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Table 2 Outcomes of trial procedures

From: Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial

Feasibility outcomes Data source Feasibility success Timing
Feasibility of recruitment
• Dropouts from the trial/completion of sessions screening logs, supervision minutes and session records 50% or more women complete sessions Pre- and during intervention
▪ Feasibility and suitability of eligibility criteria restrictive/too inclusive Administrative (screening logs)
Proceedings of weekly supervision meeting (Agenda: suitability of eligibility)
# of women excluded due to each exclusion criteria Pre-intervention
Feasibility of data collection procedures
▪ Clarity of baseline questionnaires (layout, instructions, order of tools)) Proceedings of weekly supervision meeting (Agenda: clarity, time and acceptability of items 20 minutes to complete baseline and follow up battery Pre-intervention
▪ Characteristics of outcome measures (SD of the outcome and missing data) Outcome assessment tools Less than 5% missing data Post baseline assessment
▪ Time needed to complete questionnaires (reasonable or burden to participants) Time recorded on questionnaire
FGD with supervisors and research assistants
20 minutes to complete baseline and follow up battery Pre-intervention
• adequacy of masking of assessors and time needed to collect and analyse the data Administrative documents
FGD with supervisors and research assistants
  since start of recruitment
▪ Practical administrative and resource challenges to conduct the study (e.g. budget requirements, time, space, staff, skill, intervention materials) In-depth interviews with participants and healthcare providers, FGD with supervisors and research assistants   Post/ During intervention
Acceptability of trial procedures
▪ Obstacles to recruitment (recruitment rates, number of eligible patients, number of refusals and screenings) Administrative data and qualitative data from healthcare providers and participants
Proceedings of weekly supervision meeting (Agenda: recruitment challenges)
Less than 10% refusal to be randomized and screened in the flowchart Pre-intervention
▪ Participant willingness to be randomized (# of women) Administrative data (enrolment log) Less than 10% refusal to be randomized Post/during intervention