Background The COVID-19 pandemic has entailed a significant socio-economic impact on various layers of the population. In many countries, attempts to control viral dissemination involved lockdown measures that limited citizens' overall mobility and professional and leisure activities. Objective This systematic review investigates the impact of COVID-19-induced lockdowns on university student physical activity and sedentary behav-ior, as these relate to physical and mental well-being. Methods Data was collected through PubMed/MEDLINE, Embase, SCOPUS, and APA PsycInfo databases until January 2021. Results Seven studies conducted in five different countries (United States, Spain, Italy, China, and United Kingdom) were included in the final review. Overall, most studies reported a significant decrease in mild physical activity (i.e., walking) among undergraduate students but not among graduate students. Consistently, most studies reported a significant increase in sedentary time (i.e., sitting time on weekdays) in undergraduate students but not in graduate students. We observed that students who were more sedentary previous to lockdown, increased or did not change their moderate and/or vigorous physical activity. In contrast, those who were less sedentary previous to lockdown decreased their moderate and/or vigorous physical activity. Conclusions COVID 19 induced lockdowns appear to have negatively affected walking and sedentary behavior among undergraduate students but not among graduate students. Our results highlight the importance of promoting the World Health Organization recommendations for physical activity and sedentary behavior among university students to improve health outcomes.

Objective The objective of this study was to investigate whether glycated hemoglobin (HbA1c) is a valid surrogate for evaluating the effectiveness of antihyperglycemic drugs in diabetes mellitus (DM) trials. Methods We conducted a systematic review of placebo-controlled randomized clinical trials (RCTs) evaluating the effect of a treatment on HbA1c (mean difference between groups) and clinical outcomes (relative risk of mortality, myocardial infarction, stroke, heart failure, and/or kidney injury) in patients with DM. Then, we investigated the association between treatment effects on HbA1c and clinical outcomes using regression analysis at the trial level. Lastly, we interpreted the correlation coefficients (R) using the cut-off points suggested by the Institute for Quality and Efficiency in Healthcare (IQWiG). HbA1c was considered a valid surrogate if it demonstrated a strong association: lower limit of the 95 percent confidence interval (95 percent CI) of R greater than or equal to .85. Results Nineteen RCTs were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate for any clinical outcome: mortality (R = .34; 95 percent CI −.14 to .69), myocardial infarction (R = .20; −.30 to .61), heart failure (R = .08; −.40 to .53), kidney injury (R = −.04; −.52 to .47), and stroke (R = .81; .54 to .93). Conclusions The evidence from multiple placebo-controlled RCTs does not support the use of HbA1c as a surrogate to measure the effectiveness of antihyperglycemic drugs in DM studies.

s231 produced a statistically significant reduction over placebo in rTNSS (standardized mean difference [SMD] -0.390; 95% CI -0.476 to -0.303, p< 0.001) in both the short (less than 6 weeks) and long term (52 weeks or more). A greater improvement was also established in iTNSS (-0.360, -0.484 to -0.236, p< 0.001), rTOSS (-0.163, -0.293 to -0.033, p= 0.014), iTOSS (-0.165, -0.295 to -0.035, p= 0.013) and QoL (-0.322, -0.452 to -0.191, p< 0.001) in the short term. All effect sizes were greater than -0.5, indicating small changes according to Cohen's guidelines. The incidence of most adverse events with FFNS was similar to that with placebo, with the exception of epistaxis, which was more frequent with FFNS in both the short (FFNS 7%, placebo 4%, p= 0.004) and long term (FFNS 25%, placebo 13%, p< 0.001). ConClusions: FFNS in adults and adolescents with PAR resulted in statistically significant but not clinically relevant improvements in symptoms and QoL compared with placebo.

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IntroductionDecision making in publicly funded healthcare systems must rely on patient-relevant outcomes that directly measure clinical benefit, such as overall survival and quality of life (QoL). However, studies that support market authorization of oncology drugs usually assess surrogate outcomes, without having previously demonstrated that these intermediate outcomes reliably predict clinical outcomes. As part of an HTA process, we evaluated the clinical benefit of osimertinib, compared with platinum-pemetrexed combination chemotherapy, in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive advanced non-small cell lung cancer (NSCLC) that has progressed after first-line EGFR tyrosine kinase inhibitor (TKI) therapy.MethodsWe conducted a systematic search of the PubMed database for randomized controlled trials (RCT) published from inception to January 2019. The clinical outcomes of interest were overall survival and QoL. Where trials reported surrogate outcomes, we conducted additional PubMed searches for evidence of validity for predicting clinical outcomes and used guidance on surrogate outcome validation in oncology from the Institute for Quality and Efficiency in Health Care.ResultsEvidence on osimertinib, compared with chemotherapy, for patients with T790M-positive advanced NSCLC that has progressed after EGFR-TKI therapy was obtained from the AURA3 trial. In this study, overall survival data were immature and the results for QoL and symptom domains were not clinically meaningful. In addition, median progression-free survival (PFS) was six months longer for osimertinib than for chemotherapy. However, to date, no study has demonstrated that PFS reliably predicts longer survival or better QoL.ConclusionsOur HTA suggested that, unless proven, PFS should not be used as a valid surrogate outcome for decision making in public health. For example, the results of the AURA3 trial showed that osimertinib has an effect on the surrogate outcome of PFS in patients with EGFR T790M-positive advanced NSCLC that has progressed after first-line EGFR-TKI therapy, but not on the clinically relevant outcomes of overall survival and QoL. Furthermore, currently available evidence has failed to prove that PFS reliably predicts outcomes that are clinically relevant. Despite this, osimertinib has been given marketing authorization and is widely recommended in clinical guidelines.

IntroductionIn the absence of direct evidence from randomized controlled trials (RCTs), real-world evidence (RWE) can play an important role in healthcare decision making. As part of a health technology assessment, we assessed the comparative risk of tuberculosis (TB) associated with using infliximab and etanercept in patients with rheumatoid arthritis.MethodsWe performed a systematic literature search using the PubMed database to identify relevant meta-analyses.ResultsWe located two relevant meta-analyses: one based on RCTs and one based on observational studies. Evidence from seven RCTs on infliximab (2,686 patients; 12 TB events) and two RCTs on etanercept (663 patients; 2 TB events) suggested no significant differences in the risk of TB between the two treatments, compared with placebo. In contrast, evidence from ten observational studies that directly compared the two treatments (443,941 patients; 253 TB events) indicated a significantly higher risk of TB with infliximab than with etanercept.ConclusionsAlthough RWE is prone to confounding and bias, in this case it had the advantage of providing direct comparisons with larger sample sizes and longer follow up than evidence from RCTs. As a result, RWE was used to inform decision making on the risk of TB with infliximab and etanercept in patients with rheumatoid arthritis.

Objetivo: Analizar la prevalencia y componentes del Síndrome Metabólico (SM) premórbido en trabajadores asegurados al seguro social de salud en una zona de altitud moderada (Chachapoyas, Perú). Materiales y métodos: Se realizó un estudio transversal con datos de diverso tipo de trabajadores pertenecientes a un programa de EsSalud enfocado a diagnosticar SM premórbido, obesidad y sobrepeso en trabajadores en sus centros laborales durante el periodo octubre 2017 a agosto 2018. Se trabajó con datos previamente registrados por el programa mencionado. El SM se diagnosticó según los criterios de la guía “Harmonizing the Metabolic Syndrome”. Resultados: Se incluyeron un total de 1021 sujetos. La prevalencia global de SM premórbido fue de 32,8 % (312/952). En hombres, la prevalencia fue de 35,4 % (160/452) y en mujeres de 30,4 % (152/500), no existiendo diferencias estadísticamente significativas entre ambos sexos (p=0,101). La frecuencia de los componentes del SM en la población total del estudio fue: Obesidad central 73,4 %, hipertrigliceridemia 45,6 %, HDL-C bajo 66,3 %, hiperglicemia 10,0 % y presión arterial elevada 6,5 %. Los participantes con SM premórbido fueron significativamente mayores en edad que aquellos sin SM premórbido (44 versus 36 años, p<0,001). Conclusiones: Existe una alta prevalencia de SM premórbido en trabajadores residentes en Chachapoyas, contrariamente a lo sugerido por la evidencia previa.

Objective To assess the clinical effectiveness of fluticasone furoate nasal spray (FFNS) versus placebo on nasal symptoms and safety in children with perennial allergic rhinitis (AR). Methods A comprehensive review was conducted with data obtained from Medline and Embase databases up to April 2023. The population of interest was patients aged 2–12 years with perennial AR. The selection was limited to randomized controlled trials (RCTs), comparing FFNS with placebo. Outcomes of interest included the reflective total nasal symptoms scores (rTNSS) and safety. To assess the minimal clinically important difference for rTNSS, the Cohen’s guideline was used. If the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceeded the threshold of −0.20, effects were considered clinically significant. Results Three RCTs (959 pediatric patients) were selected. One study evaluated the short-term use of FFNS, another evaluated the long-term use of FFNS, and another evaluated both the short-term and long-term use of FFNS. FFNS produced a statistically significant reduction over placebo in rTNSS (SMD −0.18; 95 percent CI −0.35 to −0.01, p = 0.03) in long-term treatment studies, but not in short-term treatment studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD −0.20), these results were considered clinically not relevant. Safety outcomes with FFNS were similar to placebo. Conclusions The currently available evidence suggests that FFNS, 110 μg once daily, compared to placebo, does not produce a meaningful clinical effect on nasal symptom in children with perennial AR.