Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.

OBJECTIVES: To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. METHODS: Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. RESULTS: A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of "other serious infection" and "other central nervous system-related events," with no significant differences in associated hospitalization rates or deaths. CONCLUSIONS: Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of "other serious infections" and "other central nervous system-related events" without higher hospitalization rates.

Contraceptive and noncontraceptive benefits of the LNG-IUS in a vertically integrated HMO.

BACKGROUND: The study was conducted to assess outcomes among women using the levonorgestrel-releasing intrauterine system (LNG-IUS). STUDY DESIGN: The data were collected via a retrospective claims database analysis of 152 women. Two nested cohorts were further distinguished based on length of follow-up: two and three continuous years (n=73 and n=29, respectively). RESULTS: Over 90% had a single insertion, and fewer than 4% experienced an LNG-IUS-related complication. Thirteen percent of women experienced menorrhagia in the year preceding insertion; this figure dropped to 12.5%, 1.2% and 0% in the 1, 2 and 3 years postinsertion. Mean number of gynecology-related visits decreased from four to two in the overall cohort, from seven to four in the cohort with 2 years of follow-up and from nine to four in the cohort with 3 years of follow-up. CONCLUSION: LNG-IUS use prevented pregnancy in all patients and was associated with decreased vaginal bleeding starting in the second year postinsertion.

The impact of indirect (herd) protection on the cost-effectiveness of pneumococcal conjugate vaccine.

BACKGROUND: The heptavalent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) confers protection against invasive pneumococcal disease (IPD) caused by serotypes that are responsible for substantial morbidity and mortality throughout the world. In 2000, the 7 serotypes covered by PCV7 accounted for 80% to 90% of serotypes isolated from the blood or cerebrospinal fluid of children aged <6 years in the United States. A previous review of the literature spanning the years 1998 to 2005 pertaining to the incidence of IPD among nonimmunized individuals in countries with universal PCV7 immunization suggested an indirect protective effect (herd protection, or community immunity) after widespread vaccination. Consideration of indirect protection against IPD may enhance cost-benefit evaluations of vaccination programs. OBJECTIVE: The objective of this analysis was to review the literature on cost-effectiveness analyses of PCV7 vaccination to determine whether inclusion of the indirect effect in decision-analysis models substantially affects the cost-effectiveness findings in favor of vaccination. METHODS: A literature review of cost-effectiveness analyses of PCV7 vaccination was conducted using the DIMDI (Deutschen Institut fur Medizinische Dokumentation und Information) superbase, which comprises 12 databases, to identify articles published between January 2000 and October 2006 using the search terms 7-valent pneumococcal conjugate vaccine AND herd immunity/herd effect, and 7-valent pneumococcal conjugate vaccine AND cost-effectiveness, cost-utility, or cost-benefit analyses. Monetary values were converted to euros and inflated to 2006 values, and events avoided were converted to rates per 100,000 vaccinated to allow comparison across studies. The sensitivity analyses from the models that included indirect effects were examined. RESULTS: There was wide variability in the health-economic results of the 16 studies that met the inclusion criteria. In studies that did not include indirect effects, the adjusted cost per life-year gained ranged from cost saving to euro140,723 from the societal perspective and from euro56,724 to euro324,218 from the payer perspective. In the 4 studies that included indirect effects, a significant and consistent improvement was seen in the health-economic results in favor of vaccination with PCV7. No trends in variability across time or geographic region were observed. CONCLUSIONS: Indirect effects had a significant effect on cost-effectiveness, as seen in the sensitivity analyses. Future models should include indirect effects in evaluating the cost-effectiveness of PCV7.

Cancer incidence and mortality in the Caribbean.

BACKGROUND: Nearly 10% of immigrants to the United States come from the Caribbean region. In this paper, we analyzed incidence and mortality rates of the major cancers in the Bahamas, Barbados, Cuba, the Dominican Republic, Haiti, Jamaica, Puerto Rico, and Trinidad and Tobago, and compared them with US patterns. METHODS: We obtained age-standardized, sex-specific cancer incidence and mortality rates for cancers of the bladder, breast, cervix, esophagus, large bowel, liver, lung, pancreas, prostate, and stomach for 8 Caribbean countries and the United States from the GLOBOCAN program of the International Agency for Research in Cancer (IARC) and for the U.S. population from the Surveillance, Epidemiology, and End Results (SEER) Program of the NCI. RESULTS: GLOBOCAN incidence and mortality rates for the overall United States were lower than but correlated with overall SEER rates. Based on GLOBOCAN data, the incidence and mortality rates of cancers of the breast, prostate, large bowel, and lung, and, among males, bladder cancer were lower in the Caribbean countries than the United States. Caribbean countries had higher rates of cancers of the cervix, esophagus, liver, and stomach. Haiti had the highest incidence and mortality rates of cervix and liver cancers. Jamaica and Haiti had the highest rates of stomach cancer. CONCLUSIONS: Cancer incidence and mortality in the Caribbean generally follow known patterns of association with economic development, infectious agents, and racial/ethnic origin. Studying these patterns and how immigration changes them may yield clues to cancer etiology. A better understanding of cancer incidence and mortality rates may help health policymakers to implement state-of-the-art treatment and preventive services for people of Caribbean descent both in their native countries and in immigrant communities in the United States.

Improving patient and nurse outcomes: a comparison of nurse tasks and time associated with two patient-controlled analgesia modalities using delphi panels.

Increased demand on nursing time may adversely affect nurse satisfaction and patient outcomes. Technologies to reduce nursing time and burden may improve patient care. Two Delphi panels assessed the perceived nursing time of fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) for postoperative pain management. The panels were asked to estimate the time spent on individual nursing tasks from a list. The Clinical Trial panel (n = 14) was composed of nurses who participated in two clinical trials, and data for both PCA modalities were collected from this panel. The routine practice panel (n = 13) was composed of nurses from various hospital units, and only data for IV PCA were collected from this panel. From the Clinical Trial panel, the estimated total average task time was 251 minutes for IV PCA and 210 minutes for fentanyl ITS. From the Routine Practice panel, the estimated total average task time was 163 minutes for IV PCA. Thirteen extra tasks were identified by the Clinical Trial panel to be associated only with IV PCA, and these eliminated steps primarily explained the estimated total nursing time difference between IV PCA and fentanyl ITS. According to the two Delphi panels, the perceived nursing time consumed was less and the number of tasks was lower for fentanyl ITS than for IV PCA. This benefit associated with fentanyl ITS may lead to other positive outcomes, such as improved nurse satisfaction and improved patient outcomes.

Management of opioid side effects in cancer-related and chronic noncancer pain: a systematic review.

Side effects can limit opioid dosage and reduce quality of life. The purpose of this systematic review was to assess the management of opioid side effects in the context of cancer pain management or, in the event that no evidence was available for cancer pain, for chronic noncancer pain. The side effects studied were constipation, pruritus, nausea and vomiting, myoclonus, sedation, respiratory depression, and delirium. Opioid rotation to manage side effects was also studied. For each side effect, we searched MEDLINE and the Cochrane Controlled Trials Register and identified 657 possible titles for inclusion. Of these, 67 studies met inclusion criteria for analysis. The lack of well-designed, randomized controlled trials and the heterogeneity of populations and study designs made the drawing of firm conclusions difficult and precluded performance of meta-analysis. The type, strength, and consistency of evidence for available interventions to manage opioid side effects vary from strong (eg, on the use of naloxone to reverse respiratory depression or constipation) to weak (eg, changing from the oral to epidural route of morphine administration to manage sedation). Well-designed trials in the specified populations are required to furnish clinicians with secure evidence on managing opioid side effects successfully.