Depression in South Yorkshire (DEPSY) · Depression in South Yorkshire (DEPSY) Using the ‘cohort...
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Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design
to assess treatment by homeopaths for self-reported depression
Petter Viksveen, PhD Student The University of Sheffield
Presentation at the Trials within Cohorts (TwiCs) Symposium
London School of Hygiene & Tropical Medicine 10 – 11 Nov 2014
Supervisors: Dr. Clare Relton, Prof. Jon Nicholl Advisor qualiative study: Prof. Paul Bissell
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Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design
to assess treatment by homeopaths for self-reported depression
Aims
To assess the acceptability, the effectiveness, the cost-effectiveness, and the safety of treatment provided by homeopaths for patients with self-reported depression.
To learn from patients’ experiences with treatment provided by homeopaths.
ISRCTN02484593
Viksveen & Relton (2014)
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Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design
to assess treatment by homeopaths for self-reported depression
Methods: Pragmatic RCT
Recruitment through the Yorkshire Health Study (YHS)
Screening & baseline data collection: postal questionnaire
Primary outcome: PHQ-9 (6 months), Secondary outcomes: PHQ-9 (12 mo.), GAD-7 (6 & 12 mo.), and EQ-5D (12 mo.)
Intervention: Treatment by homeopaths (9 mo.) + TAU
Control: Treatment as usual (TAU)
Venues: 4 clinics in 4 cities, 7 practitioners
Random selection (1:2 ratio for Offer and No Offer group)
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Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design
to assess treatment by homeopaths for self-reported depression
Methods: Qualitative study
Qualitative semi-structured interview study
Offer group patients who received treatment by a homeopath
Interviews at 1-2 and at 6 months, until saturation (max. 30 + 30)
Thematic analysis
Mixed methods (triangulation at interpretation stage)
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REC (IRB) experience
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REC (IRB) experience
Leeds Central REC:
No questions about or objections to the cmRCT design
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Approvals – 23 months
Apr May Feb July Nov 2012 2013 2014
Dec Mar Apr Jul Aug Jan
ISR REC Research Passport
Research Governance
Approval venues
Barnsley Rotherham
Sheffield Doncaster 1 month 3.5 months
4 months
5 months
7 months
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Approvals – 23 months
Apr May Feb July Nov 2012 2013 2014
Dec Mar Apr Jul Aug Jan
ISR REC Research Passport
Research Governance
Approval venues
Barnsley Rotherham
Sheffield Doncaster
"[...] the multitude of different application processes that have been implemented mean that research governance presents another large barrier to research." (Torgerson & Dumville 2004, p.710)
1 month 3.5 months 4 months
5 months
7 months
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Approvals – 23 months
Apr May Feb July Nov 2012 2013 2014
Dec Mar Apr Jul Aug Jan
ISR REC Research Passport
Research Governance
Approval venues
Barnsley Rotherham
Sheffield Doncaster
Throughout the research governance approval process no objection was made to the use of the cmRCT design.
1 month 3.5 months 4 months
5 months
7 months
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Recruitment: Time & financial resources
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Recruitment: Time & financial resources
Yorkshire Health Study
22,000 patients consented to be contacted again, of which:
- Long-standing depression: n=1,917 (8.7%)
- Moderately/extremely anxious/depressed: n=3,823 (17.4%)
- LSD or moder./extr. anxious/depressed: n=5,740 (26.1%)
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Sent to 5,740 patients
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Random selection within 2-3 months
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Recruitment: Costs
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Recruitment: Costs
5,740 questionnaires: £ 4,200
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Recruitment: Costs
5,740 questionnaires: £ 4,200
22,000 questionnaires (est.): £ 13,000
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Recruitment: Reaching targets
114 multi-centre trials:
2/3 did not achieve recruitment targets (McDonald et al. 2006)
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Recruitment: Reaching targets Numbers of patients in the DEPSY trial, using a "rolling" recruitment procedure (Dec 2013 – Feb 2014):
Sample size calculation Total 484 "No offer" group 323 "Offer" group 162
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Recruitment: Reaching targets Numbers of patients in the DEPSY trial, using a "rolling" recruitment procedure (Dec 2013 – Feb 2014):
Sample size calculation Result Total 484 566 (+17%) "No offer" group 323 381 "Offer" group 162 185
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Recruitment: Reaching targets Numbers of patients in the DEPSY trial, using a "rolling" recruitment procedure (Dec 2013 – Feb 2014):
Sample size calculation Result Total 484 566 (+17%) "No offer" group 323 381 "Offer" group 162 185 Accepted & treated 75 Not accepted/treated 110
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Recruitment: Reaching targets Numbers of patients in the DEPSY trial, using a "rolling" recruitment procedure (Dec 2013 – Feb 2014):
Sample size calculation Result Total 484 566 (+17%) "No offer" group 323 381 "Offer" group 162 185 Accepted & treated 75 Not accepted/treated 110
How will the acceptance rate affect statistical analyses?
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%)
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
Why is there a difference in response rates within the Offer group?
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
Why is there a difference in response rates within the Offer group? How do differences in response rates influence analyses?
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
Why is there a difference in response rates within the Offer group? How do differences in response rates influence analyses? Can CACE analysis be carried out?
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Follow-up: response rates & attrition Responders to Mood & Health Questionnaire at 6 months
Random selection 6 month responders Total 566 458 (81%) "No offer" group 381 333 (87%) "Offer" group 185 125 (68%) Treated 75 65 (87%) Not treated 110 60 (55%)
Why is there a difference in response rates within the Offer group? How do differences in response rates influence analyses? Can CACE analysis be carried out? Do treated and untreated patients in the Offer group differ?
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Do baseline values for treated and untreated patients in the Offer group differ?
No significant differences for 16 of 19 baseline characteristics
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Do baseline values for treated and untreated patients in the Offer group differ?
No significant differences for 16 of 19 baseline characteristics PHQ-9: Treated 16.30(4.47), Untreated 17.57(4.22), p=0.146
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Do baseline values for treated and untreated patients in the Offer group differ?
No significant differences for 16 of 19 baseline characteristics PHQ-9: Treated 16.30(4.47), Untreated 17.57(4.22), p=0.146 - Depr. onset: Treated patients more chronic depression - Past AD use: Treated patients more past AD use Differences could be accounted for by a lower response rate to baseline questions
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Do baseline values for treated and untreated patients in the Offer group differ?
No significant differences for 16 of 19 baseline characteristics PHQ-9: Treated 16.30(4.47), Untreated 17.57(4.22), p=0.146 - Depr. onset: Treated patients more chronic depression - Past AD use: Treated patients more past AD use Differences could be accounted for by a lower response rate to baseline questions
- City/Borough: Untreated more from Doncaster, fewer from Barnsley & Sheffield
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Pros and cons of using the cmRCT design?
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
Recruitment ☺ Higher N? Faster? Refusal of offer
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
Recruitment ☺ Higher N? Faster? Refusal of offer
Attrition ? No resentful Non-responders among demoralisation untreated in Offer group
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
Recruitment ☺ Higher N? Faster? Refusal of offer
Attrition ? No resentful Non-responders among demoralisation untreated in Offer group
Costs ☺ $ probably reduced ?
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
Recruitment ☺ Higher N? Faster? Refusal of offer
Attrition ? No resentful Non-responders among demoralisation untreated in Offer group
Costs ☺ $ probably reduced ?
Generalisability ☺ "Real world" practice ?
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Pros and cons of using the cmRCT design?
Advantages Disadvantages
Ethics = Cohort has approval ?
Consent ☺ Only from Offer group ?
Recruitment ☺ Higher N? Faster? Refusal of offer
Attrition ? No resentful Non-responders among demoralisation untreated in Offer group
Costs ☺ $ probably reduced ?
Generalisability ☺ "Real world" practice ?
Aims achieved ? ? ?
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References
McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006; 7:9 doi:10.1186/1745-6215-7-9.
Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic RCTs: introducing the ‘cohort multiple RCT’ design. BMJ 2010, 340:c1066.
Torgerson DJ, Dumville JC. Ethics review in research. Research governance also delays research. BMJ 2004; 328:710.
Viksveen P, Relton C. Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial. Homeopathy 2014; 103:147-152.