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Acute otitis media is the most frequent upper respiratory tract infection in pediatric patients 1. It is the main cause of medical visits or consultations, use of antibiotics, and ambulatory surgeries in developed countries 1-3. Acute otitis media is an infection of the middle ear with an acute clinical onset of effusion and inflammation signs and symptoms, such as fever, irritability, otalgia, and otorrhea 4.
Around the world, there are approximately 361,590,000 cases of acute otitis media per year in children younger than five years of age. In the USA, at least eight out of every ten will have presented one or more episodes of acute otitis media by the time they are three years old 1,3,5,6. The highest incidence of acute otitis media occurs between six and 18 months old 1,6. The probability of developing acute otitis media decreases with age. Children older than three years present a lower incidence, probably because they have developed partial immunity against many of the microbial pathogens 6. In the study by Teele, et al. from 1989 the average number of episodes decreased from 1.2 cases per child during the first year to 0.4 cases per child in the seventh year of life 5. Other studies 1,7 have reported an average of 1.9, 1.7, and 1.1 episodes per year in children between 6-11, 12-23, and 24-35 months old, respectively. In Latin America, the incidence of acute otitis media varies between 4.25% and 6.78%2.
In developing countries where access to health services is difficult, complications and sequels of acute otitis media are more frequent and this increases the burden of the disease due to handicaps like deafness and language and cognitive skills deficit 2,7,8. Mortality is related to the complications derived from acute otitis media and chronic otitis media 2.
Acute otitis media is associated with an important economic burden. An annual expenditure between 3 and 5 billion dollars was calculated for 1996 in the USA, with estimated costs by acute otitis media episode that varied between USD $108 and USD $1,330 9. Nevertheless, indirect acute otitis media costs, which are relevant in this pathology, have been underestimated 3. It has been estimated that acute otitis media patients’ caretakers spend between two to 18 hours of their day on each emergency consult and between 1.5 to three hours on ambulatory medical consults . Thus,while direct costs of acute otitis media patients’ care vary from USD $133.74 to USD $142.14, indirect costs are between USD $858.26 and USD $1,526.93, which represents approximately 89.7% of the total costs9.
The economic evaluation of sanitary interventions corresponds to the comparative analysis of alternative actions in terms of their costs and consequences 11. The cost analysis is the main part of the evaluations and a concern for the evaluators 12. The wide assortment of drugs, the complexity of the diagnostic and therapeutic procedures, the need to restructure the service offer, and the occurrence of a pandemic are examples of the need to evaluate alternatives and analyze costs 12. With progressive incremental sanitary costs 13, Colombia needs to set up rational intervention measures in the expenditure and the use of cost-effective health technologies. In this scenario, it is relevant to estimate the economic burden of the services or interventions, such as vaccination, which decreases the incidence, and to the handicaps, as well as the economic costs associated to this condition. The two most common types of economic study of the costs of the technologies or sanitary programs in clinical literature are the cost-of- illness studies and the evaluations based on cost-minimization analyses 14.
In spite of its complexity, cost analyses are a central part of the economic evaluation in health 13. The cost-of-illness studies economically quantify the resources spent in preventing, treating, and managing the disease 15. Additionally, they are important because they estimate the amount of money that would be saved in the absence of the disease, they help to make political decisions in public health, and they are a fundamental input to carry out cost- effectiveness studies16,17.
In the cost-of-illness studies, it is important to specify the perspective that is being analyzed, the most frequent being the costs for society, the health system, and the patient 18. The perspective of society includes all the costs (direct and indirect) 12.
The majority of the studies have focused their research on the costs related to the sanitary system while those centered on the perspective of society have become more important in the last few years because it is a broader approach. In this context, the objective of this study was to estimate the costs of acute otitis media in children from the perspective of the society in a city of the Colombian Caribbean coast.
Materials and methods
We carried out a prospective and partial economic evaluation with a description of the costs according to Dummond 19, where costs were estimated in pediatric patients with signs and/or symptoms of AOM seen in the ambulatory consult in the Hospital Infantil Napoleón Franco Pareja in the city of Cartagena.This is anon-profit private institution and the only third level pediatric university hospital in the Colombian Caribbean region.
All patients were assessed by an otorhinolaryngologist who gave the final acute otitis media diagnosis and by means of a survey we collected the socio demographic characteristics of the patients.
The costing was carried out with patients seen between December, 2014, and March, 2015. In this way, we wanted to establish how frequently patients used health services by type, as well as their respective associated costs.
In this study, we estimated both the direct and indirect costs. The former refer to those directly related to the use of resources as a result of treatment and care processes due to the disease. These include the costs of drugs, consults, nursing, hospital stays, procedures, materials and supplies, equipment used during service, and diagnostic exams, among others 20. Direct costs also include non-medical direct costs, which are assumed by the patient, especially transport, food, and family care costs, among others, derived from the disease, also called out-of-pocket expenditures 20. Additionally, direct costs allow for the measuring of intangible costs, such as pain, insecurity, fear, dissatisfaction, incapacity, and anxiety 21.
Indirect costs are related to the losses incurred because of the impact of the disease 20. While direct costs are associated to the resources of the health systems, indirect costs allow for assessing the time spent by the patients during the disease or loss of profit (transfer, wait, recovery) and are related to the salary and their productivity 12.
There are three perspectives that are generally accepted in economic evaluation studies: The perspective of the health system, the perspective of the patient/family, and the perspective of society. Our study was made from a societal perspective. It is important to specify the perspective of the costing, given the fact that an item can be a cost from one perspective and not be considered as such from another one. For example, the costs of transport of the family of the patient are an assumed cost from the patient’s and the society’s perspectives, but not from the health system’s perspective19.
To estimate indirect costs in this study, we built a formand applied it (Annex 1.) to the parents or caretakers of the children with acute otitis media to collect the data related to the loss of productivity and out-of-pocket expenses, as well as on their socio- demographic, epidemiological, and economic characteristics.
To estimate the loss of productivity in terms of money, we asked about the income of the breadwinner and the work time lost, which were associated with the disease for each episode of acute otitis media.
The loss of productivity was calculated using the following formula 22:
To calculate the loss of productivity for housewives, we used the minimum legal wage in 2014 (COP $616,000).
For direct costs derived from medical attention, we took into account the cost of the consult due to the first level emergency room services and at the Hospital, as well as the cost of being seen by the specialist (pediatrician and otorhinolaryngologist), and the verification of the invoice generated by each of the patients during their stay at the health centers to determine the expenses due to drugs, paraclinical tests, and imaging services.
The costs are presented in Colombian pesos (COP) for 2014, and they were converted to US dollars (USD) based on the average official exchange rate for that year as established by the Banco de la República (exchange rate COP $2,000.33).
Costing information was included in a database to process it using Microsoft Excel. For the descriptive analysis of the costs, we used the average summary measurements and their respective 95% confidence intervals (CI). The economic costs were presented by discriminating the direct costs (direct medical costs and out-of-pocket expenses) and indirect costs (related to the loss of productivity or loss of income).
We used a non-probabilistic convenience sampling applying the survey to all caretakers of the patients. Regarding the ethical considerations of the study, it was approved by the ethics committee of the Universidad de Cartagena and the Hospital Infantil Napoleón Franco Pareja. Furthermore, we gave information to the parents and/or caretakers about the research and we asked them to give written informed consent. The researchers guaranteed the protection of the anonymity of the participants and the confidentiality of the data. The participants were not submitted to any risks or damage to their physical integrity. We used codes to identify each participant. No data identifying the participants was published or disclosed. This study was classified as risk-free research for the patients, according to Resolution No. 8430 of 1993 from the Ministerio de Salud23.
Results
In total, we analyzed 62 pediatric patients, 59.7% of whom were female. The age mean was 16.0 months ± (SD=13.5); 90% of patients came from urban areas, and 44 (70.9%) of the 62 mothers were housewives. Regarding the acute otitis media episodes, the majority (95.2%) of the patients reported only one episode. In terms of vaccinations, 79% of the patients had their vaccines up to date when they took the survey, and 4.8% did not report any vaccination data. Table 1 presents the rest of the socio-demographic and epidemiological characteristics of the pediatric patients understudy.
Table 1 Socio-demographic and epidemiological characteristics of the study patients
AOM: Acute otitis media
The average monthly income of the surveyed caretakers was COP $743,536(CI95%:COP$638,958-848,115).Concerning the direct medical costs of the attention, the average per case was COP $ 225,288(USD $112.6), from which 70% was due to consults, 21% to laboratory exams and images, and 9% to drugs (table 2, figure 1).
Table 2 Economic costs associated with the health service in pediatric patients with acute otitis media (AOM) in Cartagena, Colombia
Source: Authors’ calculations a COP: Colombian pesos; bUSD: United States dollars
Likewise,non-medicaldirectcosts(out-of-pocketexpensesassumedbythe acute otitis media patient) were COP $32,265 (USD $16.1) on average. From these, the expenses on food/cleaning and transport per pediatric case were COP $13,566 (USD $6.8), and COP $18,698 (USD $9.3), respectively (table 2).The frequency of patients without-of-pocket expenses is shown in table 3.
The cost associated with the loss of productivity due to the disease (indirect cost) perpatient was COP $97,402(USD$49). Additionally,the average time spent by the parents on caring was 3.7days.
Figure 2 shows the average costs of an acute otitis media case by gender and their 95%CI. We did not find any statistically significant differences between the estimated costs for boys and girls(p=0.8122).
The economic cost (direct medical costs + out-of-pocket expenses + indirect costs) per acute otitis media patient was COP $354,954 (USD $177.5), with a 95%CI of COP $254,419 - COP $455,490 (table 2). From these costs, 63% were direct attention costs, 9% were pocket expenses, and the rest (28%) were associated with indirect costs.
The economic burden of seeing the 62 patients was COP $22,007,141 (USD $11,001.8) in total (table 2).
Discussion
This study estimated the direct and indirect economic costs associated with the attention of pediatric patients with acute otitis media in a third level health service institution in the Colombian Caribbean region. Our findings are among the first approximations in Colombia to the economic study of acute otitis media in children.
Worldwide there have been various studies that have estimated direct and indirect costs, out-of-pocket expenses, and economic burden associated with the attention of acute otitis media patients 9,24-27. However, comparing the cited results with our estimations is not recommended given the heterogeneity of the methods employed, the variability of the contexts of the populations, and the different characteristics of the health systems in the countries where the costs were estimated, which makes them incomparable even if all currencies were converted to international dollars 25.
On average, the economic cost of an acute otitis media case was COP $354,954 (USD $177.4) and may vary between COP $254,418 and COP $455,490. In a prospective cohort study carried out with children between one and three years old in the US, direct costs of the attention represented 10.3% of the total, transport, 2.7%, and work loss, 87.0%, which are higher than our findings 9.
The estimation of the costs of the disease is an important tool for decision-making, as well as a useful input for performing complete economic evaluations of cost-effectiveness and cost-utility, as it has been done in other countries 28,29.
In our study, we took into account expenses due to exams such as cultures, procedures such as myringotomies, and images such as computerized tomographies, which in spite of not being prerequisites for the diagnosis of acute otitis media were ordered in patients with recurring acute otitis media. Similarly, we found that some patients had been previously assessed by private non-specialist physicians who ordered exams and diagnostic tests that were unnecessary for the diagnosis of the pathology. For this reason, we also collected information on these in the survey and we classified them as out-of-pocket expenses. This explains why we observed an elevated percentage of expenses for laboratory tests and images.
One of the strengths of this study was that it assessed the costs from a societal perspective. As suggested by Boonacker, et al. in their systematic review 3, to avoid underestimating the costs he highlights the importance of estimating the costs related to the loss of productivity or loss of profit, and the out-of-pocket expenses of the family, which for this research, were 37% of the total cost of an acute otitis media case.
Additionally, the exhaustive micro-costing analysis of the disease and the use of methodological techniques of economic and epidemiological analyses contributed to the soundnesso four conclusions. On the other hand, the lack of studies that estimate economic costs of otitis media in countries with mid-low and mid-high incomes generates short-term research challenges that should be considered by the decision-makers, public policy makers, and national and international cooperation organisms in health or economics because such a frequent disease as acute otitis media and its related pathologies should be studied in developing countries not only from an epidemiological point of view but also from an economic and social perspective.
However, the study has limitations that must be considered when generalizing its results. The main one is related to the potential memory bias that is present in studies with this design but asking parents and caretakers about expenses related with the disease at the time of consultation at the emergency room could be considered a good approach for estimating the cost associated with the disease. Another limitation arises from evaluating a series of cases that were not probabilistically selected of patients enrolled at the emergency consult in only one health center receiving patients belonging mainly to low socioeconomic strata.
