Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline [protocol].

BACKGROUND Observational studies are increasingly used to inform health decision-making when randomised trials are not feasible, ethical or timely. The target trial approach provides a framework to help minimise common biases in observational studies that aim to estimate the causal effect of interventions. Incomplete reporting of studies using the target trial framework limits the ability for clinicians, researchers, patients and other decision-makers to appraise, synthesise and interpret findings to inform clinical and public health practice and policy. This paper describes the methods that we will use to develop the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) reporting guideline. METHODS/DESIGN The TARGET reporting guideline will be developed in five stages following recommended guidance. The first stage will identify target trial reporting practices by systematically reviewing published studies that explicitly emulated a target trial. The second stage will identify and refine items to be considered for inclusion in the TARGET guideline by consulting content experts using sequential online surveys. The third stage will prioritise and consolidate key items to be included in the TARGET guideline at an in-person consensus meeting of TARGET investigators. The fourth stage will produce and pilot-test both the TARGET guideline and explanation and elaboration document with relevant stakeholders. The fifth stage will disseminate the TARGET guideline and resources via journals, conferences and courses. ETHICS AND DISSEMINATION Ethical approval for the survey has been attained (HC220536). The TARGET guideline will be disseminated widely in partnership with stakeholders to maximise adoption and improve reporting of these studies

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.

IMPORTANCE Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. OBJECTIVE To assess the reporting of observational studies that explicitly aimed to emulate a target trial. EVIDENCE REVIEW We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. FINDINGS A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. CONCLUSION AND RELEVANCE In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts

Echocardiographic findings predict in-hospital and 1-year mortality in left-sided native valve Staphylococcus aureus endocarditis:Analysis from the international collaboration on endocarditis-prospective echo cohort study

BACKGROUND: Staphylococcus (S.) aureus left-sided native valve infective endocarditis (LNVIE) has higher complication and mortality rates compared with endocarditis from other pathogens. Whether echocardiographic variables can predict prognosis in S. aureus LNVIE is unknown. METHODS AND RESULTS: Consecutive patients with LNVIE, enrolled between January 2000 and September 2006, in the International Collaboration on Endocarditis were identified. Subjects without S. aureus IE were matched to those with S. aureus IE by the propensity of having S. aureus. Survival differences were determined using log-rank significance tests. Independent echocardiographic predictors of mortality were identified using Cox-proportional hazards models that included inverse probability of treatment weighting and surgery as a time-dependent covariate. Of 727 subjects with LNVIE and 1-year follow-up, 202 had S. aureus IE. One-year survival rates were significantly lower for patients with S. aureus IE overall (57% S. aureus IE vs. 80% non-S. aureus IE, p<0.001) and in the propensity-matched cohort (59% S. aureus IE vs. 68% non-S. aureus IE, p<0.05). Intracardiac abscess (HR 2.93; 95%CI 1.52–5.40, p<0.001) and left ventricular ejection fraction (LVEF)<40% (OR 3.01; 95%CI 1.35–6.04, p=0.004) were the only independent echocardiographic predictors of in-hospital mortality in S. aureus LNVIE. Valve perforation (HR 2.16; 95% CI 1.21–3.68, p=0.006) and intracardiac abscess (HR 2.25; 95%CI 1.26–3.78, p=0.004) were the only independent predictors of one-year mortality. CONCLUSIONS: S. aureus is an independent predictor of one-year mortality in subjects with LNVIE. In S. aureus LNVIE, intracardiac abscess and LVEF<40% independently predicted in-hospital mortality and intracardiac abscess and perforation independently predicted one-year mortality

Echocardiographic agreement in the diagnostic evaluation for infective ă endocarditis

International audienceEchocardiography is essential for the diagnosis and management of ă infective endocarditis (IE). However, the reproducibility for the ă echocardiographic assessment of variables relevant to IE is unknown. ă Objectives of this study were: (1) To define the reproducibility for IE ă echocardiographic variables and (2) to describe a methodology for ă assessing quality in an observational cohort containing site-interpreted ă data. IE reproducibility was assessed on a subset of echocardiograms ă from subjects enrolled in the International Collaboration on ă Endocarditis registry. Specific echocardiographic case report forms were ă used. Intra-observer agreement was assessed from six site readers on ten ă randomly selected echocardiograms. Inter-observer agreement between ă sites and an echocardiography core laboratory was assessed on a separate ă random sample of 110 echocardiograms. Agreement was determined using ă intraclass correlation (ICC), coverage probability (CP), and limits of ă agreement for continuous variables and kappa statistics ă (kappa(weighted)) and CP for categorical variables. Intra-observer ă agreement for LVEF was excellent [ICC = 0.93 +/- 0.1 and all pairwise ă differences for LVEF (CP) were within 10 %]. For IE categorical ă echocardiographic variables, intra-observer agreement was best for ă aortic abscess (kappa(weighted) = 1.0, CP = 1.0 for all readers). ă Highest inter-observer agreement for IE categorical echocardiographic ă variables was obtained for vegetation location (kappa(weighted) = 0.95; ă 95 % CI 0.92-0.99) and lowest agreement was found for vegetation ă mobility (kappa(weighted) = 0.69; 95 % CI 0.62-0.86). Moderate to ă excellent intra- and inter-observer agreement is observed for ă echocardiographic variables in the diagnostic assessment of IE. A ă pragmatic approach for determining echocardiographic data ă reproducibility in a large, multicentre, site interpreted observational ă cohort is feasible

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Background: observational studies are increasingly used to inform health decision-making when randomised trials are not feasible, ethical or timely. The target trial approach provides a framework to help minimise common biases in observational studies that aim to estimate the causal effect of interventions. Incomplete reporting of studies using the target trial framework limits the ability for clinicians, researchers, patients and other decision-makers to appraise, synthesise and interpret findings to inform clinical and public health practice and policy. This paper describes the methods that we will use to develop the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) reporting guideline.Methods design: the TARGET reporting guideline will be developed in five stages following recommended guidance. The first stage will identify target trial reporting practices by systematically reviewing published studies that explicitly emulated a target trial. The second stage will identify and refine items to be considered for inclusion in the TARGET guideline by consulting content experts using sequential online surveys. The third stage will prioritise and consolidate key items to be included in the TARGET guideline at an in-person consensus meeting of TARGET investigators. The fourth stage will produce and pilot-test both the TARGET guideline and explanation and elaboration document with relevant stakeholders. The fifth stage will disseminate the TARGET guideline and resources via journals, conferences and courses.Ethics and dissemination: ethical approval for the survey has been attained (HC220536). The TARGET guideline will be disseminated widely in partnership with stakeholders to maximise adoption and improve reporting of these studies