[A plea for the reduction in upper gastrointestinal endoscopy: upper gastrointestinal endoscopy is not the solution for dyspepsia]. / Pleidooi voor minder gastroscopieën.

Upper gastrointestinal (GI) endoscopies are often performed in patients with dyspepsia. The diagnostic yield, however, is known to be limited, in particular in patients below 60 years without alarm symptoms. Furthermore, there are limits to the endoscopy capacity. In the Netherlands, an upper GI endoscopy may be requested by the general practitioner (also known as open access endoscopy) or medical specialists. Approximately 40% of the open access upper GI endoscopies is not indicated according to the Dutch guidelines, resulting in substantial costs weighed against limited diagnostic yield. In this article we outline several potential solutions to reduce the number of unnecessary upper GI endoscopies. These include providing patients with digital education, consulting a gastroenterologist, educating health care professionals on the diagnostic yield and reduction of the financial compensation through health insurance policy.

Up-Front Endoscopy Maximizes Cost-Effectiveness and Cost-Satisfaction in Uninvestigated Dyspepsia.

BACKGROUND & AIMS: Practice guidelines promote a routine noninvasive, non-endoscopic initial approach to investigating dyspepsia without alarm features in young patients, yet many patients undergo prompt upper endoscopy. We aimed to assess tradeoffs among costs, patient satisfaction, and clinical outcomes to inform discrepancy between guidelines and practice. METHODS: We constructed a decision-analytic model and performed cost-effectiveness/cost-satisfaction analysis over a 1-year time horizon on patients with uninvestigated dyspepsia without alarm features referred to gastroenterology. A RAND/UCLA expert panel informed model design. Four competing diagnostic/management strategies were evaluated: prompt endoscopy, testing for Helicobacter pylori and eradicating if present (test-and-treat), testing for H pylori and performing endoscopy if present (test-and-scope), and empiric acid suppression. Outcomes were derived from systematic reviews of clinical trials. Costs were informed by prospective observational cohort studies and national commercial/federal cost databases. Health gains were represented using quality-adjusted life years. RESULTS: From the patient perspective, costs and outcomes were similar for all strategies (maximum out-of-pocket difference of $30 and <0.01 quality-adjusted life years gained/year regardless of strategy). Prompt endoscopy maximized cost-satisfaction and health system reimbursement. Test-and-scope maximized cost-effectiveness from insurer and patient perspectives. Results remained robust on multiple one-way sensitivity analyses on model inputs and across most willingness-to-pay thresholds. CONCLUSIONS: Noninvasive management strategies appear to result in inferior cost-effectiveness and patient satisfaction outcomes compared with strategies promoting up-front endoscopy. Therefore, additional studies are needed to evaluate the drivers of patient satisfaction to facilitate inclusion in value-based healthcare transformation efforts.

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.

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.

Economic Impact and Prognostic Factors of Functional Dyspepsia in Children.

OBJECTIVES: Functional dyspepsia (FD) is a functional abdominal pain disorder. There is paucity of data on the economic impact of FD in children. Primary aim of our study was to estimate annual evaluation cost ("diagnosis and visit" cost) and secondary aim was to identify potential prognostic factors of FD in children. METHODS: Out of the 136 patients 86 met inclusion criteria and were divided into 2 clinical groups: Complete Improvement Group (CIG-30 patients) and Partial/No Improvement Group (PIG/NIG-56 patients). Medications used were noted descriptively. Annual evaluation cost was calculated using 2017 Medicare reimbursement rates. RESULTS: Annual evaluation cost in all patients was $724.874 ±â€Š$180.075 ($544.799 ±â€Š$87.995 in CIG and $904.949 ±â€Š79.083 in PIG/NIG). An extrapolated annual cost of evaluation in children with FD would be approximately $5.79 billion. Average number of clinic visits (3.1 ±â€Š1.2 in CIG vs 4.40 ±â€Š3.1 in PIG/NIG), duration of follow-up in months (9.2 ±â€Š6.6 in CIG vs 17.1 ±â€Š13.6 in PIG/NIG), use of imaging studies (7 patients in CIG [23.3%] vs 29 in PIG/NIG [51.8%]) and endoscopic procedures (17 in CIG [56.7%] vs 46 in PIG/NIG [82.1%]) were significantly higher in PIG/NIG (P < 0.005). PIG/NIG required multiple medications for control of symptoms compared to CIG (4 patients in CIG [13.5%] vs 30 in PIG [53.6%], P value <0.001]. For every $500.00 decrease in total evaluation cost the odds of having a complete response was 0.998 (P = 0.027). No prognostic factors were identified in children with FD. CONCLUSIONS: FD in children has a significant economic impact on health care expenditure. Patients with FD who have partial/no response to treatment incur greater financial cost potentially adding to health care expenditure.

The Nepean Dyspepsia Index is a valid instrument for measuring quality-of-life in functional dyspepsia.

BACKGROUND: The Nepean Dyspepsia Index (NDI) has been in widespread use since its publication in 1999 and the addition of a short form in 2001. The NDI was one of the first disease-specific quality-of-life instruments created for functional dyspepsia (FD). However, its psychometric properties have never been validated in an independent sample. AIM: This study aimed to evaluate the validity and reliability of the NDI in an a-priori driven approach in an independent population. PATIENTS AND METHODS: In 289 individuals who fulfilled the Rome criteria for FD enrolled in a randomized placebo-controlled trial (FD treatment trial), we examined construct validity, convergent validity, and internal consistency. RESULTS: Construct validity was supported in its 25-item unweighted and weighted forms as well as the 10-item short form. All items in the 25-item form yielded considerable (>0.5) standardized loadings on their respective latent variables and all reached statistical significance (P<0.0001), supporting their relationships with the hypothesized domains. Convergent validity was strongly supported, with every domain being correlated with multiple external instruments; the majority of correlations were in the range 0.3-0.5 (in absolute values). The items comprising each domain showed good internal consistency, with the lowest value of Chronbach α at 0.80. Scores based on the short form (10-item) version of the NDI correlated strongly with the full 25-item form (tension ρ=0.88, interference ρ=0.94, eat/drink ρ=0.95, knowledge ρ=0.84 and work/study ρ=0.97; all P<0.0001). CONCLUSION: The NDI is a valid instrument that can be used to measure the disease-specific impact of FD on quality of life.

Management of dyspepsia-The role of the ED Observation unit to optimize patient outcomes.

BACKGROUND: Dyspepsia is a common complaint that can confer significant burden on one's quality of life and may also be associated with serious underlying conditions. The objective of this study was to determine if patients admitted to the emergency department observation unit (EDOU) for severe or persistent dyspepsia would have cost effective management in terms of investigations performed, length and cost of hospital stay. The secondary objective was to determine if any patient characteristics could predict a need for admission to the inpatient unit. METHODS: Retrospective chart reviews of patients admitted to the EDOU under the Dyspepsia protocol between January 2008 and August 2014 were conducted. Baseline demographics, investigations performed, outcomes related to EDOU stay, admission and 30-day re-presentation outcomes were recorded. RESULTS: A total of 1304 patients were included. Median length of stay was 1day. Cumulative bed-saved days were 38 per month. Two hundred eighteen (16.7%) patients required admission to the inpatient service for further management, while 533 (40.9%) and 313 (24.0%) patients underwent esophagogastroduodenoscopy and hepatobiliary ultrasonography, respectively. No major adverse events were attributed to the EDOU admissions or delays in treatment. No significant clinically relevant factors were associated with a need for admission from the EDOU to the inpatient unit. Median cost of the EDOU admission was approximately one-third that of a similar admission to the inpatient unit. CONCLUSION: The EDOU is an appropriate setting to facilitate investigations and treatment of patients with dyspepsia with considerable bed-saved days.

The prevalence and sociodemographic determinants of uninvestigated dyspepsia in the Czech Republic: a multicentre prospective study accomplished 10 years after the first study from the same geographical areas.

OBJECTIVE: The epidemiology of uninvestigated dyspepsia was studied in the Czech Republic for the first time in 2001. The aim of the current multicenter prospective study was to evaluate dyspepsia using the same methods in a representative sample of general unselected population from the same geographical areas 10 years later. PARTICIPANTS AND METHODS: A total of 38 147 individuals comprised the general population for a random two-step selection process. A total of 1836 participants (863 males and 973 females; aged 5-98 years) took part in the questionnaire-based study. Helicobacter pylori status was investigated in all participants by means of C-urea breath test. RESULTS: The overall prevalence of dyspepsia was 2.6% among children and adolescents aged 5-17 years and 16.0% among adults aged 18-98 years. We did not detect any statistically significant sex differences in the prevalence of total dyspepsia or its subtypes. Overall, 2.4% of H. pylori-negative children and adolescents aged less than 18 years reported dyspepsia, and 16.8% of H. pylori-negative adults reported it. Among H. pylori-positive children and adolescents and adults, dyspepsia was present in 8.3 and 15.8%, respectively. Type A dyspepsia (as the only long-lasting symptom) was statistically significantly associated with H. pylori status among children and adolescents. Among adults aged 18 years or older, we noted a lower prevalence of dyspepsia in adults with elementary education compared with university education. Current use of antibiotics was associated with an increased prevalence of dyspepsia in adults. CONCLUSION: Despite the substantial decrease of H. pylori infection in the Czech Republic over the past 10 years, the prevalence and sociodemographic determinants of uninvestigated dyspepsia did not change significantly.

Validation of the Leuven Postprandial Distress Scale, a questionnaire for symptom assessment in the functional dyspepsia/postprandial distress syndrome.

BACKGROUND: A validated patient-reported outcome instrument is lacking for the functional dyspepsia/postprandial distress syndrome. AIM: To validate the Leuven Postprandial Distress Scale (LPDS). METHODS: The LPDS diary, comprising eight symptoms with verbal descriptors rated for severity (0-4), was derived from focus groups and cognitive debriefing. It was used in a 2-week run-in, 8-week double-blind placebo-controlled trial of itopride 100 mg t.d.s. Results in 60 patients, with concealed treatment allocation, were used to analyse LPDS content validity, consistency, reliability and responsiveness. Patients also filled out Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM), Nepean Dyspepsia Index, overall treatment evaluation and overall symptom severity questionnaires. Construct validity was evaluated by known-group analyses and by correlating LPDS with these additional questionnaires. Minimum Clinically Important Difference was determined from threshold changes in anchor questionnaires. RESULTS: Symptom patterns and factor analysis identified three cardinal symptoms of postprandial distress syndrome (early satiation, postprandial fullness, upper abdominal bloating), whose mean intensities generate weekly LPDS scores. Known-groups analysis showed large-effect-size differences in LPDS scores (Cohen's d = 2.16). Strong correlations (r > 0.57) between LPDS scores and relevant anchors at baseline indicate good convergent validity. Internal consistency of LPDS was good (α > 0.85) with high inter-item correlations (0.67-0.76), and test-retest reliability (r = 0.85). Changes in LPDS scores were highly convergent with changes in overall treatment evaluation, overall symptom severity and PAGI-SYM (r > 0.52). minimum clinically important difference analysis generated thresholds of 0.4-0.6. CONCLUSIONS: The Leuven Postprandial Distress Scale, which is supported by the European Medicines Agency, is a sensitive and reliable patient-reported outcome instrument to assess symptoms in the functional dyspepsia/postprandial distress syndrome.

Value of the "Test & Treat" Strategy for Uninvestigated Dyspepsia at Low Prevalence Rates of Helicobacter pylori in the Population.

BACKGROUND AND AIM: In populations with a low prevalence rate of Helicobacter pylori (H. pylori) infection from Western countries, guidelines for the management of uninvestigated dyspepsia generally recommend that the "test and treat" strategy should be avoided in favor of empiric proton-pump inhibitor therapy in younger patients (on average < 50 years of age) without alarm symptoms and signs. The prevalence of H. pylori infection has fallen from about 30% to about 10% in Sweden and other countries. We aimed to explore whether the rationale for test and treat is relevant in contemporary clinical practice. MATERIALS AND METHODS: In settings with an infection rate in the adult population of 30% and 10%, we modeled the positive and negative predictive values for indirect (nonendoscopy) tests on current H. pylori infection with a presumed sensitivity and specificity of 95%. We then calculated the difference in false-negative and false-positive test outcome, and eradication prescription rates in the two scenarios. RESULTS: While the positive predictive value for the test decreased from 0.89 to 0.68 when the prevalence of H. pylori fell from 30% to 10%, there were only 1% more false-negative tests and 1% less false-positive tests. The eradication prescription rate would decrease by 18% with a 10% prevalence rate. CONCLUSION: The recommendation to stop applying "test and treat" at lower prevalence rates of H. pylori should be reconsidered. The test and treat strategy is the preferred approach for most patients who present with dyspepsia.

Prevalence of Helicobacter pylori in dyspeptic patients at a tertiary hospital in a low resource setting.

BACKGROUND: More than half of the world's population is infected with Helicobacter pylori (H. pylori), the primary cause of chronic gastritis. Chronic gastritis is associated with peptic ulcer and in advanced stages with an increased risk of developing gastric adenocarcinoma. In many developing countries access to upper gastrointestinal (UGI) endoscopy services is limited. As a result, many UGI diseases are treated empirically. OBJECTIVE: To determine the prevalence of H. pylori in patients presenting with dyspepsia, and the mean time from onset of symptoms to performing an endoscopy examination. METHODS: A cross sectional descriptive study conducted from 5th January to 30th April 2014. Adult patients with dyspepsia who were referred for UGI endoscopy were recruited consecutively. Questionnaires were used to collect data which were analyzed using STATA software. IRB approval was obtained. RESULTS: In total, 111 participants' data were analyzed. The F:M ratio was 1:1.4, mean age 43 years (SD = 16). The prevalence of H. pylori gastritis was 36%. The minimum time to endoscopy was 3 weeks, maximum 1,248 weeks and the mean time 57 weeks. CONCLUSION: The burden of H. pylori infection in patients with dyspepsia was high. Patients had prior empirical antibiotic therapy. Access to endoscopic services is limited.

Non-cardiac chest pain: a clinical assessment tool.

A simple clinical approach to patients presenting with chest pain is outlined, which is easily taught and can be quickly applied. This approach was demonstrated in a large cohort of patients and this article discusses the characteristics of the various diagnostic sub-groups.

Clinical value of chest pain presentation and prodromes on the assessment of cardiovascular disease: a cohort study.

OBJECTIVES: The recognition of coronary artery disease (CAD) among patients who report chest pain remains difficult in primary care. This study investigates the association between chest pain (specified, unspecified or musculoskeletal) and prodromes (dyspepsia, fatigue or dyspnoea), with first-ever acute CAD, and increased longer term cardiovascular risk. DESIGN: Cohort study. SETTING: Anonymised clinical data recorded electronically by general practitioners from 140 primary care surgeries in London (UK) between April 2008 and April 2013. PARTICIPANTS: Data were extracted for all patients aged 30 years and over at the beginning of the study period, registered in the surgeries. MAIN OUTCOME MEASURES: Clinical data included chest pain, dyspepsia, dyspnoea and fatigue, first-ever CAD and long-term cardiovascular risk (QRisk2). Regression models were used to analyse the association between chest pain together with prodromes and CAD and QRisk2≥20%. RESULTS: 354,052 patients were included in the study. 4842 patients had first-ever CAD of which 270 reported chest pain in the year before the acute event. 257,019 patients had QRisk2 estimations. Chest pain was associated with a higher risk of CAD. HRs: 21.12 (16.68 to 26.76), p<0.001; 7.51 (6.49 to 8.68), p<0.001; and 1.84 (1.14 to 3.00), p<0.001 for specified, unspecified and musculoskeletal chest pain. Dyspepsia, dyspnoea or fatigue was also associated with a higher risk of CAD. Chest pain of all subtypes, dyspepsia and dyspnoea were also associated with an increased 10-year cardiovascular risk of 20% or more. CONCLUSIONS: All patients with chest pain, including those with atypical symptoms, require careful assessment for acute and longer term cardiovascular risk. Prodromes may have independent diagnostic value in the estimation of cardiovascular disease risk.

Incidence and psychological-behavioral characteristics of refractory functional dyspepsia: a large, multi-center, prospective investigation from China.

AIM: To explore the incidence and psychological and behavioral characteristics of refractory functional dyspepsia (RFD) in China. METHODS: The subjects of this study were 1341 new outpatients with functional dyspepsia (FD) who were diagnosed according to the Rome III criteria at four hospitals in Guangdong Province between June and September 2012, and 100 healthy volunteers. All subjects completed questionnaires and scales administered. RESULTS: Three-hundred and twenty-seven of the 1341 patients with FD had RFD (24.4%). Patients with RFD had a longer disease duration and a more severe form of the disease than patients with non-refractory FD (NRFD). The prevalence of depression and anxiety symptoms was higher in patients with RFD than in patients with NRFD. The prevalence of unhealthy eating behaviors, lack of physical activity, and sleeping disorders was higher in patients with RFD than in patients with NRFD. Patients with RFD sought medical advice on more occasions and spent more money on treatment than patients with NRFD. Finally, patients with RFD had poorer quality of life than patients with NRFD. CONCLUSION: RFD is not rare in clinical practice and should get attention by patients and doctors because of its long duration, severe symptoms, and associations with abnormal psychology and poor quality of life.

Yields of dual therapy containing high-dose proton pump inhibitor in eradication of H. pylori positive dyspeptic patients.

UNLABELLED: BACKGROUND/AIMs: H. pylori eradication has been recommended for dyspeptic patients in high prevalance regions. Triple therapies are still prescribed mostly because culture and antibiotic susceptibility tests aren't widely available in the world. Dual therapy with high-dose proton pump inhibitors reported to have higher eradication rates. Our objective was to determine eradication success and cost-effectivity of dual therapy in dyspeptic patients. METHODOLOGY: Patients were treated orally with either dual (n:74,omeprazole 20mg q.i.d and amoxicillin 1g b.i.d) or triple therapy (n:116,omeprazole 20mg b.i.d and amoxicillin 1g b.i.d and clarithromycin 500mg b.i.d) for 14 days. HpSA was requested 3 months later. The results were evaluated statistically, p values ˂0,05 were considered significant. RESULTS: Patients (n:190) were included the study((80 female,110 male, mean age: 35.6±11year(p<0.001)). Alcohol/smoking, endoscopic findings and H. pylori rates with pathological examinations were not significantly different between groups whereas there was a significant difference in HpFast tests(p<0.01). When examined with HpSA tests 3 months after the treatment, eradication rate was 81.1% in the dual therapy group versus 63.8% in the triple therapy group (p:0.011). Dual therapy was economic than triple therapy (144USDvs.107USD,p<0.001). CONCLUSIONS: Dual therapy seems more successful, cost-effective and is less risky in terms of side effects compared to standard triple therapy in patients with dyspepsia.

[Assessment of microscopic state of stomach mucous membrane in children with functional dyspepsia].

The results of morphological research of stomach's mucouse membrane in children with functional dyspepsia are presented in the article. Microscopic changes were found in all examined children regardless of endoscopic state of the gastric and duodenum mucosa. Microscopic picture of the epithelium damage and regeneration was revealed; in more complicated cases, under the decline of regeneration potential features of interstitial inflammation appear. Actuality of morphological research in differential diagnostic of functional dyspepsia and chronic gastritis in children has been shown.

Functional dyspepsia: outcome of focus groups for the development of a questionnaire for symptom assessment in patients suffering from postprandial distress syndrome (PDS).

BACKGROUND: To date, no patient reported outcomes (PRO) instrument is available for evaluation of treatment efficacy in functional dyspepsia (FD)/postprandial distress syndrome (PDS). The aim of our study was to perform focus group interviews for the development of a new questionnaire for assessing symptom pattern and severity in PDS. METHODS: Random ambulatory patients diagnosed with FD/PDS based on Rome III criteria and no predominant gastro-esophageal reflux disease (GERD) symptoms were invited to participate. Focus group sessions were organized where patients reported and discussed their symptoms, facilitated by an experienced physician. After reaching saturation of identified symptom items, questions for a pilot PRO instrument were drafted and evaluated in cognitive interviews for relevance, clarity, and consistency. KEY RESULTS: Of 225 screened patients, 26 patients were diagnosed with PDS without overlapping GERD as single final diagnosis. Fifteen of these (87% female, 48 ± 3.2 years) participated in one of three focus groups. All (100%) confirmed experiencing symptoms that were triggered or aggravated by ingestion of a meal, corresponding to early satiation (100%), and postprandial fullness (100%). In addition reported gastroduodenal symptoms were nausea (40%, postprandial in all, interprandial in 20%), upper abdominal bloating (33%), excessive belching (27%), and vomiting (13%). Epigastric pain and burning were present in respectively 20% and 13%. Non-gastroduodenal symptoms that patients reported included heartburn (33%, but mostly sporadic), weight loss (93%, on average 5.0 ± 1.7 kg), and fatigue (67%). Questions evaluating these symptoms were validated in 15 cognitive interviews. CONCLUSIONS & INFERENCES: This focus group study confirms symptoms corresponding to postprandial fullness and early satiation as the key items for developing a PRO for PDS.

Tongue diagnosis system for quantitative assessment of tongue coating in patients with functional dyspepsia: a clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Tongue diagnosis is a significant procedure to examine the physiological and pathological changes of the human body in oriental medicine. However, the conventional method of tongue diagnosis including direct observation of tongue has limitations because of various external factors and subjective factors. Therefore, the current study investigated the usefulness of the tongue diagnosis system (TDS) as a diagnostic tool for evaluating tongue coating thickness (TCT) by assessing the agreement between the TDS and a gold standard established by assessors using the conventional method. MATERIALS AND METHODS: The present study was designed as a prospective clinical trial including 60 patients with functional dyspepsia. The TDS was used to capture tongue images twice within a 30-min interval to assess its reproducibility. Tongue coating percentage was measured by the TDS, and TCT was classified as either no coating, thin coating, or thick coating according to the existing diagnostic criteria. After both TDS examinations, the weight of tongue coating was quantitatively measured, and the correlation between the actual quantity of tongue coating and the percentage of the coating measured by the TDS was analyzed using Pearson׳s correlation. After collecting tongue images in all 60 patients, tongue coating was evaluated using a conventional method by 5 well-trained assessors to establish the gold standard for evaluating TCT, which allowed us to assess the diagnostic agreement between the TDS and the gold standard. After 2 weeks, TCT evaluation was repeated by the same assessors using the same images but in a random order. RESULTS: The agreement between the TDS and the gold standard for evaluating TCT was almost perfect (weighted kappa, 0.840), as was the reproducibility of the TDS (weighted kappa, 0.851). The percentage of tongue coating measured by the TDS was significantly correlated with the weight of tongue coating (r=0.442, p <0.001). The levels of intra-rater reliability ranged from substantial to almost perfect (range of weighted kappa, 0.777-0.923). The inter-rater reliability of 5 assessors was moderate (weighted kappa, 0.563). CONCLUSIONS: The present study demonstrated that the TDS can be used as a diagnostic tool for the objective and standardized evaluation of TCT in actual clinical practice.