Christian P. DiPaola, Nicolas Dea, Marcel F. Dvorak, Robert S. Lee, Dennis Hartig and Charles G. Fisher
Conflict of interest (COI) as it applies to medical education and training has become a source of considerable interest, debate, and regulation in the last decade. Companies often pay surgeons as faculty for educational events and often sponsor and give financial support to major professional society meetings. Professional medical societies, industry, and legislators have attempted to regulate potential COI without consideration for public opinion. The practice of evidence-based medicine requires the inclusion of patient opinion along with best available evidence and expert opinion. The primary goal of this study was to assess the opinion of the general population regarding surgeon-industry COI for education-related events.
A Web-based survey was administered, with special emphasis on the surgeon's role in industry-sponsored education and support of professional societies. A survey was constructed to sample opinions on reimbursement, disclosure, and funding sources for educational events.
There were 501 completed surveys available for analysis. More than 90% of respondents believed that industry funding for surgeons' tuition and travel for either industry-sponsored or professional society educational meetings would either not affect the quality of care delivered or would cause it to improve. Similar results were generated for opinions on surgeons being paid by industry to teach other surgeons. Moreover, the majority of respondents believed it was ethical or had no opinion if surgeons had such a relationship with industry. Respondents were also generally in favor of educational conferences for surgeons regardless of funding source. Disclosures of a surgeon-industry relationship, especially if it involves specific devices that may be used in their surgery, appears to be important to respondents.
The vast majority of respondents in this study do not believe that the quality of their care will be diminished due to industry funding of educational events, for surgeon tuition, and/or travel expenses. The results of this study should help form the basis of policy and continued efforts at surgeon-industry COI management.
Charles G. Fisher, Christian P. DiPaola, Vanessa K. Noonan, Christopher Bailey and Marcel F. S. Dvorak
The nature of physician-industry conflict of interest (COI) has become a source of considerable concern, but is often not discussed in the research setting. With reduced funding available from government and nonprofit sources, industry support has enthusiastically grown, but along with this comes the potential for COI that must be regulated. In this era of shared decision making in health care, society must have input into this regulation. The purpose of this study was to assess the opinions of a North American population sample on COI regarding industry-funded research and to analyze population subgroups for trends.
A survey was developed for face and content validity, underwent focus group evaluation for clarity and bias reduction, and was administered via the World Wide Web. Demographic and general survey results were summarized as a percentage for each answer, and subgroup analysis was done using logistic regression. Generalizability of the sample to the US population was also assessed.
Of 541 surveys, 40 were excluded due to missing information, leaving 501 surveys for analysis. The sample population was composed of more females, was older, and was more educated than a representative cross-section of the American population. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies the most to head this effort. Respondents trust government officials and company representatives the least with respect to regulation of COI. Most respondents feel that industry-sponsored research can involve physicians and be both objective and beneficial to patients.
Most respondents in this study felt that surgeons should be involved in industry-sponsored research and that more research, regardless of funding source, will ultimately benefit patients. The majority of respondents distrust government or industry to regulate COI. The development of evidence-based treatment recommendations requires the inclusion of patient preference. The authors encourage regulatory bodies to follow suit and include society's perspective on regulation of COI in research.
John T. Street, R. Andrew Glennie, Nicolas Dea, Christian DiPaola, Zhi Wang, Michael Boyd, Scott J. Paquette, Brian K. Kwon, Marcel F. Dvorak and Charles G. Fisher
The objective of this study was to determine if there is a significant difference in surgical site infection (SSI) when comparing the Wiltse and midline approaches for posterior instrumented interbody fusions of the lumbar spine and, secondarily, to evaluate if the reoperation rates and specific causes for reoperation were similar for both approaches.
A total of 358 patients who underwent 1- or 2-level posterior instrumented interbody fusions for degenerative lumbar spinal pathology through either a midline or Wiltse approach were prospectively followed between March 2005 and January 2011 at a single tertiary care facility. A retrospective analysis was performed primarily to evaluate the incidence of SSI and the incidence and causes for reoperation. Secondary outcome measures included intraoperative complications, blood loss, and length of stay. A matched analysis was performed using the Fisher's exact test and a logistic regression model. The matched analysis controlled for age, sex, comorbidities, number of index levels addressed surgically, number of levels fused, and the use of bone grafting.
All patients returned for follow-up at 1 year, and adverse events were followed for 2 years. The rate of SSI was greater in the midline group (8 of 103 patients; 7.8%) versus the Wiltse group (1 of 103 patients; 1.0%) (p = 0.018). Fewer additional surgical procedures were performed in the Wiltse group (p = 0.025; OR 0.47; 95% CI 0.23–0.95). Proximal adjacent segment failure requiring reoperation occurred more frequently in the midline group (15 of 103 patients; 14.6%) versus the Wiltse group (6 of 103 patients; 5.8%) (p = 0.048). Blood loss was significantly lower in the Wiltse group (436 ml) versus the midline group (703 ml); however, there was no significant difference between the 2 groups in intraoperative complications or length of stay.
The patients who underwent the Wiltse approach had a decreased risk of wound breakdown and infection, less blood loss, and fewer reoperations than the midline patients. The risk of adjacent segment failure in short posterior constructs is lower with a Wiltse approach.