Introduction

Safety in endoscopy is of paramount importance with increasingly therapeutic and complex procedures. Despite safety initiatives, incidents still occur. In order to learn from these, we need to be able to better detect issues. The patient voice has been crucial in understanding healthcare from a different perspective. Specifically, patient reporting has been able to detect safety-related issues, which may not have been identified through other means [1, 2]. This is an area not previously explored in endoscopy.

Aims & Methods

Our aims were to develop a novel tool for patient reporting of safety incidents in endoscopy (PRISE), co-designed with patients. Secondary aims were to identify safety incidents, factors and perceptions.
This study was split into two phases. Phase one involved a literature review of articles related to patient reported incidents, followed by patient focus groups to identify key topic areas to address and survey design ideas. These findings informed development of the PRISE survey tool. A patient panel was created and, through regular refinement meetings with the research team, question items were created.
Phase two was a prospective pilot of the PRISE tool in a single academic centre. The survey was disseminated over an 8 month period through physical and electronic media. Patients were asked to complete this within 2 weeks of their procedure. Outcome measures included the percentage of positive responses (PPR) across question item domains, safety perception scores and number of safety incidents detected. Descriptive and comparative analyses were performed.

Results

In phase one, over 1600 articles were identified from search criteria. Following title, abstract and full text screens, 17 full text articles were included in the literature review. A total of 24 incident topic areas were identified. Three focus groups were conducted with 22 participants. Outcomes were focussed around five themes: question style, content, question items, timing, and dissemination. The PRISE co-design process was conducted over ten sessions. The final survey consists of the following sections: demographics, safety incidents and factors – 24 items, grouped into domains (pre-procedure, post-procedure, unit and staff), safety concerns – a qualitative section, and safety perceptions – a quantitative score.
In phase two, 596 patients responded to the survey. Perceptions of safety were overwhelmingly high (mean rating 9.7/10). The PPR for all domains was > 90%, with the staff domain (items on staff characteristics) rated significantly higher than all others (96.7% PPR; p < 0.001). Four clear PSIs were identified - three related to equipment failure and one regarding wrong bowel preparation. Six patients (1.0%) declared safety concerns. Two patients felt they suffered from a mistake. The five highest negatively rated question items were related to information handover, management of patient concerns during procedure, physical space in the unit, equipment faults during procedure, and unnecessary delays in care respectively. Thematic analysis of comments identified negative themes related to bowel preparation, care process issues, communication, constraints on service, environment, equipment, procedures, and staff.

Conclusion

A patient co-designed pilot prospective survey identified high perceived safety in the endoscopy unit. Staff characteristics were rated highly. Safety incidents were detected as well as areas to focus on for safety improvement.

References

1. Armitage, G., et al., Patient-reported safety incidents as a new source of patient safety data: an exploratory comparative study in an acute hospital in England. Journal of Health Services Research & Policy, 2017. 23(1): p. 36-43.
2. Weingart, S.N., et al., What can hospitalized patients tell us about adverse events? Learning from patient-reported incidents. Journal of general internal medicine, 2005. 20(9): p. 830-6.

Disclosure

HA is Chief Scientific Officer of Pre-emptive Medicine and Health Security at Flagship Pioneering. AD is Executive Chair of Pre-emptive Medicine and Health Security at Flagship Pioneering

Introduction

Ustekinumab has been proven to be effective for treatment of patients with Crohn's disease; however, 30–40% of patients have been reported to lose clinical response within 2 years. We aimed to evaluate the efficacy of ustekinumab and identify predictors of short- and long-term efficacy in Crohn's disease.

Aims & Methods

Patients with Crohn's disease receiving their first ustekinumab infusion in our hospital between June 2017 and September 2020 were prospectively enrolled. Concentrations of serum cytokines and chemokines were measured using a multiplex bead array assay. Trough concentration of ustekinumab in serum samples collected after 8 weeks of intravenous administration were measured by ELISA.

Results

Fifty-nine Crohn's disease patients were enrolled in this study. Among 34 clinically active patients, 38.2% achieved a clinical response at week 8. None of the assayed factors were associated with short-term clinical response. Cumulative persistence rates of ustekinumab were 77.6% at 1 year and 58.9% at 2 years. Univariate Cox regression analysis revealed that Harvey–Bradshaw Index scores at baseline, concomitant immunomodulator treatment, and concentrations of interferon gamma-induced protein-10, monocyte chemoattractant protein-1 (MCP-1), and interleukin (IL)-1RA, IL-4, IL-6, and IL-8, but not other baseline parameters and trough concentrations of ustekinumab (hazard ratio (HR): 0.9846, 95% confidence interval (CI): 0.9561–1.014), were significantly associated with loss of efficacy. Multivariate Cox regression analysis found that biologic naïve status (HR: 0.1264, 95% CI: 0.02595–0.6158) and MCP-1 concentrations (HR: 1.037, 95% CI: 1.014–1.062) were significantly and associated with loss of sustained efficacy for ustekinumab treatment.

	Univariate analysis HR	Lower limit of the 95% CI	Upper limit of the 95% CI	p value	Multivariate analysis HR	Lower limit of the 95% CI	Upper limit of the 95% CI	p value
Biologic naïve, Yes	0.2367	0.05582	1.004	0.05061	0.1264	0.02595	0.6158	0.01047
Concomitant IM, Yes	2.644	1.144	6.113	0.02297
IL-4, pg/mL	1.562	1.028	2.375	0.03685
IL-6, pg/mL	1.07	1.02	1.123	0.00568
IL-8, pg/mL	1.067	1.025	1.111	0.001415
IL-1RA, pg/mL	1.003	1.001	1.005	0.00439
IP-10, pg/mL	1.001	1.001	1.001	0.02067
MCP-1, pg/mL	1.022	1.003	1.04	0.02055	1.037	1.014	1.062	0.001754
Trough level of UST at week 8	0.9846	0.9561	1.014	0.3029

Furthermore, if patients were divided into four groups according to prior biologics use and MCP-1 level which cut-off value was determined from receiver operating characteristics (ROC) at 1 year, MCP-1 low and biologics naïve group had 100% cumulative persistence rate of ustekinumab at week 140. On the other hand, MCP-1 high and biologics exposure group had below 20%.

Conclusion

Our findings suggest that pre-treatment serum MCP-1 analysis, combined with a history of biologic use could be a novel biomarker for predicting the long-term efficacy of ustekinumab in patients with Crohn's disease. However, predicting of long-term efficacy by a trough concentration of ustekinumab at week 8 might be limited.

Disclosure

The authors declare no conflicts of interest associated with this manuscript.

Clinical Case Summary

A 28-year-old patient presented with recurrent episodes of overt gastrointestinal bleeding, requiring multiple blood transfusions over the past two months (5 units of packed red blood cells). Despite undergoing UGI endoscopy and colonoscopy twice at other medical centers, no abnormalities were detected. CT enterography with CT angiography yielded normal results. To further investigate, the patient underwent antegrade and retrograde power spiral enteroscopy, revealing gross active bleeding from a site of hookworm bite in the jejunum. Following the procedure, the patient was discharged with antihelminthic therapy. However, a week later, he experienced abdominal pain, difficulty passing stools, intermittent rectal bleeding again, and low-grade fever. A relook sigmoidoscopy revealed a large hematoma with intraluminal compression in the sigmoid colon. CT scan confirmed a localized sealed-off perforation along with the hematoma. Management included percutaneous aspiration of the hematoma, intravenous antibiotics, and repeat blood transfusion. Anti-helminthic therapy continued, and the patient recovered completely after approximately four weeks which was confirmed by sigmoidoscopy. The mechanism of this sigmoid colon hematoma involves potential mechanical injury by the overtube's spiral tip during insertion or manipulation. Although the localized perforation was sealed off in this case, the preceding bleeding and drop in hemoglobin complicated the initial treatment plan. Considering such technical challenges, the equipment and technology have now been withdrawn globally by the manufacturer. Close monitoring of patient symptoms, and vital signs, and prompt discontinuation of the procedure in case of discomfort or pain are crucial in preventing such complications. As advanced endoscopic techniques become more prevalent, maintaining a cautious approach towards technology and addressing complications promptly is essential for ensuring patient safety and effective care