Search

e16159 Background: Evidence synthesis can be used to demonstrate the economic value of medical technologies. Transarterial radioembolization (TARE) is a clinically effective therapy for hepatocellular carcinoma (HCC); however, a synthesis of the comparative economic outcomes is lacking. This study systematically reviewed and summarized the available economic evaluations of TARE for the treatment of HCC. Methods: A systematic review of economic evaluations of TARE for HCC treatment following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed. English and Spanish publications were identified from PubMed, Embase, Cochrane, MEDES, health technology assessment agencies, and scientific congress databases published through May 2021. Results: Among 423 records screened, 20 economic evaluations (two cost-effectiveness analyses (CEAs), eight cost-utility analyses (CUAs), one cost-minimization analysis, six cost analyses, and three budget impact analyses) met the pre-defined criteria for inclusion. Included studies were evaluated from a payer perspective (n = 20) and included both payer and societal perspectives (n = 2). Thirteen studies were published from a European perspective, six from the United States, and one from the Canadian perspective. Included studies evaluated early (n = 4) vs. intermediate and advanced HCC (n = 15). TheraSphere and Sir-Spheres were the most evaluated TARE therapies compared to transarterial chemoembolization (TACE) (n = 12) alone or TACE/sorafenib agents (n = 10). The time horizon in the included studies varied: TARE vs. sorafenib (5-years and lifetime) and TARE vs. TACE (5-years). Variability in health outcomes was observed with greater health benefits reported for TARE vs. TACE for intermediate (n = 1) and advanced-stage patients (n = 2) and TARE vs. sorafenib for intermediate (n = 1) and advanced-stage patients (n = 6). All CEAs compared the costs and survival benefits of TARE vs. TACE/Transarterial embolization (TAE)/sorafenib/tyrosine-kinase inhibitor. Of the 20 studies, TARE was associated with lower treatment costs in ten studies. From the payer perspective, TARE costs varied widely in the Barcelona Clinic Liver Cancer (BCLC) staging system and ranged from $1,770 (BCLC-A) to $66,800 (BCLC-C). The life-years gained (LYG) ranged from 1.1 years (TARE vs. sorafenib/lenvatinib) to 3.1 years (TARE vs. TACE/TAE/drug-eluting bead-TACE). The incremental cost-utility ratio (ICUR) for TARE vs. sorafenib ranged from $38,352/QALY to $71,386 (dominant) and one CUA of TARE vs. TACE and showed an ICUR of $22,181/QALY. Conclusions: Economic evaluations of TARE for HCC treatment are heterogeneous. Overall, TARE is a cost-effective short- and long-term treatment for HCC, driven by increased LYG compared to other HCC therapies.

SummaryThe objective of this 1-week cross-sectional survey was to assess the clinical features of outpatients with chronic obstructive pulmonary disease (COPD). A one-page questionnaire was used to collect demographic data, smoking status, and COPD-related variables. Ten or 20 consecutive patients were selected from Primary care or specialised setting during a week. Pulmonary function (FEV1) was measured using an electronic device (Piko-1). The study sample comprised 11,973 COPD patients (83% men) with a mean (sd) age of 67 (10.7) years. Thirty-five percent of patients were current smokers and smoked a mean of 17.4 (9.9) cigarettes daily. COPD severity according to GOLD stages was mild in 20% of patients, moderate in 38%, severe in 30%, and very severe in 12%. A higher percentage of men showed severe (33%) or very severe (14%) disease compared to women (16% and 6%, respectively) (P

To evaluate the burden of illness in irritable bowel syndrome (IBS), in terms of resource utilisation (direct and indirect) and health-related quality of life (HR-QOL), in individuals with IBS who meet Rome I and Rome II criteria.A cross-sectional study, carried out by personal interview, on a representative sample (n = 2000) of the Spanish population. Individuals with suspected IBS were identified via a screening question and subsequently given an epidemiological questionnaire to complete. The questionnaire collected information on IBS symptoms, resource utilisation, and HR-QOL [Medical Outcomes Study 36-item Short Form (SF-36)].Sixty-five individuals met Rome II criteria for IBS, while 146 individuals met exclusively Rome I criteria. Of Rome II individuals, 67.7% had consulted some type of healthcare professional in the previous 12 months, compared with only 41.8% of those individuals meeting exclusively Rome I criteria (p vs 17.1%); 'drug consumption' (70.8 vs 45.2%); and 'reduced performance in main activity' (60 vs 27.4%). Compared with the general population, the study sample reported significantly worse HR-QOL scores in four dimensions of the SF-36 ('bodily pain', 'vitality', 'social functioning' and 'role-emotional'. Additionally, individuals meeting Rome II criteria reported worse HR-QOL scores than those individuals meeting exclusively Rome I criteria, especially in the 'bodily pain' and 'general health' dimensions.The burden of illness in IBS is important and correlated to the diagnostic criteria employed. Individuals who met Rome II criteria reported a higher level of resource utilisation and worse HR-QOL than individuals meeting exclusively Rome I criteria.

Helicobacter pylori plays a pivotal role in gastroduodenal disease. Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proven to be an effective treatment for H. pylori. The aim of this study was to compare the eradication efficacy and tolerability profile of a 7-day course of RBC plus clarithromycin and amoxicillin, RBC plus clarithromycin, and omeprazole plus clarithromycin and amoxicillin. Prospective, randomised, double-blind, multicentre study. A total of 154 H. pylori-positive patients with dyspeptic symptoms were randomised to RBC 400mg twice daily (bid) plus clarithromycin 500mg bid and amoxicillin 1g bid (RBCCA group, n = 53); RBC 400mg bid plus clarithromycin 500mg bid (RBCC group, n = 52); or omeprazole 20mg bid plus clarithromycin 500mg bid and amoxicillin 1g bid (OCA group, n = 49) administered for 7 days. H. pylori infection was initially detected on an antral biopsy by the rapid urease test and confirmed by 13C-urea breath test. H. pylori status was assessed by 13C-urea breath test at least 28 days after the end of treatment. There were no statistically significant differences in eradication rates per intention-to-treat (ITT) analysis (n = 149) and per protocol (PP) analysis (n = 135) among the three regimens. Eradication rates per ITT were 82.6% [95% confidence interval (CI), 69.2 to 92%] for RBCCA; 82% (95% CI, 68.7 to 91.9%) for RBCC; and 72.3% (95% CI, 57.7 to 85.6%) for OCA. The corresponding figures for the PP analysis were 85.1% (95% CI, 71.1 to 93.1%), 83% (95% CI, 68.7 to 91.9%), and 73.2% (95% CI, 56.8 to 85.2%), respectively. All regimens were well tolerated. Adverse events occurred in 59 (38%) of the 154 patients and included minor gastrointestinal symptoms and neurological complaints (anxiety, insomnia and headache). The results of this study suggest that the best approach to eradicate H. pylori may be the combination of ranitidine bismuth citrate with clarithromycin either with or without amoxicillin.

OBJECTIVES Diagnosis of irritable bowel syndrome (IBS) and other functional bowel disorders (FBD) is based on symptom evaluation. Clinical criteria have changed over time, yielding different proportions of subjects fulfilling diagnostic requirements. According to new diagnostic criteria (Rome II), subjects considered some years ago to have IBS no longer do so. The aim of this article is to evaluate how patients diagnosed as having IBS according to original Rome criteria have been split, and to which clinical diagnosis they belong today. METHODS Two hundred and eleven subjects meeting original Rome IBS diagnostic criteria were studied: 65 also met Rome II criteria while 146 did not. Subjects were extracted from an epidemiological survey, using home-based personal interviews, on 2000 subjects randomly selected as representative of the Spanish population. Clinical complaints, personal well-being, resource utilization, and health-related quality of life (HRQOL) were compared. RESULTS Of the subjects meeting original Rome but not Rome II criteria, the present diagnosis should be: 40%"minor" IBS (IBS symptoms of less than 12 wk duration), 37% functional constipation, 12% alternating bowel habit, 7% functional diarrhea, 3% functional abdominal bloating, and 1% unspecified functional bowel disorder (FBD). Thus, 52 subjects (36%) should not be diagnosed with IBS because they really had other FBD, 59 (40%) because of symptoms consistent with IBD diagnosis but not the required duration or frequency, and 35 (24%) because of symptoms consistent with some other FBD diagnosis but not meeting the required duration. Clinical complaints, personal well-being, resource utilization, and HRQOL were more severely affected in IBS than in other FBD as a group, and in "major" rather than in "minor" forms. CONCLUSIONS Many subjects meeting original Rome criteria for IBS do not meet Rome II criteria: approximately one quarter of subjects do not have sufficient symptom duration or frequency to be diagnosed with IBS and almost half are now considered as having other ("major" or "minor") FBD.

Background Disturbed bowel habit, diarrhoea or constipation is a key manifestation of irritable bowel syndrome (IBS). In some patients, diarrhoea and constipation alternate, giving rise to the so-called alternating subtype. Aims To assess IBS subtype breakdown (constipation (C-IBS), diarrhoea (D-IBS) or alternating (A-IBS)) according to the Rome II criteria and patients' self-assessment, the predominance in the alternating subtype (i.e. constipation, diarrhoea or neither), and the medical and personal impact, including health-related quality of life (HRQoL), of the different IBS subtypes. Subjects and methods Two thousand individuals selected randomly to represent the general population were classified as potential IBS subjects (n = 281) or as non-potential IBS subjects (n = 1719) according to a validated questionnaire. Bowel habit classification was determined using the Rome II IBS supportive symptoms. Results Among 201 subjects meeting the Rome I criteria, 15% presented with D-IBS, 44% presented with C-IBS, 19% presented with A-IBS, and 22% presented with normal bowel habit. Among the 63 subjects meeting the Rome II criteria, 23% presented with A-IBS. According to the subjects' self-assessment, of those meeting the Rome I criteria, 16% considered themselves to have D-IBS, 66% to have C-IBS and 18% to have A-IBS. In subjects meeting the Rome II criteria, 24% considered themselves to have A-IBS. Among those classified with A-IBS by the Rome II criteria, most considered themselves to be constipated. Regardless of the subtype self-classification, most subjects reported a normal frequency of bowel movements. Clinical manifestations in A-IBS were very similar to those of C-IBS but with the added presence of defecatory urgency. Abdominal discomfort/pain and frequency of visits to physicians were greater in the A-IBS subtype than in the other two IBS subtypes. HRQoL was affected similarly in all IBS subtypes. Conclusions Approximately one-quarter of subjects with IBS belong to the A-IBS subtype by the Rome II criteria, although the majority consider themselves to be constipated; indeed, clinical manifestations are more akin to the C-IBS subtype than to the D-IBS subtype. Abdominal discomfort/pain and frequency of visits to physicians are greater in the A-IBS subtype than in the other two IBS subtypes, while HRQoL is impaired similarly.

Irritable bowel syndrome (IBS) prevalence estimates are essential for measuring the importance of the problem and the burden of the illness. However, IBS diagnosis is based on clinical criteria which have changed over time. The aim of this study was to assess how the use of different diagnostic criteria influences estimated IBS prevalence and, in particular, to compare how this prevalence varies using the new Rome II criteria and previous diagnostic criteria.An epidemiological survey was conducted in the general population using personal interviews in a home setting. Two thousand individuals stratified by gender, age, social class and geographic location were randomly selected from the general population of Spain. Participants were classified as 'potential IBS subjects' (n = 281) or 'non-potential IBS subjects' (n = 1719) as a result of their response to a screening question regarding the presence of abdominal pain, constipation or diarrhoea. Thus, we estimated IBS prevalence according to the following diagnostic criteria: Manning, Rome I, Rome II, Drossman, Talley and KayJorgensen.Prevalences of IBS according to the Manning and Rome I criteria were 10.3% and 12.1%, respectively. These were higher than the prevalences obtained with the other criteria used, which varied from 2.1% to 4.9%. IBS was more prevalent in females than males irrespective of the criteria used (the female:male ratio ranged from 2.33 to 4.33). Subjects who fulfilled the Rome II, Drossman, Talley or KayJorgensen criteria also fulfilled the Rome I and Manning criteria. However, between 44% and 80% of subjects who fulfilled the Rome I or Manning criteria did not fulfil the more stringent diagnostic criteria.The prevalence of IBS varies enormously depending on the diagnostic criteria employed. Criteria based on the frequency of symptoms, such as the Rome II criteria, produce much lower prevalence values compared to criteria based solely on the presence of symptoms. In fact, more than two-thirds of subjects who fulfilled the Rome I criteria would not have been diagnosed with IBS if Rome II criteria had been employed.