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

Nearly 25% of patients are diagnosed with Inflammatory Bowel Disease (IBD) under 18 years old of age. To date, there are no transition models established and recommended in IBD setting, so each center tends to develop a transition model based on its own needs and experience.

Aims & Methods

To compare the effectiveness on transition readiness and quality of life of two different modes of transition, one based on sending the subject to a first gastroenterological visit in the clinic with the support of a clinical report prepared by the pediatrician (letter-based transition) and the other one characterized by combined visits in the presence of both the pediatrician and adult gastroenterologist (combined-visit- based transition).
From 2018 to 2021, patients diagnosed with IBD, aged between 16 and 19 years, and followed at the Paediatric Gastroenterology and Hepatology Unit of the Azienda Ospedale Università Padova, were randomized to the letter-based transition or the combined- visits-based transition. The transition readiness was verified using the Transition Readiness Assessment Questionnaire (TRAQ), whilst the quality of life was analysed using the Pediatric Quality of Life Inventory TM at the start of the study, at six months and after one year.

Results

The final sample analyzed consisted of 40 patients, 22 assigned to the letter-based group (10 males, mean age 18.6 ± 0.4) and 18 to the combined-visits groups (10 males, mean age 18.6 ± 0.5) with similar age and sex distribution. Twenty-one and 18 reached T2, respectively, and 17 in both groups reached T3. The clinical activity and calprotectin value did not change along the study in both groups (p >0.05). Three azathioprine and 4 anti-TNF therapy were stopped after transition. The TRAQ questionnaire improved significantly during the study both in the letter-based group (from 72.1 ± 12.46 to 82.35 ± 5.88, p 0.002) and in the combined-visits group (from 66.52 ± 15.06 to 76.0 ± 12.83, p 0.008). No significant change was observed in patients' perceived quality of life along the study in the letter-based group (from 83.9±8 to 86.2 ± 9.54, p = 0.17) while it improved in the combined-visits group (from 82.5 ± 8.23 to 89.1 ± 7.63, p <0.05).

Conclusion

Our data suggest that both transition models are able to obtain a marked improvement in transition readiness, while the quality of life improves only in the combined-visits transition. Therefore, despite the letter-based transition approach is a good option interms of costs and time sparing, the combined-visits process should be preferable when possible to improve both transition readiness and quality of life.

Introduction

The randomized controlled OPTIC trial reported that optimised mercaptopurine treatment was superior to placebo in achieving clinical, endoscopic and histological outcomes at one year in ulcerative colitis (UC) patients failing 5-aminosalicylates after receiving induction treatment with corticosteroids.

Aims & Methods

We aimed to assess cost-effectiveness and cost-utility of therapeutic drug monitoring (TDM)-guided mercaptopurine treatment in UC. Data were collected during the OPTIC trial to perform a health economic evaluation for mercaptopurine treatment versus placebo in UC patients. The economic evaluation was performed from a health care and societal perspective using a cost-effectiveness and cost-utility analysis with a time horizon of one year. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses and productivity loss were assessed. Main outcomes were the costs per patient who achieved combined corticosteroid-free clinical remission and endoscopic improvement at one year and the costs per quality-adjusted life-year (QALY).

Results

In total, 59 patients were randomized to the intervention (n = 29) and control (n = 30) group. Patients on mercaptopurine treatment showed a non-significant gain in QALYs of 0.047 (-0.024 to 0.117) (P=0.184) corrected for baseline health utility. Non-significant differences in costs were €63 (-€1267 to €1434; P=0.927) in favour of placebo from a health care perspective and -€742 (-€3683 to €2016; P=0.644) in favour of mercaptopurine from a societal perspective, including patients’ out-of-pocket expenses and employers’ productivity loss. The probability of optimised mercaptopurine treatment being cost-effective was 0.80 at a willingness to pay per additional QALY of €20,000.

Conclusion

Optimised mercaptopurine treatment in UC patients failing 5-aminosalicylates is a cost-effective strategy from a societal perspective.

References

1. de Boer NKH, Peyrin-Biroulet L, Jharap B, et al. Thiopurines in inflammatory bowel disease: new findings and perspectives. J Crohns Colitis 2018;12:610–20.
2. Löwenberg, M., Volkers, A., van Gennep, S., Mookhoek, A., Montazeri, N., Clasquin, E., Duijvestein, M., van Bodegraven, A., Rietdijk, S., Jansen, J., van Asseldonk, D., van der Zanden, E., Dijkgraaf, M., West, R., de Boer, N., & D'Haens, G. (2023). Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial. Journal of Crohn's & Colitis, 17(7), 1055–1065.

Disclosure

NA