BACKGROUND CONTEXT: Surgeon-industry conflict of interest (COI) has become a source of considerable interest. Professional medical societies, industry, and policy makers have attempted to regulate potential COI without consideration for public opinion. PURPOSE: The objective of this study was to report on the opinions of individuals representing the general public regarding surgeon-industry consulting relationships. STUDY DESIGN/SETTING: Web-based survey. METHODS: Survey was administered using a "spine Web site," and opinions are collected on surgeon-industry consulting and regulation. Associations among responses to similar questions were assessed to ensure validity and subgroup analysis performed for respondent age, sex, education, insurance, employment, and patient status. RESULTS: Six hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort. CONCLUSIONS: Despite the known potential negative impact of surgeon-industry COI on patient care, this study revealed that this does not seem to be reflected in the opinion of the general public. The respondents felt that disclosure is deemed one of the most important means of self-regulation and COI management, which is in agreement with current trends of most spine societies and journals that are increasing the stringency of disclosure policies.

STUDY DESIGN: A systematic review of the available medical literature from 1980 to 2010 was conducted and combined with expert opinion from a recent survey of experts regarding cervical spine fractures. Using an objective, hierarchical approach, the best available evidence is presented for health-related quality-of-life outcomes for these injuries. OBJECTIVE: To provide an evidence-based set of guidelines for cervical spine injuries in order to reduce variability in the information given to patients and their families. SUMMARY OF BACKGROUND DATA: Patients' expectations regarding quality-of-life outcomes are highly dependent on the information provided by surgeons early in the treatment course. Our previous work has demonstrated that there is substantial variability in what surgeons tell patients regarding outcomes of cervical spine injuries, thus patients' expectations will differ and outcomes vary. METHODS: Four common cervical spine injuries (C1 burst, Hangman fracture, odontoid fracture, and unilateral facet fracture) treated both surgically and nonsurgically were considered. We assessed the evidence regarding 5 health-related quality-of-life outcomes: time to return to work, activity level, hospital stay, the proportion of patients who are pain free and patients who have regained full range of motion at 1 year after the injury. RESULTS: Published outcome data were available for most injuries. Using consensus expert opinion and the literature, answers to each question were achieved. Overall, expert opinion was relatively homogeneous across injury types, suggesting that experts do not distinguish between specific injuries when advising patients of expected outcomes such as pain. CONCLUSION: By overcoming gaps in the literature with consensus expert opinion, our study provides surgeons and others with evidence-based medicine guidelines for patient-centered outcomes after cervical spine injury. This information can be presented to patients to frame expectations of typical outcomes during and after treatment to optimize patient care and quality of life.

OBJECT: 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. METHODS: 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. RESULTS: 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 physiciansand be both objective and beneficial to patients. CONCLUSIONS: 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.

BACKGROUND CONTEXT: There is very little evidence to guide treatment of patients with spinal surgical site infection (SSI) who require irrigation and debridement (I&D) in deciding need for single or multiple I&Ds or more complex wound management such as vacuum-assisted closure dressing or soft-tissue flaps. PURPOSE: The purpose of this study was to build a predictive model that stratifies patients with spinal SSI, allowing us to determine which patients will need single versus multiple I&D. The model will be validated and will serve as evidence to support a scoring system to guide treatment. STUDY DESIGN: A consecutive series of 128 patients from a tertiary spine center (collected from 1999 to 2005) who required I&D for spinal SSI were studied based on data from a prospectively collected outcomes database. METHODS: More than 30 variables were identified by extensive literature review as possible risk factors for SSI and tested as possible predictors of risk for multiple I&D. Logistic regression was conducted to assess each variable's predictability by a "bootstrap" statistical method. A prediction model was built in which single or multiple I&D was treated as the "response" and risk factors as "predictors." Next, a second series of 34 different patients meeting the same criteria as the first population were studied. External validation of the predictive model was performed by applying the model to the second data set, and predicted probabilities were generated for each patient. Receiver operating characteristic curves were constructed, and the area under the curve (AUC) was calculated. RESULTS: Twenty-four of one hundred twenty-eight patients with spinal SSI required multiple IandD. Six predictors: anatomical location, medical comorbidities, specific microbiology of the SSI, the presence of distant site infection (ie, urinary tract infection or bacteremia), the presence of instrumentation, and the bone graft type proved to be the most reliable predictors of need for multiple I&D. Internal validation of the predictive model yielded an AUC of 0.84. External validation analysis yielded AUC of 0.70 and 95% confidence interval of 0.51 to 0.89. By setting a probability cutoff of .24, the negative predictive value (NPV) for multiple I&D was 0.77 and positive predictive value (PPV) was 0.57. A probability cutoff of .53 yielded a PPV of 0.85 and NPV of 0.46. CONCLUSIONS: Patients with positive methicillin-resistant Staphylococcus aureus culture or those with distant site infection such as bacteremia were strong predictors of need for multiple I&D. Presence of instrumentation, location of surgery in the posterior lumbar spine, and use of nonautograft bone graft material predicted multiple I&D. Diabetes also proved to be the most significant medical comorbidity for multiple I&D. The validation of this predictive model revealed excellent PPV and good NPV with appropriately chosen probability cutoff points. This study forms the basis for an evidence-based classification system, the Postoperative Infection Treatment Score for the Spine that stratifies patients who require surgery for SSI, based on specific spine, patient, infection, and surgical factors to assess a low, indeterminate, and high risk for the need for multiple I&D.