Characteristics and laboratory findings on admission to the emergency department among 2873 hospitalized patients with COVID-19: the impact of adjusted laboratory tests in multicenter studies. A multicenter study in Spain (BIOCOVID-Spain study)
Luis García de Guadiana‐RomualdoDaniel Morell‐GarcíaCristian Morales‐IndianoJosep Miquel BauçàMaria José Alcaide MartínC. Esparza Del ValleJosé Ignacio Gutiérrez RevillaEloísa UrrechagaJ.M. Álamo-MartínezAna María Hernando HolgadoMaría-Carmen Lorenzo-LozanoSilvia Sánchez Fdez‐PachecoPatricia de la Hera CagigalMaría Ángeles Juncos TobarraJuan A. VílchezIsabel Vírseda ChamorroIrene Gutiérrez GarcíaYolanda Pastor MurciaL. FríasLaura Altimira QueralElisa Nuez‐ZaragozaJuan Adell Ruiz de LeónAlicia Ruiz RipaPaloma Salas Gómez‐PablosIria Cebreiros LópezAmaia Fernandez-UriarteÁlex LarruzeaMaría Luisa López YepesPatricia Esteban TorrellaMaría C. Zamorano AndrésJosé Pedregosa DíazCristina Acevedo AlcarazA.L. Blázquez ManzaneraAna María Lourdes Padilla JiménezMaría C. Baamonde CalzadaMarina VeraMatilde Cháfer RudillaMagdalena Canalda CampásSara García MuñozLuis Vicente GutiérrezLaura Jiménez AñónAlfonso Pérez MartínezAurelio Pons CastilloRuth González TamayoJ. VivancosOlaia Rodríguez‐FragaVicente Ferrer Díaz de Brito FernándezVicente AguaderoMaría Gloria García ArévaloMaría Arnaldos CarrilloMercedes González MoralesMaría Núñez GárateCristina Ruiz IruelaNatalia Sancho‐RodríguezMartí Vila PérezJosé M. Egea-CaparrósLuis Felipe Loaiza SáenzÁlvaro Blasco BarberoAmparo Galán Ortega
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Identification of predictors for severe disease progression is key for risk stratification in COVID-19 patients. We aimed to describe the main characteristics and identify the early predictors for severe outcomes among hospitalized patients with COVID-19 in Spain. This was an observational, retrospective cohort study (BIOCOVID-Spain study) including COVID-19 patients admitted to 32 Spanish hospitals. Demographics, comorbidities and laboratory tests were collected. Outcome was in-hospital mortality. For analysis, laboratory tests values were previously adjusted to assure the comparability of results among participants. Cox regression was performed to identify predictors. Study population included 2873 hospitalized COVID-19 patients. Nine variables were independent predictors for in-hospital mortality, including creatinine (Hazard ratio [HR]:1.327; 95% Confidence Interval [CI]: 1.040-1.695, p = .023), troponin (HR: 2.150; 95% CI: 1.155-4.001; p = .016), platelet count (HR: 0.994; 95% CI: 0.989-0.998; p = .004) and C-reactive protein (HR: 1.037; 95% CI: 1.006-1.068; p = .019). This is the first multicenter study in which an effort was carried out to adjust the results of laboratory tests measured with different methodologies to guarantee their comparability. We reported a comprehensive information about characteristics in a large cohort of hospitalized COVID-19 patients, focusing on the analytical features. Our findings may help to identify patients early at a higher risk for an adverse outcome.Recent cohort studies in chronic obstructive pulmonary disease (COPD) have questioned the validity of previously reported associations between inhaled corticosteroids (ICS) and reductions in mortality and rehospitalization in observational studies. Using time-dependent versions of statistical survival models, these studies have suggested immortal time bias as responsible for the proposed beneficial association.We explored the extent of this bias in a study of patients with COPD monitored for a year from COPD discharge with two designs free of any immortal time bias in the General Practice Research Database in the United Kingdom.In Design 1, we used only patients whose treatment status was defined on the same day of discharge to obtain a matched cohort based on propensity scores, which were derived from the patient-level baseline characteristics. In Design 2, we identified all in the study cohort who experienced death or rehospitalization and then matched each case to up to four noncases by randomly sampling from the cohort risk sets without regard to treatment status.The propensity scores matched cohort analysis of 786 patients without a wait time found a significant risk reduction associated with use of ICS: hazard ratio, 0.69 (95% confidence interval, 0.52-0.93). The matched nested case-control analysis of 2,222 patients, designed without regard to exposure status and hence free of immortal time bias, gave a similar association with exposure to ICS in the last 6-month period: hazard ratio, 0.71 (0.56-0.90).We conclude that immortal time bias cannot account for the risk reduction associated with ICS exposure in observational studies.
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Background and objectives
Sedentary behavior is associated with increased mortality in the general population. Whether replacing sedentary behavior with low- or light-intensity activities confers a survival benefit in the general or CKD populations is unknown.Design, setting, participants, & measurements
This observational analysis of the 2003–2004 National Health and Nutrition Examination Survey examined the associations of low- and light-intensity activities with mortality. On the basis of the number of counts/min recorded by an accelerometer, durations of sedentary (<100/min), low (100–499/min), light (500–2019/min), and moderate/vigorous (≥2020/min) activity were defined and normalized to 60 minutes. The mortality associations of 2 min/hr less sedentary duration in conjunction with 2 min/hr more (tradeoff) spent in one of the low, light, or moderate/vigorous activity durations while controlling for the other two activity durations were examined in multivariable Cox regression models in the entire cohort and in the CKD subgroup.Results
Of the 3626 participants included, 383 had CKD. The mean sedentary duration was 34.4±7.9 min/hr in the entire cohort and 40.8±6.8 in the CKD subgroup. Tradeoff of sedentary duration with low activity duration was not associated with mortality in the entire cohort or the CKD subgroup. Tradeoff of sedentary duration with light activity duration was associated with a lower hazard of death in the entire cohort (hazard ratio, 0.67; 95% confidence interval, 0.48 to 0.93) and CKD subgroup (hazard ratio, 0.59; 95% confidence interval, 0.35 to 0.98). Tradeoff of sedentary duration with moderate/vigorous activity duration had a nonsignificant lower hazard in the entire cohort and CKD subgroup.Conclusions
Patients with CKD are sedentary nearly two thirds of the time. Interventions that replace sedentary duration with an increase in light activity duration might confer a survival benefit.Subgroup analysis
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Background Although most people with relapsing onset multiple sclerosis (R-MS) eventually transition to secondary progressive multiple sclerosis (SPMS), little is known about disability progression in SPMS. Methods All R-MS patients in the Cardiff MS registry were included. Cox proportional hazards regression was used to examine a) hazard of converting to SPMS and b) hazard of attaining EDSS 6.0 and 8.0 in SPMS. Results 1611 R-MS patients were included. Older age at MS onset (hazard ratio [HR] 1.02, 95%CI 1.01–1.03), male sex (HR 1.71, 95%CI 1.41–2.08), and residual disability after onset (HR 1.38, 95%CI 1.11–1.71) were asso- ciated with increased hazard of SPMS. Male sex (EDSS 6.0 HR 1.41 [1.04–1.90], EDSS 8.0 HR 1.75 [1.14–2.69]) and higher EDSS at SPMS onset (EDSS 6.0 HR 1.31 [1.17–1.46]; EDSS 8.0 HR 1.38 [1.19–1.61]) were associated with increased hazard of reaching disability milestones, while older age at SPMS was associated with a lower hazard of progression (EDSS 6.0 HR 0.94 [0.92–0.96]; EDSS 8.0: HR 0.92 [0.90–0.95]). Conclusions Different factors are associated with hazard of SPMS compared to hazard of disability progres- sion after SPMS onset. These data may be used to plan services, and provide a baseline for comparison for future interventional studies and has relevance for new treatments for SPMS RobertsonNP@cardiff.ac.uk
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The purposes of this study were to develop and implement an observational training program and to assess the effects of a video observational training program on video and live observational proficiency. Physical education majors took a pretest in both a video and a live environment to assess observational proficiency. The task was observing children batting and answering questions regarding the critical features of the movement. The students were then placed into either a treatment ( n = 12) or a control ( n = 11) group. There were no differences between groups on either assessment ( p > .05). The treatment group then participated in a video observational training program. After the training, all subjects took a posttest in each environment to assess observational proficiency. The training was found to be effective in improving video observational proficiency ( p < .05) but not live observational proficiency ( p > .05). These results provide support for the effectiveness of video observational training in developing video observational proficiency but not live observational proficiency.
Observational learning
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Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.
Causality
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The hazard ratio and median survival time are the routine indicators in survival analysis. We briefly introduced the relationship between hazard ratio and median survival time and the role of proportional hazard assumption. We compared 110 pairs of hazard ratio and median survival time ratio in 58 articles and demonstrated the reasons for the difference by examples. The results showed that the hazard ratio estimated by the Cox regression model is unreasonable and not equivalent to median survival time ratio when the proportional hazard assumption is not met. Therefore, before performing the Cox regression model, the proportional hazard assumption should be tested first. If proportional hazard assumption is met, Cox regression model can be used; if proportional hazard assumption is not met, restricted mean survival times is suggested.风险比（hazard ratio，HR）和中位生存时间是生存分析时的常规分析和报告指标。本文简要介绍了HR和中位生存时间的关系以及比例风险假定在这两者之间的作用，分析了检索出的58篇文献中的110对风险比和中位生存时间比的差异，并通过实例阐明了产生这种差异的原因。结果表明，在不满足比例风险假定时，Cox回归模型计算得到的风险比是不合理的，且与中位生存时间之比不等价。因此，在使用Cox回归模型前，应先进行比例风险假定的检验，只有符合比例风险假定时才能使用该模型；当不符合比例风险假定时，建议使用限制性平均生存时间。.
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Journal Article Potential impact of observational cohort studies in Japan on rheumatoid arthritis research and practice Get access Hisashi Yamanaka, Hisashi Yamanaka Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan Correspondence to: Hisashi Yamanaka, Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan Tel. +81-3-5269-1725; Fax +81-3-5269-1726 e-mail: yamanaka@ior.twmu.ac.jp Search for other works by this author on: Oxford Academic Google Scholar Shigeto Tohma Shigeto Tohma Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan Search for other works by this author on: Oxford Academic Google Scholar Modern Rheumatology, Volume 16, Issue 2, 1 April 2006, Pages 75–76, https://doi.org/10.3109/s10165-006-0464-8 Published: 01 April 2006 Article history Received: 24 January 2006 Accepted: 20 February 2006 Published: 01 April 2006
Clinical Practice
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For better management of rheumatoid arthritis (RA) patients, we need information both from well-designed clinical trials, such as randomized controlled trials, and from observational cohorts. Observational cohort study has not been developed in Japanese RA patients; however, two cohorts, IORRA (formerly J-ARAMIS) from 2000 and NinJa by iR-net from 2002, have been established. These two cohorts are an important source not only for better management of Japanese RA patients but also for solutions to a variety of issues concerning RA clinical practice in general. In this minireview, necessities of observational cohort studies are discussed.
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Observational cohort studies in early RA are a key source of evidence, despite inconsistencies in methodological approaches. This narrative review assesses the spectrum of methodologies used in addressing centre-level effect and case-mix adjustment in early RA observational cohort studies.An electronic search was undertaken to identify observational prospective cohorts of >100 patients recruited from two or more centres, within 2 years of an RA or early inflammatory arthritis diagnosis. References and author publication lists of all studies from eligible cohorts were assessed for additional cohorts.Thirty-four unique cohorts were identified from 204 studies. Seven percent of studies considered centre in their analyses, most commonly as a fixed effect in regression modelling. Reporting of case-mix variables in analyses varied widely. The number of variables considered in case-mix adjustment was higher following publication of the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement in 2007.Centre effect is unreported or inadequately accounted for in the majority of RA observational cohorts, potentially leading to spurious inferences and obstructing comparisons between studies. Inadequate case-mix adjustment precludes meaningful comparisons between centres. Appropriate methodology to account for centre and case-mix adjustment should be considered at the outset of analyses.
Case mix index
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