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Observational data provide invaluable real-world information in medicine, but certain methodological considerations are required to derive causal estimates. In this systematic review, we evaluated the methodology and reporting quality of individual-level patient data meta-analyses (IPD-MAs) conducted with non-randomized exposures, published in 2009, 2014, and 2019 that sought to estimate a causal relationship in medicine. We screened over 16,000 titles and abstracts, reviewed 45 full-text articles out of the 167 deemed potentially eligible, and included 29 into the analysis. Unfortunately, we found that causal methodologies were rarely implemented, and reporting was generally poor across studies. Specifically, only three of the 29 articles used quasi-experimental methods, and no study used G-methods to adjust for time-varying confounding. To address these issues, we propose stronger collaborations between physicians and methodologists to ensure that causal methodologies are properly implemented in IPD-MAs. In addition, we put forward a suggested checklist of reporting guidelines for IPD-MAs that utilize causal methods. This checklist could improve reporting thereby potentially enhancing the quality and trustworthiness of IPD-MAs, which can be considered one of the most valuable sources of evidence for health policy.

The goal of much observational research is to identify risk factors that have a causal effect on health and social outcomes. However, observational data are subject to biases from confounding, selection and measurement, which can result in an underestimate or overestimate of the effect of interest. Various advanced statistical approaches exist that offer certain advantages in terms of addressing these potential biases. However, although these statistical approaches have different underlying statistical assumptions, in practice they cannot always completely remove key sources of bias; therefore, using design-based approaches to improve causal inference is also important. Here it is the design of the study that addresses the problem of potential bias – either by ensuring it is not present (under certain assumptions) or by comparing results across methods with different sources and direction of potential bias. The distinction between statistical and design-based approaches is not an absolute one, but it provides a framework for triangulation – the thoughtful application of multiple approaches (e.g. statistical and design based), each with their own strengths and weaknesses, and in particular sources and directions of bias. It is unlikely that any single method can provide a definite answer to a causal question, but the triangulation of evidence provided by different approaches can provide a stronger basis for causal inference. Triangulation can be considered part of wider efforts to improve the transparency and robustness of scientific research, and the wider scientific infrastructure and system of incentives.

Background Mediation analysis methodology underwent many advancements throughout the years, with the most recent and important advancement being the development of causal mediation analysis based on the counterfactual framework. However, a previous review showed that for experimental studies the uptake of causal mediation analysis remains low. The aim of this paper is to review the methodological characteristics of mediation analyses performed in observational epidemiologic studies published between 2015 and 2019 and to provide recommendations for the application of mediation analysis in future studies. Methods We searched the MEDLINE and EMBASE databases for observational epidemiologic studies published between 2015 and 2019 in which mediation analysis was applied as one of the primary analysis methods. Information was extracted on the characteristics of the mediation model and the applied mediation analysis method. Results We included 174 studies, most of which applied traditional mediation analysis methods ( n  = 123, 70.7%). Causal mediation analysis was not often used to analyze more complicated mediation models, such as multiple mediator models. Most studies adjusted their analyses for measured confounders, but did not perform sensitivity analyses for unmeasured confounders and did not assess the presence of an exposure-mediator interaction. Conclusions To ensure a causal interpretation of the effect estimates in the mediation model, we recommend that researchers use causal mediation analysis and assess the plausibility of the causal assumptions. The uptake of causal mediation analysis can be enhanced through tutorial papers that demonstrate the application of causal mediation analysis, and through the development of software packages that facilitate the causal mediation analysis of relatively complicated mediation models.

Observational studies that use a combination of complementary methods can providekey insights into everyday behavior in natural settings. Many elements of human behavior areperfectly perceivable ---and hence observable--- in a multitude of everyday activities and settings,ranging from low-intervention programs to interactive studies analyzing different aspects offamily life, social relations, performance in sport or at school, etc. Human behavior, however,also has elements that are only partially perceivable but that can be captured through indirectobservation and subsequent analysis of oral behavior or written text or graphics. In this article,we present a schematic overview of the main steps involved in an observational study.The aim is to provide authors interested in embarking on such a study with some practical insights andguidelines that we hope will provide them with the knowledge and motivation to delve furtherinto this field and ultimately design their own observational study.

Food-based dietary guidelines have been the basis of public health recommendations for over half a century, but more recently, there has been a trend to classify the health properties of food not by its nutrient composition, but by the degree to which it has been processed. This concept has been supported by many association studies, narrative reviews and the findings from one randomised controlled feeding trial, which demonstrated the sustained effect of ultra-processed diets on increasing both energy intake and body weight. This has led to widespread speculation as to specific features of ultra-processed foods that promote increased energy intakes. Rising interest in the ultra-processed topic has led to proposals to include guidance and restrictions on the consumption of processed foods in national dietary guidelines, with some countries encouraging consumers to avoid highly processed foods completely, and only choose minimally processed foods. However, there remains a lack of consensus on the role of processed foods in human health when faced with the challenges of securing the food supply for a growing global population, that is, healthy, affordable and sustainable. There has also been criticism of the subjective nature of definitions used to differentiate foods by their degree of processing, and there is currently a lack of empirical data to support a clear mechanism by which highly processed foods promote greater energy intakes. Recommendations to avoid all highly processed foods are potentially harmful if they remove affordable sources of nutrients and will be impractical for most when an estimated two-thirds of current energy purchased are from processed or ultra-processed foods. The current review highlights some considerations when interpreting the dietary association studies that link processed food intake to health and offers a critique on some of the mechanisms proposed to explain the link between ultra-processed food and poor health. Recent research suggests a combination of higher energy density and faster meal eating rates are likely to influence meal size and energy intakes from processed foods and offers new perspectives on how to manage this in the future. In going beyond the ultra-processed debate, the aim is to summarise some important considerations when interpreting existing data and identify the important gaps for future research on the role of processed food in health.

Causal inference methods for observational data represent an alternative to randomised controlled trials when they are not feasible or when real-world evidence is sought. Inverse-probability-of-treatment weighting (IPTW) is one of the most popular approaches to account for confounding in observational studies. In medical research, IPTW is mainly applied to estimate the causal effect of a binary treatment, even when the treatment has in fact multiple categories, despite the availability of IPTW estimators for multiple treatment categories. This raises questions about the appropriateness of the use of IPTW in this context. Therefore, we conducted a systematic review of medical publications reporting the use of IPTW in the presence of a multi-category treatment. Our objectives were to investigate the frequency of use and the implementation of these methods in practice, and to assess the quality of their reporting. Using Pubmed, Embase and Web of Science, we screened 5660 articles and retained 106 articles in the final analysis that were from 17 different medical areas. This systematic review is registered on PROSPERO (CRD42022352669). The number of treatment groups varied between 3 and 9, with a large majority of articles (90 [84.9%]) including 3 or 4 groups. The most commonly used method for estimating the weights was multinomial regression (51 [48.1%]) and generalized boosted models (48 [45.3%]). The covariates of the weight model were reported in 91 articles (85.9 %). Twenty-six articles (24.5 %) did not discuss the balance of covariates after weighting, and only 16 articles (15.1 %) referred to the assumptions needed to obtain correct inferences. The results of this systematic review illustrate that medical publications scarcely use IPTW methods for more than two treatment categories. Among the publications that did, the quality of reporting was suboptimal, in particular in regard to the assumptions and model building. IPTW for multi-category treatments could be applied more broadly in medical research, and the application of the proposed guidelines in this context will help researchers to report their results and to ensure reproducibility of their research. [Display omitted] •Medical publications scarcely use inverse-probability-of-treatment weighting methods for more than two treatment categories.•The quality of reporting was suboptimal, in particular in regard to the assumptions and model building.•A recommended guideline will help to report results and to ensure reproducibility of the research.

The propensity score is a common tool for estimating the causal effect of a binary treatment in observational data. In this setting, matching, subclassification, imputation or inverse probability weighting on the propensity score can reduce the initial covariate bias between the treatment and control groups. With more than two treatment options, however, estimation of causal effects requires additional assumptions and techniques, the implementations of which have varied across disciplines. This paper reviews current methods, and it identifies and contrasts the treatment effects that each one estimates. Additionally, we propose possible matching techniques for use with multiple, nominal categorical treatments, and use simulations to show how such algorithms can yield improved covariate similarity between those in the matched sets, relative the pre-matched cohort. To sum, this manuscript provides a synopsis of how to notate and use causal methods for categorical treatments.

In response to the coronavirus disease (COVID-19) pandemic, public health scientists have produced a large and rapidly expanding body of literature that aims to answer critical questions, such as the proportion of the population in a geographic area that has been infected; the transmissibility of the virus and factors associated with high infectiousness or susceptibility to infection; which groups are the most at risk of infection, morbidity and mortality; and the degree to which antibodies confer protection to re-infection. Observational studies are subject to a number of different biases, including confounding, selection bias, and measurement error, that may threaten their validity or influence the interpretation of their results. To assist in the critical evaluation of a vast body of literature and contribute to future study design, we outline and propose solutions to biases that can occur across different categories of observational studies of COVID-19. We consider potential biases that could occur in five categories of studies: (1) cross-sectional seroprevalence, (2) longitudinal seroprotection, (3) risk factor studies to inform interventions, (4) studies to estimate the secondary attack rate, and (5) studies that use secondary attack rates to make inferences about infectiousness and susceptibility.

Background When conducting randomised controlled trials is impractical, an alternative is to carry out an observational study. However, making valid causal inferences from observational data is challenging because of the risk of several statistical biases. In 2016 Hernán and Robins put forward the ‘target trial framework’ as a guide to best design and analyse observational studies whilst preventing the most common biases. This framework consists of (1) clearly defining a causal question about an intervention, (2) specifying the protocol of the hypothetical trial, and (3) explaining how the observational data will be used to emulate it. Methods The aim of this scoping review was to identify and review all explicit attempts of trial emulation studies across all medical fields. Embase, Medline and Web of Science were searched for trial emulation studies published in English from database inception to February 25, 2021. The following information was extracted from studies that were deemed eligible for review: the subject area, the type of observational data that they leveraged, and the statistical methods they used to address the following biases: (A) confounding bias, (B) immortal time bias, and (C) selection bias. Results The search resulted in 617 studies, 38 of which we deemed eligible for review. Of those 38 studies, most focused on cardiology, infectious diseases or oncology and the majority used electronic health records/electronic medical records data and cohort studies data. Different statistical methods were used to address confounding at baseline and selection bias, predominantly conditioning on the confounders ( N  = 18/49, 37%) and inverse probability of censoring weighting ( N  = 7/20, 35%) respectively. Different approaches were used to address immortal time bias, assigning individuals to treatment strategies at start of follow-up based on their data available at that specific time ( N  = 21, 55%), using the sequential trial emulations approach ( N  = 11, 29%) or the cloning approach ( N  = 6, 16%). Conclusion Different methods can be leveraged to address (A) confounding bias, (B) immortal time bias, and (C) selection bias. When working with observational data, and if possible, the ‘target trial’ framework should be used as it provides a structured conceptual approach to observational research.

We aim to investigate the implementation of Target Trial Emulation (TTE) for causal inference, involving research topics, frequently used strategies, and issues indicating the need for future improvements. We performed a scoping review by following the Joanna Briggs Institute (JBI) guidance and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. A health research–focused librarian searched multiple medical databases, and two independent reviewers completed screening and extraction within covidence review management software. Our search resulted in 1,240 papers, of which 96 papers were eligible for data extraction. Results show a significant increase in the use of TTE in 2018 and 2021. The study topics varied and focused primarily on cancer, cardiovascular and cerebrovascular diseases, and infectious diseases. However, not all papers specified well all three critical components for generating robust causal evidence: time-zero, random assignment simulation, and comparison strategy. Some common issues were observed from retrieved papers, and key limitations include residual confounding, limited generalizability, and a lack of reporting guidance that need to be improved. Uneven adherence to the TTE framework exists, and future improvements are needed to progress applications using causal inference with observational data. •Target trial emulation (TTE) was used in various observational studies, with the most frequent topic being cancer research (22.9%), followed by cardiovascular disease (15.6%).•Time-zero, random assignment emulation, and contrast strategies are critical for guaranteeing the quality of causal evidence generated from a TTE study, but not all papers using the TTE framework identified all three elements.•The unavailability of variables, which contributed to residual confounding, was the most frequently mentioned limitation of the research applying TTE to observational data.•There is no reporting guidance for TTE research, which poses a challenge in ensuring the implementation quality of TTE and the resulting causal evidence.