Collective uncertainty project hope for randomised clinical trials in trauma and orthopaedics
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Collective Uncertainty Project: Hope for Randomised Clinical Trials in Trauma and Orthopaedics. Glossary Collective equipoise (Freedman, 1987) justifiable uncertainty within the medical profession about which treatment is most effective for a particular condition

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Collective Uncertainty Project: Hope for Randomised Clinical Trials in Trauma and Orthopaedics

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Collective uncertainty project hope for randomised clinical trials in trauma and orthopaedics

Collective Uncertainty Project: Hope for Randomised Clinical Trials in Trauma and Orthopaedics

Glossary

  • Collective equipoise (Freedman, 1987)

    • justifiable uncertainty within the medical profession about which treatment is most effective for a particular condition

    • implies that there is no (rational) preference whatever

  • Collective uncertainty

    • in reality collective equipoise is rarely exactly evenly balanced, but uncertainty remains about the best treatment option

    • though individuals may have a preference for one treatment, they are balanced by the others with the opposite view

    • required before any clinical trial can be approved by ethics committee

  • Prior probability

    • Prior sense of the effects of treatment(s)

    • Can be based entirely on expert opinion

Kulikov Y1, Brydges S2, Girling A3, Lilford R3, Griffin D1

1Warwick Medical School, UK

2eLab, University of Warwick, UK

3Public Health & Epidemiology, University of Birmingham, UK

[email protected]


Randomised controlled clinical trials rcts in trauma orthopaedics

Randomised controlled clinical trials (RCTs) in Trauma & Orthopaedics

  • produce the most reliable evidence about the effects of clinical care

    but

  • are (very) expensive and (very) difficult for a number of reasons (McCulloch et al, 2002)

    in particular because

  • lack of surgeons’ individual equipoise in a specific clinical situation, which is often rational, has been shown to be a major obstacle in participant recruitment

Collective Uncertainty Project

  • to apply Collective Uncertainty to individual clinicalscenarios

  • to assess degree to which uncertainty must be present as the fundamental criterion for eligibility for a trial

[email protected]


Design materials and methods

Design (materials and methods)

  • Secure website

  • Clinical images

  • Clinical data

  • Interactive Voting Scale

[email protected]


Design materials and methods1

Design (materials and methods)

  • Integrated into the UK Heel Fracture Trial (UK HeFT) – conservative versus operative treatment for displaced fractures of calcaneum

  • Expert panel of 10 Consultant Trauma Surgeons from 8 hospitals across the UK

  • Consequent potentially eligible for randomisation clinical cases identified via the UK HeFT published via secure online forum after consent being obtained in 6 weeks follow up clinic or later

  • Surgeons alerted about new cases via email and SMS (optional) and express their opinion online

  • Level of uncertainty assessed by application of 80:20 ethical uncertainty distribution limit (Johnson et al, 1991), by accounting all votes in favour of operative treatment (a bit better + significantly better + much better)

  • “strong votes” (significantly better + much better) were accounted separately to demonstrate support or otherwise for recommendation

[email protected]


Results

Results

  • 30 eligible cases, of those 17 (56.7%) not randomised for HeFT

    • 4 bilateral injuries

    • 11 declined participation

      • 4 did not want to have surgery

      • 5 wanted to have surgery

      • 1 wanted to be treated privately

      • 1 did not want to be randomised

    • 1 randomised in error

    • 1 had previously infected tibial plate same side (removed)

  • Of 13 randomised 2 (15.4%) declined intended treatment (surgery)

  • On average 5 surgeons voted per case (min 3, max 8)

  • 26 cases incl. all bilateral injuries could be recommended for randomisation

Legend

  • chXXX – case number

  • Grey bars – votes by individual surgeons

  • Burgundy bars – cumulative average votes

[email protected]


Results1

Results

  • 3 cases the panel recommended for non-operative treatment

    • CH007 – 8.4% for surgery (1.2% strong votes)

    • CH027 – 13.7% for surgery(1.7% strong votes)

    • CH014 – 15% for surgery (4% strong votes)

  • 1 case the panel recommended for operative treatment

    • CH015 – 87% for surgery (72% strong votes)

  • UK HeFT: CH007 – randomised to non-operative treatment; CH015 – randomised to operative treatment;

    CH014 – declined to take part (did not want surgery);CH027 – declined randomisation (treated non-operatively)

[email protected]


Discussion

Pitfalls

Surgeons’ reluctance to vote (maybe overcome if votes will be more relevant)

Technical (PACS required in hospitals involved; very few glitches so far, overall simple cheap and stable system)

Strengths

Ease of use (3-5 min to vote per case)

No geographical boundaries

Instant application in real time (48 hours required to obtain votes)

Ethical value (randomisation only when the panel feels appropriate; individual, personal approach )

Discussion

  • Measuring Collective Uncertainty in our study showed potential to DOUBLE (from 43.3% to 86.7%) patient recruitment for the UK HeFT

  • At the same time patients would not have been offered randomisation where current specialist opinion (prior probability) is strongly in favour of one or another treatment

  • Broader inclusion criteria possible, because every patient is assessed for randomisation individually

  • Both surgeon and patient are supported in their decision by an expert panel

  • The Uncertainty Measurement is an opinion (prior probability); the final decision remains between a treating surgeon and a patient

[email protected]


Conclusion

Conclusion

  • We propose Measurement of Collective Uncertainty to be introduced into Surgical RCTs where decision about randomisation is especially challenging (operative vs non-operative; standard against new but popular well-marketed treatments etc)

  • It is possible to set up international expert panels to suite international studies

  • “Empowering choice will be given precedence by those who, like me [us], think the obligation to respect individual autonomy outweighs the common good in all but the most extreme cases…” (Lilford, 2003)

References

  • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5

  • Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical. Journal of Medical Ethics 1991;17:30-34

  • Lilford RJ. Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ 2003;326:980-1

  • McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ 2002;324:1448-51

[email protected]


Collective uncertainty project hope for randomised clinical trials in trauma and orthopaedics

Warwick

Medical School

University Hospitals of Coventry and Warwickshire

[email protected]


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