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Table 2 APPEAL data collection process and timing

From: Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial

Outcome/data

Timing of data capture

Process

Midwifery team characteristics (clusters); midwife experience of trial processes

Various times throughout the cluster trial process

Number of births per team, number and grades of midwives per team and team location, number of women/births per team from NHS trust managers/community-team leads.

Interviews with individual midwives in both study arms.

Health outcomes & PFME performance

Questionnaire follow up of all women in participating clusters at 10-12 weeks postpartum.

Overseen by local NHS trust Research Midwives. If no response to initial follow up, questionnaire resent. If no response after a further two weeks, other options will include sending a text message reminder

Data from women’s maternity records

On return of consent in women’s questionnaire.

Extracted by local trust Research Midwives from maternity records.

Data from telephone/online interviews with women from both trial arms

Interviews with 10-15 women from each trial arm

A sample of up to 30 women who agreed to be approached. Interviews to qualitatively explore their experiences of receiving (or not) information and advice about doing PFME during pregnancy; and to explore any possible contamination between arms.

Intervention cluster midwives’ views of training

Questionnaire to all midwives attending training, at start & end of the training session.

On completing training roll-out in intervention clusters. Up to 15 midwives (including champions).

To evaluate the acceptability and effect on confidence of the training.

Purposive sampling to represent cluster site/size. Telephone/online interviews during the practice month to assess acceptability, fidelity to intervention.

APPEAL midwives’ views of implementation of the intervention

Prior to completion of roll-out. All midwives in intervention clusters

Questionnaire to explore how midwives administered the intervention in practice, how often PFME were discussed with women at routine AN contacts, barriers and facilitators to implementation

APPEAL midwife champions views of role supporting roll-out and implementation of training intervention

On completion of intervention roll-out.

The APPEAL champions included in the aforementioned intervention cluster interviews. Telephone/online interviews to assess acceptability, fidelity to intervention pertaining to the champion role.

Midwives’ views on acceptability of the intervention/standard PFME advice (intervention and control clusters) and study processes (intervention and control midwives)

Interviews with up to 15 midwives from each trial arm.

Purposive sampling to represent cluster site/size. Telephone/online interviews to assess acceptability, fidelity to intervention (intervention) and potential contamination (control).