1 randomised controlled trials in the social sciences: challenges and prospects i. boutron dept of...
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Randomised Controlled Trials in the Social Sciences:Challenges and Prospects
I . Boutron
Dept of Epidemiology, Biostatistics and Clinical Research
Assessing Nonpharmacological treatments
Challenges and reporting guidelines for Randomised Controlled Trials
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Overview
• Specific methodological issues when assessing Nonpharmacological treatments
• Quality tools
• Reporting guidelines
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Overview
• Specific methodological issues when assessing Nonpharmacological treatments
• Quality tools
• Reporting guidelines
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Different types of NPT
- surgery
- technical operation (arthroscopy,…)
- rehabilitation
- education
- orthopedic braces or orthosis
- laser treatment
Participative interventions
Non implantable devicesTherapist-dependent interventions
Non-pharmacological treatments (NPT) take in many different treatments
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Assessing Nonpharmacological treatments
• Randomized controlled trials (RCT)– Gold standard of therapeutic evaluation
• The design, conduct and reporting of RCTs aim at providing valid results
• Standard of the methodology of RCTs has been developed in the context of pharmacological treatments (PT)
• Specific methodological issues when assessing NPTs– Blinding– Placebo– Complexity of treatments– Care providers’ influence
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Are NPT trials specific?Quality
A. PT (n=60) versus NPT (n=50)
B. Comparison
(1) Oral drug, intra-venous, intra-muscular (n = 46)
(2) Intra-articular injection (n = 14)
(3) Surgery, arthroscopy, joint lavage (n = 23)
(4) Rehabilitation, acupuncture, education(n = 27)
Quality of trials assessing PT and NPT of hip and knee osteoarthritis publishedin high impact factor journals (1992-2002)*
* Boutron, Tubach, Giraudeau, Ravaud Jama, 2003
scale
A B
- 1 0 1 2 3 4 5 6
Jadad - 1 0 1 2 3 4 5 6
Jadad scale
P T NPT
1
2 3 4
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Are NPT trials specific?The feasibility of blinding
Feasibility of blinding patients
96
2
48
2
10
42
0%
20%
40%
60%
80%
100%
NPT (n = 50) PT (n = 60)
%
Possible
Difficult
Impossible
Feasibility of blinding care providers
9686
2
2
2
12
0%
20%
40%
60%
80%
100%
NPT (n = 50) PT (n = 60)
%
Possible
Difficult
Impossible
Feasibility of blinding outcome assessors
98
502
16
34
0%
20%
40%
60%
80%
100%
NPT (n = 50) PT (n = 60)
%
Possible
Difficult
Impossible
* Boutron I, Tubach F, Giraudeau B, Ravaud P, JCE, 2003
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Are NPT trials specific?The success of blinding
Risk of unblinding patients
27
14
6586
80%
20%
40%
60%
80%
100%
NPT (n = 26) PT (n = 59)
%
Null
Moderate
Important
Risk of unblinding care providers
5719
43
68
130%
20%
40%
60%
80%
100%
NPT (n = 7) PT (n = 59)
%
Null
Moderate
Important
Risk of unblinding outcome assessors
8 10
36
90
56
0%
20%
40%
60%
80%
100%
NPT (n = 25) PT (n = 60)
%
Null
Moderate
Important
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Are NPT trials specific? Placebo
PT Surgery Rehabilitation, education
Placebo Matching placebo
Simulated procedure Sham intervention
Example Saline solution in identical syringes
Sham arthroscopy* Sham education program with similar frequency
and duration of sessions but with
different content **
Issue - Ethical issue False negative
* Moseley et al., NEJM 2002
**Edworthy et al. J Rheumatol 1999
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Are NPT trials specific?Placebo
Paterson, C. et al. BMJ 2005
Characteristic element(e.g., content of the education program)
Incidental element (e.g., healthcare providers – patients’ interaction effect)
Incidental element (placebo effect)
Effect not related to treatment (e.g., natural course of the disease, regression to mean )
Real treatment
effect
Measured treatment
effect
Characteristic element(e.g., content of the education program)
Incidental element (e.g., healthcare providers – patients’ interaction effect)
Incidental element (placebo effect)
Effect not related to treatment (e.g., natural course of the disease, regression to mean )
Real treatment
effect
Measured treatment
effect
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Are NPT trials specific? Placebo
• Externally clearly different placebo
– Physiotherapy for knee OA* • Placebo treatment consisted of sham
ultrasonography
– Assessment of lifestyle advice**• Placebo treatment consisted of a syrup placebo
*Bennell, Ann Rheum Dis, 2005**Spigt, JCE, 2005
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Are NPT trials specific? The methods of blinding – Full blinding
• Full blinding attempted • externally identical placebo/control
• Unblinded care providers not involved in the subsequent patient care
• Example– Transplantation of embryonic dopamine neurons**
• four twist-drill holes made through the frontal bone after local anesthesia
• the dura mater was not penetrated
* Boutron, Ravaud, Submitted** Freed, NEJM, 2001
Study cohort: 145 non-pharmacological trials (2004)*
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Are Non pharmacological trials specific? The methods of blinding – Partial blinding
• Partial blinding attempted (blind trial hypothesis)
– Externally clearly different placebo / control
– Manipulation of information • Patients not informed of the existence of a placebo
• Patients not aware of the nature of the placebo
• Confidence in treatments sometimes tested
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Are Non pharmacological trials specific? The methods of blinding – Partial blinding
• Zelen design or modified zelen design– Usual care compared to a complex, physical
therapy-based intervention for patello-femoral joint osteoarthritis of the knee
• 1) Researchers invited patients to participate in a cohort.
• 2) Randomization
• 3) Patients randomized to the intervention arm informed that they would receive the experimental treatment and signed a second consent form
Quilty, J Rheumatol. 2003
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Are Non pharmacological trials specific? The methods of blinding – Outcome assessors• Blinding of outcome assessors
– Centralized assessment (video, audiotape or photography )
– Outcome assessors blinded of study hypothesis• To assess the analgesic effect of breast feeding in term neonates
compared to mothers’ arms, pacifiers, placebo (i.e., sterile water) or glucose
– Videotape of the children during the painful procedure– Two specially trained observers independently assessed the recordings using
a specific scale. – Observers were blinded to the purpose of the study and had been told that
they were assessing agreement of their scores in different situations
– Patients reported outcomes• Blinding is impossible if patients cannot be blinded
Carbajal R, Bmj. 2003
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Are NPT trials specific? Complex intervention
• Several components– Rehabilitation : exercises, drugs, education etc
• Description of the intervention– Quantitative data
• Number of sessions, timing of each session, duration of each session
– Qualitative data• Content of each session, how it is delivered, supervision, content of
information exchanged etc
• Standardization procedure– Specific training– Quality control procedures
• Potential gap between the intended intervention (as described in the protocol ) and the actual administered intervention
• Barrier for systematic reviews
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Are NPT trials specific? Influence of care providers
• Systematic review of the surgical and medical volume-outcome literature (Jan 1, 1980 - Dec 31, 2000)*– 71% of hospital volume-outcomes studies positive (88/124)
– 70% of physician volume-outcomes studies positive (31/44)
– No studies showed the opposite relationship
– Relationship strongest for high risk/rare surgeries:• Pancreas/esophagus cancer, pediatric cardiac surgery• NNT at high v. low volume provider: 7 to 11
– Much more modest volume-outcome effect for common procedures (CABG, CEA, PTCA, breast/colon cancer)
• NNT: 62 to 500
*Halm et al, Ann Intern Med 2002
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Are NPT trials specific?
• Specific issues in assessing NPT – Blinding– Placebo– Complexity of treatments– Healthcare providers’ influence
• Need of specific standards
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Overview
• Specific methodological issues when assessing Nonpharmacological treatment
• Quality tools
• Reporting guidelines
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Quality toolsWhy?
• Assessing the quality of reports of trials is particularly important – clinicians’ critical appraisal of healthcare
literature
– systematic reviews
• Accurate estimates of the treatment effect
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Quality toolsWhy?
• Several quality tools• Few quality tools were developped according to
scientific standards– Jadad scale*– Delphi list**
• Validated quality tools were mainly developped in the context of PT– Importance of blinding– No item related to care providers and the complexity
of the intervention
** Jadad, Control Clin Trials, 1996* Verhagen, JCE, 1998
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Development of a specific checklistThe example of CLEAR NPT
• Quality: Internal validity• Delphi consensus method• Selection of items
• From existing checklist or scales• From specific items• From the Collaborative Review Groups of the Cochrane
Collaboration recommandations• Interviews of clinicians
• Experts• Members of Collaborative Review Groups of the Cochrane
Collaboration (n=41)• Clinicians involved in RCTs assessing NPTs (n=58)• Methodologists, epidemiologists (n=55)
– 55 experts participated(36%)
Boutron & Ravaud, JCE, 2005
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Decision of the steering comitteeSelection of items
with a score of 8/9for more than 40% of experts
Decision of the steering comitteeSelection of items
With a score of 9/9for more than 40% of experts
Decision of the steering comitteeSélection of all items
Addition of 2 items for randomisationAddition of 1 item for the intention-to-treat analyses
Final Checklist10 items
5 sub items
Checklist11 items
Checklist21 items
Initial checklist38 items
1st Round54 experts/55
2nd Round46 experts/55
3rd Round49 experts/55
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CLEAR NPT
• Was the generation of allocation sequences adequate?• Was the treatment allocation concealed?• Were the main outcomes analyzed according to the
intention-to-treat principle?
• Were details of the intervention administered to each group made available?
• Were care providers’ experience or skill in each arm appropriate?
• Was participant (ie, patients) adherence assessed quantitatively?
• Was the follow-up schedule the same in each group?
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CLEAR NPT
• Were participants adequately blinded?
• Were care providers or persons caring for the participants adequately blinded?
– If care providers and or participants were not adequately blinded• Were all other treatments and care (ie, co-interventions) the same in each
randomized group?
• Were withdrawals and lost to follow-up the same in each randomized group?
• Were outcome assessors adequately blinded to assess the primary outcomes? – If outcome assessors were not adequately blinded,
• Were specific methods used to avoid ascertainment bias (systematic differences in outcome assessment)
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CLEAR NPT
• Adequate assessment of trials quality
• Improvement of critical appraisal of medical litterature
• Improvement of the quality of systematic reviews
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Overview
• Specific methodological issues when assessing Nonpharmacological treatment
• Quality tools
• Reporting guidelines
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Reporting guidelinesWhy?
• Critical appraisal of the quality of clinical trials is possible only if the design, conduct, and analysis of RCTs are thoroughly and accurately described in published articles
• Evidence of incomplete and inadequate reporting
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Reporting guidelines
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Reporting guidelines
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Reporting guidelinesDissemination
• Publication– 11 journals– Over than 1000 citations
• Editors endorsements including the ICMJE (International Committee for Medical Journal Editors)
– instructions to authors– submission check-list
• Website– www.consort-statement.org
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Reporting guidelinesDissemination
• Various extensions of the CONSORT Statement since the original version (parallel arm, superiority, efficacy)
• Cluster RCT
• Harm
• Herbal therapy
• Non inferiority trials
• Several other extensions are in progress• 2x2 factorial design
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Reporting guidelines for NPT trials Why?
• 119 RCTs published in 1998 and 1999 in three major cardiothoracic journals (Annals of Thoracic Surgery, European Journal of Cardio-thoracic Surgery, The Journal of Thoracic and Cardiovascular Surgery)
• 70 % of RCTs fulfilled less than half of the CONSORT criteria
Anyannu, Eur J of Cardio-thoracic Surgery, 2004
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Reporting guidelines for NPT trials Why?
NPT PT
Blinding of patients 46% 98%
Blinding of healthcare providers 43% 83%
Blinding of outcome assessors 72% 98%
Study of trials assessing PT and NPT of hip and knee osteoarthritis (1992-2002)
When blinding was judge possible, blinding was less often
reported in NPT trials
* Boutron & Ravaud, Jama, 2003
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Reporting guidelines for NPT trials Why?
Study of surgical papers (n = 158) published in 2004*
• Reporting of details of the intended intervention– Surgical procedure 87 %– Pre-operative care 15 %– Anesthesia 35 %– Post-operative care 49 %
• Surgeons– Selection criteria for surgeon 40 %– Number of interventions performed
by surgeon 11 %– Number of surgeons involved 33 %
* Jacquier I, Boutron I, Ravaud P, Ann. Surgery
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Reporting guidelines for NPT trials Why?
Study of rehabilitation papers (n = 171) published between 1997-1998*
• Timing of the intervention 68 %
• Description of the intervention 50 %
• Intervention’s adherence 34%
* Dijkers at al. Am J Phys Med Rehabil, 2002.
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Reporting guidelinesDevelopment of the extention of the CONSORT to NPT
Steering committee– D. Moher– P. Ravaud– I. Boutron
Selection of experts– Editors– Clinicians– Methodologists
Two stages method– Preliminary survey
– Consensus meeting
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Preliminary survey
• Objective– To identify items to be discussed based the
experts’ opinion
• Methods– All items of the CONSORT checklist– 7 specific questions on key issues were added– Items were selected for discussion if more than
1/3 of the experts answered that the item should be modified or another item should be added
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Consensus meeting
• 3 days– February 8-10th 2006, Paris
• 30 experts
• Agenda– Presentations– Discussions– Consensus
• Manuscript in process
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Conclusions
• Specific issues in assessing NPT– Placebo– Blinding– Complexity of the intervention– Care providers’ influence
• Specific guidelines– Specific quality tools
• CLEAR NPT
– Specific reporting guidelines• Development of an extension of the CONSORT for
NonPharmacological treatment (CONSORT meeting, Paris, 2006)