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* From the Salvatore Maugeri Foundation IRCCS, Lung Function Unit, Scientific Institute of Gussago, Italy.
Correspondence to: Enrico Clini, MD, FCCP, Division of Pneumology, Fondazione Maugeri IRCCS, Via Pinidolo 23, 25064 Gussago (BS), Italy; e-mail: eclini{at}qubisoft.it
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Abstract |
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 TOP Abstract IntroductionMaterials and MethodsResultsDiscussionReferences |
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Design: Retrospective case-control study.
Setting: Pulmonary ward and outpatient clinic of a rehabilitation center.
Patients: Forty-three patients (case subjects) selected on the basis of selection criteria were compared with control subjects matched to them for age, sex, FEV1, and diagnosis of either COPD or asthma. Case subjects performed 10 to 12 daily sessions (5 sessions a week) of inpatient PRP; control subjects performed 20 to 24 sessions (3 sessions a week) of outpatient PRP.
Measurements: At baseline and after the PRP, an incremental exercise test was performed, including evaluation of dyspnea and leg fatigue by Borg scale (D and F, respectively) at each workload step. The cost of PRP was also evaluated.
Results: Both PRPs resulted in similar significant improvements in cycloergometry peak workload (from 68 ± 18 to 82 ± 22 and from 75 ± 17 to 87 ± 27 W in case subjects and control subjects, respectively), isoload D (from 6.4 ± 1.6 to 4.2 ± 1.8 for case subjects and from 8.5 ± 1.9 to 6.3 ± 2.4 for control subjects) and isoload F (from 6.6 ± 1.8 to 4.2 ± 1.8 for case subjects and from 8.9 ± 1.9 to 7.0 ± 1.8 for control subjects). Although the single daily session was less expensive, the outpatient PRP total costs were greater because of the higher number of sessions and the cost of daily transportation.
Conclusions: In patients with CAO, a shorter inpatient PRP may result in improvement in exercise tolerance similar to a longer outpatient PRP but with lower costs. Whether a shorter outpatient PRP may get physiologic and clinical benefits, while further reducing costs, must be evaluated by future controlled, randomized, prospective studies.
Key Words: bronchial asthma • COPD • dyspnea • exercise training
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Introduction |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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In a previous observational study,5 we observed that CAO patients undergoing an outpatient PRP, including 20 to 24 exercise training sessions (3 sessions a week), improved their exercise tolerance. We hypothesized whether similar benefits might be obtained with a shorter duration of the PRP and in different location. Therefore, in a retrospective case-control study, we compared the functional benefits and relative costs of administering an intense, short-term, inpatient PRP with a longer, outpatient PRP. We observed that a shorter but equally effective PRP may result in cost savings.
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Materials and Methods |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Patients
Patients in stable condition with CAO who were admitted to our
Rehabilitation Center for either inpatient or outpatient PRP between
July 1, 1998 and June 30, 1999 were evaluated. Patients were referred
to the PRPs by their general practitioners or by respiratory
physicians. In our institution, these patients who were in stable
condition were also admitted to an inpatient PRP according to
transportation requirements: if the patient had to spend > 1 h
traveling from home to the hospital, the patient was admitted to the
inpatient PRP, independent of the stage of disease or the severity of
symptoms.
Diagnosis of COPD was made according to the American Thoracic Society (ATS) guidelines.11 COPD patients had a history of smoking ( > 20 pack-year) but had to be (and were) ex-smokers. Asthma was characterized by dyspnea with wheezing, variable airflow limitation with reversible obstruction (range 9–35%; mean ± SD: 18 ± 12%), and bronchial hyperresponsiveness,12 in the absence of smoking history. Stable condition was defined by stability in blood gas values and no exacerbation in the 4 weeks before patient admission to the hospital. Patients with exercise-induced hypoxemia, other organ failure, cancer, or an inability to cooperate were excluded from the study. All asthmatic patients received inhaled steroids and bronchodilators. All COPD patients received regular treatment with inhaled bronchodilators but they received no regular treatment with inhaled or oral steroid or long-term oxygen. No change in the routine drugs had been made in the week preceding the admission to PRP.
Definitions
This is a retrospective study conducted on the basis of chart
review. Patients admitted to the inpatient PRP according to selection
criteria were designated as case subjects. Control subjects were chosen
from among patients admitted to our day-hospital–based outpatient PRP,
which has been described elsewhere,5
and were matched to
the case subjects. The variables used to match individual case subjects
and control subjects included: diagnosis (COPD or asthma), age ( ± 5
years), sex, and severity of airway obstruction as assessed by
postbronchodilator FEV1 ( ± 12% predicted).
When more than one potential control subject was well matched to a case
subject, the control subject with the closest data was then selected
for the study. Furthermore, the two groups were compared and evaluated
on the basis of other nonmatched parameters: arterial blood gases, body
mass index, maximal inspiratory pressure (MIP), maximal expiratory
pressure (MEP), and peak workload achieved at the baseline exercise
test. The number of previous PRPs in the 3 years before the study was
also determined for all patients. The characteristics of patients and
their matching criteria are illustrated in Table 1 .
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The same multidisciplinary team consisting of chest physicians, nurses, physical therapists, a dietician, and a psychologist performed both PRPs. Both PRPs included optimization of the pharmacologic treatment and 3-h sessions including the following: (1) supervised incremental exercise until the patient achieved 30 min of continuous cycling at 70 to 80% of the maximal load achieved on an incremental cycloergometer exercise test carried out at hospital admission13 ; (2) abdominal muscle activities, upper and lower limb muscle activities lifting weights progressively (from 300 to 500 g), and shoulder and full arm circling14 ; (3) patient’s diagnosis-specific education sessions; and (4) nutritional programs and psychosocial counseling, when appropriate.
Measurements
Baseline lung volumes and FVC were measured with a spirometer
(Medical Graphic Corp, PF/DX; St. Paul, MN). The predicted values
determined by Quanjer15
were used. Arterial blood was
sampled at the radial artery while the patients were seated and were
breathing room air for at least 1 h.
PaO2,
PaCO2, and pH were measured with an
automated analyzer (800 Series, Ciba Corning Diagnostic Corp; Medfield,
MA).
Physiologic Outcomes
At baseline (T0) and after PRP
(T1), respiratory muscle strength was assessed by
measuring MIP and MEP16
using a respiratory module system
(Medical Graphic Corp). The predicted values determined by Bruschi et
al17
were used. Symptom-limited incremental exercise tests
were performed on an electrically braked cycloergometer (Ergometris
800-S; Sensormedics; Yorba Linda, CA) using the standard incremental
cycle exercise protocol. Functional and metabolic data were determined
at rest and during exercise by means of a computerized system (2900Z,
Sensormedics). Mixed expired gas data, minute ventilation
(
E) and breathing pattern, oxygen consumption
(O2), carbon dioxide
production, and respiratory exchange ratio were continuously monitored
as average values of 20-s intervals. ECG activity was monitored
continuously, and systemic arterial BP was registered every minute
using a sphygmomanometer. After stabilization and a 2-min period of
unloaded pedaling at 60 cycles min-1, the
load was increased by 10 W each minute. Patients were strongly
encouraged to cycle to the point of intolerable breathlessness,
discomfort, or exhaustion, until the maximal heart rate was achieved,
an abnormal ECG was noted, or whenever the patient wanted to stop
(symptom-limited exercise test). At rest and at 10- W intervals,
patients were asked for their perceived breathlessness/dyspnea and leg
fatigue by pointing to a number or phrase on a 10-point modified
Borg scale set in large type on a sheet in front of
them.18
Costs
Daily PRP costs per patient were assessed according to a
modified calculation proposed by Goldstein et al.8
Data
relating to the costs of providing each PRP were gathered from the
staff involved in managing the service provision and staff from the
finance department of the hospital. The following costs were
identified: medical and nursing care, services, and medications. The
cost of transport for patients to and from the hospital was calculated
as follows: car fuel cost to run the distance from and to home,
multiplied by the number of hospital accesses (admission and discharge
days for case subjects and each session day for control subjects). The
total PRP cost was then calculated by multiplying the cost per day per
patient for the mean number of training sessions.
Statistical Analysis
All analyses were performed using a specific software package
(BMDP PC 90; Statistical Software Inc.; Los Angeles, CA). Unless
otherwise indicated, all data are presented as mean ± 1 SD. Two-way
analysis of variance for repeated measures was used to test differences
between groups and times. Contrasts among groups and times were
evaluated by t test with Bonferroni adjustment and were
applied as requested by analysis of variation interaction. A p value
< 0.05 was considered statistically significant.
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Results |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Effectiveness of Matching
Case subjects and control subjects did not differ for any matching
characteristics, nor for the other comparability variables (Table 1)
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Six of 9 asthmatic case subjects and 5 of 9 asthmatic control subjects
were atopic. Eight of 34 COPD and 26 of 34 COPD subjects of both groups
were in ATS stage I and II, respectively. The mean number of
PRPs that each patient had performed in the previous 3 years was
similar in both groups (2.1 ± 0.9 PRPs, median = 2 in case
subjects, and 2.1 ± 0.7 PRPs, median = 2 in control subjects),
although significantly more case subjects than control subjects were at
their first PRP (14 case subjects and 8 control subjects). There were
no differences in the medications required by the patients.
Physiologic Outcomes
The effects of PRP on respiratory muscle strength and exercise
tolerance in both groups are shown in Table 2
. Both PRPs induced a significant increase in peak workload (by 20% and
16% in case subjects and control subjects, respectively, p < 0.05).
As shown in Table 3 , baseline dyspnea and leg fatigue at peak workload were significantly
more severe in control subjects. After PRP, compared with
T0, isoload of dyspnea and leg fatigue
significantly decreased in both groups. No change in MIP and MEP was
observed for either group. Results were not influenced by diagnosis of
either COPD or asthma nor by whether patients were at their first PRP
or had previous PRP experience.
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Discussion |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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The role of PRP in improving the health status of these patients has been widely recognized, and guidelines for rehabilitation have been published.9 19 Our study confirms the positive effects of PRP on exercise tolerance and dyspnea in patients with CAO5 and suggests that a shorter PRP may result in similar physiologic benefits as a longer PRP. Most of the COPD patients of our study were in ATS stage II, confirming the results by Berry et al.4 In that study, all patients with COPD with different stages of severity (ATS stages I to III) did benefit from participation in an outpatient exercise training program.4
Both case subjects and control subjects showed a significant increase
in the peak workload achieved at cycloergometry at the end of PRP.
Despite the lack of significant changes in
isoload-O2 (Table 2)
, our
patients showed a trend toward the increase of
O2 aerobic threshold (by 33%
and 20% in case subjects and control subjects, respectively), which
did not reach statistical significance. This may be because 15 case
subjects (35%) and 21 control subjects (49%) did not reach the target
80% of baseline peak workload of the exercise protocol. Maltais et
al13
reported that only 12% of their COPD patients
tolerated the high-intensity training (80% of the baseline peak
workload).
Baseline dyspnea and leg fatigue at peak workload were significantly more severe in control subjects. This difference might suggest a difference in the condition of patients. Nevertheless, this was the only difference among several physiologic characteristics assessed at baseline. Such a bias (if any) would have influenced the results in terms of effects of the PRPs,20 which did not happen.
Although more control subjects were previously submitted to one or more PRP, the results were not influenced whether patients were at their first PRP or had previous PRP experience. A previous submission to PRP might indicate a better familiarity with the treatment and/or better motivation, but the bias (if any) would have favored the control population, which was not the case in this study.
The programs in the two settings were the same for case subjects and control subjects, but were differed for total sessions (12 and 24 for case subjects and control subjects, respectively) and weekly sessions (5 and 3, respectively). In a prospective, controlled study, Vogiatzis et al21 found that COPD patients in ATS stage II significantly improved the physiologic response to training performed twice a week in a 12-week PRP for a total of 24 sessions, a duration similar to that of our control subjects, thus suggesting that even a low session frequency may be useful in exercise training programs. More recently, Green et al22 found that a 7-week, twice weekly course of pulmonary rehabilitation provided greater benefits to patients with severe COPD than a 4-week course in terms of improvements in health status but not in exercise tolerance.
The lack of changes in respiratory muscle function is not surprising because our PRP did not include any specific ventilatory muscle training.9 A meta-analysis reported only little evidence of clinically important benefits of this modality in patients with COPD.23 More research is needed before final recommendations can be made regarding which patients, if any, are likely to benefit from ventilatory muscle training.
Our study found no difference in the results of PRP performed in different locations. Despite substantial variability in program structure, PRPs performed in inpatient, outpatient, or home setting have documented clinical benefits.24 25 26 In particular, hospital-based PRPs are known to be as beneficial as home-care PRPs for improving function and health-related quality of life (HRQL) in patients with COPD.10
Others have reported the cost of providing a predominantly inpatient PRP with measurements of effectiveness in terms of disease-specific health status.8 Previous studies in our institution5 25 and other institutions6 7 reported a reduction in health service usage in rehabilitated outpatients. The cost analysis in our study involved direct costs and only transportation among the indirect costs. We were unable to calculate other indirect costs, such as time spent by relatives to transport patients to and from the hospital. The single session cost per patient was lower for control subjects, whereas the total PRP cost was lower for case subjects (Table 4) . The cost for transportation further increased the total costs of outpatient PRP.
We are aware of the difficulty of comparing the cost analysis of different PRPs. Comparisons of cost-effectiveness between programs performed in different institutions and countries are difficult because of variation in case-mix, the outcome measure used, and the time-points at which outcomes are measured. Nevertheless, one randomized, controlled study of PRP, which included economic evaluation of the program1 8 may suggest different conclusions than our results. Indeed these authors reported clinical results1 and costs8 of a Canadian PRP1 involving a 2-month inpatient PRP followed by a 4-month outpatient supervision. The bulk of costs was contributed by hospitalization costs. In that study, an outpatient PRP appeared highly cost-effective in comparison with a PRP incorporating a substantial period of inpatient care. In consideration of costs, it is noteworthy that the impact of cost trade-offs is specific to location and affected by the different health-care systems; therefore, the applicability of our results to other systems must be considered with caution.
Our study, showing the improvement in exercise tolerance of a shorter, inpatient PRP, may suggest its cost-effectiveness. Given the similar effectiveness in improving exercise tolerance and the lower total costs, it could be argued that a shorter, inpatient PRP is better than a longer, outpatient PRP. The inpatient schedule provided on an outpatient basis may keep the patients out of the hospital, may further reduce costs, and may not expose them unnecessarily to hospital pathogens. Nevertheless, this notion must be considered with caution. In the present study, the long-term effects on exercise tolerance, HRQL, or health resource consumption were not assessed. In previous studies5 25 we demonstrated that the outpatient PRP used in this study resulted also in long-term improvement in HRQL and reduction in hospitalizations. Whether a shorter, outpatient PRP may result in the same long-term benefits remains to be elucidated.
In conclusion, within the limitations of a retrospective case-control study, our results show that for patients with CAO, a short-term, inpatient PRP may induce short-term improvement in exercise tolerance, similar to a longer, outpatient program. The duration of PRP and the need for daily transportation significantly influenced the total costs of the outpatient PRP. Whether a shorter, outpatient PRP might result in long-term physiologic and clinical benefits, while further reducing costs, must be evaluated by future controlled, randomized, prospective studies.
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Footnotes |
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E = minute ventilation;
O2 = oxygen consumption Received December 12, 2000; revision accepted May 15, 2001.
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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