Microsoft word - wp7 form description 10 03 11_v2_.doc

EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 The EUROCHIP 3 is funded by DG SANCO in the strand of HEALTH INFORMATION of the 2007 health Programme with mandate to study and help reduce cancer care inequalities. The EUROCHIP projects are coordinated by INT, Milan and are supported by a network of over 150 multidisciplinary experts from the 27EU Member States. EUROCHIP-3 involves 4 vertical Work Packages respectively on cancer screening, cancer registration, cancer rehabilitation and cancer costs (WP7) and its duration is 2008-2011. The rationale of EUROCHIP-3 WP7 is the present incapability of the EU health systems to provide equally a care service that is adequate to the growing demand. WP7 mandate is to investigate evidences on whether scientific research on alternative cancer procedures at unchanged outcome and lower cost may help improve healthcare performances in the EU. EUROCHIP-3 WP7 Methods The cancer sites of early and advanced breast cancer (BC) and childhood Acute Lymphoblastic Leukemia (ALL) are chosen for this discussion, the procedures discussed are classified in “Minimal requirements” and “Additional tools”. The WP7 group of multidisciplinary experts conducts a discussion on alternative cancer procedures at same outcome and lower costs; in synergy with the WP7 clinical group, the WP7 group of HTA experts is invited to study the issue of the impact of cancer costs on cancer outcomes. A WP7 form is used to track the discussion on the evidence linked with the different tools with possible alternatives. A WP7 Report will be including one ACCESS form per each tool discussed. In this document: The description of all fields in the WP7 ACCESS form EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 (1.Sc.01) Breast MRI (familial risk or mutation) (1.Di.07) Chest X-Ray, liver US, Brain CT, (2.Pa.01) Histological type/Grade/ Vascular (2.Pa.03) Proliferation (Ki67 or MIB1) (2.Pa.04) HER2 by DAKO (2.Pa.13) (FISH if DAKO 2+) treatment/Mastectomy (3.Su.02) Sentinel node biopsy/Axillary sampling (3.Su.03) Axillary dissection (3.Su.04) Reconstruction surgery (4.Ra.01) Postoperative Radiotherapy (loco- suppression/oophorectomy in premenopausal EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 (1.Di.13) Breast ultrasound 10 MHz > (1.Di.14) Cyto/histo confirmation (1.Di.15) CT if symptomatic (2.Pa.09) Histological type/ Grade/ Vascular (2.Pa.10) ER and PgR expression (2.Pa.12) HER2 by DAKO (FISH if DAKO 2+) Mastectomy (3.Su.07) Sentinel node biopsy/Axillary sampling (3.Su.08) Axillary dissection (3.Su.09) Reconstruction surgery (4.Ra.04) Radiotherapy (loco-regional) with LINAC (4.Ra.05) Palliative RT in bone and brain metastases (5.On.06) Endocrine treatment in endocrine (5.On.11) Biophosphonates for symptomatic bone (6.Rh.08) Consider local treatment (surgery, EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 ALL non-HR/ non-B mature (about 80% of cases with ALL) (1.Di.02) immunophenotype in cytofluorimetry (1.Di.03) cytogenetics t(9;22) – t(4;11) (1.Di.04) MRD (minimal residual disease) (1.Di.06) BM + MRD at end of induction therapy (1.Ra.01) Only on specific demand (only HR (5.On.2) Daunomycin (5.On.3) Prednisone (5.On.4) L-Asparaginase (5.On.5) Cyclophosphamide (5.On.6) Cytosine-Arabinoside (5.On.7) 6-Mercaptopurine (5.On.8) Methotrexate (5.On.9) HD-MTX (5.On.10) Maintenance w/6-Mercaptopurine daily (5.On.11) Oral MTX weekly (5.On.12) t.MTX every 8 weeks for 2 yrs (5.On.13) tailored follow-up Indirect costs (6.Rh.01) Social support Long term follow-up (1.FU.01)To be established if HR EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 procedure identification code NOT TO BE CHANGED 3 options offered. The form was filled in: meeting/ e-mail/ other acronym of the procedure NOT TO BE CHANGED multiple choice field: primary prevention, screening, diagnosis, first treatment, clinical follow-up, palliative care (is intended to include palliative chemotherapy and endocrine treatment), rehabilitation 2 options offered: BREAST CANCER or ACUTE LYMPHOBLASTIC LEUKAEMIA “stage of the disease at diagnosis” For BC, 2 options offered: early/advanced early: T 1-2, N 0-1, M 0 advanced: stage III-IV histological type for BC: pre/post menopausal class 2) DISCUSSION procedure in the word file this formal and concise statement to describe the procedure discussed this field answers to the question WHAT IS DONE? formal and concise statement to introduce in which case the procedure is this field answers to the question WHY IS THIS DONE? this field answers to the question WHO DOES IT? this field enquires on the evidence supporting the procedure, and answers to the question: Is this procedure demonstrated to increase the care accuracy parameter of efficacy?effectiveness? or is it done because of traditional choice or other reasons? 3 options offered: Efficacy (1-2 evidence base scientific literature) Effectiveness (1-2 evidence base scientific literature) traditional choice other open field for bibliographic references and related discussion open field on possible problems linked with the procedure Data from the WP7 HTA literature research Protocol no alternative with same outcome exists/ alternatives with same outcome are in use/ alternatives with same outcome exist and should be promoted/ other EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 EUROCHIP-3 WP7 FORM DESCRIPTION DOCUMENT 10.03.11 level of evidence base literature on the efficacy or cost effectiveness contrasting references and discussion on efficacy data from the WP7 HTA literary research protocol Alternatives should be considered (see discussion below) Alternatives may exist pending further research (see discussion below) Alternatives should be considered / Alternatives may exist pending further research

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