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Background: Physiologic data that is automatically collected during anesthesia is widely used for medical record keeping and clinical research. These data contain artifacts, which are not relevant in clinical care, but may influence research results. The aim of this study was to explore the effect of different methods of filtering and processing artifacts in anesthesiology data on study findings in order to demonstrate the importance of proper artifact filtering.Methods: The authors performed a systematic literature search to identify artifact filtering methods. Subsequently, these methods were applied to the data of anesthesia procedures with invasive blood pressure monitoring. Different hypotension measures were calculated (i.e., presence, duration, maximum deviation below threshold, and area under threshold) across different definitions (i.e., thresholds for mean arterial pressure of 50, 60, 65, 70 mmHg). These were then used to estimate the association with postoperative myocardial injury.Results: After screening 3,585 papers, the authors included 38 papers that reported artifact filtering methods. The authors applied eight of these methods to the data of 2,988 anesthesia procedures. The occurrence of hypotension (defined with a threshold of 50 mmHg) varied from 24% with a median filter of seven measurements to 55% without an artifact filtering method, and between 76 and 90% with a threshold of 65 mmHg. Standardized odds ratios for presence of hypotension ranged from 1.16 (95% CI, 1.07 to 1.26) to 1.24 (1.14 to 1.34) when hypotension was defined with a threshold of 50 mmHg. Similar variations in standardized odds ratios were found when applying methods to other hypotension measures and definitions.Conclusions: The method of artifact filtering can have substantial effects on estimates of hypotension prevalence. The effect on the association between intraoperative hypotension and postoperative myocardial injury was relatively small. Nevertheless, the authors recommend that researchers carefully consider artifacts handling and report the methodology used. [ABSTRACT FROM AUTHOR]

Background: Concerns about the cost and convenience of postsurgical physical therapy (PT) have sparked interest in unsupervised, home-based rehabilitation. However, the effectiveness of unsupervised home exercise after primary TKA has not been previously evaluated.Questions/purposes: (1) Can unsupervised home exercise after surgery provide noninferior recovery of passive knee flexion compared with formal outpatient PT? (2) Does a web-based platform for home-based exercise provide an advantage compared with a printed PT manual?Methods: We conducted a randomized, noninferiority trial involving 290 patients (20% of the 1464 eligible patients who could be contacted) who underwent primary TKA from March 2016 to April 2018. We included patients > 18 years old who were undergoing primary, unilateral TKA and provided written consent. We excluded patients with preoperative knee flexion < 90°, patients considering surgical intervention in a hip or the contralateral knee, patients discharged to an extended care facility, and revision or conversion TKA. We randomized patients to one of three groups: outpatient PT, unsupervised home exercise using a web-based platform (web PT), or unsupervised home exercise using a printed paper manual (paper PT). We also implemented a "delayed recovery intervention" within the home exercise program, in which patients were obliged to begin outpatient PT if knee flexion was < 70° at 2 weeks or < 90° at 4 weeks. The primary outcome was change in knee flexion from preoperative baseline after 4 to 6 weeks and 6 months. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), time back to activities of daily living, and time off narcotics. All analyses were intention to treat, and the noninferiority margin was 5% with maximum flexion as the outcome of interest for this parameter.Results: Adjusted differences in change in passive flexion for web PT +3° (95% confidence interval [CI], -1.2° to 6.4°) and paper PT +5° (95% CI, 0.99°-8.6°) were not inferior to outpatient PT based on a predefined 5° margin. Change in knee flexion from baseline was 0° for outpatient PT, -2° for web PT, and -1° for paper PT after 4 to 6 weeks and 8°, 8°, and 12° for the three groups, respectively, after 6 months. Additionally, there was no difference in the change in KOOS from baseline at 4 to 6 weeks or 6 months postoperatively as well as time back to work, driving, and walking without an assistive device.Conclusions: Unsupervised home exercise is an effective rehabilitation strategy after primary TKA and was noninferior to formal outpatient PT in selected patients. It is worthwhile to reconsider the current practice of automatically designating patients for outpatient PT after primary TKA, because appropriately selected patients with adequate clinical support can achieve similar results at home.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Although tenotomy and tenodesis are frequently used for long head of the biceps tendon lesions, controversies remain as to which technique is superior regarding pain, functionality, complications, and cosmetic appearance.Questions/purposes: (1) For long head of biceps tendon lesions, does tenotomy or tenodesis result in greater improvements in VAS score for pain? (2) Which approach has superior results when evaluating function outcome (Constant) scores? (3) Does tenotomy or tenodesis have fewer complications? (4) Does tenotomy or tenodesis result in better cosmesis (Popeye sign)?Methods: A systematic review was performed in the Cochrane Library, Embase, PubMed, and Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS) using the keywords "long head of the biceps tendon," "biceps tenodesis," and "tenotomy." We completed the search in June 2020. The inclusion criteria were randomized controlled trials and quasirandomized controlled trials that investigated tenodesis and tenotomy with no language restriction and evaluation of adult patients who presented with a long head of the biceps tendon lesion, associated with other lesions or not, without previous shoulder surgeries and who had no response to nonoperative treatment. The initial search yielded 239 studies, 40 of which were duplicates. We assessed the titles and abstracts of 199 articles and excluded all studies that were not randomized controlled trials (literature reviews) or that compared different techniques. We assessed the full text of 14 articles and excluded the ones that were protocols and cohort studies. We evaluated the risk of bias using the Cochrane Collaboration tool. We included eight studies in this systematic review and meta-analysis, with a total of 615 participants, 306 of whom were treated with tenotomy and 309 with tenodesis. The median duration of follow-up was 2 years. Overall, the included studies had a low risk of bias. The complications evaluated were adhesive capsulitis, biceps brachii tear, cramps, and a subsequent second surgical procedure. We used a random model in this meta-analysis so that we could generalize the results beyond the included studies. In this study, we only reported differences between the groups if they were both statistically valid and larger than the minimum clinically important difference (MCID).Results: Comparing tenotomy and tenodesis, we observed no difference between the groups regarding pain in the long term (mean difference 0.25 [95% confidence interval -0.29 to 0.80]; p = 0.36). There was no difference in Constant score in the long-term (mean difference -1.45 [95% CI -2.96 to 0.06]; p = 0.06). There were no differences when evaluating for major complications (odds ratio 1.37 [95% CI 0.29 to 6.56]; p = 0.70). There were not enough papers evaluating adhesive capsulitis, cramping, and risk of revision surgery. Popeye sign was more frequent in the tenotomy group than in the tenodesis group (OR 4.70 [95% CI 2.71 to 8.17]; p < 0.001).Conclusion: This systematic review demonstrated that tenotomy and tenodesis offer satisfactory treatment for long head of the biceps tendon lesions. In terms of pain improvement and Constant score, there was no difference between the techniques, but patients undergoing tenotomy have worse cosmetic results. Therefore, surgeons should choose the technique based on their skills and the patient's expectations of surgery, such as cosmesis and time to recovery. More studies are needed to evaluate complications such as adhesive capsulitis and cramping, as well as to compare duration of surgery and recovery time for each technique.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Displaced mid-third clavicle fractures are common, and their management remains unclear. Although several meta-analyses have compared specific operative techniques with nonoperative management, it is not possible to compare different operative constructs with one another using a standard meta-analysis. Conversely, a network meta-analysis allows comparisons among more than two treatment arms, using both direct and indirect comparisons between interventions across many trials. To our knowledge, no network meta-analysis has been performed to compare the multiple treatment options for displaced clavicle fractures.Questions/purposes: We performed a network meta-analysis of randomized, controlled trials (RCTs) to determine from among the approaches used to treat displaced midshaft clavicle fractures: (1) the intervention with the highest chance of union at 1 year, (2) the intervention with the lowest risk of revision surgery, and (3) the intervention with the highest functional outcome scores. Secondarily, we also (4) compared the surgical subtypes in the available RCTs on the same above endpoints.Methods: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were reviewed for relevant randomized controlled trials published up to July 25, 2018. Two hundred and eighty four papers were reviewed, with 22 meeting inclusion criteria of RCTs with appropriate randomization techniques, adult population, minimum of 1 year follow-up and including at least one operative treatment arm. In total, 1002 patients were treated with a plate construct, 378 with an intramedullary device, and 585 patients were managed nonoperatively. Treatment subtypes included locked intramedullary devices (56), unlocked intramedullary devices (322), anterior plating (89), anterosuperior plating (150), superior plating (449) or plating not otherwise specified (314). We performed a network meta-analysis to compare and rank the treatments for displaced clavicle fractures. We considered the following outcomes: union achievement, revision surgery risk and functional outcomes (DASH and Constant Scores). The minimal clinically important difference (MCID) was considered for both Constant and DASH scores to be at 8 points, representing the average of MCID scores reported for both DASH and Constant in the evidence, respectively.Results: Union achievement was lower in patients treated nonoperatively (88.9%), and higher in patients treated operatively (96.7%, relative risk [RR] 1.128 [95% CI 1.1 to 1.17]; p < 0.001), Number needed to treat (NNT) = 10). Union achievement increased with any plate construct (97.8%, RR 1.13 [95% CI 1.1 to 1.7]; p < 0.0001, NNT = 9) and with anterior or anterosuperior plates (99.3%, RR 1.14 [95% CI 1.1 to 1.8]; p < 0.0001, NNT = 8). Risk of reoperation, when considering planned removal of hardware, was similar across all treatment arms. Lastly, operative treatment outperformed nonoperative treatment with minor improvements in DASH and Constant scores, though not approaching the MCID. At the subtype level, anterosuperior plating ranked highest in DASH and Constant functional scores with mean differences reaching 10-point improvement for Constant scores (95% CI 4.4 to 2.5) and 7.6 point improvement for DASH (95% CI 5.2 to 20).Conclusions: We found that surgical treatment led to a greater likelihood of union at 1 year of follow-up among adult patients with displaced mid-third clavicle fractures. In aggregate, surgical treatment did not increase functional scores by amounts that patients were likely to consider clinically important. Use of specific subtypes of plating (anterior, anterosuperior) resulted in improvements in the Constant score that were slightly above the MCID but did not reach the MCID for the DASH score, suggesting that any outcomes-score benefits favoring surgery were likely to be imperceptible or small. In light of these findings, we believe patients can be informed that surgery for this injury can increase the likelihood of union incrementally (about 10 patients would need to undergo surgery to avoid one nonunion), but they should not expect better function than they would achieve without surgery; most patients can avoid surgery altogether with little absolute risk of nonunion. Patients who opt for surgery must be told that the decision should be weighed against complications and the possibility of undergoing a second procedure for hardware removal. Patients opting not to have surgery for acute midshaft clavicle fractures can be told that nonunion occurs in slightly more than 10% of patients, and that these can be more difficult to manage than acute fractures.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Traditional patient-reported outcome instruments like the Foot and Ankle Ability Measure (FAAM) quantify patient disability but often are limited by responder burden and incomplete questionnaires. The Patient-Reported Outcome Measurement Information System (PROMIS) overcomes such obstacles through computer-adaptive technology and can capture outcome data from various domains including physical and psychosocial function. Prior work has compared the FAAM with PROMIS physical function; however, there is little evidence comparing the association between foot and ankle-specific tools like the FAAM with more general outcomes measures of PROMIS pain interference and depression in foot and ankle conditions.Questions/purposes: (1) We asked whether there was a relationship between FAAM Activities of Daily Living (ADL) scores with PROMIS physical function, pain interference, and depression in patients with hallux valgus. (2) Additionally, we asked if we could identify specific factors that are associated with variance in FAAM and PROMIS physical function scores in patients with hallux valgus.Methods: Eighty-five new patients with either a primary or secondary diagnosis of hallux valgus based on clinic billing codes from July 2015 to February 2016 were retrospectively identified. Patients completed FAAM ADL paper-based surveys and electronic PROMIS questionnaires for physical function, pain interference, and depression from new patient visits at a single time. Spearman rho correlations were performed between FAAM ADL and PROMIS scores. Analyses then were used to identify differences in FAAM ADL and PROMIS physical function measures based on demographic variables. Stepwise linear regressions then determined which demographic and/or outcome variable(s) accounted for the variance in FAAM ADL and PROMIS physical function scores.Results: FAAM scores correlated strongly with PROMIS physical function (r = 0.70, p < 0.001), moderately with PROMIS pain interference (r = -0.65, p < 0.001), and weakly with PROMIS depression (r = -0.35, p < 0.001) scores. Regression analyses showed that PROMIS pain interference scores alone were associated with sizeable portions of the variance in FAAM ADL (R2 = 0.44, p < 0.001) and PROMIS physical function (R2 = 0.57, p < 0.001) measures.Conclusions: PROMIS function and pain measures correlated with FAAM ADL scores, highlighting the interrelationship of pain and function when assessing outcomes in patients with hallux valgus. PROMIS tools allow for more-efficient data collection across multiple domains and, moving forward, may be better poised to monitor changes in pain and function with time compared with traditional outcome measures like the FAAM.Clinical Relevance: The relationships shown here between PROMIS and FAAM scores further support the use of PROMIS tools in outcomes-based research. In patients with hallux valgus, pain-related disability appears to be a central feature of the patient-experience. Future studies should assess the association of various outcome domains on other common foot and ankle diagnoses. [ABSTRACT FROM AUTHOR]

Misclassification of binary outcome variables is a known source of potentially serious bias when estimating adjusted odds ratios. Although researchers have described frequentist and Bayesian methods for dealing with the problem, these methods have seldom fully bridged the gap between statistical research and epidemiologic practice. In particular, there have been few real-world applications of readily grasped and computationally accessible methods that make direct use of internal validation data to adjust for differential outcome misclassification in logistic regression. In this paper, we illustrate likelihood-based methods for this purpose that can be implemented using standard statistical software. Using main study and internal validation data from the HIV Epidemiology Research Study, we demonstrate how misclassification rates can depend on the values of subject-specific covariates, and we illustrate the importance of accounting for this dependence. Simulation studies confirm the effectiveness of the maximum likelihood approach. We emphasize clear exposition of the likelihood function itself, to permit the reader to easily assimilate appended computer code that facilitates sensitivity analyses as well as the efficient handling of main/external and main/internal validation-study data. These methods are readily applicable under random cross-sectional sampling, and we discuss the extent to which the main/internal analysis remains appropriate under outcome-dependent (case-control) sampling. [ABSTRACT FROM AUTHOR]

Ill-defined causal questions present serious problems for observational studies-problems that are largely unappreciated. This paper extends the usual counterfactual framework to consider causal questions about compound treatments for which there are many possible implementations (for example, "prevention of obesity"). We describe the causal effect of compound treatments and their identifiability conditions, with a special emphasis on the consistency condition. We then discuss the challenges of using the estimated effect of a compound treatment in one study population to inform decisions in the same population and in other populations. These challenges arise because the causal effect of compound treatments depends on the distribution of the versions of treatment in the population. Such causal effects can be unpredictable when the versions of treatment are unknown. We discuss how such issues of "transportability" are related to the consistency condition in causal inference. With more carefully framed questions, the results of epidemiologic studies can be of greater value to decision-makers. [ABSTRACT FROM AUTHOR]

Uncontrolled confounding in observational studies gives rise to biased effect estimates. Sensitivity analysis techniques can be useful in assessing the magnitude of these biases. In this paper, we use the potential outcomes framework to derive a general class of sensitivity-analysis formulas for outcomes, treatments, and measured and unmeasured confounding variables that may be categorical or continuous. We give results for additive, risk-ratio and odds-ratio scales. We show that these results encompass a number of more specific sensitivity-analysis methods in the statistics and epidemiology literature. The applicability, usefulness, and limits of the bias-adjustment formulas are discussed. We illustrate the sensitivity-analysis techniques that follow from our results by applying them to 3 different studies. The bias formulas are particularly simple and easy to use in settings in which the unmeasured confounding variable is binary with constant effect on the outcome across treatment levels. [ABSTRACT FROM AUTHOR]

Background: Data with some values below a limit of detection (LOD) can be analyzed using methods of survival analysis for left-censored data. The reverse Kaplan-Meier (KM) estimator provides an effective method for estimating the distribution function and thus population percentiles for such data. Although developed in the 1970s and strongly advocated since then, it remains rarely used, partly due to limited software availability. Methods: In this paper, the reverse KM estimator is described and is illustrated using serum dioxin data from the University of Michigan Dioxin Exposure Study (UMDES) and the National Health and Nutrition Examination Survey (NHANES). Percentile estimates for left-censored data using the reverse KM estimator are compared with replacing values below the LOD with the LOD/2 or LOD/ radical2. Results: When some LODs are in the upper range of the complete values, and/or the percent censored is high, the different methods can yield quite different percentile estimates. The reverse KM estimator, which is the nonparametric maximum likelihood estimator, is the preferred method. Software options are discussed: The reverse KM can be calculated using software for the KM estimator. The JMP and SAS (SAS Institute, Cary, NC) and Minitab (Minitab, Inc, State College, PA), software packages calculate the reverse KM directly using their Turnbull estimator routines. Conclusion: The reverse KM estimator is recommended for estimation of the distribution function and population percentiles in preference to commonly used methods such as substituting LOD/2 or LOD/ radical2 for values below the LOD, assuming a known parametric distribution, or using imputation to replace the left-censored values. [ABSTRACT FROM AUTHOR]