Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study
Objectives To determine the prevalence in the neonatal literature of statistical approaches accounting for the unique clustering patterns of multiple births and to explore the sensitivity of an actual trial to several analytic approaches to multiples. Study design A systematic review of recent perin...
Gespeichert in:
| Veröffentlicht in: | The Journal of pediatrics 2010-02, Vol.156 (2), p.202-208 |
|---|---|
| Hauptverfasser: | , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 208 |
|---|---|
| container_issue | 2 |
| container_start_page | 202 |
| container_title | The Journal of pediatrics |
| container_volume | 156 |
| creator | Hibbs, Anna Maria, MD, MSCE Black, Dennis, PhD Palermo, Lisa, MA Cnaan, Avital, PhD Luan, Xianqun, MS Truog, William E., MD Walsh, Michele C., MD, MS Ballard, Roberta A., MD |
| description | Objectives To determine the prevalence in the neonatal literature of statistical approaches accounting for the unique clustering patterns of multiple births and to explore the sensitivity of an actual trial to several analytic approaches to multiples. Study design A systematic review of recent perinatal trials assessed the prevalence of studies accounting for clustering of multiples. The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) trial served as a case study of the sensitivity of the outcome to several statistical strategies. We calculated odds ratios using nonclustered (logistic regression) and clustered (generalized estimating equations, multiple outputation) analyses. Results In the systematic review, most studies did not describe the random assignment of twins and did not account for clustering. Of those studies that did, exclusion of multiples and generalized estimating equations were the most common strategies. The NO CLD study included 84 infants with a sibling enrolled in the study. Multiples were more likely than singletons to be white and were born to older mothers ( P < .01). Analyses that accounted for clustering were statistically significant; analyses assuming independence were not. Conclusions The statistical approach to multiples can influence the odds ratio and width of confidence intervals, thereby affecting the interpretation of a study outcome. A minority of perinatal studies address this issue. |
| doi_str_mv | 10.1016/j.jpeds.2009.08.049 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2844328</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0022347609008701</els_id><sourcerecordid>733807348</sourcerecordid><originalsourceid>FETCH-LOGICAL-c609t-d7bf636cfb0512e8045aa0c44d8ae4b1e99e0a2c1fe93ae02a03353312f0caf83</originalsourceid><addsrcrecordid>eNqFkltv1DAQhSMEotvCL0BCeUE8JYwvm8RIVCorblK5iC3P1qwzab1k7a3ttNp_T9JdlcsLT9bI3zkzmjNZ9oxByYBVr9blekttLDmAKqEpQaoH2YyBqouqEeJhNgPgvBCyro6y4xjXMIIS4HF2xJSqlID5LMMzY_zgknWXeedD_nnok932lL-1IV3F3Lr8C3mHCfscXZt_o2D31UWw2MfX-XIXE20wWZN_pxtLt3fcAiPlyzS0uyfZo24E6enhPcl-vH93sfhYnH_98Glxdl6YClQq2nrVVaIy3QrmjFMDco4IRsq2QZIrRkoRIDesIyWQgCMIMReC8Q4Mdo04yU73vtthtaHWkEsBe70NdoNhpz1a_fePs1f60t9o3kgp-GTw8mAQ_PVAMemNjYb6Hh35IepaiAZqISdS7EkTfIyBuvsuDPSUjV7ru2z0lI2GRo_ZjKrnfw74W3MIYwReHACMBvsuoDM23nOcCwVSyJF7s-doXOe48aCjseQMtTaQSbr19j-DnP6jN711dmz5k3YU134IbkxKMx25Br2czmi6IlAATQ1M_ALAJ8Ss</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>733807348</pqid></control><display><type>article</type><title>Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Hibbs, Anna Maria, MD, MSCE ; Black, Dennis, PhD ; Palermo, Lisa, MA ; Cnaan, Avital, PhD ; Luan, Xianqun, MS ; Truog, William E., MD ; Walsh, Michele C., MD, MS ; Ballard, Roberta A., MD</creator><creatorcontrib>Hibbs, Anna Maria, MD, MSCE ; Black, Dennis, PhD ; Palermo, Lisa, MA ; Cnaan, Avital, PhD ; Luan, Xianqun, MS ; Truog, William E., MD ; Walsh, Michele C., MD, MS ; Ballard, Roberta A., MD</creatorcontrib><description>Objectives To determine the prevalence in the neonatal literature of statistical approaches accounting for the unique clustering patterns of multiple births and to explore the sensitivity of an actual trial to several analytic approaches to multiples. Study design A systematic review of recent perinatal trials assessed the prevalence of studies accounting for clustering of multiples. The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) trial served as a case study of the sensitivity of the outcome to several statistical strategies. We calculated odds ratios using nonclustered (logistic regression) and clustered (generalized estimating equations, multiple outputation) analyses. Results In the systematic review, most studies did not describe the random assignment of twins and did not account for clustering. Of those studies that did, exclusion of multiples and generalized estimating equations were the most common strategies. The NO CLD study included 84 infants with a sibling enrolled in the study. Multiples were more likely than singletons to be white and were born to older mothers ( P < .01). Analyses that accounted for clustering were statistically significant; analyses assuming independence were not. Conclusions The statistical approach to multiples can influence the odds ratio and width of confidence intervals, thereby affecting the interpretation of a study outcome. A minority of perinatal studies address this issue.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2009.08.049</identifier><identifier>PMID: 19969305</identifier><identifier>CODEN: JOPDAB</identifier><language>eng</language><publisher>Maryland Heights, MO: Mosby, Inc</publisher><subject>Adult ; Bias ; Biological and medical sciences ; Bronchodilator Agents - therapeutic use ; Bronchopulmonary Dysplasia - prevention & control ; Cluster Analysis ; Confidence Intervals ; Data Interpretation, Statistical ; Female ; General aspects ; Humans ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Logistic Models ; Medical sciences ; Miscellaneous ; Multiple Birth Offspring - statistics & numerical data ; Nitric Oxide - therapeutic use ; Odds Ratio ; Pediatrics ; Pregnancy ; Pregnancy, Multiple - statistics & numerical data ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Randomized Controlled Trials as Topic - statistics & numerical data ; Research Design - statistics & numerical data ; Sensitivity and Specificity ; Survival Analysis</subject><ispartof>The Journal of pediatrics, 2010-02, Vol.156 (2), p.202-208</ispartof><rights>Mosby, Inc.</rights><rights>2010 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Mosby, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c609t-d7bf636cfb0512e8045aa0c44d8ae4b1e99e0a2c1fe93ae02a03353312f0caf83</citedby><cites>FETCH-LOGICAL-c609t-d7bf636cfb0512e8045aa0c44d8ae4b1e99e0a2c1fe93ae02a03353312f0caf83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpeds.2009.08.049$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,315,781,785,886,3551,27928,27929,45999</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22390434$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19969305$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hibbs, Anna Maria, MD, MSCE</creatorcontrib><creatorcontrib>Black, Dennis, PhD</creatorcontrib><creatorcontrib>Palermo, Lisa, MA</creatorcontrib><creatorcontrib>Cnaan, Avital, PhD</creatorcontrib><creatorcontrib>Luan, Xianqun, MS</creatorcontrib><creatorcontrib>Truog, William E., MD</creatorcontrib><creatorcontrib>Walsh, Michele C., MD, MS</creatorcontrib><creatorcontrib>Ballard, Roberta A., MD</creatorcontrib><title>Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>Objectives To determine the prevalence in the neonatal literature of statistical approaches accounting for the unique clustering patterns of multiple births and to explore the sensitivity of an actual trial to several analytic approaches to multiples. Study design A systematic review of recent perinatal trials assessed the prevalence of studies accounting for clustering of multiples. The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) trial served as a case study of the sensitivity of the outcome to several statistical strategies. We calculated odds ratios using nonclustered (logistic regression) and clustered (generalized estimating equations, multiple outputation) analyses. Results In the systematic review, most studies did not describe the random assignment of twins and did not account for clustering. Of those studies that did, exclusion of multiples and generalized estimating equations were the most common strategies. The NO CLD study included 84 infants with a sibling enrolled in the study. Multiples were more likely than singletons to be white and were born to older mothers ( P < .01). Analyses that accounted for clustering were statistically significant; analyses assuming independence were not. Conclusions The statistical approach to multiples can influence the odds ratio and width of confidence intervals, thereby affecting the interpretation of a study outcome. A minority of perinatal studies address this issue.</description><subject>Adult</subject><subject>Bias</subject><subject>Biological and medical sciences</subject><subject>Bronchodilator Agents - therapeutic use</subject><subject>Bronchopulmonary Dysplasia - prevention & control</subject><subject>Cluster Analysis</subject><subject>Confidence Intervals</subject><subject>Data Interpretation, Statistical</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infant, Very Low Birth Weight</subject><subject>Logistic Models</subject><subject>Medical sciences</subject><subject>Miscellaneous</subject><subject>Multiple Birth Offspring - statistics & numerical data</subject><subject>Nitric Oxide - therapeutic use</subject><subject>Odds Ratio</subject><subject>Pediatrics</subject><subject>Pregnancy</subject><subject>Pregnancy, Multiple - statistics & numerical data</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Randomized Controlled Trials as Topic - statistics & numerical data</subject><subject>Research Design - statistics & numerical data</subject><subject>Sensitivity and Specificity</subject><subject>Survival Analysis</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkltv1DAQhSMEotvCL0BCeUE8JYwvm8RIVCorblK5iC3P1qwzab1k7a3ttNp_T9JdlcsLT9bI3zkzmjNZ9oxByYBVr9blekttLDmAKqEpQaoH2YyBqouqEeJhNgPgvBCyro6y4xjXMIIS4HF2xJSqlID5LMMzY_zgknWXeedD_nnok932lL-1IV3F3Lr8C3mHCfscXZt_o2D31UWw2MfX-XIXE20wWZN_pxtLt3fcAiPlyzS0uyfZo24E6enhPcl-vH93sfhYnH_98Glxdl6YClQq2nrVVaIy3QrmjFMDco4IRsq2QZIrRkoRIDesIyWQgCMIMReC8Q4Mdo04yU73vtthtaHWkEsBe70NdoNhpz1a_fePs1f60t9o3kgp-GTw8mAQ_PVAMemNjYb6Hh35IepaiAZqISdS7EkTfIyBuvsuDPSUjV7ru2z0lI2GRo_ZjKrnfw74W3MIYwReHACMBvsuoDM23nOcCwVSyJF7s-doXOe48aCjseQMtTaQSbr19j-DnP6jN711dmz5k3YU134IbkxKMx25Br2czmi6IlAATQ1M_ALAJ8Ss</recordid><startdate>20100201</startdate><enddate>20100201</enddate><creator>Hibbs, Anna Maria, MD, MSCE</creator><creator>Black, Dennis, PhD</creator><creator>Palermo, Lisa, MA</creator><creator>Cnaan, Avital, PhD</creator><creator>Luan, Xianqun, MS</creator><creator>Truog, William E., MD</creator><creator>Walsh, Michele C., MD, MS</creator><creator>Ballard, Roberta A., MD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20100201</creationdate><title>Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study</title><author>Hibbs, Anna Maria, MD, MSCE ; Black, Dennis, PhD ; Palermo, Lisa, MA ; Cnaan, Avital, PhD ; Luan, Xianqun, MS ; Truog, William E., MD ; Walsh, Michele C., MD, MS ; Ballard, Roberta A., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c609t-d7bf636cfb0512e8045aa0c44d8ae4b1e99e0a2c1fe93ae02a03353312f0caf83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Bias</topic><topic>Biological and medical sciences</topic><topic>Bronchodilator Agents - therapeutic use</topic><topic>Bronchopulmonary Dysplasia - prevention & control</topic><topic>Cluster Analysis</topic><topic>Confidence Intervals</topic><topic>Data Interpretation, Statistical</topic><topic>Female</topic><topic>General aspects</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infant, Very Low Birth Weight</topic><topic>Logistic Models</topic><topic>Medical sciences</topic><topic>Miscellaneous</topic><topic>Multiple Birth Offspring - statistics & numerical data</topic><topic>Nitric Oxide - therapeutic use</topic><topic>Odds Ratio</topic><topic>Pediatrics</topic><topic>Pregnancy</topic><topic>Pregnancy, Multiple - statistics & numerical data</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Randomized Controlled Trials as Topic - statistics & numerical data</topic><topic>Research Design - statistics & numerical data</topic><topic>Sensitivity and Specificity</topic><topic>Survival Analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hibbs, Anna Maria, MD, MSCE</creatorcontrib><creatorcontrib>Black, Dennis, PhD</creatorcontrib><creatorcontrib>Palermo, Lisa, MA</creatorcontrib><creatorcontrib>Cnaan, Avital, PhD</creatorcontrib><creatorcontrib>Luan, Xianqun, MS</creatorcontrib><creatorcontrib>Truog, William E., MD</creatorcontrib><creatorcontrib>Walsh, Michele C., MD, MS</creatorcontrib><creatorcontrib>Ballard, Roberta A., MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hibbs, Anna Maria, MD, MSCE</au><au>Black, Dennis, PhD</au><au>Palermo, Lisa, MA</au><au>Cnaan, Avital, PhD</au><au>Luan, Xianqun, MS</au><au>Truog, William E., MD</au><au>Walsh, Michele C., MD, MS</au><au>Ballard, Roberta A., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2010-02-01</date><risdate>2010</risdate><volume>156</volume><issue>2</issue><spage>202</spage><epage>208</epage><pages>202-208</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><coden>JOPDAB</coden><abstract>Objectives To determine the prevalence in the neonatal literature of statistical approaches accounting for the unique clustering patterns of multiple births and to explore the sensitivity of an actual trial to several analytic approaches to multiples. Study design A systematic review of recent perinatal trials assessed the prevalence of studies accounting for clustering of multiples. The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) trial served as a case study of the sensitivity of the outcome to several statistical strategies. We calculated odds ratios using nonclustered (logistic regression) and clustered (generalized estimating equations, multiple outputation) analyses. Results In the systematic review, most studies did not describe the random assignment of twins and did not account for clustering. Of those studies that did, exclusion of multiples and generalized estimating equations were the most common strategies. The NO CLD study included 84 infants with a sibling enrolled in the study. Multiples were more likely than singletons to be white and were born to older mothers ( P < .01). Analyses that accounted for clustering were statistically significant; analyses assuming independence were not. Conclusions The statistical approach to multiples can influence the odds ratio and width of confidence intervals, thereby affecting the interpretation of a study outcome. A minority of perinatal studies address this issue.</abstract><cop>Maryland Heights, MO</cop><pub>Mosby, Inc</pub><pmid>19969305</pmid><doi>10.1016/j.jpeds.2009.08.049</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0022-3476 |
| ispartof | The Journal of pediatrics, 2010-02, Vol.156 (2), p.202-208 |
| issn | 0022-3476 1097-6833 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2844328 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adult Bias Biological and medical sciences Bronchodilator Agents - therapeutic use Bronchopulmonary Dysplasia - prevention & control Cluster Analysis Confidence Intervals Data Interpretation, Statistical Female General aspects Humans Infant, Newborn Infant, Premature Infant, Very Low Birth Weight Logistic Models Medical sciences Miscellaneous Multiple Birth Offspring - statistics & numerical data Nitric Oxide - therapeutic use Odds Ratio Pediatrics Pregnancy Pregnancy, Multiple - statistics & numerical data Public health. Hygiene Public health. Hygiene-occupational medicine Randomized Controlled Trials as Topic - statistics & numerical data Research Design - statistics & numerical data Sensitivity and Specificity Survival Analysis |
| title | Accounting for Multiple Births in Neonatal and Perinatal Trials: Systematic Review and Case Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-17T07%3A32%3A49IST&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=Accounting%20for%20Multiple%20Births%20in%20Neonatal%20and%20Perinatal%20Trials:%20Systematic%20Review%20and%20Case%20Study&rft.jtitle=The%20Journal%20of%20pediatrics&rft.au=Hibbs,%20Anna%20Maria,%20MD,%20MSCE&rft.date=2010-02-01&rft.volume=156&rft.issue=2&rft.spage=202&rft.epage=208&rft.pages=202-208&rft.issn=0022-3476&rft.eissn=1097-6833&rft.coden=JOPDAB&rft_id=info:doi/10.1016/j.jpeds.2009.08.049&rft_dat=%3Cproquest_pubme%3E733807348%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=733807348&rft_id=info:pmid/19969305&rft_els_id=S0022347609008701&rfr_iscdi=true |