Economic impact of inflammatory bowel disease in Catalonia: a population-based analysis.

Background: Inflammatory bowel disease (IBD) has a major economic impact on healthcare costs. Objectives: The aim of this study was to evaluate the current healthcare expenditure associated with IBD in a population-wide study in Catalonia. Design: Retrospective observational study. Methods: All patients with IBD included in the Catalan Health Surveillance System (CHSS) were considered eligible. The CHSS compiles data on more than 7 million individuals in 2020 (34,823 with IBD). Data on the use of healthcare resources and its economic impact were extracted applying the International Classification of Diseases, 10th revision, Clinical Modification codes (ICD-10-CM codes). Health expenditure, comorbidities, and hospitalization were calculated according to the standard costs of each service provided by the Department of Health of the Catalan government. The data on the IBD population were compared with non-IBD population adjusted for age, sex, and income level. IBD costs were recorded separately for Crohn's disease (CD) and ulcerative colitis (UC). Results: Prevalence of comorbidities was higher in patients with IBD than in those without. The risk of hospitalization was twice as high in the IBD population. The overall healthcare expenditure on IBD patients amounted to 164M€. The pharmacy cost represents the 60%. The average annual per capita expenditure on IBD patients was more than 3.4-fold higher (IBD 4200€, non-IBD 1200€). Average costs of UC were 3400€ and 5700€ for CD. Conclusion: The risk of comorbidities was twice as high in patients with IBD and their use of healthcare resources was also higher than that of their non-IBD counterparts. Per capita healthcare expenditure was approximately 3.4 times higher in the population with IBD. Trial registration: The study was not previously registered.

Economic impact of inflammatory bowel disease in Catalonia The manuscript includes data of the most recent epidemiologic data about the high economic impact of IBD in Catalonia.

Correction: Chaparro et al. Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study. J. Clin. Med. 2021, 10, 2885.

The authors wish to make the following corrections to this paper [...].

The Global Incidence of Peptic Ulcer Disease Is Decreasing Since the Turn of the 21st Century: A Study of the Organisation for Economic Co-Operation and Development (OECD).

INTRODUCTION: Peptic ulcer disease (PUD) is a common cause of hospitalization worldwide. We assessed temporal trends in hospitalization for PUD in 36 Organisation for Economic Co-operation and Development (OECD) countries since the turn of the 21st century. METHODS: The OECD database contains data on PUD-related hospital discharges and mortality for 36 countries between 2000 and 2019. Hospitalization rates for PUD were expressed as annual rates per 100,000 persons. Joinpoint regression models were used to calculate the average annual percent change (AAPC) with 95% confidence intervals (CIs) for each country, which were pooled using meta-analyses. The incidence of PUD was forecasted to 2021 using autoregressive integrated moving average and Poisson regression models. RESULTS: The overall median hospitalization rate was 42.4 with an interquartile range of 29.7-60.6 per 100,000 person-years. On average, hospitalization rates (AAPC = -3.9%; 95% CI: -4.4, -3.3) and morality rates (AAPC = -4.7%; 95% CI: -5.6, -3.8) for PUD have decreased from 2000 to 2019 globally. The forecasted incidence of PUD hospitalizations in 2021 ranged from 3.5 per 100,000 in Mexico to 92.1 per 100,000 in Lithuania. Across 36 countries in the OECD, 329,000 people are estimated to be hospitalized for PUD in 2021. DISCUSSION: PUD remains an important cause of hospitalization worldwide. Reassuringly, hospitalizations and mortality for PUD have consistently been falling in OECD countries in North America, Latin America, Europe, Asia, and Oceania. Identifying underlying factors driving these trends is essential to sustaining this downward momentum.

Multicriteria Decision Analysis for Updating of Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units in Spain.

BACKGROUND AND AIMS: Management of inflammatory bowel disease [IBD] is complex and IBD Comprehensive Care Units [ICCUs] facilitate the delivery of quality care to IBD patients. The objective of this study was to update the existing set of quality indicators [QIs] for ICCUs, based on a nationwide quality certification programme carried out in Spain, from a multi-stakeholder perspective and using multicriteria decision analysis [MCDA] methodology. METHODS: An MCDA comprising three different phases was conducted. In phase 1, a systematic literature review was performed, and after validation by a scientific committee comprising 11 experts, a preliminary set of QIs was developed. In phase 2, a larger group of 49 experts determined the relevance and relative importance of each QI by prioritising and weighing the preliminary set. Finally in phase 3, the scientific committee reviewed the results and made a final selection via a deliberative process. RESULTS: The final set comprised 67 QIs, classified as Structure [23 QIs], Process [35 QIs] and Outcome [9 QIs], which were ranked according to their relative importance. Multidisciplinary management was the most important requirement in ICCUs, followed by continuity of care, standardisation of clinical care and, especially, the incorporation of patients' reported outcomes. CONCLUSIONS: This updated set of QIs comprises a weighted and prioritised set of items that represent the essential minimum of criteria for ensuring appropriate quality of care in the management of IBD patients.

Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study.

(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD-Crohn's disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)-during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31-56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery.

Perception of disease burden and treatment satisfaction in patients with ulcerative colitis from outpatient clinics in Spain: UC-LIFE survey.

OBJECTIVES: Ulcerative colitis (UC) conditions patients' everyday life. With this survey, we aimed to assess the perceived disease burden, preferred treatment attributes, and treatment satisfaction reported by Spanish UC patients. METHODS: Consecutive unselected UC patients aged at least 18 years were recruited from outpatient hospital clinics. Patients completed the survey at home, returning it by postmail. With test-like questions, they described UC behavior, preferences, and satisfaction with treatment. RESULTS: Of 585 patients invited, 436 (75%) returned the survey (mean age 46 years, 53% men). Of these, 47.1% described their disease during the past year as 'controlled or nearly controlled', 28.0% as 'symptoms not impairing everyday life,' and 24.9% 'disruptive symptoms'. Only 8.7% reported the complete absence of symptoms during the previous year, and 18.8, 30.7, and 47.4%, respectively, described at least one hospital admission, emergency room visit, or nonscheduled visit because of UC activity. Urgency of defecation was the most disruptive symptom. The most important therapy attribute was continuous control of symptoms (44.6%). Most patients (78.8%) were 'very satisfied' or 'satisfied' with current treatment, even those reporting a high burden of symptoms. CONCLUSION: Half of the patients considered their UC as 'controlled or nearly controlled' and the degree of satisfaction with their therapies was high. However, they reported a high burden of symptoms and resource consumption during the previous year. These findings indicate that patients may get used to living with symptoms, underestimating the potential of therapy for achieving a complete remission. Urgency of defecation was mentioned as highly disrupting and should probably be included in scores and patient-reported outcomes.

Incidence, Clinical Characteristics, and Management of Psoriasis Induced by Anti-TNF Therapy in Patients with Inflammatory Bowel Disease: A Nationwide Cohort Study.

BACKGROUND: Psoriasis induced by anti-tumor necrosis factor-α (TNF) therapy has been described as a paradoxical side effect. AIM: To determine the incidence, clinical characteristics, and management of psoriasis induced by anti-TNF therapy in a large nationwide cohort of inflammatory bowel disease patients. METHODS: Patients with inflammatory bowel disease were identified from the Spanish prospectively maintained Estudio Nacional en Enfermedad Inflamatoria Intestinal sobre Determinantes genéticos y Ambientales registry of Grupo Español de Trabajo en Enfermedad de Croh y Colitis Ulcerosa. Patients who developed psoriasis by anti-TNF drugs were the cases, whereas patients treated with anti-TNFs without psoriasis were controls. Cox regression analysis was performed to identify predictive factors. RESULTS: Anti-TNF-induced psoriasis was reported in 125 of 7415 patients treated with anti-TNFs (1.7%; 95% CI, 1.4-2). The incidence rate of psoriasis is 0.5% (95% CI, 0.4-0.6) per patient-year. In the multivariate analysis, the female sex (HR 1.9; 95% CI, 1.3-2.9) and being a smoker/former smoker (HR 2.1; 95% CI, 1.4-3.3) were associated with an increased risk of psoriasis. The age at start of anti-TNF therapy, type of inflammatory bowel disease, Montreal Classification, and first anti-TNF drug used were not associated with the risk of psoriasis. Topical steroids were the most frequent treatment (70%), achieving clinical response in 78% of patients. Patients switching to another anti-TNF agent resulted in 60% presenting recurrence of psoriasis. In 45 patients (37%), the anti-TNF therapy had to be definitely withdrawn. CONCLUSIONS: The incidence rate of psoriasis induced by anti-TNF therapy is higher in women and in smokers/former smokers. In most patients, skin lesions were controlled with topical steroids. More than half of patients switching to another anti-TNF agent had recurrence of psoriasis. In most patients, the anti-TNF therapy could be maintained.

Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose or oral iron as preoperative treatment in patients with colon cancer and iron deficiency anaemia.

BACKGROUND: Ferric Carboxymaltose (FCM), Iron Sucrose (IS) and Oral Iron (OI) are alternative treatments for preoperative anaemia. OBJECTIVE: To compare the cost implications, using a cost-minimization analysis, of three alternatives: FCM vs. IS vs. OI for treating iron-deficient anaemia before surgery in patients with colon cancer. METHODS: Data from 282 patients with colorectal cancer and anaemia were obtained from a previous study. One hundred and eleven received FCS, 16 IS and 155 OI. Costs of intravenous iron drugs were obtained from the Spanish Regulatory Agency. Direct and indirect costs were obtained from the analytical accounting unit of the Hospital. In the base case mean costs per patient were calculated. Sensitivity analysis and probabilistic Monte Carlo simulation were performed. RESULTS: Total costs per patient were 1827® in the FCM group, 2312® in the IS group and 2101® in the OI group. Cost savings per patient for FCM treatment were 485® compared to IS and 274® compared to OI. A Monte Carlo simulation favoured the use of FCM in 84.7% and 84.4% of simulations when compared to IS and OI, respectively. CONCLUSIONS: FCM infusion before surgery reduced costs in patients with colon cancer and iron-deficiency anaemia when compared with OI and IS.

How to compare biologic drugs.

This consensus document reviews the evidence on the evaluation of biological drugs. The main conclusions of the group are: a) the current evidence on biological comparisons is based on indirect comparisons and is generally unreliable and with important methodological limitations. Therefore, b) it is considered necessary to amend the regulatory directives in the sense of strongly favoring randomized non-inferiority studies comparing face to face the new biological treatment with current standards, avoiding trials versus placebo, c) A key element in this process will be determined by consensus among regulatory agencies, scientific societies, the pharmaceutical industry and health authorities regarding the clinical differences that should be considered relevant in each of the conditions tested.

[How to write a medical report for the assessment of disability]. / Cómo redactar un informe médico para la valoración de minusvalía o discapacidad.

The present article revises practical aspects on the format and content of the clinical reports used for the evaluation of disability for the Spanish Disability Grants System. As a framework for understanding how these clinical reports should be, the review includes also a short overview of the different types of disability grants and the administrative and court mechanisms for granting.

Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose for the ambulatory treatment of severe iron deficiency.

OBJECTIVE: Intravenous iron is widely used to treat iron deficiency in day-care units. Ferric carboxymaltose (FCM) allows administration of larger iron doses than iron sucrose (IS) in each infusion (1000 mg vs. 200 mg). As FCM reduces the number of infusions required but is more expensive, we performed a cost-minimization analysis to compare the cost impact of the two drugs. MATERIALS AND METHODS: The number of infusions and the iron dose of 111 consecutive patients who received intravenous iron at a gastrointestinal diseases day-care unit from 8/2007 to 7/2008 were retrospectively obtained. Costs of intravenous iron drugs were obtained from the Spanish regulatory agencies. The accounting department of the Hospital determined hospital direct and indirect costs for outpatient iron infusion. Non-hospital direct costs were calculated on the basis of patient interviews. In the pharmacoeconomic model, base case mean costs per patient were calculated for administering 1000 mg of iron per infusion using FCM or 200 mg using IS. Sensitivity analysis and Monte Carlo simulation were performed. RESULTS: Under baseline assumptions, the estimated cost of iron infusion per patient and year was €304 for IS and €274 for FCM, a difference of €30 in favour of FCM. Adding non-hospital direct costs to the model increased the difference to €67 (€354 for IS vs. €287 for FCM). A Monte Carlo simulation taking into account non-hospital direct costs favoured the use of FCM in 97% of simulations. CONCLUSION: In this pharmacoeconomic analysis, FCM infusion reduced the costs of iron infusion at a gastrointestinal day-care unit.

The sequential therapy regimen for Helicobacter pylori eradication.

IMPORTANCE OF THE FIELD: Standard triple therapy (STT) is the most used treatment for Helicobater pylori infection. The prevalence of antibiotic resistance has increased substantially in recent years and there has been a corresponding decrease in efficacy. AREAS COVERED IN THIS REVIEW: Bibliographical searches were performed in MEDLINE and international congresses up to 2009 for 'Helicobacter pylori' AND 'sequential regimen/therapy'. WHAT THE READER WILL GAIN: Several meta-analyses have demonstrated that sequential therapy (SQT) is more effective than STT. SQT is not affected by bacterial and host factors that have, until now, predicted the outcome of STT. Primary clarithromycin resistance is the only factor reducing the efficacy of SQT; however, even in these patients an acceptable > 75% eradication can be achieved. So far, almost all the studies have been performed in Italy. The advantages of SQT over STT should be confirmed in different countries. Whether it is necessary to provide the drugs sequentially or if the four components of SQT can be given concurrently is unclear. TAKE HOME MESSAGE: SQT is a promising new treatment approach that deserves consideration as a treatment strategy for H. pylori infection. However, further robust assessment across a much broader range of patients is required before SQT could supplant existing treatment regimens and be generally recommended in clinical practice.

What is the best strategy for diagnosis and treatment of Helicobacter pylori in the prevention of recurrent peptic ulcer bleeding? A cost-effectiveness analysis.

BACKGROUND: Clinical trials provide evidence of the high effectiveness of Helicobacter pylori eradication for preventing recurrent ulcer-related gastrointestinal hemorrhage. The best strategy for curing the infection in this setting is, however, still under debate. OBJECTIVE: To evaluate four different strategies for prevention of rebleeding in patients with peptic ulcer hemorrhage: 1) test for H. pylori and treatment, if positive; 2) proton pump inhibitor maintenance; 3) no preventive treatment; 4) empirical H. pylori eradication immediately after bleeding. METHODS: A decision analysis model was used, with a time horizon of 2 years and a third-party payer perspective. Costs were estimated for two different settings: a low-cost-for-care area (Spain) and a high-cost area (USA). Main outcome measure was incremental cost-effectiveness ratio for each upper gastrointestinal hemorrhage avoided. RESULTS: Empirical H. pylori eradication was the dominant strategy: its estimated rate of recurrent bleeding was lower (6.1%) than those of strategies 1 (7.4%), 2 (11.1%), and 3 (18.4%) and it was the least expensive strategy. The results remained stable when variables were changed inside a wide range of plausible values. Sensitivity analysis also showed that the prevalence of H. pylori in bleeding ulcer was the variable that most influenced the results: when it was below 45% in Spain or below 51% in the United States, empirical eradication was not a dominant strategy although it remained cost-effective. CONCLUSION: In patients with bleeding peptic ulcer, empirical treatment of H. pylori infection immediately after feeding is restarted is the most cost-effective strategy for preventing recurrent hemorrhage.

Analysis of court criteria for awarding disability benefits to patients with Crohn's disease.

BACKGROUND & AIMS: Chronic disability and its consequences for social life and employment are important but often neglected aspects of Crohn's disease. No specific scores have been developed to evaluate chronic disability in patients with Crohn's disease; the medical criteria used by government authorities to award disability benefits have not been analyzed. We aimed to determine the courts' criteria for awarding disability benefits to patients with Crohn's disease in Spain. METHODS: We systematically searched case law databases in Spain's regional Supreme Courts to identify sentences regarding awards of disability benefits to patients with Crohn's disease. Selected decisions were reviewed to extract variables related to the awarding of benefits. Univariate and multivariate analyses were performed to determine which variables predicted the awarding of benefits. RESULTS: Two hundred eighty sentences were reviewed. The rate of judicial decisions in favor of the claimants varied considerably between the various tribunals. Multivariate analysis showed that adequate description of the disease (odds ratio, 8.6), fecal incontinence (odds ratio, 8.9), the number of associated diseases (odds ratio, 2.3), and the presence of an ostomy (odds ratio, not estimable) were independent predictors of the awarding of Social Security benefits. CONCLUSIONS: The amount of Social Security benefits awarded to patients with Crohn's disease varied depending on the tribunal. The most important predictors of a court's disability award were the adequate description of the patient's disease, fecal incontinence, associated diseases, and presence of an ostomy.

[Seven or ten days? Cost-effectiveness study on the duration of H. pylori treatment in primary care]. / 'Siete o diez días? Estudio de coste-efectividad sobre la duración del tratamiento de la infección por H. pylori en atención primaria.

OBJECTIVE: To determine through an economic evaluation study whether it is cost-effective to extend treatment of dyspeptic patients from 7 to 10 days, distinguishing between functional dyspepsia, unexamined dyspepsia, and ulcer disease. DESIGN: Cost-effectiveness study by means of a decision 3 comparing direct costs per patient cured with 2 strategies: a) 7 days treatment versus b) 10 days. Two-year study in the National Health System. SETTING: Primary care. PARTICIPANTS: One-hundred patients with peptic ulcer, functional dyspepsia, or unexamined dyspepsia who received treatment for H pylori infection. INTERVENTIONS: H pylori eradication treatment with a proton pump inhibitor, clarithromycin, and amoxycillin for 7 or 10 days. Measurement variable: incremental cost per patient cured. RESULTS: In peptic ulcer patients, the incremental cost per patient cured on extending the eradication treatment from 7 to 10 days was euro147 (95% CI, 121.3-162.7), whereas in patients with functional or unexamined dyspepsia, it was -euro39.8 (95% CI, -28.5 to -60.7) and -euro27.3 (95% CI, -14.92 to -52.72), respectively. The sensitivity analysis showed that the efficacy of eradication treatment (7 vs 10) was the factor that most affected the stability of the results. CONCLUSIONS: Seven days is the most cost-effective duration of the triple therapy for eradicating H pylori in ulcer patients. However, 10 days is more cost-effective in functional dyspepsia patients or those with no prior endoscope diagnosis.

Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis.

BACKGROUND: First-line proton pump inhibitor-based triple and quadruple therapies for Helicobacter pylori eradication present similar levels of efficacy. Cross-over treatment (quadruple following triple failure, and triple following quadruple failure) seems the most sensible approach to treatment failures, but the two strategies -'quadruple first' versus 'triple first'- have not been previously compared. The aims of our study were to assess the usefulness and the cost-effectiveness of the two treatment strategies. MATERIAL AND METHODS: Forty-nine out of 344 patients included in a previous study comparing triple therapy - 7 days of omeprazole, amoxicillin and clarithromycin twice a day - with quadruple therapy - 7 days of omeprazole twice a day, plus tetracycline, metronidazole and bismuth subcitrate three times a day - failed initial treatment and were assigned to cross-over therapy. Cure was determined by urea breath test. A decision analysis was performed to compare the two eradication strategies. RESULTS: Intention to treat cure rates were 46% (10/22 patients; 95% CI 24-68%) for second-line triple therapy and 63% (17/27 patients; 95% CI 42-81%) for second-line quadruple therapy. Per protocol cure rates were 71% and 85%, respectively. Intention to treat cure rates were 87% (95% CI 81-92%) for the 'triple first' versus 86% (95% CI 80-91%) for the 'quadruple first' strategy (p = .87). The 'quadruple first' strategy was more cost-effective. The incremental cost of 'triple first' strategy per person was 19 in the low-cost area and 65 US dollars in the high-cost area. CONCLUSIONS: The effectiveness of 'triple first' and 'quadruple first' strategies is similar, although the latter seems slightly more cost-effective.