Nationally Automated Colonoscopy Performance Feedback Increases Polyp Detection: The NED APRIQOT Randomized Controlled Trial.

BACKGROUND & AIMS: Postcolonoscopy colorectal cancer incidence and mortality rates are higher for endoscopists with low polyp detection rates. Using the UK's National Endoscopy Database (NED), which automatically captures real-time data, we assessed if providing feedback of case-mix-adjusted mean number of polyps (aMNP), as a key performance indicator, improved endoscopists' performance. Feedback was delivered via a theory-informed, evidence-based audit and feedback intervention. METHODS: This multicenter, prospective, NED Automated Performance Reports to Improve Quality Outcomes Trial randomized National Health Service endoscopy centers to intervention or control. Intervention-arm endoscopists were e-mailed tailored monthly reports automatically generated within NED, informed by qualitative interviews and behavior change theory. The primary outcome was endoscopists' aMNP during the 9-month intervention. RESULTS: From November 2020 to July 2021, 541 endoscopists across 36 centers (19 intervention; 17 control) performed 54,770 procedures during the intervention, and 15,960 procedures during the 3-month postintervention period. Comparing the intervention arm with the control arm, endoscopists during the intervention period: aMNP was nonsignificantly higher (7%; 95% CI, -1% to 14%; P = .08). The unadjusted MNP (10%; 95% CI, 1%-20%) and polyp detection rate (10%; 95% CI, 4%-16%) were significantly higher. Differences were not maintained in the postintervention period. In the intervention arm, endoscopists accessing NED Automated Performance Reports to Improve Quality Outcomes Trial webpages had a higher aMNP than those who did not (aMNP, 118 vs 102; P = .03). CONCLUSIONS: Although our automated feedback intervention did not increase aMNP significantly in the intervention period, MNP and polyp detection rate did improve significantly. Engaged endoscopists benefited most and improvements were not maintained postintervention; future work should address engagement in feedback and consider the effectiveness of continuous feedback. CLINICAL TRIALS REGISTRY:  www.isrctn.org ISRCTN11126923 .

Initiatives to increase colonoscopy capacity - is there an impact on polyp detection? A UK National Endoscopy Database analysis.

BACKGROUND: To address mismatch between routine endoscopy capacity and demand, centers often implement initiatives to increase capacity, such as weekend working or using locums/agency staff (insourcing). However, there are concerns that such initiatives may negatively impact quality. We investigated polyp detection for weekend vs. weekday and insourced vs. standard procedures using data from the UK National Endoscopy Database. METHODS: We conducted a national, retrospective, cross-sectional study of diagnostic colonoscopies performed during 01/01-04/04/2019. The primary outcome was mean number of polyps (MNP) and the secondary outcome was polyp detection rate (PDR). Multi-level mixed-effect regression, fitting endoscopist as a random effect, was used to examine associations between procedure day (weekend/weekday) and type (insourced/standard) and these outcomes, adjusting for patient age, sex, and indication. RESULTS: 92 879 colonoscopies (weekends: 19 977 [21.5 %]; insourced: 9909 [10.7 %]) were performed by 2496 endoscopists. For weekend colonoscopies, patients were less often male or undergoing screening-related procedures; for insourced colonoscopies, patients were younger and less often undergoing screening-related procedures (all P < 0.05). Fully adjusted MNP was significantly lower for weekend vs. weekday (incidence rate ratio [IRR] 0.86 [95 %CI 0.83-0.89]) and for insourced vs. standard procedures (IRR 0.91 [95 %CI 0.87-0.95]). MNP was highest for weekday standard procedures and lowest for weekend insourced procedures; there was no interaction between procedure day and type. Similar associations were found for PDR. CONCLUSIONS: Strategies to increase colonoscopy capacity may negatively impact polyp detection and should be monitored for quality. Reasons for this unwarranted variation require investigation.

Decision making in the management of adults with malignant colorectal polyps: An exploration of the experiences of patients and clinicians.

AIM: A diagnosis of colorectal polyp cancer presents a treatment dilemma. The decision between segmental resection versus endoscopic surveillance is difficult due to a lack of good quality clinical evidence for either option. The aim of this study was to understand the decision making experiences of both clinicians and patients when faced with such a diagnosis. METHODS: Qualitative, semi-structured interviews were undertaken with 10 clinicians involved in the care of patients diagnosed with polyp cancer and five patients who had experience of a diagnosis of polyp cancer. All clinicians and patients were from four hospital trusts across the north of England. Interviews were audio-recorded, transcribed verbatim and analysed using the principles of interpretative phenomenological analysis. RESULTS: Analysis of the interview transcripts evidenced that clinicians and patients were supportive of a shared approach to treatment decision making in the context of a diagnosis of colorectal polyp cancer. Uncertainty, influences and information were among the themes identified to be preventing this happening at present. This study identified themes which were common to both groups. These were complexity of the risk information, lack of patient information resources, and system factors and time. CONCLUSION: This research study has evidenced several factors such as uncertainty, complexity of risk information and influences on decisions which are preventing patients being involved in treatment decisions following a diagnosis of colorectal polyp cancer. Recommendations for improvements in practice, including a framework to assist treatment decision making in the future, are highlighted.

A case of painless acute Type-A thoracic aortic dissection.

We describe the case of an 83-year-old lady with a known aneurysmal thoracic aorta, developing acute breathlessness and hypoxia, with no pain and unremarkable cardiovascular examination. As D-dimers were raised, she was treated with low-molecular-weight heparin (LMWH) for suspected pulmonary embolism. CT pulmonary angiography showed acutely dissecting, Type-A, thoracic aortic aneurysm. The patient was treated medically with ß-blockers. Despite a poor prognosis, she remains well 2 months later. Observational studies of patients over 70 with Type-A dissection show only 75.3% experience pain, are offered surgery less and have higher mortality. d-Dimers are almost always elevated in aortic dissection. No previous studies document breathlessness as the only presenting symptom. This case emphasises the need, in older populations, for a low suspicion threshold for aortic dissection.

Quantifying the cost savings and health impacts of improving colonoscopy quality: an economic evaluation.

OBJECTIVE: To estimate and quantify the cost implications and health impacts of improving the performance of English endoscopy services to the optimum quality as defined by postcolonoscopy colorectal cancer (PCCRC) rates. DESIGN: A semi-Markov state-transition model was constructed, following the logical treatment pathway of individuals who could potentially undergo a diagnostic colonoscopy. The model consisted of three identical arms, each representing a high, middle or low-performing trust's endoscopy service, defined by PCCRC rates. A cohort of 40-year-old individuals was simulated in each arm of the model. The model's time horizon was when the cohort reached 90 years of age and the total costs and quality-adjusted life-years (QALYs) were calculated for all trusts. Scenario and sensitivity analyses were also conducted. RESULTS: A 40-year-old individual gains 0.0006 QALYs and savings of £6.75 over the model lifetime by attending a high-performing trust compared with attending a middle-performing trust and gains 0.0012 QALYs and savings of £14.64 compared with attending a low-performing trust. For the population of England aged between 40 and 86, if all low and middle-performing trusts were improved to the level of a high-performing trust, QALY gains of 14 044 and cost savings of £249 311 295 are possible. Higher quality trusts dominated lower quality trusts; any improvement in the PCCRC rate was cost-effective. CONCLUSION: Improving the quality of endoscopy services would lead to QALY gains among the population, in addition to cost savings to the healthcare provider. If all middle and low-performing trusts were improved to the level of a high-performing trust, our results estimate that the English National Health Service would save approximately £5 million per year.

Power of big data to improve patient care in gastroenterology.

Big data is defined as being large, varied or frequently updated, and usually generated from real-world interaction. With the unprecedented availability of big data, comes an obligation to maximise its potential for healthcare improvements in treatment effectiveness, disease prevention and healthcare delivery. We review the opportunities and challenges that big data brings to gastroenterology. We review its sources for healthcare improvement in gastroenterology, including electronic medical records, patient registries and patient-generated data. Big data can complement traditional research methods in hypothesis generation, supporting studies and disseminating findings; and in some cases holds distinct advantages where traditional trials are unfeasible. There is great potential power in patient-level linkage of datasets to help quantify inequalities, identify best practice and improve patient outcomes. We exemplify this with the UK colorectal cancer repository and the potential of linkage using the National Endoscopy Database, the inflammatory bowel disease registry and the National Health Service bowel cancer screening programme. Artificial intelligence and machine learning are increasingly being used to improve diagnostics in gastroenterology, with image analysis entering clinical practice, and the potential of machine learning to improve outcome prediction and diagnostics in other clinical areas. Big data brings issues with large sample sizes, real-world biases, data curation, keeping clinical context at analysis and General Data Protection Regulation compliance. There is a tension between our obligation to use data for the common good and protecting individual patient's data. We emphasise the importance of engaging with our patients to enable them to understand their data usage as fully as they wish.

Using a dark logic model to explore adverse effects in audit and feedback: a qualitative study of gaming in colonoscopy.

BACKGROUND: Audit and feedback (A&F) interventions improve patient care but may result in unintended consequences. To evaluate plausible harms and maximise benefits, theorisation using logic models can be useful. We aimed to explore the adverse effects of colonoscopy A&F using a feedback intervention theory (FIT) dark logic model before the National Endoscopy Database Automated Performance Reports to Improve Quality Outcomes Trial study. METHODS: We undertook a qualitative study exploring A&F practices in colonoscopy. Interviews were undertaken with endoscopists from six English National Health Service endoscopy centres, purposively sampled for professional background and experience. A thematic framework analysis was performed, mapping paradoxical effects and harms using FIT and the theory of planned behaviour. RESULTS: Data saturation was achieved on the 19th participant, with participants from nursing, surgical and medical backgrounds and a median of 7 years' experience.When performance was below aspirational targets participants were falsely reassured by social comparisons. Participants described confidence as a requirement for colonoscopy. Negative feedback without a plan to improve risked reducing confidence and impeding performance (cognitive interference). Unmet targets increased anxiety and prompted participants to question messages' motives and consider gaming.Participants described inaccurate documentation of subjective measures, including patient comfort, to achieve targets perceived as important. Participants described causing harm from persevering to complete procedures despite patient discomfort and removing insignificant polyps to improve detection rates without benefiting the patient. CONCLUSION: Our dark logic model highlighted that A&F interventions may create both desired and adverse effects. Without a priori theorisation evaluations may disregard potential harms. In colonoscopy, improved patient experience measures may reduce harm. To address cognitive interference the motivation of feedback to support improvement should always be clear, with plans targeting specific behaviours and offering face-to-face support for confidence. TRIAL REGISTRATION NUMBER: ISRCTN11126923.

JAG/BSG national survey of UK endoscopy services: impact of the COVID-19 pandemic and early restoration of endoscopy services.

INTRODUCTION: The COVID-19 pandemic has profoundly affected UK endoscopy workload. The Joint Advisory Group on GI endoscopy and British Society of Gastroenterology issued guidelines on endoscopy service delivery changes and restoration. We surveyed UK endoscopy clinical leads to gain insights into service restoration. METHODS: A Google Forms-designed survey, assessing endoscopy provision, Covid minimisation and referral pathways was circulated to all UK endoscopy leads. The survey was open between 19 and 24 May 2020. RESULTS: 97 endoscopy leads completed the survey, with all UK nations and regions represented. Analysis showed 20% of endoscopy services were not providing endoscopy. Workload limitations were due to enforced interprocedural downtime (92%; with some services enforcing >1-hour downtime between procedures), social distancing (88%) and working in personal protective equipment (PPE) (87%). 91% of services reported a referral backlog (urgent median 2 months, routine median 6 months). 96% of services reported no current problems accessing PPE. Level 1/2 PPE use in colonoscopy was not uniform. 63% of services routinely swab patients for COVID-19 before endoscopy, 88% of services do not routinely swab asymptomatic staff. Comments addressed reducing endoscopy demand through vetting and changing referral criteria, the mostly commonly cited strategy being increased faecal immunochemical testing in symptomatic patients (70% of services). CONCLUSION: This survey demonstrates the pandemic's profound impact on UK endoscopy. Challenges include standardising Covid-minimisation strategies and recovering staffing levels. To improve endoscopy services, there is a need to refine referral pathways, improve vetting and clarify guidance on downtime and PPE within endoscopy.

Infection frequently triggers thrombotic microangiopathy in patients with preexisting risk factors: a single-institution experience.

Thrombotic microangiopathies are rare conditions characterized by microangiopathic hemolytic anemia, microthrombi, and multiorgan insult. The disorders, which include hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, are often acute and life threatening. We report a retrospective analysis of 65 patients presenting to our institution from 1997 to 2008 with all forms of thrombotic microangiopathy. Therapeutic plasma exchange was a requirement for analysis and 65 patients were referred to our institution; 66% of patients were female and median age at presentation was 52 years. Bacterial infection was the most commonly identified etiologic factor and in the multivariate model was the only significant variable associated with survival outcome (odds ratio 5.1, 95% confidence interval, 1.2-21.7). As infection can be considered a common trigger event for thrombotic microangiopathy, patients with hepatobiliary sepsis may benefit from elective cholecystectomy. We conclude that bacterial infection frequently triggers TTP and other thrombotic microangiopathies in patients with preexisting risk factors and propose a model for the development of these syndromes.

The National Endoscopy Database (NED) Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) randomized controlled trial design.

Background and study aims Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates. The United Kingdom's National Endoscopy Database (NED) automatically captures patient level data in real time and provides endoscopy key performance indicators (KPI) at a national, endoscopy center, and individual level. Using an electronic behavior change intervention, the primary objective of this study is to assess if automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI) improves polyp detection performance. Methods This multicenter, prospective, cluster-randomized controlled trial is randomizing NHS endoscopy centres to either intervention or control. The intervention is targeted at independent colonoscopists and each center's endoscopy lead. The intervention reports are evidence-based from endoscopist qualitative interviews and informed by psychological theories of behavior. NED automatically creates monthly reports providing an opadKPI, using mean number of polyps, and an action plan. The primary outcome is opadKPI comparing endoscopists in intervention and control centers at 9 months. Secondary outcomes include other KPI and proximal detection measures at 9 and 12 months. A nested histological validation study will correlate opadKPI to adenoma detection rate at the center level. A cost-effectiveness and budget impact analysis will be undertaken. Conclusion If the intervention is efficacious and cost-effective, we will showcase the potential of this learning health system, which can be implemented at local and national levels to improve colonoscopy quality, and demonstrate that an automated system that collects, analyses, and disseminates real-time clinical data can deliver evidence- and theory-informed feedback.

Nuclear factor κB predicts poor outcome in patients with hormone-naive prostate cancer with high nuclear androgen receptor.

Despite recent advances in prostate cancer treatments, disease recurrence is common and associated with significant morbidity and mortality. The need for more effective antitumor agents has led researchers to target signaling pathways that drive tumorigenesis by modulating or bypassing androgen receptor signaling--attenuation or blockade of which current treatments aim to effect. The transcription factor nuclear factor κB/p65 has been implicated in prostate cancer progression; however, few studies have examined the involvement of nuclear factor κB in hormone-naive disease. We used immunohistochemistry to investigate expression of p65, androgen receptor, Ki-67, and phosphorylation status of p65 at serine 536, in 154 tumor samples taken from patients before hormone ablation or radical treatment. Nuclear p65 expression was significantly associated with disease-specific mortality: P = .005; hazard ratio, 2.2. When patients were stratified according to androgen receptor status, this relationship was abolished in low androgen receptor-expressing patients and potentiated in high androgen receptor-expressing patients: P = .002; hazard ratio, 3.1. Ki-67 expression was also prognostic of shorter disease-specific mortality: P = .001; hazard ratio, 2.3. When the cohort was stratified according to androgen receptor status, this relationship held for high androgen receptor expressers but not low expressers: P = .0003; hazard ratio, 3.5. Neither androgen receptor nor p65 phosphorylated at S536 were significantly prognostic when considered individually. These data suggest that future prostate cancer treatments that target nuclear factor κB signaling should be assigned primarily to patients with concomitant high nuclear p65 and androgen receptor expression.

Tumoral C-reactive protein and nuclear factor kappa-B expression are associated with clinical outcome in patients with prostate cancer.

Prostate cancer (Pca) is the most common form of cancer affecting men, despite recent advances in PCa treatments, one third of patients diagnosed each year succumb to this disease. The inflammatory response has been implicated in prostate cancer progression. The pro-inflammatory transcription factor, NFκB/p65 has been implicated in PCa progression. Few studies have examined the involvement of NFκB and inflammatory signalling in PCa.Immunohistochemistry was employed to investigate the expression of NFκB/p65, C-reactive protein and Ki67 in 61 clinical samples. Tumours expressing high levels of p65 (p=0.004), CRP (p=0.011) and Ki67 (p=0.0003) had a shorter disease specific survival. Upon combining p65 and CRP status it was observed that those tumours with low expression of both proteins had a median survival of 11 years compared to 3.9 years for those with tumours with high expression of both (p=0.005). CRP expression was significantly higher in the 21 patients who died of their disease and on multivariate analysis CRP expression retained independent significance (p=0.005). This study suggests CRP and NFκB may function collectively to drive prostate cancer progression in a subset of patients. Tumoral CRP is a significant independent predictor of cancer specific survival. The relationship between tumour CRP and signalling pathways warrants further investigation in a larger cohort.