Validation of a symptom diary for patients with gastro-oesophageal reflux disease.

BACKGROUND: Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease. METHODS: We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up. RESULTS: Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64). CONCLUSIONS: The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

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.

Health-related quality of life during treatment of elderly patients with hypertension: results from the Study on COgnition and Prognosis in the Elderly (SCOPE).

The Study on COgnition and Prognosis in the Elderly (SCOPE) was a multinational, randomised, double-blind study to assess the effects of candesartan 8-16 mg daily on cardiovascular events and cognitive function in elderly patients (aged 70-89 years) with mild to moderate hypertension. A total of 4937 patients were randomised to candesartan or placebo with other antihypertensive drugs (mostly diuretics, beta-blockers, and calcium antagonists) added as needed to control blood pressure. Only 16% of the patients in the control group received placebo alone. The mean follow-up was 3.7 years. The aim of this health-related quality of life (HRQL) substudy analysis was to investigate changes in HRQL during antihypertensive treatment, and possible differences in patients receiving candesartan-based or other antihypertensive treatment. Three validated HRQL instruments were used: the Psychological General Well-being (PGWB) Index, the Subjective Symptoms Assessment Profile (SSA-P), and the EuroQoL Health Utility Index (EuroQoL). The HRQL was generally good at baseline and well preserved during follow-up in the presence of substantial blood pressure reductions in both treatment groups. Several of the observed changes in score from baseline to last visit favoured candesartan-based compared to control treatment, particularly the changes in PGWB Anxiety (-0.5 vs -1.0, P=0.01), PGWB Positive well-being (-0.8 vs -1.1, P=0.04), SSA-P Cardiac symptoms (0.03 vs 0.10, P=0.03), and EuroQoL Current health (-3.1 vs -5.3, P=0.008). This favourable result may be related to the somewhat lower blood pressure associated with candesartan-based treatment. In conclusion, there should be no reason to withhold modern antihypertensive therapy in elderly patients due to concerns for a negative effect on HRQL.

Development and validation of a disease-specific treatment satisfaction questionnaire for gastro-oesophageal reflux disease.

BACKGROUND: Currently, no disease-specific, patient-based, treatment satisfaction instruments related to gastro-oesophageal reflux disease exist. AIM: To develop and validate a treatment satisfaction questionnaire for gastro-oesophageal reflux disease (TSQ-G). METHODS: A new questionnaire was developed from patient focus groups, clinician input and literature review. A validation study was conducted in treated gastro-oesophageal reflux disease patients. Ancillary measures included the Medical Outcomes Study Short Form-36, Quality of Life in Reflux and Dyspepsia, Gastrointestinal Symptom Rating Scale, Socially Desirable Response Scale, Patient Satisfaction Questionnaire-18 and physician and patient measures of symptoms and satisfaction. Statistical analyses included exploratory factor analysis, Cronbach's alpha, intra-class correlations, analyses of variance and t-tests. RESULTS: A total of 198 gastro-oesophageal reflux disease patients participated in the study, with a mean age of 50.7 years, 68% female and 84% Caucasian. The physician-rated severity of gastro-oesophageal reflux disease was mild (32%), moderate (50%) and severe (18%); 83% were on proton pump inhibitors. The final TSQ-G consisted of 28 items with seven sub-scales; Cronbach's alpha ranged from 0.58 to 0.94. Correlations with the expected sub-scales of the ancillary measures were moderate to strong. The TSQ-G sub-scales discriminated significantly between levels of physician-rated disease severity, symptom days and patient and physician ratings of satisfaction. CONCLUSIONS: The TSQ-G has excellent reliability and construct validity and appears to be a useful tool for the evaluation of treatment satisfaction in gastro-oesophageal reflux disease patients.

The influence of prolactin response to d-fenfluramine on executive functioning in major depression.

BACKGROUND: The main purpose of this study was to assess the influence of serotonergic activity, as measured by prolactin response to d-fenfluramine, on executive functioning in major depression. METHODS: Forty-one persons between 22 and 71 years of age who met the DSM-IV criteria for major depressive episode were administered the Wisconsin Card Sorting Test (WCST) in computerized format, and d-fenfluramine was administered orally. Postfenfluramine blood samples for ascertaining plasma prolactin levels were obtained. RESULTS: The key finding was that prolactin response was positively related to four out of five selected WCST variables. Also, increasing age was associated with decreasing WCST performance. There was no interaction between prolactin response and age, indicating that the effects of prolactin response on the WCST generalized across the age range examined. CONCLUSIONS: The overall pattern of results suggests that there may be a relationship between serotonergic activity and executive functioning in major depression.

Source memory in major depression.

BACKGROUND: Research demonstrating episodic memory deficits in clinical depression has dealt with item memory exclusively. The present research sought to determine whether memory for source is differentially affected by depression. METHODS: Patients with major depression and normal control subjects were examined in item memory and two types of source memory, requiring discriminations between (e.g. something that the subject said and something another person said) and within (e.g. something that one person said and something another person said) classes. RESULTS: Depression-related deficits in item memory were exacerbated in source memory. However, deficits in source memory in depressed patients were restricted to those conditions requiring within-class discriminations. CONCLUSION: The overall pattern of results may reflect that those symptoms of major depression that affect the individuals basic processing resources (e.g. concentration difficulties, lack of effort, loss of energy) results in an impairment of episodic memory, particularly when the demands of differentiating perceptual and cognitive information are high.

Executive deficits in major depression.

Clinically depressed patients and control subjects were examined by means of different tests to assess executive functions (the Wisconsin Card Sorting Test, the Stroop Color Word Test and a test of verbal fluency). The results indicate that the depressed patients were generally slower than the controls, as reflected by longer retrieval times for both words and colours. Furthermore, the depressed patients showed impairment with regard to altering behaviour appropriately in response to feedback. However, there were no depression-related increases in perseverative responses, and the ability to inhibit irrelevant information was unaffected by depression. No relationship was found between specific depressive symptoms or the severity of depression and cognitive performance. The overall pattern of results suggests that depression may affect various executive functions in a differentiated manner.