The implementation of guidelines and computerised forms improves the completeness of cancer pathology reporting. The CROPS project: a randomised controlled trial in pathology
Introduction
Timely, complete and accurate pathology reports are fundamental to the provision of quality cancer services. Inconsistent pathology reporting, such that essential data items of therapeutic or prognostic relevance are sometimes missing, can lead to inconvenience for the patient and the clinician, delays in treatment, and inadequate or inappropriate postoperative therapy. Consequently, pathology reporting contributes to differences in standards of treatment between clinical teams. Previous audits carried out in Wales on breast and colorectal cancer histopathology reporting showed significant inter- and intra-hospital variation in the data items mentioned in reports, indicating scope for standardisation. For example, in 1991 only 55% of pathology reports on invasive breast cancer specimens contained information on histological grade [1] when there is strong evidence that grade predicts survival and response to chemotherapy 2, 3, 4, 5. In 1993, only 51.5% of rectal cancer reports contained a statement on the completeness of excision at the circumferential margin [6] when this predicts local recurrence and may indicate the need for post-operative radiotherapy [7]. There is evidence to show that the use of standardised pre-defined forms (as opposed to the use of free text) improves the quality and completeness of pathology reports 8, 9. However, these studies have only been carried out in specialist teaching hospitals, and the generalisability of the findings to district hospital laboratories has not been investigated.
Histopathology data also form an important element of cancer registration and accurate, complete recording of pathology information contributes to the overall quality of a registry by facilitating high levels of ascertainment and satisfying national requirements for data completeness, including pathological staging. Currently data entry in most registries depends on the interpretation of free text pathology reports by trained coders. The reliability of coding is affected by the fact that pathology reports are actually intended for communication with clinicians making therapeutic decisions rather than clinical coders who work to objective rules. Free text pathology reports therefore raise data quality issues from a Registry perspective because they are not designed for cancer registration purposes. The potential for collecting histopathology data electronically and its direct transmission to the Cancer Registry in coded format, obviating the need for any interpretative stage, has been recognised for some time [10], but there has been little attempt at its implementation on a regional or national scale.
We report here the findings of the Cancer Registration through On-line Pathology Systems (CROPS) project in Wales, UK. This project was funded in 1996 when the (then) Welsh Office of the UK Government was implementing an all Wales pathology computer system. This provided an opportunity to investigate the use of standardised computerised forms containing a set of specified data items, supplemented by written and on-screen guidelines, for reporting cancer specimens in all 16 hospitals in the Principality, and to consider the possibility of using electronic transfer of this standardised pathology data to the Cancer Registry.
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Project design
The project used a split unit design with stratified cluster randomisation by pathology laboratory. The 16 pathology laboratories, employing 39 consultant histopathologists and six registrars, in Wales were randomised into either the breast or the colorectal cancer reporting group. Laboratories were stratified according to workload, whether they reported breast screening programme specimens and the type of computer system they operated. In each hospital, the pathologists completed a
Results
2042 reports from 16 hospitals were available for analysis (Table 3). For breast cancer, there were 602 reports in the study arm and 539 in the control arm. For colorectal cancer, there were 442 and 459, respectively. A thorough search of hospital databases for all possible specimens identified that 680 specimens had not received a form report in the study arm. Over half 376 of these missing study reports were either breast core biopsies or colorectal biopsies of less than 5 mm which could not
Discussion
In this paper, we have described the first use of a randomised controlled trial to investigate an intervention in the process of pathology reporting. The results show that a package of guidelines and computerised forms made a significant impact on the completeness of data available, both to the clinicians treating the patients and to the Cancer Registry, compared with interpretation of free text reports by medical staff and Cancer Registry coders, respectively. Furthermore, the benefit has been
Acknowledgements
This research was funded by a grant from the Wales Office of Research and Development for Health and Social Care, with additional support from the Royal College of Pathologists Audit Office, the Welsh Cancer Intelligence and Surveillance Unit and Breast Test Wales — the Welsh breast screening programme. This project could not have been completed without collaboration and data collection by histopathologists in Wales: Dr M. Appleton; Dr R. Attanoos; Dr A.H. Burdge; Dr S. Burroughs; Dr T.
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