Probabilidad de corte y tasa de transferencia exitosa

a) Inclusion Criteria

One of the key findings from the pilot study was the slow recruitment of women to the study. The time to recruit the small number of participants took much longer than initially anticipated. Sixteen potential participants had been referred into the study and nine participants took part over a period of six-months.

Discussions with health visitors suggested that the inclusion criteria on the EPDS should be reduced from 13 to 10, with 10 being the clinical cut-off point for mild

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depression. This EPDS range was also increased from 21 to 22, the higher end being subject to the approval of the health visitor. This was intended to allow more

participants to be eligible to take part in the study. Again, due to the vulnerability of the participants, a substantial amendment was required, and ethical approval was sought before putting these changes into practice.

b) Recruitment Strategy

Changes to the recruitment strategy were made alongside the changes to the inclusion criteria above and were part of the same substantial amendment to the ethics committee. These were as follows:

Referrals via Health Visitors and GPs

The health visitor or GP were provided with a brief expression of interest study leaflet, which could be given to any participant who they were treating / visiting for postnatal depression (see Appendix Five). The leaflet asked the participant for their permission for their GP / health visitor to give their name and address to the research team, in order for them to be provided with a full PIS. This initial permission request did not provide confirmation that the potential participant had agreed to take part in the study, and at this point the participant had not been screened for eligibility. When the researcher received the study leaflet, telephone contact was made with the

participant to inform them that they would be receiving further information

regarding the study through the post. The participant was then sent a copy of the PIS (see Appendix Six).

After one-week the participant was contacted by telephone to answer any questions and ask if they wanted to take part.

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If they were interested in taking part, and before proceeding any further, the researcher asked them the ten questions from the EPDS to assess their eligibility. The questionnaire was scored on the same day, and the participant was informed of whether they are eligible (only women with an EPDS score above 10 and below 22 were eligible). If the participant declined, no further contact was required. If the participant was not eligible, the researcher explained that they did not meet the study entry criteria (i.e. as was explained in the PIS). They were reassured that they would continue to receive all existing support.

If the participant was eligible and wanted to take part, they were sent a questionnaire pack together with the consent forms to complete and return in an enclosed prepaid envelope. The participant would then be contacted by telephone to inform them which group they had been randomised to. The statement that was read out to participants informing them of their group allocation was prepared and given ethical approval (see Appendix Twelve). A letter was sent notifying the GP and health visitor of their participation in the study (see Appendix Thirteen). The procedure was then continued as per the original study protocol.

GP Practices

GP Practices were more robustly targeted with the support of the Central England Primary Care Research Network (PCRN) research facilitator from the University of Warwick. Twenty-six local surgeries were sent information about the study in the post, and this was followed up by a telephone call offering to visit the medical practice and present the study information to the team. They were also provided with posters and leaflets. While the majority of practice managers from these targeted

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surgeries agreed to display posters and leaflets, none of them agreed for the researcher to go and visit them.

Self-Referral

Posters (see Appendix Fourteen) were displayed in local Children’s Centres, with the contact details of the researcher.

All participants who self-referred were then recruited following the above procedure (i.e. the research team would arrange to provide them with further information etc.)

Webpage

A Mums4Mums study web page was developed that linked to the Warwick Infant and Family Wellbeing Unit (WIFWU) website on the Warwick Medical School website.

This web page consisted of the following:

• Introductory page with links to the next page

• Full information sheet with a link to a screening questionnaire

• A final link that thanks the mother and explains what will happen next.

Online self-Referral

We also developed an online self-referral route via the University Webpages. We provided information on the study, developed a ‘frequently asked questions’ page for women wanting more information, and the EPDS scale was provided online for potential participants to complete.

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An online consent form was not required because it was assumed that the decision to submit the questionnaire and their contact details were a sufficient indication of consent. Participants could not access the screening questionnaire until they had accessed the information sheet

.

Netmums

‘Netmums’ is the UK's fastest-growing online parenting organisation with over 756,000 members, mostly new mothers. The study information on their local web pages was updated to inform new mothers that the Mums4Mums study was now recruiting for the RCT.

Netmums also agreed to place the ‘Mums4Mums’ weblink on their home page within the Warwickshire area. This enabled potential participants to learn about the study, access information, and contact the research team if they wished to do so.

Local NHS Health Online Forum

We provided information about the study on the Local NHS Forum under the heading of ‘Warwick study investigates support for postnatal depression’. See the following link http://www.nhslocal.nhs.uk/story/warwick-study-investigates- support-postnatal-depression

Local Mother and Toddler Groups

A list of local mother-and-toddler groups was extracted from the ‘Netmums’ site and telephone contact was made with approximately fifty groups. The aim was to

identify if the mothers attending these groups had multiple births, and if the toddlers had siblings who were infants. We offered to leave posters and leaflets at these

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groups. This approach proved difficult as the group organisers were difficult to contact and group workers were not in a position to offer their support.

Local Magazines

We contacted the editor of ‘Raring2go!’ in Nuneaton and Hinckley. They agreed to place an A5 advertisement in their magazine for a small charge (see Appendix Fifteen).

Midwifery Departments

Midwifery departments at the George Elliot Hospital in Nuneaton, and Warwick Hospital, agreed to provide the Mums4Mums brief expression of interest leaflets. They agreed to place these leaflets in the maternity discharge wards, and also to promote the study where possible.

Improved Access to Psychological Therapies

The Improved Access to Psychological Therapies (IAPT) team in Coventry and Warwickshire were approached as another avenue for recruitment1.

As part of the IAPT programme, patients are asked at the initial assessment process to consent if they would like to take part in current research. Patients who ticked a box consenting to be contacted to take part in research, and who met the inclusion criteria for the study, could then be telephoned by the researcher and provided with

1_{The Improving Access to Psychological Therapies (IAPT) programme supports the frontline NHS in}

implementing National Institute for Health and Clinical Excellence (NICE) guidelines for people suffering from depression and anxiety disorders.@@It was created to offer patients a realistic and routine first-line treatment, combined where appropriate with medication which traditionally had been the only treatment available. The programme was first targeted at people of working age but in 2010 was opened to adults of all ages (http://www.iapt.nhs.uk/about-iapt/).

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the Mums4Mums PIS (See Appendix Sixteen for the strategy adopted as part of recruitment for Mums4Mums).