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Showing papers by "Gordon H. Guyatt published in 2003"


Journal ArticleDOI
TL;DR: 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.
Abstract: Background: The optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with al- ternatives including arthroplasty and internal fixation Our objective was to determine the effect of arthroplasty (hemiar- throplasty, 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 or- thopaedic 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 rela- tive risk of death in the first four months after arthroplasty compared with the risk in the first four months after inter- nal fixation (relative risk, 127) At one year, the relative risk of death was 104 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 = 175 and 086, respectively; p < 005) Fourteen trials that in- cluded a total of 1901 patients provided data on revision surgery The relative risk of revision surgery after arthro- plasty compared with the risk after internal fixation was 023 (p = 00003) Pain relief and the attainment of overall good function were similar in patients treated with arthroplasty and those treated with internal fixation (relative risk, 112 for pain relief and 099 for function) Infection rates ranged from 0% to 18%, and arthroplasty significantly in- creased the risk of infection (relative risk, 181; p = 0009) 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 Level of Evidence: Therapeutic study, Level I-2 (systematic review of Level-I randomized controlled trials (studies were homogeneous)) See Instructions to Authors for a complete description of levels of evidence

549 citations


Journal ArticleDOI
TL;DR: It is concluded that, overall, specific instruments are more responsive than generic tools, and that investigators may come to misleading conclusions about relative instrument responsiveness if they include studies in which the magnitude of the underlying therapeutic effect is zero.

503 citations


Journal ArticleDOI
TL;DR: The strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physicians' predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors.
Abstract: Background In critically ill patients who are receiving mechanical ventilation, the factors associated with physicians' decisions to withdraw ventilation in anticipation of death are unclear. The objective of this study was to examine the clinical determinants that were associated with the withdrawal of mechanical ventilation. Methods We studied adults who were receiving mechanical ventilation in 15 intensive care units, recording base-line physiological characteristics, daily Multiple Organ Dysfunction Scores, the patient's decision-making ability, the type of life support administered, the use of do-not-resuscitate orders, the physician's prediction of the patient's status, and the physician's perceptions of the patient's preferences about the use of life support. We examined the relation between these factors and withdrawal of mechanical ventilation, using Cox proportional-hazards regression analysis. Results Of 851 patients who were receiving mechanical ventilation, 539 (63.3 percent) were successfully weaned, 146 (17.2 percent) died while receiving mechanical ventilation, and 166 (19.5 percent) had mechanical ventilation withdrawn. The need for inotropes or vasopressors was associated with withdrawal of the ventilator (hazard ratio, 1.78; 95 percent confidence interval, 1.20 to 2.66; P=0.004), as were the physician's prediction that the patient's likelihood of survival in the intensive care unit was less than 10 percent (hazard ratio, 3.49; 95 percent confidence interval, 1.39 to 8.79; P=0.002), the physician's prediction that future cognitive function would be severely impaired (hazard ratio, 2.51; 95 percent confidence interval, 1.28 to 4.94; P=0.04), and the physician's perception that the patient did not want life support used (hazard ratio, 4.19; 95 percent confidence interval, 2.57 to 6.81; P Conclusions Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors.

404 citations


Journal ArticleDOI
TL;DR: In a survey of investigators who had not had a full-text article published after presenting the abstract at a national meeting, it was found that the failure to publish was due to one of three main reasons: they did not have enough time to prepare a manuscript for publication, relationships with co-authors sometimes presented a barrier to final publication.
Abstract: 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.

256 citations


Journal ArticleDOI
TL;DR: 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 are identified.
Abstract: BackgroundAccurate 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 factorsObjectiveWe conducted an observational study to determ

204 citations


Journal ArticleDOI
TL;DR: The ATICE measures the adaptation of mechanically ventilated patients to the ICU environment and demonstrates high reliability, validity, and responsiveness of this instrument.
Abstract: ObjectiveTo develop a valid, reliable, and responsive bedside instrument assessing Adaptation to the Intensive Care Environment (ATICE) in mechanically ventilated adult intensive care unit (ICU) patients.DesignInstrument development and prospective clinimetric evaluation.SettingUniversity-affiliated

179 citations


Journal ArticleDOI
TL;DR: These MID estimates should facilitate interpretation of clinical trials in which outcome measures include the SGRQ or FT, and approximates the previously suggested estimate of 4 on a scale of 0 to 100.

174 citations


Journal ArticleDOI
01 Jul 2003-Chest
TL;DR: This meta-analysis of 3 months of NIPPV in patients with stable COPD showed that ventilatory support did not improve lung function, gas exchange, or sleep efficiency; the high upper limit of the confidence interval for the 6MWD suggested that some people do improve their walking distance.

166 citations


Journal ArticleDOI
TL;DR: Examination of surgical trainees’ barriers to implementing and adopting evidence-based medicine (EBM) in the day-to-day care of surgical patients found a general lack of education, time constraints, lack of priority, and staff disapproval limiting incorporation of EBM.
Abstract: 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 Onta

99 citations


Journal ArticleDOI
TL;DR: In this article, the effectiveness of amiodarone in converting atrial fibrillation (AF) to sinus rhythm over a 4-week period was evaluated in randomized trials.
Abstract: Background Although clinicians sometimes choose amiodarone to convert atrial fibrillation (AF) to sinus rhythm, no current and comprehensive systematic review has summarized its effectiveness. Objective To review the effectiveness of amiodarone in converting AF to sinus rhythm over a 4-week period. Methods Two reviewers conducted a systematic search for randomized trials in databases, complemented by hand searches and contact with experts. Selected trials compared amiodarone with placebo, digoxin, or calcium channel blockers for conversion of AF to sinus rhythm. Reviewers evaluated the methodology and extracted data from each primary study. Results Twenty-one studies met eligibility criteria. Duration of AF proved to be a source of heterogeneity, leading to 2 analyses. The relative risk (RR) for achieving sinus rhythm was 4.33 (95% confidence interval [CI], 2.76-6.77) for trials with mean AF duration of greater than 48 hours and 1.40 (95% CI, 1.25-1.57) for those with AF of 48 hours or less. The risk differences for these 2 groups were 27% and 26%, respectively, yielding a number needed to treat of 4 for both groups. The low control event rate among trials with long duration of AF, compared with that of trials with a duration of 48 hours or less, explained the difference in the RR for conversion. We found that the size of the left atrium, presence of cardiovascular disease, and protocols of amiodarone administration did not influence the magnitude of effect. Serious adverse events were infrequent. Conclusions Amiodarone is effective for converting AF to sinus rhythm in a wide range of patients. Although use of amiodarone is apparently safe, safety data are too scarce for definitive conclusions.

90 citations


Journal ArticleDOI
01 Oct 2003-Chest
TL;DR: By increasing sample size, investigators can use the more efficient standardized version of the CRQ without compromising validity, and improve the cross-sectional validity, maintains longitudinal validity, but reduces the responsiveness.

Journal ArticleDOI
01 May 2003-Thorax
TL;DR: In COPD patients with heterogeneous emphysema, LVRS resulted in important benefits in disease specific quality of life compared with medical management, which were sustained at 12 months after treatment.
Abstract: Background: The clinical value of LVRS has been questioned in the absence of trials comparing it with pulmonary rehabilitation, the prevailing standard of care in COPD. Patients with heterogeneous emphysema are more likely to benefit from volume reduction than those with homogeneous disease. Disease specific quality of life is a responsive interpretable outcome that enables health professionals to identify the magnitude of the effect of an intervention across several domains. Methods: Non-smoking patients aged 1 1 /FVC Results: LVRS resulted in significant between group differences in each domain of the CRQ at 12 months (change of 0.5 represents a small but important difference): dyspnoea 1.9 (95% confidence interval (CI) 1.3 to 2.6; p 1 0.3 l (95% CI 0.1 to 0. 5; p=0.0003); submaximal exercise 7.3 min (95% CI 3.9 to 10.8; p Conclusions: In COPD patients with heterogeneous emphysema, LVRS resulted in important benefits in disease specific quality of life compared with medical management, which were sustained at 12 months after treatment.

Journal ArticleDOI
TL;DR: Although mothers may be used as proxies for their children in some circumstances and for some purposes, the views of both should be obtained in order to fully represent child oral health-related quality of life.
Abstract: – Objectives: To assess the agreement between mothers and children concerning the child's oral health-related quality of life. Methods: A total of 42 pairs of mothers and children aged 11–14 years with oral and orofacial conditions completed the parental (PPQ) and child (CPQ11–14) components of the Child Oral Health Quality of Life Questionnaire. The PPQ and CPQ11–14 are analogous questionnaires with 31 common items. Agreement between overall and subscale scores derived from the questionnaires were assessed in comparison and in correlation analyses. The former used mean directional differences between mothers and children to assess bias and mean absolute differences to assess agreement at the group level. The latter used intraclass correlation coefficients (ICCs) to assess agreement at the level of individual mother–child pairs. Results: At the group level, agreement between mothers and children was good. There was little evidence of bias in mothers' reports compared to those of their children. The mean absolute difference in overall scores constituted 9% of the possible range of scores. However, the significance of this difference is difficult to interpret. The ICC for overall scores was 0.70 indicating substantial agreement between mother and child pairs. However, the ICCs for the emotional and social well-being subscales indicated moderate agreement only. There was a suggestion that the level of agreement varied according to the characteristics of the child. Conclusion: Although mothers may be used as proxies for their children in some circumstances and for some purposes, the views of both should be obtained in order to fully represent child oral health-related quality of life.

Journal ArticleDOI
TL;DR: Clinicians, who are making decisions regarding the relevance of study results, and investigators who are designing studies are addressed, offering basic guidelines for the measurement of health-related quality of life as an outcome in clinical research.
Abstract: Limited healthcare dollars have resulted in insistence that the benefit of new therapies be evaluated before being approved for marketing or reimbursement under health service systems. Adequate evidence of a treatment's effectiveness includes evidence of impact on patient's health-related quality of life, including physical, mental, and emotional health. There are two types of measures of health-related quality of life. One, general health and utility measures, inquire about health in a broad sense, and can be applied and compared across many situations. The second type, specific measures, addresses narrower aspects of life related to a specific problem, function, or manifestations of an underlying disease process. Results of studies focusing on health-related quality of life only will be useful if the measurement instrument is valid and capable of detecting important change. Investigators should make a good choice of measurement instrument, and then ensure their study design will yield valid results. We offer basic guidelines for the measurement of health-related quality of life as an outcome in clinical research. This discussion addresses clinicians, who are making decisions regarding the relevance of study results, and investigators who are designing studies.

Journal ArticleDOI
TL;DR: In this article, a medical consultant was asked by a surgical colleague to see a 78 year old woman, now 10 days after abdominal surgery, who has become increasingly short of breath over the last 24 hours.
Abstract: You are a medical consultant asked by a surgical colleague to see a 78 year old woman, now 10 days after abdominal surgery, who has become increasingly short of breath over the last 24 hours. She has also been experiencing what she describes as chest discomfort which is sometimes made worse by taking a deep breath (but sometimes not). Abnormal findings on physical examination are restricted to residual tenderness in the abdomen and scattered crackles at both lung bases. Chest radiograph reveals a small right pleural effusion, but this is the first radiograph since the operation. Arterial blood gases show a PO2 of 70, with a saturation of 92%. The electrocardiogram shows only non-specific changes.

Journal ArticleDOI
TL;DR: Head injury does not seem to be a contraindication to reamed intramedullary nailing in patients with lower extremity fractures, and functional independence scores between patients with reamed nails and patients with plates were similar at 1 year.
Abstract: 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.

Reference EntryDOI
TL;DR: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures and there is evidence from randomized trials that risedonate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.
Abstract: BACKGROUND Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated. OBJECTIVES To systematically review the efficacy of risedronate on bone density, and fracture reduction in postmenopausal women. SEARCH STRATEGY The Cochrane Controlled Trials Registry Medline, and Current Contents were searched from 1990 - 2001. The electronic search was supplemented by handsearching four osteoporosis journals and their conference proceedings, as well as contacting content experts and industry sources for unpublished data. SELECTION CRITERIA We included eight trials that randomised women to risedronate or an alternative (placebo or calcium and /or vitamin D) and measured bone mineral density for at least one year. DATA COLLECTION AND ANALYSIS For each trial three independent reviewers assessed the methodological quality and abstracted data. Data was extracted for outcomes of fracture, bone mineral density and adverse events. The more conservative random effects model was used to pool data. The quality of trials was assessed according to the Jadad five-point scale. MAIN RESULTS Both vertebral and non-vertebral fractures were statistically and clinically reduced with risedronate. Eleven out of one hundred women who received risedronate had a vertebral fracture compared to 17 out of one hundred of those who received an alternative treatment (pooled relative risk for vertebral fractures of 0.64 (95% CI 0.52 - 0.77). Three percent of participants who received risedronate had a non-vertebral fracture compared to 4.6% of those who received an alternative treatment (pooled relative risk for nonvertebral fractures of 0.73 (95% CI 0.61 - 0.87). The weighted mean difference for the percent change from baseline for bone mineral density with 5 mg daily for lumbar spine, femoral neck and trochanter was 4.54% (95%CI 4.12 - 4.97), p<0.01; 2.75% (95% CI 2.32 - 3.17), p<0.01; and 4.38% (95% CI 3.51 - 5.25), p<0.01 respectively. REVIEWER'S CONCLUSIONS There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.

Journal ArticleDOI
TL;DR: The addition of a letter listing expert surgeons who endorse the survey lead to significantly lower primary response rates, and those interested in influencing physician responses cannot always assume a positive effect from endorsement by opinion leaders.
Abstract: 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.

Journal ArticleDOI
TL;DR: The authors found nonsignificant trends toward superior responsiveness when patients rated hypothetical health states before rating their own health state, but fails to show convincing advantage for use of marker states.
Abstract: Background. Health economists recommend that when patients provide preference ratings of their own health state using utility and health state preference measures such as the feeling thermometer (FT) and standard gamble (SG), they first rate hypothetical health states (clinical marker states [CMS]). However, there is no evidence to support improvement in measurement properties with the use of CMS. The authors evaluated validity and responsiveness of the SG and FT with and without administration of the CMS. Methods. Respiratory rehabilitation improves health-related quality of life in patients with chronic airflow limitation. The authors randomized 84 patients undergoing pulmonary rehabilitation to administration of the FT and SG with (FT+ or SG+) or without (FT- or SG-) CMS before and after a standard 12-week respiratory rehabilitation program. Patients also completed the Health Utilities Index 3 (HUI3), the Chronic Respiratory Questionnaire (CRQ), and the St. George Respiratory Questionnaire (SGRQ) to ev...


Journal ArticleDOI
TL;DR: Functional status impairment perceived by the ICU team is associated clearly with do-not-resuscitate directives in patients unable to participate in decision making, but the association appears much weaker in patients able to participateIn decision making.

Journal ArticleDOI
TL;DR: The importance of conducting systematic reviews of diagnostic evidence and their contribution to the practice of evidence-based laboratory medicine are discussed.
Abstract: In this issue of Clinical Chemistry , Brown et al. (1) report a metaanalysis of studies of the test characteristics of the latex turbidimetric D-dimer test for the diagnosis of pulmonary embolism. In this editorial, we will discuss the importance of conducting systematic reviews of diagnostic evidence and their contribution to the practice of evidence-based laboratory medicine. Evidence-based practitioners complement, or at times substitute, diagnostic intuition with the explicit use of the best available quantitative evidence about the power of symptoms, signs, and laboratory tests to increase or decrease the probabilities associated with alternative diagnoses. Summarizing studies that have high validity will yield unbiased results, and pooling across studies will reduce the random error associated with individual smaller studies. In addition to generating more precise, accurate summaries, pooling across different patient groups will, if tests perform similarly in those groups, yield results that apply to a broader population than the individual studies. Thus, systematic summaries of valid diagnostic evidence are at the top of the hierarchy of diagnostic evidence. Summaries of evidence will yield misleading results if they try to combine results across patient groups or test methods that are too heterogeneous; if they assemble an incomplete, biased sample of potentially available studies; or if they use results from studies that are themselves methodologically weak and very susceptible to bias. To avoid these sources of error, authors of systematic reviews should (a) ask a sensible question; (b) conduct a detailed and exhaustive search for relevant studies; (c) if possible, focus on studies of high methodologic quality; and (d) use reproducible approaches to assess the limitations in the methodologic quality of the studies on which they focus (2). Brown et al. (1) asked a narrowly focused and sensible question and translated their review question into appropriate eligibility criteria. Using procedures …



Journal ArticleDOI
TL;DR: rebuttals to Senn's paper on the estimation of the number needed to treat (NNT) index are made and concerns Senn’s own example, which is intended to illustrate that the individuals who have a mean-
Abstract: Reprint Address Stephen D. Walter, PhD, McMaster University, Department of Clinical Epidemiology E. Biostatistics, HSC-2 C 16, Hamilton, Ontario. Canada L8N 325 (e-mail: walter@mcmaster.ca). In a recent paper (l), Senn is very critical of three analyses of clinical data sets purported to make statements about assessments of benefit from therapy at the individual level. Included in these examples is a report of ours (2), in which we discuss the estimation of the number needed to treat (NNT) index. Senn argues that our calculations are inappropriate because they do not take into account the possibility of subject-bytreatment interaction. Using data from a crossover study (3), Senn argues that our method of calculating NNT leads to inconsistent and inappropriate results. We wish to make two brief rebuttals to Senn’s paper. First, we point out that nowhere have we attempted to identify which specific patients in our example were the ones for whom clinically meaningful benefit has occurred. Our calculation of NNT is based on the overall proportion of patients whose outcomes exceed the minimally important difference (MID), and in particular, the difference of those proportions. The reciprocal of the difference in proportions of patients achieving the MID is then equal to the NNT index. NNT indicates the number of patients who would need to be treated with the experimental therapy in order to produce an expected one additional patient who has achieved the degree of improvement that patients, in general, experience as important, compared to the expected rate of such improvements in the control arm. To repeat, this is a calculation of overall benefit, and is in no way intended to identify which particular patients may have achieved that benefit. As we have discussed elsewhere, if one thinks that there may be important treatment-bypatient interaction, then a different type of study may be required. An obvious candidate, where appropriate and feasible, would be the Nof-1 trial design (4,5). We agree with Senn that in some situations certain patients will respond differentially to a given treatment. However, the reasons for such variation may not be easily identifiable or measurable. Indeed, if we were aware of good predictors, clinicians would be far better at individualizing treatment than, in fact, they are. Lacking detailed indicators of the treatment-by-patient interaction, and lacking data from an appropriate crossover design in which such interactions could be assessed, we must fall back on the calculation of NNT based on the overall distribution of patient responses to a single administration of therapy. The second issue we wish to discuss concerns Senn’s own example (l), which is intended to illustrate that the individuals who have a mean-


Journal Article
TL;DR: A glossary of commonly used terms encountered among evidence-based orthopaedicpractitioners is presented to help surgeons become familiar with common terminology.
Abstract: As surgeons incorporate the philosophy of evidence-based orthopaedics into patient care, they need to become familiar with common terminology. A glossary of commonly used terms encountered among evidence-based orthopaedicpractitioners is presented.

Journal Article
TL;DR: In this article, the authors present guidelines for the measurement of health-related quality of life as an outcome in clinical research, and discuss the relevance of study results to clinicians and investigators who are designing studies.
Abstract: Limited healthcare dollars have resulted in insistence that the benefit of new therapies be evaluated before being approved for marketing or reimbursement under health service systems. Adequate evidence of a treatment's effectiveness includes evidence of impact on patient's health-related quality of life, including physical, mental, and emotional health. There are two types of measures of health-related quality of life. One, general health and utility measures, inquire about health in a broad sense, and can be applied and compared across many situations. The second type, specific measures, addresses narrower aspects of life related to a specific problem, function, or manifestations of an underlying disease process. Results of studies focusing on health-related quality of life only will be useful if the measurement instrument is valid and capable of detecting important change. Investigators should make a good choice of measurement instrument, and then ensure their study design will yield valid results. We offer basic guidelines for the measurement of health-related quality of life as an outcome in clinical research. This discussion addresses clinicians, who are making decisions regarding the relevance of study results, and investigators who are designing studies.

Journal ArticleDOI
TL;DR: An international survey of practicing orthopedic surgeons with an interest in fracture care found that surgeons aged > 50 years, those with past trauma fellowship training, and those practicing in North America were more likely to believe reamed intramedullary nailing reduced nonunion rates.
Abstract: While most surgeons agree that intramedullary nails are the implant of choice in the treatment of tibial shaft fractures, the decision to ream the intramedullary canal prior to nail insertion remains controversial. We therefore conducted an international survey of practicing orthopedic surgeons with an interest in fracture care (1) to identify surgeons’ beliefs regarding the risks of infection and nonunion with intramedullary reaming, and (2) to identify factors associated with surgeons’ beliefs. We utilized focus groups, key informants and sampling to redundancy strategies to develop a survey to examine surgeons’ preferences in the treatment of tibial shaft fractures. We mailed this survey to members of the Orthopedic Trauma Association, American Academy of Orthopedic Surgeons, and European trauma centers affiliated with AO International. Of the 577 surgeons surveyed, 444 (77%) responded. Of the respondents, 60% had an academic practice, 84% supervised residents, and 65.1% had fellowship training in trauma. Surgeons, in general, believed reamed nails decreased the risk of nonunion and had no effect on infection risk in closed tibial shaft fractures; however, surgeons, on average, believed that there was no difference in reducing the risk of nonunion or infection in patients with open tibial shaft fractures. Surgeons aged > 50 years, those with past trauma fellowship training, and those practicing in North America were more likely to believe reamed intramedullary nailing reduced nonunion rates. The continued disagreement and controversy reflect the lack of definitive evidence regarding the relative merits of the two approaches, and indicate that more studies are needed to resolve this issue.