Validation of the inflammatory bowel disease questionnaire IBDQ-D, German version, for patients with ileal pouch anal anastomosis for ulcerative colitis

BACKGROUND AND AIMS: The inflammatory bowel disease questionnaire (IBDQ) is the standard instrument for assessment of health-related quality of life (HRQOL) in patients with inflammatory bowel diseases. It has not been validated for patients with ileal pouch anal anastomosis (IPAA) and ulcerative colitis (UC). METHODS: To determine acceptance (percentage of completed items), reliability (Cronbach's alpha of the IBDQ-D subscales) and convergent validity (correlations of the IBDQ subscales with the questionnaires used for validation) 61 patients with UC (age 52.7 +/- 13.9 years; 47 % female, 53 % male) and IPAA completed the German (Competence Network IBD) version of the Inflammatory Bowel Disease Questionnaire (IBDQ-D), the Short Form Health Survey (SF-36) the Hospital Anxiety and Depression Scale German Version (HADS-D) and the Giessener Symptom List (GBB 24). Face validity was assessed by a physicians' and patients' panel. All 37 patients underwent endoscopy making it possible to differentiate between patients with and without pouchitis (discriminant validity). RESULTS: With 97.7 % completed items the acceptance was high. Cronbach's alpha value for the subscales ranged from 0.71 to 0.93. Missing items covering extraintestinal manifestations of IBD were criticized by patients. The correlation coefficients with comparable subscales of other instruments ranged between 0.41 and 0.76. Patients with clinical pouchitis scored significantly lower in all subscales than patients without pouchitis (p < 0.001). CONCLUSION: The IBDQ-D has good acceptance, reliability, convergent and discriminant validity, but limited face and construct validity in patients with IPAA and UC.     

Development and evaluation of the quality of life instrument in chronic liver disease patients with minimal hepatic encephalopathy

Objectives:  The objective was to develop a valid and reliable health-related quality of life (HRQOL) assessment tool to measure the functional and health status of patients with minimal hepatic encephalopathy (mHE).
Methods:  Items potentially affecting the HRQOL of these patients were identified, based on the responses from 53 patients with minimal hepatic encephalopathy, from seven liver experts, four epidemiologists and from a PubMed search of the literature. Results were explored using factor analysis and redundant questions were eliminated. The final stated questionnaire was used in 178 patients with mHE to evaluate its reliability and validity.
Results:  Thirty-five items proved to be important for 32 respondents in the item reduction sample. The final instrument included five domains (30 items) which were shown as follows: physical functioning (8 items), psychological well-being (7 items), symptoms/side effects (7 items), social functioning (4 items) and general-health (4 items). An inter-item correlation for each of the five domains ranged from 0.220 to 0.776, with a mean of 0.280. Cronbach's alpha for above five domains was 0.8775, 0.8446, 0.8360, 0.7087 and 0.7016 respectively. The test-retest coefficients for the five domains were 0.94, 0.93, 0.96, 0.82 and 0.83 respectively. Factor analysis showed preservation of five components structure. Cumulative variance of principal components was 63.12%. Patients with more advanced disease seemed to have more impairment of their well-being, especially in the symptoms/side effects domain.
Conclusions:  The instrument is short, easy to administer and is of good validity and reliability in patients with mHE.     

Validation of a German Version of the Fatigue Impact Scale FIS-D

OBJECTIVE: The Fatigue Impact Scale, FIS, is an internationally used instrument for the assessment of the impact of fatigue on Health-Related Quality of Life, HRQOL, also in patients with chronic liver diseases. In the German-speaking countries a validated instrument for measuring the impact of fatigue on patients with chronic liver diseases has not been available so far. METHODS: The German linguistic adaptation of the FIS using a forward-backward procedure was administered to 204 patients (age 52,7 +/- 13,9 years; 47 % female, 53 % male, 45 % no cirrhosis, 22 % Child's A, 15 % Child's B and 17 % Child's C cirrhosis; 53 % with chronic viral hepatitis, 32 % with alcoholic and 15 % with other liver diseases) of a secondary care hospital. The following internationally accepted instruments were used for validation: The Short Form Health Survey, SF 36, the Hospital Anxiety and Depression Scale German Version, HADS-D, and the Giessener Symptom Scale, GBB 24. Fifty patients in clinically stable situation filled out the FIS-D within 3 - 8 days. RESULTS: The acceptance of the FIS-D was high with 98 % answered items. The internal consistency of the three subscales was excellent (0.94 - 0.96), the test-retest reliability of the three subscales was good (0.72 - 0.83). The correlation coefficients with the validation instruments ranged between 0.49 and 0.80 (all p < 0 001). No differences in the FIS-D subscale scores were found in patients with and without cirrhosis and between the different Child-Pugh stages of liver cirrhosis. Patients treated with tranquilizer or antidepressants scored higher in the FIS-D than patients without this treatment (p < 0.05). CONCLUSION: The FIS-D is well accepted by patients in clinical routine care and has been shown to have good acceptance and reliability in the assessment of fatigue in chronic liver patients.     

Development and validation of a disease-targeted quality of life instrument in chronic hepatitis B: the hepatitis B quality of life instrument, version 1.0

Despite the increasing realization that health-related quality of life (HRQOL) is an important outcome in chronic HBV infection, there are no validated, disease-targeted instruments currently available. We sought to develop and validate the first disease-targeted HRQOL instrument in noncirrhotic HBV: the Hepatitis B Quality of Life instrument, version 1.0 (HBQOL v1.0). We established content validity for the HBQOL v1.0 by conducting a systematic literature review, an expert focus group, and cognitive interviews with HBV patients. We administered the resultant questionnaire to 138 HBV patients. We used factor analysis to test hypotheses regarding HRQOL domains and measured construct validity by comparing HBQOL v1.0 scores across several anchors, including viral response to treatment, SF-36 scores, and global health. Finally, we measured test-retest and internal consistency reliability. Content validation revealed that HBV affects multiple aspects of psychological, social, and physical health. The resultant questionnaire summarized this HRQOL impact with 31 items across six subscales: psychological well-being, anticipation anxiety, vitality, disease stigma, vulnerability, and transmissibility. Internal consistency and test-retest reliability were excellent. The HBQOL v1.0 discriminated between viral responders versus nonresponders and correlated highly with SF-36 scores and global health. CONCLUSION: Patients with chronic HBV infection attribute a wide range of negative psychological, social, and physical symptoms to their condition, even in the absence of cirrhosis or cancer. The HBQOL v1.0 is a valid and reliable measure that captures this HRQOL decrement. This instrument may be useful in everyday clinical practice and in future clinical trials.     

Development and initial evaluation of a measure of self-management for adults with antineutrophil cytoplasmic antibody-associated small-vessel vasculitis

OBJECTIVE: To develop a measure of illness self-management for adults living with antineutrophil cytoplasmic antibody (ANCA)-associated small-vessel vasculitis (ANCA-SVV) and to gather evidence of its reliability and validity. METHODS: Development of the Vasculitis Self-Management Scale (VSMS) was guided by previous research on self-management in other chronically ill populations, a review of the current treatment literature for ANCA-SVV, interviews with patients, and consultation with experts. A total of 205 patients living with ANCA-SVV or a closely related condition then completed the VSMS, along with measures of sociodemographic and clinical variables, social desirability bias, and general adherence to medical recommendations, using a self-administered mailed questionnaire. A principal components analysis was conducted on the VSMS items. Internal consistency reliability and construct validity of the resulting subscales were assessed. Forty-four patients completed the VSMS a second time, for the purpose of assessing test-retest reliability. RESULTS: Analyses suggested an 8-factor solution. The final VSMS consisted of 43 items representing these 8 behavioral domains. Correlations among the 8 domains were null to modest in magnitude. The internal consistency reliability of the 8 subscales ranged from minimally acceptable (alpha = 0.67) to excellent (alpha = 0.94), and correlations between subscale scores at time 1 and time 2 suggested good temporal stability. Preliminary evidence for validity was mixed. CONCLUSION: These findings suggest that the VSMS is a promising method for assessing illness self-management in adults with ANCA-SVV. More research exploring the validity of the measure is warranted.     

Translation and validation of Arthritis Impact Measurement Scales 2 into Chinese: CAIMS2

OBJECTIVE: To evaluate the validity, reliability, and cultural relevance of the Arthritis Impact Measurement Scales 2 (AIMS2) as a health assessment tool for Chinese-speaking patients with arthritis. METHODS: The cultural relevance, language equivalency, and content validity of the AIMS2, Chinese version (CAIMS2) were evaluated by an expert panel. Measurement performance was tested on 240 subjects (rheumatoid arthritis = 81, osteoarthritis = 77, healthy = 82). Subjects (n = 175) were retested within 2 weeks for testing of reliability. RESULTS: Three items were modified and 2 items were added, as suggested by the expert panel. Interitem reliability was satisfactory (intraclass correlation coefficient 0.8552-0.9594). Test-retest reliability of the CAIMS2 subscales ranged from 0.770 to 0.952 in subjects in whom the CAIMS2 was self administered. Significant score differences between patients with arthritis and healthy subjects were found in all 12 subscales, except for the support from family and friends and tension subscales. CAIMS2 subscale scores correlated with clinical and laboratory measures of disease activity and patients' perceived quality of life as measured using the Chinese version of the World Health Organization Quality of Life instrument. CONCLUSION: Empirical data support CAIMS2 is a valid and reliable health status measure for Chinese speaking patients with arthritis.     

Development of a preliminary scleroderma gastrointestinal tract 1.0 quality of life instrument

OBJECTIVE: Gastrointestinal tract (GIT) involvement occurs in approximately 90% of patients with systemic sclerosis (SSc) and has a major impact on health-related quality of life (HRQOL). We developed an HRQOL instrument for persons with SSc. METHODS: The Scleroderma Gastrointestinal Tract 1.0 (SSC-GIT 1.0) survey was developed after an extensive literature search, solicitation and consideration of experts' opinions, and 2 focus groups of 16 subjects with SSc and GIT involvement. A 75-item, self-reported measure assessing bowel involvement, emotional well-being, and social functioning was administered to subjects with SSc and GIT involvement. Also, subjects completed the Short Form 36 and rated the severity of their GIT symptoms (very mild to very severe), and items were transformed linearly to a scale with a possible range of 0 (worse health) to 100 (better health). Evaluation of psychometric properties included internal consistency reliability, test-retest reliability (1.3-week median time interval), multitrait scaling analysis, and exploratory factor analysis. RESULTS: Study participants (n = 88) were primarily female (95.5%), white (79.3%), and had a mean age of 52.4 years. Self-rated severity of GIT involvement ranged from very mild or mild (36.0%) to moderate (44.0%) to severe or very severe (20.0%). Of 75 items, 23 had low item-total correlations (相似文献   

Validation of a German version of the Fibromyalgia Impact Questionnaire (FIQ-G)

OBJECTIVE: To translate the Fibromyalgia Impact Questionnaire (FIQ) into German and to evaluate its reliability and validity for the use of German speaking patients with fibromyalgia (FM). METHODS: We administered the FIQ to 55 patients with FM (15 patients filled out the questionnaire 10 days later) together with German versions of the Stanford Health Assessment Questionnaire (HAQ), the Medical Outcomes Survey Short Form-36 (SF-36), and a tender point count (TPC). All patients were asked about the severity of pain today (10 cm visual analog scale) and the duration of symptoms. Tenderness thresholds were assessed by dolorimetry at all tender points with a Fisher dolorimeter and laboratory tests were obtained. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FIQ was evaluated by correlating the HAQ and subscales of the SF-36 as well as the TPC and the tenderness thresholds. RESULTS: Mean age of participants was 54.3 years and mean duration of symptoms 9.5 years. Test-retest reliability was between 0.62 and 1 for the physical functioning as well as for the total FIQ and other components. Internal consistency was 0.92 for the overall FIQ. Significant correlations were obtained between the FIQ items, the HAQ, and the SF-36. CONCLUSION: The German FIQ is a reliable and valid instrument for measuring functional disability and health status in German patients with FM.     

Quality of life in coeliac patients: Italian validation of a coeliac questionnaire

BackgroundCoeliac disease (CD) is a chronic condition requiring a gluten-free diet, which is a very demanding diet to maintain on a life-long basis. For this reason it is a condition that can have serious repercussions on the quality of life (QOL). Therefore the need to elaborate a questionnaire on QOL specifically for patients with CD (CDQ): its original language is German, and the translation/validation process represents a considerable challenge involving not only a translation into Italian but also an adaptation to the country's specific cultural differences.MethodsThe questionnaire has been translated according to a “German→Italian→Italian→German” algorithm with reconciliation of the differences. Scores for CDQ are computed overall and over four areas of four items each: emotion, gastrointestinal symptoms, gastrointestinal worries, social problems.ResultsCDQ was administered to 171 coeliacs (F 132, mean age 38 yrs ± 14). Completeness was optimal. Item internal consistency was satisfied for 100% and 97% of patients for the specific and generic part, respectively. Cronbach's α coefficient was 0.7 for all scales. The general CDQ was higher in patients reporting subjective well-being (discriminant validity).ConclusionsThe Italian translation of CDQ sounds natural, is easy to understand and reduces possible cultural biases to a minimum. A field test gave results comparable to the original validation, supporting the use of CDQ in cross-national surveys.     

Gender differences in health-related quality of life in patients complaining of chronic cough

STUDY OBJECTIVES: To confirm that more women than men who complain of chronic cough seek medical attention, to determine whether the health-related quality of life (HRQOL) of these women is more adversely affected than men, and to determine whether there are gender differences in the ways that chronic cough adversely affects HRQOL. DESIGN: Analysis of previously, prospectively collected data, but not previously analyzed or reported data, plus additional prospectively collected data to enrich the database to make meaningful gender comparisons. SETTING: Cough clinic in an academic, tertiary care medical center. PARTICIPANTS: Subjects seeking medical attention complaining of cough of at least 8 weeks duration and a control group of smokers not complaining of cough. MEASUREMENTS: Assessment of chronic cough on HRQOL utilizing a valid and reliable cough-specific HRQOL instrument, the cough-specific quality-of-life questionnaire (CQLQ). INTERVENTIONS: All subjects completed the CQLQ prior to any contact with the cough specialist and medical intervention. RESULTS: In the original cohort of subjects, women (116 subjects) outnumbered the men (38 subject) by 3:1 (p < 0.0001). In the current study, total CQLQ scores for women were higher than for men (67.1 vs 59.7, respectively; p = 0.002). Women had higher scores than men in three of six subscales, as follows: physical complaints (21.6 vs 19.0, respectively; p = 0.004); psychosocial issues (14.7 vs 12.9, respectively; p = 0.002); and extreme physical complaints (8.9 vs 6.6, respectively; p < 0.001). Men and women had similar scores on the remaining subscales. Women scored significantly higher on 10 of the 28 items that make up the six subscales. The item that showed the greatest disparity and the most significant difference between women and men was wetting the pants (p < 0.001) as a result of chronic coughing. CONCLUSIONS: Women with chronic cough were probably more inclined to seek medical attention than men because their HRQOL was more adversely affected and because they were more apt to suffer from physical complaints such as stress incontinence, which provoked psychosocial issues such as becoming embarrassed.     

The clinimetric properties of the World Health Organization Disability Assessment Schedule II in early inflammatory arthritis

OBJECTIVE: To assess the clinimetric properties of a new health-related quality of life (HRQOL) instrument, the World Health Organization Disability Assessment Schedule II (WHODAS II), in patients with early inflammatory arthritis. METHODS: Internal consistency as well as criterion, construct, and discriminative validity of the WHODAS II were assessed in 172 patients with early inflammatory arthritis who completed the WHODAS II, the Medical Outcomes Study Short Form 36 (SF-36), and other measures of disease severity, functioning, pain, depression, and resource use. Test-retest reliability of the WHODAS II was assessed by having a subset of 20 patients complete the WHODAS II a second time, 1 week after the first assessment. RESULTS: The WHODAS II had high internal consistency (Cronbach's alpha = 0.96 for patients working or in school and 0.93 for patients not working or in school). Test-retest intraclass correlation coefficients of the WHODAS II total score and subscales ranged from 0.82-0.96. The WHODAS II total score was strongly correlated with the SF-36 physical component score (Kendall's tau-b 0.51, P < 0.001) and moderately correlated with the SF-36 mental component score (tau-b 0.43, P < 0.001). WHODAS II correlations with disease outcomes ranged from Kendall's tau-b 0.15-0.55. The WHODAS II significantly differentiated between every aspect of disease severity assessed with the exception of measures of health resource use. CONCLUSION: The WHODAS II is a valid and reliable measure of HRQOL in cross-sectional studies of patients with early inflammatory arthritis. Research is still required to investigate potential item redundancy and determine its usefulness in longitudinal studies.     

Quality of life and economic burden of illness in very early arthritis. A population based study in southern Sweden

OBJECTIVE: To measure health related quality of life (HRQOL) in patients with very early arthritis in a population based study in southern Sweden, and to compare HRQOL at baseline between the different diagnostic groups. Further, we investigated whether HRQOL at baseline correlated with the costs the patients incurred during the study. METHODS: Seventy-one adult patients with arthritis of less than 3 months' duration were referred from primary health care centers to rheumatologists. HRQOL was measured with the Arthritis Impact Measurement Scales (AIMS) and EuroQol at baseline. A comparison of HRQOL measures at baseline and the costs the patients incurred during the study was conducted in 56 of the patients. RESULTS: Twenty-seven (38%) patients had reactive arthritis (ReA), 17 (24%) undifferentiated arthritis, 15 (21%) rheumatoid arthritis (RA), 4 (6%) psoriatic arthritis, and the rest (11%) other diagnoses. Statistically significant differences were found between the 4 patient groups concerning the AIMS subscales of dexterity, household activity, activities of daily living (ADL) and pain, the patients with RA being most severely affected. There were no statistically significant differences between the 4 diagnosis groups concerning the EuroQol utility and EuroQol visual analog scale (VAS) scores. Of the AIMS subscales, the mobility, physical activity, household activity, ADL, and pain subscales correlated significantly with the incurred costs. Also the EuroQol utility scores and EuroQol VAS scores correlated significantly with the costs. Only the AIMS household activity subscale predicted the costs in the regression analysis. CONCLUSION: Patients with RA had significantly worse scores in the AIMS dexterity, household activities, ADL, and pain subscales compared to patients with other arthritides very early in the disease. The EuroQol generic quality of life instrument was less sensitive in detecting differences between patients with early arthritis than the disease-specific AIMS instrument. There was a correlation between the costs and the EuroQol utility scores and EuroQol VAS scores during the very first months of the disease, as well as with costs and the AIMS subscales of mobility, physical activity, household activity, ADL, and pain.     

For the common good: Measuring residents' efforts to protect their community from drug- and sex-related harm

People in high-risk neighbourhoods try to protect their friends, neighbours, relatives and others from the social and physical risks associated with sex and drug use. This paper develops and validates a community-grounded questionnaire to measure such ‘intravention’ (health-directed efforts to protect others). An initial ethnography, including life-history interviews and focus groups, explored the forms of intravention activities engaged in by residents of Bushwick (a high-risk New York City neighbourhood). Grassroots categories of intraventions were derived and questions developed to ask about such behaviours. Face validity and adequacy of the questions were assessed by independent experts. Pre-testing was conducted, and reliability and validity were assessed. An instrument including 110 intravention items was administered to 57 community-recruited residents. Analysis focused on 57 items in 11 domain-specific subscale. All subscales had good to very good reliability; Cronbach's alpha ranged from .81 to .95. The subscales evidenced both convergent and discriminant validity. Although further testing of this instrument on additional populations is clearly warranted, this intravention instrument seems valid and reliable. It can be used by researchers in comparative and longitudinal studies of the causes, prevalence and affects of different intravention activities in communities. It can benefit public health practitioners by helping them understand the environments in which they are intervening and by helping them find ways to cooperate with local neighbourhood-level health activists.     

Development and Evaluation of an Asthma-Specific Quality of Life (A-QOL) Questionnaire

Background. Few health-related quality of life (HRQOL) studies of asthma patients have been conducted in Korea, mainly due to the lack of a psychometrically validated asthma-specific instrument. Objective. The aims of the present study were to develop and evaluate an instrument for assessing HRQOL in Korean asthma patients (asthma-specific quality of life, [A-QOL]). Methods. Items were generated using in-depth interviews and a review of the literature and were subsequently reviewed by a panel of experts. Content-validated items were evaluated psychometrically with the aid of 422 asthma patients who were recruited from university hospitals in South Korea. The participants were asked to complete a preliminary A-QOL questionnaire (comprising the content-validated items), the Asthma Control Test, the Center for Epidemiologic Studies-Depression Survey (CES-D), and the Short Form-36 Health Survey. The Global Initiative for Asthma Guideline classification was also used to classify the severity of asthma. The psychometric properties of the data were analyzed. Results: Thirty-six preliminary items were generated, from which factor analysis extracted a six-factor solution. Six of the items were not loaded significantly on any of the factors, such that they were not heterogeneous items. Multi-trait scaling analysis supported item convergence and discriminant validity. The A-QOL was associated significantly with the CES-D. Patients with controlled asthma had higher A-QOL scores than those whose asthma was not controlled. The quality of life measured by the A-QOL was more sensitive than that measured by the generic Short Form-36 Health Survey. The values of Cronbach's alpha for the subscales of the A-QOL were all greater than 0.70. The responsiveness of all subscales, excluding the “environmental distress” subscale, was established. Conclusions. The A-QOL is an easily applied tool that exhibits good psychometric properties for asthma patients. The A-QOL questionnaire is valid for and can be used reliably in both practice and clinical trials.     

Determinants of health-related quality of life in patients with chronic liver diseases.

BACKGROUND AND AIMS: The study aims to assess influence of the liver disease, active medical and psychiatric comorbidities, and sociodemographic variables in the determination of health-related quality of life (HRQOL) measured by a generic and a liver-specific instrument in unselected patients with chronic liver disease. METHODS: Two hundred four of 255 consecutive patients (80%) with all stages of various liver diseases attending a tertiary-care center completed the following self-report questionnaires: sociodemographic questionnaire of the Competence Network Bowel Disease, morbidity list of the German Pain Questionnaire, the German version of the Hospital Anxiety and Depression Scale (HADS-D), and Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) as generic instruments; and the German version of the Chronic Liver Disease Questionnaire (CLDQ) as a disease-specific HRQOL-instrument. RESULTS: Stepwise multiple regression showed that cause of liver disease, severity of disease (cirrhosis vs. no cirrhosis, Child-Pugh score), sex, age, and social class had no effect on HRQOL. Anxiety resp. depression scores >/= 11 in the German version of the HADS, indicating a probable psychiatric disorder, contributed independently to the impaired HRQOL in the total score of the CLDQ and the Physical and Mental Summary Scores of the SF-36 (P < 0.0001). Number of active medical comorbidities contributed independently to the reduced HRQOL in the total score of the CLDQ and the Physical Summary Score of the SF-36 (P < 0.0001). Furthermore, the SF-36 Mental Summary Score was influenced negatively by active cardiovascular comorbidity (P < 0.003). CONCLUSIONS: Psychiatric comorbidity and active medical comorbidity, and not severity of the liver disease according to Child-Pugh score, determine reduced HRQOL in patients with chronic liver diseases.     

Psychometric testing of the self-care of heart failure index

BACKGROUND: Self-care is believed to improve outcomes in heart failure (HF) patients. However, research testing this assumption is hampered by difficulties in measuring self-care. The purpose of this study was to evaluate the psychometric properties of a revised instrument measuring self-care in persons with HF, the Self-Care of Heart Failure Index (SCHFI). The SCHFI is a self-report measure comprised of 15 items rated on a 4-point response scale and divided into 3 subscales. METHODS AND RESULTS: Psychometric testing was done using data from 760 HF patients (age 70.36 +/- 12.3 years, 51% male) from 7 sites in the United States. Reliability of the SCHFI (alpha.76) was adequate. Reliability of the Self-Care Maintenance subscale was lower than desired (alpha.56) but the reliability of the other subscales was adequate: Self-Care Management (alpha.70) and Self-Care Self-Confidence (alpha.82). Construct validity was supported with satisfactory model fit on confirmatory factor analysis (NFI=.69, CFI.73). Construct validity was supported further with significant total and subscale (all P <.05) differences between patients experienced with HF and those newly diagnosed, consistent with the underlying theory. CONCLUSION: Low reliability of the Self-Care Maintenance subscale was expected because the items reflect behaviors known to vary in individuals. The reliability and validity of the SCHFI are sufficient to support its use in clinical research.     

Health utilities and psychometric quality of life in patients with early- and late-stage hepatitis C virus infection

Background and Aim: Hepatitis C virus (HCV) infection is associated with impairment in health‐related quality of life (HRQOL). The purpose of this study was to evaluate HRQOL across the HCV disease spectrum using preference‐based (utility) and non‐preference‐based (psychometric) methods, adjusting for sociodemographic factors and co‐morbidity. Methods: Hepatitis C virus patients (n = 751) were recruited from several tertiary care settings in Vancouver, Canada for this observational, cross‐sectional cohort study. Patients completed the Health Utilities Index Mark 2/3, a self‐administered time trade‐off utility instrument, and the Hepatitis Quality of Life Questionnaire (SF‐36 with HCV‐specific items). We examined the association between HRQOL and disease stage using linear regression adjusting for age, education, marital status, income, and co‐morbidities. Results: Utility scores were low across disease stage and instrument, ranging from 0.51 to 0.80. On the SF‐36, the mean Physical Component Summary score ranged from 37.2 to 49.2 across disease stage, and the Mental Component Summary score ranged from 39.7 to 45.7 (United States norms = 50). In general, patients with viral clearance had the highest scores, and those with late‐stage disease (cirrhosis, liver cancer) had the lowest. Multivariable linear regression showed that the effect of disease stage was modest overall. Increasing age, lower income, unattached marital status, and high comorbidity were strongly associated with impairment in HRQOL. Conclusions: The effect of stage of disease on HRQOL is modest, although viral clearance is associated with higher HRQOL. HCV patients' HRQOL is strongly associated with concomitant illness and sociodemographic factors.     

Development and initial evaluation of a measure of self‐management for adults with antineutrophil cytoplasmic antibody–associated small‐vessel vasculitis

Objective

To develop a measure of illness self‐management for adults living with antineutrophil cytoplasmic antibody (ANCA)–associated small‐vessel vasculitis (ANCA‐SVV) and to gather evidence of its reliability and validity.

Methods

Development of the Vasculitis Self‐Management Scale (VSMS) was guided by previous research on self‐management in other chronically ill populations, a review of the current treatment literature for ANCA‐SVV, interviews with patients, and consultation with experts. A total of 205 patients living with ANCA‐SVV or a closely related condition then completed the VSMS, along with measures of sociodemographic and clinical variables, social desirability bias, and general adherence to medical recommendations, using a self‐administered mailed questionnaire. A principal components analysis was conducted on the VSMS items. Internal consistency reliability and construct validity of the resulting subscales were assessed. Forty‐four patients completed the VSMS a second time, for the purpose of assessing test–retest reliability.

Results

Analyses suggested an 8‐factor solution. The final VSMS consisted of 43 items representing these 8 behavioral domains. Correlations among the 8 domains were null to modest in magnitude. The internal consistency reliability of the 8 subscales ranged from minimally acceptable (α = 0.67) to excellent (α = 0.94), and correlations between subscale scores at time 1 and time 2 suggested good temporal stability. Preliminary evidence for validity was mixed.

Conclusion

These findings suggest that the VSMS is a promising method for assessing illness self‐management in adults with ANCA‐SVV. More research exploring the validity of the measure is warranted.