Extrait

Background and study aims This project looks at the best way of providing information to parents about the newborn blood spot screening programme (NBSP) via studies conducted both nationally and locally in the North West. Study 1: A realist review. Information from expanded NBSPs about how they give parents NBSP information and publications about NBSP communication are reviewed. We will also contact NBSP researchers internationally to gather information about ongoing research. From this we create a range of ways of providing NBSP information to parents. Study 2: Parents, midwives and screening professionals will be interviewed about their experiences of NBSPs and we will look at what factors affect parents' understanding. We will collect their views of the alternative ways of providing NBSP information we designed in study 1. Study 3: A national survey of midwives will show us which resources midwives use when giving NBSP information. Also, 5-8 midwives locally will be watched when giving NBSP information. We can see how long midwifes takes to provide information and what resources they use. We can then calculate the current cost of providing NBS information and compare the alternatives to this. Study 4: A national study with parents and midwives to examine which of the alternative ways of giving NBSP information is preferred. Study 5: An expert panel will look at the impact of the alternative ways of giving NBSP information on midwife practice to enable us to calculate the cost of the alternatives. Study 6: Focus groups (like group discussions) with parents and NBSP health professionals will discuss the study findings and recommendations. This will help us to ensure that guidance fits with parents and health professional's needs. We will conduct telephone interviews with parents who need interpreters. Who can participate? Study 2: All regional NBSP co-ordinators will be invited to participate (N=9); front-line professionals involved in communication of NBSP information: 18 hospital screening co-ordinators, 14 community midwives and 4 hospital based midwives. 15 prospective parents after the initial time they should have received NBSP information, but prior to screening and birth of child; 15 parents following the heel prick test, but prior to results; 15 parents who receive normal results; 20 parents who receive a false positive result and 12 parents who receive a positive result for one of the metabolic disorders currently screened for. Study 3: The survey aims to identify current practice in a national sample of midwives (N=300) recruited via the RCM register. 5-8 midwives in the North West SHA to be directly observed for one week each. Study 4: 250 midwives and 500 parents Study 5: Five NBSP experts Study 6: Thus we plan to run one focus group with service providers (N=10-12) and two with parents (N=~20). Telephone interviews (N=~7) will augment this data, target negative cases or facilitate parents who need interpreters to participate. What does the study involve? Study 2: Interviews with service providers and parents regarding experiences and views of current newborn screening practice and potential alternative communication and consent models identified in study 1. Study 3: This study involved two parts: (i) a national survey of midwives and (ii) Direct observation of midwife practice. Study 4: A discrete choice experiment (DCE). A DCE is a form of survey which identifies and measures what outcomes or aspects of service delivery service users or providers prefer and value the most and can be used to help policy makers decide which type of service is best. This DCE will test out the different alternative models discussed in study 2. Study 5: A preliminary economic model of the proposed alternatives. Data from studies 2-3 will be used to create a model that compares current practice with the alternatives. Study 6: Focus groups will provide a chance to check the study’s conclusions with participants and gather suggestions for future research. What are the possible benefits and risks of participating? In any interview there is a chance that interviewees may become distressed. The questions asked in the interviews will be designed by team members experienced in collecting sensitive data, and training and support will be provided to the interviewers to ensure that data is collected professionally. Written records of the interviews will have any identifiable information removed to protect participants' identities. It is impossible to guarantee confidentiality of focus group data due to the group setting. Participants will be asked to respect others' views and maintain confidentiality of data, but will also be advised that as this cannot be guaranteed they should not discuss issues which they feel uncomfortable being disclosed outside the group. It is our experience that although parents may become distressed when participating in research about newborn screening, they value the opportunity to discuss their experiences. They do, occasionally, however require more support. It is our experience that when researching actual service provision health professionals may disclose that the service is not being provided in a way that fits with guidance. Thus, all data will either be collected anonymously or the identity of those observed will be protected. The sounding out of study findings with health professionals in study six will help the project team report any such findings in a sensitive manner. The project team includes a psychologist, lawyer, health economist, statistician, professor of midwifery, and neonatologist. All have experience of a conducting research with parents and health professionals and the person leading the research has expertise in research about NBSP communication and the ethical issues such research entails. Where is the study run from? The University of Manchester (UK). When is the study starting and how long is it expected to run for? The study is starting in May 2013 and will run for 30 months. Within this participants will be recruited for the studies between August 2013 and December 2014 Who is funding the study? This study is funded by the National Institute for Health Research Health Technology Assessment Programme Who is the main contact? Dr Fiona Ulph [email protected]

Critère d'inclusion

• Expanded newborn screening programme

Liens

• isrctn
• ictrp