Table 2 Outcomes of trial procedures
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 |
â–ª 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 | |||
â–ª 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 |
â–ª Characteristics of outcome measures (SD of the outcome and missing data) | Outcome assessment tools | Less than 5% missing data | Post baseline assessment |
â–ª 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 |
â–ª 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 | Â | Post/ During intervention |
Acceptability of trial procedures | |||
â–ª 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 |
â–ª Participant willingness to be randomized (# of women) | Administrative data (enrolment log) | Less than 10% refusal to be randomized | Post/during intervention |