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OBJECTIVE: To comprehensively describe the quality of conduct, reporting, and publication integrity characteristics for all trials included in a large Cochrane review, comparing those published by presumed predatory publishers with those published by nonpredatory publishers. DESIGN: Cross-sectional meta-epidemiological study. STUDY SELECTION: Two hundred seventy-nine studies (25,704 participants) eligible for the recent update of the "Exercise therapy for chronic low back pain" Cochrane review were included. DATA EXTRACTION: Study and manuscript characteristics, including predatory publication status and other quality and integrity characteristics were extracted along with treatment effect. RESULTS: Nine percent of trials included were in presumed predatory publications; 12% in the period since 2010. We found frequency of other concerning characteristics to range from low (eg, plagiarism, 5%) to common (eg, lack of evidence of trial registration or protocol publication [75%]; insufficient sample size [84%]) in included studies. Studies published by presumed predatory publishers consistently had inferior conduct, reporting and publication integrity characteristics. Presumed predatory publication was associated with missing conflict of interest statement (OR 7.6, 95% CI 3.0-19.1), inadequate follow-up duration (OR 11.2, 95% CI 3.7-33.7), incomplete study methods (OR 12.1, 95% CI 2.8-52.2) and baseline reporting (OR 4.3, 95% CI 1.6-11.7), and high risk of bias (OR 2.7, 95% CI 1.2-6.3). All (100%) presumed predatory publications were missing trial registrations (vs. 72%) and had inadequate sample sizes (vs. 82%). Trials published in presumed predatory journals did not appear to have inflated effect sizes. CONCLUSIONS: Predatory publishers pose a distinct challenge to the consumption and synthesis of randomized controlled trials. More work is needed in other clinical areas to understand the potential impact of randomized controlled trials published in predatory publications, and as a result, the potential impact on evidence from systematic reviews that include these studies.
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Terapia por Ejercicio , Dolor de la Región Lumbar , Publicaciones Periódicas como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Femenino , Humanos , Masculino , Estudios Transversales , Estudios Epidemiológicos , Terapia por Ejercicio/métodos , Dolor de la Región Lumbar/rehabilitación , Publicaciones Periódicas como Asunto/normas , Plagio , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Tamaño de la Muestra , Revisiones Sistemáticas como AsuntoRESUMEN
The increase in the prevalence and impact of infections caused by carbapenemase-producing Enterobacteriaceae is a global health concern. Therefore, rapid and accurate methods to detect these organisms in any clinical microbiology laboratory, including those in resource-limited settings, are essential to prevent and contain their spread. It is also important to differentiate between serine- and metal-dependent carbapenemases elaborated by carbapenemase-producing isolates for epidemiologic, infection control and prevention, and therapeutic purposes. Here, we describe the development and evaluation of the EDTA-modified carbapenem inactivation method (eCIM), an assay for discriminating between serine- and metal-dependent (i.e., metallo-ß-lactamases [MBLs]) carbapenemases when used in conjunction with the modified carbapenem inactivation method (mCIM). The eCIM had an overall sensitivity and specificity of 100% and was adopted by the Clinical and Laboratory Standards Institute as a method to use in combination with the mCIM to identify MBL-producing Enterobacteriaceae.
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Bioensayo/métodos , Enterobacteriaceae Resistentes a los Carbapenémicos/aislamiento & purificación , Carbapenémicos/química , Ácido Edético/química , beta-Lactamasas/clasificación , Antibacterianos/química , Bioensayo/normas , Enterobacteriaceae Resistentes a los Carbapenémicos/efectos de los fármacos , Metales , Pruebas de Sensibilidad Microbiana , Fenotipo , Sensibilidad y Especificidad , Serina , beta-Lactamasas/aislamiento & purificaciónRESUMEN
BACKGROUND: Chronic low back pain (LBP) is the leading cause of pain and disability, resulting in a major socioeconomic impact. The Cochrane Review which examined the effect of spinal manipulative therapy (SMT) for chronic LBP concluded that SMT is moderately effective, but was based on conventional meta-analysis of aggregate data. The use of individual participant data (IPD) from trials allows for a more precise estimate of the treatment effect and has the potential to identify moderators and/or mediators. The aim is (1) to assess the overall treatment effect of SMT for primary and secondary outcomes in adults with chronic LBP, (2) to determine possible moderation of baseline characteristics on treatment effect, (3) to identify characteristics of intervention (e.g., manipulation/mobilization) that influence the treatment effect, and (4) to identify mediators of treatment effects. METHODS: All trials included in the Cochrane Review on SMT for chronic LBP will be included which were published after the year 2000, and the search will be updated. No restrictions will be placed on the type of comparison or size of the study. Primary outcomes are pain intensity and physical functioning. A dataset will be compiled consisting of individual trials and variables included according to a predefined coding scheme. Variables to be included are descriptive of characteristics of the study, treatment, comparison, participant characteristics, and outcomes at all follow-up periods. A one-stage approach with a mixed model technique based on the intention-to-treat principle will be used for the analysis. Subsequent analyses will focus on treatment effect moderators and mediators. DISCUSSION: We will analyze IPD for LBP trials in which SMT is one of the interventions. IPD meta-analysis has been shown to be more reliable and valid than aggregate data meta-analysis, although this difference might also be attributed to the number of studies that can be used or the amount of data that can be utilized. Therefore, this project may identify important gaps in our knowledge with respect to prognostic factors of treatment effects. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015025714.
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Manipulación Espinal , Metaanálisis como Asunto , Enfermedad Crónica , Humanos , Dolor de la Región Lumbar/terapia , Manipulación Espinal/métodos , Resultado del TratamientoRESUMEN
This review aimed to identify childhood and adolescence risk and prognostic factors associated with onset and persistence of persistent abdominal pain and related disability and assess quality of the evidence. While findings suggest a possible role for negative emotional symptoms and parental mental health as risk and prognostic factors for onset and persistence of persistent abdominal pain, the evidence is of poor quality overall and nonexistent when it comes to prognostic factors associated with disability. CONCLUSION: Further research is needed to increase confidence in existing evidence and to explore new factors. This research will inform prevention.
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Dolor Abdominal/epidemiología , Adolescente , Niño , Humanos , Factores de RiesgoRESUMEN
PURPOSE: We analyzed patterns and factors associated with receipt of breast and cervical cancer screening in a cohort of colorectal cancer survivors. METHODS: Individuals diagnosed with colorectal cancer in Nova Scotia between January 2001 and December 2005 were eligible for inclusion. Receipt of breast and cervical cancer screening was determined using administrative data. General-population age restrictions were used in the analysis (breast: 40-69 years; cervical: 21-75 years). Kaplan-Meier and Cox proportional hazards models were used to assess time to first screen. RESULTS: Of 318 and 443 colorectal cancer survivors eligible for the breast and cervical cancer screening analysis respectively, 30.1% [95% confidence interval (ci): 21.2% to 39.0%] never received screening mammography, and 47.9% (95% ci: 37.8% to 58.0%) never received cervical cancer screening during the study period. Receipt of screening before the colorectal cancer diagnosis was strongly associated with receipt of screening after diagnosis (hazard ratio for breast cancer screening: 4.71; 95% ci: 3.42 to 6.51; hazard ratio for cervical cancer screening: 6.83; 95% ci: 4.58 to 10.16). CONCLUSIONS: Many colorectal cancer survivors within general-population screening age recommendations did not receive breast and cervical cancer screening. Future research should focus on survivors who meet age recommendations for population-based cancer screening.
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Understanding prognosis is important in managing low back pain. In this article, we discuss the available evidence on low back pain prognosis and describe how prognostic evidence can be used to inform clinical decision making. We describe three main types of related prognosis questions: 'What is the most likely course?' (Course studies); 'What factors are associated with, or determine, outcome?' (Prognostic factor or explanatory studies); and 'Can we identify risk groups who are likely to have different outcomes?' (Risk group or outcome prediction studies). Most low back pain episodes are mild and rarely disabling, with only a small proportion of individuals seeking care. Among those presenting for care, there is variability in outcome according to patient characteristics. Most new episodes recover within a few weeks. However, recurrences are common and individuals with chronic, long-standing low back pain tend to show a more persistent course. Studies of mixed primary care populations indicate 60-80% of health-care consulters will continue to have pain after a year. Important low back pain prognostic factors are related to the back pain episode, the individual and psychological characteristics, as well as the work and social environment. Although numerous studies have developed prediction models in the field, most models/tools explain less than 50% of outcome variability and few have been tested in independent samples. We discuss limitations and future directions for research in the area of low back pain prognosis.
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Dolor de la Región Lumbar/diagnóstico , Atención Primaria de Salud , Actividades Cotidianas , Empleo , Humanos , Dolor de la Región Lumbar/fisiopatología , Dolor de la Región Lumbar/rehabilitación , Práctica Profesional , Pronóstico , Recurrencia , Proyectos de Investigación , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: Systematic reviews of prognostic factors for low back pain vary substantially in design and conduct. The objective of this study was to identify, describe, and synthesize systematic reviews of low back pain prognosis, and explore the potential impact of review methods on the conclusions. STUDY DESIGN AND SETTING: We identified 17 low back pain prognosis reviews published between 2000 and 2006. One reviewer extracted and a second checked review characteristics and results. Two reviewers independently assessed review quality. RESULTS: Review questions and selection criteria varied; there were both focused and broad reviews of prognostic factors. A quarter of reviews did not clearly define search strategies. The number of potential citations identified ranged from 15 to 4,458 and the number of included prognosis studies ranged from 3 to 32 (of 162 distinct citations included across reviews). Seventy percent of reviews assessed quality of included studies, but assessed only a median of four of six potential biases. All reviews reported associations based on statistical significance; they used various strategies for syntheses. Only a small number of important prognostic factors were consistently reported: older age, poor general health, increased psychological or psychosocial stress, poor relations with colleagues, physically heavy work, worse baseline functional disability, sciatica, and the presence of compensation. We found discrepancies across reviews: differences in some selection criteria influenced studies included, and various approaches to data interpretation influenced review conclusions about evidence for specific prognostic factors. CONCLUSION: There is an immediate need for methodological work in the area of prognosis systematic reviews. Because of methodological shortcomings in the primary and review literature, there remains uncertainty about reliability of conclusions regarding prognostic factors for low back pain.
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Dolor de la Región Lumbar/diagnóstico , Literatura de Revisión como Asunto , Femenino , Humanos , Dolor de la Región Lumbar/rehabilitación , Masculino , Pronóstico , Proyectos de Investigación , Factores de Riesgo , Factores SexualesRESUMEN
OBJECTIVE: To present an explanatory framework for understanding prognosis and illustrate it using data from a systematic review. STUDY DESIGN AND SETTING: A framework including three phases of explanatory prognosis investigation was adapted from earlier work and a discussion of causal understanding was integrated. For illustration, prognosis studies were identified from electronic and supplemental searches of literature between 1966 and December 2006. We extracted characteristics of the populations, exposures, and outcomes and identified three phases of explanatory prognosis investigation: Phase 1, identifying associations; Phase 2, testing independent associations; and Phase 3, understanding prognostic pathways. The purpose of each phase is exploration, confirmation, and development of understanding, respectively. RESULTS: It is important to consider a framework of explanatory prognosis studies for: (1) defining the study objectives, (2) presenting the study methods and data, and (3) interpreting and applying the results of the study. CONCLUSION: When conducting and reporting prognosis studies, researchers should consider the approach to prognosis (explanatory or outcome prediction) and phase of investigation, use best methods to limit biases, report completely, and cautiously interpret results. Readers of health care research will then be better able to evaluate the goals and interpret and appropriately use the results of prognosis studies.
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Evaluación de Resultado en la Atención de Salud/métodos , Pronóstico , Causalidad , Evaluación de la Discapacidad , Investigación sobre Servicios de Salud/métodos , Humanos , Responsabilidad Legal , Dolor de la Región Lumbar/rehabilitación , Proyectos de Investigación , Literatura de Revisión como AsuntoRESUMEN
BACKGROUND: Exercise therapy is widely used as an intervention in low-back pain. OBJECTIVES: To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE, EMBASE, PsychInfo, CINAHL databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews. SELECTION CRITERIA: Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short, intermediate, and long-term follow-up. MAIN RESULTS: Sixty-one randomized controlled trials (6390 participants) met inclusion criteria: acute (11), subacute (6) and chronic (43) low-back pain (1 unclear). Evidence was found of effectiveness in chronic populations relative to comparisons at all follow-up periods; pooled mean improvement was 7.3 points (95% CI, 3.7 to 10.9) for pain (out of 100), 2.5 points (1.0 to 3.9) for function (out of 100) at earliest follow-up. In studies investigating patients (i.e. presenting to healthcare providers) mean improvement was 13.3 points (5.5 to 21.1) for pain, 6.9 (2.2 to 11.7) for function, representing significantly greater improvement over studies where participants included those recruited from a general population (e.g. with advertisements). There is some evidence of effectiveness of graded-activity exercise program in subacute low-back pain in occupational settings, though the evidence for other types of exercise therapy in other populations is inconsistent. There was evidence of equal effectiveness relative to comparisons in acute populations [pain: 0.03 points (95% CI, -1.3 to 1.4)]. LIMITATIONS: This review largely reflects limitations of the literature, including low quality studies with heterogeneous outcome measures, inconsistent and poor reporting, and possibility of publication bias. AUTHORS' CONCLUSIONS: Exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low-back pain, particularly in healthcare populations. In subacute low-back pain there is some evidence that a graded activity program improves absenteeism outcomes, though evidence for other types of exercise is unclear. In acute low-back pain, exercise therapy is as effective as either no treatment or other conservative treatments.
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Terapia por Ejercicio , Dolor de la Región Lumbar/terapia , Enfermedad Aguda , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Methods used to evaluate the inhalation hazard of soil contaminated with plutonium were investigated. Four soil fractionation procedures were used to separate three size fractions of soil particles taken from two locations at the Department of Energy's Rocky Flats facility. The results show that increasing amounts of soil mass and plutonium activity (0.5 to 38 percent and 7 to 84 percent, respectively) remain in the fraction of soil smaller than 10 micrometers as the in situ particle associations are increasingly disrupted by physical and chemical forces. The introduction of forces of dispersion unrelated to ambient conditions yields results that are unrelated to the original particle associations.
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Uranium is separated from plutonium by adsorption on an anion-exchange resin from a concentrated hydrochloric acid solution and is eluted from the resin, collected on a disc of cation-exchange paper, and determined by X-ray fluorescence. The lower limit of detection is 2mug of uranium, and 50mug may be determined with a recovery of 98% and a standard deviation of 3.2mug. In plutonium metal, 19ppm of uranium were found, with a standard deviation of 2 ppm (6 results).