Table 1 Scoring using the PRECIS-2 tool
Items | Score | Rationale |
|---|---|---|
Eligibility - to what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care | 4 | Target population: elderly with depression. Inclusion criteria are wide. No exclusion criteria will be applied in terms of setting of recruitment, severity of depression, past use of psychotropic drugs, current use of benzodiazepines, number and severity of medical comorbidities and multiple pharmacotherapies. Diagnoses are based on clinical judgment (considering DSM-5 criteria as a reference), as it is in usual practice |
Recruitment - how much extra effort is made to recruit participants over and above what that would be used in the usual care setting to engage with patients? | 5 | Participants will be recruited without extra efforts. They will be recruited during usual appointments and/or visits |
Setting - how different is the setting of the trial and the usual care setting? | 4 | The study is multicentre, based in more than 10 psychiatric centres of the National Health System in Italy with a University centre |
Organisation - how different are the resources, provider expertise and the organisation of care delivery in the intervention arm of the trial and those available in usual care? | 4 | We will use usual staff and resources, but some extra resources will be necessary to hire researchers for the study. Visits will be conducted at the usual care facilities in each centre |
Flexibility (delivery) - how different is the flexibility in how the intervention is delivered and the flexibility likely in usual care? | 5 | The intervention is flexible, similar to usual care |
Flexibility (adherence) - how different is the flexibility in how participants must adhere to the intervention and the flexibility likely in usual care? | 4 | No extra measures. Participants will be free to partake in the intervention or drop it, but drugs will be prescribed and given to the participants during visits. This is different from usual care (patients have a prescription and go to the pharmacy to buy drugs) |
Follow up - how different is the intensity of measurement and follow up of participants in the trial and the likely follow up in usual care? | 4 | The primary outcome will be assessed after 1, 3 and 6 months, as it is usually in everyday practice. Six months represent a clinically sound time frame for assessing the overall tolerability of medications, including both acute, short-term and medium-to-long-term effects. Visits could be slightly longer than usual to assess all the scales and long-term effects and adverse events could occur after 6 months |
Primary outcome - to what extent is the trial’s primary outcome relevant to participants? | 5 | Primary outcome is relevant to participants and policy makers |
Primary analysis - to what extent are all data included in the analysis of the primary outcome? | 5 | The intention-to-treat (ITT) population will consist of all randomized participants. This ITT population will be used for the analysis of both primary and secondary outcomes. Missing values in rating scales will be imputed using the last observation carried forward (LOCF) approach |