The Külliye of Sultan Bayezid II - Psychiatry in history.

Abstract

(iii) if SAEs were not monitored, this should be listed as a study limitation. (c) Hospital admissions: (i) hospital admissions should always be reported as adverse events, even when admission is a study outcome (ii) if there were none, this should be clearly stated (iii) should be supplemented with data on usage of crisis services if possible (iv) if admissions were not monitored, this should be listed as a study limitation. (d) Adverse events: (i) list which instances of less serious adverse events were monitored (ii) list how they were monitored (e.g. case note review). (iii) provide detailed descriptions of any adverse events that occur. (e) Side-effects: (i) include standardised patient-reported measure of sideeffects. (f) Symptom deterioration: (i) all instances of clinically meaningful deterioration in symptoms or psychological functioning should be reported. (g) Drop out: (i) report study drop out, and reason for drop out (including direct or indirect link to harm), by treatment arm (ii) report separately drop out and non-completion of therapy. (h) Public and patient involvement (PPI): (i) ensure meaningful PPI in decision-making about how harm is operationalised and monitored.