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Quality Assurance in Oncology The European Cancer Centre Certification System (ECC) 2017

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Quality Assurance in OncologyThe European Cancer Centre Certification System (ECC)

2017

1. What are certified centres?

2. Prerequisites for and implementation of the cerftication systema. National Cancer Planb. 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 assuranceb. From the patients`viewpointc. From the point of view of health-care providersd. From the point of view of health –care policy partners

Agenda

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 http://www.bmg.bund.de/fileadmin/dateien/Downloads/N/Nationaler_Krebsplan/Ziel_5-Nationaler_Krebsplan.pdf

1. What are certified centres?

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)

Certified centers: “interdisciplinary and transsectoral […] institutions”

Certified Centres: “that [...] if possible represent the entire chain of health care”

= Network in oncology

Certified centers:“A network of qualified and jointly certified ... institutions”

Certificate:provides guidance and

serves as a decision-making aid for patients

• National Cancer Plan• Current status of the certification system

2. Pre-requisits for and implementation of the certification system

National Cancer Plan

Goal 5: Standardization of certification and quality assurance in oncological treatment institutionsZiel 6: Leitlinien Ziel 8: Klinische KrebsregisterZiel 9: Psychoonkologische Versorgung

2. Further development of health-care structures in oncology and quality assurance

NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions

Three-level modelof oncological care

This should be reflected in a uniform approach using uniform terms for the oncological care structures.

Aims of the National Cancer Plan:

• An organ cancer centre is a centrespecializing in one organ or specialty (breast, bowel, lung, prostate, skin, gynecological tumors)

• Certified by German Cancer Society (DKG)

• An Oncology Centre extends to several organs or specialties, particularly for rare cancers

• Certified by German Cancer Society (DKG)

• 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)

3-level model of oncological care:

Current status of the certification system (as of 31.03.2016)

NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions

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.

Aims of the National Cancer Plan:

Judiciary

Structure of the certification system

Structure of the certification system

Judiciary

Structure of the certification system (1/3)

Structure of the certification system (2/3)

Structure of the certification system (3/3)

From the point of view of quality assuranceFrom the patients viewpointFrom the point of view of health-care providersFrom the point of view of health-care policy partners

4. What effects does certification have?

From the point of view of quality assurance

• 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, research2. Presentation of main treatment partners’ expert reports

Indicators: e.g., results for operations/interventions, post-op./post-intervention complications

3. Presentation of guideline-appropriate treatmentQuality indicators from evidence-based oncological guidelines

Collection of treatment quality data:

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

From the point of view of qualty assurance

The indicator results are presented annually as:

1. An anonymized annual report per cancertype

2. An individual annual report for eachcentre

Presentation of treatment quality:

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 2010–

2014

https://www.krebsgesellschaft.de/gcs/german-cancer-society/certification/documents.html?file=files/dkg/deutsche-krebsgesellschaft/content/pdf/Zertifizierung/breast_annual%20report-2016-A2%28160413%29.pdf

From the point of view of quality assurance

Example: anastomic insufficiency, rectal carcinomaFor 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

Collection of treatment quality data:

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 (2012–2014)— Contains the results for the individual center in

comparison with other centers

From the point of view of quality assurance

Audit + internal discussion:identifying measures

Data sheetinput

Zentrum

Analyses

Certified network

Certified network

Improving the quality of treatment:

Plan Do Check Act !

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, Kreienberg R, Schulte H, Pfaff H: The patients view on accredited breast cancer centres: strengths and potential forimprovement. Geburtshilfe und Frauenheilkunde. 2012;72(2):137-43

From the patients viewpoint

(Some) results from the questionnaire:

When the results for the scales and items are examined in detail, the patientsconfidence in the physicians and nursing staff must be emphasized in particular. Thepatients 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 iteasier 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 thepreparation provided for further interdisciplinary treatment (90.8%).

It is also notable that the breast cancer centres certification played a decisive role inthe choice of hospital for 35.8% of the respondents…

From the patients viewpoint

With prostate cancer:

From the patients viewpoint

Lent, V, Schultheis, H M, Strauß, L, Laaser, M K, Buntrock, S. (2013) Belastungsinkontinenz nach Protatektomie in der Versorgungswirklichkeit. Der Urologe. 52, 8, 1104-1109.

Conclusion for practice

In the reality of health care at largeconvalescent hospitals, only approximatelyhalf of the hospitals (but approximately80% of certified prostate centres) reach thetarget of preserving continence inapproximately one-third of the patiens…

With breast cancer:

From the patients viewpoint

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, 303-308.

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

With breast cancer:

From the patients viewpoint

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, 362-367

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.

With rectal carcinoma:

From the patients viewpoint

With kind permission form Dr. Klinkhammer-Schalke (ADT)

Analysis:The proportion of RO resections (= complete tumour removal) in rectal carcinomaResults:Clinical cancer registry83% of the 4,267 patients received R0 resections (in certified + noncertified institutions)Certified centres:95.2% of the 6,859 patients received R0 resections

With rectal carcinoma:

From the patients viewpoint

With kind permission form Dr. Klinkhammer-Schalke (ADT)

Analysis:Proportion of patients who received combined chemoradiotherapy before surgeryResults:Clinical cancer registry69.8% of the 1,706 patientsreceived neoadjuvantchemoradiotherapy (in certified + noncertified institutions)Certified centres:77.3% of the 3,151 patients received neoadjuvant chemoradiotherapy

With colon carcinoma:

From the patients viewpoint

With kind permission form Dr. Klinkhammer-Schalke (ADT)

Analysis:Proportion of patients receiving postoperative chemotherapy for stage III colon carcinomaResults:Clinical cancer registry59.2% of the 2,442 patients received chemotherapy (in certified + noncertified institutions)Certified centres:70.9% of the 3,177 patients received chemotherapy

With colonrectal carcinoma:

From the patients viewpoint

With kind permission form Dr. Klinkhammer-Schalke (ADT)

Analysis:Proportion of patients in whom at least 12 lymph nodes were removed during surgeryResults:Clinical cancer registry92% 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

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

From the point of view of health-care providers

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):235-42Huthmann D, Sueferlien T, Post S, Benz S, Stinner B, Wesselmann S. Certified stomach cancer centres as seen by their directors: results of aquestionnaire to key personnel. Zeitschrift für Gastroenterologie. 2012;50(8):753-9.

(Some) results from the questionnaire:

From the point of view of health-care providers

(Some) results from the questionnaire:

From the point of view of health-care providers

What is your assessment of the concept of….

Breast cancer centres? Colorectal cancer centres?

From the point of view of health-care providers

Quality loop in Oncology

Aims of the National Cancer Plan:

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

From the point of view of health-care providers

Collaboration on oncological guideline groups and certification system:The results of the QI analysis are returnedto:- The centres- The guideline groupsAnd represent an important basis forfurther development of the guidelinesand of the certification system

• 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-level-model 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.

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 theGerman Guideline Programme in Oncology (GGPO), cancer registries and certification system

Conclusion