Showing papers by "William B. Armstrong published in 2013"

Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial

Abstract: Oral premalignancy serves as an ideal model for study of chemopreventive agents. Although 13-cis-retinoic acid showed reversal of oral premalignancy, toxicity, and reversal of clinical response after cessation of therapy obviated its widespread use. A search for nontoxic agents with cancer preventive activity led us to evaluate Bowman Birk Inhibitor (BBI) formulated as BBI Concentrate (BBIC). We previously reported encouraging results in a phase IIa trial of BBIC in patients with oral leukoplakia with measurable clinical responses and favorable biomarker changes. On the basis of these results, we undertook a randomized, placebo controlled phase IIb trial with patients receiving BBIC or placebo for 6 months, with assessment of clinical response and change in lesion area as primary end point and an intent-to-treat analysis. One hundred and thirty two subjects were randomized; and 89 subjects completed six months on study drug or placebo. Both placebo and BBIC showed a statistically significant decrease in mean lesion area of 17.1% and 20.6%, respectively, and partial or greater clinical responses of 30% and 28% respectively. No significant difference between placebo and study drug arms was observed. Histologic review, review of photographs of lesions, and comparison of serum neu protein and oral mucosal cell protease activity also did not show significant differences between study arms. Probable reasons for these negative results were considered, are discussed, and include a placebo with non-BBIC clinical activity and reduced pharmacokinetic availability of the second batch of BBIC. This experience should be a strong cautionary note to those considering "Green" chemoprevention.

The role and utilization of electronic medical records in ambulatory otolaryngology.

Abstract: Objectives/Hypothesis To estimate the usage of electronic medical records (EMRs) in ambulatory otolaryngology and to compare the usage trends between otolaryngologists and physicians in other specialties. Study Design Cross-sectional analysis of data taken from the National Ambulatory Medical Care Survey (NAMCS). Methods The 2005 to 2010 NAMCS datasets were analyzed for whether storage of patient records in otolaryngology practices were completely electronic, partly electronic, or paper based. The trend of EMR utilization in the studied period was compared between otolaryngology and other specialties. Furthermore, the usage of different EMR functions (e.g., ordering tests) was also evaluated. Results The proportion of otolaryngology practices with complete or partial EMR usage increased from 27.0% in 2005 to 2006, to 48.5% in 2009 to 2010 (P < .001), and was projected to increase to 80.3% in 2015 to 2016. Otolaryngologists had variable usage of different functions of EMRs. Neither the overall use of EMRs nor their different functions were statistically different between otolaryngologists and other specialists. Further exploration of data revealed that 34.0% of otolaryngologists intended to install new EMR systems within the following years. Finally, 39.9% of otolaryngologists had plans to apply for Medicare or Medicaid incentive payments, of which 92.3% expected to start meaningful use in 2011. Conclusions The increasing utilization of EMRs in ambulatory otolaryngology is an important marker of progress in compliance with health care reform. Despite this upward trend, however, <50% of ambulatory offices had adopted EMRs in 2009 to 2010, and it remains to be seen how the field will adapt to the evolving challenge of EMR adoption and implementation. Laryngoscope, 123:2418–2422, 2013

Contributing factors to adoption of electronic medical records in otolaryngology offices

Abstract: Objectives/Hypothesis (1) To determine the characteristics of outpatient otolaryngology offices with an electronic medical record (EMR) system, and (2) to compare those characteristics with the trends in surgical and medical specialties. Study Design Cross-sectional analysis of U.S. representative data from the National Ambulatory Medical Care Survey (NAMCS). Methods The 2005 to 2010 NAMCS datasets were analyzed. Physicians' specialty was recoded as otolaryngology, all surgical specialties, and all specialties combined. Physician offices with all- or partial-EMR system adoption were then compared to offices without EMR systems with respect to year; geographic region; urban setting; office setting; practice type; practice ownership; employment status; and revenues from Medicare, Medicaid, private insurance, and patient payment. Results Upon univariate analysis, EMR use was significantly higher among otolaryngology practices located in metropolitan areas and practices run or owned by larger groups of practitioners. Sources of patient revenue did not correlate with the likelihood of EMR use. Multivariate analysis revealed that EMR use by otolaryngologists was significantly associated with group practices and offices owned by institutions. Similar associations were observed with surgical specialties combined in addition to a higher EMR usage in practices with more than 25% of total revenue from private insurance. Conclusions EMR utilization by otolaryngology practices appears similar to that of other specialties, and is more likely in metropolitan areas and larger practice settings. Despite the announcement of incentive programs under Medicare and Medicaid in 2009, EMR usage was not dependent on the percentage of physicians' total revenue from these sources. Level of Evidence N/A. Laryngoscope, 123:2658–2663, 2013