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BACKGROUND: Differentiating clinical near-complete and complete responses (cCR) after neoadjuvant therapy (NT) is challenging in rectal cancer patients. We hypothesized that magnetic resonance imaging staging limitations for low rectal cancers may increase the proportion of abdominoperineal resection (APR) with permanent colostomy for those without a cCR. METHODS: Single institution retrospective analysis of rectal cancer cases before and after adoption of nonoperative "watch and wait" (W&W) pathway. APR as a percentage of rectal resections was the primary outcome. RESULTS: There were 76 total mesorectal excisions (TME) in the pre-W&W group and 98 in the post-W&W group. NT was significantly more common in the post-W&W group. There was no significant difference in the APR primary outcome (pre-W&W APR 33.3% vs. post-W&W APR 26.5%, p = 0.482). APR patients had fewer complete TME grades (69.2% vs. 46.2%) and more pathologic complete responses (0% vs. 26.9%) in the post-W&W period. The cCR rate for patients with nonoperative management was 51.4% (n = 37) and 13.5% (n = 5) had regrowths, all of whom underwent salvage surgery. CONCLUSION: APR for those without a cCR to NT has not increased in the nonoperative management era. Balancing the pathologic complete response rate may require restaging some patients with clinical near-complete responses.
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Terapia Neoadjuvante , Neoplasias Retais , Humanos , Neoplasias Retais/terapia , Neoplasias Retais/patologia , Neoplasias Retais/cirurgia , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Conduta Expectante , Protectomia , Seguimentos , Imageamento por Ressonância Magnética , Colostomia/estatística & dados numéricosRESUMO
Statistical regression models are used for predicting outcomes based on the values of some predictor variables or for describing the association of an outcome with predictors. With a data set at hand, a regression model can be easily fit with standard software packages. This bears the risk that data analysts may rush to perform sophisticated analyses without sufficient knowledge of basic properties, associations in and errors of their data, leading to wrong interpretation and presentation of the modeling results that lacks clarity. Ignorance about special features of the data such as redundancies or particular distributions may even invalidate the chosen analysis strategy. Initial data analysis (IDA) is prerequisite to regression analyses as it provides knowledge about the data needed to confirm the appropriateness of or to refine a chosen model building strategy, to interpret the modeling results correctly, and to guide the presentation of modeling results. In order to facilitate reproducibility, IDA needs to be preplanned, an IDA plan should be included in the general statistical analysis plan of a research project, and results should be well documented. Biased statistical inference of the final regression model can be minimized if IDA abstains from evaluating associations of outcome and predictors, a key principle of IDA. We give advice on which aspects to consider in an IDA plan for data screening in the context of regression modeling to supplement the statistical analysis plan. We illustrate this IDA plan for data screening in an example of a typical diagnostic modeling project and give recommendations for data visualizations.
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Modelos Estatísticos , Humanos , Análise de Regressão , Interpretação Estatística de Dados , Análise Multivariada , Reprodutibilidade dos Testes , Software , Análise de DadosRESUMO
BACKGROUND: Same-day discharge after colectomy in enhanced recovery pathways has been shown to be feasible. It is not clear how early patients with rectal resections may be safely discharged. The study aim was to determine if patients discharged ≤ 3 days after rectal resections are associated with increased rates of emergency department (ED) visits and hospital readmissions. METHODS: Retrospective analysis of enhanced recovery low anterior resection, abdominoperineal resection, and proctocolectomy patients in a prospectively maintained single institution colorectal surgery database from 01/01/2018 to 07/15/2022. Clinic visits were scheduled within 4-7 days and at 30 days after discharge, and every 1-2 weeks for stoma patients until no longer needed. Logistic regression models were used to analyze the association of discharge on postoperative days (POD)-1-3, POD-4-5, and POD ≥ 6 days with incidence of ED visits and readmissions. RESULTS: A total of 118 patients met inclusion criteria, 76 with stomas. Median postoperative length of stay was 5 [IQR 6.5] days. Mean age was 58.6 years; 59.3% were ASA-3; and 69.5% had a minimally invasive surgical approach. ED visits were not significantly different between discharge-day groups (p = 0.096). No patients were discharged same-day, one without a stoma was discharged on POD-1, ten patients (2 with stomas) on POD-2, and twenty-four patients (13 with stomas) on POD-3. ED visits were lowest for the POD-1-3 group (14.3%) but not significantly different than later discharge groups (p = 0.166). Readmission rate was also lowest for the POD-1-3 group (11.4%) and also not significantly different than later discharge groups (p = 0.261) and this was confirmed with logistic regression. Complication rate was lowest in the POD-1-3 group (p < 0.001). CONCLUSION: Early discharge after enhanced recovery partial or complete proctectomy is not associated with increased ED visits and readmissions. Follow up studies should identify post-discharge resources that allow safe early discharge and that may be standardized and generalizable.
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Visitas ao Pronto Socorro , Serviço Hospitalar de Emergência , Recuperação Pós-Cirúrgica Melhorada , Alta do Paciente , Readmissão do Paciente , Protectomia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Visitas ao Pronto Socorro/estatística & dados numéricos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Alta do Paciente/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Protectomia/métodos , Estudos RetrospectivosRESUMO
[This corrects the article DOI: 10.1371/journal.pone.0243652.].
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CONTEXT: Chronic low back pain (CLBP) has long plagued mankind, but little progress has been made in finding a rational and effective treatment, let alone a common cause. This study is an attempt to fill that void by measuring short- and long-term effects of osteopathic manipulative treatment (OMT), including psychosocial and pain reduction in CLBP patients. OBJECTIVES: The objectives of this study were to investigate the effectiveness of neuromusculoskeletal medicine/osteopathic manipulative medicine (OMM) in treating CLBP, with a focus on biopsychosocial (pain sensitivity questionnaire [PSQ]) and pain control in chronic conditions. METHODS: The study involved a large, single cohort observational design of 101 patients. The inclusion criteria for selecting patients targeted those with "nonspecific" CLBP. The National Institutes of Health (NIH) Minimum Dataset for Chronic Low Back Pain (NMD) was the measurement tool and was administered at consent (baseline), 2, 4, and 8 weeks and at 6 and 12 months. Time trends were analyzed as overall mean. Pairwise differences were compared between time points. Mixed-effects models were utilized to test the association of time with pain and biopsychosocial scores. RESULTS: Pain and PSQ scores decreased over the study timeline. The most significant change for both pain and biopsychosocial scores occurred at 6 months compared to baseline, with a further reduction at 12 months. CONCLUSIONS: OMT has been demonstrated to significantly reduce pain and psychosocial factors related to CLBP in both the short and long term.
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Dor Crônica , Dor Lombar , Osteopatia , Humanos , Dor Lombar/terapia , Dor Lombar/psicologia , Osteopatia/métodos , Feminino , Masculino , Dor Crônica/terapia , Dor Crônica/psicologia , Adulto , Pessoa de Meia-Idade , Medição da Dor , Resultado do Tratamento , Fatores de Tempo , Inquéritos e Questionários , Estudos de Coortes , IdosoRESUMO
Johne's disease (JD) is a chronic enteric infection of dairy cattle worldwide. Mycobacterium avium subsp. paratuberculosis (MAP), the causative agent of JD, is fastidious often requiring eight to sixteen weeks to produce colonies in culture-a major hurdle in the diagnosis and therefore in implementation of optimal JD control measures. A significant gap in knowledge is the comprehensive understanding of the metabolic networks deployed by MAP to regulate iron both in-vitro and in-vivo. The genome of MAP carries MAP3773c, a putative metal regulator, which is absent in all other mycobacteria. The role of MAP3773c in intracellular iron regulation is poorly understood. In the current study, a field isolate (K-10) and an in-frame MAP3773c deletion mutant (ΔMAP3773c) derived from K-10, were exposed to iron starvation for 5, 30, 60, and 90 min and RNA-Seq was performed. A comparison of transcriptional profiles between K-10 and ΔMAP3773c showed 425 differentially expressed genes (DEGs) at 30 min time post-iron restriction. Functional analysis of DEGs in ΔMAP3773c revealed that pantothenate (Pan) biosynthesis, polysaccharide biosynthesis and sugar metabolism genes were downregulated at 30 min post-iron starvation whereas ATP-binding cassette (ABC) type metal transporters, putative siderophore biosynthesis, PPE and PE family genes were upregulated. Pathway analysis revealed that the MAP3773c knockout has an impairment in Pan and Coenzyme A (CoA) biosynthesis pathways suggesting that the absence of those pathways likely affect overall metabolic processes and cellular functions, which have consequences on MAP survival and pathogenesis.
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Doenças dos Bovinos , Mycobacterium avium subsp. paratuberculosis , Paratuberculose , Animais , Bovinos , Ferro , Paratuberculose/genética , Paratuberculose/microbiologia , Redes e Vias Metabólicas/genética , Doenças dos Bovinos/microbiologiaRESUMO
BACKGROUND: Same-day discharge after colorectal surgery in enhanced recovery pathways is increasing. This study aimed to determine if discharge on postoperative days (POD) one or two is associated with increased rates of emergency department (ED) visits and hospital readmissions after left and right colectomy. METHODS: Single institution retrospective analysis of prospective institutional colorectal surgery database between 07/01/2018 and 07/15/2022. Primary outcomes were ED visit and readmission rates for enhanced recovery open and minimally invasive right and left colectomy using logistic regressions models. RESULTS: 820 patients met inclusion criteria. There were significant differences in discharge-day by diagnosis-58.5% of patients with Crohn's disease were discharged on POD ≥4 and 21.6% with benign colon neoplasia were discharged on POD-0-1 (P < .001). ED visits occurred in 12.9% of the study population and were not significantly different between discharge-day groups (P = .096). Overall readmission rate was 8.5% and significantly different between discharge-day groups (0% POD-0 vs 8.3% POD-1 vs 5.8% POD-2 vs 6.9% POD-3 vs 12.9% POD ≥4, P = .041). Logistic regression showed that ED visits and readmissions for longer discharge-days (POD-2, POD-3, POD ≥4) were not significantly different than POD-0-1. Readmission diagnoses for the study population were higher for ileus (17.1%) and surgical site infection (SSI) type-III (22.9%) than for acute kidney injury (1.4%) and SSI type-I/II (1.4%). CONCLUSION: Early discharge after left and right colectomy is not associated with increased rates of ED visits and readmissions. Same-day discharge may be feasible in selected enhanced recovery patients. Standardized post-discharge resources that safely allow same-day discharge require further investigation.
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Colectomia , Serviço Hospitalar de Emergência , Recuperação Pós-Cirúrgica Melhorada , Alta do Paciente , Readmissão do Paciente , Humanos , Readmissão do Paciente/estatística & dados numéricos , Colectomia/estatística & dados numéricos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Masculino , Feminino , Pessoa de Meia-Idade , Alta do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Idoso , Adulto , Complicações Pós-Operatórias/epidemiologia , Visitas ao Pronto SocorroRESUMO
Initial data analysis (IDA) is the part of the data pipeline that takes place between the end of data retrieval and the beginning of data analysis that addresses the research question. Systematic IDA and clear reporting of the IDA findings is an important step towards reproducible research. A general framework of IDA for observational studies includes data cleaning, data screening, and possible updates of pre-planned statistical analyses. Longitudinal studies, where participants are observed repeatedly over time, pose additional challenges, as they have special features that should be taken into account in the IDA steps before addressing the research question. We propose a systematic approach in longitudinal studies to examine data properties prior to conducting planned statistical analyses. In this paper we focus on the data screening element of IDA, assuming that the research aims are accompanied by an analysis plan, meta-data are well documented, and data cleaning has already been performed. IDA data screening comprises five types of explorations, covering the analysis of participation profiles over time, evaluation of missing data, presentation of univariate and multivariate descriptions, and the depiction of longitudinal aspects. Executing the IDA plan will result in an IDA report to inform data analysts about data properties and possible implications for the analysis plan-another element of the IDA framework. Our framework is illustrated focusing on hand grip strength outcome data from a data collection across several waves in a complex survey. We provide reproducible R code on a public repository, presenting a detailed data screening plan for the investigation of the average rate of age-associated decline of grip strength. With our checklist and reproducible R code we provide data analysts a framework to work with longitudinal data in an informed way, enhancing the reproducibility and validity of their work.