Health status reports in the care of patients with rheumatoid arthritis

0895-4356/90 S3.00 + 0.00 Copyright 0 1990 Pcrgamon Pres8 pk

J CMnEpidah Vol. 43, No. 11, pp. 1243-1253, 1590 FVintcdin Great Britain. Al1 rights -Cd

HEALTH

STATUS REPORTS IN THE CARE OF PATIENTS ARTHRITIS* WITH RHEUMATOID

LEWIS

E. tiz&’

LRIGH F. CALLAHAN,’ ROBERT F. MEENAN’t

and

THEODORE PIN~US* ‘Arthritis Center, Boston University School of Medicine and Departments of Medicine, Boston City and University Hospitals, Boston, Massachusetts and *Division of Rhemtology and Immunology, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, U.S.A. (Received in revised forrn 18 December 1989; received for publication 26 April 1990)

Abstract-We examined the use of formal health status reports every 3 months over 1 year in the clinical care of patients with rheumatoid arthritis (RA). The reports consisted of single-page, computer-generated summaries of scores derived from either the AIMS (Arthritis Impact Measurement Scales) or the MHAQ (Modified Health Assessment Questionnaire) health status questionnaires. A total of 1920 subjects from 27 community practice sites were randomly assigned to three study groups in each practice: intervention, attention placebo and control. Results showed that 55% of the physicians found the reports to be at least moderately useful as an aid to patient management, primarily for improving the doctor-patient relationship. However, no detectable differences among the three groups were seen in terms of medication compliance, number of physician visits, number of referrals, frequency of major medication changes, attitudes towards the physician, patient satisfaction or change in health status over 1 year. The failme to demonstrate objective benefits of health status reports in this study may be due to physician unfamiliarity with health status scores, faihue to link the report with an office visit, the relative stability of clinical status in the subjects over 1 year and the relatively short time-frame of the study.

Health status reports Measurement Sales

Clinical practice Rheumatoid arthritis Health Assessment Questionnaire

INTRODUCTION

status measurement has received increasing attention in rheumatology during the past decade, and a number of new and revised

Health

*Supported by grants from the Robert Wood Johnson Foundation Program on Functional Status, NIH Multipurpose Arthritis Center Grant AR20613, NIH Grant AM-21393 (ARAMIS), the Arthritis Foundation and the Jack C. Massey Foundation. The conclusions put forth in this paper do not necessarily represent the views of the Robert Wood Johnson Foundation. tReprint mquests should be addressed to Dr Meenan, Multipurpose Arthritis Center, Boston University School of Medicine, 80 Rast Concord St, Boston, MA 02118, U.S.A.

Arthritis Impact

health status self-report questionnaires have been reported in the literature [ 11. Scores derived from these questionnaires are signifìcantly correlated with traditional physical, radiographic and laboratory data in patients with rheumatoid arthritis (RA) [2-4], and they are as effective as those measures in assessing differences in patient outcome in clinical trials [SI. Furthermore, health status scores have been documented to be as accurate as traditional clinical measures for describing and predicting health services utilization, work disability and morbidity and mortality in RA

W-81.

LEWISE. KAZISet

1244

While the value of health status questionnaires in clinical research has been amply demonstrated, their possible use in clinical practice remains far from clear [9]. There are a number of substantial barriers to the routine clinical use of health status questionnaires. Patient-derived data are generally regarded as “subjective” and “soft”, although patient selfreport provides data as reproducible as observer-derived data [lol. These measures are expressed in newly developed units that have not had a basis in traditional patient assessment. The questionnaires consist of multiple items that are then summed and expressed in units of measurement that may be difficult to relate to a specific clinical problem, and the clinician may have difficulty in interpreting these health status scores. The time needed to complete and score the questionnaires may also present difficulties for the practicing physician, and some physicians may fee1 that the use of a questionnaire may compromise effective doctor-patient communication. Nevertheless, health status measures have the potential for providing physicians with an informative summary of important patient data [ll]. PATIENT NAME: DATE: 07/20/1985 AIMS ID: 118

PHYSICIAN: ADMINISTRATION:

In this study, we attempted to document the value of health status information in the clinical care of individuals with RA. Forma1 health status reports containing information on multiple dimensions of health status were provided on a regular schedule over 1 year to rheumatologists regarding RA patients under their care. Subjects in this 1-year clinical trial were divided into three groups: a control group, an attention placebo group and a true intervention group, in which computer-generated health status reports were used as the intervention. The impacts of the intervention were measured in three ways: (a) physicians’ opinions; (b) possible impact on the process of medical care; and (c) possible impact on patient outcome. METHODS

This study was conducted at two independent arthritis centers using similar study designs, interventions and evaluation instruments. This provided an important opportunity to validate and generalize the findings. The Boston University (BU) Arthritis Center component of the study used computer-generated health status summary reports derived from the Arthritis

3

BATTERY

POP f sd

12112

03124

MOBILITY PHYSICAL

23k34 84&25

50’ 80’

50 100

6:

+

DEXTERITY

14&15

20

80

80

- - -

HOUSEHOLD

48&35

23

15

23

ADL

lok17

25’

25

38

SOCIAL ANXIETY DEPRESSION PAIN

46 f 20 29*19 4Ok21 62*23

40 43’ 33 75’

35

45 30 26 65

PHYSICAL PSYCH PAIN

31119 34*19 62*23

ARTHRITIS IMPACT

44f23

;: 65

07120

al.

CHGS

-

+

Patient reports PROBLEMS in the following area(s): NO problems reported WALKING BLOCKS/STAIRS BENDING OR LIFTING VIGOROUS ACTIVITY USING PEN OR PENCIL TURNING KEY IN LOCK BUTTONING CLOTHING OPENING JAR PREPARING MEALS ALONE GROCERY SHOPPING ALONE DOING HOUSEWORK ALONE DRESSING UNASSISTED BATHING UNASSISTED NO major problems UNABLE TO RELAX NO major problems PAIN IN 2 OR MORE JTS OFTEN HAS SEVERE PAIN ARTHRITIS PAIN SEVERE

75’

:: 65

65

SUMMARY OF FIRST 5 BATTERIES SUMMARY OF DEPRESSION 81 ANXIETY PAIN SCALE

53

50

54

SINGLE

+

VISUAL

ANALOGUE

RESPONSE

Fig. 1. AIMS health status summary report. *Initial patient score substantially different from reference population (POP) score. $CHG indicates improvement (+) or worsening (-) since previous administration using one symbol for each half standard deviation of change.

Health Status Reports in Clinkal Practice

Impact Measurement Scales (AIMS). The Vanderbilt University (VU) Division of Rheumatology and Immunology used a generically similar summary report from the Modified Health Assessment Questionnaire (MHAQ). The reliability and validity of both of these questionnaires for measuring health status in subjects with RA have been well-documented [12, 131. Both components of the study included an intervention that was generically similar since it involved sending forma1 health status reports to clinicians on a quarterly basis over a 1-year period. Both components of the study also included the same set of clinical utility measures to assess physician opinion, process of care effects and outcome of care effects. Intervention Figure 1 shows an example of an AIMS health status summary report. For each patient,

1245

this AIMS summary included scores for nine AIMS scales, three health status components and an overall arthritis impact item. Scores ranged from 0 to 100, where 100 denoted poorer health. Scores were reported for up to 5 AIMS administrations over 1 year. The reports also contained reference population scores and standard deviations for each scale derived from an AIMS data base. Substantial ditferences between patient scores and the reference scores were flagged by an asterisk. Major changes in patients’ status since the prior administration were noted with a plus for improvement and minus for worsening for each one-half standard deviation of change. Finally, the report identified specifìc items in each scale with which the patient was having problems. Figure 2 shows the MHAQ report which also consisted of a single-page summary of scores. This report contained scores for eight activities PHYSICIAN: DIAGNOSIS:

PATIENT: VALID ID: A3004

Rheumatoid arthritis

Each INDEX is computed from patient self-report of degree of DIFFICULTY, PAIN or DISSATISFACTION in activities of daily living (ADL), as wel1 as other self-report responses. Each index is scored on the basis of 1-4, analogous to American Rheumatism Association Functional Class, to indicate degree of.. . 1= 2= 3= 4=

DIFFICULTY NO difficulty Some difficulty Much difficulty Unable to do

PAI N Never painful Sometimes painful Painful most of the time Always painful

ACTIVITIES OF DAILY LIVING (ADL) INDEX-scores tion in performance of each of 8 ADL. DATE:

01/17/85

Dressing Arising from bed Eating Walking outdoors Bathing Bending down Gripping faucets In and out of a car MOBILITY

INDEX:

04122185

:::

2.4

for difficulty, pain and dissatisfac-

1.0 1.3

:.: 1:o 1.0 2.0

1 .o 1 .o 1.3 1 .o 1.0 1.0

:.: 2:o 1.3

Means scores of 255 Vanderbilt RA patients 2.32 2.15 1.98 2.18 2.32 2.27 2.37 2.37

1.3

1.0

1.2

2.21

1.2

1.4

2.49

1.3

2.38

1 .o 2:: 2.3

DISSATISFACTION Very satisfied Somewhat satisfied Somewhat dissatisfied Very dissatisfied

07125185

10/24/85

1::

IADL “Difficultv” and alobal oerformance status) PAIN INDEX:

2.9

1.4

(ADL “Pain” and visual analog scale mark for degree of pain) ATTITUDES

INDEX:

2.0

1.5

1.0

(ADL “Dissatisfaction” and degree of helplessness in coping with arthritis) COMPOSITE

INDEX (%):

48.2

13.5

COMPOSITE INDEX calculated from MOBILITY, Overall range &lOo%: 0 = no impairment 100 = maximum impairment

2.1

9.8

PAIN and ATTITUDES

45.0 INDICES.

Fig. 2. Vanderbilt Activities and Lifestyle Index Database (VALID), functional status report.

LEWISE. KAZISet al.

1246

of daily living. These scores combined patient reports of difficulty, pain and dissatisfaction in each activity. In addition, the report included separate indices for mobility, pain and patient attitudes, plus an overall composite index. The mobility index combined the overall ADL difficulty score with the score on a global performance item. The pain index combined the overall ADL pain score with the score on a visual analog pain item. The attitude index combined the overall ADL satisfaction score with a score derived from an arthritis helplessness scale [14]. Finally, the report contained a composite index that aggregated the mobility, pain and attitude index scores. Al1 scores on this report except the composite index ranged from 1 to 4, where higher scores indicated poorer health status. The composite index ranged from 0 to 100, where a higher score also indicated poorer health status.

health status since it was possible that patients so sensitized might begin to raise these issues with their doctors. Subjects in the control group in each practice were assessed only at the start and end of the study, and their physicians were not sent either of those health status reports. In the BU component, there were 359 patients in the intervention group, 176 in the attention placebo group and 175 in the control group. For the VU component the totals were 614, 306 and 290, respectively. Al1 patients were monitored for 1 year. Health status questionnaires were administered by mail and returned to the respective arthritis center for processing. For the intervention group patients, computer-generated health status reports were mailed to physicians within 1 week of the receipt of a completed questionnaire.

Study design

Table 1 lists the three types of clinical utility measures that were used to evaluate the impact of the health status reports. These included physicians’ opinions about the value of the health status reports, changes in the process of care and differences in patient outcome. These measures were chosen to cover al1 the major areas in which health status information might have demonstrable clinicial impact. The same clinical utility measures were used for both the BU and the VU components of the study. Physicians’ opinions about the clinical utility of the health status reports were assessed using a questionnaire that was completed at the end of study. The questionnaire consisted of 12 visual

In the BU component of the study, 710 RA patients from 12 community practices were randomized into three groups within each practice. The VU component involved 1210 RA patients from 15 practices, also randomized into three groups within each practice. The health status report intervention group in each practice involved quarterly patient assessments coupled with quarterly health status reports sent to the patients’ doctors. The attention placebo group completed quarterly assessments, but health status reports were not fed back to the doctors. This group was designed to control for the effects of sensitizing patients to the issues of

Measures

of clinical utility

Table 1. Measures used to estimate clinical utilitv Category

Measure

Number of items

Timing of assessment

Calculation of variables

Physician’s opinion

Responses to physician debriefing auestionnaire

12

End only

Response distribution

Process of care

Medication compliance Perception of doctor’s personal qualities Number of office visits to the rheumatologist in the prior 3 months Number of drug category changes during the year Number of arthritis related referrals durina the vear

4 14

Start and end Start and end

Differente” Differente

1

Start and end

Differente

3

Quarterly

Total?

8

Quarterly

Total?

4 $

Start and end Quarterly

Differente Differente

Outcome of care

Satisfaction Health status

*Differences measured as the change between scores at the start and at the end of 1 year. TThese variables could not be calculated for the control group since they required quarterly data. JMeasured by AIMS (64 items, 9 scales, 4 components) or MHAQ (24 items, 6 scales).

Health Status Rcports in Clinical F’racticc

analog items that included the overall clinical utility of the health status reports, the contribution that the reports made to various aspects of the doctor-patient encounter, and the actions taken by the physician upon receipt of the reports. Process measures of clinical utility included medication compliance, patient’s perceptions about the interpersonal qualities of their physician, the number of visits made to the physician in the previous 3 months, major changes in drug treatment over 1 year and referrals to other arthritis professionals during that year. Patient compliance and patient perception measures were included as proxies measures for better patient-physician communication that might result from the provision and discussion of health status information. Kaplan and colleagues have demonstrated the important effects that better patient-physician interaction can have on outcome in chronic disease [15]. Compliance was assessed using a previously-reported, 4-item scale that asks the patient about forgetting to take medications, carelessness about taking medications, stopping medications when he/she feels better and stopping medications when he/she feels worse. Scores for the compliance index range from 1 to 4, where higher scores indicate worse compliance behavior [16]. Compliance was determined in al1 subjects at the start and end of the study. Patient perceptions about the doctor were assessed using a battery of 15 questions that sought opinions about the doctor’s personal qualities. The reliability of this scale has been documented in the literature [17]. Each item has 5 response options ranging from strongly agree to strongly disagree. The scale has a lOO-point range, where higher scores indicate that the patient perceives the doctor to have been more agreeable with more positive personal qualities. The scale was administered to al1 subjects at the start and end of the study. A process of medical care questionnaire was included for al1 subjects each time that they completed a health status questionnaire. This instrument was used to collect data on drug therapy changes, frequency of physician visits and frequency of referrals to other health professionals. The number of visits was assessed by asking patients to report how often they saw the doctor for arthritis care in the preceding 3 months. Changes in drug therapy were assessed by grouping drugs into three categories as follows: Category 1 included salicylates in any

1247

form, analgesics and non-steroidal anti-inflammatory drugs; Category 2 included al1 second-line agents such as plaquenil, gold, penicillamine, methotrexate and azathioprine; Category 3 included oral corticosteroids. A computer algorithm was developed that assessed the total number of changes from one category of medication to another over al1 of the quarterly questionnaire administrations. Medication changes within a single category were not counted. The rationale was to include only those changes that were clearly significant therapeutic decisions. Patient referrals to other health professionals were also assessed quarterly. Beferrals inquired about included those to physicial therapists, occupational therapists, podiatrists, orthopedie surgeons, social workers, psychologists or psychiatrists, rehabilitation counselors and educators or self-help group leaders. The total number of health professional referrals over the 12-month study period was derived by summing those referrals reported by the patient on each of the quarterly process of care questionnaires. Participating physicians were not aware that the subjects were being asked to provide this information about their medical care. The outcome of care measures used to assess the clinical utility of the health status reports were patient satisfaction with medical care and the patient’s health status at the end of the trial. Satisfaction with care was derived from a 4-item scale that included 2 items about satisfaction with the medical care received in general, 1 item about satisfaction with the care received from doctors and 1 item about whether medical care could be better. Items were scored on a 5-point range from strongly agree to strongly disagree. Total scores could range from 4 to 20, with higher scores indicating less satisfaction. The reliability and validity of this scale have been described [18]. Satisfaction was measured at the beginning and end of the trial. Health status as an outcome of care was measured by using the changes in AIMS and MHAQ scores for the three intervention groups from the beginning to the end of the trial. The same scales and storing systems used to generate the health status re ports were utilized in the analysis of health status outcome. Statistical analysis

Separate analyses were conducted at the BU and VU components. Process variable effects were calculated as the differente between the

1248

LEWIS

E. KAZISet al.

patients’s score at baseline and 1 year later for medication compliance, patient attitudes about doctors and the number of visits made to the doctor in the previous 3 months. Drug treatment changes and referrals to other health professionals were summed for each quarterly assessment and expressed as the totals for 1 year. Since these variables were assessed quarterly, they were available only for the attention placebo and intervention groups. The outcome measures, including patient satisfaction and health status, were expressed as the differente between scores at baseline and at the end of the year. The signs for al1 differente variables were adjusted so that positive results indicated a change to a better state (higher better health status, better satisfaction, compliance etc.) and negative changes denoted a worse state. Statistical analyses included overall tests for the differences between the three study groups using analysis of variante F-tests. Pair-wise comparisons using t-tests were performed when the F-tests were significant at the p < 0.05 level. For the process variables, least squares mean changes f the standard error are given with adjustment for age, sex, years of arthritis and the initial baseline values of the variable. In the analysis of the health status scores, adjustments are also made for age, sex, years of arthritis and the initial health status scores. Based upon pre-trial sample size calculations for each of the sites, it was determined that there was at least 80% power for the detection of smal1 to moderate effects (ES = 0.20-0.50) in the intervention group compared to each of the control groups at u = 0.05. RESULTS

Eighty-three percent of the subjects completed the 1-year study (1585 of 1920), 87% at BU (617 of 710) and 80% at VU (970 of 1210). Subjects from the BU group who completed the study had an average age of 56 years, were predominantly female (78%) white (99%) and married (74%). A large majority had at least a high school education (86%), and more than half reported an annual income over $20,000. Subjects in the VU group averaged 57 years of age, and were also mostly female (78%), married (71%) and white (93%). Fewer subjects in this group had at least a high school education (57%). The duration of arthritis at the start of the study was 14 years in the BU subjects and

13 years in those from VU. Baseline comparability assessments of those completing the study showed that there were no differences between these subjects and those who dropped out during the year. Subjects who completed the study made 9.45 (range 4-16) visits to their rheumatologist during the study year. There were no significant differences in baseline demographic measures across the control, attention placebo and report intervention study groups within the BU component of the study. This was also the case for the VU study groups with the exception of a differente across groups in the percentage of females (84, 79 and 76% for the control, attention placebo and report intervention group, respectively). Analysis of the baseline values for the process and outcome measures also revealed no significant differences across the three study groups in either the BU or VU components. Baseline health status scores by intervention group are shown in Table 2. Table 3 summarizes the physicians’ opinions about the value of the health status reports. A total of 24 of the 27 participating physicians responded to the debriefing questionnaire at the end of the study, 11 of 12 from the BU component and 13 of 15 from the VU component. A majority of the doctors (79%) felt that health status reports provided some overall clinical utility as an aid to patient management, with 55% indicating that the reports had moderate or substantial value. More specifically, the clinicians indicated that the reports contributed most to overall patient assessment and the doctor-patient relationship and least to physical examination and referral decisions. In terms of the actions that the physicians took upon receipt of the reports, nearly two-thirds always examined the reports and filed them in the patient’s chart. Half of the physicians discussed the report with the patient most of the time, while 38% never discussed it at all. A substantial majority did not use the report information in discussions with other physicians or arthritis health professionals. Tables 4 and 5 summarize the analyses of possible effects of the AIMS and MHAQ health status reports on the process of medical care. There were no differences in medication compliante or patient attitudes across the AIMS study groups. A trend was seen towards fewer doctor visits, more drug changes and more referrals in the report intervention group, but none of these differences achieved statistical significante.

Health Status Reports in Clinical Practice

1249

Table 2. Baseline health status by study group at enrolhnent* Attention placebo

Control 1. AIMS Measuret

(n = 175)

Report intervention

(n - = 176)

(n = 359)

Scaies

Mobility Physical activity Dexterity Activities of daily living Household activities Social activities Anxiety Depression Pain Components Physical fimction Psychological status Pain Arthritis impact

1.21 f 5.73 * 4.31 f 0.58 f 0.91 f 3.91 f 3.31 f 2.30 f 4.88 f

2.42$ 2.51 3.04 1.45 1.31 1.56 1.87 1.56 2.05

1.02 f 5.30 f 4.05 f 0.45 f 0.81 f 3.98 f 3.36 f 2.19 f 4.74 f

2.17 2.79 3.14 1.15 1.11 1.78 2.01 1.58 2.29

1.04 f 2.28 5.21 f 2.63 4.11 k3.20 0.49 f 1.23 0.80 f 1.19 3.88 f 1.79 3.63 f 2.10 2.36 f 1.61 4.88 f 2.25

2.52 f 2.80 f 4.87 f 3.13 f

1.72 1.59 2.05 2.01

2.28 f 2.77 i: 4.74 f 3.05 f

1.54 1.67 2.29 1.93

2.30 f 2.99 f 4.88 i: 3.27 f

II. MHAQ Meaaure$ Global status by self-report ADL Ditlìculty scale score ADL Dissatisfaction scale score ADL Pain scale score Visual analog pain scale score Rhemnatology attitudes index

(n = 290) 2.40 f 0.72 1.70 f 0.59 1.95 f 0.84 2.09 f 0.75 4.1752.71 2.31 i: 0.30

(n = 306) 2.35 f 0.76 1.63 f 0.57 1.86 * 0.82 2.03 f 0.75 4.13 f 2.76 2.30 f 0.30

1.61 1.76 2.25 2.10

(n = 614) 2.35 f 0.77 1.64 f 0.57 1.83 f 0.79 2.03 f 0.76 4.11 k 2.84 2.28 f 0.39

*NO significant differences between groups at the p < 0.05 level. TAIMS scores can range from 0 to 10 where higher scores indicate worse health. $Baseline mean score f standard deviation. #MHAQ scores can range from 1 to 4 with the exception of the visual analog pain scale which can range from 0 to 10. Higher scores indicate worm. health.

Similarly, in the MHAQ study groups, no differences were seen in the medical care process variables that favored the report intervention group. In terms of the outcome variables, there were no significant differences in patient satisfaction with care across the groups in either component of the study. Tables 6 and 7 summarize the changes in health status of the subjects at the end of 1 year as measured by the AIMS and MHAQ instruments, respectively. The overall

test for differences was significant for 2 AIMS scales and 2 AIMS components. In each case, however, the pair-wise comparisons did not indicate that these differences were due to better health status outcomes in the report intervention group. There were no significant differences across the study groups for any of the MHAQ health status scores. The health status change scores in al1 of the AIMS and MHAQ groups were small, averaging substantially less than 50% of the baseline standard deviation,

Table 3. Physicians’ attitudes about the health status reports (N = 24) Overall clinical utility (%) Contributions of health status reports (%) to: Dverall patient assessment Medical history taking Physical examination Making patient referrals Medication decisions Doctorlpatient relationship Actions taken on receipt of reports (%): Examining it Including it in patient’s chart Discussing it with the patient Discussing it with other MD colleagues Discussing it with other arthritis health professionals

None 21*

Some 25

Moderate 17

Substantial 38

None of the time 29 42 63 50 54 33

Some of the time 17 2: 33 21 13

Most of the time 21 8 17 17 17 25

Al1 of the time 33 29 0 0 8 29

2:

13 8 13 4 17

17 4 42 8 8

63 63 8 4 13

38 83 63

*Percentage of doctors with this response. Row totals may not equal 100% due to rounding error.

1250

LEWIS

E. KAZISet al.

Table 4. Impact of AIMS health status reports on process of care (n = 615)

Measure Medication compliancet Patient attitudes8 Change in number of visits made to doctor in past 3 months Drug category changes over 1 year Referrals to other arthritis health professionals over 1 year

Control

Attention nlacebo

Report intervention

OvZrall differente*

0.09 f 0.05$ -0.07 f 0.07 - 0.03 f 0.08

0.06 f 0.05 -0.15 f 0.07 -0.11 kO.08

0.03 + 0.04 -0.15 f 0.05 -0.20 i: 0.06

0.62 0.59 0.14

0.60 k 0.06 1.30 + 0.12

0.20 0.22

-

0.47 f 0.09T 1.07 f 0.167[

*Overall test for differences between groups using analysis of variante F-test. tPossible score range is 1-4. fLeast squares mean change f standard error adjusted for age, sex, years of arthritis and baseline value of the variable. §Possible score range is (rlO0. TNot adjusted for baseline value of variable.

Table 5. Imoact of MHAO health status reoorts on orocess of care (n = 970)

Medication compliancet Patient attitudes8 Change in number of visits made to doctor in past 3 months Drug category changes over 1 year Referrals to other arthritis health arofessionals over 1 vear

Control

Attention placebo

Report intervention

Overal* differente*

0.04 f 0.05$ 0.05 f 0.03 -0.18 * 0.07

0.00 f 0.06 -0.11 t0.03 0.04 f 0.07

0.11 f 0.04 - 0.07 f 0.02 -0.06 f 0.05

0.53 0.08 0.54

0.65 f 0.04 1.07 f 0.07

0.15 0.14

-

0.55 f 0.057 1.28 f 0.137

*Overall test for differences between groups using analysis of variante F-test. tPossible score range is 1-4. SLeast squares mean change f standard error adjusted for age, sex, years of arthritis and baseline value of the variable. $Possible scores range is (r100. TNot adjusted for baseline values of variable.

Table 6. Impact of AIMS report on health status (n = 615)

AIMS measure”

Control

Attention placebo

Report intervention

Overall differencet

Scales

Mobility Physical activity Dexterity ADL Household activities Social activities Anxiety Depression Pain

0.05 f 0.133 0.18 f0.16 -0.03 * 0.21 -0.00 * 0.07 -0.00 f 0.07 -0.12*0.11 -0.21 *0.13 -0.18 f 0.10 0.21 f 0.16

0.01 f 0.13 0.15kO.16 0.15 f 0.21 0.00 i 0.07 -0.02 f 0.07 -0.20 * 0.10 0.28 f 0.13 0.14*0.10 0.13 f 0.16

-0.08 f -0.19 f -0.29 f -0.05 f -0.09 f 0.01 f 0.01 * -0.00 f 0.01 f

0.04 f -0.22 * 0.21 f -0.05 f

0.06 f 0.20 * 0.13 i -0.25 f

-0.16 f 0.06 0.01 f 0.07 0.01 f 0.12 -0.17*0.11

0.10 0.12 0.15 0.05 0.05 0.08 0.09 0.07 0.12

0.66 0.07 0.17 0.77 0.47 0.19 0.024 0.05g 0.52

Components

Physical function Psychological status Pain Arthritis impact

0.08 0.10 0.16 0.16

0.08 0.10 0.16 0.16

0.02n 0.009§ 0.52 0.87

*Change scores can range from - 10 to + 10 where positive change denotes improvement. tOveral test for differente between the three groups using analysis of variante F-test. $Least squares mean change f standard error adjusted for age, sex, years of arthritis and baseline value of the variable. §Pair-wise comparisons using t-tests indicate that the differente for placebo VS attention placebo is significant at p c 0.05. TIPair-wise comparisons using t-tests indicate that the differences for placebo versus the intervention and attention placebo versus the intervention are significant at p < 0.05.

Health Status Reports in Clinical Practice

1251

Table 7. Impact of MHAQ report on health status (n = 970) MHAQ health status outcome measure+ Global status by self-report ADL Di5culty scale score ADL Dissatisfaction scale score ADL Pain scale score Visual analog pain scale score Rheumatology attitudes index

c0lltr01 -0.07 f -0.04 f 0.00 f 0.01 f -0.32 f -0.00 f

0.04$ 0.02 0.04 0.03 0.16 0.02

Attention Placebo 0.04 f - 0.08 f -0.00 f - 0.05 f -0.25 f -0.02 f

0.04 0.03 0.04 0.04 0.20 0.02

Report intervention 0.004 f -0.02 f 0.01 f -0.03 f -0.06 f -0.01 f

0.03 0.02 0.03 0.03 0.14 0.02

Gvfrall differencet 0.14 0.15 0.93 0.45 0.41 0.41

*Change scores can range from - 3 to + 3 except for the visual analogue which can range from - 10 to + 10. Positive change indicates improvement. tGvera test for differente between the 3 groups using analysis of variante F-test. tLeast squares mean change &-standard error adjusted for age, sex, years of arthritis and baseline value ‘of the variable.

that little health status change occurred in the subjects during the year of the study.

clearly been shown to distinguish between placebo and intervention groups in a number of drug trials in which disease flare was a criterion for admission [5,22,23]. A second limitation in our design has to do DISCUSSION with the timing of the health status reports. NO We did not find evidente that forma1 health attempt was made in any of the groups to relate status reports provided any consistent or signifi- the timing of questionnaire mailing directly to cant effects on the process or outcome of care of the timing of an office visit. In many cases the patients who participated in this study. While physician may have received the information physicians felt that the health status reports had either long after or long before the patient was a moderate degree of overall clinical utility, they seen. The utility of information provided in reported that the information did not contribute this way may be substantially reduced, just as in a substantial way to specific aspects of patient the informational value of a laboratory test assessment or to specific decisions regarding result done 2 months before a visit may be quite referrals. A majority of physicians reported that low. A third limitation has to do with the possithey examined the health status reports and across intervention included them in the patient’s chart, but they bility for contamination apparently did not find the information to be groups within each practice. It is possible that physician exposure to health status reports on consistently helpful. The simplest interpretation of these results is some patients altered their behavior toward that health status reports do not provide useful other patients as well. It is also possible that information in clinical practice. However, sev- patients in the “no feedback” groups discussed era1 explanations for the negative results can be their questionnaire responses with the physician. Both forms of contamination would tend considered. First, the smal1 changes in health to reduce the process and outcome differences status seen over the year in al1 three groups indicate that these subjects had relatively stable across the study groups. A fourth limitation involves the relatively disease. In contrast to the approach in clinical trials designed to assess the efficacy of a drug VS short time-frame of 1 year in a study of a chronic disease, particularly in a group in a placebo in RA [19,20], we did not require that patients show evidente of active disease or whom disease is expected to be stable [21]. improvement is disease flare in order to be admitted to the Indeed, while short-term study. In the absente of disease flare subjects typical with any intervention in RA, including have less room for improvement and there is less placebo, many patients experience clinical prolikelihood that an effective intervention can be gression over 5-20 years [24]. The degree of distinguished from placebo. Patients with progression over 1 year may not provide statistidisease duration of greater than 10 years who cal power to recognize different outcomes recomplete regular self-report questionnaires, as is sulting from different interventions, even if the case in the study, tend to be relatively stable the study design had involved inclusion or exor radio[21]. It is unlikely that the scores are simply clusion of traditional laboratory insensitive, as health status questionnaires have graphic data.

indicating

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This study did not include any attempt to educate physicians about health status information. The physicians were simply asked to participate and to provide names of subjects. Once the study was underway, physicians began to receive mailings that contained the singlepage health status reports. Although the health status reports were designed to include interpretation aids such as the mean population score and change columns, and clinicians can understand health status information wel1 enough to produce consistent rankings of overall health when given reports on 10 typical RA patients [25], the physicians’ unfamiliarity with these types of data may have been a limiting factor in this study. Rubenstein and colleagues have reported some effects of providing functional status information to physicians in a range of genera1 medicine and specialty medicine practices [26]. Their intervention included a formal, 2-hour education session designed to train physicians on the interpretation and use of functional status reports. Their results suggest that while physician unfamiliarity may be a limiting factor in the clinical utility of health status reports, simple approaches to education may not be sufficient to overcome this barrier. Two other approaches could be used to increase the clinical utility of health status information. The first involves using simpler measures. Such measures could be used directly in the office setting, avoiding the delays inherent in storing and processing more complex measures such as the AIMS and the MHAQ. This approach would allow the physician to have access to the information at the most appropriate time: simpler measures would also be easier to interpret. A number of investigators are working on the development and refinement of such measures. One group at Dartmouth has developed cartoons that allow patients to indicate which of five levels on a number of health status scales best describes their current situation [27]. The methodology of the national Medical Outcome Study also relies on shorter versions of established health status scales [28]. Another approach to using health status information in the clinical setting would be to provide the reports to the patient instead of, or in addition to, providing them to the physician. This might allow patients to understand their health status better both in terms of how they are doing compared to a reference group and how they are doing compared to their own

status measured at a prior time. This information could result in more focused and effective doctor-patient interactions designed to address particular health status problems. Greenfield et al. [29] have demonstrated the beneficial results of increased patient participation on blood sugar control when diabetics are given access to their medical records. A similar approach could be used for forma1 health status reports. We continue to believe that arthritis health status reports can have an important role to play in clinical practice, just as they have been shown to have an important role to play in clinical research. This contention is based on our belief that the assessment and maintenance of health status is a crucial part of clinical care. In a recent position paper, a committee of the American College of Physicians specifically supported the view that maintenance of a patient’s functional well-being is a fundamental goal of medical practice. They also noted that the assessment of the physical, psychological and social functioning of the patient in terms of the impact of disease is “an essential part of clinical diagnosis, a major determinant of therapeutic choices, a measure of their efficacy, and a guide in planning long-term care. . .” [30]. We strongly agree with this viewpoint. Nevertheless, the use of a new test or technique in medicine cannot be justified, particularly in the current climate of medical tost containment, unless it has been shown to have clinical utility. This can be demonstrated through assessment of physician opinion or, more appropriately, through documentation of measurable impacts on the process or outcome of medical care. We believe that further studies should be conducted to examine the utility of forma1 health status reports in clinical practice. Future studies might emphasize patients with evidente of active disease. Designs might be used that prevent contamination across groups and that relate the report more directly to the time of the patient-physician encounter. Pretrial education interventions for participating physicians, the use of simpler health status reports and the provision of reports to patients as wel1 as to physicians should also be considered. Finally, a longer-term study might lead to recognition of effects not seen over a 1-year period. Acknowledgements-We express our thanks to the following physicians who gave US access to their time and their patients: Larry Anderson and Paulding Phelps, Portland, ME; Robert Gatter, Joseph Scarola and Ronald Andrews,

Health Status Reports in Clinical Practice Willow Grove, PA; Caryn Libbey, Nashua, NH; J. Timothy Harrington, Madison, WI; Louis Healy, Seattle, WA, Justus J. Fiechtner, Fargo, ND, Arthur Weaver, Lincoln, NE; Sidney Black, Bangor, ME: Herbert Kaplan, Denver, CO; R. Franklin Adams, Memphis, TN; Joan Barber, Santa Crux, CA; Wemer Barth, Washington, M=, Melvin Britton, Palo Alto, CA, Gary Gordon, Philadelphia, PA; Joseph H. Huston, Thomas John, John S. Johnson and John S. Sergent, Nashville, TN, Alastair Kennedy, Vero Beach, FL; J. Robert Polk, Boise, ID; James W. Raitt, Menlo Park, CA; James L. Reinertsen and Eric Schned, Minneapolis, MN; John C. Whelton, Palm Beach, FL.

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