Expanded newborn screening programme Not Applicable
Conditions
Interventions
Study 1: Realist review (no patients so no further information provided)
Study 2: Interview study involving regional screening co-ordinators, midwives and parents. Each participant is involved for one
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study 2: 1. Health professionals: All regional screening co-ordinators 2. Midwives with experience of providing NBSP information in the community or a hospital. 3. Parents: a sampling framework will be constructed to ensure maximum variation. Parents will be included from across the screening pathway (e.g. antenatally, screening conducted but results not received, post results) as research suggests that parents ability to process information during this time are reduced increasing the likelihood of recollection biases, making the use of whole pathway recollection designs problematic as they are likely to capture particularly salient recollections, rather than a realistic assessment of information needs. Using immediacy recall has been advocated in this setting. Parents will be sought with a range of results including negative, positive and false positives (for each disorder). Participation of parents who do not speak fluent English will be facilitated by offering study materials in their own language and providing interpreters. Specific attempts will also be made to ensure participation of fathers, young parents and those with lower education achievement as these are commonly underrepresented in the research or may have different communication needs. Study 3: Practising midwives of any grade Study 4: Practising midwives of any grade and adults of child bearing age (18+ years) Study 5: A hypothetical cohort of parents and up to five NBSP experts Study 6: Participants from study 2. Key stakeholders for cystic fibrosis and sickle cell NBSPs.
Exclusion criteria
Exclusion criteria: Study 2: Parents whose child has died or their child was born prematurely; who had newborn screening performed >180 days, or where multiple abnormalities were identified. Parents who do not have the capacity to consent Study 4: Parents who do not read English fluently due to the linguistic demands of the discrete choice experiment (DCE) Study 6: Parents who require interpreters will be excluded from focus groups due to the fast paced discussion style of focus groups. Low participation rates of non-English speakers in research are likely to make it impractical to run language specific groups. These parents' views will be collected via interviews with translators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a mixed methods project which will generate a range out outcomes. The qualitative work will provide an outline of parents' and health professionals' views of alternative communication and models grounded in their personal experience of the NBSP. In the final phase focus groups will seek a consensus view on the preference, feasibility and acceptability of nascent models of communication and consent. These data will also illustrate how such preferences are shaped by social group processes. Telephone interviews will permit the inclusion of views from participants who are unable to participate in focus groups. This will also enable an in-depth and personal reflection at the idiopathic case study level of the implications of the study findings. This final phase of the study will be conducted between 9-15 months after the parents were initially interviewed. It is our experience from previous work that returning to parents in this fashion enables them to reflect on their earlier accounts and also add to the depth of the data by reflecting on their current adaptation to NBSP information. This will be crucial as work suggests that the mode in which parents are informed may be used by parents to in turn convey information to the wider family. Thus, whilst changes in communication models may be sufficient for individuals at the time of testing, it is important to look at the wider implications of this communication event which commonly occurs many months after initial screening. The costing study will provide a description of the types of resources driving the total cost of current models of communication and consent. The primary outcome will be the mean costs (total, fixed, semi-fixed and variable) with a description of the variation and distribution of the mean costs. The DCE will provide a measure of stated preferences that reflect a quantitative description of the trade-offs that people make between service and outcome attributes when valuing preferences for a mod | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed