BEST3 - A trial of a new GP-based test for patients with heartburn symptoms

Conditions

Specialty: Primary Care, Primary sub-specialty: Cancer

Ghimire B, Landy R, Maroni R, Smith SG, Debiram-Beecham I, Sasieni PD, Fitzgerald RC, Rubin G, Walter FM, Waller J, BEST3 Consortium, Offman J.

2023-01-103 citations

10.1186/s12876-022-02630-1

Patient-reported experiences and views on the Cytosponge test: a mixed-methods analysis from the BEST3 trial

Roberta Maroni, Jessica Barnes, Judith Offman, Fiona Scheibl, Samuel G. Smith et al. (11 authors)

BMJ Open2022-04-0122 citations

10.1136/bmjopen-2021-054258

Use of a Cytosponge biomarker panel to prioritise endoscopic Barrett's oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot.

Pilonis ND, Killcoyne S, Tan WK, O'Donovan M, Malhotra S, Tripathi M, Miremadi A, Debiram-Beecham I, Evans T, Phillips R, Morris DL, Vickery C, Harrison J, di Pietro M, Ortiz-Fernandez-Sordo J, Haidry R, Kerridge A, Sasieni PD, Fitzgerald RC.

2022-01-1145 citations

10.1016/s1470-2045(21)00667-7

Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.

Fitzgerald RC, di Pietro M, O'Donovan M, Maroni R, Muldrew B, Debiram-Beecham I, Gehrung M, Offman J, Tripathi M, Smith SG, Aigret B, Walter FM, Rubin G, BEST3 Trial team, Sasieni P.

2020-08-01174 citations

10.1016/s0140-6736(20)31099-0

Barrett’s oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux

Judith Offman, Beth Muldrew, Maria O’Donovan, Irene Debiram–Beecham, Francesca Pesola et al. (18 authors)

BMC Cancer2018-08-0350 citations

10.1186/s12885-018-4664-3

Acceptability of the Cytosponge procedure for detecting Barrett's oesophagus: a qualitative study

Madeleine Freeman, Judith Offman, Fiona M Walter, Peter Sasieni, Samuel G. Smith

BMJ Open2017-03-0138 citations

10.1136/bmjopen-2016-013901

Interventions

120 practices will be randomised on a 1:1 basis to either the intervention or control arm. Practices will be randomised via block randomisation and be stratified by number of eligible patients. A clus

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 50 years and over 2. Records of at least 6 months of prescription for acid-suppressant medication in the last year

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 15/08/2017: 1. Recorded regular prescriptions of NSAIDs 2. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database 3. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour 4. Recorded diagnosis of Barrett’s oEsophagus (BE) 5. Unable to attend the GP surgery 6. Deemed not fit enough by their GP Previous exclusion criteria: 1. Recorded regular prescriptions of NSAIDs 2. Recorded regular prescription of Clopidogrel 3. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database 4. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour 5. Recorded diagnosis of Barrett’s oEsophagus (BE) 6. Unable to attend the GP surgery 7. Deemed not fit enough by their GP

Design outcomes

Primary

Measure	Time frame
Effectiveness is assessed using GP and hospital records of histologically-confirmed Barrett’s oesophagus at 12 months post GP recruitment.	—

Secondary

Measure	Time frame
1. Cost-effectiveness is assessed using GP and hospital records to determine mean cost per patient receiving the Cytosponge™ -TFF3 test versus usual care and incremental cost per QALY gained of the Cytosponge™ TFF3 test versus usual care at 12 months post GP recruitment 2. Patient acceptability is measured using a bespoke questionnaire at 7-14 days post procedure 3. Accuracy is measured using Positive Predictive Value (PPV) and Negative Predictive Value (NPV) in relation to the length of BE at 12 months post GP recruitment 4. Safety is measured using number of adverse events reported by patients up to 7 days post procedure	—

Measure

Time frame

1. Cost-effectiveness is assessed using GP and hospital records to determine mean cost per patient receiving the Cytosponge™ -TFF3 test versus usual care and incremental cost per QALY gained of the Cytosponge™ TFF3 test versus usual care at 12 months post GP recruitment 2. Patient acceptability is measured using a bespoke questionnaire at 7-14 days post procedure 3. Accuracy is measured using Positive Predictive Value (PPV) and Negative Predictive Value (NPV) in relation to the length of BE at 12 months post GP recruitment 4. Safety is measured using number of adverse events reported by patients up to 7 days post procedure

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Countries

England, United Kingdom

Contacts

Public ContactAisling Redmond

amr75@MRC-CU.cam.ac.uk+44 (0)207 882 2932

Outcome results

None listed