Development and Psychometric Assessment of a Self-evaluation Questionnaire for Gastroesophageal Reflux Disease.

BACKGROUND/AIMS: There is uncertainty about how to measure outcomes reported by patients in gastroesophageal reflux disease (GERD). This study was conducted to develop an instrument and to determine of the definition of respondent for a patient reported outcomes to assess the efficacy of a treatment used for GERD treatment. METHODS: A structural process has developed a self-evaluation questionnaire for GERD (SEQ-GERD); health-related quality of life questionnaire for GERD (GERD-QOL) was translated through cross-cultural validation. Two-week reproducibility was evaluated and construct validity was assessed by correlating the SEQ-GERD with the Patient Assessment of Gastrointestinal Disorders (PAGI-SYM), the reflux disease questionnaire (RDQ), and GERD-QOL. Changes in SEQ-GERD scores were compared to assess the discriminative validity following 4 weeks of proton pump inhibitor administration. RESULTS: A total of 83 Korean patients were included (mean age 46 ± 14 years, females 61.4%). The internal consistency of the 19-item SEQ-GERD was good (alpha = 0.60-0.94) and the test-retest reliability was high (intra-class correlation coefficient = 0.67-0.95). The SEQ-GERD highly correlated with the GERD domain of the PAGI-SYM (correlation coefficient r = 0.894, P < 0.001), the RDQ-GERD (r = 0.877, P < 0.001), and GERD-QOL (r = -0.536, P < 0.05). SEQ-GERD scores significantly varied according to the overall treatment effectiveness scale of drug responsiveness and significantly decreased after drug treatment (mean differences according to the overall treatment effectiveness scale, P = 0.020). CONCLUSION: This study supports that SEQ-GERD is reliable and valid, and can be used to evaluate the treatment response in patients with GERD.

Global Incidence and mortality of oesophageal cancer and their correlation with socioeconomic indicators temporal patterns and trends in 41 countries.

Oesophageal cancers (adenocarcinomas [AC] and squamous cell carcinomas [SCC]) are characterized by high incidence/mortality in many countries. We aimed to delineate its global incidence and mortality, and studied whether socioeconomic development and its incidence rate were correlated. The age-standardized rates (ASRs) of incidence and mortality of this medical condition in 2012 for 184 nations from the GLOBOCAN database; national databases capturing incidence rates, and the WHO mortality database were examined. Their correlations with two indicators of socioeconomic development were evaluated. Joinpoint regression analysis was used to generate trends. The ratio between the ASR of AC and SCC was strongly correlated with HDI (r = 0.535 [men]; r = 0.661 [women]) and GDP (r = 0.594 [men]; r = 0.550 [women], both p < 0.001). Countries that reported the largest reduction in incidence in male included Poland (Average Annual Percent Change [AAPC] = -7.1, 95%C.I. = -12,-1.9) and Singapore (AAPC = -5.8, 95%C.I. = -9.5,-1.9), whereas for women the greatest decline was seen in Singapore (AAPC = -12.3, 95%C.I. = -17.3,-6.9) and China (AAPC = -5.6, 95%C.I. = -7.6,-3.4). The Philippines (AAPC = 4.3, 95%C.I. = 2,6.6) and Bulgaria (AAPC = 2.8, 95%C.I. = 0.5,5.1) had a significant mortality increase in men; whilst Columbia (AAPC = -6.1, 95%C.I. = -7.5,-4.6) and Slovenia (AAPC = -4.6, 95%C.I. = -7.9,-1.3) reported mortality decline in women. These findings inform individuals at increased risk for primary prevention.

Electroacupuncture plus standard of care for managing refractory functional dyspepsia: protocol of a pragmatic trial with economic evaluation.

INTRODUCTION: This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). METHODS AND ANALYSIS: This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. ETHICS AND DISSEMINATION: The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. TRIAL REGISTRATION NUMBER: ChiCTR-IPC-15007109; Pre-result.

High morbidity and mortality of Clostridium difficile infection and its associations with ribotype 002 in Hong Kong.

OBJECTIVES: We aim to study the disease burden, risk factors and severity of Clostridium difficile infection (CDI) in Hong Kong. METHODS: We conducted a prospective, case-control study in three acute-care hospitals in Hong Kong. Adult inpatients who developed CDI diarrhoea confirmed by PCR (n = 139) were compared with the non-CDI controls (n = 114). Ribotyping of isolates and antimicrobial susceptibility testing were performed. RESULTS: The estimated crude annual incidence of CDI was 23-33/100,000 population, and 133-207/100,000 population among those aged ≥65 years. The mean age of CDI patients was 71.5. Nursing home care, recent hospitalization, antibiotics exposure (adjusted OR 3.0, 95% CI 1.3-7.1) and proton-pump inhibitors use (adjusted OR 2.2, 95% CI 1.2-3.9) were risk factors. Severe CDI occurred in 41.7%. Overall mortality was 16.5% (among severe CDI, 26.5%). The commonest ribotypes were 002 (22.8%), 014 (14.1%), 012 and 046; ribotype 027 was absent. Ribotype 002 was associated with fluoroquinolone resistance and higher mortality (47.6% vs. 12.7%; adjusted HR 2.8, 95% CI 1.1-7.0). CONCLUSIONS: Our findings show high morbidity and mortality of CDI in the older adults, and identify ribotype 002 as a possible virulent strain causing serious infections in this cohort.

Colorectal Cancer Screening Based on Age and Gender: A Cost-Effectiveness Analysis.

We evaluated whether age- and gender-based colorectal cancer screening is cost-effective.Recent studies in the United States identified age and gender as 2 important variables predicting advanced proximal neoplasia, and that women aged <60 to 70 years were more suited for sigmoidoscopy screening due to their low risk of proximal neoplasia. Yet, quantitative assessment of the incremental benefits, risks, and cost remains to be performed.Primary care screening practice (2008-2015).A Markov modeling was constructed using data from a screening cohort. The following strategies were compared according to the Incremental Cost Effectiveness Ratio (ICER) for 1 life-year saved: flexible sigmoidoscopy (FS) 5 yearly; colonoscopy 10 yearly; FS for each woman at 50- and 55-year old followed by colonoscopy at 60- and 70-year old; FS for each woman at 50-, 55-, 60-, and 65-year old followed by colonoscopy at 70-year old; FS for each woman at 50-, 55-, 60-, 65-, and 70-year old. All male subjects received colonoscopy at 50-, 60-, and 70-year old under strategies 3 to 5.From a hypothetical population of 100,000 asymptomatic subjects, strategy 2 could save the largest number of life-years (4226 vs 2268 to 3841 by other strategies). When compared with no screening, strategy 5 had the lowest ICER (US$42,515), followed by strategy 3 (US$43,517), strategy 2 (US$43,739), strategy 4 (US$47,710), and strategy 1 (US$56,510). Strategy 2 leads to the highest number of bleeding and perforations, and required a prohibitive number of colonoscopy procedures. Strategy 5 remains the most cost-effective when assessed with a wide range of deterministic sensitivity analyses around the base case.From the cost effectiveness analysis, FS for women and colonoscopy for men represent an economically favorable screening strategy. These findings could inform physicians and policy-makers in triaging eligible subjects for risk-based screening, especially in countries with limited colonoscopic resources. Future research should study the acceptability, feasibility, and feasibility of this risk-based strategy in different populations.

Screening strategies for colorectal cancer among patients with nonalcoholic fatty liver disease and family history.

Patients with nonalcoholic fatty liver disease (NAFLD) and family history of colorectal cancer (CRC) are at higher risks but how they should be screened remains uncertain. Hence, we evaluated the cost-effectiveness of CRC screening among patients with NAFLD and family history by different strategies. A hypothetical population of 100,000 subjects aged 40-75 years receive: (i) yearly fecal immunochemical test (FIT) at 50 years; (ii) flexible sigmoidoscopy (FS) every 5 years at 50 years; (iii) colonoscopy 10 yearly at 50 years; (iv) colonoscopy 10 yearly at 50 years among those with family history/NAFLD and yearly FIT at 50 years among those without; (v) colonoscopy 10 yearly at 40 years among those with family history/NAFLD and yearly FIT at 50 years among those without and (vi) colonoscopy 10 yearly at 40 years among those with family history/NAFLD and colonoscopy 10 yearly at 50 years among those without. The incremental cost-effectiveness ratio (ICER) was studied by Markov modeling. It was found that colonoscopy, FS and FIT reduced incidence of CRC by 49.5, 26.3 and 23.6%, respectively. Using strategies 4, 5 and 6, the corresponding reduction in CRC incidence was 29.9, 30.9 and 69.3% for family history, and 33.2, 34.7 and 69.8% for NAFLD. Compared with no screening, strategies 4 (US$1,018/life-year saved) and 5 (US$7,485) for family history offered the lowest ICER, whilst strategy 4 (US$5,877) for NAFLD was the most cost-effective. These findings were robust when assessed with a wide range of deterministic sensitivity analyses around the base case. These indicated that screening patients with family history or NAFLD by colonoscopy at 50 years was economically favorable.

Cost-effectiveness of Helicobacter pylori "test and treat" for patients with typical reflux symptoms in a population with a high prevalence of H. pylori infection: a Markov model analysis.

OBJECTIVE: Patients with typical reflux symptoms may have underlying peptic ulcer disease (PUD) in a population with a high prevalence of Helicobacter pylori infection. In the present study we sought to compare the cost-effectiveness of the H. pylori "test and treat" strategy with that of empirical proton-pump inhibitor (PPI) therapy and endoscopy in patients with typical reflux and a high prevalence of H. pylori infection. MATERIAL AND METHODS: A Markov model was designed to compare the outcomes of three treatment strategies over 12 months among a hypothetical cohort of patients presenting with typical reflux symptoms. There were four exclusive underlying H. pylori- and PUD-related comorbidities in the hypothetical cohort: (1) H. pylori-related PUD, (2) H. pylori infection without PUD, (3) PUD without H. pylori infection and (4) absence of both PUD and H. pylori infection. The transition probabilities and resource utilization were derived from the literature. Percentage of PUD patients treated, total number of symptom-free patient-years gained and total direct medical cost were estimated. RESULTS: By comparing each strategy individually with the no therapy strategy, it was found that the incremental costs per ulcer treated for H. pylori "test and treat", endoscopy and empirical PPI therapy were USD 1778, USD 1797 and USD 2158, respectively. The results of the model were sensitive to the prevalence of H. pylori infection. CONCLUSIONS: Both the H. pylori "test and treat" and initial endoscopic strategies were shown to be more cost-effective than empirical PPI therapy for treating undiagnosed PUD among patients presenting with typical reflux symptoms. The H. pylori "test and treat" strategy appeared to be only slightly more cost-effective than initial endoscopy in a population with a high prevalence of H. pylori infection.