DA8 Evaluating Health Outcomes and Pharmacoeconomic Literature

In 1997, the United States Pharmacopeia (USP) established an Ad Hoc Outcomes/Cost Effectiveness Advisory Panel to consider the development of specifications for compiling, indexing, and evaluating outcomes research/cost-effectiveness literature on a disease-specific basis. Such a resource could be used to support pharmaceutical therapy choice decision making by a variety of potential users. The USP had developed a protype health outcomes and pharmacoeconomic annotated registry of the literature on the disease state, congestive heart failure. Other organizations have established and are marketing pharmacoeconomic and health outcome literature registries, with two examples being the HEED database (OHE-IFPMA Database Ltd.) and the University of York NHS Centre for Reviews and Dissemination (DARE).
OBJECTIVE: To share experiences and to identify the needs of decision makers for outcome/pharmacoeconomic information and to discuss whether they are being met by currently available literature sources. Decision makers include health care practitioners, managed care organizations, third party payers, industry and governments.
WORKSHOP FORMAT: The USP congestive heart failure protype literature registry will be described and compared to currently available pharmacoeconomic/outcome databases. Participants will share their assessment of the currently available abstracting service/databases and determine if there is a role for further developments.
DESIRED OUTCOME: To determine if there is a need for a collaborative approach among interested parties to make relevant health outcome/pharmacoeconomic information more accessible to the drug therapy decision makers in a format that is "user friendly."     

Return to work of breast cancer survivors: a systematic review of intervention studies

Background  

Breast cancer management has improved dramatically in the past three decades and as a result, a population of working age women is breast cancer survivor. Interventions for breast cancer survivors have shown improvements in quality of life and in physical and psychological states. In contrast, efforts aimed at stimulating re-employment and return-to-work interventions for breast cancer survivors have not kept pace. The objective of this review was to study the effects and characteristics of intervention studies on breast cancer survivors in which the outcome was return to work.     

SEVENTY-TWO HOUR COMPARISON OF METHYLPREDNISOLONE SULEPTANATE AND METHYLPREDNISOLONE SODIUM SUCCINATE IN PATIENTS WITH ACUTE ASTHMA

SUMMARY The efficacy and safety of the methylprednisolone prodrugs methylprednisolone suleptanate and methylprednisolone sodium succinate were evaluated in a multicentre, randomised, double-blind, double-dummy parallel study of 88 patients hospitalised with acute asthma. Each study drug was administered as a bolus intravenous injection of 40mg methylprednisolone equivalents every 6 hours for 48 hours. Methylprednisolone 32mg was administered orally 6 hours after the last dose. Pulmonary function, medical events, and clinical laboratory values were assessed at predefined intervals before and during the 72-hour study. The primary response measure of pulmonary function was per cent predicted forced expiratory volume in one second (FEV₁) at 48 hours. Secondary response measures were peak expiratory flow rate (PEFR) and FEV₁/forced vital capacity (FVC) ratio. Although both drugs demonstrated within-group mean changes from baseline (starting at 6 hours) that were statistically significant for each response, there were no statistically significant differences between the two groups. The mean percent predicted FEV₁ at 48 hours and mean per cent change from baseline were 64% and 13% (p<0.0001) for the methylprednisolone suleptanate group and 67% and 17% (p<0.0001) for the methylprednisolone sodium succinate group, respectively. The mean PEFR and FEV₁/FVC ratio at 48 hours were 5.77 l/s and 73% for the methylprednisolone suleptanate group and 5.78 l/s and 76% for the methylprednisolone sodium succinate group, respectively. There were no clinically or statistically significant between-group differences in any of the safety parameters. In this study, methylprednisolone suleptanate and methylprednisolone sodium succinate have been shown to be therapeutically equivalent in the treatment of patients hospitalized with acute asthma.