65pragmatic reason is that changes in laboratory values are seen over days and are the
most signifi cant predictor of radiographic progression [ 17 ], which could be recog-
nized over 6–12 months in patient groups in clinical trials [ 48 ]. By contrast, out-
comes of work disability and premature mortality require 5–15 years for analyses
[ 49 ]. Observation of long-term outcomes is outside the time frame of clinical trials
and requires maintenance of long-term databases, which remain unavailable in most
rheumatology clinical settings. Therefore, more attention concerning outcomes of
RA has been directed to radiographic progression than to work disability and pre-
mature mortality, for which biomarkers are not nearly as signifi cant in prognosis as
physical function on a patient questionnaire.
Patient Questionnaires for Research Versus Clinical Care
The experience of most physicians with patient questionnaires has been in clinical
trials and other clinical research, and/or in many clinical care using an “intake”
questionnaire for new patients (Table 3.2 ). Patient questionnaires for many clinical
trials and clinical research studies frequently are long, and not amenable to easy
completion by patients or review by physicians in busy clinical settings. Indeed, in
clinical trials, a clinician generally is directed not to review the questionnaire, other
than for completeness (often the responsibility of a study coordinator), which is
forwarded to a “data center” for analysis. The questionnaire is not designed to have
any impact on clinical care (Table 3.2 ).
Patient “intake” questionnaires for initial clinical care visits are used to facilitate
compilation of a patient’s medical history and demographic data. Information on an
intake questionnaire generally is not recorded in a standard , “scientifi c,” protocol-
driven format. Furthermore, most intake questionnaires do not include quantitative
scores (for pain, function, fatigue, etc.), analogous to laboratory tests. Therefore,
most intake questionnaires remain “subjective” and “nonscientifi c” (Table 3.2 ). The
information is entered into a medical record by a physician or assistant through typ-
ing, dictation, or handwriting. Patients who see a new doctor, particularly in a dif-
ferent locale from a previous doctor (but sometimes in the same locale), usually
must complete a new intake questionnaire, as the information from previous intake
questionnaires has not been recorded in an easily retrievable format.
By contrast, patient questionnaires designed to guide clinical care, such as a
health assessment questionnaire (HAQ) (see Appendix chapter) [ 50 ], derivative
multidimensional HAQ (MDHAQ) [ 51 , 52 ], HAQii [ 53 ], and others, are short—
generally two sides of a single sheet of paper (Table 3.2 ). The emphasis is on feasi-
bility and clinical utility, although psychometric criteria (see Appendix chapter A)
for validity and reliability required for all questionnaires must be met. A 4-page
format of the MDHAQ facilitates a more advanced intake questionnaire, as described
later. The MDHAQ (see Appendix chapter B) and similar questionnaires are stan-
dardized and meet criteria for “scientifi c” measures, involving protocol- driven
(same format) quantitative scores, analogous to laboratory tests, to help guide clini-
cal decisions (Table 3.2 ).
3 PROMs (MDHAQ/RAPID3) and Physician RheuMetric Measures