OBJECTIVE To review and critically appraise published and preprint reports of prediction models for diagnosing coronavirus disease 2019 (covid-19) in patients with suspected infection, for prognosis of patients with covid-19, and for detecting people in the general population at increased risk of becoming infected with covid-19 or being admitted to hospital with the disease. DESIGNLiving systematic review and critical appraisal. DATA SOURCESPubMed and Embase through Ovid, Arxiv, medRxiv, and bioRxiv up to 7 April 2020.Cite this as: BMJ 2020;369:m1328 http://dx.
BackgroundConventional systematic review techniques have limitations when the aim of a review is to construct a critical analysis of a complex body of literature. This article offers a reflexive account of an attempt to conduct an interpretive review of the literature on access to healthcare by vulnerable groups in the UKMethodsThis project involved the development and use of the method of Critical Interpretive Synthesis (CIS). This approach is sensitised to the processes of conventional systematic review methodology and draws on recent advances in methods for interpretive synthesis.ResultsMany analyses of equity of access have rested on measures of utilisation of health services, but these are problematic both methodologically and conceptually. A more useful means of understanding access is offered by the synthetic construct of candidacy. Candidacy describes how people's eligibility for healthcare is determined between themselves and health services. It is a continually negotiated property of individuals, subject to multiple influences arising both from people and their social contexts and from macro-level influences on allocation of resources and configuration of services. Health services are continually constituting and seeking to define the appropriate objects of medical attention and intervention, while at the same time people are engaged in constituting and defining what they understand to be the appropriate objects of medical attention and intervention. Access represents a dynamic interplay between these simultaneous, iterative and mutually reinforcing processes. By attending to how vulnerabilities arise in relation to candidacy, the phenomenon of access can be better understood, and more appropriate recommendations made for policy, practice and future research.DiscussionBy innovating with existing methods for interpretive synthesis, it was possible to produce not only new methods for conducting what we have termed critical interpretive synthesis, but also a new theoretical conceptualisation of access to healthcare. This theoretical account of access is distinct from models already extant in the literature, and is the result of combining diverse constructs and evidence into a coherent whole. Both the method and the model should be evaluated in other contexts.
Summary estimates of treatment effect from random effects meta-analysis give only the average effect across all studies. Inclusion of prediction intervals, which estimate the likely effect in an individual setting, could make it easier to apply the results to clinical practice
Meta-analysis methods involve combining and analysing quantitative evidence from related studies to produce results based on a whole body of research. As such, metaanalyses are an integral part of evidence based medicine. Traditional methods for meta-analysis synthesise aggregate study level data obtained from study publications or study authors, such as a treatment effect estimate (for example, an odds ratio) and its associated uncertainty (for example, a standard error or confidence interval). An alternative but increasingly popular approach is meta-analysis of individual participant data, or individual patient data, in which the raw individual level data for each study are obtained and used for synthesis.1 In this article we describe the rationale for individual participant data meta-analysis and illustrate through applied examples why this strategy offers numerous advantages, both clinically and statistically, over the aggregate data approach.1 2 We outline when and how to initiate an individual participant data meta-analysis, the statistical issues in conducting one, how the findings should be reported, and what challenges this approach may bring. What are individual participant data?The term "individual participant data" relates to the data recorded for each participant in a study. In a hypertension trial, for example, the individual participant data could be the pre-treatment and post-treatment blood pressure, a treatment group indicator, and important baseline clinical characteristics such as age and sex, for each patient in each study (table). A set of individual participant data from multiple studies often comprises thousands of patients; this is the case in the table, so for brevity we do not show all rows of data here. This concept is in contrast to the term "aggregate data," which relates to information averaged or estimated across all individuals in a study, such as the mean treatment effect on blood pressure, the mean age, or the proportion of participants who are male. Such aggregate data are derived from the individual participant data themselves, so individual participant data can be considered the original source material. What is an individual participant data meta-analysis?As with any meta-analysis, an individual participant data meta-analysis aims to summarise the evidence on a particular clinical question from multiple related studies, such as whether a treatment is effective. The statistical implementation of an individual participant data meta-analysis crucially must preserve the clustering of patients within studies; it is inappropriate to simply analyse individual participant data as if they all came from a single study. Clusters can be retained during analysis by using a two step or a one step approach. 3 In the two step approach, the individual participant data are first analysed in each separate study independently by using a statistical method appropriate for the type of data being analysed; for example, a linear regression model might be fitted for continuous responses such as blo...
In this article, the third in the PROGRESS series on prognostic factor research, Sara Schroter and colleagues review how prognostic models are developed and validated, and then address how prognostic models are assessed for their impact on practice and patient outcomes, illustrating these ideas with examples.
IMPORTANCE Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. OBJECTIVE To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. DESIGN Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. FINDINGS Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach. CONCLUSIONS AND RELEVANCE PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.
Background: Clinical prediction models combine several predictors (risk or prognostic factors) to estimate the risk whether a particular condition is present (diagnostic model) or whether a certain event will occur in the future (prognostic model). Large numbers of diagnostic and prognostic prediction model studies are published each year and a tool facilitating their quality assessment is needed, e.g. to support systematic reviews and evidence syntheses.Objective: To introduce and describe the development of PROBAST, a tool for assessing the risk of bias and applicability of prediction model studies.Methods: Web-based Delphi procedure (involving 40 experts in the field of prediction model research) and refinement of the tool through piloting. The scope of PROBAST was determined with consideration of existing risk of bias tools and reporting guidelines, such as CHARMS, QUADAS, QUIPS, and TRIPOD.Results: After seven Delphi rounds, a final tool was developed which utilises a domain-based structure supported by signalling questions. PROBAST assesses the risk of bias of prediction model studies and any concerns for their applicability. Studies that PROBAST can be used for include those developing, validating, and extending a prediction model. We define risk of bias to occur when shortcomings in the study design, conduct or analysis lead to systematically distorted estimates of model predictive performance or to an inadequate model to address the research question. The predictive performance is typically evaluated using calibration and discrimination, and sometimes (notably in diagnostic model studies) classification measures. Applicability refers to the extent to which the prediction model study matches the systematic review question in terms of the target population, predictors, or outcomes of interest. PROBAST comprises 20 signalling questions grouped into four domains: participant selection, predictors, outcome, and analysis.Conclusions: PROBAST can be used to assess the risk of bias and any concerns for applicability of studies developing, validating or extending (adjusting) prediction, both diagnostic and prognostic, models.
Types of Predictors, Outcomes, and Modeling TechniquesPROBAST can be used to assess any type of diagnostic or prognostic prediction model aimed at individualized predictions regardless of the predictors used; outcomes being predicted; or methods used to develop, validate, or update (for example, extend) the model.Predictors range from demographic characteristics, medical history, and physical examination results; to imaging results, electrophysiology, blood, urine, or tissue measurements, and disease stages or characteristics; to results from "omics" and other new biological measurements. Predictors are also called covariates, risk indicators, prognostic factors, determinants, index test results, or independent variables (4, 6 -8, 49, 50, 55, 56, 57).PROBAST distinguishes between candidate predic-Prediction model external validation: These studies aim to assess the predictive performance of existing prediction models using data external to the development sample (i.e., from different participants).Adopted from the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) and CHARMS (CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies) guidance (8, 16).
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