Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form

BACKGROUND: The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in functional dyspepsia, but responsiveness has been little studied. The Nepean Dyspepsia Index originally contained 42 items designed to measure impairment of a subject's ability to engage in relevant aspects of their life because of dyspepsia, and their enjoyment of these aspects; in addition, the individual importance of areas was assessed. It was subsequently shortened to 25 items, yielding five sub-scales. AIM: To test the Nepean Dyspepsia Index's responsiveness and develop a responsive, very short form. METHODS: A randomized, double-blind controlled trial was performed in 589 patients with documented functional dyspepsia. Symptoms and quality of life were measured at baseline, 2 and 4 weeks. Responsiveness of the Nepean Dyspepsia Index quality-of-life section was evaluated by correlation with symptom scores and calculation of standardized changes in scores. Two items from each sub-scale which best represented the area of life (by factor loadings) were selected to create the 10-item short form (SF; short form-Nepean Dyspepsia Index). Internal consistency was assessed by Cronbach's alpha and responsiveness was assessed as above. RESULTS: The Nepean Dyspepsia Index quality-of-life scales demonstrated excellent responsiveness to change in both the active and placebo arms (standardized response means all > 1.0). The Nepean Dyspepsia Index accounted for only 8% of the variance in percentage change in symptoms (by visual analogue scales), indicating that it was evaluating areas of life not covered by symptoms. The 10-item short form had adequate internal consistency (all scales > or = 0.70) and all strongly (and significantly) correlated with the long form sub-scales; it was also highly responsive. CONCLUSION: The Nepean Dyspepsia Index is a responsive disease-specific quality-of-life measure; the 10-item short form can be applied in clinical trials of functional dyspepsia.     

Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial

BACKGROUND: This study aimed to assess the efficacy of artichoke leaf extract (ALE) in the treatment of patients with functional dyspepsia (FD). METHODS: In a double-blind, randomized controlled trial (RCT), 247 patients with functional dyspepsia were recruited and treated with either a commercial ALE preparation (2 x 320 mg plant extract t.d.s.) or a placebo. The primary efficacy variable was the sum score of the patient's weekly rating of the overall change in dyspeptic symptoms (four-point scale). Secondary variables were the scores of each dyspeptic symptom and the quality of life (QOL) as assessed by the Nepean Dyspepsia Index (NDI). RESULTS: Two hundred and forty-seven patients were enrolled, and data from 244 patients (129 active treatment, 115 placebo) were suitable for inclusion in the statistical analysis (intention-to-treat). The overall symptom improvement over the 6 weeks of treatment was significantly greater with ALE than with the placebo (8.3 +/- 4.6, vs. 6.7 +/- 4.8, P < 0.01). Similarly, patients treated with ALE showed significantly greater improvement in the global quality-of-life scores (NDI) compared with the placebo-treated patients (- 41.1 +/- 47.6 vs. - 24.8 +/- 35.6, P < 0.01). CONCLUSION: The ALE preparation tested was significantly better than the placebo in alleviating symptoms and improving the disease-specific quality of life in patients with functional dyspepsia.     

Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia

Aim: To validate the gastrointestinal symptom score as an outcome measure for functional dyspepsia. Methods: In focus groups, 10 dyspepsia‐specific items including nausea, sickness, vomiting, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, epigastric pain/upper abdominal pain were identified. Ninety‐five patients with functional dyspepsia and 56 healthy controls were recruited and responsiveness evaluated by analysing gastrointestinal symptom score data from 357 patients from previous placebo‐controlled trials. Gastrointestinal symptom score response data were correlated with the patient's global assessments of efficacy. Convergent validity was assessed by correlating the gastrointestinal symptom score with the results obtained by the Nepean Dyspepsia Index. Results: Sensitivity: In patients and healthy controls gastrointestinal symptom score yielded consistently different scores (all P < 0.0001). Test–retest reliability: Gastrointestinal symptom score determined at the two time points were significantly correlated (r‐values ranging from 0.842 to 0.901). Convergence validity: Gastrointestinal symptom score of both rating groups were significantly correlated with the symptom‐specific component of the Nepean Dyspepsia Index (r‐vales ranging from 0.666 to 0.764, P < 0.01). Responsiveness: Responses of gastrointestinal symptom score during treatment were different for patients with a global self assessment as responders compared with non‐responders (all P < 0.0055). Conclusion: The gastrointestinal symptom score is a valid and reliable instrument to assess symptom intensities in patients with functional dyspepsia.     

Asimadoline, a kappa-opioid agonist, and satiation in functional dyspepsia

Background  Asimadoline, a kappa-opioid agonist, reduces visceral sensitivity in experimental animal models and may decrease satiation and postprandial fullness in healthy individuals. However, its effect on satiation in functional dyspepsia is unclear, and any symptom benefit has not been explored.
Aim  To evaluate the effects of asimadoline on satiation volume and postchallenge symptoms in functional dyspepsia.
Methods  A randomized, double-blind trial evaluated gastric satiation and symptoms before and after 8 weeks of asimadoline 0.5 mg ( n  = 13) or 1.0 mg ( n  = 13) or placebo ( n  = 14) b.d. in patients with functional dyspepsia (Rome II). Gastrointestinal Symptom Rating Scale and Nepean Dyspepsia Index were used to assess symptoms during the 8-week treatment.
Results  Over 8 weeks of treatment, asimadoline had no significant effect on maximum-tolerated volume or aggregate symptom score with nutrient drink challenge, and on the mean of the total daily symptom severity score compared to placebo. In a post hoc analysis, asimadoline 0.5 mg significantly increased the maximum-tolerated volume (1217 mL ± 90.2) compared to placebo (807 mL ± 111.8) in patients with higher postprandial fullness scores ( P  = 0.01).
Conclusion  Asimadoline overall did not significantly alter maximum-tolerated volume, symptoms postnutrient challenge or symptoms over 8 weeks in functional dyspepsia.     

Impact of functional gastrointestinal disorders on health-related quality of life: a population-based case-control study

BACKGROUND: The health-related quality of life is impaired in patients with functional gastrointestinal disorders seen in referral centres. AIM: To determine whether the health-related quality of life is impaired in subjects with functional disorders in the community and whether any differences can be explained by psychological co-morbidity. METHODS: In a population-based, nested, case-control study, subjects reporting symptoms of either dyspepsia or irritable bowel syndrome and healthy controls were interviewed and completed a battery of psychological measures plus a validated, generic, health-related quality of life measure (Medical Outcomes Study 36-item short form health survey, SF-36). The association between irritable bowel syndrome and dyspepsia and the physical and mental composite scores of SF-36 were assessed with and without adjustment for psychological state. RESULTS: One hundred and twelve cases (30 dyspepsia, 39 irritable bowel syndrome, 32 dyspepsia and irritable bowel syndrome and 11 gastrointestinal symptoms but not dyspepsia or irritable bowel syndrome) and 110 controls were enrolled. In the unadjusted linear regression models, irritable bowel syndrome (but not dyspepsia) was negatively associated with the physical composite score (P < 0.05); in an adjusted model, the association between the physical health-related quality of life and irritable bowel syndrome was explained by the Symptom Checklist-90 somatization score alone. In unadjusted models, irritable bowel syndrome and dyspepsia were each negatively associated with the mental composite score (P < 0.05). The association between the mental health-related quality of life and dyspepsia remained after adjusting for psychological covariates, but the association between this and irritable bowel syndrome was not significant after adjustment. CONCLUSIONS: In the community, health-related quality of life is impaired in subjects with irritable bowel syndrome and dyspepsia; however, much of this association can be explained by psychological factors.     

Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia

Background  Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden.
Aim  To study the efficacy of a combination of flupenthixol and melitracen (F + M) with anxiolytic and antidepressant properties in functional dyspepsia using a randomized controlled cross-over design.
Methods  Patients met the Rome III criteria for functional dyspepsia and a validated questionnaire was used to exclude those with anxiety or depression. Moreover, patients had to have failed a trial of acid-suppressive therapy and Helicobacter pylori eradication when positive. End points included subjective global symptom relief and QoL assessed by the Nepean Dyspepsia Index (NDI).
Results  Twenty-five patients (14 females, 11 males; mean age = 34.3 ± 9.9 years) were enrolled and 24 completed the 8-week study. There was a significant improvement in subjective global symptom relief with F + M vs. placebo (ITT: 73.9% vs. 26.1%, P  = 0.001) and a significant drop in the NDI score vs. placebo (ITT: −9.0 ± 11.9 vs. −2.4 ± 8.9, P  = 0.03). No difference was noted whether the initial treatment was F + M or placebo. No significant side effects were noted.
Conclusions  A combination of F and M is safe and effective in the short-term treatment of functional dyspepsia. F + M is associated with significant improvement in QoL independent of the presence of anxiety or depression.     

Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease-- an analysis based on the ProGERD initiative

AIMS: To determine the impact of gastro-oesophageal reflux disease (GERD) on the quality of life, to assess changes in the quality of life during treatment with esomeprazole and to define factors that can predict these changes. METHODS: Patients with GERD (n=6215) were included in a prospective cohort study (ProGERD). All patients underwent endoscopy and received esomeprazole. At baseline and after 2 weeks of treatment, symptoms and quality of life were assessed. Factors that influenced changes in the quality of life were determined by multiple regression analyses. RESULTS: At baseline, the quality of life in GERD patients was lower than that in the general population, and was similar to that in patients after acute coronary events. No differences in symptoms or quality of life were observed between the subgroups of patients with non-erosive GERD, erosive GERD and Barrett's oesophagus. After treatment with esomeprazole, the symptoms and quality of life were improved in all subscales within 2 weeks (P<0.001). The mean score of the disease-specific quality of life instrument (Quality of Life in Reflux and Dyspepsia Patients) increased from 4.6 to 6.2 points, representing a highly relevant clinical improvement. The generic quality of life (SF-36) reached levels similar to those in the general population, but, again, no difference was found between the three different subgroups of GERD patients. The main factors associated with an improvement in the quality of life after treatment were symptom relief, severe erosive reflux disease, absence of extra-oesophageal disorders, avoidance of non-steroidal anti-inflammatory drug intake and positive Helicobacter pylori status. CONCLUSIONS: GERD causes a significant impairment in the quality of life that can be attenuated or normalized within a time period as short as 2 weeks by treatment with esomeprazole. These findings were similar across the whole GERD patient spectrum.     

The Short-Form Leeds Dyspepsia Questionnaire validation study

BACKGROUND: Assessment of symptoms should be the primary outcome measure in dyspepsia clinical trials. This requires a reliable, valid and responsive questionnaire that measures the frequency and severity of dyspepsia. The Leeds Dyspepsia Questionnaire fulfils these characteristics, but is long and was not designed for self-completion, so a shorter questionnaire was developed (the Short-Form Leeds Dyspepsia Questionnaire). AIM: To assess the acceptability, interpretability, internal consistency, reliability, validity and responsiveness of the Short-Form Leeds Dyspepsia Questionnaire in primary and secondary care. METHODS: Unselected primary and secondary care patients completed the Short-Form Leeds Dyspepsia Questionnaire. Test-retest reliability was assessed after 2 days. Validity was measured by comparison with general practitioners' diagnosis. Sensitivity analysis and logistic regression were employed to determine the most valid scoring system. Responsiveness was determined before and after treatment for endoscopically proven disease. RESULTS: The Short-Form Leeds Dyspepsia Questionnaire was administered to 388 primary care and 204 secondary care patients. The Pearson coefficient for test-retest reliability was 0.93. The Short-Form Leeds Dyspepsia Questionnaire had a sensitivity of 77% and a specificity of 75%. A highly significant response to change was observed (P < 0.005). CONCLUSIONS: The Short-Form Leeds Dyspepsia Questionnaire is a reliable, valid and responsive self-completed outcome measure for quantifying the frequency and severity of dyspepsia symptoms, which is shorter and more convenient than the Leeds Dyspepsia Questionnaire.     

Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials

BACKGROUND: Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. AIM: To validate the 7-point Global Overall Symptom scale. METHODS: The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test-retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. RESULTS: Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. CONCLUSION: The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.     

Determinants of quality of life in chronic liver patients

BACKGROUND AND AIM: Health-related quality of life of patients with chronic liver disease has been shown to be impaired in numerous studies. However, the factors which influence health-related quality of life in treated chronic liver patients are not quite known. This is the first study to assess the impact of physical and psychosocial determinants on a weighted score of health-related quality of life in patients with chronic liver disease. METHODS: The data of 1175 chronic liver patients were used to assess the relationship between items of the disease-specific Liver Disease Symptom Index 2.0 and the Short Form (SF)-6D weighted utility score by means of linear regression analyses. RESULTS: Health-related quality of life was most strongly related to disease severity (B = -0.029) and joint pain (B = -0.023). Depression (B = -0.014), pain in the right upper abdomen (B = -0.014), decreased appetite (B = 0.014) and fatigue (B = -0.013) were also strongly related to health-related quality of life. In hepatitis C virus patients, disease severity (B = -0.037) and depression (B = -0.030) were strong determinants of health-related quality of life. CONCLUSIONS: This study shows that health-related quality of life in chronic liver patients is clearly determined by disease severity, joint pain, depression, decreased appetite and fatigue. These patients may benefit most from interventions aimed at improving adaptation to the symptoms described.     

Symptoms in patients on long-term proton pump inhibitors: prevalence and predictors

Background  Symptom control in primary care patients on long-term proton pump inhibitor (PPI) treatment is poorly understood.
Aim  To explore associations between symptom control and demographics, lifestyle, PPI use, diagnosis and Helicobacter pylori status.
Methods  A cross-sectional survey ( n  = 726) using note reviews, questionnaires and carbon-13 urea breath testing. Determinants of symptom control [Leeds Dyspepsia Questionnaire (LDQ), Carlsson and Dent Reflux Questionnaire (CDRQ), health-related quality-of-life measures (EuroQoL: EQ-5D and EQ-VAS)] were explored using stepwise linear regression.
Results  Moderate or severe dyspepsia symptoms occurred in 61% of subjects (LDQ) and reflux symptoms in 59% (CDRQ). Age, gender, smoking and body mass index had little or no influence upon symptom control or PPI use. Average symptom scores and PPI use were lower in patients with non-ulcer dyspepsia and gastro-protection than gastro-oesophageal reflux disease (GERD) and uninvestigated dyspepsia. H. pylori infection was associated with lower reflux symptom scores only in patients with GERD and uninvestigated dyspepsia. EQ-5D was not able to discriminate between diagnostic groups, although the EQ-VAS performed well.
Conclusions  A majority of patients suffered ongoing moderate or severe symptoms. GERD and uninvestigated dyspepsia were associated with poorer long-term symptom control; H. pylori appeared to have a protective effect on reflux symptoms in these patients.     

Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study

BACKGROUND: The impact of gastro-oesophageal reflux symptoms on health-related quality of life in the general population is poorly characterized. AIM: To identify the frequency of troublesome reflux symptoms associated with impaired health-related quality of life in the general population. METHODS: A representative random sample of 3000 adult inhabitants of northern Sweden was surveyed using the validated Abdominal Symptom Questionnaire (response rate 74%). In total, 1001 random responders were endoscoped and assessed using the Short Form-36 Health Survey. RESULTS: Complete data were obtained for 999 subjects: 6% reported reflux symptoms (heartburn and/or regurgitation) daily, 14% weekly and 20% less than weekly during the previous 3 months. Compared with no reflux symptoms, a clinically relevant impairment of health-related quality of life (>or=5 points and P < 0.05) was seen in all eight Short Form-36 dimensions for daily symptoms, in five dimensions for weekly symptoms and in one dimension for less than weekly symptoms. There were no meaningful differences in Short Form-36 scores between subjects with and without oesophagitis. CONCLUSIONS: Most aspects of health-related quality of life were impaired in individuals with daily or weekly reflux symptoms. Troublesome reflux symptoms at least weekly may identify gastro-oesophageal reflux disease.     

Burden of illness in Italian patients with gastro-oesophageal reflux disease

OBJECTIVE: Gastro-oesophageal reflux disease (GORD), characterized by frequent episodes of heartburn, imposes considerable burdens on both patients and health services. In addition to both patients and health services. In addition to gastrointestinal symptoms, GORD may precipitate a variety of extra-oesophageal complications, such as asthma and chest pain, which can significantly impair patients' quality of life. This paper aims to describe the impact of heartburn on patients' health-related quality of life (HRQL) in Italy. RESEARCH DESIGN AND METHODS: Consecutive patients from general practices and gastroenterology clinics who were experiencing heartburn were invited to complete a selection of standardized patient-reported outcomes instruments, including Italian translations of the Gastrointestinal Symptom Rating Scale (GSRS), Short-Form 36 (SF-36), Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) and Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn in the preceding week were recorded. RESULTS: Assessments were completed by 152 patients (mean age, 47 years), of whom 60% were female. Sixty-one per cent had moderate symptoms and 74% had symptoms on three or more days in the previous week. Patients were most bothered by reflux, abdominal pain and indigestion. As a result of their symptoms, patients experienced impaired vitality, sleep disturbance and other alimentary problems. This led to impaired HRQL across all but one SF-36 domain. According to the HAD scale, 21% of patients were depressed and 19% were anxious. CONCLUSION: GORD substantially impairs many aspects of HRQL, including sleep, vitality and emotional health.     

Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study

Aliment Pharmacol Ther 2011; 34: 714–723

Summary

Background Patients with dyspepsia often experience troublesome symptoms. Aim To assess the burden of uninvestigated dyspepsia (symptoms, health‐related quality of life [HRQL] and work productivity) before and after 8 weeks’ esomeprazole treatment. Methods Patients (n = 1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤2 endoscopies within 10 years) underwent a 1‐week esomeprazole acid‐suppression test before randomisation to 7 weeks’ esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1‐week off‐treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid‐suppression test. Results The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub‐population of acid‐suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. Conclusions Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1‐week acid‐suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.     

Quality of life in cystic fibrosis

Cystic fibrosis is a chronic, multisystem genetic disease with a wide variability in clinical severity. In recent years, advances in therapy have led to improved patient survival into adulthood. New treatments are rapidly being developed and require evaluation to determine their efficacy. The measurement of health-related quality of life in cystic fibrosis provides additional information about the impact of this disease that cannot be obtained by physiological tests such as pulmonary function. An instrument to measure health-related quality of life is especially useful as an outcome measure for clinical trials. To date, only a few general quality-of-life (QOL) measures have been used in people with cystic fibrosis. There has been some demonstration of validity in 2 measures (the Quality of Well-Being Scale and the Functional Status Index) but the responsiveness of these instruments in this population has not been established. A cystic fibrosis-specific QOL instrument would be valuable as an outcome measure because of its potential for increased responsiveness, but no published measures exist as yet.     

Do physicians correctly assess patient symptom severity in gastro‐oesophageal reflux disease?

BACKGROUND: The accuracy of physicians' assessment of the severity of gastro-oesophageal reflux disease is unclear. AIM: To correlate physician and patient assessment of gastro-oesophageal reflux disease severity and its response to treatment. METHODS: Adult uninvestigated gastro-oesophageal reflux disease patients (n = 217) completed symptom and health-related quality of life questionnaires at baseline and after treatment with esomeprazole 40 mg p.o. daily. Pearson coefficients quantified correlations between physician assessments and patient responses. RESULTS: At baseline, the strongest correlations were heartburn severity (0.31), overall symptom severity (0.44) and a domain of the quality of life in reflux and dyspepsia questionnaire (0.31) (P < 0.001). Correlations of change with treatment were greater than baseline correlations: heartburn (0.39), overall symptoms (0.50) and global rate of change -- stomach problems (0.72, all P < 0.001). The mean difference between the physicians' assessment of change and the patients' global rating of change was 0.20 (95% confidence intervals: 0.10-0.29) with physicians overestimating benefit. CONCLUSIONS: Correlations were often significant, although weak to moderate and better with symptom severity than with health-related quality of life instruments as well as with change after therapy than at baseline. Increasing attention to health-related quality of life may help physicians better understand patients' experience. In clinical trials, treatment success should be assessed by the patient as well as the physician.     

Missing gastric cancer in dyspepsia

BACKGROUND: Dyspepsia is common in gastric cancer, but also in many benign conditions. European Helicobacter pylori Study Group and American Gastroenterological Association guidelines recommend endoscopy in dyspepsia for patients with alarm symptoms or at age >45 years. However, recommendations are controversial. AIM: To investigate whether criteria for endoscopy in patients with dyspepsia are adequate to detect gastric cancer. METHODS: In 215 patients at initial diagnosis of gastric adenocarcinoma, symptoms were classified as alarm and non-alarm. Cases were staged according to the TNM system. Stages T(1)-T(3)N(x)M(0) were defined as potentially curable. RESULTS: Dyspepsia was present in 128 patients. Among patients with dyspepsia, 15 were < or =45 years and 41 denied alarm symptoms. The combination of both criteria excluded only three (2.3%) patients from endoscopy, but increasing the threshold to >50 and >55 years would have raised the rate of excluded patients to seven (5.5%) and 11 (8.6%). Only 53 potentially curable stages and 18 early gastric cancers occurred, but the tumour stage was not associated with dyspepsia duration, age threshold of 45 years, or alarm symptoms. CONCLUSIONS: Our results support current European Helicobacter Study Group and American Gastroenterological Association criteria for endoscopy in patients with dyspepsia to detect gastric cancer. Regardless, most cancers are advanced at detection.     

Health-related quality of life in patients with gastro-oesophageal reflux disease under routine care: 5-year follow-up results of the ProGERD study

Background  Gastro-oesophageal reflux disease (GERD) is a common disorder associated with substantial reductions in health-related quality of life (HRQL).
Aim  To describe patterns of change in HRQL during 5 years of follow-up in a large population of GERD patients.
Methods  In 2000, a total of 6215 GERD patients were enrolled in the Progression of GERD (ProGERD) study. During follow-up, patients received any medication considered necessary. HRQL was assessed yearly with the Short-Form 36 and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. Associations between patient characteristics and changes in HRQL were analysed using multiple logistic regression models.
Results  After 5 years, data on HRQL were available for 4597 (74%) patients. Both generic and disease-specific HRQL improved after baseline and remained well above baseline levels in the following years. A clinically relevant decrease in QOLRAD scores was reported by 3–5% of patients. According to our multivariate analysis, a decrease in HRQL was associated with a higher reflux symptom load and the presence of night-time heartburn.
Conclusions  Only a small minority of the ProGERD population reported a clinically relevant decrease in HRQL, which was associated most strongly with nocturnal heartburn.     

Multi-attribute preference functions. Health Utilities Index

Multi-attribute utility theory, an extension of conventional utility theory, can be applied to model preference scores for health states defined by multi-attribute health status classification systems. The type of preference independence among the attributes determines the type of preference function required: additive, multiplicative or multilinear. In addition, the type of measurement instrument used determines the type of preference score obtained: value or utility. Multi-attribute utility theory has been applied to 2 recently developed multi-attribute health status classification systems, the Health Utilities Index (HUI) Mark II and Mark III systems. Results are presented for the Mark II system, and ongoing research is described for the Mark III system. The theory is also discussed in the context of other well known multi-attribute systems. The HUI system is an efficient method of determining a general public-based utility score for a specified health outcome or for the health status of an individual. In clinical populations, the scores can be used to provide a single summary measure of health-related quality of life. In cost-utility analyses, the scores can be used as quality weights for calculating quality-adjusted life years. In general populations, the measure can be used as quality weights for determining population health expectancy.     

Is it possible to predict treatment response to a proton pump inhibitor in functional dyspepsia?

BACKGROUND: The efficacy of proton pump inhibitors in functional dyspepsia is modest and the prognostic factors are almost unknown. METHODS: Data were pooled on patients (n = 826) with a diagnosis of functional dyspepsia from two placebo-controlled trials who were treated with omeprazole, 10 or 20 mg once daily, for 4 weeks. Self-administered questionnaires for the assessment of symptoms and health-related quality of life were completed before entry, and epigastric pain/discomfort was recorded on diary cards. Treatment success was defined as the complete absence of epigastric pain/discomfort on each of the last 3 days of week 4. Prognostic factors were identified by multiple logistic regression analysis. RESULTS: The most discriminating predictor of treatment success (P < 0.0001) was the number of days with epigastric pain/discomfort during the first week of treatment. Fewer days with symptoms during the first week led to higher response rates at 4 weeks. In addition, age > 40 years, bothersome heartburn, low scores for bloating, epigastric pain and diarrhoea, history of symptoms for < 3 months and low impairment of vitality at baseline were identified as positive predictors of outcome. CONCLUSIONS: Early response to treatment with a proton pump inhibitor, during the first week, seems to predict the outcome after 4 weeks in patients with functional dyspepsia.