, has an effect on the psychosocial well-being of sufferers. Measuring the quality of life (QOL) of people with epilepsy (PWE) is increasingly recognized as an important component of clinical management. QOL measures differ between countries and there is limited information regarding PWE in Malaysia. The aim of this study was to determine the health related QOL and its relationship with the presence of seizures in PWE at a Malaysian tertiary referral center.
A total of 106 adults with epilepsy attending the weekly neurology clinic of Universiti Sains Malaysia Hospital were interviewed in this cross-sectional study. The QOL was measured using a validated Malay translated version of the Quality of Life in Epilepsy Scale-31 (QOLIE-31). Analysis of covariance was used for data analysis.
The mean age was 31.8 years old (standard deviation (SD) 11.0) and 56.6% were females. The mean total score of QOLIE-31was 68.9 (SD 15.9). The highest subscale score was the medication effects with a mean of 79.4 (SD 28.5) and the lowest was seizure worry with 47.5 (SD 25.0). Respondents who had one or more seizures in the past four weeks had significantly lower mean score of QOL [63.4, 95% CI: 59.2, 67.5] than those who had no seizure [mean score 73.5, 95% CI: 69.3, 77.9] after adjusting for age, sex, treatment, duration and age at onset of epilepsy [F test =11.215, p = 0.001, R2 = 0.159]. All the sub-scales of QOL showed significant moderate correlation with the frequency of seizures except for cognitive functioning.
Worrying about seizure had the major contribution on QOL, while medication effect had the least. This study confirms the importance of seizure control for a better QOL in Malaysian patients with epilepsy.
Epilepsy; Quality of life; QOLIE-31; Frequency of seizures; Malaysia
This study aimed to determine the associations of various clinical factors with generic health-related quality of life (HRQOL) scores among Hong Kong Chinese patients with type 2 diabetes mellitus (T2DM) in the outpatient primary care setting using the short-form 12 (SF-12).
A cross-sectional survey of 488 Chinese adults with T2DM recruited from a primary care outpatient clinic was conducted from May to August 2008. Data on the standard Chinese (HK) SF-12 Health Survey and patients’ socio-demographics were collected from face-to-face interviews. Glycaemic control, body mass index (BMI), chronic co-morbidities, diabetic complications and treatment modalities were determined for each patient through medical records. Associations of socio-demographic and clinical factors with physical component summary (PCS-12) and mental component summary scores (MCS-12) were evaluated using multiple linear regression.
The socio-demographic correlates of PCS-12 and MCS-12 were age, gender and BMI. After adjustment for socio-demographic variables, the BMI was negatively associated with PCS-12 but positively associated with MCS-12. The presence of diabetic complications was associated with lower PCS-12 (regression coefficient:-3.0 points, p < 0.05) while being on insulin treatment was associated with lower MCS-12 (regression coefficient:-5.8 points, p < 0.05). In contrast, glycaemic control, duration of T2DM and treatment with oral hypoglycaemic drugs were not significantly associated with PCS-12 or MCS-12.
Among T2DM subjects in the primary care setting, impairments in the physical aspect of HRQOL were evident in subjects who were obese or had diabetic complications whereas defects in the mental aspect of HRQOL were observed in patients with lower BMI or receiving insulin injections.
Quality of life; SF-12; Hong Kong; Chinese; Type 2 diabetes mellitus
The aim of the present study was to estimate the prevalence of mood disorders and examine a range of predictors for psychological well-being among Iranian women with polycystic ovary syndrome (PCOS).
A cross-sectional study was undertaken to ascertain the factors related to psychological distress in PCOS patients in Kashan, Iran. Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS). In addition we assessed quality of life using the Short Form Health Survey (SF-36). Socio-demographic details and clinical information of PCOS including obesity (body mass index), excessive body hair (hirsutism score), acne, menstrual cycle disturbances, infertility and endocrine profile also were recorded for each patient.
In all 300 women with PCOS were entered into the study. Of these 32% (n =96) showed elevated HADS anxiety while depression was high in 5% (n =15). Quality of life was significantly impaired in women with anxiety (P <0.05), and depression (P <0.001) and in particular, in women with coexistence anxiety and depression (P <0.001) compared with unaffected participants. Compared with the non-depressed PCOS patients, the depressed women had significantly higher menstrual irregularities (P = 0.008). Moreover, we found significant difference in FAI level between the depressed and non depressed (p = 0.05), the anxious and non anxious patients (p < 0.001) compare to non affected PCOS women.
The high prevalence of depression and anxiety in this population suggests that initial evaluation of all women with PCOS should also include assessment of mental health disorders. The clinician should further pay attention to background of their patients especially in view of the factors influencing psychological well-being.
Anxiety; Depression; Quality of life; Polycystic ovary syndrome
The demographic, health and contextual factors associated with quality of life impairment are investigated in older persons from New South Wales, Australia. We examine the impact of cardiovascular and affective conditions on impairment and the potential moderating influence of comorbidity and remoteness.
Data from persons aged 55 and over were drawn from two community cohorts sampling from across urban to very remote areas. Hierarchical linear regressions were used to assess: 1) the impact of cardiovascular and affective conditions on physical and psychological quality of life impairment; and 2) any influence of remoteness on these effects (N = 4364). Remoteness was geocoded to participants at the postal code level. Secondary data sources were used to examine the social capital and health service accessibility correlates of remoteness.
Physical impairment was consistently associated with increased age, male gender, lower education, being unmarried, retirement, stroke, heart attack/angina, depression/anxiety, diabetes, hypertension, current obesity and low social support. Psychological impairment was consistently associated with lower age, being unmarried, stroke, heart attack/angina, depression/anxiety and low social support. Remoteness tended to be associated with lower psychological impairment, largely reflecting overall urban versus rural differences. The impacts of cardiovascular and affective conditions on quality of life were not influenced by remoteness. Social capital increased and health service accessibility decreased with remoteness, though no differences between outer-regional and remote/very remote areas were observed. Trends suggested that social capital was associated with lower psychological impairment and that the influence of cardiovascular conditions and social capital on psychological impairment was greater for persons with a history of affective conditions. The beneficial impact of social capital in reducing psychological impairment was more marked for those experiencing financial difficulty.
Cardiovascular and affective conditions are key determinants of physical and psychological impairment. Persons affected by physical-psychological comorbidity experience greater psychological impairment. Social capital is associated with community remoteness and may ameliorate the psychological impairment associated with affective disorders and financial difficulties. The use of classifications of remoteness that are sensitive to social and health service accessibility determinants of health may better inform future investigations into the impact of context on quality of life outcomes.
Cardiovascular disease; Urban–rural; Social capital; Quality of life; Physical and psychological health; Over 55 years
Although most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up.
Prospective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).
Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant.
One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was –35.7 (95% CI, –40.1 to –31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124).
Radiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.
Radiofrequency ablation; Ultrasound; Laparoscopic ultrasound; Fibroid; Myoma; Quality of life
Though several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instrument’s use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed.
A 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, ‘Glucose Management’ (GM), ‘Dietary Control’ (DC), ‘Physical Activity’ (PA), and ‘Health-Care Use’ (HU), as well as a ‘Sum Scale’ (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQ’s item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA.
The items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA1c: -0.23 ± 0.09). Overall internal consistency (Cronbach’s alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA.
This study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients.
Diabetes care; Self-management; Self-care behaviour; Metabolic control; HbA1c; Hyperglycaemia; Measurement; Assessment; Psychometric instrument
The responsiveness of oral health-related quality of life (OHRQoL) instruments has become relevant, given the increasing tendency to use OHRQoL measures as outcomes in clinical trials and evaluations studies. The purpose of this study was to assess the responsiveness of the Brazilian Scale of Oral Health Outcomes for 5-year-old children (SOHO-5) to dental treatment.
One hundred and fifty-four children and their parents completed the child self- and parental’ reports of the SOHO-5 prior to treatment and 7 to 14 days after the completion of treatment. The post-treatment questionnaire also included a global transition judgment that assessed subject’s perceptions of change in their oral health following treatment. Change scores were calculated by subtracting post-treatment SOHO-5 scores from pre-treatment scores. Longitudinal construct validity was assessed by using one-way analysis of variance to examine the association between change scores and the global transition judgments. Measures of responsiveness included standardized effect sizes (ES) and standardized response mean (SRM).
The improvement of children’s oral health after treatment are reflected in mean pre- and post-treatment SOHO-5 scores that declined from 2.67 to 0.61 (p < 0.001) for the child-self reports, and 4.04 to 0.71 (p < 0.001) for the parental reports. Mean change scores showed a gradient in the expected direction across categories of the global transition judgment, and there were significant differences in the pre- and post-treatment scores of those who reported improving a little (p < 0.05) and those who reported improving a lot (p < 0.001). For both versions, the ES and SRM based on change scores mean for total scores and for categories of global transitions judgments were moderate to large.
The Brazilian SOHO-5 is responsive to change and can be used as an outcome indicator in future clinical trials. Both the parental and the child versions presented satisfactory results.
Australia’s ageing population means that there is increasing emphasis on developing innovative models of health care delivery for older adults. The assessment of the most appropriate mix of services and measurement of their impact on patient outcomes is challenging. The aim of this evaluation was to describe the health related quality of life (HRQoL) of older adults with complex needs and to explore the relationship between HRQoL, readmission to acute care and survival.
The study was conducted in metropolitan Melbourne, Australia; participants were recruited from a cohort of older adults enrolled in a multidisciplinary case management service. HRQoL was measured at enrolment into the case-management service using The Assessment of Quality of Life (AQoL) instrument. In 2007–2009, participating service clinicians approached their patients and asked for consent to study participation. Administrative databases were used to obtain data on comorbidities (Charlson Comorbidity Index) at enrolment, and follow-up data on acute care readmissions over 12 months and five year mortality. HRQoL was compared to aged-matched norms using Welch’s approximate t-tests. Univariate and multivariate logistic regression models were used to explore which patient factors were predictive of readmissions and mortality.
There were 210 study participants, mean age 78 years, 67% were female. Participants reported significantly worse HRQoL than age-matched population norms with a mean AQOL of 0.30 (SD 0.27). Seventy-eight (38%) participants were readmitted over 12-months and 5-year mortality was 65 (31%). Multivariate regression found that an AQOL utility score <0.37 (OR 1.95, 95%CI, 1.03 – 3.70), and a Charlson Comorbidity Index ≥6 (OR 4.89, 95%CI 2.37 – 10.09) were predictive of readmission. Multivariate analysis demonstrated that age ≥80 years (OR 7.15, 95%CI, 1.83 – 28.02), and Charlson Comorbidity Index ≥6 (OR 6.00, 95%CI, 2.82 – 12.79) were predictive of death.
This study confirms that the AQoL instrument is a robust measure of HRQoL in older community-dwelling adults with chronic illness. Lower self-reported HRQoL was associated with an increased risk of readmission independently of comorbidity and kind of service provided, but was not an independent predictor of five-year mortality.
Health-related quality of life; Chronic disease; Case management; Mortality; Health care utilisation
While there are numerous instruments for capturing the symptoms of fibromyalgia syndrome (FMS) patients, there is a lack of questionnaires capable of measuring in detail FMS patients’ participation and social functioning. It was our aim to develop and methodologically test a new patient questionnaire specific to FMS measuring these concepts (the “Fibromyalgia Participation Questionnaire” FPQ).
We first conducted a qualitative prestudy (focus groups, N = 38) to identify which impairments FMS patients experience in daily life because of their illness. To analyze the data we developed a coding system that contained 10 supercategories and a total of 105 subcategories. Items for the FPQ were developed from the subcategories. The psychometric analysis was done on a sample of N = 256 FMS patients undergoing inpatient rehabilitation in Germany.
The final version of the FPQ contained 27 items and three scales (participation in social life FPQ-S, 11 items; participation in daily life FPQ-D, 11 items, participation in work-life FPQ-W 5 items). The FPQ displays good distribution properties, all the scales are unidimensional, and the scales fit to the Rasch model. Cronbach’s Alpha range from 0.85 to 0.94. We noted indications of construct validity in that the FPQ correlates as expected with the Fibromyalgia Impact Questionnaire (physical scale), Pain Disability Index and scales from the PROMIS® item banks for satisfaction with participation. The FPQ scales generally reveal greater responsiveness than other instruments. By linking FPQ items to the categories of the International Classification of Functioning, Disability and Health (ICF) we demonstrate content validity.
The FPQ captures participation and social functioning in FMS patients. As its psychometric properties are good, it can be recommended for use in evaluation studies and clinical trials.
Fibromyalgia syndrome; Social participation; Outcome assessment (Health Care); Rehabilitation
The impact of psychological factors is often taken into account in the evaluation of quality of life. However, the effect of optimism and trait anxiety remains controversial and they are rarely studied simultaneously. We aimed to study the effect of this factor on health-related quality of life (HRQOL) of patients after a hospitalization in relation with their chronic disease.
Using cross-sectional data from the SATISQOL cohort, we conducted a multicentric study, including patients hospitalized for an intervention in connection with their chronic disease. Six months after hospitalization, patients completed a generic HRQOL questionnaire (SF-36), and the STAI and LOT-R questionnaires to evaluate optimism and trait anxiety. We studied the effect of each trait on HRQOL separately, and simultaneously, taking account of their interaction in 3 models, using an ANOVA.
In this study, 1529 patients were included in three participating hospitals and there existed wide diversity in the chronic diseases in our population. The HRQOL score increased for all dimensions of SF36 between 15,8 and 44,5 when the level of anxiety decreased (p < 0.0001) for the model 1, assessing the effect of anxiety on HRQOL and increased for all dimensions of SF36 between 3.1 and 12.7 with increasing level of optimism (< 0.0001) in the model 2 assessing the effect of optimism on HRQOL. In the model 3, assessing the effect of both anxiety and optimism on HRQOL, and their interaction, the HRQOL score for all dimensions of the SF36 increased when the level of anxiety decreased (p < 0.0001). It increased with increasing level of optimism (p < 0.006) in the model for all dimensions of SF36 except the Role Physical dimension. In this model, interaction between anxiety and optimism was significant for the Social Functioning dimension (p = 0.0021).
Optimism and trait anxiety appeared to be significantly correlated with HRQOL. Furthermore, an interaction existed between the trait anxiety and optimism for some dimensions of SF36. Contrary to optimism, it seems essential to evaluate trait anxiety in future studies about HRQOL, since it could represent a confounding factor.
Quality of life; Chronic diseases; Validated questionnaires; Anxiety; Optimism
To investigate the relationship between health-related quality of life (HRQOL) and survival in Chinese patients with chronic liver disease (CLD).
HRQOL was measured with the Chinese version of Short Form 36 (SF-36). SF-36 scores, demographic and clinical data were collected at baseline and after 18 months follow-up. Kaplan-Meier and Cox Proportional Hazard Regression survival analyses were used for interpretation of data. Surviving patients were censored in the analyses.
A total of 415 Chinese patients with CLD and 86 healthy controls were enrolled. During the follow-up period 50 patients died. SF-36 scores in healthy controls and surviving patients were higher compared with those in deceased patients. Scores of physical component summary (PCS) in healthy controls, surviving and deceased patients were 54.1 ± 5.2, 48.9 ± 7.7 and 33.5 ± 8.2 respectively (p < 0.001). Scores of mental component summary (MCS) in healthy controls, surviving and deceased patients were 56.6 ± 8.2, 53.0 ± 5.6 and 37.1 ± 12.1 (p < 0.001) respectively. Survival was significantly associated with PCS and MCS scores, and the presence of ascites.
HRQOL was associated with survival in patients with CLD. PCS and MCS scores were predictors of survival.
Health-related quality of life; Chronic liver disease; SF-36; Survival
The Revised version of the Fibromyalgia Impact Questionnaire (FIQR) was published in 2009. The aim of this study was to prepare a Spanish version, and to assess its psychometric properties in a sample of patients with fibromyalgia.
The FIQR was translated into Spanish and administered, along with the FIQ, the Hospital Anxiety Depression Scale (HADS), the 36-Item Short-Form Health Survey (SF-36), and the Brief Pain Inventory (BPI), to 113 Spanish fibromyalgia patients. The administration of the Spanish FIQR was repeated a week later.
The Spanish FIQR had high internal consistency (Cronbach’s α was 0.91 and 0.95 at visits 1 and 2 respectively). The test-retest reliability was good for the FIQR total score and its function and symptoms domains (intraclass correlation coefficient (ICC > 0.70), but modest for the overall impact domain (ICC = 0.51). Statistically significant correlations (p < 0.05) were also found between the FIQR and the FIQ scores, as well as between the FIQR scores and the remaining scales’ scores.
The Spanish version of the FIQR has a good internal consistency and our findings support its validity for assessing fibromyalgia patients. It might be a valid instrument to apply in clinical and investigational grounds.
Fibromyalgia; Revised fibromyalgia impact questionnaire; Linguistic validation; Psychometric properties; Instrumental study; Fibromialgia; Cuestionario de impacto de fibromialgia revisado; Validación lingüística; Propiedades psicométricas; Estudio instrumental
The aim was to assess the association of internalising and externalising pathology with the child’s health-related quality of life (QoL), and to determine which child and environmental characteristics beyond pathology were related to poor QoL.
Data was obtained for 120 children and adolescents (aged 6 to 18) commencing outpatient psychotherapy treatment. Parents and children (aged 11 years and older) filled out questionnaires. QoL was measured with the KIDSCREEN-27.
QoL was more strongly associated with internalising than externalising pathology according to both self- and parent report. Multiple regression analyses showed that beyond internalising and externalising pathology, gender, age, family functioning, functional impairment, and prior mental health treatment were associated with individual QoL scales.
The data underscored the relationship between mental pathology and impaired QoL even if potential item overlap was controlled for. This stresses the importance of extending therapy goals and outcome measures from mere pathology to measures of QoL in psychotherapy research particularly for patients with internalising pathology.
Quality of life; Internalising disorders; Externalising disorders; Child; Adolescent
Controlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners. COS also requires concerted efforts by the patients in administering medication and general compliance to treatment protocols. Little is known about the impacts on patients that may be specific to this important first step in treatment. The absence of a conceptually sound and well-validated measure assessing patient experience and functioning during ovarian stimulation has been an obstacle to understanding the impacts of ovarian stimulation on women pursuing IVF. To address this gap, the Controlled Ovarian Stimulation Impact Measure (COSI) was developed based upon accepted methods for designing patient reported outcome (PRO) measures. The purpose of this study was to psychometrically validate the COSI.
267 patients from three countries (Ireland, United Kingdom, United States) were administered the COSI. Psychometric validation was conducted according to an a priori statistical analysis plan.
The final 28-item COSI was found to have robust scale structure with four domains: Interference in Daily Life (Work and Home), Injection Burden, Psychological Health and Compliance Worry. Internal consistency of all domains was adequate (between 0.80 to 0.87) as was test-retest reliability (between 0.72-0.87). All a-priori hypotheses for convergent and known-groups validity tests were met.
There is a measurable impact of COS on patient functioning and well-being. The COSI is a well-developed and validated PRO measure of this impact. Future work should include examination of responsiveness and confirmation of concepts in non-western countries.
Controlled ovarian stimulation; Validation; Controlled ovarian stimulation impact measure; Quality of life
It is unclear if there is a clinically important improvement in the six to 12-month recovery period after hip and knee replacement. This is an obvious gap in the evidence required by patients undergoing these procedures. It is also an issue for the English PROMs (Patient-Reported Outcome Measures) Programme which uses 6-month outcome data to compare the results of hospitals that perform hip and knee replacements.
A systematic review of studies reporting the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) at 12 months after surgery was performed. This was compared with six-month outcome data collected for 60, 160 patients within the English PROMs programme. A minimally important difference of one standard error of the measurement, equivalent to 2.7 for the OHS and 2.1 for the OKS, was adopted.
Results and discussion
Six studies reported OHS data for 10 different groups containing 8,308 patients in total. In eight groups the change scores reported were at least 2.7 points higher than the six-month change observed in the PROMs programme (20.2 points). Nine studies reported OKS data for 13 different groups containing 4,369 patients in total. In eight groups the change scores reported were at least 2.1 points higher than the six-month change observed in the PROMs programme (15.0 points).
There is some evidence from this systematic review that clinically important improvement in the Oxford hip and knee scores occurs in the six to 12 month recovery period. This trend is more apparent for hip than knee replacement. Therefore we recommend that the English Department of Health study the impact on hospital comparisons of using 12- rather than six-month outcome data.
Quality of life; Patient-reported outcomes; Hip replacement; Knee replacement; Oxford hip score; Oxford knee score
Responsiveness, defined as the ability to detect a meaningful change, is a core psychometric property of an instrument measuring quality of life (QoL) rarely reported in multiple sclerosis (MS) studies.
To assess the responsiveness of the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire to change in disability over 24 months, defined by change in the Expanded Disability Status Scale (EDSS) score.
Patients with MS were enrolled into a multicenter, longitudinal observational study. QoL was assessed using both the MusiQoL and the 36-Item Short-Form (SF-36) instruments at baseline and every 6 months thereafter up to month 24; neurological assessments, including EDSS score, were performed at each evaluation.
The 24-month EDSS was available for 524 patients. In the 107 worsened patients, two specific dimensions of MusiQoL, the sentimental and sexual life and the relationships with health care system dimensions, and ‘physical’ scores of SF-36 showed responsiveness.
Whereas specific dimensions of MusiQoL identified EDSS changes, the MusiQoL index did not detect disability changes in worsened MS patients in a 24-month observational study. Future responsiveness validation studies should include longer follow-up and more representative samples.
Multiple sclerosis; Quality of life; Outcome research; Responsiveness; MusiQoL; SF-36; Longitudinal studies
The Upper Limb Functional Index (ULFI) is an internationally widely used outcome measure with robust, valid psychometric properties. The purpose of study is to develop and validate a ULFI Spanish-version (ULFI-Sp).
A two stage observational study was conducted. The ULFI was cross-culturally adapted to Spanish through double forward and backward translations, the psychometric properties were then validated. Participants (n = 126) with various upper limb conditions of >12 weeks duration completed the ULFI-Sp, QuickDASH and the Euroqol Health Questionnaire 5 Dimensions (EQ-5D-3 L). The full sample determined internal consistency, concurrent criterion validity, construct validity and factor structure; a subgroup (n = 35) determined reliability at seven days.
The ULFI-Sp demonstrated high internal consistency (α = 0.94) and reliability (r = 0.93). Factor structure was one-dimensional and supported construct validity. Criterion validity with the EQ-5D-3 L was fair and inversely correlated (r = −0.59). The QuickDASH data was unavailable for analysis due to excessive missing responses.
The ULFI-Sp is a valid upper limb outcome measure with similar psychometric properties to the English language version.
Upper limb; Psychometrics; Outcome measure; Spanish
Valuations of depression are useful to evaluate depression interventions offered to patients with chronic somatic conditions. The only classification system to describe depression developed specifically for valuation purposes is the McSad, but it has not been used among somatic patients. The aim of this study was to test the construct validity of the McSad among diabetes and cancer patients and then to compare the McSad to the commonly used EuroQol – 5 Dimensions (EQ-5DTM) classification system. The comparison was expected to shed light on their capacity to reflect the range of depression states experienced by somatic patients.
Cross-sectional data were collected online from 114 diabetes and 195 cancer patients; additionally, 241 cancer patients completed part of the survey on paper. Correlational analyses were performed to test the construct validity. Specifically, we hypothesized high correlations of the McSad domains with depression (Center for Epidemiological Studies Depression Scale (CES-D) and the Patient Health Questionnaire (PHQ-9)). We also expected low/moderate correlations with self-esteem (Rosenberg Self-Esteem scale - RSE) and extraversion (Eysenck Personality Questionnaire Extraversion scale - EPQ-e). Multiple linear regression analyses were run so that the proportion of variance in depression scores (CES-D, PHQ-9) explained by the McSad could be compared to the proportion explained by the EQ-5D classification system.
As expected, among all patients groups, we found moderate to high correlations for the McSad domains with the CES-D (.41 to .70) and the PHQ-9 (.52 to .76); we also found low to moderate correlations with the RSE (-.21 to .-48) and the EPQ-e (.18 to .31). Linear regression analyses showed that the McSad explained a greater proportion of variance in depression (CES-D, PHQ-9) (Diabetes: 73%, 82%; Cancer: 72%, 72%) than the EQ-5D classification system (Diabetes: 47%, 59%; Cancer: 51%, 47%).
Findings support the construct validity of the McSad among patients with somatic conditions and demonstrate that it performs better than the EQ-5D classification system to reflect the range of depression states. For future valuation purposes, the McSad classification system could therefore be recommended to describe depression as experienced by patients with a chronic medical condition.
Long-term oxygen therapy (LTOT) extends life in patients with chronic obstructive pulmonary disease with severe hypoxaemia. Questionnaire-based studies of the effects of LTOT have not suggested uniformly positive findings. The few qualitative studies suggest that patients report benefits but also concerns about dependency on oxygen therapy. The aim of the study was to explore the views and experiences of COPD patients, their carers and the healthcare professionals who deliver these services, on the long-term use of oxygen therapy.
Focus groups were conducted with 16 patients with from the LTOT service, six carers, and nine healthcare professionals (n = 31). Eleven patients with COPD, four carers and one staff manager (n = 16) participated in semi-structured interviews. Interviews and focus group were digitally recorded and field notes were taken. Data were analysed using the thematic network analysis approach.
Patients and carers reported the benefits of LTOT including increased social activity, perceived improvements in health status and self-management in routine daily activities. Concerns were raised regarding stigma, dependency on LTOT and deterioration in health status. Staff accounts included negative perceptions, suggesting that LTOT was often inappropriately prescribed and under-used but recommended active patient management to address this challenge.
LTOT has some beneficial effects in improving daily activities and social interaction of patients with COPD but also some limitations. Increased support and monitoring by healthcare professionals would address some concerns, as would better information for patients, carers and the general public.
Chronic obstructive pulmonary disease; COPD; Long term oxygen therapy; Patient perspectives; Carers; Healthcare professionals; Compliance