Registries as a tool in evidence-based medicine: example of KIMS (Pfizer International Metabolic Database).
OBJECTIVE
To evaluate the value of a registry, set in 'real-life practice', as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders.


METHODS
Analysis of data collected prospectively for a pharmacoepidemiological registry--KIMS (Pfizer International Metabolic Database)--in assessing long-term clinical and safety outcomes of GH treatment (Genotropin) in patients with GH deficiency. The study was based on 11,374 treated (40,000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed.


RESULTS
The study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals.


CONCLUSIONS
These findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials.
Gutiérrez
Lia P
LP
Pfizer, Safety and Risk Management, Barcelona, Spain.
Kołtowska-Häggström
Maria
M
Jönsson
Peter J
PJ
Mattsson
Anders F
AF
Svensson
Dag
D
Westberg
Björn
B
Luger
Anton
A
D000328:Adult; D001823:Body Composition / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D019317:Evidence-Based Medicine; D005260:Female; D020249:Hormone Replacement Therapy; D019382:Human Growth Hormone / Q000172:deficiency* / Q000627:therapeutic use*; D006801:Humans; D007018:Hypopituitarism / Q000188:drug therapy*; D008297:Male; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012042:Registries; D016896:Treatment Outcome
D011994:Recombinant Proteins; D019382:Human Growth Hormone; D002784:Cholesterol