Content Validation of the Patient Attainment Scale-Essential Tremor (PAS-ET): A Novel Patient-Reported Outcome Measure Assessing Patient-Level Perceptions of the Importance, Current Function and Definitions of Meaningful Improvement in Tremor-Related...
Author(s)
Elizabeth Exall, MSc1, Ginny Shand, MSc1, Margaret Gerbasi, PhD2, Sarah Acaster, MSc1;
1Acaster Lloyd Consulting, London, United Kingdom, 2Sage Therapeutics, Inc., Cambridge, MA, USA
1Acaster Lloyd Consulting, London, United Kingdom, 2Sage Therapeutics, Inc., Cambridge, MA, USA
Presentation Documents
OBJECTIVES: To evaluate the content validity of the Patient Attainment Scale-Essential Tremor (PAS-ET), a patient-reported outcome measure assessing patient-level perceptions of the importance, current function and definitions of meaningful improvement in tremor-related impacts on activities of daily living (ADLs).
METHODS: Cognitive debriefing interviews were conducted with adults with essential tremor (ET) across three iterative rounds. Recruitment targets were used to ensure a range of ages and severity levels (patient-reported severity of tremor-related ADL impacts) were reflected in the sample. Structured interviews explored participant understanding of the PAS-ET, including instructions, item wording, response options, and the patient-relevance of included concepts. Interviews were analysed using content analysis. Evidence-based revisions were made between rounds, with changes evaluated in subsequent interviews until no further modifications were required.
RESULTS: Twenty-two participants completed an interview (Round 1: n=12; Round 2: n=4; Round 3: n=6); all recruitment targets were met within the sample. Across rounds, most participants demonstrated good understanding of the PAS-ET content, and all concepts were relevant to most participants. Notable evidence-based revisions were made to the PAS-ET following Round 1, including the removal of an example item and wording revisions on items assessing ‘current ability’ and definitions of ‘meaningful improvement’ on ADL concepts. Updates to the PAS following Round 2 were limited to a minor wording update on one item. By Round 3, all content was well understood, and no further revisions were required.
CONCLUSIONS: Through iterative rounds of cognitive debriefing interviews, evidence-based revisions were made to the PAS-ET, with the revised version demonstrating good evidence of content validity. When used in clinical research, the PAS-ET allows researchers to consider patient’s individual priorities and definitions of meaningful improvement when examining the benefit of treatments on tremor-related ADL impacts. Prior to use in clinical studies, the psychometric validity of the PAS-ET should be investigated.
METHODS: Cognitive debriefing interviews were conducted with adults with essential tremor (ET) across three iterative rounds. Recruitment targets were used to ensure a range of ages and severity levels (patient-reported severity of tremor-related ADL impacts) were reflected in the sample. Structured interviews explored participant understanding of the PAS-ET, including instructions, item wording, response options, and the patient-relevance of included concepts. Interviews were analysed using content analysis. Evidence-based revisions were made between rounds, with changes evaluated in subsequent interviews until no further modifications were required.
RESULTS: Twenty-two participants completed an interview (Round 1: n=12; Round 2: n=4; Round 3: n=6); all recruitment targets were met within the sample. Across rounds, most participants demonstrated good understanding of the PAS-ET content, and all concepts were relevant to most participants. Notable evidence-based revisions were made to the PAS-ET following Round 1, including the removal of an example item and wording revisions on items assessing ‘current ability’ and definitions of ‘meaningful improvement’ on ADL concepts. Updates to the PAS following Round 2 were limited to a minor wording update on one item. By Round 3, all content was well understood, and no further revisions were required.
CONCLUSIONS: Through iterative rounds of cognitive debriefing interviews, evidence-based revisions were made to the PAS-ET, with the revised version demonstrating good evidence of content validity. When used in clinical research, the PAS-ET allows researchers to consider patient’s individual priorities and definitions of meaningful improvement when examining the benefit of treatments on tremor-related ADL impacts. Prior to use in clinical studies, the psychometric validity of the PAS-ET should be investigated.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR13
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Neurological Disorders