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Main Outcome Measures: Chedoke-McMaster Stroke Arm Assessment, distance, velocity, smoothness, straightness, and direction of the hand path during each reach.
In the intervention arm, assessment measures used at baseline to characterize the intervention patient population will include the Mini International Neuropsychiatric Interview MINII) [ 28], Quick Inventory of Depressive Symptomatology-Self Rated Scale (QIDS-SR) (see Appendix 2) [ 29], Global Assessment of Functioning (GAF) [ 21], and Schwartz Outcome Scale (SOS-10) [ 30].
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In phase 1, reviewers were unsure of trial arm allocation in 33% of intervention and 30% of control arm assessments.
In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria.
In phase 2 there was a reduction in the proportion of correct guesses and much greater uncertainty: reviewers were unsure of the trial arm in 45% of all intervention and 48% of control arm assessments.
The rate of inaccurate diagnosis (difference of more than 45 degrees) was hypothesized to be 20% in the usual care arm (clinical assessment alone) and 10% in the intervention arm (clinical assessment and ultrasound).
Patient characteristics were compared using Fisher exact tests and analyses of variance that had terms for intervention arm and assessment time.
Arm symptoms assessment by the EORTC QLQ-BR23 questionnaire showed no significant difference in both the groups at t3 (Table 3).
Recruitment of women at the point of decision making, inclusion of a usual care arm and assessment of baseline predispositions and follow up of participants 3 months postpartum all increased the generalisability of the study findings.
Costs and outcomes will be described by arm and assessment point but the economic evaluation will focus on 15-month findings in the form of cost-effectiveness analyses based on SF-36 mental and physical component scores and cost-utility analyses based on quality-adjusted life years (QALYs).
In most of these studies, standard supervision continued in all groups (74, 83); however, in the Ugandan study, there were three arms: self-assessment, self-assessment with supervisors trained in problem solving, and a control group with standard supervision.
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