I appreciate the comments put forth by Drs Galgano and Orenstein in their respective letters regarding the original contribution Dr Kuchera and I published in the June 2006 issue of JAOA—The Journal of the American Osteopathic Association (2006;106:327-334). An important task of physicians in this era of evidence-based medicine is to be critical of the research being presented. I appreciate their interest and motivation to directly participate in the peer critique of published manuscripts. 

Considering the hierarchy of modern medical research—beginning with in vitro and animal research and progressing to double-blind, randomized controlled trials (Figure)—a single cohort study or a series of case reports is located in the middle of the hierarchy and has slightly more value than ideas, editorials, opinions, or individual case reports. Our June 2006 JAOA report focused on 8 cases that, based on reviews of patients' primary care medical records, met the criteria for recurrent otitis media established by the Agency for Healthcare Research and Quality,¹ as well as consensus statements from research leaders, such as Klein and coauthors,² in the 1980s. Dr Kuchera and I originally intended for my residency research project to have a control group, but difficulties with subject recruitment in a small Mid-western town and the lack of research-oriented physicians resulted in a prospective “case series,” single-cohort study, which relied on community physicians for medical diagnosis and management. There were no potential enrollees meeting the inclusion criteria who were disqualified because of the exclusion criteria. Prior to conducting our study, reports in the literature on the usefulness of manual treatments for children with otitis media were primarily limited to ideas and opinions.^3,4 

One of the main challenges in otitis media research is establishing consistent standards for diagnosis and follow-up for various forms of otitis media—not only regarding standard medical diagnostic and intervention procedures, but also regarding osteopathic structural examination and osteopathic manipulative treatment (OMT). This challenge has been identified in the literature as among several problems revealed in decades of otitis media and osteopathic medical research.^5-7 To systematically address the biomedical, non-musculoskeletal factors related to otitis media, a panel of experts from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) created guidelines for the diagnosis and management of acute otitis media (AOM) a decade after our study was performed.⁸ 

While it seemed reasonable at the time to rely on well-trained community physicians to be independent care providers for the subjects in our JAOA study, Dr Kuchera and I recognized and reported as a limitation of the study that there could have been a lack of consistent standards used in the evaluation, diagnosis, and reporting of otitis media among these physicians. As a result, we recommended that this shortcoming be addressed to improve future studies. We do assume, however, that the consistency of standards of evaluation and assessment by each physician, when compared over time, would be quite high. 

Although the AAP/AAFP consensus guidelines⁸ are an important step in improving the classification and management of AOM, they will not be the final solution to this problem. As far as the scientific standardization of osteopathic palpatory diagnosis and OMT for children with otitis media, such work has not yet been initiated. Thus, osteopathic medical research in this field today is at a similar stage in the scientific process to biomedical research in otitis media when it was in its infancy 40 years ago. 

The protocol for our JAOA study consisted of the following steps: 

The data in our JAOA study were considered in three ways: as individual cases, as a group, and compared with other published research. The duration of follow-up after OMT in our study is particularly noteworthy. In a majority of intervention studies on recurrent otitis media prior to our own, follow-up was limited to the duration of the intervention (ie, the completion of a course of prophylactic antibiotics) or up to 6 months postintervention.⁹ In our study, follow-up was for 1-year posttreatment or—in the case of Subject D—until the subject underwent surgical intervention. Another subject moved to a different city, leaving no forwarding information, so the last entry on the medical record for that subject was 8 months after completion of the intervention period. In a randomized controlled trial, this subject would not be considered a success, as noted by Dr Orenstein. Yet, because the duration of follow-up for this particular case was longer than most previously reported follow-up periods,⁹ we contend that it is reasonable to consider this subject as a treatment success in a case study design. 

We believe that Dr Orenstein inaccurately interpreted 2 other cases reported in our article. Current standards for the diagnosis of AOM require a history of acute onset of signs and symptoms, signs of middle-ear inflammation, and the presence of middle-ear effusion.⁸ Using these criteria, Dr Orenstein's interpretation of Subjects F and G is not accurate because neither of these subjects had an episode of AOM during the follow-up year. Furthermore, corticosteroids are still of questionable efficacy for treating children with otitis media and middle-ear effusion,^10,11 and they are not recommended for treating patients with AOM.⁸ Because of the limitation of using unstandardized medical records, Dr Orenstein's opposing interpretation is appreciated as potentially valid, yet so is the one put forth by Dr Kuchera and myself—further illustrating both the reported limitations of the study and the need for additional research. 

By way of clarification, we would like to note that Figure 2 in our article represents a timeline that was associated with only 1 of the study's subjects. Figure 2 illustrates the rate of recurrence of otitis media for Subject H in the 9 months prior to the initiation of OMT and during the study's 1-year follow-up period. 

Since we completed our study, there has been only one published study that begins to approach the level of rigor that Drs Galgano and Orenstein advocate. That study, by Mills and colleagues,¹² consisted of 57 subjects randomized into one of two groups—OMT with standard-of-care treatment or standard-of-care treatment only. While that study found trends that supported the use of OMT for children with recurrent AOM, it, like all studies, had limitations, including limited statistical power due to the small number of subjects enrolled.¹² 

At this stage, it is important that current and future researchers learn from studies that have been performed and, subsequently, develop more rigorous research procedures. This goal can be accomplished only by building a published base of systematic observations so that potentially fertile areas of research can be identified—even if there are limitations to those observations. There are clear limitations in our JAOA report that were detailed in the article, and we urged caution about deriving any conclusions other than the need for additional research. Our hope is that the lessons learned from our pilot project might support and improve future research on the efficacy of OMT in otitis media. 

The next level of research in this area has been undertaken at the direction of Karen M. Steele, DO, of the West Virginia School of Osteopathic Medicine in Lewisburg, and the staff at the Osteopathic Research Center in Fort Worth, Tex (K.M. Steele, DO, written communication, May 2007). The research model being developed by Dr Steele's team has the potential of achieving the level of rigor that Drs Galgano and Orenstein desire and that the osteopathic medical profession deserves. Unfortunately, this prospective, randomized, blinded, and controlled clinical trial design will require funds totaling more than $2 million—a level of funding that, until now, has been unprecedented for osteopathic manipulative research (K.M. Steele, DO, written communication, May 2007). 

I would like to remind readers that the scientific process involves a progressive series of steps before a high level of certainty about any particular hypothesis can be achieved. Studies on the efficacy of OMT remain in their infancy and will have to progress sequentially through the lower levels of research before the appropriate resources can be obtained to reach more definitive conclusions about osteopathic manipulative medicine.