Are rehabilitation programs for rheumatoid arthritis patients effective?

Are Rehabilitation

Programs for Rheumatoid Patients Effective?

Arthritis

By Jane Sinden Spiegel, Timothy M. Spiegel, and Nancy B. Ward

H

ISTORICALLY, treatment for rheumatic diseases has been recognized since the Roman use of the natural springs of Bath, England, in 300 AD.’ In modern medicine, the disabling consequences of rheumatoid arthritis (RA) are still well recognized and rehabilitation programs for these patients have evolved.2-4 These programs are multidisciplinary efforts aimed at preserving the patients’ quality of life by improving functional ability, mental and social health, vocational status, and disease activity. Riggs and Gall’ recently identified the components of this team treatment approach in their state-of-the-art discussion of arthritis rehabilitation. Many health professionals and patients are zealous supporters of these programs, claiming that they actually produce substantial improvements. However, strong endorsement for these programs is not universally shared, partially because the scientific community has been slow to establish their effectiveness. Do these intensive programs truly produce these benefits, or would many patients with standard care and the passage of time achieve similar improvements? Although rheumatologists are familiar with the principles of arthritis rehabilitation, many believe that medications account for most improvements. Consequently, many of these physicians refer few patients to rehabilitative programs or for routine evaluation and treatment by allied health professionals. Few primary care physicians have more than a vague idea regarding the principles or benefits of multidisciplinary rehabilitative programs or the services provided by allied health professionals.’

From the Department of Medicine, University of California, Los Angeles. Jane Sinden Spiegel, MD, MSPH: Assistant Professor of Medicine, UCLA; Timothy M. Spiegel, MD: Associate Professor of Medicine, UCLA; and Nancy B. Ward, BA: Senior Editor, Logicon Inc, San Pedro, CA. Address reprint requests to Jane Sinden Spiegel, MD, MSPH, Department of Medicine. Factor B-544, University of California, Los Angeles. CA 90024. 0 1987 by Grune & Stratton, Inc. 0049-0172/87/l 604-0004$5.00/O 260

Seminars

Establishing the efficacy of multidisciplinary rehabilitation care is of particular importance with the recent changes in reimbursement for inpatient hospitalization. In the current diagnosis related groups (DRG) prospective payment system, rheumatologic disease patients, depending on age, are primarily included in DRG-240 and DRG-241.6 In these DRG categories, the mean length of in-hospital stay permitted is 8.6 and 8.0 days, respectively. This contrasts sharply with the prolonged hospitalizations of most rehabilitation units. Because of the difficulty hospitalizing RA patients in acute medical facilities, many rheumatologists have begun to examine other alternatives. Acute rehabilitation units that provide comprehensive multidisciplinary care and are DRG exempt are attractive. These units can provide an environment in which RA patients may receive intensive rest during an acute flare, change medications, and have multidisciplinary rehabilitative care by skilled health professionals. Professionals frequently included in a rehabilitation team are physicians (rheumatologists, physiatrists, orthopedic surgeons, psychiatrists), nurses, physical and occupational therapists, social workers, psychologists, patient educators, podiatrists, and vocational counselors. In this report, we review the available literature in an attempt to answer the question of whether rehabilitation programs for RA patients are effective. We have summarized the evidence of program effectiveness and potential methodologic pitfalls of 15 published studies that represent the best available data for answering this question.

METHODS We reviewed the literature published over the past I5 years using the Medline computer search, the Index Medicus, and referenced articles. We selected studies evaluating either inpatient or outpatient rehabilitation programs, or similar multidisciplinary interventions, directed toward improving the functional ability or employment status of RA patients.7’*4 We excluded rehabilitation studies in which the type of “arthritis” was not specified, or in which the results of RA patients could be separated from the results of patients with other medical conditions.2’*u Two reviewers independently abstracted or

in Arthritis

and Rheumatism,

Vol 16. No 4 (May), 1987: pp 260-270

261

REHABILITATION PROGRAM FOR RA

“classical” The study cho Los included patients,” from the England) tients.14

summarized each study for characteristics of the intervention, improvement in functional ability, and pertinent methodologic characteristics, including presence of a control group, percentage of patients lost to follow-up, and methods used to assess function. When recording improvements in functional ability, we attempted when possible, to quantify this into a percentage of patients who had improved at the end of the follow-up period. Any differences between the two reviewers were resolved by reexamining the study and subsequent consensus.

or “definite” RA were included.25 by Conaty and Nickel from the RanAmigos Hospital (Downey, CA) only ARA functional class IV and the study by Barraclough et al Droitwich Center (Birmingham, included only non-walking RA pa-

RESULTS

Table 1 displays characteristics of 15 studies: 11 inpatient and four outpatient programs.7-22 Five of the studies were from Great Britain,8*9.143’5*22 two from Canada,‘o*12one from Sweden2’ and the remaining seven from the United Combined, these studies States. 73”~‘3~16-‘83’9~21 report 1,7 12 RA patients, as summarized at the bottom of Table 1. For the seven studies that listed the American Rheumatism Association (ARA) patient classification, only patients with

Characteristics of the Intervention Patients from one inpatient study were hospitalized in a rehabilitation unit at the University of Pennsylvania (Philadelphia) that treated patients with a variety of conditions.’ For this study, we abstracted the data for RA patients only. For all other inpatient studies, patients were hospitalized in specified rheumatic disease or rheumatology rehabilitation units.8-‘7 Most of

Table 1. Evaluations of Rehabilitation No. Reference

of

Length of

Patients

COntrd

With RA

QWP

Tvpaof l”teNe”tlOn

Programs for RA Patients

PwCSlltage

Method of

Functional

Intervention

Length of

Lost to

FunctionsI

Abili*

IMean)

Follow-Up

Follow-Up

Assessment

at Follow-Up

Few mo

26%

EmplO)lXIitt

Dthu

Stat”5

Factors

lnpmisnt studies Rosenthal’

50

NO

Inpatient multi-

1.6 mo

disciplinary rehe

to 6 v

Activities of daihl

lndapmuknce

in

24% employed a

living 3 gadas.

AM

from

cmmg for hwsehdd

11s

inueased

bilitatinn unit,

sessed by a thsra-

13% to 64% of pa-

University of

pist 0T qu*stionnan*

tiants

Disabilii

Not dmxssed

_

at follow-up

PnnltSVlVaIXa Had

100

NO

Inpatient rhsw

2.5 mo

matic unit. Er+ gland

3 mo fw

49%

lOOpa-

to 3 yr

at 2

ratmg, 6

Employment

tients; 2

40%

tosrfa

low-w,

51 p*

atZto3yrfdkw

tients Duthis. et al’

307

NO

-

ic-

creasad from 0% to

grad=

at 3 mo fdand to 46%

up 24%

Functional cap&&f.

Severe r*Hrbtion

Increased from 6%

Oniysspiin given

matic unit. Scot-

died.

4 grades

functbnal capacity

to66%at4yrfc,-

duing

land

10% bat

decreasedfmnl

lOV+UP

tion. otha

to follow-

60%

“P

tient*: most im-

lbpatimt ml%-

2.3 mo

9Yr

to 40%

in

hcepitsliza rh~gs

gven after dii-

of pa-

charge

provement seen in fistzyr Aobinm’”

62

NO

Inpatient rhew maic

2.6 mo

dieeases

NIX

Evaluation of se&s

35% of patients

For 34 otbar pa-

stated

of functional tests

had 25%

tients full or part

to 44%

impcwement

unit, Canada

in

-

time emplpyment

function

inaeased

from

16% to 79% with 2 yr fdlow-up

NO

carstyB”d

67 (ARA

Nikel”

Func-

itorion unit, s-

tional

thritis sectice,

those fdkwed

11% diihaged

Class I”

Ranch0 Los

maintained im-

from unit a* not

patk.ntd

Amigos Hospi-

movement

treatable

Inpatient rehabiC

4 mo

4w

ARA functimal

36%

cbs-

sification. 4 wades

73% impovad

on

Not discussed

discharge. 74% of

.I61

WaltaS”

males

Kanen. et al”

101

NO

Inpatient rheu-

2.6 mo

3.6 y,

20%

Intew~,

matic disease

regar*“g

Not discussed

I”cmased 40%

emplcqment

from

to 66%

unit, Canada NO

ARA functional clsg

63%

sificatvxl. obwfvb

functial.9l Status,

ti8 rehabilitation

tbnof actlvi*iMl of

53% improved

wad

daily living and

dressing and

Multidisciplin~ inpatkot

Ilthd-

in a

chronic ds.+ase

3.5 nw

1.7w

26%

died

waking

13 madasl

improved

I”creased fram 6%

grooming, 20% im-

hcspital. New

proved waking

Yolk

transta

and

had OT-

thopedic swgsw.

01, CA R*inaMand

63%

iOZl%

-

262

SPIEGEL, SPIEGEL, AND WARD

Table 1. Evaluations of Rehabilitation No. of Reference Barradou~h

et

all’

Length of

Patients

CO”Wd

With RA

Group

32 lncm-

NO

TWof l”tewBntw” lnpaient

rlmu-

walking

matic umt.

patients)

Droitwich

Programs for RA Patients

PWCBn,&W

Method Of

Intervention

Length of

Lc6t to

FWCtialld

IMMll)

Follow-Up

Follow-Up

Assessment

6.3 VT

36%

3mo

Cen-

ter, England

(Cont’d)

Functional Ability

Employment

Other

StatUs

Factors

at Fdlow-Up

5 grades Of func-

37%

13% lost

bond capacity ds

maintained func-

surgery: knee in-

to fdlow-

twmined by inta-

tional capaciw

“dvenlsm

M

view w question-

counted fa “on-

naue

walking statw

died

improved or

Not discussed

6% had orthopedic

ac-

m

50% of patients Scott et a116

112

Inpatient rhea-

NO

2.3 mo

Intensive use of dis-

at 10 yr

eaoemodiiing

Modified ARA func-

At 10 yr. 44%

tional classification

proved to sytnptwn

Droitwlch Cen-

to fonow-

I5 grades) s&men-

frse. a mild incB_

drugs far all pa-

ter. England

“P

tat,on rate

pacity

twnts; 30%-60%

1Ov

unit.

im-

22% able to wti

15% died 4% last

matdogV

had orthopedic SWW-Y Show

et all6

61

Standardiied

ques-

Both grwps

im-

Not discwsed

Articular m**

per-

Hospitalization cm multipwposa

twnnaire for actw-

proved in ADL and

famed

assigned

Bnhritis center.

t#ss of daily living

pain by 14%

pTivats rheumatol-

University of

isrdc”llr

Mochigan for

imentstion rate)

expaimentsl

10d

26%

Yes, cat randomly

lyr

index. sed-

by patient’s

Ogist. sugar

not

recorded

pa-

tients: two private rheumatology pactices for control pauents Sp,egal et al”

92

2% lost

Standardized

func-

Experimental pa-

to follow-

tional quastmnnaire

tients had signifi-

bilitation umt for

up: 1%

(joint deformity and

ant

expaimental

died

tenderness. walk

compaed

tients. UCLA:

tnne, gip strength,

trols in disease sc-

la, and 14% of con-

14 private rhea-

sedimentatnn

ttvmtvand in 40% of

trols had wthopedc

functional and 75%

swgenl

Yes. not

Inpatient rhau-

randomly

matdow

assigned

mawlogy

Outpatient

2wk

In

rshe

pa-

rate,)

pram-

Not discussed

All clinical mdasues p-srfwmedbyMwof

impovement

two physocians: 30% of sxpannen-

with con-

ticas for control

of mental and social

pllt*nts

health measures

Studes

Katz et sI’~.‘~

40

Yes. ran-

Cwnprehensive

domly

o”tpatia”t

esslgned

wsitmg nurses,

t v

None

0%

Observation of

gradssl. index of

multidisciplinary W”fWe”C*S.

functioning,

Cleveland

b,q

25% of expwimen

Ewarimental

of experimental

tal and 5% of con-

improved in wcial

group and 35% of

nd p~ltiants or,-

adjustment

controls for ADL.

PWWJ

Deter~cati~l

ADL (7

waling.

ctle.

Lans-

Index (for Bs-

ease activityI

in 5%

5% experirnaw3l

gurp

and had

lzsd days, ckmc and

and 25% contrds

physocal thaapy

for sociceconomic

visits. and or-

funnio”,

thopedic co”s”l,s

40%

ox-

pernnental and JO%

control for

Lansbury Index Brattstrcm

and

Ee@ndzo

265 with

NO

Outpatient

dwitis I250

with

80

16%

1 yT

Db,sct,“e *tive

and sub-

assessment

hebilitsttcm clinic

of whethe

IAmbulataium).

goals were achieved

specific

30%-50%

Of pa-

dents achlewd goal. 45%

111

im-

77%

WC&

Function not re

tidsciplirzarq

rate functiaral

Pa-ted; expenmen-

ewe with con-

uati(x~. joint count.

tsl patlt~ts

faences.

grip strength. and

improved daseasa

sedimentation

activity

Outpatient

danfY assigned

mul-

1 yr

visiting

nurses and ther-

evaI-

rate

tional classes II and

proved in cwking

Unspecified elabw

Yes. rsn-

6est results in func-

Not discussed

their

and househdd

Sweden

RAI Duff a d2’

mu!-

tidiscipknary r*

POW-

50% had RA on~ yr

Not d+.c”sssd

or less

showed

apists. University of Michogan Standardized

None

wdu-

NO

dlf-

No change, 74%

Yes. ran-

OuTpatient UIB

hmhl

by guleml psc-

assigned

titicnsr. hospital

personal CEe. dc-

tional &Iii,

clinic. a visiting

mastic and soad

ease activity. 0T

pat-tima

home thsmpist

activities, muI*

soa11 seNica utllu&

men,

after discharge

l”d.9X

ucn

2 v

l”,srgovp

ferencss in func-

ation of mobiliw.

men, 30% women

dis-

mawxainsd full w empby-

from a rhwme t&gy

unit. Er+

glsnd Total: 1.7 12

Yes -

pat*“ts,

studies

15 studiis

5

Inpatmm Outpatient

11 -

4

Median -

Median -

median -

Five studies used

Improved in 10112

Employment

2.5llwfor

3yrf.x

26%

~0”

studies which a-

proved in 6/J

singh func-

nm-

stud

inpatient

10 inpb

tooral masuss

cussad function. im-

iw repwting

unit

tlent

ARA dassif~anon):

proved for 41%

change. improved

p.¶t*nts

st”&

4 studies had

With fol-

vagwfy &scrib8d

IOW-UD

8*)801uMHlts

(ea.

bnsdan,

of

fa 34% of pat&ants (median)

_

REHABILITATION

PROGRAM FOR RA

these programs emphasized a multidisciplinary team approach toward patient care that incorporated input from physicians, physical and occupational therapists, nurse educators, and social workers. Additional professionals frequently involved included orthopedic surgeons, vocational rehabilitation counselors, podiatrists, and psychologists. Most programs used formal weekly conferences to formulate therapy and goals and coordinate care among team members.26 Some programs had exercise sessions and educational programs held as patient group activities, and the studies from Great Britain particularly emphasized the benefits of bed rest during the initial phases of the hospitalization. In Table 1, characteristics of each program are listed under “Type of Intervention” and “Other Factors.” We will describe a few of the interventions in more detail, although many studies contained very limited descriptions of their rehabilitation program. Some programs placed more emphasis on certain components of therapy. Listed under “Other Factors” in Table 1, we recorded rates of orthopedic surgery whenever available. The program of Conaty and Nickel at Ranch0 Los Amigos Hospital had the highest orthopedic surgery rate, providing reconstructive surgery for 63% of patients.” The program of Karten et al from a rehabilitation ward at Goldwater Memorial Hospital (New York) had a 16% orthopedic surgical rate,13 and 6% of Barraclough et al’s non-walking patients from the Droitwich Center had surgery.14 In a recent controlled trial of inpatient rehabilitation from the University of California (Los Angeles) by Spiegel et al, 30% of experimental and 14% of control patients had surgery.” Another recent controlled trial from the University of Michigan Multipurpose Arthritis Center (Ann Arbor, MI) did not discuss surgery.16 Although most studies stated that medications were adjusted or changed to control disease activity, in the study by Scott et al of 112 patients from the Droitwich Center, all patients received a disease-modifying drug (including prednisane).” For this program, patients were hospitalized for approximately 10 weeks, in which the first 3 to 6 weeks primarily consisted of bed rest and static exercises. For the next 3 to 6 weeks, patients were slowly mobilized with intensive

263

physio- and hydrotherapy. As shown in Table 1, all patients received a disease-modifying drug, and between 30% and 50% of patients had an orthopedic surgical procedure. Following discharge, most patients were seen in the hospital’s outpatient clinic at least every 6 months, with a mean follow-up period of 10 years. The report from Northern General Hospital (Edinburgh) by Duthie et al has several similarities.’ The lo-week hospitalization period consisted first of bed rest, then of active and resistive exercises, and finally of weight-bearing and endurance activities. Most patients returned to the hospital for outpatient care with a 9-year mean follow-up period. In contrast to the study of Scott et al, however, during the inpatient period aspirin was emphasized and disease-modifying drugs were avoided. During the follow-up period these other drugs were added when indicated. When analyzing the results, the investigators state that patients receiving drugs other than aspirin showed no more improvements than those receiving only aspirin, although they acknowledge that patients treated with the other drugs may have shown more deterioration if they had not been so treated. Rates of surgical procedures are not discussed. This longitudinal sample of 307 patients is often cited in descriptions of the prognosis and course of RA.27*28 Length of Intervention For all inpatient programs, the median length of stay was 2.5 months, as summarized at the bottom of Table 1. The Ranch0 Los Amigos program of Conaty and Nickel, with frequent reconstructive surgical procedures, had the longest hospitalization at 4 months.” Karten et al’s patients, who were hospitalized in an arthritis ward of a chronic disease hospital in New York, had the next longest hospital stay at 3.5 monthsI The two recent controlled inpatient studies (Shope et alI6 and Spiegel et al”) had interventions of ten and 14 days, respectively. Only in their brevity did these inpatient programs appear substantially different from the longer interventions. For both studies, patients received care from a multidisciplinary arthritis rehabilitation team and were hospitalized on a specialized unit created within a university hospital.

264

Length of Follow-up As shown in Table 1, only one inpatient study, from Vancouver (Canada), did not incorporate a post-hospitalization follow-up period, and reported outcomes only at the time of discharge.” In the study from the University of Pennsylvania, the actual length of follow-up was difficult to determine, ranging from a few months to 6 years.’ However, when follow-up was attempted, the median post-hospitalization follow-up period was approximately 3 years. As noted previously, the studies from Great Britain by Scott et al, from the Droitwich Center,15 and Duthie et al9 had the longest follow-up periods of 10 and 9 years, respectively. Barraclough et al’s non-walking patients from the Droitwich Center had a 6.3 year follow-up period.14 Conaty and Nickel’s patients were followed for 4 years,” and the recent studies by Shope et alI6 and Spiegel et al” had a l-year post-hospitalization follow-up.

Presence of a Control Group As shown under “Control Group” in Table 1, none of these inpatient studies incorporated a control group until the 198Os, when two studies @hope et alI6 and Spiegel et al”) had nonrandomized control groups. The control patients of Shope et al were drawn from two private rheumatology practices located near the University of Michigan.16 The patients of Spiegel et al came from the private practices of 14 rheumatologists associated with Cedars-Sinai Medical Center (Los Angeles).” Although outpatient studies will be discussed separately, three of four outpatient studies were able to incorporate a randomized control group.

Patients Lost to Follow-Up When data were available, we recorded separately the percentage of patients who died or were lost to follow-up, as shown under “Percentage Lost to Follow-Up” in Table 1. For all inpatient and outpatient studies, the median number of patients who either died or were lost to follow-up was 28%, as shown at the bottom of Table 1. An outpatient study by Duff et al, with a 12-month intervention, lost 77% of patients at the end of the year.21 In three inpatient studies with a 6- to IO-year follow-up period (Barraclough et a1,l4 Duthie et aL9 and Scott”), death accounted for 15% to 38% of the attrition rate.

SPIEGEL, SPIEGEL, AND WARD

Other studies with shorter follow-up periods and high attrition rates did not comment on the percentage of patients who died.‘,‘.“,” Karten et al’s study of 101 patients hospitalized in New York had a 1.7 year follow-up period and a 28% death rate.13 These patients were severely disabled, 45% were ARA Functional Classification IV on admission, and most deaths occurred in the more functionally disabled patients. Other studies have also reported higher death rates in patients who are more functionally impaired.‘4329 In the study of Karten et al, 40% of deaths were due to infection. Although many patients were receiving corticosteroids, infectious complications did not occur more frequently in this group. In the other three studies reporting frequent deaths, approximately one third of the patients died of an infection and another third died of cardiovascular complications.9.‘4.‘5

Assessing Function The methods used to assess patients’ functional ability are summarized under “Method of Functional Assessment” in Table 1. Particularly in the older studies, these methods were often difficult to ascertain. Some earlier studies assessed function in an un- or semi-constructed interview or by observation. Four studies used assessments such as these, which were only vaguely described.‘0,‘3,20*2’ Five other studies (including Duthie et al, 1964; Conaty and Nickel, 1971; and Scott et al, 1983) used a gross unidimensional measure of function with four to six gradations, such as the ARA functional classification 8*9~“~‘4~‘5 Katz et al’s outpatient study in 1968 used their Activities of Daily Living (ADL) measure.‘8,‘9 For this measure, using data obtained in an interview and by observation, patients are assigned to one of three levels according to the degree of assistance required from another person to perform six ADL functions.30s3’ Based on this information, patients are then assigned to one of seven gradations for overall ADL performance. The two controlled inpatient studies by Shope et alI6 and Spiegel et al” used standardized self-reported functional questionnaires. Shope et al used the Functional Status Index (FSI), which assesses the degree of dependence, pain, and difficulty experienced with certain activities of daily living.32 The questionnaire used by Spiegel

REHABILITATION

PROGRAM FOR RA

et al was based on the Arthritis Impact Measurement Scales (AIMS),33*34and on measures from the Rand Health Insurance Experiment,35-37which assess functional ability, pain, and mental and social health. Functional Ability, Employment Status at Follow-up Overwhelmingly, both inpatient and outpatient studies reported that their intervention led to improved functional ability and employment status. Ten of 12 studies that specifically analyzed function reported improvements for approximately 41% of patients, as shown at the bottom of Table 1.7~9~11~13~1s~17~‘8~20 In this calculation, we included the randomized outpatient trial of comprehensive care of Katz et al, which reported less functional deterioration in experimental patients as compared with control patients.‘* Seven studies examined change in employment status.8~‘0*‘2*‘3~‘8~22 In six of these studies, employment status improved for 27% of patients (median). Although results of each study are listed under “Functional Ability at Follow-Up” in Table 1, we will provide specific examples of a few inpatient programs. Rosenthal’s University of Pennsylvania study reported that independence in ADL increased from 13% to 54% of patients.’ The 9-year study of Duthie et al reported that severe restriction in functional capacity was present in 60% of the 307 patients at baseline, but in only 40% at follow-up, and that most improvement was observed in the first 2 years after hospitalization.’ However, Duthie et al states that after 2 years, patients showed gradual but progressive functional deterioration.’ They report that of the 200 patients surviving 9 years after the hospitalization, 20% had no disability, 41% were moderately incapacitated, 27% were severely crippled, and 11% were totally dependent on others. At 4 years, the percentage of patients employed or able to do at least light housework had increased from 6% on admission to 68%. Harris’ program, from Devonshire Royal Hospital (Buxton, England), which emphasized vocational rehabilitation, found that 2 to 3 years after discharge, 48% of patients were employed, whereas no patients were employed before admission. Conaty and Nickel reported that 73% of patients were functionally improved on dis-

265

charge from Ranch0 Los Amigos Hospital and that 74% of this group maintained their improvement for 4 years. ” As stated previously, 63% of these patients had orthopedic surgery, and 11% of patients admitted to the arthritis unit (but not included in their study) were discharged as not treatable. The study by Barraclough et al, from the Droitwich Center, of 32 non-walking RA patients, reported that only 6% had orthopedic surgery.14 Although not all patients were returned to walking status, after 6 years of follow-up, 37% continued to improve or maintain the functional improvements that were observed at discharge. In Scott et al’s program, which emphasized disease-modifying drugs and provided 10 years of follow-up care, 44% of patients had improved to the point of being symptom free or having only a mild incapacity and 22% were employed. However, all of these studies had no control group for comparison. Two studies reported no functional improvements. Interestingly, both were controlled trials, Shope et al’s inpatient studyI and an outpatient trial by Mowat et al,** which will be discussed later. Shope et al evaluated a ten-day hospitalization on a multipurpose arthritis center unit, with control patients selected from two private rheumatology practices.“j Both control and experimental patients were clinically experiencing a disease flare. This study has several methodologic problems, which may account for its negative findings. Although a control group was present, patients were not randomized. Sociodemographic characteristics of both groups were similar; however, control patients had more active disease and poorer functional ability at study entry. The investigators used covariate analysis to control for differences at entry of a given variable. Although covariate analysis can be used to control for recognized group differences, non-randomized as compared with randomized groups have a greater likelihood of differing in variables that may not be measured or recognized. These uncontrolled variables may therefore bias many non-randomized trials. Another limitation of the study by Shope et al is that we don’t know the quality of care provided in the two control practices; it may have been exceptional. We do know that 37% of the control patients were hospitalized during the l-year follow-up period. For the experimental patients, we

266

don’t know the source or quality of care received after hospitalization, and one third of this group was lost to follow-up. Although the study used a well recognized standard functional questionnaire (the FSI), the articular index and physician rating of disease activity and overall functional ability were performed by the patients’ individual physicians. These latter measures are subjective, and inter- and intraobserver reliability for an articular index has been documented as poor.38,39 The other controlled inpatient trial by Spiegel et al, as summarized in Table 1, found significant improvement in the experimental group at 1 year in disease activity, functional ability, and mental and social health.” In this study, both experimental and control patients were required to have recent functional deterioration and moderate pain or difficulty with daily activities. Patients were not randomized, however, and in this study experimental patients had more disease activity and poorer functioning. However, study outcomes may be potentially less biased than in the Shope et al study, because control patients were referred by 14 private practice rheumatologists. Thus, one exceptionally good or poor physician would have less overall impact on the outcomes of the control group. Other methodologic strengths of this report include having only 2% of patients lost to follow-up, having only two physicians perform all clinical measures (with all measurements for each patient performed by the same physician), and including standardized mental and social health measures. As stated previously, experimental patients had more orthopedic surgery and were started more frequently on disease-modifying drugs than control patients. The investigators statistically controlled for these group differences and differences at study entry with covariate analysis when examining 12-month outcomes. Again, however, unrecognized variables could also bias this study.

SPIEGEL. SPIEGEL. AND WARD

using outpatient multidisciplinary management conferences.‘8,‘9,2’ The fourth outpatient study, by Mowat et al from England, consisted of 132 patients who were randomized after discharge from a rheumatology unit to follow-up care from ( 1) a general practitioner, (2) a hospital (rheumatology) clinic, or (3) home visits by an occupational therapist associated with the inpatient rheumatology unit.22 After receiving care from these different providers for 2 years, these patient groups showed no significant differences in functional ability, disease activity, or use of social services. The three remaining outpatient studies reported benefits. However, one study had no control group,” but two studies used randomized controls.‘8.2’ Katz et al’s 1968 randomized trial from Cleveland is the best study available for evaluating multidisciplinary outpatient care.‘8,2o As shown in Table 1, after 1 year, 5% of patients receiving comprehensive outpatient care with visiting nurses had functional deterioration, as compared with deterioration in 35% of controls. In addition, 5% of experimental and 2.5% of controls had poorer socioeconomic function, and 40% of experimental and 70% of control patients had worsening measures of disease activity. The other randomized multidisciplinary outpatient trial by Duff et al was terminated prematurely because of budget cutbacks.2’ Although the investigators planned to evaluate function, only changes in disease activity were reported. At I year, experimental patients had less disease activity, although at this point, 77% of patients had been lost to follow-up. The uncontrolled study was reported by Brattstrom and Berglund from Sweden.20 Using objective and subjective assessments of whether specific goals were achieved, the investigators report that after 1 year, 30% to 50% of patients achieved their goal, with 45% of patients improving their ability to cook and do household work.2o DISCUSSION

Outpatient Studies Characteristics of the outpatient studies are summarized at the end of Table 1. Interventions in three of the four outpatient studies involved multidisciplinary care, incorporating home nursing or therapist visits, and coordinating care

We reviewed 15 studies of rehabilitation interventions for RA patients. Despite differences in characteristics of the program and methods of evaluation, these studies overwhelmingly reported that patients’ functional ability or employment status improved. Another review of

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ten studies evaluating team care for patients with various chronic illnesses, including RA, also found that most studies report functional improvements.40 With this evidence of effectiveness, why are these programs not unanimously accepted and supported? We believe the answer lies in many of the methodologic problems besetting these studies; particularly the absence of a control group. RA is well known for its variable course of remissions and exacerbations. With these fluctuations, many readers are skeptical about studies, especially longitudinal ones that do not incorporate a control group. The control group would preferably be randomized. Given the financial constraints of unfilled beds in rehabilitation units, randomization is often difficult. However, if at all possible, patients should be randomized; if not possible, a non-randomized control group for comparison is crucial. When using non-randomized controls, investigators need to carefully select patients who appear as similar as possible to the experimental group and measure all variables that may conceivably differ between the groups and influence study outcomes. Follow-up

Evaluations,

Mortality

Rates

For inpatient studies, a follow-up period after discharge from the rehabilitation unit is extremely important. We need to know how RA patients are functioning at home and whether benefits persist beyond bed rest alone.41-43W’hen follow-up evaluations are performed, vigorous effort is required to contact and evaluate all patients. Since mobility is a major problem for this population, many rehabilitation studies have a large number of patients lost to follow-up; we saw 77% in one study.” One could argue that patients who returned for follow-up were most likely doing better, and observations on this group would make a program appear more successful. Follow-up evaluations are particularly difficult for many rehabilitation programs because patients frequently do not return to this facility, but receive follow-up care from their private physicians. Investigators need to recognize these inherent problems and perhaps plan on home evaluations for 25% of these patients, Increased mortality in RA patients at referral centers was seen in several studies reviewed here

and has been reported elsewhere.29@48We found a 15% to 38% death rate in studies that reported deaths in a 6- to lo-year follow-up period.9*14v’5 This is similar to the 20% to 25% mortality rate for RA patients reported in most long term survival studies.29*4’48When causes of death have been compared with causes in the general population, deaths from infectious diseases appear particularly increased.4’ RA patients with increased mortality appear to be those with severe disease, particularly with rapid onset. 29V46,48 These patients receive aggressive treatment, are frequently hospitalized, and often receive care at referral centers. One epidemiologic, population based study, which sampled patients from Olmstead County, Minnesota, as opposed to a university hospital, found no increased mortality in RA patients.49 However, when long term studies are based at referral centers, the unavoidable attrition from death needs to be recognized. Assessing

Outcomes

The first step in developing or choosing a measure for a study is to clearly define major anticipated outcomes. After this is done, specific measures can be developed or the investigator can select previously developed measures that best assess these outcomes. For instance, if pain reduction is targeted as an important outcome, then one of the better available pain measures should be selected. There are many functional and health status questionnaires from which to choose. A few, such as the AIMS,33*34 the FSI,32,50the Health Assessment Questionnaire (HAQ),s1*52 and several others53*s4 have been developed particularly for arthritis patients. Many other excellent health status questionnaires exist that are not disease specific, but have been used for arthritis patients,55-59including the Index of Well-Being (IWB),55956the Sickness Impact Profile (SIP),57 and the Rand Health Insurance Experiment measures.35-37 A recent study compared patient responses with five of the more commonly used arthritis questionnaires before and after total hip or knee replacement.‘j’ The questionnaires (which included the FSI, AIMS, HAQ, IWB, and SIP) were then compared for relative efficiency and sensitivity to change over time. Certain measures appeared

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better than others, particularly for social and global outcomes. Although no single questionnaire was consistently superior, the HAQ tended to score more poorly than the others in detecting change over time. If patient function is measured in an interview or by direct observation, the assessor should be blinded to the patient’s experimental or control group status. ADL measures particularly are frequently assessed in an interview conducted by an occupational or physical therapist.3093’*61 Choosing measures that can detect change over time is obviously important for studies attempting to examine the impact of a rehabilitative intervention. The problem is well recognized, but has received little investigation.62-65 Many of the older studies that we reviewed used the four ARA functional classifications as their only functional measure. Clearly, many gradations of function exist within each of these four classifications, and substantial improvements could be missed if only this gross measure was used. Similarly, some of the more recent functional questionnaires are not adequately sensitive to change. For example, a patient may be asked whether he/she is able to dress him/herself (1) with no difficulty, (2) with some difficulty, or (3) not at all. These questions will miss some clinically meaningful improvement. A patient may have “some difficulty” dressing and will improve substantially, but not to the point of dressing with “no difficulty.” For many of these questions, respondents should be offered five or six possible responses, such as: (1) with no difficulty, (2) with a little difficulty, (3) with some difficulty, (4) with moderate difficulty, (5) with much difficulty, or (6) not able to do this. If necessary, responses to questions may need to be expanded or additional questions developed to assure that a questionnaire will be sensitive to change and will detect all anticipated major outcomes. It is interesting that even with insensitive functional measures, such as the four ARA functional classifications, many previous studies reported significant functional improvements. Most of these studies had no control groups. The five studies with a control group are divided on program effectiveness. Two out of three outpatient and one out of two inpatient studies report benefits.

Summary-Future

Directions

Under the current prospective payment system, the model of a rheumatic disease unit that cares for both acute and chronic diseases may no longer be feasible. Multidisciplinary care in an outpatient acute rehabilitation facility may better serve the unique needs of RA patients. Or, alternatively, intensive multidisciplinary outpatient care following a short hospitalization may also prove beneficial. In any case, the efficacy of such programs should be documented in well designed, randomized controlled trials. In order to better use our resources, we also need further research to determine which individual program components produce most benefits. Potential benefits may be related to medication change, surgery, physical therapy, occupational therapy, compliance, education, or psychological or social interventions. Many programs combine most of these components, often synthesizing therapy plans in a multidisciplinary conference. Although the process of formulating patient goals and therapy plans in these conferences has been demonstrated, further studies are needed to determine whether this synthesis actually leads to improved patient outcomes.26 Are rehabilitation programs for RA patients effective? Although the literature suggests that this is true, methodologic shortcomings preclude a definite conclusion. There are only two controlled inpatient studies. Spiegel et al’s study found significant improvements and had less methodologic problems than the other controlled inpatient study, which reported no benefits. Of the controlled outpatient studies, two of three suggest that comprehensive multidisciplinary care for RA patients is beneficial. To definitively conclude whether multidisciplinary rehabilitative programs for RA patients are beneficial, rigorous studies are greatly needed. Future studies must have a control group, preferably randomized. For outpatient studies, randomization should be relatively easy. A follow-up period after termination of the intervention is also important. This allows determination of whether benefits are temporary, resulting from the immediate effect of a program, or persistent, perhaps providing long term benefits. Future investigations need to recognize prior problems of large

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numbers of patients lost to follow-up. For long term studies, patient mortality must be considered and provisions should be made for home evaluations for perhaps 25% of patients. Finally, anticipated outcomes for a study should be clearly defined. Measures that are sensitive in showing change can then be selected, modified, or developed. Although the literature suggests,

and we suspect, that rehabilitation programs are beneficial for RA patients, further definitive data are needed. ACKNOWLEDGMENT The authors wish to thank Dr Harold E Paulus for reviewing the manuscript and Beagle Mullen for secretarial assistance.

REFERENCES I. Licht S: History of therapeutic heat, in Licht S (ed): Therapeutic Heat. New Haven, CT, Elizabeth Licht, 1958, pp 185-186

17. Spiegel JS, Spiegel TM, Ward NB, et al: Rehabilitation for rheumatoid arthritis patients: A controlled trial. Arthritis Rheum 29:628-637, 1986

2. Meenan RF, Yelin EH, Henke CJ, et al: The costs of rheumatoid arthritis: A patient oriented study of chronic disease costs. Arthritis Rheum 21:827-833, 1978

18. Katz S, Vignos PJ Jr, Moskowitz RW, et al: Comprehensive outpatient care in rheumatoid arthritis. A controlled study. JAMA 206~1249-1254, 1968

3. Meenan RF, Yelin EH, Nevitt M, et al: The impact of chronic disease: A sociomedical profile of rheumatoid arthritis. Arthritis Rheum 24:544-549, 1980

19. Vignos PJ Jr, Thompson HM, Katz S, et al: Comprehensive care and psycho-social factors in rehabilitation in chronic rheumatoid arthritis: A controlled trial. J Chronic Dis 25~457-467, 1972

4. Yelin E, Meenan R, Nevitt M, et al: Work disability in rheumatoid arthritis: Effects of disease, social, and work factors. Ann Intern Med 93551-556, 1980 5. Riggs GK, Gall EP: Rheumatic Disease Rehabilitation Management. Stoneham, MA, Butterworth, 1984 6. Lockshin MD: DRG legislation Bull Rheum Dis 34:l-5, 1984

and rheumatic

disease.

7. Rosenthal AM: Five-year follow-up study of the patients admitted to the rehabilitation center of the hospital of the University of Pennsylvania. Am J Phys Med 41:19821 I, 1962 8. Harris R: The rehabilitation unit in the treatment of rheumatoid arthritis. Can Med Assoc J 88:139-144, 1963 9. Duthie JJR, Brown PE, Truelove LH, et al: Course and prognosis in rheumatoid arthritis: A further report. Ann Rheum Dis 23:193-202, 1964 IO. Robinson HS: How do rheumatic diseases relate to economic potential as influenced by: The rehabilitation specialist. Penn Med 72:70-73, 1969 Il. Conaty JP, Nickel VL: Functional incapacitation in rheumatoid arthritis: A rehabilitation challenge. J Bone Joint Surg 53A:624-637, I97 I 12. Robinson HS, Walters K: Return to work after treatment of rheumatoid arthritis. Can Med Assoc J 105:166-169, 1971 13. Karten I, Lee M, McEwen C: Rheumatoid arthritis: Five-year study of rehabilitation. Arch Phys Med Rehabil 54:120-128, 1973 14. Barraclough D, Alderman WW, Popert AJ: Rehabilitation of non-walkers in rheumatoid arthritis. Rheumatol Rehabil 15:287-29 I, 1976 15. Scott DL, Coulton BL, Chapman JH, et al: The long-term effects of treating rheumatoid arthritis. J R Coll Physicians Lond 17:79-85, 1983 16. Shope JT, Banwell BA, Jette AM, et al: Functional status outcome after treatment of rheumatoid arthritis. Clin Rheum Practice 1:243-248, 1983

20. Brattstriim M, Berglund K: Ambulant rehabilitation of patients with chronic rheumatic disease. Stand J Rehabil Med 2:133-142, 1970 21. Duff IF, Carpenter JO, Neukom JE: Comprehensive management of patients with rheumatoid arthritis. Arthritis Rheum 17:635-645, 1974 22. Mowat AC, Nichols PJR, Holdings EM: A comparison of follow-up regimes in rheumatoid arthritis. Ann Rheum Dis 39:12-17, 1980 23. Scranton J-A, Fogel ML, Erdman, WJ II: Evaluation of functional levels of patients during and following rehabilitation. Arch Phys Med Rehabil 5l:l-21, 1970 24. Granger CV, Greer MD: Functional status measurements and medical rehabilitation outcomes. Arch Phys Med Rehabil57:103-109, 1976 25. Ropes MW, Bennett GA, Cobb S, et al: 1958 Revision of diagnostic criteria for rheumatoid arthritis. Bull Rheum Dis 9:175-176, 1958 26. Spiegel JS, Spiegel TM: An objective examination of multidisciplinary patient conferences. J Med Educ 59:436438, 1984 27. Duthie JJR, Thompson M, Weir MM, et al: Medical and social aspects of the treatment of rheumatoid arthritis with special reference to factors affecting prognosis. Ann Rheum Dis 14:133-149, 1955 28. Duthie JJR, Brown PE, Knox JDE, et al: Course and prognosis in rheumatoid arthritis. Ann Rheum Dis 16:4l l423,1957 29. Pincus T, Callahan LF, Sale WG, et al: Severe functional declines, work disability, and increased mortality in seventy-five rheumatoid arthritis patients studied over nine years. Arthritis Rheum 27:864-872, 1984 30. Katz S, Ford AB, Moskowitz RW, et al: Studies of illness in the aged. JAMA 185:914-919, 1963 31. Katz S, Downs TD, Cash HR, et al: Progress in development of the index of ADL. Gerontologist 10:20-30, 1970

270

32. Jette AM: Functional status chronic disease evaluation instrument. bil61:395-401, 1980

SPIEGEL, SPIEGEL, AND WARD

index: Reliability of a Arch Phys Med Reha-

33. Meenan RF, Gertman PM, Mason JH: Measuring health status in arthritis: The arthritis impact measurement scales. Arthritis Rheum 23:146-l 52, 1980 34. Meenan RF, Gertman PM, Mason JH, et al: The arthritis impact measurement scales: Further investigations of a health status measure. Arthritis Rheum 25:1048-1053, 1982 35. Stewart AL, Ware JE, Brook RH, et al: Conceptualization and measurement of health for adults in the health insurance study, in Physical Health in Terms of Functioning, vol 2. Santa Monica, CA, The Rand Corporation, 1978, R-1987/2-HEW 36. Ware JE, Johnston SA, Davies-Avery A, et al: Conceptualization and measurement of health for adults in the health insurance study, in Mental Health, vol 3. Santa Monica, CA, The Rand Corporation, 1979, RJ-1987/3HEW 37. Ware JE, Davies-Avery A, Donald CA: Conceptualization and measurement of health for adults in the health insurance study, in General Health Perceptions, vol 5. Santa Monica, CA, The Rand Corporation, 1978, R-1987/5HEW 38. Ritchie DM, Boyle JA, Mclnnes JM, et al: Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med 37:393-406, 1968 39. Cooperating Clinics Committee of the American Rheumatism Association: A seven-day variability study of 499 patients with peripheral rheumatoid arthritis. Arthritis Rheum 8:302-334, 1965 40. Halstead LS: Team care in chronic illness: A critical review of the literature of the past 25 years. Arch Phys Med Rehabil 57:507-5 11, 1976 41. Partridge REH, Duthie JJR: Controlled trial of the effect of complete immobilization of the joints in rheumatoid arthritis. Ann Rheum Dis 22:91-99, 1963 42. Mills JA, Pinals RS, Ropes MW, et al: Value of bed rest in patients with rheumatoid arthritis. N Engl J Med 284:453-458, I97 1 43. Lee P, Kennedy AC, Anderson J, et al: Benefits of hospitalization in rheumatoid arthritis. Q J Med 43:205-214, 1974 44. Cobb S, Anderson F, Bauer W: Length of life and cause of death in rheumatoid arthritis. N Engl J Med 249:553-556, 1953 45. Uddin J, Kraus AS, Kelly HG: Survivorship and death in rheumatoid arthritis. Arthritis Rheum 13: 125-I 30, 1975 46. Rasker JJ, Cosh JA: Cause and age at death in a prospective study of 100 patients with rheumatoid arthritis. Ann Rheum Dis 40:115-120.1981 47. Jacoby RK, Jayson MIV, Cosh JA: Onset, early stages, and prognosis of rheumatoid arthritis: A clinical study

of 100 patients with 1 l-year follow-up. Br Med J 2:96-100, 1973 48. Abruzzo JL: Rheumatoid arthritis and mortality. Arthritis Rheum 25:1020-1023, 1982 49. Linos A, Worthington JW, O’Fallon WM, et al: Epidemiology of rheumatoid arthritis in Rochester, Minnesota: A study of incidence, prevalence and mortality. Am J Epidemiol 111:87-98, 1980 50. Jette AM: Functional capacity evaluation: An empirical approach. Arch Phys Med Rehabil61:85-89, 1980 5 1. Fries JF, Spitz P, Kraines RG, et al: Measurement of patient outcome in arthritis. Arthritis Rheum 23:137-145, 1980 52. Fries JF, Spitz PW, Young DY: The dimensions of health outcomes: The health assessment questionnaire, disability and pain scales. J Rheumatol9:789-793, 1982 53. Lee P, Jasani MK, Dick WC, et al: Evaluation of a functional index in rheumatoid arthritis. Stand J Rheumatol 2:71-77, 1973 54. Chambers LW, MacDonald LA, Tugwell P et al: The McMaster health index questionnaire as a measure of quality of life for patients with rheumatoid disease. J Rheumatol 9:780-784, 1982 55. Patrick DL, Bush JW, Chen MM: Toward an operational definition of health. J Health Sot Behav 14:6-23, 1973 56. Kaplan RM, Bush JW, Berry CC: Health status: Types of validity for an index of well-being. Health Serv Res 11:478-507, 1976 57. Bergner M, Bobbitt RA, Pollard WE, et al: The sickness impact profile: Validation of a health status measure. Med Care 14:57-67, 1976 58. Deniston OL, Jette A: A functional status assessment instrument: Validation in an elderly population. Health Serv Res 15:21-34, 1980 59. Granger CV, Albrecht GL, Hamilton BB: Outcome of comprehensive medical rehabilitation: Measurement by PULSES profile and the barthel index. Arch Phys Med Rehabil 60:145-154, 1979 60. Liang MH, Larson MG, Cullen KE, et al: Comparative measurement efficiency and sensitivy of five health status instruments for arthritis research. Arthritis Rheum 28542-547, 1985 6 I. Convery FR, Minteer MA, Amiel D, et al: Polyarticular disability: A functional assessment. Arch Phys Med Rehabil 58:494-499, 1977 62. Liang MH, Jette AM: Measuring functional ability in chronic arthritis. Arthritis Rheum 24:80-86, 1981 63. Jette AM: Health status indicators: Their utility in chronic-disease evaluation research. J Chronic Dis 33:567579, 1980 64. Tugwell P, Bombardier C: A methodologic framework for developing and selecting endpoints in clinical trials. J Rheumatol9:758-762, 1982 65. Liang MH, Cullen K, Larson M: In search of a more perfect mousetrap (health status or quality of life instrument). J Rheumatol9:775-779, 1982