PINSA (Provision of Information about Newborn Screening Antenatally): the provision of antenatal information for the NHS Newborn Bloodspot Screening Programme (NBSP)

Not Applicable

Completed

• Conditions: Expanded newborn screening programme; Not Applicable

• Registration Number: ISRCTN70227207
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-03
• Last Update Posted: 27 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1219

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified