Use of Methodological Standards in Diagnostic Test Research

Reid, M. Carrington; Lachs, Mark S.; Feinstein, Alvan R.

doi:10.1001/jama.1995.03530080061042

Cited by 544 publications

(79 citation statements)

References 134 publications

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“…In addition to its prognostic significance in breast cancer patients, HER-2/neu protein over-expression may gain greater values if current ongoing studies confirm its role in predicting response to hormonal and radiotherapy as well as the type of combination and/or dose of chemotherapy (6 -9). However, the utility of this biological marker can be enhanced and better evaluated if we can reach consensus on the appropriate methodology and the most clinically significant cut off points (10).…”

Section: Discussionmentioning

confidence: 99%

Defining a Test for HER-2/neu Evaluation in Breast Cancer in the Diagnostic Setting

et al. 2001

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In breast cancer amplification of the HER-2/neu oncogene and over-expression of the protein product is associated with poor prognosis, predicts response to some chemotherapeutic regimens and is the target for Herceptin treatment. To date there are several methods to assess the amplification/overexpression of HER-2/neu with each having advantages and disadvantages. We have studied amplification and over-expression of HER-2/neu in 250 consecutive cases of breast cancer (220 invasive and 30 in situ carcinomas) presenting to the Department of Pathology at Women's College Campus of Sunnybrook and Women's College Health Sciences Center. Thirty percent of the invasive carcinomas were node positive. HER-2/neu protein overexpression was assessed by immunohistochemistry (IH) using antibody CB11 and amplification of the gene by differential PCR. The percentage of tumor cells showing CB11 staining was determined and the most significant cut off point for positivity was >10% moderate or strong complete membranous staining. The gene was considered amplified if the density score of the product was >2. There was 94% concordance between the two methods (P value .0001). Both methods were positive in 16% of cases and negative in 78% of cases. Discrepant cases were examined by FISH which confirmed the IH results in 9/11 invasive carcinomas. These results show that there is excellent concordance between IH and PCR. However, immunohistochemistry is easier to perform and cheaper than PCR and could be used in routine assessment of HER-2/neu in breast cancer patients.

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Section: Discussionmentioning

confidence: 99%

Defining a Test for HER-2/neu Evaluation in Breast Cancer in the Diagnostic Setting

et al. 2001

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“…No test was classified as indeterminate (17). The exercise tests were performed, analyzed, and reported per standard protocol and utilizing a computerized database (EXTRA, Mosby Publishers, Chicago, IL) (18).…”

Section: Exercise Testingmentioning

confidence: 99%

The prognostic value of exercise testing in elderly men

Spin

Prakash

Froelicher

et al. 2002

The American Journal of Medicine

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“…No test was classified as indeterminate, 15 medications were not withheld, and no maximal heart rate targets were applied. 16 The exercise tests were performed, analyzed, and reported per standard protocol and utilizing a computerized database (EXTRA; Mosby Publishers; Chicago, IL).…”

Section: Exercise Testingmentioning

confidence: 99%

Clinical Utility of the Exercise ECG in Patients With Diabetes and Chest Pain

Lee

Fearon

Froelicher³

2001

Chest

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Objective: The purpose of this study was to determine the characteristics of exercise treadmill testing in diabetic patients presenting with chest pain. Background: The diagnosis of coronary artery disease (CAD) in diabetic patients is confounded by different manifestations of coronary disease than are seen in the general population. Because of the association of diabetes with accelerated CAD, it is critical to assess the diagnostic utility of the standard exercise test in diabetic patients with chest pain. Methods: This study was a retrospective analysis of standard exercise test results in 1,282 male patients without prior myocardial infarction who had undergone coronary angiography and were being evaluated for possible CAD at two Veterans' Administration institutions. Results: In patients with diabetes, 38% had an abnormal exercise test result, and the prevalence of angiographic CAD was 69%; the sensitivity of the exercise test was 47% (95% confidence interval [CI], 41 to 58), and specificity was 81% (95% CI, 68 to 89). In patients without diabetes, 38% had an abnormal exercise test result, and the prevalence of angiographic CAD was 58%; the sensitivity of the exercise test was 52% (95% CI, 48 to 56), and specificity was 80% (95% CI, 76 to 83). The receiver operating characteristic curves were also similar in both diabetic and nondiabetic patients (0.67 and 0.68, respectively).Conclusion: These data demonstrate that the standard exercise test has similar diagnostic characteristics in diabetic as in nondiabetic patients.(CHEST 2001; 119:1576 -1581)

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Use of Methodological Standards in Diagnostic Test Research

Cited by 544 publications

References 134 publications

Defining a Test for HER-2/neu Evaluation in Breast Cancer in the Diagnostic Setting

Defining a Test for HER-2/neu Evaluation in Breast Cancer in the Diagnostic Setting

The prognostic value of exercise testing in elderly men

Clinical Utility of the Exercise ECG in Patients With Diabetes and Chest Pain

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