The world was turned upside down this year. For many, that has also included how we do our jobs. Academics with teaching responsibilities have had to adapt to new challenges and workload distributions. Additionally, active researchers have been forced to reflect on how the COVID-19 pandemic will affect their research portfolios in the short- and medium-term.
In this blog post, I will discuss my experience of being a co-investigator on a funded study of mindfulness for stroke survivors (https://www.stroke.org.uk/research/helping-people-affected-stroke-self-manage-symptoms-anxiety-and-depression). This includes the steps taken by the research team to account for pandemic public health protocols. My reflections on the implications of the pandemic for CAM researchers in planning future projects and research themes will also be explored.
HEADS: UP (Helping Ease Anxiety and Depression for Stroke Survivors) is a project funded by The Stroke Association, consisting of a stage 1 single-group feasibility study and a stage 2 randomised controlled pilot trial; both stages aim to assess the feasibility and potential effectiveness of an adapted mindfulness course for improving mood disorder in stroke survivors.
At the beginning of the UK lockdown in March, stage 1 feasibility analysis was underway, having already successfully recruited participants, delivered the intervention, and collected their data. Whilst the lockdown did not have a significant impact on this phase, the team needed to reconsider the study as a whole. The first question that needed to be answered was “is the pandemic going to affect study methods and timelines?” Stage 2 was due to commence in late 2020 and so the answer was yes. That necessitated communication with the funder and identification of what COVID-19 adaptations would be required. Three crucial adaptations were identified: recruitment; intervention delivery; and data collection methods.
It was clear that the group format of the intervention would be problematic with respect to social distancing, reduced capacity, and the risk-benefit ratio for participants. The team concluded that online delivery of the course was the optimal solution. As a result of online delivery, geographical restrictions became irrelevant so recruitment could be conducted nationally. Finally, given preferable limitations to close contact, data collection was moved to an online interface.
Given these changes to fundamental aspects of study design, stage 1 feasibility results became effectively meaningless. Those relating to recruitment processes, intervention delivery, and data collection were simply not transferable to the new study design. This necessitated an additional feasibility stage to assess the new design elements, before moving on to the larger-scale pilot trial. Although our plans were accepted by the funder, there was an impact on timescales and costs.
Having reflected on this experience and the impact of COVID-19 on my wider research portfolio, I have identified several areas that other CAM researchers may find valuable to consider:
- Intervention format: some CAMs are group interventions that face similar issues to the HEADS: UP study – social distancing requires reduced capacity and participants still face additional risk. Reduced capacity will influence cost effectiveness, intervention delivery timetable, and staffing. Online delivery may be feasible for some interventions (e.g. mindfulness courses, herbalist consultations) but not for all – despite amazing technological advances, it is not yet possible to receive a massage, for example, over the internet. Thus researchers planning CAM studies based on interventions that require close physical contact (e.g. massage, acupuncture, shiatsu) need to mitigate the additional risks or consider postponing that strand of research. It could be argued that, even when several interventions could be potentially feasible for online delivery, some lend themselves more naturally to online delivery than others (e.g. mindfulness vs yoga or tai chi).
- Recruitment: online delivery potentially opens up recruitment, which may have been based on geographical centres, to a national level. Given that recruitment is a perennial problem in clinical research, this is a net benefit. Recruiting to studies of close proximity CAMS will need to present the additional risks whilst still attempting to appear to be attractive to potential participants. A higher reliance on social media and other virtual networking options may be required.
- Data collection: reducing risk by limiting face to face contact is preferable, which highlights the need to prioritise online data collection where possible. Although raising questions of IT literacy and access, it is relatively easy to administer questionnaires on electronic systems. The pros and cons of online interviews or focus groups should be weighed up on an individual basis – the reduced risk of online interviews needs to be balanced against the limitations in rapport building and personal dynamics.