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· DOS Abstracts

Appropriate Methods for Development, Validation,

and Use of Patient Reported Outcome Measures

Jonathan Comins, Michael Krogsgaard, Svend Kreiner, John Brodersen

Department of Rheumatology , Copenhagen University, Institute of Public

Health /University Hospital Zeeland; Copenhagen University Hospital Bispebjerg;

Copenhagen University, Institute of Public Health; Copenhagen University,

Institute of Public Health

Background:

Patient-Reported Outcome Measures (PROMs) in the form of

clinical questionnaires have become a fundamental component of healthcare

assessment today. Also in the realm of sports medicine and orthopedics, clini-

cians and researchers besiege their patients with PROMs, only to be burdened

with the extensive administration and interpretation of these measures. From a

clinical standpoint, PROMs are important because they measure health from the

perspective of the patient. However, in order to understand how a sum score

(a number), which has been derived from the responses to a group of questions

can be considered a measure of anything, it is necessary to consider the basic

principles of what measurement in fact is. Clinicians and clinical researchers us-

ing PROMs need to have a basic understanding of the purpose and application

of PROMs as measurement scales.

Purpose / Aim of Study:

The objective of this paper is to illustrate how Rasch

Item Response Theory (IRT) is the most appropriate method for constructing

and validating PROMs.

Materials and Methods:

We present an in-depth description of how questions

that are confirmed to be relevant and comprehensive for the targeted patient

group should be generated, and we show how the Rasch model is used to con-

firm statistically the measurement/scaling properties of these questions.

Findings / Results:

Rasch IRT is the only statistical method used to validate

PROMs, which satisfies the fundamental mathematical constraints of measure-

ment.

Conclusions:

If we are to use instruments to measure non-physical attributes

such as pain, self perceived function, or psychosocial consequences as primary

outcome measures in comparative studies, then the validation methods must be

as stringent as possible and should include Rasch IRT analyses.

No conflicts of interest reported

101.