Loading…

A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes

Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult...

Full description

Saved in:
Bibliographic Details
Published in:BJOG : an international journal of obstetrics and gynaecology 2021-11, Vol.128 (12), p.1894-1904
Main Authors: Kgosidialwa, O, Bogdanet, D, Egan, A, Newman, C, O'Shea, PM, Biesty, L, McDonagh, C, O'Shea, C, Devane, D, Dunne, F
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623
cites cdi_FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623
container_end_page 1904
container_issue 12
container_start_page 1894
container_title BJOG : an international journal of obstetrics and gynaecology
container_volume 128
creator Kgosidialwa, O
Bogdanet, D
Egan, A
Newman, C
O'Shea, PM
Biesty, L
McDonagh, C
O'Shea, C
Devane, D
Dunne, F
description Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. Objectives To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.
doi_str_mv 10.1111/1471-0528.16842
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2551581299</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2551581299</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623</originalsourceid><addsrcrecordid>eNqFkTtPwzAUhSMEEqUws1piYUnrRx7OWCqeqtQFZst1boqrxA62S9Wfwr_FaREDC158dfydI9snSa4JnpC4piQrSYpzyiek4Bk9SUa_yulhxilmlJ8nF95vMCYFxWyUfM2Q3_sAnQxaIQefGnbIGmS3QdkOotJbF7RZI22Qk6a2nfZQI2VNcLZt4xiclq1H0nvwfiCDAxk6MCF6ArjPOGlr_JDQO1gbGU92MdygnQ7vBw18kAMkW1RruYIA_jI5a2IuXP3s4-Tt4f51_pQulo_P89kiVYxXNC0ZcEVzVcuaAKt4wSTQgkGjGqUwzqoas6ouGsmzgpOVKuso8IaTZkVo_AQ2Tm6Pub2zH9t4ERFfqKBtpQG79YLmOck5oVUV0Zs_6MZuXbz0QJVVTjNe8EhNj5Ry1nsHjeid7qTbC4LFUJUYihFDMeJQVXTkR8dOt7D_Dxd3L8uj7xvR7pof</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2579524868</pqid></control><display><type>article</type><title>A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes</title><source>Wiley</source><creator>Kgosidialwa, O ; Bogdanet, D ; Egan, A ; Newman, C ; O'Shea, PM ; Biesty, L ; McDonagh, C ; O'Shea, C ; Devane, D ; Dunne, F</creator><creatorcontrib>Kgosidialwa, O ; Bogdanet, D ; Egan, A ; Newman, C ; O'Shea, PM ; Biesty, L ; McDonagh, C ; O'Shea, C ; Devane, D ; Dunne, F ; the INSPIRED research group</creatorcontrib><description>Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. Objectives To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.</description><identifier>ISSN: 1470-0328</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/1471-0528.16842</identifier><language>eng</language><publisher>London: Wiley Subscription Services, Inc</publisher><subject>Clinical outcomes ; Clinical trials ; Core outcome set ; Data collection ; Diabetes ; Diabetes mellitus ; Fetuses ; Gestational diabetes ; Glucose monitoring ; Infants ; Insulin ; interventions ; Metformin ; pregestational diabetes ; Pregnancy ; Systematic review ; Womens health</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2021-11, Vol.128 (12), p.1894-1904</ispartof><rights>2021 The Authors. : published by John Wiley &amp; Sons Ltd.</rights><rights>2021. This article is published under http://creativecommons.org/licenses/by-nc/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-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623</citedby><cites>FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623</cites><orcidid>0000-0001-6127-5049 ; 0000-0002-4249-6302 ; 0000-0003-0379-9279</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Kgosidialwa, O</creatorcontrib><creatorcontrib>Bogdanet, D</creatorcontrib><creatorcontrib>Egan, A</creatorcontrib><creatorcontrib>Newman, C</creatorcontrib><creatorcontrib>O'Shea, PM</creatorcontrib><creatorcontrib>Biesty, L</creatorcontrib><creatorcontrib>McDonagh, C</creatorcontrib><creatorcontrib>O'Shea, C</creatorcontrib><creatorcontrib>Devane, D</creatorcontrib><creatorcontrib>Dunne, F</creatorcontrib><creatorcontrib>the INSPIRED research group</creatorcontrib><title>A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes</title><title>BJOG : an international journal of obstetrics and gynaecology</title><description>Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. Objectives To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.</description><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Core outcome set</subject><subject>Data collection</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Fetuses</subject><subject>Gestational diabetes</subject><subject>Glucose monitoring</subject><subject>Infants</subject><subject>Insulin</subject><subject>interventions</subject><subject>Metformin</subject><subject>pregestational diabetes</subject><subject>Pregnancy</subject><subject>Systematic review</subject><subject>Womens health</subject><issn>1470-0328</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNqFkTtPwzAUhSMEEqUws1piYUnrRx7OWCqeqtQFZst1boqrxA62S9Wfwr_FaREDC158dfydI9snSa4JnpC4piQrSYpzyiek4Bk9SUa_yulhxilmlJ8nF95vMCYFxWyUfM2Q3_sAnQxaIQefGnbIGmS3QdkOotJbF7RZI22Qk6a2nfZQI2VNcLZt4xiclq1H0nvwfiCDAxk6MCF6ArjPOGlr_JDQO1gbGU92MdygnQ7vBw18kAMkW1RruYIA_jI5a2IuXP3s4-Tt4f51_pQulo_P89kiVYxXNC0ZcEVzVcuaAKt4wSTQgkGjGqUwzqoas6ouGsmzgpOVKuso8IaTZkVo_AQ2Tm6Pub2zH9t4ERFfqKBtpQG79YLmOck5oVUV0Zs_6MZuXbz0QJVVTjNe8EhNj5Ry1nsHjeid7qTbC4LFUJUYihFDMeJQVXTkR8dOt7D_Dxd3L8uj7xvR7pof</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Kgosidialwa, O</creator><creator>Bogdanet, D</creator><creator>Egan, A</creator><creator>Newman, C</creator><creator>O'Shea, PM</creator><creator>Biesty, L</creator><creator>McDonagh, C</creator><creator>O'Shea, C</creator><creator>Devane, D</creator><creator>Dunne, F</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</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/0000-0001-6127-5049</orcidid><orcidid>https://orcid.org/0000-0002-4249-6302</orcidid><orcidid>https://orcid.org/0000-0003-0379-9279</orcidid></search><sort><creationdate>202111</creationdate><title>A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes</title><author>Kgosidialwa, O ; Bogdanet, D ; Egan, A ; Newman, C ; O'Shea, PM ; Biesty, L ; McDonagh, C ; O'Shea, C ; Devane, D ; Dunne, F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Core outcome set</topic><topic>Data collection</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Fetuses</topic><topic>Gestational diabetes</topic><topic>Glucose monitoring</topic><topic>Infants</topic><topic>Insulin</topic><topic>interventions</topic><topic>Metformin</topic><topic>pregestational diabetes</topic><topic>Pregnancy</topic><topic>Systematic review</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kgosidialwa, O</creatorcontrib><creatorcontrib>Bogdanet, D</creatorcontrib><creatorcontrib>Egan, A</creatorcontrib><creatorcontrib>Newman, C</creatorcontrib><creatorcontrib>O'Shea, PM</creatorcontrib><creatorcontrib>Biesty, L</creatorcontrib><creatorcontrib>McDonagh, C</creatorcontrib><creatorcontrib>O'Shea, C</creatorcontrib><creatorcontrib>Devane, D</creatorcontrib><creatorcontrib>Dunne, F</creatorcontrib><creatorcontrib>the INSPIRED research group</creatorcontrib><collection>Wiley_OA刊</collection><collection>Wiley-Blackwell Free Backfiles(OpenAccess)</collection><collection>CrossRef</collection><collection>Calcium &amp; 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 &amp; 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>Kgosidialwa, O</au><au>Bogdanet, D</au><au>Egan, A</au><au>Newman, C</au><au>O'Shea, PM</au><au>Biesty, L</au><au>McDonagh, C</au><au>O'Shea, C</au><au>Devane, D</au><au>Dunne, F</au><aucorp>the INSPIRED research group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes</atitle><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle><date>2021-11</date><risdate>2021</risdate><volume>128</volume><issue>12</issue><spage>1894</spage><epage>1904</epage><pages>1894-1904</pages><issn>1470-0328</issn><eissn>1471-0528</eissn><abstract>Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. Objectives To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Tweetable Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.</abstract><cop>London</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/1471-0528.16842</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-6127-5049</orcidid><orcidid>https://orcid.org/0000-0002-4249-6302</orcidid><orcidid>https://orcid.org/0000-0003-0379-9279</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 1470-0328
ispartof BJOG : an international journal of obstetrics and gynaecology, 2021-11, Vol.128 (12), p.1894-1904
issn 1470-0328
1471-0528
language eng
recordid cdi_proquest_miscellaneous_2551581299
source Wiley
subjects Clinical outcomes
Clinical trials
Core outcome set
Data collection
Diabetes
Diabetes mellitus
Fetuses
Gestational diabetes
Glucose monitoring
Infants
Insulin
interventions
Metformin
pregestational diabetes
Pregnancy
Systematic review
Womens health
title A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T07%3A38%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20systematic%20review%20on%20outcome%20reporting%20in%20randomised%20controlled%20trials%20assessing%20treatment%20interventions%20in%20pregnant%20women%20with%20pregestational%20diabetes&rft.jtitle=BJOG%20:%20an%20international%20journal%20of%20obstetrics%20and%20gynaecology&rft.au=Kgosidialwa,%20O&rft.aucorp=the%20INSPIRED%20research%20group&rft.date=2021-11&rft.volume=128&rft.issue=12&rft.spage=1894&rft.epage=1904&rft.pages=1894-1904&rft.issn=1470-0328&rft.eissn=1471-0528&rft_id=info:doi/10.1111/1471-0528.16842&rft_dat=%3Cproquest_cross%3E2551581299%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c3892-73e8c25cdad1e39863ae263efcfcc0049d039d6fa84681bc7dd038f81fb121623%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2579524868&rft_id=info:pmid/&rfr_iscdi=true