MDHAQ/RAPID3 scores: quantitative patient history data in a standardized "scientific" format for optimal assessment of patient status and quality of care in rheumatic diseases.
|Abstract:||Quantitative measurement according to a laboratory test such as hemoglobin A1c or creatinine provides a "gold standard" for care of every individual with a specific diagnosis. By contrast, no single "gold standard" quantitative measure is available in rheumatic diseases. Laboratory tests are limited, and clinical decisions are based more on patient history and physical examination than laboratory tests. A quantitative patient history is provided by a self-report questionnaire as standardized, "scientific" data to compare from one visit to the next. Patient questionnaires for usual clinical care emphasize feasibility, acceptability to patients and physicians, and clinical utility, which are not considered in research questionnaires. Development of a multidimensional health assessment questionnaire (MDHAQ) over 27 years is seen as a continuous quality improvement (CQI) rather than research activity, to account for all rather than a few selected patients for a research study. Both the traditional HAQ and MDHAQ are 2-page questionnaires, easily completed by patients in 5 to 10 minutes, although scoring a HAQ disability index (HAQ-DI) requires 42 seconds, compared to 5 seconds for an MDHAQ/RAPID3. The MDHAQ includes, within 2pages: complex activities, psychological queries, visual analog scales (VAS) as 21 numbered circles rather than 10-cm lines, a fatigue VAS, RADAI (rheumatoid arthritis disease activity index) self-report joint count, traditional "medical" review of systems and recent medical history, and demographic data, as well as a data management system that incorporates medication data and laboratory tests, reports for physicians and patients, and flow sheets to compare a current visit with a previous visit.|
|Article Type:||Disease/Disorder overview|
(Care and treatment)
Medical care (Quality management)
Systemic lupus erythematosus
|Publication:||Name: Bulletin of the NYU Hospital for Joint Diseases Publisher: J. Michael Ryan Publishing Co. Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 J. Michael Ryan Publishing Co. ISSN: 1936-9719|
|Issue:||Date: July, 2011 Source Volume: 69 Source Issue: 3|
Quantitative measurement, generally a laboratory test, provides the
primary information for diagnosis, assessment of patient status,
management decisions, and estimation of the quality of care in many
chronic diseases. Laboratory tests are performed according to a
standardized scientific protocol. A "gold standard" laboratory
test such as hematocrit, hemoglobin A1c, or creatinine can be applied to
every individual with a specific diagnosis in formulating clinical
decisions. Therefore, most patients, physicians, and payers view
laboratory tests as providing the most important information in medical
The prominence of laboratory tests has led to a decline of interest in the traditional patient history in diagnosis and management of many diseases, although several reports suggest that a patient history may provide most of the information for diagnosis in most patients. (1-4) Nonetheless, a patient history generally continues to be recorded a "subjective," non-quantitative, "gestalt" narrative description of clinical impressions. By contrast, laboratory tests are described as "objective," quantitative, prominent data.
Quantitative patient history data can be collected as standardized "scientific" data using a patient self-report questionnaire, which in rheumatology is focused on physical function, pain, fatigue, patient estimate of global status, and symptoms in specific joints. (5-10) Standardized patient questionnaire measures, rather than laboratory tests or radiographs, are the most significant quantitative predictors of severe outcomes of rheumatoid arthritis (RA), including work disability (11-13) and mortality. (14,15) Scores for physical function predict mortality in the general population at levels similar to smoking and hypertension. (16) Patient questionnaire measures are as efficient as joint counts, laboratory tests or radiographs to distinguish active from control treatments in RA clinical trials. (17,18) Patient questionnaires provide documentation of patient status at each encounter, prepare the patient for a visit with the doctor, and save time for both doctor and patient. (19)
Despite the documented value of patient questionnaires in rheumatic diseases, most visits to most rheumatologists at this time continue not to include quantitative self-report questionnaire scores. Indeed, the only quantitative data in the medical records of most patients seen by rheumatologists usually are laboratory tests, which have many limitations for clinical decisions. (20) This essay updates previous essays (19,21,22) concerning approaches to use of a self-report multidimensional health assessment questionnaire (MHDAQ) and routine assessment of patient index data (RAPID3) in the infrastructure of all usual rheumatology care.
Rationale for the MDHAQ: Quantitative Measurement in Rheumatic Diseases Compared to Other Chronic Diseases
Quantitative measurement in rheumatic diseases is characterized by three important differences from many chronic diseases:
1. Laboratory tests have substantial limitations for assessment and monitoring in rheumatic diseases. For example, at presentation, only 70% of patients with RA have a positive test for rheumatoid factor or anti-citrullinated protein antibodies (ACPA), (23) and only 60% have an abnormal erythrocyte sedimentation rate or C-reactive protein (CRP). (24) Although laboratory science has led to major advances such as the discovery of rheumatoid factor (25) and DNA antibodies, (26-28) laboratory tests remain limited for usual outpatient clinical care
2. The diagnosis and management of RA, and most rheumatic diseases, depends primarily on a patient history and physical examination rather than a laboratory test. The absence of quantitative, standardized medical history data limits assessment, monitoring, recognition of quality of care, and possibly patient outcomes.
3. A single "gold standard" measure (such as hematocrit, hemoglobin A1c, or creatinine) is not available in rheumatic diseases, whether from a patient history, physical examination, laboratory test, or ancillary studies. Therefore, pooled indices, (29) which generally include quantitative information from a patient history and physical examination as well as laboratory tests, are required for comparison of patient status from one visit to another.
Quantitative Measurement in Clinical Research Versus Clinical Care of Patients with Rheumatic Diseases
Quantitative measurement in rheumatic diseases differs in clinical research versus clinical care. Development of quantitative measurement for patients with rheumatic diseases has been largely a research activity, similar to laboratory research, with support for research to develop new questionnaires and indices. A rheumatologist advances her or his career far more from grant support and publications for developing a new questionnaire than from implementing an available questionnaire to improve the quality of care.
The view of a questionnaire as a research activity, rather than as a clinical tool, generally has resulted in long questionnaires and complex indices. Research questionnaires are focused on validity (does it measure what it says it measures?) and reliability (is it reproducible?). Little attention is directed to feasibility, acceptability to patients and physicians, and utility in busy clinical settings to improve clinical decisions. Indeed, protocols of most clinical trials and many clinical research projects direct the investigator to avoid review the data collected from the patient. In this view, quantitative measurement appears to add a burden to the patient and clinician, without apparent benefits for patient care.
Many extensively-characterized pooled indices (29) have been developed in many rheumatic diseases, including rheumatoid arthritis (RA), (30-34) psoriatic arthritis, (35,36) systemic lupus erythematosus (SLE), (37-43) ankylosing spondylitis, (44-49) vasculitis, (50-54) osteoarthritis, (55) fibromyalgia, (56) pain, (57-60) fatigue, (61-63) and others. These quantitative measures and indices are used widely in clinical trials and other clinical research but are too complex for usual clinical care. Therefore, extensive advances in measurement in clinical rheumatology (beyond laboratory tests) remain restricted to 1% to 5% of patients who participate in research studies but are not available to the majority of patients.
All measures include measurement error, and more feasible measures may involve larger measurement error. However, a balance of feasibility versus minimal error for usual clinical care appears reasonable. An elaborate measure with low measurement error that is rarely if ever performed hardly seems as desirable to improve clinical outcomes and quality of care as a less stringent but more feasible measure.
A theme of the activities of the senior author (TP) has involved measurement in usual clinical care. Early research involved a radioimmunoassay for anti-DNA antibodies to facilitate capacity for a diagnosis of SLE in the community, rather than as a "research test" performed only at specialized centers in 1968. (64-66) A reduced 28-joint count, based on a traditional 66- to 68-joint count, is far more easily completed in a usual clinical setting and gives information comparable to the more elaborate joint count. (67-69) Disadvantages of a 28-joint count compared to a 66- to 68-joint count have been described, (70) but problems are seen only in a small fraction of patients.
Development of the MDHAQ for Usual Care as a Clinical Tool for Continuous Quality Improvement, Rather than a Research Agenda
Development of patient questionnaires by the senior author (TP) has been based on the health assessment questionnaire (HAQ), (5) which was introduced in 1980. A modified version (MHAQ) was reported in 1983, (7) toward a multidimensional health assessment questionnaire (MDHAQ) in 19999 and 2005. (10) The initial requirement was that the questionnaire be no longer than two sides of a single page for completion by the patient. A second page (reverse side of an 11 x 17 inch single sheet of paper) was added to obtain additional medical history information through self-report. This allows a report of illnesses, surgeries, hospitalizations, allergies, family history, and medications completed by the patient, without any effort on the part of the doctor or other health professional, although the data obviously must be reviewed by the health professional.
Development of the MDHAQ is viewed primarily as a continuous quality improvement (CQI) activity to improve the quality of patient care, rather than as a research activity, although the MDHAQ provides excellent research data. (71-73) CQI is directed to advance the efficiency and safety of complex processes, historically used in many industries but applied only recently in medical activities. (74,75) Some differences between CQI and traditional medical research, including the randomized controlled clinical trial, as well as practice guidelines, are summarized in Table 1.
Traditional medical research involves "reductionism" to isolate a single variable, such as a bacterium or toxin, determine the effects of this variable, with report of conclusions that are regarded as valid unless supplanted by new information. A clinical trial is designed to mimic laboratory research, again isolating a single test variable, a therapy, keeping all other variables constant through randomization, with results depicting the efficacy (or lack of efficacy) of the therapy. Development of practice guidelines introduces a modification of this procedure, with an effort to develop a consensus of experts based on "evidence" in the medical literature, with a major emphasis on data from clinical trials, regarded as "best evidence"--and expert opinion when "best evidence" is not available. The result is regarded as applicable to medical care until supplanted by new guidelines.
[FIGURE 1 OMITTED]
In contrast to traditional research and clinical trials, CQI seeks to account for all patients rather than a few selected patients, and to implement findings in actual care. CQI may recognize that most individual patients with rheumatic diseases may be treated in many different ways that are equally valid and supported by "evidence." For example, the choice of a biologic agent for a patient with RA, or the frequency of laboratory monitoring of methotrexate therapy in an individual patient, may differ widely on the basis of available "evidence."
Quantitative monitoring of each patient with any rheumatic disease at each visit led to a CQI rather than a traditional research agenda, including 20 CQI cycles over a 27-year period (Fig. 1), as reviewed in previous reports. (71-73) The MDHAQ is a quality improvement, rather than a research, instrument, although much research data may emerge from its collection.
Structure of the MDHAQ: Comparison with the Traditional HAQ
Both the HAQ and MDHAQ (Table 2) are 2-page questionnaires (both sides of a single sheet of paper), which are easily distributed to patients by receptionists when the patients arrive for a visit, the simplest method for distributing questionnaires. Both can be completed by a patient in 5 to 10 minutes, and both have templates for a quantitative score. However, a HAQ score for a disability index (HAQDI) requires 42 seconds, while a RAPID3 score on the MDHAQ requires 5 seconds. (76) A data management system is available for the MDHAQ, incorporating medication data and laboratory tests, with reports for physicians and patients, as well as flow sheets to compare a current visit with a previous visit.
The HAQ includes 20 activities grouped into 8 categories of 2 or 3 activities each--dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities--on a 0-3 scale (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The total score is the mean of the highest score for each of the 8 categories. Queries are included concerning "help from another person" and "use of aids and devices"--positive responses result in raising the score for a category by 1 unit.
The MDHAQ includes 10 activities, 8 from the HAQ (also reported on the MHAQ) performed by each person each day. The 8 items chosen for the MHAQ were activities that all individuals would perform each day (NB, "shampoo your hair" and "run errands" were dropped). At the same time, these simpler activities led to systematically lower scores than a HAQ, by about 0.3 units on a 0 to 3 scale, or 10%. These considerations, as well as the improving status of patients with rheumatic diseases, led in the mid-1990s to inclusion of additional complex activities into what is now known as a multidimensional HAQ (MDHAQ) (Fig. 2). (9,10)
The MDHAQ includes 10 activities, 8 from the HAQ and MHAQ, and 2 additional complex activities: "Are you able to walk two miles or three kilometers?" and "Are you able to participate in recreational activities and sports as you would like?" These activities were added in the 1990s, when it became apparent that patients could have normal physical function (FN) scores on a HAQ or MHAQ as a result of early treatment with methotrexate, low-dose prednisone, and other disease-modifying anti-rheumatic drugs (DMARDs), but nonetheless feel limited in their physical function. (9) Scoring templates are available for physical function, to convert the sum of ten 0 to 3 scores (range 0 to 30) to a 0 to 10 physical function (FN) score through division by 3. No queries concerning "help" or "aids and devices" are included, so the score is not modified from the 10 activities
2. Psychological Queries in HAQ Format
Three queries were introduced into the MDHAQ concerning sleep, anxiety and depression in the patient-friendly HAQ format. These items were initially scored 0, 1.1, 2.2 and 3.3--rather than 0, 1, 2 or 3--so that the highest possible total would be 9.9, giving a virtual 0 to 10 scale. However, formal scoring of this scale generally is not done. Nonetheless, the data are quite useful. Scores for sleep, anxiety, and depression are higher than for any of the 8 queries of the original HAQ or MHAQ, indicating that these are greater problems to patients at this time than simple activities of daily living.
[FIGURE 2 OMITTED]
[FIGURE 3 OMITTED]
3. Visual Analog Scales (VAS)
Two visual analog scales (VAS) scored 0 to 10 for pain (PAIN) and patient global estimate of status (PATGL) are found on the HAQ and MDHAQ. The VAS on the MDHAQ are in 21-circle format, rather than 10 cm lines as on the HAQ. (77) This format was introduced so that a ruler is not needed for scoring; boxes are available to enter scores for individual measures. The MDHAQ also includes a 0 to 10 VAS for fatigue, not found on the HAQ.
[FIGURE 4 OMITTED]
4. RAPID3 Scoring Template
A box is available for a RAPID3 score, as a simple total of FN, PAIN, and PATGL (each scored 0 to 10, for a total 0 to 30 score), in the "For Office Use Only" sections on the MDHAQ.
5. Self-report Joint Count
A rheumatoid arthritis disease activity index (RADAI) (8) self-report joint count (PATJT) is positioned on the MDHAQ between two 0 to 10 visual VAS for pain and global status in order to reduce the likelihood of patients giving the same answer on both VAS. Earlier reports indicated scoring the RADAI self-report joint count on a 0 to 3 scale, but the data are regarded as useful to describe status without quantitative scores.
6. Traditional Medical Information
The HAQ does not include any traditional medical information, which is found on the MDHAQ. Two particular features include a Review of Systems and recent medical history (see Fig. 2), which includes 12 queries concerning recent surgeries, illnesses, hospitalization, pain, smoking, possible changes in medications, adverse effects of medications, and possible changes in marital status, residence, employment, primary care physician, insurance, etc. A series of "no" responses saves a physician at least 2 to 5 minutes, whereas a "yes" response indicates a matter that should be covered at the visit.
7. Demographic Data
Demographic data include date of birth, gender, level of formal education, occupation, and work status (see Fig. 2).
8. New Patient Format--Complete (Lifetime) Medical History Information
The 4-page MDHAQ also includes a more complete past medical history of all illnesses, surgeries, hospitalizations, and medications, as well as family history, which allows a preparation of a report in a familiar medical-record-note style (Fig. 3). Furthermore, a report is available to patients (Fig. 4) that allows correction and updating of this information at each visit.
The most efficient strategy for collection of an MDHAQ in standard clinical care is to distribute the questionnaire to each patient with any diagnosis (78) upon registration at the clinical setting. (19) Any selective strategy generally involves much extra time, particularly if a patient completes a questionnaire in the examination rather than waiting room. Completion of the questionnaire by the patient in the waiting area helps prepare the patient for the visit and saves time for both doctor and patient. Scoring of RAPID3 is simple, (79) and should be performed before seeing the patient and compared to previous visits on flow sheets, (80) using the MDHAQ data management system.
Theodore Pincus, M.D., receives royalties from profit-making companies for use of the MDHAQ, all of which support clinical research. Isabel Castrejon, M.D., has no financial or proprietary interest in the subject matter or materials discussed, including, but not limited to, employment, consultancies, stock ownership, honoraria, and paid expert testimony.
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Theodore Pincus, M.D., and Isabel Castrejon, M.D., are from the Division of Rheumatology, Department of Medicine, New York University School of Medicine and NYU Hospital for Joint Diseases, New York, New York.
Correspondence: Theodore Pincus, M.D., Division of Rheumatology, Room 1608, NYU Hospital for Joint Diseases, 301 East 17th Street, New York, New York 10003; Theodore. Pincus@nyumc.org
This work has been supported in part by the Arthritis Foundation, the Jack C. Massey Foundation, and Bristol-Myers Squibb.
Table 1 Comparison of Methodologies of Traditional Medical Research Methods Traditional research Feature of Method methodology Clinical trials Approach to problem "Reductionist" "Reductionist" approach--isolate a approach--isolate single variable therapy from other variables through randomization Result of process Published report Published report based on evidence to regarding efficacy or support a conclusion lack of efficacy of regarded as a valid test therapy until new reports may supplant this conclusion Patients included None or very limited Limited number number based on power calculations, inclusion and exclusion criteria Underlying assumption A scientific "truth" Definitive data is established by available from trial laboratory experiment results or other systematic methodology Responsibility of None None author of report to implement results Level of physician High High comfort to approach Methods Development of Continuous quality Feature of Method practice guidelines improvement Approach to problem "Delphic" approach to Include "real world" consensus based on conditions--no effort evidence and expert to isolate variables opinion Result of process Published guidelines, New strategies based regarded as on ongoing evaluation applicable to all regarded as amenable patients with a to continuous particular diagnosis, improvement through regarded as valid "plan-do-study-act" until new guidelines cycles are developed Patients included Limited number All patients included included in published "evidence" Underlying assumption It is possible to The world is develop a series of imperfect, and all guidelines based on strategies are available evidence subject to doubt and and expert opinion to continuous effort to improve medical care improve them based on actual observations Responsibility of Some Required author of report to implement results Level of physician Moderate Low comfort to approach Table 2 Comparison of Original Health Assessment Questionnaire (HAQ) (5) with Multidimensional Health Assessment Questionnaire (MDHAQ) (9,10) HAQ 2-page MDHAQ Features First report 1980 1999 Patient completion 5-10 minutes 5-10 minutes Scoring templates Yes Yes Data management system--medical notes, No Yes flow sheets Content 1. Activity Queries Yes Yes * Total number of activities 20 10 * Complex activities None 2/10-walk 2 miles or 3 km, recreation and sports * Scoring scale for each activity 0-3 0-3 * Includes "aids and devices or help Yes No from another person" (adds 1 point to category score) 2. Psychological Queries in HAQ Format No Sleep, Anxiety, Depression 3. Visual Analog Scales (VAS) 10-cm line 21 numbered circles * Pain Yes Yes * Patient global estimate of status Yes Yes * Fatigue No Yes (on page 2) 4. RAPID3 Scoring Template No Yes * scoring time * 42 seconds * 5 seconds 5. RADAI Self-Report Joint Count No Yes 6. Traditional Medical Information * Review of Systems No Yes * Recent medical history No Yes (previous 6 months) 7. Demographic Data No Yes 8. New Patient-Complete (Lifetime) No Yes, in Medical History Information 4-page MDHAQ (New Patient version) 10-15 minutes * Patient completion N/A Yes * All Illnesses, surgeries, No hospitalizations, allergies, drug allergies, family history, medications * Report of medical history for No Yes physicians in standard medical note format, to incorporate into evaluation note * Report of medical history for No Yes patients to update and correct for further notes
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