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A physician checklist to record patient levels of inflammation, damage and distress as quantitative data rather than as narrative impressions.

Physician global estimate (DOCGL) of patient clinical status on a 0 to 10 visual analogue scale (VAS) is one of seven measures in the Core Data Set for quantitative assessment of patients with rheumatoid arthritis (RA). (1) DOCGL was developed initially to provide a quantitative estimate of the level of inflammation in RA and is most often the most efficient Core Data Set measure to distinguish active from control treatments in RA clinical trials of adalimumab, (2) abatacept, (3) certolizumab, (4) and infliximab. (5)

DOCGL is described most often in RA but has been applied to many rheumatic diseases. Some physicians restrict DOCGL estimates to the level of inflammation, ignoring possible organ (joint) damage and patient distress, which are unexplained by symptoms and signs of inflammation or damage, e.g., fibromyalgia. However, other physicians may incorporate damage and distress into their DOCGL estimate, in addition to inflammation. (6,7)

One approach to clarify DOCGL is to estimate three additional 0 to 10 VAS for inflammation, or reversible symptoms and signs; damage, or irreversible symptoms and signs; and distress, or symptoms and signs explained by neither inflammation nor damage. A RheuMetric physician checklist (Fig. 1) includes a 0 to 10 VAS for overall DOCGL, and three 0 to 10 subscales VAS for inflammation (DOCINF), damage (DOCDAM), and distress (DOCSTR). (7) This report presents analyses of RheuMetric estimates in 205 patients with 4 primary rheumatic diagnoses, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), osteoarthritis (OA), and fibromyalgia (FM).

Materials and Methods

Since 2007, all patients (with all diagnoses) seen by rheumatologists at Rush University Medical Center have completed a two-page MDHAQ (Fig. 2) in 5 to 10 minutes in the waiting area at all visits, prior to seeing the rheumatologist. The MDHAQ8 is a two-page, single-sheet questionnaire, adapted from the Stanford health assessment questionnaire (HAQ) (9) to improve the quality of care in busy clinical settings while saving time for patients and doctors. (10) The MDHAQ includes queries concerning 10 activities, in the format of the original HAQ, (9) scored 0 to 3: 0 = "without any difficulty," 1 = "with some difficulty," 2 = "with much difficulty," and 3 = "unable to do." A total physical function score of 0 to 30 is converted to 0 to 10, using a template on the MDHAQ. Three 0 to 10 VAS scores for pain, patient global assessment (PATGL), and fatigue (8) are included.

RAPID3 (routine assessment of patient index data 3) is a composite of the three patient-reported RA Core Data Set measures for RA (1): physical function, pain, and PATGL from the MDHAQ, (11) each scored 0 to 10, for a total of 0 to 30. (11) MDHAQ also includes a RA disease activity index (RADAI) self-report joint count (12) to score pain in 16 specific joint groups, reported to be useful in patients with different rheumatic diseases. (13)

Physician RheuMetric Checklist

Since 2014, eight Rush University Medical Center rheumatologists have completed a RheuMetric checklist, a onepage physician checklist with four 0 to 10 VAS for overall global patient status (DOCGL), and levels of inflammation or reversible symptoms and signs) (DOCINF), damage or irreversible symptoms and signs (DOCDAM), and distress (DOCSTR) (Fig. 2).

Statistical Analyses

Mean MDHAQ scores and RheuMetric estimates were compared in patients in the four diagnosis groups: RA, SLE, OA, and FM. Correlations of DOCGL with the three sub-scale scores were computed. MANOVA (multivariate analysis of variance) was performed to compare estimates in the four groups, adjusted for age, disease duration, and education with RA as the reference group.

Results

Overall, 205 patients were studied, 50 with RA, 66 with SLE, 57 with OA, and 32 with FM (Table 1). Mean scores on each of five MDHAQ scales, including physical function, PATGL, RAPID3, fatigue, and number of symptoms, were all highest in FM (p < 0.001) followed by OA, RA, and SLE. Although MDHAQ scores were higher in OA than in RA, and higher in RA than in SLE, scores for physical function, patient global estimate, and fatigue were within 1 unit for patients with OA, RA, or SLE. Only scores for FM differed significantly from the other diseases (p < 0.001).

The RheuMetric checklist was completed in 10 to 15 seconds by the treating rheumatologists. DOCGL RheuMetric estimates were highest for FM, followed by OA, RA, and SLE, a pattern similar to patient MDHAQ scores, including PATGL (Table 2). However, mean PATGL (Table 1) was 1.0 to 2.6 units higher than DOCGL (Table 2), reflecting discordance of DOCGL and PATGL in many rheumatic diseases. (14-20)

DOCINF estimates were 2.4 in patients with RA followed by 1.4 in SLE, 1.0 in OA, and 0.8 in FM (p < 0.001) (Table 2). DOCDAM estimates were 4.4 in OA compared to 2.6 in RA, 1.8 in SLE, and 1.9 in fibromyalgia (p < 0.001). DOCSTR estimates were 5.4 in FM versus 2.1 in OA, 1.1 in SLE, and 0.6 in RA (p < 0.001) (Table 2).

Differences between DOCDAM in OA and other diseases were at least 1.8, and differences between DOCDAM in OA and other RheuMetric estimates were at least 2.2. Differences between DOCSTR in FM and other diseases were at least 3.2, and differences between DOCSTR in FM and other RheuMetric estimates were at least 3.5. By contrast, estimates for the three scales ranged over 2 units in RA and 0.7 units in SLE. DOCDAM estimates were somewhat higher than DOCINF estimates in RA (2.6 versus 2.4) and SLE (1.8 versus 1.4) (Table 2). These data suggest that damage may be as important a clinical problem as inflammation in contemporary management of RA and SLE; furthermore, all three constructs, inflammation, damage, and distress are clinically important in SLE.

DOCGL was correlated significantly with PATGL in RA, OA, and SLE, but not in FM (Table 3). Correlations of overall DOCGL with RheuMetric subscales indicated significant correlations greater than 0.5 for DOCINF with RA and SLE, DOCDAM with OA and SLE, and DOCSTR only with FM (all p < 0.001) (Table 3).

Discussion

These data extend previous reports that physician estimates of inflammation, damage, and distress can be assessed quantitatively in routine care using a physician RheuMetric checklist. (6-7) The scale was previously termed "RHEUMDOC" (7); however, an electronic medical record termed RHEUMDOC is currently being marketed, and it seemed most pragmatic to change the name of the scale. Furthermore, in previous versions, the final subscale for distress "DOCSTR" was termed "DOCNON" to indicate symptoms and signs explained by neither inflammation nor damage. (6,7)

As in previous reports of databases from Tennessee (6) and Pennsylvania, (7) data reported here from Rush University Medical Center in Illinois indicate that most patient MDHAQ scores for all variables were higher in FM than in other diagnoses, and physician RheuMetric estimates were highest for DOCINF in RA and SLE, for DOCDAM in OA, and for DOCSTR in FM (Table 2). Differences between DOCDAM in OA and DOCSTR in fibromyalgia were more pronounced than differences between DOCINF, DOCDAM and DOCSTR in RA and SLE. The data suggest that damage and distress may complicate management of RA and SLE.

Physician global estimates were about 1 unit lower than patient global estimates in RA, SLE, and OA, but differed by 2.2 units in FM (Tables 2 and 3), findings that reflect discordance of physician and patient global estimates in many rheumatic diseases. (14-20) The greater discordance seen in FM is consistent with the absence of significant correlations between patient and physician global estimates in FM, in contrast to significant correlations in RA, SLE, and OA (Table 3). Although a diagnosis of FM generally is easily made on the basis of a patient history and physical examination in most patients. Simple patient and physician questionnaires may provide useful clues to recognize FM, (21,22) particularly secondary FM, which may be difficult in some patients. Fibromyalgia is seen in 20% to 40% of patients with RA (23-25) and SLE (23,26) and may complicate management of all rheumatic diseases.

It may appear ironic that a physician checklist helps to clarify a patient self-report questionnaire. Checklists have long been used by pilots and more recently by surgeons to improve quality and safety. (27) The possible value in rheumatic diseases of quantitative patient MDHAQ scores and physician RheuMetric checklists with estimates of inflammation, damage, and distress is consistent with data that the patient history and physical examination are far more important to guide clinical decisions in treatment of RA than in seven other chronic diseases. (28) A self-report questionnaire may be regarded as providing quantitative data from a patient history, and a RheuMetric checklist as providing quantitative data from a physical examination and overall impressions of a physician, to supplement narrative descriptions.

Quantitative physical examination data have traditionally been collected in RA as a formal tender and swollen joint count. However, while formal joint counts are performed in all clinical trials, they are not performed at most rheumatology encounters. (29,30) Furthermore, a formal joint count for tender and swollen joints does not recognize damage or distress, which may be important considerations in patient management. For example, joint damage and fibromyalgia appear to explain in part some limitations to "treat-to-target" in RA, (31) as intensification of therapy in some patients with high to moderate RA index scores may not be appropriate on the basis of damage or distress. (32,33) In addition, estimation of inflammation (or damage and distress) in other rheumatic diseases cannot be accomplished according to a formal joint count.

Several limitations are seen in this report. First, the data were collected from only one setting; however, results indicating highest scores for DOCINF in RA, DOCDAM in OA, and DOCSTR in fibromyalgia are similar to those from two previous settings. (6,7) Second, data concerning test-retest reliability of RheuMetric are not yet available but under study. Third, face validity is not yet documented, e.g., comparisons of DOCINF with swollen joint counts in RA, DOCDAM with radiographic damage in OA, and DOCSTR with fibromyalgia tender points. At the same time, the recorded estimates form the basis of clinical decisions by physicians in busy clinical care. Some quantitative documentation of these constructs might be preferable to only narrative descriptions without any quantitative data, as is the case in most settings at this time. (34)

The expertise of a rheumatologist is not only to recognize the severity of symptoms and signs but also to interpret whether symptoms and signs are explained by inflammation, damage, or distress, or two or three of these components. Recording this information quantitatively may help clarify clinical decisions to doctors, patients, and payers. Our findings suggest that many patients have clinically important levels of both inflammation and damage or distress, and some patients may have inflammation, damage, and distress, indicating the complexity of management of many patients seen in rheumatology care.

Conclusion

Documentation of physician estimates of inflammation, damage, and distress on a RheuMetric checklist may be useful to recognize some of the challenges presented by many patients with rheumatic diseases and to help clarify and support clinical decisions to meet these challenges.

Isabel Castrejon, M.D., Ph.D., Joel A. Block, M.D., Sarah L. Everakes, M.D., Ruchi Jain, M.D., and Theodore Pincus, M.D., Division of Rheumatology, Rush University Medical Center, Chicago, Illinois. Kathryn A. Gibson, M.D., Ph.D., Department of Rheumatology, Liverpool Hospital, Liverpool, Australia.

Correspondence: Theodore Pincus, M.D., Division of Rheumatology, Rush University Medical Center, 1611 West Harrison Street, Suite 510, Chicago, IL 60612; tedpincus@gmail.com.

Disclosure Statement

Theodore Pincus, M.D., is president of Health Report Services, Inc. which owns a copyright and trademark for MDHAQ/RAPID3. No license is needed for clinicians and non-profit researchers, who may freely use paper copies of MDHAQ/RAPID3 to monitor patient status in usual clinical care and academic research. Royalties and license fees are received from for-profit organizations, including pharmaceutical companies and electronic medical record companies, for use of MDHAQ/RAPID3; all license fees are used to support further development of quantitative measurement in clinical rheumatology care.

References

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Caption: Figure 1 RheuMetric checklist for four physician estimates of overall global status (DOCGL), inflammation (DOCINF), damage (DOCDAM), and Distress (DOCSTR).

Caption: Figure 2 Page 1 of multi-dimensional health assessment questionnaire (MDHAQ), a two-page patient self-report questionnaire.

Figure 2 Page 2 of multi-dimensional health assessment questionnaire (MDHAQ), a two-page patient self-report questionnaire.

Table 1 Mean MDHAQ Patient Scores in
Patients with Four Rheumatic Diseases

Variable (range)    All (205)     RA (50)      SLE (66)

Physical Function   2.5 (1.9)    2.4 (2.0)    1.8 (1.7)
  (0 to 10)
Pain (0 to 10)      5.7 (3.0)    5.1 (3.1)    4.3 (3.2)
Patient Global      5.0 (3.0)    4.5 (3.2)    4.0 (3.0)
  Estimate
  (0 to 10)
RAPID3 (0 to 30)    13.0 (7.2)   11.4 (7.4)   9.9 (7.3)

Fatigue (0 to 10)   5.0 (3.0)    4.6 (3.2)    4.4 (3.1)
Number of           11.1 (8.5)   8.1 (8.5)    10.4 (8.2)
  Symptoms
  (0 to 60)

Variable (range)      OA (67)             FM (32)            P-value

Physical Function    2.9 (1.9)          3.6 (1.9) *         p = 0.001
  (0 to 10)
Pain (0 to 10)      6.8 (2.2) *         7.6 (1.7)t          p < 0.001
Patient Global       5.4 (2.8)              7.1             p < 0.001
  Estimate                           (1.9) ([dagger])
  (0 to 10)
RAPID3 (0 to 30)    15.1 (5.8)             18.2             p < 0.001
                                     (4.4) ([dagger])
Fatigue (0 to 10)    5.2 (3.0)          6.7 (1.8) *         p = 0.007
Number of           11.1 (7.1)             17.9             p < 0.001
  Symptoms                        (8.2) ([double dagger])
  (0 to 60)

Numbers are mean (standard deviation); * p < 0.05 ([dagger]) p < 0.01
([double dagger]) p < 0.001 (p-values using RA as reference group).

Table 2 Mean RheuMetric Physician Estimates in Four
Rheumatic Diseases

Variable (range)    All (205)    RA (50)     SLE (66)

Patient Global      3.9 (2.1)   3.9 (2.2)    2.9 (2.1)
Estimate (PATGL)
(0 to 10)

Inflammation        1.5 (1.8)   2.4 (2.4)   1.4 (1.6) *
(DOCINF)
(0 to 10)

Damage (DOCDAM)     2.8 (2.1)   2.6 (2.2)    1.8 (1.8)
(0 to 10)

Distress (DOCSTR)   2.1 (3.0)   0.6 (1.9)    1.1 (2.3)
(0 to 10)

Variable (range)      OA (67)      FM (32)      P-value

Patient Global       4.5 (1.6)    4.9 (1.8)    p < 0.001
Estimate (PATGL)
(0 to 10)

Inflammation         1.0 (1.5)    0.8 (1.2)    p = 0.001
(DOCINF)            ([dagger])    ([dagger])
(0 to 10)

Damage (DOCDAM)      4.4 (1.6)    1.9 (1.8)    p < 0.001
(0 to 10)            ([double
                     dagger])

Distress (DOCSTR)   2.1 (3.1) *   5.4 (2.2)    p < 0.001
(0 to 10)                          ([double
                                   dagger])

Numbers are mean (standard deviation); * p < 0.05
([dagger]) p < 0.01 ([double dagger]) p < 0.001 (p-values
using RA as reference group).

Table 3 Correlations of Physician Global Estimates
(DOCGL) with Subscales and Patient Global Estimates
(PATGL)

Variable (range)          All (205)        RA (50)

Inflammation (DOCINF)   0.42 ([double   0.73 ([double
                          dagger])        dagger])
Damage (DOCDAM)         0.57 ([double      0.38 *
                          dagger])
Distress (DOCSTR)       0.43 ([double       0.27
                          dagger])
Patient Global          0.64 ([double   0.67 ([double
  Estimate (PATGL)        dagger])        dagger])

Variable (range)           SLE (66)          OA (67)

Inflammation (DOCINF)    0.69 ([double        -0.02
                           dagger])
Damage (DOCDAM)          0.70 ([double    0.71 ([double
                           dagger])         dagger])
Distress (DOCSTR)           0.40 *           0.43 *

Patient Global          0.41 ([dagger])   0.57 ([double
  Estimate (PATGL)                          dagger])

Variable (range)        FM (32)        P-value

Inflammation (DOCINF)    -0.05    p = 0.42 ([double
                                      dagger])
Damage (DOCDAM)          0.09     p = 0.57 ([double
                                      dagger])
Distress (DOCSTR)       0.65 *    p = 0.43 ([double
                                      dagger])
Patient Global           0.19     p = 0.64 ([double
  Estimate (PATGL)                    dagger])

* p < 0.05 ([dagger]) p < 0.01 ([double dagger]) p < 0.001.


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Title Annotation:RheuMetric
Author:Castrejon, Isabel; Gibson, Kathryn A.; Block, Joel A.; Everakes, Sarah L.; Jain, Ruchi; Pincus, Theo
Publication:Bulletin of the NYU Hospital for Joint Diseases
Article Type:Report
Date:Jul 1, 2015
Words:3901
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