Randomized Controlled Trial

. 2023 Jan 10;23(1):7.

doi: 10.1186/s12876-022-02630-1.

Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial

Bhagabati Ghimire^#^{1

2}, Rebecca Landy^#³, Roberta Maroni⁴, Samuel G Smith⁵, Irene Debiram-Beecham⁶, Peter D Sasieni¹, Rebecca C Fitzgerald^{6

7}, Greg Rubin⁸, Fiona M Walter^{9

10}, Jo Waller¹; BEST3 Consortium; Judith Offman^{11

12}

Collaborators, Affiliations

Collaborators

BEST3 Consortium:
Stephen Attwood, Max Parmar, Brendan Delaney, John de Caestecker, Wendy Atkin, Allan Hackshaw, Charles van Heyningen, Tim Underwood, Alberto Stella, Charlotte Saxby, Attila Lorincz, Naomi Turnbull, Jamie Doorbar, Georgia Mannion-Krase, Irene Kaimi, Mary Kasanicki, Stephen Kelleher, Louise Stockley, Tracy Assari, Sonakshi Kadyan, Victoria Hollamby, Katie Edwards, Helen MacDonald, Viv Shaw, Heather Leishman, Holly Roper, Kate McCloskey, Helen Jung, Alex Phillips, Gosia Masjak-Newman, Kim Fell, Helen Collins, Olga Zolle, Pauline McGlone, Tania Crabb, Lauren Merrin, Martine Cross, Alex Jones, Tom Simpson, Emma Murray, Andrew Perugia, Marie Thompson, Jen Dumbleton, Monique Morar, Nadia Frowd, Antonia Hardcastle, Debbie Carmichael, Fiona Maxton, Frances Farnworth, Elaine Baddeley

Affiliations

¹ Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.
² Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University London, London, UK.
³ Division of Cancer Epidemiology and Genetics, Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁴ Cancer Research UK and King's College London Cancer Prevention Trials Unit, Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.
⁵ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
⁶ Early Cancer Institute, Department of Oncology, University of Cambridge, Cambridge, UK.
⁷ Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁸ Population Health Sciences Institute, Newcastle University, 5th Floor, Ridley 1, Newcastle Upon Tyne, UK.
⁹ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
¹⁰ Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
¹¹ Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK. judith.offman@kcl.ac.uk.
¹² Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK. judith.offman@kcl.ac.uk.

^# Contributed equally.

PMID: 36627580
PMCID: PMC9832657
DOI: 10.1186/s12876-022-02630-1

Randomized Controlled Trial

Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial

Bhagabati Ghimire et al. BMC Gastroenterol. 2023.

. 2023 Jan 10;23(1):7.

doi: 10.1186/s12876-022-02630-1.

Authors

Collaborators

BEST3 Consortium:
Stephen Attwood, Max Parmar, Brendan Delaney, John de Caestecker, Wendy Atkin, Allan Hackshaw, Charles van Heyningen, Tim Underwood, Alberto Stella, Charlotte Saxby, Attila Lorincz, Naomi Turnbull, Jamie Doorbar, Georgia Mannion-Krase, Irene Kaimi, Mary Kasanicki, Stephen Kelleher, Louise Stockley, Tracy Assari, Sonakshi Kadyan, Victoria Hollamby, Katie Edwards, Helen MacDonald, Viv Shaw, Heather Leishman, Holly Roper, Kate McCloskey, Helen Jung, Alex Phillips, Gosia Masjak-Newman, Kim Fell, Helen Collins, Olga Zolle, Pauline McGlone, Tania Crabb, Lauren Merrin, Martine Cross, Alex Jones, Tom Simpson, Emma Murray, Andrew Perugia, Marie Thompson, Jen Dumbleton, Monique Morar, Nadia Frowd, Antonia Hardcastle, Debbie Carmichael, Fiona Maxton, Frances Farnworth, Elaine Baddeley

Affiliations

¹ Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.
² Department of Health Sciences, College of Health, Medicine and Life Sciences, Brunel University London, London, UK.
³ Division of Cancer Epidemiology and Genetics, Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁴ Cancer Research UK and King's College London Cancer Prevention Trials Unit, Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.
⁵ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
⁶ Early Cancer Institute, Department of Oncology, University of Cambridge, Cambridge, UK.
⁷ Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁸ Population Health Sciences Institute, Newcastle University, 5th Floor, Ridley 1, Newcastle Upon Tyne, UK.
⁹ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
¹⁰ Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
¹¹ Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK. judith.offman@kcl.ac.uk.
¹² Centre for Prevention, Detection and Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK. judith.offman@kcl.ac.uk.

^# Contributed equally.

PMID: 36627580
PMCID: PMC9832657
DOI: 10.1186/s12876-022-02630-1

Abstract

Background: The Cytosponge is a cell-collection device, which, coupled with a test for trefoil factor 3 (TFF3), can be used to diagnose Barrett's oesophagus, a precursor condition to oesophageal adenocarcinoma. BEST3, a large pragmatic, randomised, controlled trial, investigated whether offering the Cytosponge-TFF3 test would increase detection of Barrett's. Overall, participants reported mostly positive experiences. This study reports the factors associated with the least positive experience.

Methods: Patient experience was assessed using the Inventory to Assess Patient Satisfaction (IAPS), a 22-item questionnaire, completed 7-14 days after the Cytosponge test.

Study cohort: All BEST3 participants who answered ≥ 15 items of the IAPS (N = 1458).

Statistical analysis: A mean IAPS score between 1 and 5 (5 indicates most negative experience) was calculated for each individual. 'Least positive' experience was defined according to the 90th percentile. 167 (11.4%) individuals with a mean IAPS score of ≥ 2.32 were included in the 'least positive' category and compared with the rest of the cohort. Eleven patient characteristics and one procedure-specific factor were assessed as potential predictors of the least positive experience. Multivariable logistic regression analysis using backwards selection was conducted to identify factors independently associated with the least positive experience and with failed swallow at first attempt, one of the strongest predictors of least positive experience.

Results: The majority of responders had a positive experience, with an overall median IAPS score of 1.7 (IQR 1.5-2.1). High (OR = 3.01, 95% CI 2.03-4.46, p < 0.001) or very high (OR = 4.56, 95% CI 2.71-7.66, p < 0.001) anxiety (relative to low/normal anxiety) and a failed swallow at the first attempt (OR = 3.37, 95% CI 2.14-5.30, p < 0.001) were highly significant predictors of the least positive patient experience in multivariable analyses. Additionally, sex (p = 0.036), height (p = 0.032), alcohol intake (p = 0.011) and education level (p = 0.036) were identified as statistically significant predictors.

Conclusion: We have identified factors which predict patient experience. Identifying anxiety ahead of the procedure and discussing particular concerns with patients or giving them tips to help with swallowing the capsule might help improve their experience. Trial registration ISRCTN68382401.

Keywords: Barrett’s oesophagus; Cytosponge; Inventory to assess patient satisfaction; Patient experience.

PubMed Disclaimer

Conflict of interest statement

RCF is named on patents related to the Cytosponge and related assays that have been licenced to Medtronic by the Medical Research Council. RCF is a shareholder in Cyted Ltd, a company working on early detection technology. PDS reports consulting fees paid to his organisation from GRAIL Inc, outside of the submitted work and being on the advisory committee for NHS England on the use of the Cytosponge (unpaid). The remaining authors have no conflicts of interest to declare.

Figures

**Fig. 1**
Trial flowchart for the IAPS analysis of the BEST3 trial

See this image and copyright information in PMC

References

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1. Thrift AP. Global burden and epidemiology of Barrett oesophagus and oesophageal cancer. Nat Rev Gastroenterol Hepatol. 2021;18(6):432–443. doi: 10.1038/s41575-021-00419-3. - DOI - PubMed
1. Dulai GS, Guha S, Kahn KL, Gornbein J, Weinstein WM. Preoperative prevalence of Barrett's esophagus in esophageal adenocarcinoma: a systematic review. Gastroenterology. 2002;122(1):26–33. doi: 10.1053/gast.2002.30297. - DOI - PubMed
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Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial

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Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial

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Collaborators

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Abstract

Conflict of interest statement

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