Developing a core outcome set for future infertility research: an international consensus development study

被引：61

作者：

Duffy, J. M. N. ^{[1
,2
]}

AlAhwany, H. ^{[3
]}

Bhattacharya, S. ^{[4
]}

Collura, B. ^{[5
]}

Curtis, C. ^{[6
,7
]}

Evers, J. L. H. ^{[8
]}

Farquharson, R. G. ^{[9
]}

Franik, S. ^{[10
]}

Giudice, L. C. ^{[11
,12
]}

Khalaf, Y. ^{[13
]}

Knijnenburg, J. M. L. ^{[14
]}

Leeners, B. ^{[15
]}

Legro, R. S. ^{[16
]}

Lensen, S. ^{[17
]}

Vazquez-Niebla, J. C. ^{[18
]}

Mavrelos, D. ^{[19
]}

Mol, B. W. J. ^{[20
]}

Niederberger, C. ^{[21
]}

Ng, E. H. Y. ^{[22
,23
]}

Otter, A. S. ^{[24
]}

Puscasiu, L. ^{[25
]}

Rautakallio-Hokkanen, S. ^{[26
]}

Repping, S. ^{[27
]}

Sarris, I ^{[1
]}

Simpson, J. L. ^{[28
]}

Strandell, A. ^{[29
]}

Strawbridge, C. ^{[30
]}

Torrance, H. L. ^{[31
]}

Vail, A. ^{[32
]}

van Wely, M. ^{[27
]}

Vercoe, M. A. ^{[33
]}

Vuong, N. L. ^{[34
]}

Wang, A. Y. ^{[35
]}

Wang, R. ^{[20
]}

Wilkinson, J. ^{[32
]}

Youssef, M. A. ^{[36
]}

Farquhar, C. M. ^{[33
]}

机构：

[1] Kings Fertil, Fetal Med Res Inst, London, England

[2] UCL, Inst Womens Hlth, London, England

[3] Univ Nottingham, Sch Med, Derby, England

[4] Univ Aberdeen, Sch Med Med Sci & Nutr, Aberdeen, Scotland

[5] RESOLVE Natl Infertil Assoc, McLean, VA USA

[6] Fertil New Zealand, Auckland, New Zealand

[7] Univ Waikato, Sch Psychol, Hamilton, New Zealand

[8] Maastricht Univ, Med Ctr, Maastricht, Netherlands

[9] Liverpool Womens NHS Fdn Trust, Dept Obstet & Gynaecol, Liverpool, Merseyside, England

[10] Munster Univ Hosp, Dept Obstet & Gynaecol, Munster, Germany

[11] Univ Calif San Francisco, Ctr Res Innovat & Training Reprod & Infertil, Ctr Reprod Sci, San Francisco, CA 94143 USA

[12] Int Federat Fertil Soc, Philadelphia, PA USA

[13] Kings Coll London, Guys Hosp, Dept Women & Childrens Hlth, London, England

[14] Freya Dutch Infertil Assoc, Gorinchem, Netherlands

[15] Univ Hosp Zurich, Dept Reprod Endocrinol, Zurich, Switzerland

[16] Penn State Coll Med, Dept Obstet & Gynaecol, Hershey, PA USA

[17] Univ Melbourne, Dept Obstet & Gynaecol, Melbourne, Vic, Australia

[18] Biomed Res Inst St Pau, Cochrane Iberoamer, Barcelona, Spain

[19] Univ Coll Hosp, Reprod Med Unit, London, England

[20] Monash Univ, Dept Obstet & Gynaecol, Melbourne, Vic, Australia

[21] Univ Illinois, Coll Med, Dept Urol, Chicago, IL USA

[22] Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Peoples R China

[23] Univ Hong Kong, Shenzhen Key Lab Fertil Regulat, Shenzhen Hosp, Hong Kong, Peoples R China

[24] Osakidetza OSI, Bilbao, Basurto, Spain

[25] Univ Med Pharm Sci & Technol, Targu Mures, Romania

[26] Fertil Europe, Evere, Belgium

[27] Univ Amsterdam, Ctr Reprod Med, Amsterdam Reprod & Dev Inst, Med Ctr, Amsterdam, Netherlands

[28] Florida Int Univ, Dept Human & Mol Genet, Miami, FL 33199 USA

[29] Univ Gothenburg, Sahlgrenska Acad, Dept Obstet & Gynecol, Gothenburg, Sweden

[30] Fertil Network UK, London, England

[31] Univ Med Ctr Utrecht, Dept Reprod Med, Utrecht, Netherlands

[32] Univ Manchester, Manchester Acad Hlth Sci Ctr, Ctr Biostat, Manchester, Lancs, England

[33] Univ Auckland, Cochrane Gynaecol & Fertil Grp, Auckland, New Zealand

[34] Univ Med & Pharm Ho Chi Minh City, Dept Obstet & Gynaecol, Ho Chi Minh City, Vietnam

[35] Univ Technol, Fac Hlth, Sydney, NSW, Australia

[36] Cairo Univ, Fac Med, Dept Obstet & Gynaecol, Cairo, Egypt

来源：

HUMAN REPRODUCTION | 2020年 / 35卷 / 12期

基金：

英国医学研究理事会;

关键词：

Consensus development study; core outcome sets; modified Delphi method; modified Nominal Group Technique; outcome measures; outcomes; CLINICAL-TRIALS; PROTOCOL;

D O I：

10.1093/humrep/deaa241

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set.

引用

页码：2725 / 2734

页数：10

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