The burden of uterine fibroids in five European countries.

OBJECTIVE: To quantify the burden of uterine fibroids (UF) on health-related quality of life (HRQOL) and work productivity in a general population of women. STUDY DESIGN: Women diagnosed with or experiencing UF-related symptoms living in five Western European countries (France, Germany, Italy, Spain, and the United Kingdom) were identified through a cross-sectional Internet-based survey. The following parameters and outcomes of interest were captured and analysed: patient history and demographics, treatment and diagnosis patterns, symptom severity and HRQOL, work productivity and activity impairment, and disease or symptom-related health care resource use for the past year (e.g., provider visits, hospitalisation). RESULTS: This analysis included 1756 women (France, 358; Germany, 345; Italy, 351; Spain, 352; United Kingdom, 350). Prevalence of a diagnosis of UF ranged from 11.7% to 23.6%, and that of undiagnosed bleeding symptoms from 14.7% to 24.6% across the five countries. Between 9.0% and 32.5% of women waited > or =5 years before seeking treatment for UF. Mean UFS-QOL symptom severity scores ranged from 24.7 (95% confidence interval [CI], 21.1-28.3) to 37.6 (95% CI, 32.2-43.0; P<0.001), suggesting mild to moderate severity. Mean UFS-QOL scores ranged from 59.2 (95% CI, 54.2-64.2) to 69.7 (95% CI, 66.5-73.0; P=0.002), suggesting moderate impairment. In pooled analyses, absenteeism was reported by 32.7% of employed women with a diagnosis of UF. Overall worker productivity was reduced by 36.1% and general activity was impaired by 37.9%. CONCLUSIONS: UF are common in women residing in Western Europe. They are associated with impairment of HRQOL and productivity. A substantial number of women delay seeking medical help. Encouraging symptomatic women to seek help and treatment earlier may benefit women by improving their HRQOL and may also benefit society through enhanced worker productivity.

Frequency and outcomes of blood products transfusion across procedures and clinical conditions warranting inpatient care: an analysis of the 2004 healthcare cost and utilization project nationwide inpatient sample database.

The objective of this retrospective cohort study was to assess frequency and outcomes associated with blood products transfusion. Data from the 2004 Nationwide Inpatient Sample database were used. Length of stay (LOS), postoperative infections, noninfectious transfusion-related complications, in-hospital mortality, and total charges were evaluated for transfused and nontransfused cohorts. Of the estimated 38.66 million discharges in the United States in 2004, 5.8% (2.33 million) were associated with blood products transfusion. Average LOS was 2.5 days longer, and charges were $17 194 higher for the transfused cohort (P < .0001). Odds of death were 1.7 times higher (P < .0001) and odds of infection 1.9 times higher (P < .0001) for the transfused cohort. Increased provider awareness and recognition of the frequency and potential negative outcomes of blood products transfusion may encourage the adoption of novel approaches to minimize intraoperative and early postoperative bleeding, reduce transfusion requirements, and most important, improve patient-level postoperative outcomes and health-related quality of life.

Development and validation of the Gastroesophageal Reflux Disease Treatment Satisfaction Questionnaire.

There is growing recognition of the importance of assessing patient perceptions of treatment, especially patient satisfaction. The Gastroesophageal Reflux Disease (GERD) Treatment Satisfaction Questionnaire (GTSQ) was developed to assess satisfaction with GERD medication. A web-based survey, which included the GTSQ and the GERD Symptom Assessment Scale (GSAS), was administered in September 2003 to 2511 subjects taking prescription GERD medication, identified as H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). Results showed excellent reliability of the GTSQ subscales (from 0.82-0.95) and validity with respect to two GSAS subscales. Rabeprazole (Aciphex) subjects taking 1 pill per day were statistically more satisfied than those taking 2 pills per day for all subscales except "Daytime Relief" and "Quick and Long-Lasting." Those who stayed on rabeprazole therapy longer showed statistically significant greater satisfaction on the "Daytime Relief" and "Health-Related Quality of Life" scales. The GTSQ has high reliability and can be used to assess aspects of satisfaction with GERD medication.

Monitoring outcomes during long-term opioid therapy for noncancer pain: results with the Pain Assessment and Documentation Tool.

The increasingly common practice of long-term opioid therapy for chronic noncancer pain must be guided by ongoing assessment of four types of outcomes: pain relief, function, side effects, and drug-related behaviors. Our objective was to gather initial pilot data on the clinical application of a specialized chart note, the Pain Assessment and Documentation Tool (PADT), which was developed and tested with 27 physicians. This pilot test provided the means to collect cross-sectional outcome data on a large sample of opioid-treated chronic pain patients. Each of the physician volunteers (located in a variety of settings across the United States) completed the PADT for a convenience sample of personally treated chronic pain patients who had received at least three months of opioid therapy. Completion of the PADT required a clinical interview, review of the medical chart, and direct clinical observation. Data from the PADTs were collated and analyzed. The results suggested that the majority of patients with chronic pain achieve relatively positive outcomes in the eyes of their prescribing physicians in all four relevant domains with opioid therapy. Analgesia was modest but meaningful, functionality was generally stabilized or improved, and side effects were tolerable. Potentially aberrant behaviors were common but viewed as an indicator of a problem (i.e., addiction or diversion) in only approximately 10 percent of cases. Using the PADT physician ratings can be developed in four domains. In this sample, outcomes suggested that opioid therapy provided meaningful analgesia.

Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain.

OBJECTIVES: The Brief Pain Inventory (BPI) is a short, self-administered questionnaire that was developed for use in cancer patients. While most empirical research with the BPI has been in pain of that etiology, the questionnaire is increasingly evident in published studies of patients with non-cancer pain. The current research addresses the need for formal evaluation of the reliability and validity of the BPI for use in non-cancer pain patients. METHODS: Approximately 250 patients with arthritis or low back pain (LBP) self-administered a number of generic and condition-specific health status measures (including the BPI) in the clinic of their primary care provider at 2 time points: the initial clinic visit and the first visit following treatment. RESULTS: The reliability of BPI data collected from non-cancer pain patients was comparable to that reported in the literature for cancer patients and sufficient for group-level analyses (coefficient alphas were greater than 0.70). The factor structure of the BPI was replicated in this sample and the relationship of the BPI to generic measures of pain was strong. The BPI exhibited similar relationships to general and condition-specific measures of health as did a generic pain scale (SF-36 Bodily Pain). Finally, the BPI discriminated among levels of condition severity and was sensitive to change in condition over time in arthritis and LBP patients. DISCUSSION: Results support the validity of the BPI as a measure of pain in patients without cancer and, in particular, as a measure of pain for arthritis and LBP patients.

A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy.

BACKGROUND: Opioid analgesics are the cornerstone of management for malignant pain. Their use in managing chronic, nonmalignant pain, albeit controversial, has increased in recent years. The decisions about whether to initiate opioid therapy or continue it over time should be guided by a comprehensive patient assessment. During long-term treatment, this assessment should focus on a broad range of outcomes, each of which should be documented in the medical record. OBJECTIVE: The goal of this study was to develop an instrument, the Pain Assessment and Documentation Tool (PADT), to focus on key outcomes and provide a consistent way to document progress in pain management therapy over time. METHODS: Items that assess 4 domains (pain relief, patient functioning, adverse events, and drug-related behaviors) were generated with input from a MEDLINE literature search and experts in pain and addiction management. The original tool was field tested by clinicians who applied it to the assessment of patients receiving long-term opioid therapy for the management of chronic, nonmalignant pain. Data analysis and debriefing telephone interviews with a formalized set of questions were then used to rephrase, delete, and refine items to create the final tool. RESULTS: A 6-member expert panel contributed to the initial development of the PADT. Twenty-seven clinicians completed the preliminary version of PADT for 388 patients. The original 59-item tool was modified to create a 41-item tool. The revised PADT was formatted for use as a chart note designed to assist clinicians in assessing and documenting 4 main outcome domains during long-term opioid use. CONCLUSIONS: In this study, the PADT appeared to be a useful tool for clinicians to guide the evaluation of several important outcomes during opioid therapy and provide a simple means of documenting patient care.

Comparison of resource utilization by patients treated with transdermal fentanyl and long-acting oral opioids for nonmalignant pain.

OBJECTIVE: To quantify resource utilization and costs incurred for patients who received transdermal fentanyl as their first long-acting analgesic for non-malignant pain, and to compare these with utilization and costs for similar patients dispensed other long-acting oral opioids. DESIGN: A retrospective matched cohort study using medical claims data from a large New England Insurer. PATIENTS: We identified 478 patients without cancer who received transdermal fentanyl during 1995-1998. We selected patients who had no previous long-acting opioid dispensings and were enrolled during the 180 days before and 30 days following the initial dispensing. We used propensity scores to identify a matched comparison group of 478 long-acting oral opioid users. RESULTS: Transdermal fentanyl and matched long-acting oral opioid users incurred identical median costs for outpatient medical services and prescriptions during 2 years of follow-up. A larger proportion of transdermal fentanyl patients were still taking their initial opioid analgesic at the end of the 2-year follow-up than were patients initially taking other long-acting opioids. Use of short-acting opioids tapered off more slowly among transdermal fentanyl patients than among long-acting opioid patients. In the first 6 months, the transdermal fentanyl patients had more hospital discharges than the long-acting oral opioid patients, but this difference appeared to reflect preexisting conditions. CONCLUSIONS: Users of fentanyl transdermal system and other long-acting opioids experienced essentially identical evolution of health services utilization and costs over a 2-year period. The choice of long-acting opioid analgesia does not appear to be a determinant of future medical costs.