Saturation Reporting in COA Development and Validation Studies: A Scoping Overview


Girardi A1, Ridley M2, Suminski N3, Gold A4, Rudell K5
1Parexel International, London, LON, UK, 2Parexel International, Stockholm, Sweden, 3Parexel International, San Diego, CA, USA, 4Parexel International, Lafayette, CA, USA, 5Parexel International, LONDON, LON, UK

Presentation Documents

OBJECTIVES: In qualitative research, saturation , is often used to confirm the representativeness of the sample size. In clinical outcome assessment (COA) development, this is defined as the point at which “collecting additional data will not likely add to the understanding of how patients perceive the concept of interest and the items in the questionnaire”.

Thematic analysis (TA) is one of the most common qualitative methods used in COA studies. However, saturation is not always recommended with TA (Braun & Clarke, 2019).

To ensure the implementation of rigorous methods, a better understanding of the use of saturation in COA studies is needed. The aim of this overview is to understand the use and reporting of saturation in COA studies.

METHODS: The focus of this preliminary overview was limited to ISPOR database as the leading scientific and educational organization for outcomes research. ISPOR database was searched to identify saturation procedures for COA studies. No time limits were applied. Studies which used concept elicitation were included. Data analysis and saturation details were extracted.

RESULTS: Thirteen studies were accessed. Among the studies that described the analysis (n =7; 54%), six implemented TA. Of these, five (83%) reported the results of saturation. Three (50%) provided details of the process of saturation analysis, with the remaining only mentioning that ‘saturation was reached’.

CONCLUSIONS: The findings confirm that saturation is often used in conjunction with TA. Furthermore, operational details of how saturation was reached are not always reported. The rationale for saturation use and the analysis process associated to it needs to be described in detail to enhance robustness and support sample representativeness. Due to the overview being conducted only on ISPOR poster, further research is needed to confirm these preliminary findings, and help inform saturation reporting standards in COA studies.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)




Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment


No Additional Disease & Conditions/Specialized Treatment Areas

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