Explore This IssueMay 2013
ORLANDO—Three researchers received awards for excellence in their Triological Society candidate theses this year, including two co-Mosher winners for recognition in clinical research and one Fowler winner for basic research. The awards were presented here on April 12 at the 116th Annual Meeting of the Triological Society, held as part of the Combined Otolaryngology Spring Meetings.
Joseph M. Chen, MD, an otolaryngologist at the Sunnybrook Health Sciences Centre at the University of Toronto and co-Mosher winner, presented his study, “Cost Utility Assessment of Bilateral Cochlear Implantation: A Health Economic Evaluation in Adults from the Perspective of a Publicly Funded Program,” which brought into question the cost effectiveness of bilateral cochlear implants.
The second co-Mosher winner, Adam M. Zanation, MD, assistant professor of otolaryngology/head and neck surgery at the University of North Carolina Chapel Hill, took a look at how multidisciplinary tumor conferences
affect treatment in head and neck cancer in his thesis, “How Does Coordinated Multidisciplinary Care Impact Head and Neck Tumor Treatment and Planning? A Prospective Evaluation of a Multidisciplinary Tumor Conference.”
The Fowler Award was given to Subinoy Das, MD, assistant professor of otolaryngology-head and neck surgery at Ohio State University in Columbus and director of The Ohio State University Sinus and Allergy Center, whose study, “Improving Patient Care Via a Protein-Based Diagnostic Test for Microbe-Specific Detection of Chronic Rhinosinusitis,” used protein analysis to identify whether infections are viral or bacterial in cases of chronic rhinosinusitis, with the ambition of developing a simple, point-of-care test that could help avert antibiotic overuse.
Cost of Bilateral Cochlear Implants
Dr. Chen said that he and his team set out to assess the cost utility of bilateral cochlear implants because the literature includes such a wide range of costs. The most favorable cost utility figures put bilateral implants at a cost that ranges between $30,000 and $40,000 per quality-adjusted life year (QALY). But the high end of the range runs to $94,000 per QALY for children and up to $132,000 per QALY for adults, which is quite a bit higher than $50,000 per QALY, a standard that’s been established as society’s “willingness to pay.” Dr. Chen said, “The evidence is sort of all over the place.”
His analysis, involving 142 participants comprised of 52 health professionals and 90 patients, was based on Canada’s publicly run health care system, but he said it could be valuable to the system that exists in the United States.
The direct costs to the Canadian Ministry of Health were included to come up with the total cost for unilateral and bilateral implants—from the cost of the system itself to the price discount given for the second side to an expected failure rate of 15 percent. The analysis considered a service provision of 25 years. This cost was used as the base case, and sensitivity analyses were performed to determine cost as cases deviated from the base case.
Three groups were compared: those who were deaf, with no intervention; those with a unilateral implant, at a cost of $63,622; and those with a bilateral implant, at a cost of $111,764. The utility of the implants was assessed using four methods; the most conservative, and therefore the least likely to overestimate the cost utility of bilateral implants, was the Health Utility Index (HUI-3). The research team found that moving from unilateral to bilateral implantation added only 12 percent to the overall utility seen from moving from no intervention to bilateral.
The implant groups’ cost utility was compared using the Incremental Cost Utility Ratio, or the change in cost over the change in utility. The cost utility of a unilateral implant compared with no intervention was found to be $14,658 per QALY, with a range of $10,000 to $19,000, using the HUI-3. The cost utility of bilateral implant compared with a unilateral was $55,020 per QALY, with “lesser cost” but also “much lesser gain.”
Dr. Chen noted that there was a wide range for the bilateral calculation, from $32,000 to $192,000, meaning that it was a less reliable calculation.
In his paper, Dr. Chen argued that the diminishing of benefit and productivity resulting from implantation over time should be factored into the analysis, a process known as “differential discounting,” though he suspects that this step would be controversial when it comes to “big table” decision making. “I believe our data translates relatively well across jurisdictions in countries with a strong publicly funded health care system, and that would include the United States,” he said.
Cost utility analyses can allow governments to expand or contract programs based on rankings, he said. And, he added, “with sensitivity analysis, each of our programs can use it to adjust for opportunity and efficiency to make you more competitive within your own health care system.”
Impact of the Multidisciplinary Tumor Conference
In the other co-Mosher Award-winning study, Dr. Zanation assessed how head and neck cancer cases were affected by the use of the multidisciplinary tumor conference (MDTC) by comparing certain items before and after the conference.
The idea was to use a prospective, observational study to get a better handle on the value of coordination in these complex cases, although at this point in the research, outcomes haven’t been ascertained. “Surgery, radiation therapy and chemotherapy all have significant and overlapping roles in the treatment of head and neck cancers,” Dr. Zanation said.
Researchers characterized the frequency of changes in the histopathological diagnosis, tumor staging and treatment as a result of the MDTC, along with the nature of those changes. All new head and neck tumor patients who were presented at the MDTC were included in the study, but patients previously treated or receiving follow-up care were not. Ultimately, 413 patients were enrolled.
The most common tumor sites were the oral cavity and oropharynx, followed by sinonasal and skull base, with 287 malignancies, 88 benign lesions and 38 masses that couldn’t be definitely diagnosed at the outset. Primary squamous cell carcinoma was the most common histopathological diagnosis, accounting for 44 percent of the tumors. Data collected by the intake physician was compared with data collected after MDTC re-review, and the main outcomes were straightforward, Dr. Zanation said: “Did we change pathologic diagnosis? Did we change stage? Did we change treatment?”
Researchers found a change in the histopathological diagnosis in 12 percent of the cases, including 7 percent originally designated as malignant, 8 percent of those that were benign and 61 percent in which the pathology was initially unknown.
Nine percent of patients had a change in T classification, 9 percent had a change in N classification and 4 percent had a change in M classification, with 24 percent having a change in more than one classification. Changes in stage appeared to be associated with an initial T classification, but not with N or M. Patients with an initial T2 classification had a change in stage 15 percent of the time, compared with 8 or 9 percent of the time for T0, T1 and T3 classifications and in no cases for T4.
An “intermodality” treatment change (in which a treatment method was changed, added or deleted) happened in 27 percent of cases, with escalation of treatment in 17 percent. An “intramodality” treatment change, such as moving from a unilateral to a bilateral neck dissection, occurred in 14 percent of all cases.
For both intermodal and intramodal changes, the change was more likely to be an escalation—an addition of a modality, such as adding radiation to chemotherapy—rather than a de-escalation or a lateral change, Dr. Zanation said. The same pattern was seen for intramodal changes.
Tumors initially classified as malignant were more likely to have an intermodal change in treatment than benign masses, the researchers found. Additionally, higher-stage malignancies were more likely to result in treatment changes than lower-stage malignancies. “This data supports the impact of tumor boards and the notions that comprehensive head and neck tumor treatment should involve a tumor board and a multidisciplinary discussion as a best practice recommendation,” Dr. Zanation said.
Researchers are now evaluating the changes seen in this study and comparing them with best practice guidelines, which Dr. Zanation said will be a first step in correlating tumor conferences to patient outcomes.
Bacterial or Viral?
Dr. Das, the Fowler Award winner, led a team that explored protein analysis for the potential development of a test to tell whether chronic rhinosinusitis is bacterial or viral.
With 258 million prescriptions a year, enough for 80 percent of the U.S. population, antibiotic use poses “not only a cost problem but also a potential catastrophic consequence if an antibiotic-resistant superbacteria propagates,” he said.
His lab hypothesized that bacteria develop unique characteristics when they undergo phenotypic changes distinct from viral infections. These characteristics, if diagnosed, could help doctors decide whether to treat an infection as bacterial.
The team started with non-typeable haemophilus influenzae (NTHI), the most common bacteria present in sinus infections. Using the common protein-analysis techniques of nano liquid chromatography/tandem mass spectrometry to perform a kind of “mini-human genome project,” researchers identified all the proteins present in the secretome of NTHI biofilm.
They used a sinusitis model of a chinchilla to assess the proteins present in the animal’s biofilm and came away with proteins that were candidates for reliable biomarkers.
The researchers then developed an assay, based on work completed by the Centers for Disease Control and Prevention studying meningitis in Mongolia, to test the sensitivity and specificity of certain signature proteins in eight samples of human isolates of bacteria from sinusitis patients. There was 100 percent sensitivity and 100 percent specificity for two types of proteins—outer membrane proteins P2 and P5 (OMP-P2 and OMP-P5).
Researchers now hope to develop a test similar to a pregnancy test that can be placed through a balloon at the time of sinuplasty. They also hope to develop a simple test that can be used by primary care physicians.
“The problem of whether this is a bacterial or viral infection is probably one of the biggest problems in U.S. medicine today,” Dr. Das said. “Ideally, to stop this problem, our physicians would have a meaningful test that allowed them to know if a patient was having a bacterial or viral infection.”