Appendix 1 DIAGNOSIS AND TREATMENT OF CNSLD. Prof. Dr. H.J. Sluiter, Dr. J.C. de Jongste. 1 Introduction

Transcription

1 Appendix 1 DIAGNOSIS AND TREATMENT OF CNSLD Prof. Dr. H.J. Sluiter, Dr. J.C. de Jongste 1 Introduction In the last few decades there have been radical changes in the ideas surrounding chronic non-specific lung disease (CNSLD). There has been a greatly improved knowledge of its pathogenesis and the available therapeutic options. Before placing the pathogenesis and the diagnostic/ therapeutic options in an historical context, we shall start by introducing the concept of CNSLD and then provide brief case histories of three "typical" CNSLD patients. The article concludes with a number of expectations and target objectives for the future. 2 A brief introduction to the concept of CNSLD The concept of CNSLD comprises the syndromes of broncial asthma, chronic bronchitis and emphysema. These give rise to varying degrees of cough, bringing up sputum and breathlessness, either in the form of sudden attacks and/or as a result of physical exertion. It is often difficult to make a clear distinction between the various syndromes. This explains the frequent confusion that arises when trying to give specific names to particular conditions. In the Netherlands the term CNSLD (in Dutch, CARA) is mostly used; this covers all variants of the syndrome. Internationally, two separate syndromes are currently recognized: asthma and chronic obstructive pulmonary disease (COPD). These two syndromes often do not differ greatly from one another, at least in the case of most older patients. To be able to use an unifying term such as CNSLD with any degree of accuracy, it is vitally important in clinical and research work for a number of defining characteristics to be recorded, such as age, sex, previous medical history, results of physical examinations, data concerning pulmonary function, allergies and bronchial hyperreactivity. 215

2 3 Description of typical patients a. The patient with bronchial asthma is characterized by attacks of breathlessness alternating with symptom-free periods. Pulmonary function testing reveals that the airflow obstruction that occurred in attacks often disappears completely during the symptom-free periods. These patients also suffer from cough and the bringing up of mucus. b. The patient with chronic bronchitis is characterized by chronic cough and the bringing up of sputum. Breathlessness is a less pronounced symptom but may gradually become more severe with advancing age. c. The patient with emphysema typifies the somewhat older patient who suffers mainly from breathlessness upon physical exertion, while also suffering less severely from attacks of breathlessness, cough and the bringing up of sputum. In principle, CNSLD can. occur at any age. As a broad generalization, asthma is more prevalent in children and young adults, whereas chronic bronchitis and emphysema are typical of the older patient. Once again there are many exceptions to this rule. 4 Aetiology of the CNSLD syndrome No single cause of CNSLD can be identified. Previously the cause was mostly sought in external or congenital factors, but nowadays it is usually accepted that the syndrome is the result of both hereditary and external factors. Age and sex have a clearly-defined modulating influence on the syndrome; not least in older age groups through factors such as loss of pulmonary elasticity, which then playa contributory role in the condition. Diffuse bronchial obstruction is responsible for the onset of complaints and symptoms. Bronchial obstruction is mainly due to three separate components: (1) an abnonnal contraction of the airways muscle (bronchospasm), (2) a process of inflammation of the mucous membrane of the airways and/or (3) (in older patients) a loss of elasticity of the pulmonary tissue. As regards point 1 (bronchospasm), in nonnal circumstances the diameter of the airways is controlled by a balance of two opposing forces: the sympathetic nervous system dilates the airways, while the parasympathetic (or cholinergic) nervous system constricts them. There is still a great deal 216

3 of uncertainty surrounding the role of the "peptidergic system". the third - and recently discovered - form of regulation by the nervous system. It would appear that this system both codetermines the diameter of the airways and can influence the degree of inflammation of the bronchial mucous membrane ("neurogenic inflammation"). During bronchospasm, the normal balance of sympathetic and parasympathetic forces is disturbed. There is still much uncertainty as to the question of hereditary factors. It is usually assumed that CNSLD patients have a hereditary tendency to develop allergies that are very specifically directed towards substances in the environment. such as housedust, moulds, pollens, and products made from the skin and fur of certain types of animals. There are definite indications of this kind of allergy particularly in the case of young CNSLD (asthma) patients. When the CNSLD patient makes renewed contact with an allergen certain substances are released into the lungs and airways that directly or indirectly can cause bronchial obstruction. Particularly during the so-called late-phase allergic reaction (6-10 hours after the initial contact), processes of inflammation can be observed in the smaller airways which are the direct result of substances released into the airways and lungs during the early-phase allergic reaction (a quarter of an hour after the initial contact). Another important characteristic of the CNSLD patient is bronchial hyperreactivity, i.e. bronchial obstruction caused by inhaled substances or by physical irritants in such low concentrations as to provoke no reaction at all in normal persons. There are indications to suggest that bronchial hyperreactivity is also a hereditary condition; whether this is in fact the case remains highly uncertain. A significant proportion (probably about 10%) of young CNSLD patients develop symptoms as a result of an infection of the airways by certain viruses (bronchiolitis). There are indications to suggest that the virus is the cause of these chronic respiratory disorders. Definite proof of this does not exist as yet. Here as well the question arises whether hereditary factors are present. Other forms of chronic respiratory impairment in young children can lead to the onset of CNSLD symptoms at a later age, e.g. damage caused as a result of damage resulting from artificial mechanical ventilation in premature new horns. The clinical picture of the CNSLD patient is determined by a) symptoms of bronchial obstruction (especially breathlessness, and to a lesser extent 217

4 coughing and the release of sputum), and b) additional complications such as viral or bacterial infections of the airways and anatomical changes of the airways. 5 Diagnostic options Generally there are no great problems in diagnosing CNSLD, certainly not in clearly-defmed cases. However, diagnosing CNSLD can be trickier in the case of the very young and the elderly. The patient's medical history, which also includes the family medical history, pulmonary function tests and allergy and bronchial hyperreactivity tests all play an important part in diagnosing CNSLD. It may be noted that a physical examination can at certain points fail to reveal any abnormalities. Particularly in general practice, repeated periods of illness can sometimes be interpreted as independent occurrences and not be recognized as signs of a chronic syndrome. The diagnosis of CNSLD is largely up to general practitioners, who will be guided by the patient's medical history, the physical examination and a preliminary test of pulmonary function using a peak-flow meter. This instrument has been used in general practice for about ten years now. It provides a reasonably good indication of the extent of pulmonary function impairment and can also provide information on the degree of reversibility of the bronchial obstruction after the administration of a bronchodilator. Whether allergy tests also belong in general medical practice is still a matter of dispute. Performing and interpreting the skin tests is often far more difficult than one might suspect. The test for establishing the presence of antibodies in the blood does yield clear results but it is relatively costly. Tests for bronchial hyperreactivity are a matter for the specialists. With all the information that is obtained, it must be borne in mind that the data often refers to the patient's condition at a given moment, i.e. provides a snapshot of the condition; this certainly applies to pulmonary function. Other parameters, such as allergy and bronchial hyperreactivity, are less variable, but they can alter over a period of several years. Certainly in the case of the more serious CNSLD patients regular specialist monitoring of their condition is therefore appropriate, even though we feel that the general practitioner should still continue to exercise primary control. 218

5 6 Therapeutic options It will be clear that the essentially hereditary factor is as yet resistant to medical intervention. The additional options may be divided into two categories: preventive measures and curative measures. These two categories are not sharply separated. Preventive measures On the basis of recent scientific research, a virtually universal consensus has been reached in recent times that the use of preventive measures should be started at the youngest possible age. This is certainly true for children with one or both parents suffering from CNSLD. Contact with potential allergens (e.g. animals, dust) must be avoided as much as possible. Full programmes of vaccination must be carried out. Smoking must be banned in the patient's immediate surroundings. Particular attention needs to be devoted to the patient's living and sleeping arrangements. Later on, attention must also be paid to conditions at school, work, and in leisure activities. To the extent that preventive measures alone cannot prevent the onset of specific illnesses, medication must also be relied upon. Medications may be divided into different categories according to their effect. Medicines (1) Prophylactics/anti-inflammatory agents: - cromoglycate: when, after inspiration of an allergen, an allergic reaction occurs in the airways, cromoglycate can prevent the release of substances from the local mast cells leading to bronchoconstriction and inflammation. The drug can only be effective if it is administered prior to contact with the allergen. This drug has been in use for several decades and has few if any side-effects. - corticosteroids: these are synthetic substances derived from adrenocortex hormones with a very powerful anti-inflammatory effect. The immediate effect on the bronchial obstruction is relatively mild. These drugs are particularly effective in alleviating the late-phase allergic reaction and reducing bronchial hyperreactivity. A prolonged period of treatment with oral corticosteroids can result in serious side-effects. With the advent some years ago of corticosteroids in aerosol form, systematic treatment with corticosteroids is now 219

6 seldom recommended. At present, there is widespread and increasing use of corticosteroids in aerosol form; administered in normal doses, these aerosols produce minimal side-effects. (2) Bronchodilators (more specifically). These consist of the following categories: - jj2-sympathomimetics: these are drugs that mimic the effects of the sympathetic nervous system. They are powerful and rapidly-acting against bronchial obstruction, and act mainly on bronchospasm. They have no effect on the obstruction caused by inflammation. In aerosol form the side-effects are minor and often transient. Overdosing - almost always caused by incorrect usage - can result in unpleasant and even dangerous conditions, such as impaired circulation and even death in extreme cases. This sometimes occurs when the patient. while experiencing a temporary worsening of the condition, still persists in self-medication rather than alerting the doctor. Examples of B2-sympathomimetics include terbutaline, fenoterol and salbutamol. - anticholinergics: these drugs block the effects of the parasympathetic nervous system (the cholinergic system). They have a favourable effect on bronchial obstruction, particularly in the older and very young patient. Here as well the aerosol method has been in almost universal use for the last few years, resulting in very limited if any side-effects. One example of this category is ipratropium bromide. - theophylline preparations: the use of these preparations has gradually declined in recent times, not least because the effective dosage is often relatively close to the dose that provokes serious side-effects. The serum levels are subject to a variety of factors and must be regularly monitored during use. The introduction of delayed-action preparations some 10 years ago has improved the "patient-friendliness" of these drugs. In view of the widely-varying effects of these different drugs, it is no surprise to learn that in practice the medical profession makes fairly frequent use of a combination of different drugs. Other measures/medications - Physiotherapy of the chest and airways is of no use during an acute attack of breathlessness. Physiotherapy is more important for the "clogged up" patient who is either unable to or can no longer expectorate properly; 220

7 it is also particularly important for the older patient who suffers from a poor breathing technique. - Rehabilitation programmes, which also make extensive use of physiotherapy, can play an important role in treating the (frequently) older patient who has become increasingly inactive as a result of increasing breathlessness upon exertion. This state of inactivity leads to a further decline in the patient's pulmonary function and remaining capacity. There is a range of rehabilitation programmes that all aim to do away with this pattern of inactivity and to teach the patient to make the maximum use of his/her remaining options. The patient's co-operation and the involvement of his/her support network are crucial factors in a successful rehabilitation programme. Programmes such as these often yield very favourable shortterm results; more attention should be given to improving the longer-term effects of these programmes. - When complications occur, such as bacterial inflammation of the airways, antibiotics or chemotherapy must be administered. An essential part of the treatment is that medications must also be administered that counteract the swelling of the mucous membrane that accompanies the process of inflammation; these are mainly corticosteroids. During an acute phase, it may be necessary for a short period of time to administer corticosteroids, either in tablet form or parenterally. The combination of corticosteroids and antibiotics is usually extremely effective. - Reference was made at the outset to the usefulness of vaccinating children. The serious CNSLD patient also benefits from vaccination; in exceptional circumstances pneumococcal vaccination should also be considered. It is still not possible to vaccinate against the cause of bronchiolitis, the respiratory syncytial virus. 7 Future expectations and objectives In addition to the changes in attitude toward CNSLD over the last few decades, a number of expectations and future objectives may be noted. The view is gradually gaining acceptance that treatment should begin at the earlest possible age, and that the treatment should be both prolonged and consistent - even, in many cases, during periods of respite or periods relatively free of symptoms. One should therefore also bear in mind the 221

8 well-known fact that every chronic patient has a tendency to get used to a certain level of disability. If it is left to the patient's own initiative to report to his/her doctor for monitoring of the condition, practical experience shows that this approach does not produce satisfactory results. When treating CNSLD, it is therefore vitally important that the OP assumes or resumes the initiative for monitoring the patient's condition. Another important factor is the resistance shown by many patients and doctors to medication. Thanks to medicinal aerosols, the risks of sideeffects are now so slight that doctors can now recommend - more forcefully than hitherto - a lengthy period of medication. Delayed-action drugs have a favourable effect on the degree of patient compliance. In the future one of the most important tasks facing the medical profession in treating CNSLD will be to promote a sense of active cooperation between doctor and patient. While it is true that new forms of medicine, e.g. antileukotrienes may still be developed, the emphasis must remain on an optimal use at the earliest possible age of the wide range of options currently available. 222

9 Appendix 2 ECONOMIC ASPECTS OF CNSLD L..J.K. van der Velde, R. Gijsen, D. Ruwaard, H. Verkleij, A.F. Casparie 1 Introduction To gain some idea of the economic impact of the growing numbers of CNSLD patients and new developments in the diagnosis and treatment of CNSLD, we need to know the current social costs of CNSLD and how these are built-up. In this Appendix. we shall attempt to provide some idea of the direct costs of CNSLD. First, we shall deal with the question of costing. This will be followed by financial data relating to CNSLD; here grateful use was made of the "CNSLD in Figures" report by Van Molken et al. (1). After this. a number of future developments and policy recommendations are discussed. 2 Problems in costing health care Costing health care facilities is no easy, clear-cut matter (2,3). Often the only data available are from fees and bills that usually do not correspond with the true costs incurred. In addition, it is important to know whether just the direct costs of diagnosis and treatment were included in the total cost or whether the indirect costs were also included in the calculations, e.g. travelling expenses for the patient and his/her relatives. payments from public funds in connection with sickness absenteeism. employment disability. invalidity and loss of working-life due to premature death. Furthermore, other categories of expenditure must also be taken into account. e.g. the cost of preventive measures. scientific research, education and extra training. It becomes even harder when comparing the cost-effectiveness of a number of different treatments. Often only the variable costs are considered. i.e. those costs directly linked to the level of production. Far more important than these, however. are the longer-term costs and the fixed 223

10 costs, such as staffmg costs, depreciation and interest. A totally different problem is that of calculating the cost of life-saving treatment, but where the patients - as a result of ageing - fall victim to other diseases requiring medical care. 3 Current financial impact of CNSLD on health care In this section an estimate will be made of the direct costs (Le. costs of treatment) of diagnosed CNSLD patients in When estimating the fmancial effects of CNSLD (see Table 1), the data from Table 2.29 in this report were used to determine the level of medical consumption. These consumption figures are based on research data originating from the period; they were then revised to allow for demographic changes. The "Health Care Financial Report" (FOZ) (4), which contains statements of annual expenditure for each of the separate health care facilities, was used when estimating these costs. The use of the FOZ data is, however, subject to a number of drawbacks. In particular, the most recent FOZ report (4) only contained data for In the calculations below, it has been assumed that the 1988 costs correspond with those of Another assumption in calculating costs is that the volume of consumption (number of consultations, days, etc.) alone determines the level of expenditure, and not the specific nature or content of the consumption. The possibility has therefore been disregarded that CNSLD-related consultations or admissions might cost more or indeed less than the "average" consultation or admission. A subsequent problem when using FOZ data is caused by the division between the cost-items for (specialist) outpatient departments and inpatient care (hospitals, asthma centres). The FOZ bases its figures for specialist care on the cost of private medical specialists. These costs however refer to both outpatient and hospital care. If the cost of private specialists as provided by the FOZ is used to determine the costs of specialist consultations, this will lead to some overestimation of the costs as some of the cost of hospital care is already included in these figures. On the other hand, there is also a degree of underestimation, in that the costs of medical specialists' consultations are listed not under the heading of the payments made to them but under the heading of hospital expenditure. It needs therefore to be borne in mind when interpreting the figures in Table 1 that the distinction between specialists and hospitals is not an entirely realistic 224

11 one. This does not, however, have any effect on the total costs of medical consumption incurred by CNSLD patients. Although specific data could be assembled for a reasonable number of health facilities on the extent of the role of CNSLD, no numerical data could be obtained for a number of facilities, such as family care, general social work, physiotherapy and old peoples' homes. However, in order to form a judgement of the extent to which CNSLD absorbs health care resources, the following method has been adopted. On the basis of the available data, estimates were made in Table I for the share of resources accounted for by CNSLD. Based on these results, an estimate was then made of the importance of CNSLD in those facilities for which no information is available. On the basis of these data, an estimate will finally be made of the proportion of total costs directly attributable to CNSLD. Table I has been compiled in the following manner. For each facility, estimates have been made of the proportion of consumption attributable to CNSLD (column 3). Estimates were next made of the financial impact of CNSLD (column 5) by multiplying the total level of expenditure for each health facility as shown in the FOZ by the percentage figure in column 3 (column 4). In this respect it is therefore assumed that the volume of consumption is the sole determinant of the costs of a particular facility. Table 1 Financial burden of CNSLD on five health care facilities in 1990 column I column 2 column 3 column 4 column 5 column 6 consultations! Number of CNSLD share Total health Financial % contacts! CNSLD-relaled in total costs in 1988 burden of share nursing days cons. units medical in Fl. m. CNSLD in 1990* consumption (FOZ) in Fl. m General practitioners 989, % 1, % Oi strict nursing 411, % % Specialists 429, % 2, % Hospital/Asthma Centre 510, % ll, % Nursing Homes 831, % 3, % Total 20,268** % * based on the results of the scenario study (also see Table 2.29). ** comprises 46% of total health care costs in 1988 (FOZ). The remaining 54% consists of costs for facilities not included in the Table, such as general social work, physiotherapy, consumption of medication, rest homes, dental care and mental health care, etc, 225

12 On the basis of the data in Table 1, it may be concluded that CNSLD in 1990 results in 600 million guilders worth of expenditure in five separate facilities. It is notable that institutional care is far and away the most costly category within CNSLD health care. On the basis of the data in Table 1, it may be concluded that of the five facilities under review CNSLD accounts for 3% of total expenditure. With regard to the non-institutional consumption of drugs, the authors of "CNSLD in Figures" arrive, on the basis of data from the Institute of Medical Statistics (IMS), at an estimated figure of 148 million guilders, which represents 4% of the total expenditure on non-institutional medical consumption. To recapitulate, the total CNSLD expenditure for the six facilities described above amounts to almost 750 million guilders. To obtain an estimate of the total CNSLD claim on health care funds, it is unrealistic to assume a percentage rate of 3-4% as calculated above, in view of the fact that care facilities other than those described here (e.g. general social work, family care, old peoples' homes, mental homes, maternity care, dental care and psychiatric hospitals) very probably playa much smaller part in the care of CNSLD patients. Assuming CNSLD claims 2-3% of total health care resources, the total cost of CNSLD for the year 1990 would be between 936 and 1,400 million guilders. Assuming the existence of 457,000 known CNSLD patients in 1990 (see Tables 1 and 2 of Annex 3), the health care costs directly resulting from CNSLD will be between 2,000 and 3,000 guilders per patient on an annual basis. A large proportion of these costs consists of the utilization of institutional (inpatient) facilities. Older patients in particular make use of these institutional facilities. Given the age-distribution of the CNSLD patient population and the absolute scale of the disorder, chronic bronchitis may therefore be assumed to make the greatest demands on resources. 4 Comparison with the results of the "CNSLD in Figures" report As already stated, the "CNSLD in Figures" report also includes estimates of the direct costs of CNSLD. Although the report used another method of costing and worked mainly on the basis of amounts calculated per unit of consumption, these calculations also indicated a claim on resources of around 2-3%. The breakdown of costs per level of facility does however vary, as do the costs per patient. Whereas the above estimates revealed a unit-cost of 2,000-3,000 guilders per patient (assuming there are 457,

13 CNSLD patients), the "CNSLD in Figures" report produced an estimated figure of an annual 625 guilders per CNSLD patient, partly because a larger CNSLD population (totalling about one million) was assumed. The following explanations can be provided for the discrepancies between the two sets of estimates for the cost-breakdown according to level of facility. With regard to GP care "CNSLD in Figures" assumes over four times as many consultations. This is due in particular to the fact that, like Van der Lende, they considered that 75% of the consultations for colds were either directly or indirectly caused by CNSLD. This assumption thus calls for an adjustment to compensate for underdiagnosis and underrecording. In the Delphi-study forming part of the scenario project 30 experts were asked to estimate the level of underdiagnosis and underrecording (also see section 3.2.2). They estimated that 50% of CNSLD patients are not diagnosed as such and that 10% of consumption due at least in part to CNSLD by diagnosed CNSLD patients is not recorded under the diagnosis of CNSLD. If it is further assumed that undiagnosed CNSLD patients (given their less acute forms of CNSLD) consume half as much as diagnosed CNSLD patients, this produces a total figure of around 1.5 million GP consultations. On the basis of the most extreme replies of the respondents (Le. 70% of patients were not diagnosed as such and 50% of consumption by diagnosed CNSLD patients was incorrectly recorded) a total number of consultations is arrived at roughly equivalent to the figure quoted in the "CNSLD in Figures" report, Le. about 4 million consultations, which in financial terms would total around 140 million guilders. Also in the case of specialist (outpatient clinic) consultations, "CNSLD in Figures" bases its fmdings on a total number of consultations that is four times higher than the number used in this report. This was mainly due to the fact that the scenario study assumed that there was a much lower prevalence of CNSLD, namely 3% against more than double that level in "CNSLD in Figures". With regard to the consumption of inpatient facilities, the ratios were however reversed and the scenario study produced far higher figures. The scenario report assumes 15,000 extra days of hospitalization, which are partly the result of also including under this heading the nursing days at asthma centres. In addition, the sum on which the castings are based is somewhat higher, in that the FOZ data have been used in this appendix to arrive at an estimated figure; this was necessary because the FOZ funds were also used to estimate the cost of specialist (outpatient) care. The 227

14 interrelationship between both fonns of care in the FOZ has already been described. "CNSLD in Figures" is based on the costs calculated by Nederstigt per Diagnosis Related Group (the DRG system). On the basis of research carried out in three general hospitals and excluding transferred, deceased, and extremely long-tenn patients, Nederstigt arrives for CNSLD at a cost figure for each day of hospitalization that is almost half the final figure of the scenario study. "CNSLD in Figures" has therefore arrived at a total figure of million guilders for hospital care. Although in the case of nursing home care the two different sets of costings of the volume element of health care are based on the same source of data, the scenario study has arrived at a figure some 36 million guilders higher than that shown in "CNSLD in Figures". The scenario study assumes higher sums on both the volume and the cost side. A partial explanation for the differences lies in the fact that "CNSLD in Figures" describes the situation as it was in It may therefore be concluded that, although due consideration must be given in costing to the costs of patients not diagnosed as suffering from CNSLD (i.e. underdiagnosis) and the consumption of diagnosed CNSLD patients that had not been recorded as CNSLD consumption (i.e. underrecording), these costs are - relatively speaking - insufficient to cause any significant change in the share in the total costs of health care. This is particularly due to the fact that the problems of underdiagnosis and underrecording mainly occur within the field of primary care, a relatively inexpensive area when compared with other health care facilities. On the basis of the most extreme replies of the Delphi respondents concerning the problems of underdiagnosis and underrecording, the costs of GP care exceed the sum estimated in Table 1 by about 100 million guilders. 5 Financial impact of CNSLD in the future Estimating the future cost of CNSLD is an interesting albeit risky exercise. Assuming that demographic trends alone will feature in future developments and that no other changes are likely to occur, in the year 2005 (based on costs of 2,000-3,000 guilders per CNSLD patient), billion guilders will be spent on CNSLD (in line with the demographic model an increase of 17% compared to 1990). This is however a very rough estimate as it is not based on age-specific cost elements. Because the ageing of the population also affects the CNSLD population, thus putting ad- 228

15 ditional claims on costly, inpatient facilities, the costs per individual CNSLD patient are also set to rise in the future, thereby increasing the total cost. The Delphi respondents consider that the assumption that no changes other than demographic growth are likely to occur applies only to the level of severity of CNSLD (Le. exacerbations/complications). Under unchanged demographic conditions, the respondents predict a shift from inpatient to community care. This trend may reduce the rise in costs, but this is by no means certain. With respect to the number of CNSLD patients, a number of other developments are predicted for the future apart from demographic changes. The Delphi respondents consider for example that increased (medical) awareness in the year 2005 will raise the diagnostic rate (Le. the proportion of CNSLD patients diagnosed as such) from 50 to 75%. This would generate almost 300,000 more diagnosed CNSLD patients. In addition, the Delphi respondents predict that, independently of demographic changes, the life expectancy of CNSLD patients in the year 2005 will have increased by one to two years compared to that in 1990 and a 5% rise,in the incidence of CNSLD in These latter developments however cannot be quantified any further. As a consequence of the above trends in the growing numbers of patients, there will also be increased costs in the year The following qualification is, however, in order. The majority of these new patients suffer from less acute forms of CNSLD and consequently have different patterns of consumption. These will chiefly be the use of medication and GP care, where it is quite likely that. in view of the comparative mildness of the disease, this "new" category of patients will make fewer demands on these facilities. A new development that may very well significantly affect future costs is the application of guidelines for the diagnosis and treatment of patients, the so-called NHG code of practice. In the case of CNSLD, the guidlines for the treatment of CNSLD patients by GPs are still incomplete, which means that we are unable to discuss in any detail the financial implications of this new development A brief comment may however be made. The code of practice will very probably incorporate the required number of consultations. At present CNSLD patients receive approximately two consultations a year specifically for CNSLD problems (5). If the code of practice were to demand a higher frequency of consultation, this would not 229

16 automatically imply that the patient will in fact consult his/her GP more frequently, as it is quite probable that GPs would also attend to CNSLD problems (in accordance with the NHG code of practice) in the course of the six to seven consultations that CNSLD have with their GP anyway in the course of a year. If the code of practice is applied in this way, this will generate few if any extra consultations - and hence also cost - at macro level. If however the future application of the code of practice is financed by a system of separate payments, as in the case with diabetes mellitus, the costs could well start to rise. Conclusion No single unambiguous answer can be given to the question of the financial impact of CNSLD on our society. It can roughly be estimated on the basis of many assumptions - that 2-3% of total health care expenditure is currently devoted to the treatment of CNSLD patients. This amounted to a sum of 0.9 to 1.4 billion guilders in Assuming there were roughly 450,000 known CNSLD patients in 1990, this produced an annual sum of 2,000-3,000 guilders per patient. Inpatient care and the consumption of drugs accounted for much of this sum. In absolute terms, chronic bronchitis makes the heaviest claims on resources. Based on the fact that health care costs for the average Dutch citizen amount to about 3,000 guilders a year (4), the total costs for an "average" CNSLD patient range from 3,000 guilders (the patient is otherwise healthy) to 6,000 guilders (the patient suffers from other diseases besides CNSLD) on an annual basis. If one compares this with the estimated costs of diabetes mellitus in the previous scenario report (6), it turns out that diabetes mellitus claims about 1% of health care resources, or about 2,000 guilders per diabetes mellitus patient. Lack of data made it impossible to include any "indirect" costs in the estimates, such as costs resulting from premature death, sickness absenteeism, employment disability, invalidity, costs of scientific research, preventive measures, education and training. Although no reliable data are available, these costs are even more important in economic terms to society than the health care costs estimated here (1). Bearing in mind all the different assumptions that need to be made, it is difficult to outline the fmancial impact of CNSLD on future developments. Assuming in the year 2005 that one need only allow for demographic 230

17 trends, the sum required would be in the region of I to 1.5 billion guilders (figures not adjusted for inflation). It is hard to predict whether the total sum will rise towards the lor, instead, 1.5 billion guilder level in view of the various predicted developments with conflicting financial consequences, e.g. a shift from hospital to community care, increased numbers of (non-acute) CNSLD patients and the application of the CNSLD code of practice by GPs. Although the latter two innovations may in the period result in increased costs, an earlier and improved course of treatment may result over the longer term in a reduction of costs due to a possible decline in the numbers of seriously ill patients who, because of their condition, require a great deal of care. References 1. Van M6lken MPMH, Van Doorslaer EKA, Rutten FFH. CARA in Offers, verslag van een pilotstudie (CNSLD in Figures, report of a pilot-study). Institute for Medical Technology Assessment, Maastricht Drummond M, Stoddart G, Labelle R, Cushman R. Health Economics: an introduction for clinicians. Ann Int Med 1987; 107: Klein R. The role of health economics. Br Med J 1989: Financieel Overzicht Zorg 1990 (Financial Report on Health Care). Parliamentary Proceedings, session, 21310, nos. 1-2, Staatsuitgeverij, The Hague Central Bureau of Statistics. Health Interview Survey. Statistical information obtained on request Casparie AF. Economic aspects of diabetes mellitus. In: Chronic diseases in the year 2005, Vol. I: Scenarios on diabetes mellitus; Casparie AF, Verldeij H. Bohn, Scheltema, and Holkema, Utrecht/Antwerpen

18 Annex 1 Diagnostic criteria for classifying CNSLD by levels of clinical severity On the basis of data obtained from a standard questionnaire and pulmonary function testing, the TNO Working Party has assembled combinations of data representing five different levels of clinical severity. Also included here are the relevant questions from the Dutch version of the international questionnaire (1). Diagnostic criteria Level 0: No respiratory symptoms (no CNSLD) Negative response to Q.3 (chronic cough), Q.7 (chronic expectoration), Q.9 (one or more periods of bronchitis), Q.12 (dyspnoea), Q.17 (wheezing chest), and Q.19 (asthma attacks) of the standard questionnaire, AND No deviations in pulmonary function FEVI %VC no more than 5% lower than the predicted value. Levell: (possibly mild CNSLD) Respiratory symptoms Positive response to one of the following questions: 1. chronic cough (Q.3, positive) 2. chronic expectoration, (Q.7, positive) 3. a period of bronchitis of at least three weeks duration (Q.9, positive; Q.lO, negative) 4. grade 2 dyspnoea (Q.12, positive; Q.13, negative; age < 30; no overweight; no cardiac disorders; no hypertension) 5. grade 2 wheezing (Q.17, positive; Q.18, negative; does not smoke 10 or more cigarettes a day), AND Negative response to Q.19 (asthma attacks), AND No deviations in pulmonary function See under Level O. 232

19 Level 2: (probably mild CNSLD) Level 3: (moderately serious CNSLD) Level 4: (serious CNSLD) Respiratory symptoms (a) Positive response to more than one of the Level 1 respiratory complaints and (or) (b) Positive response to one or more of the following questions: 1. more than one period of bronchitis of at least three weeks duration (Q.9 and Q.lO, positive) 2. grade 3 or higher dyspnoea (Q.13, positive) 3. grade 3 or higher wheezing (Q.18, positive) 4. asthma attacks (Q.19, positive) OR Exclusively deviations in pulmonary function FEV1 %VC 5-15% lower than the predicted value. Respiratory symptoms: as listed under 2a and (or) 2b and in addition Deviations in pulmonary function: FEVI %VC more than 5% lower than the predicted value OR Respiratory symptoms: as listed under Level 1 and in addition Deviations in pulmonary function: FEV1 %VC more than 10% lower than the predicted value OR Exclusively deviations in pulmonary function FEV1 %VC more than 15% lower than the predicted value. Respiratory symptoms: as listed under Levelland in addition one or more symptoms listed under Level 2b, or more than one of the symptoms listed under 2b AND Deviations in pulmonary function FEVI %VC 10-25% lower than the predicted value. 233

20 Level 5: (very serious CNSLD) Respiratory symptoms As listed under Level 2a and in addition one or more symptoms listed under Level 2b, or more than one of the symptoms listed under 2b AND Deviations in pulmonary function FEVI %VC more than 25% lower than the predicted value. 234

21 Relevant questions on symptoms affecting the airways taken from the Dutch version (1) of the international questionnaires (2,3) Symptoms A Medical history of respiratory diseases Introduction: I am going to ask you a few questions about your chest. Would you please answer - as far as possible - with a simple "yes" or "no". If you do not understand a particular question, please say so. I Cough 1. In the winter do you normally cough when getting up in the morning? (Record as positive responses: coughing when smoking first cigarette of the day, or when going outside. Ignore clearing the throat or single cough.) 2. In the winter do you normally cough during the day - or at night? (Ignore sporadic coughing.) Only ask Q.3 and QA if respondent answered at least one of the previous questions with a "yes": 3. Do you cough this way almost every day, or for three months of the year? 4. What age were you when you started to cough? II Sputum 5. In the winter do you normally cough up phlegm when getting up in the morning? (Record as positive responses: coughing up phlegm while smoking first cigarette of the day, or when going outside. Also include swallowed phlegm. Ignore nasopharyngeal secretions.) 6. In the winter do you normally cough up phlegm during the day - or at night? (Record as positive two or more incidents a day.) 235

22 Only ask Q.7 and Q.8 if respondent answered at least one of the previous questions with a "yes": 7. Do you cough up phlegm this way almost every day, or for three months of the year? 8. What age were you when you started to cough up phlegm? 9. Have you sometimes had in the last three years a period of (increased) coughing and release of phlegm of at least three weeks duration? If the respondent answers with a "yes": 10. Did this happen more than once? ill Breathlessness (The questions refer to the average condition of the respondent during the winter period.) 11. Insert a "1" here, if the respondent has difficulty in running due to causes other than heart or lung diseases. 12. Do you suffer from breathlessness when having to hurry on level ground, or when having to ascend a slight incline or climb stairs at an ordinary rate? ("no" - Levell, go to Q.16. "yes" - carry on to next question) 13. Do you suffer from breathlessness when walking at normal speeds on level ground with other people of your own age? ("no" - Level 2, go to Q.16. "yes" - carry on to next question) 14. Do you sometimes have to stop to get your breath back when walking at your own pace on level ground? ("no" - Level 3, go to Q.16. "yes" - carry on to next question) 15. Are you short of breath when relaxing? ("no" - Level 4, go to Q.l6. "yes", carry on to next question) 15a. Sometimes or always? 236

23 16. What age were you when you first found you suffered from breathlessness? (If respondent says "at about this age", this is acceptable). IV Wheezing breathing 17. Have you ever suffered from a wheezing chest? If so: 18. Do you have this most days or nights? If so: 18a. Do you have this almost every day or night? V Asthma attacks 19. When relaxing have you sometimes suffered attacks of tightness of the chest combined with wheezing? (Asthma attacks) If so: 20. What age were you when you had your first attack? (If respondent says "at about this age", this is acceptable). 21. What age were you when you had your last attack? (If respondent says "at around this age", this is acceptable). 1. Lende R van der, Jansen-Koster EJ, Knijpstra S, Meinesz AF, Wever AMJ, Orie NGM. Definitie van CARA in epidemiologie en preventie (Definition of CNSLD in epidemiology and prevention). Ned T Geneesk 1975; 119: EGKS. Questionnaire pour l'etude de la bronchite chronique et de l'emphyseme pulmonaire. Luxembourg: CECA, MRC. Medical Research Council's Committee on research into chronic bronchitis. Instructions for the use of the questionnaire on respiratory symptoms. London: Medical Research Council,

24 Annex 2 I.C.D. codes Chronic Obstructive Pulmonary Disease and allied conditions (codes ) There follows an abbreviated classification of Chronic Obstructive Pulmonary Disease and allied conditions according to the International Classification of Diseases, 9th revision (1). 490 Bronchitis not further specified as acute or chronic 491 Chronic bronchitis subdivided in Simple chronic bronchitis Mucopurulent chronic bronchitis Obstructive chronic bronchitis Other chronic bronchitis Unspecified chronic bronchitis 492 Emphysema 493 Asthma Extrinsic asthma Intrinsic asthma Asthma, unspecified 494 Bronchiectasis 495 Extrinsic allergic alveolitis 496 Chronic airway obstruction, not elsewhere classified The registration of chronic bronchitis (incl. emphysema) and asthma in the Nijmegen general practices is based on ICHPPC-2-defined (2). In this chronic bronchitis (incl. emphysema) broadly corresponds with the ICD codes 491, 492, 494 and 496. Asthma corresponds with ICD code International classification of diseases. Manual of the international statistical classification of diseases, injuries and causes of death. World Health Organisation, Geneva 1977; 1: ICHPPC-2-defined. International Oassification of Health Problems in Primary Care. Oxford University Press,

25 Annex 3 The number of patients with asthma, chronic bronchitis (including emphysema) and CNSLD in 2005 compared with 1990 according to the static model Table 1 The number of asthma patients in the period by age and sex based on the NUHI prevalence figures (1) increase absolute (%) men women men women men women ,195 17,494 41,832 17,656 1,637 ( 4.1) 162 ( 0.9) ,165 36,329 27,964 34,180-2,201 (-7.3) -2,149 (-5.9) ,232 14,035 4,547 19,579 1,315 (40.7) 5,544 (39.5) ,176 5,479 2,538 6, (16.6) 548 (10.0) , ,616 0 (0.0) ) Total 75,768 74,610 76,881 79,058 1,113 ( 1.5) 4,448 (6.0) Table 2 The number of chronic bronchitis patients (including emphysema) in the period by age and sex based on the NUHI prevalence figures (1) increase absolute (%) men women men women men women ,497 5,292 6,899 4, ( 6.2) -303 (-5.7) ,757 19,330 21,994 18, ( 1.1) -523 (-2.7) ,630 22,705 85,806 31,451 26,176 (43.9) 8,746 (38.5) ,288 28, ,505 31,421 18,217 (18.5) 2,941 (10.3) ,251 13,291 41,170 17,670 9,919 (31.7) 4,379 (32.9) Total 217,423 89, , ,338 54,951 (25.3) 15,240 (17.1) 239

26 Table 3 Number of CNSLD patients in the period by age (up to 65) and sex based on the Vlaardingen prevalence figures (up to age 15 10%) (2) increase absolute (%) men women men women men women , , , , , , ,143 74, , Total 164,188 1,193 ( 0.6) 143,363-12,138 (-3.8) 103,491 85,301 (42.0) ( ) ( - ) ( - ) 4,036 (2.5) -10,160 (-ti.6) 29,074 (39.1) ( ) ( - ) ( - ) 1. University of Nijmegen Institute of General Practitioners Continuous Morbidity SUiveillance Project, Data obtained on request. 2. Lende R van der, Jansen-Koster EJ, Knijpstra S, Meinesz AF, Wever AMJ, Orie NGM. Prevalentie van CARA in Vlagtwedde en Vlaardingen (prevalence of CNSLD in Vlagtwedde and Vlaardingen (computer diagnosis versus GP diagnosis). Ned Tijdschr Geneesk 1975; 119:

27 Annex 4 Description of three "typical" Dutch CNSLD patients on whom questions were asked in the Delphi questionnaire In most of the questions we used the blanket tenn "CNSLD". However, in some of the questions we wanted to distinguish between the three separate categories of asthma, chronic bronchitis and emphysema. Because these categories also encompass a wide range of different conditions, the tenn "an average patient", for example, will mean different things to different people. We have therefore described three "typical" Dutch CNSLD patients on whom questions were asked in the questionnaire. The asthma patient A 20-year old patient suffering from attacks of breathlessness combined with wheezing expiration. Between attacks he has no complaints. He is able to do his work properly. Outside the periods of the attacks his vital capacity (VC) and forced expiratory volume in one second (FEV!) are both nonnal. The chronic bronchitis patient A 40-year old patient suffering from frequent periods of severe and prolonged coughing and bringing up slimy white sputum. He also frequently experiences mild attacks of breathlessness of varying degrees of intensity. On average he misses 6-8 weeks work each winter as a result of his "bronchitis": a worsening cough and release of sputum, with frequent bouts of fever. His pulmonary function initially shows no signs of impaired expiration, but clear signs of impainnent are confinned later on; these are only partly alleviated after inhalation of a bronchodilator. The emphysema patient A 60-year old patient who after his 20th year had gradually begun to cough and bring up small quantities of white sputum. To begin with he suffered little discomfort. The last five years have meant ever-increasing breathlessness, particularly upon physical exertion. In addition, in the mornings he definitely needs a few hours to get into his stride. Since the age of 14 he has smoked cigarettes a day. A physical examination revealed a rigid thorax in the position of full inspira- 241