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Summary
Pruritus is a primary symptom of many dermatological dis- inconsistent and partial relief. Therefore, novel treatments are
eases, including atopic dermatitis, psoriasis, urticaria and necessary. However, well-designed clinical trials require
postburn healing. It is also a common feature of several sys- appropriate outcome measures to evaluate the response of
temic diseases, including chronic kidney failure, hepatobiliary pruritus to treatment.
disease, human immunodeficiency virus (HIV) and haemato- Currently, only a few resources are available to measure
poietic disorders. More than just an annoyance, chronic pru- pruritus. A visual analogue scale (VAS; Fig. 1) has been used
ritus significantly reduces quality of life and can ultimately most often to quantify pruritus. While the VAS is adequate in
lead to severe disability. Its sequelae may include sleep assessing the severity of the symptom, it does not take into
disturbance, embarrassment, prolonged wound healing and account other aspects of pruritus, such as the relative impact
secondary skin changes. Current treatments provide of pruritus on quality of life. Some patients also have difficulty
Draw a line anywhere on the scale that best represents the severity of your itching:
conditions of patient care and clinical trials; and (iii) review
No itching Worst possible itching of the pruritus literature. The preliminary version included
both open-ended questions and specific response questions
regarding the patient’s perception of pruritus. This preliminary
version was administered to 21 patients participating in a trial
Example:
of sertraline for a treatment of cholestatic pruritus.5 Ambigu-
ous items or response choices were revised and response
choices selected < 5% of the time were removed.
The remaining items were grouped into five domains: dura-
Fig 1. Visual analogue scale. tion, degree, direction, disability and distribution. Accordingly,
the scale was titled the ‘5-D itch scale’ (Fig. 2). The duration,
translating a subjective symptom, such as pruritus, into a degree and direction domains each included one item, while
point on a line. Despite its historical use, the ability of the the disability domain had four items. All items of the first four
VAS to detect changes over time has never been validated. In domains were measured on a five-point Likert scale.
our experience, individuals often have similar responses on The distribution domain included 16 potential locations of
the VAS repeated measures even when they verbally report itch, including 15 body part items and one point of contact
significant changes in their pruritus. Accordingly, the VAS with clothing or bandages. The preliminary version of the
may fail to detect some changes in pruritus severity. The sub- questionnaire also included an ‘other’ item which allowed
jective and multidimensional nature of pruritus requires an subjects to write in a response. This led to further refinement
evaluation tool that is sensitive to these qualities. In an effort of the body part list by the addition of ‘groin’, which was
to address this deficit, Darsow et al. developed the Eppendorf reported by nine subjects. Additional items written in for the
Itch Questionnaire (EIQ) and Yosipovitch et al. developed the free text ‘other’ item were determined by the authors to fit
‘Questionnaire for the Assessment of Pruritus’, modified from conceptually into items which were already present on the
the McGill Pain Questionnaire, respectively.1–3 The EIQ col- 5-D (e.g. ‘breast’ could be categorized as ‘chest’). Therefore,
lects information about a patient’s subjective experience with the instructions were modified to instruct the participant to
pruritus using a detailed list of sensory and affective descrip- select the anatomically closest body part for areas that they
tors. The Questionnaire for the Assessment of Pruritus also might not find on the list.
collects information about the impact of pruritus on quality of
life. While these questionnaires provide valuable information,
Sample population and data collection
better to understand the pruritus experience, they are time
consuming and do not provide a quantifiable measure of pru- This study was approved by the Institutional Review Board of
ritus. A shorter form of the Questionnaire for the Assessment the University of Texas Southwestern Medical Center at Dallas.
of Pruritus, renamed the ‘Itch Severity Scale’, was recently The conditions under which a new measure is studied should
developed and utilized to quantify and describe pruritus in closely resemble the conditions of eventual use.6 Thus, five
subjects with psoriasis. None of these scales, however, has different patient groups representing the most common causes
been demonstrated to be sensitive to change over time: a criti- of itching were studied. Subjects were recruited from univer-
cal feature that determines whether they are useful as an out- sity-affiliated clinics for dermatology, burn, HIV, liver disease
come measure in clinical trials. Time sensitivity, as well as and emergent dialysis. Eligibility criteria for the study
ease of administration and scoring, are all important qualities included: (i) pruritus secondary to one of the following con-
of a desirable outcome measure to be used in clinical trials. ditions: primary dermatological disease, burn wounds, HIV,
The 5-D itch questionnaire was specifically developed to be a hepatobilary disease or chronic kidney disease; (ii) between
measure of itch that is brief (one page), easy to complete, the ages of 8 and 90 years; and (iii) able to complete the
easy to score (either manually at the bedside or electronically questionnaires in English.
as part of a large clinical trial), sensitive to the multidimen- After providing written informed consent, subjects were
sional nature of pruritus and its effect on quality of life, appli- asked about their medical diagnosis, stage of disease, comor-
cable to multiple diseases, and capable of detecting change bid medical conditions and current medication. All subjects
over time. then completed a questionnaire packet which included the
5-D, the VAS, and the itch domain of the PBC-40, a quality of
life assessment in patients with the chronic itchy liver disease,
Materials and methods
primary biliary cirrhosis (PBC). Six weeks later, subjects were
asked to repeat the questionnaires and report any changes in
Instrument development
stage of disease, medication or skin care regimens. Follow-ups
Preliminary items for the 5-D itch scale were derived from (i) were completed (i) with patients in their regularly scheduled
modification of the Total Neuropathy Scale4 to be relevant to clinic visits whenever possible and (ii) by contacting subjects
pruritus rather than neuropathy; (ii) clinical experience by the by telephone and recording responses to the questionnaires at
authors and expert consultants with chronic pruritus under the time of telephone contact. A subset of patients (n = 50)
1 2 3 4 5
2. Degree : Please rate the intensity of your itching over the past 2 weeks
Not present Mild Moderate Severe Unbearable
1 2 3 4 5
3. Direction : Over the past 2 weeks has your itching gotten better or worse compared to the
previous month?
Completely Much better, but Little bit better,
resolved still present but still present Unchanged Getting worse
1 2 3 4 5
4. Disability: Rate the impact of your itching on the following activities over the last 2
weeks
Delays falling asleep Delays falling
Occasionally Frequently and occasionally asleep and frequently
Never delays delays wakes me up wakes me up
affects sleep falling asleep falling asleep at night at night
Sleep
1 2 3 4 5
Housework/
Errands 1 2 3 4 5
Work/School
1 2 3 4 5
5. Distribution: Mark whether itching has been present in the following parts of your body
over the last 2 weeks. If a body part is not listed, choose the one that is closest
anatomically.
Present Present
Head/Scalp Soles
Face Palms
Chest Tops of Hands/Fingers
Abdomen Forearms
Back Upper Arms
Buttocks Points of Contact w/ Clothing
Thighs (e.g waistband, undergarment)
Lower legs Groin
Tops of Feet/Toes
Fig 2. 5-D itch scale.
2·50
0·00
–2·50
–5·00
iability in individual domain scores indicates that the very be validated in the same population and under the same con-
high test–retest agreement is not due to memorization of pre- ditions in which it will ultimately be used.
vious responses, but rather short-term stability of pruritus and In summary, the 5-D is a new tool that can be used to mea-
its assessment using the 5-D. sure pruritus. The 5-D has demonstrated ease of use, content
Although there was no change in 5-D score over a 3-day validity, test–retest reliability, internal consistency and ability
interval, there were significant changes in 5-D score over a to detect change in itch over time in patients with skin dis-
6-week interval, indicating that the 5-D is responsive to change. ease, liver disease, kidney disease, HIV ⁄AIDS and burns. The
No other pruritus instrument, to our knowledge, has been 5-D is the first written pruritus measure to be validated in
formally demonstrated to detect changes over time—a critical postburn itch, HIV and liver disease. It offers improvement
feature of any instrument to be used as an outcome measure in over current methodologies because of its ease of use, supe-
a therapeutic trial. All of the subjects entered into this study rior performance characteristics, and demonstrated efficacy in
had been identified and referred to the study by their physician. multiple patient groups.
Thus, many received treatment for their condition during the
6-week follow-up interval. This was an observational study of
Acknowledgments
clinical course, not an interventional treatment trial, so we
expected that some patients would be treated for itching and S.E. was salary supported by a grant from the Doris Duke
others not treated; some patients would improve and others Foundation. Statistical support for this publication was pro-
would not. Unfortunately, there is no gold standard to establish vided by grant number UL1RR024982, titled ‘North and Cen-
whose pruritus actually did improve in order to determine tral Texas Clinical and Translational Science Initiative’ (Milton
whether the 5-D was accurate in the magnitude and direction Packer, M.D., PI) from the National Center for Research
of change in pruritus that it detected. Data were extracted from Resources, a component of the National Institutes of Health
the medical record regarding diagnoses, medications, treat- (NIH) and NIH Roadmap for Medical Research.
ments and physician assessments. However, the data (obtained
from chart review) were not complete enough to make valid
References
statistical correlations. In fact, over 40% of physicians who
referred their patients for this study did not even document 1 Darsow U, Scharein E, Siman D et al. New aspects of itch patho-
pruritus as one of the medical problems at the referral visit. physiology: component analysis of atopic itch using the ‘Eppendorf
Itch Questionnaire’. Int Arch Allergy Immunol 2001; 124:326–31.
The observed change in 5-D did correlate very well with the
2 Yosipovitch G, Zucker I, Boner G et al. A questionnaire for the
observed change in VAS, a historical but not gold standard.
assessment of pruritus: validation in uremic patients. Acta Derm Vene-
Because the study group was large and contained five sub- reol (Stockh) 2001; 81:108–11.
groups of patients, we were able to evaluate the behaviour of 3 Melzack R. The McGill Pain Questionnaire: major properties and
the instrument in several distinct subject groups with adequate scoring methods. Pain 1975; 1:277–99.
statistical power. It was remarkable that responses to each of 4 Cornblath DR, Chaudry V, Carter K et al. Total neuropathy score:
the domains and the total score were similar in all groups, validation and reliability study. Neurology 1999; 53:1660–4.
5 Mayo MJ, Handem I, Saldana S et al. Sertraline as a first-line treat-
with the exception of the burn patients. Burn patients score
ment for cholestatic pruritus. Hepatology 2007; 45:666–74.
lower on the 5-D as a result of lower scores on the distribu-
6 Nunnally JC, Bernstein IH. Psychometric Theory, 3rd edn. New York,
tion domain because they itch only at the site of the burn. NY: McGraw-Hill, Inc., 1994; 301.
This finding underscores the dictum that an instrument should