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

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66 PROCARE – phase 2 KCE reports 813.3 DISCUSSION3.3.1 Measurability of the selected quality indicatorsA major objective of the present study was to analyse the feasibility of measuring QI forrectal cancer care using a prospective database and an administrative database. Of the40 final QI, 30 were measurable for the prospective cohort and 9 were measurable forthe administrative cohort. For the overall 5-year survival (and relative 5-year survival)the follow-up in the prospective cohort was too short to be measurable yet. This QI(and the relative 5-year survival) was measurable for the administrative cohort. Of the 8QI that were not measurable for the prospective cohort, 2 were measurable for theadministrative cohort (discussion in MDT and proportion of patients with stoma 1 yearafter sphincter-sparing surgery). Six QI were measurable for both cohorts, while 7other QI were not measurable for both cohorts (including the disease-specific 5-yearsurvival).In the prospective database, the main reason for not being measurable was the absenceof a code (n = 5) or a specific code (n = 2). One QI was not measurable because ofinconsistencies in the database. In theory, these problems can be solved by addingvariables to or adjusting existing variables in the PROCARE registration form. However,adding variables would increase the burden of registration for the involved healthcareproviders. Ideally and where possible, the PROCARE database should be linked to theadministrative databases for those QI that are not measurable using the PROCAREdatabase alone. In theory, this is possible through the unique patient identifier.In the administrative database, the absence of codes for clinical outcomes (mainly R0resection) and results (e.g. cCRM) was the main reason for not being measurable (n =21). For 7 other QI, the available administrative codes were too unspecific. Incomparison to the prospective database, it is much more difficult (and probablyimpossible) to add codes. The used administrative databases, in particular the HIC andTC databases, were build for financing reasons rather than for measuring the quality ofcare.3.3.2 Definition of quality indicatorsSome of the selected QI are defined for specific subpopulations, such as patientsundergoing surgery or treatment in general. Of course, many of these QI are alsoapplicable to a broader group of patients with rectal cancer. For example, stagingprocedures (such as pelvic CT, large bowel-imaging, etc.) are necessary to decide onfurther treatment for all patients, and not only for patients eventually undergoingtreatment [1]. Nevertheless, the message of this study should be that most QI aremeasurable or can be rendered measurable. In a later phase, it can be decided toenlarge the scope of each individual QI. Additional risk-adjustment will then benecessary for some QI.3.3.3 Possible problems with the interpretation of the quality indicatorsA high number of missing data was identified. For 18 of the 30 QI measurable with theprospective database, the % missing data exceeded 10% (Table 57). Most frequently,missing data were caused by an unknown cStage or (y)pStage or an unknownchemotherapy or radiotherapy regimen. The % missing data was lower for theadministrative database, with more than 10% missing data for 2 of the 10 measurableQI. The single most important cause was an unknown cStage.For 6 QI it was impossible to calculate the exact % of missing data in the prospectivedatabase because of the presence of variables with a default value ‘0’. To increase thereliability of the PROCARE database, all variables with default value ‘0’ should beidentified and adapted to allow an identification of missing data.
KCE Reports 81 PROCARE – phase 2 67Partially related to the problem of missing data, a high number of QI – measurable withthe PROCARE database – had small denominators, with 13 QI having less than 250patients included in the denominator (Table 57). For some QI, the follow-up was tooshort to include an adequate number of patients in the denominator. The problem ofsample size is also reflected in the number of patients included in the denominator percentre (Table 57). For 15 QI measurable with the PROCARE database this number isless than 10. This problem emphasizes the need to improve the exhaustiveness of thePROCARE database, not only in terms of participating centres, but also in terms ofpatients. Indeed, it is not inconceivable that some centres did not register all of theirpatients or even selectively transmitted their ‘good’ patients. Also, in some centres onlyone surgeon is involved in the project, while others aren’t. To avoid this threat ofselection bias, the PROCARE database can be coupled with the administrative databaseto check the completeness of the patient inclusion.In order to provide meaningful feedback to the participating centres, their individualscore should be positioned against the other (anonymized) centres and against a desiredscore. For most QI these desired scores are available from the literature [9, 11] and/orthe PROCARE guideline [1]. However, since it is not the intention of the authors tojudge the quality already, these desired scores are not provided in the document. Forthe interpretation of most QI, it is also necessary to risk-adjust and to provideadditional ‘third level’ information to the participating centres. For example stage andlevel of the tumour (upper vs. middle vs. lower third of the rectum) have an importantinfluence on the choice of treatment and on patient outcomes.It is important to emphasize that the results of the 6 QI that are measurable in bothdatabases cannot be compared between the 2 databases. First, a time lag exists betweenthe 2 databases, with different treatment standards available. Second, both cohortsdiffer in terms of age and stage distribution (see chapter 3.2.1), mainly because of theselection bias mentioned above.Based on the results of this feasibility study, suggestions were made for each individualQI to improve the measurability or interpretability. These suggestions are summarisedin Table 58. Although it is tempting for the reader to already interpret the QI resultspresented in this report, the suggested adaptations are first needed. Therefore, theseresults cannot be used to judge the quality of rectal cancer care at present.
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