Generic Health Status Instruments Research Articles

Abstract 16929: Defining Thresholds for Meaningful 30-day Health Status Changes Following Transfemoral Carotid Artery Stenting

Introduction: Carotid artery stenosis treatment trials have focused on clinical endpoints such as stroke, death, and MI, but evidence of carotid revascularization’s impact on health status is limited. This study aims to establish minimal clinically important differences (MCIDs) to assess clinical improvement or worsening from the perspectives of patients with carotid artery stenosis undergoing transfemoral carotid artery stenting (TF-CAS). Methods: We studied patients in the multicenter Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) registry who underwent TF-CAS between 2010 and 2014 and who completed either the EQ-5D-3L or SF-36, two generic health-related quality-of-life surveys. Distribution-based MCIDs were calculated as 0.5 standard deviations for 30-day changes in health status scores post-TF-CAS for the EQ-5D-3L index value and visual analog scale (VAS) subscales and the SF-36 mental and physical component summary (MCS and PCS) subscales. We then stratified this analysis by symptom status (presence or abscence of prior stroke or TIA). Results: The study included 3,930 patients (27.7% symptomatic) who completed the EQ-5D-3L and 3,018 (30.5% symptomatic) who completed the SF-36. The MCIDs for the overall cohorts were 0.09, 11.02, 4.73, and 5.39 for the EQ-5D-3L index value, EQ-5D-3L VAS, SF-36 MCS, and SF-36 PCS, respectively. All MCIDs are summarized in Table 1. The MCIDs for each subscale were similar between asymptomatic and symptomatic subpopulations. Conclusions: Distribution-based thresholds for improvement and worsening of health status in patients undergoing TF-CAS were established for commonly-used generic health status instruments. These reference values can be used in both symptomatic and asymptomatic disease and will be important for interpreting future trial results focusing on the benefit of TF-CAS from patients’ perspectives.

Impact of COVID-19 on health-related quality of life in patients with cardiovascular disease: a multi-ethnic Asian study

BackgroundLittle is known about the impact of the global coronavirus disease-2019 (COVID-19) pandemic on patients with cardiovascular disease (CVD), the biggest global killer and major risk factor for severe COVID-19 infections. We aim to explore the indirect consequences of COVID-19 on health-related quality of life (HRQoL) of patients with CVD.MethodsEighty-one adult outpatients with CVD were assessed using the EQ-5D, a generic health status instrument with five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), before and during the pandemic. Changes in the EQ-5D dimensional responses were compared categorically as well as using the dimension-specific sum-score (range 1–3, with a higher score indicating worse health). The responses and sum-score were compared using the exact test of symmetry and the paired t-test, respectively.ResultsThese patients [mean age (SD) 59.8 (10.5); 92.6% males; 56% New York Heart Association (NYHA) functional class I] had coronary artery disease (69%), heart failure (28%), or arrhythmias (15%). None experienced change in NYHA class between assessments. About 30% and 38% of patients reported problems with at least one of the EQ-5D dimensions pre-pandemic and during the pandemic, respectively. The highest increase in health problems was reported for anxiety/depression (12.5% pre-pandemic vs 23.5% during pandemic; p = 0.035) with mean domain-specific score from 1.12 (SD 0.33) to 1.25 (SD 0.46) (standardized effect size = 0.373, p = 0.012). There was no meaningful change in other dimensions as well as overall HRQoL.ConclusionThe COVID-19 pandemic is associated with a significant worsening of the mental health of patients with CVD.

Results of Arthroscopic Talar Osteochondral Lesions with Bone Marrow Stimulation and BST-CarGel

Category:Ankle, TraumaIntroduction/Purpose:Osteochondral lesions (OCL) are described as any defect involving both the articular surface and the subchondral bone of the talus. They are commonly associated with acute ankle injuries occurring often in active population. Bone marrow stimulation with microfracture is a standard reparative treatment for OCD however decline in related functional outcome has been reported.BST-CarGel contains chitosan which binds to negatively charged cartilage surface acting as biocompatible scaffold. This allows repair tissue with significant filling volume and proper integration into the surroundings. There has been reported better quantitative and qualitative cartilage repair tissue at 12 months with BST-CarGel.We first report on clinical results of bone marrow stimulation and BST-Cargel for recalcitrant talar OCL in patients previously treated with microfracture alone in a prospective study.Methods:This prospective single surgeon series was limited to patients with symptomatic OCL who previously had arthroscopic debridement and microfracture for same lesion. The pre-operative evaluation of all patients involved clinical assessment, weight bearing plain radiographs and magnetic resonance imaging of ankle joint. Inclusion criteria were age 18-55 years, single focal OCL of talus less than 3 cm2 and previous microfracture. Exclusion criteria was evidence of ankle osteoarthritis and allergy to chitosan or known hypersensitivity to crustaceans such as shrimp, lobster, and crab.Functional outcome assessment was measured using Foot and Ankle outcome score (FAOS) and EQ5D (Health related quality of life) pre and post-operatively. We used paired Student’s t-test for statistical analysis. Values for p < 0.05 were regarded as significant. The surgical technique used have been previously described in literature for OCL of the talus treated with bone marrow stimulation and Cargel.Results:There were fourteen patients who were treated with arthroscopic BST-Cargel with BMS and followed up prospectively. There was no loss to follow-up. The mean follow-up post-operatively was 28 months. There were eight males and six females in the study group. Patient mean age at the time of operation was 42 years (21–60 years). The mean size of talar OCL treated was 2.8 cm2 . Mean FAOS score for symptoms pre-operatively was 41.7 and post-operative was 52.8 (P<0.01). Mean FAOS pain subscale pre-operatively was 45.7 and post-operatively 55.6 (P<0.01). FAOS function and daily living score pre-operatively was 41.4 and post-operatively was 55.8 (P<0.01). Mean FAOS quality of life score was 39.2 pre-operatively and post-operative score 57.2 (P<0.01). EQ5D pre-operatively was 15 and post-operatively was 8 (P<0.01).Conclusion:We noted statistically significant improvement in each subscale of The Foot and Ankle Outcome questionnaire scores post-operatively. There was also significant improvement in generic health status instrument EQ-5D. We also noted talar OCL improvement on MRI scan taken pre and post BST-CarGel treatment.Recalcitrant OCL of talus present considerable challenge with persistent pain, functional limitations and secondary osteoarthritis. BST-Cargel treatment in our clinical study improved functional outcome scores similar to previously reported hip and knee studies. It requires standard arthroscopic technique and no complications were observed in our study.

Patient-Centered Item Selection for a New Preference-Based Generic Health Status Instrument: CS-Base

ObjectivesTo develop patient-centered health content for a novel generic instrument (Château Santé Base [CS-Base]) that is suitable to generate values for health status. MethodsCandidate items were drawn from existing health frameworks of generic health status instruments and placed in a diagram (HealthFANTM, Zeist, the Netherlands). Through an online survey, patients with a wide range of diseases were asked to select the 9 items that were most important to them. The importance of the items for the whole study group was determined by means of frequency distributions. ResultsAfter handling duplicates and overlap, the remaining set of 47 items was placed in the HealthFAN. Among the 2256 Dutch patients who started the survey, the most common diagnoses were neck and back pain, diabetes, and asthma/chronic obstructive pulmonary disease. The 5 health items mentioned most frequently as most important were pain, personal relationships, fatigue, memory, and vision. Hearing and vision, anxiety and depression, and independence and self-esteem seemed highly intertwined, so we chose to pair these items. ConclusionsA total of 12 health items were included in CS-Base. Its content is largely based on patient input and enables classification of patients' health status. CS-Base can be administered by means of an app on a mobile phone, which makes it a convenient and attractive tool for patients and researchers.

PHP339 - MINIMALLY IMPORTANT DIFFERENCE (MID) OF EQ-5D-5L INDEX SCORE IN HONG KONG ADULTS POPULATION USING HONG KONG SCORING ALGORITHM

The EQ-5D is one of the globally used generic health status instrument to measure health-related quality of life (HRQoL). It contains a five-dimension descriptive system [i.e., mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD)]. The reported health states could be converted to an index scores. The MID is a minimal amount of self-reported difference in a HRQoL score considered to the smallest health transition (change). The purpose of the present study was to estimate MIDs of EQ-5D-5L index score in the adult population in Hong Kong (HK). A simulation-based approach based on instrument-defined single-level transitions suggested by McClure et al. was adopted to estimate the summary statistics for the MID value of the EQ-5D-5L HK using the established HK values set. The estimation involved calculating the average absolute difference between the index score of the baseline health state and the index score of all single-level transitions from the baseline health state. The adjusted MID was also estimated by excluding the maximum-valued HK scoring parameters within each dimension. According to the HK scoring algorithm, the minimum-valued scoring parameter is 0.026 for transitions between level 2 and 3 in the SC dimension. The MO dimension has the maximum-valued scoring parameter of 0.189, which represents transitions between 3 and 4. The maximum-valued scoring parameter in each dimension is also for transitions between levels 3 and 4. The mean and median of MID estimates were 0.091 (SD 0.011) and 0.093 (interquartile range IQR 0.085 – 0.101) respectively. The adjusted mean MID decreased to 0.071 (SD 0.008), whereas the median was 0.071 with IQR 0.066 – 0.077. The preference based HRQoL measures and its MID estimation may enable us to understand and interpret the change in health status of the respondents in responding to health care policy and intervention.

Assessing the validity of the ICECAP-A capability measure for adults with depression

BackgroundEffectiveness and cost-effectiveness are increasingly important considerations in determining which mental health services are funded. Questions have been raised concerning the validity of generic health status instruments used in economic evaluation for assessing mental health problems such as depression; measuring capability wellbeing offers a possible alternative. The aim of this study is to assess the validity of the ICECAP-A capability instrument for individuals with depression.MethodsHypotheses were developed using concept mapping. Validity tests and multivariable regression analysis were applied to data from a cross-sectional dataset to assess the performance of ICECAP-A in individuals who reported having a primary condition of depression. The ICECAP-A was collected alongside instruments used to measure: 1. depression using the depression scale of the Depression, Anxiety and Stress Scale (DASS-D of DASS-21); 2. mental health using the Kessler Psychological Distress Scale (K10); 3. generic health status using a common measure collected for use in economic evaluations, the five level version of EQ-5D (EQ-5D-5L).ResultsHypothesised associations between the ICECAP-A (items and index scores) and depression constructs were fully supported in statistical tests. In the multivariable analysis, instruments designed specifically to measure depression and mental health explained a greater proportion of the variation in ICECAP-A than the EQ-5D-5L.ConclusionThe ICECAP-A instrument appears to be suitable for assessing outcome in adults with depression for resource allocation purposes. Further research is required on its responsiveness and use in economic evaluation. Using a capability perspective when assessing cost-effectiveness could potentially re-orientate resource provision across physical and mental health care services.

Validation study of the prototype of a disease-specific index measure for health-related quality of life in dementia

BackgroundIndex measures for health-related quality of life (HRQoL) quantify the desirability (utility) of a certain health state. The commonly used generic index measure, e.g. EuroQol: EQ-5D, may underestimate relevant areas of specific diseases, resulting in lower validity. Disease-specific index measures on the other hand combine disease-specificity and quantification of perceived quality on several health domains of a certain disease into one single figure. These instruments have been developed for several diseases, but a dementia-specific HRQoL index instrument was not yet available. Facing the increasing individual and societal burden of dementia, specific HRQoL values with metric characteristics are especially useful because they will provide vital information for health outcome research and economic evaluations.Aims of the studyTo develop and validate the prototype of a dementia-specific HRQoL index measure: Dementia Quality of life Instrument (DQI), as the first step towards valuation of the dementia health state.MethodsFor development of the DQI we created a conceptual framework based on a review of the literature, qualitative interviews with people with dementia and their carers, expert opinion and team discussion. To assess validity we undertook a survey under 241 dementia professionals. Measurements consisted of ranking (1–5) and rating (1–10) of 5 dementia-specific DQI domains (memory, orientation, independence, social activities and mood) and simultaneously rating of 9 DQI-derived health states on a visual analogue scale (VAS). We also performed a cross-sectional study in a large sample of people with very mild to moderate dementia and their caregivers (N = 145) to assess feasibility and concurrent validity. In addition, caregivers valued 10 DQI and 10 EQ-5D + C derived health states of the patient simultaneously on the same VAS. Setting: outpatient clinics, nursing homes and patient residences.ResultsAll professionals judged the selected DQI domains to be relevant. Differences in ranking and rating behaviors were small. Mood was ranked (≥3.3) and rated (≥8.2) as most, orientation as least important (rank ≤2.6, value 7.5) health domain for dementia. For the validation part of this study the completion rates for all domains were above 98% for patients and 100% for caregivers on patients. A priori hypothesized DQI versus QOL-AD correlations that were significant in both patients and caregivers were: memory/memory, orientation/memory, independence/physical health, social activities/energy and mood/mood. Patient/caregiver inter-rater agreement was low (K < 0.2) for memory/independence, fair (K 0.2-0.4) for orientation/mood, and moderate (K 0.4-0.6) for social activities. Concurrent validity of the DQI with the EQ-5D + C was moderate. The fact that most of the correlations between the domains of these two instruments were low (≤0.40) showed that both instruments measure different elements of health status. As expected, modest correlations (≥0.40) were observed between corresponding domains of the two instruments.ConclusionsProfessionals judged all domains as relevant. The DQI prototype proved valid and feasible for patients and caregivers and is appropriate for very mild to moderate dementia. The differences in concurrent correlations with generic health status instruments imply that the dementia-specific DQI health domains indeed provide different information. The finding that patient HRQoL measured with the DQI was lower supports this notion. The new DQI shows comparable psychometric properties to the best available dementia-specific (QOL-AD) and generic (EQ-5D + C) measures. Further research is needed to generate values in the general population for each of the possible DQI states and to derive an algorithm that converts the 5 separate DQI domain scores into one single DQI Index score. Introducing the DQI Index will advance dementia-related HRQoL measurement by overcoming the shortcomings of generic and non-index instruments. This will allow more unequivocal interpretation of subjective dementia HRQoL states in dementia research.

A review of quality of life instruments used in liver transplantation

With improvements in patient and graft survival after liver transplantation, recipient quality of life (QOL) has become an important focus of patient care and clinical outcomes research. To provide a better understanding of the instruments used to assess QOL in the adult liver transplant population, we conducted a systematic review of the MEDLINE database and Cochrane library. Our review identified 128 relevant articles utilizing more than 50 different QOL instruments. Generic health status instruments are the most commonly used, and among them the Medical Outcomes Study Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and the Beck Depression Inventory (BDI) are the most prevalent. Few studies (16%) included targeted, disease-specific instruments. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Quality of Life questionnaire, the Liver Disease Quality of Life questionnaire, and the Chronic Liver Disease questionnaire are the most frequently employed targeted instruments; however, these instruments have been designed to assess QOL in patients with chronic liver disease rather than patients after liver transplantation. The present review focuses on the psychometric properties of the existing QOL instruments and discusses their individual strengths and limitations in evaluating liver transplantation recipients. The lack of a gold-standard QOL instrument for liver transplant recipients is an impediment to cross-study comparisons. We conclude that the development of a QOL instrument specifically for liver transplant recipients will improve QOL assessment in this population leading to a more nuanced understanding of the factors that influence transplant recipients' well-being.

Responsiveness of the Chinese Quality of Life Instrument in patients with congestive heart failure

The Chinese Quality of Life Instrument (ChQOL) was developed as a valid generic health status instrument based on the well-established theory of health in Chinese medicine. Psychometric properties of the ChQOL were good. In the present study, the responsiveness of the ChQOL in patients with congestive heart failure (CHF) were investigated and compared with two generic questionnaires, the Medical Outcomes Study Short Form 36-item Health Survey (SF-36) and World Health Organization Quality of Life Assessment (WHOQOL-BREF), as well as one disease-specific questionnaire, the Minnesota Living with Heart Failure Questionnaire (MLHF). Thirty-nine in-patients with CHF who had undergone treatment with integrative medicine were recruited. The health status measurements were performed at enrolment and after a 4-week treatment. The following responsiveness indices were used: the effect size (ES) and standardized response mean (SRM). All patients were classified into those groups with stable measures and those groups with changes after a 4-week treatment, based upon both the doctor's global rating of changes in heart function tests, and the patient's global rating of changes in overall quality of life. All domains of the ChQOL showed significant improvement. In the comparison of the responsiveness indices, the ChQOL was regarded as more responsive than the WHOQOL-BREF or SF-36 utility, but it was less responsive than the MLHF. The ChQOL was better in sensitivity and responsiveness for assessing congestive heart failure as a generic measure than the SF-36 and WHOQOL-BREF. The ChQOL is considered suitable as an outcome measure for clinical trials in patients with congestive heart failure.

Trends in the Measurement of Health Utilities in Published Cost-Utility Analyses

The Panel on Cost-Effectiveness in Health and Medicine recommended the compilation of a catalog of health state utility weights for use in cost-utility analyses (CUAs), and has given methodological recommendations. This study presents an update, through 2001, to our current registry of utility weights (available at http://www.tufts-nemc.org/cearegistry; previously at http://www.hsph.harvard.edu/cearegistry), and documents recent changes in methods used for utility weight elicitation. We searched the English-language medical literature for original CUAs reporting outcomes as cost per quality-adjusted life-year (QALY). Two trained readers independently audited each article, abstracting data on the health state descriptions, corresponding utility weights, methods of elicitation, and sources of the estimates. The utility elicitation methods from 1998 to 2001 were compared with the methods used to obtain utilities before 1998. We identified 306 CUAs published after 1998, reporting 1210 separate health-related utility estimates, bringing the total in our catalog to 2159 weights. Most frequently, health states pertained to the circulatory system and oncology. Methods varied substantially: 36% of authors used direct elicitation (standard gamble, time trade-off or rating scale), 23% used generic health status instruments (EQ-5D, Health Utilities Index, etc.), and 25% estimated weights based on clinical judgment. Community preferences were used in 27% of the values. Compared with pre-1998, utilities published from 1998 to 2001 were more likely to be elicited using a generic instrument, more likely elicited from community samples, and less likely derived from expert opinion, with no formally employed methodology. Increasingly, analysts conducting CUAs are using generic, preference-weighted instruments, and relying on community-based preferences. Our catalog of utility weights provides a useful reference tool for producers and consumers of CUAs, but also highlights the continued need for improvement in methods and transparency.

Estimating the Association between SF-12 Responses and EQ-5D Utility Values by Response Mapping

Reliably mapping from generic or disease-specific health status measures into health state utilities would assist health economists. Existing studies mainly use ordinary least squares (OLS) regression equations to predict utility values for particular health states. The authors examine an alternative approach to map between 2 generic health status instruments, the SF-12 and the EQ-5D. Multinomial logit regression is used to estimate the probability that a respondent will select a particular level of response to questions in the EQ-5D, using individual question responses and summary scores from the SF-12 as predictors. Monte Carlo simulation methods are used to generate predicted EQ-5D responses, and utility scores (tariffs) are then attached. Results are compared with an alternative approach based on direct mapping to utility scores using OLS. The authors estimate equations using 12,967 adult survey responses-from the 2000 US Medical Expenditure Panel Survey. They report mean squared error (MSE) and mean absolute error (MAE) of their predicted utilities within this sample, and out-of-sample using 13,304 adults from the 1996 Health Survey for England. The authors obtain an in-sample and out-of-sample MSE of 0.03, compared with 0.02 for the OLS approach. Their MAE of 0.11 is similar to OLS results. The authors' method predicts group mean utility scores and differentiates between groups with or without known existing illness. The authors' approach has higher MSE than the direct OLS approach but gives more descriptive data on domains of health effects. Further out of sample prediction work will help test the validity of these methods.

The WHO-DAS II: Psychometric Properties in the Measurement of Functional Health Status in Adults With Acquired Hearing Loss

The World Health Organization's (WHO) Disability Assessment Scale II (WHO-DAS II) is a generic health-status instrument firmly grounded in the WHO's International Classification of Functioning, Disability and Health (WHO-ICF). As such, it assesses functioning for six domains: communication, mobility, self-care, interpersonal, life activities, and participation. Domain scores aggregate to a total score. Because the WHO-DAS II contains questions relevant to hearing and communication, it has good face validity for use as an outcome measure for audiologic intervention. The purpose of the present study was to determine the psychometric properties of the WHO-DAS II on a sample of individuals with adult-onset hearing loss, including convergent validity, internal consistency, and test-retest stability. Convergent validity was established by examining correlations between the WHO-DAS II (domain and total scores) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Hearing Aid Handicap for the Elderly (HHIE), two disease-specific measures, as well as with the Short Form-36 for veterans (SF-36V), a second generic measure. Data on all four measures were collected from 380 older individuals with adult-onset hearing loss who were not hearing aid users. The results of the convergent validity analysis revealed that the WHODAS II communication domain score was moderately and significantly correlated with scores on the APHAB and the HHIE. WHO-DAS II interpersonal and participation domain scores and the total scores were also moderately and significantly correlated with HHIE scores. These findings support the validity of using the WHO-DAS II for assessing activity limitations and participation restrictions of adult-onset hearing loss. Several WHO-DAS II domain scores and the total score were also significantly and moderately-markedly correlated with scores from the SF-36V. These findings support the validity of the WHO-DAS II as a generic health-status instrument. Internal consistency reliability for all the domain scores was adequate for all but the interpersonal domain. Test-retest stability for all the domain scores was adequate. Critical difference values were calculated for use in clinical application of the WHO-DAS II. From these findings, we concluded that the WHO-DAS II communication, participation, and total scores can be used to examine the effects of adult-onset hearing loss on functional health status. Further work examining the utility of the WHO-DAS II as an outcome measure for hearing aid intervention is warranted.

The WHO-DAS II: Measuring Outcomes of Hearing Aid Intervention for Adults

The World Health Organization's Disability Assessment Scale II (WHO-DAS II) is a generic health-status instrument that provides six domain scores and a total, aggregate score. Two of the domain scores, communication and participation, and the total score, have good validity, internal-consistency reliability, and test-retest stability in individuals with adult-onset hearing loss. As such, these two domain scores and the total WHO-DAS II score may be useful as generic outcome measures to assess the effectiveness of hearing aid intervention for this population. Before the use of the WHO-DAS II in hearing aid clinical trials, however, the responsiveness of the instrument and the short- and long-term outcomes to hearing aid intervention had to be determined. Responsiveness and outcomes were assessed in 380 veterans (approximately half received hearing aids and half served as controls) by examining group differences, effect-size estimates, and individual differences as a function of hearing aid intervention. For comparison, data also were obtained on two disease-specific measures, the APHAB and the HHIE. The WHO-DAS II communication domain and total scores were sufficiently responsive to hearing aid intervention for use in future studies in which group differences are to be detected. The WHO-DAS II participation domain was not sufficiently responsive to hearing aid intervention. The APHAB and HHIE, both disease-specific measures, were more sensitive to hearing aid intervention than the generic measure. The short- and long-term outcomes of hearing aid intervention were also examined in the present study. Group outcomes for hearing aid intervention can be expected to be stable for at least 6 months when measured by WHO-DAS II total score and for at least 12 months when measured by the WHO-DAS II communication domain scores. Effect-size estimates and examination of the number of individuals exhibiting change scores exceeding 90% critical differences for true changes in scores indicate that for clinical applications, disease-specific instruments are more useful than the WHO-DAS II. The findings of this study support the use of the WHO-DAS II as a generic measure in hearing aid trials research so as to allow for comparisons of health-status outcomes across different diseases or disorders.

Quality of life in elderly patients with dizziness: analysis of the short-form health survey in 197 patients

ConclusionElderly patients with chronic dizziness had a poor HRQoL, which could be successfully assessed using the SF-36, a generic health-status instrument. The frequency of dizziness and comorbid psychological distress were predictive of impairment in QoL.ObjectivesTo evaluate health-related quality of life (HRQoL) and its relationship to characteristics of dizziness in elderly persons with chronic dizziness.Material and methodsA standardized dizziness questionnaire was used to evaluate characteristics of dizziness as well as medical, functional and demographic data in 197 consecutive patients with chronic dizziness aged≥60 years. HRQoL was evaluated using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS).ResultsCompared with normative data, results from patients with dizziness indicated a pervasive multidimensional decline in SF-36 scores. This decline was most notable in terms of role limitations in the physical and emotional dimensions. The frequency of attacks of dizziness correlated with perceived disability. Patients with chronic dizziness also had great psychological distress, as measured by the HADS score, which had a detrimental influence on their QoL.

Assessing the quality of life of adults with chronic respiratory diseases in routine primary care: construction and first validation of the 10-Item Respiratory Illness Questionnaire-monitoring 10 (RIQ-MON10).

As doctors' judgements about the burden of a disease often differ from patients' own assessments a manageable method to incorporate the latter into routine care might support patient-centered decision-making. For this purpose we shortened the 55-Item Quality of Life for Respiratory Illness Questionnaire (QoL-RIQ). Secondary analyses of the data of 3 controlled studies (n = 328, 502 and 555). inter-item correlations, scale distributions, Cronbach's alpha and factor analysis. Dyspnoea, forced expiratory volume in 1 s (FEV1), COOP/WONCA charts, the Medical Research Council-ECCS symptoms questionnaire and the MOS-SF 36 served as criteria to test validity and responsiveness. Item-reduction resulted in a 10-item short form (alpha's 0.87-0.90), consisting of 2 5-item factors: (1) physical and emotional complaints and (2) physical and social limitations. The correlations of the short form with dyspnoea (r from 0.57 to 0.60), the generic health status instruments (r from 0.39 to 0.59) and lung function (r from 0.10 to 0.15) fulfilled the criteria. FURTHER RESULTS: a clinical relevant score difference (> 0.5) between upper and lower quartiles of the convergent instruments, an intraclass correlation between repeated scores in a stable group of 0.82 and a standardised response mean of 0.86 in an improved group of patients. The short form (RIQ-MON10) maintained the psychometric properties of the original instrument and is promising for assessing quality of life (QoL) during routine primary care visits.

Valores poblacionales de referencia del perfil de salud CHIP-AE a partir de una muestra representativa de adolescentes escolarizados

AimThe Child Health and Illness Profile (CHIP-AE) is a generic health status instrument for adolescents aged 12-19 years adapted for use in Spain. The aim of this study was to obtain reference population values of the Spanish version of the CHIPAE. MethodsThe CHIP-AE was administered to a representative sample of adolescents from schools in Barcelona. The sample was selected by using cluster-sampling, stratified by type of school (public or private) and an ecological socioeconomic index (Índice de Capacidad Familiar: low, middle, and high). The CHIP-AE scores were standardized to a mean of 20 and a standard deviation (SD) of 5. Means and percentiles were computed. Means were compared by age, gender, and socioeconomic status using analysis of variance. ResultsThe response rate was 81% (n = 902). The distribution of the CHIP-AE scores presented a wide range with scores generally skewed toward positive health status. Nevertheless, the results suggest that the sample selected from a general population was not free of health problems. Twentyfive percent of adolescents presented scores below 17.2 in the domain of discomfort, indicating an effect size of 0.56 standardized SD units. The distribution of scores in the reference samples from Barcelona was similar to the original results in Baltimore (USA), with some marginal differences in individual risks. ConclusionsThe CHIP-AE systematically gathers information on health domains in adolescents. The results from this reference sample will allow comparisons with adolescents from other regions, and/or with different health problems, as well as description of inequalities in health during adolescence.

The SIP68: an abbreviated sickness impact profile for disability outcomes research.

The Sickness Impact Profile (SIP) is one of the most widely recognized generic health status instruments, but its length has often left it out of consideration for outcomes research. We assess a short alternative, the Sickness Impact Profile 68 (SIP68), for retest and proxy reliability, validity, and scaling properties, in a population of adults with disability (PWD). For convergent validity, the SIP68 was compared to the instrumental activities of daily living (IADLs), activities of daily living (ADLs) and the short-form 36 (SF-36). We completed 398 interviews with PWD, 131 index-proxy sets, and 40 retests. Retest intraclass correlations were above 0.75 for all scales and dimensions except the physical dimension (0.61). Proxy reliability ranged from 0.26 (psychological autonomy and communication) to 0.85 (somatic autonomy). Correlation between the SIP68 and SIP was 0.94 overall; between the SIP68 and similar scales of the SF-36 correlations was moderate, and highest for physical health scales. We repeated the SIP68 development factor analysis and reproduced a structure of the full SIP that included 65 of SIP68 items. However, 36 additional items were retained that are not part of the SIP68. Overall, the SIP68 shows promise for use as a disability outcomes tool.

Monitoring the quality of life of patients with asthma and COPD in general practice: psychometric properties of a 10-item questionnaire (the RIQ-MON10)

Physicians need a good assessment of patients' perceived burden of the disease in order to provide adequate treatment and support. As doctors' judgements often differ from patients'own assessments, a manageable method to incorporate the latter into routine primary care might support patient-centered decision-making. For this purpose we converted a 55-item 7-point Likert scale questionnaire, measuring quality of life of patients with mild to moderate respiratory diseases (QOL-RIQ), into a short form. Prototypes proved applicable in normal care. We analysed the data of three controlled studies performed in primary care (N = 328, 502 and 555 patients). Procedures: inter-item correlations, scale distributions, Cronbach's alpha and factor analysis. A panel of 15 GP-experts judged the clinical relevance of the selection. Dyspnoea, FEV1 % pred, the MRC-ECCS, COOP/WONCA charts and the MOS-SF 36 served as external criteria to test validity and responsiveness. Item reduction resulted in a 10-item short form (alpha's. 87 to. 90), consisting of two 5-item factors: physical and emotional complaints and physical and social limitations. The panel (>70%) considered the selection fit for monitoring in routine care. The correlation of the shortlist with the original instrument (r=.89–.92) was high as well as with dyspnoea (r=.57–.60) and the generic health status instruments (r=.39–.59). As expected there was a low correlation with lung function (r=.10–.15). The short form shows a clinical relevant score difference (>.5) between upper and lower quartiles of the convergent instruments and a high correlation between the repeated scores in a stable group of patients (ICC =.82). The short form reflected the change in a group of 15 improved patients (SRM =.86). The short form questionnaire (RIQ-MON10) maintained the psychometric properties of the original instrument. It has good discriminative properties and seems promising as a practical tool for monitoring quality of life in routine primary care. Large-scaled testing of its reliability and sensitivity to change is planned.

A new measure for assessing the health-related quality of life of patients with vertigo, dizziness or imbalance: the VDI questionnaire.

Vertigo, dizziness and imbalance are frequent symptoms among patients in clinical practice. We present the development of a new multipurpose measure specific to patients with these symptoms: the VDI questionnaire. Items of the VDI questionnaire were generated through an international panel of clinicians, in-depth interviews with 25 patients and an extensive literature search. Items were reduced by qualitative and quantitative methods. Psychometric properties were tested in 130 patients recruited in primary care general practices, neurologists and ENT out-patient clinics. Patients were clinically evaluated and administered several specific and generic health status instruments: the Balance Scale, the SF-12 Health Survey and the General Health Questionnaire 12 items. The VDI symptoms and the VDI health related quality of life (HRQoL) scales were administered during the visit and some weeks after. Correlation and confirmatory factor analysis were used. Reliability of the VDI was high (0.92 for VDI HRQoL scale and 0.86 for VDI symptoms). VDI scores were more correlated with Balance Scale scores than with mental health indicators. All factor loadings were significantly different from zero and confirmed the expected relations. In the second administration, VDI scores showed a deterioration among those reporting a worsening in their symptoms and an improvement among those reporting feeling better. The data presented suggest that the VDI questionnaire is a reliable, valid and responsive instrument for patients with vertigo, dizziness or imbalance. The VDI questionnaire could be a useful complement of the clinical evaluation of these patients at both group and individual level.

Measuring patient benefit from botulinum toxin in the treatment of dystonia. Feasibility of cost-utility analysis.

The dystonias are a group of movement disorders arising from CNS dysfunction and characterised by involuntary and prolonged spasms of muscle contraction. Recently there has been increasing demand for treatment with botulinum toxin (BT), a relatively expensive neurological paralytic agent. As there has been no systematic assessment of patient benefit from BT, this study was undertaken to develop and test a methodology for assessing the cost utility of BT therapy for patients with dystonias. A generic health status instrument, the EuroQOL, was completed at regular intervals over at least 6 months by 130 patients with a current diagnosis of dystonia. A general population tariff was used to calculate quality-adjusted life-year (QALY) gains from BT treatment, and relevant cost data were obtained from patients and medical records. The cost-per-QALY estimates ranged considerably, depending on the type of dystonia, the duration of BT treatment, type of health-related quality-of-life (HR-QOL) tariff used and baseline characteristics of participants. The study findings reflect the general clinical impression of BT: that it can benefit patients with dystonia, but the benefit may be small compared with many treatments for other diseases. The nature of the disease and its cyclical treatment caused practical difficulties in recruiting participants, administering questionnaires and in estimating QALY gains.