TY - JOUR
T1 - Patient-reported experiences and views on the Cytosponge test
T2 - a mixed-methods analysis from the BEST3 trial
AU - BEST3 Consortium
AU - Maroni, Roberta
AU - Barnes, Jessica
AU - Offman, Judith
AU - Scheibl, Fiona
AU - Smith, Samuel
AU - Debiram-Beecham, Irene
AU - Waller, Jo
AU - Sasieni, Peter
AU - Fitzgerald, Rebecca C.
AU - Rubin, Greg
AU - Walter, Fiona
N1 - Funding Information:
This research is linked to the CanTest Collaborative, which is funded by Cancer Research UK (C8640/A23385), of which FMW is Director and GR is Chair of the Steering Committee. We would also like to acknowledge patient input from Heartburn Cancer UK, and the contributions of our CanTest PPI lead, Mrs Margaret Johnson. We acknowledge the contribution of statistician Irene Kaimi, who had a leading role early in the trial but who tragically died before the study was completed. We thank all of the sites and patients who participated in the BEST3 trial, without whom this research would not have been possible.
Funding Information:
The laboratory of RCF is funded by a Core Programme Grant from the Medical Research Council (RG84369). The BEST3 study was primarily funded by Cancer Research UK (C14478/A21047). The National Institute for Health Research (NIHR) covered service support costs and National Health Service commissioners funded excess treatment costs, while Medtronic funded Cytosponge devices and TFF3 antibodies. This research was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215–20014). Cancer Research UK provide funding to the Cancer Prevention Trials Unit (C8162/A25356) and Cancer Prevention Group at King’s College London (C8162/A16892). SS is supported by a Yorkshire Cancer Research Fellowship (L389SS). JW is funded by a Cancer Research UK career development fellowship (C7492/A17219).
Funding Information:
The laboratory of RCF is funded by a Core Programme Grant from the Medical Research Council (RG84369). The BEST3 study was primarily funded by Cancer Research UK (C14478/A21047). The National Institute for Health Research (NIHR) covered service support costs and National Health Service commissioners funded excess treatment costs, while Medtronic funded Cytosponge devices and TFF3 antibodies. This research was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215–20014). Cancer Research UK provide funding to the Cancer Prevention Trials Unit (C8162/A25356) and Cancer Prevention Group at King’s College London (C8162/A16892). SS is supported by a Yorkshire Cancer Research Fellowship (L389SS). JW is funded by a Cancer Research UK career development fellowship (C7492/A17219)
Publisher Copyright:
©
PY - 2022/4
Y1 - 2022/4
N2 - OBJECTIVES: The BEST3 trial demonstrated the efficacy and safety of the Cytosponge-trefoil factor 3, a cell collection device coupled with the biomarker trefoil factor 3, as a tool for detecting Barrett's oesophagus, a precursor of oesophageal adenocarcinoma (OAC), in primary care. In this nested study, our aim was to understand patient experiences. DESIGN: Mixed-methods using questionnaires (including Inventory to Assess Patient Satisfaction, Spielberger State-Trait Anxiety Inventory-6 and two-item perceived risk) and interviews. OUTCOME MEASURES: Participant satisfaction, anxiety and perceived risk of developing OAC. SETTING: General practices in England. PARTICIPANTS: Patients with acid reflux enrolled in the intervention arm of the BEST3 trial and attending the Cytosponge appointment (N=1750). RESULTS: 1488 patients successfully swallowing the Cytosponge completed the follow-up questionnaires, while 30 were interviewed, including some with an unsuccessful swallow.Overall, participants were satisfied with the Cytosponge test. Several items showed positive ratings, in particular convenience and accessibility, staff's interpersonal skills and perceived technical competence. The most discomfort was reported during the Cytosponge removal, with more than 60% of participants experiencing gagging. Nevertheless, about 80% were willing to have the procedure again or to recommend it to friends; this was true even for participants experiencing discomfort, as confirmed in the interviews.Median anxiety scores were below the predefined level of clinically significant anxiety and slightly decreased between baseline and follow-up (p < 0.001). Interviews revealed concerns around the ability to swallow, participating in a clinical trial, and waiting for test results.The perceived risk of OAC increased following the Cytosponge appointment (p<0.001). Moreover, interviews suggested that some participants had trouble conceptualising risk and did not understand the relationships between test results, gastro-oesophageal reflux and risk of Barrett's oesophagus and OAC. CONCLUSIONS: When delivered during a trial in primary care, the Cytosponge is well accepted and causes little anxiety. TRIAL REGISTRATION NUMBER: ISRCTN68382401.
AB - OBJECTIVES: The BEST3 trial demonstrated the efficacy and safety of the Cytosponge-trefoil factor 3, a cell collection device coupled with the biomarker trefoil factor 3, as a tool for detecting Barrett's oesophagus, a precursor of oesophageal adenocarcinoma (OAC), in primary care. In this nested study, our aim was to understand patient experiences. DESIGN: Mixed-methods using questionnaires (including Inventory to Assess Patient Satisfaction, Spielberger State-Trait Anxiety Inventory-6 and two-item perceived risk) and interviews. OUTCOME MEASURES: Participant satisfaction, anxiety and perceived risk of developing OAC. SETTING: General practices in England. PARTICIPANTS: Patients with acid reflux enrolled in the intervention arm of the BEST3 trial and attending the Cytosponge appointment (N=1750). RESULTS: 1488 patients successfully swallowing the Cytosponge completed the follow-up questionnaires, while 30 were interviewed, including some with an unsuccessful swallow.Overall, participants were satisfied with the Cytosponge test. Several items showed positive ratings, in particular convenience and accessibility, staff's interpersonal skills and perceived technical competence. The most discomfort was reported during the Cytosponge removal, with more than 60% of participants experiencing gagging. Nevertheless, about 80% were willing to have the procedure again or to recommend it to friends; this was true even for participants experiencing discomfort, as confirmed in the interviews.Median anxiety scores were below the predefined level of clinically significant anxiety and slightly decreased between baseline and follow-up (p < 0.001). Interviews revealed concerns around the ability to swallow, participating in a clinical trial, and waiting for test results.The perceived risk of OAC increased following the Cytosponge appointment (p<0.001). Moreover, interviews suggested that some participants had trouble conceptualising risk and did not understand the relationships between test results, gastro-oesophageal reflux and risk of Barrett's oesophagus and OAC. CONCLUSIONS: When delivered during a trial in primary care, the Cytosponge is well accepted and causes little anxiety. TRIAL REGISTRATION NUMBER: ISRCTN68382401.
KW - Barrett’s oesophagus
KW - primary care
KW - oesophageal cancer
KW - Cytosponge
KW - anxiety
KW - perceived risk
KW - patient satisfaction
KW - acceptability
KW - mixed methods
KW - questionnaires
KW - interviews
UR - http://www.scopus.com/inward/record.url?scp=85134439997&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-054258
DO - 10.1136/bmjopen-2021-054258
M3 - Article
SN - 2044-6055
VL - 12
SP - e054258
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e054258
ER -
