Prospects for research in haemophilia with real-world data-An analysis of German registry and secondary data.

INTRODUCTION AND AIM: Open questions in haemophilia, such as effectiveness of innovative therapies, clinical and patient-reported outcomes (PROs), epidemiology and cost, await answers. The aim was to identify data attributes required and investigate the availability, appropriateness and accessibility of real-world data (RWD) from German registries and secondary databases to answer the aforementioned questions. METHODS: Systematic searches were conducted in BIOSIS, EMBASE and MEDLINE to identify non-commercial secondary healthcare databases and registries of patients with haemophilia (PWH). Inclusion of German patients, type of patients, data elements-stratified by use in epidemiology, safety, outcomes and health economics research-and accessibility were investigated by desk research. RESULTS: Screening of 676 hits, identification of four registries [national PWH (DHR), national/international paediatric (GEPARD, PEDNET), international safety monitoring (EUHASS)] and seven national secondary databases. Access was limited to participants in three registries and to employees in one secondary database. One registry asks for PROs. Limitations of secondary databases originate from the ICD-coding system (missing: severity of haemophilia, presence of inhibitory antibodies), data protection laws and need to monitor reliability. CONCLUSION: Rigorous observational analysis of German haemophilia RWD shows that there is potential to supplement current knowledge and begin to address selected policy goals. To improve the value of existing RWD, the following efforts are proposed: ethical, legal and methodological discussions on data linkage across different sources, formulation of transparent governance rules for data access, redefinition of the ICD-coding, standardized collection of outcome data and implementation of incentives for treatment centres to improve data collection.

Meta-analysis: upper gastrointestinal tolerability of valdecoxib, a cyclooxygenase-2-specific inhibitor, compared with nonspecific nonsteroidal anti-inflammatory drugs among patients with osteoarthritis and rheumatoid arthritis.

AIM: To compare the incidence of abdominal pain, dyspepsia and/or nausea associated with valdecoxib, nonspecific nonsteroidal anti-inflammatory drugs and placebo in patients with rheumatoid arthritis and osteoarthritis. METHODS: Data from five randomized, double-blind 12-week trials were pooled. Independent risk factors for abdominal pain, dyspepsia and/or nausea were also determined. RESULTS: The final analysis consisted of 4394 patients. Nonspecific nonsteroidal anti-inflammatory drug users (n = 1185) received naproxen 1000 mg/day (n = 766), ibuprofen 2400 mg/day (n = 207) or diclofenac sodium 150 mg/day (n = 212). Valdecoxib users received 10 mg/day (n = 955), 20 mg/day (n = 851) or 40 mg/day (n = 430). A total of 973 patients received placebo. The nonspecific nonsteroidal anti-inflammatory drug group was most likely to report abdominal pain or dyspepsia, while the placebo group reported the highest incidence of nausea. The most important risk factors for abdominal pain, dyspepsia and/or nausea were nonspecific nonsteroidal anti-inflammatory drug use, gastrointestinal history of nonspecific nonsteroidal anti-inflammatory drug-related intolerance or gastroduodenal ulcers, osteoarthritis diagnosis, female gender and age <65 years. CONCLUSION: This pooled analysis demonstrates a clear decrease in dyspepsia and an improvement in upper gastrointestinal tolerability for patients with osteoarthritis and rheumatoid arthritis taking valdecoxib, even at supratherapeutic doses, compared with those taking nonspecific nonsteroidal anti-inflammatory drugs over 12 weeks.

Analysis and interpretation of cost data in dialysis: review of Western European literature.

BACKGROUND: Constant improvements in dialysis technology, combined with a growing chronic renal failure population and limited funds, have put clinicians under pressure to prescribe the most cost-effective therapies. Improvements in dialysis, which eliminates metabolic waste products and preserves a normal electrolyte and fluid balance, have enhanced the quality of care among renal patients but at high monetary cost to health systems. Several recent studies report that yearly costs of peritoneal dialysis (PD) (because of technical differences in treatment strategies) are less than hemodialysis (HD) with hospital and other costs included. However, cost analyses of dialysis modalities are not always complete. As a result they are often difficult to directly compare. Furthermore, input costs, health care organizations, and patient use of dialysis vary from country to country in important ways. OBJECTIVE: To review critically the European literature in dialysis where cost data in caring for patients is available, and maximize information about the nature of the cost data in dialysis. METHODS: Survey of published literature including an economic evaluation with cost values in Western Europe; 25 such studies were identified, described in 20 publications. The search focused primarily on articles and reports published since 1990. The appraisal of studies took place according to standard costing procedures, covering, but not limited to, specification of analytic perspective and cost components considered. RESULTS: Costs between dialysis modalities vary from country to country in important ways, although power to detect such differences was limited. The disclosure of details regarding costing methods ranged widely. Only four studies presented adequate descriptive information for dialysis costs. CONCLUSIONS: Errors should be expected in all exercises to estimate dialysis costs. But, potentially misleading conclusions about the relative costs of dialysis therapies have been published in the absence of supporting evidence. Costing information in this field is often handled inconsistently and unsatisfactorily. The analysis and reporting of costs within publications concerning dialysis needs improvement. The review suggests a positive cost advantage to peritoneal dialysis over hemodialysis, but the magnitude of the difference is difficult to evaluate at this time.

Uneasy marks.

Germany earned a reputation as a European nirvana, marked by a booming job market and generous health and social programs. Now, thanks to the high costs of rebuilding the former East Germany and other factors, national health programs face cutbacks. But just about everyone has a stake in guarding the status quo.

Medical technology in Canada, Germany, and the United States: an update.

Major medical technology is internationally mobile and rapidly diffusing. This study compares the proliferation of six complex medical technologies in Canada and Germany with that in the United States, the traditional high-tech leader. The technologies--open-heart surgery, cardiac catheterization, organ transplantation, radiation therapy, extracorporeal shock wave lithotripsy, and magnetic resonance imaging--are more prevalent in the United States, on a per capita basis, than in the other two countries. This was the case five years ago, too. The differences are large in some cases and small in others. Lithotriptors and imagers are growing annually at double-digit rates in all three countries.

Health care über alles: how it works in Germany.

The German healthcare financing system combines regulated, employment-based "sickness funds" for most workers and private insurance available to those above an income threshold. Costs are paid on a fee-for-service basis to private physicians and at an all-inclusive per diem rate to hospitals. Workers and their employers contribute to sickness funds at a percentage of their earnings. The German government sets regulations by which services are provided but does not actively administer either services or payment.

Recent trends in expenditures on physicians' services in Canada.

Analysis of Canada's restraints on the growth in volume of physicians' services can help shape the framework and direction of policy development in other countries. This paper analyzes trends in recent expenditures on physicians' services in Canada from 1982 to 1987. Growth in payments to physicians who were paid fee-for-service is broken down into three component parts in Canada nationwide and in four provinces: Ontario, Quebec, Nova Scotia and British Columbia. The three component parts are: (1) growth in the number of services billed; (2) physician service prices; and (3) the mixture of high- and low-priced services billed. Expenditure increases are disaggregated according to some major categories of medical services, both per physician and per capita. Increases in growth in physician payments were explained mainly by increases in prices, while some evidence of an increase in higher priced services per physician was found. The varying payment restraint policies across Canadian provinces were manifested in different patterns with respect to components of payment change. Higher rates of payment and volume growth were found for diagnostic/therapeutic and office medical services than for surgeries, although a few contrary patterns across provinces occurred. Interprovincial utilization growth, both per physician and per capita, was variable. This suggests that Canada's regionally administered system is neither uniform nor monolithic.

Trade-offs for German physicians: a look at income and supply.

Most health policy experts agree that Germany has proved successful at restraining health care expenditures, but what price do physicians pay for this efficiency? A policy analyst for the American Medical Association examines some of the drawbacks physicians are encountering.

Joint ventures in medical services.

This paper is an overview of joint-venture activity in healthcare, describing trends in joint ventures and raising issues for physicians. The purposes are to discuss the major current facets of joint-venture alliances in healthcare and to identify policy issues that arise from the trend to use joint ventures as an organizational tool. Speculation is made about the future role of joint ventures in the organization of healthcare.

Organizational aspects of physician joint ventures.

This article describes organizational forms of physician joint ventures. Four models are described that typify physician involvement in health care joint ventures: limited partnership syndication, venture capital company, provider network, and alternative delivery system. Important practical issues are discussed.

Instructional units of death education: the impact of amount of classroom time on changes in death attitudes.

The present study sought to provide a better understanding of the impact instructional time devoted to death education had on death attitudes. The study incorporates a three-group experimental research design with repeated measures. Three experimental groups of college students randomly were assigned to one of three short units of death education. The groups varied in terms of the amount of instructional time they were given. One group received three class sessions of death education, while the other two groups received six and nine classes, respectively. Only in the group that received nine class sessions of death education were death attitudes changed significantly. Such changes occurred on one dimension of death attitudes. Results suggest that very brief units of death education are not effective in changing attitudes. When attitude change is deemed important, the most rational length of time to devote to death education is roughly nine class sessions. Even then, attitudes related to death may be affected only partially.