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Assessment procedures Intention to Treat analyses in psychopharmacology Definition of outcome Intent to Attend
Smaller N reduces statistical power Limits feasibility and generalizability Magnitude of attrition bias is function of:
Association of attrition with unobserved outcome Attrition rate
mean: 37%
Active 44%
mean: 32%
# trials
N 8360
PLA 21.7%
Active 28.1%
Geriatric Depression
68
Acute Depression
(7-8 wks)
Kemp et al. 2008 LA Smith et al. BD, 2007 Gao et al. 2009
14 14 5
Maintenance
(12-30 months)
Maintenance
(12-24 months)
N 3483
PLA 59.0%
Active 48.3%
16
Restrict duration of assessments (quality vs quantity) 2, 3, 4+ hour baseline assessments are not unusual Only include assessments linked to hypotheses
Differentiate between med termination & study termination Attempt assessments for entire course of RCT - regardless of adherence to study meds Adhere to Intention to Treat: Analyze as randomized
Alternative Outcomes
Psychoeducation for families increased retention in RCT for bipolar disorder (Sherrill, Psychiatric Services, 1997) Incentives for Participants
Lithium Treatment - Moderate dose Use Study for Bipolar Disorder: LiTMUS
Ongoing RCT with 6 month course of tx: 12% attrition
Comparator condition Randomized to optimized tx +/- lithium augmentation Reimbursed $50/visit: costs of travel, child care, parking, time burden Intent to Attend items administered with follow-up questions
Predict Dropout:
Baseline:
Intent to Attend
unlikely (0)
Weekly:
Intent to Attend
Intent to Attend :
Intent to Attend :
Intent to Attend
Incorporate in sensitivity analyses Value of Intent to Attend will depend on it association with Attrition, Outcome, and Group. Strength of association will likely vary across indications This item could change non-ignorable attrition to ignorable
Do not exclude Ss with some missing data With ignorable dropout, mixed-effects models can be used for valid inference. Assume attrition explained by observed outcome or covariates Intent to Attend could prove to be a useful predictor of attrition.
Summary
Attrition rates are substantial in psychopharmacology Design RCTs to minimize attrition
Reduce burden of assessments Continue to assess regardless of adherence to study meds Operationalize outcome to incorporate dropout Provide incentives Collect data that predict dropout Accommodate participants needs