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IntroductionClinical Trials Units (CTUs) are a key component of delivering non-commercial and commercial clinical research globally. Within the UK, CTUs are seen as a specialist and independent entity available to all researchers requiring support to setup, conduct and deliver clinical trials. Therefore, an involvement of a CTU is highly recommended by national regulators and positively accepted by funders, especially for drug and/or medical device and/or complex intervention trials. AimThis study aims to determine the challenges associated with the management of Covid-19 research managed via the CTU workforce, including the challenges associated with quality assurance, trial setup and data management. Additionally, this study will explore the by-stander effect on trial staff by way of evaluating the mental and physical health impact. Methods/ DesignThis is a mixed methods study. An online novel questionnaire survey study will be conducted among the UK CTU workforce. Quantitative data will be collected using the Qualtrics XM platform. We aim to recruit up to 1,500 CTU staff across the UK workforce. A subgroup sample will be randomly invited to take part in semi-structured interviews. Therefore, this survey will generate both quantitative and qualitative data inclusive of demographic data. ResultsThe findings will inform current initiatives and identify key themes for prioritising in further research to develop robust approaches to support CTU staff, including the development of a start-re-start framework for CTUs for any future pandemics relevant to developing and delivering communicable diseases and non-communicable diseases-based research. Strengths/LimitationsThe validation of the EPIC impact questionnaire used qualitative and quantitative methods which is a strength of the study. However, the study has a single timepoint to obtain data with the secondary outcome measures to be completed at two timepoints as this is an exploratory study attempting to obtain a wider data pool.
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ObjectiveThe clinical trial unit (CTU) workforce in the UK have been delivering COVID-19 research since the inception of the pandemic. Challenges associated with COVID-19 research have impacted the global healthcare communities differently. Thus, the overall objective of the study was to determine the mental health impact among CTU staff working during the COVID-19 pandemic. DesignA mixed-methods based observational study was designed using a new workforce impact questionnaire using validated mental health assessments of Vancouver Index of Acculturation (VIA), Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), Pandemic Stress Index (PSI), Burnout Assessment Too-12 (BAT-12), General Self Efficacy Scale (GSE) and The Everyday Discrimination Scale (EDS). SettingThe Qualtrics platform was used to deploy the questionnaire where a quantitative analysis was conducted. The qualitative part of the study used the Microsoft Teams digital application to complete the interviews. ParticipantsAll participants were CTU staff within the United Kingdom.
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BackgroundSevere Acute Respiratory Syndrome Coronavirus (SARS-CoV) is a respiratory disease causing coronavirus. SARS-CoV has caused the Middle East Respiratory Syndrome (MERS), SARS-CoV in Hong King and SARS-CoV-2 (COVID-19). COVID-19, to date, have had the highest mortality and morbidity globally, thus reaching the pandemic status. In comparison to research conducted to explore the impact of pandemics on the general wellbeing, there appears to be a paucity on its association with womens mental health. Many pregnant women have reported that the pandemic negatively impacted their mental health. AimThis study aimed is to explore the prevalence of the impact of the COVID-19, MERS and SARS pandemics on the mental health of pregnant women. MethodA study protocol was developed and published in PROSPERO (CRD42021235356) to explore a number of key objectives. For the purpose of this study PubMed, Science direct, Ovid PsycINFO and EMBASE databases were searched from December 2000 - July 2021. The search results were screened, first by title, and then by abstract. A meta-analysis was conducted to report the findings. ResultsThere were no studies reporting the mental health impact due to MERS and SARS. We systematically identified 316 studies that reported on the mental health of women that were pregnant and soon after birth. The meta-analysis indicated 24.9% (21.37%-29.02%) of pregnant women reported symptoms of depression, 32.8% (29.05% to 37.21%) anxiety, 29.44% (18.21% - 47.61%) stress, 27.93% (9.05%-86.15 %) PTSD, and 24.38% (11.89%-49.96%) sleep disorders during the COVID-19 pandemic. Furthermore, the I2 test showed a high heterogeneity value. ConclusionThe importance of managing the mental health during pregnancy and after-delivery improves the quality of life and wellbeing of mothers. Developing an evidence based mental health framework as part of pandemic preparedness to help pregnant women would improve the quality of care received during challenging times.