{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T09:06:23Z","timestamp":1781427983769,"version":"3.54.1"},"reference-count":35,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,29]],"date-time":"2022-03-29T00:00:00Z","timestamp":1648512000000},"content-version":"unspecified","delay-in-days":28,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["NIHR300484"],"award-info":[{"award-number":["NIHR300484"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,2,21]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>New guidance, from NHS England (Saving Babies Lives Care Bundle Version 2 Element 5 (SBLCBv2)) has recommended a best practice pathway for women at risk of preterm birth (the Preterm Birth Pathway). This is to help meet the Department of Health\u2019s aim to reduce preterm birth from 8% to 6% by 2025. Considering most hospitals do not currently have a preterm prevention clinic, implementing this pathway will require significant coordination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The study will aim to investigate key features of contexts, mechanisms and outcomes, and their interactions in the implementation of the asymptomatic prediction and prevention components of the SBLCBv2 Preterm Birth Surveillance Pathway. This will be through a theory driven realist evaluation, utilising mixed methods (interviews with staff and women, observational analysis and analysing routinely collected hospital and admin data) in three case sites in England. The study has a Project Advisory Group composed of five women who have recently given birth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has ethical approval (King\u2019s College London REC approval number: MRSP-20\/21-20955, and, IRAS:289144). A dissemination plan will be fully created with the Project Advisory Group, and we anticipate this will include presenting at conferences, publications, webinars, alongside dissemination to the wider population through parent and baby groups, the media and charities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ISRCTN57127874\">ISRCTN57127874<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-061302","type":"journal-article","created":{"date-parts":[[2022,3,29]],"date-time":"2022-03-29T12:16:13Z","timestamp":1648556173000},"page":"e061302","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Protocol for the IMPART study: IMplementation of the preterm birth surveillance PAthway \u2013 a RealisT evaluation"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"isrctn57127874","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8943-8700","authenticated-orcid":false,"given":"Naomi","family":"Carlisle","sequence":"first","affiliation":[{"name":"Department of Women and Children's Health, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3266-5926","authenticated-orcid":false,"given":"Sonia Michelle","family":"Dalkin","sequence":"additional","affiliation":[{"name":"Faculty of Health and Life Sciences, Northumbria University Faculty of Health and Life Sciences, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew H","family":"Shennan","sequence":"additional","affiliation":[{"name":"Department of Women and Children's Health, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Sandall","sequence":"additional","affiliation":[{"name":"Department of Women and Children's Health, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,3,29]]},"reference":[{"key":"2025121514254128000_12.3.e061302.1","unstructured":"WHO . Born Too Soon: Preterm Birth In Europe. Trends, Causes and Prevention [Internet, 2015. http:\/\/www.euro.who.int\/__data\/assets\/pdf_file\/0004\/277735\/Born-too-soon_preterm-birth-in-Europe-trends,-causes-and-prevention.pdf?ua=1"},{"key":"2025121514254128000_12.3.e061302.2","doi-asserted-by":"crossref","unstructured":"Liu L , Oza S , Hogan D . Global, regional, and national causes of under-5 mortality in 2000\u201315: an updated systematic analysis with implications for the sustainable development goals. Lancet. 2016.","DOI":"10.1016\/S0140-6736(16)31593-8"},{"key":"2025121514254128000_12.3.e061302.3","doi-asserted-by":"publisher","DOI":"10.1055\/s-0035-1571202"},{"key":"2025121514254128000_12.3.e061302.4","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-1827"},{"key":"2025121514254128000_12.3.e061302.5","unstructured":"Department of Health . Safer Maternity Care - The National Maternity Safety Strategy - Progress and Next Steps [Internet]., 2017. Available: http:\/\/www.euro.who.int\/__data\/assets\/pdf_file\/0004\/277735\/Born-too-soon_preterm-birth-in-Europe-trends,-causes-and-prevention.pdf?ua=1"},{"key":"2025121514254128000_12.3.e061302.6","unstructured":"NHS England . z NHS Long Term Plan \u00bb Overview and summary [Internet]. England: NHS, 2019. https:\/\/www.longtermplan.nhs.uk\/online-version\/overview-and-summary\/"},{"key":"2025121514254128000_12.3.e061302.7","unstructured":"NHS England . a Saving Babies Lives Care Bundle Version 2 [Internet], 2019. https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2019\/03\/Saving-Babies-Lives-Care-Bundle-Version-Two-Final-Version2.pdf"},{"key":"2025121514254128000_12.3.e061302.8","unstructured":"NHS England . NHS Standard Contract 2019\/20 [Internet], 2019. Available: https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2019\/03\/3-FL-SCs-1920-sepsis.pdf"},{"key":"2025121514254128000_12.3.e061302.9","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15549"},{"key":"2025121514254128000_12.3.e061302.10","doi-asserted-by":"publisher","DOI":"10.1016\/0029-7844(96)00035-X"},{"key":"2025121514254128000_12.3.e061302.11","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1111\/j.1471-0528.2006.01124.x","article-title":"Preterm birth: the value of sonographic measurement of cervical length","volume":"113","author":"Kagan","year":"2006","journal-title":"BJOG An Int J Obstet Gynaecol [Internet]"},{"key":"2025121514254128000_12.3.e061302.12","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-10-787"},{"key":"2025121514254128000_12.3.e061302.13","unstructured":"Pawson R , Tilley N . Realistic evaluation. London: Sage, 1997."},{"key":"2025121514254128000_12.3.e061302.14","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-017-1232-9","article-title":"Specialist antenatal clinics for women at high risk of preterm birth: a systematic review of qualitative and quantitative research","volume":"17","author":"Malouf","year":"2017","journal-title":"BMC Pregnancy Childbirth"},{"key":"2025121514254128000_12.3.e061302.15","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD004667.pub5"},{"key":"2025121514254128000_12.3.e061302.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2014.02.027"},{"key":"2025121514254128000_12.3.e061302.17","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.midw.2018.06.001","article-title":"Threatened preterm labour: women's experiences of risk and care management: a qualitative study","volume":"64","author":"Carter","year":"2018","journal-title":"Midwifery"},{"key":"2025121514254128000_12.3.e061302.18","first-page":"CD005470","article-title":"Tailored interventions to address determinants of practice","volume":"308","author":"Baker","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121514254128000_12.3.e061302.19","first-page":"CD010669","article-title":"Tools developed and disseminated by guideline producers to promote the uptake of their guidelines","volume":"14","author":"Flodgren","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121514254128000_12.3.e061302.20","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1186\/s13012-016-0464-9","article-title":"Evaluating the implementation of a national clinical programme for diabetes to standardise and improve services: a realist evaluation protocol","volume":"11","author":"McHugh","year":"2015","journal-title":"Implementation Science"},{"key":"2025121514254128000_12.3.e061302.21","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1186\/s13012-018-0811-0","article-title":"A realist process evaluation within the facilitating implementation of research evidence (fire) cluster randomised controlled international trial: an exemplar","volume":"13","author":"Rycroft-Malone","year":"2018","journal-title":"Implement Sci"},{"key":"2025121514254128000_12.3.e061302.22","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1258\/1355819054308530","article-title":"Realist review--a new method of systematic review designed for complex policy interventions","volume":"10 Suppl 1","author":"Pawson","year":"2005","journal-title":"J Health Serv Res Policy"},{"key":"2025121514254128000_12.3.e061302.23","doi-asserted-by":"crossref","unstructured":"Pawson R . The science of evaluation: a realist manifesto [Internet]. London: Sage, 2013.","DOI":"10.4135\/9781473913820"},{"key":"2025121514254128000_12.3.e061302.24","doi-asserted-by":"crossref","unstructured":"Dalkin SM , Greenhalgh J , Jones D . What\u2019s in a mechanism? Development of a key concept in realist evaluation.. Implement Sci [Internet]. 2015;10.","DOI":"10.1186\/s13012-015-0237-x"},{"key":"2025121514254128000_12.3.e061302.25","unstructured":"Punton M , Vogel I , Lloyd R . Reflections from a realist evaluation in progress: scaling ladders and Stitching theory. 2016."},{"key":"2025121514254128000_12.3.e061302.26","unstructured":"ImpRes . Implementation Science Research Development Tool \u2013 A practical guide to using the ImpRes Tool [Internet], 2018. Available: https:\/\/impsci.tracs.unc.edu\/wp-content\/uploads\/ImpRes-Guide.pdf"},{"key":"2025121514254128000_12.3.e061302.27","doi-asserted-by":"crossref","first-page":"160940691774179","DOI":"10.1177\/1609406917741796","article-title":"Building realist program theory for large complex and messy interventions","volume":"16","author":"Shearn","year":"2017","journal-title":"Int J Qual Methods"},{"key":"2025121514254128000_12.3.e061302.28","doi-asserted-by":"publisher","DOI":"10.1186\/s13012-018-0836-4"},{"key":"2025121514254128000_12.3.e061302.29","unstructured":"NHS England . Sustainability and Transformation Plan footprints [Internet]., 2016. Available: https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2016\/02\/stp-footprints-march-2016.pdf"},{"key":"2025121514254128000_12.3.e061302.30","unstructured":"MVP . Implementing Better Births: a resource pack for Local Maternity Systems\u2019 (LMS): a summary of points about Maternity Voices Partnership [Internet], 2017. Available: http:\/\/nationalmaternityvoices.org.uk\/wp-content\/uploads\/2017\/11\/Better-Births-resource-pack-for-LMS-a-summary-for-MVPs-v1.pdf"},{"key":"2025121514254128000_12.3.e061302.31","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-010-0319-7"},{"key":"2025121514254128000_12.3.e061302.32","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f6753"},{"key":"2025121514254128000_12.3.e061302.33","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000001195"},{"key":"2025121514254128000_12.3.e061302.34","unstructured":"Mason M . Sample Size and Saturation in PhD Studies Using Qualitative Interviews. Forum Qual Sozialforsch \/ Forum Qual Soc Res Vol 11, No 3 Methods Qual Manag Res Context Soc Syst Thinking DO - 1017169\/fqs-1131428 [Internet]. Available: http:\/\/www.qualitative-research.net\/index.php\/fqs\/article\/view\/1428\/3027 [Accessed 24 Aug 2010]."},{"key":"2025121514254128000_12.3.e061302.35","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.ijnurstu.2018.10.004","article-title":"Supporting General Hospital staff to provide dementia sensitive care: a realist evaluation","volume":"96","author":"Handley","year":"2019","journal-title":"Int J Nurs Stud"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-061302","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T22:25:49Z","timestamp":1765837549000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-061302"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":35,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2022,3,29]]},"published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1136\/bmjopen-2022-061302"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-061302","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3]]}}}