Evidence of bias and variation in diagnostic accuracy studies

Rutjes, Anne W S; Reitsma, Johannes B.; Nisio, Marcello Di; Smidt, Nynke; Rijn, Jeroen C. van; Bossuyt, Patrick M.

doi:10.1503/cmaj.050090

Cited by 508 publications

(414 citation statements)

References 55 publications

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“…The inclusion of participants without hearing loss introduces significant bias into accuracy studies (Rutjes et al, 2006). The potential for bias is clear; normal hearing patients are known to have hearing within a certain range, thereby limiting the potential range of variation between two methods of assessment.…”

Section: Introductionmentioning

confidence: 99%

Clinical validation of automated audiometry with continuous noise-monitoring in a clinically heterogeneous population outside a sound-treated environment

Brennan‐Jones

Eikelboom

Swanepoel

et al. 2016

International Journal of Audiology

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ABSTRACT:Objective: Examine the accuracy of automated audiometry in a clinically heterogeneous population of adults using the KUDUwave automated audiometer.Design: Prospective accuracy study. Manual audiometry was performed in a sound-treated room and automated audiometry was not conducted in a sound-treated environment.Study Sample: 42 consecutively recruited participants from a tertiary otolaryngology department in Western Australia.Results: Absolute mean differences ranged between 5.12 -9.68 dB (air-conduction) and 8.26 -15.00 dB (bone-conduction). 86.5% of manual and automated 4FAs were within 10 dB (i.e. ±5 dB); 94.8% were within 15 dB. However, there were significant (p<0.05) differences between automated and manual audiometry at 0.25, 0.5, 1 and 2 kHz (air-conduction) and 0.5 and 1 kHz (bone-conduction). The effect of age (≥55 years) on accuracy (p = 0.014) was not significant on linear regression (p>0.05; R 2 = 0.11). The presence of a hearing loss (better ear ≥26 dB) did not significantly affect accuracy (p = 0.604; air-conduction), (p = 0.218; boneconduction). Conclusions:This study provides clinical validation of automated audiometry using the KUDUwave in a clinically heterogeneous population, without the use of a sound-treated environment. Whilst threshold variations were statistically significant, future research is needed to ascertain the clinical significance of such variation.

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Section: Introductionmentioning

confidence: 99%

Clinical validation of automated audiometry with continuous noise-monitoring in a clinically heterogeneous population outside a sound-treated environment

Brennan‐Jones

Eikelboom

Swanepoel

et al. 2016

International Journal of Audiology

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“…Large overestimation of diagnostic accuracy has been shown when studies enroll only patients with advanced symptoms compared to normal controls. 7,8 The sensitivity and specificity of a test depends on the characteristics of the population studied. There needs to be a spectrum of patients similar to the patients we would use the test on in normal clinical practice.…”

Section: Was There An Appropriate Consecutive Population Of Patients mentioning

confidence: 99%

“…Failure to enroll patients consecutively (selection bias) and retrospective studies 9 are associated with an overestimation of diagnostic accuracy. 8 In the first article of this series 1 it was proposed that post-test probabilities and predictive values vary with target disease prevalence. In contrast, sensitivities, specificities and likelihood ratios do not.…”

Section: Was There An Appropriate Consecutive Population Of Patients mentioning

confidence: 99%

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How to Evaluate an Article on Diagnosis for Validity

Turlik¹

2009

FAOJ

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The Foot and Ankle Online Journal 2 (11): 6This is the second of four articles discussing the evaluation of diagnostic studies for podiatric physicians. This article deals with the evaluation of internal and external validity of a diagnostic study. Diagnostic articles from the foot/ankle literature will be used to illustrate the concepts of critical analysis.Key words: Evidence-based medicine. he first article of this series 1 discussed two different methods of how clinicians solve diagnostic problems. When clinicians use probabilistic diagnostic reasoning to solve clinical problems they often require diagnostic tests to help refine and revise the diagnostic hypotheses they generate. The use of likelihood ratios (LR) for diagnostic test results was discussed and it was advanced that LRs were based upon the results of published diagnostic studies. The strength of the inference from these studies depended upon the validity of the methods used to obtain the information about the diagnostic test. Different study designs may produce different results for diagnostic accuracy. The purpose of this article is to provide instruction regarding the critical analysis of diagnostic studies. Whether one can believe the results of a study is determined by the methods used to carry it out. This is the second of four articles explaining how to evaluate diagnostic foot/ankle studies.

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“…One hundred nineteen of 476 patients (25%) were excluded from analysis based on the presence of infarction or revascularization. Nonconsecutive inclusion of patients has been shown to increase the estimated diagnostic accuracy of the test (13).…”

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confidence: 99%

Angina pectoris: Has the cornerstone of symptomatic coronary artery disease been moved?

Hessian

2007

Canadian Journal of Cardiology

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But there is a disorder of the breast marked with strong and peculiar symptoms, considerable for the kind of danger belonging to it, and not extremely rare, which deserves to be mentioned more at length. The seat of it and sense of strangling, and anxiety with which it is attended, may make it not improperly be called angina pectoris. They who are afflicted with it are seized while they are walking (more especially if it be up hill, and soon after eating) with a painful and most disagreeable sensation in the breast, which seems as if it would extinguish life, if it were to increase or continue; but the moment they stand still this uneasiness vanishes.William Heberden 1768 (1-3)A classical history of angina pectoris has long been considered to be a symptom of myocardial ischemia and, as such, a predictor of the presence of significant coronary artery disease. The work by Høilund-Carlsen et al (pages 641-647 of the current issue of the Journal) challenges this cornerstone of care.This work provides an interesting window into the correlation of clinical history with the presence of angiographic disease. This study was a substudy of a larger prospective study that looked at myocardial perfusion scintigraphy (MPS) as a gatekeeper for coronary angiography (CA) in patients referred for angiography with angina pectoris and possible coronary artery disease.The data collected for this study are unique. At the time of the study, MPS was not a routine part of the work-up of patients with suspected coronary artery disease in Denmark. The patients were isolated on the island of Funen. Patients were sent directly for angiography from local general practitioners or through local hospitals. Before angiography, they received MPS, and only after the angiogram were the results available to the investigator or clinician. This local practice variation enabled a comparison of MPS with CA in a group of patients who would not normally be selected for angiography based on the results of the MPS study, thus eliminating the effect of 'referral' or 'work-up' bias on the correlation of MPS and CA. Work-up bias has been examined in the literature, and the overall effect is that a greater number of angiograms are performed in patients with abnormal scans. This increases the sensitivity and reduces the specificity of the test being evaluated -in this case, the MPS (4,5).This study has a number of companion publications (6-8); the purpose of the original study was to compare patient findings on MPS with those found on CA. In this population, the overall sensitivity of MPS was found to be 75% and the specificity was 79% (8). At publication, these results were attributed to the absence of a referral or work-up bias.The focus of the current publication was the correlation of clinical features to the angiogram. Three clinical assessment scales were used to classify patients undergoing angiography. The subgroups of patients who were thought to have a high probability of disease were then segregated, and the correlation to significant angiographic cor...

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Evidence of bias and variation in diagnostic accuracy studies

Cited by 508 publications

References 55 publications

Clinical validation of automated audiometry with continuous noise-monitoring in a clinically heterogeneous population outside a sound-treated environment

Clinical validation of automated audiometry with continuous noise-monitoring in a clinically heterogeneous population outside a sound-treated environment

How to Evaluate an Article on Diagnosis for Validity

Angina pectoris: Has the cornerstone of symptomatic coronary artery disease been moved?

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