Development of CRIteria to assess appropriate Medication use among Elderly complex patients (CRIME) project: rationale and methodology.

Pharmacological treatment of complex older adults with comorbidities, multiple impairments in function, cognition, social status and geriatric syndromes represents a challenge for prescribing physicians and often results in a high rate of iatrogenic illnesses. Clinical guidelines are commonly used to indicate appropriate prescription, but they are often based on the results of clinical trials that are conducted on young subjects with a low level of complexity. Therefore, the recommendations of clinical guidelines may be difficult to apply to older complex adults. In this paper we present the rationale and methodology of the Development of CRIteria to assess appropriate Medication use among Elderly complex patients (CRIME) project, a study aimed at producing recommendations to evaluate the appropriateness of pharmacological prescription in older complex patients, translating the recommendations of clinical guidelines to this type of patient. A literature search will be performed to integrate and revise the recommendations of disease-specific guidelines on the pharmacological treatment of patients with common chronic conditions. New recommendations will be provided and approved in a consensus meeting of international experts. Both data from randomized controlled trials and observational studies will be used to meet this aim. Recommendations provided by the CRIME project are not meant to replace existing clinical guidelines, but they may be used to help physicians in the prescribing process. Once completed these recommendations should be validated in interventional studies.