TIME-CONSTRAINED TARGETED REVIEW METHODS TO IDENTIFY CLINICAL OUTCOME ASSESSMENT INSTRUMENTS IN LONG COVID AND POST-COVID VACCINATION SYNDROME
Author(s)
Tom Macmillan, MSc1, Alice Sanderson, MPhil1, Paul Miller, MSc1, Sarolta Borbely, MSc2, Jose Luis Bartelt Hofer, PhD3.
1York Health Economics Consortium, York, United Kingdom, 2Sanofi, Budapest, Hungary, 3Sanofi Vaccines, Lyon, France.
1York Health Economics Consortium, York, United Kingdom, 2Sanofi, Budapest, Hungary, 3Sanofi Vaccines, Lyon, France.
OBJECTIVES: This study aimed to identify (1) clinical outcome assessment (COA) instruments suitable for capturing Post-COVID-19 Vaccination Syndrome (PCVS) symptoms, including instruments developed for post-acute COVID-19 syndrome (PACS) (“long COVID”); and (2) key psychometric properties captured by these instruments. While PCVS appears analogous to PACS, there remain symptomatic differences. It is unclear if COA instruments developed for PACS are appropriate for PCVS.
METHODS: Due to a limited project timeline, a targeted approach was taken. Traditional medical databases were replaced by searches for trials, registered since 2022, in ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. Records were screened for relevant indication (PCVS/PACS) and instruments measuring PCVS/PACS symptoms. Supplementary searches were conducted in ePROVIDE COA database, CDER & CBER Drug Development Tool Qualification Project Search database, FDA COA Compendium, and ad hoc searches of MEDLINE. An iterative hierarchical approach to data extraction saw the inclusion of instruments focusing on PACS or PCVS, measuring multiple symptoms and quality of life, and supported by publications detailing their development and/or validation. Instruments with comprehensive symptom coverage and the most robust supporting evidence (and/or prior use in PCVS) were chosen for further evaluation.
RESULTS: Searches conducted in January 2026 identified 1,727 deduplicated records, of which 582 included 366 instruments measuring symptoms of PACS or PCVS. Extraction was conducted for 24 instruments, and 6 were selected for further evaluation. The published instruments showed varied development and validation methods, with the most relevant demonstrating some validity and reliability in PACS that may cautiously extend to suspected PCVS cases within specific study settings.
CONCLUSIONS: Where limited project timelines preclude a traditional systematic review, a targeted approach omitting typical medical databases is a feasible option for certain review topics, such as identifying COA instruments. Iterative hierarchies allowed a rapid focus on extracting data from the most relevant instruments.
METHODS: Due to a limited project timeline, a targeted approach was taken. Traditional medical databases were replaced by searches for trials, registered since 2022, in ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. Records were screened for relevant indication (PCVS/PACS) and instruments measuring PCVS/PACS symptoms. Supplementary searches were conducted in ePROVIDE COA database, CDER & CBER Drug Development Tool Qualification Project Search database, FDA COA Compendium, and ad hoc searches of MEDLINE. An iterative hierarchical approach to data extraction saw the inclusion of instruments focusing on PACS or PCVS, measuring multiple symptoms and quality of life, and supported by publications detailing their development and/or validation. Instruments with comprehensive symptom coverage and the most robust supporting evidence (and/or prior use in PCVS) were chosen for further evaluation.
RESULTS: Searches conducted in January 2026 identified 1,727 deduplicated records, of which 582 included 366 instruments measuring symptoms of PACS or PCVS. Extraction was conducted for 24 instruments, and 6 were selected for further evaluation. The published instruments showed varied development and validation methods, with the most relevant demonstrating some validity and reliability in PACS that may cautiously extend to suspected PCVS cases within specific study settings.
CONCLUSIONS: Where limited project timelines preclude a traditional systematic review, a targeted approach omitting typical medical databases is a feasible option for certain review topics, such as identifying COA instruments. Iterative hierarchies allowed a rapid focus on extracting data from the most relevant instruments.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA57
Topic
Methodological & Statistical Research, Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Vaccines