A core outcome set for studies of gestational diabetes mellitus prevention and treatment
Aims/hypothesis The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Methods We identified previously reported outcomes through a systematic review of the literature. Thes...
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| Veröffentlicht in: | Diabetologia 2020-06, Vol.63 (6), p.1120-1127 |
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| creator | Egan, Aoife M. Bogdanet, Delia Griffin, Tomás P. Kgosidialwa, Oratile Cervar-Zivkovic, Mila Dempsey, Eugene Allotey, John Alvarado, Fernanda Clarson, Cheril Cooray, Shamil D. de Valk, Harold W. Galjaard, Sander Loeken, Mary R. Maresh, Michael J. A. Napoli, Angela O’Shea, Paula M. Wender-Ozegowska, Ewa van Poppel, Mireille N. M. Thangaratinam, Shakila Crowther, Caroline Biesty, Linda M. Devane, Declan Dunne, Fidelma P. |
| description | Aims/hypothesis
The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).
Methods
We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.
Results
Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).
Conclusions/interpretation
This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.
Trial registration
This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database:
http://www.comet-initiative.org/studies/details/686/ |
| doi_str_mv | 10.1007/s00125-020-05123-6 |
| format | Article |
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The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).
Methods
We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.
Results
Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).
Conclusions/interpretation
This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.
Trial registration
This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database:
http://www.comet-initiative.org/studies/details/686/</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-020-05123-6</identifier><identifier>PMID: 32193573</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Age ; Birth weight ; Clinical outcomes ; Clinical trials ; Diabetes ; Diabetes mellitus ; Gestational age ; Gestational diabetes ; Human Physiology ; Hyperglycemia ; Hypoglycemia ; Insulin ; Internal Medicine ; Literature reviews ; Medicine ; Medicine & Public Health ; Metabolic Diseases ; Neonates ; Pregnancy ; Premature birth ; Prevention ; Small-for-gestational age ; Systematic review</subject><ispartof>Diabetologia, 2020-06, Vol.63 (6), p.1120-1127</ispartof><rights>The Author(s) 2020</rights><rights>The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-72285c9ec7ccc5ff52490d51b2c7f3ff9b8edb7bbc2575cc168bf93e2f4ce7a3</citedby><cites>FETCH-LOGICAL-c474t-72285c9ec7ccc5ff52490d51b2c7f3ff9b8edb7bbc2575cc168bf93e2f4ce7a3</cites><orcidid>0000-0001-9392-1711 ; 0000-0002-6825-4440 ; 0000-0002-6266-3462 ; 0000-0002-2195-3228 ; 0000-0002-4254-6664 ; 0000-0003-3682-9403 ; 0000-0002-5492-8651 ; 0000-0002-8056-9816 ; 0000-0003-4134-6246 ; 0000-0002-9079-4451 ; 0000-0003-0553-6915 ; 0000-0003-1625-9394 ; 0000-0002-9750-3944 ; 0000-0002-9393-7075 ; 0000-0002-4249-6302 ; 0000-0003-0379-9279 ; 0000-0001-5694-4324 ; 0000-0001-6127-5049 ; 0000-0002-1108-1518</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00125-020-05123-6$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00125-020-05123-6$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32193573$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Egan, Aoife M.</creatorcontrib><creatorcontrib>Bogdanet, Delia</creatorcontrib><creatorcontrib>Griffin, Tomás P.</creatorcontrib><creatorcontrib>Kgosidialwa, Oratile</creatorcontrib><creatorcontrib>Cervar-Zivkovic, Mila</creatorcontrib><creatorcontrib>Dempsey, Eugene</creatorcontrib><creatorcontrib>Allotey, John</creatorcontrib><creatorcontrib>Alvarado, Fernanda</creatorcontrib><creatorcontrib>Clarson, Cheril</creatorcontrib><creatorcontrib>Cooray, Shamil D.</creatorcontrib><creatorcontrib>de Valk, Harold W.</creatorcontrib><creatorcontrib>Galjaard, Sander</creatorcontrib><creatorcontrib>Loeken, Mary R.</creatorcontrib><creatorcontrib>Maresh, Michael J. A.</creatorcontrib><creatorcontrib>Napoli, Angela</creatorcontrib><creatorcontrib>O’Shea, Paula M.</creatorcontrib><creatorcontrib>Wender-Ozegowska, Ewa</creatorcontrib><creatorcontrib>van Poppel, Mireille N. M.</creatorcontrib><creatorcontrib>Thangaratinam, Shakila</creatorcontrib><creatorcontrib>Crowther, Caroline</creatorcontrib><creatorcontrib>Biesty, Linda M.</creatorcontrib><creatorcontrib>Devane, Declan</creatorcontrib><creatorcontrib>Dunne, Fidelma P.</creatorcontrib><creatorcontrib>INSPIRED research group</creatorcontrib><creatorcontrib>the INSPIRED research group</creatorcontrib><title>A core outcome set for studies of gestational diabetes mellitus prevention and treatment</title><title>Diabetologia</title><addtitle>Diabetologia</addtitle><addtitle>Diabetologia</addtitle><description>Aims/hypothesis
The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).
Methods
We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.
Results
Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).
Conclusions/interpretation
This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.
Trial registration
This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database:
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A. ; Napoli, Angela ; O’Shea, Paula M. ; Wender-Ozegowska, Ewa ; van Poppel, Mireille N. M. ; Thangaratinam, Shakila ; Crowther, Caroline ; Biesty, Linda M. ; Devane, Declan ; Dunne, Fidelma P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-72285c9ec7ccc5ff52490d51b2c7f3ff9b8edb7bbc2575cc168bf93e2f4ce7a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Age</topic><topic>Birth weight</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Gestational age</topic><topic>Gestational diabetes</topic><topic>Human Physiology</topic><topic>Hyperglycemia</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Internal Medicine</topic><topic>Literature reviews</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic Diseases</topic><topic>Neonates</topic><topic>Pregnancy</topic><topic>Premature birth</topic><topic>Prevention</topic><topic>Small-for-gestational age</topic><topic>Systematic review</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Egan, Aoife M.</creatorcontrib><creatorcontrib>Bogdanet, Delia</creatorcontrib><creatorcontrib>Griffin, Tomás P.</creatorcontrib><creatorcontrib>Kgosidialwa, Oratile</creatorcontrib><creatorcontrib>Cervar-Zivkovic, Mila</creatorcontrib><creatorcontrib>Dempsey, Eugene</creatorcontrib><creatorcontrib>Allotey, John</creatorcontrib><creatorcontrib>Alvarado, Fernanda</creatorcontrib><creatorcontrib>Clarson, Cheril</creatorcontrib><creatorcontrib>Cooray, Shamil D.</creatorcontrib><creatorcontrib>de Valk, Harold W.</creatorcontrib><creatorcontrib>Galjaard, Sander</creatorcontrib><creatorcontrib>Loeken, Mary R.</creatorcontrib><creatorcontrib>Maresh, Michael J. 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M.</creatorcontrib><creatorcontrib>Thangaratinam, Shakila</creatorcontrib><creatorcontrib>Crowther, Caroline</creatorcontrib><creatorcontrib>Biesty, Linda M.</creatorcontrib><creatorcontrib>Devane, Declan</creatorcontrib><creatorcontrib>Dunne, Fidelma P.</creatorcontrib><creatorcontrib>INSPIRED research group</creatorcontrib><creatorcontrib>the INSPIRED research group</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetologia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Egan, Aoife M.</au><au>Bogdanet, Delia</au><au>Griffin, Tomás P.</au><au>Kgosidialwa, Oratile</au><au>Cervar-Zivkovic, Mila</au><au>Dempsey, Eugene</au><au>Allotey, John</au><au>Alvarado, Fernanda</au><au>Clarson, Cheril</au><au>Cooray, Shamil D.</au><au>de Valk, Harold W.</au><au>Galjaard, Sander</au><au>Loeken, Mary R.</au><au>Maresh, Michael J. A.</au><au>Napoli, Angela</au><au>O’Shea, Paula M.</au><au>Wender-Ozegowska, Ewa</au><au>van Poppel, Mireille N. M.</au><au>Thangaratinam, Shakila</au><au>Crowther, Caroline</au><au>Biesty, Linda M.</au><au>Devane, Declan</au><au>Dunne, Fidelma P.</au><aucorp>INSPIRED research group</aucorp><aucorp>the INSPIRED research group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A core outcome set for studies of gestational diabetes mellitus prevention and treatment</atitle><jtitle>Diabetologia</jtitle><stitle>Diabetologia</stitle><addtitle>Diabetologia</addtitle><date>2020-06-01</date><risdate>2020</risdate><volume>63</volume><issue>6</issue><spage>1120</spage><epage>1127</epage><pages>1120-1127</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>Aims/hypothesis
The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM).
Methods
We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised.
Results
Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth).
Conclusions/interpretation
This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies.
Trial registration
This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database:
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| fulltext | fulltext |
| identifier | ISSN: 0012-186X |
| ispartof | Diabetologia, 2020-06, Vol.63 (6), p.1120-1127 |
| issn | 0012-186X 1432-0428 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7228989 |
| source | SpringerLink Journals |
| subjects | Age Birth weight Clinical outcomes Clinical trials Diabetes Diabetes mellitus Gestational age Gestational diabetes Human Physiology Hyperglycemia Hypoglycemia Insulin Internal Medicine Literature reviews Medicine Medicine & Public Health Metabolic Diseases Neonates Pregnancy Premature birth Prevention Small-for-gestational age Systematic review |
| title | A core outcome set for studies of gestational diabetes mellitus prevention and treatment |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-13T13%3A45%3A21IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20core%20outcome%20set%20for%20studies%20of%20gestational%20diabetes%20mellitus%20prevention%20and%20treatment&rft.jtitle=Diabetologia&rft.au=Egan,%20Aoife%20M.&rft.aucorp=INSPIRED%20research%20group&rft.date=2020-06-01&rft.volume=63&rft.issue=6&rft.spage=1120&rft.epage=1127&rft.pages=1120-1127&rft.issn=0012-186X&rft.eissn=1432-0428&rft_id=info:doi/10.1007/s00125-020-05123-6&rft_dat=%3Cproquest_pubme%3E2403241131%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2403241131&rft_id=info:pmid/32193573&rfr_iscdi=true |