The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol
Background: Pregnant and postpartum women have been historically excluded from clinical trials, with data on the safety of drugs relying on observational research. Methodological concerns regarding the timing and dosing of medications, data sources, study designs, and methods used for estimating ass...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.904824/full |
| _version_ | 1818475638412017664 |
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| author | Lisiane Freitas Leal Sonia Marzia Grandi Sonia Marzia Grandi Daniel Marques Mota Paulo José Gonçalves Ferreira Genevieve Gore Robert William Platt |
| author_facet | Lisiane Freitas Leal Sonia Marzia Grandi Sonia Marzia Grandi Daniel Marques Mota Paulo José Gonçalves Ferreira Genevieve Gore Robert William Platt |
| author_sort | Lisiane Freitas Leal |
| collection | DOAJ |
| description | Background: Pregnant and postpartum women have been historically excluded from clinical trials, with data on the safety of drugs relying on observational research. Methodological concerns regarding the timing and dosing of medications, data sources, study designs, and methods used for estimating associations are still problematic in observational studies. Answering causal questions is even more complex. Despite the increased interest in emulating target trials using observational data, little is known about this approach in perinatal pharmacoepidemiology.Objective: This scoping review protocol aims to describe the methodology for assessing the available literature concerning emulating target trials for studying outcomes in women exposed to medications in the preconception, perinatal, or postpartum periods.Methods and Analysis: We will follow the methods detailed in the Joanna Briggs Institute reviewer’s manual. We will adopt the six-stage framework recommended by Arksey and O'Malley and Levac and others. Web scraping techniques will be used for identifying relevant studies. Two authors will select articles based on the title and abstract, with discrepancies resolved by consensus, by a third reviewer. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews flow diagram will be presented to reflect the search process. We will use existing statements to identify quality gaps in the current literature. Variables related to the content for perinatal pharmacoepidemiologic research will be included. The Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) will guide the assessment of the target trial emulation (i.e., treatment strategies compared, assignment procedures, follow-up period, outcome, and causal contrasts).Discussion: Data regarding the safety of drugs taken, prior to and during pregnancy and while lactating are lacking and it is necessary to understand how we can answer these questions using rigorous methods in observational research. Through this scoping review, we intend to understand to what extent the target trial approach is being used in perinatal pharmacoepidemiology and provide recommendations to improve its use in this field.Ethics and Dissemination: Secondary data from published scientific articles will be used, not requiring approval by the Research Ethics Committee with human beings. Findings will be submitted to a peer-reviewed journal. |
| first_indexed | 2024-12-10T09:15:18Z |
| format | Article |
| id | doaj.art-4f445dd8ac0e44b6949c957cfbe672f1 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-10T09:15:18Z |
| publishDate | 2022-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-4f445dd8ac0e44b6949c957cfbe672f12022-12-22T01:54:52ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-07-011310.3389/fphar.2022.904824904824The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review ProtocolLisiane Freitas Leal0Sonia Marzia Grandi1Sonia Marzia Grandi2Daniel Marques Mota3Paulo José Gonçalves Ferreira4Genevieve Gore5Robert William Platt6Faculty of Medicine and Health Sciences, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, CanadaDivision of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, CanadaBrazilian Health Regulatory Agency (Anvisa), Brasília, BrazilBrazilian Health Regulatory Agency (Anvisa), Brasília, BrazilSchulich Library of Physical Sciences, Life Sciences and Engineering, McGill University, Montreal, QC, CanadaFaculty of Medicine and Health Sciences, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, CanadaBackground: Pregnant and postpartum women have been historically excluded from clinical trials, with data on the safety of drugs relying on observational research. Methodological concerns regarding the timing and dosing of medications, data sources, study designs, and methods used for estimating associations are still problematic in observational studies. Answering causal questions is even more complex. Despite the increased interest in emulating target trials using observational data, little is known about this approach in perinatal pharmacoepidemiology.Objective: This scoping review protocol aims to describe the methodology for assessing the available literature concerning emulating target trials for studying outcomes in women exposed to medications in the preconception, perinatal, or postpartum periods.Methods and Analysis: We will follow the methods detailed in the Joanna Briggs Institute reviewer’s manual. We will adopt the six-stage framework recommended by Arksey and O'Malley and Levac and others. Web scraping techniques will be used for identifying relevant studies. Two authors will select articles based on the title and abstract, with discrepancies resolved by consensus, by a third reviewer. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews flow diagram will be presented to reflect the search process. We will use existing statements to identify quality gaps in the current literature. Variables related to the content for perinatal pharmacoepidemiologic research will be included. The Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) will guide the assessment of the target trial emulation (i.e., treatment strategies compared, assignment procedures, follow-up period, outcome, and causal contrasts).Discussion: Data regarding the safety of drugs taken, prior to and during pregnancy and while lactating are lacking and it is necessary to understand how we can answer these questions using rigorous methods in observational research. Through this scoping review, we intend to understand to what extent the target trial approach is being used in perinatal pharmacoepidemiology and provide recommendations to improve its use in this field.Ethics and Dissemination: Secondary data from published scientific articles will be used, not requiring approval by the Research Ethics Committee with human beings. Findings will be submitted to a peer-reviewed journal.https://www.frontiersin.org/articles/10.3389/fphar.2022.904824/fullscoping reviewtarget trial emulationpreconceptionperinatalpostpartumpharmacoepidemiogy |
| spellingShingle | Lisiane Freitas Leal Sonia Marzia Grandi Sonia Marzia Grandi Daniel Marques Mota Paulo José Gonçalves Ferreira Genevieve Gore Robert William Platt The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol Frontiers in Pharmacology scoping review target trial emulation preconception perinatal postpartum pharmacoepidemiogy |
| title | The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol |
| title_full | The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol |
| title_fullStr | The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol |
| title_full_unstemmed | The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol |
| title_short | The Use of the Target Trial Approach in Perinatal Pharmacoepidemiology: A Scoping Review Protocol |
| title_sort | use of the target trial approach in perinatal pharmacoepidemiology a scoping review protocol |
| topic | scoping review target trial emulation preconception perinatal postpartum pharmacoepidemiogy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.904824/full |
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