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Abstract
Objectives To examine the feasibility and acceptability of breath research in primary care.
Design Non-randomised, prospective, mixed-methods cross-sectional observational study.
Setting Twenty-six urban primary care practices.
Participants 1002 patients aged 18–90 years with gastrointestinal symptoms.
Main outcome measures During the first 6 months of the study (phase 1), feasibility of patient enrolment using face-to-face, telephone or SMS-messaging (Short Message Service) enrolment strategies, as well as processes for breath testing at local primary care practices, were evaluated. A mixed-method iterative study design was adopted and outcomes evaluated using weekly Plan-Do-Study-Act cycles, focus groups and general practitioner (GP) questionnaires.
During the second 6 months of the study (phase 2), patient and GP acceptability of the breath test and testing process was assessed using questionnaires. In addition a ‘single practice’ recruitment model was compared with a ‘hub and spoke’ centralised recruitment model with regards to enrolment ability and patient acceptability.
Throughout the study feasibility of the collection of a large number of breath samples by clinical staff over multiple study sites was evaluated and quantified by the analysis of these samples using mass spectrometry.
Results 1002 patients were recruited within 192 sampling days. Both ‘single practice’ and ‘hub and spoke’ recruitment models were effective with an average of 5.3 and 4.3 patients accrued per day, respectively. The ‘hub and spoke’ model with SMS messaging was the most efficient combined method of patient accrual. Acceptability of the test was high among both patients and GPs. The methodology for collection, handling and analysis of breath samples was effective, with 95% of samples meeting quality criteria.
Conclusions Large-scale breath testing in primary care was feasible and acceptable. This study provides a practical framework to guide the design of Phase III trials examining the performance of breath testing in primary care.
- gastrointestinal tumours
- primary care
- gastroenterology
Data availability statement
Data are available on reasonable request. Relevant anonymised data are included in the article or uploaded as online supplemental information. Additional anonymised data are available on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Data availability statement
Data are available on reasonable request. Relevant anonymised data are included in the article or uploaded as online supplemental information. Additional anonymised data are available on reasonable request.
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Footnotes
Contributors All authors made substantial contributions to the work; specifically GW and GBH conceived the work with IB, PRB, CvW and AJC making substantial contributions to the design, CvW in particular with regards to the patient acceptability questionnaire. GW planned and executed the study process. GW, IB, PRB, AW and MF contributed to data acquisition and analysis, with interpretation overseen by CvW, AJC and GBH. GW, IB and PRB drafted the first manuscript version, where all authors revised it critically and then approved the final version. All authors can account for the integrity of this work.
Funding The research was supported by awards from Rosetrees and Stoneygate Trusts via Imperial College Charity (grant number 171812) and by infrastructure funding from the NIHR London In Vitro Diagnostic Cooperative programme (grant number P67522). Piers R Boshier was funded by the NIHR (grant number not applicable).
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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