Low prevalence & emerging SCD in Europe: Italian perspectives
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1 6th Annual Sickle Cell and Thalassaemia: Advanced Conference 24-27th September, 2012 London, UK Low prevalence & emerging SCD in Europe: Italian perspectives Dr. Raffaella Colombatti Clinic of Pediatric Hematology-Oncology Department of Pediatrics Azienda Ospedaliera-Università di Padova Padova, Italy
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3 ITALY Thalassemia National public health interventions since the 70 (prevention and screening) Network for treatment and care since the 70, involving centers located mainly in the Center and South of Italy Guidelines for the Management of Thalassemia patients have been implemented and are well known by physicians across the country Sound Research Patients Associations
4 ITALY: background data Population: 60,7 milions Immigrants: (7.5%), (13,9%) children born from immigrant couples in 2011 Immigrants from English or French-speaking countries For the general population Health care is almost free: - no charge for admissions or emergency room visits - prescription token for exams and outpatient visits - some drugs are given with only a prescription token (2 ) In addition Patients with Rare Diseases: - do not pay exams and outpatients visits - drugs are almost free Illegal immigrants have the right to receive urgent health care for free (children receive complete health care)
5 Now 2012 >1500 pediatric pts estimated Mainly Africans In the North HbS/HbS Increased burden Colombatti, Haematologica 2008 and Italian Association of Ped Hematol-Oncology data 2012 SCD? Before year pediatric pts Mainly white sicilians In the South HbS/βthalassemia low burden on health system Russo-Mancuso, Eur J Epidemiol. 2003
6 Presentation overview 1. Response to SCD at a Local Level: Experience of a Tertiary Care University Hospital 1. Specific Challenges of facing a new disease 1. Patient Population related 2. Health operators related 2. Solutions developed and open problems 2. Response to SCD at a National Level 1. Creation of a National Network 2. Development of Italian National Guidelines 3. Educational Events for physicians 4. Collaborative Research
7 Response to SCD at a Local Level: Experience of a Tertiary Care University Hospital
8 SCD Specific Issues-Barriers to health care Patient - SCD is a recent issue - The majority of pts. are Immigrants (African) - Pts. live mainly in Northern Italy where hemoglobinopathies are less known - Pts. not aware or informed about SCD Health System - SCD is a recent issue - No National Newborn screening for hemoglobinopathies - Specific Counselling for SCD scarse and performed by people trained for thalassemia and not for SCD - Symptoms and Signs of SCD not recognized by health staff
9 SCD Pilot Program Treatment and Care of children with SCD in Padova Tertiary Care University Hospital National Reference Center for Pediatric Leukemia, Lymphomas and Sarcomas 3 Italian Center for Pediatric BMT European Reference Center for Sarcomas
10 SCD Pilot Program Barriers to health care Patient-related - Language difficulties - Socio-economic factors (no permit of stay, precarious living conditions, low income, difficult relationship with school) - Cultural beliefs (shame) Health operator-related - Lack of knowledge about SCD-related complications - No pathways of care for Acute events (ER) - Lack of subspecialists to treat chronic complications - TCD - Isolation
11 -60% diagnosed with SCD in the ER -Mean age of diagnosis was 30 months (range 1-64) -Only 3% of children with SCD that were admitted were asked information about prophylaxis, vaccination or pain medication taken at home
12 Colombatti R, Dalla Pozza LV, Mazzucato M, Sainati L, Pierobon M, Facchin P, Haematologica 2008
13 Raffaella Colombatti, Giorgio Meneghetti, Mario Ermani, Marta Pierobon and Laura Sainati, 2009
14 Organize Comprehensive care focused on the needs of immigrant patients
15 Health System/Health operator related interventions 1.Training of two pediatric hematologists in the USA In the UK 2.Involvement of multidisciplinary teamà TCD 3.Protocols and pathways of care for ER personnel for management of acute events 4.Involvement of the Transfusion Team 5. Educational Events for Pediatric General Practitioners
16 Organize a Specialized Comprehensive care focused on the needs of immigrant patients Parental Health Education LINGUISTIC, SOCIAL CULTURAL ISSUES as PRIORITY Flexible Schedule Continuous Social Support Assistance via telephone 24 h/day Reminders (tel. calls, letters)
17 Parental Health Education in their own language 1. A three-language (English, French, Italian), image rich educational book on SCD (including a pain diary) was given to every family at diagnosis 2. Repeated health education at every visit (in Italian, English or French) on: pain and fever management; on the need for vaccination and TCD screening
18 Flexible Schedule One stop weekly clinic (on Tuesday afternoon) Possibility of late - hour visits Possibility of MRI-MRA and TCD on Saturdays
19 Continuous Social Support To obtain disability benefits To obtain/renew permit of stay
20 Assistance via telephone 24 h/day - Mobile number of hematologist (SCD); - Number and name of SCD secretary Reminders (telephone calls, letters) - To families (phone calls as reminders for appointments; letters for vaccinations) - To primary care pediatricians (letters as reminders for vaccinations and amoxacillin prescription)
21 Are we doing the right thing for our patients? Are we giving them what they need/want? ADHERENCE Colombatti et al. Ped Blood Cancer 2012
22 Other indicators of adherence to comprehensive care All families accepted the proposed treatment (20 HU, 20 transfusion, 4 BMT) All families accepted neuropsychological evaluation and school support (48/90) All patients were registered in the Rare Disease Registry and obtained the rare disease certificate All families used the certificate to renew the permit of stay Colombatti et al. Ped Blood Cancer 2012
23 ADHERENCE effect on Outpatient visits and Admissions pts pts hematology visits/yr DH for transfusion/yr 5 60 hematology visits/pts/yr * ED access/pt/yr * Inpatient admission/pt/yr * *p<0.001 Colombatti et al. Ped Blood Cancer 2012
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25 .still a long way to go..
26 QUALITY OF MEDICAL CARE Colombatti et al. Ped Blood Cancer 2012
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28 More than people participated
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30 Response to SCD at a National Level
31 Clinical issues for Pediatric SCD No common policy of diagnosis, treatment and patient care Diagnosis and treatment were mainly case-directed or locally directed Symptoms and Signs of SCD were not recognized by health staff? What do we do with these patients?
32 AIEOP Italian Association of Pediatric Hematology-Oncology Red Cell Disorders Study Group Nov Sickle Cell Disease Working Group 1 To develop Guidelines for the Management of children with SCD in Italy, tailoring to our health system the international guidelines. Make them accessed on the AIEOP website 2 To create a Working Group focused on pediatric SCD in Italy
33 Guidelines 1 AIEOP Centers were invited to participate to the Sickle Cell Disease Working Group Issues to be addressed in the Guidelines were chosen by the entire group Every topic was developed by a subgroup of members in a single document Each document included a brief description of the state-of-art on the subject (literature review and other countries guidelines), the recommendations with ABC strength and references (A or P) Each document was then revised by the entire group and modified accordingly after exhaustive discussion
34 Internal revision was performed by four members of the group (Sainati, Colombatti, Russo, Samperi) External revision was performed by three Italian expert hematologists (Forni, Piga, Galanello) External Revision was performed by one Italian patient association (Associazione Ligure Talassemici - Brunetta)
35 21 pediatric hematologists 13 Centers (8 North, 1 Center, 4 South)
36 5 meetings 20 months ( ) 120 hours 940 sent 4 GB of data 1 more meeting (2012) 8 hours 20 sent
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38 24 Chapters à 242 Recommendations Diagnosis, Prevention, Treatment
39 Local Italian issues Amoxicillin prophylaxis because oral Penicillin is not available in Italy Disparity in health care facilities and resources between North and South (i.e. blood colture) TCD performed by Adult Neurosonologists or cardiologists Pain protocol for the Emergency Room and not for Hematology Day Hospital
40 Recommendations Penicillin Prophylaxis
41 Recommendations Primary Stroke Prevention
42 WEBSITE
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44 National Working Group 2 Educational Events - National Meeting Clinical SCD in childhood, April International Meeting Neurological Complications of SCD, March TCD Course (UK-Italy), May TCD Course (UK-Italy) July 2011
45 10 neurosonologists trained + 1 expert SCATES: Sickle Cell Anaemia Transcranial Study Transcranial Doppler (TCD) in sickle cell disease (SCD): An educational project to facilitate a screening program with the purpose to achieve systematic evaluation of stroke risk in children Principal Investigator Dr Baba Inusa (GSTT) Co-investigators Drs Soundrie Padayachee (GSTT) Laura Sainati (Padova Paediatric Department) - standardize TCD application in different European Settings - make it a common practice in routine health care of children with SCD across Italy 3 Italian Centers partecipated
46 CASIRE Sickle Cell RENAL DISEASE COHORT INTERNATIONAL STUDY (USA-Europe) Co-Principal Investigators: Andrew Campbell, Kassim Adetola CASIRE TWIN SIB INTERNATIONAL STUDY: Evaluating Phenotypic Variations amongst Twins and Siblings with Sickle Cell Disease (USA-Europe-Africa) Co-Principal Investigators: Andrew Campbell, Kassim Adetola
47 TOGO (West Africa): Screening of Pregnant Women and development of a Comprehensive Center GUINEA BISSAU (West Africa): Establishment of a Sickle Cell Comprehensive Center
48 Italian National Cooperative Projects Multicenter Study on Neuropsychological evaluation of Immigrant and Italian Pediatric patients with SCD Newborn screening -1 pilot selective newborn in Pordenone since January pilot selective screening of pregnant women in Modena -1 universal newborn screening due to start in Padova in January 2013 TCD Project
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50 Sickle Cell Dbase Homogeneous data collection across Italy
51 Conclusions 1 Comprehensive care can be delivered to vulnerable groups obtaining high adherence if linguistic, cultural, social issues are addressed LINGUISTIC, CULTURAL and SOCIAL issues are not secondary but PRIORITY issues in chronic diseases like SCD Inclusion in a comprehensive care program increases the integration into the society and the community of immigrant families having children with SCD
52 2006 The World Health Organization released the Sickle Cell Anemia A59/9 Report, inviting Governments and Health Ministries: to design, implement, reinforce in a systematic, equitable and effective manner, comprehensive national integrated programs for the prevention and management of SCD, reducing morbidity and mortality The General Assembly of the United Nations approved the Resolution Recognition of sickle-cell anaemia as a public health problem (resolution A/63/L. 63): - invited all States to raise awareness on SCD - defined the 19th of June of every year as the Sickle Cell Disease World Day /ga10803.doc.htm
53 Data Manager Resident Director Biologist Neurosonologist Sickle Cell Group Biologist Psycologist Biologist TCD-TCDi technician Pediatrician Neuroradiologist Clinic of Pediatric Hematology-Oncology, Director
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55 THANK YOU for YOUR ATTENTION
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