Journal List > J Rheum Dis > v.23(4) > 1064268

Pincus, Chua, and Gibson: Evidence from a Multidimensional Health Assessment Questionnaire (MDHAQ) of the Value of a Biopsychosocial Model to Complement a Traditional Biomedical Model in Care of Patients with Rheumatoid Arthritis

Abstract

Patient self-report questionnaires such as a multidimensional health assessment questionnaire (MDHAQ) have advanced knowledge concerning prognosis, care, course and outcomes of rheumatoid arthritis (RA). The MDHAQ may overcome some limitations of a “biomedical model,” the dominant paradigm of contemporary medical services, including limitations of laboratory tests, radiographs, joint counts, and clinical trials, to predict and depict the long-term course and outcomes of RA. A complementary “biopsychosocial model” captures components of a patient medical history on patient questionnaires as quantitative, standard, “scientific” scores for physical function, pain, fatigue, and other problems, rather than as “subjective” narrative descriptions. A rationale for a biopsychosocial model in RA includes the importance of a patient history in diagnosis and management compared to biomarkers in many chronic diseases such as hypertension and diabetes. Some important observations which support a biopsychosocial model in RA based on patient questionnaires include that MDHAQ physical function scores are far more significant than radiographs or laboratory tests to predict severe RA outcomes such as work disability and premature death; patient self-report measures are more efficient than tender joint counts and laboratory tests to distinguish active from control treatments in RA clinical trials involving biological agents; and MDHAQ scores are more likely than laboratory tests to be abnormal at presentation and to document incomplete responses to methotrexate at initiation of biological agents. Patient questionnaires can save time for doctors and patients, and improve doctor-patient communication. A standardized database of MDHAQ scores consecutive patients over long periods might be considered by all rheumatologists in routine clinical care.

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Figure 1.
Standard composite treatment effect (in standard units). Meta-analysis of 66 clinical trials reported in 1990 concerning the efficacy of DMARDs in the treatment of RA [91]. This meta-analysis included 117 treatment groups: 11 for anti-malarial drugs (e.g., hydroxychloroquine), 23 for auranofin, 29 for injectable gold, 7 for methotrexate, 19 for d-penicill-amine, 6 for sulfasalazine, and 22 for placebo. All drugs have greater efficacy than placebo in the management of RA, determined according to a composite of grip strength (a measure of effectiveness of grip), TJC, and ESR, adjusted for disease duration, trial length, initial tender joint count, and blinding. In these analyses, no significant differences were seen between sulfasalazine, d-penicillamine, methotrexate, and injectable gold (From Felson et al. The comparative efficacy and toxicity of second-line drugs in rheumatoid arthritis. Results of two metaanalyses. Arthritis Rheum 1990;33:1449-61; with per-mission) [63]. DMARDs: disease-modifying anti-rheumatic drugs, RA: rheumatoid arthritis, TJC: tender joint count, AUR: auranofin, AntiM: antimalarial drug, AZA: azathioprine, MTX: methotrexate, DPen: d-penicillamine, SSZ: sulfasalazine, ESR: erythrocyte sedimentation rate.
jrd-23-212f1.tif
Figure 2.
(A) Estimated continuation of all 1,083 courses of second line therapies in 532 patients with rheumatoid arthritis over 60 months. Differences between methotrexate and all other drugs, as well as between oral gold (auranofin) and all other drugs, are statistically significant (p<0.001), while differences among other drugs are not significant. (B) Estimated continuation of 477 courses of the initial second line therapy used in the same 532 patients over 12 months. Differences between methotrexate versus oral gold (auranofin) are not statistically significant, and are considerably less apparent than in (A), in which estimated continuation was studied for all courses over 60 months (Pincus et al. Longterm drug therapy for rheumatoid arthritis in seven rheumatology private practices: II. Second line drugs and prednisone. J Rheumatol 1992;19:1885-94) [64].
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Figure 3.
The multidimensional health assessment questionnaire (MDHAQ). (From Pincus et al. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol 2008;35:2136-47) [83].
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Figure 4.
Time to score various rheumatoid arthritis indices in seconds, including 28 joint count, health assessment questionnaire-disability index (HAQ-DI), disease activity score 28 (DAS28), clinical disease activity index (CDAI), routine assessment of patient index data (RAPID3) scores 0∼10, RAPID3 scored 0∼30 (Pincus et al. RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds. Arthritis Care Res (Hoboken) 2010;62:181-9) [60].
jrd-23-212f4.tif
Figure 5.
Nine to ten year survival according to quantitative markers in three chronic diseases, rheumatoid arthritis, Hodgkin's disease, coronary artery disease. Adapted from Figure 1 in the article of Pincus and Callahan (J Rheumatol 1986;13:841-5) [102].
jrd-23-212f5.tif
Figure 6.
Significance of 8 variables as predictors of mortality, in a review of 84 reports concerning mortality in rheumatoid arthritis, 53 cohorts presented predictors of mortality. For each variable, n=the number of reports that included the variable, and bars indicate the percentage of those reports in which the variable was a significant predictor of mortality in multivariate analyses (black), in univariate analyses (dotted), or not significant (white). ESR: erythrocyte sedimentation rate. Adapted from Figure 2 in the article of Sokka et al. (Clin Exp Rheumatol 2008;26(5 Suppl 51):S35-61) [100].
jrd-23-212f6.tif
Figure 7.
Relative efficiencies of 7 rheumatoid arthritis Core Data Set measures to distinguish active from control treatments in 9 clinical trials, involving methotrexate, leflunomide, placebo, infliximab, adalimumab, and abatacept according to arithmetic and percentage changes. TJC: tender joint count, SJC: swollen joint count, DOCGL: physician global assessment, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, HAQ-FN: health assessment questionnaire-function, PATGL: patient global estimate of status, MTX: methotrexate, PBO: placebo, LEF: leflunomide, INF: infliximab, ADA: adalimumab, ABA: abatacept. Adapted from Figure 3 in the article of Pincus et al. (Clin Exp Rheumatol 2014;32 Suppl 85(5):S-47-54) [55].
jrd-23-212f7.tif
Figure 8.
Spearman correlations of routine assessment of patient index data 3 (RAPID3) scores with (A, C) the disease activity score 28 (DAS28) and (B, D) clinical disease activity index (CDAI) in (A, B) the rheumatoid arthritis prevention of structural damage 1 (RAPID1) clinical trial of certolizumab pegol in 982 patients at 52 weeks and (C, D) in 285 patients with RA seen in usual clinical care. Adapted from (A, B) Figure 1 in the article of Pincus et al. (Arthritis Care Res (Hoboken) 2011;63:1142-9) [107] and (C, D) Figure 3 in the article of Pincus et al. (Bull NYU Hosp Jt Dis 2009;67:211-25) [90].
jrd-23-212f8.tif
Figure 9.
Improvement in routine assessment of patient index data 3 (RAPID3) scores over 2 months in patients with 5 rheumatic diseases, rheumatoid arthritis (RA), osteoarthritis (OA), systemic lupus erythematosus (SLE), spondyloarthritis (SpA), gout. CI: confidence interval. Adapted from Figure 1 in the article of Castrejón et al. (J Clin Rheumatol 2013;19:169-74) [116].
jrd-23-212f9.tif
Table 1.
Comparison of a “biomedical model” and a “biopsychosocial model” of disease
Variable Biomedical model Biopsychosocial model
Cause Each disease has a single “cause” Disease etiology is multifactorial: external pathogens, toxins, and internal host milieu, genes, behavior, social support
Diagnosis Identified primarily through laboratory tests, radiographs, scans; information from patients of value primarily (or only) to suggest appropriate tests A patient medical history provides 50%∼90% of the information needed to make many, perhaps most, diagnoses
Assessment of status and prognosis Also established most accurately on the basis of information from high technology sources, rather than from a patient Information provided by a patient often is the most valuable data to assess clinical status and establish a prognosis
Results of treatment Involves only actions of health professionals, e.g., medications, surgery Must involve patient, family, social structure
Role of health professionals and patients in general Health and disease outcomes are determined primarily by decisions and actions of health Health and outcomes of chronic diseases are determined as much by actions of individual
health and disease outcomes professionals patient as by health professionals
Table 2.
Some limitations of a biomedical model approach to rheumatoid arthritis
  • 1) Some limitations of laboratory tests in RA

    • a. Rheumatoid factor positive in 69% – negative in 31% of patients

    • b. ACPA positive in 67% – negative in 33% of patients

    • c. ESR and CRP normal in >40% of patients at presentation

    • d. 5% of normal people have positive test for rheumatoid factor or ACPA – more people who do not have RA are positive than RA patients

    • e. Laboratory tests not available at clinical visit in most settings

    • f. Patient questionnaire physical function scores more significant in prognosis of work disability and mortality

  • 2) Some limitations of radiographs in RA

    • a. Not as sensitive as ultrasound, MRI

    • b. Treatment should occur when normal – prior to damage

    • c. Quantitative scoring not feasible in routine clinical care

    • d. Patient questionnaire physical function scores more significant in prognosis of work disability and mortality

  • 3) Some limitations of joint counts in RA

    • a. Poorly reproducible – need for same observer at each visit, excluding other health professionals

    • b. Similar or lower relative efficiencies than global and patient measures to document differences between active and control treatments in clinical trials

    • c. Not as sensitive to detect inflammatory activity as ultrasound

    • d. Most visits to a rheumatologist include a careful joint examination, but do not include a formal joint count

  • 4) Limitations of clinical trials in RA (1) Pragmatic limitations

    • a. Relatively short time frame in chronic diseases – too short to identify important clinical benefits or possible loss of efficacy over time

    • b. Inclusion and exclusion criteria restrict eligibility to fewer than 10% of patients

    • c. Statistical significance may not be clinically significant and vice versa

    • d. Important variables affecting outcomes such as socioeconomic status usually ignored in reporting of clinical trial results

    • e. Inflexible dosage schedules and restriction of concomitant medications

    • f. Surrogate markers and indices may be suboptimal to detect changes in clinical status (2) Intrinsic limitations

    • g. Design can greatly influence results – availability of a control group does not eliminate bias

    • h. Data are reported in groups – ignore possible substantial variation in individual patients

    • i. Risk/benefit of a therapy interpreted differently by different patients – all may be “correct”

    • j. Loss of a “placebo effect” in a clinical trial

RA: rheumatoid arthritis, ACPA: anti-cyclic citrullinated peptide antibodies, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, MRI: magnetic resonance.

Table 3.
Comparison of HAQ and MDHAQ
Variable HAQ MDHAQ
First report 1980 1999
Patient completion 5∼10 minutes 5∼10 minutes
Number of activities of daily living 20 10
Pain VAS 10 cm line 21 circles
Patient global VAS 10 cm line 21 circles
Fatigue No 21 circles
Psychological variables: sleep, anxiety, depression No 3-HAQ format
Review of systems No 60 symptoms
Medical history No Yes
Demographic data No Yes
Social history No Yes
Scoring templates No Yes
MD scan (“eyeball”) 30 seconds 5 seconds
Time to score 41.8 seconds 4.5 seconds
Time to score index of 3 measures Not available 9.5 seconds

HAQ: health assessment questionnaire, MDHAQ: multidimensional health assessment questionnaire, VAS: visual analog scales, MD scan: Time for physician to scan questionnaire.

Table 4.
Value of patient questionnaire data to overcome limitations of biomedical model approach in prognosis and monitoring of RA
1. Physical function scores on MDHAQ and other questionnaires are far more significant than radiographs or laboratory tests in the prognosis of severe outcomes in RA, including work disability, costs, joint replacement surgery and premature death [33-35]
2. Formal education level, a surrogate for patient actions in disease, are as significant in the prognosis of mortality and more significant than age or duration of disease in RA status [101-105]
3. Individual patient self-report measures of physical function, pain, and patient global estimate of status, and RAPID3, are as efficient as joint counts, laboratory tests to distinguish active from control treatments in clinical trials [54,55,106]
4. Patient questionnaire scores, including RAPID3, are correlated significantly with DAS28 and CDAI in clinical trials [82,107-109] and clinical care [60,83]
5. MDHAQ scores are more reproducible than formal joint counts by physicians [16,51,52,110-113]
6. Patient questionnaire scores are more likely to be abnormal at baseline [8] and to document incomplete response to methotrexate and initiation of biological agent in RA than laboratory tests [114]
7. Remission criteria based on RAPID3 are similar to ACR/EULAR Boolean and SDAI remission criteria [115]
8. RAPID3 is effective to document change in clinical status in all rheumatic diseases [116]
9. Continuation of courses of DMARDs is more accurately described by observational data from clinical care than by data from clinical trials [64]
10. A survey of rheumatologists and non-rheumatologists, indicated that a medical history is far more prominent in diagnosis and management decisions in RA than laboratory tests or ancillary studies, in contrast to other chronic diseases [26]

RA: rheumatoid arthritis, MDHAQ: multidimensional health assessment questionnaire, RAPID3: routine assessment of patient index data 3, DAS: disease activity score, CDAI: clinical disease activity index, ACR: American College of Rheumatology, EULAR: European League Against Rheumatism, SDAI: simplified disease activity index, DMARDs: disease-modifying anti-rheumatic drugs.

Table 5.
Correlations and test-retest reliability of rheumatoid arthritis measures and indices at two time points
Measure/Index Spearman rho Interclass correlation coefficient
TJC28 0.76 0.83
SJC28 0.74 0.78
Physician global 0.69 0.79
Patient global 0.80 0.78
Function 0.98 0.96
Pain 0.83 0.88
ESR 0.84 0.95
CRP 0.71 0.97
DAS28 0.85 0.85
SDAI 0.87 0.88
CDAI 0.89 0.89
RAPID3 0.88 0.90
RADAI 0.89 0.92

TJC: tender joint count, SJC: swollen joint count, ESR erythrocyte sedimentation rate, CRP: C-reactive protein, DAS disease activity score, SDAI: simplified disease activity index CDAI: clinical disease activity index, RAPID3: routine assessment of patient index data 3, RADAI: rheumatoid arthritis disease activity index.

From the article of Uhlig et al. Test-retest reliability of disease activity core set measures and indices in rheumatoid arthritis Ann Rheum Dis 2009;68:972-5 [52].

Table 6.
Median levels of all patients for ESR, 3 (0∼10) MDHAQ scores for physical function, pain and patient global estimate and composite RAPID3 scores at initiation of methotrexate 1996∼2001 and mean of 2.6 years later in: A. 30 incomplete responders initiating biologic agent, B. 63 “control” adequate responders continuing methotrexate
Variable A. 30 incomplete responders B. 63 adequate responders (“controls”)
MTX start Biologic start MTX start Follow-up 6 2.6 years later (no biologic)
ESR (mm/hr) 28 18 24 16
MDHAQ-function (0∼10) 3.2 3.3 2.3 1.0
Pain (0∼10) 5.2 6.8 4.1 1.4
Patient global (0∼10) 5.5 5.5 4.2 0.9
RAPID3 (0∼30) 14.9 16.2 10.6 3.6

ESR: erythrocyte sedimentation rate, MDHAQ: multidimensional health assessment questionnaire, RAPID3: routine assessment of patient index data 3, MTX: methotrexate.

From the article of Pincus. RAPID3, an index of only 3 patient self-report core data set measures, but not ESR, recognizes incomplete responses to methotrexate in usual care of patients with rheumatoid arthritis. Bull Hosp Jt Dis 2013;71:117-20 [114].

Table 7.
Rheumatic diseases in which routine assessment of patient index data 3 (RAPID3) has been reported to be informative about patient status and/or change in status
Rheumatic disease Reference
Systemic lupus Askanase et al., 2011 [117]
erythematosus Castrejon et al., 2013 [116]
Osteoarthritis Castrejon et al., 2013 [116]
Ankylosing spondylitis Castrejon et al., 2013 [116]
  Danve et al., 2015 [118]
  Cinar et al., 2015 [119]
  Michelsen et al., 2015 [120]
  Park et al., 2015 [121]
Psoriatic arthritis Castrejon et al., 2013 [116]
Gout Castrejon et al., 2013 [116]
Vasculitis Annapureddy et al., 2015 [122]
Fibromyalgia Callahan et al., 1989 [104]
  DeWalt et al., 2004 [86]
  Pincus et al., 2009 [123]
Other Castrejon et al., 2013 [116]
  Pincus et al., 2009 [123]
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