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PubMed · 9333348

Receiver operating characteristic studies and measurement errors.

Abstract

A receiver operating characteristic (ROC) curve expresses the probability of a true positive (PTP) as a function of the probability of a false positive (PFP) for all possible values of the cutoff between cases and controls. Theta, the area under ROC curve, is a measure of the diagnostic ability of the separator variable. The usual nonparametric estimate of theta is shown to be based when the separator is measured with error. An expression for the largest-order term of the bias is found. The observed values and the measurement error variance are used to form a kernel estimate of the underlying distribution. These kernel estimates are used to estimate the bias. Monte Carlo simulation indicates that, for several families of distributions, the bias-corrected estimators have smaller bias and comparable MSE to the usual estimator. An application to the data of Clayton, Moncrieff, and Roberts (1967, British Medical Journal 3, 133-136) illustrates the technique.

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BibTeXRIS

M Coffin, S Sukhatme. 1997. Receiver operating characteristic studies and measurement errors.. https://pubmed.ncbi.nlm.nih.gov/9333348/

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Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 &#xb1; 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

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