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* From the Department of Allergy and Clinical Immunology (Drs. Moscato, Dellabianca, Perfetti, Brame, Galdi, and Niniano), Salvatore Maugeri Foundation, Occupational and Rehabilitation Clinic, IRCCS, Medical Center of Pavia, Specialization School of Allergology and Clinical Immunology, University of Pavia; and the Department of Cardiology, Angiology, and Pneumology (Dr. Paggiaro), University of Pisa, Italy.
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Abstract |
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Subjects and methods: Twenty-five patients with OA both to high- and low-molecular-weight agents (3 and 22, respectively) confirmed by specific inhalation challenge were followed up for 12 months after the diagnosis. Upon diagnosis, each patient received a diary on which to report peak expiratory flow rate (PEFR), symptoms, drug consumption, expenses directly or indirectly related to the disease, as well as information regarding personal socioeconomic status. At each follow-up visit (1, 3, 6, and 12 months), the patients underwent clinical examination, spirometry, methacholine (Mch) challenge, and assessment of diary-derived parameters and socioeconomic status. Asthma severity (AS) was classified into four levels, based on symptoms, drug consumption, and PEFR variability.
Results: At 12 months, 13 patients (group A) had ceased exposure; the remaining 12 patients (group B) continued to be exposed. At diagnosis, FEV1 percent and provocative dose causing a 20% fall in FEV1 (PD20) of Mch were lower in group A than in group B; patients of group A were also characterized by significantly higher basal AS levels. At 12 months, no significant variation in FEV1 percent or PD20 was found for either group, while AS levels improved in both groups, the change being more marked for group A than group B. Pharmaceutical expense at 12 months significantly (p < 0.05) decreased, as compared with the first month, in group A, whereas it tended to increase in group B. In group A, 9 of 13 subjects had reported a deterioration of their socioeconomic status as compared with 2 of 12 in group B (p < 0.01). A significant loss of income was registered in patients of group A (median 21.45, 25th to 75th percentiles 16.9 to 25.8 Italian liras x 106 on the year preceding diagnosis and 15.498, 10.65 to 21.087 Italian liras x 106 on the year after diagnosis; p < 0.01), whereas no significant change was seen for patients in group B.
Conclusions: In OA, cessation of exposure to the offending agent results in a decrease in asthma severity and in pharmaceutical expenses, but it is associated with a deterioration of the individual’s socioeconomic status (professional downgrading and loss of work-derived income). There appears to be a great need for legislation that facilitates the relocation of these patients.
Abbreviations: AS = asthma severity; HMW = high molecular weight; ITL = Italian liras; LMW = low molecular weight; Mch = methacholine; OA = occupational asthma; PD20 = provocative dose causing a 20% fall in FEV1; PEF, PEFR = peak expiratory flow (rate)
Key Words: costs • economic consequences • follow-up • occupational asthma • outcome
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Introduction |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Several studies have investigated the consequences of OA not only from a clinical but also from an economic point of view.3,4,5,6,7,8 In most works, however, the data have been collected by recontacting the patients at a certain time after diagnosis.6,8 In this study, we followed up prospectively at regular time intervals for 1 year a group of patients who were diagnosed in our center as suffering from OA due to various agents during 1992 to 1995. We report the individual and social disease-related costs along with the clinical and functional course of these patients.
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Materials and Methods |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Subjects
All subjects receiving a diagnosis of OA in our center from 1992
to 1995 were invited to participate in this study. There were 32
subjects eligible: in all of them, diagnosis of OA was confirmed by
means of specific inhalation challenge.9,10,11 All subjects
underwent skin tests with a panel of 11 common allergen
extracts11 (Lofarma Allergeni; Milano, Italy): a subject
was considered atopic if there was a personal history of eczema or
allergic rhinitis, or there was a positive skin reaction (wheal
diameter 
3 mm) to one or more allergens.12
Questionnaire
At the time of diagnosis (baseline), patients underwent a
careful interview. A detailed description of the current and previous
work situation was obtained by the employees. The following were also
recorded: duration of exposure, date of last exposure, time interval
from first exposure to first symptoms, duration of symptoms from onset
to first examination, and the date of the last symptoms.
Details on the current work situation of each patient were obtained from the employers, along with results of industrial hygiene surveys, when available, and with the safety data sheets of the products used by the patient at the workplace.
At the time of diagnosis, each patient was questioned about the total income of the year before diagnosis. At each follow-up visit, the income of the months preceding the visit was registered.
Asthma Severity
At each visit, on the basis of symptoms,
β2-agonist as occasion requires (prn) use, PEFR diurnal
variability, recorded on the asthma diary during the previous month,
and FEV1 percent of predicted, subjects were classified
into four subgroups according to the National Institutes of Health
classification of asthma severity:13 level 1 = mild
intermittent; level 2 = mild persistent; level 3 = moderate
persistent; and level 4 = severe persistent.
Spirometry
FEV1 and FVC were measured by a computerized
water-sealed spirometer (BIOMEDIN; Padova, Italy). The predicted values
were derived from Quanjer.14
Mch Inhalation Test
The details of the test have been reported
previously.15 The patient is first administered five
inhalations of phosphate-buffered saline solution. The latter are then
followed by increasing, doubling doses of Mch, at 2-min intervals:
dosage is increased from 30 to 3,200 µg as maximal cumulative dose or
until a fall in FEV1 of 20% from the highest postsaline
solution control level is observed. Two minutes after each series of
inhalations, FEV1 was measured as described above. The Mch
dose capable of causing a 20% fall in FEV1
(PD20) was calculated by interpolating on a semilogarithmic
dose-response curve.
Socioeconomic Parameters
Direct and indirect disease-related costs and monthly
work-derived income were analyzed. The following were considered as
direct disease-related costs: medications (total cost of the drugs
prescribed and taken by the patient for asthma maintenance), number of
visits at physician’s office and number of medical house calls, number
of visits at the emergency department, number of specialist
consultations (excluding those scheduled at our center), number of days
of hospitalization in the ICU, number of days spent in a pneumology
department, number of day-hospital visits, number of days of nursing
care, and patient transportation. As indirect costs, we considered the
number of work days lost by the patients and their
relatives.16,17 At each visit, each patient was asked
about his/her benefit claim ("have you been contacted by compensation
board?", ie, in Italy, the National Insurance Institute
for Occupational Diseases, "have you been granted benefit?").
Costs are expressed in Italian liras (ITL). Over the period of the study 1 US dollar approximately corresponded to 1,500 to 1,800 ITL.
Statistical Analysis
Data are presented as median, 25th and 75th percentiles in the
following way (median, 25th percentile to 75th percentile). Statistical
analysis was carried out by 
2 test, Wilcoxon
matched-pairs signed-ranks test, and Mann-Whitney U test,
where appropriate. Data derived from pulmonary function tests and Mch
challenge tests at 12 months were compared with those obtained at
diagnosis. The data derived from the patient diary (disease-related
costs, drug intake) at 12 months were compared with the data obtained
at the first follow-up visit (after 1 month). As concerns
pharmaceutical expenses, these were calculated separately for the first
month after diagnosis and for the last 6 months (monthly mean). The
income of the month before diagnosis was compared with that reported
for the 12th month after diagnosis. The income for the 12 months after
the diagnosis (ie, the study period) was compared with that
reported for the 12 months before the diagnosis.
A probability level < 5% was considered to be significant.
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Results |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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At 12 months, 12 patients (48%, group B) continued to be exposed. Five of them (42%) had changed their task but still worked in the same area of the plant, reporting intermittent or lower exposure to the offending agent; the remaining 7 (58%) continued to perform the same task in the same work area, being exposed daily to the offending agent. Table 3 shows the clinical and functional parameters, in group A and B respectively, at diagnosis and after 12 months.
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A significant reduction (p < 0.001) in AS, as expressed by AS distribution, was seen in the whole group of subjects at the first month follow-up visit (Fig 1), independently from the continuing or removal from exposure. In the following months, no further significant variation in the overall AS distribution was found; nevertheless, the number of subjects who reported no symptoms progressively increased. All the latter belonged to the group of subjects who were removed from exposure. At 12 months, six subjects in group A had been asymptomatic for the last 6 months of the follow-up period, whereas seven patients still complained of asthma symptoms. Of the latter, four subjects showed no improvement in AS, as compared to the baseline, whereas in the remaining three, a lower level of AS was found. In group B, all 12 subjects were still symptomatic at 12 months; 7 patients had a lower level of AS as compared with baseline, whereas in 5 patients, AS level was unchanged. Due to these figures, the distribution of the level of AS was significantly different from baseline in both groups at 12 months (Table 3).
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As concerns pharmacologic treatment, the proportion of subjects receiving inhaled steroids decreased from the time of diagnosis to 12 months in group A, while it slightly increased in group B, though neither change was statistically significant (Table 3).
With regard to the disease-related costs, only those of medications and lost work days were registered in a sufficient number of patients to allow statistical analysis. The other costs were from the follow-up program itself (scheduled visits). No cost due to unexpected events was registered in either group of patients. The pharmaceutical expenses, ie, the total cost of drugs taken by patients for asthma in ITL are reported in Table 3. In the first month after diagnosis, the pharmaceutical expense was significantly higher in group A than in group B. In the following months, a progressive decrease in group A and increase in group B, respectively, was observed. At 12-month follow-up visit, the amount of the expenses in group A was significantly lower than the baseline (first month follow-up visit) (–40.3%, p < 0.01), whereas no significant difference was found in group B.
The number of lost work days per month during the follow-up period decreased progressively: 2, 0 to 12.5 (mean, 7.5) days in the first month, 0, 0 to 2.75 (mean, 4.6) days during the second and the third month, 0, 0 to 0.9 (mean 3.8) days (p < 0.05 as compared with the first month) from the fourth to sixth month, and 0, 0 to 2.08 (mean, 2.9) days (p < 0.02 as compared with the first month) from the seventh to 12th month. In the last 6 months of follow-up, the total number of lost work days was higher in group A than in group B (0, 0 to 12, mean 28.8 vs 0.5, 0 to 13.75, mean 5.5, respectively). This difference, however, was not significant, because it was entirely due to long periods of unemployment of two subjects of group A.
At 12 months, 11 patients, 9 from group A and 2 from group B (p < 0.01), reported a deterioration of their economic condition. The remaining 14 patients reported no economic change.
Data on the annual income are reported in Table 3. At diagnosis, the annual income of the 12 months before diagnosis was similar in the two groups. At 12 months follow-up, the income of the 12 months after diagnosis of the patients in group A had significantly decreased as compared with the 12 months before diagnosis. No significant change was seen for patients in group B. The loss, as a percentage of annual income, was 26.6, 11.97 to 49.6 in group A and 0, 0.9 to 7.5 in group B (p < 0.01).
At the 12-month follow-up visit, seven patients (28%) were still awaiting to be contacted by the National Insurance Institute for Occupational Diseases. Eighteen patients (72%) had been contacted: 1 patient 1 month after diagnosis, 6 after 3 months, 11 after 6 months. Of the latter, seven patients (28%) had settled the claim for statutory compensation: four patients were awaiting compensation, three had already been granted disablement benefit. Five patients (20%) had had the claim rejected, six patients (24%) had claims that were outstanding. The amount of compensation awarded ranged from 67,000 to 522,000 ITL per month.
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Discussion |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Removal from exposure to the offending agent is recommended as the first-line measure for the management of OA.3,4 Our data show that in Italy7 as in other countries5,8 where this procedure is not mandatory, this occurs only in a limited proportion of subjects: at the 12-month follow-up, 52% of our subjects had ceased exposure to the offending agent, and 48% continued to be exposed. Moreover, in most cases, removal from exposure did not follow the diagnosis promptly, since 4 of 13 subjects continued to be exposed at reduced levels for up to 5 months.
In agreement with previous literature data,5,6,7 only about a quarter of our patients (6/25, 24%) could be relocated in the same factory without loss of employment. All these patients were employed in large corporations with an efficient medical service and the availability of areas completely clear of exposure to the causal agent. In our study, a consistent proportion of subjects who could not be relocated (28%) had to resign and look for another job, generally being professionally downgraded. One subject was unable to find another job and was still unemployed at the 12-month follow-up visit. The remaining subjects (12/25, 48%), worried by the difficulties in finding new employment, preferred not to leave their job, thus continuing to be exposed intermittently or daily. The proportion of subjects who remained exposed is higher than those reported by other authors:3,5,6,8,18 along with the different characteristics of studied populations, this finding could be accounted for by the current Italian socioeconomic condition that makes it difficult to find a new job.
Subjects who ceased exposure had more severe disease and lower PD20 of Mch at diagnosis than those who continued to be exposed. The age of the two groups was similar. These findings differ from those of previous studies3 in which the subjects who remained exposed were older and more seriously ill. Thus, in our data, the severity of disease at diagnosis seems an important determinant of the professional fate of the subjects. We suggest that in Italy, patients with OA cease exposure when are seriously ill, whereas, whenever possible, the subjects with milder asthma prefer to keep their original job, probably because of the economic difficulties related with a change of job. In addition, it is possible that the low intensity of the symptoms experienced by patients with mild OA, together with the symptomatic relief obtained by pharmacologic therapy, may lead these subjects to underestimate the consequences of continued exposure on their disease. Specific educational programs that increase the patient’s awareness regarding the health consequences of continued exposure, including cases of mild OA, would be useful.
An interesting finding of our study was that immediately after diagnosis, the degree of asthma severity ameliorated in the whole group of subjects, whether or not they were removed from exposure, probably as an effect of a better therapeutic regimen for these patients. This finding is in agreement with our recent findings that in Italy most subjects with OA are undertreated in the period before diagnosis.19 However, in the follow-up period, our results confirm those of previous studies20,21,22,23,24 inasmuch that the cessation or continuation of exposure influenced the outcome of the disease. The outcome was generally good only in the group of patients who completely discontinued exposure (group A), even if, in agreement with several other reports,24,25,26,27,28 a complete recovery was observed only in a part of the patients in this group (46.2%). Although we did not find a statistically significant reduction in PD20, even in group A, one must consider that the statistical power of the study was low depending on the small number of subjects. Indeed, the loss at 12 months of the difference in PD20 between the two groups observed at diagnosis suggests a different trend in the evolution of the disease. Furthermore, the present study reports the results of a relatively short follow-up after the diagnosis (12 months) and we cannot exclude that the patients removed from exposure reporting only clinical improvement at 12 months show complete recovery after a prolonged follow-up.29
In agreement with other recent studies,5,6,8 in our population, the short-term socioeconomic consequences of the diagnosis of OA were burdensome for the patients in group A, considering that job change resulted in professional downgrading or in periods of unemployment, and in significantly reduced income (income almost halved at 12 months). The loss of income in this group of patients who were no longer exposed was similar to that reported by Gannon et al5 in the United Kingdom and by Ameille et al8 in France. In contrast to our data, Gannon et al5 also reported a considerable loss of income for the patients who remained exposed, due to sickness, lack of promotion, or reduced opportunity for overtime. This fact did not occur in our subjects of group B, since they were able to maintain their job position, probably due to the lower degree of their asthma.
With regard to disease-related costs, only those costs concerning medications and loss of work days were registered in a sufficient number of patients to allow statistical analysis. No cost due to unexpected events (hospitalizations, visits at the emergency department, etc) was registered in either group of patients. In the first month after diagnosis, the pharmaceutical expense, as registered by the subjects in their diary cards, was significantly higher in group A, in agreement with the finding of a more severe disease at diagnosis in this group of subjects who needed more therapy. In the last 6 months of follow-up, the monthly pharmaceutical expenses of the two groups became similar due to a significant decrease in group A (–40.3% p < 0.01) and an increase in group B (+67.5%). These figures are mainly due to the fact that most patients from group A required both β2-agonists and moderate-dose inhaled corticosteroids at diagnosis and, due to the clinical improvement, only β2-agonists as needed at 12 months, whereas in group B, a reduction of asthma severity was obtained by increasing the dosage of both types of drugs (β2-agonists and inhaled corticosteroids). Therefore our observation, if projected on a longer time interval, may indicate that cessation of exposure permits a substantial saving on pharmaceuticals. The loss of work days appeared higher in group A than in group B, though the difference was not statistically significant probably due to type II error. This finding can be accounted for by the fact that a number of patients in group A were unemployed for some time after having quit their job, and others had remained at home from their illness before definitive cessation of exposure. The temporary avoidance of exposure leads to high socioeconomic costs, eg, the economic compensation that is issued by the insurance companies for sick days.
The absence of other direct and indirect costs in our follow-up group suggests that a careful follow-up program can avoid the other costs that are generally related to severe disease, disease exacerbation, and uncontrolled asthma, like, for instance, hospital admissions.30
Lastly, our data also show the difficulties encountered by our patients in obtaining disablement benefit. The Italian system for compensation does not guarantee prompt and automatic compensation of subjects with OA. Because of the delay with compensation, along with the current Italian socioeconomic condition that makes it difficult to find a job, a number of our patients who resigned after the diagnosis of OA remained without any financial support for a long period of time, with serious socioeconomic consequences.
In conclusion, in this study, cessation of exposure after the diagnosis of OA occurred in the more seriously ill patients, probably because they could not continue their job. In all cases, the diagnosis was quickly followed by an improvement in AS, probably due to a better therapeutic regimen. But in a short follow-up period, only cessation of exposure allowed recovery or a persistent clinical improvement. Cessation of exposure was followed by a decrease in the pharmaceutical expense, but more importantly, it resulted in loss of income. The slow compensation procedures from the compensation board further aggravated the economic conditions of these subjects. Legislation is needed to make mandatory the relocation of patients with OA to safe areas in the workplace and without professional downgrading. Alternatively, when relocation is not possible and the worker cannot keep his or her job, legislation should be aimed at providing prompt income replacement indemnity and developing priority pathways for the reemployment of patients with OA.
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Footnotes |
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Manuscript received November 26, 1997; revision accepted June 1, 1998.
Correspondence to: Gianna Moscato, MD, Salvatore Maugeri Foundation, Via Ferrata, 8 (loc. Cravino), 27100 Pavia, Italy; e-mail: allergo@fsm.it
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