Patient perspectives about participation in a chronic rhinosinusitis
trial during the COVID pandemic: a qualitative study.
Key points
- Telephone interviews were conducted with 19 MACRO trial participants
from 5 ENT sites across the UK.
- Trial participants experienced mixed levels of communication during
the COVID period and some felt uninformed about the trial status and
their clinical situation.
- Participants were most concerned about getting COVID through
interactions with other patients in hospital settings. Conversely,
there was a high level of trust in healthcare professionals.
- Pre-visit COVID-safety information, minimising contact with other
patients, and strict waiting room management can facilitate the
restart of the MACRO trial from the patient perspective.
- Patient confidence in trial participation is likely to continue
improving with COVID vaccination roll out.
Introduction
The NIHR-funded MACRO trial has been designed to evaluate endoscopic
sinus surgery (ESS) and clarithromycin in the management of patients
with chronic rhinosinusitis (CRS)1. The trial opened
to recruitment in 2018 and by March 2020 was actively recruiting at 15
ENT sites across the UK. The onset of the COVID pandemic brought about
considerable changes to clinical services and NIHR prioritisation of
COVID-19 research studies. Consequently, MACRO trial recruitment was
paused. In May 2020, the NIHR published a framework to support the
restart of research activities2. Preconditions for
restarting paused studies included careful consideration of research
viability, research safety, and site capacity/readiness.
As part of getting ready to restart the MACRO trial, we recognised the
importance of exploring the CRS patient perspective, with particular
focus on their priorities, concerns and expectations for taking part in
a clinical trial during the COVID period, and to identify strategies to
minimise any potential anxieties around COVID safety.
Methods
We purposefully sampled 19 trial participants from 5 ENT recruitment
sites in England to take part in a telephone interview. Participants had
given consent to interview as part of the MACRO trial which received
ethical approval from the North East - Newcastle & North Tyneside 2
Research Ethics Committee on 20th September 2018 (REC ref.:
18/NE/0210)3. Participants were contacted by email or
telephone by a researcher to arrange a suitable time for interview. We
included participants with a range of characteristics including age,
gender, treatment group (ESS, clarithromycin, placebo), +/-nasal polyps
and prior ESS. A topic guide was used to structure the interviews but
also allowed exploration of particular topics that were important to the
participants. We asked questions about their current views of CRS
treatments, concerns about COVID, and potential barriers and
facilitators to participating in the trial. The interviews were
conducted between Nov 2000 and Feb 2021 by two experienced qualitative
researchers (CM and SW) who were unknown to the participants. The
average length of interview was 25 minutes. All interviews were
audio-recorded and transcribed verbatim, and field notes captured
contextual information. Data was managed using NVivo qualitative data
analysis software4. We conducted a qualitative
thematic analysis5 of the interview data (a method of
detailed coding of the interview transcripts, and identifying themes
through refining codes and discussing within the research team). We
report the findings according to the COREQ (Consolidated criteria for
Reporting Qualitative research) checklist6.
Findings
Table 1 presents the characteristics of the participants who took part
in the study.
The findings of the study are presented in three themes: i) experiences
of trial participation, ii) safety concerns, iii) facilitating the
restart of the MACRO trial.
Experiences of trial participation during the COVID
pandemic
Participants’ reported mixed experiences of trial participation during
the first 6 months of the pandemic. Some reported feeling well-supported
by the clinical team, with good communication about the trial, their
future care and how to contact the team if needed. “I can’t
praise the process enough. I would certainly do another trial, and I
wouldn’t think about it at all. (Participant 12, female, medical arm)
In contrast, other participants felt communication paused once the
pandemic started, reporting that they felt confused or unclear about key
aspects of the trial, and the management of their CRS. This included
uncertainty about whether they had finished the trial; whether they were
to expect further treatment, and whether to report any new medical
problems or adverse events to the trial team.
“I realise that things are difficult obviously at the moment, and
so that wouldn’t necessarily be seen by them as being a huge priority.
On the other hand, what is the concluding step in the research?
(Participant 6, male, surgical arm)
Most participants were understanding about the delays and reduced
communication. However, participants who had experienced a return of
their CRS symptoms or who were uncertain about their follow on treatment
were particularly eager for communication to resume.
“I’ve a significant improvement, generally very happy, but would
like a few more answers as to why I might have experienced a second loss
of senses. (participant 13, male, surgical arm)
COVID safety concerns
Whilst a third of the participants interviewed expressed no concern
about participating in a trial during the COVID pandemic, the others
described being unwilling to participate until the COVID risks reduced,
or would need to weigh up the risks versus potential benefits.
Participants were most concerned about possible exposure to COVID from
mixing with other members of the public, especially in the main hospital
entrances and foyer, waiting areas and toilet areas. Participants
expressed minimal confidence that other members of the public would
adhere to social distancing or other COVID safety precautions.