A systematic review classifies sources of bias and variation in diagnostic test accuracy studies

Whiting, Penny; Rutjes, Anne W S; Westwood, Marie; Mallett, Susan

doi:10.1016/j.jclinepi.2013.05.014

Cited by 322 publications

(312 citation statements)

References 107 publications

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“…The culture reference standard thus inevitably leads to true CPTB case patients being misclassified as being negative for CPTB. If these misclassifications by the reference standard are ignored, then the assessment of the test accuracy can be biased (11)(12)(13)(14).To address the problem of the lack of an accurate reference standard, multivariable diagnostic algorithms for CPTB have been proposed to combine information from multiple imperfect diagnostic tests (including tests for tuberculosis infection and clinical data) in a systematic manner. Although more 690…”

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confidence: 99%

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Diagnostic Test Accuracy in Childhood Pulmonary Tuberculosis: A Bayesian Latent Class Analysis

Schumacher¹,

Smeden²,

Dendukuri³

et al. 2016

American Journal of Epidemiology

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Evaluation of tests for the diagnosis of childhood pulmonary tuberculosis (CPTB) is complicated by the absence of an accurate reference test. We present a Bayesian latent class analysis in which we evaluated the accuracy of 5 diagnostic tests for CPTB. We used data from a study of 749 hospitalized South African children suspected to have CPTB from 2009 to 2014. The following tests were used: mycobacterial culture, smear microscopy, Xpert MTB/RIF (Cepheid Inc.), tuberculin skin test (TST), and chest radiography. We estimated the prevalence of CPTB to be 27% (95% credible interval (CrI): 21, 35). The sensitivities of culture, Xpert, and smear microscopy were estimated to be 60% (95% CrI: 46, 76), 49% (95% CrI: 38, 62), and 22% (95% CrI: 16, 30), respectively; specificities of these tests were estimated in accordance with prior information and were close to 100%. Chest radiography was estimated to have a sensitivity of 64% (95% CrI: 55, 73) and a specificity of 78% (95% CrI: 73, 83). Sensitivity of the TST was estimated to be 75% (95% CrI: 61, 84), and it decreased substantially among children who were malnourished and infected with human immunodeficiency virus (56%). The specificity of the TST was 69% (95% CrI: 63%, 76%). Furthermore, it was estimated that 46% (95% CrI: 42, 49) of CPTB-negative cases and 93% (95% CrI: 82; 98) of CPTB-positive cases received antituberculosis treatment, which indicates substantial overtreatment and limited undertreatment. childhood pulmonary tuberculosis; diagnosis; latent class analysis; overtreatment; sensitivity; specificity Abbreviations: CPTB, childhood pulmonary tuberculosis; CrI, credible interval; HIV, human immunodeficiency virus; PTB, pulmonary tuberculosis; TST, tuberculin skin test.Tuberculosis in children is an important global health problem. There are an estimated 0.5 to 1 million new cases each year (1, 2), with childhood pulmonary tuberculosis (CPTB) being the most common form. One of the major challenges in diagnosing CPTB is the lack of sensitive diagnostic tests (3-6). In clinical practice, the diagnosis of CPTB therefore relies on a combination of imperfect tests, which gives rise to unknown degrees of under-or overtreatment (7,8).In recent years, new tests for CPTB have been developed, and their accuracy has been evaluated using mycobacterial culture as a reference standard (4, 9). Although culture is currently considered the best available reference standard, its sensitivity for detecting CPTB is acknowledged to be imperfect (3,4,10). The culture reference standard thus inevitably leads to true CPTB case patients being misclassified as being negative for CPTB. If these misclassifications by the reference standard are ignored, then the assessment of the test accuracy can be biased (11)(12)(13)(14).To address the problem of the lack of an accurate reference standard, multivariable diagnostic algorithms for CPTB have been proposed to combine information from multiple imperfect diagnostic tests (including tests for tuberculosis infection and clinical data) in a sy...

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confidence: 99%

mentioning

confidence: 99%

Diagnostic Test Accuracy in Childhood Pulmonary Tuberculosis: A Bayesian Latent Class Analysis

Schumacher¹,

Smeden²,

Dendukuri³

et al. 2016

American Journal of Epidemiology

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“…Moreover, there is evidence suggesting that the major sources of bias in these studies come from the prevalence of the demographic characteristics of the population and the event of interest under study (Whiting et al, 2004b). Other sources of bias to be considered in studies of diagnostic tests are if the case-control design was used, the variability of the observer, the availability of clinical information; and prevalence and severity of the disease or event of interest under study (Whiting et al, 2013).…”

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confidence: 99%

Instructions for Using the MInCir Scale to Assess Methodological Quality in Diagnostic Accuracy Studies

2016

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MANTEROLA, C.; CARTES-VELASQUEZ, R. & OTZEN, T.Instructions for using the MInCir scale to assess methodological quality in diagnostic accuracy studies. Int. J. Morphol., 34(1):78-84, 2016. SUMMARY:Globally, the assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years. Understood as a complex and multidimensional construct, various groups have proposed tools for its assessment. Our team has designed and validated scales to assess MQ of therapy and prognosis studies. However, as with other instruments, it is necessary to specify in detail how it is applied, in such a way as to be able to standardize the measurements made with this instrument. A detailed description is presented of the 3 domains (type of research design [single item domain], size of population studied [single item domain], and methodology [7 items]) and 9 items comprising the scale, specifying for each item how to assess the characteristics and score articles of diagnostic accuracy studies. The application of this instrument requires critical evaluation of each of the items to assign the respective score, which sum to give a total score of between 9 and 45 points. The cut-off point to define the construct MQ (dichotomous) for this type of study is 20 points. This article provides an application guideline that may help to improve inter-observer and intra-observer reliability of the MInCir MQ scale for diagnostic accuracy studies. The aim of this article is to provide a guideline for the standardized application of the MInCir MQ scale for diagnostic accuracy studies.

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“…19 The aim of this instrument is twofold. First, it facilitates unraveling design problems, such as the lack of blinding that may prohibit the interpretation of the studies.…”

Section: Quality Assessment Of Diagnostic Accuracy Studiesmentioning

confidence: 99%

Screening for Peripheral Neuropathies in Children With Diabetes: A Systematic Review

et al. 2014

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BACKGROUND AND OBJECTIVE: Although guidelines for the management of children with type 1 diabetes include recommendations to screen for diabetic peripheral neuropathies (DPN), the research into the diagnostic utility of screening methods has not been systematically reviewed. The goal of this study was to summarize the findings with regard to the diagnostic accuracy of the Semmes-Weinstein monofilament and the Rydel-Seiffer tuning fork in detecting DPN in children and adolescents compared with the gold standard nerve conduction studies. METHODS:Based on a PubMed search (conducted on April 26, 2013) and secondary searching, we identified 72 articles for review. We included studies that: (1) assessed DPN with the gold standard nerve conduction studies; (2) used noninvasive screening for DPN (monofilament, tuning fork, or biothesiometer); and (3) were performed in the relevant population (children with diabetes). Five articles met these criteria. Study quality was assessed by using the revised Quality Assessment of Diagnostic Accuracy Studies criteria. Heterogeneous methods precluded a formal meta-analysis of effects.RESULTS: Diagnostic accuracies were heterogeneous for the different screening methods. Sensitivities ranged from 1% to 19% for the tuning fork (3 studies); from 61% to 80% for the biothesiometer (2 studies); and from 19% to 73% for the monofilament (2 studies).CONCLUSIONS: Data show extremely low diagnostic utility for standard screening methods (tuning fork and 10-g monofilament) but acceptable utilities for biothesiometry and finer (1 g) monofilaments. Data on the diagnostic utility should be used to inform national and international guidelines on diabetes management.

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A systematic review classifies sources of bias and variation in diagnostic test accuracy studies

Cited by 322 publications

References 107 publications

Diagnostic Test Accuracy in Childhood Pulmonary Tuberculosis: A Bayesian Latent Class Analysis

Diagnostic Test Accuracy in Childhood Pulmonary Tuberculosis: A Bayesian Latent Class Analysis

Instructions for Using the MInCir Scale to Assess Methodological Quality in Diagnostic Accuracy Studies

Screening for Peripheral Neuropathies in Children With Diabetes: A Systematic Review

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