Kanu Okike

Trends in the management of open fractures : A critical analysis

Antibiotics should be administered to a patient with an open fracture as soon as possible to reduce the risk of infection.A patient with an open fracture should be taken to the operating room on an urgent basis, with the stability of the patient, the preparation of the operating room, and the availa

Conflict of Interest in Orthopaedic Research: An Association Between Findings and Funding in Scientific Presentations

BACKGROUND Financial conflict of interest has been associated with an increased likelihood that authors will report positive study outcomes. The purpose of this study was to investigate the association between types of declared conflict of interest and reported study outcomes in orthopaedic research. METHODS The abstracts of all podium presentations given at the 2001 and 2002 Annual Meetings of the American Academy of Orthopaedic Surgeons were analyzed by three orthopaedic surgeons with advanced training in clinical epidemiology. The findings reported in each abstract were graded as positive, negative, neutral, or not applicable. Self-reported conflict of interest was recorded and classified. RESULTS Conflicts of interest were reported in 40.8% (212) of 519 abstracts. The interobserver reliability of the grading of the study findings was acceptable (intraclass correlation coefficient, 0.725). Rates of conflict of interest related to royalties, stock options, or consultant or employee status varied significantly by subspecialty field (p < 0.001). The overall rate of positive study findings was 84.0% (436 of the 519 abstracts). Positive findings were more common in studies authored by individuals with a conflict of interest related to royalties (98.4% [sixty of sixty-one] compared with 88.0% [381 of 433] for studies authored by individuals without a conflict of interest related to royalties; relative risk = 1.1 [95% confidence interval = 1.0 to 1.1]; p = 0.02), in studies authored by individuals with a conflict of interest related to stock options (100.0% [twenty-nine of twenty-nine] compared with 84.7% [394 of 465]; relative risk = 1.2 [95% confidence interval = 1.0 to 1.3]; p = 0.04), and in studies authored by individuals with a conflict of interest related to consultant or employee status (97.8% [ninety-one of ninety-three] compared with 89.0% [357 of 401]; relative risk = 1.1 [95% confidence interval = 1.0 to 1.2]; p = 0.01). Positive findings were not more common in studies authored by individuals with a conflict of interest related to research or institutional funding (93.5% [143 of 153] compared with 91.8% [313 of 341]; relative risk = 1.0 [95% confidence interval = 0.95 to 1.5]; p = 0.65). In the multivariate analysis, the factors that remained significant predictors of positive outcomes were royalties (p = 0.002) and consultant or employee status (p = 0.038). CONCLUSIONS Self-reported conflicts of interest are common in orthopaedic research, particularly in the subspecialty fields of adult reconstruction of the knee, adult reconstruction of the hip, and spine. Presentations authored by individuals with a conflict of interest related to royalties, stock options, or consulting or employee status were significantly more likely to describe positive findings. While there may be distinct benefits associated with industry support of orthopaedic research, safeguards must be established to maintain public trust in the medical research establishment.

Publication Bias in Orthopaedic Research: An Analysis of Scientific Factors Associated with Publication in The Journal of Bone and Joint Surgery (American Volume)

BACKGROUND Positive outcomes are common in the orthopaedic literature, and there are many who believe it may be due to the preferential publication of studies with positive findings-a phenomenon known as publication bias. The purpose of this investigation was to determine whether positive findings rendered a manuscript submitted to The Journal of Bone and Joint Surgery (American Volume) more likely to be accepted for publication. METHODS A total of 1181 manuscripts submitted to The Journal of Bone and Joint Surgery between January 1, 2004, and June 30, 2005, for publication as scientific articles were analyzed, with 855 meeting the inclusion criteria. The direction of the study findings (positive, neutral, or negative) was independently graded by three blinded reviewers. The final disposition (acceptance or rejection) was recorded, as was information on the scientific characteristics plausibly related to acceptance or rejection. Logistic regression was used to identify factors associated with acceptance for publication. RESULTS The overall acceptance rate was 21.8% (186 of 855 studies). The study outcome was positive for 72.5% (620) of the manuscripts. The acceptance rate for the 235 manuscripts with nonpositive findings was 23.0% (fifty-four studies) compared with 21.3% (132) of the 620 studies with positive findings (crude odds ratio, 1.10 [95% confidence interval, 0.77 to 1.58]; p = 0.593). After controlling for all covariates, the adjusted odds ratio was 0.92 (95% confidence interval, 0.62 to 1.35; p = 0.652). In the multivariate analysis, the only factor significantly associated with acceptance for publication was level of evidence (p = 0.001). CONCLUSIONS We found no evidence of publication bias in the review of manuscripts for publication by The Journal of Bone and Joint Surgery, as positive and nonpositive studies were accepted at similar rates. The dearth of nonpositive studies in the orthopaedic literature is of concern, and may be due largely to investigator-based factors. Orthopaedic researchers should submit negative and neutral studies for publication, confident that the likelihood of acceptance will not be influenced by the direction of study findings.

Industry-sponsored research

Financial conflicts of interest are exceedingly common in biomedical research. Investigators with conflicts of interest are more likely to arrive at positive conclusions, perhaps as a result of biased study design, industry suppression of negative results, preferential funding by industry of projects that are likely to succeed, or biased interpretation of results on the part of investigators. Government and professional organisations have proposed guidelines for managing conflicts of interest, but in practice it is the policies of universities and medical journals that direct the actions of investigators. Academic researchers and the media have expressed concern about the influence of industry sponsorship on biomedical research, while industry is increasingly turning to private entities (such as contract research organisations) to conduct clinical trials. Research participants appear less concerned with conflicts of interest in biomedical research, perhaps due to a faith that such conflicts are being appropriately managed by institutions. After reviewing the literature, we provide recommendations for the ethical conduct of biomedical research in the presence of financial conflicts of interest.

Femoral Fracture Fixation in Developing Countries: An Evaluation of the Surgical Implant Generation Network (SIGN) Intramedullary Nail

BACKGROUND The Surgical Implant Generation Network (SIGN) intramedullary nailing system was designed to treat femoral fractures in developing countries where real-time imaging, power equipment, and fracture tables are often not available. We performed a retrospective analysis of prospectively collected data on femoral shaft fractures treated with the SIGN intramedullary nailing system. METHODS Seventy consecutive patients with a closed diaphyseal femoral fracture were treated with the SIGN intramedullary nail at Mulago National Hospital in Uganda between February 2007 and March 2008, and fifty of these patients (the study cohort) were followed for at least six months or until fracture-healing. RESULTS The mean time to surgery was 13.2 days (range, zero to thirty-three days). All fractures healed, although two required dynamization for treatment of delayed union. No hardware failures occurred. An interlocking screw missed the nail in two patients, but both fractures healed without complications. One superficial and one deep infection developed; the latter required nail removal after fracture union. Including these patients, complications requiring further treatment occurred in 14% (seven) of the fifty patients. CONCLUSIONS The SIGN intramedullary nailing system promotes predictable healing of femoral fractures in settings with limited resources including lack of real-time imaging, lack of power reaming, and delayed presentation to the operating room.

Nonscientific Factors Associated with Acceptance for Publication in The Journal of Bone and Joint Surgery (American Volume)

BACKGROUND While it is widely accepted that scientific factors may render a study more likely to be accepted for publication, it is less clear whether nonscientific factors may also be associated with publication. The purpose of this study was to identify the nonscientific factors associated with acceptance for publication by The Journal of Bone and Joint Surgery (American Volume). METHODS A total of 1173 manuscripts submitted to The Journal of Bone and Joint Surgery between January 1, 2004, and June 30, 2005, for publication as scientific articles were analyzed as part of a study on publication bias in the editorial decision-making process. Information was collected on nonscientific factors plausibly associated with acceptance for publication, including study location, conflict-of-interest disclosure, sex of the author, primary language, and the number of prior publications by the corresponding author in frequently cited orthopaedic journals. The final disposition term (acceptance or rejection) was recorded, and logistic regression was used to identify factors associated with acceptance for publication. RESULTS Manuscripts from countries other than the United States or Canada were significantly less likely to be accepted (odds ratio, 0.51; 95% confidence interval, 0.28 to 0.92; p = 0.026). Factors positively associated with acceptance for publication were conflict-of-interest disclosure involving a nonprofit entity (odds ratio, 1.92; 95% confidence interval, 1.35 to 2.73; p < 0.001) and ten or more prior publications in frequently cited orthopaedic journals by the corresponding author (odds ratio, 2.01; 95% confidence interval, 1.33 to 3.05; p = 0.001). We did not find a significant association between acceptance and conflict-of-interest disclosure involving a for-profit company, sex of the corresponding author, or primary language. CONCLUSIONS Manuscripts submitted to The Journal of Bone and Joint Surgery were more likely to be accepted if they were from the United States or Canada, reported a conflict of interest related to a nonprofit entity, or were authored by an individual with ten or more prior publications in frequently cited orthopaedic journals.

Level of evidence and conflict of interest disclosure associated with higher citation rates in orthopedics

OBJECTIVE To identify the scientific and nonscientific factors associated with rates of citation in the orthopedic literature. STUDY DESIGN AND SETTING All original clinical articles published in three general orthopedics journals between July 2002 and December 2003 were reviewed. Information was collected on variables plausibly related to rates of citation, including scientific and nonscientific factors. The number of citations at 5 years was ascertained and linear regression was used to identify factors associated with rates of citation. RESULTS In the multivariate analysis, factors associated with increased rates of citation at 5 years were high level of evidence (22.2 citations for level I or II vs. 10.8 citations for level III or IV; P=0.0001), large sample size (18.8 citations for sample size of 100 or more vs. 7.9 citations for sample size of 25 or fewer; P<0.0001), multiple institutions (15.2 citations for two or more centers vs. 11.1 citations for single center; P=0.023), self-reported conflict of interest disclosure involving a nonprofit organization (17.4 citations for nonprofit disclosure vs. 10.6 citations for no disclosure; P=0.027), and self-reported conflict of interest disclosure involving a for-profit company (26.1 citations for for-profit disclosure vs. 10.6 citations for no disclosure; P=0.011). CONCLUSION High level of evidence, large sample size, representation from multiple institutions, and conflict of interest disclosure are associated with higher rates of citation in orthopedics.

Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly.

BACKGROUND In the management of displaced proximal humerus fractures in the elderly, wide variation has been documented. However, no prior study has investigated the factors that currently lead surgeons to treat patients with surgical fixation, arthroplasty or non-operative management. The purpose of this study was to identify the factors associated with treatment selection in the management of displaced proximal humerus fractures in individuals over the age of 60 years. To this end, we conducted a retrospective review of all such injuries that presented to our two level-I trauma centres between 2006 and 2009. PATIENTS AND METHODS From our prospectively collected trauma database, we identified 229 displaced proximal humerus fractures that met all inclusion and exclusion criteria. Data were collected on patient-, fracture- and surgeon-related characteristics that were plausibly related to the decision for treatment. The choice of management was recorded, and logistic regression was used to identify factors associated with the decision for treatment. RESULTS In the multivariate analysis, the predictors of operative intervention as opposed to non-operative treatment were younger patient age (p = 0.038), associated orthopaedic injuries requiring surgery (p = 0.012), higher Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification (p = 0.012), translation-type displacement (p = 0.0012) and associated glenohumeral dislocation (p = 0.0006). In addition, shoulder and upper extremity specialists were found to choose operative intervention significantly more frequently than orthopaedic trauma specialists (49.1% vs. 26.1%, adjusted relative risk (RR) 1.96, p = 0.012). Factors associated with the decision for arthroplasty as opposed to fixation were higher Charlson score (p = 0.045), higher Neer classification (p = 0.012), and higher AO classification (p = 0.0097). CONCLUSIONS In this study of displaced proximal humerus fractures in the elderly, the decision for surgery was influenced by the patients age, the presence of associated orthopaedic injuries, the severity of the fracture and the presence of an associated glenohumeral dislocation. In addition, treatment by a shoulder or upper extremity specialist (as opposed to an orthopaedic trauma specialist) was associated with a higher likelihood of operative intervention. Further investigation into the resultant clinical outcomes is required to determine whether the use of these characteristics to select operative candidates is appropriate and beneficial for patients.

Single-blind vs Double-blind Peer Review in the Setting of Author Prestige

Methods | This study was approved by the University of Washington institutional review board and conducted at Clinical Orthopaedics and Related Research (CORR), an orthopedic journal (2015 impact factor, 3.127; acceptance rate, 20%) that allows authors to select single-blind or double-blind peer review. Potential reviewers (based on expertise) were identified from the journal’s database, informed that a study on peer review would occur in the coming year, and allowed to opt out. To avoid influencing behavior, the details and timing of the study were not described and the trial was registered after completion. The protocol appears in the Supplement. Between June 2014 and August 2015, reviewers were randomized via random number table (1:1 ratio in blocks of 8) to receive single-blind or double-blind versions of an otherwise identical fabricated manuscript, which was putatively written by 2 past presidents of the American Academy of Orthopaedic Surgeons from prominent institutions. The manuscript described a prospective study on a nonclinical topic of broad interest (team training to improve communication and safety in the operating room). Five subtle errors were included, ranging from numerical mistakes to an error in the conclusion, to determine differences in how critically the manuscript was examined. The primary outcome was recommendation of acceptance or rejection. Grades of “accept” and “reject” were taken at face value and, for grades of “major revision” and “minor revision,” reviewers’ comments were analyzed for language recommending rejection by researchers blinded to group allocation. Secondary outcomes were the number of intentionally placed errors detected and quality scores for the Methods. Post hoc, scores for the other categories usually solicited by CORR were compared. Based on 80% power and an α of .05, 98 reviewers were needed to detect a 20% difference in acceptance rates. Statistical analysis used χ2, Fisher exact, student t, and negative binomial testing, and multivariable logistic regression (SAS [SAS Institute], version 9). Significance was defined as a 2-sided P value of less than .05.

The Fate of Manuscripts Rejected by The Journal of Bone and Joint Surgery (American Volume)

BACKGROUND Of the many manuscripts that are submitted to The Journal of Bone and Joint Surgery (American Volume) (JBJS-A) for publication, the majority are not accepted. However, little is known about the outcome of these rejected submissions. To determine the fate of studies rejected by JBJS-A, we conducted a follow-up investigation of all clinical and basic science manuscripts that were submitted to The Journal between January 2004 and June 2005 but were not accepted. METHODS For each rejected manuscript, data were extracted on a wide variety of scientific and nonscientific characteristics, which were plausibly related to subsequent publication. PubMed searches were conducted to determine which manuscripts achieved full publication within five years, and logistic regression was used to identify the factors associated with publication. To further elucidate the factors associated with publication, a survey was administered to the corresponding author of each rejected manuscript. RESULTS At five years following rejection by JBJS-A, 75.8% (696 of 918) of manuscripts had reached full publication. In the multivariate analysis, factors associated with a higher likelihood of subsequent publication included grade of initial review by JBJS-A (p = 0.029), disclosure of a for-profit or nonprofit conflict of interest (p = 0.028 and 0.027, respectively), and a greater number of prior publications in frequently cited orthopaedic journals by the corresponding author (p < 0.0001). Manuscripts were less likely to reach full publication if the corresponding author was from Asia or the Middle East (p = 0.004) or was a woman (p = 0.003). Among survey respondents who indicated that their study had not yet reached full publication, the most commonly cited reason was lack of time (reported by 51.4% of respondents [thirty-eight of seventy-four]). CONCLUSIONS Most manuscripts (75.8%) not accepted by JBJS-A were published elsewhere within five years of rejection. The factors predictive of subsequent publication were primarily investigator-related as opposed to study-related. Given this low threshold for eventual publication, readers are encouraged to use criteria other than inclusion in the PubMed database to identify high-quality papers.