[Quality of life, depression and cognitive functions 1. Operational protocol and its implementation]

The QDF (Quality of life, Depression and cognitive Function) is a project elaborated and implemented by a Research Network of the nursing personnel of the cardiological services which promoted and run the GISSI-HF trial. It is a "companion study" which included up to 1/3 of all the GISSI-HF centres.

To describe the distribution and evaluation of QDF variables measured with standardised instruments (Kansas City Cardiomiopathy Quality of Life questionnaire, KCCQ; Geriaric Depression scale GDS, Mini Mental State Examination MMSE), to verify whether and how far their knowledge could influence clinical decisions; to assess the prognostic impact of QDF values measured at entrance on mortality and morbidity. The study protocol included also a comprehensive evaluation of QDF variables independent from the questionnaires, by the nurses in charge of the study patients (the results of this part of the protocol are not included in this report).

The QDF data were collected at baseline, 6 months, 1, 2 and 3 years through two self administered questionnaires (KCCQ, GDS), while the MMSE only for patients >70 years. The questionnaires were administered to the patients who accepted to participate. A specific goal of the project focuses on the degree of independence between the results of the questionnaires and the judgement of the nurses. This contribution presents the operational implementation of the study protocol and general framework.