This article presents for the first time a differentiated overview of the implementation level and development of guideline derived QI results for OC and CC in certified GCCs.
The results of the evaluated QIs show that the recommendations of the guidelines are implemented to a high or very high extent in the certified GCCs. The quality of care is made visible and results between centres can be compared. Grouping the analysed QI into two categories – process organization and treatment procedures – offers the opportunity to assess the improvement potential of QI in a differentiated way and allows to identify suitable measures for improvement which can be implemented in the certified centres.
QIs that reflect the implementation of processes and structures within the certified networks show a very good application. The results illustrate that QIs related to procedural aspects have a very high implementation rate (2019: QI 3: 100%; QI 6: 100%, QI 7: 92.3%; QI 8: 97.8%). The excellent implementation rate of this category of QIs has been realized often right from its introduction (e.g., QI 1 and QI 6 each 2015: 100% and 2019: 100%) and is maintained over the course of time. For instance, mandating that surgical therapy of advanced ovarian cancer can only be performed by specialized gynaecologists not only improves outcomes and is linked to longer survival [10, 11, 17, 18], but is also easily achievable via a top-down process arrangement. Same process can be applied within the network and to cooperation partners regarding implementation of QI 6 (= tumour board presentation rate) and defining mandatory information included in pathology reports such as initial diagnosis, tumour resection and if applicable indicating that lymphadenectomy is complete (= QI 7 and QI 8).
These procedural QIs have tremendous influence on the quality of care for patients, while being relatively easy implementable in GCCs, e.g., through standard operating procedures and handling instructions. This is also shown by a consistently high implementation rate resp. low mean SD of the PO-QI on the individual centre level. Hence, in principle, these indicators and corresponding target values are easily reachable for every certified centre, while taking into account justifiable individual cases such as emergency surgery, preventing the presentation at the pre-therapeutic tumour board. In case of repeated not-justifiable non-fulfilment of this indicator group, a “deviation” in the audit will be given. An ultimately failure to fulfil the indicators can lead to the withdrawal of the certificate.
Results from QIs that report on treatment procedures such as surgical interventions and recommendations for systemic therapy present a slightly different picture. For evaluation of adherence to recommendations for treatment procedures it has to be taken into account that situations in routine care are very complex and conclusions from raw QI data on quality of care are not easily possible . For example, QIs results not reaching a pre-defined threshold (target value) do not necessarily indicate insufficient performance of the providers. Under such circumstances, additional information is needed to decide whether quality of care is adequate or not . Therefore, the given explanations by the certified centres are discussed with the auditor during the on-site audit and checked through random samples of patient files. If explanations of the centres seem to be not adequate, the auditors pronounce “deviations” that need to be remedied by the centres . If explanations are plausible and justifiable no further action is required.
QIs that call for the implementation of systemic therapies in line with the guideline recommendations show a good yet decreasing implementation rate over course of time in this analysis (QI 4: 2014 94.6% to 2019 88.9% and QI 5 2014 69.2% to 2019 60.3%). Explanations from the centres that fell below the target value included for both QI mainly patient-related reasons (i.e., patient death after surgery, patient wish, existing comorbidities and/or poor general health, therapy termination due to side effects). For QI 5 (= First-line chemotherapy of advanced OC) comorbidities and poor general health often also caused changes in therapy regimes. Patients being treated ex domo / outside the network as well as time of data reporting time (i.e., patients can only be counted in the numerator when the therapy is completed) were named as reasons why patients even though the recommendations for chemotherapy was provided during the tumour boards were missing. It must be kept in mind that written explanations have only to be provided in case the number of patients is below the threshold (QI 4 < 30%; QI 5 < 20%) i.e., if the overall number of eligible patients in the numerator or the median decreases, but remains above the threshold, the certified GCCs do not have to provide a reason.
Thus, based on this preliminary evaluation, it can be argued, that in contrast to the results of the PO-QIs the implementation rate for QI documenting application of systemic therapies reaches a plateau where the guideline recommendation is known to the practitioners, but patient-related reasons meaningfully prevent a further increase of the rate. Hence fluctuations of the implementation rate and higher mean SD of these TP-QIs on the individual centre level are to be expected. The decreasing implementation rate could be in relation to higher age and/or existence of multiple comorbidities and/or other therapy regimes. Unfortunately, this cannot be further explored with the present data set as socio-demographic information and detailed information about comorbidities is not yet available or too superficial.
In contrast, TP-QIs that report on surgical interventions offer more room for improvement measures. This set of Qis not only reflects patient-related factors (i.e., comorbidities, poor overall health status, patient rejection of surgery) but also the professional expertise of the surgical team. The surgical therapy is one of the fundamental pillars of the treatment strategy for OC and CC. It is not only the most important diagnostic instrument, but also has direct and strong influence on the prognosis and is part of the is part of a mostly multimodal and interdisciplinary therapy concept . Like QI reporting on systemic therapy, the data shows an increase over the course of time and also reaches a plateau in the implementation rate (i.e., QI 1 2014: 75% to 2019 81.8%; QI 2 2014: 58.8% to 2019: 75.0%% and QI 9 2015 63.2% to 2019 72.9%). While keeping in mind that the denominator of the surgical QIs was often small, explanations for not meeting Q9 (= cytological/histological lymph node staging) target value included mostly the application of a radio chemotherapy prior to the cytological/histological lymph node staging. For QI 2 (= macroscopic complete resection advanced OC) existence of multiple (distant) metastasis was given as the most frequent reason for a not complete macroscopic resection. As reported above, some patients also decided to undergo the procedures outside of the certified network. However, besides patient-related topics, the most frequent reasons for not reaching the QI target value include inoperable situs due to advanced spreading of carcinoma or inter-operative assessment which deemed the surgery as not possible. In the case of QI 2 it was stated several times that the tumour size could only be reduced but not removed. The data unfortunately does not allow to assess if other surgical teams would have come to different conclusion and assessments. During the audit, auditors, and physicians of the GCC discuss if the results are justifiable, but explanations regarding the deviations are typically brief and often superficial .
Following further limitations need to be pointed out in the light of the data interpretation. Firstly, only aggregated data is submitted by the individual centres, hence assessment of individual patients’ information in regard to severity of the case or socio-demographics is not possible. Secondly, centres included in this analysis could be prone to a selection bias as often only already good performing centres are joining quality assurance programmes. Also, the data investigated here cannot be linked to survival data from registries.
As for these QIs the most relevant factors are the personal skills of the practitioners combined with technical prerequisites the opportunity for identifying measures for improvement are given. Thus, measures for improvement of the implementation rate of this QI-set, besides the discussion of results amongst peers during the audit, could include offers of surgical courses or coaching, additionally.
Interestingly, the data also shows that on the individual centre level the results for macroscopic complete resection, sugical staging early OC and cytological/hostological LN staging can widely vary from one year to another with an overall standard deviation of up to 19. Reasons for these fluctuations cannot be provided with the current data available. When interpreting the results, we have to bear in mind the primary purpose of the data collection, i.e., creating a basis for the decision of whether or not the certificate should be issued. . Further investigation is thus necessary. None withstanding, one hypothesis could be that, for instance, staff changes in the surgical team could explain why several centres with high indicator results in one year can have lower results in the forthcoming year. It could be argued that meanwhile, the certified GCCs who maintain a constantly high implementation rate provide a good environment for surgeons in training and could be the ones selected to offer coaching courses for other GCCs.