eHealth – Friend or Foe?

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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.

CANKADO

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