Ingela Wiklund

RELIABILITY AND VALIDITY OF THE GASTROINTESTINAL SYMPTOM RATING SCALE IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

The objective of this study was to evaluate the reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) in US patients with gastroesophageal reflux disease (GERD). Five hundred and sixteen adults with predominant heartburn symptoms of GERD were recruited from gastroenterologist and family physician practices and treated with 6 weeks of 150mg ranitidine twice daily to identify poorly responsive symptomatic GERD. The GSRS, the Medical Outcomes Study Short Form-36 (SF-36) Health Survey and the Psychological General Well-being (PGWB) scale were administered at baseline and after 6 weeks of treatment. Reported ratings of GERD-related symptoms from physician and patient diaries were measured. The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. The internal consistency reliabilities for the GSRS scales ranged from 0.61 to 0.83 and the intraclass correlation coefficients ranged from 0.42 to 0.60. The GSRS scale scores were correlated with the SF-36 and PGWB scales and with the number and severity of heartburn symptoms. Patients with two or three clinician-rated GERD-related symptoms reported worse GSRS scale scores compared with patients with fewer symptoms (p < 0.0001). Statistically significant differences in the mean GSRS scale scores were observed between treatment responders and non-responders (p < 0.0001) and patients showing a response to treatment had larger mean changes in their GSRS scales than patients not showing a response to treatment (p < 0.0001). The standardized response means ranged from 0.42 to 1.43 for the GSRS scale scores. It was concluded that the GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The GSRS has good reliability and construct validity and the GSRS scales discriminate by GERD symptom severity and are responsive to treatment. The GSRS is a useful patient-rated symptom scale for evaluating the outcomes of treatment for GERD.

A critical review of dimension-specific measures of health-related quality of life in cross-cultural research

This article reviews six dimension-specific health-related quality of life (HRQL) measures which have been used cross-culturally. The instruments reviewed are: the Beck Depression Inventory (BDI); the McGill Pain Questionnaire (MPQ); the Center for Epidemiologic Studies—Depression (CES-D); the Zung Self-Rating Depression Scale (SDS); the General Health Questionnaire (GHQ); and the Psychological General Well-Being Index (PGWB). These instruments primarily represent the psychological or emotional dimension of HRQL, and are scales that were developed and validated in the USA, Canada or the UK. The review of specific studies for each of the six instruments was not meant to be exhaustive, but rather to give an indication of the ways in which the instruments have been assessed or used in various countries. The focus throughout this article is on the psychometric properties (reliability, validity and responsiveness) of these scales in different cultures, as well as the processes used to translate the instruments from English into another language. Implications of the results of this review for cross-cultural use of dimension-specific HRQL instruments are drawn.

Coenzyme Q10 as an adjunctive in the treatment of chronic congestive heart failure

Seventy-nine patients with stable chronic congestive heart failure were randomized into a double-blind, crossover placebo controlled study with 3-month treatment periods, where either 100 mg coenzyme Q10 (CoQ10) or placebo was added to conventional therapy. Mean patient age was 61 +/- 10 years, ejection fraction at rest was 22% +/- 10%, and maximal exercise tolerance was 91 +/- 30 W. The follow-up examinations included ejection fraction (primary objective), exercise test, and quality of life questions. Ejection fraction at rest, during a slight volume load, and during a submaximal supine exercise increased slightly compared with placebo: 24% +/- 12% versus 23% +/- 12% (NS), 25% +/- 13% versus 23% +/- 12% (P < .05), and 23% +/- 11% versus 22% +/- 11% (NS). Maximal exercise capacity increased from 94 +/- 31 W during the placebo period to 100 +/- 34 W during the CoQ10 period (P < .05). Total score for the quality of life assessment increased significantly from 107 +/- 23 during the placebo period to 113 +/- 22 during the CoQ10 period (P < .05). The results indicate that oral long-term treatment with 100 mg CoQ10 in patients with congestive heart failure only slightly improves maximal exercise capacity and the quality of life and that the clinical importance of this needs to be further evaluated.

Determinants of an impaired quality of life five years after coronary artery bypass surgery

OBJECTIVE To identify determinants of an inferior quality of life (QoL) five years after coronary artery bypass grafting (CABG). SETTING University hospital. PARTICIPANTS Patients from western Sweden who underwent CABG between 1988 and 1991. MAIN OUTCOME MEASURES Questionnaires for evaluating QoL before CABG and five years after operation. Three different instruments were used: the Nottingham health profile (NHP), the psychological general wellbeing index (PGWI), and the physical activity score (PAS). RESULTS 2121 patients underwent CABG, of whom 310 died during five years’ follow up. Information on QoL after five years was available in 1431 survivors (79%). There were three independent predictors for an inferior QoL with all three instruments: female sex, a history of diabetes mellitus, and a history of chronic obstructive pulmonary disease. Multivariate analysis showed that a poor preoperative QoL was a strong independent predictor for an impaired QoL five years after CABG. An impaired QoL was also predicted by previous disease. CONCLUSIONS Female sex, an impaired QoL before surgery, and other diseases such as diabetes mellitus are independent predictors for an impaired QoL after CABG in survivors five years after operation.

Impact of coronary artery bypass grafting on various aspects of quality of life.

OBJECTIVE To prospectively study the improvement in quality of life (QoL) after coronary artery bypass surgery (CABG). PATIENTS AND METHODS Consecutive patients (n = 2121) who underwent CABG at Sahlgrenska University Hospital between 1988 and 1991 received 3 questionnaires for the study of QoL: the Physical Activity Score, the Nottingham Health Profile and the Psychological General Well-being Index, which were responded both before surgery and at 3 months (n = 1059), 1 year (n = 1045) and 2 years (n = 1027) postoperatively. RESULTS All differences were tested against baseline. The Physical Activity Score improved (mean 4.3 before CABG, 3.1, 3 months after (P < 0.0001), and 2.8, 2 years postoperatively (P < 0.0001)). The Nottingham Health Profile score improved (mean 20.5 before CABG, 11.4, 3 months (P < 0.0001), and 10.4, 2 years postoperatively (P < 0.0001)). The Psychological General Well-being Index improved (mean 91.1 before CABG, 103.8, 3 months (P < 0.0001), and 105.8 (P < 0.0001), 2 years after CABG). The subscale analyses of the Nottingham Health Profile and the Psychological General Well-being Index 2 years after CABG showed the greatest improvement in areas reflecting physical capacity and pain, to be followed by mental qualities. At 2 years after CABG only sexual problems were still markedly frequent, and independent predictors for sexual problems after surgery were preoperative problems (P < 0.00001), male sex (P < 0.0001), and diabetes mellitus (P = 0.0008). CONCLUSION QoL was markedly and significantly improved after CABG. The major improvement was seen already at 3 months, with further slight improvement observed 2 years after surgery. The major improvement was found in areas reflecting physical capacity and pain, which is consistent with symptomatic and objective measurements after CABG. In contrast to the overall improvement in QoL sexual problems were still markedly common 2 years after CABG. The mechanism for this is not fully understood and needs further investigation.

Relationship between quality of life and exercise test findings after coronary artery bypass surgery

We studied the correlation between quality of life and exercise testing in 554 patients 2 years after coronary artery bypass surgery. Quality of life constitutes a persons perceptions of physical and mental functional capacity, health and symptoms. Traditionally, evaluations after coronary bypass surgery have focused on physical performance, medication and anginal symptoms, which cannot be said to represent quality of life. We used the Physical Activity Score, the Nottingham Health Profile and the Psychological General Well-being Index for evaluation of quality of life. Significant correlations were found between quality of life and exercise capacity (P < 0.0001), and quality of life and chest pain at exercise for all questionnaires (P < 0.0001). Significant correlations, although of small or moderate magnitude, were found between exercise capacity, chest pain and most subscales of quality of life, with the highest correlation coefficients for dimensions reflecting physical abilities and pain. We conclude that quality of life correlates significantly with exercise capacity and chest pain during exercise 2 years after coronary bypass surgery. However, only dimensions of pain and physical performance are reasonably well correlated with exercise test results. Several aspects of quality of life are only weakly related to exercise test results and may escape identification in an exercise test.

Prognosis and gender differences in chest pain patients discharged from an ED

A large proportion of patients evaluated for chest pain in the emergency department (ED) will be sent home because the probability of acute myocardial infarction, unstable angina, or other severe disease processes is determined to be sufficiently low. Patients who came to the ED at Sahlgrenska Hospital, Göteborg during a 21-month period because of chest pain were registered and followed up for one year. Survivors after one year were asked to complete a mailed questionnaire regarding different kinds of symptoms. Of 5,362 patients evaluated in the ED, 2,175 were sent home on their first visit. Fifty-four percent were men and 46% were women. The one-year mortality rate was 3% in men and 3% in women. Recurrent chest pain, dyspnea, and psychological symptoms were more frequently reported by patients with known cardiac disease than by patients without cardiac disease. Female patients with and without cardiac disease reported significantly more frequent recurrent chest pain, dyspnea, and psychological and psychosomatic complaints than male patients with and without cardiac disease. These data suggest that there are specific gender differences between men and women who are discharged from the ED after being evaluated for chest pain. In particular, psychological gender differences may exist and need to be addressed when evaluating patients with chest pain.

Effects of 12 weeks of ramipril treatment on the quality of life in patients with moderate congestive heart failure: Results of a placebo-controlled trial

SummaryThe assessment of quality of life (QoL) has become recognized as an important tool for evaluating heart failure therapy. The angiotensin-converting enzyme inhibitor ramipril (mean dose 8 mg) was evaluated in 223 patients with moderate chronic congestive heart failure at 24 centers in 4 Nordic countries following a randomized, double-blind, placebo-controlled, parallel group design. The follow-up period was 12 weeks. QoL was evaluated using a questionnaire with 47 items, including the disease-specific Severe Heart Failure Questionnaire, the Sleep Dysfunction Scale, and the Psychological General Well-Being Index. In both treatment groups the total score increased from baseline to 12 weeks for both the Severe Heart Failure Questionnaire and for the Psychological Well-Being Index, reflecting relief of symptoms and improved well-being. However, no significant differences between the placebo and ramipril groups could be detected. Only a trend toward improvement in sleep on ramipril compared with placebo therapy was observed. In conclusion, in this placebo-controlled trial no significant effects of 12-week ramipril treatment of QoL could be demonstrated in patients with moderate congestive heart failure.

Measuring change in quality of life in response to Helicobacter pylori eradication in peptic ulcer disease: the QOLRAD.

This study was designed to determine if a new condition-specific quality of life measure, the Quality Of Life in Reflux And Dyspepsia (QOLRAD), was responsive to clinical change over a four-week period when evaluating peptic ulcer disease patients undergoing Helicobacter pylori (Hp) eradication. A secondary aim was to evaluate QOLRADs psychometric performance. Hp-positive patients with peptic ulcer disease were recruited from primary care and gastroenterology clinics (N = 155). QOLRAD scores improved significantly (P < 0.0001) and mean total score increase was 1.07 points on a 7-point scale among 111 subjects who responded to Hp eradication. Effect sizes were moderate for responders (0.64) and low for nonresponders (0.36). Score changes below 0.60 were associated with the smallest improvement in patient and physician condition rating; scores above 1.2 were associated with the greatest improvement. The QOLRAD demonstrates reliability and validity. Changes in QOLRAD score can be meaningfully related to clinical changes, aiding evaluation of health-related quality of life in peptic ulcer disease.

Quality of Life in Postmyocardial Infarction Patients in relation to Drug Therapy

Quality of life (QL) was assessed in relation to drug therapy in 539 patients who were still alive five years after myocardial infarction (MI), and the interaction between drug therapy and QL was investigated. The patients originally participated in a double-blind trial that evaluated the effect of early administration of the beta blocker metoprolol. A cardiac follow-up questionnaire (CFQ) and the Nottingham Health Profile (NHP) were answered by 82%. In the CFQ, sel-fassessed cardiac symptoms, medication (diuretics, digitalis, antiarrhythmics, long-acting nitrates, beta blockers, psychoactive drugs), smoking habits, and work status were described. NHP described QL within the sections of mobility, energy, pain, sleep, emotional reactions, and social isolation. The independent relation between morbidity, drugs, and QL was analyzed multivariately. Apart from symptoms of angina pectoris and dyspnoea, anxiety resulted in impaired QL. A relation between diuretics and decreased QL was found, but no indications of adverse effects of the beta blocker metoprolol.