Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial
Abstract Background The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recrui...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2220-0 |
| _version_ | 1818027977509699584 |
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| author | Theresa A. Lawrie Ana Pilar Betrán Mandisa Singata-Madliki Alvaro Ciganda G. Justus Hofmeyr José M. Belizán Tina Dannemann Purnat Sarah Manyame Catherine Parker Gabriela Cormick on behalf of the Calcium and Pre-eclampsia Study Group |
| author_facet | Theresa A. Lawrie Ana Pilar Betrán Mandisa Singata-Madliki Alvaro Ciganda G. Justus Hofmeyr José M. Belizán Tina Dannemann Purnat Sarah Manyame Catherine Parker Gabriela Cormick on behalf of the Calcium and Pre-eclampsia Study Group |
| author_sort | Theresa A. Lawrie |
| collection | DOAJ |
| description | Abstract Background The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Methods Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Results Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. Conclusions In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low-resource settings with suboptimal medical records and other challenges. Trial planners should ensure that trial budgets cover sufficient on-site researchers with pre-trial training, and should consider using mobile phone and web-based electronic tools to optimize recruitment and retention. This should lead to greater efficiency and shorter trial durations. Trial registration Pan-African Clinical Trials Registry, Registration Number: PACTR201105000267371 . The trial was registered on 6 December 2016. |
| first_indexed | 2024-12-10T04:56:28Z |
| format | Article |
| id | doaj.art-df1d814c1a904d9aaf829f90f0f35931 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T04:56:28Z |
| publishDate | 2017-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-df1d814c1a904d9aaf829f90f0f359312022-12-22T02:01:29ZengBMCTrials1745-62152017-10-0118111110.1186/s13063-017-2220-0Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trialTheresa A. Lawrie0Ana Pilar Betrán1Mandisa Singata-Madliki2Alvaro Ciganda3G. Justus Hofmeyr4José M. Belizán5Tina Dannemann Purnat6Sarah Manyame7Catherine Parker8Gabriela Cormick9on behalf of the Calcium and Pre-eclampsia Study GroupEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort HareHRP – UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health OrganizationEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort HareDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS)Effective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort HareDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS)Division of Information, Evidence, Research and Innovation, World Health Organization Regional Office for EuropeUniversity of Zimbabwe College of Health SciencesEffective Care Research Unit, Eastern Cape Department of Health/Universities of the Witwatersrand, Walter Sisulu and Fort HareDepartment of Mother and Child Health Research, Institute for Clinical Effectiveness and Health Policy (IECS)Abstract Background The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Methods Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Results Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. Conclusions In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low-resource settings with suboptimal medical records and other challenges. Trial planners should ensure that trial budgets cover sufficient on-site researchers with pre-trial training, and should consider using mobile phone and web-based electronic tools to optimize recruitment and retention. This should lead to greater efficiency and shorter trial durations. Trial registration Pan-African Clinical Trials Registry, Registration Number: PACTR201105000267371 . The trial was registered on 6 December 2016.http://link.springer.com/article/10.1186/s13063-017-2220-0CalciumPre-eclampsiaPreconceptionRecruitmentRetentionRandomized |
| spellingShingle | Theresa A. Lawrie Ana Pilar Betrán Mandisa Singata-Madliki Alvaro Ciganda G. Justus Hofmeyr José M. Belizán Tina Dannemann Purnat Sarah Manyame Catherine Parker Gabriela Cormick on behalf of the Calcium and Pre-eclampsia Study Group Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial Trials Calcium Pre-eclampsia Preconception Recruitment Retention Randomized |
| title | Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial |
| title_full | Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial |
| title_fullStr | Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial |
| title_full_unstemmed | Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial |
| title_short | Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial |
| title_sort | participant recruitment and retention in longitudinal preconception randomized trials lessons learnt from the calcium and pre eclampsia cap trial |
| topic | Calcium Pre-eclampsia Preconception Recruitment Retention Randomized |
| url | http://link.springer.com/article/10.1186/s13063-017-2220-0 |
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