Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023)
Objective We aim to assess which variables are associated with recruitment failure of obstetrical and gynaecological randomised controlled trials (RCTs), leading to an extension of the study period.Design Nationwide study.Setting A cohort of RCTs supported by the trial centre of the Dutch Consortium...
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BMJ Publishing Group
2025-01-01
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| author | Ben W Mol Madelon van Wely L Ramos J J Duvekot J B Derks Fulco van der Veen Ruben Duijnhoven H J van Beekhuizen M J E Mourits J A M van der Post E Pajkrt M A Oudijk H C J Scheepers Mariette Goddijn J Huirne Marijke C van der Weide A Kwee C Willekes M Y Bongers Judith Rikken Romee Casteleijn S Middeldorp I M Custers M P Lambregtse – van den Berg V Mijatovic F J M Broekmans A Hoek J P de Bruin M H Mochtar S Mastenbroek J P W R Roovers F Mol A Vollebregt C H van der Vaart K B Kluivers M E Vierhout R C Painter P M A J Geomini |
| author_facet | Ben W Mol Madelon van Wely L Ramos J J Duvekot J B Derks Fulco van der Veen Ruben Duijnhoven H J van Beekhuizen M J E Mourits J A M van der Post E Pajkrt M A Oudijk H C J Scheepers Mariette Goddijn J Huirne Marijke C van der Weide A Kwee C Willekes M Y Bongers Judith Rikken Romee Casteleijn S Middeldorp I M Custers M P Lambregtse – van den Berg V Mijatovic F J M Broekmans A Hoek J P de Bruin M H Mochtar S Mastenbroek J P W R Roovers F Mol A Vollebregt C H van der Vaart K B Kluivers M E Vierhout R C Painter P M A J Geomini |
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| description | Objective We aim to assess which variables are associated with recruitment failure of obstetrical and gynaecological randomised controlled trials (RCTs), leading to an extension of the study period.Design Nationwide study.Setting A cohort of RCTs supported by the trial centre of the Dutch Consortium of Obstetrics and Gynaecology.Population We included 83 RCTs that recruited patients between 1 March 2003 and 1 December 2023.Main outcome measures Main outcome was recruitment target not achieved within 6 months after the preplanned recruitment period. Secondary outcomes were recruitment target not achieved within an extension period of at least 12 months and premature termination of the trial. In all RCTs, we collected information on variables with a potential effect on recruitment failure, recorded at five levels; patient, doctor, participating centre, study organisation and study design.Results In total, 46 of 83 RCTs (55%) did not achieve their targeted recruitment within the preplanned study period with a maximal extension period of 6 months. The most relevant variables for recruitment failure in multivariable risk prediction modelling were presence of a no-treatment arm (where treatment is standard clinical practice), a compensation fee of less than €200 per included patient, funding of less than €350 000, while a preceding pilot study lowered this risk.Conclusions We identified that the presence of a no-treatment arm, low funding and a low compensation fee per included patient were the most relevant risk factors for recruitment failure within the preplanned period, while a preceding pilot study lowered this risk. Awareness of these variables is important when designing future studies. |
| format | Article |
| id | doaj-art-e79f55dc4b2d4f55b5dab7633398dac9 |
| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-e79f55dc4b2d4f55b5dab7633398dac92025-01-23T10:40:15ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-087766Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) Ben W Mol0Madelon van Wely1L RamosJ J DuvekotJ B DerksFulco van der Veen2Ruben Duijnhoven3H J van BeekhuizenM J E MouritsJ A M van der PostE PajkrtM A OudijkH C J ScheepersMariette Goddijn4J HuirneMarijke C van der Weide5A KweeC WillekesM Y BongersJudith Rikken6Romee Casteleijn7S MiddeldorpI M CustersM P Lambregtse – van den BergV MijatovicF J M BroekmansA HoekJ P de BruinM H MochtarS MastenbroekJ P W R RooversF MolA VollebregtC H van der VaartK B KluiversM E VierhoutR C PainterP M A J Geomini4 Obstetrics and Gynecology, Monash Medical School, Clayton, Victoria, Australia3 Center for Reproductive Medicine, Amsterdam UMC, Amsterdam, The Netherlands3 Center for Reproductive Medicine, Amsterdam UMC, Amsterdam, The Netherlands2 Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands1 Reproduction and Development Research Institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands2 Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands1 Reproduction and Development Research Institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands1 Reproduction and Development Research Institute, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsObjective We aim to assess which variables are associated with recruitment failure of obstetrical and gynaecological randomised controlled trials (RCTs), leading to an extension of the study period.Design Nationwide study.Setting A cohort of RCTs supported by the trial centre of the Dutch Consortium of Obstetrics and Gynaecology.Population We included 83 RCTs that recruited patients between 1 March 2003 and 1 December 2023.Main outcome measures Main outcome was recruitment target not achieved within 6 months after the preplanned recruitment period. Secondary outcomes were recruitment target not achieved within an extension period of at least 12 months and premature termination of the trial. In all RCTs, we collected information on variables with a potential effect on recruitment failure, recorded at five levels; patient, doctor, participating centre, study organisation and study design.Results In total, 46 of 83 RCTs (55%) did not achieve their targeted recruitment within the preplanned study period with a maximal extension period of 6 months. The most relevant variables for recruitment failure in multivariable risk prediction modelling were presence of a no-treatment arm (where treatment is standard clinical practice), a compensation fee of less than €200 per included patient, funding of less than €350 000, while a preceding pilot study lowered this risk.Conclusions We identified that the presence of a no-treatment arm, low funding and a low compensation fee per included patient were the most relevant risk factors for recruitment failure within the preplanned period, while a preceding pilot study lowered this risk. Awareness of these variables is important when designing future studies.https://bmjopen.bmj.com/content/15/1/e087766.full |
| spellingShingle | Ben W Mol Madelon van Wely L Ramos J J Duvekot J B Derks Fulco van der Veen Ruben Duijnhoven H J van Beekhuizen M J E Mourits J A M van der Post E Pajkrt M A Oudijk H C J Scheepers Mariette Goddijn J Huirne Marijke C van der Weide A Kwee C Willekes M Y Bongers Judith Rikken Romee Casteleijn S Middeldorp I M Custers M P Lambregtse – van den Berg V Mijatovic F J M Broekmans A Hoek J P de Bruin M H Mochtar S Mastenbroek J P W R Roovers F Mol A Vollebregt C H van der Vaart K B Kluivers M E Vierhout R C Painter P M A J Geomini Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) BMJ Open |
| title | Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) |
| title_full | Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) |
| title_fullStr | Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) |
| title_full_unstemmed | Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) |
| title_short | Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003–2023) |
| title_sort | which variables are associated with recruitment failure a nationwide review on obstetrical and gynaecological multicentre rcts 2003 2023 |
| url | https://bmjopen.bmj.com/content/15/1/e087766.full |
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