This study demonstrates that an enhanced training package can improve knowledge of research methods and governance. However, despite some improvement in mean scores, we found that scores did not increase statistically significantly between start and end of the study period.
This study was subjected to an unexpected pause due to the Covid-19 pandemic which limited the sample size, delivery and dissemination of training, and the end of the study assessments. The training leads had attended the 5-day training course in November 2019 and training sessions took place in December 2019. The study was due to commence in February 2020, however there was a delay with receiving ethical approval and once received, the Covid-19 global pandemic had been declared. Clinical staff in the hospitals in Kenya and India understandably had to prioritise clinical activity. The study opened on 1 August 2020, some nine months after training had been undertaken. Whilst the funder granted a small time-only extension, it was not possible to provide complete re-training prior to the start of data collection due to the need to complete the project quickly. Instead, ad-hoc training was provided to the training leads. In addition, the UK study coordinator worked closely with the study coordinators in Kenya and India to answer any queries they had. The long pause in research activity could have substantially contributed to the very small differences seen between questionnaires completed at the start and end of the study period. Despite this, the results are encouraging and provide some evidence to support this model of research training.
The Global Health Network Training centre classifies a ‘pass’ mark as ≥ 80% for the introduction to informed consent questionnaire and ICH-GCP questionnaire. In this study the mean scores were substantially lower than this at both time-points but improved by the end of the study (from 56% and 69% for informed consent, and from 45% and 56% for ICH-GCP). Whilst an increase was seen in scores, particularly in India, scores remained low, indicating that additional training, incorporating alternative methods, with refresher training are required in future studies. The biggest gains in questionnaire scores were in questionnaires completed by participants in India, particularly in the consent questionnaire; with a difference in means of 19 between the beginning and end of the study period. This could perhaps reflect that the team in India were research naïve and had not previously participated in research training of this nature. Only three participants in India completed the questionnaires at the end of the study period; these three participants were very involved in the conduct of the study which could explain the larger increase in scores as they were working on the study on a daily basis, unlike other participants who had a less active role.
A strength of this study is that, to the best of our knowledge, this is the first time a clinical trials training package has been evaluated for use in a global health neonatal trial. However, there are some limitations. The substantial delay between the provision of training and the study starting, imposed by the pandemic, may have affected performance at the end of the study period. We did not assess immediate impact of the training. An additional set of questionnaires at the end of the initial training session could have provided additional information and comparison to assess gain or decline in knowledge over the study period. Finally, very few staff (n = 3) in India completed the questionnaires at the end of the study period. This could be in part due to the type of staff that attended the original training session and completed baseline questionnaires: the majority were nurses who, by the time the study started, were moved from the project to work clinically for the pandemic response.
Our results demonstrate the need for training for researchers in LMICs, both for individual studies and generically to increase research capacity. This is arguably even more critical since substantial cuts have been made to global health funding by the UK government(15). For research to be conducted where need is greatest, enabling researchers and health workers in LMICs to acquire research and research management skills is essential. Adapting the approach described here, by including additional training sessions throughout the study and providing the “trainers” with more standardised training tools for them to replicate the training when required, could be helpful for the future. During the Covid-19 pandemic, research teams have adapted training materials to enable virtual training sessions, since much travel between countries has been prohibited. Whilst this reduces the cost and environmental impact of in-person training conducted in LMICs by research teams outside of the setting, we strongly believe a blended approach is required. In-person training is important to understand the context and to enable detailed interactions between staff, in order to pick-up on issues that may need further input. Training packages designed to improve the skills of research teams in LMICs should continue to be evaluated, both in order to upskill staff in LMICs and to add to the trials methodology evidence-base. Researchers at the Global Health Network, interested in methodology research, are in the process of developing a core curriculum, via the Essential Research Skills Project (https://globalresearchmethods.tghn.org/methodology-projects/essential-research-skills-training-curriculum/), developed by analysis of training needs surveys, workshops and a Delphi survey, and the content from this curriculum could be utilised to support training in global health studies in the future.