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Biomedical subjects

I Wiklund

Publications and source records attributed to I Wiklund.

At least 19 recordsLinked to original sources
PubMed2006

Newborn skin temperature two days postpartum during breastfeeding related to different labour ward practices.

AIM: To investigate (1) the skin temperature pattern in newborns two days after birth in connection to breastfeeding and to examine (2) if the administration of epidural analgesia (EDA) and oxytocin (OT) infusion during labour influences this parameter at this point of time. METHOD: Forty-seven mother-infant pairs were included in the study: nine mothers had received OT stimulation during labour (OT group), 20 mothers had received an EDA and OT during labour (EDA group), while 18 mothers had received neither EDA nor OT stimulation during labour (control group). A skin temperature electrode was attached between the newborn's shoulder blades. The newborn was placed skin-to-skin on the mother's chest and covered with a blanket. The temperature was recorded immediately after the newborn was put on the mother's chest and at 5, 10, 20 and 30 min. RESULTS: The temperature measured when the newborns were put skin-to-skin on their mothers' chest was significantly higher in the infants of the EDA group (35.07 degrees C) when compared to the control group (34.19 degrees C, p=0.025). Skin temperature increased significantly (p=0.001) during the entire experimental period in the infants belonging to the control group. The same response was observed in infants whose mothers received OT intravenously during labour (p=0.008). No such rise was observed in infants whose mothers were given an EDA during labour. CONCLUSION: The results show that the skin temperature in newborns rises when newborns are put skin-to-skin to breastfeed two days postpartum. This effect on temperature may be hampered by medical interventions during labour such as EDA.

Adult↗
PubMed2006

Predictors of treatment response in patients with non-erosive reflux disease.

BACKGROUND: Up to 40% of patients with non-erosive reflux disease (NERD) fail to respond to proton pump inhibitor therapy. AIM: To determine useful prognostic factors for response to and suppression in NERD. METHODS: A pooled analysis from three multicentre, double-blind trials of patients with a normal endoscopy and heartburn for 4 days or more during the 7 days prior to the start of each treatment. Patients received omeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg/day for 4 weeks. Complete resolution of heartburn was defined as no heartburn during the last week. RESULTS: Of 2458 patients included, complete heartburn resolution was achieved in 63% at the end of 4 weeks treatment. Response on days 5-7 provided an 85% probability of complete resolution of heartburn at 4 weeks; the probability of complete heartburn resolution at 4 weeks in those with moderate to severe symptoms on days 5-7 was 22%. Sensitivity and specificity of no heartburn on days 5-7 was 55% and 83% respectively. Patient demographics, duration of symptoms, medications used, other symptoms and body mass index were not predictors. CONCLUSION: Assessment of heartburn resolution during the first week of therapy was the best predictor of treatment success at 4 weeks in non-erosive reflux disease, but was suboptimal as a test.

Adolescent↗
PubMed2006

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.

Antacids↗
PubMed2006

Long-term management of patients with symptoms of gastro-oesophageal reflux disease -- a Norwegian randomised prospective study comparing the effects of esomeprazole and ranitidine treatment strategies on health-related quality of life in a general practitioners setting.

This article reports quality of life (QoL) aspects of a study that investigated the efficacy of three treatment regimens in gastro-oesophageal reflux disease patients. Following a 4-week symptom-control phase (esomeprazole 40 mg once daily), patients were randomised to 6 months' esomeprazole 20 mg once daily continuously (n = 658), on-demand (n = 634) or ranitidine 150 mg twice daily continuously (n = 610). Esomeprazole 40 mg once daily improved QoL during the symptom-control phase. At 6 months, both esomeprazole regimens were more effective than ranitidine in all dimensions of the Quality of Life in Reflux and Dyspepsia questionnaire (p < 0.0001). Esomeprazole continuous and on-demand led to a significant improvement in symptoms (Overall Treatment Evaluation questionnaire) compared with ranitidine (continuous: 80.2%, on-demand: 77.8%, vs. ranitidine 47.0%; p < 0.001). Esomeprazole once daily continuously maintained QoL better than esomeprazole on-demand and was associated with greater patient satisfaction. In conclusion, esomeprazole 20 mg once daily continuously and on-demand were more effective than ranitidine continuously for maintaining QoL.

Adolescent↗
PubMed2006

Quality of life following liposuction and conservative treatment of arm lymphedema.

Arm lymphedema can produce an additional burden from a psychosocial point of view. Although edema reduction through treatment can be an advantage in terms of reduced weight of the arm and simplified clothing needs, the purpose of the present study was to register changes in psychosocial parameters during one year after treatment. Thirty-five patients underwent liposuction combined with postoperative CCT (Controlled Compression Therapy), while 14 received CCT alone. Edema volume and range of motion in the shoulder joint were measured and effects on quality of life were assessed with various questionnaires. Liposuction+CCT removed the arm lymphedema completely, whereas CCT alone reduced it by half. The treatments improved range of motion in the shoulder joint and patients' quality of life in relationship to the volume reduction. Liposuction+CCT improves patients' quality of life, particularly qualities related to the volume reduction and hence qualities associated with everyday activities. CCT is beneficial too, but the effect is less obvious than when combined with surgery, probably because the edema reduction is less. The consequences of arm lymphedema for more psychologically oriented qualities and social life in general seem to be less serious and we found few notable effects of treatment in these domains.

Aged↗
PubMed2005

Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease.

BACKGROUND: Quality of life has been assessed in a large, multicentre randomized, open label study. AIM: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. METHODS: Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II-IV oesophagitis according to Savary-Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. RESULTS: A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%). CONCLUSIONS: Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy.

Acute Disease↗
PubMed2005

[Psychometric validation of translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) in patients with gastroesophageal reflux disease].

INTRODUCTION: Pyrosis symptoms and their impact on the quality of life related with health (QLRH) are frequently evaluated in clinical trials. When a questionnaire is translated into a language other than the original, it is necessary to have a linguistic validation, although this is not sufficient unless the psychometric characteristics have been verified. This study aims to document the psychometric characteristics of the translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD). MATERIAL AND METHOD: One hundred fifty eight patients with pyrosis symptoms (age: 51.0; SD: 16.3 years; men: 42.4%) completed the translation to Spanish of the GSRS, the pyrosis version of the QOLRAD, the Short-Form-36 (SF-36) and the hospital of anxiety and depression (HAD) scale. Seventy six patients were given an appointment for a second visit after one week, to fill out the GSRS and QOLRAD again. RESULTS: The reliability of the internal consistence of the GSRS was 0.59-0.83 and that of the QOLRAD: 0.87-0.95, and test-retest reliability of the GSRS was 0.44-0.63 and QOLRAD: 0.77-0.85. Score of the important domains of the GSRS "reflux", "abdominal pain" and "indigestion" and above all those of the QOLRAD correlated significantly. The domain "abdominal pain" of the GSRS had a strong correlation (negative) with the relevant domains of the SF-36. The QOLRAD domains significantly correlated with all the related domains of the SF-36. CONCLUSIONS: The psychometric characteristics of the translation to Spanish of the GSRS and QOLRAD were good, with satisfactory reliability and validity. However, the test-retest reliability of the "reflux" domain of the GSRS was not optimum.

Adult↗
PubMed2004

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.

Adolescent↗
PubMed2004

The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-specific anxiety scale.

BACKGROUND: Anxiety related to gastrointestinal sensations, symptoms or the contexts in which these may occur is thought to play a significant role in the pathophysiology as well as in the health outcomes of patients with irritable bowel syndrome. AIM: To develop a valid and reliable psychometric instrument that measures gastrointestinal symptom-specific anxiety. METHODS: External and internal expert panels as well as a patient focus group evaluated a large pool of potential item stems gathered from the psychological and gastrointestinal literature. Potential scale items were then administered to 96 patients diagnosed with irritable bowel syndrome along with a set of validating questionnaires. Final item selection was based upon rigorous empirical criteria and the psychometric properties of the final scale were examined. RESULTS: A final unidimensional 15-item scale, the Visceral Sensitivity Index, demonstrated excellent reliability as well as good content, convergent, divergent and predictive validity. CONCLUSIONS: The findings suggest that the Visceral Sensitivity Index is a reliable, valid measure of gastrointestinal symptom-specific anxiety that may be useful for clinical assessment, treatment outcome studies, and mechanistic studies of the role of symptom-related anxiety in patients with irritable bowel syndrome.

Adult↗
PubMed2004

[Burden of gastroesophageal reflux disease. Evidence from a recent methodological study in Spain].

INTRODUCTION: The clinical and socioeconomic burden of gastroesophageal reflux disease (GERD) is considerable. AIM: The aim of this study was to describe the impact of heartburn on patients' health-related quality of life (HRQL) in Spain, using validated generic and disease-specific instruments to measure patient-reported outcomes. PATIENTS AND METHODS: Patients with symptoms of heartburn completed the Spanish versions of the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), the Short Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. The frequency and severity of heartburn in the previous 7 days were also recorded. RESULTS: One hundred fifty-eight patients completed the assessments (mean age: 51 years, SD = 16; 58% female). Sixty-one percent of the patients had moderate symptoms and 73% had symptoms on three or more days in the previous week. Patients were most bothered by symptoms of reflux (mean GSRS score of 3.8 on a scale of 1 [not bothered] to 7 [very bothered]), abdominal pain (3.1) and indigestion (3.1). As a result of their symptoms, patients experienced problems with food and drink (mean QOLRAD score of 4.5 on a scale of 1 to 7, where 1 represents the most severe impact on daily functioning), impaired vitality (4.7) and emotional distress (4.8). This led to impaired overall HRQL across all domains (mean SF-36 score of this heartburn population compared with a general population in Spain). The HAD scale showed that 28% of patients were anxious and 13% were depressed. CONCLUSION: There is consistent evidence that GERD substantially impairs all aspects of HRQL.

Adult↗
PubMed2004

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.

Aged↗
PubMed2004

Validation of the translation and cross-cultural adaptation into Finnish of the Abdominal Symptom Questionnaire, the Hospital Anxiety and Depression Scale and the Complaint Score Questionnaire.

BACKGROUND: Epidemiological surveys require questionnaires to be validated in the native language of the participants. The aim of this study was to validate the Finnish translations of the Abdominal Symptom Questionnaire (ASQ), the Hospital Anxiety and Depression Scale (HAD) and the Complaint Score Questionnaire (CSQ). METHODS: A random sample of adults (n = 3000) in a northern Swedish bilingual district was surveyed using a mailed ASQ offered in both SwedIsh and Finnish, and 2122 responded (239 in Finnish). A random subsample of the responders (n = 1001, 123 preferring Finish) was then surveyed once more using the ASQ, the HAD and the CSQ. The first 50 responders of the latter survey were then given the three questionnaires again within two weeks. The Finnish versions had been put through a comprehensive translation procedure RESULTS: A factor analysis comparison between the responders using either language in the mailed survey gave a comparable factor construction, and this was also comparable with an earlier analysis of the Swedish version. The Finnish responses to the second survey were further evaluated by testing internal consistency reliability, convergent validity towards previously validated relevant instruments (ShortForm-36 and the Gastrointestinal Symptom Rating Scale) and the test/re-test accuracy of the three questionnaires. These were found to be reliable, as was the correlation between the ASQ and the CSQ, for relevant domains. CONCLUSION: The Finnish translations of the ASQ, HAD and CSQ questionnaires all seem to be robust and usable for population-based surveys among Finnish adults.

Acculturation↗
PubMed2003

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.

Female↗
PubMed2001

Relief of symptoms and improvement of health-related quality of life five years after coronary artery bypass graft in women and men.

BACKGROUND: Severe coronary artery disease can be successfully treated with coronary artery bypass graft (CABG), with considerable improvement in the symptoms of angina pectoris. Approximately three of four patients are free of ischemic events for 5 years; however, increased survival is demonstrated only in selected subgroups with advanced coronary artery disease, and this effect has not been established in elderly patients. HYPOTHESIS: The study was undertaken to determine the relief of symptoms and improvement in other aspects of health-related quality of life (QoL) during 5 years after CABG in women and men. METHODS: Patients who underwent CABG in western Sweden were approached prior to and 5 years after surgery. Health-related QoL was estimated with Physical Activity Score (PAS), Nottingham Health Profile, and Psychological General Well-Being Index. RESULTS: Women (n = 381) had a 5-year mortality of 17% compared with 13% for men (n = 1,619; NS). After 5 years, 1,719 patients (survivors) were available for the survey; of these, 876 (51%) answered the inquiry both prior to and after 5 years. Both women and men improved markedly and highly significantly, both with respect to symptoms and other aspects of health-related QoL. Women suffered more than men in terms of limitation of physical activity, dyspnea, chest pain, and others aspects of health-related QoL. There was a significant interaction between time and gender, with more improvement in men with regard to chest pain when walking uphill or quickly on level ground, when walking on level ground at the speed of other persons their own age, when under stress, and in windy and cold weather. For those parameters as well as for PAS, improvement was more marked in men than in women. In the other aspects of health-related QoL, there was no interaction between time and gender. CONCLUSION: Five years after CABG, limitation of physical activity, symptoms of dyspnea, and chest pain were reduced, and various aspects of health-related QoL had improved in both women and men. In general, women suffered more than men both prior to and after CABG; however, in some aspects the improvement was more pronounced in men. Because of the limited response rate, the results may not be applicable to a nonselected population who had undergone CABG.

Coronary Artery Bypass↗
PubMed2001

Health-related quality of life in patients with adolescent idiopathic scoliosis: a matched follow-up at least 20 years after treatment with brace or surgery.

No results on long-term outcome in terms of health-related quality of life (HRQL) have previously been presented for patients treated for adolescent idiopathic scoliosis. A consecutive series of patients with adolescent idiopathic scoliosis, treated between 1968 and 1977 before the age of 21, either with distraction and fusion using Harrington rods [surgical treatment group (ST), n=156; 145 females and 11 males] or with a brace [brace treatment group (BT), n=127; 122 females and 5 males] were followed at least 20 years after completion of the treatment. Ninety-four percent of ST and 91% of BT patients filled in a questionnaire comprising the SF-36, Psychological General Well-Being Index (PGWB), Oswestry Disability Back Pain Questionnaire, parts of SRS/MODEM'S questionnaire and study-specific questions concerning the treatment, as a part of an unbiased personal follow-up examination including radiography and clinical examination. An age- and sex-matched control group of 100 persons was randomly selected and subjected to the same examinations. The results showed no differences in terms of sociodemographic data between the groups. Both ST and BT patients had a slightly, but significantly, reduced physical function using the SF-36 subscales, SF-36/Physical Component Summary (PCS) score as well as the Oswestry Disability Back Pain Questionnaire compared to the controls. Neither the mental subscales and the Mental Component Summary (MCS) score of SF-36 nor the PGWB index showed any significant difference between the groups. Forty-nine percent of ST, 34% of BT and 15% of controls admitted limitation of social activities due to their back [P<0.001 ST vs controls, P=0.0010 BT vs controls, and n.s. (P=0.024) ST vs BT], mostly due to difficulties with physical participation in activities or self-consciousness about appearance. Pain was a minor reason for limitation. No correlation was found between the outcome scores and curve size after treatment, curve type, total treatment time or age at completed treatment. Patients treated for adolescent idiopathic scoliosis were found to have approximately the same HRQL as the general population. A minority of the patients (4%) had a severely decreased psychological well-being, and a few (1.5%) were severely physically disabled due to the back.

Adolescent↗
PubMed2001

Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease.

BACKGROUND: The efficacy of antireflux surgery (ARS) and proton pump inhibitor therapy in the control of gastroesophageal reflux disease is well established. A direct comparison between these therapies is warranted to assess the benefits of respective therapies. STUDY DESIGN: There were 310 patients with erosive esophagitis enrolled in the trial. There were 155 patients randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. Because of various withdrawals during the study course, 122 patients originally having an antireflux operation completed the 5-year followup; the corresponding figure in the omeprazole group was 133. Symptoms, endoscopy, and quality-of-life questionnaires were used to document clinical outcomes. Treatment failure was defined to occur if at least one of the following criteria were fulfilled: Moderate or severe heartburn or acid regurgitation during the last 7 days before the respective visit; Esophagitis of at least grade 2; Moderate or severe dysphagia or odynophagia symptoms reported in combination with mild heartburn or regurgitation; If randomized to surgery and subsequently required omeprazole for more than 8 weeks to control symptoms, or having a reoperation; If randomized to omeprazole and considered by the responsible physician to require antireflux surgery to control symptoms; If randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the course of the study. Treatment failure was the primary outcomes variable. RESULTS: When the time to treatment failure was analyzed by use of the intention to treat approach, applying the life table analysis technique, a highly significant difference between the two strategies was revealed (p < 0.001), with more treatment failures in patients who originally were randomized to omeprazole treatment. The protocol also allowed dose adjustment in patients allocated to omeprazole therapy to either 40 or 60 mg daily in case of symptom recurrence. The curves subsequently describing the failure rates still remained separated in favor of surgery, although the difference did not reach statistical significance (p = 0.088). Quality of life assessment revealed values within normal ranges in both therapy arms during the 5 years. CONCLUSIONS: In this randomized multicenter trial with a 5-year followup, we found antireflux surgery to be more effective than omeprazole in controlling gastroesophageal reflux disease as measured by the treatment failure rates. But if the dose of omeprazole was adjusted in case of relapse, the two therapeutic strategies reached levels of efficacy that were not statistically different.

Aged↗
PubMed2001

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 QOLRAD's 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.

Dyspepsia↗