Rifaximin Treatment of Collagenous Colitis: A Randomised, Double-Blind, Placebo-Controlled Trial.

Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long-term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single-centre trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in CC. Methods: Eligible patients with active, biopsy-verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after 4 weeks of treatment were randomised to receive either rifaximin or placebo for 4 weeks. Results: Fifteen patients were randomised to receive either rifaximin (n = 7) or placebo (n = 8). At 12-week follow-up, 2 patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (interquartile range [IQR] 33-126) compared to 18.5 (IQR 10.5-51.5) in the placebo group (p = 0.189). At 12-week follow-up, the relapse rate per 100 person-days in the placebo group was higher (3.25 [1.40-6.41]) than in the rifaximin group (1.33 [0.43-3.10]). Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.

Prevalence of factors contributing to unplanned hospital readmission of older medical patients when assessed by patients, their significant others and healthcare professionals: a cross-sectional survey.

OBJECTIVE: To describe the prevalence of factors contributing to readmission of older medical patients perceived by patients, significant others and healthcare professionals and to examine the agreement of factors contributing to readmission. METHODS: This cross-sectional survey was conducted at Horsens Regional Hospital from September 2020 to June 2021. Patients aged ≥ 65 years and who were readmitted within 30 days were included. The questionnaire covered eight themes: disease; diagnosing, treatment and care; network; organisation; communication; skills and knowledge; resources; and practical arrangements. Response groups were patients, significant others, GPs, district nurses and hospital physicians. Outcomes were the prevalence of factors contributing to 30-day readmission and inter-rater agreement between respondents. RESULTS: In total, 165 patients, 147 significant others, 115 GPs, 75 district nurses and 165 hospital physicians were included. The patients' median age was 79 years (IQR 74-85), and 44% were women. The following were the most prevalent contributing factors: (1) relapse of the condition that caused the index admission, (2) the patient could not manage the symptoms or illness, (3) worsening of other illnesses or conditions, (4) the patient was not fully treated at the time of discharge and (5) the patient's situation was too complex for the medical practice to handle. Kappas ranged from 0.0142 to 0.2421 for patient-significant other dyads and 0.0032 to 0.2459 for GP-hospital physician dyads. CONCLUSION: From the perspectives of the included respondents, factors associated with the disease and its management were the most prevalent contributors to readmission for older medical patients. Agreement on the contributing factors was generally low. TRIAL REGISTRATION: Clinical trial number NCT05116644. Registration date October 27, 2021.

Root-cause Analysis of 762 Danish Post-colonoscopy Colorectal Cancer Patients.

BACKGROUND & AIMS: The term post-colonoscopy colorectal cancer (PCCRC) refers to colorectal cancer (CRC) diagnosed after a negative colonoscopy. Using the root-cause algorithm proposed by the World Endoscopy Organization, we aimed to investigate plausible explanations for PCCRCs and potential changes in plausible explanations for PCCRCs over time in a Danish Region. METHODS: During 1995 to 2021, we used national health registries and electronic medical records in the Central Denmark Region to identify PCCRC cases, defined as CRCs recorded within 6 to 48 months after a colonoscopy. We then applied the World Endoscopy Organization algorithm to categorize explanations for PCCRC as follows: (A) possible missed lesion, prior examination adequate; (B) possible missed lesion, prior examination inadequate; (C) detected lesion, not resected; or (D) likely incomplete resection of previously identified lesion. PCCRCs were identified before (1995-2013) and after (2014-2021) implementation of nationwide fecal immunochemical test-based CRC screening and quality indicators for colonoscopy. RESULTS: We identified 762 PCCRCs, 53.5% among males and 57% among individuals ≥70 years. Forty-five percent were located in the proximal colon. We identified 616 (80.8%; 95% confidence interval [CI], 74.6%-87.5%) category A PCCRCs; 36 (4.7%; 95% CI, 3.3%-6.5%) category B PCCRCs; 26 (3.4%; 95% CI, 2.2%-4.9%) category C PCCRCs; and 84 (11%; 95% CI, 8.8%-13.6%) category D PCCRCs. Similar patterns were observed during the early (1995-2013) and late (2014-2021) study periods. CONCLUSIONS: Most PCCRCs originate from possible missed lesions and incompletely resected lesions during the complete study period. These findings indicate the importance of quality assurance of colonoscopy procedures and polypectomy techniques.

Effects of a transitional care intervention on readmission among older medical inpatients: a quasi-experimental study.

PURPOSE: To evaluate the effect of a transitional care intervention (TCI) on readmission among older medical inpatients. METHODS: This non-randomised quasi-experimental study was conducted at Horsens Regional Hospital in Denmark from 1 February 2017 to 31 December 2018. Inclusion criteria were patients ≥ 75 years old admitted for at least 48 h. First, patients were screened for eligibility. Then, the allocation to the intervention or control group was performed according to the municipality of residence. Patients living in three municipalities were offered the hospital-based intervention, and patients living in a fourth municipality were allocated to the control group. The intervention components were (1) discharge transportation with a home visit, (2) a post-discharge cross-sectorial video conference and (3) seven-day telephone consultation. The primary outcome was 30-day unplanned readmission. Secondary outcomes were 30- and 90-day mortality and days alive and out of hospital (DAOH). RESULTS: The study included 1205 patients (intervention: n = 615; usual care: n = 590). In the intervention group, the median age was 84.3 years and 53.7% were females. In the control group, the median age was 84.9 years and 57.5% were females. The 30-day readmission rates were 20.8% in the intervention group and 20.2% in the control group. Adjusted relative risk was 1.00 (95% confidence interval: 0.80, 1.26; p = 0.99). No significant difference was found between the groups for the secondary outcomes. CONCLUSION: The TCI did not impact readmission, mortality or DAOH. Future research should conduct a pilot test, address intervention fidelity and consider real-world challenges. TRIAL REGISTRATION: Clinical trial number: NCT04796701. Registration date: 24 February 2021.

Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial.

BACKGROUND: Endoscopic screening with polypectomy reduces the incidence of colorectal cancer (CRC). Incomplete polyp removal may attenuate the effect of screening. This randomized trial compared cold snare polypectomy (CSP) with hot snare polypectomy (HSP) in terms of complete polyp resection. METHODS: We included patients ≥ 40 years of age at eight hospitals in four countries who had at least one non-pedunculated polyp of 4-9 mm detected at colonoscopy. Patients were randomized 1:1 to CSP or HSP. Biopsies from the resection margins were obtained systematically after polypectomy in both groups. We hypothesized that CSP would be non-inferior to HSP, with a non-inferiority margin of 5 %. Logistic regression models were fitted to identify the factors explaining incomplete resection. RESULTS: 425 patients, with 601 polyps, randomized to either CSP or HSP were included in the analysis. Of 318 polyps removed by CSP and 283 polyps removed by HSP, 34 (10.7 %) and 21 (7.4 %) were incompletely resected, respectively, with an adjusted risk difference of 3.2 % (95 %CI -1.4 % to 7.8 %). There was no difference between the groups in terms of post-polypectomy bleeding, perforation, or abdominal pain. Independent risk factors for incomplete removal were serrated histology (odds ratio [OR] 3.96; 95 %CI 1.63 to 9.66) and hyperplastic histology (OR 2.52; 95 %CI 1.30 to 4.86) in adjusted analyses. CONCLUSION: In this randomized trial, non-inferiority for CSP could not be demonstrated. Polyps with serrated histology are more prone to incomplete resection compared with adenomas. CSP can be used safely for small polyps in routine colonoscopy practice.

Impact of transitional care interventions on hospital readmissions in older medical patients: a systematic review.

OBJECTIVES: To identify and synthesise available evidence on the impact of transitional care interventions with both predischarge and postdischarge elements on readmission rates in older medical patients. DESIGN: A systematic review. METHOD: Inclusion criteria were: medical patients ≥65 years or mean age in study population of ≥75 years; interventions were transitional care interventions between hospital and home with both predischarge and postdischarge components; outcome was hospital readmissions. Studies were excluded if they: included other patient groups than medical patients, included patients with only one diagnosis or patients with only psychiatric disorders. PubMed, The Cochrane Library, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science were searched from January 2008 to August 2019. Study selection at title level was undertaken by one author; the remaining selection process, data extraction and methodological quality assessment were undertaken by two authors independently. A narrative synthesis was performed, and effect sizes were estimated. RESULT: We identified 1951 records and included 11 studies: five randomised trials, four non-randomised controlled trials and two pre-post cohort studies. The 11 studies represent 15 different interventions and 29 outcome results measuring readmission rates within 7-182 days after discharge. Twenty-two of the 29 outcome results showed a drop in readmission rates in the intervention groups compared with the control groups. The most significant impact was seen when interventions were of high intensity, lasted at least 1 month and targeted patients at risk. The methodological quality of the included studies was generally poor. CONCLUSION: Transitional care interventions reduce readmission rates among older medical patients although the impact varies at different times of outcome assessment. High-quality studies examining the impact of interventions are needed, preferably complimented by a process evaluation to refine and improve future interventions. PROSPERO REGISTRATION NUMBER: CRD42019121795.

Split-Dose Regimen With Bisacodyl Increases the Quality of Bowel Preparation for Colonoscopy.

The aim of the present study was to compare 2 different bowel preparations procedures (split-dose with PicoPrep and bisacodyl vs. same-day preparation with PicoPrep) in patients undergoing colonoscopy with regard to quality of bowel preparation, compliance, and willingness to repeat. A retrospective quasi-experimental investigation was conducted. Adults with outpatient diagnostic and surveillance colonoscopies were included. A total of 540 patients participated: group 'split-dose with bisacodyl' (n = 293) and group 'same-day' (n = 247). Patients in group 'split-dose with bisacodyl' had a higher chance for having an excellent quality of bowel preparation (21.2%; 95% CI [13.5, 28.9]) and a reduced risk of an incomplete colonoscopy (4.1%; 95% CI [1.2, 7.0]). Group 'split-dose with bisacodyl' drank more fluid, had more nightly visits to the bathroom, and had more bathroom stops on the way to the endoscopic site. No differences were found between groups regarding adenoma detection rate, withdrawal time, overall time of colonoscopy, well-being during cleansing, patient satisfaction, the professional's assessment of the patient's tolerability of colonoscopy, and willingness to repeat the bowel preparation process. The split-dose regimen with PicoPrep and bisacodyl is now the standard bowel preparation procedure for patients undergoing elective colonoscopy as it is superior to the same-day regimen with PicoPrep regarding colon cleansing and incomplete colonoscopy. Hence, the written and verbal information at our institution regarding the bowel preparation procedure was altered according to the split-dose regimen, emphasizing the importance of adequate oral fluid intake and complete intake of the solution in order to ensure a safe and effective procedure.

Diagnostic Accuracy of a Point-of-Care Test for Celiac Disease Antibody Screening among Infertile Patients.

BACKGROUND: Screening for celiac disease among infertile patients has been suggested. Several rapid point-of-care (POC) tests aimed at detecting celiac disease antibodies have been developed. It has been suggested that these POC tests can be implemented as a replacement for standard laboratory tests. OBJECTIVE: To evaluate the diagnostic accuracy of a POC test (Simtomax®) that detects celiac disease antibodies compared with standard laboratory tests when screening for celiac disease among patients referred for fertility treatment in 2 Danish fertility clinics. METHODS: Serum samples were analyzed for IgA anti-tissue transglutaminase (TGA) as the reference standard test with a cutoff of ≥7 kU/L and by the index POC test based on IgA and IgG antibodies against deamidated gliadin peptides (DGP). In IgA deficiency, the reference standard test was IgG DGP with a cutoff of ≥7 kU/L. Participants answered a questionnaire on gluten intake, symptoms, and risk factors. Diagnostic confirmation was made by duodenal biopsies. IgA TGA/IgG DGP were used as the reference standard to calculate positive and negative predictive values. RESULTS: A total of 622 men and women (51.6%) were enrolled during 2015. The reference standard IgA TGA/IgG DGP was positive in 7 participants (1.1% [95% CI 0.5-2.3]) and the POC test was positive in 84 participants (13.5% [95% CI 10.9-16.4]), 3 of whom also had positive reference standard tests. This yields a sensitivity of the index POC test of 42.9% (95% CI 9.9-81.6) and a specificity of 86.8% (95% CI 83.9-89.4). Positive and negative predictive values were 3.57% (95% CI 0.7-10.1) and 99.3% (95% CI 98.1-99.8). CONCLUSION: The sensitivity of the POC test was low; however, the specificity was moderately good. The POC test had a high negative predictive value in this low prevalent population but missed 1 patient with biopsy-confirmed celiac disease. However, because of many false-positive tests, it cannot be recommended as replacement for standard laboratory tests but rather as a triage test to decide if the standard serology tests should be performed.

Unrecognised coeliac disease among men and women undergoing fertility treatment: A screening study.

BACKGROUND: Coeliac disease is an autoimmune disease triggered by dietary gluten and has been associated with several conditions influencing female and male reproduction. Due to unspecific symptoms, coeliac disease can be unrecognised for years. OBJECTIVE: To estimate the prevalence of unrecognised coeliac disease among couples referred to fertility treatment. METHODS: Cross-sectional screening for coeliac disease in men and women referred to fertility treatment using IgA tissue transglutaminase antibodies as a marker of coeliac disease and small-bowel biopsies to confirm the diagnosis. Participants answered a questionnaire on gluten intake, gastrointestinal symptoms and reproductive history. RESULTS: A total of 893 participants (51% women) were screened and eight were coeliac disease antibody positive. Small-bowel biopsies were obtained from seven antibody positive participants and unrecognised coeliac disease was confirmed in one woman and three men, corresponding to a prevalence of 0.45% (95% confidence interval 0.12-1.14). The total prevalence, combining already diagnosed and unrecognised CD cases, was 0.63% (95% confidence interval 0.29-1.12). CONCLUSION: The prevalence of unrecognised coeliac disease in a group of infertile patients was equivalent to that of the Danish general population and low compared with that observed in the majority of other screening studies of infertile patients. Surprisingly, it should be noted that more men than women had coeliac disease. This result does not support a need for routine screening among infertile patients.

Prevalence, incidence, and autoimmune comorbidities of celiac disease: a nation-wide, population-based study in Denmark from 1977 to 2016.

AIM: The aim of this study was to describe and identify potential trends with respect to prevalence, incidence, age, sex, and autoimmune comorbidity of celiac disease (CD). PATIENTS AND METHODS: A Danish nationwide cohort study of CD using data from The National Patient Register. Patients with a primary or secondary diagnosis code of CD during the period 1977 to 2016 were identified. Information on sex, date of birth, death, or immigration was obtained from the Danish Civil Registration System, and autoimmune comorbidities were identified in the Danish National Patient Register. The CD cohort was compared with the general Danish population using a control cohort and aggregated data obtained from Statistics Denmark. RESULTS: The CD cohort consisted of 11 802 (65% women) patients. The median age at diagnosis of CD varied between 30 years in 1980-1984 and 45 years in 1995-1999 and 27 years in 2015-2016. The prevalence of CD in 1986 and 2016 was 14 and 180 per 100 000 persons, respectively, with a female/male ratio changing from 1.3 to 2.0. Incidence rates (per 100 000 person-years) changed from 1.6 in 1980-1984 to 15.2 in 2015-2016, with the largest increase among females aged 0-9 years. In 2016, prevalence of autoimmune comorbidities was 16.4% among the CD patients compared with 5.3% in the general population. CONCLUSION: The prevalence of diagnosed CD has doubled every decade in Denmark from 1986 to 2016, and in the same period the female/male ratio has increased and the median age at diagnosis has decreased. The prevalence of autoimmune comorbidity in 2016 was three times higher among CD patients compared with the general Danish population.

A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study.

PURPOSE: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. METHODS: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012 and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and post-traumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. RESULTS: At 12 months, we found no differences in HRQOL between groups (mean difference in the Physical Component Summary score, 1.41 [95 % CI, -1.53 to 4.35; p = 0.35] (n = 235); and in the Mental Component Summary score, 1.92 [95 % CI, -1.06 to 4.90; p = 0.11] (n = 235). No differences were found on self-reported SOC (p = 0.63), anxiety (p = 0.68), depression (p = 0.67), PTSD (p = 0.27), or the utilization of healthcare services including rehabilitation. We found a difference on anxiety, when a cut-off point ≥11 was applied, in per protocol analysis of complete cases at 3 months favoring the intervention (8.8 % vs. 16.2 %, p = 0.04). CONCLUSIONS: The tested recovery program was not superior to standard care during the first 12 months post-ICU. TRIAL REGISTRATION: The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.

Improvement of nutritional care after colon surgery: the impact of early oral nutrition in the postanesthesia care unit.

PURPOSE: The purpose of this study was to evaluate the impact of implementing early oral nutritional supplements in the postanesthesia care unit (PACU) after colon surgery. DESIGN: A randomized controlled intervention study. METHODS: Patients admitted for elective colon surgery were randomly assigned to either a group receiving early oral nutritional supplements (n=24) or traditional treatment with water or lemonade (n=22) in the PACU. FINDING: On the second postoperative day, patients in the early nutritional supplement group had a higher cumulative intake of energy (P=.019) and protein (P=.015) compared with the traditional treatment. Postoperative nausea and vomiting, pain, length of stay in the PACU, and need of a nasogastric tube did not differ significantly between the groups. CONCLUSIONS: The nutritional course for patients undergoing colon surgery can be improved by implementing early oral nutritional supplements in the PACU.