A core outcome set for hyperemesis gravidarum research: an international consensus study
Objective To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG). Design Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round. Setting An international web‐based survey combined wit...
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| Veröffentlicht in: | BJOG : an international journal of obstetrics and gynaecology 2020-07, Vol.127 (8), p.983-992 |
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| container_title | BJOG : an international journal of obstetrics and gynaecology |
| container_volume | 127 |
| creator | Jansen, LAW Koot, MH van‘t Hooft, J Dean, CR Duffy, JMN Ganzevoort, W Gauw, N Goes, BY Rodenburg, J Roseboom, TJ Painter, RC Grooten, IJ |
| description | Objective
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
Design
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.
Setting
An international web‐based survey combined with a consensus development meeting.
Population
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.
Methods
We used systematic review, semi‐structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web‐based survey rounds, followed by a face‐to‐face consensus development meeting and a web‐based consultation round.
Main outcome measures
A core outcome set for research on HG.
Results
Fifty‐six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short‐ and long‐term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).
Conclusions
This core outcome set will help standardise outcome reporting in HG trials.
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A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.
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A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence. |
| doi_str_mv | 10.1111/1471-0528.16172 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2355940028</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2411953864</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4372-af53ef01fefb94e796acad44baf4839af91d94e25179618be1a79ca2353de47b3</originalsourceid><addsrcrecordid>eNqFkDlPwzAYQC0EoqUwsyFLLCxpfeViKxWnKnUBic1yks80VRIXOwHl3-MedGDBi63Pz0_yQ-iSkjH1a0JFTAMSsmRMIxqzIzQ8TI63ZxIQzpIBOnNuRQiNGOGnaMAZCSMu2BC9T3FuLGDTtbmpATtosTYWL_s1WKjBlQ5_WPVVFsp2NbbgQNl8eYtVg8umBduotjSNqrymcdC4zmHXdkV_jk60qhxc7PcRenu4f509BfPF4_NsOg9ywWMWKB1y0IRq0FkqIE4jlatCiExpkfBU6ZQWfs5C6q9okgFVcZorxkNegIgzPkI3O-_ams8OXCvr0uVQVaoB0znpyTAVhLDEo9d_0JXp_AcqTwlK05AnkfDUZEfl1jhnQcu1LWtle0mJ3ESXm8Ryk1huo_sXV3tvl9VQHPjfyh4Id8B3WUH_n0_evSx24h80DYvx</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2411953864</pqid></control><display><type>article</type><title>A core outcome set for hyperemesis gravidarum research: an international consensus study</title><source>MEDLINE</source><source>Wiley Online Library All Journals</source><creator>Jansen, LAW ; Koot, MH ; van‘t Hooft, J ; Dean, CR ; Duffy, JMN ; Ganzevoort, W ; Gauw, N ; Goes, BY ; Rodenburg, J ; Roseboom, TJ ; Painter, RC ; Grooten, IJ</creator><creatorcontrib>Jansen, LAW ; Koot, MH ; van‘t Hooft, J ; Dean, CR ; Duffy, JMN ; Ganzevoort, W ; Gauw, N ; Goes, BY ; Rodenburg, J ; Roseboom, TJ ; Painter, RC ; Grooten, IJ</creatorcontrib><description>Objective
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
Design
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.
Setting
An international web‐based survey combined with a consensus development meeting.
Population
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.
Methods
We used systematic review, semi‐structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web‐based survey rounds, followed by a face‐to‐face consensus development meeting and a web‐based consultation round.
Main outcome measures
A core outcome set for research on HG.
Results
Fifty‐six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short‐ and long‐term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).
Conclusions
This core outcome set will help standardise outcome reporting in HG trials.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.</description><identifier>ISSN: 1470-0328</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/1471-0528.16172</identifier><identifier>PMID: 32056342</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Antiemetics - therapeutic use ; Biomedical Research - methods ; Clinical trials ; Congenital defects ; Consensus ; Core outcomes ; CROWN ; Dehydration ; Delphi ; Delphi Technique ; Female ; Gestational age ; Humans ; hyperemesis gravidarum ; Hyperemesis Gravidarum - therapy ; Intravenous administration ; Maternal Health ; Medical personnel ; Morbidity ; Nausea ; Neonates ; Oral fluids ; Patient satisfaction ; Patients ; Pregnancy ; Pregnancy complications ; Premature birth ; Prenatal Care - methods ; Quality of Life ; Research Design ; Small-for-gestational age ; Vomiting</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2020-07, Vol.127 (8), p.983-992</ispartof><rights>2020 Royal College of Obstetricians and Gynaecologists</rights><rights>2020 Royal College of Obstetricians and Gynaecologists.</rights><rights>Copyright © 2020 Royal College of Obstetricians and Gynaecologists</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4372-af53ef01fefb94e796acad44baf4839af91d94e25179618be1a79ca2353de47b3</citedby><cites>FETCH-LOGICAL-c4372-af53ef01fefb94e796acad44baf4839af91d94e25179618be1a79ca2353de47b3</cites><orcidid>0000-0002-7243-2115</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1471-0528.16172$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1471-0528.16172$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32056342$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jansen, LAW</creatorcontrib><creatorcontrib>Koot, MH</creatorcontrib><creatorcontrib>van‘t Hooft, J</creatorcontrib><creatorcontrib>Dean, CR</creatorcontrib><creatorcontrib>Duffy, JMN</creatorcontrib><creatorcontrib>Ganzevoort, W</creatorcontrib><creatorcontrib>Gauw, N</creatorcontrib><creatorcontrib>Goes, BY</creatorcontrib><creatorcontrib>Rodenburg, J</creatorcontrib><creatorcontrib>Roseboom, TJ</creatorcontrib><creatorcontrib>Painter, RC</creatorcontrib><creatorcontrib>Grooten, IJ</creatorcontrib><title>A core outcome set for hyperemesis gravidarum research: an international consensus study</title><title>BJOG : an international journal of obstetrics and gynaecology</title><addtitle>BJOG</addtitle><description>Objective
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
Design
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.
Setting
An international web‐based survey combined with a consensus development meeting.
Population
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.
Methods
We used systematic review, semi‐structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web‐based survey rounds, followed by a face‐to‐face consensus development meeting and a web‐based consultation round.
Main outcome measures
A core outcome set for research on HG.
Results
Fifty‐six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short‐ and long‐term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).
Conclusions
This core outcome set will help standardise outcome reporting in HG trials.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.</description><subject>Adult</subject><subject>Antiemetics - therapeutic use</subject><subject>Biomedical Research - methods</subject><subject>Clinical trials</subject><subject>Congenital defects</subject><subject>Consensus</subject><subject>Core outcomes</subject><subject>CROWN</subject><subject>Dehydration</subject><subject>Delphi</subject><subject>Delphi Technique</subject><subject>Female</subject><subject>Gestational age</subject><subject>Humans</subject><subject>hyperemesis gravidarum</subject><subject>Hyperemesis Gravidarum - therapy</subject><subject>Intravenous administration</subject><subject>Maternal Health</subject><subject>Medical personnel</subject><subject>Morbidity</subject><subject>Nausea</subject><subject>Neonates</subject><subject>Oral fluids</subject><subject>Patient satisfaction</subject><subject>Patients</subject><subject>Pregnancy</subject><subject>Pregnancy complications</subject><subject>Premature birth</subject><subject>Prenatal Care - methods</subject><subject>Quality of Life</subject><subject>Research Design</subject><subject>Small-for-gestational age</subject><subject>Vomiting</subject><issn>1470-0328</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkDlPwzAYQC0EoqUwsyFLLCxpfeViKxWnKnUBic1yks80VRIXOwHl3-MedGDBi63Pz0_yQ-iSkjH1a0JFTAMSsmRMIxqzIzQ8TI63ZxIQzpIBOnNuRQiNGOGnaMAZCSMu2BC9T3FuLGDTtbmpATtosTYWL_s1WKjBlQ5_WPVVFsp2NbbgQNl8eYtVg8umBduotjSNqrymcdC4zmHXdkV_jk60qhxc7PcRenu4f509BfPF4_NsOg9ywWMWKB1y0IRq0FkqIE4jlatCiExpkfBU6ZQWfs5C6q9okgFVcZorxkNegIgzPkI3O-_ams8OXCvr0uVQVaoB0znpyTAVhLDEo9d_0JXp_AcqTwlK05AnkfDUZEfl1jhnQcu1LWtle0mJ3ESXm8Ryk1huo_sXV3tvl9VQHPjfyh4Id8B3WUH_n0_evSx24h80DYvx</recordid><startdate>202007</startdate><enddate>202007</enddate><creator>Jansen, LAW</creator><creator>Koot, MH</creator><creator>van‘t Hooft, J</creator><creator>Dean, CR</creator><creator>Duffy, JMN</creator><creator>Ganzevoort, W</creator><creator>Gauw, N</creator><creator>Goes, BY</creator><creator>Rodenburg, J</creator><creator>Roseboom, TJ</creator><creator>Painter, RC</creator><creator>Grooten, IJ</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7243-2115</orcidid></search><sort><creationdate>202007</creationdate><title>A core outcome set for hyperemesis gravidarum research: an international consensus study</title><author>Jansen, LAW ; Koot, MH ; van‘t Hooft, J ; Dean, CR ; Duffy, JMN ; Ganzevoort, W ; Gauw, N ; Goes, BY ; Rodenburg, J ; Roseboom, TJ ; Painter, RC ; Grooten, IJ</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4372-af53ef01fefb94e796acad44baf4839af91d94e25179618be1a79ca2353de47b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Antiemetics - therapeutic use</topic><topic>Biomedical Research - methods</topic><topic>Clinical trials</topic><topic>Congenital defects</topic><topic>Consensus</topic><topic>Core outcomes</topic><topic>CROWN</topic><topic>Dehydration</topic><topic>Delphi</topic><topic>Delphi Technique</topic><topic>Female</topic><topic>Gestational age</topic><topic>Humans</topic><topic>hyperemesis gravidarum</topic><topic>Hyperemesis Gravidarum - therapy</topic><topic>Intravenous administration</topic><topic>Maternal Health</topic><topic>Medical personnel</topic><topic>Morbidity</topic><topic>Nausea</topic><topic>Neonates</topic><topic>Oral fluids</topic><topic>Patient satisfaction</topic><topic>Patients</topic><topic>Pregnancy</topic><topic>Pregnancy complications</topic><topic>Premature birth</topic><topic>Prenatal Care - methods</topic><topic>Quality of Life</topic><topic>Research Design</topic><topic>Small-for-gestational age</topic><topic>Vomiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jansen, LAW</creatorcontrib><creatorcontrib>Koot, MH</creatorcontrib><creatorcontrib>van‘t Hooft, J</creatorcontrib><creatorcontrib>Dean, CR</creatorcontrib><creatorcontrib>Duffy, JMN</creatorcontrib><creatorcontrib>Ganzevoort, W</creatorcontrib><creatorcontrib>Gauw, N</creatorcontrib><creatorcontrib>Goes, BY</creatorcontrib><creatorcontrib>Rodenburg, J</creatorcontrib><creatorcontrib>Roseboom, TJ</creatorcontrib><creatorcontrib>Painter, RC</creatorcontrib><creatorcontrib>Grooten, IJ</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jansen, LAW</au><au>Koot, MH</au><au>van‘t Hooft, J</au><au>Dean, CR</au><au>Duffy, JMN</au><au>Ganzevoort, W</au><au>Gauw, N</au><au>Goes, BY</au><au>Rodenburg, J</au><au>Roseboom, TJ</au><au>Painter, RC</au><au>Grooten, IJ</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A core outcome set for hyperemesis gravidarum research: an international consensus study</atitle><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle><addtitle>BJOG</addtitle><date>2020-07</date><risdate>2020</risdate><volume>127</volume><issue>8</issue><spage>983</spage><epage>992</epage><pages>983-992</pages><issn>1470-0328</issn><eissn>1471-0528</eissn><abstract>Objective
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
Design
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.
Setting
An international web‐based survey combined with a consensus development meeting.
Population
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.
Methods
We used systematic review, semi‐structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web‐based survey rounds, followed by a face‐to‐face consensus development meeting and a web‐based consultation round.
Main outcome measures
A core outcome set for research on HG.
Results
Fifty‐six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short‐ and long‐term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).
Conclusions
This core outcome set will help standardise outcome reporting in HG trials.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.
Tweetable
A core outcome set for treatment of hyperemesis gravidarum in order to create high‐quality evidence.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32056342</pmid><doi>10.1111/1471-0528.16172</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-7243-2115</orcidid></addata></record> |
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| identifier | ISSN: 1470-0328 |
| ispartof | BJOG : an international journal of obstetrics and gynaecology, 2020-07, Vol.127 (8), p.983-992 |
| issn | 1470-0328 1471-0528 |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Adult Antiemetics - therapeutic use Biomedical Research - methods Clinical trials Congenital defects Consensus Core outcomes CROWN Dehydration Delphi Delphi Technique Female Gestational age Humans hyperemesis gravidarum Hyperemesis Gravidarum - therapy Intravenous administration Maternal Health Medical personnel Morbidity Nausea Neonates Oral fluids Patient satisfaction Patients Pregnancy Pregnancy complications Premature birth Prenatal Care - methods Quality of Life Research Design Small-for-gestational age Vomiting |
| title | A core outcome set for hyperemesis gravidarum research: an international consensus study |
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