Patient reported outcomes of home diagnostics with colon capsule endoscopy – results from the 5G-SUCCEEDS study

Introduction

Evaluation of patients with lower GI symptoms (low-intermediate risk group) represents significant pressure for colonoscopy services. The COVID-19 pandemic, and the resulting elective care recovery, has placed significant pressure on healthcare systems. ¹ The aerosol generating potential of endoscopy led to multiple gastroenterology and endoscopy clinical societies suggesting immediate cessation of all but emergency colonoscopy during the peak phase of the pandemic, putting colonoscopy capacity under greater stress and reducing the rates of colorectal cancer diagnosis.^1–4

To reduce potential diagnostic delays, the accuracy and role of colon capsule endoscopy (CCE) as a non-invasive diagnostic test is being increasingly recognised.^5,6 In centres with availability, the European Society of Gastrointestinal Endoscopy and European Society of Gastrointestinal and Abdominal Radiology suggest that CCE may be considered in patients with ‘non-alarm' symptoms as an alternative to colonoscopy, although further evidence is needed. ⁷ In the English National Health Service (NHS), a national pilot has recently been completed to evaluate CCE as a first-line diagnostic test for patients with a positive faecal immunochemical test (FIT).^8,9

As well as the burden on healthcare systems, patients have also reported finding the colonoscopy procedure uncomfortable. Difficulties encountered by patients included anxiety, the anticipation of pain, and feelings of embarrassment and vulnerability. ¹⁰ CCE allows for colonic assessment by eliminating the need for instrument insertion, gas insufflation or sedation along with associated pain. In CCE, after laxative bowel cleansing, patients swallow an ingestible pill-like capsule containing miniature cameras that travels through the gut providing full images of the bowel. The imaging data is sent to a data receiver which the patient wears on a belt.

At present, in settings performing CCE, patients are required to attend a clinic location, usually attended by one healthcare professional. In the clinic, patients are fitted with the receiver belt and a healthcare professional supervises oral administration of the disposable capsule. University Hospitals Coventry and Warwickshire NHS Trust (UHCW), a teaching hospital in England, has conducted a small-scale feasibility study of a home delivery service with patient self-administration of CCE, ¹¹ facilitated by 5G technology and the widespread use and proliferation of videoconferencing in people’s day-to-day life, work and healthcare since the COVID 19 pandemic. ¹² Called 5G-SUCCEEDS (Setting Up CCE home Delivery System), patients are courier-delivered a InteliGI Smartbox containing the bowel preparation solutions, colon capsule, belt and system recorder, along with an electronic tablet, cellular WiFi device and GPS tracking device to allow for remote communication with clinical staff ¹¹ (Figure 1.).OPEN IN VIEWER

The primary objective of the 5G SUCCEEDS feasibility study of 25 participants was to assess the feasibility of home delivery of CCE service. ¹¹ This paper reports on the patient experience and acceptability of undertaking CCE at home with a focus on:

• Patient perspective - levels of confidence, satisfaction, convenience, and experience of the service.

Methods

A mixed methods process service evaluation used a patient survey and interviews to explore patient experiences as part of a prospective feasibility study (5G-SUCEEDS) designed to test the feasibility, patient acceptability and carbon impact of delivering CCE to patients in their home. This study was approved by the Health Research Authority (HRA) and Health and Care Research Wales (IRS number: 311685). Patients eligible for the 5G-SUCCEEDS study were referred to the hospital from primary care with lower gastrointestinal symptoms with low or intermediate risk for colorectal cancer or were from a post-polypectomy surveillance group. ¹¹ Age, sex, and ethnicity were collected as part of the main 5G-SUCCEEDS feasibility study (Table 1) but were not analysed within this patient experience sub-study, and interview participants were not sampled based on demographic or socioeconomic characteristics.

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Table 1.

Baseline characteristics.

Mean age(years)	51	​
Gender	8 (32 %)	Female
	17 (68 %)	Male
Ethnicity	24 (96 %)	White
	1 (4 %)	Black

Twenty five patient participants were recruited to the feasibility study. As part of the recruitment and consent process, participants were offered a choice between colonoscopy and CCE. Participants were informed that CCE is a diagnostic procedure, that polyps cannot be removed during CCE, and that follow-up colonoscopy might be required if the examination was incomplete or pathology was detected.

All 25 participants of the 5G SUCCEEDS study were asked to complete a paper survey, given to them with the InteliGI Smartbox and returned along with the Smartbox following completion of the CCE procedure (see online supplemental table 1). A convenience sample of patients (based on time and resources) were approached by their clinician by telephone to invite them to participate in an interview. Patient information sheets were supplied to participants and participants provided verbal consent to a written consent form that was read to them over the telephone. If consent was given, an appropriate interview time was agreed with an evaluator. Questionnaires were completed immediately after the CCE procedure and returned with the equipment the following day, whereas interviews were conducted weeks to months later, after participants had been informed of their CCE results.

Interviews were conducted and recorded either via telephone or Microsoft Teams, depending on patient preference. Interviews lasted between 21 and 50 min. One participant requested that their partner listen in to the interview to assist with participant recall, the other interviews were conducted one-to-one with the interviewer. Patients were interviewed once between 1 and 7 months (following approval of the patient experience sub-study by the Research Ethics Committee) after their CCE procedure by a female independent evaluator, (C. Conway, PhD) commissioned from an NHS consultancy to capture patient experience. The evaluator was unknown to the patients prior to being consented by their clinician. Semi-structured interviews were conducted using a topic guide based on the topic guide used by Bond et al., ¹³ and adapted to consider the differences in the services being evaluated (online supplement).

Interview recordings were transcribed and imported into a qualitative data management and analysis software package (NVivo 14, Lumivero). The evaluator reviewed transcripts for accuracy before analysis. No transcripts or analysis were returned to participants for comment. The evaluator used the same thematic coding strategy as Bond et al., ¹³ whereby the nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework’s constructs ¹⁴ were used as a priori themes for organising and coding the data. The NASSS framework allows exploration of the data in the following domains: condition or illness, technology, value proposition (perceived value of service), adopter system (comprising professional staff, patients, and lay caregivers), organisation, wider (institutional and societal) context, and interaction and mutual adaptation between all these domains over time. ¹⁴ Transcripts were also coded inductively with subthemes identified and created in NVivo.

Results

Analytic framework

A similar approach to using the NASSS framework as Bond et al.'s ¹³ study of clinic-managed CCE was employed in this study to thematically organise the data from the semi-structured interviews. Data from this study mapped to only 3 of the 7 primary domains of the NASSS framework: technology, value proposition and the adopter system (see Table 2). Although sub-themes were identified inductively during coding, most of the same sub-themes arose in this study compared to Bond et al., ¹³ which had similar patient pathways; Clinic-managed CCE and CCE home delivery. Notable exceptions were the Smartbox/tablet sub-theme identified under Theme 1: Technology and coding of data to Theme 3: The adopter system.

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Table 2.

Themes from patient experience interviews.

NASSS domain	Study subthemes identified
1. Technology	1.1. Smartbox/electronic tablet
	1.2. Bowel cleansing
	1.3. Colon capsule endoscopy capsule
	1.4. Results
2. Value proposition	2.1. Patient willingness
	2.2. Information and communication
	2.3. Impact on daily life and routine
	2.4. Comparing colon capsule endoscopy to optical colonoscopy
	2.5. Comparing clinic delivered colon capsule endoscopy to at home colon capsule endoscopy
3. The adopter system	3.1 Support required by clinic from caregiver

Discussion

Findings from a survey and interviews with 25 patients were that the home delivery and self-administration of the CCE procedure was acceptable, and for most, preferable to both a colonoscopy and clinic-delivered CCE. Benefits included convenience and comfort of being in their own home and close to their toilet facilities, avoiding any anxiety associated with attending a hospital setting, and the greater convenience and reduced costs of not having to travel, Most patients reported they would be very likely (n = 12 (55%)) or likely (n = 6 (27%)) to have remote CCE if clinically indicated in future. In the 5G-SUCCEEDS study, a high proportion of patients (n = 18, 72%) went on to require further investigations either because the CCE was of insufficient quality (poor bowel preparation) or because positive findings demanded a therapeutic procedure. ¹¹ The conversion rate into a colonoscopy pathway is not static between different studies, and clinicians acknowledge that this could be as low as 28%. ¹¹ A previous meta-analysis of patient preference had found that tolerance of both CCE and colonoscopy was high and that while patient preference before having either procedure favoured CCE, the preference for colonoscopy is much higher after the procedure, indicating that the expectations for colonoscopy may be much worse than the actual experience. ¹⁶ The authors suggest that if the tolerance is very high for both, the risk of two examinations following a positive CCE could be considered too high. ¹⁶ We probed this in the interviews with participants that required further investigations. Of those interviewed, only one participant who had experienced a colonoscopy after CCE would choose a colonoscopy as a first choice if indicated in the future. The other four would still choose at-home CCE if there was the possibility they could avoid colonoscopy, demonstrating a high patient preference for at home CCE over a colonoscopy for investigative procedures. Patient experience and acceptability should be interpreted within the broader diagnostic pathway, particularly where follow-up colonoscopy is required following incomplete examinations or detection of pathology.

While most respondents reported the bowel preparation to be either very easy (n = 10) or easy (n = 7) to use, like Bond et al., ¹³ the interview findings revealed negative experiences with the bowel preparation for CCE. Most patients viewed the bowel prep as an unpleasant procedure but a means to an end. Any improvements that could be made to the taste of the preparations, or to reduce the volume, would improve patient experience of the bowel prep.

Patients felt confident carrying out the procedure in their home but identified that visual confirmation from clinicians (via teleconference) was essential during the procedure to ensure that the belt and recorder were set up properly, something that patients reported they might struggle with, or feel anxious about, on their own. Improvements to simplify the appearance and wearability of the belt and data receiver might reduce the necessity for clinical contact for larger scale-up in the future. All the patients found the electronic tablet device simple to use, even those that did not have any previous experience of teleconferencing. To participate in the 5G SUCCEEDS pilot, patients were required to have a minimum of 3G coverage in their home and be IT literate. The interviews with patients suggested that the level of IT literacy required was minimal, and future roll-out expansions may want to test this latter requirement.

No patients reported any issue swallowing the capsule, even though the capsule was larger than they expected. Five out of the eight patients interviewed said that support of a person with them was not needed. The reported number of capsule aspirations for capsule endoscopy is very low. ¹⁷ For future roll-out and scale-up, consideration might be given to the necessity of having a support person, to enable the procedure for people without access to support. Any removal of this eligibility requirement would have to consider the risks of capsule aspiration.

Once the capsule had been swallowed patients felt able to get on with activities of their choosing, wearing the belt did not particularly interfere with them going about their routines. However, where applicable, patients had taken some off work and the day of the procedure and almost all patients did not leave their home, wanting to be close to toilet facilities. Many felt in retrospect that they might have been able to work but a larger study would be needed to elucidate any potential benefits on patients’ ability to continue to work while receiving home delivery of CCE.

The unlimited (all hours) access to contact a specialist nurse was appreciated and used. Future roll-out will need to consider the level and provision of remote clinical support that can be provided if the service were to be scaled up, in the context of what is currently provided for clinic-managed delivery of CCE.

Receiving results was an area where patient expectation was not always met, with one patient experiencing mixed communication about whether a follow-up colonoscopy was required, and another being informed they needed a follow-up colonoscopy without explanation. Two patients expressed lacking confidence in the technology to detect problems in use. There may be scope to develop protocols/guidance in reporting the results of CCE where these are not already in existence with consideration to including information on the efficacy of CCE as this may offer reassurance to those patients. This should be balanced against the environmental impact of such investigations in line with the NHS Greener plan. ¹⁸ While cost-effectiveness and willingness-to-pay were not assessed in this study, perceived convenience and value were important themes and may inform future economic evaluations of home-delivered diagnostic services.

Supplemental material