A s s e s s i n g Ps o r i a s i s

S e v e r i t y an d O u t c o m e s
f o r Cl i n i c a l Tr i a l s an d R o u t i n e
C l i n i c a l Pr a c t i c e
Robert J.G. Chalmers, MB, FRCP

KEYWORDS
 Psoriasis  Psychosocial morbidity  Quality of life  Severity assessment  Outcome measures
 Self-assessment  PROM  COSMIN

KEY POINTS
 Psoriasis is a disease with the potential to be life ruining.
 To justify health expenditure on its management, it is vital to be able to show that interventions
make a difference to a patient’s skin disease and ability to function normally.
 With modern methods of validating health care measurement instruments, more appropriate tools
are being developed for use in clinical trials and routine clinical practice.
 The place of long-established tools is examined in the light of new tools that have recently been
promoted.

ASSESSMENT AND OUTCOMES it has been rare for formal assessments of severity
to be undertaken outside the setting of clinical tri-
Historically, dermatologists and others looking af- als. Doctors managing hypertension would expect
ter patients with psoriasis have tended to record to get their patients’ blood pressure checked on a
response to treatment, if at all, with rather impre- regular basis. It should be a routine for at least
cise phrases such as “nearly clear,” “a bit better,” some form of formal assessment of psoriasis
“slightly improved,” “worse,” or “flared up.” This severity and impact to be recorded on a regular
probably still holds true for the majority of consul- basis for all patients receiving active treatment
tations between psoriasis patients and health care for psoriasis. The situation is slowly changing for
professionals. If they have instituted a new ther- the better, largely as a result of the cost implica-
apy, there is almost certainly a tendency for them tions of instituting expensive new agents for psori-
to write “slightly better” rather than “no change,” asis and the need to demonstrate that they are
even if there is no clear evidence of meaningful producing benefit. Guidance is available from a
benefit: Such wishful thinking is understandable, range of specialist societies, patient organizations,
but can lead to long delays in changing to more and national health care bodies.1–3
appropriate therapy. Furthermore, the views of Psoriasis is a disease with multiple dimensions,
the patient may either not be sought or alterna- each of which can contribute in a range of different
tively be dismissed as insignificant. Until recently, ways to its overall impact on the individual. To be

Funding Sources: None.

derm.theclinics.com

Conflict of Interest: Dr R.J.G. Chalmers has been involved in the development of the Simplified Psoriasis Index,
but has no financial interests in this or in other matters relating to psoriasis.
Department of Dermatology, Manchester Royal Infirmary, Dermatology Centre, Salford Royal NHS Foundation
Trust, University of Manchester, 16 Oaker Avenue, West Didsbury, Manchester M20 2XH, UK
E-mail address: [email protected]

Dermatol Clin 33 (2015) 57–71

http://dx.doi.org/10.1016/j.det.2014.09.005
0733-8635/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.
58 Chalmers

able to demonstrate objectively that any interven- successful outcome as a change of the parameter
tion for psoriasis can successfully modify that in question from abnormal/unacceptable to
impact, it is necessary firstly to have tools for normal/acceptable. Thus, the outcomes of inter-
capturing and measuring that impact meaningfully ventions to reduce risk of developing overt type II
and reliably (severity assessment) and second to diabetes in individuals found to have high glycosy-
understand what any given changes in such as- lated hemoglobin levels (hemoglobin A1c 6.5%)
sessments actually mean in terms of modifying can be assessed by measuring whether the inter-
that impact. Only then can a meaningful assess- vention has resulted in change to levels (eg, hemo-
ment of the outcome of that intervention be globin A1c 6.0%) known to confer a lower risk.7
derived. With many inflammatory or mental health condi-
Measuring change without reference to baseline tions, however, it is not possible to assess change
severity (eg, “worse,” “no change,” “better”) is little with such simple means. In disorders such as
different from the traditional approach used by psoriasis and arthritis, there is a complex interplay
doctors in routine practice. In a chronic condition between the externally apparent manifestations of
such as psoriasis, such assessments are of limited the disease, the symptoms experienced by the
value for charting an individual patient’s long-term patient, and the gamut of possible further phys-
disease behavior, because recall of fluctuations in ical, social, and psychological consequences of
disease severity over time is unlikely to be reliable. them. Furthermore, the latter are not necessarily
Neither are they useful for evaluating outcomes directly related to the objective severity of the
across a cohort of patients with unknown and condition. The medical profession has been rather
potentially widely varying initial disease severity, slow to recognize this complexity, but over the
as in a clinical trial comparing different interven- past 20 years significant progress has been
tions. Severity assessment at least 2 time points made. In fact, the new discipline of clinimetrics
is a prerequisite for adequate documentation of has grown up around developing and validating
change and thus for assessing outcomes. disease severity assessments and outcome mea-
The difference between severity assessment sures. This topic is well reviewed by Fava and
and outcome assessment can be illustrated clearly colleagues.8
using the best known instrument for assessing
psoriasis, the Psoriasis Area and Severity Index PSORIASIS ASSESSMENT TOOLS: A
(PASI)4: The PASI assesses severity whereas a HISTORICAL PERSPECTIVE
75% reduction in PASI score (PASI-75) assesses
outcome. Unfortunately, the term “outcome” is For the current generation of dermatologists
all too often used indiscriminately to describe brought up to consider randomized, controlled tri-
both types, particularly in relation to so-called pa- als as the norm for investigating new therapies for
tient-reported outcome measures (PROMs). For skin disease, it is instructive to look back a few de-
instance, NHS England (The UK National Health cades. Until the advent of potent topical cortico-
Service as it applies to England) states: “PROMs steroids in the late 1950s, very few comparative
measure a patient’s health status or health- trials in the field of psoriasis were conducted.
related quality of life at a single point in time.”5 In The mainstays of treatment up until then had
similar vein, the US Food and Drug Administration been tar, anthralin (dithranol), and broadband
states: “A PRO (patient-reported outcome) is any UVB phototherapy. At that time, there was no
report of the status of a patient’s health condition accepted methodology for performing clinical tri-
that comes directly from the patient, without inter- als in inflammatory skin disease. Systemic ther-
pretation of the patient’s response by a clinician or apy was largely limited to arsenic: Methotrexate
anyone else. The outcome can be measured in ab- was first investigated for treating psoriasis in the
solute terms (eg, severity of a symptom, sign, or 1950s, but it was not until 2003 that this use of
state of a disease) or as a change from a previous the drug was subjected to a randomized,
measure.”6 Outcome can be assessed only by controlled trial.9
examining change, whether the desired outcome A study selected at random from among the
be change, as in interventions to treat disease, or small number of formal psoriasis trials conducted
no change, as in interventions intended to halt dis- in the 1960s exemplifies how much has
ease progression. changed.10 It is clear that the investigators thought
In many fields of medicine, outcome is straight- carefully how to design their study comparing 2
forward to assess. Where there are well under- topical corticosteroid preparations with topical
stood and easily measurable risk factors for tar. Looked at from our perspective, however, it
adverse health outcomes, such as hypertension seems crude, with small patient numbers entered
or hyperglycemia, it is straightforward to define a into an unblinded, unrandomized within-patient,
 Assessing Psoriasis Severity and Outcomes 59

left-right comparison of the 2 corticosteroids, trials they examined. Nevertheless, a systematic

which are then also compared with the patient’s review of treatments for severe psoriasis pub-
historical response to tar. What the investigators lished in 2000 showed that PASI had become as
did do, however, was make an attempt to define widely used as “clearance” for defining outcomes,
what they meant by each of their outcome cate- with each being utilized to define outcomes in
gories (Box 1) and this is by no means always about one quarter of all randomized controlled tri-
the case, even in much more recent psoriasis als judged to be of sufficient quality for inclusion in
trials. the review (Table 1).16 In the absence of a suitable
In studies of psoralen photochemotherapy, alternative instrument, PASI was promoted for
which began to appear in the 1970s and where clinical trials of cyclosporine for psoriasis in the
treatment could be expected to produce, at least 1980s. There are many problems with PASI (which
in the short term, total or near total remission, are discussed elsewhere), but a global consensus
the concept of “clearance” was introduced as on how best to assess psoriasis and its response
the outcome success criterion.11 In a large, ran- to treatment remains elusive. Many of the regula-
domized study from 1979 with well over 100 pa- tory bodies continue to demand some form of
tients in each treatment arm, clearance was PASI-based response criterion but supplemented
defined explicitly as “when all the lesions were by a simpler measure such as a change in global
flat and free of scales”; this was achieved in 91% assessment score.17,18 The need for both has
and 82% of those who received psoralen photo- recently been questioned.19
chemotherapy and dithranol, respectively.12 It is only much more recently that it has been
More recently, “clearance” has tended to be qual- recognized that there may be much to be gained
ified with phrases such as “clear or nearly clear” by getting patients to assess their own disease
and “clear or minimal residual activity” to cater severity either to complement or to replace an
for those patients who may be left with a small “objective” observer-rated assessment by a health
residuum of psoriasis.13 The UK National Institute professional. In diseases in which symptoms
of Health and Care Excellence (NICE) has further rather than signs predominate (eg, chronic pain),
defined “minimal residual activity” as equivalent it is only the patient who can judge severity. In
to greater than 90% reduction in PASI score.14 such a visible disease as psoriasis, however,
With the development of new systemic agents rather little thought has been given to the potential
such as the oral retinoids, which were rarely advantages of asking patients to score their own
capable of producing such clear-cut outcomes, disease. Not only may it be time saving for health
the need for alternative outcome criteria became professionals, but it can also give patients greater
clear. It was for a dose-ranging study of etretinate ownership of and participation in the management
published in 1978 that the PASI was created.4 The of their psoriasis. An adaptation of the PASI for
PASI was, however, just one of the proliferation of completion by patients was introduced in the mid
scoring systems for psoriasis that Naldi and col- 1990s as the Self-Administered PASI.20,21 It repli-
leagues15 found among psoriasis trials published cates the drawbacks of PASI itself and requires a
in major journals between 1977 and 2000: They professional to convert the patient’s shading on
identified 44 separate measures among the 249 line drawings to percentage body surface area
(BSA) involvement. More recently the self-
assessment Simplified Psoriasis Index (saSPI)
Box 1 has been proposed for patient self-reporting of
Example of outcome measure used in 1964 psoriasis severity.22,23
It has been recognized for at least 70 years that
ISQ 5 No change in the lesions.
there is an intimate relationship between psoriasis
O 5 Worse, when lesions became redder, more and psychological distress.24–26 It has now
scaly, and thicker. become standard practice to include some mea-
111 5 Marked improvement, when lesions sure of psychosocial impact in clinical trials of in-
almost cleared up completely. terventions for psoriasis. Such measures may be
11 5 Fair or moderate improvement as shown generic (applicable to any disease state), skin dis-
by less erythema, scaling, and thickness. ease specific, or psoriasis specific.
1 5 Slight improvement. The advantage of using a generic measure is
that it may then be possible to compare the impact
From Khoo OT, Fung WP, Koh KY. Clinical trial of P- of a skin disease such as psoriasis with that of
1742 topical or fluperolone (9 fluoro-21 methyl pred-
nisolone) in psoriasis. Singapore Med J 1964;5:69–72;
completely different disorders, such as musculo-
with permission. skeletal or respiratory disease. The disadvantage
is that such generic measures may not capture
60 Chalmers

Table 1
Outcome measures used in randomized, controlled trials for severe psoriasis up to 2000

Psoriasis Area
No. of Clear/Almost and Severity
Active Intervention(s) Studies Clear Index Other/NR
Phototherapy regimens 21 4 2 15
Phototherapy plus topicals 19 6 1 12
Phototherapy with retinoids 11 1 4 6
Retinoids without phototherapya 17 6 2 9
Cyclosporinea 18 3 12 3
Fumaric acid esters 4 2 1 1
Total 90 22 22 46

Abbreviation: NR, not reported.

a
Comparison of retinoid versus cyclosporine included under cyclosporine only.
Data from Griffiths CE, Clark CM, Chalmers RJ, et al. A systematic review of treatments for severe psoriasis. Health Tech-
nol Assess 2000;4(40):1–125.

the particular elements of skin disease satisfacto-

Box 2
rily, because they were not designed with skin dis-
The questions of the dermatology life quality
ease in mind. Study of the impact of chronic
indexa
disease (eg, chronic pain, arthritis, stroke) on psy-
chological well-being and functioning, together 1. Over the last week, how itchy, sore, painful,
with developing methods of quantifying it, has or stinging has your skin been?
spawned its own society (International Society 2. Over the last week, how embarrassed or
for Quality of Life Research), the mission of which self-conscious have you been because of
is “to advance the scientific study of health-related your skin?
quality of life and other patient-centered outcomes 3. Over the last week, how much has your skin
to identify effective interventions, enhance the interfered with you going shopping or
quality of health care and promote the health of looking after your home or garden?
populations.”27 One of the first and still most
4. Over the last week, how much has your skin
widely used generic quality of life instruments is influenced the clothes you wear?
the Medical Outcomes Study 36-Item Short Form
5. Over the last week, how much has your skin
Survey (SF-36).28 The SF-36 has been used widely
affected any social or leisure activities?
for psoriasis trials, but its components do not cap-
ture well much of the psychosocial impact that de- 6. Over the last week, how much has your skin
rives from having psoriasis. made it difficult for you to do any sport?
The SF-36 was preceded by some 7 years by 7. Over the last week, has your skin prevented
the Psoriasis Disability Index (PDI), which was pio- you from working or studying? If “no,”
neering when it was published in 1985.29 This has over the last week how much has your
been used widely in clinical studies30; in more skin been a problem at work or studying?
recent times, however, the PDI has been largely 8. Over the last week, how much has your skin
supplanted by the more generic and simpler created problems with your partner or any
Dermatology Life Quality Index (DLQI; Box 2) of your close friends or relatives?
that, like the PDI, was developed by Professor An- 9. Over the last week, how much has your skin
drew Finlay.31 There is a range of other skin caused any sexual difficulties?
disease-specific, quality-of-life instruments that 10. Over the last week, how much of a problem
have been promoted, the most important of which has the treatment for your skin been, for
are discussed elsewhere in this article. example, by making your home messy or
by taking up time?

THE DIMENSIONS OF PSORIASIS

a
The 10 questions contribute 3 points each
(maximum 30) in answer to the question: “How
Psoriasis is a complex disease, is often lifelong, much has your skin problem affected your life over
the last week?”
and, in severe cases, life ruining. There is much
Copyright Ó Finlay AY, Khan GK, April 1992. Used with
more to it than its outwardly visible manifestations. permission.
This has recently been neatly summarized in the
 Assessing Psoriasis Severity and Outcomes 61

UK’s NICE Guidance on the assessment and man- attributed to the deficiencies of PASI itself as an
agement of psoriasis17: assessment tool or to the absence of a number
of important items from DLQI, such as sleep depri-
Death directly due to psoriasis is rare, but the vation or the economic cost of having psoriasis.
chronic, incurable nature of psoriasis means Neither the presence nor absence of psoriatic
that associated morbidity is significant. Peo- arthritis, nor information about the historical
ple with psoriasis, like those with other major behavior of an individual’s psoriasis feature in
medical disorders, have reduced levels of any of the 3 measures, although they may be
employment and income as well as a very important in reaching appropriate manage-
decreased quality of life. The impact of psori- ment decisions. Nevertheless, the acceptance
asis encompasses functional, psychological, that both “objective” severity and quality of life
and social dimensions. Factors that must be considered when assessing overall psori-
contribute to this include symptoms specif- asis severity has been a major advance.
ically related to the skin (eg, chronic itch,
bleeding, scaling and nail involvement), prob- DESIDERATA FOR PSORIASIS ASSESSMENT
lems related to treatments (mess, odor, AND OUTCOME MEASURES
inconvenience and time), psoriatic arthritis,
and the effect of living with a highly visible, When PASI was born, its creators had very little
disfiguring skin disease (difficulties with rela- guidance on how to go about the task. PASI was
tionships, difficulties with securing employ- then adopted with rather little critical thought
ment and poor self esteem). Even people about its suitability for the tasks it was expected
with minimal involvement state that psoriasis to perform. Since that time, there have been
has a major effect on their life. The combined considerable advances in developing and evalu-
costs of long-term therapy and social costs of ating assessment tools.
the disease have a major impact on health- It is important to recognize that it is impossible
care systems and on society in general. About to produce a “one size fits all” measure for assess-
a third of people with psoriasis experience ing all aspects of psoriasis. The requirements for a
major psychological distress, and the extent proof-of-concept study of a new drug for psoriasis
to which they feel socially stigmatised and may be quite different from those for a tool that is
excluded is substantial. Healthcare profes- sufficiently straightforward that it will be accepted
sionals, including dermatologists, often fail for use in everyday clinical practice. There needs
to appreciate the extent of this disability and to be clarity about what it is important to measure
even when it is correctly identified, some esti- and in which circumstances. Appraisal of any tool
mates suggest that less than a third of people demands that a number of simple questions are
with psoriasis receive appropriate psycholog- asked.
ical interventions. The following list is based on the recommenda-
tions of Alvin Feinstein from the 1980s8,36:
In attempting to capture these different dimen-  What is it for? (Purpose)
sions, it is important to recognize that limiting  Is it readily understood? (Comprehensibility)
assessment of psoriasis to its outward signs may  Does it make sense? (Face validity)
grossly misrepresent the impact of that disease  Is it measuring the right things? (Content
on the individual with psoriasis. Dermatologists validity)
have worked hard to ensure that the major regula-  Is it reliable? (Replicability)
tory and health care funding authorities incorpo-  Can it detect differences? (Sensitivity)
rate some measure of quality of life impact into  Can it detect change? (Responsiveness)
their appraisal of treatments for psoriasis. The  When and where should it be used?
principle of the “Rule of Tens,” in which scores (Applicability)
greater than 10 of any 1 of 3 measures, percent  Is it practical to use? (Employability)
BSA involvement, PASI, or DLQI, would constitute
evidence of current severe psoriasis,32 has been The international COSMIN (COnsensus-based
adopted with minor modifications in a number of Standards for the selection of health Measurement
guidelines for the management of psoriasis.17,33–35 INstruments) group based at the University Medi-
There are, however, other dimensions of psoriasis cal Center, Amsterdam, has set the standards
that may be equally relevant in helping patients required of new instruments for use in health
and clinicians to make informed decisions about care measurement, especially in the field of
management but that may not be captured by health-related quality of life.37 The group has
these tools. These omissions may in part be developed a critical appraisal tool (a checklist) to
62 Chalmers

assist not only in assessing the methodological its location, such that equal weight is given to a
quality of published studies in which such mea- large plaque on the lower back as is given to the
sures are used, but also to guide the development same-sized plaque covering the face. For each
and validation of new health measurement instru- of 4 body sites (the head and neck, the trunk, the
ments (eg, clinical rating scales and patient- upper extremities, and the lower extremities), 3
reported quality of life measures; Table 2). For a components of the psoriatic plaques within it (ery-
new instrument to be accepted its quality should thema, induration, and desquamation) are graded
be tested against these criteria. from 0 (“complete lack of”) to 4 (“severest
possible”). An estimate is then made of the extent
INSTRUMENTS FOR OBSERVER-RATED of psoriasis in that site by estimating the BSA with
ASSESSMENT OF PSORIASIS SEVERITY possible scores ranging from 0 to 6 (Fig. 1). A com-
plex formula (Fig. 2) is then applied to derive a
A large number of scoring systems for psoriasis score which may theoretically range from 0 to
have been devised, the majority of which can be 72, although in practice scores above 36 are rare.
classed as “objective” in the sense that the Despite its widespread use, the PASI has never
assessment is performed by someone other than been formally validated. Its gradings have never
the patient (observer-rated). The most well- been properly defined or standardized. Although
known of these is the PASI. the original publication4 is used as the standard
reference source, it is not desquamation (shedding
The Psoriasis Area and Severity Index
of skin scales) but scale thickness that is generally
The PASI has become the “gold standard” for pso- scored. There is no agreement on how erythema
riasis severity measurement despite major flaws. should be scored when obscured by overlying
The PASI was devised on the premise that a pla- adherent scale. It is not explicitly stated whether
que of psoriasis is of equal significance wherever induration excludes scale thickness. Its complex

Table 2
Domains of importance in appraising measurement instruments

Domain Measurement
Reliability The degree to which the measurement is free from measurement error.
Test–retest reliability The extent to which scores for patients who have not changed are the same
when measured repeatedly under different conditions.
Intrarater reliability The patient or examiner rating on different (but temporally closely related)
occasions.
Interrater reliability Different examiners rating the same patient on the same occasion.
Validity The degree to which an instrument measures what it purports to measure
(the construct).
Content validity The degree to which the content of an instrument is an adequate reflection
of the construct to be measured.
Face validity The degree to which the items of an instrument indeed look as though they
are an adequate reflection of the construct to be measured.
Construct validity The degree to which the scores of an instrument are consistent with
hypotheses based on the assumption that the instrument validly
measures the construct to be measured.
Structural validity The degree to which the scores of an instrument are an adequate reflection
of the dimensionality (“size and shape”) of the construct to be measured.
Criterion validity The degree to which the scores of an instrument are an adequate reflection
of a ‘gold standard.’
Responsiveness The ability of an instrument to detect changes in severity over time in the
construct to be measured.
Interpretability Interpretability is the degree to which one can assign qualitative
meaning—that is, clinical or commonly understood connotations—to an
instrument’s quantitative scores or change in scores. Does it make sense?
Adapted from COSMIN. COnsensus-based Standards for the selection of health Measurement Instruments. Available at:
http://www.cosmin.nl/cosmin_1_0.html. Accessed May 31, 2014; with permission.
 Assessing Psoriasis Severity and Outcomes 63

The PASI gives equal weight to psoriasis wher-

ever it is located. From a patient’s perspective, how-
ever, the impact of psoriasis is likely to be much
greater if it involves the face, the hands, or the ano-
genital area than the back. Severe and disabling
psoriasis of the hands and feet may result in the
same score as a single large plaque on the lower
back. The presence of a few scattered thick plaques
can result in a PASI score equal to that from near er-
ythrodermic psoriasis (Table 3).40 There are, there-
fore, many reasons to criticize the PASI:
 Adopted without proper validation;
 Meanings not standardized and agreed
 Potential for wide interobserver variation
 Not linearly related to severity
 The upper half of the scale is rarely used
 Pseudoscientific precision has given it unjusti-
fied credence
 Often poorly correlated with patient percep-
Fig. 1. Psoriasis Area and Severity Index (PASI) scoring
guide.
tion of severity
 Insensitive to change for mild-to-moderate
psoriasis
arithmetical leaves it open to errors of calculation  Insensitive to involvement of “sensitive” sites
and its use of decimals for the final score gives it (eg, face, genitalia, hands, and feet); and
a false impression of precision.  Cumbersome to use and prone to error in
These are not, however, its main drawbacks. calculation.
The accuracy of BSA estimation by dermatologists
is poor, with wide interrater variability and a ten- There have been various attempts to overcome
dency to overestimate. Studies have shown up some of these problems including the Psoriasis
to 4-fold differences between observers and up Log-based Area and Severity Index,41 the Psoria-
to 11-fold overestimate of BSA compared with sis Exact Area and Severity Index,41 and the
measurement of plaque tracings, particularly with Simplified Psoriasis Area Severity Index,42 but
nummular (small plaque) psoriasis.38,39 The esti- none of these has found general favor.43
mates by 3 dermatologists and 1 experienced
Physician Global Assessment Instruments for
dermatology nurse of the BSA extent of psoriasis
Psoriasis
in the patient illustrated in Fig. 3 ranged from
12% to 41%; plaque tracings and photographic There is no single physician global assessment
analysis gave figures of 5% and 8%, respectively, (PGA) tool for psoriasis. The various versions of
for which the PASI extent score would be 1 PGA have in common, however, much greater
(<10%).38 Similar findings have been reported by simplicity than PASI and usually employ a 5- to 7-
others. From the point of view of the patient, how- point ranked scale from clear to severe. The differ-
ever, his psoriasis is all over his body. ences relate to the number of points in the scale and
the means by which each point is defined. This can
be by very simple description (“clear,” “mild,” mild-
to-moderate,” etc) or may require comparison with
images or with reference cards embossed with ele-
vations to assist with estimation of plaque thick-
ness.44 In general, they do not take psoriasis
extent into account. Changes in score may be
more useful for documenting response to therapy
than a static score to document severity.

Modified Physician Global Assessment

Instruments
Fig. 2. Psoriasis Area and Severity Index (PASI) Investigators have recognized that the omission
formula. of scoring extent in PGA limits its usefulness.
64 Chalmers

Fig. 3. Illustration of Psoriasis Area and Severity Index (PASI) extent score 51 (<10% body surface area). (From
Ramsay B, Lawrence CM. Measurement of involved surface area in patients with psoriasis. Br J Dermatol
1991;124:565–70; with permission.)

Table 3
Examples of problems with Psoriasis Area and Severity Index (PASI) scoring

BSA Mean
Affected Area PASI
Distribution (%) Score Lesion Character Lesion Score Score Comment
A few plaques 4 1 Moderately thick, 2121256 3.6 Mild disease
elbows and red, scaly
knees plaques
Hands and feet 3 1 Disabling 2131257 4.2 Severe and
only confluent disabling
psoriasis psoriasis
One small plaque 2 1 Very thick and 4 1 4 1 4 5 12 12.0 Mild disease
on scalp, 1 scaly
thigh, 1 arm,
and on trunk
Nearly half of 40 3 Thin, quite red 3111155 15.0 Very severe
body covered with slight scale psoriasis
Near total body 85 5 Quite red, but no 3101053 15.0 Severe, potentially
erythroderma thickness or life threatening
scale
Data from Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatolog Treat
2004;15:27–9.
 Assessing Psoriasis Severity and Outcomes 65

There are 2 instruments that set out to combine weight to plaque thickness than to scale or ery-
extent with a PGA in an attempt to redress this. thema, to derive a final severity score ranging
In the Lattice System Physician’s Global Assess- from 0 (clear) to 7 (very severe) (Fig. 4). The extra
ment (LS-PGA),45 percent BSA involvement is weighting for plaque thickness was felt to be a
categorized into 1 of 7 unequal ranges (0%, better indicator of disease severity than erythema
1%–3%, 4%–9%, 10%–20%, 20%–29%, 30%– or scale, particularly because the latter can
50%, and 50%–100%). Average overall plaque readily be removed by emollients and keratolytics
thickness (ignoring scale), erythema and scale without fundamentally altering the underlying
are graded according to defined criteria into severity of the psoriasis.
none, mild, moderate or marked. The single high- More recently, it has been proposed that the
est plaque quality score and the BSA are then product of PGA and BSA (PGAxBSA) might pro-
entered into a lattice grid, which allots greater vide a simpler alternative to PASI.46 This provides

Fig. 4. Extract from lattice–Physician Global Assessment (PGA) score sheet. (From Langley RG, Ellis CN. Evaluating
psoriasis with psoriasis area and severity index, psoriasis global assessment, and lattice system physician’s global
assessment. J Am Acad Dermatol 2004;51:563–9; with permission.)
66 Chalmers

a more continuous range of possible scores than psychosocially important body sites. Thus, 50%
the LS-PGA, but is conceptually similar. It has of the total possible extent score is allotted to
been tested mainly in patients with mild-to- scalp, face, hands (1nails), feet (1nails), and ano-
moderate psoriasis with a median PASI score of genital area (Fig. 5). For each site the assessor has
only 3.2. Further validation is required. Both the 3 options from which to choose:
LS-PGA and PGAxBSA have the disadvantage
shared with PASI that they rely on an accurate esti-  Clear or minimal with no more than a few scat-
mation of BSA. tered thin plaques (0)
 Obvious but still leaving plenty of normal skin
The Simplified Psoriasis Index (0.5); or
 Widespread and involving much of the
Simplified Psoriasis Index (SPI)22 is a composite affected area (1).
summary measure of psoriasis with separate com-
ponents for current severity (SPI-s), psychosocial The maximum extent score is 10 with each site
impact (SPI-p), and past history and interventions scored 0, 0.5, or 1. It thus differs from PASI in
(SPI-i). It is available in 2 complementary versions, that dispersion of plaques in each given area is
one for completion by health care professionals more important than actual BSA involvement. It
including dermatologists, dermatology nurses, also allows minimal psoriasis in any given site to
and primary care physicians (proSPI) and a be disregarded. Furthermore, nail disease can
self-assessment version for completion by the pa- contribute up to 20% of the total extent score,
tient (saSPI). The current severity component, SPI- even in the absence of skin involvement.
s, dispenses with the need for estimation of BSA. In common with LS-PGA and PGAxBSA, a sin-
Assessors are asked to judge psoriasis extent in gle average is used for scoring plaque severity
10 unequal body areas, weighted to reflect the with a 6-point score ranging from 0 (essentially
impact of psoriasis affecting functionally or clear, with faint erythema or residual pigmentation

Fig. 5. Simplified psoriasis index body sites.

 Assessing Psoriasis Severity and Outcomes 67

only) to 5 (intensely inflamed skin, with or without INSTRUMENTS FOR ASSESSING THE
pustulation). A photographic key with thumbnail PSYCHOSOCIAL IMPACT OF PSORIASIS
images is available in addition to the text descrip-
tors to aid consistency in scoring each gradation. These instruments have been systematically re-
Separate scoring of scale, plaque thickness, and viewed.47 Eight scales were found to perform
induration is not required. satisfactorily in terms of validity, reliability, sensi-
The observer-rated psoriasis severity score tivity to change (responsiveness), and accept-
(proSPI-s) has a maximum value of 10  5 5 50. ability. By far the most widely used in psoriasis
The proSPI-s has been validated according to trials are the DLQI29 and SF-36.26 The other scales
COSMIN criteria. In 100 patients with plaque that were approved have been used much less
psoriasis, there was a wide response distribution frequently and included Skindex 29, Skindex 17,
with close correlation between proSPI-s and Dermatology Quality of life Scale PDI,29 Impact
PASI (r 5 0.91). Strong intrarater and interrater reli- of Psoriasis Questionnaire, and Psoriasis Index
ability was demonstrated (intraclass correlation of Quality of Life. The SPI-p has been published
coefficients, >0.75). PASI-equivalent cutoff scores too recently to have been considered in this
for mild (PASI <10) and severe (PASI >20) psoriasis review.
were less than 9 and greater than 18, respectively
(n 5 300). Dermatology Life Quality Index
This index was introduced earlier in this review. It
INSTRUMENTS FOR SELF-ASSESSMENT OF consists of 10 questions (see Table 3), each of
PSORIASIS SEVERITY BY PATIENTS which can contribute up to 3 points toward a total
of 30. It is not psoriasis specific, but has been used
Despite focus in recent years on patient-reported widely in psoriasis trials and for longer term moni-
assessments, there has been surprisingly little toring of patients. It is simple to complete and can
attempt to develop these for psoriasis. help health care professionals to understand bet-
ter the ways in which psoriasis may be affecting
Self-Administered Psoriasis Area and Severity a patient’s life.
Index
The Simplified Psoriasis Index
This instrument has already been described earlier
in this article.20,21 It is sufficiently similar to the The SPI-p is one of the three domains of SPI. Pa-
PASI to inherit many of the latter’s disadvantages. tients are presented with a simple 10-cm visual
It has, however, been found to be a valid and reli- analog scale and the instruction20: “Please make
able tool with reasonable correlation with PASI a mark on the line below to show us how much
(r2 5 0.59).18,19 It does require a professional to es- your psoriasis is affecting you in your day-to-day
timate BSA from the patient’s sketches. life today.” They are given some guidance with
the following examples of responses:
Self-Assessment Simplified Psoriasis Index 0 5 my psoriasis is not affecting me at all.
5 5 my psoriasis is affecting me quite a lot.
The Self-Assessment Simplified Psoriasis Index
10 5 my psoriasis is affecting me very much (I
(saSPI-s) is the counterpart of proSPI-s and apart
could not imagine it affecting me more).
from simplification of the language it is identical
(Fig. 6).22,23 It was shown to correlate more Their responses are converted into an 11-point
closely with DLQI (r 5 0.82) and the psychosocial Likert score (0–10). In 100 patients who completed
impact score of SPI (SPI-p; r 5 0.78) than did DLQI at the same time, there was a wide response
either proSPI-s (r 5 0.59) or PASI (r 5 0.60), sug- distribution and a close correlation between SPI-p
gesting that it better reflected the patients’ own and DLQI (r 5 0.89). Although the precise compo-
perceptions of their disease severity than did nents contributing to psychosocial distress cannot
the observer-rated scores.20 There was never- be deduced from this simple measure, it can be
theless good correlation between the saSPI-s used very readily and repeatedly within the setting
and both the PASI (r 5 0.70) and the proSPI-s of the routine clinic.
(r 5 0.70). Furthermore, the saSPI-s had a wide
response distribution. The authors reported that COMPOSITE INSTRUMENTS FOR THE
most patients have little difficulty in completing ASSESSMENT OF PSORIASIS
the proforma and recommended that it was suit-
able for use in the routine clinic as well as for clin- In the field of rheumatology, a large number of com-
ical trials. posite assessment scores have been developed to
68 Chalmers

Fig. 6. Self-assessment version of simplified psoriasis index (first side). (From Chularojanamontri L, Griffiths CE,
Chalmers RJ. The simplified psoriasis index (SPI): a practical tool for assessing psoriasis. J Invest Dermatol
2013;133:1956–62; with permission.)
 Assessing Psoriasis Severity and Outcomes 69

assist in defining response to interventions. For OUTCOME MEASURES FOR PSORIASIS

example, the American College of Rheumatolo-
gists/European League Against Rheumatism Core Outcome measures involve either assessing the
Data Set for rheumatoid arthritis studies includes magnitude of change or the attainment of a partic-
3 assessor-derived measures—tender joint count, ular goal, which in the case of psoriasis would nor-
swollen joint count, and PGA; 1 laboratory test— mally be clearance or near clearance. There is a
erythrocyte sedimentation rate or C-reactive pro- presumption that psoriasis was present when the
tein level; and 3 patient self-reported question- intervention was instituted. It would be rare, how-
naires—on functional disability, pain, and overall ever, for some measure of psoriasis severity not
assessment. The magnitude of improvement is to have been recorded at enrollment into an inter-
then based on attaining a given percentage reduc- ventional study for psoriasis.
tion both in tender and in swollen joint counts, as Clearance or Minimal Residual Activity
well as specified improvements in 3 of the 5 other
measures, to achieve ACR20, ACR50, or ACR70 This category involves change from an undefined
responses.48 prior severity to clearance and has largely been
Because of its visibility, psoriasis is fortunately restricted to phototherapy trials.
simpler to measure than is rheumatoid arthritis,
even though the ideal means of doing so have Psoriasis Area and Severity Index-75 and -90
yet to be agreed. There is rightly a reluctance to These measures record a reduction in PASI score
combine very different types of data into a single by at least 75% and 90%, respectively. They have
composite, as is required for many of the rheuma- been widely used in clinical trials. The PASI-90 is
tology measures. Nevertheless, it can be informa- similar to clearance or minimal residual activity
tive to present summary information in an easily and, with the development of more effective
comprehensible format. agents for psoriasis, there have been calls to
make PASI-90 rather than the currently used
Salford Psoriasis Index PASI-75 the standard criterion of success.50

This instrument was developed in the late 1990s Physician Global Assessment 0 to 1
and was the prototype for SPI.49 It introduced
The attainment of a PGA score of 0 or 1 in a 6- or 7-
the concept of a triplet summary score comprising
point PGA scale may be regarded as equivalent to
current severity, psychosocial impact, and psoria-
clearance or minimal residual activity.
sis history. Although well-received by commenta-
tors, its wide adoption was hindered by the Professionals Simplified Psoriasis Index and
requirement for prior calculation of PASI and its Self-Assessment Simplified Psoriasis Index
complex history and interventions score.
The SPI equivalents of PASI-75 were shown to be
85% and 95% reductions in proSPI-s and saSPI-s,
The Simplified Psoriasis Index respectively.23
The SPI was designed as a simple, 3-part sum-
mary measure including current psoriasis severity SUMMARY
(SPI-s), psychosocial impact (SPI-p), and past his- The advent of powerful new agents for treating
tory and interventions (SPI-i).22,23 Most of its ele- psoriasis has put a spotlight on the need for reli-
ments have been discussed previously. It is able and practical tools for assessing psoriasis
available in complementary observer-rated (pro- and its impact. Further work is still needed to vali-
SPI) and patient self-assessed (saSPI) versions, date existing instruments and to develop new
which differ only in the means of scoring current ones, with the hope that PASI will no longer remain
psoriasis severity (proSPI-s and saSPI-s, respec- the mainstay of psoriasis severity assessment. The
tively). The SPI-i includes information on interven- International Psoriasis Council recognizes the
tions received and on age of onset and duration of need for change and will continue to work to
psoriasis. Good correlation between proSPI-s and improve the tools at our disposal.
saSPI-s has been demonstrated (r 5 0.70)47 and,
as mentioned, the correlation between saSPI-s REFERENCES
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