© Springer International Publishing Switzerland 2016 21
Y. El Miedany (ed.), Patient Reported Outcome Measures in Rheumatic Diseases,
DOI 10.1007/978-3-319-32851-5_2
Chapter 2
A Guide to PROMs Methodology
and Selection Criteria
Maha El Gaafary
Introduction
In general, medical management outcomes can be classified into clinical (e.g., cure,
survival), personal (e.g., emotional status, self-helplessness, ability to carry out
activities of daily living), and economical (e.g., expenses, cost effectiveness). In a
clinical scenario, the outcomes can be clinician reported (e.g., progression of the
case in response to therapy), physiologic (e.g., tumor size assessed by ultrasound
[US] or magnetic resonance imaging [MRI]), caregiver reported (e.g., functional
disability), or patient reported (e.g., symptoms or quality of life) [ 1 , 2 ]. If the patient
is monitored for the outcomes by clinician, caregiver, or researcher, then the out-
comes become observer reported outcomes (OROs). On the other hand, if the patient
is revealing how he/she feels about their medical problem and its impact on their
lives, it becomes patient reported outcome (PRO). Proxy reported outcome is differ-
ent from a PRO or ORO, as it is a measurement based on the report given by some-
one else on behalf of the patient or as if he or she is the patient.
As the patient is considered “the center” for any healthcare system, “patient-
centered care” got to center stage in discussions of the modern healthcare system
[ 3 ]. Patient-centered care is considered the best approach able to reflect the quality
of personal, professional, and organizational relationships. According to the US
Food and Drug Administration (FDA), a patient reported outcome is any report of
the status of a patient’s health condition that comes directly from the patient, with-
out interpretation of the patient’s response by a clinician or anyone else [ 4 , 5 ]. No
wonder PRO has been used as effectiveness end points in clinical trials as well as in
standard clinical practice.
M. El Gaafary (*)
Community and Public Health Department, Ain Shams University, Cairo, Egypt
e-mail: [email protected]