Patient Reported Outcomes in Randomized Controlled Trials of Nervous System and Mental Health Disorders: Current Status in India
Author(s)
Ali Hashmi MA1, Kandregula N1, Vullengala N1, Kalakota C1, Vallish BN1, Dang A2
1MarksMan Healthcare Communications, Hyderabad, India, 2MarksMan Healthcare Communications, Hyderabad, AP, India
Presentation Documents
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
Systematic review protocol registration: OSF [Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
PCR49
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas