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Biomedical subjects

I Wiklund

Publications and source records attributed to I Wiklund.

At least 109 records · Page 6Linked to original sources
PubMed1993

Psychosocial predictors of mortality in the Cardiac Arrhythmia Suppression Trial-1 (CAST-1).

Psychosocial variables predict the recurrence of clinical events in symptomatic patients, controlling for measures of disease severity. The Cardiac Arrhythmia Suppression Trial-1, a pharmacologic test of the arrhythmia suppression and mortality hypothesis among postmyocardial infarction patients, allowed a prospective test of the relationship of distress, perceived support, social interaction, life stress, and other variables, to mortality, adjusting statistically for ejection fraction, arrhythmia rates, and other known risk factors for coronary heart disease. Results indicated that the treatment medications, encainide and flecainide, were powerful predictors of mortality. Although the psychosocial variables were significant as univariate predictors, these variables were not significant as predictors in a multivariate model that included drug treatment. When the data analysis was restricted to patients randomized to placebo, thereby eliminating the antiarrhythmic drug effect, the level of perceived social support was a significant multivariate predictor of mortality, adjusting for measures of disease severity. The adjusted hazards ratio for a 1-point decrease in the perceived support score is equal to 1.46, based on the multivariate model.

Arrhythmias, Cardiac↗
PubMed1993

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.

Cross-Cultural Comparison↗
PubMed1993

Integrating health-related quality of life into cross-national clinical trials.

When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Cross-Cultural Comparison↗
PubMed1993

Quality of life of postmenopausal women on a regimen of transdermal estradiol therapy: a double-blind placebo-controlled study.

OBJECTIVE: The effect of transdermal estradiol and placebo therapy on the quality of life of postmenopausal women was compared in a randomized trial over 12 weeks. STUDY DESIGN: Two hundred forty-two women were randomized, and 223 were analyzed for efficacy (n = 112 for estradiol and n = 111 for placebo). The quality of life was assessed by means of a battery of standard questionnaires. RESULTS: Quality of life improved after both therapies, but health-related quality of life (p = 0.0003) and well being (p = 0.003) improved more after transdermal estradiol therapy than after placebo. This was also the case for all specific climacteric aspects, including sexual problems (p < 0.0001) and dysfunction (p = 0.01), at comparison with placebo. Self-rated symptom relief was more pronounced with estrogen therapy than with placebo (p < 0.0001). CONCLUSION: It was concluded that estradiol therapy was superior to placebo in relieving symptoms and improving quality of life.

Administration, Cutaneous↗
PubMed1993

The influence of urinary incontinence on the quality of life of elderly women.

The quality of life assessed by the Nottingham Health Profile Questionnaire was compared in a group of women (n = 120) suffering from urinary incontinence (age 75.4 +/- 1.9, range 65-84 years) and an age-matched representative sample of the total population (n = 313). There were no significant differences between the two groups of women in occurrence of other illnesses or social characteristics. Women suffering from urinary incontinence obtained higher scores in the domains of emotional disturbances (p < 0.05) and social isolation (p < 0.001) than women from the control group. When subdividing the incontinent women by type of incontinence it was found that women suffering from urge and mixed incontinence reported emotional disturbances (p < 0.05) more than women from the control group. There was, however, no difference within the domain of emotional disturbances between stress-incontinent women and the control group. Women suffering from urge incontinence reported more disturbance of sleep (p < 0.05) than the control group. Women suffering from all types of urinary incontinence (p < 0.05) were socially more isolated than those from the age-matched group of women from the total population. Urinary incontinence in women has a detrimental effect on their daily lives and causes them to avoid social contacts.

Aged↗
PubMed1993

Subjective symptoms and well-being differ in women and men after myocardial infarction.

The frequency of subjective cardiac and psychological complaints among men and women a year after a confirmed diagnosis of myocardial infarction (MI) were compared. Among 660 survivors, 595 patients completed mailed questionnaires at home one year after the MI. There were 421 men, mean age 67.1 +/- 10.7 years, and 174 women, mean age 72.1 +/- 10.6 years. Controlling for the significantly higher mean age among the women, the latter more often had a previous history of angina pectoris, 54.6% (P < or = 0.05) versus 42.9%, and heart failure, 24.7% versus 13.5% (P < or = 0.01). Despite these facts, the women were significantly less often referred to CCU, 82.2% versus 91.7% (P < or = 0.05). One year after the MI, controlling for differences in age and co-morbidity, women reported significantly higher frequencies of psychological and psychosomatic complaints, including sleep disturbances. These differences may have clinical implications for diagnosis and treatment of women with coronary heart disease.

Adult↗
PubMed1993

Transdermally administered oestradiol combined with oral medroxyprogesterone acetate: the effects on lipoprotein metabolism in postmenopausal women.

OBJECTIVE: To investigate the effects of two doses of transdermally applied oestradiol on lipid and lipoprotein metabolism in climacteric women. DESIGN: A randomised double blind cross-over comparison. SETTING: Departments of Obstetrics and Gynaecology, Ostra and Sahlgren's Hospital, Göteborg and Karolinska Hospital, Stockholm, Sweden. SUBJECTS: Fifty-two women with climacteric symptoms were treated with oestradiol transdermally applied (50 micrograms and 100 micrograms/24 h). A daily dose of 5 mg oral medroxyprogesterone acetate was added 14 days each treatment cycle of four weeks. INTERVENTIONS: Blood samples were drawn after an overnight fast before and after four and eight months of treatment. MAIN OUTCOME MEASURES: Assays for serum triglycerides and cholesterol as well as low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol including the subfractions HDL2 and HDL3 were performed. RESULTS: Significant decrements were found in triglycerides and serum and LDL cholesterol during treatment with both doses. A modest rise in HDL2 cholesterol was observed after treatment with the 100 micrograms/24 h dose. CONCLUSIONS: The serum lipid and lipoprotein profile encountered in these women was similar to that reported with oral formulations except for a decrease in triglycerides. The metabolic differences between the two doses of transdermal oestradiol is probably of minor clinical significance in normal postmenopausal women.

Administration, Cutaneous↗
PubMed1993

Can sensory stimulation improve the functional outcome in stroke patients?

After obtaining informed consent, we randomized 78 patients with severe hemiparesis of the left or right side within 10 days of stroke onset: 40 to a control group receiving daily physiotherapy and occupational therapy, and 38 to a group that, in addition, we treated with sensory stimulation (acupuncture) twice a week for 10 weeks. The median age was 76 years for both groups. Motor function, balance, and ADL (Barthel's Index) were assessed before the start of treatment and at 1 and 3 months after stroke onset; ADL was also assessed after 12 months. We assessed the quality of life (QL) using the Nottingham Health Profile 3, 6, and 12 months after stroke onset. Patients given sensory stimulation recovered faster and to a larger extent than the controls, with a significant difference for balance, mobility, ADL, QL, and days spent at hospitals/nursing homes. Whether acupuncture per se is responsible for the differences requires further study.

Activities of Daily Living↗
PubMed1993

A Swedish version of the Women's Health Questionnaire. A measure of postmenopausal complaints.

We wanted to provide details on the psychometric documentation of the Swedish version of the Women's Health Questionnaire (WHQ), a patient based measure of postmenopausal complaints. The results of two clinical trials in Sweden in which the WHQ had been used as one out of several measurement tools were used to document the reliability, the validity and the responsiveness to change of the WHQ. More than 350 women suffering from postmenopausal complaints were included in the two trials. A factor analysis, using the baseline values of all women in each study, showed that the Swedish version of the WHQ was very close to the English original. The internal consistency reliability was excellent. The clinical validity was confirmed by a significant correlation between change in E2 levels and change in the WHQ during estrogen therapy. A high construct validity was established by the agreement between the WHQ and other quality of life scales. For use in clinical trials the WHQ was sensitive to treatment-induced changes, and added important information to the clinical effect variables.

England↗
PubMed1993

Is sexual life influenced by transdermal estrogen therapy? A double blind placebo controlled study in postmenopausal women.

Two hundred and forty-two postmenopausal women between 45 and 65 years of age requiring hormone replacement therapy for climacteric symptoms were blindly and randomly allocated to treatment either with transdermal estradiol therapy (Estraderm 50 micrograms/24h) (E) or placebo (P). The patches were changed twice a week and treatment continued for 12 weeks. No progestogen supplement therapy was given during the study. No previous hormone replacement therapy had been given for the last six months and the women had had their last menstruation more than six months ago. As a part of a larger study assessing women's quality of life, a Swedish version of 'McCoy's Sex Scale Questionnaire' was administered at the start of treatment and after 12 weeks. This questionnaire contains nine items regarding different aspects of sexual life. The difference between the scorings at the start of treatment and after 12 weeks were calculated for each item and the values of the E and the P groups were compared. Items regarding 'satisfaction with frequency of sexual activity, sexual fantasies, degree of enjoyment, vaginal lubrication and pain during intercourse' were positively influenced in the E group compared to the P group. Items not affected were 'frequency of orgasm and sexual arousal'. A correlation between improved sexual life and quality of life was also found when the results from the McCoy scale were compared with a battery of quality of life questionnaires.

Administration, Cutaneous↗
PubMed1993

Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens?

There is growing interest in measuring quality of life (QoL) in medicine. Together with objective variables such as healing rate, as recorded with endoscopy, this is believed to give a better basis for evaluation of treatment regimens in patients with upper gastrointestinal diseases. A strategy for the assessment of QoL in patients with upper gastrointestinal symptoms is presented here. The QoL evaluation was based on a battery of questionnaires, covering both general and specific aspects of life. General well-being was evaluated with the Psychological General Well-being Index (PGWB), and subjective symptoms with two specific questionnaires, the Gastrointestinal Symptom Rating Scale (GSRS) and the Ulcus Esophagitis Subjective Symptoms Scale (UESS). This new strategy was applied clinically in a study including 146 outpatients with suspected peptic ulcer. Initially, the patients reported a low degree of general well-being as evaluated with the PGWB, but the values returned to those found in normal populations within 4 weeks. Evaluation of the GSRS and UESS with regard to internal consistency, construct validity, and the ability to detect changes showed them to be satisfactory. The psychometric documentation of the measures indicates that they may give reliable and clinically valid information when used for evaluation of medical treatments in upper gastrointestinal disease. Further documentation of the methods is, however, needed to establish a generally acceptable QoL assessment in gastroenterology.

Dyspepsia↗
PubMed1992

Acute and long-term effects on myocardial ischemia of intermittent and continuous transdermal nitrate therapy in stable angina.

The aim of this study was to compare the efficacy and safety of continuous and intermittent transdermal nitrate therapy using ambulatory electrocardiographic (Holter) monitoring. Eighty-five patients with stable angina pectoris and positive exercise test results participated during their concomitant antiischemic medication in a randomized open trial lasting 12 weeks. After a 3-week run-in period with continuous therapy (10 mg/24 hours), patients were randomized to either continuous- or intermittent-therapy groups. In the intermittent-therapy group the patients removed their patch at night (the mean patch-off period was 10 hours). Forty-eight-hour Holter monitoring was performed in each patient after randomization, and again after 2 and 12 weeks. Eighteen patients withdrew, 9 in each group. A total of 11,194 hours of electrocardiography were recorded and 607 ischemic episodes were detected, of which 79% were asymptomatic and 95% appeared during daytime. The number of ischemic episodes per 48 hours with intermittent therapy was 3.1 +/- 0.7 (mean +/- SEM) after randomization, 1.8 +/- 0.4 at 2 weeks and 2.0 +/- 0.6 at 12 weeks. With continuous therapy the respective numbers were 3.8 +/- 1.1, 3.5 +/- 0.9 and 4.2 +/- 1.2. The differences were not statistically significant because a large number of patients (30%) had no ischemic episodes on Holter recording. However, when examining 47 patients with episodes during the study, the number of episodes was significantly reduced in the intermittent-therapy group (p less than 0.05 at 12 weeks). The changes in asymptomatic and symptomatic episodes were concordant. No changes and differences between the treatment groups were seen in nighttime episodes.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed1992

A new methodological approach to the evaluation of quality of life in postmenopausal women.

An approach employing a range of standardized questionnaires, which included the Nottingham Health Profile (NHP), the Psychological General Well-Being (PGWB) index and the Mood Adjective Check List (MACL), was used to assess health-related quality of life (QoL) in conjunction with a study comparing two doses of transdermal oestrogen (50 or 100 micrograms/24 h) combined with an oral progestogen (5 mg medroxyprogesterone acetate for 14 days each cycle). In addition to the QoL measures, climacteric symptoms were self-rated and also summarized by means of the Kupperman index. In all, 59 women, median age 52 (39-71) years, who completed 4 months of therapy were evaluated. The use of a battery of standardized questionnaires enabled a comprehensive evaluation to be made of perceived health, well-being and day-to-day functioning. Not only was symptomatic relief, e.g. reduced frequency of sweating episodes, sleep disturbance and hot flushes, observed during treatment, but there were also improvements in terms of sleep, energy and emotions. The frequency of health-related problems associated with paid employment, housework, social life, home life and sex life decreased, indicating enhanced ability to take part in daily activities. The PGWB index showed improvement in the subscales representing well-being, anxiety, depression, vitality, health and self-control, while the mood scales indicated that the women experienced less tension and more satisfaction. Although the results of this study need to be further documented on the basis of a placebo-controlled trial, the findings nevertheless imply that the use of a battery of standardized questionnaires optimizes the possibility of evaluating climacteric complaints reliably before and after treatment.

Administration, Cutaneous↗