GETTY
longitudinally related to health-related quality of life
(HRQoL), societal costs, and healthcare costs.
Disability, measured using the Oswestry Scale, had
a stronger association with all outcomes compared
with pain. 9
A complex illness
cLBP has many different aetiologies, different
clinical signs and symptoms and comorbidities;
it may have nociceptive or neuropathic
components (some studies show that up to 90% of
cLBP patients have a neuropathic component), 10 or
a combination of both. It is extremely probable for
cLBP that the important outcomes are not
represented by a simple measure such as the
intensity of the pain. So far, clinical studies often
only use pain intensity as the primary outcome
parameter, although other parameters and patientreported
and relevant outcomes of quality of life and
functionality are more relevant and important to be
evaluated and monitored. 11,12
Physical functioning outcome measures and
assessing dimensions of daily living
Physical functioning or functionality can be defined
as the “Ability to ambulate, function cognitively,
return to work, complete activities of daily living,
sleep etc.” 13
Physical functioning and dimensions of daily
living are altered in patients with cLBP; the patients
experience problems in undertaking certain
activities or increased symptoms during or after
physical activity. Physical functioning outcome
measures are important because they provide data
not only on the impact of pain and treatment effects
beyond symptom reduction alone, but also on the
impact on individuals’ quality of life. IMMPACT
(Measurement and Pain Assessment in Clinical
Trials) recommended that assessing health-related
quality of life (HRQoL), and physical, emotional and
social functioning should be included as core
outcome domains in every chronic pain clinical
trial. 14
Patient-reported outcome measures
The US Food and Drug Administration defines
patient-reported outcome measures (PROMs) as, “any
report of the status of a patient’s health condition
that comes directly from the patient, without
interpretation of the patient’s response by
a clinician or anyone else”. 15 At least some of these
data, especially that reported directly by the patient
suffering from cLBP, should be taken into account in
the usual clinical practice. The new International
Classification of Diseases (ICD-11) acknowledges pain
as a disease in its own right and, within it, cLBP,
as one of the main causes of pain in general, and
almost a disease on its own. 16 The International
Classification of Functioning, Disability, and Health
(ICF) details physical functioning at the level of
specific tasks with an important independent
outcome domain. 17,18
The combined use of ICD-11 and ICF is expected
to improve research reports on chronic pain by
creating a more precise and adequate coding, as well
as improved patient management through better
diagnostic classification. Increased attention to the
functional impact of chronic pain is an important
step forward for its management. Useful codes are
required in the ICD and ICF but will not be sufficient
to improve patient care unless they are regularly
used in clinical practice (ICF is difficult to use
routinely as it is very long). A lack of therapeutic
guidelines in patient care in cLBP contributes to the
Physical functioning outcomes
measures are important because they
provide data on the impact of pain and
treatment effects beyond symptom
reduction alone
4 | 2020 | hospitalpharmacyeurope.com