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Colorectal cancer (CRC) is one of the most common cancers worldwide, and a leading cause of cancer deaths. Better classifying multicategory outcomes of CRC with clinical and omic data may help adjust treatment regimens based on individual's risk. Here, we selected the features that were useful for classifying four-category survival outcome of CRC using the clinical and transcriptomic data, or clinical, transcriptomic, microsatellite instability and selected oncogenic-driver data (all data) of TCGA. We also optimized multimetric feature selection to develop the best multinomial logistic regression (MLR) and random forest (RF) models that had the highest accuracy, precision, recall and F1 score, respectively. We identified 2073 differentially expressed genes of the TCGA RNASeq dataset. MLR overall outperformed RF in the multimetric feature selection. In both RF and MLR models, precision, recall and F1 score increased as the feature number increased and peaked at the feature number of 600-1000, while the models' accuracy remained stable. The best model was the MLR one with 825 features based on sum of squared coefficients using all data, and attained the best accuracy of 0.855, F1 of 0.738 and precision of 0.832, which were higher than those using clinical and transcriptomic data. The top-ranked features in the MLR model of the best performance using clinical and transcriptomic data were different from those using all data. However, pathologic staging, HBS1L, TSPYL4, and TP53TG3B were the overlapping top-20 ranked features in the best models using clinical and transcriptomic, or all data. Thus, we developed a multimetric feature-selection based MLR model that outperformed RF models in classifying four-category outcome of CRC patients. Interestingly, adding microsatellite instability and oncogenic-driver data to clinical and transcriptomic data improved models' performances. Precision and recall of tuned algorithms may change significantly as the feature number changes, but accuracy appears not sensitive to these changes., (© 2021. The Author(s), under exclusive licence to United States and Canadian Academy of Pathology.)

Background: There are a variety of criteria for defining successful treatment after two-stage exchange arthroplasty for prosthetic joint infection (PJI). To accurately assess current practices and improve techniques, it is important to first establish reliable, clinically relevant, reproducible criteria for defining persistent infection and "successful" outcomes., Question/purpose: Is the proportion of patients considered to have successful management of PJI after two-stage resection arthroplasty smaller using 2019 Musculoskeletal Infection Society Outcome Reporting Tool (MSIS ORT) criteria than when using a Delphi-based criterion?, Methods: Patients were retrospectively identified by Current Procedural Technology codes for resection arthroplasty with placement of an antibiotic spacer for infected THA or TKA between April 1, 2011 and January 1, 2018 at a tertiary academic institution. The initial review identified 180 procedures during this time period. Nine patients had documented transition of care outside the system, 16 did not meet the MSIS criteria for chronic PJI, and 34 patients were excluded for lack of documented 2-year follow-up. The mean follow-up duration of the final cohort of 121 procedures in 120 patients was approximately 3.7 ± 1.7 years. Forty percent (49 of 121) of the procedures were performed on the hip and 60% (72 of 121) were performed on the knee. The mean time from primary THA or TKA to explantation was 4.6 years. The mean age of the patients at the time of explantation was 66 years. The mean time from spacer placement to replantation was 119 days. The final 121 patient records were reviewed by a single reviewer and outcomes were subsequently assigned to "successful" and "unsuccessful" outcomes based on the MSIS ORT and Delphi-based consensus criterion, two previously published and validated multidimensional definition schemes. Chi-squared and t-test analyses were performed to identify differences between "successful" and "unsuccessful" outcomes with respect to patient baseline characteristics using each outcome-reporting criterion., Results: Overall, the MSIS ORT classified a smaller proportion of patients as having a "successful" treatment outcome after two-stage exchange arthroplasty for PJI than the Delphi-based consensus method did (MSIS: 55% [63 of 114], Delphi: 70% [71 of 102]; relative risk 0.79 [0.65-0.98]; p = 0.03). However, there were no differences when stratified by hips (MSIS: 55% [26 of 47], Delphi: 74% [29 of 39]; relative risk 0.74 [0.54-1.02]; p = 0.07) and knees (MSIS: 55% [37 of 67], Delphi: 67% [42 of 63]; relative risk 0.83 [0.63-1.09]; p = 0.19). Notably, the disease of 16% of the patients (19 of 121) was not classifiable per the Delphi method because these patients never underwent reimplantation., Conclusion: The present study demonstrated that the MSIS criteria detect fewer instances of "successful" infection management after two-stage resection arthroplasty for PJI than the Delphi method in this cohort. Based on these findings, researchers and surgeons should aim for standardized reporting after intervention for PJI to allow for a better comparison of outcomes across different studies and ultimately allow for improved techniques and approaches to the treatment of PJI., Level of Evidence: Level III, diagnostic study., Competing Interests: Each author certifies that neither he nor she, nor any of his or her immediate family members, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2021 by the Association of Bone and Joint Surgeons.)

Objectives: to develop nursing diagnoses and outcomes for children with nutritional anomalies based on terms found in a children's clinical protocol and on the 2017 International Classification for Nursing Practice., Methods: exploratory-descriptive study, conducted with the validation of diagnoses/outcomes by six nurses of the children's clinic of the Federal District's teaching hospital. It was based on the cross-mapping between the terms of International Classification for Nursing Practice 2017 and the terms of a children's health care protocol. The list of nursing diagnosis/outcomes was developed, then submitted to the validation process using a Likert-type scale and considering statements with content validity index > 0.79 to be validated., Results: a total of 51 diagnoses/outcomes were generated, and of those, 11 were contained in International Classification for Nursing Practice. Those that were not in it were evaluated for similarity and comprehensiveness in relation to International Classification for Nursing Practice. Thirty nursing diagnoses/outcomes were validated with CVI > 0.79 among the nurses in the validation process., Conclusions: this study will allow the formation of a terminological International Classification for Nursing Practice subset aimed at children's nutrition.

Objective: To describe the associations between autoantibodies, clinical presentation, and outcomes among patients with systemic sclerosis (SSc) in order to develop a novel SSc classification scheme that would incorporate both antibodies and the cutaneous disease subset as criteria., Methods: Demographic and clinical characteristics, including cutaneous subset, time of disease and organ complication onset, and autoantibody specificities, were determined in a cohort of SSc subjects. Survival analysis was used to assess the effect of the autoantibodies on organ disease and death., Results: The study included 1,325 subjects. Among the antibody/skin disease subsets, anticentromere antibody-positive patients with limited cutaneous SSc (lcSSc) (n = 374) had the highest 20-year survival (65.3%), lowest incidence of clinically significant pulmonary fibrosis (PF) (8.5%) and scleroderma renal crisis (SRC) (0.3%), and lowest incidence of cardiac SSc (4.9%), whereas the frequency of pulmonary hypertension (PH) was similar to the mean value in the SSc cohort overall. The anti-Scl-70+ groups of patients with lcSSc (n = 138) and patients with diffuse cutaneous SSc (dcSSc) (n = 149) had the highest incidence of clinically significant PF (86.1% and 84%, respectively, at 15 years). Anti-Scl-70+ patients with dcSSc had the lowest survival (32.4%) and the second highest incidence of cardiac SSc (12.9%) at 20 years. In contrast, in anti-Scl-70+ patients with lcSSc, other complications were rare, and these patients demonstrated the lowest incidence of PH (6.9%) and second highest survival (61.8%) at 20 years. Anti-RNA polymerase antibody-positive SSc patients (n = 147) had the highest incidence of SRC (28.1%) at 20 years. The anti-U3 RNP+ SSc group (n = 56) had the highest incidence of PH (33.8%) and cardiac SSc (13.2%) at 20 years. Among lcSSc patients with other autoantibodies (n = 295), the risk of SRC and cardiac SSc was low at 20 years (2.7% and 2.4%, respectively), while the frequencies of other outcomes were similar to the mean values in the full SSc cohort. Patients with dcSSc who were positive for other autoantibodies (n = 166) had a poor prognosis, demonstrating the second lowest survival (33.6%) and frequent organ complications., Conclusion: These findings highlight the importance of autoantibodies, cutaneous subset, and disease duration when assessing morbidity and mortality in patients with SSc. Our novel classification scheme may improve disease monitoring and benefit future clinical trial designs in SSc., (© 2019, American College of Rheumatology.)

Misclassification of outcomes or event types is common in health sciences research and can lead to serious bias when estimating the cumulative incidence functions in settings with competing risks. Recent work has shown how to estimate nonparametric cumulative incidence functions in the presence of nondifferential outcome misclassification when the misclassification probabilities are known. Here, we extend this approach to account for misclassification that is differential with respect to important predictors of the outcome using misclassification probabilities estimated from external validation data. Moreover, we propose a bootstrap approach in which the observations from both the main study data and the external validation study are resampled to allow the uncertainty in the misclassification probabilities to propagate through the analysis into the final confidence intervals, ensuring appropriate confidence interval coverage probabilities. The proposed estimator is shown to be uniformly consistent and simulation studies indicate that both the estimator and the standard error estimation approach perform well in finite samples. The methodology is applied to estimate the cumulative incidence of death and disengagement from HIV care in a large cohort of HIV infected individuals in sub-Saharan Africa, where a significant death underreporting issue leads to outcome misclassification. This analysis uses external validation data from a separate study conducted in the same country., (© 2019 John Wiley & Sons, Ltd.)

Background: Suicidal outcomes, including ideation, attempt, and completed suicide, are an important drug safety issue, though few epidemiological studies address the accuracy of suicidal outcome ascertainment. Our primary objective was to evaluate validated methods for suicidal outcome classification in electronic health care database studies., Methods: We performed a systematic review of PubMed and EMBASE to identify studies that validated methods for suicidal outcome classification published 1 January 1990 to 15 March 2016. Abstracts and full texts were screened by two reviewers using prespecified criteria. Sensitivity, specificity, and predictive value for suicidal outcomes were extracted by two reviewers. Methods followed PRISMA-P guidelines, PROSPERO Protocol: 2016: CRD42016042794., Results: We identified 2202 citations, of which 34 validated the accuracy of measuring suicidal outcomes using International Classification of Diseases (ICD) codes or algorithms, chart review or vital records. ICD E-codes (E950-9) for suicide attempt had 2-19% sensitivity, and 83-100% positive predictive value (PPV). ICD algorithms that included events with 'uncertain' intent had 4-70% PPV. The three best-performing algorithms had 74-92% PPV, with improved sensitivity compared with E-codes. Read code algorithms had 14-68% sensitivity and 0-56% PPV. Studies estimated 19-80% sensitivity for chart review, and 41-97% sensitivity and 100% PPV for vital records., Conclusions: Pharmacoepidemiological studies measuring suicidal outcomes often use methodologies with poor sensitivity or predictive value or both, which may result in underestimation of associations between drugs and suicidal behaviour. Studies should validate outcomes or use a previously validated algorithm with high PPV and acceptable sensitivity in an appropriate population and data source., (Published by Oxford University Press on behalf of the International Epidemiological Association 2019. This work is written by US Government employees and is in the public domain in the US.)

Background: Pulmonary embolism (PE)-related death is a component of the primary outcome in many venous thromboembolism (VTE) studies. The absence of a standardized definition for PE-related death hampers study outcome evaluation and between-study comparisons., Objectives: To summarize definitions for PE-related death used in recent VTE studies and to assess the PE-related death rate., Patients/methods: A systematic literature search was conducted on 26 April 2018 from 1 January 2014 up to the search date in MEDLINE, Embase, and CENTRAL. Cohort studies and randomized trials in which PE-related death was included in the primary outcome were eligible. Screening of titles, abstracts, and full-text articles, and data extraction were independently performed in duplicate by two authors. Study outcomes included the definition for PE-related death, VTE case-fatality rate, and death due to PE rate. Descriptive statistics were used to analyze the data., Results: Of the 6807 identified citations, 83 studies were included of which 27% were randomized trials, 31% were prospective, and 42% retrospective cohort studies. Thirty-five studies (42%) had a central adjudication committee. Thirty-eight (46%) reported a definition for PE-related death of which the most frequently used components were "autopsy-confirmed PE" (50%), "objectively confirmed PE before death" (55%), and "unexplained death" (58%). Median VTE case-fatality rate was 1.8% (interquartile range, 0.0-13)., Conclusions: Only half of the included studies reported definitions for PE-related death, which were very heterogeneous. Case-fatality rate of VTE events varied widely across studies. Standardization of the definition and guidance on adjudication and reporting of PE-related death is needed., (© 2019 Amsterdam University Medical Center, AMC. Journal of Thrombosis and Haemostasis © 2019 International Society on Thrombosis and Haemostasis.)

Purpose: To investigate the impact of the risk group disagreement between the Memorial Sloan Kettering Cancer Center (MSKCC) and the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) models on prognosis., Patients and Methods: We retrospectively evaluated 176 patients with metastatic renal-cell carcinoma who were treated with tyrosine kinase inhibitors as first-line therapy in 5 hospitals between October 2008 and August 2018. The risk group classification differences between the MSKCC and the IMDC models were evaluated using criteria of agreement (identical risk group in both the MSKCC and IMDC models) and disagreement (not identical risk group in both the MSKCC and IMDC models). The agreement of risk stratification between the models was evaluated using the Cohen κ coefficient. Oncologic outcomes were compared between the agreement and disagreement groups., Results: The number of patients with agreement, upgrade, and downgrade was 135 (77%), 39 (22%), and 2 (1.1%), respectively. Of 41 patients with disagreement, reclassification from the MSKCC-intermediate to the IMDC-poor risk group was most frequent (n = 34, 19%). The Cohen κ coefficient for agreement was substantial, with κ = 0.613 (P < .001). Significantly poorer prognosis was observed in patients with disagreement than in those with agreement. Neutrophil count, hemoglobin, serum calcium concentration, and C-reactive protein were significantly different between the groups., Conclusion: Disagreement between the MSKCC and IMDC models may have a negative impact on prognosis in patients with metastatic renal-cell carcinoma. The inclusion of systematic inflammation markers in a risk model may be essential for prognosis prediction., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Out-of-hospital cardiac arrest (OHCA) affects nearly 400,000 people each year in the United States of which only 10% survive. Using data from the Cardiac Arrest Registry to Enhance Survival (CARES), and machine learning (ML) techniques, we developed a model of neurological outcome prediction for OHCA in Chicago, Illinois., Methods: Rescue workflow data of 2639 patients with witnessed OHCA were retrieved from Chicago's CARES. An Embedded Fully Convolutional Network (EFCN) classification model was selected to predict the patient outcome (survival with good neurological outcomes or not) based on 27 input features with the objective of maximizing the average class sensitivity. Using this model, sensitivity analysis of intervention variables such as bystander cardiopulmonary resuscitation (CPR), targeted temperature management, and coronary angiography was conducted., Results: The EFCN classification model has an average class sensitivity of 0.825. Sensitivity analysis of patient outcome shows that an additional 33 patients would have survived with good neurological outcome if they had received lay person CPR in addition to CPR by emergency medical services and 88 additional patients would have survived if they had received the coronary angiography intervention., Conclusions: ML modeling of the complex Chicago OHCA rescue system can predict neurologic outcomes with a reasonable level of accuracy and can be used to support intervention decisions such as CPR or coronary angiography. The discriminative ability of this ML model requires validation in external cohorts to establish generalizability., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: To propose a new classification of inner-ear anomalies that is more clinically oriented and surgically relevant: the SMS (Sawai Man Singh) classification of cochleovestibular malformations., Methods: A retrospective multicentric study was conducted of 436 cochlear implantations carried out in 3 Indian tertiary care institutes. Patients with anomalous anatomy were included and classified, as per the new SMS classification, into cochleovestibular malformation types I, II, III and IV, based on cochlear morphology, modiolus and lamina cribrosa., Results: There were 19, 23, 8 and 4 patients with cochleovestibular malformation types I, II, III and IV, respectively. Two-year post-operative Meaningful Auditory Integration Scale scores were statistically analysed., Conclusion: This new classification for inner-ear anomalies is a simpler, more practical, outcome-oriented classification that can be used to better plan the surgery. These merits make it a more uniform classification for recording results.

People with diabetes have to self-manage their health conditions to promote, maintain, and restore their health. The Nursing Outcomes Classification provides two outcomes for people with diabetes to evaluate their knowledge and self-management behaviors. The purpose of this study was to validate these two Nursing Outcomes Classification outcomes for adults with diabetes. A descriptive exploratory design using the Delphi technique was used. Two groups of experts were invited for validation of the outcomes. Descriptive statistics were used to determine definition adequacy, clinical usefulness, and content similarity. The Outcome Content Validity method was used to evaluate each outcome and the indicators. A total of 16 nurse experts participated in this study. The definition adequacy of the two Nursing Outcomes Classification outcomes was rated higher than 4.0 out of 5. Clinical usefulness was rated higher than 4.0 out of 5. The range of content validity of the two Nursing Outcomes Classification outcomes was from 0.89 to 0.92 (perfect score is 1.0). The invited experts reported that the content of this outcome pair was very similar. By using validated Nursing Outcomes Classification outcomes, nurses who take care of patients with diabetes can evaluate patient outcomes effectively and determine the effect of nursing interventions accurately.

Objective: We evaluated whether deep learning applied to whole-brain presurgical structural connectomes could be used to predict postoperative seizure outcome more accurately than inference from clinical variables in patients with mesial temporal lobe epilepsy (TLE)., Methods: Fifty patients with unilateral TLE were classified either as having persistent disabling seizures (SZ) or becoming seizure-free (SZF) at least 1 year after epilepsy surgery. Their presurgical structural connectomes were reconstructed from whole-brain diffusion tensor imaging. A deep network was trained based on connectome data to classify seizure outcome using 5-fold cross-validation., Results: Classification accuracy of our trained neural network showed positive predictive value (PPV; seizure freedom) of 88 ± 7% and mean negative predictive value (NPV; seizure refractoriness) of 79 ± 8%. Conversely, a classification model based on clinical variables alone yielded <50% accuracy. The specific features that contributed to high accuracy classification of the neural network were located not only in the ipsilateral temporal and extratemporal regions, but also in the contralateral hemisphere., Significance: Deep learning demonstrated to be a powerful statistical approach capable of isolating abnormal individualized patterns from complex datasets to provide a highly accurate prediction of seizure outcomes after surgery. Features involved in this predictive model were both ipsilateral and contralateral to the clinical foci and spanned across limbic and extralimbic networks., (Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.)

Objectives: Using patient global impression of change (PGIC) as an anchor, an approximately 30% reduction on an 11-point numeric pain intensity rating scale (PI-NRS) is considered a clinically important difference (CID) in pain. Our objective was to define the CID for another pain measure, the worst pain severity (WPS) item of the modified Brief Pain Inventory (m-BPI)., Methods: In this post hoc analysis of a double-blind, placebo-controlled, phase 2 study, 452 randomized patients with diabetic peripheral neuropathic pain (DPNP) were followed over 5 weeks, with m-BPI data collected weekly and PGIC at treatment conclusion. Receiver operating characteristic (ROC) curves (via logistic regression) were used to determine the changes in the m-BPI-WPS score that best predicted ordinal clinical improvement thresholds (i.e., "minimally improved" or better) on the PGIC., Results: Similar to the PI-NRS, a change of -3 (raw) or -33.3% from the baseline on the m-BPI-WPS optimized prediction for the "much improved" or better PGIC threshold and represents a CID. There was a high correspondence between observed and predicted PGIC categories at each PGIC threshold (ROC AUCs were 0.78-0.82)., Conclusions: Worst pain on the m-BPI may be used to assess clinically important improvements in DPNP studies. Findings require validation in larger studies.

Context: Since 2012 uniformed reporting of complications after urological procedures has been advocated by the European Association of Urology (EAU) guidelines. The Clavien-Dindo grading system was recommended to report the outcomes of urologic procedures., Objective: To validate the Clavien-Dindo grading system in urology., Design, Setting, and Participants: Members of the EAU working group compiled a list of case scenarios including those with minor and major complications. A survey was administered online via Survey Monkey to the members of EAU committees for the appropriate grading according to the Clavien-Dindo classification of surgical complications. Scenarios with intraoperative complications were intentionally included to assess respondents' awareness of the Clavien-Dindo applicability., Outcome Measurements and Statistical Analysis: Survey data collected were used to calculate agreement rates and to estimate the overall inter-rater agreement on all cases using Fleiss' kappa (κ). Differences in agreement rates for each scenario among groups with different criteria about the system were estimated using the chi-square test., Results and Limitations: Evaluable responses were received from 81 out of 174 invited raters (46.5%). Of them 56.9% believed that the Clavien-Dindo system was adequate for grading postoperative complications. The agreement rate was over a score of ≥80% in nine cases, 60-79% in 10 cases, 40-59% in 14 cases, and <40% in two cases. Interestingly, the agreement rate on the nonapplicability of the Clavien-Dindo system was quite low, ranging from 27.5% to 67.2% (κ=0.147). Being a resident rather than a specialist affected only the distribution of agreement rates in case 1 (ie, score IIIb: 83.3% vs 94.1%). Being an academic or having affiliation did not have any impact on the distribution of agreement rates in all cases but one., Conclusions: The Clavien-Dindo classification is a standardised approach to grade and report postoperative complications in urology and should be used systematically. However, it does not apply for intraoperative complications, and there is a need for an additional tool., Patient Summary: A rigorous methodology is mandatory when surgeons report about complications after surgery. In this study, the European Association of Urology Guidelines Panel has validated the use of the Clavien-Dindo grading system in urology., (Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objectives: There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery., Study Design and Setting: A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system., Results: Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events., Conclusions: This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To verify the long-term efficacy of resective surgery, we created a classification system in which strictly defined patterns of postoperative seizure emergence are incorporated as basic components and the seizure states throughout the entire follow-up period are assessed comprehensively., Methods: In our system, Class I has three subclasses (A-C); subclasses A and B are identical to Engel I-A and I-B, respectively. Subclass C comprises patients whose disabling seizures remit within the first 2 years postoperatively. Patients in Class II have only 1-3 days with disabling seizures throughout follow-up after the first 2 years. Patients in Class III have a maximum of 3 seizure days annually, and those in Class IV have ≥4 seizure days annually after the first 2 years. Classes II-IV each have 2 subclasses (A and B): subclass A, late recurrence (i.e., the first seizure occurs after 2 years postoperatively); and subclass B, early recurrence (i.e., first seizure within 2 years). In 646 patients who underwent resective surgery (temporal lobe resection, 74.6%) and were followed for at least 8 years (mean, 14.6 years), we analyzed three patterns of postoperative seizures: early remission, late recurrence, and occasional seizures. In addition, we investigated the differences between the long-term seizure outcomes of the cohort as determined according to our system and the Engel scale., Results: Overall, 52.9% of the cohort experienced at least one disabling seizure postoperatively throughout the follow-up period; in 1/3 of these patients, the first seizure occurred after 2 years. In 73.8% of the 80 patients who manifested the running-down phenomenon, seizure remission occurred within the first 2 years. In addition, 36.7% of the 283 patients who had disabling seizures after 2 years experienced only 1-3 seizure days. Engel Class I-C included about 30% of the patients who had ≥4 seizure days after 2 years. The long-term seizure outcomes, determined according to our system, were: Class I, 56.2% (C, 9.1%) of the overall cohort; Class II, 16.1% (A, 11.0%); and Class III/IV, 27.7% (A, 6.6%)., Conclusion: Our system clarifies the actual effect of resective surgery more precisely than the Engel scale and thus may be useful for comparing outcomes between different surgical procedures or for identifying potential risk factors predicting unfavorable outcome., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required., Methods: A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB. A systematic search of databases (PubMed, MEDLINE, EMBASE, CENTRAL and LILACs) was conducted on 30 November 2017 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes., Results: Of 248 included studies, 229 considered "on-treatment" outcomes whilst 148 reported "off-treatment" outcomes. There was wide variation and ambiguity in the definition of reported outcomes, including their relationship to treatment and in the time points evaluated. Additional challenges were observed regarding the analysis approach taken (per protocol versus intention to treat) and the varying durations of "intensive" and "continuation" phases of treatment. Bacteriological outcomes were most frequently reported but radiological and clinical data were often included as an implicit or explicit component of the overall definition of outcome., Conclusions: Terminology used to define long-term outcomes in phase III trials is inconsistent, reflecting evolving differences in protocols and practices. For successful future cumulative meta-analysis, the findings of this review suggest that greater availability of individual patient data and the development of a core outcome set would be desirable. In the meantime, we propose a simple and logical approach which should facilitate combination of key evidence and inform improvements in the methodology of TB drug development and clinical trials.

Background: The Whitaker classification is a simple and widely used system for describing aesthetic outcomes after craniosynostosis surgery. The purpose of this study is to evaluate its interrater reliability for patients who have undergone fronto-orbital surgery., Methods: A retrospective review of patients with craniosynostosis who underwent surgical intervention at a tertiary referral center was conducted. Inclusion criteria were as follows: single-suture craniosynostosis, surgical intervention before age 2 years, and photographs taken before revisions between 5 and 20 years of age. Thirteen craniofacial surgeons independently reviewed the subjects' photographs and assigned Whitaker classifications. Interrater reliability was assessed with the Cohen kappa statistic., Results: Twenty-nine subjects were included. Average ages at surgery and at the time of postoperative photography were 0.8 year and 12.8 years, respectively. The κ value for all 13 raters was 0.1567 (p < 0.0001), indicating "slight agreement." Pairwise comparisons demonstrated κ values ranging from 0.0384 to 0.5492. The average rating for the set of 29 photographs differed significantly across the 13 raters (p = 0.0020) and ranged from 1.79 ± 0.68 to 2.79 ± 0.77. Finally, we found that average Whitaker classification did not differ significantly between subjects who subsequently underwent cranioplasty and/or fronto-orbital advancement and those who did not (subsequent procedures, 2.45 ± 0.55; no subsequent procedures, 1.88 ± 0.78; p = 0.1087)., Conclusions: The Whitaker classification exhibits low interrater reliability and does not predict future treatment. It may benefit craniofacial surgeons to create new evaluation tools with greater precision, to improve the quality of patient care and craniofacial outcomes research.

Objective: Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics., Methods: A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks., Results: Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (p<.001 for all). Intervention patients also had significantly improved quality-of-care indicators, including the proportion of patients receiving either psychotherapy or antidepressant medication (77% versus 21%, p<.001)., Conclusions: Collaborative care for depression can greatly improve care and outcomes in public-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging endoscopic procedure, harboring a wide range of complexities within every single investigation. Classifications of the complexity of ERCP have been presented, but do not include modern endoscopic treatment modalities. In order to be able to target resources and compare the results of different endoscopic centers, a new complexity grading system for ERCP is warranted. This study launches a new complexity grading scale for ERCP-the H.O.U.S.E.-classification., Methods: The medical record of every patient undergoing ERCP 2009-2011 at the Karolinska University Hospital was reviewed, regarding the complexity of the procedure, and categorized into one out of three-grades in the HOUSE classification system, and concomitantly graded according to the Cotton grading system. All ERCP-procedures were also registered in the Swedish registry for gallstone surgery and ERCP (GallRiks) and correlations between the grading systems and procedure related variables as well as outcomes were made., Results: Between 2009 and 2011, 2185 ERCPs were performed at the Karolinska University Hospital, Huddinge. One thousand nine hundred fifty-four of those were index-ERCPs. Another 23 patients were excluded due to lack of postoperative complication registrations, leaving 1931 ERCP procedures to be analyzed. The procedure times were 40 ± 0.7, 65 ± 1.5 and 106 ± 3.2 min, respectively (HOUSE 1-3). The corresponding pancreatitis rates were 3.4, 7.0 and 6.8% and the postoperative complication rates 11.1, 15.7 and 12.8%, respectively., Conclusions: The HOUSE-classification is a novel grading scale for ERCP-complexity. The system can be implemented in clinical practice to allocate resources and allow the comparisons of results between different endoscopic centers. Further studies are warranted to further sharpen this instruments validitity and general clinical relevance.

Objective: The aim of this study was to verify the clinical applicability of the Nursing Outcomes Classification (NOC) to the evaluation of cancer patients with a nursing diagnosis of acute or chronic pain in a palliative care unit., Method: A prospective longitudinal study performed on a sample of 13 adult cancer patients in a palliative care unit. Patients were followed for at least 4 days. Data were collected with an instrument containing eight nursing outcomes and nineteen NOC indicators. Statistical analysis was performed using generalized estimating equation models., Results: The following outcome and indicator scores changed significantly over the course of the study: reported pain and length of pain episodes in the pain level outcome; social relationships in the personal well-being outcome; respirator rate in the vital signs outcome; and describes causal factors in the pain control outcome., Conclusion: The NOC outcomes and indicators included in this study were able to successfully evaluate the clinical evolution of cancer patients in palliative care. These scores proved to be applicable for use in palliative nursing care., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: To identify the knowledge produced from the outcomes of the Nursing Outcomes Classification (NOC)., Method: A literature review using the integrative databases: Latin American and Caribbean Health Sciences (LILACS), US National Library of Medicine (PubMed), Cumulative Index to Nursing & Allied Health Literature (CINAHL) and Scopus Info Site (SCOPUS), during the months of August and September 2014., Results: The review consisted of 21 articles that addressed different issues: Translation and Cultural adaptation (4.77%); Applicability in clinical practice (33.33%); and, Validation (63.90%). Analysis of these articles showed that the knowledge produced from the Nursing Outcomes Classification includes translation and cultural adaptation, evaluation of applicability and validation of its items., Conclusion: Considering the continuous evolution of this classification, periodic reviews should be carried out to identify the knowledge, use and effects of the NOC.

Background: The effects of clustering in randomized controlled trials (RCTs) and the resulting potential violation of assumptions of independence are now well recognized. When patients in a single study are treated by several therapists, there is good reason to suspect that the variation in outcome will be smaller for patients treated in the same group than for patients treated in different groups. This potential correlation of outcomes results in a loss of independence of observations. The purpose of this study is to examine the current use of clustering analysis in RCTs published in the top five journals of orthopaedic surgery., Methods: RCTs published from 2006 to 2010 in the top five journals of orthopaedic surgery, as determined by 5-year impact factor, that included multiple therapists and/or centers were included. Identified articles were assessed for accounting for the effects of clustering of therapists and/or centers in randomization or analysis. Logistic regression used both univariate and multivariate models, with use of clustering analysis as the outcome. Multivariate models were constructed using stepwise deletion. An alpha level of 0.10 was considered significant., Results: A total of 271 articles classified as RCTs were identified from the five journals included in the study. Thirty-two articles were excluded due to inclusion of nonhuman subjects. Of the remaining 239 articles, 186 were found to include multiple centers and/or therapists. The prevalence of use of clustering analysis was 21.5%. Fewer than half of the studies reported inclusion of a statistician, epidemiologist or clinical trials methodologist on the team. In multivariate modeling, adjusting for clustering was associated with a 6.7 times higher odds of inclusion of any type of specialist on the team (P = 0.08). Likewise, trials that accounted for clustering had 3.3 times the odds of including an epidemiologist/clinical trials methodologist than those that did not account for clustering (P = 0.04)., Conclusions: Including specialists on a study team, especially an epidemiologist or clinical trials methodologist, appears to be important in the decision to account for clustering in RCT reporting. The use of clustering analysis remains an important piece of unbiased reporting, and accounting for clustering in RCTs should be a standard reporting practice.

Objective: Select and validate the clinical indicators to monitor patients on risk for ineffective cerebral tissue perfusion, according to the Nursing Outcomes Classification (NOC)., Methodology: Validation study carried out between November 2012 and August 2013, in a Brazilian hospital. Seventeen judges nurses evaluated the clinical indicators of Nursing Outcomes, according to NOC for patients on risk for ineffective cerebral tissue perfusion. In the first stage, were selected the nursing results for the assessment of the studied diagnosis and, in the second nurses assessment the importance of the indicators of the validated results in the previous step through a five points Likert scale (1 = not important to 5 = extremely important). Were used the content validity index (CVI) that corresponds to the calculation of weighted averages of them marks awarded for each indicator, as it considered the following weights: 1=0.00, 2=0.25, 3=0.50; 4=0.75; 5=1.00. For categorization, the CVI considered as critical = ≥0.80; supplementary =≥0.50 to 0.79 and were disposed results <0.50., Results: Of the 9 nursing results, only the cerebral tissue perfusion obtained a 100% consensus. The CVI of the 18 indicators of this result showed that five were validated as critical (impaired neurological reflexes, systolic blood pressure, diastolic blood pressure, reduced level of consciousness and mean arterial pressure), 12 were validated as supplementary (Agitation, Impaired cognition, Intracranial pressure, Syncope, Vomiting, Findings of cerebral angiography, Headache, Restlessness, Fever, Unexplained anxiety, listlessness and Hiccughs) and one was disposed (carotid bruit)., Conclusions: The validation of information about the conditions of risk may allow early intervention to minimize the consequences of ineffective cerebral tissue perfusion.

The response definitions proposed by the European Leukemia Net (ELN) have been recently modified. We evaluated the new criteria for de novo imatinib (400 mg/d) chronic phase chronic myeloid leukemia (CP-CML) patients. Response status according to the 2009 and 2013 criteria were determined in 180 unselected patients. Outcome of the subgroups of patients were then compared. The 180 patients were classified as optimal responders (OR2009; n = 113, 62.7%), suboptimal responders (SOR2009; n = 47, 26.1%) and failures (FAIL2009; n = 20, 11.1%) according to the 2009 ELN criteria and optimal responders (OR2013; n = 77, 42.7%), warnings (WAR2013; n = 59, 32.7%), and failures (FAIL2013; n = 44, 24.4%) according to the 2013 ELN criteria. No difference in terms of outcome was observed between OR2009 patients who became WAR2013 when compared with OR2013 patients. When compared with FAIL2009 patients, SOR2009 patients who became WAR2013 had better EFS, FFS, PFS, and OS. No difference was observed in PFS or OS in SOR2009 patients who became FAIL2013. The 2013 ELN response status criteria have improved patients classification in terms of response status. However, in our patient population this improvement is related to a better definition of failure rather than that of optimal response for CP-CML patients treated with IM frontline therapy., (© 2014 Wiley Periodicals, Inc.)

Many trauma survivors face challenges of impaired functioning, limited activities and reduced participation. Recovery from injury after acute care, therefore, becomes an important public health issue. This commentary discusses a framework for evaluating outcomes of acute care.

This research provides a critical consideration of the outcome measures used to assess physical activity in individuals with severe mental illness. A narrative synthesis was utilised to provide a simple juxtapose of the current research. A sensitive topic-based search strategy was conducted in order to identify studies that met the eligibility criteria. Fifty two studies met the inclusion criteria and 5 were identified specially as validation studies. The current research identified several methodological shortcomings. The justification and choice of outcome measure used is often weak and only five studies have validated a specific outcome measure of physical activity. Within these validation studies, the validation process often lacked a consideration of agreement between measures. Accelerometers have been most frequently used as a criterion measure, notably the RT3 tri-axial accelerometer. Objective based measures may be best placed to consider physical activity levels, although, methodological considerations for the utilization of such tools is required. Self-report questionnaires have benefits for use in this population but require further validation. Researchers and clinicians need to carefully consider what outcome measure they are using and be aware of the development, scope and purpose of that measure., (Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.)

Aim: Neuroprotection trials for neonatal encephalopathy use moderate or severe disability as an outcome, with the Bayley Scales of Infant Development, Second Edition (Bayley-2) Index scores of <70 as part of the criteria. The Bayley Scales of Infant and Toddler, 3rd Development, Third Edition (Bayley-3) have superseded Bayley-2 and yield higher than expected scores in typically developing and high-risk infants. The aim of this study, therefore, was to compare Bayley-2 scores and Bayley-3 scores in term-born infants surviving neonatal encephalopathy treated with hypothermia., Method: Sixty-one term-born infants (37 males, 24 females; median gestational age at birth 40 wks, range 36-42 wks; median birthweight 3280 g, range 2295-5050) following neonatal encephalopathy and hypothermia had contemporaneous assessment at 18 months using the Bayley-2 and Bayley-3., Results: The median Bayley-3 Cognitive Composite score was 7 points higher than the median Bayley-2 Mental Developmental Index (MDI) score and the median Bayley-3 Motor Composite score was 18 points higher than the median Bayley-2 Psychomotor Developmental Index (PDI) score. Ten children had a Bayley-2 MDI of <70; only three children had Bayley-3 combined Cognitive/Language scores of <70. Eleven children had Bayley-2 PDI scores of <70 and four had modified Bayley-3 Motor Composite scores of <70. Applying regression equations to Bayley-3 scores adjusted rates of severe delay to similar proportions found using Bayley-2 scores., Interpretation: Fewer children were classified with severe delay using the Bayley-3 than the Bayley-2, which prohibits direct comparison of scores. Increased Bayley-3 cut-off thresholds for classifying severe disability are recommended when comparing studies in this clinical group using Bayley-2 scores., (© 2013 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)

The Oral Rehabilitation Outcomes Network (ORONet) Longevity Working Group undertook a search of the literature from 1995 to 2009 on randomized controlled trials related to longevity of osseointegrated implants. Outcomes measures used in these studies were identified and subjected to the OMERACT component criteria of truth, validity, and feasibility. Through this process, it was a challenge to identify clinical outcomes measures that fully met the criteria. An attenuated version of the component criteria was applied, and clinical measures were identified for implant outcomes, prosthetic outcomes, and indices. A recommendation on standardized reporting periods was also presented for future consideration. The endpoint of the evaluation process is to develop consensus on clinical outcomes measures that can be applied across broad populations for osseointegrated implant care. The present ORONet initiative represents a beginning toward continual improvement and consensus development for clinical outcomes measures for osseointegrated implants.

Objective: Atlanta classification divides patients with acute pancreatitis (AP) into mild and severe disease. A 4-category severity classification has been proposed based on the presence or absence of local and systemic determinants, giving rise to mild, moderate, severe, or critical AP. The aim of this study was to validate this new 4-category system of severity classification by examining markers of severity and outcome., Methods: Data from 151 consecutive patients with AP from January 2009 to December 2010 [mean age (SD), 41.1 (3.5) years; 101 men] were collected. Management was standardized. Patients were classified as mild [no necrosis or organ failure (OF)], moderate (sterile necrosis or transient OF), severe [infected necrosis (IN) or persistent OF], or critical (IN and persistent OF) AP. Data were compared between groups for severity and outcome., Results: There were 21 (13.9%) patients with mild, 63 (41.7%) moderate, 59 (39.1%) severe, and 8 (5.3%) critical AP. There was a significant difference between these categories for length of hospital stay, computed tomographic severity index scores, occurrence of bloodstream infections, incidence of IN, requirements for percutaneous catheter drain, numbers of operations, and mortality., Conclusions: This prospective case series clinically validated the 4-category classification of AP severity.

Background: Surgical outcomes are determined by complex interactions among a variety of factors including patient characteristics, diagnosis, and type of procedure., Objective: The aim of this study was to prioritize the effect and relative importance of the surgeon (in terms of identity of a surgeon and surgeon volume), patient characteristics, and the intraoperative details on complications of colorectal surgery including readmission, reoperation, sepsis, anastomotic leak, small-bowel obstruction, surgical site infection, abscess, need for transfusion, and portal and deep vein thrombosis., Design: This study uses a novel classification methodology to measure the influence of various risk factors on postoperative complications in a large outcomes database., Methods: Using prospectively collected information from the departmental outcomes database from 2010 to 2011, we examined the records of 3552 patients who underwent colorectal surgery. Instead of traditional statistical methods, we used a family of 7000 bootstrap classification models to examine and quantify the impact of various factors on the most common serious surgical complications. For each complication, an ensemble of multivariate classification models was designed to determine the relative importance of potential factors that may influence outcomes of surgery. This is a new technique for analyzing outcomes data that produces more accurate results and a more reliable ranking of study variables in order of their importance in producing complications., Patients: Patients who underwent colorectal surgery in 2010 and 2011 were included., Settings: This study was conducted at a tertiary referral department at a major medical center., Main Outcome: Postoperative complications were the primary outcomes measured., Results: Factors sorted themselves into 2 groups: a highly important group (operative time, BMI, age, identity of the surgeon, type of surgery) and a group of low importance (sex, comorbidity, laparoscopy, and emergency). ASA score and diagnosis were of intermediate importance. The outcomes most influenced by variations in the highly important factors included readmission, transfusion, surgical site infection, and abscesses., Limitations: This study was limited by the use of data from a single tertiary referral department at a major medical center., Conclusions: Body mass index, operative time, and the surgeon who performed the operation are the 3 most important factors influencing readmission rates, rates of transfusions, and surgical site infection. Identification of these contributing factors can help minimize complications.

Building machine learning models that identify unproven cancer treatments on the Health Web is a promising approach for dealing with the dissemination of false and dangerous information to vulnerable health consumers. Aside from the obvious requirement of accuracy, two issues are of practical importance in deploying these models in real world applications. (a) Generalizability: The models must generalize to all treatments (not just the ones used in the training of the models). (b) Scalability: The models can be applied efficiently to billions of documents on the Health Web. First, we provide methods and related empirical data demonstrating strong accuracy and generalizability. Second, by combining the MapReduce distributed architecture and high dimensionality compression via Markov Boundary feature selection, we show how to scale the application of the models to WWW-scale corpora. The present work provides evidence that (a) a very small subset of unproven cancer treatments is sufficient to build a model to identify unproven treatments on the web; (b) unproven treatments use distinct language to market their claims and this language is learnable; (c) through distributed parallelization and state of the art feature selection, it is possible to prepare the corpora and build and apply models with large scalability.

Introduction: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fifth of a series of 14 articles that were prepared by an international panel to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on what type of evidence and outcomes to include in guidelines., Methods: In this review we addressed the following topics and questions. (1) What methods should be used to select important outcomes? (2) What types of outcomes should be considered? (3) What sources of evidence should be considered? (4) How should the importance of outcomes be ranked? (5) How to deal with surrogate outcomes. (6) What issues related to outcomes should be considered in the evidence review? (7) What quality of evidence should be used? (8) How to interpret the effect on outcomes. (9) How to incorporate outcomes related to harm. We based our responses on a PubMed literature review, prior reviews, relevant methodological research, and workshop discussions., Results and Discussion: Guideline panels should use transparent and systematic methods to select both the evidence and important outcomes, with input from groups that represent a wide range of expertise and constituencies. Outcomes should address both benefits and downsides, with consideration of the definitions, severity, and time course of the outcomes. Guideline panels should use a transparent approach to rank outcome importance recognizing that stakeholder and patient values and preferences may vary. Intermediate and surrogate outcomes are frequently reported, but their correlation with patient important outcomes may be low. A guideline panel should determine a priori the magnitude of effect judged clinically significant, factors that may influence outcome reporting, and whether different ways of measuring the outcomes permit the outcomes to be combined. Comprehensive identification of the evidence includes the use of multiple data sources. While randomized controlled trials (RCTs) provide the highest quality evidence, reviewers of evidence also need to consider nonrandomized studies such as case series, registries, and case-control studies if randomized trials are not available. This is particularly true for harms. The outcomes reported from RCTs may not always directly apply to clinical practice settings (i.e., they may not be generalizable).

Despite widespread agreement that stakeholder engagement is needed in patient-centered outcomes research (PCOR), no taxonomy exists to guide researchers and policy makers on how to address this need. We followed an iterative process, including several stages of stakeholder review, to address three questions: (1) Who are the stakeholders in PCOR? (2) What roles and responsibilities can stakeholders have in PCOR? (3) How can researchers start engaging stakeholders? We introduce a flexible taxonomy called the 7Ps of Stakeholder Engagement and Six Stages of Research for identifying stakeholders and developing engagement strategies across the full spectrum of research activities. The path toward engagement will not be uniform across every research program, but this taxonomy offers a common starting point and a flexible approach.

Experienced bedside nurses identified 14 nursing diagnoses, 78 interventions, and 76 health outcomes for hospitalized persons with diabetes. Using these terms, the nursing department revised the standards of care and the electronic health record. Nurses' engagement in generating knowledge translated to increased interest in research. This methodology is recommended for other agencies., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Public reports of provider performance on measures of the quality, costs, and outcomes of health care can spur improvement and help patients find the best providers. However, the likelihood that these benefits will materialize depends on the methods underlying each performance report. This paper presents a five-point methodological checklist to guide those who want to improve their performance reporting methods. The central goal is to help report makers minimize the frequency and severity of provider performance misclassification and avoid adverse unintended consequences of reporting. We believe that if those who produce the reports publicly explain how they address each checklist item, this increased transparency will encourage more rigorous methods and improve the chances that reports will lead to better, more efficient care.

The nominal group technique generates quantitative data through a process of experts ranking items of interest. This article focuses on the additional collection of qualitative data from nominal groups with rheumatoid arthritis (RA) patients, used to explore the influences on prioritizing treatment outcomes. Across all groups, the top five outcomes with the highest importance scores were identified as: pain; joint damage; fatigue; activities of daily living; and mobility. Qualitative findings showed that the personal impact of RA influenced decisions on how to rank specific outcomes through four domains: disease impact; adaptation to illness; external resources and stressors; and social expectations.

This contribution deals with the use, within healthcare systems, of patient-reported outcomes (PROs), i.e., all measures aimed at quantifying the state of health through the evaluation of outcomes reported by the patient himself. A survey of their cultural background, identified in the patient-centered model of medicine, is followed by a delineation of their historical profile (from 1914, the year of the first outcome measure, to the more recent examples of their use in clinical trial and practice), a classification based on the size they wish to detect and the reconstruction of the main lines of debate around their use in health care.

Background: When cause-specific clinical events (for instance, hospitalization for cardiac disease) are used as the primary or key secondary outcomes, it is important to assess how accurately these events have been classified and estimate the error-corrected treatment effects to ensure validity. However, it may not be feasible to verify cause classification for every event in large clinical trials., Purpose: We present statistical methods for the design and analysis of outcome-classification accuracy and for estimating error-corrected treatment effects., Methods: Using the Hemodialysis (HEMO) Study, in which primary causes were designated for all 7822 hospitalizations by the 15 participating clinical centers - but only two subsets were audited by the Outcome Committee - we applied existing methods to obtain unbiased estimates of the sensitivity and specificity of clinical-center classifications. The multiple imputation method was used to correct for the misclassification of events. We then examined how trial results were affected by three methods of event classification: unaudited, imputed, and adjudicated., Results: We applied a three-step procedure to extend the results for the two subsets of audited events to estimate the sensitivity and specificity for the complete set. Finite population sample size formulas were developed for designing the quality control sample. Based on the HEMO analysis, the estimate of the intervention effect using the unaudited outcome was biased; the bias was reduced using the outcome corrected by imputation., Limitations: The methods are limited to situations in which there are clinical-center classifications for all clinical events but only partial availability of reference standard classifications, and the verification process does not depend on the true event cause or other unobserved information., Conclusions: Designing a quality control study to estimate the accuracy of outcome classification is important. The multiple imputation method can be used to correct for errors in outcome classification and to estimate the error-corrected treatment effect. Trial results need to be reexamined using the error-corrected outcome.

Introduction: Although evaluating at multiple outcome levels has been proposed for continuing education activities and programs, it is a complex undertaking and is not done routinely, especially in collaborative, multicomponent programs. This article reports on strategies used and results obtained in an evaluation project that examined multiple outcomes of a US-based collaborative, multicomponent smoking cessation educational program for clinicians., Methods: Evaluation was organized conceptually around the 6 levels of an outcomes-based evaluation model and was conducted using registration data, postactivity evaluations, clinical vignettes with questions assessing knowledge and competence in participants and in a comparison group, a commitment to change approach, data from patient charts to assess clinician compliance on 8 performance measures, and tobacco cessation rates. Additional methods included a success case method study of 9 practices participating in performance improvement (PI) activities and assessment of partner collaboration using a written survey and interviews., Results: The program reached more than 43,000 clinicians who participated in a variety of activities. Participants indicated a high level of satisfaction with the program's educational activities and demonstrated higher scores than a comparison group on 6 of 7 competencies. The majority of participants who responded to commitment to change questions reported intended and implemented practice changes consistent with desired outcomes. Performance outcomes of 3 PI activities varied, with greater improvements observed in 1 activity (9.0% to 36.2% improvement across 8 measures). Lower performance outcomes, but a smoking quit rate of 46.8%, was observed in 2 other PI activities., Discussion: The program had an overall positive impact on the measured variables for clinicians and their patients. Use of 1 outcomes assessment framework acceptable to all members of the collaborative, common measures and evaluation techniques, and centralized data repositories contributed to the success of the program evaluation reported here and is recommended to others who are considering a collaborative program evaluation., (Copyright © 2011 The Alliance for Continuing Medical Education, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.)

Objectives: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions., Study Design and Setting: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices., Results: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events., Conclusion: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Recent studies have examined the effectiveness of hand rehabilitation programmes and have linked the outcomes to the concept of ICF but not to specific ICF category codes. The objective of this study was to gain experience using ICF concepts to describe occupational therapy interventions during postsurgery hand rehabilitation, and to describe improvement in functioning using ICF categories. In addition, investigated was the agreement between the ICF categories for occupational therapy interventions and the outcome measures used. Fifteen patients with traumatic hand injuries agreed to participate. Outcome measures were used to assess the following variables: range of motion, grip strength, pain intensity, upper-extremity functioning and health-related quality of life. Analysis of variance for repeated measures was used between the measures at baseline and at 3-month and 12-month follow-ups. The results showed that a pattern of occupational therapy interventions concerning body functions and body structures, activities and environmental factors could be identified during the early postsurgery phase and for interventions at participation level during the later phase. Agreement between occupational therapy interventions and outcome measures was found for 11 pairs. Three of the pairs concerned body function and eight were at the activity and participation level. During the rehabilitation process, the majority of improvements took place between baseline and the 3-month follow-up. We concluded that ICF categories can be used to describe occupational therapy interventions in postsurgery hand rehabilitation after trauma; that the use of ICF as a reference framework provides a clear picture of which health domains are addressed; and that a consistent use of ICF categories facilitates linking between rehabilitation interventions and outcome assessments, thereby increasing the possibility of showing the effects of these interventions.

Aim: The FIM instrument is broadly applied in varying rehabilitation services for outcome assessment. Thus, it is important to examine its applicability for services which may differ from the situations and patients for which it was originally developed. The aims of the present study were to examine 1) whether the four FIM dimensions "activities of daily living", "sphincter management", "mobility", and "executive function" can be retrieved by Latent Class Factor Analysis (LCFA); and 2) whether the four dimensions show floor effects in patients with acquired brain injuries undergoing intensive post-acute rehabilitation., Methods: We analyzed the FIM data of 269 patients with acquired brain injuries undergoing intensive post-acute rehabilitation. To examine the dimensional structure of the FIM instrument we carried out LCFA. Cronbach's alpha was used to measure the internal consistency. We examined the distribution of the dimension scores to identify floor effects., Results: LCFA confirmed the postulated four dimensions. The explained variance of items assigned to the four dimensions ranged from 46% to 89%. Cronbach's alpha coefficients of the four subscales ranged from 0.94 to 0.96. The percentage of patients scoring the minimum possible score in each of the retrieved dimensions ranged from 22.3% to 47.9%., Conclusion: When applying the FIM instrument to patients undergoing intensive neurological rehabilitation its dimensionality should be kept in mind. For some patients this outcome measure might not be discriminative enough due to floor effects.