Severity Of Morning Stiffness Research Articles

Switching From Immediate-Release to Delayed-Release Prednisone in Moderate to Severe Rheumatoid Arthritis: A Practice-Based Clinical Study.

IntroductionRheumatoid arthritis (RA) produces debilitating morning stiffness. Exogenous glucocorticoids can help with these symptoms when timed appropriately. Bedtime dosing of delayed-release prednisone (DR-prednisone) matches the rise of inflammatory cytokines before awakening and can improve stiffness and other RA symptoms. A prospective open-label study was conducted in patients currently on stable doses of immediate-release prednisone (IR-prednisone) who were switched to DR-prednisone to analyze the incremental benefit of better timed and lower dose glucocorticoid therapy.MethodsTwelve US sites enrolled patients with moderate-severe RA into a 12-week prospective study. Patients were switched from IR- to DR-prednisone while maintaining other existing background therapies. Change from baseline in morning stiffness severity, morning stiffness duration, swollen and tender joint counts (S-TJC), 28 joint disease activity score (DAS28), and patient/physician global assessment (PGA/PhGA), among others, were measured. Post-hoc analyses were performed on those completing 10 weeks of treatment and those with >60 min of morning stiffness at baseline.ResultsFifty-six patients had at least one follow-up visit and were similar in demographics to previous controlled trials with DR-prednisone with regard to baseline age and DAS28-CRP but had lower morning stiffness and RA duration. DR-prednisone produced a trend toward lower morning stiffness severity and duration with a reduction in daily prednisone dose of almost 1 mg. Patients treated with DR-prednisone for ≥10 weeks demonstrated significant reductions in morning stiffness duration, SJC, TJC, DAS28-CRP, and PhGA (all p ≤ 0.04). Patients treated for ≥10 weeks with >60 min of baseline morning stiffness produced similar results in these measures as well as a 21% reduction in morning stiffness severity (p = 0.02).ConclusionPatients switched to DR-prednisone from IR-prednisone in this practice-based study maintained or improved their outcomes across a variety of domains, and results were comparable to previous controlled trials in which patients completed at least 10 weeks of treatment.FundingHorizon Pharma USA, Inc.Trial RegistrationClinicalTrials.gov identifier, NCT02287610.

Direct and Indirect Determinants of the Patient Global Assessment in Rheumatoid Arthritis: Differences by Level of Disease Activity.

In rheumatoid arthritis (RA), the patient global assessment (PGA) has been strongly associated with pain severity, but less often with other measures, including disease activity measures. We tested whether RA activity and psychological measures had direct associations with the PGA or indirect associations that were mediated by pain. We also tested whether the correlates of the PGA differed with the degree of RA activity. We studied 260 patients with active RA on 2 visits in a prospective longitudinal study. We used path analysis to test direct and indirect associations of Disease Activity Score in 28 joints (DAS28), morning stiffness, Health Assessment Questionnaire (HAQ), fatigue, physical role limitations, social functioning, depressive symptoms, and health distress with the PGA. Among the 509 visits, the median PGA score was 50 (25th-75th percentile: 24-66). Pain severity had the strongest association with the PGA, but direct associations were also found for morning stiffness severity, health distress, fatigue, and DAS28. Morning stiffness severity, DAS28, health distress, and HAQ were also indirectly associated with the PGA through pain. Among visits with DAS28 ≥5.4, pain, morning stiffness severity, and HAQ were the only determinants of the PGA. Among visits with DAS28 <4.2, health distress and age were additional determinants, and fatigue was marginally associated with the PGA. Although pain was the strongest determinant of the PGA in RA, morning stiffness severity, health distress, fatigue, and DAS28 were also important. Determinants of the PGA differed with RA activity, with health distress, age, and to a lesser degree, fatigue, contributing only in patients with less active RA.

Chronotherapy for rheumatoid arthritis: current perspectives

Chronotherapy for rheumatoid arthritis: current perspectives Hideto To Department of Medical Pharmaceutics, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan Abstract: Rheumatoid arthritis (RA) is an autoimmune disorder of unknown etiology. Morning stiffness, a characteristic feature of RA, shows a 24-hour rhythm. Cytokines, which are considered to play an important role in the pathogenesis of RA, also exhibit a 24-hour rhythm, with a peak in the early morning. These rhythms have been attributed to the endogenous hormone balance and changes in expression levels of clock-related genes. Chronotherapy based on the 24-hour rhythm of RA has been performed using glucocorticoids and disease-modifying antirheumatic drugs. In a previous study, it was reported that modified-release prednisone tablets were administered to patients with RA at night, which demonstrated that the severity of morning stiffness was markedly less than that in patients receiving the standard treatment. Methotrexate (MTX) is the most frequently used RA drug worldwide. In a basic study, cytokines and inflammatory responses in RA model animals showed 24-hour rhythms, based on which MTX was administered and exerted dosing time-dependent antirheumatic effects. Plasma C-reactive protein and cytokine levels also exhibit 24-hour rhythms in patients with RA, with peaks occurring in the early morning. MTX has been shown to markedly inhibit the exacerbation of arthritis in patients with RA when it is administered as inflammatory responses and tumor necrosis factor-α levels begin to increase. Tacrolimus (TAC) is an immunosuppressive agent that is administered to patients who undergo organ transplants. Since one of the mechanisms of action of TAC is the inhibition of inflammatory cytokine production, it is used as an RA therapeutic drug. When TAC was previously administered in the early light or early dark phase to RA model animals, the group treated in the early light phase had notably inhibited increase in arthritis scores compared with that in the early dark phase. The selection of an optimal dosing time associated with 24-hour rhythms in RA symptoms may lead to more effective and safer treatments for RA using glucocorticoids and disease-modifying antirheumatic drugs. Keywords: methotrexate, steroid, circadian rhythm, cytokines

Influence of magnetic field parameters on therapy outcomes in patients with rheumatoid arthritis – preliminary study

Abstract Introduction: Magnetic field is used in therapies designed for patients with rheumatic disorders such as rheumatoid arthritis (RA). The question of selecting adequate treatment parameters to obtain optimal therapeutic effects still needs to be answered. The purpose of the study was to assess the influence of magnetic field, depending on its nature, on problems and dysfunctions experienced in upper limbs by patients with RA. Materials and methods: The study group included 14 patients with RA (10 females, 4 males), referred for magnetotherapy to be administered in selected areas of upper limbs. On average, the subjects were 57 years old, and the mean duration of the disorder was 13 years. Magnetotherapy was administered with the use of static or pulsed magnetic field. The patients were examined for the level of disorder, disability level (HAQ-20), severity and duration of morning stiffness, pain intensity (VAS scale), hand volume, swelling and functional capacity. The examinations were carried out before and after a series of ten magnetotherapy treatments. Results: All the patients reported decreased severity and shorter duration of morning stiffness, reduced level of pain and general disability. There was no statistically significant difference between the groups treated with static and pulsed magnetic field. Statistically significant differences between the groups treated with static and pulsed field were observed in reduced swelling, improved range of motion and muscle strength in the upper limb. The study revealed better effects of pulsed field therapy. Conclusions: When administered to areas within upper limbs in patients with RA, pulsed magnetic field produced better effects related to the reduction of swelling as well as improving range of motion and muscle strength in the relevant area of the body compared to static field. The findings did not confirm the relationship between the type of magnetic field and its therapeutic effectiveness in reducing pain, morning stiffness and disability level.

What Is the Relationship Between Morning Symptoms and Measures of Disease Activity in Patients With Rheumatoid Arthritis?

Little is known about the relationship between morning symptoms of rheumatoid arthritis (RA) and measures of disease activity currently used to assess RA. Information available from the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA-2) study was used to investigate these relationships. CAPRA-2 included 350 patients with RA who were symptomatic despite treatment with disease-modifying antirheumatic drugs, randomized 2:1 to additional treatment with a 5-mg daily dose of delayed-release prednisone or placebo. Pearson's correlations were used to evaluate the relationships between change from baseline in symptoms (duration of morning stiffness, severity of morning stiffness, and intensity of pain on waking) and measures of disease activity (the American College of Rheumatology 20% improvement criteria [ACR20], the Disease Activity Score in 28 joints [DAS28], and the Health Assessment Questionnaire disability index). Correlations were defined as weak (<0.3), moderate (0.3-0.7), or strong (>0.7). There was a strong correlation between the severity of morning stiffness and the intensity of morning pain (Pearson's correlation 0.91, P < 0.001). There was a weak correlation between the duration of morning stiffness and measures of disease activity (0.24-0.28), with moderate correlations between the severity of morning stiffness or intensity of pain on waking and DAS28 or ACR20 scores (0.44-0.48). Severity of morning stiffness showed less variability and a greater effect size than did duration of morning stiffness. Morning symptoms and measures of disease activity show weak to moderate correlations. Severity of morning stiffness showed less variability and greater effect size than did duration of morning stiffness. These findings suggest that severity is the preferred construct to measure the impact of morning stiffness in patients with RA, information that is not fully captured in the RA core set.

SAT0147 Is IT Possible to Quantify Morning Stiffness Objectively?

BackgroundMorning stiffness exhibits a circadian rhythm. Its assessment is subjective and no method has been introduced yet to measure it quantitatively. Morning stiffness may cause a delay in response to...

Impact of morning stiffness on working behaviour and performance in people with rheumatoid arthritis.

Work disability remains a considerable problem for many patients with rheumatoid arthritis (RA). Morning stiffness is a symptom of RA associated with early retirement from work and with impaired functional ability. We aimed to explore the patient’s perception of the impact of morning stiffness on the working life of patients with RA. A survey was conducted in 11 European countries. Patients of working age, with RA for ≥6 months and morning stiffness ≥3 mornings a week, were interviewed by telephone using a structured questionnaire. Responses were assessed in the total sample and in subgroups defined by severity and duration of morning stiffness and by country. A total of 1,061 respondents completed the survey, 534 were working, 224 were retired and the rest were, i.e. homemakers and unemployed. Among the 534 working respondents, RA-related morning stiffness affected work performance (47 %), resulted in late arrival at work (33 %) and required sick leave in the past month (15 %). Of the 224 retired respondents, 159 (71 %) stopped working earlier than their expected retirement age, with 64 % giving RA-related morning stiffness as a reason. There was a differential impact of increasing severity and increasing duration of morning stiffness on the various parameters studied. There were notable inter-country differences in the impact of RA-related morning stiffness on ability to work and on retirement. This large survey showed that from the patient’s perspective, morning stiffness reduces the ability to work in patients with RA and contributes to early retirement.

Measurement of stiffness in patients with rheumatoid arthritis in low disease activity or remission: a systematic review.

BackgroundRecent qualitative research has shown that stiffness is an important symptom for patients to identify remission. However, it is unclear how to measure stiffness in low disease activity. This systematic review aims to summarise the existing literature on validity of patient reported outcomes to measure stiffness in RA low disease activity states, to aid the choice for a measurement instrument.MethodsAn extensive pubmed-search was undertaken, identifying measurement instruments for patient perceived stiffness used in low disease activity. Eligible studies reported on 1) stiffness as an outcome in relation to other core set measures, 2) development of a patient reported tool to measure stiffness, or 3) comparison of two different tools to measure aspects of stiffness, all in low disease activity.ResultsOf 788 titles, only two studies report on validity of stiffness measures within low disease activity. Morning stiffness (MS) is reported in 44 to 80% of patients in low disease activity. A difference of 40 to 60 minutes in duration until maximum improvement is observed between active and inactive patients. Severity of MS might discriminate better between high and low disease activity compared to measurement of duration of MS.ConclusionsThere is insufficient data on measurement of stiffness in the spectrum of low disease activity or remission.

FRI0552 Systematic review of patient reported outcome measures used to measure stiffness in patients with rheumatoid arthritis

BackgroundPatients with rheumatoid arthritis (RA) often experience stiffness of joints, with considerable impact on functional capacity. While morning stiffness (MS) has been excluded from the core set due to poor...

Impact of impaired morning function on quality of life in rheumatoid arthritis: results of an exploratory patient survey

Aim: A pan-European survey was conducted to assess the impact of impaired morning function on patients with rheumatoid arthritis. Materials & methods: Patients aged 18–65 years with rheumatoid arthritis for ≥6 months and impaired morning function arising from joint stiffness and pain ≥three-times a week were interviewed using a structured questionnaire. Responses were assessed in the total sample and in subgroups defined by severity of morning stiffness. Results: Of the 608 respondents, only approximately a third could perform, unimpaired, morning tasks requiring mobility, with impairment increasing with severity of morning stiffness (p < 0.05). Impaired morning function affected quality of life in 84% of respondents (severe morning stiffness: 98 vs mild: 56%; p < 0.05). Impaired morning function affected the jobs of 74% of the 271 employed respondents (severe morning stiffness: 79 vs mild: 50%; p < 0.05). Conclusion: Impaired morning function adversely affects daily activities, quality of life and work, ...

Health-related quality of life in Turkish patients with Ankylosing spondylitis: impact of peripheral involvement on quality of life in terms of disease activity, functional status, severity of pain, and social and emotional functioning

Ankylosing spondylitis (AS) affects sacroiliac joints at early stages and may involve the axial skeleton at later stages of disease. Peripheral involvement usually occurs in lower extremities. When it develops early in the disease course, it is a predictor of more aggressive disease. The aim of this study is to evaluate health-related quality of life (HRQoL) in AS and to assess the impact of peripheral involvement on HRQoL domains in terms of disease activity, functional status, pain, and social and emotional functioning. Seventy-four AS patients were included. Peripheral involvement was present in 51.35 % of the patients. In 65.79 % of these cases the hips, in 31.58 % the knees, in 18.42 % the shoulders and in 13.16 % the ankles were affected. Patients were evaluated by Ankylosing Spondylitis Quality of Life (ASQoL), Short Form-36 (SF-36), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Functional Index (BASFI). ASQoL was strongly correlated with ASDAS, BASDAI, BASFI, and Bath Ankylosing Spondylitis Metrology Index (BASMI), severity of total pain, night pain, fatigue, morning stiffness and ESR. ASDAS and BASDAI showed the strongest correlation with ASQoL. Severity of total pain, functional status and severity of night pain followed it, respectively. Patients with peripheral involvement scored significantly lower in all subgroups of SF36 and significantly higher in ASDAS, BASDAI, BASFI, BASMI and ASQoL scores and levels of pain, night pain, fatigue and morning stiffness. Peripheral involvement is associated with more active disease and functional disability and has a negative influence on HRQoL including physical, social and emotional functioning.

Consistency of assessments and willingness to pay for a reduction in morning symptoms over time in patients with rheumatoid arthritis

Objectives: To determine the variation in morning symptoms and in the corresponding monetary equivalents assigned to their reduction.Methods: The sampled (n = 100) rheumatoid arthritis (RA) patients were interviewed twice by a trained interviewer using the same interview, 2 weeks apart. Patients assessed fatigue, pain, and severity of morning stiffness (MS) on waking up and after maximum improvement on a numeric rating scale (NRS). Patients estimated the duration of MS in minutes and reported the number of tender and swollen joints. Patients were also asked to estimate how much they would be willing to pay on a daily basis if pain, duration of MS, and severity of MS when waking up could be reduced by 25, 50, 75, and 100%. Weighted averages of the monetary assessments for symptom reduction were computed.Results: On average, the NRS values at the first and second assessments were close to each other, except for fatigue and pain, which were significantly lower (p < 0.01) in the second assessment. There was limited within-patient variation, with the majority of symptom assessments within a range of ±10%. Weighted average willingness-to-pay (WTP) estimates were consistent across time points for reduction in pain and MS severity and duration. Changes in symptom assessments were reflected in the WTP estimates.Conclusions: The duration and severity of MS seemed to be more consistent over time than pain and fatigue. WTP estimates and their changes corresponded closely to changes in symptom assessments.

Comparing Analgesic Effects of a Topical Herbal Mixed Medicine with Salicylate in Patients with Knee Osteoarthritis

Knee osteoarthritis is the most common cause of disability among people and it is a common disease of joints that can lead to cartilage damage. In this study the analgesic effects of a herbal ointment containing cinnamon, ginger, mastic (Saghez) and sesame oil is compared with Salicylate ointment in patients suffering from knee osteoarthritis. It was a double-blind randomized controlled trail study. Patients with diagnosed arthritis were involved in the study and they were divided in two groups via block randomization method. For six weeks, twice a day, intervention group applied herbal ointment and control group used Salicylate ointment. The severity of pain, morning stiffness and limited motion were measured using Visual Analog Pain Scale. In order to analyze the trends of these three indexes, repeated measurement test was used. Ninety two participates with the mean age of 52.2 (+/- 12.4) years and with the mean disease period of 30.45 (+/- 30.3) months were involved in the study. There was no significant difference between two groups regarding the distribution of sex, weight, height, BMI and the duration of illness. No statistical difference was observed between two groups regarding pain relief, morning stiffness and limited motion; nevertheless in repeated measurements during second, forth and sixth weeks in both groups the decreasing trend of these three indexes had been statistically significant (p < 0.0001). It seems that using this herbal combination is clinically effective for patients suffering from knee osteoarthritis in order to decrease their pain, morning stiffness and limited motion; its effect is comparable with Salicylate ointment.

Comparison of performance of the Assessment of Spondyloarthritis International Society, the European Spondyloarthropathy Study Group and the modified New York criteria in a cohort of Chinese patients with spondyloarthritis

Early diagnosis of spondyloarthritis (SpA) is essential as anti-tumor necrosis factor therapy can achieve significant symptomatic relief and control of disease activity. This study aims to compare the clinical characteristics, disease activity, and functional status of a Chinese cohort of SpA patients who were re-classified into ankylosing spondylitis (AS) patients fulfilling the modified New York (MNY) criteria, those with undifferentiated SpA (USpA) fulfilling the European Spondyloarthropathy Study Group (ESSG) classification criteria only (USpA/ESSG) and those who fulfill Assessment of SpondyloArthritis International Society (ASAS) only (USpA/ASAS). Disease activity was evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), severity of morning stiffness, patient global assessment, and C-reactive protein. Functional status was evaluated by Bath Ankylosing Spondylitis Functional Index (BASFI), modified Schober index, and dimension of chest expansion. One hundred and twenty-eight patients with disease duration of 16.3 ± 10.4 years were recruited. Patients in USpA/ESSG and USpA/ASAS were significantly younger (p = 0.01), had shorter disease duration (p < 0.01), and lower BASFI (p = 0.03) than established AS patients. All three groups have active disease with comparable BASDAI >3. BASFI correlated inversely with dimension of chest expansion and negatively modified Schober index in AS patients (p < 0.01) and modestly with BASDAI (r = 0.25, p < 0.01). BASFI correlated moderately with BASDAI in USpA/ESSG (r = 0.61, p < 0.01) but not with chest expansion or modified Schober index. Compared with established AS patients recognized by MNY criteria, patients fulfilling USpA defined by ESSG or ASAS criteria had earlier disease, as active disease and less irreversible functional deficit.

How should morning function in rheumatoid arthritis be assessed? Bibliographic study of current assessment

In patients with rheumatoid arthritis (RA), symptoms of joint stiffness and pain may be most severe in the morning, resulting in impaired ability to carry out normal morning functions. Although morning stiffness was included in the criteria for classification and remission of RA, defined by the American College of Rheumatology (ACR) in 1987, the approach to assessment of this circadian symptom has not been standardized, and other circadian aspects of the disease (i.e. pain, functional ability) were not included. A bibliographic study of papers published in English in the period January 2007 to January 2010 and reporting morning stiffness, pain or function was undertaken to investigate methods of assessing circadian aspects of RA. A total of 73 studies were identified using Medline, including 62 clinical trials. Full papers were obtained for 52 reports of clinical studies (84%), most of which (44/52, 85%) assessed duration of morning stiffness. Only two studies (4%) specified that severity of morning stiffness was assessed, only three (6%) assessed pain in the morning, and none assessed morning functional ability. These findings suggest the need for consistent reporting of a measure to reflect the impaired morning function, arising from joint stiffness and pain that is commonly experienced by patients.

How much is a reduction in morning stiffness worth to patients with rheumatoid arthritis?

Objective: The aim of this study was to determine the monetary equivalent of the emotional and functional impact of morning stiffness (MS) in patients with rheumatoid arthritis (RA), using alternative valuing methods.Methods: Telephone interviews were conducted among 166 patients with RA to assess utility and clinical symptoms, including MS. Three standard economic methods were used: the human capital approach (HCA), marginal value of time (MVT), and willingness-to-pay (WTP).Results: The monetary equivalent of the impact of MS varied with the method used (from EUR 5.74 to EUR 17.87 per patient per day) and severity of MS (5–8-fold higher in patients with severe MS compared with mild MS). Patients placed considerable value on a reduction in duration and severity of MS. Patients with MS lasting an hour or more were willing to pay EUR 21.74/day to stop the symptom and EUR 10.63/day to halve the duration. Patients with severe MS were willing to pay EUR 47.86/day to stop the symptom and EUR 21.68/day to halve the severity.Conclusions: The observed variation in the monetary equivalent of the impact of MS obtained with the three estimation methods indicates that the findings of studies using different valuing methods should not be compared directly. The study demonstrates that a reduction in MS is worth a considerable amount to patients with RA, particularly those with severe or prolonged MS. These findings suggest that clinical treatment decisions to improve patients' quality of life should also incorporate therapy that reduces MS.

Validation of a prediction rule for disease outcome in patients with recent‐onset undifferentiated arthritis: Moving toward individualized treatment decision‐making

The decision to start disease-modifying antirheumatic drugs in patients with recent-onset undifferentiated arthritis (UA) is complicated by a varied natural disease course in which the disease in one-third of patients progresses to rheumatoid arthritis (RA), whereas 40-50% of patients experience spontaneous remission. Recently, a prediction rule was developed to estimate the chance of progression to RA in individual patients presenting with UA. This study investigates the accuracy of this prediction rule in independent cohorts of patients with UA. In 3 cohorts of patients with recent-onset UA, from the UK, Germany, and The Netherlands, the prediction score and the corresponding chance of developing RA were calculated. These data were compared with the observed disease outcome after > or =1 year of followup. Positive predictive values (PPVs) and negative predictive values (NPVs) were calculated and the overall discriminative ability of the prediction rule was assessed using area under the receiver operating characteristic curves (AUCs). Since data on the severity of morning stiffness were not available in all validation cohorts, the prediction rule was rederived with the duration of morning stiffness as a substitute. The AUC for this rule was 0.88 (SEM 0.015). For each validation cohort, the AUC was 0.83 (SEM 0.041), 0.82 (SEM 0.037), and 0.95 (SEM 0.031) in the British, German, and Dutch cohorts, respectively. The NPV (for a prediction score < or =6) in these 3 cohorts was 83%, 83%, and 86%, respectively; the PPV (for a prediction score > or =8) was 100%, 93%, and 100%, respectively. The recently derived prediction rule, when applied to 3 independent cohorts of patients with UA, has an excellent discriminative ability for assessing the likelihood of progression to RA. Application of this rule will allow individualized treatment decision-making for patients with UA.

Relationship between the severity of enthesitis and clinical and laboratory parameters in patients with ankylosing spondylitis

In this study, we evaluated the relationship between the severity of enthesitis and outcome of measurement indices, clinical and laboratory parameters in patients with ankylosing spondylitis (AS). Thirty-three patients who fulfilled the modified New York criteria for AS were included in this study. Patients were asked to record the severity of current pain, night pain and morning stiffness on a 10-cm visual analogue scale. Stoke Enthesitis Index (SEI) was used to measure the severity of enthesitis. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) were calculated. SEI was correlated positively only with BASDAI (r = 0.370, P = 0.034). There was no relation between SEI and laboratory parameters (Erythrocyte Sedimentation Rate and C Reactive Protein). Our data suggest that using an enthesitis index such as SEI can be a valuable tool in the evaluation of disease activity in patients with AS. However, evaluation of enthesitis severity is based on information given by patient and should be combined with objective parameters such as spinal measurements when assessing disease activity.

Validation of a Korean version of the Fibromyalgia Impact Questionnaire.

The aim of this study was to translate the Fibromyalgia Impact Questionnaire (FIQ) into Korean and to evaluate its reliability and validity for use with Korean-speaking patients with fibromyalgia (FM). After translating the FIQ into Korean, we administered it to 55 patients with FM (28 patients filled out the questionnaire again 7 days later) together with a Korean version of the Health Assessment Questionnaire (HAQ) and the Symptom Checklist-90-Revision (SCL-90-R). The tender-point count (TPC) was calculated from tender points identified by thumb palpation. In addition to sociodemographic characteristics, the severity of relevant current clinical symptoms, e.g., pain intensity, fatigue, and morning stiffness, were assessed by 10-cm visual analog scales (VAS). The test-retest reliability was between 0.466 and 0.780 (total 0.778). Cronbach's alpha was 0.800 for FIQ1 (the first assessment) and 0.857 for FIQ2 (the second assessment), indicating acceptable levels of internal consistency for both assessments. Significant correlations were obtained between the FIQ items, the HAQ, the severity of clinical symptoms, and the subscales of the SCL-90-R. In conclusion, the Korean version of the FIQ is a reliable and valid instrument for measuring health status and physical functioning in Korean patients with FM.

Measurement of Morning Stiffness in Rheumatoid Arthritis Clinical Trials

Objective. Morning stiffness (MS) is a common problem for patients with rheumatoid arthritis (RA). However the clinical evaluation of the symptom has proved to be difficult. The aim of the study was to determine the responsiveness of two methods for measuring MS. Methods. Data from an uncontrolled ( n = 63) and a controlled study ( n = 80) of inpatient multidisciplinary team care for RA were analyzed. MS was measured by its duration to maximum improvement and by its severity on a visual analog scale (VAS). The responsiveness of both assessment methods was computed by calculating effect sizes and t-statistics, and by receiver operating characteristic (ROC) curves with clinical improvement according to the definition of the American College of Rheumatology as an external criterion. Results. With respect to the ability to detect a clinical improvement between admission and discharge in the uncontrolled study, and a difference in improvement between the treatment and the control group in the controlled study, the effect sizes and t-values of the VAS for severity of MS were consistently higher than those of the duration of MS. In contrast to the duration, the responsiveness of the VAS for MS compared favorably with the responsiveness of other endpoint measures. The ROC surface area of the VAS was higher than that of the duration. Conclusion. For the evaluation of MS in RA clinical trials, the assessment of MS by a severity score is more responsive than one based on duration and compares favorably with the performance of other endpoint measures.