Supplements Balancing Outcomes in AOM and ABS: Impact of Efficacy and Adherence and the Implications for Managed
Rethinking the Total Cost of Care in AOM and ABS: The Impact of Improved Diagnostic Accuracy and Antibiotic Treatment Where High Efficacy and Adherence Are Achievable
Acute otitis media (AOM) and acute bacterial sinusitis (ABS) each pose a considerable financial burden to all involved. Total annual costs for AOM are estimated between $1.4 billion and $4.1 billion,1-5 and in 1996, the total direct healthcare costs for the treatment of sinusitis (defined as primary diagnosis of sinusitis or related airway disease with sinusitis as a comorbid condition) were estimated at $5.8 billion, of which $1.8 billion was attributed to treatment expenditures for children aged 12 years or younger.6 Cost of care is influenced not only by medication costs, but additional direct costs such as office-based provider visits and indirect costs such as caregiver/parent missed work days, which affect employers who provide health insurance to their employees. In cases of treatment failure, the cost of care can far exceed the costs associated with successful therapy.7 Therefore, improved diagnosis and the use of the most effective agents with the highest tolerability profile will improve outcomes and lower the overall cost of therapy.
Treatment success in AOM and ABS is largely dependent on proper diagnosis, the efficacy of agents used to treat these common conditions, and adherence to therapy. Diagnosis of AOM and ABS can be challenging, with many AOM symptoms such as irritability, otalgia, and fever in children also observed in uncomplicated viral upper respiratory tract infections.8,9 Similarly, ABS symptoms mirror symptoms of viral sinusitis. Consequently, AOM and ABS are often overdiagnosed. It is estimated that AOM in children may be overdiagnosed in as many as 50% to 60% of cases.10,11 Often-cited high spontaneous cure rates in AOM (as high as 80%) and ABS (as high as 50%) frequently reflect a high proportion of patients inaccurately diagnosed with these conditions. If the patient never had the disease, spontaneous resolution will be observed.
In industry-sponsored and investigator-initiated research studies, treatment success is determined by clinical and/or microbiologic criteria–specifically, clinical response rates and eradiation rates. In these treatment circumstances, patients are highly motivated, often compensated, and usually carefully monitored to ensure treatment adherence. In contrast, in the less controlled environment of daily clinical practice, adherence to therapy greatly influences treatment outcomes. Therefore, in the clinical practice setting, selection of antibiotic therapy should focus on agents that have the potential to eradicate the causative pathogens and have a tolerability profile such that full course completion of therapy is likely. This need has recently become recognized and incorporated in national guideline recommendations for antibiotic selection options.12,13
Diagnosing AOM and ABS
Diagnostic accuracy in AOM and ABS is essential for optimal medical management. However, these conditions are frequently misdiagnosed. Recent studies of diagnostic accuracy in AOM demonstrate a high rate of diagnostic inaccuracy among pediatricians, family physicians, and nurse practitioners.14,15 In one study, 514 pediatricians viewed 9 different videotaped pneumatic otoscopic examinations of tympanic membranes during a continuing medical education (CME) course and were asked to differentiate between AOM, otitis media with effusion (OME), and a normal tympanic membrane.16 Pediatricians made the correct diagnosis approximately 50% of the time.
Considerable attention was given to improving diagnostic accuracy, especially in AOM. Video-otoscopy was also used to improve diagnostic accuracy of AOM.16 In Rochester, NY, local health maintenance organizations (HMOs) jointly sponsored a CME course that included video-based instruction on improving visual diagnoses for accuracy and differentiation of AOM, OME, and variations of normal.17 Among the studied providers who attended, there was a 19% drop in diagnosis of AOM with a comparative 29% drop in antibiotic use. The providers improved in OME recognition as evidenced by a 17% increase in use of this diagnosis code. The HMOs recovered the cost of attendance for the providers in less than 9 months by the reduction in antibiotic prescriptions. The training's effects were sustained for the entire 16 months of follow-up from August 1, 1997, to January 1, 1999, an indication of the providers' altered behavior.
Explanations of national guideline antibiotic selection recommendations were beneficial because they were a second component of the CME course. However, adoption of guideline recommendations was notoriously poor.18 Included in the instruction was an explanation by an authoritative expert on the reasons and evidence supporting the guideline rationale, interpretation of the applicability to specific patient populations, and making the recommendations locally relevant. A significant shift toward use of guideline-endorsed antibiotics and away from courses of nonguideline-endorsed drugs was observed. The total cost of antibiotic prescriptions was unaffected, but the use of appropriate drugs improved quality and reduced the costs of failed therapy (discussed later).
Tympanocentesis training was the third component included in the CME course. Infant mannequins were used for training this skill. Tympanocentesis can improve diagnostic accuracy because it confirms or refutes the clinical impression made with visual examination. Although some providers were reluctant to perform tympanocentesis in the office setting after the training (possibly out of concern for potential complications or liability), a proportion of the providers went on to perform tympanocentesis in their offices in accordance with national guideline recommendations.
In ABS, the overlap in symptoms with acute viral sinusitis and allergic rhinitis often results in misdiagnosis,11,19 with clinical studies showing that as many as 60% of patients with colds are prescribed antibiotics.10,11 Patients and providers too often associate yellow/green-colored nasal mucus and/or pressure covering the sinuses with ABS. To help differentiate viral sinusitis from ABS, national guidelines recommend that a patient should have yellow/green nasal discharge for 10 or more days, with or without fever, before the diagnosis of ABS can be made.12,20 Few physicians have adopted the recommendations, as a survey of pediatricians and family physicians showed that over 50% treated patients with antibiotics and diagnosed ABS when yellow/green nasal discharge occurred for only 1 day.21
Impact on Managed Care of Accurate Diagnosis and Appropriate Antibiotic Selection for AOM and ABS
An accurate diagnosis of AOM and ABS impacts the cost of care. When a patient is diagnosed with AOM or ABS, antibiotic therapy is usually prescribed. If the patient does not actually have either condition, taking the antibiotic therapy places them at unnecessary risk for adverse effects from treatment. If no improvement is noted, the patient will be considered a treatment failure, and another antibiotic will likely be prescribed. In AOM, recurrent episodes, especially those that do not appear to respond to therapy, lead to referral to an ear, nose, and throat (ENT) specialist and/or possible surgery. In ABS, recurrent infection may result in referral to an ENT specialist for consideration for functional endoscopic sinus surgery. Surgical intervention increases cost of care.
A retrospective study published in 1999 that included more than 22 000 cases of AOM in the pediatric population of a large health plan examined the cost of treatment failure including prescription costs and per-case costs that included clinic visits for each AOM episode.22 For each episode of AOM, amoxicillin was noted as the first choice in therapy; however, selection of amoxicillin declined progressively, because of the greater probability with each additional visit to the clinic that treatment failure occurred. The per-case costs increased from the first to the fifth episodes, from $94 to $134 (see Figure). The increase was attributed to extra office visits, phone consultations, other professional or laboratory services, and surgical intervention, which increased 4-fold in children with 1 episode versus 4 episodes. Overall costs may have been underestimated because visits to hospital outpatient clinics or emergency room visits were not included. These data highlight the economic burden of treatment failure in AOM.
Improved diagnosis of AOM and ABS and the selection of effective therapy will have a positive effect on reducing treatment costs to managed care. Some costs may increase; for example, drug acquisition costs for agents with superior efficacy compared with generic alternatives. However, these costs may be offset by a reduction in total expenditures as a result of a decline in the number of cases of AOM or ABS and the number of treatment failures due to overdiagnosis. In addition, use of effective, guideline-based therapy should reduce the number of treatment failures. In turn, this will decrease the cost of therapy by reducing the cost of managing treatment failures, including expenditures for follow-up office visits, specialist care, and surgical procedures. Rethinking the cost of care to include components such as the cost of unnecessary treatment and treatment failure emphasizes the importance of an accurate diagnosis and selecting effective therapy.
The impact of AOM diagnostic training with an authoritative explanation of the rationale for antibiotic preferences in national guidelines and use of the tympanocentesis procedure in primary care providers' office settings was recently assessed (Casey and Pichichero, 2006 manuscript in progress). The main outcome measured was total cost of care including physician office visits, pharmacy costs, ENT referrals, and surgical costs. Providers were grouped as follows: (1) CME course attendees who adopted strict diagnostic criteria for AOM, use of national guideline-recommended antibiotics for =80% of treatment courses, and tympanocentesis according to guidelines; (2) CME course attendees similar to group 1 but nonadopters of tympanocentesis; (3) non-CME course attendees. Preliminary analysis of the results shows that group 1 had 36% lower total costs of care, primarily derived from fewer office visits and second courses of antibiotics for failed therapy and lower ENT referrals and surgery rates. Group 2 was intermediate with an 18% lower total cost compared to the non-CME course attendees group. It should be noted that although numerous studies show that interactive techniques are the most effective at changing physician care and patient outcomes, traditional methods of CME such as didactic lectures and print pieces were shown to have little or no beneficial effect in changing physician practice.23 Therefore, it is important for educators to pursue programs such as those previously described in their efforts to improve diagnostic accuracy in AOM.