116
views
0
recommends
+1 Recommend
2 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Evaluation of non-invasive prenatal testing (NIPT) for aneuploidy in an NHS setting: a reliable accurate prenatal non-invasive diagnosis (RAPID) protocol

      research-article

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          Non-invasive prenatal testing (NIPT) for aneuploidies is now available through commercial companies in many countries, including through private practice in the United Kingdom (UK). Thorough evaluation of service delivery requirements are needed to facilitate NIPT being offered more widely within state funded healthcare systems such as the UK’s National Health Service (NHS). Successful implementation will require the development of laboratory standards, consideration of stakeholder views, an analysis of costs and development of patient and health professional educational materials.

          Methods/Design

          NIPT will be offered in an NHS setting as a contingent screening test. Pregnant woman will be recruited through six maternity units in England and Scotland. Women eligible for Down’s syndrome screening (DSS) will be informed about the study at the time of booking. Women that choose routine DSS will be offered NIPT if they have a screening risk ≥1:1000. NIPT results for trisomy 21, 18, 13 will be reported within 7–10 working days. Data on DSS, NIPT and invasive testing uptake, pregnancy outcomes and test efficacy will be collected. Additional data will be gathered though questionnaires to a) determine acceptability to patients and health professionals, b) evaluate patient and health professional education, c) assess informed choice in women accepting or declining testing and d) gauge family expenses. Qualitative interviews will also be conducted with a sub-set of participating women and health professionals.

          Discussion

          The results of this study will make a significant contribution to policy decisions around the implementation of NIPT for aneuploidies within the UK NHS. The laboratory standards for testing and reporting, education materials and counselling strategies developed as part of the study are likely to underpin the introduction of NIPT into NHS practice.

          NIHR Portfolio Number

          13865

          Related collections

          Most cited references54

          • Record: found
          • Abstract: not found
          • Article: not found

          Using thematic analysis in psychology

            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            The development of a six‐item short‐form of the state scale of the Spielberger State—Trait Anxiety Inventory (STAI)

              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Validation of a decisional conflict scale.

              The study objective was to evaluate the psychometric properties of a decisional conflict scale (DCS) that elicits: 1) health-care consumers' uncertainty in making a health-related decision; 2) the factors contributing to the uncertainty; and 3) health-care consumers' perceived effective decision making. The DCS was developed in response to the lack of instruments available to evaluate health-care-consumer decision aids and to tailor decision-supporting interventions to particular consumer needs. The scale was evaluated with 909 individuals deciding about influenza immunization or breast cancer screening. A subsample of respondents was retested two weeks later. The test-retest reliability coefficient was 0.81. Internal consistency coefficients ranged from 0.78 to 0.92. The DCS discriminated significantly (p < 0.0002) between those who had strong intentions either to accept or to decline invitations to receive influenza vaccine or breast cancer screening and those whose intentions were uncertain. The scale also discriminated significantly (p < 0.0002) between those who accepted or rejected immunization and those who delayed their decisions to be immunized. There was a weak inverse correlation (r = -0.16, p < 0.05) between the DCS and knowledge test scores. The psychometric properties of the scale are acceptable. It is feasible and easy to administer. Evaluations of responsiveness to change and validation with more difficult decisions are warranted.
                Bookmark

                Author and article information

                Contributors
                Journal
                BMC Pregnancy Childbirth
                BMC Pregnancy Childbirth
                BMC Pregnancy and Childbirth
                BioMed Central
                1471-2393
                2014
                16 July 2014
                : 14
                : 229
                Affiliations
                [1 ]North East Thames Regional Genetics Service, Great Ormond Street Hospital for Children NHS Foundation Trust, Level 5, York House, 37 Queen Square, London WC1N 3BH, UK
                [2 ]Genetics and Genomic Medicine, UCL Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
                [3 ]Centre for Medical Statistics & Bioinformatics, Plymouth University, Plymouth, UK
                [4 ]Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, UK
                [5 ]UCL Genetics Institute, London, UK
                [6 ]Clinical Biochemistry Department, Barking, Havering & Redbridge University Hospitals NHS Trust, Essex, UK
                [7 ]Antenatal Results and Choices, London, UK
                [8 ]PHG Foundation, Cambridge, UK
                [9 ]Research Department of Applied Health Research, University College London, London, UK
                Article
                1471-2393-14-229
                10.1186/1471-2393-14-229
                4226037
                25027965
                ee753363-951b-4fc9-8d9c-33d939ab1e3b
                Copyright © 2014 Hill et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 3 July 2014
                : 11 July 2014
                Categories
                Study Protocol

                Obstetrics & Gynecology
                non-invasive prenatal testing,cell-free fetal dna,aneuploidy,prenatal diagnosis

                Comments

                Comment on this article