OBJECTIVES: To evaluate the current status of Patient-reported outcomes (PROs) captured in Randomized Controlled Trials (RCTs) performed on nervous system and mental health disorders in India

METHODS: After prospectively registering the study protocol with the Open Science Framework, we searched PubMed for relevant records published between 1-Jan-2012 and 31-Mar-2022 using appropriate search strategies. Publication details, demographics, intervention and comparator details, and details of PROs were extracted from eligible records.

RESULTS: Out of 306 records screened, 15 studies (14 RCTs, 1 cluster RCT) involving 1168 Indian patients (576, 43.9% males) with different neurological conditions (epilepsy: 3; depression: 3; migraine: 3; other conditions: 4) were included. A total of 14 different interventions, 6 placebos and 8 active comparators were evaluated in 14/15 studies; one study had 2 placebo and 1 active comparator arm against an intervention.The included studies evaluated a total of 23 PROs (7 unique PROs), the three most frequent being symptoms, QoL, and behavior (9, 8, and 2 studies respectively). Twenty-seven different PRO scales were used. All studies measured PROs in pairs for before-after comparison. Many generic scales were used to measure PROs; none were India-specific

CONCLUSIONS: Recording and analyzing PROs in RCTs on nervous system and mental health disorders in India is inadequate and has a large amount of variation