Search PubMed⌕ Search

Biomedical subjects

Sheila Sprague

Publications and source records attributed to Sheila Sprague.

30 records · Page 2Linked to original sources

Predictors of reoperation following operative management of fractures of the tibial shaft.

BACKGROUND: Accurate prediction of likelihood of reoperation in patients with tibial shaft fractures would facilitate optimal management. Previous studies were limited by small sample sizes and noncomprehensive examination of possible risk factors. OBJECTIVE: We conducted an observational study to determine which prognostic factors were associated with an increased risk of reoperation following operative treatment in a heterogeneous population of patients with tibial shaft fractures. DESIGN: Retrospective observational study. SETTING: Level 1 trauma center. METHODS: We identified 200 patients with tibial shaft fractures from two university-affiliated centers. Two reviewers independently abstracted data regarding 20 possible prognostic variables, reviewed preoperative and postoperative radiographs, and documented reoperations (defined as any surgical procedure </=1 year after the initial surgery that was aimed specifically at achieving bony union of the fracture, including bone grafts, implant exchanges, or débridement for infections). We chose a Cox proportion hazards model to conduct a survival analysis for time to reoperation and constructed a multivariable model to estimate the relative risk of reoperation and associated 95%confidence interval (CI) for each predictor variable. MAIN OUTCOME MEASURES: Time to reoperation following the initial surgery. RESULTS: Complete follow-up information was available for 192 of 200 (96%) patients. Three variables predicted reoperation: the presence of an open fracture wound (relative risk 4.32, 95% CI 1.76 to 11.26), lack of cortical continuity between the fracture ends following fixation (relative risk 8.33, 95% CI 3.03 to 25.0), and the presence of a transverse fracture (relative risk 20.0, 95% CI 4.34 to 142.86). CONCLUSIONS: We identified a set of three simple prognostic variables (open fracture, transverse fracture, and postoperative fracture gap) that can assist surgeons in predicting reoperation following operative treatment of tibial shaft fractures.

Adult↗

The risk of false-positive results in orthopaedic surgical trials.

The risk of concluding that the results of a particular study are true, when, in fact, they really are attributable to chance (or random sampling error) is underappreciated by investigators. This erroneous false-positive conclusion is designated as a Type I or alpha error. The extent to which randomized trials in surgery risk Type I errors is unclear. The current authors hand-searched four orthopaedic journals, six general surgery journals, and five medical journals to identify recently published randomized trials (within the past 2 years). Information on outcomes and statistical adjustment for multiple outcomes was recorded for each study. The risk of a Type I error was calculated for each study that did not explicitly state a primary outcome measure for the main statistical comparison. One hundred fifty-nine studies met the inclusion criteria for the study: 60 studies from orthopaedic journals, 49 studies from nonorthopaedic surgical journals, and 50 studies from medical journals. Of the trials that did not state a primary outcome measure, the risk of Type I errors (false-positive results) in orthopaedic and nonorthopaedic surgery journals (mean 37.3% +/- 13.3% and 37.6% +/- 10.5%, respectively) were significantly greater than medical journals (10.1% +/- 1.9%). In the current review of randomized trials in surgery and medicine, the following is reported: (1) reporting of primary outcomes in trials was inadequate; (2) one in three trials in surgery and one in 10 trials in medicine risked false-positive results; and (3) few trials in surgery and medicine considered adjustment for multiple comparisons.

Humans↗

Barriers to full-text publication following presentation of abstracts at annual orthopaedic meetings.

BACKGROUND: Oral presentations at national and international meetings offer an excellent forum for the dissemination of current research findings. However, publication rates of full-text articles after presentation of abstracts at international meetings have ranged from 11% to 78%, which suggests that at least 32% of the abstracts presented are never published as complete articles in peer-reviewed journals. In an effort to identify the reasons that surgeons had not had a paper published following presentation of their work at an international orthopaedic meeting, we conducted a survey of a cross section of authors of orthopaedic papers presented at a national meeting. METHODS: We retrieved all abstracts from the 1996 scientific program of the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons. A computerized Medline and PubMed search established whether the abstract had been subsequently published as a full-text article. The authors of the abstracts that had not been subsequently published were surveyed to identify the reasons for the failure to publish. RESULTS: A total of 465 abstracts were presented at the sixty-third Annual Meeting of the American Academy of Orthopaedic Surgeons in 1996. We surveyed the authors of 306 abstracts for which we were unable to locate a subsequent full-text publication on Medline. One hundred and ninety-nine investigators (65%) responded to the questionnaire. At the time of the survey, seventy-two manuscripts had been published, thirty-two had been submitted and rejected, fourteen were under consideration by journals, seven had been accepted for publication or were in press, and three were not recalled by the investigator. In addition, seventy-one abstracts (35.7%) of the 199 had not been submitted for publication. The authors of those abstracts were asked to indicate one or more reasons why they had not submitted a manuscript for publication. Thirty-three investigators (46.5%) indicated that they lacked sufficient time for research activities, twenty-two (31.0%) reported that the study presented at the meeting in 1996 was still in progress, fourteen (19.7%) believed that the responsibility for writing the manuscript belonged to someone else, and twelve (16.9%) reported that difficulties with co-authors who would not participate had impeded the completion of the manuscript. Nine investigators (12.7%) responded that the pursuit of publication was a low priority. CONCLUSIONS: In a survey of investigators who had not had a full-text article published after presenting the abstract at a national meeting, we found that the failure to publish was due to one of three main reasons: (1) they did not have enough time to prepare a manuscript for publication (the reason most frequently given); (2) almost one-third of the studies that had not been submitted for publication were ongoing; and (3) relationships with co-authors sometimes presented a barrier to final publication. Thorough preparation before the study and the establishment of stricter guidelines to limit the presentation of preliminary data at national and international meetings may improve publication rates.

Abstracting and Indexing↗

Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis.

BACKGROUND: The optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with alternatives including arthroplasty and internal fixation. Our objective was to determine the effect of arthroplasty (hemiarthroplasty, bipolar arthroplasty, and total hip arthroplasty), compared with that of internal fixation, on rates of mortality, revision, pain, function, operating time, and wound infection in patients with a displaced femoral neck fracture. METHODS: We searched computerized databases for randomized clinical trials published between 1969 and 2002, and we identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic textbooks, and personal files. Of 140 citations initially identified, fourteen met all eligibility criteria. Three investigators independently graded study quality and abstracted relevant data, including information on revision and mortality rates. RESULTS: Nine trials, which included a total of 1162 patients, provided detailed information on mortality rates over the first four postoperative months, which ranged from 0% to 20%. We found a trend toward an increase in the relative risk of death in the first four months after arthroplasty compared with the risk in the first four months after internal fixation (relative risk, 1.27). At one year, the relative risk of death was 1.04. The risk of death after arthroplasty appeared to be higher than that after fixation with a compression screw and side-plate but not higher than that after internal fixation with use of screws only (relative risk = 1.75 and 0.86, respectively; p < 0.05). Fourteen trials that included a total of 1901 patients provided data on revision surgery. The relative risk of revision surgery after arthroplasty compared with the risk after internal fixation was 0.23 (p = 0.0003). Pain relief and the attainment of overall good function were similar in patients treated with arthroplasty and those treated with internal fixation (relative risk, 1.12 for pain relief and 0.99 for function). Infection rates ranged from 0% to 18%, and arthroplasty significantly increased the risk of infection (relative risk, 1.81; p = 0.009). In addition, patients who underwent arthroplasty had greater blood loss and longer operative times than those who were treated with internal fixation. CONCLUSIONS: In comparison with internal fixation, arthroplasty for the treatment of a displaced femoral neck fracture significantly reduces the risk of revision surgery, at the cost of greater infection rates, blood loss, and operative time and possibly an increase in early mortality rates. Only larger trials will resolve the critical question of the impact on early mortality.

Arthroplasty↗

Humeral shaft fractures as predictors of intra-abdominal injury in motor vehicle collision victims.

To assess the utility of humeral shaft fractures as predictors of organ injuries and skeletal injuries in multiply injured patients involved in motor vehicle collisions (MVCs). A prospectively collected database of multiply injured motor vehicle occupants with an Injury Severity Score (ISS) greater than 12 admitted to a level I regional trauma centre during a 102-month period (January 1992 to June 2000) was reviewed to assess skeletal and organ injuries associated with a humeral shaft fracture. The effect of occupant location within the vehicle, the point of collision, and the use of a seat belt restraint was also examined to identify trends in injury patterns. Data from 1070 motor vehicle occupants - 65 with concomitant humeral shaft fractures and 1005 without humeral shaft fractures - revealed that 63% of motor vehicle occupants who sustained humeral fractures were drivers, compared with 77% in the non-humeral fracture group. Those patients who sustained a humeral shaft fracture had a significantly greater number of liver injuries (p = 0.022), forearm/hand fractures (p < 0.001), tibial fractures (p < 0.01) and femoral fractures (p < 0.01) compared with controls. A lateral collision impact showed a trend towards increased splenic and hepatic injuries within the humeral shaft fracture group. The presence of a humeral shaft fracture in a multiply injured patient involved in a MVC is significantly associated with an increased incidence of both upper and lower extremity fractures and liver injury. Moreover, humeral shaft fractures may serve as a predictor of potential intra-abdominal pathology in multiply injured trauma patients involved in MVCs.

Abdominal Injuries↗

Treatment of acute Achilles tendon ruptures: a systematic overview and metaanalysis.

A quantitative systematic review of randomized and quasirandomized trials was conducted to determine the effect of surgical versus conservative treatment of acute Achilles tendon ruptures on rates of rerupture. Secondary outcomes included deep infection rates, return to normal function, and minor complaints. A search of computerized databases was conducted to locate clinical studies published from 1969 to 2000. Additional studies were located through hand searches of major orthopaedic journals, bibliographies of major orthopaedic texts, and personal files. Of the 273 citations initially identified, 11 proved potentially eligible, and six met all eligibility criteria. Three investigators independently graded study quality and abstracted relevant data. Among the studies, surgical repair revealed a significant reduction in the risk of rerupture when compared with conservative treatment. Alternatively, the risk of infection with surgical repair was significantly increased. Pooled analysis of studies did not reveal any difference in the risk of minor complaints or return to normal function between surgical repair and conservatively treated groups. Surgical treatment significantly reduces the risk of Achilles tendon rerupture, but increases the risk of infection, when compared with conservative therapy. Wide confidence intervals around the estimates of risk reduction suggest a large trial is needed to establish risks and benefits.

Achilles Tendon↗

A lack of consensus in the assessment of fracture healing among orthopaedic surgeons.

BACKGROUND: The assessment of fracture healing is both a clinically relevant and frequently used outcome measure following lower extremity trauma. However, it remains uncertain whether there is a consensus in the assessment of fracture healing among orthopaedic surgeons. Variability in the assessment of healing may have important implications in surgeons' decisions to intervene when they perceive fracture healing is slow to progress. OBJECTIVE: To identify surgeons' approaches in the assessment of tibial fracture healing and the definitions of a delayed union, nonunion, and malunion among orthopaedic surgeons. STUDY DESIGN: Cross-sectional survey of 577 orthopaedic surgeons. METHODS: Focus groups, key informants, and sampling to redundancy strategies were used to develop a survey to examine surgeons' opinions in the assessment of tibial shaft fractures. Surgeons were asked how often the following variables were used in the assessment of fracture healing: (a) callus size; (b) cortical continuity; (c) progressive loss of fracture line; (d) pain with weight bearing; and (e) pain to palpation at the fracture site. Further, surgeons were asked to provide a time point beyond which a delayed union becomes a nonunion. Finally, surgeons specified their limits of acceptable fracture alignment (translation, shortening, rotation, varus/valgus, and procurvatum/recurvatum). The survey was pilot tested for clarity and content validity. This survey was mailed to 577 orthopaedic surgeons who were members of the Orthopaedic Trauma Association, American Academy of Orthopaedic Surgeons, and European-AO International-affiliated trauma centers. RESULTS: Responses were obtained from 444 surgeons (response rate 77%). For each variable, the proportion of surgeons who always used the criterion ranged from 39.7% to 45.4%, and those who occasionally or never used the criterion ranged from 20.7% to 26.9%. Surgeons' definitions of delayed union ranged from 1 to 8 months, whereas definitions of nonunion ranged from 2 to 12 months. There was also variability in definitions of fracture malunion. Acceptable degrees of fracture shortening and translation ranged from less than 5 mm to greater than 15 mm. Surgeons' definitions of acceptable angular malunions (rotational, varus/valgus, and procurvatum/recurvatum) ranged from less than 5 degrees to 20 degrees. CONCLUSIONS: There is a lack of consensus in the assessment of fracture healing in tibial shaft fractures among orthopaedic surgeons. Varying definitions of nonunion and malunion may influence the decision to intervene in an effort to promote fracture healing and/or realign the fracture.

Adult↗

Current practice in the intramedullary nailing of tibial shaft fractures: an international survey.

BACKGROUND: Tibial fractures are the most common of all long bone fractures. Although many tibial fractures may be managed conservatively, a certain subset, including unstable fractures and open fractures, require operative stabilization. Intramedullary nails have become the popular choice of implant in the treatment of tibial shaft fractures. The variability in outcomes with tibial shaft fractures may reflect technical aspects of the surgical procedure and perioperative care regimens among surgeons. Identifying the distribution of surgeons' preferences in nailing technique, and the rationale for their choices, will aid in focusing educational activities for the orthopedic community and planning future clinical trials. Our objectives were to clarify surgeons' opinions regarding technical aspects of surgery and perioperative care after intramedullary nailing of closed and open tibial shaft fractures, and to identify predictors of surgeons' preferences in technique and perioperative care. METHODS: This study was a cross-sectional survey using focus groups, key informants, and sampling to redundancy strategies to develop a survey to examine surgeons' preferences in the treatment of tibial shaft fractures. The survey was pilot tested for clarity and content validity. We mailed this survey in July 2000 to 577 orthopedic surgeons who have an interest in trauma care. These were members of the Orthopaedic Trauma Association, American Academy of Orthopaedic Surgeons, or European AO International affiliated trauma centers. We used several strategies to improve response rates including personalized cover letters, stamped return envelopes, follow-up telephone calls, and repeat mailing of questionnaires. Main outcome measures included technical issues such as reduction, exposure, intramedullary reaming, and interlocking screws; and factors associated with surgeons' preferences such as age, fellowship, academic practice, and geographic location. RESULTS: Four hundred forty-four surgeons (77%) responded. Sixty percent of respondents had an academic practice, 84% supervised residents, and 65.1% had fellowship training in trauma. Approximately half (51.5%) of surgeons used a tourniquet. The odds that a surgeon in Asia or Africa used tourniquets was 10 times that of a North American surgeon (p = 0.004 and p = 0.002, respectively). Patellar tendon retraction and an inferior-based entry portal was the popular choice among surgeons (70.1% and 70.8%, respectively). Surgeons from Australia (odds ratio [OR] = 50, p < 0.001), South America (OR = 9.0, p < 0.001), Europe (OR = 3.7, p = 0.001), and Asia (OR = 3.8, p = 0.006) were significantly more likely to use a patellar splitting approach compared with North American surgeons. In the perioperative care of open tibial shaft fractures, there was consensus in the use of intravenous antibiotics and wound irrigation (96.5% and 95.6%, respectively). However, we found considerable variability in surgeons' preference in wound irrigation pressures (high, 38.7%; low, 45.4%). Surgeons in South America were 10 times more likely to use low-pressure irrigation than North American surgeons (p = 0.0005). In grade IIIB open tibial shaft fractures, 94% of surgeons believed wound closure should be obtained within the first 7 days after the injury. A surgeon's geographic location was a significant predictor of the timing of soft tissue coverage (p = 0.001). CONCLUSION: Consensus in the use of irrigation and intravenous antibiotics in open fractures was achieved among surgeons. However, there remains considerable variability in the surgical technique of intramedullary nailing, the duration of antibiotic use, and the timing of wound closure in open tibial fracture care. Continued education and large multicenter trials are needed to establish best practice in the operative treatment of tibial shaft fracture.

Adult↗

The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000.

BACKGROUND: The purpose of this study was threefold: (1) to determine the scientific quality of published randomized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000, (2) to identify predictors of study quality, and (3) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale. METHODS: Hand searches of The Journal of Bone and Joint Surgery were conducted in duplicate to identify randomized clinical trials. Of 2468 studies identified, seventy-two (2.9%) met all eligibility criteria. Two investigators each assessed the quality of the study under blinded conditions and abstracted relevant data. RESULTS: The mean score (and standard error) for the quality of the seventy-two randomized trials was 68.1% plus minus 1.6%; 60% (forty-three) scored <75%. Drug trials had a significantly higher mean quality score than did surgical trials (72.8% compared with 63.9%, p < 0.05). Regression analysis revealed that cited affiliation with an epidemiology department and cited funding were associated with higher quality scores. Failure to conceal randomization, to blind outcome assessors, and to describe why patients were excluded resulted in significantly lower quality scores (p < 0.05), more than the 5% decrease expected by removal of each item. A priori calculations of sample size were rarely performed in the reviewed studies, and only 2% of the studies with negative results included a post hoc power analysis. The Detsky quality scale met accepted standards of interobserver reliability (kappa, 0.87; 95% confidence interval, 0.70 to 0.95). CONCLUSIONS: Few studies published in The Journal of Bone and Joint Surgery were randomized trials. More than half of the trials were limited by a lack of concealed randomization, lack of blinding of outcome assessors, or failure to report reasons for excluding patients. Application of standardized guidelines for the reporting of clinical trials in orthopaedics should improve quality.

Humans↗

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.

Abstracting and Indexing↗

An economic evaluation of early versus delayed operative treatment in patients with closed tibial shaft fractures.

There are few reports examining the effect of surgical delay on outcomes following operative treatment of lower extremity fractures. Delays in the surgery for closed tibial shaft fractures have been reported to increase the overall complication rate, postoperative hospital stays and crude costs to the health care system. Our purpose was to estimate the cost-effectiveness and cost-utility associated with the adoption of a programme of early operative treatment of all closed tibial shaft fractures. We performed cost analyses based upon data obtained from an observational study. A cohort of patients with closed tibial shaft fractures was identified at a university-affiliated level I trauma centre. Patients were divided into an early surgical group (within 12 h) and delayed surgical group (longer than 12 h). Study outcomes included time to fracture union (weeks), direct inpatient and outpatient costs associated with each intervention, loss of productivity costs, and utilities (patient health perception) as determined from content experts. Sixteen patients were operated on within 12 h of injury and 19 patients were treated later than 12 h after their fracture. These groups were similar for all baseline variables. The average time to fracture union was 28.2 weeks (SD 9.4) and 44.2 weeks (SD 7.4) for the early surgical group and the delayed surgical group, respectively ( p<0.01). When the costs associated with productivity losses were included in the cost-effectiveness analysis, savings were noted of 7,330 CD dollars per patient and of 458 CD dollars for each week that a fracture healed more quickly with early treatment. However, when the loss of patient productivity was not included, there was a cost per week of 67 CD dollars. A difference of 0.09 quality adjusted life years (QALYs) in favour of the early surgery was found, which yielded a savings of 81,444 CD dollars per QALY gained when the productivity losses were included and a cost per QALY of 11,922 CD dollars when the productivity losses were not included. Both cost-effectiveness and cost-utility analyses were robust. Early plate fixation of closed tibial shaft fractures results in significantly shorter time to fracture union, fewer postoperative complications, significant cost effectiveness and greater QALYs gained when compared with delayed treatment. Inferences from this study are strengthened by the comprehensive abstraction of cost data and detailed cost-effectiveness and cost-utility analyses.

Ambulatory Care↗