2nd Concertation Meeting

Brussels, September 8, 2011

Reinhard Prior, Scientific Coordinator, HIM

Evidence in telemedicine: a literature review

Telemedicine vseHealth

Telemedicine

"Medicine at a Distance"

Alexander Graham Bell inaugurating the first telephone line from New York to Chicago, 1892

1892

•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

2011Health care changes

2011What ist the evidence?

• Evidenced based medicine

• HTA

• MAST et al.

What is the current evidence?

Levels of Evidence

Cochranereviews

Evidence by numbers

Total number of publications: 13504

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: 13504

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

www.consort-statement.org

J Am Med Inform Assoc, July 29, 2011

32 / 3784 papers analyzed

43 % : Objectives not clearly defined34%: Sample size calculation missing29%: Outcomes not clearly identified62%: Adverse events not reported80%: 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: 13504

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

(1909-1988)

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

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 treated270 control

Single blinded

Thank you!

Explanatory Pragmatic

Question? Efficacy—can the intervention work?Effectiveness—does the intervention work when used in normal practice?

Setting Well resourced, “ideal” setting Normal practice

ParticipantsHighly 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

OutcomesOften 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