Upload
buixuyen
View
212
Download
0
Embed Size (px)
Citation preview
Guideline development in rare cancer:
a combined patient-physician effort
in sarcoma
Peter Hohenberger
Div. of Surgical Oncology & Thoracic Surgery
UMM Mannheim
University of Heidelberg, Germany
Guideline development in rare cancer:
a combined patient-physician effort
in sarcoma
……. with the experience derived from sarcoma
to be used for other rare cancers
Problems of rare cancers
� Unexperienced physicians outside expertise centers
� Expert patients often have more expertise than
unexperienced physicians
� Well-trained patients
(knowledge about methodology, data on toxicity
not officially reported, PROs)
� Not much data from randomised studies available
� Radiation therapy
� Chemotherapy
� Radio-Chemotherapy
� Isolated limb perfusion
� Chemotherapy + hyperthermia
AJCC stage III sarcomas: neoadjuvant treatment options
Facts
� In sarcoma, there is not much (good) Cochrane
evidence
� Not many prospective randomized phase III
studies
� How good are guidelines ?
� LoE ? Best level: big randomized phase III studies
Even if we think:
EORTC 62012: No patients beyond 60years
Age distributionof sarcomas in Germany, epidemiological data
Zeissig et al. 2017, submitted
Main aspect
What would an experienced, well-trained, well-
informed patient:
� - accept as a treatment and
� - recommend to other patients
� - important contribution
Since 2007
FP6 & FP7 projects on sarcoma & RC
� Analysis of current practice
� Description of weaknesses
� Comparison between countries
� Expectations of patients
JARC working packages
Peter Hohenberger, MD
Div. of Surgical Oncology & Thoracic Surgery
Mannheim University Medical Center
University of Heidelberg, Germany
WP 6 Clinical practice guidelines
WP 6 Clinical practice guidelines
� Actions to assess the scenario of existing
clinical practice guidelines on RCs
� To provide recommendations on
how to ensure best production,
dissemination and implementation of
clinical practice guidelines on RCs
� at local level and within future ERNs
� This WP will consider all the already available and ongoing
efforts in the field of guidelines on cancers& rare cancers
� Will collaborate with key players in this areas: European
Society of Medical Oncology (ESMO),
State of Art in oncology (START),
European Cancer Patient Coalition (ECPC),
EURORDIS,
OECI,
Orphanet,
Istituto Superiore di Sanità (ISS - Rare Best Practice), M
MAPPING_NCD (http://www.ncd-map.eu.)
� Experiences available outside Europe will be also considered.
WP 6 Clinical practice guidelines
Objectives:
� to map available clinical practice guidelines at the European level on all families of rare cancers and identify gaps;
� to provide a quality evaluation of existing clinical practice guidelines for rare cancer subtypes
� to identify open issues about implementation of clinical practice guidelines at the local level
� to work out solutions on how to incorporate clinical practice guidelines within ERNs
� Not: to create guidelines
WP 6 Clinical practice guidelines
� Explore the existing database of clinical practice guidelines at
INSERM (Orphanet).
� Collect the existing clinical practice guidelines produced by
European societies/efforts/etc, such as ESMO, START
considering the work already undertaken by RARECAREnet.
� Carry out a survey within OECI among its member
institutions about which clinical practice guidelines are used
in clinical practice.
� Carry out a survey within the Network of Comprehensive
Cancer Centers in Germany, INCa in France, Cancer Research
UK and its member institutions in the UK.
� Lead partner: INSERM
WP 6/ T6.1 Available clinical practice guidelines
at the European level on all families of RCs
� Assess accessibility of existing CPGs for physicians and patients - online
and printed
� Assess the degree of updating of CPGs over time.
� Validation process of guidelines (consensus mechanisms, peer-review, ... )
� Assess the contribution of partners during guideline development (uni- vs.
multi-centricity, uni- vs. multi-disciplinarity, involvement of PAGs, etc).
� Finally, score CPGs according to available quality criteria.
� Summaries referring to guideline availability and quality per family of RC
� Patients Advocacy Groups (PAGs) will contribute by assessing the impact of
patients to influence the development of guidelines
� Lead partner: DKG.
WP 6/ T6.2 Quality evaluation of existing clinical
practice guidelines for rare cancer subtypes
Table to Task 6.2
Cancer
family
H
&
N
Thoracic Male
GU
Female
GU
Neuro-
endocrine
Endocri
ne CNS Sarcoma
Guideline1 subpar Guideline2 ok Guideline3 good Guideline4 superb Respon-
sibility of
assessment
DKG, ECPC, SIOP, GPOH, EURORDIS combine their expertise in assessing quality of guidelines in the rare cancer
families
Intended result: map of guidelines and their quality
WP 6 Milestones
M6.1 Results of the surveys of guidelines within OECI, Network of
Comprehensive Cancer Centers Germany, INCa and Cancer Research UK
and other interested stakeholders
(Task 6.1, M12)
M6.2 List of criteria to evaluate the clinical practice guidelines available
(Task 6.2, M15)
M6.3 Results of the “pilot assessments” of the interplay between clinical
practice guidelines, practicing physicians and local reimbursement
mechanisms
(Task 6.3, M20)
M6.4 Report on possible solutions for assessing the effect of improving
cancer care by clinical guidelines implementation at population level
(Task 6.4, M24)
WP 6 Deliverables
D6.1 Report and survey on availability of clinical practice
guidelines for all rare cancer families
(M18)
D6.2 Report on the assessment of the quality of existing
clinical practice guidelines
(for each family of rare cancers, M24)
D6.3 Recommendations on optimal implementation of
clinical practice guidelines on rare cancers (M30)
D6.4 Recommendations on how to integrate clinical practice
guidelines into existing healthcare networks, with special
reference to ERNs (M36)
� Special regard: relation with local reimbursement mechanisms
� To study innovative models to provide value-based RC care
� study the interplay between clinical practice guidelines and local
reimbursement mechanisms with “pilot assessments”
� assess accessibility of available clinical practice guidelines and
awareness thereof by the oncology community.
� identify gaps in available guidelines at the European level with
regard to some rare cancers.
� provide recommendations to improve quality of guidelines and to
make them more broadly available (language, dissemination)
� try to identify target “communities”, with a view to multi-
disciplinarity (involving all professional oncology societies).
� Lead partner: DKG
WP 6/ T6.3 Open issues about implementation of clinical
practice guidelines at the local level
� Consider disease outcomes on a country basis, in collaboration with
the WP4 and European cancer registries,
� Use results of the RARECAREnet high resolution and pilot studies to
evaluate to which extent the use of CPGs could improve.
� Review data about adherence to guidelines and its impact on disease
outcome in rare cancers.
� Study models to integrate clinical practice guidelines into existing
healthcare networks, with special reference to ERNs.
� Discuss with European cancer registries possible ways to assess the
implementation of CPGs at population level (collab: Task5, WP4).
� Lead partner: DKG.
WP 6/ T6.4 Solutions on how to incorporate
clinical practice guidelines within ERNs.
We did that already ! And it works.
� Chordoma
� Desmoid
We did that already ! And it works.
� Chordoma
� Desmoid
ERNssince Dec 16, 2016
1 BOND ERN on Rare Bone Disorders
2 CRANIO ERN on Rare craniofacial anomalies and ENT disorders
3 Endo-ERN ERN on Rare Endocrine Conditions
4 EpiCARE ERN on Rare and Complex Epilepsies
5 ERKNet European Rare Kidney Diseases Reference Network
6 ERN-RND ERN on Rare Neurological Diseases
7 ERNICA ERN on Rare inherited and congenital anomalies
8 ERN-LUNG European Reference Network on Rare Respiratory Diseases
9 ERN-SKIN ERN on Rare and Undiagnosed Skin Disorders
10 EURACAN ERN on Rare Adult Cancers (solid tumors)
11 EuroBloodNet ERN on Rare Hematological Diseases
12 EURO-NMD ERN for Rare Neuromuscular Diseases
13 ERN-EYE ERN on Rare Eye Diseases
14 ERN GENTURIS ERN on GENetic TUmour RIsk Syndromes
15 GUARD-HEART Gateway to Uncommon And Rare Diseases of the HEART
16 ITHACA ERN on Rare Congenital Malformations and Rare Intellectual Disability
17 MetabERN ERN for Rare Hereditary Metabolic Disorders
18 PaedCan-ERN ERN for Paediatric Cancer (haemato-oncology)
19 RARE-LIVER ERN on Rare Hepatological Diseases
20 ReCONNET Rare Connective Tissue and Musculoskeletal Diseases Network
21 RITA Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases
22 TRANSCHILD ERN on Transplantation in Children (incl. HSCT, heart, kidney, liver, intestinal, lung and
multiorgan)
23 VASCern ERN on Rare Multisystemic Vascular Diseases