Journal of investigative medicine : the official publication of the American Federation for Clinical Research
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In pulmonary function testing by spirometry, bronchodilator responsiveness (BDR) evaluates the degree of volume and airflow improvement in response to an inhaled short-acting bronchodilator (BD). The traditional, binary categorization (present vs absent BDR) has multiple pitfalls and limitations. To overcome these limitations, a novel classification that defines five categories (negative, minimal, mild, moderate and marked BDR), and based on % and absolute changes in forced expiratory volume in 1 s (FEV1), has been recently developed and validated in patients with chronic obstructive pulmonary disease, and against multiple objective and subjective measurements. ⋯ A partition that uses delta % predicted FEV1 with the following intervals ≤0%, 0%-2%, 2%-4%, 4%-8% and >8% may be a valid and easy-to-use tool for assessing BDR in spirometry. We confirmed in our cohorts that these thresholds are characterized by low variance and that they are generally gender-independent and race-independent. Future validation in other cohorts and in other populations is needed.
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Acute septic arthritis (ASA) is a common orthopedic infection of children which may produce devastating sequelae and chronic morbidity. Improved understanding of the intra-articular inflammatory response in ASA may identify cytokine targets with diagnostic or therapeutic potential, though no detailed investigations to this end have been performed. Given this, we used a multiplex cytokine assay for assessment of levels of 40 different cytokines in the synovial fluid and blood of children with ASA. ⋯ Subjects with ASA were younger than controls (mean age 8.0 vs 13.1 years, p=0.0400). Significant elevations were seen in interleukins (IL) with chemokine properties, IL-6 and those in the common-γ chain group in the blood and synovial fluid of children with ASA compared with controls, while significant elevations in 5 additional cytokine groups were seen in synovial fluid from children with ASA compared with controls, most notably IL-6 (median 8294.3 vs 10.7 pg/mL, p=0.0066). Our pilot study is the first to describe in detail the cytokine response in children with ASA, and highlights the need for additional study.
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Observational Study
Impact of coexisting pneumonia in the patients admitted with Clostridium difficile infection: a retrospective study from a national inpatient database.
Clostridium difficile is a gram-positive anaerobic spore forming bacillus that can cause infection in a setting of antibiotic use. Pneumonia is a major cause of morbidity and mortality in an inpatient setting and is frequently associated with significant antibiotic administration. This study aims to compare the outcomes of C. difficile infection (CDI) with and without pneumonia to determine the impact of pneumonia in hospitalized patients with CDI. ⋯ In-hospital mortality was noted to be higher in patients with pneumonia than those without (6.5% vs 1.2%, adjusted OR (aOR) 3.85; 95% CI 2.90 to 5.11, p<0.001). The following outcomes were more prevalent in patients with pneumonia compared with those without pneumonia: sepsis (9.8% vs 1.8%, aOR 4.69, 95% CI 3.73 to 5.87, p<0.001), septic shock (4.0% vs 0.5%, aOR 6.32, 95% CI 4.43 to 9.03, p<0.001), NSTEMI (1.9% vs 0.5%, aOR 2.95, 95% CI 1.85 to 4.71, p<0.001), and acute renal failure (31.5% vs 23.1%, aOR 1.23, 95% CI 1.07 to 1.40, p=0.003). In conclusion, patients with pneumonia were associated with significantly higher rates of system-based complications and higher in-hospital mortality rates.
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There are not many real-world studies evaluating daily insulin doses requirements (DIDR) in patients with type 1 diabetes (T1D) using second-generation basal insulin analogs, and such comparison is necessary. The aim of this study was to compare DIDR in individuals with T1D using glargine 300 UI/mL (IGlar-300) or degludec (IDeg) in real clinical practice. An observational, retrospective study was designed in 412 patients with T1D (males: 52%; median age 37.0±13.4 years, diabetes duration: 18.7±12.3 years) using IDeg and IGla-300 ≥6 months to compare DIDR between groups. ⋯ Patients with HbA1c ≤7% (n=113) used significantly lower basal (p=0.045) and total (p=0.024) DIDR, but not prandial insulin (p=0.241), than patients with HbA1c between 7.1% and 8% and >8%. Patients using IGla-300 and IDeg used similar basal, prandial and total DIDR regardless of metabolic control subgroup. No difference in basal, prandial and total DIDR was observed between patients with T1D using IGla-300 or IDeg during at least 6 months in routine clinical practice.
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Data and Safety Monitoring Boards (DSMBs) derived from the need to monitor large federally funded multi-center clinical trials and evolved to include commercial and other large and complex trials. Eventually, academic health centers also created institutionally focused trial monitoring mechanisms. The basic general principles that define traditional DSMBs extend to the institutional level. ⋯ Academic health centers should recognize the importance and existence of institution level safety and data monitoring and provide support as much as possible. Investigators should have sufficient resources available to assemble DSMBs. The Clinical and Translational Science Awards Collaborative DSMB Workgroup provides an online manual to assist investigators.