title: Analysis of Existing Guidelines for the Systematic Planning Process of Clinical Registries.
abstract: Clinical registries are a powerful method to observe the clinical practice and natural disease history. In contrast to clinical trials, where guidelines and standardized methods exist and are mandatory, only a few initiatives have published methodological guidelines for clinical registries. The objective of this paper was to review these guidelines and systematically assess their completeness, usability and feasibility according to a SWOT analysis. The results show that each guideline has its own strengths and weaknesses. While one supports the systematic planning process, the other discusses clinical registries in great detail. However, the feasibility was mostly limited and the special requirements of clinical registries, their flexible, expandable and adaptable technological structure was not addressed consistently.
authors: Institute of Medical Biometry and Informatics, Heidelberg University, Germany.
authors: Martin
authors: M
authors: Löpprich
authors: Institute of Medical Biometry and Informatics, Heidelberg University, Germany.
authors: Petra
authors: P
authors: Knaup
mesh_terms: D004282:Documentation / Q000379:methods; D017408:Guidelines as Topic; D006801:Humans; D063868:Patient Outcome Assessment; D012042:Registries / Q000592:standards*