Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy : a signal detection study protocol
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ..
INTRODUCTION: Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk-benefit safety profile of their often-complex treatment plan, more research is needed to optimise prescribing. In this study, we aim to detect adverse and protective effect signals of exposure to individual and pairwise combinations of medications during pregnancy.
METHODS AND ANALYSIS: Using a range of real-world data sources from the UK, we aim to conduct a pharmacovigilance study to assess the safety of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy. Women aged between 15 and 49 years with a record of pregnancy within the Clinical Practice Research Datalink (CPRD) Pregnancy Register, the Welsh Secure Anonymised Information Linkage (SAIL), the Scottish Morbidity Record (SMR) data sets and the Northern Ireland Maternity System (NIMATS) will be included. A series of case control studies will be conducted to estimate measures of disproportionality, detecting signals of association between a range of pregnancy outcomes and exposure to individual and combinations of medications. A multidisciplinary expert team will be invited to a signal detection workshop. By employing a structured framework, signals will be transparently assessed by each member of the team using a questionnaire appraising the signals on aspects of temporality, selection, time and measurement-related biases and confounding by underlying disease or comedications. Through group discussion, the expert team will reach consensus on each of the medication exposure-outcome signal, thereby excluding spurious signals, leaving signals suggestive of causal associations for further evaluation.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Independent Scientific Advisory Committee, SAIL Information Governance Review Panel, University of St. Andrews Teaching and Research Ethics Committee and Office for Research Ethics Committees Northern Ireland (ORECNI) for access and use of CPRD, SAIL, SMR and NIMATS data, respectively.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
BMJ open - 13(2023), 10 vom: 09. Okt., Seite e073162 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Themen: |
Epidemiology |
|---|
| Anmerkungen: |
Date Completed 02.11.2023 Date Revised 13.03.2024 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2023-073162 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM36306687X |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM36306687X | ||
| 003 | DE-627 | ||
| 005 | 20240313233703.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2023-073162 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1326.xml |
| 035 | |a (DE-627)NLM36306687X | ||
| 035 | |a (NLM)37813531 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Subramanian, Anuradhaa |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy |b a signal detection study protocol |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 02.11.2023 | ||
| 500 | |a Date Revised 13.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk-benefit safety profile of their often-complex treatment plan, more research is needed to optimise prescribing. In this study, we aim to detect adverse and protective effect signals of exposure to individual and pairwise combinations of medications during pregnancy | ||
| 520 | |a METHODS AND ANALYSIS: Using a range of real-world data sources from the UK, we aim to conduct a pharmacovigilance study to assess the safety of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy. Women aged between 15 and 49 years with a record of pregnancy within the Clinical Practice Research Datalink (CPRD) Pregnancy Register, the Welsh Secure Anonymised Information Linkage (SAIL), the Scottish Morbidity Record (SMR) data sets and the Northern Ireland Maternity System (NIMATS) will be included. A series of case control studies will be conducted to estimate measures of disproportionality, detecting signals of association between a range of pregnancy outcomes and exposure to individual and combinations of medications. A multidisciplinary expert team will be invited to a signal detection workshop. By employing a structured framework, signals will be transparently assessed by each member of the team using a questionnaire appraising the signals on aspects of temporality, selection, time and measurement-related biases and confounding by underlying disease or comedications. Through group discussion, the expert team will reach consensus on each of the medication exposure-outcome signal, thereby excluding spurious signals, leaving signals suggestive of causal associations for further evaluation | ||
| 520 | |a ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Independent Scientific Advisory Committee, SAIL Information Governance Review Panel, University of St. Andrews Teaching and Research Ethics Committee and Office for Research Ethics Committees Northern Ireland (ORECNI) for access and use of CPRD, SAIL, SMR and NIMATS data, respectively | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a epidemiology | |
| 650 | 4 | |a maternal medicine | |
| 650 | 4 | |a obstetrics | |
| 700 | 1 | |a Lee, Siang Ing |e verfasserin |4 aut | |
| 700 | 1 | |a Hemali Sudasinghe, Sudasing Pathirannehelage Buddhika |e verfasserin |4 aut | |
| 700 | 1 | |a Wambua, Steven |e verfasserin |4 aut | |
| 700 | 1 | |a Phillips, Katherine |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Megha |e verfasserin |4 aut | |
| 700 | 1 | |a Azcoaga-Lorenzo, Amaya |e verfasserin |4 aut | |
| 700 | 1 | |a Cockburn, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jingya |e verfasserin |4 aut | |
| 700 | 1 | |a Fagbamigbe, Adeniyi |e verfasserin |4 aut | |
| 700 | 1 | |a Usman, Muhammad |e verfasserin |4 aut | |
| 700 | 1 | |a Damase-Michel, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Yau, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Kent, Lisa |e verfasserin |4 aut | |
| 700 | 1 | |a McCowan, Colin |e verfasserin |4 aut | |
| 700 | 1 | |a OReilly, Dermot |e verfasserin |4 aut | |
| 700 | 1 | |a Santorelli, Gillian |e verfasserin |4 aut | |
| 700 | 1 | |a Hope, Holly |e verfasserin |4 aut | |
| 700 | 1 | |a Kennedy, Jonathan |e verfasserin |4 aut | |
| 700 | 1 | |a Mhereeg, Mohamed |e verfasserin |4 aut | |
| 700 | 1 | |a Abel, Kathryn Mary |e verfasserin |4 aut | |
| 700 | 1 | |a Eastwood, Kelly-Ann |e verfasserin |4 aut | |
| 700 | 1 | |a Black, Mairead |e verfasserin |4 aut | |
| 700 | 1 | |a Loane, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Moss, Ngawai |e verfasserin |4 aut | |
| 700 | 1 | |a Brophy, Sinead |e verfasserin |4 aut | |
| 700 | 1 | |a Brocklehurst, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Dolk, Helen |e verfasserin |4 aut | |
| 700 | 1 | |a Nelson-Piercy, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Nirantharakumar, Krishnarajah |e verfasserin |4 aut | |
| 700 | 0 | |a MuM-PreDiCT Group |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2012 |g 13(2023), 10 vom: 09. Okt., Seite e073162 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2023 |g number:10 |g day:09 |g month:10 |g pages:e073162 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2023-073162 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2023 |e 10 |b 09 |c 10 |h e073162 | ||