2nd Concertation Meeting Brussels, September 8, 2011 Reinhard Prior, Scientific Coordinator, HIM Evidence in telemedicine: a literature review

Telemedicine vs eHealth

Telemedicine "Medicine at a Distance"

Alexander Graham Bell inaugurating the first telephone line from New York to Chicago,

Safety? Clinical effectiveness? Patient perspectives? Economic aspects? Organisational aspects? Socio-cultural,ethical and legal aspects? The MAST domains RCT ! 1911 How are you doing?

You must be crazy ! RCT? HTA? MAST?

IT Body sensors Mobile health 2011 Video

More chronic disease Sophisticated medical protocols Clinical guidelines to be followed Budget restrictions 2011 Health care changes

2011 What ist the evidence? Evidenced based medicine HTA MAST et al.

What is the current evidence?

Levels of Evidence Cochrane reviews

Evidence by numbers Total number of publications: Medline Search for "Telemedicine or Telemonitoring" (5.9.11) TM + Meta-Analysis: 50 TM + Randomized controlled trial: 756 TM + Systematic review: 110 TM+ Cochrane review: 4 TM + Trial: 1269

Evidence by numbers Total number of publications: Medline Search for "Telemedicine or Telemonitoring" (5.9.11) TM + Meta-Analysis: 50 TM + Randomized controlled trial: 756 TM + Systematic review: 110 TM+ Cochrane review: 4 TM + Trial: 1269

Consolidated standards of reporting trials 25 item checklist Flow diagram

J Am Med Inform Assoc, July 29, 2011

32 / 3784 papers analyzed 43 % : Objectives not clearly defined 34%: Sample size calculation missing 29%: Outcomes not clearly identified 62%: Adverse events not reported 80%: Information on long-term implementation missing Only 40% were of superior quality (> 3 Jadad points) Augestad et al, 2011

Evidence by numbers Total number of publications: Medline Search for "Telemedicine or Telemonitoring" (5.9.11) TM + Meta-Analysis: 50 TM + Randomized controlled trial: 756 TM + Systematic review: 110 TM+ Cochrane review: 4 TM + Trial: 1269

Archibald Leman Cochrane ( ) 1972

"28000 health care professionals from over 100 countries work together to help health care providers, policy makers, patients and carers to make well informed decisions based on the best available research evidence by systematic reviews of RCTs"

2000: General review on telemedicine versus face to face patient care "Establishing systems for patient care using telecommunications technologies is feasible, but there is little evidence of clinical benefits. The studies provided variable and inconclusive results for other outcomes such as psychological measures, and no analysable data about the cost effectiveness of telemedicine systems. The review demonstrates the need for further research and the fact that it is feasible to carry out randomised trials of telemedicine applications. Policy makers should be cautious about recommending increased use and investment in unevaluated technologies".

2010: Asthma (21 RCTs analyzed) "Telehealthcare interventions are unlikely to result in clinically relevant improvements in health outcomes in those with relatively mild asthma, but they may have a role in those with more severe disease who are at high risk of hospital admission. Further trials evaluating the effectiveness and cost-effectiveness of a range of telehealthcare interventions are needed."

July 2011: COPD (10 RCTs analyzed) 70% reduction in ermergency room visits 54% reduction in hospital admissions No difference in death rate "Telehealthcare in COPD appears to have a possible impact on the quality of life of patients and the number of times patients attend the emergency department and the hospital. However, further research is needed to clarify precisely its role since the trials included telehealthcare as part of more complex packages."

August 2010: CHF (25 RCTs analyzed, 16 telephone support, 9 telemonitoring) 34 % mortality reduction for telemonitoring (!) Structured telephone support and telemonitoring are effective in reducing the risk of all-cause mortality and CHF-related hospitalisations in patients with CHF; they improve quality of life, reduce costs, and evidence-based prescribing.

November 2010

Single, but large studies may be more appropriate to avoid invalid conclusions even from high quality meta-analyses

Current directions in CHF: 1: Still more studies (TIM-HF II) 2: Subgroup analysis Which patients do benefit? Which components of the interventions are most effective? Which level of technology is appropriate?

Lancet, Feb 10, 2011

40% reduction in hospitalisation 270 treated 270 control Single blinded

Thank you!

ExplanatoryPragmatic Question? Efficacy—can the intervention work? Effectiveness—does the intervention work when used in normal practice? Setting Well resourced, “ideal” settingNormal practice Participants Highly selected. Poorly adherent participants and those with conditions which might dilute the effect are often excluded Little or no selection beyond the clinical indication of interest Intervention Strictly enforced and adherence is monitored closely Applied flexibly as it would be in normal practice Outcomes Often short term surrogates or process measures (e.g. change in blood pressure) Directly relevant to participants, and health care authorities (e.g. quality of life, cost analysis). Relevance to practice Indirect—little effort made to match design of trial to decision making needs of those in usual setting in which intervention will be implemented Direct—trial is designed to meet needs of those making decisions about treatment options in setting in which intervention will be implemented