Assurance de qualité pour le cancer rectal – phase 2 ...

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12 PROCARE – phase 2 KCE reports 81One QI was found addressing the need to start adjuvant chemotherapy within 8 weeksof surgical resection [5]. The rationale is that adjuvant therapy is able to treatmicrometastatic disease at a time when tumour burden is at a minimum. This QI wasselected, but adapted to the PROCARE recommendation of administering adjuvantchemotherapy within 3 months of surgery [1].QI 1244 and 1245 were not found in the literature, but were added to the final QIselection based on the PROCARE recommendations [1]. The rationale behind QI 1244is that 5-FU given by IV injection for 5 days every 4 weeks for 6 cycles is the regimenfor which the most evidence is available and that is clearly effective in prolongingsurvival in patients with stage III [1]. Treatment with chemotherapy is associated with anacceptable complication rate. However, complication rate is dose-dependent and can beartificially kept low by lowering the dose.2.2.2.6 Quality indicators related to palliative careTwo QI on palliative care were selected:• Rate of cStage IV patients receiving chemotherapy (QI 1251) (high level ofevidence• Rate of acute grade 4 chemotherapy-related complications in stage IVpatients (QI 1252) (expert opinion)Two QI were identified in the literature addressing palliative chemotherapy [3]. The aimof palliative systemic therapy is to improve survival and quality of live in patients withadvanced rectal cancer [1].No QI was identified in the literature addressing chemotherapy-related complications.However, this was considered a very important topic related to manyrecommendations of the PROCARE guideline [1]. It was therefore added to the final QIselection.2.2.2.7 Quality indicators related to follow-upThree QI on follow-up were selected:• Rate of curatively treated patients that received a total colonoscopywithin 1 year after resection (QI 1261) (moderate level of evidence)• Rate of patients undergoing regular follow-up (according to thePROCARE recommendations) (QI 1262) (moderate level of evidence)• Late grade 4 complications of radiotherapy or chemoradiation (QI 1263)(expert opinion)For curatively treated patients it is recommended to perform a colonoscopy 1 yearafter the resection [1]. Several related QI were identified in the literature [3], andmerged into 1 final QI.The aim of regular follow-up is to detect local recurrence and/or metastasis at an earlypotentially (surgically) curable stage, and to detect new primary tumours [1]. Patientsthat are fit for further treatment in case of recurrent disease should be offered intensivefollow-up. However, individual randomised trials show no advantage of follow-up interms of survival. Meta-analyses indicate that follow-up can offer survival benefit bymeans of earlier detection of metastatic or recurrent disease. There is some evidencethat intensive follow-up does improve long-term survival for stage II and III colorectalcancer [1]. No related QI were identified in the literature, but based on the PROCARErecommendations this QI was added to the final selection.QI addressing late (chemo)radiotherapy-related complications were also not found inthe literature, but was added to the final selection in view of the relation with severalPROCARE recommendations [1].
KCE Reports 81 PROCARE – phase 2 132.2.2.8 Quality indicators related to histopathologic examinationSix QI related to histopathologic were selected:• Use of the pathology report sheet (QI 1271) (expert opinion)• Quality of TME assessed according to Quirke and mentioned in thepathology report (QI 1272) (low level of evidence)• Distal tumour-free margin mentioned in the pathology report (QI 1273)(low level of evidence)• Number of lymph nodes examined (QI 1274) (low level of evidence)• (y)pCRM mentioned in mm in the pathology report (QI 1275) (low levelof evidence)• Tumour regression grade mentioned in the pathology report (afterneoadjuvant treatment) (QI 1276) (low level of evidence)For most of the selected QI on pathology, no QI were identified in the literature. Thefinal selection is therefore primarily based on the PROCARE recommendations [1].Only for QI 1274, several QI were found in the literature [5, 6]. The pathologist shouldfind as many lymph nodes as possible. The median number found is an indication of thequality of the pathological examination. Ideally, it should exceed 12 lymph nodes [1].During the first external expert meeting of this project, it was suggested to use thementioning of the (y)pTN in the pathology report as a QI. However, to our opinion thisis not a QI, since it has no direct relation with the quality of care. Nevertheless, it isessential information for stage grouping and adjustment, and resultantly for thecalculation of many selected QI. Therefore, this information will always be reportedalong the results of the QI where relevant.2.3 DISCUSSIONIn total, 40 QI were selected covering all aspects of the management of rectal cancerand representing a balanced mix of process and outcome indicators. The selection ofthese QI was based on a literature search and completed with QI based on thePROCARE recommendations [1]. No formalised procedure was used to select the QI,but on different occasions the selection was discussed with a multidisciplinary expertpanel. Above this, the selection was approved by the PROCARE board and an externalexpert panel. The final selection is therefore considered very relevant.Several selected (mainly outcome) QI are also relevant for other cancers, such as 5-yearsurvival, local recurrence rate, multidisciplinary discussion, time to treatment, rate of(late) grade 4 chemotherapy and/or radiotherapy-related complications, proportion ofR0 resections, and the inpatient or 30-day mortality. The routine registration of theseparameters for all cancers would therefore be of high relevance for the measurement ofthe quality of care in oncology.The final QI selection represents the current state of the art according to thePROCARE recommendations [1]. In view of the changing evidence, this QI set willprobably need an update in about 5 years.
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