Alexandra Bargiota Assist. Prof. in Endocrinology University Hopsital of Larissa Thessaly, Greece.

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1 Applying Evidence-Based Medicine with Telehealth the clinician view Assessing the impact of telehealth/telemedicine either via an RCT or an observational study the voice of a clinician Alexandra Bargiota Assist. Prof. in Endocrinology University Hopsital of Larissa Thessaly, Greece

2 Current status and need for Evidence Based Medicine in telehealth RENEWING HEALTH selection of preliminary clinical outcomes from Central Greece UNITED4HEALTH: Transforming Renewing Health outcomes in everyday clinical practice.

3 Chronic illnesses, such as asthma, COPD, diabetes, heart failure and hypertension represent a significant burden of disease Telehealth has attracted interest as a potential solution to the global challenge of providing care for populations living with chronic diseases. Current findings lend some support to the assertion that a service redesign that included telehealth can improve care, reduce admissions and mortality in people with long term conditions.

4 Action 75: Give Europeans secure online access to their medical health data and achieve widespread telemedicine deployment -Undertake pilot actions to equip Europeans with secure online access to their medical health data by and to achieve by 2020 widespread deployment of telemedicine services.

5 The clinicians questions: -Is there sufficient evidence to support the effectiveness of telehealth on improving patients care -Where does this evidence come from -What is the transferability of this evidence to the every day clinical practice

6 Evidence-based clinical practice: Is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best. Gray JAM Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone.

7 Where clinical evidence comes from? Health Information Technology Knowledge Base, (2010)The USA Office of the National Coordinator for Health Information Technology (ONC)

8 A randomised controlled trial (or randomised control trial.rct): is a specific type of scientific experiment, and the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention within a patient population Chalmers TC, Controlled Clinical Trials 2 (1): 31 49, 1981.

9 Telemedicine Standards and Clinical Guidelines are required

10 Current evidence of telehealth in chronic deseases

11 Medline publications on telemedicine and five chronic diseases. There were 1324 publications between 1990 and 2011

12 CURRENT EVIDENCE: Telemedicine use for diabetes care is feasible and acceptable. Its effectiveness though on improving HbA 1c, reducing costs while maintaining HbA 1c levels and improving other aspects of diabetes management still needs to be proved. Comparison of changes in HbA 1c control vs. intervention Farmer A. Diabetic Medicine, Volume 22, Issue 10, pages , 12 MAY 2005

13 Remote monitoring (no implanted device) The optimum approach to non-invasive remote monitoring is uncertain, and RCTs performed to date have given inconsistent results and do not yet support a guideline recommendation. Structured telephone support Although a meta-analysis of RCTs suggests that structured telephone support in addition to conventional care may reduce the risk of hospitalization in patients with HF, few individual RCTs showed this benefit, and the evidence is not robust enough to support a guideline recommendation.

14 CURRENT EVIDENCE: Home telehealth interventions for COPD were similar or better than usual care for quality of life and patient satisfaction outcomes, but the available evidence is limited. J Polisena et al. Journ. of Telemedicine and Telecare 2010; 16:

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16 Despite calls for robust effectiveness trials of telemonitoring in chronic diseases systematic reviews have reported inconclusive results. Despite patients attitudes and receptiveness towards this approach being promising, But the evidence is insufficient to draw firm conclusions about clinical effectiveness

17 Where is the problem?

18 Sustainability of healthcare systems is at stake The nature of usual care delivered to a control group was not well defined and varied a lot Heterogeneity of telehealth interventions outcomes ranging from simple telephone follow-up to daily telemonitoring of physiological or symptom scores or to more complex telemonitoring interventions with greatly enhanced clinical contributes to the difficulty in interpreting the result Telemonitoring was integrated into existing clinical services, such that monitoring was provided by clinical teams who already had (or were about to assume) clinical responsibility for the patients. Most studies address only one chronic condition (e.g diabetes), an not evaluate all chronic diseases together

19 Studies also differ in -Characteristics of the patients (e.g., may include patients whose prognosis is better than average, or may exclude "women, the elderly, and those with common medical conditions) -Outcome measures (e.g., may use composite measures infrequently used in clinical practice) -Incomplete reporting of adverse effects of interventions

20 Why is EU action needed? -Patients' empowerment and deployment of telehealth services are key to ensuring the sustainability of healthcare systems. Telehealth is also a promising tool to improve mental health, increase the social impact of public health intervention, provide efficient health support in remote areas, and to respond to the shortage of healthcare professionals and the lack of financial resources."

21 REgioNs of Europe WorkINg together for HEALTH Renewing Health

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23 Renewing health multicenter trial cluster 2 : Long-term telemonitoring of patients with type 2 diabetes mellitus Primary Outcome Measures: Health related quality of life of the patients measured by the SF-36 version 2 questionnaire [ Time Frame: 12 months minimum- at the entry point of the intervention and the end. ] Glycated hemoglobin (HbA1c) levels at the entry point and after a period of 12 months.

24 Renewing Health multicenter trial cluster 4 : Telemedicine follow up after hospital discharge for chronic obstructive pulmonary disease (COPD) exacerbation RENEWING HEALTH Secondary Outcome Measure (analyzed): Health related quality of life of the patients as measured by the SF- 36 version 2 questionnaire (Time Frame: 3 months - at the entry point of the intervention and the end)

25 Renewing Health RCT in Thessaly outomes: HBA1c levels (Decrease in score denotes improvement) mean HBA1c (%) 1 st month 12 th month CONTROL 8.62 (1.43) 7.77 (0.78) p=0.000 (Wilcoxon Test) INTERVENTION 8.55 (1.38) 7.14 (0.61) p=0.000 (Wilcoxon Test)

26 Renewing Health RCT in Thessaly outomes: The Effect on Quality of Life (SF36v2 Physical Component Scale) IN CONTROL AND INTERVENTION GROUP AT 1 ST AND 12 TH MONTH mean score 1 st month 12 th month CONTROL (6.12 ) (5.08) p= (Wilcoxon Test) INTERVENTION (4.34 ) (2.97) p=0.053 Wilcoxon Test (Range 0-100, increase in scores denotes improvement)

27 Renewing Health RCT in Thessaly outomes: The Effect on Quality of Life (SF36v2 Mental Component Scale) IN CONTROL AND INTERVENTION GROUP AT 1 ST AND 12 TH MONTH mean scores 1 st month 12 th month CONTROL (10.17) (8.90) p= 0,000 (Wilcoxon Test) INTERVENTION (8.42 ) 53.50(6.54) p= 0,000 (Wilcoxon Test) (Range 0-100, increase in score denotes improvement)

28 Renewing Health Diabetes type 2 RCT in Thessaly outcomes Preliminary Conclusions: Our preliminary results indicate that home telemonitoring is more effective in improving glycemic control and health related Quality of Life in DMT2 patients compared with the usual care. Usual care model needs to address the aspects related to the health related Quality of Life in DMT2 patients, and not only focus in improving glycemic control.

29 From RCT to everyday clinical practice: From Renewing Health to UnitedforHealth Randomized controlled trials have specific inclusion and exclusion criteria that are often quite restrictive Observational Studies usually apply to a much broader population and are frequently even population-based. Thus, extrapolation to the entire population may be unwise. On the other hand, the results for all patients in the observational studies are of great interest because they reflect actual practice patterns and because they allow subset analyses that will speak to precisely which patients benefit from each treatment/intervention.

30 United4Health objectives: Collect and assess data at large scale from across many regions and institutions in Europe that can be aggregated at European level; thus providing data. Adapt clinically validated services from some regions and institutions in Europe (Renewing Health partners) in the local setting of a large number of other regions and institutions (United4Health partners). Maximize the transferability of services and knowledge among European healthcare providers at such large scale and in close collaboration.

31 Partners of UNITED4HEALTH and RENEWING HEALTH in Central Greece 1. The 5th Regional Health Authority of Thessaly and Sterea (Regional University Health Authority Hospital) 2. e-trikala SA, a company owned by the Municipality of Trikala (competence center) 3. Digital Cities of Central Greece SA (Cities Net SA) a company owned by the 10 Municipalities of the Digital Community of Central Greece

32 Other Challenges with telehealth services harmonization of diagnosis related groups that can be treated by telemedicine accreditation of health professionals who provide telemedicine applications interoperability issues cost effectiveness reimbursement for telemedicine services legal framework and liability issues COM(2008)689 Final November 2008

33 Funding RENEWING HEALTH and UNITED4HEALTH are partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community Ministry of Health and Social Solidarity of Greece Prefecture of Thessaly Municipality of Trikala

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