Methodological quality of studies evaluating the burden of drug-resistant infections in humans due to the WHO Global Antimicrobial Resistance Surveillance System target bacteria

BackgroundThe health impact of antimicrobial resistance (AMR) has not been included in the Global Burden of Disease (GBD) report, as reliable data have been lacking. AMR burden estimates have been derived from models combining incidence and/or prevalence data from national and/or international surveillance systems and mortality estimates from clinical studies. Depending on utilized empirical data, statistical methodology and applied endpoints, the validity and reliability of results can differ substantially.ObjectivesWe assessed comprehensiveness, and internal and external validity of studies estimating the clinical impact of infections caused by the priority antibiotic resistant pathogens monitored by the WHO Global Antimicrobial Resistance Surveillance System.Data sourcesOvid MEDLINE, January 1950 to March 2019, In-Process and other non-indexed citations were searched.Study eligibility criteriaStudies reporting mortality, length of hospital stay, duration of the disease until remission and/or death, complications, hospital re-admissions, and follow-up beyond hospital discharge were eligible.MethodsThe literature was searched according to the Cochrane recommendations and reported according to Preferred Reporting Items for Systematic Reviews.ResultsTwo-hundred and eighty-six studies out of 3529 were eligible. Studies derived mainly from high-income countries (215, 75%) and relied on data from retrospective (226, 79%), single-centre (201, 70%), cohort studies (243, 85%). The health impact was mostly limited to all-cause mortality (128, 45%) with heterogeneity in timing of assessment; attributable length of hospital stay was seldom adjusted for pre-infection admission time and a few studies had enough follow-up for assessing long-term sequelae. Overall, adjustment for confounding has shown a substantial improvement. Data on health state definitions and duration of diseases are generally lacking, precluding calculation of disability-adjusted life years, critical for application of the GBD study methodology.ConclusionEfforts to improve harmonization, representativeness, quality of AMR surveillance data and cohort studies to determine AMR attributable mortality and morbidity are urgently required. Policy makers need accurate and detailed burden estimates to inform prioritization of resource allocation, and to select the most effective intervention strategies to halt the AMR crisis.     

Análisis de supervivencia en investigación cardiovascular (II): metodología estadística en situaciones complejas

This article is the second of a series of 2 educational articles. In the first article, we described the basic concepts of survival analysis, summarizing the common statistical methods and providing a set of recommendations to guide the strategy of survival analyses in randomized clinical trials and observational studies. Here, we introduce stratified Cox models and frailty models, as well as the immortal time bias arising from a poor assessment of time-dependent variables. To address the issue of multiplicity of outcomes, we provide several modelling strategies to deal with other types of time-to-event data analyses, such as competing risks, multistate models, and recurrent-event methods. This review is illustrated with examples from previous cardiovascular research publications, and each statistical method is discussed alongside its main strengths and limitations. Finally, we provide some general observations about alternative statistical methods with less restrictive assumptions, such as the win ratio method, the restrictive mean survival time, and accelerated failure time model.     

Non-alcoholic fatty liver disease and Atherosclerosis at a crossroad:The overlap of a theory of change and bioinformatics

Atherosclerosis(ATH) and non-alcoholic fatty liver disease(NAFLD) are medical conditions that straddle a communal epidemiology, underlying mechanism and a clinical syndrome that has protean manifestations, touching every organ in the body. These twin partners, ATH and NAFLD, are seemingly straightforward and relatively simple topics when considered alone, but their interdependence calls for more thought. The study of the mutual relationship of NAFLD and ATH should involve big data analytics approaches, given that they encompass a constellation of diseases and are related to several recognized risk factors and health determinants and calls to an explicit theory of change, to justify intervention. Research studies on the "association between aortic stiffness and liver steatosis in morbidly obese patients", published recently, sparsely hypothesize new mechanisms of disease, claiming the "long shadow of NAFLD"as a risk factor, if not as a causative factor of arterial stiffness and ATH. This statement is probably overreaching the argument and harmful for the scientific credence of this area of medicine. Despite the verification that NAFLD and cardiovascular disease are strongly interrelated, current evidence is that NAFLD may be a useful indicator for flagging early arteriosclerosis, and not a likely causative factor. Greater sustainable contribution by precision medicine tools, by validated bioinformatics approaches, is needed for substantiating conjectures,assumptions and inferences related to the management of big data and addressed to intervention for behavioral changes within an explicit theory of change.     

Upper Limb Pain in Anational Sample of Veterans With Paraplegia

Abstract

Background and Objectives: The purpose of this survey study was to examine the prevalence and intensity of pain and associated patient characteristics in a national sample of veterans with paraplegia. Of particular interest were upper limb (UL) pain conditions, which pose unique challenges to individuals who use a wheelchair for mobility. Because the risk for UL pain conditions appears to increase over time, the associations among age, duration of wheelchair use, and UL pain were evaluated.

Methods: A group of 1 ,6 7 5 individuals between the ages of 1 8 and 65 with a lesion between T2 and L2 and a mailing address on file were selected randomly from the Veteran's Affairs Spinal Cord Dysfunction Registry and mailed a survey packet. Of the deliverable packets, -46% were completed and returned.

Results: Approximately 81% of the respondents reported at least a minimal Ievei of ongoing unspecified pain and 69'7'o experienced current UL pain. Shoulder pain intensity was most severe du ring the performance of wheelchair-related mobility and transportation activities, suggesting that UL pain may have a significant impact on functional independence. Duration of wheelchair use modestly predicted shoulder pain prevalence and intensity, but age and the interaction between age and duration of wheelchair use did not.

Condusion: The data of the present study suggest that the development, persistence, and exacerbation of UL pain conditions in persans with paraplegia aremultidimensional processes. A comprehensive theoretic model is needed to integrate the existing empiric Iiterature in this area.     

Rehabilitation of very severe unilateral neglect by visuo-spatio-motor cueing: Two single case studies

Robertson, North, and Geggie (1992) have suggested that the voluntary activation of the left upper limb in the left hemispace (spatio-motor cueing) could reduce unilateral neglect. This study assesses the efficacy of visuo-spatio-motor cueing, and particularly the generalisation to daily-life activities, in two patients with very severe neglect who had failed to improve with scanning training. The patients were included in the trial 4 and 7 months after a severe unilateral right hemispheric stroke. They both suffered from disabling unilateral neglect despite intensive conventional therapy. A single-case experimental ABAB design was used (A = baseline with conventional treatment; B = visuo-spatio-motor cueing; each period = 2 weeks). A randomisation test was used to assess the presence of a specific therapeutic effect. In both cases, there was a statistically significant treatment-related improvement on a line bisection test. A parallel improvement was found on neglect behaviourin daily life, as assessed by the Catherine Bergego Scale (Azouvi et al., 1996). The therapeutic effect was maintained at 1-month follow up. These results suggest that visuo-spatio-motor cueing may be efficient in very severe neglect and may help in obtaining generalisation to daily-life activities.     

Comparison of three different methods to estimate the burden of disease of burn injuries in Western Australia in 2011-2018

BackgroundPriority setting and resource allocation in health care, surveillance and interventions is based increasingly on burden of disease. Several methods exist to calculate the non-fatal burden of disease of burns expressed in years lived with disability (YLDs). The aim of this study was to assess the burden of disease due to burns in Western Australia 2011–2018 and compare YLD outcomes between three existing methods.MethodsData from the Burns Service of Western Australia was used. Three existing methods to assess YLDs were compared: the Global Burden of Disease (GBD) method, a method dedicated to assess injury YLDs (Injury-VIBES), and a method dedicated to assess burns YLDs (INTEGRIS-burns).ResultsIncidence data from 2,866 burn patients were used. Non-fatal burden of disease estimates differed substantially between the different methods. Estimates for 2011–2018 ranged between 610 and 1,085 YLDs per 100.000 based on the Injury-VIBES method; between 209 and 324 YLDs based on the INTEGRIS-burns method; and between 89 and 120 YLDs based on the GBD method. YLDs per case were three to nine times higher when the Injury-VIBES method was applied compared to the other methods. Also trends in time differed widely through application of the different methods. There was a strong increase in YLDs over the years when the Injury-VIBES method was applied, a slight increase when the INTEGRIS-burns method was applied and a stable pattern when the GBD method was applied.ConclusionThis study showed that the choice for a specific method heavily influences the non-fatal burden of disease expressed in YLDs, both in terms of annual estimates as well as in trends over time. By addressing the methodological limitations evident in previously published calculations of the non-fatal burden of disease, the INTEGRIS-burns seems to present a method to provide the most robust estimates to date, as it is the only method adapted to the nature of burn injuries and their recovery.     

20种中成药微生物限度检查方法验证

目的：建立20种中成药微生物限度检查方法。方法：按《中国药典》（2010版）的规定,进行各品种微生物限度检查方法的验证。结果：13个品种（感冒清热颗粒、解郁安神颗粒、千柏鼻炎片、男宝胶囊、心脑康胶囊、利肺片、养血安神片、护肝片、清脑降压片、治咳枇杷露、小儿化痰止咳糖浆、复方胆通片、血栓心脉宁胶囊）无抑菌作用,回收率均大于70%,可采用常规法进行细菌数测定;5个品种（抗骨增生片、炎立消片、痹欣片、炎可宁片、痔速宁片）对金黄色葡萄球菌和枯草芽孢杆菌有不同程度的抑菌作用,可采用培养基稀释法（前3个0.5 mL/皿、后2个0.2 mL/皿）进行细菌数测定;2个品种（四季三黄片、板兰根咀嚼片）对金黄色葡萄球菌和枯草芽孢杆菌有较强的抑制作用,可采用薄膜过滤法进行细菌数测定,所有品种的霉菌、酵母菌和控制菌数均采用常规法进行测定。结论：以上验证方法作为各品种微生物限度检查方法是可行的。     

不同厂家通便灵胶囊微生物限度检查方法学验证的探讨

目的：通过对不同厂家同一品种的方法学验证,建立通便灵胶囊微生物限度检查方法。方法按《中国药典》2010版的要求。通过接种代表性的阳性菌株,用常规法及培养基稀释法对五株阳性菌进行回收率测定。结果该品种有抑菌性,采用培养基稀释法对五株阳性菌株回收率均高于70%。结论本样品微生物限度检查中,细菌检查可用培养基稀释法,霉菌酵母菌及控制菌检查可采用常规法。     

应用追踪方法学持续改进医院药物管理

成立追踪评价组,应用追踪方法学,追踪药品从进入医院到贮存、流转再到患者使用及不良反应上报的全过程,对质量缺陷进行持续改进.追踪方法学能真正体现“以患者为中心”理念,能有效促进相关系统间沟通与协作,但需联合运用其它质量管理工具方能获得最佳成效.