Published Nov 2011
Citation
Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity - establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: part 1 - eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967-977.
Abstract
The importance of content validity in developing patient reported outcomes
(PRO) instruments is stressed by both the US Food and Drug Administration
and the European Medicines Agency. Content validity is the
extent to which an instrument measures the important aspects of concepts
that developers or users purport it to assess. A PRO instrument
measures the concepts most significant and relevant to a patient’s condition
and its treatment. For PRO instruments, items and domains as reflected
in the scores of an instrument should be important to the target population
and comprehensive with respect to patient concerns.
Documentation of target population input in item generation, aswell as evaluation
of patient understanding through cognitive interviewing, can provide
the evidence for content validity.
Developing content for, and assessing respondent
understanding of, newly developed PRO instruments for medical
product evaluation will be discussed in this two-part ISPOR PRO Good Research
Practices Task Force Report. Topics include the methods for generating
items, documenting item development, coding of qualitative data from
item generation, cognitive interviewing, and tracking item development
through the various stages of research and preparing this tracking for submission
to regulatory agencies.
Part 1 covers elicitation of key concepts using
qualitative focus groups and/or interviews to inform content and structure of
a new PRO instrument. Part 2 covers the instrument development process,
the assessment of patient understanding of the draft instrument using cognitive
interviews and steps for instrument revision. The two parts are meant
to be read together. They are intended to offer suggestions for good practices
in planning, executing, and documenting qualitative studies that are used to
support the content validity of PRO instruments to be used in medical product
evaluation.
Keywords: content validity, European Medicines Agency, Food and Drug
Administration, patient reported outcomes, quality of life.
Copyright © 2017, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
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