Too Many PICOS for Joint Clinical Assessments (JCA)? How To Adapt The Systematic Literature Reviews for Achieving Desired Outcomes
Author(s)
Jitender Takyar, M.Pharm1, Sugandh Sharma, MSc2, Rito Bergemann, MBA, PhD, MD3, Sangeeta Budhia, PhD4.
1Parexel International, Mohali, India, 2Parexel International, Chandigarh, India, 3Parexel International, Basel, Switzerland, 4Parexel International, London, United Kingdom.
1Parexel International, Mohali, India, 2Parexel International, Chandigarh, India, 3Parexel International, Basel, Switzerland, 4Parexel International, London, United Kingdom.
Presentation Documents
OBJECTIVES: With Joint Clinical Assessments (JCA) around the corner, there have been concerns regarding complex evidence generation needs due to high numbers of PICOS (Population, Intervention, Comparator(s), Outcomes). On 28th November 2024, European Member State Coordination Group on Health Technology Assessment (HTASG) released scoping guidance on how to seek, consolidate and finalize member state (MS) requirements in context of PICOS.
METHODS: We reviewed HTASG guidance on scoping for JCA and evaluated how SLRs may need to be adapted to meet multiple PICOS requirements for informing JCA dossier preparation.
RESULTS: HTASG guidance on scoping recommends MS to share PICOS requirements as per their national needs and explicitly mention if assessment is required against all comparators vs. at least one of the comparators (among many available comparators). During consolidation stage, comparators deemed desirable but not mandatory by MS can be dropped from final scope. Despite this, it is anticipated that evidence against multiple PICOS will be warranted for JCA. Therefore, it is the need of the hour to have adapted SLRs in place to meet these requirements. The adapted SLRs must involve a SMART strategy for achieving desired outcome • S: Search strategies including more comparators (investigational therapies & promising off label drugs) beside limiting it to only established comparators • M: Managing studies providing overlapping data for multiple PICOS • A: Additional reviews for understanding patient, physician and MS preferences (Preference reviews, HTA landscape reviews) • R: Reporting adaptations from “All evidence reporting” approach to “PICOS wise reporting” • T: Technological adaptations with AI (Artificial Intelligence) based tools for extracting multiple data sets across PICOS
CONCLUSIONS: HTASG guidance on scoping process is a valuable tool for researchers to understand PICOS requirements for JCA. Adapted SLR’s involving SMART strategy is a promising solution to complex evidence needs for JCA.
METHODS: We reviewed HTASG guidance on scoping for JCA and evaluated how SLRs may need to be adapted to meet multiple PICOS requirements for informing JCA dossier preparation.
RESULTS: HTASG guidance on scoping recommends MS to share PICOS requirements as per their national needs and explicitly mention if assessment is required against all comparators vs. at least one of the comparators (among many available comparators). During consolidation stage, comparators deemed desirable but not mandatory by MS can be dropped from final scope. Despite this, it is anticipated that evidence against multiple PICOS will be warranted for JCA. Therefore, it is the need of the hour to have adapted SLRs in place to meet these requirements. The adapted SLRs must involve a SMART strategy for achieving desired outcome • S: Search strategies including more comparators (investigational therapies & promising off label drugs) beside limiting it to only established comparators • M: Managing studies providing overlapping data for multiple PICOS • A: Additional reviews for understanding patient, physician and MS preferences (Preference reviews, HTA landscape reviews) • R: Reporting adaptations from “All evidence reporting” approach to “PICOS wise reporting” • T: Technological adaptations with AI (Artificial Intelligence) based tools for extracting multiple data sets across PICOS
CONCLUSIONS: HTASG guidance on scoping process is a valuable tool for researchers to understand PICOS requirements for JCA. Adapted SLR’s involving SMART strategy is a promising solution to complex evidence needs for JCA.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA52
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas