Single Assessment Numeric Evaluation (SANE) correlates with American Shoulder and Elbow Surgeons score and Western Ontario Rotator Cuff index in patients undergoing arthroscopic rotator cuff repair.

BACKGROUND: Patient-reported outcomes continue to grow in importance. This study compared the Single Assessment Numeric Evaluation (SANE) score with the American Shoulder and Elbow Surgeons (ASES) score and Western Ontario Rotator Cuff (WORC) index score in patients before and after primary rotator cuff repair. METHODS: This study was a retrospective review of a prospectively filled database of 333 subjects who underwent primary rotator cuff repair by a single surgeon between 2010 and 2017. The database included preoperative and postoperative SANE, ASES, and WORC evaluations. The mean follow-up time was 37.5 months. Spearman correlation coefficients were calculated comparing each score preoperatively and at least 1 year postoperatively. RESULTS: A strong correlation was found between the SANE and ASES scores of subjects in the preoperative period (r = 0.769, P < .0001) and the follow-up period of at least 1 year (r = 0.781, P < .0001). A similarly strong correlation was found between the SANE and WORC scores of subjects in the preoperative period (r = 0.757, P < .0001) and the follow-up period of at least 1 year (r = 0.813, P < .0001). On stratification analysis, correlation of SANE scores with ASES and WORC scores was found when subjects were grouped by sex, age, cuff tear size, and workers' compensation status. CONCLUSION: This study shows a significant correlation between the SANE, ASES, and WORC scores of primary rotator cuff repair subjects in the preoperative and long-term follow-up periods. We recommend the SANE score as an adjunct to clinical outcome data that can be used in patients regardless of sex, cuff tear size, or workers' compensation status.

Accuracy and Validity of Computer Adaptive Testing for Outcome Assessment in Patients Undergoing Total Hip Arthroplasty.

BACKGROUND: Probability-based computer algorithms that reduce patient burden are currently in high demand. These computer adaptive testing (CAT) methods improve workflow and reduce patient frustration, while achieving high measurement precision. In this study, we evaluated the accuracy and validity of the CAT Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Hip Disability and Osteoarthritis Outcome Score Joint Replacement (HOOS-JR) by comparing them to the full version of these scoring systems in a subset of patients who had undergone total hip arthroplasties. METHODS: A previously developed CAT HOOS and HOOS-JR was applied to 354 and 1547 HOOS and HOOS-JR patient responses, respectively. Mean, standard deviations, Pearson's correlation coefficients, interclass correlation coefficients, frequency distribution plots, and Bland-Altman plots were used to compare the precision, validity, and accuracy between CAT scores and full-form scores. RESULTS: By modifying the questions to past responses, the CAT HOOS demonstrated a mean reduction of 30% of questions (28 vs 40 questions). There were no significant differences between the full HOOS and CAT HOOS with respect to pain (P = .73), symptoms (P = .94), quality of life (P = .99), activities of daily living (P = .82), and sports (P = .99). There were strong linear relationships between the CAT versions and the standard questionnaires (r > 0.99). The Bland-Altman plot showed that differences between CAT HOOS and full HOOS were independent of the overall scores. CONCLUSION: The CAT HOOS and HOOS-JR have high correlation and require fewer questions to finish compared to the standard full-form questionnaires. This may represent a reliable and practical alternative that may be less burdensome to patients and may help improve compliance for reporting outcome metrics.

Modified Clavien-Dindo-Sink Classification System for operative complications in adult spine surgery.

OBJECTIVE: Currently there is no standardized mechanism to describe or compare complications in adult spine surgery. Thus, the purpose of the present study was to modify and validate the Clavien-Dindo-Sink complication classification system for applications in spine surgery. METHODS: The Clavien-Dindo-Sink complication classification system was evaluated and modified for spine surgery by four fellowship-trained spine surgeons using a consensus process. A distinct group of three fellowship-trained spine surgeons completed a randomized electronic survey grading 71 real-life clinical case scenarios. The survey was repeated 2 weeks after its initial completion. Fleiss' and Cohen's kappa (κ) statistics were used to evaluate interrater and intrarater reliabilities, respectively. RESULTS: Overall, interobserver reliability during the first and second rounds of grading was excellent with a κ of 0.847 (95% CI 0.785-0.908) and 0.852 (95% CI 0.791-0.913), respectively. In the first round, interrater reliability ranged from good to excellent with a κ of 0.778 for grade I (95% CI 0.644-0.912), 0.698 for grade II (95% CI 0.564-0.832), 0.861 for grade III (95% CI 0.727-0.996), 0.845 for grade IV-A (95% CI 0.711-0.979), 0.962 for grade IV-B (95% CI 0.828-1.097), and 0.960 for grade V (95% CI 0.826-1.094). Intraobserver reliability testing for all three independent observers was excellent with a κ of 0.971 (95% CI 0.944-0.999) for rater 1, 0.963 (95% CI 0.926-1.001) for rater 2, and 0.926 (95% CI 0.869-0.982) for rater 3. CONCLUSIONS: The Modified Clavien-Dindo-Sink Classification System demonstrates excellent interrater and intrarater reliability in adult spine surgery cases. This system provides a useful framework to better communicate the severity of spine-related complications.

The Better Care Plan: a blueprint for improving America's healthcare system.

The United States falls far short of its potential for delivering care that is effective, efficient, safe, timely, patient-centered, and equitable. We put forward the Better Care Plan, an overarching blueprint to address the flaws in our current system. The plan calls for continuously improving care, moving all payers to risk-adjusted prospective payment, and creating national entities for collecting, analyzing, and reporting patient safety and quality-of-care outcomes data. A number of recommendations are made to achieve these goals.

A format for dosimetry comparison studies.

There is no standardized format for presenting and discussing the results of a radiotherapy dosimetry comparison study. The purpose of this report is to describe a format that we have found useful in evaluating plans in our department and in reviewing studies from other groups.

Assessing the completeness and comparability of outcomes in systematic reviews addressing food security: protocol for a methodological study.

BACKGROUND: Systematic reviews should specify all outcomes at the protocol stage. Pre-specification helps prevent outcome choice from being influenced by knowledge of included study results. Completely specified outcomes comprise five elements: (1) domain (title), (2) specific measurement (technique/instrument), (3) specific metric (data format for analysis), (4) method of aggregation (how group data are summarised), and (5) time points. This study aims to assess the completeness of outcome pre-specification in systematic reviews of interventions to improve food security, specifically food availability, in low- and middle-income countries, as well as to assess the comparability of outcome elements across reviews reporting the same outcome domains. METHODS: We will examine systematic reviews from an ongoing overview of systematic reviews, which assessed the effects of interventions addressing food insecurity through improving food production, access, or utilisation compared with no intervention or a different intervention, on nutrition outcomes. We will examine the original protocols; if unavailable, we will examine the "Methods" section of the systematic reviews' most recent version. One investigator will identify and group all outcome domains that the authors of the included protocols intended to measure in the systematic review and a second investigator will verify the domains. For outcome domains reported in at least 25% of protocols, one author will extract data using a pre-specified form and a second author will verify the data. We will use descriptive statistics to report the number, types, and degree of specification of outcomes in included protocols. We will assess the extent of completeness of outcome pre-specification based on the number of outcome elements (out of five). We will assess comparability of outcome domains through examining how individual elements are described across SRs reporting the same outcome domains. DISCUSSION: Our findings will contribute to understanding about the best approach to pre-specify outcomes for systematic reviews and primary research in the field of food security.

An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements.

Recent National Institutes of Health policy changes have expanded the number of research studies that must be registered in clinicaltrials.gov beyond the requirements of the Food and Drug Administration Amendments Act of 2007. The International Committee of Medical Journal Editors has also adopted a policy that requires registration of research in a public database. The goal was to increase the transparency of research by reporting the original endpoints of a study, and to discern whether primary endpoints were excluded in subsequent publications. Efforts to increase openness and accountability in clinical trials are likely to strengthen public trust. However, first investigators and study staff must be educated about the requirements, and staff must be prepared to offer support to researchers in navigating the clinicaltrials.gov system. For academic institutions, maintaining compliance requires continuous oversight so that problems can be identified centrally and addressed with investigators. At Wake Forest University Health Sciences, because researchers often did not realize they were out of compliance, we implemented a program to assist them and provide oversight. We introduced standard operating procedures, provided education and assistance to investigators, and engaged leadership about consequences of compliance, resulting in increased budget support for a full-time employee in this role. As a result of these changes, compliance increased from 22% to 92% over 4 months. These approaches may help other institutions become compliant with registration requirements more quickly.

Which NDI domains best predict change in physical function in patients undergoing cervical spine surgery?

BACKGROUND CONTEXT: Physical function is a critical aspect of patient outcomes. NDI is a widely validated outcome measure in cervical spine disease, yet to what extent its individual domains predict changes in physical function remains unknown. PURPOSE: To examine the impact of individual NDI domains on changes in physical function in patients undergoing cervical spine surgery. STUDY DESIGN/SETTING: Prospective Cohort Study. PATIENT SAMPLE: Adult patients undergoing cervical spine surgery, excluding those undergoing surgery for instability due to trauma. OUTCOME MEASURES: Absolute change in outcome measures (Patient Reported Outcomes Measurement Information System [PROMIS] Physical Function [PF], Short Form 36 [SF-36] Physical Component Score [PCS], and Neck Disability Index [NDI]) from pre- to postoperatively, correlation of NDI individual domains with PROMIS PF and SF-36 PCS (preoperatively, postoperatively, and change from pre- to postoperatively). METHODS: Patients undergoing cervical spine surgery between 2016 and 2018 were prospectively enrolled. Patients completed questionnaires (NDI, SF-36 PCS, and PROMIS PF) preoperatively and at 6 months postoperatively. Patient demographics, including age, body mass index, Charlson Comorbidity Index, and underlying diagnoses were collected. Comparisons between NDI scores preoperatively versus postoperatively were conducted using Wilcoxon signed rank sum test. Correlations of NDI individual items and PROMIS/SF-36 were assessed using Pearson correlation. A stepwise linear regression analysis was performed to identify NDI items that are independently predictive of PROMIS PF and SF-36 PCS. RESULTS: A total of 137 patients were included in the study, with mean age 56.9 years (range 24.4-84.9). Each of the NDI domains as well as PROMIS PF and SF-36 PCS demonstrated significant improvement following cervical spine surgery (p<.001). Changes in all NDI domains demonstrated significant negative correlation with changes in PROMIS PF, with recreation (R=-0.537, p<.001), work (R=-0.514, p<.001), and pain intensity (R=-0.488, p<.001) having the greatest negative correlation. Changes in all NDI domains demonstrated significant negative correlation with changes in SF-36 PCS, with recreation (R=-0.451, p<.001), work (R=-0.443, p<.001), lifting (R=-0.373, p<.001), and driving (R=-0.373, p<.001) having the greatest negative correlation. For PROMIS PF, the NDI domains that were independently associated with changes in PF were work (R=-0.092, p=.001), pain intensity (R=-0.089, p=.003), and recreation (R=-0.067, p=.004). For SF-36 PCS, the NDI items that were independently associated with changes in PCS were work (R=-0.269, p=.003) and recreation (R=-0.215, p=.002). CONCLUSIONS: All NDI domains improve significantly after cervical spine surgery and demonstrate significant correlation with changes in PROMIS PF and SF-36 PCS. The work, recreation, and pain intensity domains were the only independent predictors of physical function changes postoperatively. Considering physical function, our findings highlight the importance of presenting changes in individual NDI domains in addition to the total score.

A Peritoneal Dialysis Access Quality Improvement Initiative: A Single-Center Experience.

Background:Little evidence exists regarding optimal peritoneal dialysis (PD) access insertion pathways, benchmarking for patency targets, and definitions of access dysfunction.Methods:This quality improvement (QI) project evaluated patients with PD catheters inserted at a single center in Toronto, Canada, following: establishment of PD catheter insertion protocols, a PD access coordinator, PD access operator training, and outcomes reporting. We define primary vs secondary PD catheter dysfunction by presentation before/after initial home PD treatment. We report catheter dysfunction rates, interventions restoring PD catheter patency (interventional radiology [IR] vs advanced laparoscopic [AL]) (embedded vs non-embedded) between 2012 and 2017.Results:A total of 297 first PD catheters were inserted between January 2012 and December 2017. Interventional radiology PD catheters (n = 94) were placed in older patients with greater comorbidities and less prior abdominal surgery than AL-placed catheters. Indications for IR insertion included need for urgent dialysis given resource availability (36.2% [n = 34]) and prohibitive surgical risk (26.6% [n = 25]). Interventional radiology-inserted catheters had overall (primary and secondary) dysfunction rates of 17%. Non-embedded AL catheters had 16.1% overall dysfunction. Embedded AL-inserted PD catheters had a 24.6% overall dysfunction rate. Among all dysfunctional catheters, IR manipulation was successful in 31% (n = 11), and surgical revision was necessary in all unsuccessful cases with either lysis of adhesions or omentopexy to establish patency.Conclusion:Our PD catheter QI initiative involved tracking, outcome reporting, defining PD catheter dysfunction and PD access insertion pathway development, yielding important insights into opportunities for program improvement. Multicenter research initiatives are needed to further improve PD access dysfunction definitions and to establish the best benchmarks for these metrics.

Evaluation of an innovative spinal cord stimulator platform for the treatment of chronic pain.

Spinal cord stimulation (SCS) is an ever-evolving therapy for the treatment of chronic pain. Currently, there are four main companies offering a variety of options for SCS. The Intellis™ system is the latest offering from Medtronic (MN, USA). Intellis offers the smallest implantable SCS pulse generator available and is capable of multiple different modes of stimulation, some of which can be run simultaneously. With an intrinsic accelerometer, the device is capable of sensing various patient positions and can automatically adjust stimulation intensity. Intellis also offers the most comprehensive MRI conditionality to date. Additionally, the new Samsung/Android® (Seoul, South Korea) clinician programmer allows for easier programming than previous Medtronic programing systems. The programer can also generate patient activity and usage reports from implantable pulse generator data.

Outcomes After Shoulder and Elbow Injury in Baseball Players: Are We Reporting What Matters?

BACKGROUND: Return to play, as well as time to return to play, are the most important metrics considered by athletes when attempting to make treatment decisions after injury. However, the consistency of reporting of these metrics in the scientific literature is unknown. PURPOSE: To investigate patterns of outcomes reporting in the medical literature of shoulder and elbow injuries in active baseball players. STUDY DESIGN: Systematic review. METHODS: A systematic review of literature published within the past 10 years was performed to identify all recent clinical studies focusing on shoulder and elbow injuries in baseball players across all levels. Review articles, case reports, and laboratory/biomechanical studies were all excluded. RESULTS: A total of 49 studies were included for review. The majority of studies were either level 3 or level 4 evidence (96%). In total, 71% of studies reported on rates of return to preinjury level of play, whereas 31% of studies reported on time to return to preinjury level of play. Only 47% of studies reported on both rate and time of return to preinjury level of play. A minority of studies (8%) reported patient satisfaction rates. Finally, 27 different subjective and patient-reported outcomes were reported, and none of these appeared in more than 14% of all studies. CONCLUSION: Time to return to preinjury level of play is inadequately reported in studies of shoulder and elbow injury in baseball players. Similarly, satisfaction rates and scores are underreported. Finally, the significant variability of subjective and patient-reported outcomes utilized may undermine the ability of clinicians to accurately compare results from different studies.

Side effects are incompletely reported among systematic reviews in gastroenterology.

OBJECTIVES: Systematic reviews are an integral component of evidence-based health care. However, little is known on how well they report the potential harms of interventions. We assessed the reporting of harms in recently published systematic reviews of interventions relevant to clinical gastroenterology. STUDY DESIGN: We identified all systematic reviews of randomized trials of gastroenterology interventions published from 2008 to 2012 in highly cited gastroenterology and general medical journals. We adapted the Consolidated Standards of Reporting Trials guidelines for harms and assessed qualitative and quantitative parameters of harms reporting. Regression analyses determined predictors of more comprehensive harms reporting. RESULTS: In total, 78 systematic reviews were identified, with 72 published in gastroenterology journals and six in general medical journals. Overall, one in three systematic reviews (26/78, 33%) did not refer to harms of the intervention anywhere in the article. Less than half of the studies included adverse events as an outcome measure, and data on absolute rates of adverse events were only provided in 28%. Most (65%) did not include any figures or tables on adverse event; however, all included these on efficacy outcomes (mean, 3 and range, 1-7). Regression analyses indicated that the use of reporting guidelines was significantly associated with better harms reporting (P = 0.04). CONCLUSION: The reporting of harms in gastroenterology systematic reviews is largely inadequate and highly asymmetrical compared with the reporting of benefits. We suggest that review authors routinely assess both efficacy and harms outcomes of an intervention and that reporting guidelines specifically targeting harms reporting be developed.