This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nagtegaal, I. D. Articles by van Krieken, J. H. J. M. Search for Related Content PubMed PubMed Citation Articles by Nagtegaal, I. D. Articles by van Krieken, J. H. J. M.

Pathology Data in the Central Databases of Multicenter Randomized Trials Need to Be Based on Pathology Reports and Controlled by Trained Quality Managers

From the Departments of PathologySurgery, and Medical Statistics, Leiden University Medical Center, Leiden, and Department of Pathology, University Medical Center St Radboud, Nijmegen, the Netherlands.

Address reprint requests to J.H.J.M. van Krieken, MD, PhD, Department of Pathology, University Medical Center St Radboud, PO Box 9101, 6500HB Nijmegen, the Netherlands; email J.vanKrieken@ pathol.azn.nl.

PURPOSE: Randomized multicenter trials form the basis of health care development. Regarding cancer research, pathology data are crucial. To maintain the quality of these trials, the auditing of subsequent processes is necessary. The aim of the present study was to examine the completeness and accuracy of data obtained from a special-purpose standardized pathology form compared with the data available through traditional hospital pathology reports.

PATIENTS AND METHODS: A retrospective comparison of pathology data case record forms with hospital pathology reports was performed using the data from 300 patients with primary rectal cancer. All of these patients had been included in a large multicenter trial in the Netherlands. Three independent audits were carried out. Special attention was given to the accuracy of parameters, which are important for prognosis and treatment decisions. Furthermore, various factors that possibly influence the occurrence of errors were investigated.

RESULTS: Quality control of the pathology data revealed a high accuracy of 86.5% of all data items. However, only one third of the forms were complete and correct. Missing values were most prominent in the number of lymph nodes examined, whereas most errors were made in relation to the circumferential margin. Trained review pathologists made fewer major errors. Discrepancies were detected in all control rounds.

CONCLUSION: Successive rounds of quality control are required for accuracy and completeness of pathology data in multicenter trials. In addition to the special-purpose pathology forms, original pathology reports have to be collected, and the data should also be controlled by a trained pathology quality manager.

This article has been cited by other articles:

				P. de Heer, M. J.E.M. Gosens, E. C. de Bruin, N. G. Dekker-Ensink, H. Putter, C. A.M. Marijnen, A. J.C. van den Brule, J. H. J.M. van Krieken, H. J.T. Rutten, P. J.K. Kuppen, et al. Cyclooxygenase 2 Expression in Rectal Cancer Is of Prognostic Significance in Patients Receiving Preoperative Radiotherapy Clin. Cancer Res., May 15, 2007; 13(10): 2955 - 2960. [Abstract] [Full Text] [PDF]

				I. D. Nagtegaal, C. J.H. van de Velde, E. van der Worp, E. Kapiteijn, P. Quirke, and J. H. J.M. van Krieken Macroscopic Evaluation of Rectal Cancer Resection Specimen: Clinical Significance of the Pathologist in Quality Control J. Clin. Oncol., April 1, 2002; 20(7): 1729 - 1734. [Abstract] [Full Text] [PDF]

				C. A.M. Marijnen, E. Kapiteijn, C. J.H. van de Velde, H. Martijn, W. H. Steup, T. Wiggers, E. K. Kranenbarg, and J. W.H. Leer Acute Side Effects and Complications After Short-Term Preoperative Radiotherapy Combined With Total Mesorectal Excision in Primary Rectal Cancer: Report of a Multicenter Randomized Trial J. Clin. Oncol., February 1, 2002; 20(3): 817 - 825. [Abstract] [Full Text] [PDF]

				E. Kapiteijn, C. A.M. Marijnen, I. D. Nagtegaal, H. Putter, W. H. Steup, T. Wiggers, H. J.T. Rutten, L. Pahlman, B. Glimelius, J. H. J.M. van Krieken, et al. Preoperative Radiotherapy Combined with Total Mesorectal Excision for Resectable Rectal Cancer N. Engl. J. Med., August 30, 2001; 345(9): 638 - 646. [Abstract] [Full Text] [PDF]

				C.A.M. Marijnen, I.D. Nagtegaal, E. K. Kranenbarg, J. Hermans, C.J.H. van de Velde, J.W.H. Leer, and J.H.J.M. van Krieken No Downstaging After Short-Term Preoperative Radiotherapy in Rectal Cancer Patients J. Clin. Oncol., April 1, 2001; 19(7): 1976 - 1984. [Abstract] [Full Text] [PDF]