{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:27:08Z","timestamp":1772166428250,"version":"3.50.1"},"reference-count":52,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,7,22]],"date-time":"2021-07-22T00:00:00Z","timestamp":1626912000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,7,22]],"date-time":"2021-07-22T00:00:00Z","timestamp":1626912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for \u2018what to measure\u2019 in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: (i) a systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement; (ii) a systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes; (iii) semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them; (iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps; and (v) a virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>COMET core outcome set registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.comet-initiative.org\/Studies\/Details\/1381\">http:\/\/www.comet-initiative.org\/Studies\/Details\/1381<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05439-7","type":"journal-article","created":{"date-parts":[[2021,7,22]],"date-time":"2021-07-22T06:03:00Z","timestamp":1626933780000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4260-7356","authenticated-orcid":false,"given":"Ebony","family":"Richardson","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"McEwen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toby","family":"Newton-John","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karine","family":"Manera","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Jacobs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,7,22]]},"reference":[{"issue":"5","key":"5439_CR1","doi-asserted-by":"publisher","first-page":"300","DOI":"10.1016\/j.ejmg.2018.11.003","volume":"62","author":"RG Resta","year":"2019","unstructured":"Resta RG. What have we been trying to do and have we been any good at it? A history of measuring the success of genetic counseling. Eur J Med Genet. 2019;62(5):300\u20137. https:\/\/doi.org\/10.1016\/j.ejmg.2018.11.003.","journal-title":"Eur J Med Genet."},{"issue":"3","key":"5439_CR2","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1002\/pd.5611","volume":"40","author":"MB Delatycki","year":"2020","unstructured":"Delatycki MB, Alkuraya F, Archibald A, Castellani C, Cornel M, Grody WW, et al. International perspectives on the implementation of reproductive carrier screening. Prenat Diagn. 2020;40(3):301\u201310. https:\/\/doi.org\/10.1002\/pd.5611.","journal-title":"Prenat Diagn."},{"issue":"2","key":"5439_CR3","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1016\/S1383-5742(98)00012-X","volume":"411","author":"K Sankaranarayanan","year":"1998","unstructured":"Sankaranarayanan K. Ionizing Radiation and Genetic Risks IX. Estimates of the frequencies of Mendelian diseases and spontaneous mutation rates in human populations: a 1998 perspective. Mutat Res. 1998;411(2):129\u201378. https:\/\/doi.org\/10.1016\/S1383-5742(98)00012-X.","journal-title":"Mutat Res."},{"key":"5439_CR4","first-page":"1","volume-title":"Contribution of gene mutations to genetic disease in humans","author":"CO Carter","year":"1982","unstructured":"Carter CO. In: Bora KC, Douglas GR, Nestmann ER, editors. Contribution of gene mutations to genetic disease in humans. Amsterdam: Elsevier; 1982. p. 1\u20138."},{"issue":"6","key":"5439_CR5","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.1038\/ejhg.2015.271","volume":"24","author":"L Henneman","year":"2016","unstructured":"Henneman L, Borry P, Chokoshvili D, Cornel MC, van El CG, Forzano F, et al. Responsible implementation of expanded carrier screening. Eur J Hum Genet. 2016;24(6):e1\u2013e12. https:\/\/doi.org\/10.1038\/ejhg.2015.271.","journal-title":"Eur J Hum Genet."},{"issue":"3","key":"5439_CR6","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1007\/s12687-012-0092-2","volume":"3","author":"HH Ropers","year":"2012","unstructured":"Ropers HH. On the future of genetic risk assessment. J Community Genet. 2012;3(3):229\u201336. https:\/\/doi.org\/10.1007\/s12687-012-0092-2.","journal-title":"J Community Genet."},{"issue":"15","key":"5439_CR7","doi-asserted-by":"publisher","first-page":"1273","DOI":"10.1001\/jama.1997.03550150077039","volume":"278","author":"A Cao","year":"1997","unstructured":"Cao A, Saba L, Galanello R, Rosatelli MC. Molecular diagnosis and carrier screening for beta thalassemia. JAMA. 1997;278(15):1273\u20137. https:\/\/doi.org\/10.1001\/jama.1997.03550150077039.","journal-title":"JAMA."},{"issue":"3","key":"5439_CR8","doi-asserted-by":"publisher","first-page":"i","DOI":"10.3310\/hta4030","volume":"4","author":"SC Davies","year":"2000","unstructured":"Davies SC, Cronin E, Gill M, Greengross P, Hickman M, Normand C. Screening for sickle cell disease and thalassaemia: a systematic review with supplementary research. Health Technol Assess. 2000;4(3):i\u2013v 1-99.","journal-title":"Health Technol Assess"},{"issue":"3","key":"5439_CR9","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1111\/jpc.12632","volume":"51","author":"RM Lew","year":"2015","unstructured":"Lew RM, Burnett L, Proos AL, Barlow-Stewart K, Delatycki MB, Bankier A, et al. Ashkenazi Jewish population screening for Tay-Sachs disease: the international and Australian experience. J Paediatr Child Health. 2015;51(3):271\u20139. https:\/\/doi.org\/10.1111\/jpc.12632.","journal-title":"J Paediatr Child Health."},{"issue":"6801","key":"5439_CR10","doi-asserted-by":"publisher","first-page":"504","DOI":"10.1136\/bmj.303.6801.504","volume":"303","author":"EK Watson","year":"1991","unstructured":"Watson EK, Mayall E, Chapple J, Dalziel M, Harrington K, Williams C, et al. Screening for carriers of cystic fibrosis through primary health care services. BMJ. 1991;303(6801):504\u20137. https:\/\/doi.org\/10.1136\/bmj.303.6801.504.","journal-title":"BMJ."},{"key":"5439_CR11","unstructured":"Australian Genomics. Mackenzie\u2019s mission: the Australian reproductive genetic carrier screening project [Available from: https:\/\/www.australiangenomics.org.au\/our-research\/disease-flagships\/mackenzies-mission\/]. Accessed July 2020."},{"issue":"8","key":"5439_CR12","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1016\/j.jogc.2016.06.008","volume":"38","author":"RD Wilson","year":"2016","unstructured":"Wilson RD, De Bie I, Armour CM, Brown RN, Campagnolo C, Carroll JC, et al. Joint SOGC-CCMG opinion for reproductive genetic carrier screening: an update for all Canadian providers of maternity and reproductive healthcare in the era of direct-to-consumer testing. J Obstet Gynaecol Can. 2016;38(8):742\u201362 e3. https:\/\/doi.org\/10.1016\/j.jogc.2016.06.008.","journal-title":"J Obstet Gynaecol Can."},{"issue":"3","key":"5439_CR13","doi-asserted-by":"publisher","first-page":"e35","DOI":"10.1097\/AOG.0000000000001951","volume":"129","author":"Committee on Genetics","year":"2017","unstructured":"Committee on Genetics. Committee Opinion No. 690: carrier screening in the age of genomic medicine. Obstet Gynecol. 2017;129(3):e35\u201340. https:\/\/doi.org\/10.1097\/AOG.0000000000001951.","journal-title":"Obstet Gynecol."},{"issue":"3","key":"5439_CR14","doi-asserted-by":"publisher","first-page":"e41","DOI":"10.1097\/AOG.0000000000001952","volume":"129","author":"Committee on Genetics","year":"2017","unstructured":"Committee on Genetics. Committee Opinion No. 691: carrier screening for genetic conditions. Obstet Gynecol. 2017;129(3):e41\u201355. https:\/\/doi.org\/10.1097\/AOG.0000000000001952.","journal-title":"Obstet Gynecol."},{"key":"5439_CR15","volume-title":"Genetic carrier screening","author":"Genomics Advisory Working Group & Women\u2019s Health Committee","year":"2019","unstructured":"Genomics Advisory Working Group & Women\u2019s Health Committee. Genetic carrier screening: RANZCOG; 2019."},{"key":"5439_CR16","volume-title":"An evidence framework for genetic testing","year":"2017","unstructured":"Committee on the Evidence Base for Genetic Testing, editor. An evidence framework for genetic testing. Washington DC: The National Academies Press; 2017."},{"key":"5439_CR17","volume-title":"Addressing challenges in genetic test evaluation: evaluation frameworks and assessment of analytic validity","author":"F Sun","year":"2011","unstructured":"Sun F, Bruening W, Erinoff E, Schoelles KM. Addressing challenges in genetic test evaluation: evaluation frameworks and assessment of analytic validity. Rockville: AHRQ Methods for Effective Health Care; 2011."},{"issue":"5","key":"5439_CR18","doi-asserted-by":"publisher","first-page":"902","DOI":"10.1007\/s10897-017-0082-y","volume":"26","author":"BA Athens","year":"2017","unstructured":"Athens BA, Caldwell SL, Umstead KL, Connors PD, Brenna E, Biesecker BB. A systematic review of randomized controlled trials to assess outcomes of genetic counseling. J Genet Couns. 2017;26(5):902\u201333. https:\/\/doi.org\/10.1007\/s10897-017-0082-y.","journal-title":"J Genet Couns."},{"issue":"3","key":"5439_CR19","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1007\/s10897-017-0067-x","volume":"26","author":"L Madlensky","year":"2017","unstructured":"Madlensky L, Trepanier AM, Cragun D, Lerner B, Shannon KM, Zierhut H. A rapid systematic review of outcomes studies in genetic counseling. J Genet Couns. 2017;26(3):361\u201378. https:\/\/doi.org\/10.1007\/s10897-017-0067-x.","journal-title":"J Genet Couns."},{"key":"5439_CR20","doi-asserted-by":"publisher","unstructured":"Payne K, Nicholls S, McAllister M, Macleod R, Donnai D, Davies LM. Outcome measurement in clinical genetics services: a systematic review of validated measures. Value Health. 2008;11(3):497\u2013508. https:\/\/doi.org\/10.1111\/j.1524-4733.2007.00259.x. Accessed July 2020.","DOI":"10.1111\/j.1524-4733.2007.00259.x"},{"issue":"5","key":"5439_CR21","doi-asserted-by":"publisher","first-page":"605","DOI":"10.1038\/s41431-018-0095-5","volume":"26","author":"E Pitini","year":"2018","unstructured":"Pitini E, De Vito C, Marzuillo C, D'Andrea E, Rosso A, Federici A, et al. How is genetic testing evaluated? A systematic review of the literature. Eur J Hum Genet. 2018;26(5):605\u201315. https:\/\/doi.org\/10.1038\/s41431-018-0095-5.","journal-title":"Eur J Hum Genet."},{"issue":"1","key":"5439_CR22","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1159\/000488086","volume":"11","author":"J Horne","year":"2018","unstructured":"Horne J, Madill J, O'Connor C, Shelley J, Gilliland J. A systematic review of genetic testing and lifestyle behaviour change: are we using high-quality genetic interventions and considering behaviour change theory? Lifestyle Genom. 2018;11(1):49\u201363. https:\/\/doi.org\/10.1159\/000488086.","journal-title":"Lifestyle Genom."},{"issue":"2","key":"5439_CR23","doi-asserted-by":"publisher","first-page":"258","DOI":"10.1038\/s41436-019-0641-8","volume":"22","author":"SJM Kessels","year":"2020","unstructured":"Kessels SJM, Carter D, Ellery B, Newton S, Merlin TL. Prenatal genetic testing for cystic fibrosis: a systematic review of clinical effectiveness and an ethics review. Genet Med. 2020;22(2):258\u201367. https:\/\/doi.org\/10.1038\/s41436-019-0641-8.","journal-title":"Genet Med."},{"issue":"41","key":"5439_CR24","doi-asserted-by":"publisher","first-page":"664","DOI":"10.3238\/arztebl.2009.0664","volume":"106","author":"GP Hammer","year":"2009","unstructured":"Hammer GP, du Prel JB, Blettner M. Avoiding bias in observational studies: part 8 in a series of articles on evaluation of scientific publications. Dtsch Arztebl Int. 2009;106(41):664\u20138. https:\/\/doi.org\/10.3238\/arztebl.2009.0664.","journal-title":"Dtsch Arztebl Int."},{"issue":"12","key":"5439_CR25","doi-asserted-by":"publisher","first-page":"1117","DOI":"10.1080\/14737159.2020.1690456","volume":"19","author":"J Cannon","year":"2019","unstructured":"Cannon J, Van Steijvoort E, Borry P, Chokoshvili D. How does carrier status for recessive disorders influence reproductive decisions? A systematic review of the literature. Expert Rev Mol Diagn. 2019;19(12):1117\u201329. https:\/\/doi.org\/10.1080\/14737159.2020.1690456.","journal-title":"Expert Rev Mol Diagn."},{"issue":"7","key":"5439_CR26","doi-asserted-by":"publisher","first-page":"442","DOI":"10.1097\/GIM.0b013e3180986767","volume":"9","author":"LS Chen","year":"2007","unstructured":"Chen LS, Goodson P. Factors affecting decisions to accept or decline cystic fibrosis carrier testing\/screening: a theory-guided systematic review. Genet Med. 2007;9(7):442\u201350. https:\/\/doi.org\/10.1097\/GIM.0b013e3180986767.","journal-title":"Genet Med."},{"key":"5439_CR27","volume":"3","author":"N Hussein","year":"2018","unstructured":"Hussein N, Weng SF, Kai J, Kleijnen J, Qureshi N. Preconception risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease. Cochrane Database Syst Rev. 2018;3:CD010849.","journal-title":"Cochrane Database Syst Rev."},{"issue":"3","key":"5439_CR28","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1038\/gim.2013.125","volume":"16","author":"L Ioannou","year":"2014","unstructured":"Ioannou L, McClaren BJ, Massie J, Lewis S, Metcalfe SA, Forrest L, et al. Population-based carrier screening for cystic fibrosis: a systematic review of 23 years of research. Genet Med. 2014;16(3):207\u201316. https:\/\/doi.org\/10.1038\/gim.2013.125.","journal-title":"Genet Med."},{"issue":"Suppl 3","key":"5439_CR29","doi-asserted-by":"publisher","first-page":"280","DOI":"10.1186\/s13063-017-1978-4","volume":"18","author":"PR Williamson","year":"2017","unstructured":"Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET handbook: version 1.0. Trials. 2017;18(Suppl 3):280.","journal-title":"Trials"},{"issue":"1","key":"5439_CR30","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1186\/s13063-019-3230-x","volume":"20","author":"JJ Kirkham","year":"2019","unstructured":"Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndardised Protocol Items: the COS-STAP statement. Trials. 2019;20(1):116. https:\/\/doi.org\/10.1186\/s13063-019-3230-x.","journal-title":"Trials."},{"key":"5439_CR31","volume-title":"Evidence-based practice in nursing & healthcare: a guide to best practice","author":"BM Melnyk","year":"2005","unstructured":"Melnyk BM, Fineout-Overholt ES. Evidence-based practice in nursing & healthcare: a guide to best practice. Philadelphia: Lippincott Williams & Wilkins; 2005."},{"key":"5439_CR32","volume-title":"Standard quality assessment criteria for evaluating primary research papers from a variety of fields","author":"LM Kmet","year":"2004","unstructured":"Kmet LM, Cook LS, Lee RC. Standard quality assessment criteria for evaluating primary research papers from a variety of fields. Edmonton: Alberta Heritage Foundation for Medical Research; 2004."},{"key":"5439_CR33","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1016\/j.jclinepi.2017.12.020","volume":"96","author":"S Dodd","year":"2018","unstructured":"Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol. 2018;96:84\u201392. https:\/\/doi.org\/10.1016\/j.jclinepi.2017.12.020.","journal-title":"J Clin Epidemiol."},{"key":"5439_CR34","volume-title":"Guidance on the conduct of narrative synthesis in systematic reviews","author":"J Popay","year":"2006","unstructured":"Popay J, Roberts H, Sowden A, Petticrew M, Arai L, Rodgers M, et al. Guidance on the conduct of narrative synthesis in systematic reviews. London: Institute for Health Research; 2006."},{"issue":"11","key":"5439_CR35","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002447","volume":"14","author":"JJ Kirkham","year":"2017","unstructured":"Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 2017;14(11):e1002447. https:\/\/doi.org\/10.1371\/journal.pmed.1002447.","journal-title":"PLoS Med."},{"issue":"1","key":"5439_CR36","doi-asserted-by":"publisher","DOI":"10.1136\/bmjdrc-2018-000615","volume":"7","author":"SL Gorst","year":"2019","unstructured":"Gorst SL, Young B, Williamson PR, Wilding JPH, Harman NL. Incorporating patients\u2019 perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes. BMJ Open Diabetes Res Care. 2019;7(1):e000615. https:\/\/doi.org\/10.1136\/bmjdrc-2018-000615.","journal-title":"BMJ Open Diabetes Res Care."},{"key":"5439_CR37","doi-asserted-by":"publisher","DOI":"10.4135\/9781526441836","volume-title":"Doing focus groups","author":"R Barbour","year":"2018","unstructured":"Barbour R. Doing focus groups. 2nd ed. London: Sage Publications; 2018. https:\/\/doi.org\/10.4135\/9781526441836.","edition":"2"},{"key":"5439_CR38","unstructured":"Qualtrics. Provo, Utah, USA 2005. Available at: https:\/\/www.qualtrics.com."},{"key":"5439_CR39","unstructured":"Corruption Perceptions Index: Transparency International. (2019). www.transparency.org\/cpi. Accessed on 10 June 2020."},{"key":"5439_CR40","unstructured":"Zoom Video Communications Inc. Security Guide: Zoom Video Communications Inc. Retrieved from https:\/\/d24cgw3uvb9a9h.cloudfront.net\/static\/81625\/doc\/Zoom-Security-White-Paper.pdf2016"},{"key":"5439_CR41","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/1609406919874596","volume":"18","author":"MM Archibald","year":"2019","unstructured":"Archibald MM, Ambagtsheer RC, Casey MG, Lawless M. Using Zoom videoconferencing for qualitative data collection: perceptions and experiences of researchers and participants. Int J Qual Methods. 2019;18:1\u20138.","journal-title":"Int J Qual Methods."},{"key":"5439_CR42","volume-title":"Basics of qualitative research: grounded theory procedures and techniques","author":"JM Corbin","year":"1990","unstructured":"Corbin JM, Strauss AL. Basics of qualitative research: grounded theory procedures and techniques. Newbury Park: Sage Publications; 1990."},{"key":"5439_CR43","first-page":"57","volume-title":"Thematic analysis. APA handbook of research methods in psychology, Vol 2: research designs: quantitative, qualitative, neuropsychological, and biological. APA handbooks in psychology\u00ae","author":"V Braun","year":"2012","unstructured":"Braun V, Clarke V. Thematic analysis. APA handbook of research methods in psychology, Vol 2: research designs: quantitative, qualitative, neuropsychological, and biological. APA handbooks in psychology\u00ae. Washington, DC: American Psychological Association; 2012. p. 57\u201371."},{"issue":"1","key":"5439_CR44","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000393","volume":"8","author":"IP Sinha","year":"2011","unstructured":"Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393. https:\/\/doi.org\/10.1371\/journal.pmed.1000393.","journal-title":"PLoS Med."},{"issue":"1","key":"5439_CR45","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1186\/1471-2288-5-37","volume":"5","author":"RB Akins","year":"2005","unstructured":"Akins RB, Tolson H, Cole BR. Stability of response characteristics of a Delphi panel: application of bootstrap data expansion. BMC Med Res Methodol. 2005;5(1):37. https:\/\/doi.org\/10.1186\/1471-2288-5-37.","journal-title":"BMC Med Res Methodol."},{"issue":"1","key":"5439_CR46","doi-asserted-by":"publisher","first-page":"300","DOI":"10.1186\/s13063-020-04233-1","volume":"21","author":"R D'Souza","year":"2020","unstructured":"D'Souza R, Hall C, Sermer M, Siu S, Silversides C. Development of a core outcome set for studies on cardiac disease in pregnancy (COSCarP): a study protocol. Trials. 2020;21(1):300. https:\/\/doi.org\/10.1186\/s13063-020-04233-1.","journal-title":"Trials."},{"issue":"4","key":"5439_CR47","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1016\/j.jclinepi.2010.09.012","volume":"64","author":"GH Guyatt","year":"2011","unstructured":"Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395\u2013400. https:\/\/doi.org\/10.1016\/j.jclinepi.2010.09.012.","journal-title":"J Clin Epidemiol."},{"issue":"8","key":"5439_CR48","doi-asserted-by":"publisher","first-page":"936","DOI":"10.1002\/bjs.9840","volume":"102","author":"JM Blazeby","year":"2015","unstructured":"Blazeby JM, Macefield R, Blencowe NS, Jacobs M, McNair AG, Sprangers M, et al. Core information set for oesophageal cancer surgery. Br J Surg. 2015;102(8):936\u201343. https:\/\/doi.org\/10.1002\/bjs.9840.","journal-title":"Br J Surg."},{"issue":"9","key":"5439_CR49","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1089\/jwh.2011.3270","volume":"21","author":"WL Bennett","year":"2012","unstructured":"Bennett WL, Robinson KA, Saldanha IJ, Wilson LM, Nicholson WK. High priority research needs for gestational diabetes mellitus. J Womens Health (Larchmt). 2012;21(9):925\u201332. https:\/\/doi.org\/10.1089\/jwh.2011.3270.","journal-title":"J Womens Health (Larchmt)."},{"issue":"5","key":"5439_CR50","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-034215","volume":"10","author":"N Tyler","year":"2020","unstructured":"Tyler N, Wright N, Grundy A, Waring J. Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups. BMJ Open. 2020;10(5):e034215. https:\/\/doi.org\/10.1136\/bmjopen-2019-034215.","journal-title":"BMJ Open."},{"issue":"6","key":"5439_CR51","doi-asserted-by":"publisher","first-page":"639","DOI":"10.3747\/pdi.2017.00022","volume":"37","author":"KE Manera","year":"2017","unstructured":"Manera KE, Tong A, Craig JC, Brown EA, Brunier G, Dong J, et al. Standardized outcomes in nephrology-peritoneal dialysis (SONG-PD): study protocol for establishing a core outcome set in PD. Perit Dial Int. 2017;37(6):639\u201347. https:\/\/doi.org\/10.3747\/pdi.2017.00022.","journal-title":"Perit Dial Int."},{"issue":"10","key":"5439_CR52","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002148","volume":"13","author":"JJ Kirkham","year":"2016","unstructured":"Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. Core Outcome Set-STAndards for Reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148. https:\/\/doi.org\/10.1371\/journal.pmed.1002148.","journal-title":"PLoS Med."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05439-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05439-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05439-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,7,22]],"date-time":"2021-07-22T06:10:42Z","timestamp":1626934242000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05439-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,22]]},"references-count":52,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5439"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05439-7","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-115947\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,22]]},"assertion":[{"value":"26 October 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 July 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 July 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study and relevant consent documents have received approval from the University of Technology Sydney Medical Research Ethics Board [UTS HREC REF NO. ETH20-5179]. Consent will be obtained verbally for patient focus groups\/interviews and the virtual consensus meeting, and electronically for the Delphi survey.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"480"}}