I am currently working on a case-control study on a rare disease using a large patient database. Using conditional logistic regression I will calculate odds ratios for different exposures in cases and controls. The validity of the records for the disease of interest (outcome) is unknown.

I have found around 550 potential cases with a record for the outcome of interest. Two specialists are going to divide those 550 patients in probable and unlikely cases based on the information they have. For 100 of those 550 potential cases, I additionally have discharge letters (which I did not give to the specialists) which confirm/refute the diagnosis. With those discharge letters I am going to be able to calculate the specificity and sensitivity of the classification made by the specialists.

However from what I know I can assume that the specificity and sensitivity will be fairly high but not at 100%, meaning that my results will be biased by misclassified cases. I have been looking for literature which addresses the issue of outcome misclassification and I have found a paper about a procedure used in cohort studies (Madger and Hughes, 1997, Logistic regression when the outcome is measured with uncertainty). This technic is however not applicable in case-control studies. The mentioned paper is in the attachment.

How can I address this issue? Is there a possibility to adjust for outcome misclassification bias in a case-control study if the sensitivity and specificity for the outcome variable is known?

Thank you very much for your help!

I have found around 550 potential cases with a record for the outcome of interest. Two specialists are going to divide those 550 patients in probable and unlikely cases based on the information they have. For 100 of those 550 potential cases, I additionally have discharge letters (which I did not give to the specialists) which confirm/refute the diagnosis. With those discharge letters I am going to be able to calculate the specificity and sensitivity of the classification made by the specialists.

However from what I know I can assume that the specificity and sensitivity will be fairly high but not at 100%, meaning that my results will be biased by misclassified cases. I have been looking for literature which addresses the issue of outcome misclassification and I have found a paper about a procedure used in cohort studies (Madger and Hughes, 1997, Logistic regression when the outcome is measured with uncertainty). This technic is however not applicable in case-control studies. The mentioned paper is in the attachment.

How can I address this issue? Is there a possibility to adjust for outcome misclassification bias in a case-control study if the sensitivity and specificity for the outcome variable is known?

Thank you very much for your help!

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