Fig 1.
PARADISE approach with literature reviews, content analysis of outcome instruments, clinical input and qualitative study.
PARADISE multi-method approach with systematic literature reviews, content analysis of patient-reported outcomes (PROs) and outcome instruments, clinical input and a qualitative study. Information from all sources was harmonized and compiled and a data collection protocol developed also including feedback from an external expert consultation. The protocol included all potentially relevant PSDs and their determinants across brain disorders. This protocol was implemented in a cross-sectional study.
Fig 2.
Decision tree used for selecting relevant psychosocial difficulties across brain disorders.
The starting point of the decision tree was the list of psychosocial difficulties (PSD) addressed in the 27 patient reported outcome (PRO) or outcome instruments identified in the literature reviews. If a PSD was addressed in at least one of the PROs or outcome instruments and had also been identified in at least two of the three sources of information (literature reviews, qualitative study and clinical input), this PSD was selected for inclusion into the data collection protocol. If a PSD had only been included in one of the sources of information, then if it had been identified in the literature reviews of at least two brain disorders and in those in > 20% of the studies included in the reviews, then the PSD was also included in the PARADISE protocol. If not, then if it had been included in the patient input studies for more than three brain disorders, or in the clinical input for more than three brain disorders, in both cases it was included in the protocol.
Table 1.
Psychosocial difficulties (PSD) included in the PARADISE data collection protocol.
Table 2.
Demographic characteristics of the persons participating in the study implementing the PARADISE data collection protocol.
Table 3.
Environmental determinants included in the data collection protocol and the percentage of persons who experienced them as having a positive or negative influence in their psychosocial difficulties.