Patient_Reported_Outcome_Measures_in_Rheumatic_Diseases

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Despite their value in assessment, monitoring, prognosis, and outcomes, patient
questionnaires are not implemented at this time in most rheumatology care settings
[ 54 ]. Changes in status of most patients with rheumatic diseases continue to be
recorded at most busy rheumatology sites only as narrative descriptions without
quantitative patient data. The only quantitative data in the medical records of most
patients of rheumatologists are laboratory tests, the limitations of which led to rec-
ognition of a need for indices [ 42 , 55 ].
Emphasis on laboratory tests, without quantitative patient or physician scores to
monitor patient status, may continue to result in a situation described more than
30 years ago in which “clinicians may easily write ‘doing well’ in the notes of the
patient who has become progressively crippled before their eyes” [ 56 ]. It is ironic
that pharmaceutical companies collect self-report questionnaires to document
improvement in patient status for registration of new therapies, but most
rheumatologists have not adopted this practice in usual clinical care. The issue of
feasibility is important, as expressed in an editorial that queried, “Is it better to have
80 % of the information in 100 % of patients or 100 % of the information in 5 % of

Table 3.2 Patient questionnaire measures for clinical research versus clinical care

Feature Clinical research New patient intake Clinical care

Design

considerations

Complete, long Provide medical

history

Patient friendly, short,

completed by patient

within 5–10 min

Effect on patient

visit

Adds time, interferes

with fl ow

Saves time for MD

and patient

Saves time for MD

and patient

Type of

questionnaire

May be “generic,”

“disease specifi c,” other

research goals

Applicable to

patients with all

rheumatic diseases

Applicable to patients

with all rheumatic

diseases

Scoring Complex, requires

computer

Simple, may

“eyeball” results in

~30 s

Simple, may “eyeball”

results; scored in

10–15 s

Goal of data Add to research database Add to clinical care Add to clinical care

Focus of analysis Groups of patients in

clinical trials or

observational databases

Individual patients

cared for by

individual physicians

Individual patients

cared for by individual

physicians

Data management Send to data center May enter into offi ce

database to initiate

patient record

Review for patient

care; may enter into

fl ow-sheet to compare

to previous visits

Quantitative scores Yes No Yes

Entry into

structured database

Yes Usually not Yes

Major criteria for

use

Validity, reliability;

assess minimal clinically

important signifi cant

difference (MCID)

New patient history Document status,

medical and medico-

legal rationale for

aggressive therapies

Disposition of

questionnaire

Central study data center

enters into computer

Physician enters into

computer

Enter into fl ow sheet

in medical record

T. Pincus et al.