44 F. Atzeni et al.and/or verbal (e.g., “Pain as bad as it could be”) indicator.There are occasional distortions throughphotocopying and printing, but adjustments can bemade so that the highest score is 10. Huskisson etal. (80) also suggested that an alternative descriptivepain relief scale based on the indications “completerelief” “moderate relief,” “slight relief” and“no pain relief” was possible, but this would bemuch less sensitive than the visual analogue scale.A number of studies have established that data fromself-report visual analogue scales are reproducible.With the development of optical scanning technologyfor the automated computer entry of scores, visualanalogue scales can be presented in a format of 11small boxes or circles for patients to assess their painfrom 0-10 (or 100) (81). Although formal direct comparativestudies have not been performed to analyzethe results of automated optical scanning, this scalingformat appears to have criterion validity.The visual analogue pain scale has proven to be agreat advance in the assessment of pain. A daily diaryhas been used to assess the impact of pain inpatients with FM and has been reported to be usefulfor demonstrating the manner in which pain influencesactivities of daily living in these individuals.The MPQ can provide detailed information onthe characteristics of pain in FM (82). It includes78 pain adjectives that are divided into 4 major categories(sensory, affective, evaluative, and miscellaneoussensory) (82, 83). This index takes 10 to15 minutes to complete. Tender point assessmentis a demonstrably useful part of the official ACRcriteria for the diagnosis of FM. However, TPs arenot unique to the syndrome. Tenderness is widespreadin patients with FM rather than being confinedto specific anatomic regions, and these individualsmay also demonstrate more hypersensitivityto heat, cold, and electrical stimulation. Somemethods of assessing tenderness (e.g., dolorimetry)may demonstrate increased pain sensitivity in patientswith FM more objectively than palpation andare relatively independent of biasing factors or patientdistress. In addition to tender point count, assessmentof tender point intensity or score has beendeveloped as an assessment tool. For example, theFM Intensity Score (FIS) is obtained by averagingthe pain intensity scores (on a 0-10 scale) for the18 sites assessed in the Manual Tender Point Survey(84).Psychological and behavioural assessmentPsychological evaluation of the patient can provideuseful information about the psychological and behaviouralfeatures that may influence their pain anddysfunction and, conversely, provide a sense of theimpact of pain, fatigue, and other symptoms on theirpsychological health (85, 86). It is often presumedthat patients with greater psychological impairmentand/or psychiatric pathology may be more symptomaticor resistant to improvement with therapeuticintervention. However, this assumption may be trueonly in some cases. Both in clinical practice and indrug trials, it is important to diagnose and effectivelytreat concomitant depression, anxiety, bipolarstates, and especially, suicidal tendencies. In additionto a careful history, a number of screeningtools are available for both clinical and researchpurposes, including the Multidimensional Pain Inventory,the Pain Behaviour Scale, the DartmouthPain Questionnaire, the Coping Strategies Questionnaire,the Ways of Coping Scale and the IllnessBehaviour Questionnaire (79, 85).Fatigue assessmentFatigue is one of the core features of FM, and itsmeasurement is important in both research andclinical settings. A variety of measures exist andhave proven useful in measuring fatigue in otherrheumatic diseases, such as RA and AS (87). Theseinclude the Multidimensional Fatigue Index, whichmeasures various types of fatigue including physicaland emotional (87); the Functional Assessmentof Chronic Illness Therapy (FACIT) system, whichhas been validated in a number of disease states andmay be customized to certain disease indications(88); And the Fatigue Severity Scale, which wasoriginally developed for multiple sclerosis and lupusfatigue assessment (89). The advantage of suchtools is their ability to explore the multiple dimensionsof fatigue. More simple, single-question fatigueassessments are embedded within such compositeinstruments as the FM Impact Questionnaire(FIQ).Sleep assessmentMultiple dimensions of sleep quality have been assessedin FM trials, including quantity, quality, easeof falling asleep, frequency of waking, and feelingrefreshed upon awakening. Sleep quality can beassessed on a 100 mm linear scale with “sleep isno problem” at one extreme and “sleep is a majorproblem” at the other extreme. Similar scales canbe used to rate number of awakenings, and “restedness”on awakening in the morning. The MedicalOutcome Study (MOS) sleep scale is an exampleof an instrument used in an FM trial.
The evaluation of the fibromyalgia patients 45Quality of life and functional assessmentMeasurement of global sense of well being, qualityof life, and functional capacity in multiple dimensions(physical, vocational, social, emotional)is a key area of assessment and is considered essentialby regulatory agencies when contemplatingapproval of medications for chronic pain states(90, 91). Assessment with the MOS Short Form-36 (SF-36) Health Survey (SF-36) has shown thatpatients with FM have reduced physical functioning,physical role functioning, body pain, generalhealth, vitality, and social functioning compared tohealthy subjects.The SF-36 is a generic instrument with scores thatare based on responses to individual questions,which are summarized in eight scales (bodily pain,physical functioning, general health perception,role function - physical aspect, role function - emotionalaspect, vitality, social functioning, and mentalhealth), each of which measures a health concept(92). These scales, weighed according to normativedata, are scored from 0 to 100, with higherscores reflecting a better quality of life. The SF-36has been validated for use in Italy, and it can becompleted within 15 min by most people. The NottinghamHealth Profile (NHP) is intended for primaryhealth care to provide a brief indication of apatient’s perceived emotional, social and physicalhealth problems (93).The questionnaire consisted of two parts, but onlypart I is now used: it contains 38 yes/no items thatcan be grouped into 6 domains (physical mobility,pain, sleep, social isolation, emotional reactions, andenergy level) with each question weighted for severity.The sum of all weighted values in a given domainrepresents a continuum between 0 (best health)and 100 (worst health). The FM Impact Questionnaire(FIQ) is an assessment instrument designed tomeasure the components of health status that are believedto be most affected by FM patients. It is composedof 20 items and is used to measure FM patientstatus, progress and outcomes (93, 94). The FIQ isa brief, self-administered instrument that takes approximately5 minutes to complete (90, 91).Table I - Proposed preliminary response criteria for fibromyalgia.Improvement in at least 3 of the 4 measures; and at least 3 ofthe post-treatment scores must satisfy the respective cutoffs:1. FIQ score
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