Best Practice & Research Clinical Rheumatology 29 (2015) 164e186

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Best Practice & Research Clinical

Rheumatology
journal homepage: www.elsevierhealth.com/berh

16

How to measure chronic pain: New concepts

Fausto Salaffi a, *, Piercarlo Sarzi-Puttini b, Fabiola Atzeni c
a
Rheumatology Department, Polytechnic University of Marche, Ancona, Italy
b
Rheumatology Unit, L. Sacco University Hospital, Milan, Italy
c
IRCCS Galeazzi Orthopedic Institute, Milan, Italy

a b s t r a c t
Keywords:
Chronic pain The assessment of chronic pain and its impact on physical,
Rheumatology emotional and social functions requires the use of multidimensional
Assessment tools qualitative and health-related quality of life instruments, but there
Pain scales is still little agreement concerning what these may be or which
Health-related quality of life approach to adopt. Increasing focus on patient-reported outcomes
Clinimetrics
in medicine has had the positive effect of giving prominence to the
Information and communication technology
views and experiences of patients with chronic pain, and the
ecological momentary assessment (EMA) approach allows patients'
symptoms to be assessed in their natural environment in real time
without the need for recall. Computerised EMA symptom diaries are
now generally regarded as the ‘gold standard’ in the field of pain
medicine, and they have recently attracted increasing attention as
an essential component of health-care monitoring systems based on
the information and communication technology. A web/Internet-
based diary and patient terminal seem to provide a ubiquitous,
easy-to-use and cost-efficient solution for patient-centred data
acquisition. In addition, telemonitoring is increasingly seen as an
effective means of supporting shared decision-making as it can
inform patients about typical symptoms, treatment options and
prognosis, and it is widely accepted as an additional source of in-
formation. This article reviews some of the instruments used to
assess chronic pain, including newly developed and well-
established validated multidimensional instruments and health-
care monitoring systems based on information and communica-
tion technology, and it discusses their advantages and limitations.
© 2015 Published by Elsevier Ltd.

* Corresponding author. Clinica Reumatologica, Universita
Politecnica delle Marche, c/o Ospedale ‘Carlo Urbani’, Via dei Colli
52, 60035 Jesi AN, Ancona, Italy. Tel.: þ39 0731 534128/32/25; fax: þ39 0731 534124.
E-mail address: fsalaff@tin.it (F. Salaffi).

http://dx.doi.org/10.1016/j.berh.2015.04.023
1521-6942/© 2015 Published by Elsevier Ltd.
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 165

Introduction

Not only is chronic pain a symptom of rheumatic disease but it may also be a disease in itself in
which the biomedical disorder only partially explains a broader biopsychosocial context [1]. This is
especially true when pain is perceived in multiple body regions as in the case of chronic widespread
pain (CWP) [1]. Patients with CWP are frequently encountered in clinical practice, but their assessment
can be a formidable challenge because of the wide range of possible diagnoses including rheumato-
logical, endocrine/metabolic, neurological, infectious, malignant and psychiatric disorders [1], and the
findings of population-based studies in the USA and UK suggest that the symptom is experienced by
10e11% of the population at any given time [2,3].
One of the manifestations of CWP is fibromyalgia (FM), a complex multifactorial disorder charac-
terised by persistent widespread pain and mechanical hyperalgesia, and it is often accompanied by a
number of associated symptoms such as fatigue, sleep disturbances, psychological and cognitive al-
terations, headache, migraine, variable bowel habits, diffuse abdominal pain and urinary frequency
[4,5].
This review considers the methodological issues relating to the clinimetric properties of a number
of instruments currently used to assess patients with chronic musculoskeletal pain, including newly
developed and well-established validated multidimensional instruments and health-care monitoring
systems based on information and communication technology, and it discusses their advantages and
limitations. It is based on an extensive search of the literature, and the knowledge and experience of
the authors. Although it makes no claim to be exhaustive, it may offer some useful recommendations
for everyday clinical practice.

Chronic pain assessment

The comprehensive assessment of any chronic complex pain condition should be based on a bio-
psychosocial model that also considers the interactions of biological, psychological and social/cultural
contributors to the experience of pain [1,5e7]. Pain assessment is an interactive and collaborative
process involving patients and their families, nurses, physicians and other health professionals, which
provides the basis for selecting the most appropriate treatment. The foundation of effective chronic
pain management includes interviews, physical assessments, reviews of medications and medical and
surgical procedures, a psychosocial review, a review of the patient's physical environment and
appropriate diagnostic investigations. Its aim should be to determine the duration, frequency, in-
tensity/severity, location, onset pattern, quality or character of the pain, its impact on the quality of life
of the patient and his/her family and the effectiveness of treatments. Self-reporting is the primary
source, and it facilitates regular reassessment and follow-up. Various uni- or multidimensional pain
measurement scales have been developed, but none of them is suitable for all patients, and using them
interchangeably is still not justified [6,8,9].

Unidimensional pain scales

In busy clinical settings, pain measures must be simple, quick to administer and easily under-
stood by patients, and unidimensional scales satisfy all of these requirements as they can be
administered several times with minimal administrative effort, and they provide rapid results [6,9].
Subjective methods for measuring pain intensity include verbal rating scales (VRS), visual analogue
scales (VAS) and numeric rating scales (NRS), all of which have proved to be reliable and valid
[10e12]; however, they are significantly different from each other in terms of the number of
response categories, patient and clinician preferences, the likelihood of missing data and admin-
istration requirements.
A VRS consists of a set of words that describe the intensity/severity of pain along a continuum from
‘no pain’ to ‘mild pain’, ‘moderate pain’, ‘severe pain’, ‘extreme pain’ and ‘worst possible pain’ (Fig. 1a).
Patients are asked to select the word that best describes the characteristics of their pain. A VRS helps
patients to describe their pain more accurately by providing frequently used words, but the fact that
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Fig. 1. Widely used one-dimensional pain intensity scales.

the differences between the word categories do not represent equal differences in pain intensity leads
to the usual limitations of non-interval scales and, inevitably, the same words may have different
meanings for different patients.
Although variations exist, a typical VAS consists of a usually 10-cm-long horizontal line with the
number ‘0’ and the words ‘no pain’ on the left, and the number ‘10’ (or 100) and the words ‘worst
possible pain’ on the right (Fig. 1b) [13]. The rest of the line is left blank, and patients are asked to put a
mark on the line indicating the intensity of their pain at the time of completion or over the previous
week or fortnight, etc. The distance between this mark and the origin is then measured to obtain the
patient's score.
A valid alternative is an NRS (Fig. 1c), which consists of a horizontal line similar to that of a VAS with
the words ‘no pain’ and ‘worst possible pain’ at either end; however, in this case, the line between the
numbers ‘0’ and ‘10’ is marked by evenly spaced vertical bars numbered ‘1’ to ‘9’. The patients are asked
to rate the intensity of their pain by selecting a number on the 11-point scale, filling in a questionnaire,
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 167

or verbally answering a spoken question such as ‘Please tell me which of the numbers from 0 to 10 best
describes your pain now’ (or over the last week or fortnight, etc.). It is more practical and easy for most
people to understand; it does not need clear vision, dexterity or paper and pen; and it may be used
verbally or purely visually. However, research indicates that a vertical NRS is more sensitive and even
easier to use [14], especially in the case of patients who feel stressed and have a narrow visual field, and
so a vertical NRS may be used for some patient populations, or offered as an alternative to patients who
have difficulty with a horizontal scale. It is also possible to determine the intensity of pain accurately
with a normal or computerised telephone interview (in the latter case, patients record the data directly
into a database via their telephone keyboard).
Pincus et al. [15] found that a circle with 21 numbers and an arithmetic scale offers an optimal
alternative, and it has at least three advantages over a 10-cm horizontal line: (i) it can be scored
without a ruler, thus saving about half the time; (ii) it eliminates the need to reproduce an exact 10-cm
line when printing or photocopying questionnaires, thus avoiding the problem of minor distortions;
and (iii) patients seem to understand how to respond better (some patients write words or even
sentences on a line).
VAS methods are sometimes criticised because they are difficult to understand, which leads to
7e16% higher failure rates than VRS and NRS [16]. A recent review comparing the use of NRS, VRS and

Fig. 2. Thermometer Pain Scale (TPS).

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VAS in assessing pain intensity in adults has also found that fewer patients can use a VAS, thus leading
to fewer correct answers and higher error rates [17]. This is particularly true of older and/or cognitively
impaired patients, or patients with a low level of literacy or visual impairments [18]. The choice of scale
should therefore be based on the setting, the clinician's goal and the patient's level of education,
keeping in mind that patient preference is central to better physicianepatient communications [16,19].
The Revised Faces Pain Rating Scale is the most popular visual scale (Fig. 1d). Designed for children
aged 3 years, the scale shows seven faces whose expressions reflect increasingly severe pain, each
numbered from ‘0’ to ‘6’, and this can therefore be used in the case of patients who do not have the
verbal skills to explain how their symptoms make them feel. The scale also seems to be valid and
reliable in the elderly, although it is not necessarily preferable to a VRS or NRS [20].
Other methods use a VAS incorporating descriptive words or colours, and a VNS or Thermometer
Pain Scale (TPS), which aligns a thermometer alongside the words representing different levels of pain
severity (Fig. 2), is often used in clinical contexts [20,21]. The VNS was developed to take advantage of
the features of numeric scales while providing multiple visual cues that may include bars of different
height, shading and faces expressing pain associated with each number (Fig. 3), and it can therefore be
considered a combination of visual and numeric components [22]. All of these instruments facilitate
understanding and communication, particularly among patients with diminished cognitive capacity or
who have difficulty with abstract thinking [23,24] or communicating verbally. However, it has been
shown that thermometer scales are preferred by older people, who find them easier to understand, and
they are therefore recommended by national and international guideline panels [25e28].

Pain location
The topography of pain can be evaluated by means of a drawing showing the front and back of a
human body on which the locations (and sometimes the characteristics) of pain are marked, or by
means of formal joint counts.

Fig. 3. Example of a VNS for measuring pain intensity.

 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 169

Pain diagrams or drawings

As widespread pain is one of the two FM classification criteria proposed by the American College of
Rheumatology (ACR) [29], and widespread pain and/or the extent of pain has been the subject of many
investigations, various simple pain diagrams or drawings have been validated, including the Regional
Pain Scale (RPS) [30] and the Self-Assessment Pain Scale (SAPS) [31]. The RPS is a valid means of
measuring the extent of pain that can be used to identify patients with FM, including those with
concomitant rheumatoid arthritis (RA) or osteoarthritis. The SAPS identifies 16 non-articular body
areas and, under the name of each, there are four boxes labelled 0 (¼ none), 1 (¼ mild), 2 (¼ moderate)
and 3 (¼ severe). Patients are asked to ‘Indicate below the amount of pain and/or tenderness you have
experienced in the last 7 days in each of the body areas’. The possible scores range from 0 to 48, but, in
order to integrate them, they are transformed into a 0e10 scale (Fig. 4).
Although such drawings may sometimes be influenced by psychosomatic disorders and used to
alert physicians, there is little high-quality evidence to support their use in psychological assessments,
and so they should only be used as reliable pain locators.

Formal joint counts

The most specific quantitative clinical means of assessing and monitoring the status of patients
with inflammatory arthritis is to count the number of swollen and/or tender joints [32]. The
number of swollen joints quantifies the amount of inflamed synovial tissue, whereas the number of
tender joints more closely reflects the amount of pain. Furthermore, joint abnormalities can be

Fig. 4. The Self-Assessment Pain Scale (SAPS).

170 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186

quantified by counting the number of affected joints, with or without grading the severity of the
abnormalities.
The number of joints considered can vary from 28 to 80, with large joints sometimes being
weighted large joints [32]. Joint tenderness is defined as pain at rest induced by sufficient thumb and
index pressure to whiten the examiner's nail bed (the ‘rule of thumb’), but pressure may be replaced by
pain on motion in the case of the shoulder, tarsal and hip joints. Fig. 5a shows a simple 28-joint count
that includes the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, wrists, el-
bows, shoulders and knees, and the joints of the feet are excluded, whereas Fig. 5b shows the 44
swollen joint count that forms part of the Disease Activity Score (DAS) and includes the sternocla-
vicular and acromioclavicular joints; the shoulders; elbows; wrists; knees; ankles; and the MCP, PIP
and metatarsophalangeal (MTP) joints.

Multidimensional pain scales

In many situations, a simple, one-item instrument is not sufficient to truly capture pain or the
quality of life [6], and so many more comprehensive instruments have been developed that typically
measure combinations of various dimensions of pain, including (among other things) pain intensity
and quality, affect, functional interference and the effects of pain on the general quality of life
[9e11,33e35]. By providing a more complex assessment of the pain experience, they may circumvent
the frequently observed lack of association between pain intensity and disability. However, they are
often lengthy documents and this may limit patient acceptance, especially when administered during
the painful experience. The most widely used multidimensional pain scales are the McGill Pain
Questionnaire (MPQ) [36e38], the Short-Form MPQ ((SF-MPQ) [39], the Brief Pain Inventory (BPI) [40]
and the Chronic Pain Grade Questionnaire (CPGQ) [41e43].
The complete MPQ is one of the most widely tested instruments, and it was designed to provide a
quantitative profile of three aspects of pain [36e38] based on 78 pain adjectives divided into four major
categories (sensory, affective, evaluative and miscellaneous sensory); questions concerning changes in
pain over time; and the classification of pain intensity as ‘mild’, ‘discomforting’, ‘distressing’, ‘horrible’
and ‘excruciating’. It takes 15e20 min to complete, and it is therefore not easily administered in non-

Fig. 5. (a). Simple 28-joint count, (b). Forty-four-joint count.

 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 171

research clinical settings, which is one reason why simpler measures such as VAS have become more
widely accepted [39].
The SF-MPQ is a 15-item self-report questionnaire based on the original MPQ that contains three
components [39]: the pain rating index consists of 15 representative words (11 sensory such as ‘tender’
and four affective such as ‘sickening’) rated on a four-point Likert-type scale ranging from 0 (none) to 3
(severe), and two items measuring pain intensity. Overall pain is assessed using an NRS consisting of a
10-cm line that approximates ratings between 0 (no pain) and 10 (unbearable pain).
The BPI was developed to provide practical information concerning the intensity of pain (the
sensory dimension) and the degree to which it interferes with seven aspects of life: general activities,
walking, normal work, relations with other people, mood, sleep and the enjoyment of life (the reactive
dimension) [40]. It also documents pain location and characteristics on a body chart. It can be self-
administered, or used during a clinical interview or even over the telephone. As pain may vary dur-
ing the course of a day, it asks patients to rate their pain at the time of responding to the questionnaire
(pain now), and also at its worst, least and average over the previous week. Ratings may also be made
for the previous 24 h.
The CPGQ consists of seven items [41,42]: the first three assess current, worst and average pain
intensity over the previous six months using 11-point rating scales (0 ¼ ‘no pain’, 10 ¼ ‘pain as bad as it
could be’); the fourth assesses the number of days over the previous 6 months the respondent has been
prevented doing his/her usual activities (work, school or housework); and the remaining three assess
disability over the previous 6 months. The extent of interference with daily activities; the ability to take
part in recreational, social and family activities; and the ability to work (including housework) are also
assessed using 11-point rating scales (0 ¼ ‘no interference’, 10 ¼ ‘unable to carry on any activities’). The
questionnaire classifies chronic pain into four hierarchical grades: grade I (low disabilityelow in-
tensity), grade II (low disabilityehigh intensity), grade III (high disabilityemoderately limiting) and
grade IV (high disabilityeseverely limiting), and it also assesses the number of days in the previous six
months on which the subject was unable to carry out his/her usual activities (work, school and
housework) due to pain (days in pain). It is easy to complete, and its brevity makes it attractive if
correctly used [44].

Health-related quality of life assessment

The importance of assessing health-related quality of life (HRQoL) in patients with chronic pain has
been documented in recent studies of patients with rheumatic diseases [45e48], and various self-
administered instruments have been developed to evaluate pain-related functional disturbances in
specific diseases or pain conditions, which typically ask patients to list the activities or tasks that have
become more difficult to perform since the onset of pain. When choosing instruments to measure
physical function and health status, it is usual to distinguish generic and specific measures: the first
provide a broad picture of health status across a range of conditions, whereas the latter are more
sensitive to the disorder in question and are therefore more likely to reflect clinically important
changes.

Generic measures

Generic measures have mainly been developed for descriptive epidemiological or social science
research purposes, and they may provide a profile of scores for the different components of health
status and HRQoL, or operational definitions of various constructs summarised by a single index value.
However, their limitations include the fact that they are sensitive to any changes in health and this may
interfere with or obscure a specific outcome of interest; a number of questions may be irrelevant to a
particular problem; and efforts to ensure a reasonable length of administration may lead to too few
items tapping a specific area. The most widely used generic measures are the Medical Outcomes Study
(MOS) 36-Item Short-Form Health Survey (SF-36) [49], the Sickness Impact Profile (SIP) [50], the
Nottingham Health Profile (NHP) of problems [51] and the European Quality of Life Measure (EuroQoL)
of outcomes [52] (Table 1).
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Table 1
Self-administered, pain-related quality-of-life instruments.

Instrument Type/domains/number of items/scores Average Indications

completion
time (min)

Short-Form 36 (SF-36) General illness; 10e15 Rheumatoid arthritis, psoriatic arthritis,

Physical functioning, psychological, osteoarthritis, osteoporosis, ankylosing
social and global aspects; spondylitis, fibromyalgia, acute surgical
36 items (Likert scales; yes/no) conditions (e.g., hip replacement), low back
Physical and mental summary scores, pain, systemic lupus erythematosus,
plus eight subscale scores. systemic sclerosis
Sickness Impact Profile General illness; 20e30 Cancer, rheumatoid arthritis, psoriatic
(SIP) Physical functioning, psychological and arthritis, osteoarthritis, hip replacement,
social aspects; back pain
135 items (yes/no);
Overall summary scores (physical,
psychological) and subscale scores.
Nottingham Health General illness 10e15 Rheumatoid arthritis, psoriatic arthritis, low
Profile (NHP) Physical functioning, psychological and back pain, fibromyalgia, osteoarthritis,
social aspects; migraine, cancer, post-surgical conditions
38 items (yes/no) plus seven items on
problems in different areas of life
Overall and six subscale scores
EuroQoL General illness; 5 Rheumatoid arthritis, psoriatic arthritis,
Physical functioning, psychological and ankylosing spondylitis, osteoarthritis,
social aspects; fibromyalgia, low back pain and other
16 items plus VAS. chronic conditions
Arthritis Impact Arthritis-specific quality of life 15e20 Rheumatoid arthritis, psoriatic arthritis,
Measurement Scales2 Physical functioning, psychological and ankylosing spondylitis, osteoarthritis,
(AIMS2) social aspects chronic arthritis, systemic lupus
78 items, 12 subscales erythematosus, crystal-associated
Each item scored separately; total arthropathy
health score obtained by adding scores
of six scales
Revised fibromyalgia Fibromyalgia-specific quality of life; 10e15 Fibromyalgia
Impact Questionnaire function, overall impact, symptoms,
(FIQR) 21 individual questions (based on an
11-point NRS).
Three items; the total score is the sum
of the three modified domain scores.
Western Ontario and Lower-limb osteoarthritis-specific 10e15 Osteoarthritis, fibromyalgia, rheumatoid
McMaster questionnaire. arthritis, psoriatic arthritis, crystal-
Universities Pain, stiffness physical function associated arthropathy
Osteoarthritis Index 24 individual items, of which five relate
(WOMAC) to pain, two to joint stiffness and 17 to
the function
Aggregate scores for each dimension
are determined by summing the
component item scores for each
dimension.
Knee Injury and Osteoarthritis-specific questionnaire 10e15 Knee osteoarthritis, knee injury, post-
Osteoarthritis for knee injuries and osteoarthritis surgical conditions, crystal-associated
Outcome Score 42 items, five subscales: pain (nine arthropathy
(KOOS) items), symptoms (seven items),
activities of daily life (17 items), sport
and recreation function (five items) and
knee-related quality of life (four items)
Hip disability and Osteoarthritis-specific questionnaire 5e10 Hip osteoarthritis, inflammatory arthritis,
Osteoarthritis for hip osteoarthritis post-surgical conditions, crystal-associated
Outcome Score 21 items, five subscales; pain (five arthropathy, osteonecrosis
(HOOS) items), symptoms (three items), daily
living function (nine items), sport and
recreation function (two items),
hip-related quality of life (two items).
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 173

Table 1 (continued )

Instrument Type/domains/number of items/scores Average Indications

completion
time (min)

Each item scored 0e4.

Each subscale score calculated
independently.
Western Ontario Disease-specific instrument for 5e10 Osteoarthritis of the shoulder, periarthritis
Osteoarthritis of the measuring the quality of life of patients of the shoulder, frozen shoulder or adhesive
Shoulder (WOOS) with osteoarthritis of the shoulder. capsulitis, crystal-associated arthropathy,
questionnaire 19 items, four domains (six for pain and post-surgical conditions
physical symptoms, five for sport,
recreation and work function, five for
lifestyle function and three for
emotional function).
Disability of the Arm, Disease-specific instrument for 10e15 Rheumatoid arthritis. psoriatic arthritis,
Shoulder and Hand measuring disability of the arm, osteoarthritis of the hand or shoulder,
(DASH) questionnaire shoulder and hand. periarthritis of the shoulder, frozen
30 items, four domains (21 items for shoulder or adhesive capsulitis, crystal-
difficulty in performing various physical associated arthropathy, post-surgical
activities; five for evaluating the conditions
severity of symptoms of pain, activity-
related pain, tingling, weakness and
stiffness; and four for impact of
problem on social activities, work, sleep
and self-image
Each item has five response options.

To be included in this review, an instrument had to be published, have at least three quality-of-life domains measured, be
available in Italian, be applicable to adult patient populations and include a pain-related subscale or item.

The SF-36 was designed as a generic indicator of health status for use in population surveys and
studies evaluating health policies [49], but, if it is administered in conjunction with disease-specific
measures, it can also be used an outcome measure in clinical practice and research. Its eight scales,
each of which measures a different aspect of health, cover functional domains and other aspects of
well-being, and there is also a single-item measure of health transition that is not used to score any of
the multi-item scales. The scales are as follows: (1) physical functioning (10 items measuring the extent
to which health limits activities such as self-care, walking, climbing stairs, bending, lifting and other
moderate and vigorous activities), (2) social functioning (two items measuring the extent to which
physical health or emotional problems interfere with normal social activities), (3) physical role func-
tioning (four items measuring the extent to which physical health interferes with working or other
daily activities), (4) emotional role functioning (three items measuring the extent to which emotional
problems interfere with working or other daily activities), (5) mental well-being (five items covering
general mental health, including depression, anxiety, behaviouraleemotional control and general
positive affect), (6) vitality (four items contrasting feeling energetic and full of pep or feeling tired and
worn out), (7) bodily pain (five items measuring pain intensity and its effect on normal working ac-
tivities inside and outside the house) and (8) general health perceptions (five items based on personal
evaluations of health, including current health, health outlook and resistance to illness). The scales are
weighted on the basis of a normative algorithm and scored 0e100, with higher scores reflecting a
better quality of life. Further algorithms were subsequently developed to calculate two psychometri-
cally based summary measures: a Physical Component Summary (PCS) and a Mental Component
Summary (MCS) score [49,53], which provide greater precision, reduce the number of statistical
comparisons needed and eliminate the floor and ceiling effects of some of the subscales [53]. It has
been reported that, in comparison with healthy populations, FM patients are significantly impaired in
all the eights SF-36 domains [54]. The SF-36 questionnaire takes about 15 min to complete, although
most elderly patients prefer a standard interview to self-administration.
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The SIP indicates changes in a person's behaviour due to sickness [50]. It has 136 items grouped into
12 daily activity dimensions (ambulation, body care and movement, mobility, social interaction,
emotional behaviour, alertness, communication, home management, recreation and pastimes, sleep
and rest, eating and work), and it can be administered by an interviewer or be self-administered. Each
item is weighted on the basis of the relative severity of dysfunction implied by each statement. The
scores for each dimension are added together and expressed as a percentage of the maximum possible
score. There are three summary scores: the total score of all domains, a physical score (ambulation,
body care and movement and mobility) and a psychosocial score (social interaction, emotional
behaviour, alertness and communication). Higher scores represent greater dysfunction. Although it is
easy to administer and score, the SIP is relatively time consuming as it takes 20e30 min to complete.
The NHP is intended to provide a brief indication of a patient's perceived emotional, social and
physical health problems for the purposes of primary health care [51]. The original questionnaire had
two parts, but part II is optional because some items (e.g., work and sex life) may not be applicable and
is now rarely used. The revised version, which is self-administered and takes about 10 min to complete,
consists of one part that contains 38 weighted items grouped into six sections: physical abilities (eight
items), pain (eight items), sleep (five items), social isolation (five items), emotional reactions (nine
items) and energy level (three items). Scores range from 0 (no problems) to 100 (all items checked) for
each scale, but an often used system simply counts the number of affirmative responses in each section.
The other part of the NHP provides a brief indicator of handicap and contains seven items that record
the effect of health problems on occupation, jobs around the house, ‘hobbies’ and holidays, which are
scored by summing the number of positive responses without any weighting.
The EuroQoL is a self-administered questionnaire for measuring health outcomes [52] that provides
a simple descriptive profile and a single index value for health status that can be used for clinical and
economic evaluations of health-care and population health surveys. It considers five dimensions of
health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which is
divided into three levels (no problems, some or moderate problems and extreme problems) to generate
a total of 243 theoretically possible health states, and it includes a self-rating of overall health based on
a 20-cm VAS whose anchor points are zero (worst imaginable health state) and 100 (best imaginable
health state) [55]. The weights may use a zero to 100 scale indicating the respondent's VAS-based
overall valuation of his/her current state of health, or a utility score can be based on established
scale values and weights derived from studies in various countries [55]. The EuroQoL is ideally suited
for use in postal surveys, clinics and face-to-face interviews; it is cognitively simple; and it takes only a
few minutes to complete.

Disease-specific measures

Disease-specific measures are designed to assess specific diagnostic groups or patient populations,
often with the aim of measuring treatment responses or ‘clinically important’ changes. One obvious
disadvantage is that not all of these measures allow comparisons of treatment outcomes in patients
with different health problems (e.g., for resource allocation studies), therefore suggesting their com-
bination with generic measures. However, there are some broad disease-specific measures such as the
Arthritis Impact Measurement Scale 2 (AIMS2) [56], the Revised Fibromyalgia Impact Questionnaire
(FIQR) [57], the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [58,59], the
Knee Injury and Osteoarthritis Outcome Score (KOOS) [60], the Hip Disability and Osteoarthritis
Outcome Score (HOOS) [61], the Western Ontario Osteoarthritis of the Shoulder (WOOS) questionnaire
[62] and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire [63], which include both
general functional aspects and specific references to states or changes of particular concern to the
target population (Table 1).
AIMS2 [56] is one of the most widely used outcome measures in arthritis research. It is well
documented and clearly described, and there is accumulating evidence (especially in Europe) of its
validity and reliability: for example, it has been demonstrated that the metric properties of the Italian
version are in line with those of the widely used original version [64]. Both the full 78-item version and
the 26-item short form (AIMS2 SF) are designed to assess the severity of chronic pain over the previous
month, and the extent to which it affects mobility, walking and bending, hand and finger function, arm
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 175

function, self-care, household tasks, social activities, family support, work, tension and mood [56]. For
each of these areas, the subjects are asked to rate the following: (a) the degree to which they are
satisfied, (b) the impact that disease has had and (c) where they would like to see improvements. They
are also asked to summarise their current, future and overall perceptions of health and describe any
existing medical problems that may affect it.
The FIQR [57] was designed in an attempt to address the limitations of the original FIQ while
retaining its essential properties [65]. It consists of 21 individual questions that, like those of the FIQ,
refer to the previous 7 days and are answered by means of a 0e10 NRS in which 10 ¼ ‘worst’. The FIQR is
divided into three linked sets of domains: (a) ‘function’ (nine questions instead of the 11 of the FIQ), (b)
‘overall impact’ (two questions as in the FIQ, but changed to relate to the overall impact of FM on
functioning and overall symptom severity) and (c) ‘symptoms’ (10 questions instead of the seven of the
FIQ, including four new questions relating to memory; tenderness; balance; and environmental
sensitivity to loud noises, bright lights, odours and cold temperatures). The FIQR is much simpler to
score than the FIQ: the summed function score (range 0e90) is divided by three, the summed overall
impact score (range 0e20) is unchanged, the summed symptom score (range 0e100) is divided by two
and the total FIQR score is the sum of these three scores. The weighting of the three domains is partially
different from that of the FIQ insofar as ‘function’ accounts for 30% (as opposed to 10% in the FIQ),
‘symptoms’ account for 50% (as opposed to 70%), and ‘overall impact’ accounts for 20% (the same as in
the FIQ). The maximum total score remains 100. The completion of the FIQR takes approximately half
as long as the completion of the FIQ [66].
The WOMAC provides a self-administered, three-dimensional measure of health status, and it is
designed to investigate patient-relevant and clinically important treatment outcomes in patients with
lower-limb osteoarthritis [58,59]. It consists of 24 items: five relating to pain (when walking, using
stairs, lying in bed at night, lying/sitting and standing), two to joint stiffness upon waking and later in
the day and 17 to difficulties in physical functions. All of the questions relate to the patient's experi-
ences over the previous 48 h. Aggregate scores for each dimension are determined by summing the
component item scores for each dimension: pain (0e500), stiffness (0e200) and function (0e1700). It
has been found that the Italian version of WOMAC is a reliable and valid means of evaluating the
severity of OA of the knee, and that its metric properties are in line with those of the widely used
original version [67].
The KOOS contains 42 self-administered items, divided into five separately scored subscales: pain
(nine items), symptoms (seven items), activities of daily life (ADL, 17 items), sport and recreation
function (five items) and knee-related quality of life (four items) [60]. All of the items are scored from
0 to 4, and the item scores are added together to make the subscale score, as in the case of the WOMAC
Osteoarthritis Index. The scores are then transformed into a 0e100 scale. As in the case of the SF-36,
missing values are replaced by the average value of the dimension. The questionnaire is self-
explanatory and user friendly, takes about 10 min to complete, and can be administered in a waiting
room or used for a mailed survey [60,68].
The HOOS, which is designed to assess patients' opinions concerning their hip and associated
problems [61], consists of five subscales (pain, other symptoms, ADL function, sport and recreation
function and hip-related quality of life), and the questions refer to the previous week. The answers are
given in the form of standardised options (five Likert boxes), and each question is scored 0e4. The
totals for each subscale are given as normalised scores (0 ¼ extreme symptoms and 100 no symptoms),
and the results can be plotted in the form of an outcome profile. HOOS is self-administered and user
friendly, and takes about 10 min to complete.
The WOOS is a self-administered, disease-specific questionnaire designed to measure the quality of
life of patients with osteoarthritis of the shoulder [62]. Its 19 items represent the four domains of pain
and physical symptoms (six questions), sport, recreational and working function (five questions),
lifestyle function (five questions) and emotional function (three questions), with each question being
answered using a 0e100 NRS. In order to arrive at a clinically more meaningful format, the total score
can be converted into a percentage of the normal by subtracting it from 1900, dividing by 1900 and
multiplying the result by 100. A score of 0 indicates an extremely poor shoulder-related quality of life,
and a score of 100 no decline in shoulder-related quality of life. The WOOS has proven to be valid,
reliable and highly responsive.
176 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186

The main part of the DASH questionnaire is a 30-item disability/symptom scale concerning health
status during the previous week [63]. The items ask about the degree of difficulty in performing various
physical activities because of arm, shoulder or hand problems (21 items); the severity of pain, activity-
related pain, tingling, weakness and stiffness (five items); and the problem's impact on social activities,
work, sleep and self-image (four items). Each item has five response options, and the item scores are
used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).

Strategies and modern technologies for assessing chronic pain in adults

Increasing focus on patient-reported outcomes (PROs) in medicine has had the positive effect of
giving prominence to the views and experiences of patients. The ecological momentary assessment
(EMA) approach allows patient symptoms to be assessed in real time without requiring recall, and to do
so in their natural environment, thus significantly improving compliance and data validity [69].
However, control over when and how pencil-and-paper diaries are completed is limited, and data
quality may be affected by whether patients complete PRO measures using pencil and paper or a
computer [70]. Research has shown that compliance with paper diaries tends to be suboptimal [71,72],
and that many problems with missing data can arise [73], whereas one major advantage of compu-
terised questionnaires is their ability to collect good-quality data without any missing or problematic
responses. Furthermore, a number of studies have found that subjects readily accept and even prefer
electronic devices (particularly touchscreen diaries) to paper diaries [74,75], and this approach can
help rheumatology nurses and physicians collect and evaluate their patients' activity and functional
scores in busy clinical practices. Furthermore, as the severity of pain is rarely static, but ebbs and flows
in relation to circadian rhythms and treatment intervals, collecting PRO data at multiple time points
makes it possible to track temporal changes in patient experiences.
Developments in communication technologies have led patients to use the Internet and social
media to obtain 24/7 access to health-care information, and it is likely that patients will soon drive the
greater use of telemonitoring as it is believed to be instrumental in ensuring that they receive the right
care at the right time and in the right setting [76,77]. It also allows the collection of clinical data (such as
pain) and its remote transmission from patients to an assessment centre [78].

Ecological momentary assessment

Ecological momentary assessment is a reliable means of acquiring self-reported information and

subjective symptoms, as well as physiological and behavioural data [79,80], that was developed to
assess phenomena at the moment they occur in natural settings, thus maximising ecological validity
while avoiding retrospective recall [79]. Many studies have demonstrated the strength of EMA in
minimising recall biases [81e83], and Burton et al. [84] have published an excellent systematic review
of the use of electronic diaries for self-reporting data such as pain and symptoms; it has also been
found that compliance with diary protocols is high (83%), and only one-third of the studies have re-
ported compliance rates of <80% [72]. EMA initially used paper diaries, but it has been reported that
these had the disadvantage of delayed or even advance data entry (i.e., ‘fake compliance’) [72], whereas
computerised electronic diaries allow the automatic recording of input times and are now generally
regarded as the ‘gold standard’ and an essential component of electronic health-care monitoring
systems [78]. Carrying and using small electronic devices such as cell phones and personal desktop
assistants has become relatively common for a variety of purposes, and these are now being used for
the real-time assessment of patient symptoms. We have used this approach in a cross-sectional study
of patients with rheumatic diseases [85], during which pain and stiffness was assessed seven times a
day (8.00, 10.00 and 12.00 a.m.; and 2.00, 4.00, 6.00 and 8.00 p.m.) on seven consecutive days using a
DataLogger® (Mattioli1885, Fidenza, Italy), a newly developed, small, battery-powered device equip-
ped with a microprocessor that uses specific software to select logging parameters (sampling intervals,
start time, etc.) and view/analyse the collected data; compliance is based on automatically recorded
dates and times (Fig. 6). The electronic diary data showed that the average verified compliance was
93.8% for pain and 93.6% for stiffness; the highest compliance rates were observed in patients with RA
(95.6% and 95.2%), and there were no statistically significant differences in compliance between males
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 177

Fig. 6. DataLogger® e Pain Level Recorder.

and females, or patients aged more or less than 60 years. The collected data revealed the existence of
significant circadian rhythms in pain and stiffness in patients with RA or osteoarthritis of the knee, but
not in those with FM. We concluded that collecting subjective data using an electronic diary is feasible
in a rheumatological setting, and it leads to high compliance rates across a range of demographic
subgroups [85]. The EMA identification of diurnal cycles of self-reported pain and stiffness has
important implications for patients in terms of the planning of daily activities and developing indi-
vidual therapeutic programmes.

Touchscreen self-assessment questionnaires

PRO data are playing an increasingly key role in evaluating pain and the HRQoL, and monitoring
medical compliance. However, most of these uses have been tested and validated using paper-based
questionnaires, which can be associated with practical difficulties in terms of questionnaire distribu-
tion, data collection and manual computations that can be time consuming and a source of error [79].
Various other advantages of electronic data acquisition over paper-based questionnaires have also
been described, including: (1) direct transfer from a user's device to a central database; (2) no need for
staff to enter or clean data, or actively manage the database; and (3) the use of a dynamic display
permits a range of user-friendly and visually meaningful data entry elements and formats. The ongoing
evolution of computer software and technology has greatly improved its ability to satisfy the clinical
requirements of PRO assessment: touchscreen data acquisition has become commonplace in physi-
cian's offices and, as mentioned above, various studies have found that patients prefer interactive
electronic diaries, regardless of age, gender or familiarity with technological devices. Furthermore,
advances in interactive computer technology have allowed patients to become more involved in the
management and evaluation of their health and health-care services. Platforms for assessing PROs
include office-based touchscreen computers [74,75], telephone-based interactive voice-response sys-
tems, handheld computers, mobile phones and, more recently, Internet-based approaches
[74,75,79,86]. Touchscreen computers and tablets can facilitate routine PRO collection and help
rheumatology nurses and physicians collect and evaluate their patients' activity and functional scores
in busy clinical practices (Fig. 7).
Our own studies of patients with RA and axial spondyloarthritis (a-SpA) have shown that the results
of touchscreen self-assessments in a rheumatology clinic are as reliable as those of paper-based
questionnaires [74,75]. The key features of the Italian touchscreen computerised system known as
RHEUMATISM that make it user friendly for subjects with RA [74] include the following: (a) the
 178
F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186
Fig. 7. Rheumatologist using a touchscreen computer in an early arthritis clinic (EAC).
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 179

presentation of each question individually with both visual (cartoon) and auditory stimuli; (b) voi-
ceetext synchronisation, which allows subjects with a low level of reading literacy to follow the au-
diovisual playback with relative ease; (c) the demonstration and practice screen that allows patients to
familiarise themselves with the system; (d) the replay buttons for the question stem and individual
response options so that there is no need to repeat the entire question; and (e) the large font size
catering to elderly subjects in whom a low level of literacy is particularly prevalent.
The 16 joints or joint groups in the patient self-reported tender joint count (TJC) include the left and
right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The degree of tenderness of each
joint is weighted using a Likert scale, and the questions are answered by touching one of the buttons.
We have also developed an innovative, multimedia touchscreen tablet application called SPEA-
Monitor [75] for the electronic collection of a-SpA data that can improve the visibility of PRO assess-
ment data, which is particularly useful as health-care centres are increasingly seeking time-efficient
and patient-centred methods for monitoring their patients. The patients' variables recorded in the
SPEAMonitor included demographic data; disease duration; and the patient's 11-numbered button
NRS format for general health status (GH, 0e100), Bath Ankylosing Spondylitis Disease Activity Index
(BASDAI) (Fig. 8) and Bath Ankylosing Spondylitis Functional Index (BASFI). Furthermore, the SPEA-
Monitor comprises a database for data processing and storage of objective measures of spinal mobility,
such as Bath AS Metrology Index (BASMI), and laboratory findings (ESR and CRP). In addition to pa-
tients' general preference for touchscreen questionnaires, other advantages include less need for staff
assistance, the reduced completion times, the automatic elimination of missing and/or incomplete data
and the absence of errors in data processing, all of which are beneficial to patients, clinicians and
health-care agencies alike.

Web/internet-based home telemonitoring

In response to the increasing burden of chronic musculoskeletal diseases, health-care systems are
looking for alternative means of improving clinical outcomes and limiting costs. It is known that the
priorities and values of patients with chronic painful diseases are of primary importance when
measuring outcomes and optimising patient adherence [87], and that greater patient/physician
discordance leads to unfavourable health outcomes [88], including general and medication non-
adherence [89], and decreases patient satisfaction, a variable that is consistently associated with
poorer adherence [90,91]. Consequently, telemonitoring can usefully support the process of shared
decision-making (SDM) in patients with chronic pain [92,93] as it is an efficient, cost-effective and
widely accepted means of informing patients about the pathogenesis, typical symptoms, treatment

Fig. 8. Patient using the SPEAMonitor tablet application.

180 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186

Fig. 9. Screenshot of the home page of the ‘Fibromyalgia Italia’ web portal.
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 181

options and prognosis of their conditions [94]. The concept of SDM emphasises the role of patients as
active partners in the choice of appropriate treatment [95,96], and it has been found that telemedicine
is a feasible alternative to face-to-face care [97], and it has the positive effects of improving therapeutic
outcomes and increasing health service efficiency.
In a recent cross-sectional study, we explored the usefulness of an Internet survey of FM patients
with a view to collecting information concerning symptoms and function, and identifying clinical
features may distinguish patient subgroups. After approximately 10 min of telephone training, regis-
tered users could access the system via a personal computer and Internet browser (http://www.
fibromialgiamonitor.net) (Fig. 9), and the graphical interface offered a quick overview and supported
straightforward navigation.
The results of the study indicated that a web/Internet-based diary used as a patient terminal was an
easy-to-use and cost-efficient means of acquiring patient-centred data, and the data itself provided a
snapshot that supported the clinical impression of the existence of distinct subgroups of patients with
FM (Fig. 10). Web/Internet-based home telemonitoring is an application of telemedicine in which
clinical data are transferred from the patients' homes to a telemonitoring centre in order to monitor the
patients' condition, interpret the data and make clinical decisions [76]. It is a relatively recent approach,
but its use is growing in both industrialised and developing countries [77]. The underlying goal is to

Fig. 10. Spydergram of FIQR domains in 353 FM patients. The domain scores range from 0 (worst, at the centre) to 10 (best, towards
the outside). The five highest scoring items (i.e., those with the greatest impact) were related to the symptoms of sleep quality
(FIQR15), fatigue/energy (FIQR13), pain (FIQR12), stiffness (FIQR14), tenderness (FIQR 19), problems of balance (FIQR20) and envi-
ronmental sensitivity (FIQR21). Abbreviations: FIQR1: Brushing or combing hair; FIQR2: Walking continuously for 20 min; FIQR3: Pre-
paring a homemade meal; FIQR4: Vacuuming, scrubbing or sweeping floors; FIQR5: Lifting and carrying a bag full of groceries; FIQR6:
Climbing one flight of stairs; FIQR7: Changing bed sheets; FIQR8: Sitting in a chair for 45 min; FIQR9: Shopping for groceries; FIQR10:
Inability to achieve goals; FIQR11: Feeling overwhelmed: FIQR12: Pain rating; FIQR13: Fatigue rating; FIQR14: Stiffness rating: FIQR15:
Sleep quality: FIQR16: Depression level; FIQR17: Memory problems: FIQR18: Anxiety level: FIQR19: Tenderness: FIQR20: Problems of
balance; FIQR21: Environmental sensitivity.
182 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186

organise ‘telecare’ on the basis of case and care management principles and use it to replace classical
methods of integrated and continuous patient monitoring. In many health-care systems around the
world, home telemonitoring is becoming an integral part of a broader view of de-institutionalisation
and it reflects society's orientation toward keeping patients at home, and the most promising means
of delivering cost-effective quality care [98]. A comprehensive analysis of the literature in Medline and
the Cochrane Library found that it provides accurate and reliable data, empowers patients, influences
their attitudes and behaviours and potentially improves their medical conditions [77]. It can also have
other effects influencing the quality of care, such as increasing compliance with prescribed medication
[97] and improving the self-management of chronically ill patients.

Conclusions

The appropriate assessment of chronic pain is an essential prerequisite of successful pain man-
agement, and a number of validated methods have been developed over the last 10 years. The
increasing focus on PROs has had the positive effect of giving prominence to the views and experiences
of patients, and it has been paralleled by a striking increase in the number of means of collecting PRO
data, ranging from questionnaires assessing HRQoL in general, to disease- and symptom-specific
questionnaires for patient groups and subgroups. The introduction of electronic HRQoL assessments
into general practice brings with it the prospect of reciprocal transfers of knowledge between PRO
research and clinical practice, and combining such data with information from electronic patient re-
cords can provide a basis for the scientific analysis of associations between pain; HRQoL; and patient
characteristics, diseases and treatments. The immediate availability of HRQoL results during a
consultation can contribute to patient-centred care, help to focus the consultation itself, support the
definition of therapeutic goals and evaluations of their achievement and provide standardised data
that can be compared intra- and inter-individually. EMAs allow patients' symptoms to be assessed in
real time in their natural environment without requiring recall, and symptom diaries derived from
computerised EMAs are now generally regarded as the ‘gold standard’ in the field of pain medicine, and
they have attracted increasing attention as an essential component of health-care monitoring systems
based on information and communication technologies. Easy-to-use web/Internet-based diaries as
patient terminals allow cost-efficient, patient-centred data acquisition. Furthermore, telemonitoring
can play a role in improving communications between health-care professionals and patients by
creating a patient-centred health-care continuum and facilitating shared responsibility.

Disclosure of interest

The authors declare that they have no conflicts of interest concerning this article.

Research agenda

 To develop new comprehensive and psychometrically sound patient-reported outcome

(PROs) measures and evaluate the adequacy and appropriateness of using existing mea-
sures in clinical trials of the efficacy and safety of chronic pain treatments.
 To determine the effects of telemonitoring on the disease-specific knowledge, self-care and
adherence of patients with chronic pain.
 To make recommendations concerning specific measures with the most favourable char-
acteristics and the widest range of applicability, methods for determining the clinical
importance to patients of changes in these measures and strategies for selecting primary
endpoints and combining multiple endpoints in assessments of treatment efficacy.
 To conduct large-scale studies with rigorous designs in order to obtain better evidence
concerning the effects of telemedicine interventions on health, patient satisfaction and costs.
 F. Salaffi et al. / Best Practice & Research Clinical Rheumatology 29 (2015) 164e186 183

Practice points

 Chronic pain assessment requires multidimensional qualitative and health-related quality-of-

life (HRQoL) instruments.
 Increasing focus on patient-reported outcomes (PROs) has given prominence to patient
views and experiences, and PRO data are playing an increasingly key role in the evaluation of
pain, HRQoL and medical compliance.
 Ecological momentary assessments (EMAs) allow patient symptoms to be assessed in real
time and in their natural environment without requiring recall, thus significantly improving
treatment compliance and data validity.
 Advances in interactive computer technology have opened up opportunities for patients to
become more involved in routine PRO collection and disease management: for example,
touchscreen data acquisition has become commonplace in outpatient offices.
 Easy-to-use web/Internet-based diaries as patient terminals allow cost-efficient, patient-
centred data acquisition, and telemonitoring is increasingly seen as an efficient and cost-
effective means of supporting shared decision-making when treating patients with chronic
pain.
 The introduction of electronic pain assessments into general practice brings with it the
prospect of reciprocal transfers of knowledge between PRO research and clinical practice.

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