A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal ... View Full Text


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Article Info

DATE

2021-03-25

AUTHORS

Bertrand Gachon, Thomas Schmitz, France Artzner, Olivier Parant, Renaud De Tayrac, Guillaume Ducarme, Camille Le Ray, Anne Cécile Pizzoferrato, Charles Garabedian, Didier Riethmuller, Fabrice Pierre, Stephanie Ragot, Xavier Fritel

ABSTRACT

BackgroundWe aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).MethodsA list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman’s history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as “not important”. In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as “not important” or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.ResultsFifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.ConclusionWe established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.Trial registrationThe INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT04446780). More... »

PAGES

251

Journal

TITLE

BMC Pregnancy and Childbirth

ISSUE

1

VOLUME

21

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12884-021-03603-0

DOI

http://dx.doi.org/10.1186/s12884-021-03603-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1136669245

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33765964


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25 schema:description BackgroundWe aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).MethodsA list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman’s history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as “not important”. In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as “not important” or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.ResultsFifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.ConclusionWe established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.Trial registrationThe INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT04446780).
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31 schema:keywords BackgroundWe
32 ConclusionWe
33 Delphi method
34 Delphi procedure
35 French study
36 MethodsA list
37 anal sphincter injury
38 association
39 association of patient
40 categories
41 characteristics
42 community
43 consensual list
44 consensus
45 core outcome
46 corpus
47 course
48 course of labor
49 course of pregnancy
50 delivery
51 development
52 effect
53 end
54 episiotomy
55 final core outcome
56 first round
57 history
58 immediate neonatal morbidity
59 injury
60 interest
61 interest sets
62 labor
63 list
64 maternal morbidity
65 mediolateral episiotomy
66 method
67 modalities
68 morbidity
69 national prospective study
70 neonatal morbidity
71 new outcomes
72 nulliparous women
73 obstetric anal sphincter injury
74 obstetricians
75 online questionnaire
76 operative delivery
77 operative vaginal delivery
78 outcomes
79 patients
80 population
81 population of women
82 pregnancy
83 procedure
84 prospective study
85 questionnaire
86 rounds
87 same method
88 second round
89 set
90 sphincter injury
91 study
92 third round
93 three-round Delphi method
94 vaginal delivery
95 variables
96 variables of interest
97 women
98 women's history
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