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1.  Psychometric validation of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in patients with reflux disease 
Background
Symptoms of heartburn has an impact on health-related quality of life (HRQL). When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim is to document the psychometric characteristics of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.
Methods
142 patients with symptoms of heartburn (Age: M = 47.5, ± 14.6; Males = 44.4%) completed the German translation of GSRS, the QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale.
Results
The internal consistency reliability of GSRS ranged from 0.53–0.91 and of QOLRAD from 0.90–0.94, respectively. The test-retest reliability of GSRS ranged from 0.49–0.73 and of QOLRAD from 0.70–0.84. The relevant domains of the GSRS and QOLRAD domain scores significantly correlated. GSRS domains of Abdominal Pain and Constipation correlated (negatively) with most of the domains of the SF-36. The relevant QOLRAD domains significantly correlated with all SF-36 domains.
Conclusions
The psychometric characteristics of the German translation of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The reliability of the GSRS Abdominal Pain domain was moderate.
doi:10.1186/1477-7525-1-62
PMCID: PMC269999  PMID: 14613560
Reliability; Validity; Reflux; Health-Related Quality of Life; Germany
2.  Psychometric validation of the Dutch translation of the quality of life in reflux and dyspepsia (QOLRAD) questionnaire in patients with gastroesophageal reflux disease 
Background
The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire is one of the best-characterized disease-specific instruments that captures health-related problems and symptom-patterns in patients with gastroesophageal reflux disease (GERD). This paper reports the psychometric validation of a Dutch translation of the QOLRAD questionnaire in gastroenterology outpatients with GERD.
Methods
Patients completed the QOLRAD questionnaire at visit 1 (baseline), visit 2 (after 2, 4 or 8 weeks of acute treatment with esomeprazole 40 mg once daily), and visit 4 (after 6 months with on-demand esomeprazole 40 mg once daily or continuous esomeprazole 20 mg once daily). Symptoms were assessed at each visit, and patient satisfaction was assessed at visits 2 and 4.
Results
Of the 1166 patients entered in the study, 97.3% had moderate or severe heartburn and 55.5% had moderate or severe regurgitation at baseline. At visit 2, symptoms of heartburn and regurgitation were mild or absent in 96.7% and 97.7%, respectively, and 95.3% of patients reported being satisfied with the treatment. The internal consistency and reliability of the QOLRAD questionnaire (range: 0.83-0.92) supported construct validity. Convergent validity was moderate to low. Known-groups validity was confirmed by a negative correlation between the QOLRAD score and clinician-assessed severity of GERD symptoms. Effect sizes (1.15-1.93) and standardized response means (1.17-1.86) showed good responsiveness to change. GERD symptoms had a negative impact on patients' lives.
Conclusions
The psychometric characteristics of the Dutch translation of the QOLRAD questionnaire were found to be satisfactory, with good reliability and responsiveness to change, although convergent validity was at best moderate.
doi:10.1186/1477-7525-8-85
PMCID: PMC2933707  PMID: 20716328
3.  Validation of a survey methodology for gastroesophageal reflux disease in China 
BMC Gastroenterology  2008;8:37.
Background
Gastroesophageal reflux disease (GERD) causes a wide range of clinical symptoms and potentially serious complications, but epidemiological data about GERD in China are limited. The aim of this pilot study was to develop and validate a methodology for the epidemiological study of GERD in China.
Methods
Regionally stratified, randomized samples of Shanghai residents (n = 919) completed Mandarin translations of the Reflux Disease Questionnaire (RDQ), GERD Impact Scale, Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and 36-item Short Form Health Survey (SF-36). Reliability and construct validity were tested by appropriate statistical analyses.
Results
The response rate was 86%. The test-retest reliability coefficients for the RDQ, GERD Impact Scale, QOLRAD and SF-36 were 0.80, 0.71, 0.93 and 0.96, respectively, and Cronbach's alpha coefficients were 0.86, 0.80, 0.98 and 0.90, respectively. Dimension scores were highly correlated with the total scores for the QOLRAD and SF-36, and factor analysis showed credible construct validity for the RDQ, GERD Impact Scale and SF-36. The RDQ GERD score was significantly negatively correlated with QOLRAD dimensions of food and drink problems and social functioning, and was significantly negatively correlated with all dimensions of the SF-36. All eight of the SF-36 dimensions were significantly correlated with the QOLRAD total score.
Conclusion
This study developed and tested a successful survey methodology for the investigation of GERD in China. The questionnaires used demonstrated credible reliability and construct validity, supporting their use in larger epidemiological surveys of GERD in China.
doi:10.1186/1471-230X-8-37
PMCID: PMC2533006  PMID: 18717991
4.  Risk factors for proton pump inhibitor refractoriness in Chinese patients with non-erosive reflux disease 
AIM: To analyze risk factors for refractoriness to proton pump inhibitors (PPIs) in patients with non-erosive reflux disease (NERD).
METHODS: A total of 256 NERD patients treated with the PPI esomeprazole were enrolled. They were classified into symptom-free and residual symptoms groups according to Quality of Life in Reflux and Dyspepsia (QolRad) scale. All subjects completed questionnaires on psychological status (self-rating anxiety scale; self-rating depression scale) and quality of life scale (Short Form 36). Multivariate analysis was used to determine the predictive factors for PPI responses.
RESULTS: According to QolRad, 97 patients were confirmed to have residual reflux symptoms, and the remaining 159 patients were considered symptom free. There were no significant differences between the two groups in lifestyle factors (smoking and alcohol consumption), age, Helicobacter pylori infection, and hiatal hernia. There were significant differences between the two groups in relation to sex, psychological distress including anxiety and depression, body mass index (BMI), and irritable bowel syndrome (IBS) (P < 0.05). Logistic regression analysis found that BMI < 23, comorbid IBS, anxiety, and depression were major risk factors for PPI resistance. Symptomatic patients had a lower quality of life compared with symptom-free patients.
CONCLUSION: Some NERD patients are refractory to PPIs and have lower quality of life. Residual symptoms are associated with psychological distress, intestinal disorders, and low BMI.
doi:10.3748/wjg.v19.i20.3124
PMCID: PMC3662953  PMID: 23716993
Risk factors; Refractoriness; Proton pump inhibitors; Non-erosive reflux disease
5.  Accounting for the effect of GERD symptoms on patients’ health-related quality of life: supporting optimal disease management by primary care physicians 
Aim
To review, from a primary care physician (PCP) perspective, the use of patient-reported outcome (PRO) instruments for assessment of gastro-oesophageal reflux disease (GERD) symptoms, their impact on health-related quality of life (HRQL) and the effectiveness of therapy.
Results
While generic and disease-specific PRO instruments have been used in the assessment of GERD, the latter can be considered to be more appropriate as they focus only on problems relevant to the disease in question (and therefore tend to be more responsive to change). Such instruments include the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the Gastrointestinal Symptom Rating Scale and the Reflux Disease Questionnaire (RDQ). Their use indicates that GERD symptoms are troublesome and significantly reduce patients’ HRQL, and that effective treatment of GERD improves HRQL. The GERD Impact Scale (GIS) questionnaire, primarily developed for use within primary care, can also help to determine the impact of symptoms on patients’ everyday lives and, in turn, the benefit of appropriately targeted therapy. Notably, these PRO instruments were developed from focus groups of GERD patients, and only aspects rated of highest importance are used in the final instruments. Consequently, PCPs can feel confident that these questionnaires encompass the most relevant points that they are likely to ask in terms of how symptoms affect patients’ everyday lives.
Conclusions
Primary care physicians are encouraged to make wider use of PRO instruments within routine practice to improve communication with their GERD patients that, in turn, could lead to improved clinical outcomes and greater patient satisfaction.
Review CriteriaWe conducted a review of validated patient-reported outcome (PRO) instruments used in gastro-oesophageal reflux disease (GERD), based on the authors’ expertise in the field and a supplementary MEDLINE search with the terms ‘health-related quality of life’, ‘quality of life questionnaire’, ‘patient-reported outcomes’, ‘patient satisfaction’ and ‘gastro-oesophageal reflux disease’.We reviewed papers reporting health-related quality of life (HRQL) data in patients with GERD, including the effect of GERD on HRQL, treatment efficacy and HRQL, patient satisfaction and physician-patient agreement, to help primary care physicians to incorporate PRO instruments into their day-to-day management of patients with GERD.Message for the ClinicAn evidence-based review shows that PRO instruments can accurately assess the nature of GERD symptoms, their impact on HRQL and the efficacy of treatment.Primary care physicians are encouraged to make wider use of PRO instruments as part of their management of patients with GERD, given that such questionnaires can facilitate patient communication and help physicians understand and satisfy the therapeutic needs of their patients.Among validated PRO instruments, the GERD Impact Scale represents a practical tool that is easy for primary care physicians to incorporate into their everyday practice.
doi:10.1111/j.1742-1241.2007.01586.x
PMCID: PMC2228387  PMID: 17927764
6.  Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: Final results of OMAREE, a large-scale clinical experience investigation 
BMC Gastroenterology  2011;11:15.
Background
For patients with reflux esophagitis (RE), endoscopic findings alone (without the frequency and severity of symptoms) may not fully reflect the associated impact on health-related quality of life (QOL). There is not enough data about symptoms and QOL of Japanese patients with RE. The present study therefore investigated the epidemiological characteristics of such patients, and evaluated the efficacy and safety of omeprazole (and other gastrointestinal drugs, except proton pump inhibitors [PPIs]) in terms of improving patients' symptoms and QOL.
Methods
In a large-scale, specific clinical experience investigation of Japanese patients with RE, epidemiological characteristics, QOL and symptoms of the disease in relation to treatment with omeprazole and other gastrointestinal drugs, except PPIs, and safety data of omeprazole were collected. The Quality Of Life in Reflux and Dyspepsia questionnaire (QOLRAD) was used for QOL assessment.
Results
9967 patients were included in the analysis (omeprazole: 7888). At baseline, 75.2% of patients had three or more upper gastrointestinal symptoms, and 31.5% of patients had six or more upper gastrointestinal symptoms. The overall mean QOLRAD score at baseline was 5.14 (the best score is 7). In the omeprazole group, the rate of satisfactory improvement in subjective symptoms was 61.7% and 81.8% at Weeks 4 and 8, respectively, and these were both significantly higher than those of patients treated with other drugs. In both the omeprazole group and the other drugs group, the QOLRAD score at Week 4 improved significantly from baseline, and the degree of improvement was significantly greater in the omeprazole group than in the other drugs group. The favourable tolerability profile of omeprazole was confirmed.
Conclusion
In a large-scale survey, omeprazole improved symptoms and QOL more effectively in Japanese patients with RE than other investigated drugs, and had a good tolerability profile.
Trial Registration
ClinicalTrials.gov identifier: NCT00859287.
doi:10.1186/1471-230X-11-15
PMCID: PMC3056825  PMID: 21356058
7.  Improvement of reflux symptom related quality of life after Helicobacter pylori eradication therapy 
The relationship between Helicobacter pylori (H. pylori) eradication therapy and the risk of developing gastroesophageal reflux disease (GERD) is controversial. We investigated the influence of H. pylori eradication on the risk of GERD by focusing on the quality of life (QOL) and evaluating reflux symptoms. Patients with H. pylori infection were administered triple therapy for H. pylori eradication. At 3 months and 1 year after the eradication therapy, surveys were conducted to determine the health-related QOL by quality of life in reflux and dyspepsia-Japanese version, (QOLRAD-J) and the severity of GERD symptoms by Carlsson-Dent questionnaire (CDQ). Forty patients were included in the analysis. Although no significant changes of these scores were apparent 3 months after H. pylori eradication, the QOLRAD-J and CDQ scores were significantly improved after 1 year. The degree of improvement was even more marked in cases with initially low scores. In conclusion, improved GERD-related QOL and reflux symptoms were noted 1 year after H. pylori eradication therapy. In addition, the degree of improvement was more marked in cases with severe reflux symptoms.
doi:10.3164/jcbn.12-107
PMCID: PMC3593136  PMID: 23524980
Helicobacter pylori; eradication therapy; reflux symptoms; quality of life; questionnaire
8.  Counselling by primary care physicians may help patients with heartburn-predominant uninvestigated dyspepsia 
OBJECTIVE:
To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life.
METHODS:
Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician’s discretion. The primary end point was the baseline change in Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire score.
RESULTS:
A total of 135 patients from nine centres were included in the intention-to-treat analysis. There was a statistically significant baseline improvement in all domains of the QOLRAD questionnaire in both study arms at four and seven months (P<0.0001). After four months, the overall mean change in QOLRAD score appeared greater in the comprehensive counselling group than in the basic counselling group (1.77 versus 1.47, respectively); however, this difference was not statistically significant (P=0.07). After seven months, the overall mean baseline change in QOLRAD score between the comprehensive and basic counselling groups was not statistically significant (1.69 versus 1.56, respectively; P=0.63).
CONCLUSIONS:
A standardized, comprehensive counselling intervention showed a positive initial trend in improving quality of life in patients with heartburn-predominant uninvestigated dyspepsia. Further investigation is needed to confirm the potential benefits of providing patients with comprehensive counselling regarding disease management.
PMCID: PMC2852225  PMID: 20352148
Counselling; Heartburn-predominant; Quality of life; Uninvestigated dyspepsia
9.  Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study 
BMC Gastroenterology  2009;9:84.
Background
Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.
Methods
This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.
Results
Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.
Conclusion
GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.
Trial Registration
D9614C00098; ClinicalTrials.gov Identifier NCT00241501
doi:10.1186/1471-230X-9-84
PMCID: PMC2784471  PMID: 19922626
10.  The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole 
Background
The correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.
Methods
Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.
Results
Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.
Conclusions
Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.
doi:10.1186/1477-7525-3-4
PMCID: PMC545938  PMID: 15649314
Demography; esomeprazole; Feeling Thermometer; GERD; QOLRAD; treatment satisfaction
11.  Effects of Omeprazole on Sleep Disturbance: Randomized Multicenter Double-Blind Placebo-Controlled Trial 
Objectives:
Gastroesophageal reflux is considered to cause sleep disturbance, whereas proton pump inhibitor (PPI) administration is reported to improve insomnia associated with gastroesophageal reflux disease (GERD). The majority of patients with gastroesophageal reflux are asymptomatic and a significant number with erosive esophagitis are also reported to be asymptomatic. We examined whether PPI administration has a therapeutic effect for improving insomnia in patients without reflux symptoms in the same manner as patients with reflux symptoms.
Methods:
We performed a randomized multicenter double-blind placebo-controlled trial using 176 patients with insomnia regardless of the presence of reflux symptoms. The patients were divided into those administered omeprazole (20 mg) or a placebo for 14 days. Four self-reporting questionnaires, QOLRAD-J (Japanese translation of Quality of Life in Reflux and Dyspepsia), Pittsburg Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and a sleep diary, were used for evaluating GERD-related quality of life (QOL) and sleep disturbance.
Results:
We evaluated 171 patients with insomnia, of whom 69 had typical reflux symptoms. Omeprazole statistically significantly improved GERD-related QOL from 30.8±0.7 to 33.0±0.5 (P<0.01) (QOLRAD-J, total) and from 6.0±0.2 to 6.6±0.1 (P<0.01) (QOLRAD-J, sleep-related) when administrated to patients with reflux symptoms. Omeprazole also improved insomnia significantly better than the placebo in patients with reflux symptoms; PSQI, from 9.3±0.5 to 7.9±0.5 (P<0.01) and sleep diary, from 2.1±0.1 to 1.8±0.1 (P<0.01). On the other hand, the therapeutic effects of omeprazole and the placebo were not different in patients without reflux symptoms.
Conclusions:
Our results showed that PPI administration is effective only for insomnia in patients with reflux symptoms.
doi:10.1038/ctg.2014.8
PMCID: PMC4077042  PMID: 24942514
12.  Rabeprazole and esomeprazole in mild-to-moderate erosive gastroesophageal reflux disease: A comparative study of efficacy and safety 
Objective:
To compare the efficacy and safety of rabeprazole and esomeprazole in mild-to-moderate erosive gastroesophageal reflux disease (GERD).
Materials and Methods:
A randomized, single-blinded, outdoor-based clinical study was conducted on 60 patients of mild-to-moderate erosive GERD. After baseline clinical assessment and investigations, rabeprazole (40 mg) was prescribed to 30 patients and esomeprazole (40 mg) to another 30 patients for 4 weeks. The efficacy variables were change in GERD symptom scoring, endoscopic findings, and Quality of Life in Reflux and Dyspepsia (QOLRAD) scoring over 4 weeks.
Result:
Heartburn, acid regurgitation, and overall GERD symptom scoring (P = 0.01) were significantly decreased with rabeprazole in comparison to esomeprazole. The comparative study of all five domains of the QOLARD questionnaire including overall scoring revealed a statistically significant improvement in the rabeprazole group. Endoscopic findings in the rabeprazole group showed an absolute improvement of 30% and relative improvement of 55% over esomeprazole. Both the drugs were well tolerated having no significant difference in the incidence of adverse effects.
Conclusion:
Rabeprazole (40 mg) is a better choice for mild-to-moderate GERD compared with esomeprazole (40 mg) because of its better efficacy and safety profile.
doi:10.4103/0976-500X.83278
PMCID: PMC3157122  PMID: 21897706
Gastroesophageal reflux disease; gastroesophageal reflux disease symptom scoring; Quality of Life in Reflux and Dyspepsia scoring; rabeprazole; esomeprazole
13.  Classification of functional dyspepsia based on concomitant bowel symptoms 
Neurogastroenterology and Motility  2012;24(4):325-e164.
Background
Functional dyspepsia (FD) is a heterogeneous disease, and categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). However, many FD patients have overlap of both PDS and EPS. The present study was designed to examine whether FD could be categorized based on the presence of concomitant gastrointestinal symptoms.
Methods
A web survey comprised of the Gastrointestinal Symptom Rating Scale (GSRS), Rome III criteria of FD, and demographic information was sent to public participants who have no history of severe illness. Factor and cluster analyses were conducted to identify sub-categories of FD based on GSRS.
Key Results
A total of 8038 participants completed the survey. A total of 563 participants met the criteria for FD, whereas 6635 participants did not have dyspepsia symptoms. The remainder had either organic disease (377) or uninvestigated dyspepsia (463). The cluster analysis categorized participants as constipation predominant (cluster C), diarrhea predominant (cluster D), or having neither diarrhea nor constipation (cluster nCnD). Cluster C and D were significantly associated with the presence of FD [odds ratio (OR) 2.57, 95% confidence interval (CI) 2.06–3.21; OR 2.80; 95% CI 2.27–3.45, respectively]. In FD, especially in PDS cases, the scores of upper gastrointestinal symptoms were higher in cluster C or D than in cluster nCnD.
Conclusions & Inferences
The severity of dyspepsia symptoms is associated with the presence of bowel symptoms especially in PDS. This novel categorization of FD based on concomitant constipation or diarrhea may improve classification of patients.
doi:10.1111/j.1365-2982.2011.01859.x
PMCID: PMC3386482  PMID: 22235936
cluster analysis; constipation; diarrhea; dyspepsia; factor analysis
14.  The impact of illness in patients with moderate to severe gastro-esophageal reflux disease 
BMC Gastroenterology  2005;5:23.
Background
Gastro-esophageal reflux disease (GERD) is a common disease. It impairs health related quality of life (HRQL). However, the impact on utility scores and work productivity in patients with moderate to severe GERD is not well known.
Methods
We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7) across 17 Canadian centers. Patients completed three utility instruments – the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3) – and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks.
Results
The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired.
Conclusion
GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL.
doi:10.1186/1471-230X-5-23
PMCID: PMC1183201  PMID: 16004616
15.  Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort 
Background
Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. Patients on different immunosuppressant regimens may feel less bothered by Gastrointestinal (GI) side effects or report better health-related quality of life (HRQL). We evaluated the reliability and validity of two GI-specific outcome instruments (Gastrointestinal Symptom Rating Scale (GSRS; higher scores = increased severity) and Gastrointestinal Quality of Life Index (GIQLI; higher scores = better GI-specific HRQL)) in renal transplant patients in South America.
Methods
Data from 5 South American centers participating in an international, longitudinal, observational study were analyzed. Patients were ≥ 1 month post transplant and on mycophenolate mofetil (MMF) and a calcineurin inhibitor. Patients completed the GSRS, GIQLI, and Psychological General Well-Being (PGWB; higher scores = better HRQL) Index at baseline and at 4–6 weeks. Internal consistency, test-retest reliability and construct and discriminant validity were assessed.
Results
Sixty-two participants were enrolled. Mean age was 42 years; mean time since transplant was 3.3 years; 57% were male; 65% received a deceased organ transplant and 68%had GI events. The GSRS and GIQLI demonstrated high internal consistency (Cronbach's alphas 0.72–0.96). Test-retest reliability was adequate (intraclass correlation coefficient > 0.6) for all GIQLI subscales and all GSRS subscales except Diarrhea and Reflux syndrome. Correlations between the GSRS and PGWB were moderate (range: -0.21 to -0.53, all p < 0.001 except 6 correlations with p < 0.05); correlations between the GIQLI and PGWB were higher (range: 0.36 to 0.71 p < 0.001), indicating good construct validity. The GSRS and GIQLI demonstrated good discriminant validity, as they clinically and statistically distinguished between patients with and without GI complaints and among patients with varying GI complication severity. Patients with GI complaints reported higher GSRS scores than patients without complaints (all p < 0.001). GIQLI scores were lower in patients with GI complaints than patients without complaints (all p < 0.001). The GSRS and GIQLI differentiated among patients with four GI severity levels (overall Kruskall-Wallis test p < 0.001, except for one scale). The GSRS and GIQLI are acceptable for use in South American renal transplant patients. These two instruments demonstrate adequate reliability and validity. Patients with GI complaints reported poor HRQL and strategies are needed to improve patients' HRQL.
doi:10.1186/1477-7525-6-53
PMCID: PMC2499997  PMID: 18644133
16.  The Association between Cholecystectomy and Gastroesophageal Reflux Symptoms: A Prospective Controlled Study 
Annals of surgery  2010;251(1):40-45.
Objective
A large controlled prospective observational study to compare pre- and post-surgery changes in reflux symptoms between cholecystectomy and hernia repair surgery patients.
Summary Background Data
Six studies have suggested that gastroesophageal reflux worsens after cholecystectomy. However, these studies all had design limitations.
Methods
We recruited 302 patients scheduled to undergo elective cholecystectomy (study group) or hernia repair (controls) at two hospitals. Both groups filled out the validated Reflux Symptom Score (RSS) and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires 1–15 days prior to and 4–12 weeks after the operation. Changes in symptom scores between the pre and post-surgery assessments were measured, and compared between the two groups.
Results
Baseline RSS and GSRS reflux subscores were higher in the study group than controls (1.44 vs. 1.02 and 1.91 vs. 1.43 respectively; p<0.05). There were no significant differences in any of the symptom score changes between the two groups except for the GSRS pain subscore, which decreased more in the study group than the control group (−0.59 vs. −0.10; p<0.001). With regard to reflux, the RSS decreased by −0.34 in the study group and −0.14 in controls (p=0.27), while the GSRS reflux subscore decreased by −0.32 in the study group and −0.05 in controls (p=0.12). GSRS diarrhea and constipation subscores decreased slightly after surgery, to the same extent in both groups.
Conclusions
This large prospective controlled study, the only one using validated reflux symptom questionnaires, shows that cholecystectomy does not lead to an increase in reflux symptoms. As expected, GSRS pain subscores were decreased in the cholecystectomy group but not the controls.
doi:10.1097/SLA.0b013e3181b9eca4
PMCID: PMC3676300  PMID: 19858706
Cholecystectomy; gastroesophageal reflux; hernia repair
17.  Gastrointestinal symptomatic outcomes of laparoscopic and open gastrectomy 
AIM: To compare the laparoscopic and the open gastrectomy approaches for short term morbidity, length of hospital stay and also long term gastrointestinal symptoms.
METHODS: Patients who have undergone gastrectomy had their medical records reviewed for demographic data, type of gastrectomy, short term morbidity, and length of hospital stay. Patients were contacted and asked to complete the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS measures three domains of GI symptoms: Dyspepsia Syndrome (DS) for the foregut (best score 0, worse score 15), indigestion syndrome (IS) for the midgut (best score 0, worse score 12), and bowel dysfunction syndrome (BDS) for the hindgut (best score 0, worse score 16). Statistical analysis was done using the Mann-Whitney U-test.
RESULTS: We had complete data on 32 patients: 7 laparoscopic and 25 open. Of these, 25 had a gastroenteric anastomosis and 6 did not. The table shows the results as medians with interquartile range. Laparoscopic gastrectomy had a better score than open gastrectomy in the DS domain (0 vs 1, P = 0.02), while gastrectomy without anastomosis had a better score than gastrectomy with anastomosis in the IS domain (0 vs 1, P = 0.05).
CONCLUSION: Patients have little adverse gastrointestinal symptoms and preserve good gastrointestinal function after undergoing any type of gastrectomy. Laparoscopic approach had better dyspepsia and foregut symptoms. Performing an anastomosis led to mild adverse midgut and indigestion effects
doi:10.4240/wjgs.v1.i1.56
PMCID: PMC2999106  PMID: 21160796
Laparoscopic; Gastrectomy; Symptomatic outcomes; Gastric tumor; Open gastrectomy; Laparoscopic gastrectomy
18.  Improved Gastrointestinal Symptoms and Quality of Life after Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients Receiving Tacrolimus 
Journal of Korean Medical Science  2010;25(12):1759-1765.
It is reported that a conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) relieves gastrointestinal (GI) symptom burden and improves health-related quality of life (HRQoL). However, it is unclear whether renal transplant recipients using tacrolimus receive the same benefit from the conversion. In this prospective, multi-center, open-label trial, patients were categorized into two groups by their GI symptom screening. Equimolar EC-MPS (n=175) was prescribed for patients with GI burdens; those with no complaints remained on MMF (n=83). Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI) were evaluated at baseline and after one month. Patients and physicians completed Overall Treatment Effect (OTE) at one month. EC-MPS-converted patients had worse GSRS and GIQLI scores at baseline than MMF-continued patients (all P<0.001). Significant improvements in GSRS and GIQLI scores were observed for EC-MPS-converted patients at one month, but MMF-continued patients showed worsened GSRS scores (all P<0.05). OTE scale indicated that EC-MPS patients improved in overall GI symptoms and HRQoL more than MMF patients did (P<0.001). In tacrolimus-treated renal transplant recipients with GI burdens, a conversion from MMF to EC-MPS improves GI-related symptoms and HRQoL.
doi:10.3346/jkms.2010.25.12.1759
PMCID: PMC2995230  PMID: 21165291
Mycophenolate mofetil; Enteric-coated mycophenolate sodium; Tacrolimus; Gastrointestinal Symptom; Quality of Life; Kidney Transplantation
19.  Analysis of the Gastrointestinal Symptoms of Uninvestigated Dyspepsia and Irritable Bowel Syndrome 
Gut and Liver  2009;3(3):192-196.
Background/Aims
Epidemiological studies suggest that there is a considerable overlap between functional dyspepsia (FD) and irritable bowel syndrome (IBS). The aim of this study was to examine concurrent gastrointestinal symptoms in FD and IBS.
Methods
A total of 186 college students filled out a questionnaire regarding whether they had uninvestigated dyspepsia (UD, FD without endoscopic examination) and IBS based on Rome-II criteria. Gastrointestinal symptoms were measured using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.
Results
A total of 181 students (98 males, mean age 24.6 years) completed both questionnaires. The prevalence of UD, IBS, and UD+IBS overlap was 12 (6.7%), 40 (22.1%), and 8 (4.4%), respectively. A significant UD+IBS overlap was observed (66.7% IBS in UD, 20.0% UD in IBS). Reflux scores of GSRS in either UD or IBS were significantly greater than in those without. Gastroesophageal reflux disease (GERD), defined as weekly occurring moderate symptoms of heartburn and/or acid regurgitation and evaluated using the GSRS, was found in 16 (8.8%) of the subjects. The prevalence of IBS was significantly higher in GERD patients than in non-GERD patients (50.0% vs 19.4%).
Conclusions
The considerable overlap not only between UD and IBS, but also between GERD and IBS, suggests the involvement of common pathophysiological disturbances in the two conditions.
doi:10.5009/gnl.2009.3.3.192
PMCID: PMC2852717  PMID: 20431745
Dyspepsia; Irritable bowel syndrome; Gastroesophageal reflux; Overlap; Gastrointestinal symptom rating scale
20.  Effect of Daikenchuto (TJ-100) on abdominal bloating in hepatectomized patients 
AIM: To evaluate the clinical usefulness of Daikenchuto (DKT) in hepatecomized patients.
METHODS: Twenty patients were enrolled with informed consent. Two patients were excluded because of cancelled operations. The remaining 18 patients were randomly chosen for treatment with DKT alone or combination therapy of DKT and lactulose (n = 9, each group). Data were prospectively collected. Primary end points were Visual Analogue Scale (VAS) score for abdominal bloating, total Gastrointestinal Symptoms Rating Scale (GSRS) score for abdominal symptoms, and GSRS score for abdominal bloating.
RESULTS: The VAS score for abdominal bloating and total GSRS score for abdominal symptoms recovered to levels that were not significantly different to preoperative levels by 10 d postoperation. Combination therapy of DKT and lactulose was associated with a significantly poorer outcome in terms of VAS and GSRS scores for abdominal bloating, total GSRS score, and total daily calorie intake, when compared with DKT alone therapy.
CONCLUSION: DKT is a potentially effective drug for postoperative management of hepatectomized patients, not only to ameliorate abdominal bloating, but also to promote nutritional support by increasing postoperative dietary intake.
doi:10.4240/wjgs.v5.i4.115
PMCID: PMC3646131  PMID: 23671738
Daikenchuto; Hepatic resection; Abdominal bloating; Visual analogue scale score; Gastrointestinal symptoms rating scale score
21.  Impact of gastro-oesophageal reflux disease on work productivity despite therapy with proton pump inhibitors in Germany 
Background
Gastro-oesophageal reflux disease (GERD) is a common disorder with consequences for the patient's health-related quality of life (HRQoL). In Germany, few data are available on the impact of GERD on work-related productivity.
Aim
To study the impact of GERD on work productivity despite proton pump inhibitor (PPI) therapy and the association between productivity and symptom duration, severity, and HRQoL.
Methods
Retrospective data from randomly selected patients with chronic GERD symptoms, treated by office-based general practitioners or general internists with routine clinical care, were analyzed together with information from self-administered instruments assessing work productivity (WPAI-GERD), symptoms (RDQ), and HRQoL (QOLRAD).
Results
Reduced productivity was reported by 152 of 249 patients (61.0%), although 89.5% of them were treated with PPI. The reduction in work productivity was 18.5% in all patients and 30.3% in those with reduced productivity. Patients with impaired productivity showed a significantly lower HRQoL and more-severe symptoms of reflux disease. In all patients, the mean sick leave attributable to reflux symptoms was 0.6 hours in the previous seven days and 1.4 work days in the previous three months.
Conclusion
GERD has a substantial impact on work productivity in Germany, even in patients receiving routine clinical care and PPI therapy.
doi:10.1186/2047-783X-15-3-124
PMCID: PMC3352219  PMID: 20452898
Gastro-oesophageal reflux; Sick leave; Medical economics; Proton Pump Inhibitors
22.  Evidence for hypomotility in non-ulcer dyspepsia: a prospective multifactorial study. 
Gut  1991;32(3):246-251.
A prospective multifactorial study of symptoms and disturbance of gastrointestinal function has been undertaken in 50 patients with non-ulcer dyspepsia. Objective tests including solid meal gastric emptying studies, gastric acid secretion, E-HIDA scintiscan for enterogastric bile reflux, and hydrogen breath studies were carried out in all patients and validated against control data. Gastroscopy and biopsy were carried out in non-ulcer dyspepsia patients only. Non-ulcer dyspepsia patients were categorised on the basis of predominant symptoms as: dysmotility-like dyspepsia (n = 22); essential dyspepsia (n = 14), gastro-oesophageal reflux-like dyspepsia (n = 11); and ulcer-like dyspepsia (n = 3). In the total non-ulcer dyspepsia population, solid meal gastric emptying was delayed (T50 mean (SEM) = 102 (6) minutes (patients) v 64 (6) minutes (controls), (p less than 0.01) and high incidences of gastritis (n = 26) and Helicobacter pyloridis infection (n = 18) were found. An inverse correlation was observed between solid meal gastric emptying and fasting peak acid output (r = -0.4; p less than 0.01). Indeed gastric emptying was particularly prolonged in eight patients (T50 mean (SEM) = 139 (15) minutes) with hypochlorhydria. In the non-ulcer dyspepsia population oral to caecal transit time of a solid meal was delayed (mean SEM = 302 (14) minutes (patients) v 244 (12) minutes (controls) (p less than 0.01]. Seven patients had a dual peak of breath hydrogen suggestive of small bowel bacterial overgrowth. No association was observed between symptoms and any of the objective abnormalities. This multifactorial study has shown that hypomotility, including gastroparesis and delayed small bowel transit, is common in non-ulcer dyspepsia and may be related to other disorders of gastrointestinal function. No relation between symptoms and disorders of function, however, has been shown.
PMCID: PMC1378827  PMID: 2013418
23.  Quality of life in South East Asian patients who consult for dyspepsia: Validation of the short form Nepean Dyspepsia Index 
Background
Treatment objectives for dyspepsia include improvements in both symptoms and health-related quality of life (HRQoL). There is a lack of disease-specific instruments measuring HRQoL in South East Asian dyspeptics.
Objectives
To validate English and locally translated version of the Short-Form Nepean Dyspepsia Index (SF-NDI) in Malaysian patients who consult for dyspepsia.
Methods
The English version of the SF-NDI was culturally adapted locally and a Malay translation was developed using standard procedures. English and Malay versions of the SF-NDI were assessed against the SF-36 and the Leeds Dyspepsia Questionnaire (LDQ), examining internal consistency, test-retest reliability and construct validity.
Results
Pilot testing of the translated Malay and original English versions of the SF-NDI in twenty subjects did not identify any cross-cultural adaptation problems. 143 patients (86 English-speaking and 57 Malay speaking) with dyspepsia were interviewed and the overall response rate was 100% with nil missing data. The median total SF-NDI score for both languages were 72.5 and 60.0 respectively. Test-retest reliability was good with intraclass correlation coefficients of 0.90 (English) and 0.83 (Malay), while internal consistency of SF-NDI subscales revealed α values ranging from 0.83 – 0.88 (English) and 0.83 – 0.90 (Malay). In both languages, SF-NDI sub-scales and total score demonstrated lower values in patients with more severe symptoms and in patients with functional vs organic dyspepsia (known groups validity), although these were less marked in the Malay language version. There was moderate to good correlation (r = 0.3 – 0.6) between all SF-NDI sub-scales and various domains of the SF-36 (convergent validity).
Conclusion
This study demonstrates that both English and Malay versions of the SF-NDI are reliable and probably valid instruments for measuring HRQoL in Malaysian patients with dyspepsia.
doi:10.1186/1477-7525-7-45
PMCID: PMC2693522  PMID: 19463190
24.  Proton pump inhibitor step-down therapy for GERD: A multi-center study in Japan 
AIM: To investigate the predictors of success in step-down of proton pump inhibitor and to assess the quality of life (QOL).
METHODS: Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy.
RESULTS: In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for step-down. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy.
CONCLUSION: OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before step-down require particular monitoring for relapse.
doi:10.3748/wjg.v17.i11.1480
PMCID: PMC3070023  PMID: 21472108
Gastroesophageal reflux disease; Proton pump inhibitor; Omeprazole; Step-down therapy; Gastrointestinal symptom rating scale
25.  Rikkunshito improves globus sensation in patients with proton-pump inhibitor-refractory laryngopharyngeal reflux 
AIM: To investigate the effect of rikkunshito on laryngopharyngeal reflux (LPR) symptoms and gastric emptying in patients with proton-pump inhibitor (PPI)-refractory LPR.
METHODS: In total, 22 patients with LPR were enrolled. Following a 2-wk treatment with PPI monotherapy, PPI-refractory LPR patients were randomly divided into two treatment groups (rikkunshito alone or rikkunshito plus the PPI, lansoprazole). LPR symptoms were assessed using a visual analog scale (VAS) score, gastrointestinal symptoms were assessed using the gastrointestinal symptom rating scale (GSRS), and gastric emptying was assessed using the radio-opaque marker method prior to and 4 wk following treatments.
RESULTS: The 4-wk treatment with rikkunshito alone and with rikkunshito plus the PPI significantly decreased the globus sensation VAS scores. The VAS score for sore throat was significantly decreased following treatment with rikkunshito plus PPI but not by rikkunshito alone. Neither treatment significantly changed the GSRS scores. Rikkunshito improved delayed gastric emptying. We found a significant positive correlation between improvements in globus sensation and in gastric emptying (r2 = 0.4582, P < 0.05).
CONCLUSION: Rikkunshito improved globus sensation in patients with PPI-refractory LPR, in part, because of stimulation of gastric emptying. Thus, rikkunshito is an effective treatment for PPI-refractory LPR.
doi:10.3748/wjg.v19.i31.5118
PMCID: PMC3746384  PMID: 23964146
Laryngopharyngeal reflux; Gastroesophageal reflux disease; Globus sensation; Gastric emptying; Rikkunshito

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