What's the new normal for research?

Katie High (Research Assistant) and Alexandria Phillips (Research Therapist).

As clinicians, Covid-19 has dramatically affected our working lives in multiple ways, including upending psychological research. The National Institute for Health Research (NIHR) has paused the site set up of new and ongoing clinical research not directly related to Covid-19 (NIHR, 2020). This includes delaying the start of new studies. If we know what has had to change for those studies remaining open, we can understand not only the implications of the changes but also how detrimental effects might be mitigated in the future if further lockdowns occur. 

With much of the country working remotely from home or furloughed, some studies have found that they need to re-design and adapt their trial protocol in order to adhere to government guidance and protect participants and colleagues. Specific adaptations vary depending on the study and their ability to make these changes. This may then affect data collection. For example, ongoing studies remotely collecting participant outcome data may no longer be directly comparable with participants finishing the study just four months ago. Researchers will need to make the decision as to whether to treat these as two datasets, significantly reducing their sample size and thus power of any inferential tests, or account for these differences by adapting their statistical analysis. As we are faced with these issues, we wonder whether there should be national guidelines for the analysis of data collected during this time period, taking into consideration that the stressors arising as a result of the pandemic may affect mental health and could therefore be a confounding factor for these studies. 

Pausing research in light of the pandemic may in turn contribute to drop-out and attrition in longitudinal studies (Twiske & de Vente, 2002). Losing participants to follow up may affect the ability to answer some hypotheses or could result in biased inferences. Attrition will also have a significant impact on sample sizes and therefore affect the ability to generalise the results. There may be additional considerations of dropping therapeutic arms in the middle of a study which may prove detrimental or interfere with the therapeutic effects if they are continued, for instance, if caring duties increased during the lockdown period.

Restarting projects following a break can also result in recruitment becoming more difficult, because trained researchers have left the project or because participants say they are “not in the right place to take part” in the study. All these effects could undermine the long term and costly research investment and undermine participant trust in mental health research. 

An example where the current guidelines have most effects is when studies measure either current mental state or functioning measures, such as participant activity, for example with the GAS (Goal Attainment Scale), and the Meaningful Activity Participation Assessment (MAPA). These may now not accurately reflect a participants’ state of mind as we know that there have been increases in mental health problems (COPE Study, in prep) and activity levels are restricted from by national guidelines. The measures could be adapted by reverting to attainment levels before lockdown… although the lockdown has been in place for so long that it may be hard to remember life before the pandemic. On the other hand, some computerised measures have remote assessment capabilities built into their software, including pre-recorded instructions and therefore can be completed remotely online. Again, there are difficulties of participant engagement without a researcher present and the potential for increasing the digital divide. 

Symptom rating scales which ask about the past week or two, such as the Positive and Negative Syndrome scale (PANSS), which assesses symptom severity of people with schizophrenia, and those such as DEMQOL, an assessment of health-related quality of life of people with dementia, are problematic to adapt due to the time period measured. A review of the psychological impact of quarantine identifies several adverse effects including emotional disturbance, depression, stress, difficulty sleeping, low mood, irritability, and anger (Brooks et al., 2020), so any mental state examination is likely to have amplified levels of specific symptoms which may also affect the overall mental state, even of those not directly implicated such as the positive symptoms of schizophrenia. 

In addition to considering the pandemic’s impact on study findings, we need to consider the effect on participants of ongoing research. Poor follow up and trial closures can have significant psychological impact on participants (Naidoo et al., 2020); these effects may be worse in the context of a pandemic. Research participation can provide structure to people’s lives, a sense of meaning and access to effective treatment (Naidoo et al., 2020). Pausing research can restrict these benefits and therefore continuation of research is encouraged by NIHR in these cases. Further research must be conducted to evaluate the impact of the pandemic on research participants and the ethical ramifications of pausing or adapting research protocols. 

Meaningful and valid

This leads us to question of what will be the ‘new normal’ for research. Looking 6-12 months into the future, when the trials that have remained open will publish their findings and we are planning to make clinical decisions based on the evidence provided. Will this evidence still be credible? Projects that have been put on hold will be restarting, but we do not know the best way to do this. To continue generating generalisable, evidence-based findings it is crucial for research to continue or begin to reopen its recruitment. To ensure the safety of both our prospective participants and ourselves, we must continue to follow national guidelines, and liaise with community teams to ensure that we contact individuals at appropriate times and monitor their mental wellbeing. We could also examine new ways of working and their effects on diverse populations such as the effectiveness of completing assessments and providing psychological interventions remotely (via telephone or Skype), as this could potentially become a new way of working within clinical research.    

In order to ensure research continues to be meaningful and valid we encourage working alongside patients and the public in the forms of advisory groups to gain their feedback on protocol amendments and to set the priorities for future plans in relation to the study. In these unprecedented times it is important to be responsive in decision making, taking into consideration all the information and options available. Working collaboratively with people who have lived experience is imperative to this process.

Adjusting to our ‘new normal’ requires us to be innovative and solution focused, working in a timely manner to ensure the agreement of all stakeholders in the research process. However, we also need to think about how adaptations and changes now will affect research, the evidence base and ultimately practice down the line. We need to take into consideration and balance the responsibilities core to clinical psychology to conduct gold standard research for the benefit of the end user. 

References

Brooks, S. K., Webster, R. K., Smith, L. E., Woodland, L., Wessely, S., Greenberg, N., & Rubin, G. J. (2020). The psychological impact of quarantine and how to reduce it: rapid review of the evidence. The Lancet.

COPE Study: Investigating the impact of the COVID-19 pandemic on mental health and well-being. Retrieved 02/07/2020 from https://www.maudsleybrc.nihr.ac.uk/posts/2020/april/cope-study-investigating-the-impact-of-the-covid-19-pandemic-on-mental-health-and-well-being/

Hodgekins, J. Time Use Survey, Presentation slides, University of East Anglia.

Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261–276.

Naidoo, N., Thu Ngyuen, V., Ravaud, P., Young, B., Amiel, P., Schante, D., Clarke., M., & Boutron, I. (2020). The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med 18, 6 https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1476-5

NIHR, National Institute of Health Research. (2020). Q&A on the impact of COVID-19 on research funded or supported by NIHR https://www.nihr.ac.uk/news/dhsc-issues-guidance-on-the-impact-on-covid-19-on-research-funded-or-supported-by-nihr/24469

Twisk, J., & de Vente, W. (2002). Attrition in longitudinal studies: how to deal with missing data. Journal of clinical epidemiology, 55(4), 329-337.​

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