Análise do perfil epidemiológico dos exames citopatológico do colo do útero em Altamira no período de 2014 a 2020: dados a partir do SISCAN / Analysis of the epidemiological profile of cervical cytopathological exams in Altamira in the period from 2014 to 2020: data from SISCAN / Análisis del perfil epidemiológico de los exámenes citopatológicos de cérvix en Altamira en el periodo de 2014 a 2020: datos del SISCAN

OBJETIVO: Este trabalho aborda sobre características referente aos exames citopatológicos do colo do útero em Altamira, coletado no Sistema de Informação do Câncer, dentro do período de 2014 a 2020. Observou-se também a qualidade da interpretação dos principais resultados encontrados, sobre a técnica de coleta e qualidade de exames. O objetivo é analisar o perfil epidemiológico dos exames citopatológicos do colo do útero do município. MÉTODO: A metodologia realizada foi estudo quantitativo, de corte transversal, epidemiológico, descritiva e analítico. RESULTADOS: Verificou- se um crescimento anual na taxa de cobertura do exame do preventivo no período de 2014 a 2019, que está ligado à implementação do Plano de Desenvolvimento Regional Sustentável do Xingu, e que esse crescimento mostra uma diferença estatística significativa entre a taxa de cobertura de Altamira, Pará, Brasil. Observou-se presença de falhas no preenchimento da ficha de notificação é referente ao campo da escolaridade das pacientes que não apresentam registro. Quanto a faixa etária mais frequente que realizam o exame do preventivo está entre 25 a 34 anos e as lesões intraepiteliais do colo uterino mais frequentes são: a de baixo grau que corresponde à população jovem (<34 anos) e de alto grau entre 25 a 44 anos.

OBJECTIVE: This paper deals with characteristics related to cytopathological examinations of the cervix in Altamira, collected in the Cancer Information System, within the period from 2014 to 2020. It was also observed the quality of interpretation of the main results found, on the technique collection and quality of exams. The objective is to analyze the epidemiological profile of cytopathological tests of the cervix in the city. METHOD: The methodology used was a quantitative, cross- sectional, epidemiological study, descriptive and analytical approach. RESULTS: As a result, there was an annual growth in the coverage rate of the preventive exam in the period from 2014 to 2019, which is linked to the implementation of the Xingu Sustainable Regional Development Plan, and that this growth shows a significant statistical difference between the coverage rate of Altamira, Pará, Brazil. It was observed the presence of failures in completing the notification form referring to the field of education of patients who do not have a record. As for the most frequent age group that undergoes the preventive examination, it is between 25 and 34 years old and the most frequent intraepithelial lesions of the uterine cervix are: low-grade, which corresponds to the young population (<34 years) and high-grade, between 25 and 34 years old. 44 years.

OBJETIVO: En este trabajo se abordan las características relacionadas con los exámenes citopatológicos de cérvix en Altamira, recogidos en el Sistema de Información del Cáncer, en el periodo comprendido entre 2014 y 2020. También se observó la calidad de interpretación de los principales resultados encontrados, sobre la técnica de recolección y calidad de los exámenes. El objetivo es analizar el perfil epidemiológico de los exámenes citopatológicos de cuello uterino en la ciudad. MÉTODO: La metodología utilizada fue un estudio cuantitativo, transversal, epidemiológico, de abordaje descriptivo y analítico. RESULTADOS: Como resultado, se observó un crecimiento anual de la tasa de cobertura del examen preventivo en el período de 2014 a 2019, que está vinculado a la implementación del Plan de Desarrollo Regional Sostenible Xingu, y que este crecimiento muestra una diferencia estadística significativa entre la tasa de cobertura de Altamira, Pará, Brasil. Se observó la presencia de fallas en el llenado del formulario de notificación referente al campo de la educación de los pacientes que no tienen un registro. En cuanto al grupo de edad más frecuente que se somete al examen preventivo, es entre 25 y 34 años y las lesiones intraepiteliales del cuello uterino más frecuentes son: de bajo grado, que corresponde a la población joven (<34 años) y de alto grado, entre 25 y 44 años.

Panorama clínico, epidemiológico e espacial da ocorrência de Leishmaniose visceral no estado do Pará, Amazônia brasileira / Clinical, epidemiological and spatial overview of visceral Leishmaniasis in the state of Pará, brazilian amazonia / Panorama clínico, epidemiológico y espacial de la Leishmaniasis visceral en el estado de Pará, amazonia brasileña

Objetivo: Essa pesquisa teve como objetivo determinar o perfil clínico, epidemiológico e espacial daLeishmaniose Visceral, bem como, sua associação com o desmatamento nos municípios pertencentesao 12º centro regional de saúde no Sudeste do Estado do Pará, Brasil de 2016 a 2020. Método: Trata-se de um estudo analítico ecológico, realizado com dados provenientes de 15 municípios do 12º Centro Regional de Saúde, obtidos por meio do banco de dados do Data-SUS-TABNET, através do SINAN. Resultados: Para o período do estudo foram notificados 415 casos de LV nos municípios analisados, o que correspondeu a uma média anual de 83 casos. O ano com maior número de notifi- cações foi 2017, apresentando 34,7%, sendo o município de Redenção com o maior número de casos.Conclusões: Portanto, há necessidade de ampliação das medidas de controle e vigilância da LV, comfoco na notificação de casos, a fim de realizar a obtenção do panorama fidedigno da LV e elaborar estratégias mais assertivas para seu controle e mitigação.

Objective: This research aimed to determine the clinical, epidemiological and spatial profile of Vis- ceral Leishmaniasis, as well as its association with deforestation in the municipalities belonging to the 12th regional health center in the Southeast of Pará State, Brazil from 2016 to 2020. Method: Thisis an ecological analytical study, conducted with data from 15 municipalities of the 12th Regional Health Center, obtained through the Data-SUS-TABNET database, through SINAN. Results: For thestudy period, 415 cases of VL were reported in the analyzed municipalities, corresponding to an an-nual average of 83 cases. The year with the highest number of notifications was 2017, present- ing 34.7%, being the municipality of Redenção with the highest number of cases. Conclu- sion: Therefore,there is a need to expand VL control and surveillance measures, focusing on the notification of casesin order to obtain a reliable picture of VL and develop more assertive strategies for its control and mitigation.

Objetivo: Esta investigación tuvo como objetivo determinar el perfil clínico, epidemiológico y espacial de la Leishmaniasis Visceral, así como su asociación con la deforestación en municipios pertenecientes al 12º Centro Regional de Salud del Sudeste del Estado de Pará, Brasil, de 2016 a 2020. Método: Trata-se de um estudo analítico ecológico, realizado com dados provenientes de 15 municípios do 12º Centro Regional de Saúde, obtidos por meio do banco de dados do Data-SUS-TABNET, através do SINAN. Resultados: Durante el período de estudio, fueron notificados 415 casos de LV en los municipios analizados, correspondiendo a una media anual de 83 casos. El año con mayor número de notificaciones fue 2017, 34,7%, y el municipio de Redenção presentó el mayor número de casos. Conclusiones: Por lo tanto, es necesario ampliar las medidas de control y vigilancia de la LV, centrándose en la notificación de casos con el fin de obtener una imagen fiable de la LV y desarrollar estrategias más asertivas para su control y mitigación.

How Large a Study Is Needed to Detect TKA Revision Rate Reductions Attributable to Robotic or Navigated Technologies? A Simulation-based Power Analysis.

BACKGROUND: Robotic and navigated TKA procedures have been introduced to improve component placement precision in the hope of improving implant survivorship and other clinical outcomes. Although numerous comparative studies have shown enhanced precision and accuracy in placing components, most comparative studies have not shown that such interventions result in improved implant survival. Given what we know about effect sizes from large arthroplasty registries, large cohort studies, and large randomized controlled trials (RCTs), we wondered how large randomized trials would need to be to detect such small differences, and if the number is very high, what that would tell us about the value of these treatments for preventing revision surgery. QUESTIONS/PURPOSES: In this simulation study, we asked: Given that survivorship differences between technology-assisted TKA (TA-TKA, which we defined as either navigated or robot-assisted TKA) and conventional TKA are either small or absent based on large arthroplasty registries, large cohort studies, and large RCTs, how large would randomized trials need to be to detect small differences between TA-TKA and conventional TKA if they exist, and how long would the follow-up period need to be to have a reasonable chance to detect those differences? METHODS: We used estimated effect sizes drawn from previous clinical and registry studies, combined with estimates of the accuracy and precision of various navigation and robotic systems, to model and simulate the likely outcomes of potential comparative clinical study designs. To characterize the ranges of patients enrolled and general follow-up times associated with traditional RCT studies, we conducted a structured search of previously published studies evaluating the effect of robotics and navigation on revision rates compared with that of conventional TKA. The structured search of the University of British Columbia's library database (which automatically searches medical publication databases such as PubMed, Embase, Medline, and Web of Science) and subsequent searching through included studies' reference lists yielded 103 search results. Only clinical studies assessing implant survival differences between patient cohorts of TA-TKA and conventional TKA were included. Studies analyzing registry data, using cadaver specimens, assessing revision TKA, conference proceedings, and preprint services were excluded. Twenty studies met all our inclusion criteria, but only one study reported a statistically significant difference between the conventional and robotic or navigated groups. Next, we generated a large set of patients with simulated TKA (1.5 million), randomly assigning each simulated patient a set of patient-specific factors (age at the index surgery, gender, and BMI) drawn from data from registries and published information. We divided this set of simulated procedures into four groups, each associated with a coronal alignment precision reported for different types of surgical procedures, and randomly assigned each patient an overall coronal alignment consistent with their group's precision. TA procedures were modeled based on the alignment precision that an intervention could deliver, regardless of whether the technology used was navigation- or robot-assisted. To evaluate the power associated with using different cohort sizes, we ran a Monte Carlo simulation generating 3000 simulated populations that were drawn (with replacement) from the large set of simulated patients with TKA. We simulated the time to revision for aseptic loosening for each patient, computed the corresponding Kaplan-Meier survival curves, and applied a log-rank test to each study for statistical differences in revision rates at concurrent follow-up timepoints (1-25 years). From each simulation associated with a given cohort size, we determined the percentage of simulated studies that found a statistically significant difference at each follow-up interval. For each alternative precision, we then also calculated the expected reduction in revision rates (effect size) attributable to TA-TKA intervention and the number needed to treat (NNT) using TA-TKA to prevent one revision at 2, 5, 10, and 15 years after index surgery for the entire set of Kaplan-Meier survival analyses. RESULTS: The results from our simulation found survivorship differences favoring TA-TKA ranging from 1.4% to 2.0% at 15 years of follow-up. Comparative studies would need to enroll between 2500 and 4000 patients in each arm of the study, depending on the precision of the navigated or robotic procedure, to have an 80% chance of showing this reduction in revision rates at 15 years of follow-up. For the highest precision simulated intervention, the NNT using TA-TKA to prevent one revision was 1000 at 2 years, 334 at 5 years, 100 at 10 years, and 50 at 15 years post-index surgery. CONCLUSION: Based on these simulations, it appears that TA-TKA interventions could potentially result in a relative reduction in revision rates as large as 27% (from 7.5% down to about 5.5% at 15 years for the intervention with the most precise coronal alignment); however, since this 2% absolute reduction in revision rates is relatively small in comparison with the baseline success rate of TKA and would not be realized until 15 years after the index surgery, traditional RCT studies would require excessively large numbers of patients to be enrolled and excessively long follow-up times to demonstrate whether such a reduction actually exists. CLINICAL RELEVANCE: Given that the NNTs to avoid revisions at various time points are predicted to be high, it would require correspondingly low system costs to justify broad adoption of TA-TKA based on avoided revision costs alone, though we speculate that technology assistance could perhaps prove to be cost effective in the care of patients who are at an elevated risk of revision.

Mouse Intensive Care Unit (MICU).

The translation of preclinical results into successful clinical therapies remains a challenge in sepsis research. One reason for this lack of translation might be the discrepancy between preclinical models and the clinical reality: nonresuscitated young healthy rodents in contrast to elderly comorbid patients in an intensive care unit. We introduce the mouse intensive care unit (MICU) as a concept to address the lack of resuscitation in preclinical studies as one of the limiting issues in translational research. The MICU reflects standard procedures of the clinical intensive care unit: fluid resuscitation, lung-protective mechanical ventilation, and hemodynamic monitoring and management, all tailored to organ- and function-specific targets. Thus, the MICU gives an experimental animal the intermediate possibility of recovery and survival due to "patient" management, which is not reflected in less complex experimental scenarios, which either result in acute survival or death.

GRADE Guidelines: 29. Rating the certainty in time-to-event outcomes-Study limitations due to censoring of participants with missing data in intervention studies.

OBJECTIVES: To provide Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidance for the consideration of study limitations (risk of bias) due to missing participant outcome data for time-to-event outcomes in intervention studies. STUDY DESIGN AND SETTING: We developed this guidance through an iterative process that included membership consultation, feedback, presentation, and iterative discussion at meetings of the GRADE working group. RESULTS: The GRADE working group has published guidance on how to account for missing participant outcome data in binary and continuous outcomes. When analyzing time-to-event outcomes (e.g., overall survival and time-to-treatment failure) data of participants for whom the outcome of interest (e.g., death and relapse) has not been observed are dealt with through censoring. To do so, standard methods require that censored individuals are representative for those remaining in the study. Two types of censoring can be distinguished, end of study censoring and censoring because of missing data, commonly named loss to follow-up censoring. However, both types are not distinguishable with the usual information on censoring available to review authors. Dealing with individuals for whom data are missing during follow-up in the same way as individuals for whom full follow-up is available at the end of the study increases the risk of bias. Considerable differences in the treatment arms in the distribution of censoring over time (early versus late censoring), the overall degree of missing follow-up data, and the reasons why individuals were lost to follow-up may reduce the certainty in the study results. With often only very limited data available, review and guideline authors are required to make transparent and well-considered judgments when judging risk of bias of individual studies and then come to an overall grading decision for the entire body of evidence. CONCLUSION: Concern for risk of bias resulting from censoring of participants for whom follow-up data are missing in the underlying studies of a body of evidence can be expressed in the study limitations (risk of bias) domain of the GRADE approach.

Five Features to Look for in Early-Phase Clinical Intervention Studies.

Neurorehabilitation relies on core principles of neuroplasticity to activate and engage latent neural connections, promote detour circuits, and reverse impairments. Clinical interventions incorporating these principles have been shown to promote recovery and demote compensation. However, many clinicians struggle to find interventions centered on these principles in our nascent, rapidly growing body of literature. Not to mention the immense pressure from regulatory bodies and organizational balance sheets that further discourage time-intensive recovery-promoting interventions, incentivizing clinicians to prioritize practical constraints over sound clinical decision making. Modern neurorehabilitation practices that result from these pressures favor strategies that encourage compensation over those that promote recovery. To narrow the gap between the busy clinician and the cutting-edge motor recovery literature, we distilled 5 features found in early-phase clinical intervention studies-ones that value the more enduring biological recovery processes over the more immediate compensatory remedies. Filtering emerging literature through this lens and routinely integrating promising research into daily practice can break down practical barriers for effective clinical translation and ultimately promote durable long-term outcomes. This perspective is meant to serve a new generation of mechanistically minded and caring clinicians, students, activists, and research trainees, who are poised to not only advance rehabilitation science, but also erect evidence-based policy changes to accelerate recovery-based stroke care.

Choosing the most appropriate PROM for clinical studies in sports medicine.

Choosing the most appropriate patient-reported outcome measure (PROM) for a clinical study is essential in order to achieve trustworthy results. This choice will depend on (a) the objective of the study and hence the research question; (b) the choice of a theoretical framework, such as the World Health Organization's International Classification of Functioning, Disability, and Health (ICF); (c) whether there currently is a PROM that possesses high content validity and high construct validity for the specific patient group and objective, and if not; (d) the decision on whether to use a suboptimal PROM or develop and validate a new PROM. This paper presents the steps that should be followed in order to assess the relevance of PROMs and suggests ways to enhance the choice depending on the goal of the study.

Recruitment of US Adolescents and Young Adults (AYA) into Human Immunodeficiency Virus (HIV)-Related Behavioral Research Studies: A Scoping Review.

PURPOSE OF REVIEW: The objective of this scoping review was to examine the range of published evidence on recruitment approaches and outcomes of US adolescents and young adults (AYA) ages (18-29 years) into human immunodeficiency virus (HIV)-related behavioral research studies during the past 10 years. RECENT FINDINGS: Implementation of effective behavioral research strategies among HIV at-risk and infected AYA is key to ending the HIV epidemic and necessitates successful recruitment strategies. A comprehensive search was executed across four electronic databases. Of the 1697 identified studies, seven met inclusion criteria with six of these seven directed to HIV prevention. Most studies used online recruitment as part of a hybrid strategy, and combined field-based/in-person and online methods. Recruitment strategies and outcomes, resources and compensation, procedures for consent, and timelines varied among all seven studies. Our results highlight the need for development of recruitment models in alignment with behavioral strategies aimed to treat and prevent HIV among US AYA.

La ruleta rusa de los análisis estadísticos de estudios clínicos. Una reflexión para lectores y autores / The Russian Roulette of Statistical Analysis in Clinical Trials. Some Considerations for Readers and Authors

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Introduction to clinical research based on modern epidemiology.

Over the past 20 years, recent advances in science technologies have dramatically changed the styles of clinical research. Currently, it has become more popular to use recent modern epidemiological techniques, such as propensity score, instrumental variable, competing risks, marginal structural modeling, mixed effects modeling, bootstrapping, and missing data analyses, than before. These advanced techniques, also known as modern epidemiology, may be strong tools for performing good clinical research, especially in large-scale observational studies, along with relevant research questions, good databases, and the passion of researchers. However, to use these methods effectively, we need to understand the basic assumptions behind them. Here, I will briefly introduce the concepts of these techniques and their implementation. In addition, I would like to emphasize that various types of clinical studies, not only large database studies but also small studies on rare and intractable diseases, are equally important because clinicians always do their best to take care of many kinds of patients who suffer from various kidney diseases and this is our most important mission.

Contextualizing Evidence for Action on Diabetes in Low-Resource Settings-Project CEAD Part I: A Mixed-Methods Study Protocol.

Challenges remain for policy adoption and implementation to tackle the unprecedented and relentless increase in obesity, diabetes and other non-communicable diseases (NCDs), especially in low- and middle-income countries. The aim of this mixed-methods study is to analyse the contextual relevance and applicability to low-resource settings of a sample of evidence-based healthy public policies, using local knowledge, perceptions and pertinent epidemiological data. Firstly, we will identify and prioritise policies that have the potential to reduce the burden of diabetes in low-resource settings with a scoping review and modified Delphi method. In parallel, we will undertake two cross-sectional population surveys on diabetes risk and morbidity in two low-resource settings in Ecuador. Patients, community members, health workers and policy makers will analyse the contextual relevance and applicability of the policy actions and discuss their potential for the reduction in inequities in diabetes risk and morbidity in their population. This study tackles one of the greatest challenges in global health today: how to drive the implementation of population-wide preventative measures to fight NCDs in low resource settings. The findings will demonstrate how local knowledge, perceptions and pertinent epidemiological data can be used to analyse the contextual relevance and applicability of potential policy actions.

Antiinflammatory and anti-cancer activities of pomegranate and its constituent, ellagic acid: Evidence from cellular, animal, and clinical studies.

Inflammation is commonly characterized as a defensive and protective reaction of the body to various exogenous or endogenous stimuli, which aims to maintain the body health. Punica granatum (pomegranate) and its constituent ellagic acid (EA) are recently more taken into accounts since their promising pharmacological effects. Therefore, we aimed to obtain a comprehensive review regarding antiinflammatory, anticancer, and antioxidant activities of both pomegranate and EA and their possible involved mechanisms. In the procedure, scientific databases, including Web of Science, PubMed, Scopus, and Google Scholar, were searched in the English language, until the end of January 2019. Pomegranate belonging to the Punicaceae has been used for medical purposes from ancient and in different cultures. Several studies have also supported that EA is the major active compound of pomegranate and possesses antimutagenic, antiinflammatory, antifibrosis, anticancer, and antiaging properties. It has been suggested that pomegranate and EA possess promising immunomodulatory effects in preclinical models as well as human studies through regulation of the T-cell function and suppressing humoral immunity. Hopefully, we wish that this review and information could be helpful for designing further experiments to investigate the potential protective effects of pomegranate and EA.

Out damn bot, out: Recruiting real people into substance use studies on the internet.

While the Internet has become a popular and effective strategy for recruiting substance users into research, there is a large risk of recruiting duplicate individuals and Internet bots that pose as humans. Strategies to mitigate these issues are outlined and categorized into two groups: (1) automatic techniques which are often embedded into surveys and (2) ongoing manual techniques implemented during recruitment. Potential limitations of these strategies are discussed, and an example of the prevalence of duplicate data within a substance using sample is provided. Overall, it is recommended that researchers consider the use of routine strategies to mitigate the risks associated with recruiting online samples such as: verifying participant contact information, IP address checks, and ongoing cross-checking of participant information for duplicates, similarities and inconsistencies.

Deferred consent for delivery room studies: the providers' perspective.

OBJECTIVE: To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios. METHODS: We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0. RESULTS: Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent. CONCLUSION: Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.

Periodontal Tissue Condition on Systemic Lupus Erythematosus Patients: A Clinical Study

Abstract Objective: To evaluate periodontal tissue condition on systemic lupus erythematosus (SLE) patients and its characteristics. Material and Methods: This descriptive and cross-sectional study involved 61 SLE patients. Clinical examination of the oral cavity was performed using periodontal index (PI), gingival index (GI), clinical attachment loss (CAL) and number of loose teeth. Also, we evaluated SLE duration, treatment duration, ethnics, marital status, educational background, family income, and occupation. Results: In the evaluation of periodontal tissue, 93.4% had bleeding on probing, 80.3% clinical attachment loss, and 16.3% loose teeth. A total of 54 patients (88.5%) with SLE had periodontitis. Seven subjects had no periodontitis, 11 mild periodontitis, 29 moderate periodontitis and 14 severe periodontitis. Mean Periodontal Index score, Gingival Index, Clinical Attachment Loss (mm), and the number of mobility teeth, Plaque Index and Calculus Index respectively were 2.66 ± 1.20, 1.95 ± 1.02, 0.75 ± 0.59 mm, 1,49 ± 1.77. There was a significant difference in periodontal index score, shown periodontitis between employment and unemployment subjects (p=0.004) and a moderate correlation between periodontitis and occupation. Conclusion: Periodontitis found as manifestations SLE patients, followed by bleeding on probing and loose teeth. Its characteristics is playing a role in periodontitis in SLE patients.

Propensity score methods and regression adjustment for analysis of nonrandomized studies with health-related quality of life outcomes.

PURPOSE: The aim of this study was to investigate the potential added value of combining propensity score (PS) methods with multivariable linear regression (MLR) in estimating the average treatment effect on the treated (ATT) in nonrandomized studies with health-related quality of life (HRQoL) outcomes. METHODS: We first used simulations to compare the performances of different PS-based methods, either alone or in combination with further MLR adjustment, in estimating ATT. PS methods were, respectively, optimal pair (OPM) and full (OFM) PS matching, subclassification on the PS (SBC), and the inverse probability of treatment weighting (IPTW). We simulated several scenarios, according to different sample sizes, proportions of treated vs untreated subjects, and types of HRQoL outcomes. We also applied the same methods to a real clinical data set. RESULTS: OPM and IPTW provided the closest Type I error to the nominal threshold α = 0.05 across all scenarios. Overall, both methods showed also lower variability in estimates than SBC and OFM. SBC performed worst, generally providing the highest levels of bias. Further MLR adjustment lessened bias for all methods, however providing higher Type I error for SBC and OFM. In the real case, all methods provided similar ATT estimates except for one outcome. CONCLUSIONS: Our findings suggest that for sample sizes up to n = 200, OPM and IPTW are to be preferred to OFM and SBC in estimating ATT on HRQoL outcomes. Specifically, OPM performed best in sample sizes of n ≥ 80, IPTW for smaller sample sizes. Additional MLR adjustment can further improve ATT estimates.

Breath analysis by two-dimensional gas chromatography with dual flame ionisation and mass spectrometric detection - Method optimisation and integration within a large-scale clinical study.

Precision medicine has spurred new innovations in molecular pathology leading to recent advances in the analysis of exhaled breath as a non-invasive diagnostic tool. Volatile organic compounds (VOCs) detected in exhaled breath have the potential to reveal a wealth of chemical and metabolomic information. This study describes the development of a method for the analysis of breath, based on automated thermal desorption (TD) combined with flow modulated comprehensive two-dimensional gas chromatography (GC×GC) with dual flame ionisation and quadrupole mass spectrometric detection (FID and qMS). The constrained optimisation and analytical protocol was designed to meet the practical demands of a large-scale multi-site clinical study, while maintaining analytical rigour to produce high fidelity data. The results demonstrate a comprehensive method optimisation for the collection and analysis of breath VOCs by GC×GC, integral to the standardisation and integration of breath analysis within large clinical studies.

[How to perform a real world clinical study of surgery].

With the development of the methodology of clinical trials and the appearance of medical big data, the real-world study (RWS) presents its unique advantages, plays a role in clinical practice and research, and its importance is more and more recognized by scholars in recent years. In surgical research field, due to the specificity of surgical diseases and operational procedures, confounding factors and risk of bias are greatly higher than those of traditional medications. Therefore, using unique advantages of the RWS to solve the actual clinical problem in surgical field is the main goal of performing surgical RWS. This article will systematically elucidate how to perform the surgical RWS and the special matters of concern in carrying out surgical RWS.

[On the use of mathematical statistics methods in clinical and experimental studies.]

In the paper a number of issues, including conceptual ones, related to the specific features of making statistical decisions, choosing tests and computing characteristics that will strengthen the evidence base of the conclusions obtained when analyzing data using methods of mathematical statistics, are considered. The paper aims not to describe the methods of mathematical statistics themselves, but to analyze the conditions and the need to apply the most common tests. In particular, the magnitude of the indicator of the statistical significance of the observed effects - p-value - and the sample size to obtain a significant effect are discussed, the effect of multiple comparisons, the application of the Bayesian approach, and others are considered.

Bridging the gap between the laboratory and the clinic for patients with sarcopenia.

Sarcopenia-the age-related loss of skeletal muscle mass and strength-is a major public health issue. Sarcopenia is associated with an increased risk of falls, disability, dependency, institutionalization, hospital stay and early death. Finding interventions to stabilize, reverse or prevent sarcopenia is therefore a key goal for clinical ageing research. If patients are to eventually benefit from discovery science on ageing skeletal muscle, we need to build a translational pipeline that facilitates progress from laboratory science and epidemiology, through feasibility testing to early-phase, and eventually late-phase clinical trials. A number of barriers need to be overcome to make this pipeline work-in particular challenges around identifying people with sarcopenia in routine clinical practice, ensuring that we study patients with clearly defined sarcopenia rather than related conditions such as functional impairment, developing capacity to run trials for older people, and selecting trial outcomes of relevance to older people with multimorbidity. A further key point is that interventions should ideally have pleiotropic actions-i.e. beneficial actions across multiple organ systems, rather than treating sarcopenia alone. Such pleiotropic interventions may be the only way to avoid the perils of polypharmacy and drug interactions that bedevil care for many older people. Maximising the potential for scientific discoveries in the biology of ageing muscle to improve health requires that discovery scientists, translational clinical scientists and clinicians come together to exchange findings and shape each others ideas within a shared culture.