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Biomedical subjects

Sheila Sprague

Publications and source records attributed to Sheila Sprague.

At least 19 recordsLinked to original sources
PubMed2006

Does flattery work? A comparison of 2 different cover letters for an international survey of orthopedic surgeons.

BACKGROUND: Surveys are an important tool for gaining information about physicians' beliefs, practice patterns and knowledge. However, the validity of surveys among physicians is often threatened by low response rates. We investigated whether response rates to an international survey could be increased using a more personalized cover letter. METHODS: We conducted an international survey of the 442 surgeon-members of the Orthopaedic Trauma Association on the treatment of femoral-neck fractures. We used previous literature, key informants and focus groups in developing the self-administered 8-page questionnaire. Half of the participants received the survey by mail, and half received an e-mail invitation to participate on the Internet. We alternately allocated participants to receive a "standard" or "test" cover letter. RESULTS: We found a higher primary response rate to the test cover letter (47%) than to the standard cover letter (30%) among those who received the questionnaire by mail. There was no difference between the response rates to the test and to the standard cover letters in the Internet group (22% v. 23%). Overall, there was a higher primary response rate for the test cover letter (34%) when both the mail and Internet groups were combined, compared with the standard cover letter (27%). CONCLUSIONS: Our test cover letter to surgeons in our survey resulted in a significantly higher primary response rate than a standard cover letter when the survey was sent by mail. Researchers should consider using a more personalized cover letter with a postal survey to increase response rates.

Adult↗
PubMed2005

Methodology and measurement properties of health-related quality of life instruments: a prospective study of patients undergoing breast reduction surgery.

BACKGROUND: Breast hypertrophy is associated with clinically important morbidity. A prospective study was conducted to assess the change in health-related quality of life (HRQL) following breast reduction mammoplasty. This paper describes the measurement properties of each of the HRQL questionnaires used. METHODS: The reliability, responsiveness, and the construct validity of each HRQL instrument (the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments) were assessed. The BRAVO instruments are a set of separate instruments including the Short Form-36 (SF-36), the Multidimensional Body Self Relations Questionnaire Appearance Assessment (MBSRQ-AS), and the Breast Related Symptoms Questionnaire (BRSQ). RESULTS: The HUI2, the HUI3, the MBSRQ-AS, and the breast severity symptom (BSS) score from the BRSQ all demonstrated good test-retest reliability. The SF-36 physical component summary, the MBSRQ-AS, and the BSS score demonstrated high responsiveness. The SF-36 mental component summary and the HUI3 had a moderate effect size and the HUI2 had a small effect size. All of the changes in scales are correlated in the same direction except for the SF-36 physical component summary and the SF-36 mental component summary. CONCLUSION: All four instruments were found to be reliable and responsive. These instruments can be used in similar clinical settings to evaluate the change in patients' HRQL.

Adult↗
PubMed2005

Methodologic issues in the comparison of microsurgical flaps/techniques in head and neck reconstruction.

This article informs head and neck microsurgeons, investigators, and readers of the head and neck microsurgical literature about key methodologic issues when comparing techniques/flaps in head and neck reconstruction. The following is discussed: (1) the principles of evidence-based microsurgery, (2) the hierarchy of the strength of evidence for treatment decisions in microsurgery, (3) types of questions asked (background and foreground questions) to identify the best available evidence, (4) strategies for searching the head and neck microsurgical literature, (5) issues regarding study outcomes (types, perspective, and time horizon) in microsurgery, (6) the relevance of incorporating economic analyses into head and neck microsurgical trials, and (7) the interpretation and applicability of published study results to an individual microsurgeon's clinical practice.

Cost-Benefit Analysis↗
PubMed2005

An economic analysis of management strategies for closed and open grade I tibial shaft fractures.

BACKGROUND: Closed and open grade I (low-energy) tibial shaft fractures are a common and costly event, and the optimal management for such injuries remains uncertain. METHODS: We explored costs associated with treatment of low-energy tibial fractures with either casting, casting with therapeutic ultrasound, or intramedullary nailing (with and without reaming) by use of a decision tree. RESULTS: From a governmental perspective, the mean associated costs were USD 3,400 for operative management by reamed intramedullary nailing, USD 5,000 for operative management by non-reamed intramedullary nailing, USD 5,000 for casting, and USD 5,300 for casting with therapeutic ultrasound. With respect to the financial burden to society, the mean associated costs were USD 12,500 for reamed intramedullary nailing, USD 13,300 for casting with therapeutic ultrasound, USD 15,600 for operative management by non-reamed intramedullary nailing, and USD 17,300 for casting alone. INTERPRETATION: Our analysis suggests that, from an economic standpoint, reamed intramedullary nailing is the treatment of choice for closed and open grade I tibial shaft fractures. Considering financial burden to society, there is preliminary evidence that treatment of low-energy tibial fractures with therapeutic ultrasound and casting may also be an economically sound intervention.

Cost of Illness↗
PubMed2004

Internet versus mailed questionnaires: a controlled comparison (2).

BACKGROUND: Low response rates among surgeons can threaten the validity of surveys. Internet technologies may reduce the time, effort, and financial resources needed to conduct surveys. OBJECTIVE: We investigated whether using Web-based technology could increase the response rates to an international survey. METHODS: We solicited opinions from the 442 surgeon-members of the Orthopaedic Trauma Association regarding the treatment of femoral neck fractures. We developed a self-administered questionnaire after conducting a literature review, focus groups, and key informant interviews, for which we used sampling to redundancy techniques. We administered an Internet version of the questionnaire on a Web site, as well as a paper version, which looked similar to the Internet version and which had identical content. Only those in our sample could access the Web site. We alternately assigned the participants to receive the survey by mail (n=221) or an email invitation to participate on the Internet (n=221). Non-respondents in the mail arm received up to three additional copies of the survey, while non-respondents in the Internet arm received up to three additional requests, including a final mailed copy. All participants in the Internet arm had an opportunity to request an emailed Portable Document Format (PDF) version. RESULTS: The Internet arm demonstrated a lower response rate (99/221, 45%) than the mail questionnaire arm (128/221, 58%) (absolute difference 13%, 95% confidence interval 4%-22%, P<0.01). CONCLUSIONS: Our Internet-based survey to surgeons resulted in a significantly lower response rate than a traditional mailed survey. Researchers should not assume that the widespread availability and potential ease of Internet-based surveys will translate into higher response rates.

Adult↗
PubMed2004

Internet versus mailed questionnaires: a randomized comparison (2).

BACKGROUND: Low response rates among surgeons can threaten the validity of surveys. Internet technologies may reduce the time, effort, and financial resources needed to conduct surveys. OBJECTIVE: We investigated whether using Web-based technology could increase the response rates to an international survey. METHODS: We solicited opinions from the 442 surgeon-members of the Orthopaedic Trauma Association regarding the treatment of femoral neck fractures. We developed a self-administered questionnaire after conducting a literature review, focus groups, and key informant interviews, for which we used sampling to redundancy techniques. We administered an Internet version of the questionnaire on a Web site, as well as a paper version, which looked similar to the Internet version and which had identical content. Only those in our sample could access the Web site. We alternately assigned the participants to receive the survey by mail (n=221) or an email invitation to participate on the Internet (n=221). Non-respondents in the mail arm received up to three additional copies of the survey, while non-respondents in the Internet arm received up to three additional requests, including a final mailed copy. All participants in the Internet arm had an opportunity to request an emailed Portable Document Format (PDF) version. RESULTS: The Internet arm demonstrated a lower response rate (99/221, 45%) than the mail questionnaire arm (129/221, 58%) (absolute difference 13%, 95% confidence interval 4%-22%, P<0.01). CONCLUSIONS: Our Internet-based survey to surgeons resulted in a significantly lower response rate than a traditional mailed survey. Researchers should not assume that the widespread availability and potential ease of Internet-based surveys will translate into higher response rates.

Adult↗
PubMed2004

Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials.

BACKGROUND: Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings. In this study, we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials. METHODS: We examined a consecutive series of 332 randomized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals. Each eligible study was independently reviewed for methodological quality using a 21-point index with 5 domains: randomization, outcomes, eligibility criteria, interventions and statistical issues. Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant. For studies that did not explicitly identify a primary outcome, we defined a "positive" study as one with at least 1 statistically significant outcome measure. We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results, while controlling for study quality and sample size. RESULTS: Among the 332 randomized trials, there were 158 drug trials, 87 surgical trials and 87 trials of other therapies. In 122 (37%) of the trials, authors declared industry funding. An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3-3.5). The association remained significant after adjustment for study quality and sample size (adjusted OR 1.8, 95% CI 1.1-3.0). There was a nonsignificant difference between surgical trials (OR 8.0, 95% CI 1.1-53.2) and drug trials (OR 1.6, 95% CI 1.1-2.8), both of which were likely to have a pro-industry result (relative OR 5.0, 95% CI 0.7-37.5, p = 0.14). INTERPRETATION: Industry-funded trials are more likely to be associated with statistically significant pro-industry findings, both in medical trials and surgical interventions.

Conflict of Interest↗
PubMed2004

A prospective cost analysis following operative treatment of unstable ankle fractures: 30 patients followed for 1 year.

BACKGROUND: Ankle fractures remain one of the commonest injuries requiring operation. Quality of life and the overall costs associated with the treatment of such injuries are rarely reported. We did a pilot study to determine the cost of treating patients operatively with unstable ankle fractures and to measure the patients' quality of life (utility scores) over time. PATIENTS AND METHODS: 30 patients (17 men) were eligible and included in the study. They were on the average 52 (18-81) years old. All patients had type B Weber fractures (OTA 44B). RESULTS: The mean utility score from the Health Utilities Index immediately after surgery was 0.4. At 12 months follow-up, this score had increased to 0.78. The cost was, on average, USD 2,143 per patient. INTERPRETATION: Our findings indicate that patients operated on for ankle fractures had significant gains in health at an acceptable cost. These results provide data for studies of larger sample size.

Adolescent↗
PubMed2004

Health-related quality of life following operative treatment of unstable ankle fractures: a prospective observational study.

BACKGROUND: Although Weber type B ankle fractures are often considered benign with a good prognosis, evidence from observational studies suggests that 17% to 24% of such patients may have less satisfactory outcomes. Although the explanation for variability in outcomes remains unclear, previous studies of other surgical procedures have suggested nonsurgery-related causes account for much of the variability in outcomes. METHODS: We conducted a prospective observational cohort study to evaluate health-related quality of life in 30 patients with unstable ankle fractures who were otherwise healthy. Only patients from 2 university-affiliated hospitals sustaining unstable type B Weber injury patterns requiring surgery were eligible. Patients provided detailed baseline information regarding alcohol consumption, smoking habits, and educational level. Patients completed the short form 36 questionnaire and a visual analogue pain scale at regular follow-up intervals. RESULTS: The average patient age was 51.6 years (SD 15.2 years), and 57% (17 out of 30) were male. The majority of fractures were the result of a fall (67%, 20 out of 30), and all were closed injuries. Almost half of all patients were smokers (47%, 14 out of 30), whereas 43% consumed alcohol on a weekly basis (13 out of 30). Forty-three percent of patients (13 out of 30) had obtained an elementary or high school level of education. Patients experienced significant improvements in all domains of the SF-36 questionnaire (P < 0.001), except general health, which remained essentially normal over the 24-month period. Study patients achieved scores similar to age-matched U.S. normative data across 6 of the 8 domains (Role Emotional, Social Function, Mental Health, Bodily Pain, Vitality, and General Health). However, patients' physical function and role physical scores remained significantly lower than US norms at 24 months (21.8 and 20.7 points lower on a 100-point scale, respectively; P < 0.001). Smoking history (P = 0.02), presence of a medial malleolar fracture (P = 0.02), and lower levels of education (P = 0.01) were significant independent predictors of lower physical function up to 3 months postoperation. Lower mental health domain scores were significantly associated with alcohol use (P = 0.02) and increasing age (P = 0.04). CONCLUSIONS: As is the case in many other areas, social factors may be important determinants of outcome in patients with traumatic fractures. Optimal orthopedic care may involve attention to modifiable risk factors, including smoking and alcohol consumption.

Adolescent↗
PubMed2004

Interobserver agreement in the application of levels of evidence to scientific papers in the American volume of the Journal of Bone and Joint Surgery.

BACKGROUND: Since January 2003, all clinical scientific articles published in the American volume of The Journal of Bone and Joint Surgery (JBJS-A) have included a level-of-evidence rating. The aim of the current study was to evaluate the interobserver agreement among reviewers, with varying levels of epidemiology training, in categorizing the levels of evidence of these clinical studies. METHODS: Fifty-one consecutive clinical papers published in the American volume of JBJS were identified by a computerized search of the table of contents from January 2003 through June 2003. Each paper was blinded so that only the title, abstract (without the level of evidence designated), and methods section were provided to the reviewers. The papers were coded and were randomly organized in a binder. Six surgeons graded each blinded paper for (1) the type of study (therapeutic, prognostic, diagnostic test, or economic or decision analysis), (2) the level of evidence (on a scale of I through V), and (3) the subcategory within the particular level of evidence. Three surgeons were members of JBJS American Editorial Board, two surgeons were reviewers for JBJS-A, and one surgeon was an active researcher not formally associated with JBJS-A. The reviewers did not receive any formal training in the application of the classification system, but each was provided with a detailed description of the classification system used by JBJS-A. Intraclass correlation coefficients with 95% confidence intervals were determined for the reviewers' agreement regarding the type of study, level of evidence, and subcategory within the level of evidence. RESULTS: The majority (69%) of the fifty-one included articles were studies of therapy, and 57% of the studies constituted Level-IV evidence. The intraclass correlation coefficients for the agreement among all reviewers with regard to the study type, level of evidence, and subcategory within the level of evidence ranged from 0.61 to 0.75. Reviewers trained in epidemiology demonstrated greater agreement (range in intraclass correlation coefficients, 0.99 to 1.0), across all aspects of the classification system, than did reviewers who were not trained in epidemiology (range in intraclass correlation coefficients, 0.60 to 0.75). CONCLUSIONS: These findings suggest that epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement. The validity of this system remains a question for future research.

Evidence-Based Medicine↗
PubMed2003

Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures.

INTRODUCTION: There have been a number of non-randomized studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. However, there remains considerable debate about whether the results of non-randomized studies are consistent with the results of randomized, controlled trials. Given the economic burden of hip fractures, it remains essential to identify therapies to improve outcomes; however, whether data from non-randomized studies of an intervention should be used to guide patient care remains unclear. We aimed to determine whether the pooled results of mortality and revision surgery among non-randomized studies were similar to those of randomized trials in studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. MATERIALS AND METHODS: We conducted a Medline search from 1969 to June 2002, identifying both randomized and non-randomized studies comparing internal fixation with arthroplasty in patients with femoral neck fractures. Additional strategies to identify relevant articles included Cochrane database, SCISEARCH, textbooks, annual meeting programs, and content experts. We abstracted information on mortality and revision rates in each study and compared the pooled results between non-randomized and randomized studies. In addition, we explored potential reasons for dissimilar results between the two study designs. RESULTS: We identified 140 citations that addressed the general topic of comparison of arthroplasty and internal fixation for hip fracture. Of these, 27 studies met the eligibility criteria, 13 of which were non-randomized studies and 14 of which were randomized trials. Mortality data was available in all 13 non-randomized studies ( n=3108 patients) and in 12 randomized studies ( n=1767 patients). Non-randomized studies overestimated the risk of mortality by 40% when compared with the results of randomized trials (relative risk 1.44 vs 1.04, respectively). Information on revision risk was available in 9 non-randomized studies ( n=2764 patients) and all 14 randomized studies ( n=1901 patients). Both estimates from non-randomized and randomized studies revealed a significant reduction in the risk of revision surgery with arthroplasty compared with internal fixation (relative risk 0.38 vs 0.23, respectively). The reduction in the risk of revision surgery with arthroplasty compared with internal fixation was 62% for non-randomized studies and 77% for randomized trials. Thus, non-randomized studies underestimated the relative benefit of arthroplasty by 19.5%. Non-randomized studies with point estimates of relative risk similar to the pooled estimate for randomized trials all controlled for patient age, gender, and fracture displacement in their comparisons of mortality. We were unable to identify reasons for differences in the revision rate results between the study designs. CONCLUSIONS: Similar to other reports in medical subspecialties, non-randomized studies provided results dissimilar to randomized trials of arthroplasty vs internal fixation for mortality and revision rates in patients with femoral neck fractures. Investigators should be aware of these discrepancies when evaluating the merits of alternative surgical interventions, especially when both randomized trials and non-randomized comparative studies are available.

Arthroplasty, Replacement, Hip↗
PubMed2003

Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery.

Even the best-designed, randomized controlled trials suffer when patients are lost to follow-up. Incomplete follow-up biases the results of a trial when patients who drop out are different from those who complete follow-up. This is exaggerated further when there are differential dropout rates between study groups. Previous randomized controlled trials in orthopedic trauma have reported up to 28% loss to follow-up. Only by striving to achieve a 0% loss to follow-up rate can we be certain that this type of bias does not affect our results. In our ongoing multicenter, randomized controlled trial comparing reamed and nonreamed intramedullary nailing of tibial shaft fractures, we have implemented several innovative strategies to minimize loss to follow-up. The exclusion criteria and consent process are designed to minimize losses. Study staff are carefully trained in communication and negotiation with patients. Additionally, a central methods center monitors all patient follow-up and aids in finding lost patients. Through these primary, secondary, and tertiary interventions, we have achieved 94% complete 1-year follow-up for the first 440 patients enrolled in the trial. Eleven patients withdrew consent, and we are unable to locate 17 patients. We have successfully minimized the loss to follow-up rate in our trial by incorporating innovative prevention and retention strategies into its design and conduct. Through planning, organization, and committing time and resources to minimizing loss to follow-up, other orthopedic trauma trials can hope to achieve the same high rates of follow-up.

Bias↗
PubMed2003

A systematic review of economic analyses of low-molecular-weight heparin for the treatment of venous thromboembolism.

INTRODUCTION: Public concerns about the increase in health care expenditure have prompted investigators to analyze the costs and benefits of health care interventions. We conducted a systematic review of economic analyses of venous thromboembolism treatment focusing on studies evaluating low-molecular-weight heparin. MATERIALS AND METHODS: We identified studies by a MEDLINE search and a review of bibliographies of retrieved articles. From each eligible study, we extracted data on the study characteristics, the effectiveness, and the cost of managing the venous thromboembolism with respect to treatment. We critically appraised the studies according to the framework from the Users' Guides to the Medical Literature XIII: How to Use an Article on Economic Analysis of Clinical Practice. RESULTS: Six of these eight economic analyses of venous thromboembolism treatment that met the inclusion criteria for this review showed that low-molecular-weight heparin is associated with less recurrent venous thromboembolism and is less costly than treatment with unfractionated heparin. Although discrete recurrent venous thromboembolism event rates were not included in the seventh study, these investigators concluded that the cost of low-molecular-weight heparin for the treatment of venous thromboembolism treatment was offset by the savings associated with fewer hospital admissions when low-molecular-weight heparin was used. In the eighth study, although the cost of treatment with low-molecular-weight heparin was higher than treatment with unfractionated heparin, the investigators concluded that low-molecular-weight heparin is cost-effective for inpatient management. CONCLUSIONS: Low-molecular-weight heparin treatment may confer economic advantages over unfractionated heparin therapy because it does not require anticoagulant monitoring and it facilitates outpatient therapy.

Anticoagulants↗
PubMed2003

A randomized trial of opinion leader endorsement in a survey of orthopaedic surgeons: effect on primary response rates.

BACKGROUND: Opinion leaders have been shown to have significant influence on the practice of health professionals and patient outcomes. METHODS: Using focus groups, key informants, and sampling to redundancy techniques, we developed a questionnaire of surgeons' preferences in the treatment of tibial shaft fractures. Twenty-two well-respected and widely known orthopaedic traumatologists endorsed the questionnaire. We randomized 395 surgeon members of the Orthopaedic Trauma Association to receive either a questionnaire that included a letter informing them of the opinion leaders' endorsement, or a questionnaire without the endorsement. RESULTS: Surgeons who received the letter of endorsement had a significantly lower response rate at 2, 4, and 8 weeks. The absolute difference in response rates was 7.8% (4.6% versus 12.4%, P < 0.05) at 2 weeks, 13.1% at 4 weeks (28.6% versus 41.7% P < 0.02), and 12.3% at 8 weeks (47.5% versus 59.8% P = 0.02). CONCLUSIONS: The addition of a letter listing expert surgeons who endorse the survey lead to significantly lower primary response rates. Those interested in influencing physician responses cannot always assume a positive effect from endorsement by opinion leaders

Adult↗
PubMed2003

Challenges to the practice of evidence-based medicine during residents' surgical training: a qualitative study using grounded theory.

PURPOSE: To examine surgical trainees' barriers to implementing and adopting evidence-based medicine (EBM) in the day-to-day care of surgical patients. METHOD: In 2000, 28 surgical residents from various subspecialties at a hospital affiliated with McMaster University Faculty of Health Sciences in Ontario, Canada, participated in a focus group (n = 8) and semistructured interviews (n = 20) to explore their perceptions of barriers to the practice of EBM during their training. Additional themes were explored, such as definitions of EBM and potential strategies to implement EBM during training. The canons and procedures of the grounded theory approach to qualitative research guided the coding and content analysis of the data derived from the focus group and semistructured interviews. RESULTS: Residents identified personal barriers, staff-surgeon barriers, and institutional barriers that limited their ability to apply EBM in their daily activities. Residents perceived their lack of education in EBM, time constraints, lack of priority, and fear of staff disapproval as major challenges to practicing EBM. Moreover, the lack of ready access to surgical EBM resource materials proved to be an important additional factor limiting EBM surgical practice. Residents identified several strategies to overcome these barriers to EBM, including hiring staff surgeons with EBM training, offering coursework in critical appraisal for all staff, improving interdepartmental communication, and providing greater flexibility for EBM training. CONCLUSIONS: Surgical residents identified a general lack of education, time constraints, lack of priority, and staff disapproval as important factors limiting incorporation of EBM. Curriculum reform and surgeon education may help overcome these barriers.

Adult↗
PubMed2003

Operative management of lower extremity fractures in patients with head injuries.

Treatment of patients with lower extremity fractures and concomitant head injury is controversial. The authors compared reamed intramedullary nailing versus plating of femoral and tibial fractures in patients with polytrauma and concomitant head injury. One thousand five hundred twenty-five patients with head injuries were identified from a prospective trauma database. Of those, 1211 patients sustained severe head injuries (Abbreviated Injury Score >/= 3). One hundred nineteen patients with severe head injuries and lower extremity long bone fractures met the inclusion criteria. Ultimately, four patient groups were identified: Group A, reamed femoral nail (n = 21); Group B, femoral plate (n = 29); Group C, reamed tibial nail (n = 23); and Group D, tibial plate (n = 46). Reamed intramedullary nails did not significantly alter the risk of mortality when compared with plates in femoral (relative risk 0.46; 95% confidence interval, 0.04-4.6) and tibial (relative risk 1.18; 95% confidence interval, 0.05-11.9) fractures. The severity of the initial head injury (Glasgow Coma Scale score) was the strongest predictor of mortality. Functional independence scores between patients with reamed nails and patients with plates were similar at 1 year. Head injury does not seem to be a contraindication to reamed intramedullary nailing in patients with lower extremity fractures. The severity of head injury alone is an important predictor of outcome. A large, randomized trial with sufficient study power is needed to clarify this issue.

Adolescent↗