Navigating the Murky Waters of Conflict of Interest: Searching for the Middle Path.

On August 23, 2011, the U.S. Department of Health and Human Services issued the Final Rule on conflict of interest. The purpose of the rule was to provide a clear framework for federally funded studies to identify, reduce, avoid, and/or manage researchers' external commercial relationships that could appear to impact the design, conduct, or reporting of research. Since the issuance of the final rule, colleges and universities have been tasked with closely monitoring external commercial relations of faculty to ensure that potential biases in research are minimized. The monitoring has become an even greater challenge as federal dollars for research decline, along with colleges and universities' ability to internally fund research. External commercial relations, including faculty start-up companies, are often an easy go-to source for funding to continue research and development. In such cases, sources of funding vary from crowdfunding to commercial incubator or innovation project start-up funds. There have been many lessons learned since implementation. This article will site some common examples encountered at one university of commercial relationships that have the potential to affect human subject research. Every industry tie to academically based research must be closely reviewed to ensure appropriate interactions between researchers and sponsors. Equally imperative is to build a collaborative relationship with faculty and conflict of interest administrators. Transparency and partnership are key to developing workable management plans. Even when there is the presence of a significant financial interest, much can be done to protect human subjects as well as the integrity of the research. Independent oversight, prohibiting the principal investigator (PI) from recruiting patients, limiting access to data, replication of results, review of annual progress reports, informing patients of potential financial gain, and so forth, are just a few of the safeguards we can put into place to reduce potential bias and inform and protect human subjects. Just like we need to be creative in identifying new ways of approaching research problems, we need to be creative in how we approach and manage academic and industry relationships. This creativity has the potential to benefit researchers who are exploring new frontiers, patients who may enjoy increased health, and companies with successful products on the market. Caution should be taken when generalizing to other institutions as resources available to manage will vary across organizations.

Endovascular abdominal aortic aneurysm repair by interventional cardiologists--a community-based experience.

INTRODUCTION: Endovascular repair of abdominal aortic aneurysm (AAA) is a relatively recent technology. In comparison to the conventional open surgical treatment for AAA, endovascular AAA repair (EVAR) combines a less-invasive approach with lower morbidity and mortality. There have been few studies regarding the performance of this procedure in a community-based setting. We report our experience of EVAR performed primarily by interventional cardiologists in a community hospital. METHODS: In our community hospital setting, between September 2005 and November 2007, we included all patients who underwent EVAR by interventional cardiologists, with available on-site vascular surgical support. Clinical and serial computed angiographic imaging outcomes were followed by a retrospective chart review. Data collection tools included demographic and clinical characteristics, anatomical aneurysm features, length of stay, peri- and postprocedural complications, and mortality. RESULTS: A total of 71 consecutive patients had EVAR attempted. The endovascular stent placement was successful in 67 (93%) patients. Thirty-day mortality in this study was 1 of 71 (1.4%). All four procedural failures and the single periprocedural mortality occurred in women. Mean follow-up was 12 months. There were a total of six mortalities and among these four were women (P ≤ 0.001); however, multivariate analysis revealed loss of significant difference in mortality (P = 0.16). Major complications following EVAR were noted in 10 of 71 (14%) patients. CONCLUSION: EVAR can be successfully performed by experienced interventional cardiologists with vascular surgical support in a community-based setting. In our experience, there is acceptable rate of complications and mortality in a carefully selected patient population.

Resident attitudes regarding the impact of the 80-duty-hours work standards.

The authors report on results from a survey assessing the attitudes of medical residents toward the American Osteopathic Association and the Accreditation Council for Graduate Medical Education duty-hour standards that became effective for all accredited residency programs on July 1, 2003. Data were gathered from 128 residents in four medical specialties: family medicine, general surgery, internal medicine, and obstetrics and gynecology. Participating residents worked at four teaching hospitals with allopathic, osteopathic, or dual-accredited programs. The dominant response of medical residents to duty-hour restrictions is clearly-though not uniformly-positive. Residents tend to agree that there are safety benefits for patients and quality-of-life benefits for themselves. A consistent pattern of positive responses toward the standards among internal medicine residents contrasts with less favorable responses among residents in general surgery programs. Gender differences are noted as well, with women generally more positive about duty-hour restrictions than their male colleagues. Male residents in surgery and obstetrics especially tend to agree that duty-hour restrictions could have negative effects on physician education with regard to their continuity of experience. The most consistent pattern in resident survey responses appears to be by medical specialty, perhaps reflecting variations in the nature of patient care and contact in each specialty.

Reasons for student debt during medical education: a Michigan study.

The authors address the need for a better understanding of the reasons for greater indebtedness among today's osteopathic medical students. In May 2000, a survey was mailed to all 219 osteopathic interns at participating institutions in Michigan. The self-administered survey contained 19 questions designed to gather basic financial information, demographic characteristics, and subjective perceptions of student debt loads from participating interns. One hundred seventy completed surveys were returned, for a response rate of 78%. The authors attempted to focus on demographic predictors of debt and found that although there is no indication that such predictors have a significant effect on a student's total debt load, financial support from the student's family remains the single most important factor in predicting low levels of student debt. The authors suggest that the higher debt rate of students entering specialty fields may reflect the fact that students incur these debts with the knowledge that those debts will be more easily repaid once the student has begun to practice medicine.