Title: Development of a Core Outcome Set and identification of outcome measurement tools for interventions after stillbirth (International Collaboration for Harmonising Outcomes fOr Stillbirth resEarch: ICHOOSE)
Funder: Department of Health and Social Care

Abstract: Background Stillbirth affects 3,000 women in the United Kingdom each year(2). It is defined as the death of a baby before or during birth after 24 weeks' gestation. The impact of stillbirth includes stigma, disenfranchised grief, broken relationships, clinical depression, chronic pain, substance misuse, increased use of health services, employment difficulties and debt(3). A wide range of interventions are offered to parents following the diagnosis of stillbirth. Examples include birthing options, families seeing and holding the baby, memory making, post mortem, support groups, counselling and care in subsequent pregnancies. Many of these interventions have not been proven to help parents and overall evidence is conflicting. Researchers do not know how to define and measure the success of these interventions.Core Outcome Sets A Core Outcome Set (COS) is a consensus-derived minimum set of outcomes that should be measured and reported in all clinical studies of a specific disease or population(4). COSs are being developed to allow comparisons across trials, to minimise reporting bias and strengthen clinical decision-making(4).Why use a COS for interventions after stillbirth? There is a need to develop and evaluate evidence-based interventions for parents experiencing stillbirth. It is essential to establish a minimum set of outcomes that would be feasible, acceptable and reliable to be measured whenever an intervention is implemented for bereaved parents after stillbirth. This will enable studies to be compared and combined and outcome measurement tools to be developed. Aim The aim of this research is to develop a COS and identify outcome measurement tools for interventions after stillbirth. Methods Stage 1: Identifying previously reported outcomes Systematic review: I will perform a systematic review to investigate what outcomes are reported in existing studies investigating the effects of stillbirth on parents and the wider family, and what measurement tools are currently used to measure those outcomes.Stage 2: Identifying outcomes that are important to parents and healthcare professionals a) Qualitative parent interviews: What are parents' experiences of and following stillbirth? What outcomes are important to women, their partners and their relatives when they experience a stillbirth? If researchers were going to develop an intervention or improve care after stillbirth, what would be important to measure to see if the intervention works? b) Healthcare professional focus group: I will set up a focus group to investigate what outcomes would be important to measure how well an intervention was implemented and triangulate my findings. c) Outcome inventory: A long-list of outcomes identified by the systematic review and qualitative interviews will be compiled for the Delphi study. Stage 3: Determining the Core Outcome Set Parents, doctors, midwives and researchers will participate in a three-round online Delphi study to prioritise outcomes identified in Stage 1 and 2 in order of importance. Stage 4: Determining how core outcomes should be measured a) Using the available literature, I will identify outcome measurement tools for each outcome in the COS. b) Quality Assessment: An in-depth quality assessment of outcome measurement tools will be performed on short-listed outcomes derived from the Delphi Study. A validated assessment framework will be used to assess the quality of outcome measures(5). c) Stakeholder consultation: A consensus meeting will be performed to validate outcomes yielded from the Delphi study and decide on appropriate measurement tools. Summary The development of a COS and the selection of measurement tools to evaluate interventions after stillbirth will make a significant contribution to advancing the usefulness of research in this field and improving clinical practice. It will enable researchers to focus research and clinical care on important outcomes, to make better use of evidence and develop effective interventions for parents experiencing stillbirth.

Lay abstract: Aim My research aims to develop a Core Outcome Set and identify outcome measurement tools for care (interventions) after stillbirthWhat is a Core Outcome Set? To help parents, doctors and other health professionals make decisions about what care to provide, we need evidence about what works best. Interventions or care packages are developed and tested by researchers to make sure they work appropriately and are safe. Researchers test the effects of an intervention by measuring an outcome'. For example, in a study of how well an intervention works after a stillbirth, outcomes' might include depression, anxiety levels or ability to return to work at various intervals after the event e.g. three months or one year. If all studies in a health condition use the same outcomes, they can all be compared and combined. This reduces waste by making best use of all the research. When a minimum set of important outcomes has been agreed for a health condition, it is called a Core Outcome Set. I plan to develop a Core Outcome Set for care and interventions following stillbirth. I plan to do this in conjunction with bereaved parents who have experienced which has not been done before. This will help parents, clinicians, and guideline developers make the best use of available stillbirth research in the future. Why should I develop a Core Outcome Set for care after stillbirth? Every year Stillbirth affects over 3,000 women in the United Kingdom (UK). It is defined as the death of a baby before or during birth after 24 weeks' gestation in the UK. It has many effects on parents and their families in the short and long term, including poor health, depression, alcohol and drug use, unemployment and can have a significant negative impact on subsequent pregnancies. The financial costs of stillbirth to the health service in subsequent pregnancies are far greater than a live birth. Despite this, care for parents following a stillbirth is not always as good as it should be, not consistent and research on how to improve this care for bereaved parents has been neglected.A wide range of care or interventions are offered to parents following the diagnosis of stillbirth. Examples of potential interventions include birthing options, families seeing and holding the baby, memory making, post mortem examination to find the cause of the stillbirth, support groups, counselling and care in subsequent pregnancies. Previous research on these or similar interventions measured their success using too many different outcomes. Researchers are still not sure how to measure the success of these and future interventions with the correct outcome measurement tools (e.g. questionnaires).My research will address this problem directly. How will I carry out this research? Deciding which outcomes should be in the Core Outcome Set requires a great deal of consideration. Core outcomes should be relevant to parents and health professionals. I am planning four research stages: 1) Identifying previously reported outcomes: I am going to investigate what outcomes are already reported in existing studies investigating the effects of stillbirth on parents and the wider family, and what measurement tools are currently used to measure those outcomes. 2) Interviews with parents and healthcare professionals: I will interview parents to find out their experiences following stillbirth. I will also interview parents and healthcare professionals to find out what outcomes they perceive are important for measuring the success of interventions to improve care following stillbirth. 3) Delphi: Using outcomes identified in Stages 1 and 2, parents, doctors, midwives, researchers and health policymakers will participate in a three-round survey called a Delphi and they will prioritise which outcomes are most important. 4) Consensus meeting: The final Core Outcome Set and measurement tools will be decided by setting up a large meeting with parents, doctors, other health professionals and policy makers.Patient and Public Involvement Parents and members of the public are at the heart of this research and will be involved throughout the study. They will take part in regular meetings and form part of the study committee. I am currently carrying out preliminary work to find out from parents who have experienced stillbirth how best to approach and engage parents into this research. How will this research be used in the future? Developing this Core Outcome Set and finding ways to measure the outcomes will help improve research and clinical care after stillbirth. This important research will facilitate future work to develop effective interventions to improve care for parents and their families.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH