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Treatment of carbapenemase-producing Enterobacterales bloodstream infections in solid organ transplant recipients is challenging. The objective of this study was to develop a specific score to predict mortality in solid organ transplant recipients with carbapenemase-producing Enterobacterales bloodstream infections. A multinational, retrospective (2004-2016) cohort study (INCREMENT-SOT, ClinicalTrials.gov NCT02852902) was performed. The main outcome variable was 30-day all-cause mortality. The INCREMENT-SOT-CPE score was developed using logistic regression. The global cohort included 216 patients. The final logistic regression model included the following variables: INCREMENT-CPE mortality score >= 8 (8 points), no source control (3 points), inappropriate empirical therapy (2 points), cytomegalovirus disease (7 points), lymphopenia (4 points), and the interaction between INCREMENT-CPE score >= 8 and CMV disease (minus 7 points). This score showed an area under the receiver operating characteristic curve of 0.82 (95% confidence interval [CI] 0.76-0.88) and classified patients into 3 strata: 0-7 (low mortality), 8-11 (high mortality), and 12-17 (very-high mortality). We performed a stratified analysis of the effect of monotherapy vs combination therapy among 165 patients who received appropriate therapy. Monotherapy was associated with higher mortality only in the very-high (adjusted hazard ratio [HR] 2.82, 95% CI 1.13-7.06, P = .03) and high (HR 9.93, 95% CI 2.08-47.40, P = .004) mortality risk strata. A score-based algorithm is provided for therapy guidance.

To combine individual participant data (IPD) from major international population-based cohorts, using harmonised OA data, to assess whether subjects with knee OA have an increased association with premature mortality.

Background Un case report è la descrizione narrativa di un caso clinico per scopi clinici, scientifici o formativi. Considerata l’assenza di specifiche linee guida per il reporting, i case report mancano del rigore necessario per guidare la pratica professionale o informare il disegno di studi clinici. Obiettivo Sviluppare, disseminare e implementare linee guida per il reporting dei casi clinici. Metodi è stato utilizzato un processo di consenso in 3 step: 1) pre-meeting: revisione della letteratura e interviste per definire gli item da includere nelle linee guida per il reporting; 2) meeting di consenso: stesura della bozza delle linee guida per il reporting; 3) post-meeting: feedback, revisione della bozza, test pilota e stesura della versione finale delle linee guida per il reporting. Risultatit Il processo di consenso, che ha coinvolto 27 partecipanti, ha portato alla stesura di una checklist di 13 item per il reporting dei casi clinici. Gli item principali di questa checklist sono: titolo, parole chiave, abstract, introduzione, informazioni sul paziente, dati clinici, timeline, valutazione diagnostica, interventi terapeutici, follow-up e outcome, discussione, punto di vista del paziente e consenso informato.] Conclusioni Auspichiamo che l’implementazione delle linee guida CARE (CAse REport) da parte delle riviste biomediche migliorerà completezza e trasparenza dei case report pubblicati, permettendone una aggregazione sistematica che potrà informare il disegno di studi clinici, fornire tempestive informazioni su efficacia ed effetti avversi e migliorare l’assistenza sanitaria.

Background Heart failure (HF) is a major public health problem with rising prevalence, especially in elderly. Survival rates for advanced HF patients are worse than those for breast or prostate cancer. Two decades of biomarker research highlighted the prognostic ability of certain markers, and informed the development of new or updated prognostic models. Despite numerous published models and NICE’s recognition of the need for prognosis information, no risk stratification models have been adequately established, nor has the quality of the models and the evidence they present being systematically brought together and tested. Objectives We hypothesise that HF–related biomarkers may offer an added value to the traditional prognostic factors for HF clinical outcomes, independent of other present co-morbidities. We aim to test this hypothesis through a systematic reviews series assessing the evidence of HF prognostic models using novel meta-analysis (MA) methodology and relevant critical appraisal tools. Methods We follow Cochrane methodology. Published search filters were combined for a sensitive literature search. Prognostic models including at least one HF-related biomarker were eligible. Independent pairs of co-authors carried out screening and data extraction. Based on the CHARMS and PROBAST checklists we considered model development studies with and without external validation in independent data, and model updating studies. MA will be carried out using recently published novel methodology. Results Searches yielded over 40,000 titles, highlighting the need for tighter, updated prognostic search filters. A pilot screening of 10% of these (ie 4000) returned only a 2% for full text screening, with an ultimate estimate of 150 included models for evaluation. Conclusions This is a complex time constrained project with potential to advise on future HF prognostic model design; contribute to improved HF clinical management; apply recently developed MA methodology for combining prognostic model data, and inform the project for developing Cochrane methodology standards of prognostic model reviews. Acknowledgements Project funded by the British Heart Foundation (grant no. PG/17/49/33099)

Background Compulsory submission of a checklist from the relevant reporting guideline is one of the most widespread journal requirements aiming to improve completeness of reporting. However, the current suboptimal levels of adherence to reporting guidelines observed in the literature may indicate that this journal policy is not having a significant effect. Findings We explored whether authors provided the appropriate CONSORT checklist extension for their study and whether there were inconsistencies between what authors claimed on the submitted checklist and what was actually reported in the published paper. We randomly selected 12 randomized trials from three journals that provide the originally submitted checklist and analyzed six core CONSORT items. Only one paper used the appropriate checklist extension and had no inconsistencies between what was claimed in the submitted checklist and what was reported in the published paper. Conclusion Journals should take further actions to take full advantage of the requirement for the submission of fulfilled CONSORT checklists, thus ensuring that these checklists reflect what is reported in the manuscript. Electronic supplementary material The online version of this article (10.1186/s13063-018-2475-0) contains supplementary material, which is available to authorized users.

Aim: To develop age-, sex-, and ethnic-Appropriate normative reference ranges for standard echocardiographic measurements of the left heart by combining echocardiographic measurements obtained from adult volunteers without clinical cardiovascular disease or significant cardiovascular risk factors, from multiple studies around the world.Methods and results: The Echocardiographic Normal Ranges Meta-Analysis of the Left heart (EchoNoRMAL) collaboration was established and population-based data sets of echocardiographic measurements combined to perform an individual person data meta-Analysis. Data from 43 studies were received, representing 51 222 subjects, of which 22 404 adults aged 18-80 years were without clinical cardiovascular or renal disease, hypertension or diabetes. Quantile regression or an appropriate parametric regression method will be used to derive reference values at the 5th and 95th centile of each measurement against age. Conclusion: This unique data set represents a large, multi-ethnic cohort of subjects resident in a wide range of countries. The resultant reference ranges will have wide applicability for normative data based on age, sex, and ethnicity. © The Author 2013.

Summary Background Charts of size at birth are used to assess the postnatal growth of preterm babies on the assumption that extrauterine growth should mimic that in the uterus. Methods The INTERGROWTH-21 st Project assessed fetal, newborn, and postnatal growth in eight geographically defined populations, in which maternal health care and nutritional needs were met. From these populations, the Fetal Growth Longitudinal Study selected low-risk women starting antenatal care before 14 weeks' gestation and monitored fetal growth by ultrasonography. All preterm births from this cohort were eligible for the Preterm Postnatal Follow-up Study, which included standardised anthropometric measurements, feeding practices based on breastfeeding, and data on morbidity, treatments, and development. To construct the preterm postnatal growth standards, we selected all live singletons born between 26 and before 37 weeks' gestation without congenital malformations, fetal growth restriction, or severe postnatal morbidity. We did analyses with second-degree fractional polynomial regression models in a multilevel framework accounting for repeated measures. Fetal and neonatal data were pooled from study sites and stratified by postmenstrual age. For neonates, boys and girls were assessed separately. Findings From 4607 women enrolled in the study, there were 224 preterm singleton births, of which 201 (90%) were enrolled in the Preterm Postnatal Follow-up Study. Variance component analysis showed that only 0·2% and 4·0% of the total variability in postnatal length and head circumference, respectively, could be attributed to between-site differences, justifying pooling the data from all study sites. Preterm growth patterns differed from those for babies in the INTERGROWTH-21 st Newborn Size Standards. They overlapped with the WHO Child Growth Standards for term babies by 64 weeks' postmenstrual age. Interpretation Our data have yielded standards for postnatal growth in preterm infants. These standards should be used for the assessment of preterm infants until 64 weeks' postmenstrual age, after which the WHO Child Growth Standards are appropriate. Size-at-birth charts should not be used to measure postnatal growth of preterm infants. Funding Bill & Melinda Gates Foundation.

Evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, researchers from extracting information for systematic reviews and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) Statement was developed to improve the reporting of randomised controlled trials. Within-person trials are a particular type of trial for conditions that can affect two or more body sites, and are a useful and efficient tool because the comparisons between interventions are within-persons. Such trials are more commonly conducted in ophthalmology, dentistry and dermatology. The reporting of within-person trials has, however, been variable and incomplete, hindering their usefulness in clinical decision making and by future researchers. This document presents the CONSORT extension to within-person trials. It aims to facilitate the reporting of within-person trials. CONSORT within-person extends 16 items of the CONSORT 2010 checklist, and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence-based rationale for CONSORT within-person checklist items are provided.

Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized clinical trials (RCTs) of CHM formulas is disappointing although there are CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions. A group of TCM clinical experts, methodologists, epidemiologists and editors has developed CONSORT–CHM Formulas through a comprehensive process including publication of the CONSORT–CHM Formulas (Draft), solicitation of comments, revision and finalization. The CONSORT 2010 Statement was extended by introducing the idea of TCM Pattern and the features of CHM formulas. One new checklist sub-item, Keywords was added to facilitate the indexation and data searching. Seven of the 25 CONSORT checklist items, namely Title and Abstract, Background and Objectives, Participants, Interventions, Outcomes, Generalizability and Interpretation, are now elaborated upon and the explanation of Harms of CHM formulas is revised. Illustrative examples and explanations are also provided. We hope that CONSORT–CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.

Risk prediction models, developed to estimate the probability of an individual developing a particular outcome, are frequently published. Few are adequately validated resulting in a large number of prediction models not used in practice. Data are often measured with some degree of error. This error can influence the performance of a prediction model. The impact of either random or systematic error in a particular covariate, the covariate’s strength or the sample size at which this measurement error could become negligible on model performance is unknown. This simulation study investigates the impact of measurement error and its relationship to sample size and a covariate’s strength on calibration (i.e. how close observed and predicted probabilities are, and quantified by the calibration slope and Brier score), discrimination (i.e. how well the model differentiates between individuals with and without the outcome, and quantified by the c-index and D statistic), and explained variation (e.g. R2).

OBJECTIVE: Coronary artery bypass grafting (CABG) using bilateral internal mammary arteries (BIMA) may improve survival over CABG using single internal mammary arteries (SIMA), but may be surgically more complex (and therefore costly) and associated with impaired sternal wound healing. We report, for the first time, a detailed comparison of healthcare resource use and costs over 12 months, as part of the Arterial Revascularisation (ART) Trial. METHODS: 3102 patients in 28 hospitals in seven countries were randomised to CABG surgery using BIMA (n=1548) or SIMA (n=1554). Detailed resource use data were collected covering surgery, the initial hospital episode, and for 12 months post randomisation. Using UK unit costs, total costs were calculated and compared between trial arms and for subgroups. RESULTS: Patients randomised to BIMA spent 20 min longer in theatre (95% CI 15 to 25, pCONCLUSIONS: At 12 months from randomisation, mean costs were approximately 9% higher in BIMA than SIMA patients, primarily due to longer time in theatre and in-hospital stay, and slightly higher costs related to sternal wound problems during follow-up. Follow-up to the primary trial endpoint of 10 years will reveal whether longer-term differences emerge in graft patency or in overall survival. TRIAL REGISTRATION NUMBER: Controlled-trials.com (ISRCTN46552265).

Objectives: We aimed to identify risk factors for antepartum stillbirth including fetal growth restriction, amongst women with well-dated pregnancies and access to antenatal care. Design: Population-based, prospective, observational study Setting: Eight international urban populations Population: Pregnant women and their babies enrolled in the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Methods: Cox proportional Hazard models were used to compare risks amongst antepartum stillborn and liveborn babies. Main outcome measures: Antepartum stillbirth was defined as any fetal death after 16 weeks of gestation before the onset of labour. Results: Of 60 121 babies, 553 were stillborn (9.2 per 1000 births), of which 445 were antepartum deaths (7.4 per 1000 births). After adjustment for site, risk factors were low socio-economic status, Hazard ratio (HR): 1·6 (95% CI 1·2-2·1); single marital status, 2·0 (1·4-2·8); age  40 years, 2·2 (1·4-3·7); essential hypertension 4·0 (2·7-5·9); HIV/AIDS 4·3 (2·0-9·1); preeclampsia 1·6 (1·1-3·8), multiple pregnancy 3·3 (2.0-5·6) and antepartum haemorrhage 3.3 (2.5-4.5). Birth weight < 3rd centile was associated with antepartum stillbirth, 4.6 (3.4-6.2). The greatest risk was in babies not suspected to have been growth restricted antenatally, 5.0 (3.6-7.0). The population attributable risk of antepartum death associated with SGA diagnosed at birth was 11%. Conclusions: Antepartum stillbirth is a complex syndrome associated with several risk factors. Although small babies are at higher risk, current growth restriction detection strategies only modestly reduced the rate of stillbirth.

Summary Research publication can both communicate and miscommunicate. Unless research is adequately reported, the time and resources invested in the conduct of research is wasted. Reporting guidelines such as CONSORT, STARD, PRISMA, and ARRIVE aim to improve the quality of research reports, but all are much less adopted and adhered to than they should be. Adequate reports of research should clearly describe which questions were addressed and why, what was done, what was shown, and what the findings mean. However, substantial failures occur in each of these elements. For example, studies of published trial reports showed that the poor description of interventions meant that 40–89% were non-replicable; comparisons of protocols with publications showed that most studies had at least one primary outcome changed, introduced, or omitted; and investigators of new trials rarely set their findings in the context of a systematic review, and cited a very small and biased selection of previous relevant trials. Although best documented in reports of controlled trials, inadequate reporting occurs in all types of studies—animal and other preclinical studies, diagnostic studies, epidemiological studies, clinical prediction research, surveys, and qualitative studies. In this report, and in the Series more generally, we point to a waste at all stages in medical research. Although a more nuanced understanding of the complex systems involved in the conduct, writing, and publication of research is desirable, some immediate action can be taken to improve the reporting of research. Evidence for some recommendations is clear: change the current system of research rewards and regulations to encourage better and more complete reporting, and fund the development and maintenance of infrastructure to support better reporting, linkage, and archiving of all elements of research. However, the high amount of waste also warrants future investment in the monitoring of and research into reporting of research, and active implementation of the findings to ensure that research reports better address the needs of the range of research users.

I read Gepner and colleagues’ article with interest. In their most common form, randomized trials compare groups of persons receiving different interventions studied simultaneously. Each participant receives 1 intervention selected at random at enrollment. The probabilities of being allocated to each treatment are usually equal (for example, an allocation ratio of 1:1). That all participants have the same probability of receiving each treatment is implied. That principle is violated if the allocation ratio is changed (for example, from 1:1 to 1:2) partway through the trial. Although all participants are randomly assigned to 1 of the same set of possible treatments, bias can arise because the sets of participants recruited in the 2 phases of the trial may differ—for example, those recruited in the second part may be healthier than those in the first part. The correct approach is to separately analyze the data for each part of the trial and then combine the results

Objective(s) The question of whether skeletonized internal mammary artery (IMA) harvesting reduces the incidence of sternal wound complications in comparison to the pedicled technique, in the context of single or bilateral IMAs, remains controversial. We studied the impact IMA harvesting strategy on sternal wound complication in the Arterial Revascularization Trial (ART). Methods Patients enrolled in the ART (n=3102) were randomised to coronary artery bypass grafting with single or bilateral IMAs. Sternal wound complication rates were examined according to the harvesting technique that was documented in 2056 patients. The IMA harvesting technique, based on surgeon preference, resulted in 4 groups: pedicled single IMA (P-SIMA, n=607), pedicled bilateral IMA (P-BIMA, n=459), skeletonized single IMA (S-SIMA, n=512) and skeletonized bilateral IMA (S-BIMA, n=478). Propensity Scores weighting was used to estimate the impact of the harvesting technique on sternal wound complications. Results A total of 219 of 2056 patients (10.6%) experienced a sternal wound complication within 1 year from the index operation. Of those, only 25 (1.2%) patients required sternal wound reconstruction. P-BIMA (OR 1.80; 95%CI 1.23 to 2.63) but not S-BIMA (OR 1.00; 95%CI 0.65 to 1.53) or S-SIMA (OR 0.89; 95%CI 0.57-1.38) was associated with a significantly increased risk of any sternal wound complications compared to P-SIMA. Conclusions The present ART sub-study suggests that, with a skeletonization technique, the risk of sternal wound complication with BIMA grafting is similar to that after standard pedicled SIMA harvesting whilst skeletonized SIMA harvesting did not add any further benefit when compared to pedicled SIMA harvesting.

Background and study aims: Terminal digit preference bias for “pleasing” numbers has been described in many areas of medicine. The aim of this study was to determine whether endoscopists, radiologists, and pathologists exhibit such bias when measuring colorectal polyp diameters. Methods: Colorectal polyp diameters measured at endoscopy, computed tomographic colonography (CTC), and histopathology were collated from a colorectal cancer screening program and two parallel multicenter randomized trials. Smoothing models were fitted to the data to estimate the expected number of polyps at 1-mm increments, assuming no systematic measurement bias. The difference between the expected and observed numbers of polyps was calculated for each terminal digit using statistical modeling. The impact of measurement bias on per-patient detection rates of polyps ≥ 10 mm was estimated for each modality. Results: A total of 92 124 individual polyps were measured by endoscopy (91 670 screening and 454 from trials), 2385 polyps were measured by CTC (1664 screening, 721 trials), and 79 272 were measured by histopathology (78 783 screening, 489 trials). Clustering of polyp diameter measurements at 5-mm intervals was demonstrated for all modalities, both in the screening program and the trials. The statistical models estimated that per-patient detection rates of polyps ≥ 10 mm were over-inflated by 2.4 % for endoscopy, 3.1 % for CTC, and 3.3 % for histopathology in the screening program, with similar trends in the randomized trials. Conclusion: Endoscopists, radiologists, and pathologists all exhibit terminal digit preference when measuring colorectal polyps. This will bias trial data, referral rates for further testing, adenoma surveillance regimens, and comparisons between tests.

Objectives: The relationship between atrial fibrillation (AF) and the development of cardiovascular and renal disease is unclear. We aimed to quantify the associations between AF and cardiovascular disease, renal disease and death. Design: Systematic Review and Meta-analysis. Data Sources: We conducted a systematic search of MEDLINE and EMBASE. Eligibility Criteria: We included cohort studies examining the association of AF with cardiovascular disease, renal disease and death. Two reviewers independently extracted study characteristics and the relative risk of outcomes associated with AF: specifically, all-cause mortality, cardiovascular mortality, major cardiovascular events, any stroke, ischemic stroke, hemorrhagic stroke, ischemic heart disease, sudden cardiac death, congestive heart failure, chronic kidney disease and peripheral arterial disease. Estimates were pooled using inverse-variance weighted random effects meta-analysis. Results: One hundred and four eligible cohort studies involving 9,686,513 participants (587,867 with AF) were identified. AF was associated with an increased risk of all-cause mortality (relative risk 1.46; 95% confidence interval 1.39 to 1.54), cardiovascular mortality (2.03; 1.79 to 2.30), major cardiovascular events (1.96; 1.53 to 2.51), stroke (2.42; 2.17 to 2. 71), ischemic stroke (2.33; 1.84 to 2.94), ischemic heart disease (1.61; 1.38 to 1.87), sudden cardiac death (1.88; 1.36 to 2.60), heart failure (4.99; 3.04 to 8.22), chronic kidney disease (1.64; 1.41 to 1.91) and peripheral arterial disease (1.31; 1.19 to 1.45), but not hemorrhagic stroke (2.00; 0.67 to 5.96). Among the outcomes examined, the absolute risk increase for heart failure was the greatest. Associations of AF with included outcomes were broadly consistent across subgroups and in sensitivity analyses. Conclusions: AF is associated with an increased risk of death and an increased risk of cardiovascular and renal disease. Interventions aimed at reducing outcomes beyond stroke are warranted in patients with AF.

INTERGROWTH-21(st) is a multicentre, multiethnic, population-based project, being conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from early pregnancy to infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. The new international standards will describe: (1) fetal growth assessed by clinical and ultrasound measures; (2) postnatal growth of term and preterm infants up to 2 years of age; and (3) the relationship between birthweight, length and head circumference, gestational age and perinatal outcomes. As the project has selected healthy cohorts with no obvious risk factors for intrauterine growth restriction, these standards will describe how all fetuses and newborns should grow, as opposed to traditional charts that describe how some have grown at a given place and time. These growth patterns will be related to morbidity and mortality to identify levels of perinatal risk. Additional aims include phenotypic characterisation of the preterm and impaired fetal growth syndromes and development of a prediction model, based on multiple ultrasound measurements, to estimate gestational age for use in pregnant women without access to early/frequent antenatal care.

Passive phase-change thermal spreaders, such as vapor chambers have been widely employed to spread the heat from small-scale high-flux heat sources to larger areas. In this paper, a numerical model for ultrathin vapor chambers has been developed, which is suitable for reliable prediction of the operation at high heat fluxes and small scales. The effects of boiling in the wick structure on the thermal performance are modeled, and the model predictions are compared with experiments on custom-fabricated vapor chamber devices. The working fluid for the vapor chamber is water and a condenser side temperature range of 293 K–333 K is considered. The model predictions agree reasonably well with experimental measurements and reveal the input parameters to which thermal resistance and vapor chamber capillary limit are most sensitive. The vapor space in the ultrathin devices offers significant thermal and flow resistances when the vapor core thickness is in the range of 0.2 mm–0.4 mm. The performance of a 1-mm-thick vapor chamber is optimized by studying the variation of thermal resistance and total flow pressure drop as functions of the wick and vapor core thicknesses. The wick thickness is varied from 0.05 to 0.25 mm. Based on the minimization of a performance cost function comprising the device thermal resistance and flow pressure drop, it is concluded that the thinnest wick structures (0.05 mm) are optimal for applications with heat fluxes below 50 W/cm2, while a moderate wick thickness of 0.1 mm performs best at higher heat flux inputs (>50 W/cm2).

Изучено влияние общей аэрокриотерапии (АКТ) на показатели биологического, кардиопульмонального и иммунологического возрастов, отражающие темп старения организма и его систем у ветеранов современных боевых конфликтов с ранними формами хронических цереброваскулярных заболеваний (ХЦВЗ). Выявлены оптимальные показатели биологического и кардиопульмонального возрастов у ветеранов с ХЦВЗ после курса охлаждения азотвоздушной смесью и наличие иммунотропных эффектов данной процедуры, улучшающей основные показатели клеточного и гуморального иммунитета. The paper presents the study of the impact of general aerocryotherapy (ACT) on the indices of biological, cardiopulmonary and immunologic ages, refleeting the aging rates of the organism and its systems of contemporary war veterans with early forms of chronic cerebrovascular diseases (CCVD). The research demonstrates optimization of the biological and cardiopulmonary age indices of war veterans with CCVD after a course of nitrogen-air mixture cooling and the presence of immunotropic effects of this procedure, which improve the basic indices of cellular and humoral immunity Кочеткова Н.Г., кандидат медицинских наук, заведующая лабораторией диагностики и коррекции преждевременного старения областного клинического терапевтического госпиталя для ветеранов войн (Челябинск); тел. 8-351-2328122; E-mail:ngp @ chel. surnet.ru Kochetkova N.G., candidate of Medical Science, Head of the Laboratory of Diagnostics and Correction of Premature Ageing, Regional Clinical Hospital for War Veterans (Chelyabinsk); ph. 8-351-2328122,E-mail: ngp@chel.surnet.ru. Альтман Д.Ш., доктор медицинских наук, профессор, Заслуженный врач Российской Федерации, начальник областного клинического терапевтического госпиталя для ветеранов войн (Челябинск); тел. 8-351-2328151. Altman D.Sh., doctor of Medical Science, Professor, Honoured Doctor of Russian Federation, Head of the Regional Clinical Hospital for War Veterans (Chelyabinsk); ph. 8-351-2328151. Теплова С.Н., доктор медицинских наук, профессор, Заслуженный деятель науки РФ, заведующая кафедрой иммунологии и аллергологии Челябинской государственной медицинской академии (Челябинск); тел. 8-351-2327412. Teplova S.N., doctor of medical sciences, professor, Honored Scientist of Russia,Chelyabinsk State Medical Academy, head of department of the immunology and allergology (Chelyabinsk); ph. 8-351-2327412. Галанова С.Н., кандидат медицинских наук, заведующая отделением физиотерапии областного клинического терапевтического госпиталя для ветеранов войн (Челябинск); тел. 8-351-2328213. Galanova S.N., candidate of Medical Science, Head of the Department of Physiotherapy Regional Clinical Hospital for War Veterans (Chelyabinsk),ph. 8-351-2328213.

Целью исследования являлся анализ интенсивности жалоб больных, особенностей психометрических показателей реактивной и личностной тревожности, качества жизни и нарушения иммунного гомеостаза у пациентов с ранними формами ХЦВЗ. Aim of the study was to analyze the intensity of the complaints of patients, characteristics of psychometric indicators of reactive and personal anxiety, quality of life and violation of immune homeostasis in patients with early forms of chronic cerebrovascular diseases. Альтман Д.Ш., доктор медицинских наук, профессор, начальник Челябинского областного клинического терапевтического госпиталя для ветеранов войн (Челябинск). Altman D.Sh., Doctor of medical sciences, professor, head of the Chelyabinsk Clinical Therapeutic Hospital for Veterans of War (Chelyabinsk). Блинова Ю.А., кандидат медицинских наук, врач-невропатолог Челябинского областного клинического терапевтического госпиталя для ветеранов войн (Челябинск). Blinova J.A., Candidate of medical sciences, Chelyabinsk Clinical Therapeutic Hospital for Veterans of War (Chelyabinsk). Королева В.В., кандидат медицинских наук, врач-невропатолог Челябинского областного клинического терапевтического госпиталя для ветеранов войн (Челябинск). Koroleva V.V., Candidate of medical sciences, Chelyabinsk Clinical Therapeutic Hospital for Veterans of War (Chelyabinsk). Светлакова В.А., очный аспирант кафедры иммунологии и аллергологии Челябинской государственной медицинской академии (Челябинск); тел. 8-351-2480012; e-mail: valent4ss@mail.ru Svetlakova V.A., intramural graduate student Department of the Immunology and Allergology Chelyabinsk State Medical Academy (Chelyabinsk); ph. 8-351-2480012; e-mail: valent4ss@mail.ru. Теплова С.Н., доктор медицинских наук, профессор, заслуженный деятель науки РФ, заведующая кафедрой иммунологии и аллергологии (Челябинск); тел. 8-351-2327412; e-mail: teplova-sn@jandex74.ru Teplova S.N., Doctor of Medical Sciences, professor, the head of Immunology and Allergology department of Chelyabinsk State Medical Academy (Chelyabinsk); ph. 8-351-2327412; e-mail: teplova-sn@jandex74.ru

Определены уровни кортизола, конечных стабильных метаболитов оксида азота, активности комплемента и его компонентов С1-С5, количества растворимого Fas рецептора и IL-12 в слюне до и после воздействия экстремального холодового и психо-эмоционального стресса. Показана принципиальная возможность использования неинвазивных методов для оценки гормонального и иммунного гомеостаза, определения общих и специфических особенностей стресс-индуцированных изменений гомеостаза под влиянием стрессов разной природы. The levels of Cortisol, terminal stabile metabolities of nitrogen oxide, activity of complement and its components C1-C5, concentration of soluble Fas receptor and interleukme-12 in saliva before and after impact of extreme cold and psychologic stress are determined. The principal possibility of application of noninvasive methods to evaluation of hormone and immune homeostasis, definition of common and specific peculiarities of stress-induced changes in homeostasis under the influence of stress of different nature is shown. Рахматулина Эльвира Хидиятулловна, соискатель кафедры Института иммунологии и физиологии УРО РАН (г. Екатеринбург). Rakhmatulina Elvira Khidiyatullovna, applicant of department of Institute of immunology and physiology of URO RSA (Ekaterinburg). Теплова Светлана Николаевна, заведующая кафедрой иммунологии и аллергологии Челябинской государственной медицинской академии (г. Челябинск), заслуженный деятель науки РФ, доктор медицинских наук, профессор (8-351-232-74-12). Teplova Svetlana Nikolaevna, head of the department of immunology and allergy of the Chelyabinsk state medical academy (Chelyabinsk), Honored Scientist of Russian Federation, doctor of medical sciences, professor (8-351-232-74-12). Альтман Давид Шурович, начальник областного клинического терапевтического воспитателя для ветеранов войн (г. Челябинск) (8-351-232-74-12). Altman David Shurovich, The head of Regional Clinical Therapeutic hospital for the veterans of wars (Chelyabinsk) (8-351-232-74-12).

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

Установлены достоверные различия в характере иммунного гомеостаза при Helicobacter pylori - ассоциированных заболеваниях желудочно-кишечного тракта у лиц старческого и зрелого возраста, характеризующиеся уменьшением с возрастом продукции специфических антител к Helicobacter pylori, процессов апоптоза лимфоцитов, ростом лабораторных маркеров воспаления (активности центрального компонента комплемента СЗ и уровня СОЭ) и перераспределением CD3, CD4, CD8 популяций лимфоцитов. Authentic distinctions in the character of an immune homeostasis were established in patients of mature and senium age with peptic and duodenal ulcer. The reduction of specific antibodies to Helicobacter pylori, numbers of lymphocytes with morphological markers of apoptosis, growth of laboratory markers of inflammation (activity of the central complement component C3 and speed of erythrocyte sedimentation) were revealed in old men.

OBJECTIVE: A schema was recently proposed for assessing the levels of evidence for surrogate validity that included 4 domains: Target, Study Design, Statistical Strength, and Penalties. This report examines one component of the schema. It surveys the literature on methods of statistical validation of surrogate markers and compares these methods head-to-head using simulated datasets. METHODS: Simulated datasets (continuous, multivariate normal) were generated to capture 3 possible relationships of surrogate (S) and true (T) outcome (none, weakly positive, strongly positive) each applied to 4 treatment effects (effect on both surrogate and true outcome, effect on neither, effect on surrogate only, and effect on true outcome only). These datasets were analyzed using single and multitrial statistical approaches, and the results were provided to participants for discussion. RESULTS: The multitrial surrogate threshold effect seemed to capture best the requirement that surrogate validation is demonstrated by a treatment-associated change in the surrogate predicting a treatment-associated change in the outcome. CONCLUSION: There was general agreement that neither a single trial nor any of the single trial statistical methods was adequate to establish surrogate validity. These exercises also showed that summary statistics developed specifically to establish surrogate validity, such as the proportion of the effect explained, were problematic. A sizable statistical research agenda remains, which includes investigating the additional advantage obtained with modeling subject-level data compared to modeling with only trial-level data; and developing and testing multitrial statistical approaches robust to settings with only a few trials.

Objectives To compare the occurrence of risk-inducing condom events (condom failures and incomplete use) and the frequency of their antecedents (condom errors fit/feel problems and erection problems) between black and white men who have sex with men (MSM) and determine the associations between risk-inducing condom events and their antecedents. Methods We studied cross-sectional data of 475 MSM who indicated using a condom as an insertive partner in the previous 6 months enrolled in a cohort study in Atlanta Georgia USA. Results Nearly 40% of black MSM reported breakage or incomplete use and they were more likely to report breakage early removal and delayed application of a condom than white MSM. Only 31% and 54% of MSM reported correct condom use and suboptimal fit/feel of a condom respectively. The use of oil-based lubricants and suboptimal fit/feel were associated with higher odds of reporting breakage (p=0.009). Suboptimal fit/feel was also associated with higher odds of incomplete use of condoms (p

Editor—Better late than never. Several years ago one group of epidemiologists put forward the number needed to treat (NNT) derived from megatrials and meta-analysis as a summary statistic suitable for expressing the effectiveness of medical interventions; now another group of epidemiologists has at long last realised that the NNT is seldom a valid measure.1 Some of us came to the conclusion that NNTs were “not necessarily true” rather more rapidly, and without the need for three and a half pages of cumbersome and dubiously appropriate statistical analysis.2 The deep flaws in the NNT statistic can be understood by a straightforward act of inference based on an understanding of the relevant clinical science and guided by the principle of “garbage in, garbage out.” The spurious precision of the NNT is a statistical artefact which derives not from clinical knowledge but from the illegitimate pooling of the large amounts of qualitatively unlike and clinically irrelevant data that are incorporated in almost all megatrials and meta-analyses. Unless trials incorporate patients with the same characteristics and the same prognosis and who are being given the same treatment as those to which the trial results will apply, then statistical summary is inevitably misleading.2 It is somewhat galling that mega-epidemiologists and biostatisticians so routinely take credit for the act of creating spurious analytic tools, and then for belatedly dismantling them—but so it goes. The wheels of epidemiology grind exceedingly slow. At least Smeeth et al got there in the end. When clinical epidemiology gives up its grandiose and self awarded claim to be “evidence-based medicine” and once again becomes an activity based in clinical science, such absurdities may become a thing of the past. I hope so.

PURPOSE: Randomized trials provide essential evidence of the effect of interventions in oral health. Such trials need to be appraised by readers in order to decide whether to incorporate new findings into clinical practice and policy in a timely manner. The CONSORT (Consolidated Standards of Reporting of Trials) Statement is a guidance to facilitate reporting of randomized controlled trials (RCTs) and was first introduced in 1996. The purpose of this article is to highlight the importance of rigorous reporting of trials in oral health and to discuss the impact of CONSORT on trial reporting. RESULTS: Empirical studies demonstrate that key aspects of trial methods influence the size of estimates of studied interventions and bias is a plausible mechanism for some of this effect. Complete and transparent reporting of these methods allows appraisal of the value of trials to be undertaken and the potential for bias to be estimated. Systematic reviews have shown that the reported quality of trials in dentistry is poor, thus hindering the understanding of the value of individual trials. Since 1996, CONSORT has been adopted by hundreds of medical journals, international editorial groups, and five dental journals. A systematic review has shown that the quality of reporting of trials improves in journals that have adopted this guidance, although with significant variation, most likely due to differing levels of editorial adherence to it.