Amy K. Rosen

A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder

&NA; This was a 12‐week, randomized, double‐blind, placebo‐controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as ≥30% reduction in this score. Compared with placebo, both duloxetine‐treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine‐treated patients had a decrease of ≥30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality‐of‐life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.

Searching for an improved clinical comorbidity index for use with ICD-9-CM administrative data

We studied approaches to comorbidity risk adjustment by comparing two ICD-9-CM adaptations (Deyo, Dartmouth-Manitoba) of the Charlson comorbidity index applied to Massachusetts coronary artery bypass surgery data. We also developed a new comorbidity index by assigning study-specific weights to the original Charlson comorbidity variables. The 2 ICD-9-CM coding adaptations assigned identical Charlson comorbidity scores to 90% of cases, and specific comorbidities were largely found in the same cases (kappa values of 0.72-1.0 for 15 of 16 comorbidities). Meanwhile, the study-specific comorbidity index identified a 10% subset of patients with 15% mortality, whereas the 5% highest-risk patients according to the Charlson index had only 8% mortality (p = 0.01). A model using the new index to predict mortality had better validated performance than a model based on the original Charlson index (c = 0.74 vs. 0.70). Thus, in our population, the ICD-9-CM adaptation used to create the Charlson score mattered little, but using study-specific weights with the Charlson variables substantially improved the power of these data to predict mortality.

Automated identification of postoperative complications within an electronic medical record using natural language processing.

CONTEXT Currently most automated methods to identify patient safety occurrences rely on administrative data codes; however, free-text searches of electronic medical records could represent an additional surveillance approach. OBJECTIVE To evaluate a natural language processing search-approach to identify postoperative surgical complications within a comprehensive electronic medical record. DESIGN, SETTING, AND PATIENTS Cross-sectional study involving 2974 patients undergoing inpatient surgical procedures at 6 Veterans Health Administration (VHA) medical centers from 1999 to 2006. MAIN OUTCOME MEASURES Postoperative occurrences of acute renal failure requiring dialysis, deep vein thrombosis, pulmonary embolism, sepsis, pneumonia, or myocardial infarction identified through medical record review as part of the VA Surgical Quality Improvement Program. We determined the sensitivity and specificity of the natural language processing approach to identify these complications and compared its performance with patient safety indicators that use discharge coding information. RESULTS The proportion of postoperative events for each sample was 2% (39 of 1924) for acute renal failure requiring dialysis, 0.7% (18 of 2327) for pulmonary embolism, 1% (29 of 2327) for deep vein thrombosis, 7% (61 of 866) for sepsis, 16% (222 of 1405) for pneumonia, and 2% (35 of 1822) for myocardial infarction. Natural language processing correctly identified 82% (95% confidence interval [CI], 67%-91%) of acute renal failure cases compared with 38% (95% CI, 25%-54%) for patient safety indicators. Similar results were obtained for venous thromboembolism (59%, 95% CI, 44%-72% vs 46%, 95% CI, 32%-60%), pneumonia (64%, 95% CI, 58%-70% vs 5%, 95% CI, 3%-9%), sepsis (89%, 95% CI, 78%-94% vs 34%, 95% CI, 24%-47%), and postoperative myocardial infarction (91%, 95% CI, 78%-97%) vs 89%, 95% CI, 74%-96%). Both natural language processing and patient safety indicators were highly specific for these diagnoses. CONCLUSION Among patients undergoing inpatient surgical procedures at VA medical centers, natural language processing analysis of electronic medical records to identify postoperative complications had higher sensitivity and lower specificity compared with patient safety indicators based on discharge coding.

Failure-to-rescue: comparing definitions to measure quality of care.

Objectives: Use of failure-to-rescue (FTR) as an indicator of hospital quality has increased over the past decade, but recent authors have used different sets of complications and deaths to define this measure. This study examines the reliability and validity of different FTR measures currently in use. Research Design: We studied 3 definitions: (1) “original” FTR (using all deaths); (2) FTR-N, a “nursing sensitive” definition that uses only specific complications and deaths; and (3) FTR-A [another restricted definition of FTR used by Agency for Healthcare Research and Quality (AHRQ) for analyzing Healthcare Cost and Utilization Project (HCUP) data]. Each FTR measure was applied to 403,679 general surgical patients across 1567 hospitals reported in 1999–2000 Medicare MEDPAR data. Results: Although FTR used all deaths, FTR-N and FTR-A definitions omitted 49% and 42% of deaths, respectively. Reliability was better for FTR than FTR-A or FTR-N (ρ = 0.32 vs. 0.18 vs. 0.18, respectively). Validity: Hospitals ranked by adjusted mortality were highly correlated with FTR (Kendall’s τ = 0.83) and less correlated with FTR-A (τ = 0.43) and FTR-N (τ = 0.41). Adjusting for patient characteristics, all FTR measures showed strong associations with bed-to-nurse ratio, nursing mix, teaching status, and hospital size; however, hospital “high technology” was not as well associated with FTR-N. Conclusions: For general surgery, more limited definitions used by FTR-N and FTR-A omit over 40% of deaths, display less reliability, and may have more questionable validity than the original FTR measure. We encourage analysts to use the original FTR definition that uses all deaths when analyzing hospital quality of care.

Measuring the quality of depression care in a large integrated health system.

Background. Guideline-based depression process measures provide a powerful way to monitor depression care and target areas needing improvement. Objectives. To assess the adequacy of depression care in the Veterans Health Administration (VHA) using guideline-based process measures derived from administrative and centralized pharmacy records, and to identify patient and provider characteristics associated with adequate depression care. Research Design. This is a cohort study of patients from 14 VHA hospitals in the Northeastern United States which relied on existing databases. Subject eligibility criteria: at least one depression diagnosis during 1999, neither schizophrenia nor bipolar disease, and at least one antidepressant prescribed in the VHA during the period of depression care profiling (June 1, 1999 through August 31, 1999). Depression care was evaluated with process measures defined from the 1997 VHA depression guidelines: antidepressant dosage and duration adequacy. We used multivariable regression to identify patient and provider characteristics predicting adequate care. Subjects. There were 12,678 patients eligible for depression care profiling. Results. Adequate dosage was identified in 90%; 45% of patients had adequate duration of antidepressants. Significant patient and provider characteristics predicting inadequate depression care were younger age (<65), black race, and treatment exclusively in primary care. Conclusions. Under-treatment of depression exists in the VHA, despite considerable mental health access and generous pharmacy benefits. Certain patient populations may be at higher risk for inadequate depression care. More work is needed to align current practice with best-practice guidelines and to identify optimal ways of using available data sources to monitor depression care quality.

Validity of Selected Patient Safety Indicators: Opportunities and Concerns

BACKGROUND The Agency for Healthcare Research and Quality (AHRQ) recently designed the Patient Safety Indicators (PSIs) to detect potential safety-related adverse events. The National Quality Forum has endorsed several of these ICD-9-CM-based indicators as quality-of-care measures. We examined the positive predictive value (PPV) of 3 surgical PSIs: postoperative pulmonary embolus and deep vein thrombosis (pPE/DVT), iatrogenic pneumothorax (iPTX), and accidental puncture and laceration (APL). STUDY DESIGN We applied the AHRQ PSI software (v.3.1a) to fiscal year 2003 to 2007 Veterans Health Administration (VA) administrative data to identify (flag) patients suspected of having a pPE/DVT, iPTX, or APL. Two trained nurse abstractors reviewed a sample of 336 flagged medical records (112 records per PSI) using a standardized instrument. Inter-rater reliability was assessed. RESULTS Of 2,343,088 admissions, 6,080 were flagged for pPE/DVT (0.26%), 1,402 for iPTX (0.06%), and 7,203 for APL (0.31%). For pPE/DVT, the PPV was 43% (95% CI, 34% to 53%); 21% of cases had inaccurate coding (eg, arterial not venous thrombosis); and 36% featured thromboembolism present on admission or preoperatively. For iPTX, the PPV was 73% (95% CI, 64% to 81%); 18% had inaccurate coding (eg, spontaneous pneumothorax), and 9% were pneumothoraces present on admission. For APL, the PPV was 85% (95% CI, 77% to 91%); 10% of cases had coding inaccuracies and 5% indicated injuries present on admission. However, 27% of true APLs were minor injuries requiring no surgical repair (eg, small serosal bowel tear). Inter-rater reliability was >90% for all 3 PSIs. CONCLUSIONS Until coding revisions are implemented, these PSIs, especially pPE/DVT, should be used primarily for screening and case-finding. Their utility for public reporting and pay-for-performance needs to be reassessed.

Hospital Teaching Intensity, Patient Race, and Surgical Outcomes

OBJECTIVES To determine if the lower mortality often observed in teaching-intensive hospitals is because of lower complication rates or lower death rates after complications (failure to rescue) and whether the benefits at these hospitals accrue equally to white and black patients, since black patients receive a disproportionate share of their care at teaching-intensive hospitals. DESIGN A retrospective study of patient outcomes and teaching intensity using logistic regression models, with and without adjusting for hospital fixed and random effects. SETTING Three thousand two hundred seventy acute care hospitals in the United States. PATIENTS Medicare claims on general, orthopedic, and vascular surgery admissions in the United States for 2000-2005 (N = 4,658,954 unique patients). MAIN OUTCOME MEASURES Thirty-day mortality, in-hospital complications, and failure to rescue (the probability of death following complications). RESULTS Combining all surgeries, compared with nonteaching hospitals, patients at very major teaching hospitals demonstrated a 15% lower odds of death (P < .001), no difference in complications, and a 15% lower odds of death after complications (failure to rescue) (P < .001). These relative benefits associated with higher resident-to-bed ratio were not experienced by black patients, for whom the odds of mortality and failure to rescue were similar at teaching and nonteaching hospitals, a pattern that is significantly different from that of white patients (P < .001). CONCLUSIONS Survival after surgery is higher at hospitals with higher teaching intensity. Improved survival is because of lower mortality after complications (better failure to rescue) and generally not because of fewer complications. However, this better survival and failure to rescue at teaching-intensive hospitals is seen for white patients, not for black patients.

Predicting costs of care using a pharmacy-based measure risk adjustment in a veteran population.

Background. Although most widely used risk adjustment systems use diagnosis data to classify patients, there is growing interest in risk adjustment based on computerized pharmacy data. The Veterans Health Administration (VHA) is an ideal environment in which to test the efficacy of a pharmacy-based approach. Objective. To examine the ability of RxRisk-V to predict concurrent and prospective costs of care in VHA and compare the performance of RxRisk-V to a simple age/gender model, the original RxRisk, and two leading diagnosis-based risk adjustment approaches: Adjusted Clinical Groups and Diagnostic Cost Groups/Hierarchical Condition Categories. Methods. The study population consisted of 161,202 users of VHA services in Washington, Oregon, Idaho, and Alaska during fiscal years (FY) 1996 to 1998. We examined both concurrent and predictive model fit for two sequential 12-month periods (FY 98 and FY 99) with the patient-year as the unit of analysis, using split-half validation. Results. Our results show that the Diagnostic Cost Group /Hierarchical Condition Categories model performs best (R2 = 0.45) among concurrent cost models, followed by ADG (0.31), RxRisk-V (0.20), and age/sex model (0.01). However, prospective cost models other than age/sex showed comparable R2: Diagnostic Cost Group /Hierarchical Condition Categories R2 = 0.15, followed by ADG (0.12), RxRisk-V (0.12), and age/sex (0.01). Conclusions. RxRisk-V is a clinically relevant, open source risk adjustment system that is easily tailored to fit specific questions, populations, or needs. Although it does not perform better than diagnosis-based measures available on the market, it may provide a reasonable alternative to proprietary systems where accurate computerized pharmacy data are available.

The exclusion of non-english-speaking persons from research

AbstractOBJECTIVE: We sought to determine how often non-English-speaking (NES) persons are excluded from medical research. DESIGN: Self-administered survey. PARTICIPANTS: A Medline search identified all original investigations on provider-patient relations published in major U.S. journals from 1989 through 1991, whose methodologies involved direct interaction between researcher and subject (N=216). Each study’s corresponding author was surveyed; 81% responded. MEASUREMENTS AND MAIN RESULTS: Of the 172 respondents, 22% included NES persons; among theseincluders, 16% had not considered the issue during the study design process, and 32% thought including the NES had affected their study results. Among the 40% who excluded the NES (excluders), the most common reason was not having thought of the issue (51%), followed by translation issues and recruitment of bilingual staff. The remaining 35% (others) indicated that there were no NES persons in their study areas. CONCLUSIONS: NES persons are commonly excluded from provider-patient communication studies appearing in influential journals, potentially limiting the generalizability of study findings. Because they are often excluded through oversight, heightened awareness among researchers and granting institutions, along with the development of valid instruments in varied languages, may increase representation of non-English-speaking subjects in research.

Effects of a worksite nonsmoking policy: evidence for increased cessation

A random sample of employees was surveyed 20 months after a non-smoking policy was implemented at the New England Telephone Company in 1986. Overall, 21 percent of respondents who were smoking at the time they heard about the policy had quit smoking; 42 percent of quitters said they stopped smoking because of the policy. Cessation was highest among those who reported less smoke in their work area, but was not related to participation in cessation programs. This study suggests that worksite nonsmoking policies may have favorable effects on smoking cessation.