Review of the quality of total mesorectal excision does not improve the prediction of outcome.

AIM: A fair to moderate concordance in grading of the total mesorectal excision (TME) surgical specimen by local pathologists and a central review panel has been observed in the PROCARE (Project on Cancer of the Rectum) project. The aim of the present study was to evaluate the difference, if any, in the accuracy of predicting the oncological outcome through TME grading by local pathologists or by the review panel. METHOD: The quality of the TME specimen was reviewed for 482 surgical specimens registered on a prospective database between 2006 and 2011. Patients with a Stage IV tumour, with unknown incidence date or without follow-up information were excluded, resulting in a study population of 383 patients. Quality assessment of the specimen was based on three grades including mesorectal resection (MRR), intramesorectal resection (IMR) and muscularis propria resection (MPR). Using univariable Cox regression models, local and review panel histopathological gradings of the quality of TME were assessed as predictors of local recurrence, distant metastasis and disease-free and overall survival. Differences in the predictions between local and review grading were determined. RESULTS: Resection planes were concordant in 215 (56.1%) specimens. Downgrading from MRR to MPR was noted in 23 (6.0%). There were no significant differences in the prediction error between the two models; local and central review TME grading predicted the outcome equally well. CONCLUSION: Any difference in grading of the TME specimen between local histopathologists and the review panel had no significant impact on the prediction of oncological outcome for this patient cohort. Grading of the quality of TME as reported by local histopathologists can therefore be used for outcome analysis. Quality control of TME grading is not warranted provided the histopathologist is adequately trained.

Completeness and registration bias in PROCARE, a Belgian multidisciplinary project on cancer of the rectum with participation on a voluntary basis.

BACKGROUND: PROCARE, a Belgian multidisciplinary project on rectal cancer, started in 2006 with participation on a voluntary basis. Completeness and bias of registration in PROCARE were assessed. METHODS: Data from 6353 patients with rectal cancer were extracted from the population based Belgian Cancer Registry for the period 2006-2008. Registration bias was studied by comparing patient, tumour and treatment characteristics of cases registered and non-registered in PROCARE. Relative survival (RS) of patient subgroups was analysed. RESULTS: PROCARE included 37% of all Belgian rectal cancer patients. Registration was highly variable between participating centres which recorded on average 56% of their patients. Significant differences in patient, tumour and treatment related characteristics were observed between registered and non-registered patients. The 5-year RS was 77% (95% confidence interval (CI): 74-80%) for registered patients and 56% (95% CI: 53-59%) for non-registered patients. After adjustment for patient, tumour characteristics and volume of centre, the relative excess risk of dying (RER) between registered and non-registered patients was 2.15 (95% CI: 1.85-2.50, p<0.001). The 5-year RS of patients treated in centres that never participated in the project was 59% (95% CI: 55-63%) and, after adjustment, the RER was 1.16 (95% CI: 1.00-1.35, p<0.050) compared to patients of the participating centres. CONCLUSION: Registration of PROCARE patient data was incomplete, biased and variable between centres. Participation on a voluntary basis should be avoided for further projects. Quality assurance on a centre level requires compulsory and complete registration with a minimal but relevant data set for all patients treated in all centres.

Need for objective and reproducible criteria in histopathological assessment of total mesorectal excision specimens: lessons from a national improvement project.

AIM: Data on quality control of the pathologic evaluation of total mesorectal excision (TME) specimens are scarce. We aimed to assess differences between evaluation by local pathologists participating in PROject on CAncer of the REctum (PROCARE; a Belgian improvement project on rectal cancer) and by a review panel of experts. METHOD: Based on photographic material and histopathology slides, a Review Committee of gastrointestinal expert pathologists re-evaluated the mesorectal plane, the tumour differentiation grade, the (y)pT stage and the tumour regression grade in 444 patients previously routinely assessed by local pathologists. RESULTS: The surgical plane was reported in 89% of patients and the circumferential resection margin in 88% of patients by the local pathologist. The median number of lymph nodes harvested in patients undergoing neoadjuvant radiochemotherapy was 11 and 14 in the other patients. The Review Committee downgraded the surgical plane from (intra)mesorectal to intramuscular in 17% of patients, and upgraded it from intramuscular to (intra)mesorectal in 27%. Tumour differentiation grade, T stage and tumour regression grade differed between local pathologists and the Review Committee in 15%, 10% and 38%, respectively, of patients. T stage was upgraded, mainly from T2 to T3, in 8% of patients. Tumour regression was judged by the Review Committee to be less advanced in 15% of patients. CONCLUSION: Acknowledging some shortcomings, this study gives a realistic view of clinical practice. There are differences in interpretation with regard to both macroscopic and microscopic analysis of TME specimens. These findings indicate a need for more objective and reproducible criteria in histopathology. Being aware of this is a first step for improvement.

Exploring limits for data registration in the context of PROCARE, a quality improvement project on rectal cancer.

BACKGROUND: A high burden of registration in the context of quality improvement projects may result in registration fatigue. METHODS: Time required for data collection and registration was measured. Quality of care indicators (QCI) were scored and factors for adjusted benchmarking were identified. The PROCARE data set was compared with 5 other European data sets. RESULTS: Time required for data collection varied per domain while time for registration was more uniform. On average, per item 33 seconds were needed for collection and registration. The number of data to be registered per patient was 48-276, depending on the stage of the disease, resulting in a minimum of 25 minutes and a maximum of 2 hours 4 minutes per patient, follow-up not included. Focusing on 43 clinically relevant QCIs would result in a 50% reduction, using aggregate scores for performance audit in a 71% reduction. The PROCARE data set was larger than comparable European data sets. Linkage of the PROCARE database with administrative databases provided confident data on the patients' survival status, but did not appear to be a practical option for other QCIs. CONCLUSIONS: Limiting the aim to performance audit could significantly reduce the burden of registration. In the context of a quality improvement project, the PROCARE Steering Group concluded that detailed clinical data from all centres are still required, which can be reconsidered in the future. Maintenance of a specific database remains of crucial value. Data collection and registration cannot be based on benevolence but should be compensated for.