Importance of complete response for outcomes of pregnancy in patients with autoimmune hepatitis.

BACKGROUND AND AIMS: While some articles describe outcome of pregnancy in autoimmune hepatitis (AIH), there are less data evaluating influence of AIH control on maternal and perinatal outcomes. This study analysed outcomes of pregnancy and related possible risk factors in AIH. METHOD: A retrospective multicentre cohort study on pregnancy in AIH was performed in 11 hospitals in the Netherlands. Maternal and neonatal outcomes were collected from records and completed by interview. Risk factors-including incomplete response, relapse and cirrhosis-for adverse outcomes were identified using logistic regression analysis. RESULTS: Ninety-seven pregnancies in 50 women resulted in 70 deliveries (72%) with a live birth rate of 98.5%. AIH relapse occurred in 6% during pregnancy, and in 27% of post-partum episodes. Absence of complete biochemical response at conception was identified as risk factor for the occurrence of gestational and post-partum relapses. Relapse of AIH in the year before conception was a risk factor for the occurrence of both gestational relapses and post-partum relapses. No complete biochemical response increased the risk for hypertensive disorders during pregnancy and intrahepatic cholestasis of pregnancy (ICP). Cirrhosis was found to be a risk factor for miscarriages, but not for other outcomes. CONCLUSION: Pregnancy in AIH is related to an increased incidence of maternal and fetal/neonatal complications; in most cases, outcome is good. Incomplete biochemical response at conception or relapse in the year before conception are risk factors for gestational and post-partum relapses, for hypertensive disorders and for ICP. Cirrhosis was a risk factor for miscarriages.

Computer-based patient education is non-inferior to nurse counselling prior to colonoscopy: a multicenter randomized controlled trial.

BACKGROUND: Optimal patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We developed computer-based education (CBE) supported by video and 3 D animations. We hypothesized that CBE could replace nurse counselling without loss of bowel preparation quality during colonoscopy. METHODS: We conducted a prospective, multicenter, endoscopist-blinded, non-inferiority randomized controlled trial. The primary outcome was adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcome measures were: sickness absence for outpatient clinic visits; patient anxiety/satisfaction scores; and information recall. We included patients in four endoscopy units (rural, urban, and tertiary). RESULTS: We screened 1035 eligible patients and randomized 845. After evaluation, 684 were included in the intention-to-treat (ITT) group. Subsequently, 497 patients were included in the per-protocol analysis, 217 in the nurse counselling and 280 in the CBE group. Baseline characteristics were similarly distributed among the groups. On per-protocol analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse-counselled patients (94.0 %; 204/217), with a difference of -0.8 % (95 % confidence interval [CI] -5.1 % to 3.5 %). Non-inferiority was confirmed in the ITT population. Sickness absence was significantly more frequent in nurse-counselled patients (28.0 % vs. 4.8 %). In CBE patients, 21.5 % needed additional information, with 3.0 % needing an extra outpatient visit. CONCLUSION: CBE is non-inferior to nurse counselling in terms of bowel preparation during colonoscopy, with lower patient sickness leave. CBE may serve as an efficient educational tool to inform patients before colonoscopy in routine clinical practice.

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy.

Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy. This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access. This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.

Computer-assisted instruction before colonoscopy is as effective as nurse counselling, a clinical pilot trial.

BACKGROUND AND STUDY AIMS: Better patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We reasoned that computer assisted instruction (CAI) using video and 3 D animations followed by nurse contact maximizes the effectiveness of nurse counselling, increases proportion of clean colons and improves patient experience. PATIENTS AND METHODS: Adults referred for colonoscopy in a high-volume endoscopy unit in the Netherlands were included. Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were prospectively divided into 2 groups, 1 group received nurse counselling and 1 group received CAI and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during examination, was measured with Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS). We assessed patient comfort and anxiety at 3 different time points. RESULTS: We included 385 patients: 197 received traditional nurse counselling and 188 received CAI. Overall patient response rates were 99 %, 76.4 % and 69.9 % respectively. Endoscopists scored cleanliness in 60.8 %. Comparative analysis of the 39.2 % of patients with missing scores showed no significant difference on age, gender or educational level. Baseline characteristics were evenly distributed over the groups. Bowel cleanliness was satisfactory and did not differ amongst groups: nurse vs. CAI group scores in BBPS: (6.54 ±â€Š1.69 vs. 6.42 ±â€Š1.62); OBPS: (6.07 ±â€Š2.53 vs. 5.80 ±â€Š2.90). Patient comfort scores were significantly higher (4.29 ±â€Š0.62 vs. 4.42 ±â€Š0.68) in the CAI group shortly before colonoscopy. Anxiety and knowledge scores were similar. CONCLUSION: CAI is a safe and practical tool to instruct patients before colonoscopy. We recommend the combination of CAI with a short nurse contact for daily practice.

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

Background and study aims The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 - 18 hours; Dose 2, 4 - 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6 - 8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0 - 14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [≥ 2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95 % confidence intervals [CI]: - 4.99, - 2.97; P < 0.0001) in the intent-to-treat analysis set. The PICOPREP TD regimen also resulted in a statistically significant increase in the odds of achieving an ascending colon OS score ≤ 1, compared to the PICOPREP DBD regimen (estimated odds ratio 9.18, 95 % CI: 4.36, 19.32; P < 0.0001). There was no statistically significant difference in the overall rate of treatment-emergent adverse events (12 % (TD) and 5.7 % (DBD), respectively, P = 0.2988). The convenience and satisfaction were comparable in the two groups. Conclusion The TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692.

Immunoglobulin G4-mediated sclerosing cholangitis as a risk factor for cholangiocarcinoma: A case report.

Immunoglobulin (Ig)G4-mediated disease is a systemic autoimmune disease, which occasionally presents solely as sclerosing cholangitis (SC). IgG4-mediated SC is challenging to diagnose, as it may mimic cholangiocarcinoma radiologically, and carcinoma cells may produce IgG4. The diagnosis of IgG4-mediated disease is based on histological consensus criteria and response to corticosteroids. In addition to the radiological and histological overlap between IgG4-mediated SC and cholangiocarcinoma, IgG4-mediated SC may be considered as a risk factor for the development of cholangiocarcinoma. We herein present the case of a patient in whom cholangiocarcinoma developed in two lesions previously characterized as IgG4-mediated SC, including a suggested mechanism underlying the contribution of IgG4-mediated SC to the development of cholangiocarcinoma.

Factors associated with anxiety and depressive symptoms in colorectal cancer survivors.

BACKGROUND: Up to 37% of colorectal cancer (CRC) survivors report depressive and anxiety symptoms. The identification of risk factors for depressive or anxiety symptoms might help focus supportive care resources on those patients most in need. The present study aims to explore which factors are associated with heightened anxiety or depression symptom severity. METHODS: In this cross-sectional study, individuals diagnosed with CRC 3.5 to 6 years ago completed questionnaires on sociodemographic information, medical comorbidities, anxiety symptoms (Beck Anxiety Inventory), and depressive symptoms (Inventory of Depressive Symptomatology). The general linear model analysis of covariance was used to identify factors associated with heightened anxiety or depressive symptom severity. RESULTS: The sample included 91 CRC survivors, 40.7% women, mean age 69.1 years. A minority of CRC survivors had moderate (3.4%) or severe (2.3%) anxiety symptoms, and moderate (7.7%) or severe (0%) depressive symptoms. Shorter time since diagnosis and higher number of comorbid diseases were associated with higher anxiety symptom severity. Female sex and higher number of comorbid diseases were associated with higher depressive symptom severity. CONCLUSION: From this explorative study, it follows that survivors with multiple comorbid diseases, shorter time since diagnosis, and female survivors might be at risk for higher anxiety and/or depressive symptom severity. Survivors with these characteristics might need extra monitoring.

[Long-term complications of bariatric surgery]. / Langetermijncomplicaties van bariatrische chirurgie: het mes snijdt aan twee kanten.

The prevalence of morbid obesity is increasing, with a corresponding increase in the demand for bariatric surgery, a proven effective treatment option. Bariatric surgery has potentially severe complications, including micro- and macronutrient deficiencies. Additionally, stenosis and ulceration of the anastomosis, reflux oesophagitis, cholelithiasis, steatohepatitis and altered pharmacokinetics and -dynamics may occur. Doctors in both the hospital setting and general practice will be increasingly confronted with the occasionally adverse long-term effects of bariatric surgery. Early detection, efficient follow-up and a multidisciplinary team approach are crucial in preventing and adequately treating the complications of bariatric surgery.

[Mesalazine and sulphasalazine for Crohn's disease: few indications, severe adverse reactions]. / Aminosalicylaten bij de ziekte van Crohn: geringe indicatie, ernstige bijwerkingen.

We report 3 cases of the occurrence of adverse events in patients with Crohn's disease who were given aminosalicylic acids. The first case involved a 43-year-old woman who developed interstitial pneumonitis requiring intubation after switching from mesalazine to sulphasalazine. Thereafter, mesalazine was used without complications. When sulphasalazine was reintroduced, the symptoms recurred. A second patient was a 56-year-old man who experienced worsening of abdominal symptoms after commencing mesalazine for an exacerbation of Crohn's disease; these symptoms improved following discontinuation of mesalazine. A third patient, a 23-year-old woman, had been treated with mesalazine for Crohn's disease for 6 months when budesonide was added because of insufficient response. After 3 weeks she was hospitalized for acute pancreatitis, which resolved after both medications were discontinued. Pancreatitis due to budesonide has not been previously described, but mesalazine is known to cause pancreatitis even after uncomplicated long-term use. Although effective in ulcerative colitis, aminosalicylic acid is not an effective treatment for Crohn's disease in general. Although adverse effects are rare, physicians should be aware of them and avoid unnecessary use.

[Switch of patients undergoing an endoscopic procedure]. / Patiëntenverwisseling bij een endoscopische ingreep. Aanleiding voor verbetering van procedures.

Due to a switch in patients, the wrong patient, an 85-year-old man, underwent endoscopic retrograde cholangiopancreatography (ERCP) with papillotomy. The mistake was reported to the healthcare inspectorate. A systematic analysis of the incident using the "Prevention and recovery information system for monitoring and analysis" (PRISMA) method brought to light various shortcomings in the care process. Based on the PRISMA analysis various measures were taken, including the introduction of a time-out procedure with a checklist before carrying out an ERCP. These measures improved the quality of the care process.