Introduction
Health care expenditure in the most economically advanced countries seems to have spiraled out of control over the last few decades. There are three main reasons accounting for this situation: ageing of the population has led to an increase in the numbers requiring health care services, the accelerating pace of technological development has given rise to new techniques that have improved the quality of treat- ment, and with the introduction of new, increasingly costly, products, patient expectations have changed and patients thus demand better medical treatment.
The combination of these three factors has resulted in health care spending becoming increasingly diffi- cult to control.
This means that the available resources must be managed to the best advantage. Clearly, this implies adopting the economic strategy that, according to Samuelson’s [1] definition, consists of maximizing the use of very limited resources that could be allo- cated for other purposes.
The need to control health care expenditure initial- ly prompted decision makers to consider implement- ing investment cuts, with little regard for the long- term repercussions that these could have. However, it soon became apparent that to optimize the use of resources allocated to health care, expenditure had to be rationalized rather than rationed. Targeted objec- tives of the health care policy (only the efficacy or only the cost of a service) have, therefore, been superseded by multidimensional objectives, which correlate the efficacy of a program with the costs that it involves. In this light, once clinical efficacy has been established, health care programs must now be assessed in terms of their economic efficiency (technical and allocational) before a new therapeutic approach is introduced.
Economic Assessments in Health Care
An economic assessment is, by definition, “the com- parative analysis of alternative courses of action in
terms of both their costs and consequences” [2]. The steps to be taken in any assessment are, therefore, to identify, measure, evaluate, and compare the costs and consequences of the alternatives under consider- ation. These operations apply to all fields, not the least of which is health care services.
As various therapeutic options have to be consid- ered, it is important that the alternatives to be com- pared are homogeneous. The aim of rationalizing the use of resources requires that costs and effects of a program be compared with costs and effects of pro- grams of the same kind, with a view to ascertaining which is the most advantageous from an economic standpoint. There are, in effect, no set rules govern- ing the choice of the optimal alternative; however, that optimal alternative should always be therapeuti- cally significant (more frequently used and/or more efficacious), readily available, and consistent with the design of the study.
For the economic evaluation to be successful in the field of health care, the purpose of the analysis undertaken must be clarified, primarily to correctly identify the costs and effects under consideration.
Cost is a subjective concept. Indeed, a cost must be borne by someone, and assessment of the cost will, therefore, depend on whom that someone is. In the field of health care, an economic assessment can be carried out from various points of view: the third- party payer (insurer), the national health service (NHS), the hospital facility, the patient, or society, the latter comprising all the other categories. The perspective of society is so vast that it embraces all possible costs and effects. To adopt this perspective would be simply too complicated, albeit more inter- esting. Moreover, society as a whole is unlikely to make direct decisions on the allocation of resources.
Having established the alternatives to be examined and the perspective of the analysis, the problem remains of quantifying costs (Table 1) and effects (Table 2). Both can be subdivided into three catego- ries: direct, indirect, and intangible. Direct costs can be further subdivided into health care and non-health care costs.
Social Aspects and Economics of Fecal Incontinence
Carlo Ratto, Patrizia Ponzi, Francesca Di Stasi, Angelo Parello, Lorenza Donisi, Giovanni B. Doglietto
7
Direct Costs Health Care
Direct health care costs are those that can be directly attributed to the procedures related to the diagnosis, treatment, and rehabilitation involved in the man- agement considered or necessary as a result of the pathological conditions addressed by that manage- ment.
Non-health Care
Non-health care costs comprise a range of expenses directly related to the intervention considered but which are not of a health care nature (e.g., the cost of transporting patients).
Indirect Costs
Indirect costs are generally regarded as those due to loss of productivity as a result of a pathological event and the treatment thereof. Estimating these social costs is one of the more difficult aspects encountered in the economic appraisal of health care interven-
tions. Quantifying these costs is useful particularly when the analysis technique is the most complete and the perspective is the broadest, i.e., the perspec- tive of society as a whole. Apart from the difficulty in establishing true productivity losses, estimating these costs often proves critical for various reasons.
Thus, with the exception of a few particular cases, these costs are usually ignored.
Intangible Costs
Intangible costs are those borne by the individual as a result of being in a poor state of health. These can- not be assessed directly or evaluated in absolute quantitative terms. Anxiety, stress, and pain are a few examples. Quantifying these costs requires the use of specific techniques and instruments ad hoc.
Direct Effects
These are the effects attributable to the diagnostic, therapeutic, and rehabilitative procedures related to the management of the case. These may manifest as variations in objective clinical parameters, variations in the probability of certain undesirable events such as a heart attack or stroke, or variations in so-called final consequences such as mortality or life expectancy.
Indirect Effects
These are generally interpreted as the effects arising from the loss of productivity caused by the patholog- ical condition and/or by the management adopted.
Intangible Effects
These refer to the effects on the individual due to the impaired state of health. As these are of an intangible nature, they cannot be assessed directly. They con- cern psychological aspects such as anxiety, stress, and pain that affect the patient’s quality of life. To estimate these effects, specific techniques and ad hoc instruments are required, as well as clinical indices (erroneously defined as subjective) capable of esti- mating the quality of life related to a specific type of treatment or health condition.
Analysis Techniques
Essentially, four different techniques are used to per- form the analyses, which, in order of increasing com- Table 1.Classification of costs and examples
Direct Indirect Intangible
Drugs
Hospitalization
Loss of work time Psychological factors Diagnostics
Loss of earnings Impaired quality of life
Rehabilitation Home care
Table 2.Classification of effects and examples
Direct Indirect Intangible
Reduction in costs of personnel and materials
Reduction in mortality
and morbidity Alleviation of pain Reduction in costs
due to side-effects
Reduction in loss Improved quality of productivity of life
Improvement in clinical parameters
plexity, are: cost minimization analysis (CMA), cost effectiveness/efficacy analysis (CEA), cost utility analysis (CUA), and cost benefit analysis (CBA) [3].
These techniques focus on the pathological condition and its treatment; however, another type of analy- sis–“not complete” economic evaluation, the cost of illness analysis (CIA)–also focuses on the burden of a pathological condition.
Cost Effectiveness/Efficacy Analysis (CEA)
In a CEA, the costs of the alternatives considered are analyzed in relation to the efficacy of those alterna- tives as expressed in clinical units. Efficacy may be expressed in terms of intermediate parameters of clinical relevance for a certain pathological condition (blood pressure, cholesterolemia) or as final out- comes (deaths prevented, life-years gained, symp- tom-free years). The result emerging from this type of analysis provides the ratio in which the numerator is a cost, and therefore expressed in monetary units, and the denominator is an effect, which is expressed in clinical units.
The final result of a CEA is a cost-effectiveness ratio, which may be either pure or incremental. In the latter case, the higher costs resulting from the more efficacious treatment are evaluated in relation to the greater efficacy of that treatment, with a view to establishing its economic efficiency [4]. This type of analysis is undoubtedly the one most commonly used in the economic evaluation of pharmaceutical drugs.
Cost Minimization Analysis (CMA)
CMA is, in essence, a cost-effectiveness analysis.
Indeed, if the efficacy of the alternative treatments is identical, a comparison can be made only with regard to costs. The CEA, therefore, becomes a cost mini- mization analysis, and the alternative chosen will be that generating the lowest costs.
Cost Utility Analysis (CUA)
CUA is a more sophisticated technique than CEA, from which it is derived. In CUA, the results of phar- macological treatment are expressed in utility- weighted years of life saved, or in the equivalent years of good health (Quality Adjusted Life Years or Healthy Years Equivalent). The utility index summa- rizes and expresses as a number between 0 and 1 the desirability of a healthy condition, also taking into account the intangible aspects, i.e., those concerning quality of life. These assessments have the advantage of also allowing comparisons to be made between heterogeneous types of intervention, as the result is
always a ratio, the numerator of which comprises costs (monetary units) and the denominator of which is usually expressed in terms of Quality Adjusted Life Years.
Cost Benefit Analysis (CBA)
In the CBA, health care effects are also expressed, as costs, in monetary terms. This is the most complex of the techniques used. Obviously, it is extremely diffi- cult to convert a life saved into monetary terms and sometimes conceptually controversial. It is achieved by means of highly complex instruments, such as that of “willingness to pay”. The result of a CBA is usually expressed in terms of net benefit or cost (the difference between costs and benefits) or as a ratio in which both the numerator (costs) and the denomina- tor (benefits) are translated into monetary units. This technique is rarely applied in pharmacoeconomic studies. Assessments of costs and effects in the vari- ous techniques of pharmacoeconomics are summa- rized in Table 3.
Cost of Illness Analysis (COI)
Studies on the COI highlight the impact of a certain disease on society, focusing on the extra resources required to manage the disease as well as productivi- ty lost as a result of the disease. Where the cost of dis- ease is high, a COI study may help to reveal the need for action to better manage this disease. The COI approach estimates the direct costs associated with an illness, sometimes including the cost to society resulting from lost earnings. It does not account for pain and suffering, the value of lost leisure time, or the costs and benefits of preventive measures.
Although COI studies cannot be considered complete economic evaluations, they are still aimed at denot- ing appropriate choices in resource consequences of health problems in relation to each other.
Very few studies have evaluated the economic impact of fecal incontinence in terms of costs related to the condition itself or the cost of the various treat- ment options. The studies carried out in various countries using a variety of techniques and mostly focusing on specific interventions and patient groups make it difficult to extrapolate the findings to the entire population with fecal incontinence. Whereas it is difficult to compare economic information related to a pathological condition across countries, it is even more difficult to compare cost-effectiveness information concerning relative treatment options.
For this reason, a review is presented herewith con- cerning findings regarding the costs of the patholog- ical condition, whereas economic aspects related to specific treatment options are not discussed here.
The Cost of Fecal Incontinence
In a Dutch study [5], published in 2005, the mean annual cost of a patient affected by fecal incontinence was reported to be 2,169 euros, namely 1,051 euros referring to direct costs and 1,118 euros to indirect costs. An Italian investigation [6], conducted in that same year, recorded the direct costs alone as 1,103 euros, an amount almost identical to that reported in the Dutch study (Table 4). The paucity of data avail- able in the literature is, therefore, offset by a certain homogeneity in the results. The individual cost items are examined below, with particular attention being focused on the distinction between the direct costs involved both in health care and non-health care.
Direct Costs
Direct Health Care Costs
Fecal incontinence is a very particular case in that some items of expenditure are not attributable to a single agent. Indeed, the local health care authorities
(territorial bodies responsible for financing and pro- viding health care services for the residents in their area) often bear some costs (direct health care costs), which are subsequently borne by the patient (direct non-health care costs). Costs related to diagnostic tests and hospitalization are unequivocally attributa- ble to the NHS.
In the case of fecal incontinence, the costs of instrumental and laboratory tests are not high in absolute terms compared with those related to other common diseases. Indeed, the unit cost of examina- tions such as manometry and colonoscopy are fairly low, as sophisticated diagnostic technology is not involved. Albeit, costs may rise, as these tests often have to be repeated. Indeed, it is not uncommon for patients to constantly search for a solution to their problem, seeking opinions from different physicians in different places (different hospitals sometimes in different regions) and, therefore, undergo the same instrumental examination several times.
Patients presenting with fecal incontinence are often not hospitalized; for instance, in Italy in 2003, the number of hospitalizations with a diagnosis of fecal incontinence on discharge amounted to 222 [7].
To place this figure in its proper perspective, it should be compared with the number of hospitaliza- tions for two very common disorders with a heavy clinical and social impact, namely, hemorrhoids and urinary incontinence, which accounted for 36,073 and 2,274 hospitalizations, respectively, in 2003 [7].
Two different issues may account for this low fre- quency of hospitalization. First, these patients face an intricate diagnostic workup and therapeutic pro- cedure. Indeed, the number of patients seeking a solution to the problem of fecal incontinence is far Table 3.Assessment of costs and effects in the various techniques of economic evaluation of pharmaceutical drugs Type of analysis Measurement/evaluation Identification of effects Measurement/evaluation
of costs for both alternatives of effects
Cost effectiveness Monetary units (e.g., euros) A single target result common Physical units of measurement
analysis (CEA) to both alternatives but (e.g., number of lives saved,
achieved to different degrees years of life gained, reduction in blood pressure, etc.) Cost minimization Monetary units (e.g., euros) Identical in all relevant aspects None
analysis (CMA)
Cost utility Monetary units (e.g., euros) One or more effects, not Quality Adjusted Life Years:
analysis (CUA) necessarily common to both years of life adjusted
alternatives and achieved for quality to different degrees
Cost benefit Monetary units (e.g., euros) One or more effects, not Monetary units (e.g., euros)
analysis (CBA) necessarily common to both
alternatives and achieved to different degrees
Table 4.Cost of fecal incontinence
Costs Deutekom et al. [5] Ratto et al. [6] Italy The Netherlands
Type
Direct 1,051 euros 1,103 euros Indirect 1,118 euros
Total 2,169 euros 1,103 euros
lower than the number actually affected by the disor- der. Moreover, of those who consult their general practitioner, not all obtain a diagnosis, whereas oth- ers receive no treatment even when a diagnosis is made. This still occurs despite the fact that it has now been demonstrated that the treatment options avail- able are both clinically efficacious and economically efficient and are, therefore, potentially able to offer long-term savings for the NHS.
The second aspect accounting for the low number of hospitalizations for fecal incontinence is related to the nature of the hospitalization itself. Indeed, a patient presenting with this disorder is unlikely to be hospitalized for diagnostic purposes, hospitalization generally being reserved for treatment purposes. In the light of these considerations, clearly, the limited number of cases treated results in a limited number of hospitalizations.
Once diagnosis is made, many patients are not referred for surgery, which could yield a definitive solution to their problem, but undergo lengthy reha- bilitation programs, which do not always yield satis- factory results. Considering that in Italy the mean cost to the NHS of a rehabilitation session is 200 euros and that the entire course is usually 10–15 ses- sions, which are often repeated due to unsatisfactory results, the impact this has on the total cost of the disorder can be readily appreciated.
Direct health care costs also include expenditure on pharmaceutical drugs, which in patients with fecal incontinence are antidiarrheal and laxatives. These drugs do not have a high unit cost, their impact on the total cost of the disorder being <10% (5.4%
according to Deutekom et al. [5] and 3.9% according to Ratto et al. [6]).
The items weighing most heavily on the total cost of the disorder undoubtedly concern incontinence materials (disposable diapers and pants, washable nappies, anal tampons, underblankets and water- proof sheets, feces bags, etc.), which account for
~25% of total expenditure [5] and is borne both by the NHS and the patient. In countries with an NHS, the patient receives incontinence materials free of charge and, theoretically at least, does not have to buy them personally. Albeit, what usually happens is that these incontinence materials, due to the need for standardization of products and prices when large quantities of materials are purchased, fail to meet the needs of the individual patient; most patients, there- fore, buy the products that they deem most useful.
Thus, the expense is incurred twice: once by the NHS (direct health care costs) and once by the patient (direct non-health care costs). This phenomenon, reported by numerous patients and common to all the countries involved, results in a waste of money that could be avoided by more carefully choosing the
devices to be supplied to patients. The situation is further aggravated by the fact that those prescribing the devices tend, for convenience, to prescribe the maximum number in order to avoid frequent requests from the patient. In Italy, for example, the maximum number of pads that can be prescribed per patient is 120 per month; the magnitude of the cost can easily be appreciated. A recent Italian study [8]
estimated the monthly cost of pads borne by local health care authorities to be 35.79 euros per patient, i.e., an annual expenditure per patient of approxi- mately 500 euros.
Direct Non-health Care Costs
Fecal incontinence compared with other disorders does not appear to have a heavy overall impact on the NHS. Indeed, as already pointed out, the costs relat- ed to the disorder are almost entirely borne by the patients themselves or their families. In addition to the cost of pads, other costs have to be borne entire- ly by the patient. The above-mentioned Dutch study [5] estimated expenditure for antidiarrheal drugs (used by 26% of the patients interviewed), skin care products (11%), special articles of clothing (10%), cleaning products (9%), and special foods (6%).
In terms both of direct and indirect costs, cleaning the incontinent patient accounts for a large propor- tion of the total costs involved in the disorder.
Indeed, taking into account how much time is spent cleaning patients who are permanently in institu- tions, it has been estimated that the personnel in charge of caring for incontinent patients devote 2 h per day (13.3% of the time available) to this duty.
Moreover, the cost is aggravated by the fact that episodes tend to occur more frequently during the night, when fewer staff members are on duty [9]. If 25% of the working hours of a health care worker employed in a residential facility are devoted to cleaning incontinent patients, the same percentage of the salary earned by that person should be regarded as a direct cost generated by fecal incontinence.
However, the costs of health care personnel are not limited only to salary; staff members who spend much of their time cleaning incontinent patients are more prone to dissatisfaction and depression as well as to infection than are those engaged in other activ- ities, and they are more likely to give up their jobs [10].
Indirect Costs
The population of incontinent patients is relatively young (33.3% <40 years of age) i.e., of working age [11]. The cost of the disorder in terms of lost work-
ing hours is high in that many patients are frequent- ly absent from work or, in the very severe cases, are prompted to take early retirement. Moreover, the indirect costs resulting from reduced working activ- ity are not attributable exclusively to the patients themselves; they may also be generated by absen- teeism on the part of those assisting the patient.
Indeed, the same considerations made above, with regard to the mean number of hours devoted per day to cleaning institutionalized patients, are also valid with regard to patients who are assisted at home.
The phenomenon of congenital incontinence mer- its particular attention. This disorder has a heavy impact on parents, who often have to curtail their working activity to take care of their sick children.
Intangible Costs
Intangible costs refer to the cost of a disease in terms of pain, suffering, and discomfort. Whereas these effects cannot be evaluated in monetary terms, they nevertheless contribute to the overall burden of the disorder. In the case of fecal incontinence, the intan- gible costs primarily concern impaired social activity resulting from the shame and embarrassment that most patients suffer. In other words, fecal inconti- nence impairs the patient’s quality of life.
The issue of intangible costs, which is extremely interesting and important, is discussed in the chapters of this volume concerning specific conditions of FI.
Conclusions
Fecal incontinence has a significant impact on health care expenditure, the burden being compara- ble to that of better known diseases such as urinary incontinence (with which fecal incontinence is often associated). It accounts, for example, for a mean cost per patient (females) per year of 500 euros in Europe (359 euros in the UK, 515 euros in Germany, and 655 euros in Spain) and US $800 in the USA [12, 13] (Table 5).
Even so, a portion of the total costs of the disease is unknown, as some patients are reluctant to declare they suffer from this disorder. Even when the disease severely affects everyday life, the patient is still reluc- tant to discuss it with his/her doctor. More than 54%
of fecal incontinence patients have never discussed the matter with their doctor [14].
To reduce the financial burden of fecal inconti- nence, it is important to invest in promoting appro- priate treatment of the disorder. As most patients are young when first struck by the disorder, investing money to prevent them from suffering from worsen- ing of the disease or complications should be consid- ered “good value for the money”. The few economic studies carried out so far on the different treatment options show a general cost-effectiveness, but more investigations are needed to complete the picture-not only of costs but also benefits-of the different alter- natives.
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