Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

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.

Non-communicable diseases (NCDs) in developing countries: a symposium report.

In recent years, non-communicable diseases (NCDs) have globally shown increasing impact on health status in populations with disproportionately higher rates in developing countries. NCDs are the leading cause of mortality worldwide and a serious public health threat to developing countries. Recognizing the importance and urgency of the issue, a one-day symposium was organized on NCDs in Developing Countries by the CIHLMU Center for International Health, Ludwig-Maximilians-Universität, Munich on 22nd March 2014. The objective of the symposium was to understand the current situation of different NCDs public health programs and the current trends in NCDs research and policy, promote exchange of ideas, encourage scientific debate and foster networking, partnerships and opportunities among experts from different clinical, research, and policy fields. The symposium was attended by more than seventy participants representing scientists, physicians, academics and students from several institutes in Germany and abroad. Seven key note presentations were made at the symposium by experts from Germany, UK, France, Bangladesh and Vietnam. This paper highlights the presentations and discussions during the symposium on different aspects of NCDs in developing countries. The symposium elucidated the dynamics of NCDs in developing countries and invited the participants to learn about evidence-based practices and policies for prevention and management of major NCDs and to debate the way forward.