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Reporting of gender-related information in clinical trials of drug therapy for myocardial infarction.

BACKGROUND: Concern has been expressed that women are not adequately represented in clinical trials evaluating treatments for medical conditions they commonly experience. This study was designed to assess the reporting of data on women in recently published trials of drug therapy for myocardial infarction, including those funded by an agency with a gender-related policy. METHODS: All randomized controlled trials and meta-analyses of drug therapies for myocardial infarction published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, the Annals of Internal Medicine and the British Medical Journal from January 1992 to December 1996 were evaluated. On preliminary review 102 articles met the inclusion criteria; these were reviewed in detail, and 59 were excluded. Two reviewers independently extracted gender-related information from the 43 articles; discrepancies were resolved by consensus. RESULTS: Women presented up to 48% of the trial participants (mean 24.1%). In the trials funded by an agency with a gender-related policy, only 16.8% of participants, on average, were women. Of the 43 articles in the sample, only 14 (32%) provided gender-related results. Funding from an agency with gender-related policy did not affect the reporting of gender-related information. Subgroup analyses were provided for 14 (32%) of the 43 trials, including 2 (29%) of 7 trials funded by an agency with a gender-related policy. Of the 12 trials that included interaction analyses (excluding the 2 trials in which secondary analyses were conducted specifically to identify differences between women and men), 7 (58%) conducted an interaction analysis to determine if women responded differently than men; for one of these the interaction analysis was for a secondary outcome measure (drug safety). Only 5 (12%) of the 43 articles mentioned the differences between men and women in the Discussion section; 2 of these were studies that used secondary analyses to examine sex differences. Of the 5, only 1 was funded by an agency with a gender-related policy. INTERPRETATION: Women were poorly represented in the randomized controlled trials in this sample, regardless of whether the trials were funded by an agency with a gender-related policy. Structured reporting of gender-related information for clinical trials may improve the quality of information available about women and therefore facilitate the application of research findings to the care of women.

Angiotensin-Converting Enzyme Inhibitors↗

Relations of serum aldosterone to cardiac structure: gender-related differences in the Framingham Heart Study.

Aldosterone is associated with myocardial fibrosis in experimental studies and with left ventricular remodeling in heart failure patients. We hypothesized that aldosterone influences ventricular remodeling in people without congestive heart failure in the community. We examined the relations between serum aldosterone and echocardiographic left ventricular measurements in 2820 Framingham Study subjects (mean age 57 years, 58% women, 88% white) free of myocardial infarction and overt heart failure. Serum aldosterone levels were higher in women compared with men. In linear regression models (adjusted for age, systolic blood pressure, weight, height, diabetes, heart rate, hypertension treatment, and ethnicity), left ventricular wall thickness and relative wall thickness were positively related, and left ventricular diastolic dimensions were inversely related to serum aldosterone in women (P<0.05 for all), but not in men (P>0.20 for all). There was no effect modification of the relations observed in women by menopausal status. The gender-related differences in relations of serum aldosterone to relative wall thickness were consistent across subgroups defined on the basis of sex-specific median values of systolic blood pressure and body mass index. Fractional shortening, left ventricular mass, and left atrial dimensions were not related to serum aldosterone in either sex. In conclusion, in our community-based sample of individuals free of myocardial infarction and heart failure, serum aldosterone was positively associated with a left ventricular geometric pattern suggestive of concentric remodeling (increased left ventricular wall thickness and relative wall thickness but decreased internal dimensions) in women but not in men. Additional investigations are warranted to confirm these findings.

Aged↗

Gender-related differences in reperfusion treatment allocation and outcome for acute myocardial infarction.

Gender-related differences in outcome after myocardial infarction may relate to biased treatment allocation. To address this concern we analyzed 573 patients presenting with ST-segment elevation acute myocardial infarction (AMI), and treated within 6 hours with reperfusion therapy. Two-hundred eighty patients (49%) received direct coronary angioplasty, whereas 293 (51%) received thrombolytics followed by angioplasty (p = NS). Seventy-four percent were men and 26% were women (p = NS for differences in sex distribution between the 2 treatment groups). Women were older in both groups (p < 0.01). Inferior AMI was seen more often in women (64% of direct angioplasty, 71% of lytic first) than in men (51% and 59%, respectively; p < 0.03). There was no gender-related differences in presence of multivessel coronary artery disease, prior AMI, prior bypass surgery, baseline ejection fraction, percentage of patients with ejection fraction < or = 40%, number of narrowings dilated, or angioplasty success. Patients who underwent direct angioplasty had more multivessel disease (p < 0.001) and prior coronary artery bypass surgery (p = 0.002). After a mean follow-up of 129 +/- 113 weeks, no gender-related differences were seen in the need for cardiac catheterization, documented restenosis, AMI, coronary artery bypass surgery, clinical ischemia, or death. Patients treated with direct angioplasty were more likely to undergo coronary artery bypass surgery (p < 0.05) or to die (p < 0.01). Thus, women undergoing reperfusion therapy for ST-segment elevation were older than men, with a higher frequency of inferior wall AMI. No specific gender-related bias in treatment allocation was evident.

Aged↗

Gender-related differences in scores of the Barthel Index and Frenchay activities index in randomly sampled elderly persons living at home in Japan.

The purpose of this study was to examine for gender-related differences in activities of daily living (ADL) and lifestyle of elderly persons living at home, and to support our hypothesis that the gender-related difference in lifestyle of stroke patients derives from their lifestyle prior to the stroke. Participants were randomly sampled elderly persons living at home. Questionnaire sheets including subject profile, Self-Rating Barthel Index (disability index), and Self-Rating Frenchay Activities Index (activity index) were mailed and collected, and the data were analyzed with the t-test and General Linear Model (factorial model with interaction). A total of 752 subjects were recruited, and their average age was 67.1 years. No significant gender-related differences were evident in the disability index including self-care and mobility domains (t-test, P > 0.05). In contrast gender-related differences in the activity index were significant (t-test, P < 0.05) for three factors; gender, age group, and living conditions, and in a covariate disability index (GLM, P < 0.05). Because randomly selected elderly persons in this study exhibited a prominent gender-related difference in lifestyle, we believe the lifestyle difference in stroke patients that we have previously described derives primarily from their premorbid attitude to daily life.

Activities of Daily Living↗

Performance factors and gender-related differences in spatial ability: another assessment.

To explore whether test-taking styles (performance factors) can contribute to explaining gender-related differences on tests of spatial ability, 15 spatial tests were administered to three samples of subjects. On each test, number-correct scores and ratio scores (number of items solved divided by the number of items attempted) were computed. In accordance with previous research findings, the use of ratio scores significantly reduced the magnitude of the gender-related differences on the Mental Rotations Test. For most of the remaining tests, however, the reduction of the gender-related score difference was small. It was concluded that the difference reduction for the Mental Rotations Test was specific to the format of this test. In common spatial tests, performance factors may account for a small portion of gender-related variance, but the bulk of this variance must be attributed to other factors.

Adolescent↗

Tobramycin gender-related nephrotoxicity in Fischer but not Sprague-Dawley rats.

Published reports suggest a gender-related difference in susceptibility to the nephrotoxicity of gentamicin which may also be strain-related in rats. However, certain ambiguities exist in the results obtained with the functional and morphologic determinants of nephrotoxicity used in these studies. Within the same experimental protocol we examined the potential gender-related differences in tobramycin nephrotoxicity in age-matched male and female rats of both the Sprague-Dawley (SD) and Fischer (F344) strains. Equal numbers of both genders were dosed at 30 mg/kg (F344) and 90 mg/kg (SD) twice daily for 9 days. Results of BUN, serum creatinine, whole body weight change and histologic score comparisons (P < 0.05) indicate that male F344 rats are more sensitive to tobramycin nephrotoxicity than F344 females but this gender-related susceptibility was not observed in SD rats.

Animals↗

Age- and gender-related changes in ligament components.

The age- and gender-related changes in extracellular matrix components (elastin, elastin cross-links, fibrillin, collagen and glycoprotein) and mineral components (calcium, Ca; phosphorus, P) in human lumbar yellow ligaments were investigated using samples obtained from surgical specimens. The mineral (Ca and P) contents increased with ageing (r = 0.703 and r = 0.772, respectively), whereas the contents of matrix components tended to decrease with ageing (elastin r = -0.261, elastin cross-links r = -0.213, fibrillin r = 0.494; collagen r = -0.322 and glycoprotein r = -0.143). Comparison of the male and female groups revealed that the ligament elastin content and elastin cross-links decreased in the male group, whereas the ligament collagen content decreased in the female group significantly in an age-dependent manner (r = -0.788, r = -0.753 and r = -0.721, respectively). These findings demonstrate age- and gender-related changes in mineral and matrix components (especially elastin and collagen) in the lumbar yellow ligaments in the Japanese population. It is suggested that elastin and collagen metabolism in ligaments changes both with age and according to gender.

Adult↗

Gender-related personal attributes and psychological adjustment among U.S. Army soldiers.

Personality characteristics associated with successful adaptation to military life are often described in gender-related terms. However, valid, reliable measures of gender-related personality characteristics have not been established for military populations. The purpose of this study was to validate an instrument for measuring gender-related personality characteristics in an active duty population. The Extended Personal Attributes Questionnaire was administered to 1,060 male soldiers and 305 female soldiers in U.S. Army support units. Results of a factor analysis indicated that there are three separate factors. The first denotes negatively valued aggressive traits (Negative Masculinity), the second denotes negatively valued passive traits (Negative Femininity), and the third combines positive instrumental and positive expressive traits, referred to as the Combined factor. Although positive instrumental traits (referred to as Masculinity) were related to fewer psychological symptoms, Negative Masculinity and Negative Femininity were associated with increased psychological symptoms. Positive expressive traits (referred to as Femininity) were unrelated to psychological symptoms.

Adaptation, Psychological↗

Long-term effects of childhood maltreatment history on gender-related personality characteristics.

OBJECTIVE: The aim of the study was to test the hypothesis that different types of gender-related personality attributes are associated with a past history of different types of childhood maltreatment. METHOD: A survey was administered to 1,060 male soldiers and 305 female soldiers in the U.S. Army. The survey instrument included the Extended Personal Attributes Questionnaire (EPAQ) which is a self-assessment instrument of personality characteristics associated with gender, and includes measures of positive masculinity (self-assertive/instrumental traits), positive femininity (expressive/interpersonal traits), negative masculinity (hyper masculine/macho traits), and negative femininity (subordination of self to others). The survey instrument also included the Childhood Trauma Questionnaire (CTQ), which contains scales measuring sexual abuse, physical-emotional abuse, physical neglect, and emotional neglect, and four questions on childhood sexual abuse developed for a national survey of U.S. adults. RESULTS: Negative masculinity was predicted by male gender, younger age, and childhood physical-emotional abuse. Negative femininity was predicted by physical-emotional abuse and sexual abuse. The relationship to sexual abuse was mainly evident for males. Positive femininity was positively correlated with sexual abuse for females and negatively correlated with sexual abuse for males. Positive masculinity was negatively correlated with emotional neglect for males but not for females. Positive femininity was negatively correlated with emotional neglect for both genders. CONCLUSIONS: Childhood abuse was associated with the presence of negative gender-related attributes; childhood neglect was associated with absence of positive gender-related attributes. Childhood physical abuse was associated with negative masculine attributes in both genders. Childhood sexual abuse was associated with positive feminine attributes in females, and negative feminine attributes in males. The finding for females is counterintuitive, and is discussed in the light of the clinical literature on certain types of adaptation to incest.

Adult↗

Gender-related differences of ventricular repolarization in LQT2 rabbit model.

To explore the cellular mechanism responsible for the gender-related differences of ventricular tachyarrhythmias in long QT syndromes (LQTS), we observed the characteristics of pre-existing electrophysiological heterogeneity and dynamics of ventricular repolarization in different gender of LQT2 rabbit models. The intracellular floating microelectrodes technique was used to record transmembrane action potentials simultaneously from epicardial and endocardial sites of the arterially perfused rabbit left ventricular wedge preparation; in the mean time, the electrocardiogram (ECG) was also recorded. The wedge preparations were placed in a small tissue bath and arterially perfused with normal Tyrode's solution (control group), 100 mumol/L dl-sotalol Tyrode's solution (LQT2 model group), and 100 mumol/L dl-sotalol plus 3.0 mmol/L KCl Tyrode's solution (LQT2 model plus hypokalemia group), buffered with 95% O2 and 5% CO2 [(36.0+/-1) degrees C]. Double diastolic threshold currents were delivered with basic cycle length (BCL) 2 000, 1 000 and 500 ms (S1), respectively, to record transmembrane action potentials and transmural ECG. Each driving train of S1 is with 20 beats. To determine action potential duration restitution (APDR) curves, the S1-S2 programmed stimuli were used. The tissue was paced at 1 000 ms and 500 ms cycle length (S1) for eight beats, followed by a single premature stimulus (S2). The S1-S2 coupling interval was progressively shortened with 10 ms decrements until the S2 failed to capture. The results showed that female rabbits exhibited significantly longer transmural dispersion of repolarization (TDR) and steeper maximal slopes of APDR curves than that in male rabbits at same pacing rates (P<0.05), and which were pacing rate-dependent. In the condition of dl-sotalol plus hypokalemia, the TDR and the maximal slopes of APDR curves were significantly increased in comparison with that in the control group (P<0.01). At a BCL of 1 000 ms of seven experiments, one female showed torsade de pointes (TdP) in the LQT2 model group; five females and two males showed TdP in LQT2 model plus hypokalemia group, showing significant gender-related differences (P<0.05). The present findings suggest that the pre-existing electrophysiological and dynamic heterogeneity in the LQT2 model shows an obvious gender-related difference and pacing rate-dependence. Both increased TDR and steepness of APDR in female rabbits are possibly the major factors which prompt the TdP generation in female LQT2 rabbits more easily than in male rabbits.

Action Potentials↗

Social identification and gender-related ideology in women and men.

The nature of women's and men's gender-derived social identification was examined with a focus on the relationships between aspects of identity and gender-related ideology. Measures of social identification, sex-role ideology, and the perception of women's collective disadvantage were completed by 171 women and 91 men who categorized themselves as either traditional, non-traditional or feminist. Factor analysis provided support for a multidimensional conception of gender-derived social identification, with viable subscales reflecting in-group ties, cognitive centrality, and in-group affect. For self-identified non-traditional and feminist women, the cognitive centrality of gender was greater, and more consistently related to gender-related ideology, than for traditional women. Traditional men reported stronger in-group ties and more positive gender-linked affect than did non-traditional men, but men's levels of identification were generally weakly related to gender-related ideology. The utility of considering both multiple dimensions and ideological correlates of group identification is discussed with reference to social identity theory.

Adult↗

Gender-related therapist attributions in couples therapy: a preliminary multiple case study investigation.

Differential treatment by gender has been an ongoing area of concern and uncertainty both in society at large and in clinical research. In this investigation, therapist attributions over the course of therapy for three different couples were coded and analyzed to determine if cause for positive and negative events was assigned differentially to females and males. Additionally, the stability and globality dimensions of the therapist's attributions about the couples were examined for stereotypical gender-related patterns. Results indicate no gender differences in locus of causal attributions but some gender-related patterns in stability and globality dimensions. Implications for both couples therapy and gender bias in couples research are discussed.

Adult↗

Gender-related differences in polyamine oxidase activity in rat tissues.

Variations in level of polyamines and their related enzymes are frequently observed in response to some treatments which affect in a different way male and female. The possibility of a gender-related difference in the oxidation of polyamines was investigated in rats by measuring the activity of polyamine oxidase, a ubiquitous enzyme of vertebrate tissues, which transforms spermine into spermidine and spermidine into putrescine. The study was carried out on thymus, spleen, kidney and liver of young rats of both sexes, and female rats showed a lower polyamine oxidase activity than male rats in all the tissues. We also found higher values of spermidine acetylation in female than male rats in thymus and liver. Owing to these gender-related differences, a higher spermidine N-acetyltransferase/polyamine oxidase ratio was found in female than in male rats. A second gender-related difference was a higher spermidine/spermine ratio in female than in male, the only exception being the thymus. These basal differences possibly account for the gender-related differences of polyamine metabolic enzyme activities in response to some treatments, including drugs or hormones.

Acetyltransferases↗

Gender-related clinical differences in older patients with schizophrenia.

BACKGROUND: Gender differences in the clinical presentation of young patients with schizophrenia have been well-documented, yet few studies have investigated gender-related clinical differences in older patients. Furthermore, the symptoms of late-onset schizophrenia have been described, but the interaction between gender and age at onset has not been examined. METHOD: In an older (46-85 years of age) outpatient sample, we assessed clinical characteristics of women and men with early-onset schizophrenia (N = 90) and late-onset schizophrenia (N = 34). Subjects did not differ with respect to age, education, ethnicity, severity of depression, daily neuroleptic dosage, subtype of schizophrenia, total score on the Mini-Mental State Examination, or severity of overall psychopathology. Diagnosis was made using the Structured Clinical Interview for the DSM-III-R or DSM-IV. RESULTS: A significantly greater proportion of women had late-onset schizophrenia (41% vs. 20%), and women overall had more severe positive psychotic symptoms. Although there was no overall gender difference in severity of negative psychotic symptoms, women with late onset had significantly less severe negative symptoms than men with early onset, men with late onset, and women with early onset. Furthermore, age at onset of schizophrenia was inversely correlated with severity of negative symptoms for women, but not for men. These results indicate that women overall may develop more severe positive symptoms than men, and that when women develop schizophrenia after age 45, they may suffer less severe negative symptoms than men or than women with earlier onset. Our results suggest that some of the clinical differences between late-onset and early-onset schizophrenia may relate to gender effects, and that there may be inherent differences in the clinical presentation of schizophrenia that are related to gender and gender by age at onset interactions. CONCLUSION: These differences may reflect the influence of sex hormones and menopause on the clinical presentation of schizophrenia or the possible existence of an "estrogen-related" form of schizophrenia in women with late-onset schizophrenia.

Adult↗

Champagne, beer, or coffee? A corpus of gender-related and neutral words.

A list of gender-related and gender-neutral words for use in testing gender stereotyping and memory was created and evaluated. Words were rated by samples of undergraduates at universities located in the northeast, southeast, and south-central United States. A substantial list of masculine, feminine, and gender-neutral words was identified. These lists allow researchers to construct large lists of gender-associated words while being able to control for extraneous variables, such as word frequency and word length. In addition, the high reliability across the samples suggests that gender ratings are a fairly stable phenomenon. Applications for this list are discussed. The word lists presented in Tables 1-3 and the raw data analyzed in this article may be downloaded from www.psychonomic.org/archive/.

Association↗

Review article: gender-related differences in functional gastrointestinal disorders.

Many functional gastrointestinal disorders and other chronic visceral pain disorders such as interstitial cystitis and chronic pelvic pain are more common in women than in men. In irritable bowel syndrome (IBS) there is a 2:1 female to male ratio in prevalence of symptoms in community samples. Female irritable bowel syndrome patients are more likely to be constipated, complain of abdominal distension and of certain extracolonic symptoms. While animal studies have clearly demonstrated gender-related differences in pain perception and antinociceptive mechanisms, unequivocal evidence for gender-related differences in human pain perception or modulation has only been provided recently. Gender-related differences may be related to constant differences in the physiology of pain perception, such as structural or functional differences in the visceral afferent pathways involved in pain transmission or modulation, and/or they may be related to fluctuations in female sex hormones. Preliminary evidence suggests that female irritable bowel syndrome patients show specific perceptual alterations in regards to rectosigmoid balloon distension and that they show differences in regional brain activation measured by positron emission tomography. This preliminary evidence suggests that gender-related differences in symptoms and in the perceptual responses to visceral stimuli exist in IBS patients and can be detected using specific stimulation paradigms and neuroimaging techniques.

Animals↗

Age- and gender-related differences in vertebral bone mass, density, and strength.

This study was designed to evaluate age- and gender-related differences in vertebral bone mass, density, and strength by dual-energy X-ray absorptiometry (DXA), quantitative computed tomography (QCT), peripheral QCT (pQCT), ash measurements, and biomechanical testing. The material comprised human lumbar vertebral bodies (L3) from 51 females and 50 males (age-range: 18-96 years). The results showed that females had significantly lower vertebral body bone mass (ash weight) than males at any given age. The decline in bone mass with age was parallel for females and males. The different bone density measurements-cancellous ash density, total vertebral body ash density, DXA bone mineral density, QCT, and pQCT-showed no gender-related difference concerning numeric value or changes with age. Morphometrical measurements showed that females had smaller vertebral bodies (volumes) than males. Hence the females had significantly smaller cross-sectional area (CSA) of L3 than males (11.6 cm2 and 14.4 cm2, respectively). This led to females having lower maximum compressive load (N) than males at all ages, whereas maximum compressive stress (load/CSA) showed no gender-related difference. In conclusion, females have lower vertebral body bone mass than males at any given age, due to smaller vertebral bodies. Hence, maximum compressive load (strength not corrected for size) was lower in females. Vertebral body cancellous bone density and total-vertebral body density were equal when comparing genders, and no gender differences were found in the size-corrected strength: maximum compressive stress. The decrease with age in vertebral body compressive strength decrease was twice as large as the age decrease in density.

Absorptiometry, Photon↗

The mysteries of the diagonal: gender-related perceptual asymmetries.

In this article, we report a perceptual asymmetry for the two diagonals that is related to gender in that females prefer the diagonal spanning from top right to bottom left (/) whereas males prefer the opposite (\). This relationship is observed in a variety of tasks, including aesthetic judgment of paintings, spotting differences between two paintings, and visual search for a tilted line among similarly tilted distractors. This article does not provide an explanation of the relationship between this asymmetry and gender but rules out several potential mediating factors, such as eye dominance, head tilt, handedness, and hemispheric differences. At the same time, the scope of the phenomenon is outlined: The asymmetry is found for both meaningful and meaningless stimuli and in both brief and extended presentations. Moreover, the asymmetry is found to be related to the tilt of the visual elements that require processing, not to their location in the visual field.

Choice Behavior↗