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In March 2020, in response to the COVID-19 pandemic, national strategies were implemented across Scotland to contain the spread of the virus, including lockdown measures, travel restrictions and the closure of schools and non-essential services. The National Institute for Health Research (NIHR) and the devolved nations prioritised nationally sponsored COVID-19 research and front-line care. 1 As a result, 78% of paediatric studies in Scotland were suspended.
In August 2020 after the first COVID-19 wave, the RESTART programme was initiated across health boards to reopen commercial and non-commercial research studies. By March 2021, most paediatric studies were categorised as open to recruitment but without the expected resurgence of patient recruitment. We therefore surveyed the principal investigators (PI) about their opinions on factors, specifically those related to the national COVID-19 strategies, that were affecting recruitment to their paediatric studies.
A survey of 11 questions, designed using the SNAP Survey software and hosted on a secure University of Aberdeen server, was sent to the 105 PIs listed in the national database (Scottish Research Management Database) under the paediatric portfolio. The survey was open from 16 March to 16 April 2021.
The 72 responses received were proportionate to the National Health Service-National Research Services Children’s Research Network portfolio categorisation by health board, specialty, study type and whether studies are embedded in clinical care (table 1).
The survey highlighted factors within the clinical environment that were considered to have a negative impact on recruitment and follow-up visits (table 2):
Availability Reduced availability of staff was reported most frequently, exacerbated by staff redeployment to COVID-19-related adult research and vaccine studies.
Frequency Factors that collectively reduced the frequency of interactions with potential study participants and their families, including reduced clinics, travel restrictions between health board areas, reduced willingness to invite patients to hospital and postponement of elective procedures.
Quality Factors that impacted on the quality of interactions with patients and families, including the replacement of face-to-face visits by telephone or video calls, socially distanced visits with less family members present and wearing of face masks.
Furthermore, changes in the incidence of some conditions were considered to have affected recruitment to specific studies including a significant reduction in seasonal respiratory infections, and in fractures presenting to emergency departments, explained by lockdown and suspension of sports and school activities.
In conclusion, the national and local NHS strategies implemented to reduce the spread of COVID-19 have collectively had a significantly negative impact on recruitment of children to research studies in Scotland. Through consultation with the NIHR Clinical Research Network: Children and Young People National Specialty Group, these findings reflect the issues faced in paediatric research in England, Northern Ireland and Wales.
We envisage that the increased frequency and quality of clinical visits in conjunction with the NIHR National Managed Recovery process should lead to paediatric research activity returning to prepandemic levels. We believe that the reinstatement of clinical services and unrestricted movement of research staff within the clinical areas will particularly benefit studies with opportunistic patient recruitment.
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Twitter @Pamela Dicks@dicks_pamela
Contributors The design, distribution and analysis of the survey were conducted by PDic and JS. The letter was written by PDic, JS and PDim.
Funding This research was supported by the Chief Scientist Office Scotland NHS-NRS Children's Research Network and the National Institute for Health Research (NIHR) CRN: Children and Young People.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the CSO, NIHR or the Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.