Assessment of health-related family role functioning in systemic lupus erythematosus: preliminary validation of a new measure.

OBJECTIVE: Individuals with systemic lupus erythematosus (SLE) often experience symptoms that affect family relationships, which are important components of quality of life. To assess the impact of SLE on family role functioning, we developed a 6-domain (Fatigue, Activity participation, Mental health, Isolation, Love and intimacy, and You/fulfilling family roles [FAMILY]) measure. The objectives of this study were to pilot test and achieve preliminary validation for the SLE-FAMILY questionnaire. METHODS: This was a 3-phase study. In phase 1 (development), domains were identified and items were generated for evaluation. During phase 2 (pilot test), a pilot test was conducted to assess the performance of candidate items. In phase 3 (initial validation), 52 individuals with SLE completed questionnaires, including the 6-item SLE-FAMILY. Data were analyzed for internal consistency reliability, and validity was assessed using correlations between the SLE-FAMILY questionnaire and well-validated measures. RESULTS: The SLE-FAMILY had good test-retest reliability (0.82) and internal consistency (0.67). Reliability analysis of individual items revealed weakness in the performance of item 5. We reviewed raw data and determined that 9 individuals likely overlooked the reverse scoring of item 5, thus explaining its poor reliability. When these 9 individuals were excluded from analysis, Cronbach's alpha increased to 0.71, while test-retest reliability remained acceptable (0.75). Spearman's rho correlations supported the validity of the SLE-FAMILY measure. A pilot test of the SLE-FAMILY questionnaire without the reverse-scored item was conducted; results suggested that the modified version is superior to the initial form. CONCLUSION: The SLE-FAMILY questionnaire is a promising new instrument for robust measurement of family role functioning.

Predictors of hospital readmission after stroke: a systematic review.

BACKGROUND AND PURPOSE: Risk-standardized hospital readmission rates are used as publicly reported measures reflecting quality of care. Valid risk-standardized models adjust for differences in patient-level factors across hospitals. We conducted a systematic review of peer-reviewed literature to identify models that compare hospital-level poststroke readmission rates, evaluate patient-level risk scores predicting readmission, or describe patient and process-of-care predictors of readmission after stroke. METHODS: Relevant studies in English published from January 1989 to July 2010 were identified using MEDLINE, PubMed, Scopus, PsycINFO, and all Ovid Evidence-Based Medicine Reviews. Authors of eligible publications reported readmission within 1 year after stroke hospitalization and identified ≥ 1 predictors of readmission in risk-adjusted statistical models. Publications were excluded if they lacked primary data or quantitative outcomes, reported only composite outcomes, or had < 100 patients. RESULTS: Of 374 identified publications, 16 met the inclusion criteria for this review. No model was specifically designed to compare risk-adjusted readmission rates at the hospital level or calculate scores predicting a patient's risk of readmission. The studies providing multivariable models of patient-level and/or process-of-care factors associated with readmission varied in stroke definitions, data sources, outcomes (all-cause and/or stroke-related readmission), durations of follow-up, and model covariates. Few characteristics were consistently associated with readmission. CONCLUSIONS: This review identified no risk-standardized models for comparing hospital readmission performance or predicting readmission risk after stroke. Patient-level and system-level factors associated with readmission were inconsistent across studies. The current literature provides little guidance for the development of risk-standardized models suitable for the public reporting of hospital-level stroke readmission performance.

National patterns of risk-standardized mortality and readmission for acute myocardial infarction and heart failure. Update on publicly reported outcomes measures based on the 2010 release.

BACKGROUND: Patient outcomes provide a critical perspective on quality of care. The Centers for Medicare and Medicaid Services (CMS) is publicly reporting hospital 30-day risk-standardized mortality rates (RSMRs) and risk-standardized readmission rates (RSRRs) for patients hospitalized with acute myocardial infarction (AMI) and heart failure (HF). We provide a national perspective on hospital performance for the 2010 release of these measures. METHODS AND RESULTS: The hospital RSMRs and RSRRs are calculated from Medicare claims data for fee-for-service Medicare beneficiaries, 65 years or older, hospitalized with AMI or HF between July 1, 2006, and June 30, 2009. The rates are calculated using hierarchical logistic modeling to account for patient clustering, and are risk-adjusted for age, sex, and patient comorbidities. The median RSMR for AMI was 16.0% and for HF was 10.8%. Both measures had a wide range of hospital performance with an absolute 5.2% difference between hospitals in the 5th versus 95th percentile for AMI and 5.0% for HF. The median RSRR for AMI was 19.9% and for HF was 24.5% (3.9% range for 5th to 95th percentile for AMI, 6.7% for HF). Distinct regional patterns were evident for both measures and both conditions. CONCLUSIONS: High RSRRs persist for AMI and HF and clinically meaningful variation exists for RSMRs and RSRRs for both conditions. Our results suggest continued opportunities for improvement in patient outcomes for HF and AMI.

Psychiatric comorbidity and other psychological factors in patients with "chronic Lyme disease".

BACKGROUND: There is no evidence of current or previous Borrelia burgdorferi infection in most patients evaluated at university-based Lyme disease referral centers. Instead, psychological factors likely exacerbate the persistent diffuse symptoms or "Chronic Multisymptom Illness" (CMI) incorrectly ascribed to an ongoing chronic infection with B. burgdorferi. The objective of this study was to assess the medical and psychiatric status of such patients and compare these findings to those from patients without CMI. METHODS: There were 240 consecutive patients who underwent medical evaluation and were screened for clinical disorders (eg, depression and anxiety) with diagnoses confirmed by structured clinical interviews at an academic Lyme disease referral center in New Jersey. Personality disorders, catastrophizing, and negative and positive affect also were evaluated, and all factors were compared between groups and with functional outcomes. RESULTS: Of our sample, 60.4% had symptoms that could not be explained by current Lyme disease or another medical condition other than CMI. After adjusting for age and sex, clinical disorders were more common in CMI than in the comparison group (P <.001, odds ratio 3.54, 95% confidence interval, 1.97-6.55), but personality disorders were not significantly more common. CMI patients had higher negative affect, lower positive affect, and a greater tendency to catastrophize pain (P <.001) than did the comparison group. Except for personality disorders, all psychological factors were related to worse functioning. Our explanatory model based on these factors was confirmed. CONCLUSIONS: Psychiatric comorbidity and other psychological factors are prominent in the presentation and outcome of some patients who inaccurately ascribe longstanding symptoms to "chronic Lyme disease."

Role of psychiatric comorbidity in chronic Lyme disease.

OBJECTIVE: To evaluate the prevalence and role of psychiatric comorbidity and other psychological factors in patients with chronic Lyme disease (CLD). METHODS: We assessed 159 patients drawn from a cohort of 240 patients evaluated at an academic Lyme disease referral center. Patients were screened for common axis I psychiatric disorders (e.g., depressive and anxiety disorders); structured clinical interviews confirmed diagnoses. Axis II personality disorders, functional status, and traits like negative and positive affect and pain catastrophizing were also evaluated. A physician blind to psychiatric assessment results performed a medical evaluation. Two groups of CLD patients (those with post-Lyme disease syndrome and those with medically unexplained symptoms attributed to Lyme disease but without Borrelia burgdorferi infection) were compared with 2 groups of patients without CLD (patients recovered from Lyme disease and those with an identifiable medical condition explaining symptoms attributed to Lyme disease). RESULTS: After adjusting for age and sex, axis I psychiatric disorders were more common in CLD patients than in comparison patients (P = 0.02, odds ratio 2.64, 95% confidence interval 1.30-5.35), but personality disorders were not. Patients with CLD had higher negative affect, lower positive affect, and a greater tendency to catastrophize pain (P < 0.001) than comparison patients. All psychological factors except personality disorders were related to level of functioning. A predictive model based on these psychological variables was confirmed. Fibromyalgia was diagnosed in 46.8% of CLD patients. CONCLUSION: Psychiatric comorbidity and other psychological factors distinguished CLD patients from other patients commonly seen in Lyme disease referral centers, and were related to poor functional outcomes.

The relationship between affect balance style and clinical outcomes in fibromyalgia.

OBJECTIVE: Affective balance, relative levels of negative affect (NA) and positive affect (PA), better describes emotional functioning than NA or PA alone. Affect balance styles and their relationship to clinical outcomes were compared between patients with fibromyalgia (FM) and controls. METHODS: FM patients (n = 79) were compared with patients with other medical conditions (controls; n = 92). Patients underwent a physical examination, completed questionnaires, and were screened for clinical disorders such as depression, with diagnoses confirmed by structured interview. Affect balance style categories were calculated as follows: healthy (high PA/low NA), low (low PA/low NA), reactive (high PA/high NA), and depressive (low PA/high NA). RESULTS: Compared with controls, FM patients had lower levels of PA (P = 0.0031; P values are adjusted for multiple testing), higher levels of NA (P = 0.0061), lower levels of functioning (P < 0.0001), and more clinical disorders (P = 0.0031). Groups differed regarding affect balance style (P = 0.0061), with FM patients being more likely than controls to be categorized as depressive (odds ratio 5.60) and reactive (odds ratio 3.81). FM patients and controls with reactive and depressive affect balance styles reported poorer functioning (P < 0.0001) compared with patients with healthy affect balance style. Finally, there was an association between affect balance style and psychiatric comorbidity (P < 0.0001), with patients with depressive and reactive affect balance styles having a 9.00 and 4.75 odds ratio, respectively, of having psychiatric comorbidity compared with patients with healthy affect balance style. CONCLUSION: Depressive (low PA, high NA) and reactive (high PA, high NA) affect balance styles were predominant in FM patients and related to poor functioning and psychiatric comorbidity.

The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study.

OBJECTIVE: To consider the feasibility of assessing multiple facets of independence in rheumatoid arthritis (RA) using a measure developed from existing items and examining its face validity, construct validity and responsiveness to change. METHODS: The ATTAIN (Abatacept Trial in Treatment of Anti-tumor necrosis factor [TNF] Inadequate responders) database was used. Patients with RA were randomized 2:1, abatacept (n = 258) and placebo (n = 133). A multi-faceted scale to measure physical and psychosocial independence was constructed using items from the Health Assessment Questionnaire (HAQ) and Short Form 36 Health Survey (SF-36). Questions assessing activity limitations and need for outside caregiver help were also examined. Interviews with 20 RA patients assessed face validity. RESULTS: Item Response Theory analysis yielded two traits - 'Psychosocial Independence', derived from the number of days with activity limitations plus the Role Emotional, Social Functioning and Role Physical subscale items from the SF-36; and 'Physical Independence', derived from 15 HAQ items assessing need for help from another. The two traits showed no significant differential item functioning for age or gender and demonstrated good face validity. Changes over 169 days on Psychosocial Independence were greater (mean 0.46 units, 95% confidence interval [CI]: 0.17-0.75) for the abatacept group than for placebo (p = 0.002). Changes in Physical Independence were greater (mean 0.59 units, 95% CI: 0.35-0.82) for the abatacept group than for placebo (p < 0.001). CONCLUSIONS: The multi-faceted assessment of independence in RA based on items from commonly used instruments is feasible suggesting promise for evaluating independence in future clinical trials. This approach demonstrated good face and construct validity and responsiveness in RA patients who had previously failed anti-TNF therapy. However, we caution against an interpretation that these data suggest that abatacept improves independence because the component parts of this assessment came from instruments used in the ATTAIN trial where data had been previously analyzed.