Quality Assurance in Oncology. The European Cancer Centre Certification System (ECC) 2017
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1 Quality Assurance in Oncology The European Cancer Centre Certification System (ECC) 2017
2 Agenda 1. What are certified centres? 2. Prerequisites for and implementation of the cerftication system a. National Cancer Plan b. Current status of the certification system 3. Structures of the certification system 4. What effects does certification have? a. From the point of view of quality assurance b. From the patients`viewpoint c. From the point of view of health-care providers d. From the point of view of health care policy partners
3 1. What are certified centres? Definition: A network of qualified and jointly certified interdisciplinary and trans sectoral [...] institutions that [...] if possible represent the entire chain of health care for those affected [...] German National Cancer Plan
4 Certified centers: interdisciplinary and transsectoral [ ] institutions The Breast Cancer Centre as an example: Obligatory members of the centre Gynecology, radiotherapy, pathology, radiology, hematology/oncology, nursing, physicians in private practice, genetic counseling, psycho-oncology, social services, physiotherapy, genetics, palliative medicine, pain therapy, rehabilitation, cancer registry and self-help group = Cooperation between medical specialties (= interdisciplinarity), professional groups (= inter-professionalism), and sectors (= transsectorally)
5 Certified Centres: that [...] if possible represent the entire chain of health care = Network in oncology
6 Certified centers: A network of qualified and jointly certified... institutions Certificate: provides guidance and serves as a decision-making aid for patients
7 2. Pre-requisits for and implementation of the certification system National Cancer Plan Current status of the certification system
8 National Cancer Plan 2. Further development of health-care structures in oncology and quality assurance Goal 5: Standardization of certification and quality assurance in oncological treatment institutions Ziel 6: Leitlinien Ziel 8: Klinische Krebsregister Ziel 9: Psychoonkologische Versorgung
9 NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions Aims of the National Cancer Plan: Three-level model of oncological care This should be reflected in a uniform approach using uniform terms for the oncological care structures.
10 3-level model of oncological care: A Comprehensive Cancer Centre (CCC) is a leading Oncology Centre with major research aims. Specifically for rare cancer diseases and special issues Certified by German Cancer Aid (DKH) An Oncology Centre extends to several organs or specialties, particularly for rare cancers Certified by German Cancer Society (DKG) An organ cancer centre is a centre specializing in one organ or specialty (breast, bowel, lung, prostate, skin, gynecological tumors) Certified by German Cancer Society (DKG)
11 Current status of the certification system (as of )
12 NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions Aims of the National Cancer Plan: Structure of the certification system Judiciary In the framework of certification procedures, it must be ensured that the interdisciplinary definition and compilation of a catalogue of requirements for certification are already established before an independent, institutionally separate evaluation is carried out on the basis of the requirements.
13 Structure of the certification system Judiciary
14 Structure of the certification system (1/3)
15 Structure of the certification system (2/3)
16 Structure of the certification system (3/3)
17 4. What effects does certification have? From the point of view of quality assurance From the patients viewpoint From the point of view of health-care providers From the point of view of health-care policy partners
18 From the point of view of quality assurance Collection of treatment quality data: The centres have to present their results annually on a data sheet There are separate indicators for each type of cancer (ca. 25) Indicators for: 1. Presentation of the certified network Indicators: e.g., tumour board, psycho-oncology, social work, research 2. Presentation of main treatment partners expert reports Indicators: e.g., results for operations/interventions, post-op./postintervention complications 3. Presentation of guideline-appropriate treatment Quality indicators from evidence-based oncological guidelines
19 From the point of view of quality assurance Collection of treatment quality data: Quality assurance in data entry: - Data can be entered via the hospital (or cancer registry) - Excel entry template - With plausibility limits for all key figures: if the plausibility limits are exceeded, the center has to explain the reasons in a free text field - With automatic copying of figures into various cells, avoiding the risk of incorrect entry - Can only be sent to OnkoZert when all the fields have been filled in and have had their plausibility checked - Before the audit: - Formal checking by OnkoZert - Checking of content by the auditor, who can request comments if needed - During the audit: - Checking of details using actual patient files - Discussion of results between center and auditor, establishing any steps that need to be taken if appropriate
20 From the point of view of qualty assurance Presentation of treatment quality: The indicator results are presented annually as: 1. An anonymized annual report per cancer type 2. An individual annual report for each centre
21 From the point of view of qualty assurance Example: anonymized annual report for certified colorectal cancer centres, 2016 Contains the results for 261 certified colorectal cancer locations in 2015 Contains the aggregate data for around 115,000 patients with a first diagnosis of bowel cancer Contains the results for 30 indicators Shows the development of the results for
22 From the point of view of quality assurance Collection of treatment quality data: Example: anastomic insufficiency, rectal carcinoma For all key figures that exceed the plausibility limits or reference ranges, the centres' explanations, planned actions, and auditors' comments are analysed in the audit report
23 From the point of view of qualty assurance Example: individual annual analysis for an individual colorectal cancer center in 2016 Contains the results of the anonymized report Contains the results for the individual center over a period of time ( ) Contains the results for the individual center in comparison with other centers
24 From the point of view of quality assurance Improving the quality of treatment: Plan Do Check Act! Data sheet input Analyses Audit + internal discussion: identifying measures Certified Zentrum network Certified network
25 From the patients viewpoint Questionnaire completed by patients in certified breast cancer centres: Initial question: How is the care provided in a breast cancer centre evaluated from the patients viewpoint? Breast centre: 8,226 patients from 128 centres participated, 7,301 responses, response rate 88.76%, questionnaire period March November 2010 Kowalski C, Wesselmann S, KreienbergR, Schulte H, Pfaff H:The patients view on accredited breast cancer centres: strengths and potential for improvement. Geburtshilfe und Frauenheilkunde. 2012;72(2):137-43
26 From the patients viewpoint (Some) results from the questionnaire: When the results for the scales and items are examined in detail, the patients confidence in the physicians and nursing staff must be emphasized in particular. The patients had the fullest confidence in the staff (physicians 97.3%, nursing staff 96.7%) and assessed them as being very competent (physicians 98.4%, nursing staff 97.2%. In addition, they stated that they felt well supported by staff and that this made it easier to cope with the disease (physicians 89.2%, nursing staff 93.7%) The process of discharge from the hospital is given a very positive evaluation i.e., the explanations provided for further treatment steps (93.8% of the patients) and the preparation provided for further interdisciplinary treatment (90.8%). It is also notable that the breast cancer centres certification played a decisive role in the choice of hospital for 35.8% of the respondents
27 From the patients viewpoint With prostate cancer: Lent, V, Schultheis, H M, Strauß, L, Laaser, M K, Buntrock, S. (2013) Belastungsinkontinenz nach Protatektomie in der Versorgungswirklichkeit. Der Urologe. 52, 8, Conclusion for practice In the reality of health care at large convalescent hospitals, only approximately half of the hospitals (but approximately 80% of certified prostate centres) reach the target of preserving continence in approximately one-third of the patiens
28 From the patients viewpoint With breast cancer: Heil, J., Gondos, A., Rauch, G., Marme, F., Rom, J., Golatta, M., Junkermann, H., Sinn, P., Aulmann, S., Debus, J., Hof, H., Schütz, F., Brenner, H., Sohn, C., Schneeweiss, A., (2012) Outcome analysis of patients with primary breast cancer initially treated at a certified academic breast unit. The Breast. 21, 3, Conclusion Compared with recent populations-based reports from Germany, more favourable patient characteristics and nominally higher survival was found amongst this large cohort of patients with primary breast cancer treatment at a single certified breast unit
29 From the patients viewpoint With breast cancer: Beckmann, M.W., Brucker, C., Hanf, V., Rauh, C., Bani, M.R., Knob, S., Petsch, S., Schick, S., Fasching, P.A., Hartmann, A., Lux, M.P., Häberle, L. (2011) Qualitätsgesicherte Versorgung in zertifizierten Brustzentren und Optimierung der Behandlung von Patientinnen mit einem Mammakarzinom. Onkologie. 34, 7, Conclusion Independently of the classic prognostic factors, care in a certified breast centre is associated with an improvement in prognosis for patients with breast carcinoma.
30 From the patients viewpoint With rectal carcinoma: With kind permission form Dr. Klinkhammer-Schalke (ADT) Analysis: The proportion of RO resections (= complete tumour removal) in rectal carcinoma Results: Clinical cancer registry 83% of the 4,267 patients received R0 resections (in certified + noncertified institutions) Certified centres: 95.2% of the 6,859 patients received R0 resections
31 From the patients viewpoint With rectal carcinoma: With kind permission form Dr. Klinkhammer-Schalke (ADT) Analysis: Proportion of patients who received combined chemoradiotherapy before surgery Results: Clinical cancer registry 69.8% of the 1,706 patients received neoadjuvant chemoradiotherapy (in certified + noncertified institutions) Certified centres: 77.3% of the 3,151 patients received neoadjuvant chemoradiotherapy
32 From the patients viewpoint With colon carcinoma: Analysis: Proportion of patients receiving postoperative chemotherapy for stage III colon carcinoma Results: Clinical cancer registry 59.2% of the 2,442 patients received chemotherapy (in certified + noncertified institutions) Certified centres: 70.9% of the 3,177 patients received chemotherapy With kind permission form Dr. Klinkhammer-Schalke (ADT)
33 From the patients viewpoint With colonrectal carcinoma: With kind permission form Dr. Klinkhammer-Schalke (ADT) Analysis: Proportion of patients in whom at least 12 lymph nodes were removed during surgery Results: Clinical cancer registry 92% of the 11,700 patients underwent surgery with removal of at least 12 LNs (in certified + noncertified institutions) Certified centres: 95.9% of the 16,080 patients underwent surgery with removal of at least 12 LNS
34 From the point of view of health-care providers Initial questions: What effects does certification have on everyday clinical work? How much acceptance is there for the concept of certified centres from the point of view of centres management? Colorectal cancer centres: 211 centres contacted, 161 responses, response rate 76,3%. Questionnaire period September October 2011 Breast cancer centres: 243 sites contacted, 149 responses, response rate 61.3%. Questionnaire period June September 2011 Kowalski C, Wesselmann S, Ansmann L, Kreenberg R, Pfaff H. Key informants perspectives on accredited breast cancer centres: results of a survey. Geburtshilfe und Freuenheilkunde. 2012;72(3): Huthmann D, Sueferlien T, Post S, Benz S, Stinner B, Wesselmann S. Certified stomach cancer centres as seen by their directors: results of a questionnaire to key personnel. Zeitschrift für Gastroenterologie. 2012;50(8):753-9.
35 From the point of view of health-care providers (Some) results from the questionnaire:
36 From the point of view of health-care providers (Some) results from the questionnaire: What is your assessment of the concept of. Breast cancer centres? Colorectal cancer centres?
37 From the point of view of health-care providers Aims of the National Cancer Plan: Quality loop in Oncology
38 From the point of view of health-care providers Collaboration on oncological guideline program and Certification: - While developing evidence-based treatment guidelines, quality indicators (QI) are derived from strong recommendations - The QI provide the basis for certification - Currently they are used for 13 guidelines
39 From the point of view of health-care providers Collaboration on oncological guideline groups and certification system: The results of the QI analysis are returned to: - The centres - The guideline groups And represent an important basis for further development of the guidelines and of the certification system
40 Conclusion A certified Centre is a network of qualified and jointly certified interdisciplinary and transsectoral institutions that if possible represent the entire chain of health care for those affected The certification of the oncological care structures follows the three-levelmodel of oncological care (national cancer plan) consisting out of organ cancer centres, oncology centres and comprehensive care centres The certification system is structured in an legislative, executive and judicative part with a division of tasks.
41 Conclusion Certification has effects from the Point of view of quality assurance: implementation of a PDCA-Cycle Patients viewpoint: improvement of quality of care Point of view of health-care providers: improvement of quality of care, tumour boards, communication etc. Point of view of health-care policy partners: cooperation between the German Guideline Programme in Oncology (GGPO), cancer registries and certification system
42
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