Dataset Information

Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair.

ABSTRACT: BACKGROUND:This study tested validity and efficiency of Orthopaedic Minimal Data Set (OrthoMiDaS) Episode of Care (OME). METHODS:We analyzed 100 isolated rotator cuff repair cases in the OME database. Surgeons completed a traditional operative note and OME report. A blinded reviewer extracted data from operative notes and implant logs in electronic medical records by manual chart review. OME and electronic medical record data were compared with data counts and agreement between 40 variables of rotator cuff disease and repair procedures. Data counts were assessed using raw percentages and McNemar test (with continuity correction). Agreement of categorical variables was analyzed using Cohen ? (unweighted) and of numerical variables using the concordance correlation coefficient (CCC). Efficiency was assessed by median time to complete. RESULTS:OME database had significantly higher data counts for 25% (10/40) of variables. A high level of proportional and statistical agreement was demonstrated between the data. Among 35 categorical variables, proportional agreement was perfect for 17%, almost perfect (0.81 ? ? ? 1.00) for 37%, substantial (0.61 ? ? ? 0.80) for 20%, moderate (0.41 ? ? ? 0.60) for 14%, fair (0.21 ? ? ? 0.40) for 6%, and slight (0.0 ? ? ? 0.20) for 6%. Of 5 numerical variables, agreement was almost perfect (CCC > 0.99) for 20% and poor (CCC < 0.90) for 80%. Median OME completion time was 161.5 seconds (interquartile range, 116-224.5). CONCLUSION:OME is an efficient, valid tool for collecting comprehensive, standardized data on rotator cuff repair.

SUBMITTER: Sahoo S

PROVIDER: S-EPMC6591049 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair.

Sahoo Sambit S Mohr Jill J Strnad Gregory J GJ Vega Jose J Jones Morgan M Schickendantz Mark S MS Farrow Lutul L Spindler Kurt P KP Iannotti Joseph P JP Ricchetti Eric T ET Derwin Kathleen A KA

Journal of shoulder and elbow surgery 20190502 7

<h4>Background</h4>This study tested validity and efficiency of Orthopaedic Minimal Data Set (OrthoMiDaS) Episode of Care (OME).<h4>Methods</h4>We analyzed 100 isolated rotator cuff repair cases in the OME database. Surgeons completed a traditional operative note and OME report. A blinded reviewer extracted data from operative notes and implant logs in electronic medical records by manual chart review. OME and electronic medical record data were compared with data counts and agreement between 40 ...[more]

PMID: 31056396

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Project description:Importance:Rotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts. Objective:To perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size. Design, Setting, and Participants:Trial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size. Intervention:Nonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation. Main Outcomes and Measures:The primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up. Discussion:The Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears. Trial Registration:ClinicalTrials.gov identifier: NCT03295994.

Project description:Myosteatosis is the pathological accumulation of lipid that occurs in conjunction with atrophy and fibrosis following skeletal muscle injury or disease. Little is known about the mechanisms by which lipid accumulates in myosteatosis, but many studies have demonstrated the degree of lipid infiltration negatively correlates with muscle function and regeneration. Our goal was to identify biochemical pathways that lead to muscle dysfunction and lipid accumulation in injured rotator cuff muscles, a model that demonstrates severe myosteatosis. Adult rats were subjected to a massive tear to the rotator cuff musculature. After a period of either 0 (healthy control), 10, 30, or 60 days, muscles were prepared for RNA sequencing, shotgun lipidomics, metabolomics, biochemical measures, electron microscopy, and muscle fiber contractility. Following rotator cuff injury, there was a decrease in muscle fiber specific force production that was lowest at 30d. There was a dramatic time dependent increase in triacylglyceride content. Interestingly, genes related to not only triacylglyceride synthesis, but also lipid oxidation were largely downregulated over time. Using bioinformatics techniques, we identified that biochemical pathways related to mitochondrial dysfunction and reactive oxygen species were considerably increased in muscles with myosteatosis. Long chain acyl-carnitines and L-carnitine, precursors to beta-oxidation, were depleted following rotator cuff tear. Electron micrographs showed injured muscles displayed large lipid droplets within mitochondria at early time points, and an accumulation of peripheral segment mitochondria at all time points. Several markers of oxidative stress were elevated following rotator cuff tear. The results from this study suggest that the accumulation of lipid in myosteatosis is not a result of canonical lipid synthesis, but occurs due to decreased lipid oxidation in mitochondria. A failure in lipid utilization by mitochondria would ultimately cause an accumulation of lipid even in the absence of increased synthesis. Further study will identify whether this process is required for the onset of myosteatosis.

Project description:BackgroundThe Rotator Cuff Quality of Life Index (RC-QOL) is a scale designed to evaluate the impact of rotator cuff (RC) disorders on the general quality of life of patients. Our study aims to adapt the RC-QOL into Chinese and to assess its reliability, validity and responsiveness in Chinese patients with RC disorders.MethodsFirst, we developed the Chinese version of RC-QOL (C-RC-QOL) through a five-step procedure. Next, the recruited patients gave three rounds of responses to the C-RC-QOL, Medical Outcomes Study Short Form 36 (SF-36) and Oxford Shoulder Score scales (OSS). Then, we calculated the Cronbach's alpha, standard error of measurement (SEM), minimally detectable change (MDC), intra-class correlation coefficient (ICC), Pearson's correlation coefficient (r), effect size (ES) and standardized response mean (SRM) to evaluate the reliability, validity and responsiveness of the C-RC-QOL respectively. The unidimensionality of each subscale was assessed by principal component analysis (PCA) of the residuals.ResultsOverall, 124 patients with RC disorders successfully completed the first two rounds of the scales, and 108 patients completed the last round of the scales. Good or excellent internal consistency (Cronbach's alpha = 0.953) was found in the overall scale and subscales of the C-RC-QOL, and good or excellent test-retest reliability (ICC = 0.854) was found as well. The SEM and MDC values of the C-RC-QOL were 4.6 and 12.8 respectively. Moderate, good or excellent correlations (r = 0.452-0.839) were obtained between the physical subscales of the C-RC-QOL and the OSS, as well as the physical subscales of the SF-36; similar results were obtained between the emotion subscale of the C-RC-QOL and the mental subscales of the SF-36 (r = 0.490-0.733), which, illustrated the good validity of the C-RC-QOL. In addition, high responsiveness was observed in the overall scale and subscales of the C-RC-QOL (ES = 1.77, SRM = 1.98). The unidimensionality of five subscales was respected according to PCA of the residuals.ConclusionsThe C-RC-QOL scale is reliable, valid and responsive for the evaluation of Chinese-speaking patients with RC disorders and it would be an effective instrument.

Project description:BackgroundThe Discovery Critical Care Research Network Program for Resilience and Emergency Preparedness (Discovery PREP) partnered with a third-party technology vendor to design and implement an electronic data capture tool that addressed multisite data collection challenges during public health emergencies (PHE) in the United States. The basis of the work was to design an electronic data capture tool and to prospectively gather data on usability from bedside clinicians during national health system stress queries and influenza observational studies.ObjectiveThe aim of this paper is to describe the lessons learned in the design and implementation of a novel electronic data capture tool with the goal of significantly increasing the nation's capability to manage real-time data collection and analysis during PHE.MethodsA multiyear and multiphase design approach was taken to create an electronic data capture tool, which was used to pilot rapid data capture during a simulated PHE. Following the pilot, the study team retrospectively assessed the feasibility of automating the data captured by the electronic data capture tool directly from the electronic health record. In addition to user feedback during semistructured interviews, the System Usability Scale (SUS) questionnaire was used as a basis to evaluate the usability and performance of the electronic data capture tool.ResultsParticipants included Discovery PREP physicians, their local administrators, and data collectors from tertiary-level academic medical centers at 5 different institutions. User feedback indicated that the designed system had an intuitive user interface and could be used to automate study communication tasks making for more efficient management of multisite studies. SUS questionnaire results classified the system as highly usable (SUS score 82.5/100). Automation of 17 (61%) of the 28 variables in the influenza observational study was deemed feasible during the exploration of automated versus manual data abstraction. The creation and use of the Project Meridian electronic data capture tool identified 6 key design requirements for multisite data collection, including the need for the following: (1) scalability irrespective of the type of participant; (2) a common data set across sites; (3) automated back end administrative capability (eg, reminders and a self-service status board); (4) multimedia communication pathways (eg, email and SMS text messaging); (5) interoperability and integration with local site information technology infrastructure; and (6) natural language processing to extract nondiscrete data elements.ConclusionsThe use of the electronic data capture tool in multiple multisite Discovery PREP clinical studies proved the feasibility of using the novel, cloud-based platform in practice. The lessons learned from this effort can be used to inform the improvement of ongoing global multisite data collection efforts during the COVID-19 pandemic and transform current manual data abstraction approaches into reliable, real time, and automated information exchange. Future research is needed to expand the ability to perform automated multisite data extraction during a PHE and beyond.

Project description:BackgroundThe purpose of this study was to demonstrate the validity and efficiency of the Outcomes Management and Evaluation (OME) system, a prospectively designed electronic data collection tool, for collecting comprehensive and standardized surgical data in shoulder arthroplasty.MethodsSurgical data from the first 100 cases of shoulder arthroplasty that were collected into the OME database were analyzed. Surgeons completed a traditional narrative operative note and also an OME case report using an encrypted smartphone. A blinded reviewer extracted data from the operative notes and implant logs in the electronic medical records (EMR) by manual chart review. OME and EMR data were compared with regard to data counts and agreement between 39 variables related to preoperative pathology, including rotator cuff status and glenoid wear, and surgical procedures. Data counts were assessed using both raw percentages and with McNemar's test (with continuity correction). Agreement of nominal variables was analyzed using Cohen's unweighted kappa (κ) and of ordinal variables using the linearly weighted Cohen's test. Efficiency was assessed by calculating the median time needed to complete OME.ResultsCompared to the EMR, the OME database had significantly higher data counts for 56% (22 of 39) of the variables assessed. A high level of proportional and statistical agreement was demonstrated between the data in the two datasets. 10 of 39 variables had 100% agreement but could not be statistically compared because both datasets had the same single response under those variables. Among the 29 variables that were compared, 79% (23 of 29) of variables had >80% raw proportional agreement, and 69% (20 of 29) of variables showed at least substantial agreement (κ > 0.6). The median time for completing OME surgery data entry was 92 seconds (IQR 70 - 126).ConclusionThe prospectively designed, electronic data entry system (OME) is an efficient and valid tool for collecting comprehensive and standardized surgical data on shoulder arthroplasty.Level of evidenceLevel IV.

Dataset Information

Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair.

Publications

Validity and efficiency of a smartphone-based electronic data collection tool for operative data in rotator cuff repair.

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