Mar 11, 2017 - CANKADO Achieving more together. 2017. Google Venture and Roche are the main investors of Flatiron Health www.gv.com/portfolio/#life ...
eHealth – Friend or Foe? Prof. Dr. Timo Schinköthe
ABC4, Lissabon 3.11.2017
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Friend or Floe – Example 1 Flatiron Health
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What is eHealth? • There is no common • • • •
standard legal framework validation process specification for data security
52% 48%
Developed by companies with at least one medical expert Developed by single programmers or companies without medical expertise https://medcitynews.com/2015/11/successful-mobile-health-app-developers/
• eHealth solutions are divided into
1. No standard 2. Follow standards such as ISO 27001, ISO 13485 or EU GMP Annex 11 3. CE-certified medical devices
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eHealth APP’s: The two major ways to implement Typical use cases in eHealth
• APP without interfaces
• Low development costs • Works also without internet • Limited functionality
• Server-Client-based APP
• High development effort • High demands on data security • High flexibility
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Amateur, semi-professional, advertising, product information (e.g. Pharma APP’s)
Professional solutions (e.g. Medical devices)
2017
eHealth, Interface (API) and Cloud Computing
• Application Programming Interface (API) are the connections to other systems • Today's eHealth solutions are based on cloud computing • Professional eHealth solutions provide connectivity to Electronic Patient Records (EPR or EHR) Vilaplana et al, BMC Med Inform Decis Mak. 2013; 13: 35.
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Flatiron Health Inc.
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Flatiron Health Inc. • works together with the FDA • Learning from real-world data • Current fields of interest • • • • • • • •
Lymphoma Melanoma Multiple Myeloma NSCLC Prostate Cancer Cancer Immunotherapy (CIT) End of Life (EOL) Cost of Care
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Flatiron Health: Big data deep learning in Cancer Care
Abernethy AP et al. J Oncol Pract. 2017 Aug;13(8):530-534
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Example: Is the billing for bone metastases justified? Cost analysis as a game changer • Analyzed 8,796 breast cancer patient records • Intention
• Examine the “validity of ICD-9 code 198.5 to identify patients diagnosed with bone metastases”
• Assumption
• “coding is populated in the patient record for billing purposes” 17%
Liede A et al. Clin Epidemiol. 2015 Nov 11;7:441-8.
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BTA: bone-targeting agent
2017
Flatiron Health: National Practice Benchmark for Oncology
Total revenue per full-time equivalent (FTE) hematology/oncology (HemOnc) physician
Balch C et al. J Oncol Pract. 2016 Apr;12(4):e437-75
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Flatiron Health: National Practice Benchmark for Oncology Revenue mix per standard hematology/oncology physician
Balch C et al. J Oncol Pract. 2016 Apr;12(4):e437-75
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Google Venture and Roche are the main investors of Flatiron Health
www.gv.com/portfolio/#life
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Friend or Floe – Example 2 Patient Reported Outcome (PRO)
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ASCO 2017 Plenary Session: Web-based PRO
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Overall survival results of a randomized trial assessing patientreported outcomes for symptom monitoring during routine cancer treatment. Method
self-report 12 common symptoms via tablet vs. standard of care
Patients
766
Age, mean (range)
61 years (26-91)
Diseases
Metastic solid tumors • 32% genitourinary • 26% lung • 23% gynecological • 19% breast
Treatment
Outpatient chemotherapy
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J Clin Oncol 35, 2017 (suppl; abstr LBA2)
2017
PRO workflow in eHealth supported group (Basch)
Doctor prescribed therapy and cared for
Patient documents 12 symptoms (weekly E-mail reminder)
Monitoring Nurse decides on action
E-mail alert to Monitoring Nurse
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Online documentation of symptoms 1) Increased patient satisfaction
2) Longer stay under therapy
18%
Usual Care
Usual Care
34%
eHeath Support Patients with improved satisfaction after 6 month
6.3 month
8.2 month
eHeath Support Mean duration; p=0.002
3) Less emergency hospital admissions Usual care eHeath Support
Basch E et al. J Clin Oncol. 2016;34(6)
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Basch E et al. JAMA. 2017 Jun 4.
2017
5 month survival benefit by eHealth-reporting (p=0.03)
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Basch E et al. JAMA. 2017 Jun 4.
2017
PRO self reporting in SCLC and NSCLC
Denis F, et al: Significant survival improvement for patients with lung cancer by implementing an eHealthapplication to monitor their well-being. J Clin Oncol 34, 2016 (suppl; abstr LBA9006)
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30 weeks survival benefit by eHealth
Denis F, et al: Significant survival improvement for patients with lung cancer by implementing an eHealthapplication to monitor their well-being. J Clin Oncol 34, 2016 (suppl; abstr LBA9006)
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PRO workflow in eHealth supported group (Denis)
Doctor prescribed therapy and cared for
Patient documents 12 items
Patient decides on action
Automated recommendations to the patient
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CANKADO PRO-React Daily use
Doctor prescribed therapy and cared for
Patient documents predefined items
Global Health Scale 0-100
Relevante Change?
Yes
Symptom questionnaire
No Score change?
Yes
Recommendations to the patient
No
Patient decides on action
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Automated recommendations to the patient
Daily use finished
2017
Example of CANKADO PRO-React and Intervention Patient (
, 75 years) with colorectal cancer under conventional chemotherapy (POSCA study, ongoing)
days of therapy
0
7
14
21
28
35
42
49
56
63
70
Daily general health
Symptom questionnaire Relevant symptoms
Nervousness Nausea
Nausea
Alergic reaction
Renewed patient education
Vergentan Treatment prolonged
Tavegil
Intervention
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PreCycle: Multicenter, randomized phase IV intergroup trial to evaluate the impact of e-Health-based patient reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with Palbociclib and an aromatase inhibitor- or Palbociclib and Fulvestrant (EudraCT 2016-004191-22, Sponsor: Palleos Healthcare, Wiesbaden) • 80 centers • 6 years
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Study Groups • AGO-B • AGO-Trafo • WSG • DGHO
2017
Patronage • DGGG • DGS
Comparison Basch E.
Denis F.
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Scope
chemotherapy
Oral drugs
both
Diseases
cancer
Lung cancer (NSCLC, SCLC)
cancer
Rhythm
Once a week
dynamic
dynamic
Feedback
Remote nurse
Software algorithm
Software algorithm
Questionnaire
12 symptoms
12 items (11 symptoms + weight)
flexible
Software
n.a.
www.sivaninnovation.com/moovcare
www.cankado.com
Multi-lingual
n.a.
No
Yes
Medical Device (EU)
No
Yes
Yes
Available for routine
No
No
Yes
Further modules
NCI PRO-CTCAE list n.a. of questions free available
Adherence, Distress, QoL, Nutrition, Geriatric, eCRF interface, HL-7
Costs
n.a.
Free (non-profit for routine)
Disadvantage CANKADO
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n.a.
More information takes more time! 2017
CANKADO Research Group
Implemented standards in CANKADO
• Non-profit
• Software development and server operation, acc. • ISO27001 • EU GMP Annex 11
• Open Research Group in Oncology for • Physicians and nurses • Other therapists and healthcare professionals • Researchers • Patient Advocacies • CANKADO can be used for • Routine care • Clinical trials • Registers
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• Total operating, acc. • ISO 13485 • Data handling, cc. • GAMP-5 • ICH-Guidelines E3, E6 • Data privacy, verified by • BfArM • PEI • Div. ethics committees • Cyber and data security, tested according to • BSI • OWASP
2017