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Importance: Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results.
Objective: Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years.
Design, Setting, and Participants: Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings.
Interventions: Random assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach.
Main Outcomes and Measures: Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation).
Results: All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups.
Conclusions and Relevance: Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach.
Trial Registration: clinicaltrials.gov Identifier: NCT01710215.
BACKGROUND&AIMS: Methylation of specific microRNAs (miRNAs) often occurs in an age-dependent manner, as a field defect in some instances, and may be an early event in colitis-associated carcinogenesis. We aimed to determine whether specific mRNA signature patterns (MIR1, MIR9, MIR124, MIR137, MIR34B/C) could be used to identify patients with ulcerative colitis (UC) patients who are at increased risk for colorectal neoplasia.
METHODS: We obtained 387 colorectal tissue specimens, collected from 238 patients with UC (152 without neoplasia, 17 with dysplasia, and 69 with UC-associated colorectal cancer [UC-CRC]), from 2 independent cohorts in Japan from 2005 and 2015. We quantified methylation of miRNAs by bisulfite pyrosequencing analysis. We analyzed clinical data to determine whether miRNA methylation patterns associated with age, location, or segment of the colorectum (cecum, transverse colon, and rectum). Differences in tissue miRNA methylation and expression levels were compared among samples and associated with cancer risk using the Wilcoxon test, Mann-Whitney and Kruskal-Wallis tests as appropriately. We performed a validation study of samples from 90 patients without UC and 61 patients with UC-associated dysplasia or cancer to confirm the association between specific methylation patterns of miRNAs in non-tumor rectal mucosa from patients with UC with risk of UC-CRC.
RESULTS: Among patients with UC without neoplasia, rectal tissues had significantly higher levels of methylation levels of MIR1, MIR9, MIR124, and MIR137 than in proximal mucosa; levels of methylation associated with age and duration of UC in rectal mucosa. Methylation of all miRNAs was significantly higher in samples from patients with dysplasia or CRC compared to samples from patients without neoplasia. Receiver operating characteristic analysis revealed that methylation levels of miRNAs in rectal mucosa accurately differentiated patients with CRC from those without. Methylation of MIR137 in rectal mucosa was independent risk factor for UC-CRC. Methylation patterns of a set of miRNAs (panel) could discriminated patients with UC patients with or without dysplasia or CRC in the evaluation cohort (area under the curve, 0.81) and the validation cohort (area under the curve, 0.78).
CONCLUSIONS: In evaluation and validation cohorts, we found specific miRNAs to be methylated in rectal mucosal samples from patients with UC with dysplasia or CRC compared with patients without neoplasms. This pattern also associated with patient age and might be used to identify patients with UC at greatest risk for developing UC-CRC. Our findings provide evidence for a field defect in rectal mucosa from patients with UC-CRC.
The presence of the meandering mesenteric artery, which is a non-constant tortuous arterial component unifying the peripheral intestinal circulation, is evidence of chronic occlusive disease of the main intestinal arteries. This collateral intestinal arterial pathway, when present, must be preserved in any abdominal intervention, as it is often the only remaining arterial supply of the intestine; its ligation can be accompanied by intestinal ischemia. We present herein, the case of a 42-year old man, heavy smoker, who had chronic mesenteric ischemia without particular clinical manifestations till the hospitalization for acute myocardial infarction for which he underwent balloon angioplasty and stenting of the left circumflex coronary artery. Three days later he experienced acute-on-chronic intestinal ischemia with crescendo clinical manifestations; intra-arterial angiography revealed the presence of a meandering mesenteric artery in a milieu of celiac, superior and inferior mesenteric and right internal iliac artery occlusion accompanied by a tight stenosis of the left internal iliac artery. Successful stenting of the orifice of the left internal iliac artery was followed by a well-defined dilatation of the meandering artery, revascularization of the peripheral branches of the inferior -through the superior hemorrhoidal artery- and superior mesenteric arteries and complete resolution of the acute mesenteric ischemia. Thus, time was gained for the patient in order to have, if needed, a future elective open revascularization of the mesenteric artery, when the perioperative risk of mortality from the recent myocardial infarction and the coronary angioplasty and stenting will be minimal.
Ischemia (6), Myocardial Infarction (2), Pathologic Constriction (1), more mentions
BACKGROUND: The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) released in 2007 eight recommendations for cancer prevention on body fatness, diet and physical activity. Our aim is to evaluate the relation between adherence to these recommendations and colorectal cancer (CRC) risk.
METHODS: We pooled data from two Italian case-control studies including overall 2419 patients with CRC and 4723 controls. Adherence to the WCRF/AICR guidelines was summarised through a score incorporating seven of the WCRF/AICR recommendations, with higher scores indicating higher adherence to the guidelines. Odds ratios (ORs) of colorectal cancer were estimated using multiple logistic regression models.
RESULTS: Higher adherence to the WCRF/AICR recommendations was associated with a significantly reduced CRC risk (OR 0.67, 95% confidence interval, CI, 0.56-0.80 for a score ≥5 versus <3.5), with a significant trend of decreasing risk for increasing adherence (p < 0.001). Consistent results were found for colon (OR 0.67) and rectal cancer (OR 0.67). Inverse associations were observed with the diet-specific WCRF/AICR score (OR 0.71, 95% CI, 0.61-0.84 for ≥3.5 versus <2.5 points) and with specific recommendations on body fatness (OR 0.82, 95% CI, 0.70-0.97), physical activity (OR 0.86, 95% CI, 0.75-1.00), foods and drinks that promote weight gain (OR 0.70, 95% CI, 0.56-0.89), foods of plant origin (OR 0.56, 95% CI, 0.42-0.76), limiting alcohol (OR 0.87, 95% CI, 0.77-0.99) and salt intake (OR 0.63, 95% CI, 0.48-0.84).
CONCLUSION: Our study indicated that adherence to the WCRF/AICR recommendations is inversely related to CRC risk.
BACKGROUND AND AIM: Several procedures for the treatment of complete rectal prolapse (CRP) exist. These procedures are performed via the abdominal or perineal approach. Perineal procedures for rectal prolapse involve either resection or suspension and fixation of the rectum. The present review aimed to assess the outcomes of the perineal resectional procedures including Altemeier procedure (AP), Delorme procedure (DP), and perineal stapled prolapse resection (PSR) in the treatment of CRP.
PATIENTS AND METHODS: A systematic search of the current literature for the outcomes of perineal resectional procedures for CRP was conducted. Databases queried included PubMed/MEDLINE, SCOPUS, and Cochrane library. The main outcomes of the review were the rates of recurrence of CRP, improvement in bowel function, and complications.
RESULTS: Thirty-nine studies involving 2647 (2390 females) patients were included in the review. The mean age of patients was 69.1 years. Recurrence of CRP occurred in 16.6% of patients. The median incidences of recurrence were 11.4% for AP, 14.4% for DP, and 13.9% for PSR. Improvement in fecal incontinence occurred in 61.4% of patients after AP, 69% after DP, and 23.5% after PSR. Complications occurred in 13.2% of patients. The median complication rates after AP, DP and PSR were 11.1%, 8.7%, and 11.7%, respectively.
CONCLUSION: Perineal resectional procedures were followed by a relatively high incidence of recurrence, yet an acceptably low complication rate. Definitive conclusions on the superiority of any procedure cannot be reached due to the significant heterogeneity of the studies.
BACKGROUND: Elderly-onset ulcerative colitis (EO-UC) is recognized as a distinct subpopulation of UC. To our knowledge, there have been no nationwide studies of EO-UC populations in the USA.
AIMS: We aim to characterize differences in presentation at diagnosis and clinical course between EO-UC and adult-onset UC (AO-UC) patients in a national cohort.
METHODS: Complete medical records of patients newly diagnosed with UC from October 2001 to October 2011 in the Veterans Affairs health system were obtained. Patients were followed until colectomy, death, or the end of the observation period on November 2015. EO-UC patients (age of diagnosis ≥65 years) were compared to AO-UC patients (age of diagnosis ≤40 years) with respect to demographic, severity, and therapeutic data. Statistical analysis was performed using JMP statistical software.
RESULTS: We identified 836 newly diagnosed UC patients, of which 207 had EO-UC and 102 had AO-UC. The mean age of diagnosis was 72.4 years (EO-UC) and 32.9 years (AO-UC), with a mean 8-year follow-up period. The incidence of pancolitis at the time of diagnosis was similar between both groups (p = 0.67). There was no difference in steroid use (36.7 vs 45.1%, p = 0.1563), thiopurine use (19.3 vs 22.6%, p = 0.5081), and colectomy rates (6.3 vs 5.9%, p = 0.8911) between EO-UC and AO-UC populations. There was lower anti-TNF use in EO-UC patients compared to AO-UC patients (5.8 vs 14.7%, p = 0.0091).
CONCLUSION: In this nationwide cohort, we found that the use of steroids, thiopurines, and colectomy was similar in both populations, while anti-TNF use was lower among the elderly.
OBJECTIVES: Real world data regarding clinical response to ustekinumab in Crohn's disease is lacking. We report our experience of ustekinumab use using a novel subcutaneous (SC) induction strategy and aim to identify predictors of response.
MATERIALS AND METHODS: A retrospective, observational study of compassionate ustekinumab use in Crohn's disease was conducted with the use of a standard or high dose SC induction protocol. Symptomatic response was assessed after 3 months (short-term), and if remaining on therapy, within 3-12 months (medium-term) and at least 12 months (long-term). Endoscopic or radiologic response was assessed when available. Survival analysis of time to failure (cessation of ustekinumab) and multivariate logistic regression to identify predictors of response were performed.
RESULTS: Seventy-nine patients commenced ustekinumab, with six patients lost to follow-up and five asymptomatic at baseline. Symptomatic response was assessed in 68 patients; 56% (38) of patients had a short-term symptomatic response. Type of preceding anti-TNF response was the only significant predictor of short-term response, with primary non-response being a strong predictor. In the medium-term, symptomatic response occurred in 72% (30/42) of patients and endoscopic or radiologic response was achieved in 72% (26/36) of patients assessed. The median time to failure was 22 months. Maintenance dose escalation to 90 mg every 4 weeks was successful in three of 16 patients.
CONCLUSIONS: Fifty-six percent of patients had short-term symptomatic response, with a history of primary non-response to prior anti-TNF therapy being a predictor of response. Dose escalation had only modest benefit.
Immune System Diseases (3) Inflammatory Bowel Diseases (1), more mentions
Anisakiasis is an emerging marine foodborne zoonosis due to accidental ingestion of Anisakis larvae, through consumption of raw or undercooked infected fishery products. In this paper we describe the first human gastric hyperinfection by A. simplex in a Portuguese woman with unusual severe presentation. Over 140 anisakid larvae were removed by gastroscopy. Massive infection is uncommon in areas where consumption of raw fish is not part of the traditional diet, as is the case in Portugal. The increase of raw fishery products consumption has been considered as a health determinant in the increment of anisakiasis. However, clinicians should be aware of the emergence of these infections, not only because of the new dietary habits of the population, but also due to the high prevalence of Anisakis larvae in different fish species usually consumed by the population, collected in the Portuguese coast.
Crohn's disease (CD) is a chronic progressive destructive inflammatory bowel disease. As in rheumatoid arthritis, there is increasing evidence that early treatment initiation with disease-modifying agents, such as biological drugs, may lead to complete disease control, prevention of disease progression thus protecting against irreversible damage and restoration of normal quality of life. Data from randomised clinical trials with immunosuppressants and biologics suggest that treating patients with a disease duration of <2 years and an absence of complications may significantly reduce the risk for complications and increase time in remission in patients with CD. Moreover, rapid disease control may effectively prevent disease progression and allow dose reduction or even withdrawal of treatment, reducing the risk of long-term adverse events and healthcare costs. However, prospective disease modification trials are needed to confirm these initial results. Here we review the literature regarding early intervention in adult patients with CD and propose criteria for future disease modification trials.
Immune System Diseases (4) Rheumatoid Arthritis (1), Inflammatory Bowel Diseases (1), more mentions
BACKGROUND: An improved understanding of Clostridium difficile is important as it is used as a measure of hospital quality and is associated with substantial morbidity. This study utilizes the National Surgical Quality Improvement Program to determine the incidence, timing, risk factors, and clinical implications of C difficile colitis in patients undergoing primary total hip or knee arthroplasty (THA or TKA).
METHODS: Patients who underwent primary THA or TKA as part of the 2015 National Surgical Quality Improvement Program were identified. The primary outcome was a diagnosis of C difficile colitis within the 30-day postoperative period. Risk factors for the development of C difficile colitis were identified using Poisson multivariate regression.
RESULTS: A total of 39,172 patients who underwent primary THA or TKA were identified. The incidence of C difficile colitis was 0.10% (95% confidence interval [CI] 0.07-0.13). Of the cases that developed C difficile colitis, 79% were diagnosed after discharge and 84% had not had a preceding infection diagnosed. Independent preoperative and procedural risk factors for the development of C difficile colitis were greater age (most notably ≥80 years old, relative risk [RR] 5.28, 95% CI 1.65-16.92, P = .008), dependent functional status (RR 4.05, 95% CI 1.44-11.36, P = .008), preoperative anemia (RR 2.52, 95% CI 1.28-4.97, P = .007), hypertension (RR 2.51, 95% CI 1.06-5.98, P = .037), and THA (vs TKA; RR 2.25, 95% CI 1.16-4.36, P = .017). Postoperative infectious risk factors were urinary tract infection (RR 10.66, 95% CI 3.77-30.12, P < .001), sepsis (RR 17.80, 95% CI 3.77-84.00, P < .001), and "any infection" (RR 6.60, 95% CI 2.66-16.34, P < .001).
CONCLUSION: High-risk patients identified in this study should be targeted with preventative interventions and have perioperative antibiotics judiciously managed.
Urology (1), Cardiovascular Diseases (1), Blood Disorders and Hematology (1) Colitis (8), Infections (2), Anemia (1), more mentions
BACKGROUND: The literature on resolution of intestinal strictures in patients with intestinal tuberculosis (ITB) after anti-tuberculous therapy (ATT) is sparse and ambivalent. We aimed to assess the frequency of stricture resolution after ATT and its predictors.
METHODS: This ambispective cohort study included consecutive ITB patients with strictures who received ATT for ≥6 months and were on regular follow-up between January 2004 and December 2015. Resolution of stricture was assessed at the end of ATT by endoscopy/radiology.
RESULTS: Of 286 patients, 128 had strictures, and 106 were finally included (63 males, median age 35 years). The stricture location was distal ileum/ileocecal in 52 (49.1%), colon in 37 (34.9%), ileocolonic in 4 (3.8%), proximal small bowel in 10 (9.4%), and gastroduodenal in 4 (3.8%) patients. Although all patients demonstrated mucosal healing (indicating resolution of active infection), stricture resolution occurred only in 25/106 (23.6%) patients. Symptoms pertaining to stricture (pain abdomen/recurrent SAIO) were present in 104/106 (98%) patients, and after a median of 6 (6-9) months of ATT, these symptoms resolved only in half, 88% (22/25) in patients with stricture resolution and 38% (30/79) in patients with persistent strictures. Colonic strictures had the least resolution (5.4%) followed by proximal small intestinal (20%) and distal ileal/ileocecal (36.5%). Although not statistically significant, stricture resolution was less frequent in patients with multiple strictures, longer strictures (>3 cm), and strictures in which scope was not negotiable prior to ATT.
CONCLUSION: Only one-fourth of ITB patients with strictures show resolution of stricture following ATT. The resolution of strictures is dependent on disease location, and majority of them exhibit symptoms pertaining to stricture even after ATT.
BACKGROUND/AIMS: We aimed to evaluate the prognostic factors that can aid in the prevention of first and second surgeries in patients with Crohn's disease (CD).
METHODS: The clinical records of 115 patients with CD whose disease onset was between January 1987 and July 2012 were retrospectively investigated. The cumulative rate of bowel resection for CD-related intestinal manifestations following onset until the first surgery and the cumulative rate of reoperation following the first to second surgeries were estimated using the Kaplan-Meier method, and the relationship to each factor was statistically analyzed using the log-rank test. The background factors that influenced the cumulative rate of the first surgery and reoperation were evaluated using univariate and multivariate analyses.
RESULTS: The cumulative bowel resection rate was significantly higher in patients with ileocolitis-type CD (p = 0.0018) and in those with CD with smoking habits (p = 0.0315). And the cumulative reoperation rate was significantly higher in patients with ileocolitis-type CD (p = 0.0161) and those without early intervention with infliximab (p = 0.0161).
CONCLUSIONS: Ileocolitis-type CD and smoking habit might be initiating factors for bowel resection due to CD-related intestinal manifestations. Early intervention with infliximab likely prevents reoperation for CD recurrence.
OBJECTIVE: To examine the association between chronic immune-mediated diseases (rheumatoid arthritis, systemic lupus erythematosus or the following chronic immune-mediated inflammatory diagnoses groups: inflammatory bowel diseases, inflammatory polyarthropathies, systemic connective tissue disorders and spondylopathies) and the 6-year coronary artery disease, stroke, cardiovascular disease incidence and overall mortality; and to estimate the population attributable fractions for all four end-points for each chronic immune-mediated inflammatory disease.
METHODS: Cohort study of individuals aged 35-85 years, with no history of cardiovascular disease from Catalonia (Spain). The coded diagnoses of chronic immune-mediated diseases and cardiovascular diseases were ascertained and registered using validated codes, and date of death was obtained from administrative data. Cox regression models for each outcome according to exposure were fitted to estimate HRs in two models(1): after adjustment for sex, age, cardiovascular risk factors and(2) further adjusted for drug use. Population attributable fractions were estimated for each exposure.
RESULTS: Data were collected from 991 546 participants. The risk of cardiovascular disease was increased in systemic connective tissue disorders (model 1: HR=1.38 (95% CI 1.21 to 1.57) and model 2: HR=1.31 (95% CI 1.15 to 1.49)), rheumatoid arthritis (HR=1.43 (95% CI 1.26 to 1.62) and HR=1.31 (95% CI 1.15 to 1.49)) and inflammatory bowel diseases (HR=1.18 (95% CI 1.06 to 1.32) and HR=1.12 (95% CI 1.01 to 1.25)). The effect of anti-inflammatory treatment was significant in all instances (HR=1.50 (95% CI 1.24 to 1.81); HR=1.47 (95% CI 1.23 to 1.75); HR=1.43 (95% CI 1.19 to 1.73), respectively). The population attributable fractions for all three disorders were 13.4%, 15.7% and 10.7%, respectively.
CONCLUSION: Systemic connective tissue disorders and rheumatoid arthritis conferred the highest cardiovascular risk and population impact, followed by inflammatory bowel diseases.
Cardiovascular Diseases (6), Immune System Diseases (4), Muscular and Skeletal Diseases (1) Cardiovascular Diseases (5), Inflammatory Bowel Diseases (4), Rheumatoid Arthritis (3), more mentions
BACKGROUND/AIMS: The role of cytomegalovirus (CMV) reactivation during exacerbations of ulcerative colitis (UC) is yet a matter of debate, and assessment of CMV infection in UC patients remains an ongoing challenge. We aimed to identify associated parameters and compare detection methods for CMV infection during UC exacerbation.
METHODS: Clinical, pathological and virological parameters were retrospectively analyzed in all patients hospitalized in our institution for UC exacerbation between January 2009 and April 2015, who underwent full evaluation for CMV infection in colonic tissue by histopathology, immunohistochemistry (IHC) and CMV-PCR.
RESULTS: Of 28 patients who underwent full examination for tissue CMV-infection, 13 (46.4%) were found to be positive for CMV. Tissue CMV-PCR was more sensitive for the detection of CMV infection than histopathology and IHC. CMV-positive patients had a statistically higher frequency of recent steroid treatment and fever, with higher mean partial Mayo scores and lower mean albumin levels. There were no significant differences between CMV-positive and CMV-negative patients in terms of age, severity of colitis and disease duration. In a multivariable model, only recent steroid treatment and fever were independently associated with colonic CMV infection.
CONCLUSIONS: This study provides a clinical model to detect the presence of CMV infection in patients hospitalized with UC exacerbation, which could direct proper investigation and facilitate timely empirical therapy.
Infections (7), Ulcerative Colitis (3), Colitis (1), more mentions
OBJECTIVES: To assess the diagnostic performance of magnetic resonance imaging (MRI) in a large cohort of pregnant females with suspected acute appendicitis and to determine the frequency of non-appendiceal causes of abdominal pain identified by MRI in this population.
METHODS: This HIPAA compliant, retrospective study was IRB-approved and informed consent was waived. 212 MRI exams were performed consecutively on pregnant women aged 17-47 years old suspected of having acute appendicitis; eight exams were excluded and analyzed separately due to equivocal findings or lack of clinical follow up. Radiology reports for the MRI and any preceding ultrasound exams were reviewed as well as the patients' electronic medical record for surgical, pathological, or clinical follow up.
RESULTS: Fifteen (7.3%) of 204 MRI scans were determined to be positive for appendicitis, 14 of which were proven on surgical pathology, and one was found to have ileocecal diverticulitis. Out of the remaining 189 scans, none were subsequently shown to have acute appendicitis either surgically or based on clinical follow up. Negative predictive value (NPV) was 100% and positive predictive value was 93.3%. Sensitivity and specificity were 100% and 99.5%, respectively. Non-appendiceal findings which may have accounted for the patient's abdominal pain were seen in 91 (44.2%) of 189 scans. The most common extra-appendiceal causes of abdominal pain identified on MRI include degenerating fibroids (n = 11), significant hydronephrosis (n = 12), cholelithiasis (n = 6), and pyelonephritis (n = 3).
CONCLUSION: Our large study cohort of pregnant patients confirms MRI to be of high diagnostic value in the workup of acute appendicitis with 100% NPV and sensitivity and 99.5% specificity. Furthermore, an alternative diagnosis for abdominal pain in this patient population can be made in nearly half of MRI exams which are deemed negative for appendicitis.
Appendicitis (8), Cholelithiasis (1), Pyelonephritis (1), more mentions
BACKGROUND AND AIMS: Advances in drug development for ulcerative colitis (UC) have been paralleled by innovations in trial design. Development of a core outcome set (COS) to standardize outcome definitions and reporting in clinical trials is desirable. We aim to systematically review the efficacy and safety outcomes reported in UC placebo-controlled RCTs.
METHODS: We searched MEDLINE, EMBASE, and the Cochrane Library from inception through March 1, 2017 for placebo-controlled RCTs in adult patients with UC treated with aminosalicylates, immunosuppressants, corticosteroids, biologics, and oral small molecules. Efficacy and safety outcomes, definitions, and measurement tools were extracted and stratified by decade of publication.
RESULTS: Eighty-three RCTs (68 induction, 15 maintenance) were included, enrolling 17,737 patients. Clinical or composite-clinical efficacy outcomes were reported in all trials; the Ulcerative Colitis Disease Activity Index (UCDAI) and the Mayo Clinic Score (MCS) were commonly used tools for assessing clinical response/remission. Remarkably, substantial variability in the definition of clinical or composite-clinical endpoints was observed with over 50 definitions of response or remission utilized. Endoscopic, histologic, and fecal/serum biomarker outcomes were reported in 83.1% (69/83), 24.1% (20/83), and 24.1% (20/83) of RCTs, respectively. A greater proportion of trials published after 2007 reported objective outcomes (96.5% endoscopic, 26.3% histologic, and 36.8% biomarker outcomes), but no standardized definitions of histologic or biomarker endpoints exists. Patient-reported efficacy and quality of life outcomes were described in 25 RCTs (30.1%) and safety outcomes were reported in 77 RCTs (92.8%).
CONCLUSIONS: Despite recent advances in clinical trials methodology, important heterogeneity in reporting and variability in endpoint definitions still remains. A need exists to develop and validate a COS for UC clinical trials.
BACKGROUND: Perforated gastric cancer (PGC) is a rare condition of gastric cancer (GC). In this study, we sought to assess the outcome of PGC from the aspects of both acute care surgery and surgical oncology at a single institute, Chang Gung Memorial Hospital (CGMH).
METHODS: From 1997 to 2013, 6864 patients were diagnosed with GC and 2738 were diagnosed with gastroduodenal perforation at CGMH. In total, 29 patients with PGC were identified. Immediate surgical and long-term oncologic outcomes were evaluated after an appropriate matching process was performed.
RESULTS: The immediate surgical outcome of PGC, i.e., the hospital mortality rate within 30 d after surgery, did not significantly differ from that of non-cancer related gastroduodenal perforation. The long-term oncologic outcome, with matching by age, gender, year of surgery and AJCC 7th stage grouping, also did not significantly differ from that of GC without perforation.
CONCLUSIONS: Aggressive surgical treatment, including an initial emergency procedure for containing peritonitis and radical surgery for GC, may benefit PGC patients in terms of both the immediate and oncologic outcomes.
BACKGROUND: Clinical use of biosimilar infliximab (CT-P13) in inflammatory bowel diseases (IBDs) is based on extrapolation of indication from clinical studies performed in rheumatological diseases. Only few data exist of behaviour of infliximab trough levels (TLs) and anti-drug antibodies (ADAs) during switching.
AIM: The objective of this study was to evaluate changes in TLs, ADA formation and disease activity after switching from originator infliximab to biosimilar one.
METHODS: All our IBD patients receiving maintenance infliximab therapy were switched to biosimilar infliximab. TLs and ADAs were measured before the last originator infusion and before the third biosimilar infusion. Laboratory values, disease activity indices (partial Mayo score and Harvey-Bradshaw index) and demographic data were collected from patient records.
RESULTS: A total of 62 patients were included in the final analysis (32 Crohn's disease, 30 ulcerative colitis (UC) or IBD-unclassified). No significant changes in median TLs before (5.5 mg/l) and after switching (5.5 mg/l, p = .05) occurred in the entire study group or in the Crohn's disease (CD) subgroup (5.75 and 6.5 mg/l, p = .68). However, in the subgroup of ulcerative colitis, the change in median TL was significantly different (from 5.2 to 4.25 mg/l, p = .019). Two patients developed ADAs after switching. No changes in disease activity were detected during switching and no safety concerns occurred.
CONCLUSIONS: Switching from originator to biosimilar infliximab resulted in statistically significant differences in infliximab TLs in patients with UC but not in patients with Crohn's disease. The clinical significance for this difference is doubtful and in neither group changes in disease activity occurred.
Immune System Diseases (3) Ulcerative Colitis (3), Inflammatory Bowel Diseases (2), more mentions
OBJECTIVE: To describe a cohort of patients with intestinal failure (IF) and tunnelled catheters in a regional IF unit, treatment and catheter-related complication rates, and to compare the quality of care with previously published results from specialised IF centres in Denmark.
METHODS: A retrospective chart review of an adult IF patient cohort receiving parenteral therapy through tunnelled catheters in a regional IF unit from 2005 to 2014. Demographics, indication, type and frequency of parenteral therapy, dwell time, cause of removal and complications were recorded.
RESULTS: Parenteral therapy was provided to 78 patients with a median age of 64 (25-86) years. Numbers increased from seven patients in 2005 to 40 in 2014. The cause of IF was surgical complications (33%), cancer (28%), inflammatory bowel disease (IBD, 15%) and other causes (24%). The median duration of parenteral therapy was 453 days (range: 16-3651 days). One hundred and forty-two tunnelled catheters were inserted. The incidence of catheter-related blood stream infection (CRBSI) was 1.51/1000 days (95% CI: 1.20-1.90) and the incidence of thrombosis was 0.10/1000 days (0.04-0.25). Seventy-two episodes of CRBSI occurred with 89 microorganisms cultured, the most common being coagulase-negative Staphylococcus (n = 25, 28%).
CONCLUSION: The rate of CRBSI did not differ from larger centres in Denmark but the rate of thrombotic events was higher than expected. Parenteral therapy can safely and effectively be offered to patients with IF in smaller centres.