Humanistic Burden in Dementia: Which Tools Were Most Commonly Used in Studies Published in Pubmed in 2014?

Functioning can be defined as the ability to perform daily activities, and to maintain interpersonal relationships and work capacity/productivity. Major Depressive Disorder (MDD) is associated with substantial impairment in functioning. The study examined associations between various measures of functioning (patient assessment) and MDD symptoms (clinician assessment). A major challenge was to ensure MDD patient compliance with regular self-assessments and retention in a long-term study.Objectives: The purpose of the Direct to Patient Contact (DPC) approach was to maximize patient compliance to Patient Reported Outcomes (PRO) data collection and retention in a study conducted in real life settings over a two-year follow-up period. MethOds: This was an international, multicentric, observational, prospective longitudinal cohort study involving 1,500 MDD patients followed-up for two years in five European countries. Patients were recruited by General Practitioners or psychiatrists and data collected using a hybrid method: clinical data by physicians and PRO data self-assessment by patients. DPC actions included PRO questionnaire shipments to patients at five time points, followed by phone reminder contacts for non-returned questionnaires. Results: 1,450 patients were included in the study, 97.8% of whom agreed to be contacted directly by DPC staff. Overall, 71.7% of patients were reached by phone and 75.6% of PRO questionnaires were returned; the questionnaire completion rate reached 95.3%. 79.6% of patients remained until study end, 0.1% died, 3.5% voluntarily withdrew from the study and 16.7% were withdrawn for other reasons. There were no patients lost to follow up. cOnclusiOns: This study demonstrates that the use of DPC in a MDD population, likely to be study non-compliant/unresponsive, produced excellent long-term response rates. It minimized voluntary patient drop-outs and lost to follow up rates, and ensured an enhanced data collection of self-assessed PROs, thus improved reliability of study outcomes.