Title: Antenatal Prophylactic Pelvic floor Exercises And Localisation (APPEAL) Programme
Funder: Department of Health and Social Care

Abstract: The APPEAL programme is designed to facilitate implementation of antenatal pelvic floor muscle exercises (PFME) (Grade IA evidence) into practice by providing the missing elements required to effect an improvement change in line with Batalden and Davidoff's health service implementation framework. The main component of the generalisable scientific evidence (Element 1 of the framework) has already been provided by the Cochrane review by Boyle et al in 2012. The remaining elements will be achieved in four work packages (WP). The aim of the first work package is 'Context awareness to improve implementation of evidence in health service delivery' and will be derived from two studies. Study 1.1 is a qualitative meta-synthesis and study 1.2 is a primary qualitative study that will identify why, in the context of organisational practices and cultural norms, healthcare professionals and women behave the way they do regarding pelvic floor muscle assessment and exercises. This work package fulfils Knowledge System 2 of the Batalden and Davidoff's framework. The second WP is developed to fulfil Knowledge System 3 of the implementation framework, which relates to determining relevant measures of performance. This WP consists of two studies the first of which (2.1) is a diagnostic accuracy systematic review to identify the most accurate and acceptable tests performed by either practitioners or women to ensure correct pelvic floor contraction. This is an essential component in any effective PFME programme. This study will also generate evidence that is currently lacking, hence, it also links to Knowledge Systems 1 of the Batalden and Davidoff's Model. The second study (2.2) in this WP will see the development of a decision analytical health economic model. Our previous experience has proved invaluable in that a similar model helped to identify specific gaps or omissions in anticipated data collection that could be focused upon for the trial-based health economic model in WP4. WP3 provides the essential elements required for the Knowledge System 4 of the implementation framework and will be focused on developing an intervention that enables pregnant women to learn, and have confidence in performing, a correct voluntary pelvic floor muscle contraction and will ensure the intervention is deliverable by midwives and that they are confident in teaching the exercises. The first study (3.1) uses focus group methodology to identify suitable means of delivering this training to midwives and how midwives can best support women to perform the exercises in the ante- and postnatal periods. The second study (3.2) uses an intervention-development approach to determine the constituent parts of the training intervention that is directed to midwives and cascaded to women. At the end of this WP we will develop materials to facilitate the implementation and dissemination of PFME training amongst healthcare professionals, particularly midwives. These materials will be part of an APPEAL Toolkit, which will be designed to support implementation and intervention delivery to women respectively. These will be piloted in study 3.3. The main aim of WP4 is assessing the intervention, i.e. execution of the planned changes; hence, it fulfils Knowledge System 5 of the Batalden and Davidoff's framework. The first study in this WP (study 4.1) is a pilot study to test the trial questionnaires, assess the intra-cluster variability in the trial primary outcome and evaluate the trial follow-up procedure and questionnaire response rate. Study 4.2 is a cluster randomised trial where community midwifery teams will be randomised to either receiving the APPEAL intervention developed in WP3 or continuing with their usual practice. Women booking their pregnancies with the different midwifery teams over a specified time period will be considered recruited into the trial. The cohort of women included will be sent a questionnaire at 10-12 weeks postnatal to gather information about urinary incontinence (primary outcome for the trial) and other health and quality of life outcomes using validated questionnaires. Study 4.3 is a full health economic evaluation of the APPEAL intervention and its impact. This evaluation will run alongside study 4.2. The final study in WP4 (study 4.4) is designed with the objective to assess and formatively evaluate the implementation process and fidelity of the training intervention with the aim to refine the implementation Toolkit. At the end of this programme we will generate an evidence based implementation Toolkit for healthcare professionals. The Toolkit will be available in hard copy at the dissemination event at the end of the programme. An electronic version will also be available for NHS Trusts involved in the programme. We will also aim to develop a Toolkit for women in the form of an electronic copy available for download on the NHS Trust s websites and social media. We envisage that APPEAL will have a significant positive impact on the NHS and women s health.

Lay abstract: Antenatal Preventative Pelvic floor Exercises And Localisation (APPEAL) brings together a programme of research to prevent maternal health problems associated with pregnancy and childbirth-related urinary incontinence. The aim of APPEAL is to reduce the number of women who suffer urinary incontinence after birth. There is excellent evidence that pelvic floor muscle exercises, when done correctly during pregnancy, halves the risk of urinary incontinence after birth. However, many pregnant women do not do these exercises and we do not know how midwives offer women advice on pelvic floor muscle exercises. The Royal College of Midwives and the Chartered Society of Physiotherapists have highlighted the importance of this issue for women s future health. APPEAL has four linked stages. In stage 1 we will interview women and midwives to explore their views about the exercises and how and when women are advised to do them. This information will help to identify how we can improve the uptake of these exercises by pregnant women in the future. Being able to carry out these exercises properly is essential to get the most benefit from doing them. So, Stage 2 will look for the best and most acceptable way to check that women perform these exercises correctly. We will do this by comparing all assessments of performance of pelvic floor muscle exercises in the medical literature to find the best way to assess if they are being performed correctly. We also want to explore women s views of how the exercises were assessed from the literature and how economical it is to use in the NHS. Stage 3 will use information from stages 1 and 2 to develop a motivational training package to enable midwives to help pregnant women correctly and regularly perform the exercises; and to help women realise the importance of them to their future health and well-being. We will work closely with women and midwives to ensure we develop the best possible training package for this stage. In stage 4, we will examine the benefit for women of the motivational training package in a study where midwifery teams who provide antenatal care will be selected (at random) to either receive this training or continue to offer their current routine advice on pelvic floor muscle exercises. We will collect information on women s health, how often women did their exercises and how many report urinary incontinence 10-12 weeks after birth from all of the women involved in the study. We will also measure if the package is good value for money for the NHS.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;RENAL AND UROGENITAL