Economic Burden of Eosinophilic Esophagitis: A Nationwide Cost-of-Illness Study.

INTRODUCTION: Despite its increasing prevalence, the economic impact of eosinophilic esophagitis (EoE) is understudied. METHODS: We estimated the societal economic burden of EoE by using real-world data from Swedish health registers. RESULTS: Patients with EoE had 45% higher societal cost ($6,290 vs $4,349) compared with the general population, primarily driven by increased healthcare costs ($2,414 vs $1,022), which accounted for 72% of the excess societal cost in EoE. DISCUSSION: EoE is associated with a considerable economic burden to society. With the prevalence of EoE still rising, the economic burden of EoE is expected to continue to grow.

Stoma-related complications and quality-of-life assessment: A cross-sectional study with patients from Ethiopia and Sweden.

BACKGROUND: The situation for patients with ostomy can be challenging, probably more in a resource-constrained environment. Our objective was to evaluate quality of life (QoL) (using EQ5D-5L) and stoma-specific QoL (using Stoma QoL) in a high- and low-income setting. METHODS: In this cross-sectional study from the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, and South General Hospital (SGH), Stockholm, patients with a permanent or temporary ostomy at TASH (EthioPerm), (EthioTemp), and patients with ostomy at SGH (SweSto) were included in October 2022-January 2023. RESULTS: Patients N = 66 were included in groups: EthioPerm N = 28, EthioTemp N = 17, and SweSto N = 21. In EthioTemp, 88% used homemade stoma bags. Although morbidity related to the nipple itself was similar in the groups, the overall score from Stoma QoL was significantly lower in EthioPerm, 48/100 than in SweSto, 74/100. Scores were significantly lower for pouch-related problems and social interactions in Ethiopian patients. In EthioPerm, 71% of the patients worried that they were a burden to the people close to them compared to 14% in SweSto (p < 0.001). Leakage was over four times more common in EthioPerm than in SweSto. Mean overall EQ5D-5L score was 18 percentage points lower than the national mean score in EthioPerm and 2 percentage points lower in SweSto. CONCLUSION: QoL was more affected in the Ethiopian study participants than in the Swedish, even when commercial stoma bags were available. The largest problems were leakage, embarrassment with social interactions, and pouch-related problems. TRIAL REGISTRATION: NCT05970458 Clinicaltrials.gov, https://clinicaltrials.gov/study/NCT05970458?locStr=Ethiopia&country=Ethiopia&distance=50&cond=Stoma%20Ileostomy&rank=1.

Ustekinumab Versus Anti-tumour Necrosis Factor Alpha Agents as Second-Line Biologics in Crohn's Disease.

BACKGROUND: There are little data on positioning biologics in Crohn's disease (CD). AIMS: We aimed to assess the comparative effectiveness and safety of ustekinumab vs tumour necrosis factor-alpha (anti-TNF) agents after first-line treatment with anti-TNF in CD. METHODS: We used Swedish nationwide registers to identify patients with CD, exposed to anti-TNF who initiated second-line biologic treatment with ustekinumab or second-line anti-TNF therapy. Nearest neighbour 1:1 propensity score matching (PSM) was used to balance the groups. The primary outcome was 3-year drug survival used as a proxy for effectiveness. Secondary outcomes included drug survival without hospital admission, CD-related surgery, antibiotics, hospitalization due to infection and exposure to corticosteroids. RESULTS: Some 312 patients remained after PSM. Drug survival at 3 years was 35% (95% CI 26-44%) in ustekinumab compared to 36% (95% CI 28-44%) in anti-TNF-treated patients (p = 0.72). No statistically significant differences were observed between the groups in 3-year survival without hospital admission (72% vs 70%, p = 0.99), surgery (87% vs 92%, p = 0.17), hospital admission due to infection (92% vs 92%, p = 0.31) or prescription of antibiotics (49% vs 50%, p = 0.56). The proportion of patients continuing second-line biologic therapy did not differ by reason for ending first-line anti-TNF (lack of response vs intolerance) or by type of first-line anti-TNF (adalimumab vs infliximab). CONCLUSION: Based on data from Swedish routine care, no clinically relevant differences in effectiveness or safety of second-line ustekinumab vs anti-TNF treatment were observed in patients with CD with prior exposure to anti-TNF.

Work Loss in Patients With Celiac Disease: A Population-based Longitudinal Study.

BACKGROUND & AIMS: Celiac disease (CD) affects around 1% of the population worldwide. Data on work disability in patients with CD remain scarce. We estimated work loss in patients with CD, including its temporal relationship to diagnosis. METHODS: Through biopsy reports from Sweden's 28 pathology departments, we identified 16,005 working-aged patients with prevalent CD (villus atrophy) as of January 1, 2015, and 4936 incident patients diagnosed with CD in 2008 to 2015. Each patient was matched to up to 5 general-population comparators. Using nationwide social insurance registers, we retrieved prospectively recorded data on compensation for sick leave and disability leave to assess work loss in patients and comparators. RESULTS: In 2015, patients with prevalent CD had a mean of 42.5 lost work days as compared with 28.6 in comparators (mean difference, 14.7; 95% confidence interval [CI], 13.2-16.2), corresponding to a relative increase of 49%. More than one-half of the work loss (60.1%) in patients with CD was derived from a small subgroup (7%), whereas 75.4% had no work loss. Among incident patients, the annual mean difference between patients and comparators was 8.0 days (range, 5.4-10.6 days) of lost work 5 years before CD diagnosis, which grew to 13.7 days (range, 9.1-18.3 days) 5 years after diagnosis. No difference in work loss was observed between patients with or without mucosal healing at follow-up. CONCLUSIONS: Patients with CD lost more work days than comparators before their diagnosis, and this loss increased after diagnosis. Identifying patients with an increased risk of work loss may serve as a target to mitigate work disability, and thereby reduce work loss, in patients with CD.

Colorectal Cancer in Childhood-onset Inflammatory Bowel Disease: A Scandinavian Register-based Cohort Study, 1969-2017.

Through linkage of data from Danish and Swedish national registers we identified 6937 patients with childhood (<18 years)-onset Crohn disease (CD), 8514 patients with childhood-onset ulcerative colitis (UC) and up to 10 times as many matched (sex, age, residence) reference individuals 1969-2017. During follow-up to a median age of 27 (interquartile range = 21-39) years, 25 (0.36%) CD patients were diagnosed with colorectal cancer (CRC) versus 43 (0.06%) reference individuals, and 113 (1.33%) UC patients versus 45 (0.05%) reference individuals. The hazard ratio (HR) for CRC was 6.46 (95% CI = 3.95-10.6) in CD and 32.5 (95% CI = 23.0-45.9) in UC and increased with decreasing age at diagnosis. The HR for CRC was increased for all phenotypes, but with higher estimates for colonic CD [17.9 (95% CI = 7.43-43.3)] and UC with extensive/pancolitis [36.3 (95% CI = 22.8-57.8)]. The relative risk of CRC was increased for all phenotypes of childhood-onset inflammatory bowel disease. Age at onset may be considered an additional risk factor when implementing surveillance programs.

Colon cancer treatment in Sweden during the COVID-19 pandemic: A nationwide register-based study.

AIM: The COVID-19 pandemic has reduced the capacity to diagnose and treat cancer worldwide due to the prioritization of COVID-19 treatment. The aim of this study was to investigate treatment and outcomes of colon cancer in Sweden before and during the COVID-19 pandemic. METHODS: In an observational study, using the Swedish Colorectal Cancer Registry, we included (i) all Swedish patients diagnosed with colon cancer, and (ii) all patients undergoing surgery for colon cancer, in 2016-2020. Incidence of colon cancer, treatments and outcomes in 2020 were compared with 2019. RESULTS: The number of colon cancer cases in Sweden in April-May 2020 was 27% lower than the previous year, whereas no difference was observed on an annual level (4,589 vs. 4,763 patients [-4%]). Among patients with colon cancer undergoing surgery in 2020, the proportion of resections was 93 vs. 94% in 2019, with no increase in acute resections. Time from diagnosis to elective surgery decreased (29 days vs. 33 days in 2020 vs. 2019). In 2020, more patients underwent a two-stage procedure with a diverting stoma as first surgery (6.1%) vs. (4.4%) in 2019 (p = 0.0020) and more patients were treated with preoperative chemotherapy (5.1%) vs. (3,5%) 2019 (p = 0.0016). The proportion of patients that underwent laparoscopic surgery increased from 54% to 58% (p = 0.0017) There were no differences in length of stay, surgical complications, reoperation, ICU-stay or 30-day mortality between the years. CONCLUSION: Based on nationwide annual data, we did not observe adverse effects of the COVID-19 pandemic on colon cancer treatment and short time outcomes in Sweden.

Tumour necrosis factor inhibitors in Crohn's disease and the effect on surgery rates.

AIM: Surgery is an important therapeutic option for Crohn's disease. The need for first bowel surgery seems to have decreased with the introduction of tumour necrosis factor inhibitors (TNFi; adalimumab or infliximab). However, the impact of TNFi on the need for intestinal surgery in Crohn's disease patients irrespective of prior bowel resection is not known. The aim of this work is to compare the incidence of bowel surgery in Crohn's disease patients who remain on TNFi treatment versus those who discontinue it. METHOD: We performed a nationwide register-based observational cohort study in Sweden of all incident and prevalent cases of Crohn's disease who started first-line TNFi treatment between 2006 and 2017. Patients were categorized according to TNFi treatment retention less than or beyond 1 year. The study cohort was evaluated with regard to incidence of bowel surgery from 12 months after the first ever TNFi dispensation. RESULTS: We identified 5003 Crohn's disease patients with TNFi exposure: 3748 surgery naïve and 1255 with bowel surgery prior to TNFi initiation. Of these patients, 7% (n = 353) were subjected to abdominal surgery during the first 12 months after the start of TNFi and were subsequently excluded from the main analysis. A majority (62%) continued TNFi for 12 months or more. Treatment with TNFi for less than 12 months was associated with a significantly higher surgery rate compared with patients who continued on TNFi for 12 months or more (hazard ratio 1.26, 95% CI 1.09-1.46; p = 0.002). CONCLUSION: Treatment with TNFi for less than 12 months was associated with a higher risk of bowel surgery in Crohn's disease patients compared with those who continued TNFi for 12 months or more.

An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients.

BACKGROUND: Critically ill COVID-19 patients have a high reported incidence of thromboembolic complications and the optimal dose of thromboprophylaxis is not yet determined. The aim of this study was to investigate if 90-day mortality differed between patients treated with intermediate- or high-dose thromboprophylaxis. METHOD: In this retrospective study, all critically ill COVID-19 patients admitted to intensive care from March 6th until July 15th, 2020, were eligible. Patients were categorized into groups according to daily dose of thromboprophylaxis. Dosing was based on local standardized recommendations, not on degree of critical illness or risk of thrombosis. Cox proportional hazards regression was used to estimate hazard ratios of death within 90 days from ICU admission. Multivariable models were adjusted for sex, age, body-mass index, Simplified Acute Physiology Score III, invasive respiratory support, glucocorticoids, and dosing strategy of thromboprophylaxis. RESULTS: A total of 165 patients were included; 92 intermediate- and 73 high-dose thromboprophylaxis. Baseline characteristics did not differ between groups. The 90-day mortality was 19.6% in patients with intermediate-dose and 19.2% in patients with high-dose thromboprophylaxis. Multivariable hazard ratio of death within 90 days was 0.74 (95% CI, 0.36-1.53) for the high-dose group compared to intermediate-dose group. Multivariable hazard ratio for thromboembolic events and bleedings within 28 days was 0.93 (95% CI 0.37-2.29) and 0.84 (95% CI 0.28-2.54) for high versus intermediate dose, respectively. CONCLUSIONS: A difference in 90-day mortality between intermediate- and high-dose thromboprophylaxis could neither be confirmed nor rejected due to a small sample size.

Restorative Surgery Is More Common in Ulcerative Colitis Patients With a High Income: A Population-Based Study.

BACKGROUND: To avoid a permanent stoma, restorative surgery is performed after the colectomy. Previous studies have shown that less than half of patients with ulcerative colitis undergo restorative surgery. OBJECTIVE: The primary aim was to explore the association between socioeconomic status and restorative surgery after colectomy. DESIGN: This was a nationwide register-based cohort study. SETTINGS: The study was conducted in Sweden. PATIENTS: All Swedish patients with ulcerative colitis who underwent colectomy between 1990 and 2017 at the age of 15 to 69 years were included. MAIN OUTCOME MEASURES: The main outcome was restorative surgery, and the secondary outcome was failure of the reconstruction (defined as the need for a new ileostomy after the reconstruction or nonreversal of a defunctioning stoma within 2 years of the reconstruction). To calculate HRs for restorative surgery after colectomy, as well as failure after restorative surgery, multivariable Cox regression models were performed (adjusted for sex, year of colectomy, colorectal cancer diagnosis, education, civil status, country of birth, income (quartiles 1 to 4, where Q4 represents highest income), hospital volume, and stratified by age). RESULTS: In all, 5969 patients with ulcerative colitis underwent colectomy, and of those, 2794 (46.8%) underwent restorative surgery. Restorative surgery was more common in patients with a high income at the time of colectomy (quartile 1, reference; quartile 2, 1.09 (0.98-1.21); quartile 3, 1.20 (1.07-1.34); quartile 4, 1.27 (1.13-1.43)) and less common in those born in a Nordic country than in immigrants born in a non-Nordic country (0.86 (0.74-0.99)), whereas no association was seen with educational level and civil status. There was no association between socioeconomic status and the risk of failure after restorative surgery. LIMITATIONS: The study was restricted to register data. CONCLUSIONS: Restorative surgery in ulcerative colitis appears to be more common in patients with a high income and patients born in a non-Nordic country, indicating inequality in the provided care. See Video Abstract at http://links.lww.com/DCR/B433. LA CIRUGA RESTAURADORA ES MS COMN EN PACIENTES CON COLITIS ULCEROSA CON INGRESOS ALTOS UN ESTUDIO POBLACIONAL: ANTECEDENTES:Para evitar un estoma permanente, se realiza una cirugía reparadora después de la colectomía. Estudios anteriores han demostrado que menos de la mitad de los pacientes con colitis ulcerosa se someten a cirugía reconstituyente.OBJETIVO:El objetivo principal fue explorar la asociación entre el nivel socioeconómico y la cirugía reconstituyente después de la colectomía.DISEÑO:Estudio de cohorte basado en registros a nivel nacional.MARCO:Suecia.PACIENTES:Todos los pacientes Suecos con colitis ulcerosa que se sometieron a colectomía desde el 1990 a 2017 a la edad de 15 a 69 años.MEDIDAS DE RESULTADOS PRINCIPALES:El resultado principal fue la cirugía restaurativa y el resultado secundario fue el fracaso de la reconstrucción (definida como la necesidad de una nueva ileostomía después de la reconstrucción o la no-reversión de un estoma disfuncional dentro de los dos años posteriores a la reconstrucción). Para calcular los cocientes de riesgo para la cirugía restauradora después de la colectomía, así como el fracaso después de la cirugía restauradora, se realizaron modelos de regresión de Cox multivariables (ajustados por sexo, año de colectomía, diagnóstico de cáncer colorrectal, educación, estado civil, país de nacimiento e ingresos (cuartiles 1- 4; donde Q4 representa los mayores ingresos), volumen de hospitales y estratificado por edad).RESULTADOS:En total 5969 pacientes con colitis ulcerosa se sometieron a colectomía, y de ellos 2794 (46,8%) se sometieron a cirugía restauradora. La cirugía restauradora fue más común en pacientes con altos ingresos en el momento de la colectomía (referencia del cuartil 1, cuartil 2: 1,09 (0,98-1,21), cuartil 3: 1,20 (1,07-1,34), cuartil 4: 1,27 (1,13-1,43)), y menos común en los nacidos en un país nórdico que en los inmigrantes nacidos en un país no-nórdico (0,86 (0,74-0,99)), mientras que no se observó asociación con el nivel educativo y el estado civil. No hubo asociación entre el nivel socioeconómico y el riesgo de fracaso después de la cirugía reparadora.LIMITACIONES:Restricción para registrar datos.CONCLUSIONES:La cirugía reparadora en colitis ulcerosa parece ser más común en pacientes con ingresos altos y en pacientes nacidos en un país no-nórdico, lo que indica desigualdad en la atención brindada. Consulte Video Resumen en http://links.lww.com/DCR/B433.

Perirenal Fat Surface Area and Oncologic Outcome in Elective Colon Cancer Surgery.

BACKGROUND: Central obesity is associated with surgical difficulties, but few studies explore the relationship with long-term results after colon cancer surgery. OBJECTIVE: The purpose of this study was to investigate the association between perirenal fat surface area, a proxy for total visceral fat, and oncologic outcome after intestinal resection for colon cancer. DESIGN: We investigated the association between perirenal fat surface area (exposure) on recurrence and death (outcome) in patients undergoing surgery with curative intent for colon cancer. SETTINGS: The study was conducted at Stockholm South General Hospital, serving a population of 600,000. PATIENTS: Patients (N = 733) without metastases at diagnosis who had a preoperative CT and had undergone elective colon resection between 2006 and 2016 were included. MAIN OUTCOME MEASURES: We compared overall survival, recurrence-free survival, and cause-specific survival by perirenal fat surface area. RESULTS: Patients with high perirenal fat surface area (fourth quartile) had more often left-sided tumors (45% vs 32% in the first quartile) and experienced more postoperative complications (29% vs 13%), but there were no differences in pathologic T and N stage, radicality of surgery, or adjuvant chemotherapy treatment. Overall survival decreased by increasing cancer stage but was not different between perirenal fat surface area categories. The HR for recurrence-free survival per centimeter squared increase in perirenal fat surface area was 1.00 (95% CI, 0.99-1.01) adjusted for age, sex, ASA category, tumor location, and postoperative complication Clavien-Dindo ≥2. The cumulative incidence of recurrence with death as a competing risk was not statistically different between perirenal fat surface area categories (p = 0.06). Subgroup analyses showed a nonsignificant tendency for men with low perirenal fat surface area to have a lower risk of recurrence and women a higher risk. LIMITATIONS: In all register-based studies there can be randomly distributed errors. The results can only be generalized to colon resections. Our cohort ranged over a large year span. CONCLUSIONS: We found no association between perirenal fat surface area and overall survival, recurrence-free survival, or cause-specific cumulative incidence of recurrence in patients undergoing colon resection for cancer. See Video Abstract at http://links.lww.com/DCR/B326. LA SUPERFICIE DE GRASA PERIRRENAL Y EL RESULTADO ONCOLGICO EN CIRUGA ELECTIVA DE CNCER DE COLON: ANTECEDENTES:La obesidad central está asociada con dificultades quirúrgicas, pero pocos estudios exploran la relación de los resultados a largo plazo después de cirugía de cáncer de colon.OBJETIVO:Investigar la asociación entre la superficie de la grasa perirrenal, como un indicador de la grasa visceral total y el resultado oncológico después de una resección intestinal por cáncer de colon.DISEÑO:Se estudió la asociación entre el área de la superficie de la grasa perirrenal (expuesta) con la recurrencia y la muerte (resultado) de pacientes sometidos a cirugía con intención curativa por cáncer de colon.AJUSTES:Atención brindada por el Hospital General del Sur de Estocolmo a una población de 600,000 habitantes.PACIENTES:Aquellos pacientes sin metástasis (n = 733) en el momento del diagnóstico que tuvieron una tomografía computada preoperatoria y que se sometieron a una resección electiva de colon entre 2006-2016.PRINCIPALES MEDIDAS DE RESULTADO:Comparamos la sobrevida general, la sobrevida libre de recurrencia y la sobrevida específica de la causa, por área de superficie de grasa perirrenal.RESULTADOS:Los pacientes con una mayor área de superficie de grasa perirrenal (cuarto cuartil) tuvieron más frecuentemente tumores del lado izquierdo (45% frente a 32% en el primer cuartil) y sufrieron más complicaciones postoperatorias (29% frente a 13%), pero no hubieron diferencias en el Estadío patológico T y N, ni en lo radical de la cirugía o del tratamiento de quimioterapia adyuvante. La supervivencia general disminuyó al aumentar el estadio del cáncer, pero no fue diferente entre las categorías de área de superficie grasa perirrenal. La razón de riesgo para la sobrevida libre de recurrencia por aumento de cm2 en el área de la superficie grasa perirrenal fue de 1.00 (intervalo de confianza del 95%: 0.99-1.01) ajustada por edad, sexo, categoría de la Sociedad Americana de Anestesiólogos, ubicación del tumor y complicación postoperatoria según Clavien-Dindo ≥ 2) La incidencia acumulada de recurrencia con muerte como un riesgo competitivo no fue estadísticamente diferente entre las categorías de área de superficie grasa perirrenal (p = 0.06). Los análisis de subgrupos mostraron una tendencia no significativa para que los hombres con un área de superficie menor en grasa perirrenal tengan un menor riesgo de recurrencia y las mujeres un mayor riesgo.LIMITACIONES:En todos los estudios basados en registros puede haber errores distribuidos aleatoriamente. Los resultados solo pueden generalizarse a resecciones de colon. Nuestra cohorte osciló durante un gran lapso de años.CONCLUSIONES:No se encontró asociación entre el área de superficie de la grasa perirrenal y la sobrevida general, ni con la sobrevida libre de recurrencia o la incidencia acumulada de recurrencia específica de la causa en pacientes sometidos a resección de colon por cáncer. Consulte Video Resumen en http://links.lww.com/DCR/B326. (Traducción-Dr Xavier Delgadillo).

Capturing biologic treatment for IBD in the Swedish Prescribed Drug Register and the Swedish National Patient Register - a validation study.

BACKGROUND: It is not known to what extent biologic treatment for IBD is captured in the Swedish Prescribed Drug Register (PDR) and the National Patient Register (NPR). METHODS: A cross-sectional study from July 2005 until 2017, comparing data on biologic treatment in the PDR and the NPR with medical records. We assessed the proportion of started treatment episodes in the medical records that were found in the PDR/NPR ever, within +/- one year and within +/- three months; for any biologic drug, per specific drug (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), by calendar period (2005-2008, 2009-2012, and 2013-2017) and by study center. For adalimumab, we assessed the validity of end of treatment episodes. RESULTS: Medical records of 1361 patients and 2323 treatment episodes with any biologic were reviewed and 80.1% (95% CI: 78.4-81.7) were ever captured in the PDR/NPR in. A time window of +/- one year or +/- three months reduced the sensitivity to 63.3% (95% CI: 61.3-65.3) and 52.6% (95% CI: 50.5-54.6), respectively. The sensitivity was high (>85%) for the prescribed injection drugs adalimumab, golimumab, and ustekinumab for all time windows and for adalimumab end of treatment, while considerably lower for the infusion drugs infliximab and vedolizumab. CONCLUSIONS: The PDR and the NPR are reliable data sources on treatment with injection biologics in patients with IBD in Sweden. Infliximab and vedolizumab are poorly captured, why PDR/NPR data should only be used after careful consideration of their limitations or complemented by other data sources, e.g., the disease-specific quality register SWIBREG.

Costs and Use of Health Care in Patients With Celiac Disease: A Population-Based Longitudinal Study.

INTRODUCTION: Celiac disease (CD) affects 1% of the population. Its effect on healthcare cost, however, is barely understood. We estimated healthcare use and cost in CD, including their temporal relationship to diagnosis. METHODS: Through biopsy reports from Sweden's 28 pathology departments, we identified 40,951 prevalent patients with CD (villous atrophy) as of January 1, 2015, and 15,086 incident patients with CD diagnosed in 2008-2015, including 2,663 who underwent a follow-up biopsy to document mucosal healing. Each patient was compared with age- and sex-matched general population comparators (n = 187,542). Using nationwide health registers, we retrieved data on all inpatient and nonprimary outpatient care, prescribed diets, and drugs. RESULTS: Compared with comparators, healthcare costs in 2015 were, on average, $1,075 (95% confidence interval, $864-1,278) higher in prevalent patients with CD aged <18 years, $715 ($632-803) in ages 18-64 years, and $1,010 ($799-1,230) in ages ≥65 years. Half of all costs were attributed to 5% of the prevalent patients. Annual healthcare costs were $391 higher 5 years before diagnosis and increased until 1 year after diagnosis; costs then declined but remained 75% higher than those of comparators 5 years postdiagnosis (annual difference = $1,044). Although hospitalizations, nonprimary outpatient visits, and medication use were all more common with CD, excess costs were largely unrelated to the prescription of gluten-free staples and follow-up visits for CD. Mucosal healing in CD did not reduce the healthcare costs. DISCUSSION: The use and costs of health care are increased in CD, not only before, but for years after diagnosis. Mucosal healing does not seem to lower the healthcare costs.

The use of ICD codes to identify IBD subtypes and phenotypes of the Montreal classification in the Swedish National Patient Register.

Introduction: Whether data on International Classification of Diseases (ICD)-codes from the Swedish National Patient Register (NPR) correctly correspond to subtypes of inflammatory bowel disease (IBD) and phenotypes of the Montreal classification scheme among patients with prevalent disease is unknown.Materials and methods: We obtained information on IBD subtypes and phenotypes from the medical records of 1403 patients with known IBD who underwent biological treatment at ten Swedish hospitals and retrieved information on their IBD-associated diagnostic codes from the NPR. We used previously described algorithms to define IBD subtypes and phenotypes. Finally, we compared these register-generated subtypes and phenotypes with the corresponding information from the medical records and calculated positive predictive values (PPV) with 95% confidence intervals.Results: Among patients with clinically confirmed disease and diagnostic listings of IBD in the NPR (N = 1401), the PPV was 97 (96-99)% for Crohn's disease, 98 (97-100)% for ulcerative colitis, and 8 (4-11)% for IBD-unclassified. The overall accuracy for age at diagnosis was 95% (when defined as A1, A2, or A3). Examining the validity of codes representing disease phenotype, the PPV was 36 (32-40)% for colonic Crohn's disease (L2), 61 (56-65)% for non-stricturing/non-penetrating Crohn's disease behaviour (B1) and 83 (78-87)% for perianal disease. Correspondingly, the PPV was 80 (71-89)% for proctitis (E1)/left-sided colitis (E2) in ulcerative colitis.Conclusions: Among people with known IBD, the NPR is a reliable source of data to classify most subtypes of prevalent IBD, even though misclassification commonly occurred in Crohn's disease location and behaviour and also among IBD-unclassified patients.

Hernia at the stoma site after loop ileostomy reversal.

PURPOSE: To estimate the incidence of and risk factors for stoma site hernia after closure of a temporary diverting ileostomy. METHOD: In a non-comparative cohort study, charts (n = 216) and CT-scans (n = 169) from patients who had undergone loop ileostomy closure following low anterior resection for rectal cancer 2010-2015 (mainly open surgery) at three hospitals were evaluated retrospectively. Patients without hernia diagnosis were evaluated cross-sectionally through a questionnaire (n = 158), and patients with symptoms of bulging or pain were contacted and offered a clinical examination or a CT scan including Valsalva maneuver. RESULTS: In the chart review, five (2.3%) patients had a diagnosis of incisional hernia at the previous stoma site after 8 months (median). In 12 patients, the CT scan showed a hernia, of which 8 had not been detected previously. The questionnaire was returned by 130 (82%) patients, of which 31% had symptoms of bulging or pain. Less than one in five of patients who reported bulging were diagnosed with hernia, but the absolute majority of the radiologically diagnosed hernias reported symptoms. By combining clinical and radiological diagnosis, the cumulative incidence of hernia was 7.4% during a median follow up time of 30 months. Risk factors for stoma site hernia were male sex and higher BMI. CONCLUSION: Hernia at the previous stoma site was underdiagnosed. Less than a third of symptomatic patients had a hernia diagnosis in routine follow up. Randomized studies are needed to evaluate if prophylactic mesh can be used to prevent hernias, especially in patients with risk factors.

Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients.

BACKGROUND: A substantial proportion of critically ill COVID-19 patients develop thromboembolic complications, but it is unclear whether higher doses of thromboprophylaxis are associated with lower mortality rates. The purpose of the study was to evaluate the association between initial dosing strategy of thromboprophylaxis in critically ill COVID-19 patients and the risk of death, thromboembolism, and bleeding. METHOD: In this retrospective study, all critically ill COVID-19 patients admitted to two intensive care units in March and April 2020 were eligible. Patients were categorized into three groups according to initial daily dose of thromboprophylaxis: low (2500-4500 IU tinzaparin or 2500-5000 IU dalteparin), medium (> 4500 IU but < 175 IU/kilogram, kg, of body weight tinzaparin or > 5000 IU but < 200 IU/kg of body weight dalteparin), and high dose (≥ 175 IU/kg of body weight tinzaparin or ≥ 200 IU/kg of body weight dalteparin). Thromboprophylaxis dosage was based on local standardized recommendations, not on degree of critical illness or risk of thrombosis. Cox proportional hazards regression was used to estimate hazard ratios with corresponding 95% confidence intervals of death within 28 days from ICU admission. Multivariable models were adjusted for sex, age, body mass index, Simplified Acute Physiology Score III, invasive respiratory support, and initial dosing strategy of thromboprophylaxis. RESULTS: A total of 152 patients were included: 67 received low-, 48 medium-, and 37 high-dose thromboprophylaxis. Baseline characteristics did not differ between groups. For patients who received high-dose prophylaxis, mortality was lower (13.5%) compared to those who received medium dose (25.0%) or low dose (38.8%), p = 0.02. The hazard ratio of death was 0.33 (95% confidence intervals 0.13-0.87) among those who received high dose, and 0.88 (95% confidence intervals 0.43-1.83) among those who received medium dose, as compared to those who received low-dose thromboprophylaxis. There were fewer thromboembolic events in the high (2.7%) vs medium (18.8%) and low-dose thromboprophylaxis (17.9%) groups, p = 0.04. CONCLUSIONS: Among critically ill COVID-19 patients with respiratory failure, high-dose thromboprophylaxis was associated with a lower risk of death and a lower cumulative incidence of thromboembolic events compared with lower doses. TRIAL REGISTRATION: Clinicaltrials.gov NCT04412304 June 2, 2020, retrospectively registered.

Long-Term Results after Anastomotic Leakage following Rectal Cancer Surgery: A Comparison of Treatment with Endo-Sponge and Transanal Irrigation.

OBJECTIVE: We aimed to evaluate long-term results in patients from regular health care treated with endoscopic transanal closure system, that is, endoscopic vacuum-assisted closure system (EVAC) compared to transanal irrigation. METHODS: In this retrospective, medical chart-based, observational study, we included patients with anastomotic leakage after low anterior resection for rectal cancer from 3 Stockholm hospitals 2006-2016 and compared time to first stoma closure in a Kaplan-Meier model and the proportion of patients who were stoma-free at end of follow-up. RESULTS: Anastomotic leakage was found in 81 patients who were followed up in median 5.9 years (min-max: 0.53-13). EVAC was used on 14 (17%) patients and transanal irrigation on 34 (42%) patients. The remaining 33 (41%) patients either got a permanent colostomy or were treated only with antibiotics and percutaneous drainage. Treatment with EVAC or transanal irrigation led to similar rates of stoma closure, both when comparing all patients, and when comparing patients with similar defects. At the end of follow-up, 43% of patients treated with EVAC and 50% of patients treated with repeated irrigation were stoma-free (p = 0.75). CONCLUSIONS: We found no evidence of better outcomes in patients treated with EVAC. The study was, however, limited by small sample size.

Incidence and Treatment of Patients Diagnosed With Inflammatory Bowel Diseases at 60 Years or Older in Sweden.

BACKGROUND & AIMS: Diagnosis of inflammatory bowel diseases (IBD) is increasing among elderly persons (60 years or older). We performed a nationwide population-based study to estimate incidence and treatment of IBD. METHODS: We identified all incident IBD cases in Sweden from 2006 through 2013 using national registers and up to 10 matched population comparator subjects. We collected data on the patients' health care contacts and estimated incidence rates, health service burden, pharmacologic treatments, extra-intestinal manifestations, and surgeries in relation to age of IBD onset (pediatric, <18 years; adults, 18-59 years; elderly, ≥60 years). RESULTS: Of 27,834 persons diagnosed with incident IBD, 6443 (23%) had a first diagnosis of IBD at 60 years or older, corresponding to an incidence rate of 35/100,000 person-years (10/100,000 person-years for Crohn's disease, 19/100,000 person-years for ulcerative colitis, and 5/100,000 person-years for IBD unclassified). During a median follow-up period of 4.2 years (range, 0-9 years), elderly patients had less IBD-specific outpatient health care but more IBD-related hospitalizations and overall health care use than adult patients with IBD. Compared with patients with pediatric or adult-onset IBD, elderly patients used fewer biologics and immunomodulators but more systemic corticosteroids. Occurrence of extra-intestinal manifestations was similar in elderly and adult patients, but bowel surgery was more common in the elderly (13% after 5 years vs 10% in adults) (P < .001). The absolute risk of bowel surgery was higher in the elderly than in the general population, but in relative terms, the risk increase was larger in younger age groups. CONCLUSIONS: In a nationwide cohort study in Sweden, we associated diagnosis of IBD at age 60 years or older with a lower use of biologics and immunomodulators but higher absolute risk of bowel surgery, compared with diagnosis at a younger age. The large differences in pharmacologic treatment of adults and elderly patients are not necessarily because of a milder course of disease and warrant further investigation.

Changes in inflammatory bowel disease subtype during follow-up and over time in 44,302 patients.

AIM: To investigate inflammatory bowel disease (IBD) register-based subtype classifications over a patient's disease course and over time. METHODS: We examined International Classification of Diseases coding in patients with ≥2 IBD diagnostic listings in the National Patient Register 2002-2014 (n = 44,302). RESULTS: 18% of the patients changed diagnosis (17% of adults, 29% of children) during a median follow-up of 3.8 years. Of visits with diagnoses of Crohn's disease (CD) or ulcerative colitis (UC), 97% were followed by the same diagnosis, whereas 67% of visits with diagnosis IBD-unclassified (IBD-U) were followed by another IBD-U diagnosis. Patients with any diagnostic change changed mostly once (47%) or twice (31%), 39% from UC to CD, 33% from CD to UC and 30% to or from IBD-U. Using a classification algorithm based on the first two diagnoses ('incident classification'), suited for prospective cohort studies, the proportion adult patients with CD, UC, and IBD-U 2002-2014 were 29%, 62%, and 10% (43%, 45%, and 12% in children). A classification model incorporating additional information from surgeries and giving weight to the last 5 years of visits ('prevalent classification'), suited for description of a study population at end of follow-up, classified 31% of adult cases as CD, 58% as UC and 11% as IBD-U (44%, 38%, and 18% in children). CONCLUSIONS: IBD subtype changed in 18% during follow-up. The proportion with CD increased and UC decreased from definition at start to end of follow-up. IBD-U was more common in children.

Validating surgical procedure codes for inflammatory bowel disease in the Swedish National Patient Register.

BACKGROUND: About 50% of patients with Crohn's disease (CD) and about 20% of those with ulcerative colitis (UC) undergo surgery at some point during the course of the disease. The diagnostic validity of the Swedish National Patient Register (NPR) has previously been shown to be high for inflammatory bowel disease (IBD), but there are little data on the validity of IBD-related surgical procedure codes. METHODS: Using patient chart data as the gold standard, surgical procedure codes registered between 1966 and 2014 in the NPR were abstracted and validated in 262 randomly selected patients with a medical diagnosis of IBD. Of these, 53 patients had reliable data about IBD-related surgery. The positive predictive value (PPV), sensitivity and specificity of the surgical procedure codes were calculated. RESULTS: In total, 158 surgical procedure codes were registered in the NPR. One hundred fifty-five of these, representing 60 different procedure codes, were also present in the patient charts and validated using a standardized form. Of the validated codes 153/155 were concordant with the patient charts, corresponding to a PPV of 96.8% (95%CI = 93.9-99.1). Stratified in abdominal, perianal and other surgery, the corresponding PPVs were 94.1% (95%CI = 88.7-98.6), 100% (95%CI = 100-100) and 98.1% (95%CI = 93.1-100), respectively. Of 164 surgical procedure codes in the validated patient charts, 155 were registered in the NPR, corresponding to a sensitivity of the surgical procedure codes of 94.5% (95%CI = 89.6-99.3). The specificity of the NPR was 98.5% (95%CI = 97.6-100). CONCLUSIONS: Data on IBD-related surgical procedure codes are reliable, with the Swedish National Patient Register showing a high sensitivity and specificity for such surgery.

Serum Androgen Levels and Sexual Function Before and One Year After Treatment of Uterine Cervical Cancer: A Pilot Study.

INTRODUCTION: Radiotherapy or radical hysterectomy with salpingo-oophorectomy (SOE) as treatment for uterine cervical cancer causes estrogen deprivation in premenopausal women. The effects on androgen production have rarely been examined but could be relevant for survivors of cervical cancer because insufficiency has been associated with low sexual function. AIM: To investigate the effects of pelvic radiotherapy, hysterectomy with SOE, or surgery without SOE on androgen levels and to explore potential associations with sexual function. METHODS: Patients with cervical cancer (N = 60) were prospectively examined through blood sampling and questionnaires before and 1 year after treatments. MAIN OUTCOME MEASURES: Serum testosterone (measured by liquid chromatography and tandem mass spectrometry), sex hormone-binding globulin, androstenedione, dehydroepiandrosterone sulfate, follicle-stimulating hormone, luteinizing hormone, and estradiol levels and Female Sexual Function Index scores. RESULTS: In women treated with radiotherapy (n = 38), median total and free testosterone levels were significantly decreased at 1-year follow-up compared with baseline in premenopausal women (n = 16; total testosterone -29%, P = .01; free testosterone -22%, P = .007) and postmenopausal women (n = 22; total testosterone -25%, P = .03; free testosterone -29%, P = .03). Androstenedione was decreased in premenopausal women only and dehydroepiandrosterone sulfate was decreased in postmenopausal women only after radiotherapy. In women treated with hysterectomy and SOE (n = 10), testosterone levels were lower but not significantly lower, and there was no change in those having surgery without SOE (n = 12). Female Sexual Function Index scores lower than 26.5 in sexually active women were reported by 80% 1 year after radiotherapy, by 44% after hysterectomy with SOE, and by 40% after surgery without SOE, with no significant differences compared with baseline values. No direct correlation between androgen levels and Female Sexual Function Index scores were found at 1-year follow-up. CONCLUSION: Total and free testosterone levels decreased slightly but significantly after pelvic radiotherapy in pre- and postmenopausal women. The clinical importance of this decrease is unclear, but androgen levels were not directly related to sexual function in this pilot setting.