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Quality improvement interventions (QIIs) are intended to improve the care of patients. Unlike most traditional clinical research, these endeavors emphasize the sustainable implementation of scientific evidence rather than the establishment of evidence. Our purpose was to conduct a systematic review of QII publications in the field of burn care. A systematic review was conducted utilizing electronic databases (MEDLINE, Embase, and Cochrane Library) of all studies relating to "quality improvement" in burn care published until March 31, 2020. Studies were excluded if no baseline data were reported, or if no intervention was applied and tested. Studies were scored using a novel 10-point evaluation system for QII. We evaluated 414 studies involving "quality improvement" in burn care. Only 82 studies contained a QII while 332 studies were categorized as traditional research. Several traditional research studies made claims to be QIIs, but few met the criteria. Of the 82 QII references, only 20 (24%) were accessible as full-text manuscripts, the remainder were published as abstracts only. The mean score was 7.95 for full-text studies (range 6-10) and 7.4 for abstract-only studies (range 5.5-9.5). Despite the importance of quality improvement (QI) in burn care, very few studies have been published that employ true QI methodology, and many QII studies never advance beyond publication as abstracts in conference proceedings. Based on this systematic review, we propose guidelines to improve the quality of QII submissions., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Burn Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aims: The long-term course of ulcerative colitis [UC] is difficult to predict. Mortality, colectomy, cancer, and hospitalisation represent hard outcomes of disease. Moreover, knowledge on the risk of relapses and need for potent medication add important information about living with UC. We aimed to evaluate the course and prognosis of UC during the first 20 years after diagnosis, and to identify early prognostic risk factors., Methods: From 1990 to 1994, a population-based inception cohort of patients with inflammatory bowel disease was enrolled in South-Eastern Norway. A systematic follow-up [FU] was conducted at 1,5, 10, and 20 years after diagnosis. Clinical outcomes were recorded continuously, and possible relationships between early disease characteristics and outcomes were analysed using multiple regression analysis., Results: Among 519 UC patients, 119 died, 60 were lost to FU, and 340 were included in the FU cohort. The 20-year cumulative risk of colectomy was 13.0% (95% confidence interval [CI] [11.4-14.6]). Extensive colitis at diagnosis was independently associated with an increased risk of colectomy compared with proctitis (hazard ratio [HR] = 2].8, 95% CI [1.3-6.1]). In contrast, mucosal healing at 1-year FU was independently associated with reduced risk of colectomy [HR = 0.4, 95% CI [0.2-0.8]), and inversely associated with subsequent risk of relapse [adjusted HR = 0.5, 95% CI [0.3-0.7])., Conclusions: The overall risk of colectomy in our cohort was lower than expected from previous studies, although considerable for patients with extensive colitis at diagnosis. Early mucosal healing was associated with better disease outcomes 20 years after diagnosis., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

Objective: The purpose of this article was to summarize the available evidence from systematic reviews on telerehabilitation in physical therapy., Methods: We searched Medline/PubMed, EMBASE, and Cochrane Library databases. In addition, the records in PROSPERO and Epistemonikos and PEDro were consulted. Systematic reviews of different conditions, populations, and contexts-where the intervention to be evaluated is telerehabilitation by physical therapy-were included. The outcomes were clinical effectiveness depending on specific condition, functionality, quality of life, satisfaction, adherence, and safety. Data extraction and risk of bias assessment were carried out by a reviewer with non-independent verification by a second reviewer. The findings are reported qualitatively in the tables and figures., Results: Fifty-three systematic reviews were included, of which 17 were assessed as having low risk of bias. Fifteen reviews were on cardiorespiratory rehabilitation, 14 on musculoskeletal conditions, and 13 on neurorehabilitation. The other 11 reviews addressed other types of conditions and rehabilitation. Thirteen reviews evaluated with low risk of bias showed results in favor of telerehabilitation versus in-person rehabilitation or no rehabilitation, while 17 reported no differences between the groups. Thirty-five reviews with unclear or high risk of bias showed mixed results., Conclusions: Despite the contradictory results, telerehabilitation in physical therapy could be comparable with in-person rehabilitation or better than no rehabilitation for conditions such as osteoarthritis, low-back pain, hip and knee replacement, and multiple sclerosis and also in the context of cardiac and pulmonary rehabilitation. It is imperative to conduct better quality clinical trials and systematic reviews., Impact: Providing the best available evidence on the effectiveness of telerehabilitation to professionals, mainly physical therapists, will impact the decision-making process and therefore yield better clinical outcomes for patients, both in these times of the COVID-19 pandemic and in the future. The identification of research gaps will also contribute to the generation of relevant and novel research questions., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Physical Therapy Association.)

Aims: COVID-19 might have affected the care and outcomes of hospitalized acute myocardial infarction (AMI). We aimed to determine whether the COVID-19 pandemic changed patient response, hospital treatment, and mortality from AMI., Methods and Results: Admission was classified as non-ST-elevation myocardial infarction (NSTEMI) or STEMI at 99 hospitals in England through live feeding from the Myocardial Ischaemia National Audit Project between 1 January 2019 and 22 May 2020. Time series plots were estimated using a 7-day simple moving average, adjusted for seasonality. From 23 March 2020 (UK lockdown), median daily hospitalizations decreased more for NSTEMI [69 to 35; incidence risk ratios (IRR) 0.51, 95% confidence interval (CI) 0.47-0.54] than STEMI (35 to 25; IRR 0.74, 95% CI 0.69-0.80) to a nadir on 19 April 2020. During lockdown, patients were younger (mean age 68.7 vs. 66.9 years), less frequently diabetic (24.6% vs. 28.1%), or had cerebrovascular disease (7.0% vs. 8.6%). ST-elevation myocardial infarction more frequently received primary percutaneous coronary intervention (81.8% vs. 78.8%), thrombolysis was negligible (0.5% vs. 0.3%), median admission-to-coronary angiography duration for NSTEMI decreased (26.2 vs. 64.0 h), median duration of hospitalization decreased (4 to 2 days), secondary prevention pharmacotherapy prescription remained unchanged (each > 94.7%). Mortality at 30 days increased for NSTEMI [from 5.4% to 7.5%; odds ratio (OR) 1.41, 95% CI 1.08-1.80], but decreased for STEMI (from 10.2% to 7.7%; OR 0.73, 95% CI 0.54-0.97)., Conclusion: During COVID-19, there was a substantial decline in admissions with AMI. Those who presented to hospital were younger, less comorbid and, for NSTEMI, had higher 30-day mortality., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Objective: To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis., Methods: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group)., Results: A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ)., Conclusion: This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: We aimed to assess the association between alterations in serum chloride levels during hospitalisation and mortality., Methods: We reviewed all adult patients admitted to our hospital from the year 2009 to 2013, who had at least two serum chloride measurements during hospitalisation. The serum chloride change during hospitalisation, defined as the absolute difference between the highest and lowest serum chloride levels, was categorised into seven groups; 0-2, 3-4, 5-6, 7-8, 9-10, 11-12 and ≥13 mEq/L. Multivariable logistic regression was performed to assess the independent association between serum chloride change and in-hospital mortality, using the serum chloride change of 0-2 mEq/L as the reference group., Results: A total of 57 880 patients, with median serum chloride change of 5 (IQR 3-9) mEq/L, were studied. The in-hospital mortality was progressively increased with larger chloride change, from 0.6% in group of 0-2 mEq/L to 5.9% in group of ≥13 mEq/L (p<0.001). In adjusted analysis, serum chloride change of ≥7 mEq/L was significantly associated with increased in-hospital mortality. For upward trend, serum chloride change of ≥3 mEq/L was significantly associated with increased in-hospital mortality, whereas, for downward trend, serum chloride change was not consistently associated with in-hospital mortality., Conclusion: Alterations in serum chloride during hospitalisation were associated with increased hospital mortality. The association was more prominent with upward than downward trend of serum chloride., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Aims: Crohn's disease [CD] is associated with alterations in gut microbial composition and function. The present controlled-intervention study investigated the relationship between patterns of dietary intake and baseline gut microbiota in CD patients in remission and examined the effects of a dietary intervention in patients consuming a non-diversified diet [NDD]., Methods: Forty outpatients with quiescent CD were recruited in Calgary, Alberta, Canada. Based on 3-day food records, patients consuming a lower plant-based and higher red and processed meat-based diet were assigned to the NDD group [n = 15] and received a 12-week structured dietary intervention; all other patients were assigned to the diversified diet [DD] control group [n = 25] and received conventional management. Faecal microbiota composition, short chain fatty acids [SCFAs] and calprotectin were measured., Results: At baseline the NDD and DD groups had a different faecal microbial beta-diversity [p = 0.003, permutational multivariate analysis of variance]. The NDD group had lower Faecalibacterium and higher Escherichia/Shigella relative abundances compared to the DD group [3.3 ± 5.4% vs. 8.5 ± 10.6%; 6.9 ± 12.2% vs. 1.6 ± 4.4%; p ≤ 0.03, analysis of covariance]. These two genera showed a strong negative correlation [rs = -0.60, q = 0.0002]. Faecal butyrate showed a positive correlation with Faecalibacterium [rs = 0.52, q = 0.002], and an inhibitory relationship with Escherichia/Shigella abundance [four-parameter sigmoidal model, R = -0.83; rs = -0.44, q = 0.01], respectively. After the 12 weeks of dietary intervention, no difference in microbial beta-diversity between the two groups was observed [p = 0.43]. The NDD group demonstrated an increase in Faecalibacterium [p < 0.05, generalized estimated equation model], and resembled the DD group at the end of the intervention [p = 0.84, t-test with permutation]. We did not find an association of diet with faecal SCFAs or calprotectin., Conclusions: Dietary patterns are associated with specific gut microbial compositions in CD patients in remission. A diet intervention in patients consuming a NDD modifies gut microbial composition to resemble that seen in patients consuming a DD. These results show that diet is important in shaping the microbial dysbiosis signature in CD towards a balanced community., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aim: Treatment trial with antitubercular therapy [ATT] is a common strategy in tuberculosis-endemic countries in case of a diagnostic dilemma between intestinal tuberculosis and Crohn's disease [CD]. Our aim was to determine the long-term clinical course of patients who received ATT before an eventual diagnosis of CD was made., Methods: We performed retrospective comparison between CD patients who received ≥6 months of ATT vs those who did not receive ATT. Outcomes assessed were change in disease behaviour during follow-up, requirement of surgery and medication use., Results: In all, 760 patients with CD were screened for the study and, after propensity matching for location and behaviour of disease, 79 patients in each group were compared. Progression from inflammatory [B1] to stricturing/fistulising [B2/B3] phenotype was increased among CD patients who received ATT [B1, B2, B3: 73.4%, 26.6%, 0% at baseline vs: 41.8%, 51.9%, 6.3% at follow-up, respectively] as compared with those who did not receive ATT [B1, B2, B3: 73.4%, 26.6%, 0% at baseline vs: 72.2%, 27.8%, 0% at follow-up, respectively] with an odds ratio of 11.05[3.17-38.56]. The usage of 5-aminosalocylates, steroids, immunosuppressants and anti-tumour necrosis factor was similar between both the groups. On survival analysis, CD patients who received ATT had a lower probability of remaining free of surgery [45%] than those who did not [76%] at 14 years of follow-up (hazard ratio [HR] = 3.22, 95% confidence interval [CI], 1.46-7.12, p = 0.004]., Conclusions: Crohn's disease patients diagnosed after a trial with antitubercular therapy had an unfavourable long-term disease course with higher rate of stricture formation and less chance of remaining free of surgery., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The U.S. Preventive Services Task Force recommends the use of 24-hour ambulatory blood pressure monitoring (ABPM) as part of screening and diagnosis of hypertension. The optimal ABPM device for population-based surveys is unknown., Methods: We compared the proportion of valid blood pressure (BP) readings, mean awake and asleep BP readings, differences between awake ABPM readings and initial standardized BP readings, and sleep experience among three ABPM devices. We randomized a convenience sample of 365 adults to 1 of 3 ABPM devices: Welch Allyn Mobil-O-Graph (WA), Sun Tech Classic Oscar2 (STO) and Spacelabs 90227 (SL). Participants completed sleep quality questionnaires on the nights before and during ABPM testing., Results: The proportions of valid BP readings were not different among the 3 devices (P > 0.45). Mean awake and asleep systolic BP were significantly higher for STO device (WA vs. STO vs. SL: 126.65, 138.09, 127.44 mm Hg; 114.34, 120.34, 113.13 mm Hg; P < 0.0001 for both). The difference between the initial average standardized mercury systolic BP readings and the ABPM mean awake systolic BP was larger for STO device (WA vs. STO. vs. SL: -5.26, -16.24, -5.36 mm Hg; P < 0.0001); diastolic BP mean differences were ~ -6 mm Hg for all 3 devices (P = 0.6). Approximately 55% of participants reported that the devices interfered with sleep; however, there were no sleep differences across the devices (P > 0.4 for all)., Conclusion: Most of the participants met the threshold of 70% valid readings over 24 hours. Sleep disturbance was common but did not interfere with completion of measurement in most of the participants., (© Published by Oxford University Press on behalf of American Journal of Hypertension Ltd 2020.)

Background: Tofacitinib is a partially selective Janus kinase inhibitor approved for the treatment of refractory moderate to severe ulcerative colitis [UC]. We sought to define the effectiveness and adverse effects of tofacitinib in a real-world cohort., Methods: We conducted a retrospective observational cohort study of 134 patients with UC [64% male; median age 37 years [range 16-81]; 83% of patients had previously received at least one biologic] treated with tofacitinib from October 2018 to October 2019 in four UK centres. Disease activity was assessed using the Simple Clinical Colitis Activity Index [SCCAI] or partial Mayo score [PMS], depending on study site. Response and remission were defined as a reduction in SCCAI or PMS of ≥3and SCCAI ≤2 or a PMS ≤1, respectively., Results: Overall, 74% (88/119; 95 confidence interval [CI] 65-81%] patients responded to tofacitinib at Week 8 and steroid-free remission was observed in 44% [47/108; 95% CI 3453%] patients at Week 26. Primary non-response was independently associated with younger age [p = 0.014] and higher C-reactive protein [CRP] levels at baseline [p = 0.004]. Only 23% [3/13] of patients who continued tofacitinib in the setting of primary non-response were in steroid-free remission at Week 26. Prior biologic exposure did not influence response or remission rates. Dose escalation, however, recaptured response in approximately half of patients who had lost response. Dyslipidaemia was observed in 20% [27/134; 95% CI 1428%] of patients, but adverse events necessitating drug withdrawal were uncommon and no venous thromboembolic events occurred., Conclusions: In this multicentre real-world cohort, tofacitinib was well tolerated and clinically effective in a treatment-refractory UC population., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: Postoperative recurrence remains a challenging problem in patients with Crohn's disease [CD]. To avoid development of short bowel syndrome, strictureplasty techniques have therefore been proposed. We evaluated short- and long-term outcomes of atypical strictureplasties in CD patients with extensive bowel involvement., Methods: Side-to-side isoperistaltic strictureplasty [SSIS] was performed according to the Michelassi technique or modification of this over the ileocaecal valve [mSSIS]. Ninety-day postoperative morbidity was assessed using the comprehensive complication index [CCI]. Clinical recurrence was defined as symptomatic, endoscopically or radiologically confirmed, stricture/inflammatory lesion requiring medical treatment or surgery. Surgical recurrence was defined as the need for any surgical intervention. Endoscopic remission was defined as ≤i1, according to the modified Rutgeerts score. Deep remission was defined as the combination of endoscopic remission and absence of clinical symptoms. Perioperative factors related to clinical recurrence were evaluated., Results: A total of 52 CD patients [SSIS n = 12; mSSIS n = 40] were included. No mortality occurred. Mean CCI was 10.3 [range 0-33.7]. Median follow-up was 5.9 years [range 0.8-9.9]. Clinical recurrence [19 patients] was 29.7% and 39.6% after 3 and 5 years, respectively. Surgical recurrence [seven patients] was 2% and 14.1% after 3 and 5 years, respectively. At the end of the follow-up, 92% of patients kept the original strictureplasty and deep remission was observed in 25.7% of the mSSIS patients. None of the perioperative variables considered showed a significant association with clinical recurrence., Conclusions: SSIS is safe, effective, and provides durable disease control in patients with extensive CD ileitis., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: The combination of infliximab and azathioprine is more efficacious than either therapy alone for Crohn's disease [CD] and ulcerative colitis [UC]. However, it is uncertain whether these benefits extend to real-world clinical practice and to other combinations of biologics and immunomodulators., Methods: We collected health administrative data from four Canadian provinces representing 78 413 patients with inflammatory bowel disease [IBD] of whom 11 244 were prescribed anti-tumour necrosis factor [anti-TNF] agents. The outcome of interest was the first occurrence of treatment failure: an unplanned IBD-related hospitalization, IBD-related resective surgery, new/recurrent corticosteroid use or anti-TNF switch. Multivariable Cox proportional hazards modelling was used to assess the association between the outcome of interest and receiving combination therapy vs anti-TNF monotherapy. Multivariable regression models were used to assess the impact of choice of immunomodulator or biologic on reaching the composite outcome, and random effects generic inverse variance meta-analysis of deterministically linked data was used to pool the results from the four provinces to obtain aggregate estimates of effect., Results: In comparison with anti-TNF monotherapy, combination therapy was associated with a significant decrease in treatment ineffectiveness for both CD and UC (CD: adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.66-0.90; UC: aHR 0.72, 95% CI 0.62-0.84). Combination therapy was equally effective for adalimumab and infliximab in CD. In UC azathioprine was superior to methotrexate as the immunomodulatory agent (aHR = 1.52 [95% CI 1.02-2.28]) but not CD (aHR = 1.22 [95% CI 0.96-1.54])., Conclusion: In an analysis of a database of real-world patients with IBD, combination therapy decreased the likelihood of treatment failure in both CD and UC., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: Vedolizumab [VDZ] is a monoclonal antibody directed against the α4β7 integrin heterodimer, approved for patients with inflammatory bowel diseases [IBD]. This study aimed at identifying immunological variables associated with response to vedolizumab in patients with ulcerative colitis [UC] and Crohn's disease [CD]., Methods: This is a phase IV explorative prospective interventional trial. IBD patients received open-label VDZ at Weeks 0, 2, 6, and 14. Patients with a clinical response at Week 14 were maintained with VDZ up to Week 54. At Weeks 0 and 14, their peripheral blood was obtained and endoscopy with biopsies was performed. The Week 14 clinical response and remission, Week 54 clinical remission, and Week 14 endoscopic response were evaluated as endpoints of the study. The expression of surface markers, chemokine receptors, and α4β7 heterodimer in peripheral blood and lamina propria lymphocytes was assessed by flow cytometry. A panel of soluble mediators was assessed in sera at baseline and at Week 14 by 45-plex., Results: A total of 38 IBD patients [20 UC, 18 CD] were included in the study. At Week 14, the clinical response and remission rates were 87% and 66%, respectively. Higher baseline levels of circulating memory Th1 cells were strongly associated with clinical response at Week 14 [p = 0.0001], whereas reduced baseline levels of lamina propria memory Th17 and Th1/17 cells were associated with endoscopic response. Immunological clusters were found to be independently associated with vedolizumab outcomes at multivariable analysis. A panel of soluble markers, including IL17A, TNF, CXCL1, CCL19 for CD and G-CSF and IL7 for UC, associated with vedolizumab-induced Week 54 clinical remission., Conclusions: The results of this exploratory study uncovered a panel of circulating and mucosal immunological variables associated with response to treatment with vedolizumab., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: Most patients with perianal Crohn's fistula receive medical treatment with anti-tumour necrosis factor [TNF], but the results of anti-TNF treatment have not been directly compared with chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn's disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure., Methods: This randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned to: i] chronic seton drainage for 1 year; ii] anti-TNF therapy for 1 year; and iii] surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-intervention[s] at 1.5 years. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort., Results: Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate [10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, p = 0.02]. No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure., Conclusions: The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn's fistulas., (© European Crohn’s and Colitis Organisation (ECCO) 2020.)

Background and Aims: Vedolizumab was shown to be safe and effective for the treatment of Crohn's disease [CD] and ulcerative colitis [UC] in the GEMINI Long-Term Safety [LTS] study. The vedolizumab Extended Access Program [XAP] provides patients with continued treatment. This XAP pharmacokinetics [PK] sub-study investigated vedolizumab efficacy, safety, and PK., Methods: Vedolizumab dosing frequency was reduced from every 4 weeks [Q4W] to every 8 weeks [Q8W] at XAP enrolment, and patients were followed for 56 weeks. Outcomes included: efficacy, loss of clinical benefit, and re-escalation to Q4W dosing; and vedolizumab PK, immunogenicity, and adverse events., Results: Among 167 enrolled patients [CD = 88, UC = 79], 80 [91%] with CD and 73 [92%] with UC completed 56 weeks; 76 [86%] and 71 [90%] with CD and UC, respectively, remained on Q8W dosing for 56 weeks. Clinical remission, corticosteroid-free clinical remission, and C-reactive protein levels were stable among patients remaining on Q8W through Week 56. Four patients with CD and two with UC resumed Q4W dosing [three with CD regained clinical response]. Patients with CD who completed Week 56 on Q8W dosing had median trough vedolizumab concentrations of 43.6 µg/mL at enrolment and 10.4 µg/mL at Week 56; concentrations were 42.4 µg/mL and 13.3 µg/mL, respectively, in patients with UC. Treatment-related adverse events were infrequent; no new or serious adverse events related to vedolizumab were reported., Conclusions: In the XAP-PK sub-study, adherence to Q8W dosing was high, with no loss of efficacy; very few patients required re-escalation to Q4W. There were no new safety signals., (© European Crohn’s and Colitis Organisation (ECCO) 2020.)

Objective: The aim of this study was to evaluate the outcomes of implementing a sepsis screening (SS) tool based on the quick Sequential [Sepsis-Related] Organ Failure Assessment (qSOFA) and the presence of confirmed/suspected infection. The implementation of the 6-h bundle was also evaluated., Design: Interrupted times series with prospective data collection., Setting: Five hospital wards in a developing nation, Argentina., Participants: A total of 1151 patients (≥18 years) recruited within 24-48 h of hospital admission., Intervention: The qSOFA-based SS tool and the 6-h bundle., Main Outcome Measures: The primary outcome was the timing of implementation of the first 6-h bundle element. Secondary outcomes were related to the adherence to the screening procedures., Results: Of 1151 patients, 145 (12.6%) met the qSOFA-based SS tool criteria, among them intervention (39/64) patients received the first 6-h bundle element earlier (median 8 h; 95% confidence interval (CI): 0.1-16) than baseline (48/81) patients (median 22 h; 95% CI: 3-41); these times, however, did not differ significantly (P = 0.525). Overall, 47 (4.1%) patients had sepsis; intervention patients (18/25) received the first 6-h bundle element sooner (median 5 h; 95% CI: 4-6) than baseline patients (15/22) did (median 12 h; 95% CI: 0-33); however, times were not significantly different (P = 0.470). While intervention patients were screened regularly, only one-third of patients who required sepsis alerts had them activated., Conclusion: The implementation of the qSOFA-based SS tool resulted in early, but not significantly improved, provision of 6-h bundle care. Screening procedures were regularly conducted, but sepsis alerts rarely activated. Further research is needed to better understand the implementation of sepsis care in developing settings., (© The Author(s) 2020. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: The present systematic review compared arthroscopic superior capsular reconstruction (ASCR) and latissimus dorsi transfer (ALDT) for the management of massive irreparable rotator cuff lesions., Sources of Data: We performed a systematic review searching the literature on Medline, Cochrane and Scopus databases, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines., Areas of Agreement: We included a total of 20 articles, 10 on ASCR and 10 on ALDT (12 retrospective and 8 prospective studies), all published between 2013 and 2019., Areas of Controversy: ASCR and ALDT are technical demanding procedures. When compared to each other, they do not produce significantly different improvements in clinical outcome., Growing Points: Both ASCR and ALDT are valid options for surgical management of MIRCLs. Although ALDT has shown a greater complication rate and a less improvement in acromion-humeral distance, its clinical outcomes overlap those obtained with ASCR., Areas Timely for Developing Research: Further comparative prospective and retrospective studies with longer follow-up could confirm which surgical procedure can lead to better outcomes with a lower complication rate., (© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background and Aims: Ligation of the intersphincteric fistula tract [LIFT] and advancement flap [AF] procedures are well-established, sphincter-preserving procedures for closure of high perianal fistulas. As surgical fistula closure is not commonly offered in Crohn's disease patients, long-term data are limited. This study aims to evaluate outcomes after LIFT and AF in Crohn's high perianal fistulas., Methods: All consecutive Crohn's disease patients ≥18 years old treated with LIFT or AF between January 2007 and February 2018 were included. The primary outcome was clinical healing and secondary outcomes included radiological healing, recurrence, postoperative incontinence and Vaizey Incontinence Score., Results: Forty procedures in 37 patients [LIFT: 19, AF: 21, 35.1% male] were included. A non-significant trend was seen towards higher clinical healing percentages after LIFT compared to AF [89.5% vs 60.0%; p = 0.065]. Overall radiological healing rates were lower for both approaches [LIFT 52.6% and AF 47.6%]. Recurrence rates were comparable: 21.1% and 19.0%, respectively. In AF a trend was seen towards higher clinical healing percentages when treated with anti-tumour necrosis factor/immunomodulators [75.0% vs 37.5%; p = 0.104]. Newly developed postoperative incontinence occurred in 15.8% after LIFT and 21.4% after AF. Interestingly, 47.4% of patients had a postoperatively improved Vaizey Score [LIFT: 52.9% and AF: 42.9%]. The mean Vaizey Score decreased from 6.8 [SD 4.8] preoperatively to 5.3 [SD 5.0] postoperatively [p = 0.067]., Conclusions: Both LIFT and AF resulted in satisfactory closure rates in Crohn's high perianal fistulas. However, a discrepancy between clinical and radiological healing rates was found. Furthermore, almost half of the patients benefitted from surgical intervention with respect to continence., (© European Crohn’s and Colitis Organisation (ECCO) 2019.)

Background and Aims: Patients with ulcerative colitis [UC] may present as emergencies and require rapid escalation of therapy. This study aimed to assess the mortality, colectomy, and readmission risks, during and following a first emergency admission with UC., Methods: Using Hospital Episode Statistics, subjects aged between 18 and 60 years, coded with a first emergency admission with UC, were identified between 2007 and 2017. Influences of demographic factors, comorbidity, anti-tumour necrosis factor [TNF] therapy, and provider UC activity on mortality and colectomy were examined., Results: A total of 10 051 subjects (46% female; median age 33 years [interquartile range [IQR] 25-44]) were identified. Mortality was 0.2% in hospital and 0.5% at 12 months and, following colectomy during acute admission, it was 1.4% in hospital and 2.1% at 12 months. Females had reduced risk of colectomy during admission: odds ratio [OR] 0.73 (95% confidence interval [CI] 0.62-0.85). Comparing the period 2007-2011 with 2012-2017, the rate of colectomy fell during acute admissions: OR 0.85 [0.72-0.99], p = 0.038 and at 12 months after admission: OR 0.73 [0.61-0.87]. Anti-TNF therapy increased 4-fold in acute UC admissions from 2007-2017. Those receiving anti-TNF therapy had a 70% increased risk of colectomy during index admission compared with those not receiving anti-TNF: OR 1.72 [1.29-2.31]. Increased time to colectomy during first admission was associated with female sex: hazard ratio [HR] 0.84 [0.72-0.98] and Asian ethnicity: HR 0.61 [0.44-0.85], whereas reduced time was associated with increased comorbidity, lower deprivation, and high provider volume of colectomies for UC: HR 1.59 [1.31-1.93]., Conclusions: Mortality following colectomy was 1.4% in hospital and 2.1% at 12 months, and no significant change over time was observed. Colectomy during emergency admission for UC was less common in females. Rates of anti-TNF therapy during emergency admission for UC have increased and overall colectomy rates have fallen., Podcast: This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Interstitial lung [ILD] disease and granulomatous lung disease [GLD] are rare respiratory disorders that have been associated with inflammatory bowel disease [IBD]. Clinical presentation is polymorphic and aetiology is unclear., Methods: This was an ECCO-CONFER project. Cases of concomitant ILD or GLD and IBD, or drug-induced ILD/GLD, were collected. The criteria for diagnosing ILD and GLD were based on definitions from the American Thoracic Society and the European Respiratory Society and on the discretion of reporting clinician., Results: We identified 31 patients with ILD. The majority had ulcerative colitis [UC] [n = 22]. Drug-related ILD was found in 64% of these patients, 25 patients [80.6%] required hospitalisation, and one required non-invasive ventilation. The causative drug was stopped in all drug-related ILD, and 87% of patients received systemic steroids. At follow-up, 16% of patients had no respiratory symptoms, 16% had partial improvement, 55% had ongoing symptoms, and there were no data in 13%. One patient was referred for lung transplantation, and one death from lung fibrosis was reported. We also identified 22 GLD patients: most had Crohn's disease [CD] [n = 17]. Drug-related GLD was found in 36% of patients and 10 patients [45.4%] required hospitalisation. The causative drug was stopped in all drug-related GLD, and 81% of patients received systemic steroids. Remission of both conditions was achieved in almost all patients., Conclusions: ILD and GLD, although rare, can cause significant morbidity. In our series, over half of cases were drug-related and therefore focused pharmacovigilance is needed to identify and manage these cases., (© Crown copyright 2019.)

Objective: We aim to examine the effect of benchmarking on quality-of-care metrics in patients presenting with ST-elevation myocardial infarction (STEMI) through the implementation of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ACTION Registry., Design: From January 2005 to December 2017, 712 patients underwent primary percutaneous coronary intervention PCI-499 before NCDR ACTION Registry implementation (prior to 2013) and 213 after implementation., Setting: STEMI., Participants: 712 patients., Intervention(s): Primary PCI., Main Outcome Measure(s): We examined hospital performance for the quality indicators in processes and outcomes of the management of patients presenting with STEMI. Outcome measures include door-to-balloon time (DBT), antiplatelet therapy and anti-ischemic drugs prescribed at discharge from pre-NCDR ACTION Registry to post-implementation., Results: There was improvement in DBT, decreasing from 94 min in 2012 (before NCDR adoption) to reach a median of 47 min in 2017 (Ptrend < 0.001). The percentage of cases with the optimal DBT of < 90 min increased from 55.8% before to 90.1% after the implementation of the NCDR ACTION Registry (Ptrend < 0.001). The rate of aspirin (90.3-100%, P < 0.001), P2Y12 inhibitor (70.1-78.4%, P = 0.02), beta-blocker (76.8-100%, P < 0.001) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (60.1-99.5%, P < 0.001) prescribed at discharge increased from pre-NCDR ACTION Registry to post-implementation. Adjusted mortality before and after NCDR ACTION Registry implementation showed significant change (from 9.04 to 5.92%; P = 0.027)., Conclusions: The introduction of the ACC NCDR ACTION Registry led to incremental gains in the quality in STEMI management through the benchmarking of process of care and clinical outcomes, achieving reduced DBT, improving guideline-directed medication adherence and increasing patient safety, treatment efficacy and survival., (© The Author(s) 2019. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The survival advantage of surgery to the primary tumor for patients with distant metastatic esophageal cancer has not been adequately evaluated. This study aims to investigate the role of surgery to the primary tumor in distant metastatic esophageal cancer and to evaluate possible different effects of surgery on survival of esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC). This study included a cohort of 4,367 metastatic esophageal cancer patients from the Surveillance, Epidemiology, and End Results (SEER) database, registered from January 2004 to December 2014. Kaplan-Meier and Cox proportional hazardous models were used to evaluate the overall survival (OS) and corresponding 95% confidence interval (CI). Propensity score matching (PSM) was used to adjust for potential baseline confounding. Both EAC (median OS for surgery group vs. no-surgery group-14.0 vs. 9.0 months, P < 0.001) and ESCC (median OS for surgery vs. no-surgery group-11.0 vs. 7.0 months, P = 0.002) experienced survival benefits from surgery. We found that surgery to the primary tumor, when combined with chemotherapy, was associated with improved survival for patients with M1b disease, both EAC and ESCC, with a greater benefit observed in younger patients, and those with EAC. While the present data indicate a potential survival benefit from surgery for some patients with metastatic esophageal cancer, it is possible that performance status and metastatic disease burden impacted patient selection, influencing these results. Further studies are needed to determine the role of surgery for patients with metastatic esophageal cancer., (© The Author(s) 2019. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The survival advantage associated with the addition of surgical therapy in esophageal squamous cell carcinoma (ESCC) patients who demonstrate a complete clinical response to chemoradiotherapy is unclear, and many institutions have adopted an organ-preserving strategy of selective surgery in this population. We sought to characterize our institutional experience of salvage esophagectomy (for failure of definitive bimodality therapy) and planned esophagectomy (as a component of trimodality therapy) by retrospectively analyzing patients with ESCC of the thoracic esophagus and GEJ who underwent esophagectomy following chemoradiotherapy between 2004 and 2016. Of 76 patients who met inclusion criteria, 46.1% (35) underwent salvage esophagectomy. Major postoperative complications (major cardiovascular and pulmonary events, anastomotic leak [grade ≥ 2], and 90-day mortality) were frequent and occurred in 52.6% of the cohort (planned resection: 36.6% [15/41]; salvage esophagectomy: 71.4% [25/35]). Observed rates of 30- and 90-day mortality for the entire cohort were 7.9% (planned: 7.3% [3/41]; salvage: 8.6% [3/35]) and 13.2% (planned: 9.8% [4/41]; salvage: 17.1% [6/35]), respectively. In summary, esophagectomy following chemoradiotherapy for ESCC at our institution has been associated with frequent postoperative morbidity and considerable rates of mortality in both planned and salvage settings. Although a selective approach to surgery may permit organ preservation in many patients with ESCC, these results highlight that salvage esophagectomy for failure of definitive-intent treatment of ESCC may also constitute a difficult clinical undertaking in some cases., (© The Author(s) 2019. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Nowadays robotic surgery is established for abdominal and thoracic surgery. It has been shown that complex procedures are feasible using robotic systems, e.g., da Vinci Xi, with a huge benefit in precision. Different techniques for esophageal cancer surgery are reported; however, only a few robotic and partial robotic procedures are described. Therefore, a fully robotic (abdominal and thoracic) Ivor Lewis esophageal resection using four robotic arms-RAMIE4-the standard technique used for lower esophageal cancer, is presented in this paper. The technique shown in the video was performed successfully in 100 cases in 24 months. The reconstruction is performed with a gastric conduit pull-up and intrathoracic manually inserted 28-mm circular end-to-side stapled anastomosis. This video demonstrates the feasibility of RAMIE4 in the abdomen and thorax and reveals advantages of the robotic assistance., (© The Author(s) 2019. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention., Purpose: Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results-and resulting decision-making process-related to experiments at each step to display the practical challenges present at each stage., Methods: To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery., Results: Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process., Conclusions: A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase., (© Society of Behavioral Medicine 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aims: Endo-sponge [Braun Medical] assisted early surgical closure [ESC] is an effective treatment to control pelvic sepsis after ileal pouch-anal anastomosis [IPAA] leakage, and became standard treatment in our centre from 2010 onwards. The aim of this cohort study was to assess the long-term pouch function of ulcerative colitis [UC] patients treated with ESC or conventional management [CM] for anastomotic leakage after IPAA., Methods: Consecutive patients who underwent an IPAA for UC between 2002 and 2017 were included. Patients treated with ESC [2010-2017] or CM [2002-2009] for anastomotic leakage were compared with control patients without anastomotic leakage of the corresponding time period. Main endpoints were long-term pouch function on a 3-point scale and pouch failure, as measured with the validated pouch dysfunction score questionnaire., Results: Some 280 of 334 patients [84%] returned the pouch dysfunction questionnaire, of whom 18 were treated with ESC and 22 with CM for anastomotic leakage. Control cohorts included 133 [2010-2017] and 107 patients [2002-2009]. Between ESC-treated patients and control patients, pouch function [p = 0.647] and pouch failure rates [0/18 versus 5/133, p >0.99] were similar. CM resulted in worse pouch function [p = 0.016] and a higher pouch failure rate [5/22 versus 5/107, p = 0.013] compared with control patients., Conclusions: ESC, in contrast to CM, for IPAA leakage in UC patients is associated with preservation of pouch function and preclusion of pouch failure, probably due to early and effective treatment of pelvic sepsis., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aim: Acute severe colitis [ASC] is associated with significant morbidity in paediatric patients with ulcerative colitis [UC]. Most outcome studies in ASC since tumour necrosis factor alpha [TNFα] antagonists became available have focused on the first year after admission. The aim of this study was to characterise the longer-term outcomes of paediatric patients admitted with ASC., Methods: This retrospective study was conducted in 25 centres across Europe and North America. Data on patients with UC aged <18 years, admitted with ASC (defined as paediatric ulcerative colitis activity index [PUCAI] score ≥65) between 2009 and 2011, were collected at discharge and 1, 3 and 5 years after admission. The primary outcome was colectomy-free rates at each time point., Results: Of the 141 patients admitted with ASC, 137 [97.1%] were treated with intravenous corticosteroids. Thirty-one [22.6%] patients were escalated to second-line therapy, mainly to infliximab. Sixteen patients [11.3%] underwent colectomy before discharge. Long-term follow-up showed colectomy-free rates were 71.3%, 66.4% and 63.6% at 1, 3 and 5 years after initial ASC admission, respectively, and were similar across different age groups. Sub-analysis of colectomy rates in patients with new-onset disease [42.5% of the cohort] yielded similar results. In a multivariate analysis, use of oral steroids in the 3 months before admission, erythrocyte sedimentation rate >70 mm/h, and albumin <2.5 g/dL, were significantly associated with 5-year colectomy risk., Conclusions: High colectomy rates were demonstrated in paediatric UC patients admitted with ASC. Additional studies are required to determine whether intensification of anti-TNFα treatment, close therapeutic drug monitoring, and use of new drugs alter this outcome., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: To compare perioperative characteristics and outcomes between primary ileocolonic resection [PICR] and iterative ileocolic resection [IICR] for Crohn's disease [CD]., Methods: From 2013 to 2015, 567 patients undergoing ileocolonic resection were prospectively included in 19 centres of the GETAID chirurgie group. Perioperative characteristics and postoperative results of both groups [431 PICR, 136 IICR] were compared. Uni- and multivariate analyses of the risk factors of overall 30-day postoperative morbidity was carried out in the IICR group., Results: IICR patients were less likely to be malnourished [27.2% vs 39.9%, p = 0.007], and had more stricturing forms [69.1% vs 54.3%, p = 0.002] and less perforating disease [19.9% vs 39.2%, p < 0.001]. Laparoscopy was less commonly used in IICR [45.6% vs 84.5%, p < 0.01] and was associated with increased conversion rates [27.4% vs 14.6%, p = 0.012]. Overall postoperative morbidity was 36.8% in the IICR group and 26.7% in the PICR group [p = 0.024]. There was no significant difference between IICR and PICR regarding septic intra-abdominal complications, anastomotic leakage [8.8% vs 8.4%] or temporary stoma requirement. IICR patients were more likely to present with non-infectious complications and ileus [11.8% vs 3.7%, p < 0.001]. Uni- and multivariate analyses did not identify specific risk factors of overall postoperative morbidity in the IICR group., Conclusions: Surgery for recurrent CD is associated with a slight increase of non-infectious morbidity [postoperative ileus] that mainly reflects the technical difficulties of these procedures. However, IICR remains a safe therapeutic option in patients with recurrent CD because severe morbidity including anastomotic complications is similar to patients undergoing primary resection., Podcast: This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)