Рекомендации CARE для описания случаев: разъяснения и уточнения

Journal of the College of Community Physicians of Sri Lanka

ImportanceMendelian randomization (MR) studies use genetic variation associated with modifiable exposures to assess their possible causal relationship with outcomes and aim to reduce potential bias from confounding and reverse causation.ObjectiveTo develop the STROBE-MR Statement as a stand-alone extension to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guideline for the reporting of MR studies.Design, Setting, and ParticipantsThe development of the STROBE-MR Statement followed the Enhancing the Quality and Transparency of Health Research (EQUATOR) framework guidance and used the STROBE Statement as a starting point to draft a checklist tailored to MR studies. The project was initiated in 2018 by reviewing the literature on the reporting of instrumental variable and MR studies. A group of 17 experts, including MR methodologists, MR study design …

Prediction models combine values of multiple predictors to estimate an individual's risk of having a certain outcome or disease (diagnostic models) or developing a future outcome (prognostic models). Systematic reviews are needed to identify existing prediction models for a certain target population or outcome and to summarize their predictive performance and heterogeneity in their performance. Appraising the quality and reporting of a prediction model study is essential. Studies describing the development or validation of a prediction model often do not conform to prevailing methodological standards and key details are often not reported. Meta‐analysis of the predictive performance of a specific prediction model from multiple external validation studies of that model is possible, focusing on calibration and discrimination. In this chapter, we describe the types of …

Вопросы современной педиатрии

Обоснование. Доступное и понятное описание клинических случаев помогает выявлять самые ранние данные о возможной пользе, неблагоприятном влиянии и расходовании ресурсов; предоставляет информацию для клинической научной работы и разработки рекомендаций для клинической практики; интегрируется в медицинское образование. Авторы с большей вероятностью подготовят высококачественные описания случаев, если будут следовать определенным правилам написания таких публикаций. В 2011–2012 гг. группа клиницистов, ученых и редакторов журналов разработала рекомендации для точного представления информации при описании случаев, итогом которых стало Положение CARE (CAse REport—описание случаев) с Проверочным перечнем, представленное в 2013 г. на Международном конгрессе по экспертному рецензированию и биомедицинским публикациям, поддержанное многочисленными медицинскими журналами и переведенное на 9 языков.

Trials

BackgroundTo assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.MethodsWe had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor.ResultsThe proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6–69.2%) in 2012 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR …

Current Pediatrics

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www. equator-network. org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine RT Saygitov.

Here we describe the different effect measures that are typically used in meta‐analyses of randomized trials, many of which are also used in observational studies. For dichotomous data (e.g. dead or alive), the three main options are the odds ratio (OR), the risk ratio (RR) and the risk difference (RD). We describe how these are computed from results of individual trials, along with measures of uncertainty. For continuous outcomes (e.g. body mass index), the three main options are the difference in means, a standardized difference in means, and the ratio of means (RoM). Again, we provide computational formulae for these, and we also discuss effect measures suitable for time‐to‐event outcomes, rates, and ordinal outcomes. We then explore how one might decide among different effect measures when several are available. The key considerations are (i) the …

Вопросы современной педиатрии

Большинство медицинских исследований являются наблюдательными (observational). Сообщения о таких исследованиях часто невысокого качества, что затрудняет оценку сильных и слабых сторон работы, а также обобщаемости (generalisability) ее результатов. Принимая во внимание эмпирические свидетельства и теоретические соображения, группа методологов, исследователей и научных редакторов разработала рекомендации «Повышение качества отчетов о наблюдательных исследованиях в эпидемиологии (STROBE): разъяснения и уточнения». Рекомендации STROBE содержат 22 пункта, связанных с оформлением следующих разделов научных статей: название, аннотация, введение, методы, результаты и их обсуждение, при этом 18 пунктов являются общими для когортных исследований (cohort studies), исследований «случай-контроль» (case-control studies) и одномоментных исследований (cross-sectional studies); 4 пункта специфичны для каждого из указанных дизайнов исследований (study designs). STROBE - руководство для авторов, необходимое для повышения качества отчетов о наблюдательных исследованиях, облегчающее критическую оценку исследования и его интерпретацию рецензентами, редакторами журналов и читателями. Цель этой разъясняющей и уточняющей статьи - способствовать более широкому применению, пониманию и распространению стандартов STROBE. В ней даются разъяснение смысла и обоснование применения каждого пункта руководства (checklist). По каждому пункту приводятся один или …

Journal of Geriatric Cardiology: JGC

BackgroundQT dispersion (QTd) is a predictor of ventricular arrhythmia. Ventricular arrhythmia is an important factor influencing morbidity and mortality in patients with aortic stenosis. Surgical aortic valve replacement reduced the QTd in this patients group. However, the effect of transcatheter aortic valve implantation (TAVI) on QTd in patients with aortic stenosis is unknown. The aim of this study was to investigate the effect of TAVI on QTd in patients with aortic stenosis.MethodsPatients with severe aortic stenosis, who were not candidates for surgical aortic valve replacement due to contraindications or high surgical risk, were included in the study. All patients underwent electrocardiographic and echocardiographic evaluation before, and at the 6 th month after TAVI, computed QTd and left ventricular mass index (LVMI).ResultsA total 30 patients were admitted to the study (mean age 83.2±1.0 years, female 21 and …

Primary studies to identify prognostic factors are abundant, but often have conflicting findings and variable quality. This motivates systematic reviews to identify, evaluate, and summarize prognostic factor studies. Broad search strings are required to identify relevant studies, and the CHARMS‐PF checklist guides subsequent data extraction. The QUIPS tool examines each study's risk of bias; unfortunately, many studies will have high risk of bias due to poor design and analysis. Meta‐analysis can be used to combine and summarize prognostic effect estimates (such as hazard ratios or odds ratios) across studies, but may not always be sensible. Between‐study heterogeneity is expected. Ideally, separate meta‐analyses are performed; for example, for each method of prognostic factor measurement, for each cut point (for categorized continuous prognostic factors …

Digital Diagnostics

The TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) Statement includes a 22-item checklist, which aims to improve the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. This explanation and elaboration document describes the rationale; clarifies the meaning of each item; and discusses why transparent reporting is important, with a view to assessing risk of bias and clinical usefulness of the prediction model. Each checklist item of the TRIPOD Statement is explained in detail and accompanied by published examples of good reporting. The document also provides a valuable reference of issues to consider when designing, conducting, and analyzing prediction model studies. To aid the editorial process and help peer reviewers and, ultimately, readers and systematic reviewers of prediction model studies, it is recommended that authors include a completed checklist in their submission. The TRIPOD checklist can also be downloaded from www. tripod-statement. org.

Background Digital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS. Objectives The overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care. Design For the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care …

European Heart Journal-Quality of Care and Clinical Outcomes

Aims Using bilateral internal thoracic arteries (BITAs) for coronary artery bypass grafting (CABG) has been suggested to improve survival compared to CABG using single internal thoracic arteries (SITAs) for patients with advanced coronary artery disease. We used data from the Arterial Revascularization Trial (ART) to assess long-term cost-effectiveness of BITA grafting compared to SITA grafting from an English health system perspective. Methods and results Resource use, healthcare costs, and quality-adjusted life years (QALYs) were assessed across 10 years of follow-up from an intention-to-treat perspective. Missing data were addressed using multiple imputation. Incremental cost-effectiveness ratios were calculated with uncertainty characterized using non-parametric bootstrapping. Results were extrapolated beyond 10 years using Gompertz functions for survival and …

The principles and steps of systematic reviews are similar to any other research undertaking: formulation of the problem to be addressed, collection and analysis of the data, and interpretation of the results. A study protocol should be written, which states objectives and eligibility criteria, describes how studies will be identified and selected, explains how any assessment of methodological quality or risk of bias will be undertaken, and provides details of any planned synthesis methods. The results from eligible studies are expressed in a standardized format and are often displayed graphically in forest plots with confidence intervals. Heterogeneity between study results and possible biases may be explored graphically in a forest, funnel, and other plots, and in statistical analyses. If a meta‐analysis is deemed appropriate, a typical effect is estimated by combining …

Meta-analysis is a statistical technique for combining results from multiple independent studies, with the aim of estimating a single overall effect. The routines in this package provide facilities to conduct meta-analyses of binary (event) or continuous data from two groups, or intervention effect estimates with corresponding standard errors or confidence intervals. This is an updated version of metan as published in Stata Journal Issue 8, and prior to that in STB-44, authored by Michael J Bradburn, Jonathan J Deeks and Douglas G Altman. Updates include a wide range of random-effects models; cumulative and influence analysis; meta-analysis of proportions; and better handling of heterogeneity, continuity correction and returned values. The routine for constructing forest plots has been separated off (‘forestplot’ command) and hugely extended; extremely flexible and generalised forest plots may now be produced. Also included is an “immediate” command ‘metani’, which accepts numlists or matrices as input rather than variables in memory; the ‘metannt’ program for binary data, which displays estimated intervention effects in terms of the absolute reduction in risk and number needed to treat; and the ‘labbe’ program which produces L'Abbe plots to examine whether the assumption of a common odds ratio, risk ratio or risk difference is reasonable. Further information on this package, including validation scripts, may be found at https://github.com/UCL/metan; and a description of available Stata meta-analysis commands may be found at http://www.stata.com/support/faqs/stat/meta.html.

In the previous chapters we discussed how to estimate a population mean and the associated population variance from existing samples. The corresponding estimators are usually called point estimators, but we can go one step further and specify a range for plausible population parameters. This procedure is called interval estimation, and the calculated intervals are labeled confidence intervals. This chapter introduces the general form of a confidence interval and then applies it to the (common) confidence interval for the sample mean. It then contrasts the concepts of null hypothesis significance testing and confidence intervals. Finally it considers confidence intervals for dependent (paired) samples.

Digital Diagnostics

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources;(2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages.OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports.

Studies at high risk of bias may distort the results of systematic reviews and meta‐analyses. Based on empirical evidence and theoretical considerations, the following sources of bias should be assessed when including randomized trials in a review: bias arising from the randomization process, bias due to deviations from the intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias due to selective reporting. The use of summary scores from quality scales is problematic. Results depend on the choice of scale, and the interpretation of the results is difficult. Therefore, judging risk of bias within separate specified bias domains and recording the information on which each judgment is based – the domain‐based approach – are preferred. Assessments of risk of bias of included studies should routinely be incorporated in …

Medici Oggi

Molta della ricerca in campo biomedico è di natura osservazionale. La descrizione di queste ricerche è spesso inadeguata, il che rende difficile la valutazione dei punti di forza e di debolezza di uno studio e la generalizzazione dei suoi risultati. L’iniziativa STROBE (Strengthening the Reporting of Observational Studies in Epidemiology, Migliorare la descrizione degli studi clinici osservazionali in epidemiologia) è nata con lo scopo di sviluppare raccomandazioni su ciò che dovrebbe essere incluso in una descrizione accurata e completa di uno studio osservazionale. Abbiamo definito il campo di applicazione di queste raccomandazioni in modo da coprire i tre principali disegni di studio, e cioè quelli di coorte, caso-controllo e trasversali. Nel settembre 2004 si è tenuto un workshop, nel quale è stata elaborata, da parte di metodologi, direttori di riviste medico-scientifiche e ricercatori, una lista dei punti chiave da …

Digital Diagnostics

Большинство медицинских исследований являются наблюдательными (observational). Сообщения о таких исследованиях часто невысокого качества, что затрудняет оценку сильных и слабых сторон работы, а также обобщаемости (generalizability) её результатов. Принимая во внимание эмпирические свидетельства и теоретические соображения, группа методологов, исследователей и научных редакторов разработала рекомендации «Повышение качества отчётов о наблюдательных исследованиях в эпидемиологии (STROBE): разъяснения и уточнения». Рекомендации STROBE содержат 22 пункта, связанных с оформлением следующих разделов научных статей: название, аннотация, введение, методы, результаты и их обсуждение, при этом 18 пунктов являются общими для когортных исследований (cohort studies), исследований «случай-контроль»(case …

Вопросы современной педиатрии

Обоснование. Доступное и понятное описание клинических случаев помогает выявлять самые ранние данные о возможной пользе, неблагоприятном влиянии и расходовании ресурсов; предоставляет информацию для клинической научной работы и разработки рекомендаций для клинической практики; интегрируется в медицинское образование. Авторы с большей вероятностью подготовят высококачественные описания случаев, если будут следовать определенным правилам написания таких публикаций. В 2011–2012 гг. группа клиницистов, ученых и редакторов журналов разработала рекомендации для точного представления информации при описании случаев, итогом которых стало Положение CARE (CAse REport—описание случаев) с Проверочным перечнем, представленное в 2013 г. на Международном конгрессе по экспертному рецензированию и биомедицинским публикациям, поддержанное многочисленными медицинскими журналами и переведенное на 9 языков.

Вопросы современной педиатрии

Большинство медицинских исследований являются наблюдательными (observational). Сообщения о таких исследованиях часто невысокого качества, что затрудняет оценку сильных и слабых сторон работы, а также обобщаемости (generalisability) ее результатов. Принимая во внимание эмпирические свидетельства и теоретические соображения, группа методологов, исследователей и научных редакторов разработала рекомендации «Повышение качества отчетов о наблюдательных исследованиях в эпидемиологии (STROBE): разъяснения и уточнения». Рекомендации STROBE содержат 22 пункта, связанных с оформлением следующих разделов научных статей: название, аннотация, введение, методы, результаты и их обсуждение, при этом 18 пунктов являются общими для когортных исследований (cohort studies), исследований «случай-контроль» (case-control studies) и одномоментных исследований (cross-sectional studies); 4 пункта специфичны для каждого из указанных дизайнов исследований (study designs). STROBE - руководство для авторов, необходимое для повышения качества отчетов о наблюдательных исследованиях, облегчающее критическую оценку исследования и его интерпретацию рецензентами, редакторами журналов и читателями. Цель этой разъясняющей и уточняющей статьи - способствовать более широкому применению, пониманию и распространению стандартов STROBE. В ней даются разъяснение смысла и обоснование применения каждого пункта руководства (checklist). По каждому пункту приводятся один или …

Вопросы современной педиатрии

Обоснование. Мукополисахаридоз VI типа (МПС VI, синдром Марото-Лами) - редкое аутосомно-рецессивное мультисистемное заболевание из группы лизосомных болезней накопления. Патогенез МПС VI обусловлен дефицитом фермента арилсульфатазы B, вызванным нарушениями в структуре гена ARSB. Опубликовано лишь несколько клинических примеров болезни с описанием результатов ферментной заместительной терапии (ФЗТ), начатой в раннем возрасте.Описание клинического случая. В возрасте 1,5 мес у ребенка заподозрена лизосомная болезнь накопления на основании данных микроскопического анализа мазков крови, в которых была обнаружена аномалия Альдера (зернистость и включения красно-фиолетового цвета в цитоплазме нейтрофилов, моноцитов, лимфоцитов). Диагноз был подтвержден в возрасте 3 мес: обнаружены повышенная концентрация гликозаминогликанов (ГАГ) в моче, снижение активности арилсульфатазы В в пятнах высушенной крови и патогенный вариант c.943C>T (р.R315X) гена ARSB в гомозиготном состоянии. ФЗТ препаратом галсульфаза начата в возрасте 7 мес. Через 9 и 15 мес терапии отмечено снижение экскреции ГАГ с мочой до нормального уровня. Через 3 года непрерывной ФЗТ определены нормальные для возраста пациента рост и пропорции тела. Вместе с тем, отмечено прогрессирование множественного дизостоза и тугоподвижности суставов, а также поражение органа зрения.Заключение. Раннее начало ФЗТ не может полностью остановить прогрессирование МПС VI, но позволяет …