359that comprise eight categories of functioning including dressing, rising, eating,
walking, self-hygiene, and other daily activities.
Other less frequently evaluated domains were patient global assessment (15 %),
fatigue (15 %), and quality of life through a generic form, the Short-Form Health
Survey (SF-36) (10 %) [ 21 ]. In addition, anxiety and depression were included in
one of the studies aiming to evaluate outcomes of importance to patients without
any specifi c information about how to measure these two domains [ 8 ].
In summary, pain on a visual analogue scale, morning stiffness in minutes, and
physical function by HAQ were the three most frequently reported domains in pub-
lished studies. Other domains such as patient global assessment, fatigue, quality of
life, anxiety, and depression were infrequently reported in PMR studies, though
they appear important from the patient’s point of view [ 8 ].
PROs as Part of Diagnostic/Classifi cation Criteria
and to Assess Disease Activity
A variety of clinical diagnostic criteria sets have been proposed in the last years, but
to date there has been no formal consensus in which one should be used in a regular
basis. A comparison of the sensitivity of diagnostic criteria was performed in 2004,
and the authors concluded that Bird 1979 and Hunder 1982 criteria should be used
based on a higher sensitivity in the diagnosis of PMR [ 22 ]. More recently, classifi -
cation criteria for PMR were proposed by a European League Against Rheumatism/
American College of Rheumatology (EULAR/ACR) collaborative initiative [ 23 ].
These new classifi cation criteria were proposed essentially to provide a basic frame-
work for developing clinical trials of novel therapies. A summary of these diagnos-
tic and classifi cation criteria is presented in Table 14.1. There are two PROs that are
included in most of these criteria: pain assessment and morning stiffness. The evalu-
ation of pain has been included in each one of these criteria as pain/aching or tender-
ness in shoulder or pelvic girdle area, in shoulders, upper arm, hips or pelvis, and
thighs. Pain is a very important and overwhelming symptom for patients with
PMR. It is often not well localized to the joints but tended to be more responsive to
medication in comparison to other symptoms such as morning stiffness [ 24 ]. In
contrast, morning stiffness was included only in three of these criteria. Although
morning stiffness is also considered an important diagnostic clue in PMR, it is dif-
fi cult to evaluate and measure accurately. Duration of morning stiffness has been
reported to show poor test–retest reliability in PMR [ 7 ], probably because of the
fl uctuation of this symptom during the day. From the patient’s perspective, morning
stiffness is defi ned as a restriction of movement, and patients, in general, experience
this symptom as poorly responsive to treatment.
PROs have been also useful to defi ne remission and relapse in PMR. In a recent
review of relevant studies including defi nitions of PMR remission and relapse, two
14 PROMs for Polymyalgia Rheumatica