Helicobacter pylori "Test-and-Treat" strategy with urea breath test: A cost-effective strategy for the management of dyspepsia and the prevention of ulcer and gastric cancer in Spain-Results of the Hp-Breath initiative.

BACKGROUND: Data from clinical trials comparing Helicobacter pylori (H. pylori) management strategies in patients with dyspepsia are limited. Cost-effectiveness simulation models might help to identify the optimal strategy. OBJECTIVE: To assess the cost-effectiveness of the H. pylori "Test and Treat" (T&T) strategy including the use of urea breath test (UBT) vs symptomatic treatment (ST) and vs upper gastrointestinal endoscopy (UGE) as a first procedure in patients with dyspepsia. METHODS: Three main strategies: "T&T" strategy including the use of UBT, "UGE" and "ST" have been compared using cost-effectiveness models developed in accordance with the Spanish medical practice. For the model simulations, a time horizon of 4 weeks was considered for the endpoint "Dyspepsia symptoms relief" and 10 years when using "Peptic ulcer avoided" and "Gastric cancer avoided" endpoints. RESULTS: For the endpoint "Dyspepsia symptoms relief", T&T strategy appears to be the most cost-effective (883€/success) compared to UGE strategy and to ST strategy (respectively 1628€ and 990€/success). For the endpoint "Probability of peptic ulcer", the T&T strategy appears to be the most cost-effective (421€/peptic ulcer avoided/y) compared to UGE strategy and ST strategy (respectively 728€ and 632€/peptic ulcer avoided/y). For the endpoint "Gastric cancer avoided", the T&T strategy appears to be the most cost-effective (524€/gastric cancer avoided/y) compared to UGE strategy and "ST" strategy (respectively 716€ and 696€/gastric cancer avoided/y). CONCLUSIONS: T&T strategy including the use of UBT is the most cost-effective medical approach for management of dyspepsia and for the prevention of ulcer and gastric cancer.

Waterpipe Use in the Middle East and North Africa: Data From the Breathe Study.

INTRODUCTION: In recent decades, waterpipe use has gained popularity, notably in the Middle East and North Africa (MENA) region. This study describes waterpipe use and characteristics of waterpipe users among the general population of the MENA region. METHODS: This study was a sub-analysis of the BREATHE study, a cross-sectional survey of chronic obstructive respiratory disease conducted in the general population of 11 countries of the MENA region. The study population consisted of subjects aged ≥40 years who completed the screening questionnaire and who reported waterpipe use (alone or with cigarettes). This questionnaire collected data on demographics, self-reported respiratory symptoms (breathlessness and productive cough), smoking habits (cigarettes or waterpipe) and diagnosis of chronic obstructive respiratory disease, chronic bronchitis or emphysema. RESULTS: Of the 62 086 subjects screened in the BREATHE study, waterpipe use was reported by 2173 subjects (3.5% [95% CI: 3.4%-3.6%]), of whom 934 subjects (43.0%) smoked both waterpipes and cigarettes. The majority of waterpipe users were men (82%) and aged from 40 to 49 years (53.7%). Over 90% of users smoked their waterpipe for ≥1 hour per day. Waterpipe use was associated with an increased risk of productive cough (odds ratio [OR]: 1.49), breathlessness (OR: 1.33), and chronic bronchitis (OR: 1.43), independently of the risk associated with cigarette smoking. In subjects using waterpipe alone (N = 1239), breathlessness was the most frequently self-reported symptom (11.3%), followed by productive cough (6.0%) and chronic bronchitis (2.2%). CONCLUSIONS: Waterpipe smoking in the region is widespread and is associated with an increased risk of respiratory pathology independently of cigarette smoking. IMPLICATIONS: This large general population study reports an elevated risk of respiratory disease associated with waterpipe use independently of cigarette smoking; this finding emphasizes the need for public health policies to curtail the growing spread of waterpipe use by young people in the MENA region.

Cost-effectiveness modelling of use of urea breath test for the management of Helicobacter pylori-related dyspepsia and peptic ulcer in the UK.

OBJECTIVE: Clinical data comparing diagnostic strategies in the management of Helicobacter pylori-associated diseases are limited. Invasive and noninvasive diagnostic tests for detecting H. pylori infection are used in the clinical care of patients with dyspeptic symptoms. Modelling studies might help to identify the most cost-effective strategies. The objective of the study is to assess the cost-effectiveness of a 'test-and-treat' strategy with the urea breath test (UBT) compared with other strategies, in managing patients with H. pylori-associated dyspepsia and preventing peptic ulcer in the UK. DESIGN: Cost-effectiveness models compared four strategies: 'test-and-treat' with either UBT or faecal antigen test (FAT), 'endoscopy-based strategy' and 'symptomatic treatment'. A probabilistic cost-effectiveness analysis was performed using a simulation model in order to identify probabilities and costs associated with relief of dyspepsia symptoms (over a 4-week time horizon) and with prevention of peptic ulcers (over a 10-year time horizon). Clinical and cost inputs to the model were derived from routine medical practice in the UK. RESULTS: For relief of dyspepsia symptoms, 'test-and-treat' strategies with either UBT (€526/success) and FAT (€518/success) were the most cost-effective strategies compared with 'endoscopy-based strategy' (€1317/success) and 'symptomatic treatment' (€1 029/success). For the prevention of peptic ulcers, 'test-and-treat' strategies with either UBT (€208/ulcer avoided/year) or FAT (€191/ulcer avoided/year) were the most cost-effective strategies compared with 'endoscopy-based strategy' (€717/ulcer avoided/year) and 'symptomatic treatment' (€651/ulcer avoided/year) (1 EUR=0,871487 GBP at the time of the study). CONCLUSION: 'Test-and-treat' strategies with either UBT or FAT are the most cost-effective medical approaches for the management of H. pylori-associated dyspepsia and the prevention of peptic ulcer in the UK. A 'test-and-treat' strategy with UBT has comparable cost-effectiveness outcomes to the current standard of care using FAT in the UK.

Comorbidities associated with COPD in the Middle East and North Africa region: association with severity and exacerbations.

OBJECTIVE: To assess the frequency of comorbidities in subjects with COPD and their association with respiratory symptom severity and COPD exacerbations. MATERIALS AND METHODS: This was an analysis of the BREATHE study, a cross-sectional survey of COPD conducted in the general population of eleven countries in the Middle East and North Africa, including Pakistan. The study population consisted of a sample of subjects with COPD for whom the presence of comorbidities was documented. Three questionnaires were used. The screening questionnaire identified subjects who fulfilled an epidemiological case definition of COPD and documented any potential comorbidities; the detailed COPD questionnaire collected data on respiratory symptoms, COPD exacerbations, and comorbidities associated with COPD; the COPD Assessment Test collected data on the impact of respiratory symptoms on well-being and daily life. RESULTS: A total of 2,187 subjects were positively screened for COPD, of whom 1,392 completed the detailed COPD questionnaire. COPD subjects were more likely to report comorbidities (55.2%) than subjects without COPD (39.1%, P<0.0001), most frequently cardiovascular diseases. In subjects who screened positively for COPD, the presence of comorbidities was significantly (P=0.03) associated with a COPD Assessment Test score ≥10 and with antecedents of COPD exacerbations in the previous 6 months (P=0.03). CONCLUSION: Comorbidities are frequent in COPD and associated with more severe respiratory symptoms. This highlights the importance of identification and appropriate management of comorbidities in all subjects with a diagnosis of COPD.

Distribution of body mass index among subjects with COPD in the Middle East and North Africa region: data from the BREATHE study.

BACKGROUND: Data describing the potential relationship between chronic obstructive pulmonary disease (COPD) and body mass index (BMI) are limited within the Middle East and North Africa (MENA) region. OBJECTIVE: To evaluate the distribution of BMI among subjects with COPD in the general population of the MENA region. METHODS: This study was a subanalysis of the BREATHE study, a cross-sectional survey of COPD conducted in the general population of ten countries in the MENA region and Pakistan. The study population consisted of subjects screened for COPD who documented their weight and height. A COPD questionnaire was administered to subjects who screened positively for COPD in order to collect data on patient characteristics, symptom severity, management and burden of disease, comorbidities, and health care resource utilization and data allowing calculation of the BMI. The COPD Assessment Test (CAT) was administered to those screened positively for COPD to collect data on the impact of respiratory symptoms. RESULTS: Nine hundred and ninety-six subjects with COPD, who completed the detailed COPD questionnaire and documented their weight and height, were included in this analysis. The mean BMI was 27.7±5.7 kg/m(2). The proportion of COPD patients with a BMI ≥25 kg/m(2) is significantly higher than the proportion with a BMI <25 kg/m(2) (64.6% [n=643] vs 35.4% [n=353], respectively; P<0.0001). There were no significant differences between the distribution of BMI, ages, sex, COPD symptoms, exacerbations, CAT scores, COPD-associated health care resource consumption, and GOLD severity groups. However, the occurrence of comorbidities such as diabetes and cardiovascular diseases seemed to be significantly associated with obese or morbidly obese status (P=0.02). CONCLUSION: In the MENA region, the majority of COPD subjects were overweight or obese, and comorbidities such as diabetes or cardiovascular diseases are likely to be associated with COPD when BMI is in the obese or morbidly obese ranges.

Chronic obstructive pulmonary disease in the adult population within the Middle East and North Africa region: rationale and design of the BREATHE study.

The objective of the BREATHE study was to estimate the regional prevalence of chronic obstructive pulmonary disease (COPD) symptoms within the general population in the Middle East/North Africa (MENA) region and to document risk factors, disease characteristics and management using a standardised methodology. This was an observational population-based survey performed in ten countries in the Middle East and North Africa (Algeria, Egypt, Jordan, Lebanon, Morocco, Saudi Arabia, Syria, Tunisia, Turkey and United Arab Emirates), together with Pakistan. A general population sample of 10,000 subjects ≥ 40 years of age in each country or zone was generated from random telephone numbers. Structured interviews were proposed by telephone. A screening questionnaire was administered to each subject collecting information on respiratory symptoms and smoking habits. Subjects with chronic bronchitis or breathlessness and smoking ≥ 10 pack · years fulfilled the epidemiological definition of COPD ("COPD" population). This population then completed a full disease questionnaire, the COPD Assessment Test (CAT) and a cost-of-disease questionnaire. A randomly selected sample was also assessed by spirometry. In all, 457,258 telephone numbers were generated and contact was established with 210,121 subjects, of whom 65,154 were eligible and 62,086 accepted to participate. The overall response rate was 74.2%. 2,187 (3.5%) subjects fulfilled the criteria for the "COPD" population. Evaluable spirometry data were obtained from 1,847 (14.2%) subjects to whom it was proposed. The BREATHE study has collected a large amount of information on COPD variables from a representative sample of the general population of countries in the MENA region, which can be compared with other regional COPD initiatives.

Validation of the Asthma Control Test questionnaire in a North African population.

BACKGROUND: Patient-reported outcome measures are required to measure asthma control. The Asthma Control Test (ACT) is one such measure which was used in the AIRMAG study, a general population study of asthma in the Maghreb. Three dialectal Arabic versions of the ACT (Algerian, Moroccan and Tunisian) were developed. OBJECTIVE: To perform a psychometric evaluation of the properties of dialectal Arabic versions of the ACT used in the AIRMAG study. METHODS: The test data came from 624 adult subjects in a random general population sample in Algeria, Morocco and Tunisia. The internal consistency of the ACT was analysed using Cronbach's a coefficient. The factorial structure was explored by primary component analysis with varimax rotation. Test-retest reproducibility was assessed in a subgroup of 61 subjects. Face and discriminant validity were assessed. RESULTS: Cronbach's a coefficient ranged from 0.58 for the Algerian version to 0.67 for the Moroccan version. The 'use-of-rescue-treatment' item was identified as discordant, since its removal resulted in an increase in Cronbach's a coefficient. The discordance of this item was confirmed by primary component analysis, where the four remaining items were aligned along a single dimension, and the 'use-of-rescue-treatment' item offset along a second dimension. Test and retest scores were well correlated (r =0.704). The ACT showed good face and discriminant validity. CONCLUSIONS: The ACT is a valid measure of asthma control in a North African context, although its internal consistency is compromised by the 'use-of-rescue-treatment' item, probably due to limited access to care and use of short-acting beta-agonists.