des Arbeitsbereichs Versorgungsforschung im Kompetenznetz Rheuma

 

 

Health Services Research Section 

 

The members of this research section have closely collaborated with a large number of clinicians within the Competence Network and the Collaborative Arthritis Centres. They have contributed to better knowledge of the current health care situation of patients with arthritis, on the costs of rheumatic diseases, and the adequacy of care on the population level. New funds for cross-sectional tasks such as the National databases were acquired.

 

 

National database of the German Arthritis Centers (project B2.1, Zink)

 

The national database has strengthened its role as the major resource of information on healthcare and burden of illness in the rheumatic diseases in German rheumatology. It has continuously been further developed and contains now all important disease-specific outcome measures. It has been used as a tool for quality assessment in the participating sites due to the provision of individual data analysis in contrast with the other participants.

 

Since 2005, data entry is performed decentralised and IT-based. Since 2007, additional funds could be acquired from a consortium of 12 pharmaceutical companies which are being used to pay for study nurses in the participating rheumatological practices and clinics.

 

DocuMed.rh, the modular medical documentation software designed for the German national database, is actually used by 20 private practices and 20 hospitals. It can be downloaded from the web (http://www.rheumanet.org/DocumedSupport/). The use is supported by comprehensive handbook and by hotline. To increase user value and acceptance modules for statistical evaluation were implemented, the interfaces to clinical information systems and medical practice management systems were extended in co-operation with software companies and agents and external data depositories (e.g., laboratory information systems and picture archiving and communication systems) via web services were integrated. Client access via mobile devices for patients and medical staff in clinical routine patient care and for home office activities was developed.

 

Regularly, developments and trends in health care have been reported to the scientific community. Due to a large power-point collection of the results accessible for participants via the Networks’ homepage usage of the data in education and scientific meetings is widespread. Industry can use the power point presentation as well as data from the reports. Each company receives individual data analyses on heir own products. 

 

 

Pediatric database (project B2.2, Minden)

 

The pediatric rheumatological database is the major joint project of the German pediatric rheumatologists. With 45 participating pediatric rheumatology units recording more than 6,000 children per year it gives a comprehensive view of the patient spectrum and the health care in pediatric rheumatology. The database has gained additional importance by offering disease-specific data-sheets for selected rheumatic diseases as well as tackling topical tasks through add-on modules or additional question batteries (e.g. costs, ocular involvement, vaccination coverage, complementary and alternative medicine use, etc.). Results were transferred back via individual data analyses and publications.

 

 

Biometrical support to cohorts and clinical trials (project B3.1, Listing)

 

The availability and involvement of an experienced biometrical group was critical for the proper conduct of the cohorts and a number of randomised clinical trials. The biometrician helped in the preparation of study protocols, ensured that data were collected in a uniform, high-quality manner and approaches were harmonized. Data analyses were supported. Various investigator-driven, independent randomized clinical trials were performed in close collaboration with Prof. Sieper, Dr. Rudwaleit, Prof. Braun, Dr. Baraliakos. The clinical studies investigated the efficacy of TNF-alpha inhibitors, glococorticoids, and methothexate in ankylosing spondylitis. By comparing the GESPIC cohort with data from the infliximab trial, first results on the impact of therapy on radiographic progression were gained.

 

The group is also involved in a BMBF sponsored randomised clinical trial on early induction therapy (Hit HARD) which takes advantage of the network structures. They contributed to the KKS initiative on SAS macros for clinical trials. The group is also active in the international ASAS working group.

 

 

Early rheumatoid arthritis cohort (project C5.2, Westhoff)

 

The 3-year observation of 1.061 early RA patients was successfully finished in January 2006. With 916 patients completing the last follow-up, drop-out rates were low. Several questions pertaining on the association between early disease parameters and outcome were investigated and published or they are in progress.

 

 

Osteoporosis in patients with rheumatoid arthritis (RA): Prevalence, risk factors, problems in health care (project C5.3, Raspe)

 

This cross-sectional study in nine rheumatologic centres investigated the prevalence of osteoporosis among 434 female and 98 male patients with rheumatoid arthritis. All patients were examined via the DXA method. 49% turned out to be osteopenic and 22% had osteoporosis at the lumbar spine and/or the hip. Osteoporosis was as frequent in men (20%) as in women (22%). Risk factors for osteoorosis were higher age, low body mass index, and intake of glucocorticoids >7.5mg/d. Deficits in antiosteoporotic treatment compared to current guidelines were identified.

 

 

The German Rheumatoid Arthritis Population Survey (GRAPS; Westhoff)

 

Under the auspices of the competence network, a population survey on rheumatoid arthritis was conducted. The last population survey stems from 1989 and had found that only every second RA patient had ever reached a rheumatologist. Since then new drugs and therapy guidelines have been introduced. To assess the quality of contemporary healthcare, a 3 stage population survey was conducted. The TNS Healthcare panel was used to access the general population (n = 70,112). To identify the RA cases, a screening questionnaire of joint symptoms and respective diagnoses was followed by a detailed questionnaire. Positive responders were asked to participate in a clinical examination at one of 83 collaborating rheumatologists (Sept. 2006 – March 2007). Rheumatologists had to assess each RA patient if he was cared for adequately.

 

41 RA patients were found in 317 clinical examinations (17 seropositive, 24 seronegative). Almost all of them had visited a rheumatologist at least once and about two thirds were still in rheumatologic care. An unmet need for DMARDs was seen in 20% of the patients. This pertained almost exclusively to seronegative RA patients. Widespread unmet need was seen especially with regard to physical therapies (41%). In one third of the RA patients further diagnostic procedures were advised; this again pertained almost exclusively to the seronegative cases. Further investigations are needed to understand why especially the seronegative RA patients were at risk of undersupply with DMARDs.

Disclosure: Supported by an unconditional grant from Wyeth Pharma GmbH 2006-2007.