Pathology data in the central databases of multicenter randomized trials need to be based on pathology reports and controlled by trained quality managers
Id. Nagtegaal et al., Pathology data in the central databases of multicenter randomized trials need to be based on pathology reports and controlled by trained quality managers, J CL ONCOL, 18(8), 2000, pp. 1771-1779
Purpose: Randomized multicenter trials form the basis of health care develo
pment. Regarding cancer research, pathology data are crucial. To maintain t
he quality of these trials, the auditing of subsequent processes is necessa
ry. The aim of the present study was to examine the completeness and accura
cy of data obtained from a special-purpose standardized pathology form comp
ared with the data available through traditional hospital pathology reports
.
Patients and Methods: A retrospective comparison of pathology data case rec
ord forms with hospital pathology reports was performed using the data from
300 patients with primary rectal cancer. All of these patients had been in
cluded in a large multicenter trial in the Netherlands. Three independent a
udits were carried out. Special attention was given to the accuracy of para
meters, which are important for prognosis and treatment decisions. Furtherm
ore, 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 nod
es examined, whereas most errors were made in relation to the circumferenti
al margin. Trained review pathologists made fewer major errors. Discrepanci
es 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 th
e special-purpose pathology forms, original pathology reports have to be co
llected, and the data should also be controlled by a trained pathology qual
ity manager.
J Clin Oncol 18:1771-1779. (C) 2000 by American Society of Clinical Oncolog
y.