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![Page 1: Copyright 2011 Right Care IDEAL A rational approach to evaluation of complex treatments Peter McCulloch Chair, IDEAL Collaboration March 2015 Online Learning.](https://reader036.fdocuments.us/reader036/viewer/2022081519/56649d365503460f94a0ef86/html5/thumbnails/1.jpg)
Copyright 2011 Right Care
IDEALA rational approach to evaluation of complex treatments
Peter McCulloch
Chair, IDEAL Collaboration
March 2015
Online Learning Series
Right Care for Populations
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Developing Evidence for TherapyPHARMA PARADIGM
• Theory• Lab demonstration • (animal studies)• First-in-man study• Toxicity study (Phase I)• Efficacy Study (Phase II)• RCT (Phase III)• Post-Marketing Surveillance (Phase IV)
SURGICAL PARADIGM
• Idea• (animal/bench trial)• First-in-man (CS)• Outcome experience (CS)• Confirmation/dispute from others (more CS)• RCT??
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SPECIAL PROBLEMS OF SURGICAL TRIALS
1. Early “tinkering” 2. Defining the surgical intervention3. Accommodating surgical learning curves 4. Quality Control5. Developing standard outcome measures6. Strong preferences
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IDEAL: What and Why?
AIM• Improve the methodological quality of research in
surgery and interventional therapiesSTEP 1: FRAMEWORK
• Describe the natural history of surgical innovationSTEP 2: RECOMMENDATION
• Define appropriate studies for each stage in the innovation pathway
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Stage 1IDEA
Stage 2a DEVELOPMENT
Stage 2b EXPLORATION
Stage 3 ASSESSMENT
Stage 4 LONG TERM MONITORING
Initial report Innovation may be planned, accidental or forced Focus on explanation and description
“Tinkering”(rapid iterative modification of technique and indications) Small experience from one centre Focus on technical details and feasibility
Technique now more stable Replication by others Focus on adverse effects and potential benefits Learning curves important Definition and quality parameters developed
Gaining wide acceptance Considered as possible replacement for current treatment Comparison against current best practice (RCT if possible)
Monitoring late and rare problems, changes in use & quality of surgical performance
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Identifying the IDEAL Stage
• Quick literature search• Review article TYPES, NUMBER, SOURCES and
PATIENT NUMBERS• Use the Framework to identify the Stage
Leads on to RECOMMENDATIONS for evaluation
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Stage 1: IDEARECOMMENDATIONS
• Compulsory reporting of all new innovations on a Professional Innovation Database
• Confidential entry allowed to encourage reporting of failed innovations (CHRP system)
• “Light touch” local unified regulation
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Stage 2a: Development RECOMMENDATIONS
• Prospective Development Studies:- Detailed description of selection criteria- Detailed technical description- Prospective account of ALL cases consecutively- Clear STANDARDISED definitions of outcomes reported- Description of ALL modifications and when made in
series
• Registration of PROTOCOL before study starts
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PDS Example: Development of Robotic Oesophagectomy
Hospital Stay(days)
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Stage 2b ExplorationRECOMMENDATIONS
Prospective Exploration Study
(collaborative uncontrolled
prospective study)
• To evaluate technique prospectively and co-operatively
• To develop a consensus over definition of the procedure, quality standards
• To accumulate data for power calculations
• To evaluate and monitor learning curves
• To evaluate preferences and values amongst patients and clinicians
• To achieve consensus on the trial question
• To develop a multi-centre randomised trial
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PES Example:Feasibility Study for RCT of radical gastrectomy
• 8 North Italian surgical units
• Training scheme • Prospective Cohort • Review of short term
outcomes• 5 Eligible groups
enter RCT
Extended lymph node dissection for gastric cancer: results of a prospective, multi-centre analysis of morbidity and mortality in 118 consecutive cases.Degiuli M, Sasako M, Ponzetto A, Allone T, Soldati T, Calgaro M, Balcet F, Bussone R, Olivieri F, Scaglione D, Danese F, Morino M, Calderini P, Capussotti L, Fronda G, Garavoglia M, Locatelli L, Dellepiane M, Rossini FP, Calvo F.Eur J Surg Oncol. 1997 Aug;23(4):310-4.
Morbidity and mortality in the Italian Gastric Cancer Study Group randomized clinical trial of D1 versus D2 resection for gastric cancer.Degiuli M, Sasako M, Ponti A; Italian Gastric Cancer Study Group.Br J Surg. 2010 May;97(5):643-9. doi: 10.1002/bjs.6936.
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Stage 3: AssessmentRECOMMENDATIONS
Surgical RCT Or Alternative…
• Consider blinding• Standardise Terms• Use Stage 2b data to decide;
• Power calculations• Definition of intervention• Quality measures• Learning curve eligibility
• Deal with preferences• Expertise-based trials• Qualitative research• Third party randomisation• Decision support aids• Cohort/RCT mixtures
• Feasibility trials(?)
• Stepped-wedge design
• Controlled interrupted time series
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Stage 4 Long term studyRECOMMENDATIONS
• Prospective Registries• Best designed by clinical
community (with help)• Best curated by impartial
body (not manufacturer)• SPC used for quality
control (Shewart charts, CUSUM, VLAD)
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IDEALAn integrated evaluation pathway
REGISTRATION OF 1st in MAN
PROSPECTIVE DEVELOPMENT STUDY
PROSPECTIVE EXPLORATION STUDY
RCT
REGISTRY
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Uses and Implications• For designing and publishing studies of
invasive therapeutic techniques
• For defining the evidence required for licensing of therapeutic devices & implants
• For deciding what evidence is needed to justify commissioning of procedures and devices
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Get involved
• Follow us on Twitter @IDEALCollab• Link to our website from your institution’s website• Send us text about your work or IDEAL related topics so
we can upload as news items on the websitewww.ideal-collaboration.net
• Become a member and subscribe to our newsletter• Collaborate on piloting & evaluating IDEAL study designs
Contact: [email protected] Project Manager
[email protected] Chair
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17
Online Learning Series
Right Care for Populations
Follow Right Care online• Subscribe to get a weekly digest
of our blog alerts in your inbox, • Receive occasional eBulletins • Follow us on Twitter
@qipprightcare
Find the full series at:
www.rightcare.nhs.uk/resourcecentre
Find more IDEAL resources at:
www.rightcare.nhs.uk/resourcecentre