Imperial College London
TitleDevelopment of a core outcome set for trials on induction of labour (COSIOL): An international multi-stakeholder Delphi studyAuthorsFrancois Dos Santos (FDS), Stephanie Drymiotou (SD), Alba Antequera (AA), Ben W Mol (BWM), Christopher Gale (CG), Declan Devane (DD), Janneke van’t Hooft (JvH), Mark J Johnson (MJJ), Matthew Hogg (MH), Shakila Thangaratinam (ST)AffiliationsFrancois Dos Santos (Corresponding author)Research Fellow in Obstetrics and Gynaecology, Health Education England LondonBarts Health NHS Trust – The Royal London HospitalLondon, United KingdomAddress: Flat 5, 31 Great Sutton Street, EC1V 0NA, London, United KingdomTelephone number: +44 7771515471Email: francois.santos@.uk Stephanie DrymiotouTrainee in Obstetrics and Gynaecology (ST2), Health Education England LondonBarts Health NHS Trust – The Royal London HospitalLondon, United Kingdomstephaniedrymiotou@Alba Antequera MartinTrainee in Internal MedicineLa Princesa Hospital, Internal Medicine DepartmentMadrid, Spainelectrolito22@ Ben W. MolProfessor of Obstetrics and GynaecologyMonash UniversityVictoria , Australiaben.mol@adelaide.edu.au Christopher Gale Senior Lecturer in Neonatal MedicineImperial College London,London, United Kingdomchristopher.gale@imperial.ac.uk Declan DevaneProfessor of MidwiferyHRB – Trials Methodology Research Network / School of Nursing and MidwiferyNational University of Ireland GalwayRepublic of Irelanddeclan.devane@nuigalway.ie Janneke van’t HooftMD, Phd Obstetrics and GyneacologyAcademic Medical CenterAmsterdam, Netherlandsj.vanthooft@ Mark J JohnsonConsultant NeonatologistHonorary Senior Clinical Lecturer in Neonatal MedicineDepartment of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust - Princess Anne Hospital, UKNational Institute for Health Research, Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UKM.Johnson@soton.ac.uk Matthew HoggConsultant Obstetrician and GynaecologistBarts Health NHS Trust – The Royal London HospitalLondon, United KingdomMatthew.Hogg@bartshealth.nhs.uk Shakila Thangaratinam Professor of Maternal and Perinatal Health - Women's Health Research UnitBarts and the London School of Medicine and Dentistry?- Queen Mary University of London, Barts Health NHS Trust, London, United KingdomS.thangaratinam@qmul.ac.uk Running titleCore outcome set for trials on induction of labour (COSIOL)AbstractObjective: To develop a set of core outcomes to be minimally reported in trials on induction of labour.Design: Two-round Delphi survey and consensus meeting.Population: Four Stakeholder groups: midwives, obstetricians, neonatologists, and women’s representatives.Methods: Protocol registered with COMET (registration number: 695). Stakeholders rated reported outcomes for importance (1-limited to 9-critical). The median rating of each outcome was calculated. The consensus criteria to include outcomes were: ≥ 70% participants rated outcomes as critical and <15% rated outcomes as limited importance. Outcomes that did not achieve consensus were taken to round two, and if still no consensus, to the final consensus meeting. Main outcome measures: Outcomes in trials of induction of labour.Results: Of the 159 invited participants, 54% (86/159) completed the first round, and 83% completed the second round (71/86). The core outcome set included 28 core outcomes in four domains: Short-term maternal outcomes (n=18) – cardio-respiratory arrest, damage to internal organs, death, haemorrhage, hysterectomy, infection, intensive care admission, length of hospital stay, mode of delivery, need for more than one induction agent, oxytocin augmentation, postnatal depression, pulmonary embolus, satisfaction with care, stroke, time from induction to delivery, uterine hyperstimulation, uterine scar dehiscence/rupture; Short-term offspring outcomes (n=8) – admission to the neonatal unit, birth trauma, death, hypoxic ischaemic encephalopathy/need for therapeutic hypothermia, meconium aspiration syndrome, need for respiratory support, infection, seizures; Long-term maternal outcomes (n=1) – operative pelvic floor repair; Long-term offspring outcomes (n=1) – disability including neurodevelopmental delay.Conclusion: Trials on induction of labour should include this core outcome set to standardise reporting.Funding: NoneKey words: Core outcome set, CROWN, Induction of labourTweetable abstract (110 characters): International multi-stakeholder Delphi study identifies a core outcome set for trials on induction of labour.IntroductionInduction of labour is one of the commonest procedures undertaken in obstetrics; one in every five deliveries in the United Kingdom (UK) is induced. ADDIN EN.CITE <EndNote><Cite><Year>2008</Year><IDText>National Institute for Health and Clinical Excellence (2008). Inducing Labour. NICE Guideline (CG70)</IDText><DisplayText>(1)</DisplayText><record><titles><title>National Institute for Health and Clinical Excellence (2008). Inducing Labour. NICE Guideline (CG70)</title></titles><added-date format="utc">1498468798</added-date><ref-type name="Generic">13</ref-type><dates><year>2008</year></dates><rec-number>64</rec-number><last-updated-date format="utc">1498469027</last-updated-date></record></Cite></EndNote>(1) Numerous randomised trials have reported various outcomes when evaluating the effects of interventions for induction of labour. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2) Variations in reported outcomes hamper translation of evidence into clinical practice, resulting in research waste.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZWhlcjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PElE
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ADDIN EN.CITE.DATA (3-5) There are no systematic reviews on outcomes reported in trials of induction of labour but it is recognised that there is a need to develop a core outcome set (COS) for trials on induction of labour to improve the quality of evidence synthesis. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2)Careful selection of primary and secondary outcomes is a key component of clinical trial design ADDIN EN.CITE <EndNote><Cite><Author>Williamson</Author><Year>2012</Year><IDText>Developing core outcome sets for clinical trials: issues to consider</IDText><DisplayText>(6)</DisplayText><record><dates><pub-dates><date>Aug</date></pub-dates><year>2012</year></dates><keywords><keyword>Bias (Epidemiology)</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Consensus</keyword><keyword>Endpoint Determination</keyword><keyword>Evidence-Based Medicine</keyword><keyword>Guideline Adherence</keyword><keyword>Guidelines as Topic</keyword><keyword>Humans</keyword><keyword>Research Design</keyword><keyword>Treatment Outcome</keyword></keywords><urls><related-urls><url> core outcome sets for clinical trials: issues to consider</title><secondary-title>Trials</secondary-title></titles><pages>132</pages><contributors><authors><author>Williamson, P. R.</author><author>Altman, D. G.</author><author>Blazeby, J. M.</author><author>Clarke, M.</author><author>Devane, D.</author><author>Gargon, E.</author><author>Tugwell, P.</author></authors></contributors><edition>2012/08/06</edition><language>eng</language><added-date format="utc">1498471103</added-date><ref-type name="Journal Article">17</ref-type><rec-number>65</rec-number><last-updated-date format="utc">1498471103</last-updated-date><accession-num>22867278</accession-num><electronic-resource-num>10.1186/1745-6215-13-132</electronic-resource-num><volume>13</volume></record></Cite></EndNote>(6) but very few trials provide the rationale for outcome selection. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2) Many trials on induction of labour include surrogate continuous markers such as time to delivery, but provide limited or no information on maternal and offspring mortality and morbidity. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2) Maternal satisfaction, safety data and measures of cost are also poorly reported. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2) Any reported outcomes should be relevant to key stakeholders if they are to be used to influence clinical decisions and further research. ADDIN EN.CITE <EndNote><Cite><Author>Williamson</Author><Year>2012</Year><IDText>Driving up the quality and relevance of research through the use of agreed core outcomes</IDText><DisplayText>(7)</DisplayText><record><dates><pub-dates><date>Jan</date></pub-dates><year>2012</year></dates><keywords><keyword>Health Services Research</keyword><keyword>Quality Control</keyword><keyword>United States</keyword></keywords><urls><related-urls><url> up the quality and relevance of research through the use of agreed core outcomes</title><secondary-title>J Health Serv Res Policy</secondary-title></titles><pages>1-2</pages><number>1</number><contributors><authors><author>Williamson, P.</author><author>Altman, D.</author><author>Blazeby, J.</author><author>Clarke, M.</author><author>Gargon, E.</author></authors></contributors><language>eng</language><added-date format="utc">1498471983</added-date><ref-type name="Journal Article">17</ref-type><rec-number>69</rec-number><last-updated-date format="utc">1498471983</last-updated-date><accession-num>22294719</accession-num><electronic-resource-num>10.1258/jhsrp.2011.011131</electronic-resource-num><volume>17</volume></record></Cite></EndNote>(7)The current drive to standardise outcome reporting in clinical trials led by COMET (Core Outcome Measures in Effectiveness Trials) has been taken up by various specialties. ADDIN EN.CITE <EndNote><Cite><IDText>COMET Initiative?</IDText><DisplayText>(8)</DisplayText><record><urls><related-urls><url> Initiative?</title></titles><number>22 May</number><added-date format="utc">1498472496</added-date><ref-type name="Web Page">12</ref-type><rec-number>74</rec-number><last-updated-date format="utc">1498472745</last-updated-date><volume>2017</volume></record></Cite></EndNote>(8) The CROWN (Core Outcomes in Women’s Health) initiative encourages the development of core outcome sets, which are the minimum outcomes to be reported in clinical trials in women’s and newborn health.PEVuZE5vdGU+PENpdGU+PElEVGV4dD5DT01FVCBJbml0aWF0aXZlwqA8L0lEVGV4dD48RGlzcGxh
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ADDIN EN.CITE.DATA (8-10) Given the variation in outcome reporting, we developed a set of core outcomes for reporting in trials of induction of labour using the Delphi technique.The scope of this work is to identify a set of minimal outcomes to be reported in clinical trials on induction of labour, for any indication, in singleton pregnancies at term.MethodsThe study was conducted in line with COMET recommendationsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaWxsaWFtc29uPC9BdXRob3I+PFllYXI+MjAxMjwvWWVh
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ADDIN EN.CITE.DATA (6, 11) with a prospective protocol and was registered with the CROWN and COMET databases ADDIN EN.CITE <EndNote><Cite><IDText>COMET Initiative?</IDText><DisplayText>(8)</DisplayText><record><urls><related-urls><url> Initiative?</title></titles><number>22 May</number><added-date format="utc">1498472496</added-date><ref-type name="Web Page">12</ref-type><rec-number>74</rec-number><last-updated-date format="utc">1498472745</last-updated-date><volume>2017</volume></record></Cite></EndNote>(8) (Registration Number: 695, available online at ). We followed the COS-STAR statement checklist for reporting. ADDIN EN.CITE <EndNote><Cite><Author>Kirkham</Author><Year>2016</Year><IDText>Core Outcome Set-STAndards for Reporting: The COS-STAR Statement</IDText><DisplayText>(12)</DisplayText><record><dates><pub-dates><date>Oct</date></pub-dates><year>2016</year></dates><keywords><keyword>Biomedical Research</keyword><keyword>Checklist</keyword><keyword>Consensus Development Conferences as Topic</keyword><keyword>Guidelines as Topic</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Review Literature as Topic</keyword></keywords><urls><related-urls><url> Outcome Set-STAndards for Reporting: The COS-STAR Statement</title><secondary-title>PLoS Med</secondary-title></titles><pages>e1002148</pages><number>10</number><contributors><authors><author>Kirkham, J. J.</author><author>Gorst, S.</author><author>Altman, D. G.</author><author>Blazeby, J. M.</author><author>Clarke, M.</author><author>Devane, D.</author><author>Gargon, E.</author><author>Moher, D.</author><author>Schmitt, J.</author><author>Tugwell, P.</author><author>Tunis, S.</author><author>Williamson, P. R.</author></authors></contributors><edition>2016/10/18</edition><language>eng</language><added-date format="utc">1508156114</added-date><ref-type name="Journal Article">17</ref-type><rec-number>99</rec-number><last-updated-date format="utc">1508156114</last-updated-date><accession-num>27755541</accession-num><electronic-resource-num>10.1371/journal.pmed.1002148</electronic-resource-num><volume>13</volume></record></Cite></EndNote>(12) An eleven-member international Project Steering Committee (PSC) consisting of five obstetricians, two neonatologists, two midwives, one researcher and one women’s representative provided input through the different stages of the project. Literature search and identification of relevant outcomesWe undertook an electronic search of the Cochrane database of systematic reviews with the search term “induction of labour” for studies published up to 31 May 2015. The outcomes were combined and arranged into seven domains by the PSC: short-term for the women, short-term for the infant, long-term for the women, long-term for the child, maternal satisfaction, effectiveness and cost. A table of the studies identified and included from our search can be found in Table S1. Identification of stakeholdersWe included four stakeholder groups: obstetricians, neonatologists, midwives and women’s representatives. Obstetricians and neonatologist were invited through mailing lists of the National Health Service (NHS) Trusts and Journal editors, members of GONet (Global Obstetric Network), medical societies such as the British Association of Perinatal Medicine, Perinatal Society of Australia and New Zealand, specialist groups such as London Labour Ward Leads forum, and through referred contacts. Midwives were invited through mailing lists of NHS Trusts, through email discussion groups and through a mailing list of an ongoing UK-wide intrapartum clinical trial.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaGFuPC9BdXRob3I+PFllYXI+MjAxNzwvWWVhcj48SURU
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ADDIN EN.CITE.DATA (13) We invited women’s representatives from the Royal College of Obstetricians and Gynaecologists (RCOG) Women’s Voices Involvement Panel mailing list ADDIN EN.CITE <EndNote><Cite><IDText>RCOG Women's Voices</IDText><DisplayText>(14)</DisplayText><record><urls><related-urls><url> Women's Voices</title></titles><number>6 Oct</number><added-date format="utc">1498477189</added-date><ref-type name="Web Page">12</ref-type><auth-address>womensvoices@.uk</auth-address><rec-number>79</rec-number><last-updated-date format="utc">1498477442</last-updated-date><volume>2015</volume></record></Cite></EndNote>(14), Katie’s Team ADDIN EN.CITE <EndNote><Cite><IDText>KT Network</IDText><DisplayText>(15)</DisplayText><record><urls><related-urls><url> Network</title></titles><number>6 October</number><added-date format="utc">1498477383</added-date><ref-type name="Web Page">12</ref-type><auth-address>ktnetwork@qmul.ac.uk</auth-address><rec-number>80</rec-number><last-updated-date format="utc">1498477442</last-updated-date><volume>2015</volume></record></Cite></EndNote>(15) (a patient and public advisory group) and social media (private maternity group on Facebook and an invitation poster posted on Twitter – Appendix S1 – COSIOL recruitment poster). Women’s representatives had to have had experienced induction of labour themselves or supported a relative/friend undergoing induction of labour. Our aim was to recruit at least 25 participants in each of the stakeholder groups.Delphi surveyWe undertook a two-round confidential e-Delphi survey. Each round closed after a 4-week. A reminder was sent to all participants who had not completed the survey on days 7, 14 and 21. Non-responders to the first round were not invited to the subsequent round.Round OneWe sent a link to the web-based questionnaire (Appendix S2 – Delphi Survey Round 1, example) to stakeholders using Survey Monkey? (Survey Monkey Inc, San Mateo, California, USA). Participants were asked to score a long-list of potential outcomes for importance in including in a core outcome set, using a 9-point GRADE (Grading of Recommendations Assessment, Development and Evaluation) scale; ADDIN EN.CITE <EndNote><Cite><Author>Guyatt</Author><Year>2011</Year><IDText>GRADE guidelines: 2. Framing the question and deciding on important outcomes</IDText><DisplayText>(16)</DisplayText><record><dates><pub-dates><date>Apr</date></pub-dates><year>2011</year></dates><keywords><keyword>Decision Making</keyword><keyword>Evidence-Based Medicine</keyword><keyword>Female</keyword><keyword>Guideline Adherence</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Practice Guidelines as Topic</keyword><keyword>Quality Assurance, Health Care</keyword></keywords><urls><related-urls><url> guidelines: 2. Framing the question and deciding on important outcomes</title><secondary-title>J Clin Epidemiol</secondary-title></titles><pages>395-400</pages><number>4</number><contributors><authors><author>Guyatt, G. H.</author><author>Oxman, A. D.</author><author>Kunz, R.</author><author>Atkins, D.</author><author>Brozek, J.</author><author>Vist, G.</author><author>Alderson, P.</author><author>Glasziou, P.</author><author>Falck-Ytter, Y.</author><author>Schünemann, H. J.</author></authors></contributors><edition>2010/12/30</edition><language>eng</language><added-date format="utc">1498484135</added-date><ref-type name="Journal Article">17</ref-type><rec-number>81</rec-number><last-updated-date format="utc">1498484135</last-updated-date><accession-num>21194891</accession-num><electronic-resource-num>10.1016/j.jclinepi.2010.09.012</electronic-resource-num><volume>64</volume></record></Cite></EndNote>(16) scores 1 to 3 – limited importance; 4 to 6 – important but not critical; 7 to 9 – critical. We provided all stakeholders with a document that explained in lay terms the meaning of each outcome (Appendix S3 – List of outcomes with short explanation), which was informed by the Plain Language Medical Dictionary. ADDIN EN.CITE <EndNote><Cite><IDText>University of Michigan - Plain Language Medical Dictionary</IDText><DisplayText>(17)</DisplayText><record><urls><related-urls><url> of Michigan - Plain Language Medical Dictionary</title></titles><number>21 Feb</number><added-date format="utc">1498485086</added-date><ref-type name="Web Page">12</ref-type><rec-number>82</rec-number><last-updated-date format="utc">1498485227</last-updated-date><volume>2016</volume></record></Cite></EndNote>(17)Participants were invited to suggest additional relevant outcomes (no limit to the number of outcomes suggested) using free-text responses. The PSC reviewed these outcomes for addition to the next round of the survey. We determined a priori the criteria for consensus. “Consensus in” (outcome to be included in the COS) required 70% or more of participants to score the outcome as being critical and less than 15% of participants to score the outcome as being of limited importance. “Consensus out” (outcome not to be included in the core outcome set) required 70% or more of participants to score the outcome as being of limited importance and less than 15% of participants to score the outcome as being critical. Outcomes that did not meet any of these criteria were labelled as “no consensus”. ADDIN EN.CITE <EndNote><Cite><Author>Harman</Author><Year>2013</Year><IDText>MOMENT--Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey</IDText><DisplayText>(18)</DisplayText><record><dates><pub-dates><date>Mar</date></pub-dates><year>2013</year></dates><keywords><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Cleft Palate</keyword><keyword>Consensus</keyword><keyword>Delphi Technique</keyword><keyword>Evidence-Based Medicine</keyword><keyword>Feasibility Studies</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Interviews as Topic</keyword><keyword>Otitis Media with Effusion</keyword><keyword>Patient Selection</keyword><keyword>Research Design</keyword><keyword>Treatment Outcome</keyword></keywords><urls><related-urls><url> of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey</title><secondary-title>Trials</secondary-title></titles><pages>70</pages><contributors><authors><author>Harman, N. L.</author><author>Bruce, I. A.</author><author>Callery, P.</author><author>Tierney, S.</author><author>Sharif, M. O.</author><author>O'Brien, K.</author><author>Williamson, P. R.</author></authors></contributors><edition>2013/03/12</edition><language>eng</language><added-date format="utc">1498485533</added-date><ref-type name="Journal Article">17</ref-type><rec-number>83</rec-number><last-updated-date format="utc">1498485533</last-updated-date><accession-num>23497540</accession-num><electronic-resource-num>10.1186/1745-6215-14-70</electronic-resource-num><volume>14</volume></record></Cite></EndNote>(18) The median scores of each outcome were calculated as a whole and for each individual stakeholder group.Round TwoOutcomes that reached “consensus in” or “consensus out” in round one were not taken forward to round two. Outcomes suggested by stakeholders in the first round of the survey were evaluated by the PSC and used in round two as separate items. Outcomes with “no consensus” status and the additional outcomes suggested by participants were included for rating by participants in round two. We provided the median scores for each outcome by stakeholder group in round one, and the participants’ own score. They were requested to reflect on their previous rating and rating by stakeholder group before re-scoring the outcomes for a second time using the same scale (Appendix S4 – Delphi Survey Round 2, example).Consensus MeetingWe invited all the participants who had completed both rounds of the survey to attend a consensus meeting in Amsterdam in 2017. Those who could not attend the meeting were invited to participate via teleconference. We additionally requested intrapartum care experts to join the meeting. The consensus group voted on the “no consensus” outcomes from the Delphi rounds and evaluated the final list of “consensus in” outcomes and made suggestions on combining outcomes where there was significant overlap between components. ADDIN EN.CITE <EndNote><Cite><Author>Duffy</Author><Year>2017</Year><IDText>Core Outcome Sets in Women's and Newborn Health: A Systematic Review</IDText><DisplayText>(19)</DisplayText><record><dates><pub-dates><date>Apr</date></pub-dates><year>2017</year></dates><urls><related-urls><url> Outcome Sets in Women's and Newborn Health: A Systematic Review</title><secondary-title>BJOG</secondary-title></titles><contributors><authors><author>Duffy, J. M. N.</author><author>Rolph, R.</author><author>Gale, C.</author><author>Hirsch, M.</author><author>Khan, K. S.</author><author>Ziebland, S.</author><author>McManus, R. J.</author><author>International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)</author></authors></contributors><edition>2017/04/19</edition><language>eng</language><added-date format="utc">1498486249</added-date><ref-type name="Journal Article">17</ref-type><rec-number>84</rec-number><last-updated-date format="utc">1498486249</last-updated-date><accession-num>28421657</accession-num><electronic-resource-num>10.1111/1471-0528.14694</electronic-resource-num></record></Cite></EndNote>(19) Stakeholder groups who were unable to be represented in the consensus meeting were sent the final list of outcomes for comments. The PSC took these comments into consideration before finalising the final COS.The Delphi questionnaire scores were analysed using Microsoft? Excel for MAC, version 15.33, 2017 (Microsoft Corp, Redmond, WA, USA).ResultsWe identified 32 (Table S1) reviews from the literature search, extracted all the different outcomes reported (n=155), and created a comprehensive list of potential core outcomes. The number of outcomes was reduced to 93 by the PSC, by combining similar outcomes. The stakeholders who agreed to participate in the Delphi process were from the United Kingdom, Australia, China, Ireland, Netherlands and Portugal.The first round of the Delphi survey was sent to 159 participants (44 obstetricians, 30 neonatologists, 54 midwives and 31 women’s representatives). About half of all participants (54%, 86/159) completed the first round (26 obstetricians, 15 neonatologists, 27 midwives and 18 women’s representatives). The second round was completed by 71 participants (83%, 71/86 – 24 obstetricians, 9 neonatologists, 21 midwives and 17 women’s representatives). An initial list of 93 outcomes (Figure 1) was reduced to 77 by combining similar components (Table 1) following suggestions from the stakeholders participating in round one and prior to calculating the median scores for each outcome. At the end of round one, 18 of the 77 outcomes were “consensus in”, none were “consensus out”, and 59 were “no consensus” (Table S2 – Consensus in, Round 1). Stakeholders suggested the addition of “umbilical cord pH”, “need for therapeutic hypothermia”, “amniotic fluid embolism” and “intrapartum stillbirth” to be added to the survey.Of the 63 outcomes rated in round two, 14 were categorised as “consensus in”, none were “consensus out” and 49 were “no consensus” (Table S3 – Consensus in, Round 2). The final consensus meeting included eight obstetricians, one midwife and three researchers. Further input was obtained via email from two obstetricians, three women’s representatives and three neonatologists (Table 2). Of the 49 “no consensus” outcomes, four were voted to be included in the final core outcome set: “uterine hyperstimulation”, “more than one induction agent required”, “length of hospital stay” and “oxytocin augmentation”. Due to the high number of “consensus in” outcomes (n=36), the participants of the consensus meeting combined fourteen of these into six new outcomes (Table 3).The final set included 28 core outcomes in four domains (Table 4): short-term maternal outcomes (n=18), short-term offspring outcomes (n=8), long-term maternal outcomes (n=1) and long-term offspring outcomes (n=1).DiscussionMain findingsAn international multi-stakeholder group including women’s representatives, identified 28 maternal and offspring outcomes to be minimally reported in trials of induction of labour. 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ADDIN EN.CITE.DATA (23-25) By involving obstetricians, midwives and neonatologists from different countries, we captured different perspectives. We created a plain language summary mainly targeting the women’s representatives group. Health professionals also seem to prefer plain English terms over technical terms ADDIN EN.CITE <EndNote><Cite><Author>Williamson</Author><Year>2017</Year><IDText>The COMET Handbook: version 1.0</IDText><DisplayText>(22)</DisplayText><record><dates><pub-dates><date>Jun</date></pub-dates><year>2017</year></dates><urls><related-urls><url> COMET Handbook: version 1.0</title><secondary-title>Trials</secondary-title></titles><pages>280</pages><number>Suppl 3</number><contributors><authors><author>Williamson, P. R.</author><author>Altman, D. G.</author><author>Bagley, H.</author><author>Barnes, K. L.</author><author>Blazeby, J. M.</author><author>Brookes, S. T.</author><author>Clarke, M.</author><author>Gargon, E.</author><author>Gorst, S.</author><author>Harman, N.</author><author>Kirkham, J. J.</author><author>McNair, A.</author><author>Prinsen, C. A. C.</author><author>Schmitt, J.</author><author>Terwee, C. B.</author><author>Young, B.</author></authors></contributors><edition>2017/06/20</edition><language>eng</language><added-date format="utc">1508166478</added-date><ref-type name="Journal Article">17</ref-type><rec-number>101</rec-number><last-updated-date format="utc">1508166478</last-updated-date><accession-num>28681707</accession-num><electronic-resource-num>10.1186/s13063-017-1978-4</electronic-resource-num><volume>18</volume></record></Cite></EndNote>(22) hence, we sent this document to all participants. We used the Delphi technique to achieve consensus which has been used in the development of several COS. ADDIN EN.CITE <EndNote><Cite><Author>Sinha</Author><Year>2011</Year><IDText>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</IDText><DisplayText>(11)</DisplayText><record><dates><pub-dates><date>Jan</date></pub-dates><year>2011</year></dates><keywords><keyword>Clinical Trials as Topic</keyword><keyword>Consensus</keyword><keyword>Delphi Technique</keyword><keyword>Forecasting</keyword><keyword>Humans</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Patient Dropouts</keyword><keyword>Research Design</keyword><keyword>Surveys and Questionnaires</keyword></keywords><urls><related-urls><url> the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies</title><secondary-title>PLoS Med</secondary-title></titles><pages>e1000393</pages><number>1</number><contributors><authors><author>Sinha, I. P.</author><author>Smyth, R. L.</author><author>Williamson, P. R.</author></authors></contributors><edition>2011/01/25</edition><language>eng</language><added-date format="utc">1498475839</added-date><ref-type name="Journal Article">17</ref-type><rec-number>78</rec-number><last-updated-date format="utc">1498475839</last-updated-date><accession-num>21283604</accession-num><electronic-resource-num>10.1371/journal.pmed.1000393</electronic-resource-num><volume>8</volume></record></Cite></EndNote>(11) It allows confidentiality, wide geographic distribution and avoids the potential over-influence of dominant individuals.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaWxsaWFtc29uPC9BdXRob3I+PFllYXI+MjAxNzwvWWVh
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ADDIN EN.CITE.DATA (22, 26)By limiting our search to a single database and by not performing a systematic review, we might have missed outcomes reported, which is a limitation. Induction of labour is a common procedure and we identified a significant number of reported outcomes. Large systematic reviews are time consuming and may not provide additional outcomes for common conditions. ADDIN EN.CITE <EndNote><Cite><Author>Williamson</Author><Year>2017</Year><IDText>The COMET Handbook: version 1.0</IDText><DisplayText>(22)</DisplayText><record><dates><pub-dates><date>Jun</date></pub-dates><year>2017</year></dates><urls><related-urls><url> COMET Handbook: version 1.0</title><secondary-title>Trials</secondary-title></titles><pages>280</pages><number>Suppl 3</number><contributors><authors><author>Williamson, P. R.</author><author>Altman, D. G.</author><author>Bagley, H.</author><author>Barnes, K. L.</author><author>Blazeby, J. M.</author><author>Brookes, S. T.</author><author>Clarke, M.</author><author>Gargon, E.</author><author>Gorst, S.</author><author>Harman, N.</author><author>Kirkham, J. J.</author><author>McNair, A.</author><author>Prinsen, C. A. C.</author><author>Schmitt, J.</author><author>Terwee, C. B.</author><author>Young, B.</author></authors></contributors><edition>2017/06/20</edition><language>eng</language><added-date format="utc">1508166478</added-date><ref-type name="Journal Article">17</ref-type><rec-number>101</rec-number><last-updated-date format="utc">1508166478</last-updated-date><accession-num>28681707</accession-num><electronic-resource-num>10.1186/s13063-017-1978-4</electronic-resource-num><volume>18</volume></record></Cite></EndNote>(22) Outcomes were presented in alphabetical order which may have influenced the responses/response rate, ADDIN EN.CITE <EndNote><Cite><Author>McColl</Author><Year>2001</Year><IDText>Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients</IDText><DisplayText>(27)</DisplayText><record><keywords><keyword>Benchmarking</keyword><keyword>Data Collection</keyword><keyword>Databases, Bibliographic</keyword><keyword>Health Care Surveys</keyword><keyword>Health Personnel</keyword><keyword>Research Design</keyword><keyword>Surveys and Questionnaires</keyword><keyword>United Kingdom</keyword></keywords><urls><related-urls><url> and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients</title><secondary-title>Health Technol Assess</secondary-title></titles><pages>1-256</pages><number>31</number><contributors><authors><author>McColl, E.</author><author>Jacoby, A.</author><author>Thomas, L.</author><author>Soutter, J.</author><author>Bamford, C.</author><author>Steen, N.</author><author>Thomas, R.</author><author>Harvey, E.</author><author>Garratt, A.</author><author>Bond, J.</author></authors></contributors><language>eng</language><added-date format="utc">1508171336</added-date><ref-type name="Journal Article">17</ref-type><dates><year>2001</year></dates><rec-number>106</rec-number><last-updated-date format="utc">1508171336</last-updated-date><accession-num>11809125</accession-num><volume>5</volume></record></Cite></EndNote>(27) but we are not aware of a different strategy. We chose to do two rounds of the Delphi survey due to time constraints but usually three iterations are sufficient to achieve consensus ADDIN EN.CITE <EndNote><Cite><Author>Williamson</Author><Year>2017</Year><IDText>The COMET Handbook: version 1.0</IDText><DisplayText>(22)</DisplayText><record><dates><pub-dates><date>Jun</date></pub-dates><year>2017</year></dates><urls><related-urls><url> COMET Handbook: version 1.0</title><secondary-title>Trials</secondary-title></titles><pages>280</pages><number>Suppl 3</number><contributors><authors><author>Williamson, P. R.</author><author>Altman, D. G.</author><author>Bagley, H.</author><author>Barnes, K. L.</author><author>Blazeby, J. M.</author><author>Brookes, S. T.</author><author>Clarke, M.</author><author>Gargon, E.</author><author>Gorst, S.</author><author>Harman, N.</author><author>Kirkham, J. J.</author><author>McNair, A.</author><author>Prinsen, C. A. C.</author><author>Schmitt, J.</author><author>Terwee, C. B.</author><author>Young, B.</author></authors></contributors><edition>2017/06/20</edition><language>eng</language><added-date format="utc">1508166478</added-date><ref-type name="Journal Article">17</ref-type><rec-number>101</rec-number><last-updated-date format="utc">1508166478</last-updated-date><accession-num>28681707</accession-num><electronic-resource-num>10.1186/s13063-017-1978-4</electronic-resource-num><volume>18</volume></record></Cite></EndNote>(22), which we did with the final consensus meeting. The attrition rate was high for the first round of the survey but lower for the second round which is not uncommon in multi-round surveys. ADDIN EN.CITE <EndNote><Cite><Author>Al Wattar</Author><Year>2017</Year><IDText>Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study</IDText><DisplayText>(28)</DisplayText><record><dates><pub-dates><date>Mar</date></pub-dates><year>2017</year></dates><urls><related-urls><url> of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study</title><secondary-title>BJOG</secondary-title></titles><pages>661-667</pages><number>4</number><contributors><authors><author>Al Wattar, B. H.</author><author>Tamilselvan, K.</author><author>Khan, R.</author><author>Kelso, A.</author><author>Sinha, A.</author><author>Pirie, A. M.</author><author>McCorry, D.</author><author>Khan, K. S.</author><author>Thangaratinam, S.</author><author>Antiepileptic Drug Management in Pregnancy (EMPIRE) Collaborative Network</author></authors></contributors><edition>2016/11/16</edition><language>eng</language><added-date format="utc">1508170543</added-date><ref-type name="Journal Article">17</ref-type><rec-number>105</rec-number><last-updated-date format="utc">1508170543</last-updated-date><accession-num>27860117</accession-num><electronic-resource-num>10.1111/1471-0528.14430</electronic-resource-num><volume>124</volume></record></Cite></EndNote>(28) The attrition rates were higher for the neonatologists group and we addressed this by sending individual emails to those initially invited and by extending the survey response deadline by two weeks for both rounds. Despite this being a protocol deviation, we did not want a particular stakeholder group to be underrepresented. Even with all these efforts, the neonatologists group remained the least represented stakeholder group which is one of our biggest limitations. This might have affected the final list of outcomes for the offspring. We invited all the participants in the Delphi survey to attend the Consensus Meeting. Another limitation was that the meeting was held abroad and the attendance rate was low. We allowed participation via teleconference and comments via email after the COS had been agreed at the meeting. Obstetricians, neonatologists and women’s representatives sent comments via email and we took these into consideration prior to finalising the COS. Another limitation of our study is the potential knowledge gap from not including stakeholders from large high income countries such as the Unites States of America, and low and middle-income countries. ADDIN EN.CITE <EndNote><Cite><Author>United</Author><Year>2016</Year><IDText>;(29)</DisplayText><record><titles><title> May</number><contributors><authors><author>United Nations Statistics Division</author></authors></contributors><added-date format="utc">1526727418</added-date><ref-type name="Web Page">12</ref-type><dates><year>2016</year></dates><rec-number>201</rec-number><last-updated-date format="utc">1526727583</last-updated-date><volume>2018</volume></record></Cite></EndNote>(29) Although, we used global platforms and social media to invite stakeholders, certain countries remained underrepresented. One potential limitation of this study is the high number of outcomes in our final COS. Due to the nature of induction of labour interventions, we had to include outcomes for both women and offspring. There are currently four published core outcome sets in women’s and newborn health ADDIN EN.CITE <EndNote><Cite><Author>Duffy</Author><Year>2017</Year><IDText>Core Outcome Sets in Women's and Newborn Health: A Systematic Review</IDText><DisplayText>(19)</DisplayText><record><dates><pub-dates><date>Apr</date></pub-dates><year>2017</year></dates><urls><related-urls><url> Outcome Sets in Women's and Newborn Health: A Systematic Review</title><secondary-title>BJOG</secondary-title></titles><contributors><authors><author>Duffy, J. M. N.</author><author>Rolph, R.</author><author>Gale, C.</author><author>Hirsch, M.</author><author>Khan, K. S.</author><author>Ziebland, S.</author><author>McManus, R. J.</author><author>International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)</author></authors></contributors><edition>2017/04/19</edition><language>eng</language><added-date format="utc">1498486249</added-date><ref-type name="Journal Article">17</ref-type><rec-number>84</rec-number><last-updated-date format="utc">1498486249</last-updated-date><accession-num>28421657</accession-num><electronic-resource-num>10.1111/1471-0528.14694</electronic-resource-num></record></Cite></EndNote>(19) with outcome numbers ranging from 11 to 48. InterpretationShort and long-term maternal outcomesOur COS captured outcomes that are both commonly reported, such as “time from induction of labour to delivery” (reported in >50% of trials ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2)), but also outcomes which are less commonly reported such as “maternal satisfaction” (reported in 5% of trials ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2)) and “maternal death” (reported in 12% of trials ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2)). We combined “uterine scar dehiscence” with “uterine scar rupture” as uterine scar dehiscence would not be recognised during labour and therefore not change management. It would, however, require repair once identified. “Chorioamnionitis”, “septicaemia” and “puerperal infection” are a spectrum of maternal infection hence the panellists’ decision to combine them. “Cardiac” and “respiratory arrest” are rare events in maternity and often occur together hence combined as one outcome. Regarding “mode of delivery”, researchers might want to differentiate between vaginal delivery, instrumental delivery and caesarean section. Trials on induction of labour almost always report on caesarean section and about half report instrumental delivery rates. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2) The participants of the Delphi process and consensus meeting reached consensus that this should be minimally reported. “Uterine hyperstimulation” was included as panellists thought it may change an outpatient induction into an inpatient induction, could lead to sooner medical intervention and increased hospital stay. Women’s representatives made important suggestions on the potential consequences of induction of labour such as reduced contraction efficiency and reduction in prelabour oxytocin and prolactin receptors with a subsequent impact on breastfeeding, maternal adaptation and maternal-infant bond. ADDIN EN.CITE <EndNote><Cite><Author>McColl</Author><Year>2001</Year><IDText>Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients</IDText><DisplayText>(27)</DisplayText><record><keywords><keyword>Benchmarking</keyword><keyword>Data Collection</keyword><keyword>Databases, Bibliographic</keyword><keyword>Health Care Surveys</keyword><keyword>Health Personnel</keyword><keyword>Research Design</keyword><keyword>Surveys and Questionnaires</keyword><keyword>United Kingdom</keyword></keywords><urls><related-urls><url> and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients</title><secondary-title>Health Technol Assess</secondary-title></titles><pages>1-256</pages><number>31</number><contributors><authors><author>McColl, E.</author><author>Jacoby, A.</author><author>Thomas, L.</author><author>Soutter, J.</author><author>Bamford, C.</author><author>Steen, N.</author><author>Thomas, R.</author><author>Harvey, E.</author><author>Garratt, A.</author><author>Bond, J.</author></authors></contributors><language>eng</language><added-date format="utc">1508171336</added-date><ref-type name="Journal Article">17</ref-type><dates><year>2001</year></dates><rec-number>106</rec-number><last-updated-date format="utc">1508171336</last-updated-date><accession-num>11809125</accession-num><volume>5</volume></record></Cite></EndNote>(27) “Breastfeeding at discharge”, “impact on maternal-newborn bonding” and “impact on maternal mood” were included in the initial list of outcomes but did not reach consensus. The underrepresentation of women’s representatives at the consensus meeting might have contributed to these outcomes not being included.At the consensus meeting, participants were satisfied with the only long-term maternal outcome included, as induction of labour increases the risk of operative vaginal delivery ADDIN EN.CITE <EndNote><Cite><Year>2008</Year><IDText>National Institute for Health and Clinical Excellence (2008). Inducing Labour. NICE Guideline (CG70)</IDText><DisplayText>(1)</DisplayText><record><titles><title>National Institute for Health and Clinical Excellence (2008). Inducing Labour. NICE Guideline (CG70)</title></titles><added-date format="utc">1498468798</added-date><ref-type name="Generic">13</ref-type><dates><year>2008</year></dates><rec-number>64</rec-number><last-updated-date format="utc">1498469027</last-updated-date></record></Cite></EndNote>(1) and therefore, the “need for operative pelvic floor repair”. If funding is not available for long-term follow-up, the researchers can justify not reporting the long-term outcomes, but make efforts to follow this avenue if future funding becomes possible.Short and long-term offspring outcomesThe participants of the consensus meeting were satisfied with all the offspring outcomes. “Apgar score <7 at five minutes” is nearly always reported in trials of induction of labour ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2). Stakeholders suggested that this outcome might be useful in low resource settings and should be included in that case. Only 21% of trials report on neonatal death and 36% report on NICU admission – we captured both. “Hypoxic ischaemic injury” (HIE) was grouped with “need for therapeutic hypothermia” as therapeutic hypothermia is a surrogate marker for HIE.(35) “Neonatal death”, “death after discharge from the hospital” and “intrapartum stillbirth” were combined into “death of the baby (intrapartum/neonatal/perinatal)”. The consensus meeting participants suggested combining “long-term disability” and “neurodevelopmental delay” into “long-term disability including neurodevelopmental delay”. If funding is not available for long-term follow-up, the researchers can justify not reporting the long-term outcomes.Measures of costAlthough none of the cost orientated outcome measures are included in our COS, these should be considered in case of a randomised trial comparing cost effectiveness of different agents. Currently, only 10% of trials report costs. ADDIN EN.CITE <EndNote><Cite><Author>Medley</Author><Year>2015</Year><IDText>Outcomes reported in trials of methods for the induction of labour</IDText><DisplayText>(2)</DisplayText><record><titles><title>Outcomes reported in trials of methods for the induction of labour</title></titles><contributors><authors><author>Medley, Nancy</author></authors></contributors><added-date format="utc">1515154040</added-date><pub-location>Trials</pub-location><ref-type name="Generic">13</ref-type><dates><year>2015</year></dates><rec-number>180</rec-number><last-updated-date format="utc">1520266426</last-updated-date></record></Cite></EndNote>(2)ConclusionWe encourage investigators undertaking future research on induction of labour to report on this COS of 28 outcomes as a minimum. By implementing and disseminating this COS in future research on induction of labour, we hope to minimise reporting bias by allowing evidence synthesis across different trials. ADDIN EN.CITE <EndNote><Cite><Author>Sinha</Author><Year>2011</Year><IDText>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</IDText><DisplayText>(11)</DisplayText><record><dates><pub-dates><date>Jan</date></pub-dates><year>2011</year></dates><keywords><keyword>Clinical Trials as Topic</keyword><keyword>Consensus</keyword><keyword>Delphi Technique</keyword><keyword>Forecasting</keyword><keyword>Humans</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Patient Dropouts</keyword><keyword>Research Design</keyword><keyword>Surveys and Questionnaires</keyword></keywords><urls><related-urls><url> the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies</title><secondary-title>PLoS Med</secondary-title></titles><pages>e1000393</pages><number>1</number><contributors><authors><author>Sinha, I. P.</author><author>Smyth, R. L.</author><author>Williamson, P. R.</author></authors></contributors><edition>2011/01/25</edition><language>eng</language><added-date format="utc">1498475839</added-date><ref-type name="Journal Article">17</ref-type><rec-number>78</rec-number><last-updated-date format="utc">1498475839</last-updated-date><accession-num>21283604</accession-num><electronic-resource-num>10.1371/journal.pmed.1000393</electronic-resource-num><volume>8</volume></record></Cite></EndNote>(11)It is beyond the scope of this study to provide definitions for each specific outcome or provide instruments for measurement. Guidelines on how to select outcome measurement instruments have been published. ADDIN EN.CITE <EndNote><Cite><Author>Prinsen</Author><Year>2016</Year><IDText>How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline</IDText><DisplayText>(30)</DisplayText><record><dates><pub-dates><date>09</date></pub-dates><year>2016</year></dates><keywords><keyword>Delphi Technique</keyword><keyword>Humans</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Practice Guidelines as Topic</keyword><keyword>COMET</keyword><keyword>COSMIN</keyword><keyword>Core Outcome Set</keyword><keyword>Delphi study</keyword><keyword>Guideline</keyword><keyword>Instrument selection</keyword><keyword>Outcome measurement instrument</keyword><keyword>Outcomes research</keyword></keywords><urls><related-urls><url> to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline</title><secondary-title>Trials</secondary-title></titles><pages>449</pages><number>1</number><contributors><authors><author>Prinsen, C. A.</author><author>Vohra, S.</author><author>Rose, M. R.</author><author>Boers, M.</author><author>Tugwell, P.</author><author>Clarke, M.</author><author>Williamson, P. R.</author><author>Terwee, C. B.</author></authors></contributors><edition>2016/09/13</edition><language>eng</language><added-date format="utc">1526733593</added-date><ref-type name="Journal Article">17</ref-type><rec-number>211</rec-number><last-updated-date format="utc">1526733593</last-updated-date><accession-num>27618914</accession-num><electronic-resource-num>10.1186/s13063-016-1555-2</electronic-resource-num><volume>17</volume></record></Cite></EndNote>(30) Until these are developed, we suggest researchers describe how outcomes have been measured.Acknowledgements The authors would like to thank?Sarah Weist (Senior Research MW, Barts Health NHS Trust – The Royal London Hospital, UK), Deborah Turnbull (Professor and Chair in Psychology, University of Adelaide, Australia), Chris Wilkinson (Sub-specialist in Maternal Fetal Medicine, University of Adelaide, Australia), Khalid S. Khan (Women’s Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK) and?Ms Anastasia Liapi (Women’s Representative, UK) for being part of the Project Steering Committee and helping with all stages of the study including designing and piloting the survey and actively recruiting participants. A special thanks to Ms Sal Higgins (Senior Research MW, Barts Health NHS Trust – The Royal London Hospital, UK) for helping to recruit women’s representatives through social media and to Amy Thomas (Senior Research MW, Barts Health NHS Trust – The Royal London Hospital, UK) for helping with the HRA/REC application form. The authors would also like to thank all the women from Women’s Voices RCOG for their dedication and input and lastly to all the other participants from the different stakeholder groups.Disclosure of InterestsFDS, SD, AA, CG, DD, JvH, MJJ, MH and ST have nothing to disclose.BWM reports and is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck and Guerbet.Contribution of authorshipST conceived the idea, provided input during all stages of the Delphi process and all stages of the manuscript. FDS and SD moderated all stages of the Delphi process, analysed the data and prepared all drafts of the manuscript alongside AA. BWM, CG, DD, JvH, MJJ and MH revised and provided significant input to the manuscript.Ethics ApprovalThe project received approval from the Health Research Authority (HRA) in October 2016 and a favourable opinion from South East Scotland Ethics Committee (REC reference: 16/SS/0113).FundingNone References ADDIN EN.REFLIST 1. 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Trials 2016 09;17(1):449.Table/Figure/Supplementary Information/Appendix List1 - Table S1. Table of the studies included for extraction of the long-list of outcomes for the development of a core outcome set for trials on induction of labour (COSIOL)2 - Appendix S1. COSIOL Recruitment Poster3 - Appendix S2. Delphi Survey Round 1, example4 - Appendix S3. List of outcomes with short explanation5 - Appendix S4. Delphi Round 2, example6 - Figure 1. Flowchart of number of outcomes throughout the Delphi process7 - Table 1. Combination of outcomes, round 18 - Table S2. Consensus in, Round 19 - Table S3. Consensus in, Round 2 10- Table 2. Number of participants11 - Table 3. Combination of outcomes, consensus meeting12 - Table 4. COS for trials on IOL13 – Supporting information S8. GRIPP2-SF Checklist14 – DOI Forms for all authors ................
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