The Parkinson's Disease Activities of Daily Living, Interference, and Dependence Instrument.
Parkinson's disease
activities of daily living
independence
motor fluctuations
patient‐reported outcomes
Journal
Movement disorders clinical practice
ISSN: 2330-1619
Titre abrégé: Mov Disord Clin Pract
Pays: United States
ID NLM: 101630279
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
11
03
2019
revised:
09
07
2019
accepted:
24
07
2019
entrez:
21
11
2019
pubmed:
21
11
2019
medline:
21
11
2019
Statut:
epublish
Résumé
Individuals with Parkinson's disease often experience periods of To identify the consequences of motor fluctuations on day-to-day activities and areas of unmet treatment priority among individuals with moderate to advanced Parkinson's disease, to assess whether existing patient-reported outcome instruments adequately capture these consequences and priorities, and based on these evaluations, to adapt an existing or develop a new instrument. The research was conducted in 2 stages: concept exploration and content confirmation. Concept exploration included direct input from individuals with Parkinson's disease representing the intended context of use via concept elicitation interviews. Content confirmation and item refinement was achieved through 5 rounds of cognitive debriefing. Final rounds of cognitive debriefing also included usability testing of the draft instrument for electronic data capture. Concept elicitation interviews were conducted among 29 individuals with Parkinson's disease (55% male; mean age 60.8 years). Concept saturation was achieved quickly with more than 90% of concepts identified by the end of the 16th interview. None of the existing outcome instruments were found to be fit for purpose in the intended context of use; therefore, a new instrument was developed. After 5 rounds, cognitive debriefing participants indicated clear and consistent interpretation of the items. Evidence from this study supports the content validity of the Parkinson's Disease Activities of Daily Living, Interference and Dependence Instrument as the basis of a clinical trial endpoint for capturing priority treatment benefit outcomes to individuals with moderate to advanced Parkinson's disease experiencing motor fluctuations.
Sections du résumé
BACKGROUND
BACKGROUND
Individuals with Parkinson's disease often experience periods of
OBJECTIVES
OBJECTIVE
To identify the consequences of motor fluctuations on day-to-day activities and areas of unmet treatment priority among individuals with moderate to advanced Parkinson's disease, to assess whether existing patient-reported outcome instruments adequately capture these consequences and priorities, and based on these evaluations, to adapt an existing or develop a new instrument.
METHODS
METHODS
The research was conducted in 2 stages: concept exploration and content confirmation. Concept exploration included direct input from individuals with Parkinson's disease representing the intended context of use via concept elicitation interviews. Content confirmation and item refinement was achieved through 5 rounds of cognitive debriefing. Final rounds of cognitive debriefing also included usability testing of the draft instrument for electronic data capture.
RESULTS
RESULTS
Concept elicitation interviews were conducted among 29 individuals with Parkinson's disease (55% male; mean age 60.8 years). Concept saturation was achieved quickly with more than 90% of concepts identified by the end of the 16th interview. None of the existing outcome instruments were found to be fit for purpose in the intended context of use; therefore, a new instrument was developed. After 5 rounds, cognitive debriefing participants indicated clear and consistent interpretation of the items.
CONCLUSIONS
CONCLUSIONS
Evidence from this study supports the content validity of the Parkinson's Disease Activities of Daily Living, Interference and Dependence Instrument as the basis of a clinical trial endpoint for capturing priority treatment benefit outcomes to individuals with moderate to advanced Parkinson's disease experiencing motor fluctuations.
Identifiants
pubmed: 31745478
doi: 10.1002/mdc3.12833
pii: MDC312833
pmc: PMC6856450
doi:
Types de publication
Journal Article
Langues
eng
Pagination
678-686Informations de copyright
© 2019 International Parkinson and Movement Disorder Society.
Déclaration de conflit d'intérêts
This study was funded by Pfizer. Ms. Deal and Ms. Myers are currently employees of Pfizer and were so employed at the time the study was conducted. Their compensation includes company stock. Dr. Gray was also employed by Pfizer at the time this study was conducted. He is now employed by Cerevel Therapeutics. Mr. Devine was an employee of ICON, plc at the time the study was conducted. His ICON compensation included company stock. Mr. Devine is now employed by Genentech. Ms. Flood was employed ICON, plc, at the time the study was conducted. Her ICON compensation included company stock. ICON was contracted by Pfizer in connection with the conduct of the study. Ms. Flood is now employed by AstraZeneca.
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