Emil H Schemitsch

An Observational Study of Orthopaedic Abstracts and Subsequent Full-Text Publications

Background: Research abstracts are frequently referenced in orthopaedic textbooks and influence orthopaedic care. However, little is known about the quality of information provided in the abstracts, the frequency of publication of complete papers after presentation of abstracts, or any discrepancies between abstracts and published papers. The objective of this study was to determine the quality of information provided in orthopaedic abstracts, rates of publication of full-text articles after presentation of abstracts, predictors of publication of full-text articles, and consistency between abstracts and full-text articles. Methods: We retrieved all abstracts from the 1996 scientific program of the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons. For each abstract, we recorded the completeness of reporting and key features of the study design, conduct, analysis, and interpretation. A computerized Medline and PubMed search established whether the abstract had been followed by publication of a full-text article. Finally, we evaluated the consistency of reporting between abstracts and final publications. Results: The program included 465 abstracts, 66% of which were on prognostic studies. All abstracts described the study design, and 70.7% of the designs were observational. Key methodological issues were reported in less than half of the abstracts, and information on data analysis was reported in <15%. One hundred and fifty-nine (34%) of the 465 abstracts were followed by publication of a full-text article. The mean time to publication (and standard deviation) was 17.6 ±; 12 months (range, one to fifty-six months). Inconsistencies between the abstract and the full-text article included the primary outcome measure, which differed 14% of the time, and the results, which differed 19% of the time. Conclusions: Two-thirds of the orthopaedic abstracts in this sample were not followed by publication of a full-text paper. The overall quality of reporting in abstracts proved inadequate, and inconsistencies between the final published paper and the original abstract occurred frequently. The routine use of abstracts as a guide to orthopaedic practice needs to be reconsidered.

Surgeons' Preferences for the Operative Treatment of Fractures of the Tibial Shaft: An International Survey

There are more potential treatments for tibial fractures and more potential complications of those treatments than there are for any other type of fracture. The American Academy of Orthopaedic Surgeons recently reviewed malpractice claims to identify the procedures and diagnoses that have most commonly resulted in legal action. Among all orthopaedic conditions, fractures of the tibia and fibula ranked second with regard to the total number of patient malpractice claims, accounting for over thirty million dollars in indemnity1. The National Center for Health Statistics reported that more than 490,000 fractures of the tibia and fibula occur each year in the United States2. Although many tibial fractures may be managed nonoperatively, fractures for which nonoperative treatment has failed, open fractures, fractures with an associated compartment syndrome, and high-energy fractures require operative stabilization3. Surgical options include external fixation, plate fixation, and intramedullary nailing with or without reaming. Although there is a consensus among orthopaedic surgeons with regard to the optimal treatment of fractures of the femoral shaft, the appropriate treatment of closed and open tibial fractures remains controversial. Meta-analyses that include randomized trials provide the best evidence regarding the results of operative treatment of fractures of the tibial shaft4-7. In our meta-analysis6, one randomized trial8, involving fifty-six patients, showed a significant reduction in the rate of reoperation after external fixation compared with the rate after the use of plates (relative risk reduction, 87%; 95% confidence interval, 46% to 97%). Other trials showed that nailing without reaming resulted in a significant reduction in the risk of reoperation compared with the risk after external fixation (relative risk reduction, 49%; 95% confidence interval, 31% to 63%). Nailing with reaming reduced the risk of nonunion of closed and open fractures of the …

(Mis)Perceptions About Intimate Partner Violence in Women Presenting for Orthopaedic Care: A Survey of Canadian Orthopaedic Surgeons

BACKGROUND Domestic violence is the most common cause of nonfatal injury to women in North America. In a review of 144 such injuries, the second most common manifestation of intimate partner violence was musculoskeletal injuries (28%). The American Academy of Orthopaedic Surgeons is explicit that orthopaedic surgeons should play a role in the screening and appropriate identification of victims. We aimed to identify the perceptions, attitudes, and knowledge of Canadian orthopaedic surgeons with regard to intimate partner violence. METHODS We surveyed members of the Canadian Orthopaedic Association to identify attitudes toward intimate partner violence. With use of a systematic random sample, 362 surgeons were mailed questionnaires. The questionnaire consisted of three sections: (1) the general attitude of the orthopaedic surgeon toward intimate partner violence, (2) the attitude of the orthopaedic surgeon toward victims and batterers, and (3) the clinical relevance of intimate partner violence in orthopaedic surgery. Up to three follow-up mailings were performed to enhance response rates. RESULTS A total of 186 orthopaedic surgeons responded (a response rate of 51%), and 167 (91%) of them were men. Most orthopaedic surgeons (95%) estimated that <10% of their patients were victims of intimate partner violence, and most respondents (80%) believed that it was exceedingly rare (a prevalence of <1%). The concept of mandatory screening for intimate partner violence was met with uncertainty by 116 surgeons (64%). Misconceptions were perpetuated by surgeons who believed that inquiring about intimate partner violence was an invasion of the victims privacy, that investigating intimate partner violence was not part of their duty, that victims choose to be a victim, and that victims play a proactive role in causing their abuse. By the completion of the survey, the majority of surgeons (91%) believed that knowledge about intimate partner violence was relevant to their surgical practice. CONCLUSIONS Discomfort with the issue and lack of education have led to misconceptions among Canadian orthopaedic surgeons about intimate partner violence. The relevance of intimate partner violence to surgical practice is well understood, but studies regarding its prevalence are needed as a first step to change the current paradigm in orthopaedic surgery.

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds

BACKGROUND The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01). CONCLUSIONS The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).

Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results.

OBJECTIVE To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trials results. STUDY DESIGN AND SETTING We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Trial. We modeled the adjudication process, predicted the results and costs if smaller committees had been used, and tested for the presence of a dominant adjudicator. RESULTS Use of smaller committee sizes (one to five members) would have had little impact on the final study results, although one analysis suggested that the benefit in reduction of reoperations with reamed nails in closed tibial fractures would have lost significance if committee sizes of three or less were used. We identified a significant difference between adjudicators in the number of times their original minority decisions became the final consensus decision (χ(2)=9.67, P=0.046), suggesting that dominant adjudicators were present. However, their impact on the final study results was trivial. CONCLUSION Reducing the number of adjudicators from six to four would have led to little change in the final SPRINT study results irrespective of the significance of the original trial results, demonstrating the potential for savings in trial resources.

Outcome measurements in orthopedic.

The choice of outcome measure in orthopedic clinical research studies is paramount. The primary outcome measure for a study has several implications for the design and conduct of the study. These include: 1) sample size determination, 2) internal validity, 3) compliance and 4) cost. A thorough knowledge of outcome measures in orthopedic research is paramount to the conduct of a quality study. The decision to choose a continuous versus dichotomous outcome has important implications for sample size. However, regardless of the type of outcome, investigators should always use the most ‘patient-important’ outcome and limit bias in its determination.

Managing Data in Surgical Trials: A Guide to Modern-Day Data Management Systems

Data management is the strategy that is used for collecting, organizing, and managing data within an organization. Clinical data management plays a key part in the success of any clinical trial. The use of technology and computerized systems in the conduct of clinical trials has increased over the years and is now mainstream. The United States Food and Drug Administration has established requirements to ensure that electronic records and electronic signatures are trustworthy and reliable. Critical to the success of a data management protocol are the experienced members of the data management team. We review common aspects of data management and management systems.

Review: Unreamed Intramedullary Nailing Reduces Reoperation Rates More Than External Fixation in Open Tibial Fracture

Question: In patients with open tibial shaft fractures, what is the effectiveness of external fixation, plating, and reamed or unreamed intramedullary nailing on rates of reoperation, nonunion, and infection? Data sources: Studies were identified by searching Medline (1969 to 1998), SCISEARCH, and the Cochrane Library; by hand-searching major orthopaedic journals and proceedings; and by contacting experts in the field. Study selection: Randomized or quasi-randomized controlled trials (RCTs or QRTs) comparing external …