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Post Hoc Analysis (post + hoc_analysis)
Selected AbstractsPROGNOSIS OF UPPER GASTROINTESTINAL BLEEDING IN THE OLDEST-OLD PATIENTS: A POST HOC ANALYSIS OF A PROSPECTIVE STUDYJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2010Stéphane Nahon MD No abstract is available for this article. [source] Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal DataPAIN MEDICINE, Issue 8 2010R. Norman Harden MD Abstract Objective., To examine the development of analgesic tolerance in patients on oxymorphone extended-release (OxymER). Design.,Post hoc analysis of data from a previously conducted prospective 1 year multi-center open-label extension study in which patients were able to titrate as needed. Patients., Sample of 153 hip and knee osteoarthritis (OA) subjects on OxymER. Primary analyses were limited to study completers (n = 62) due to the large amount of missing data for the noncompleters (n = 91). Outcome Measures., Main outcome measures included OxymER doses (pill counts) and pain intensity ratings using a visual analog scale at monthly visits. Results., There were significant dose increases from weeks 1 to 2 and 2 to 6 (P < 0.05). Doses stabilized around week 6, suggesting the completion of what we defined as "titration." Both doses and pain ratings were stable when this titration phase was excluded from the analysis (P = 0.751; P = 0.056, respectively). Only 28% of the patients had any dose changes following this titration. While there was a significantly greater dose at week 52 compared with week 10 (P = 0.010), the increase in dose became insignificant after excluding four subjects who required two dose increases (P = 0.103). Conclusions., The results showed that most of the titration/dose stabilization changes occurred within the first 10 weeks. A minority (28%) of subjects required dosage increases after this (defined) titration period. Pain reports stabilized statistically after 2 weeks. The findings of this post hoc analysis suggest a lack of opioid tolerance in the majority (72%) of these OA patients who completed this study following a defined titration period on OxymER. Summary., This post hoc analysis of oxymorphone ER consumption in osteoarthritis pain vs pain report showed that most dose changes occurred during an initial "titration period" as defined. Following this titration few subjects increased dose and analgesia remained stable. These findings suggest a lack of longitudinal opioid tolerance in the majority of those OA subjects who completed the trial. [source] Efficacy of Phosphodiesterase Type 5 Inhibitor Treatment in Men with Erectile Dysfunction and Dyslipidemia: A Post Hoc Analysis of the Vardenafil Statin StudyTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2010Martin M. Miner MD ABSTRACT Introduction., Dyslipidemia occurs often in subjects with erectile dysfunction (ED), but there is little information about how this condition affects ED treatment responses. Aim., To determine whether low-density lipoprotein cholesterol (LDL-C) levels, total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio; or the presence of metabolic syndrome influenced efficacy of vardenafil in men with ED and dyslipidemia. Methods., Post hoc subgroup analysis of a 12-week study of the influence of lipid levels and presence of metabolic syndrome on the efficacy of vardenafil as measured by International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, responses to Sexual Encounter Profile (SEP) SEP2 and SEP3 questions, duration of erection leading to successful intercourse, and erection duration regardless of the answer to SEP3. Lipid values were obtained at study start, after patients had received at least 3 months of therapy with a statin. Main Outcome Measures., Outcomes in subjects with LDL-C <100, ,100 to <130, or ,130 mg/dL [<2.59, ,2.59 to <3.36, or ,3.36 mmol/L]; TC/HDL-C ratio <3.5 vs. ,3.5, and presence or absence of metabolic syndrome. Results., Vardenafil improved all endpoints evaluated compared with placebo in all subgroups, however, nominally significant treatment by subgroup interaction terms did not follow a distinct pattern. Increasing LDL-C (P = 0.033), but not TC/HDL-C ratio or metabolic syndrome, was associated with an increase in treatment response measured by the IIEF-EF domain score. Responses to SEP3 were nominally influenced by LDL-C levels (P = 0.019), but were not significantly influenced by TC/HDL-C ratio, or the metabolic syndrome. Only higher TC/HDL-C ratios (,3.5) were associated with larger treatment differences in duration of erection leading to successful intercourse (P = 0.028). Conclusions., Vardenafil was effective in men with dyslipidemia regardless of LDL-C levels, TC/HDL-C ratio, and/or presence of metabolic syndrome. Despite the known presence of ED and dyslipidemia, other cardiovascular risk factors were apparently not aggressively managed. Miner MM, Barnes A, and Janning S. Efficacy of phosphodiesterase type 5 inhibitor treatment in men with erectile dysfunction and dyslipidemia: A post hoc analysis of the vardenafil statin study. J Sex Med 2010;7:1937,1947. [source] Time Course of Adverse Events in Patients with Localization-related Epilepsy Receiving Topiramate Added to CarbamazepineEPILEPSIA, Issue 5 2005Jerzy Majkowski Summary:,Purpose: To explore the time course of treatment-emergent adverse events (AEs) during topiramate (TPM) adjunctive therapy. Methods: Post hoc analyses were performed by using data from a large (264 subjects) multicenter, double-blind, placebo-controlled trial in which 200 mg/day TPM was added to carbamazepine (CBZ) with or without another antiepileptic drug (AED) in adults with treatment-resistant partial-onset seizures. The daily incidence and mean duration of the most common (,5% incidence) AEs were calculated for patients completing the 12-week study. Results: The daily incidence of somnolence, headache, loss of appetite, nervousness, fatigue, dizziness, upper respiratory tract infection, and vertigo peaked during titration and declined to rates similar to that of placebo after the target TPM dose had been reached. In contrast, the daily incidence of paresthesia increased during titration and was maintained for the study duration. Relatively few patients had cognitive symptoms (9% with TPM, 5% with placebo), but these were the most common AEs associated with treatment discontinuation. Patient/investigator reports of weight loss increased gradually over the course of the trial, corresponding with the pattern of change in weight measured at study visits. Conclusions: This study demonstrates that most of the more common AEs with TPM adjunctive therapy are transient. Patients can be counseled that most AEs emerging when TPM is initially added to CBZ can be expected to diminish with continued therapy. [source] Relational Factors and Family Treatment Engagement among Low-Income, HIV-Positive African American MothersFAMILY PROCESS, Issue 1 2003Victoria B. Mitrani Ph.D. Clinically derived hypotheses regarding treatment engagement of families of low-income, HIV-positive, African American mothers are tested using univariate and multivariate logistic regression models. Predictors are baseline family relational factors (family support, mother's desire for involvement with family, and family hassles) and mother's history of substance dependence. The study examines a subsample of 49 mothers enrolled in a clinical trial testing the efficacy of Structural Ecosystems Therapy (SET). SET is a family-based intervention intended to relieve and prevent psychosocial distress associated with HIV/AIDS. Participants in the subsample were randomly assigned to SET and attended at least two therapy sessions. Findings reveal that family relational factors predicted family treatment engagement (family support, p < 004; mother's desire for involvement with family, p < 008; family hassles, p < 027). Family support predicted family treatment engagement beyond the prediction provided by the other relational factors and the mother's own treatment engagement (p < 016). History of substance dependence was neither associated with family treatment engagement nor family support. Post hoc analyses revealed that family hassles (p < 003) and mother's desire for involvement with family (p < 018) were differentially related to family treatment engagement in low-versus high-support families. Implications for clinical practice and future research are discussed. [source] Characteristics of Migraine Attacks and Responses to Almotriptan Treatment: A Comparison of Menstrually Related and Nonmenstrually Related MigrainesHEADACHE, Issue 2 2008Merle L. Diamond MD Objectives., To compare the clinical characteristics of menstrually related migraines (MRMs) and nonmenstrually related migraines (nonMRMs) and to investigate the efficacy of almotriptan in the treatment of these migraine subtypes. Design/Methods., These are post hoc analyses of data from the AXERT® Early miGraine Intervention Study (AEGIS), a multicenter, double-blind, parallel-group trial that evaluated adults with IHS-defined migraine with and without aura. Patients were randomized 1 : 1 to treat 3 consecutive headaches with almotriptan 12.5 mg or matching placebo at the first sign of headache typical of their usual migraine, at any level of pain intensity but within 1 hour of onset. MRMs were defined as those occurring ±2 days of the first day of menstrual flow. Post hoc analyses to describe headache characteristics pooled all migraine attacks experienced by patients who reported ,1 menses during the study regardless of assigned treatment group. The post hoc efficacy analyses included outcomes of almotriptan treatment compared with placebo treatment for all migraines in patients with a menstrual record. Results., Of the 275 women in the AEGIS intent-to-treat population, 190 (69.1%; 97 almotriptan, 93 placebo; aged 18-54 years) reported ,1 menses during the trial. Of the 506 migraines reported by these patients, 95 (18.8%) occurred ±2 days of the first day of menstrual flow and were defined as MRM. Aura was associated with 11.7% of MRM and 15.0% of nonMRM. Allodynia-associated symptoms were present with 62.8% of MRM and 57.0% of nonMRM. Prior to treatment, 19.1% of MRM were associated with normal functional ability, 68.1% with disturbed functional ability, and 12.8% required bed rest compared with 18.9%, 68.8%, and 12.3%, respectively, of nonMRM. Pretreatment pain intensity was mild in 40.0%, moderate in 47.4%, and severe in 12.6% of MRM compared with 43.6%, 47.2%, and 9.2%, respectively, of nonMRM. Almotriptan treatment efficacy outcomes for MRM vs nonMRM, respectively, were: 2-hour pain relief, 77.4% vs 68.3%; 2-hour pain free, 35.4% vs 35.9%; and sustained pain free, 22.9% vs 23.8%. Almotriptan was similarly effective in relieving migraine-associated symptoms and improving functional disability associated with both MRM and nonMRM. Conclusions., Prior to treatment, the presence of migraine-associated characteristics including aura, allodynia-associated symptoms, photophobia, phonophobia, and nausea were similar for both MRM and nonMRM attacks. The pretreatment levels of pain intensity and functional disability were likewise similar across the migraine subtypes. Almotriptan was equally effective in the treatment of both MRM and nonMRM attacks and was associated with an adverse event profile that was similar to placebo treatment. [source] The Impact of Multiple Dimensions of Ethnic Identity on Discrimination and Adolescents' Self-EsteesJOURNAL OF APPLIED SOCIAL PSYCHOLOGY, Issue 11 2003Andrea J. Romero The rejection-identification model is investigated with multiple dimensions of ethnic identity in a sample of Mexican American youth. It is hypothesized that more perceived discrimination will be associated with higher ethnic identity in general, but that the multiple dimensions of ethnic identity will be associated differentially with discrimination. Higher perceived discrimination will be associated with more ethnic exploration and less ethnic affirmation. Self-report questionnaires were completed by middle school students of Mexican descent (N= 881). Based on structural equation modeling, the data were found to fit the rejection-identification model (p < .05). Higher discrimination was associated with lower ethnic affirmation (p < .05) and lower ethnic exploration (p < .05). Post hoc analyses indicated a significant interaction between discrimination and ethnic affirmation (p < .01) such that youth with high ethnic affirmation who experienced high discrimination still reported high self-esteem. The findings are discussed in the context of understanding methods of coping with prejudice and discrimination that will enhance the mental well-being of minority youth. [source] Intervention program to keep girls in the science pipeline: Outcome differences by ethnic statusJOURNAL OF RESEARCH IN SCIENCE TEACHING, Issue 4 2003Toby Epstein Jayaratne This study evaluated a 2-week residential program aimed at enhancing the science interest and persistence of high-achieving 8th-grade girls. Questionnaires were administered to 38 program participants (14 of whom were of minority ethnicity) and 173 applicants who did not attend the program, at 3 time points: preprogram, 1 year postprogram, and 4 years postprogram. Outcomes, measured postprogram, included science self-concept and interest, persistence and aspirations in science, science activities, science course-taking in high school, and plans for a science college major. There was no main effect of program participation on any of the outcome measures, but a significant Participation,×,Ethnicity interaction effect occurred for all but one of the outcome variables. At Time 2, and especially Time 3, nonminority participants tended to have the most positive outcomes, whereas minority participants tended to have the most negative outcomes, compared with applicants. Post hoc analyses showed that although nonminority girls overall were more advantaged, this difference did not explain results. Several interpretations for these findings are discussed, the most likely that some global feature of the program, not any intervention component, interacted over time with the girls' postprogram experience. © 2003 Wiley Periodicals, Inc. J Res Sci Teach 40: 393,414, 2003 [source] Novel pharmacology: asimadoline, a ,-opioid agonist, and visceral sensationNEUROGASTROENTEROLOGY & MOTILITY, Issue 9 2008M. Camilleri Abstract, Asimadoline is a potent ,-opioid receptor agonist with a diaryl acetamide structure. It has high affinity for the , receptor, with IC50 of 5.6 nmol L,1 (guinea pig) and 1.2 nmol L,1 (human recombinant), and high selectively with , : , : , binding ratios of 1 : 501 : 498 in human recombinant receptors. It acts as a complete agonist in in vitro assay. Asimadoline reduced sensation in response to colonic distension at subnoxious pressures in healthy volunteers and in irritable bowel syndrome (IBS) patients without alteration of colonic compliance. Asimadoline reduced satiation and enhanced the postprandial gastric volume (in female volunteers). However, there were no significant effects on gastrointestinal transit, colonic compliance, fasting or postprandial colonic tone. In a clinical trial in 40 patients with functional dyspepsia (Rome II), asimadoline did not significantly alter satiation or symptoms over 8 weeks. However, asimadoline, 0.5 mg, significantly decreased satiation in patients with higher postprandial fullness scores, and daily postprandial fullness severity (over 8 weeks); the asimadoline 1.0 mg group was borderline significant. In a clinical trial in patients with IBS, average pain 2 h post- on-demand treatment with asimadoline was not significantly reduced. Post hoc analyses suggest that asimadoline was effective in mixed IBS. In a 12-week study in 596 patients, chronic treatment with 0.5 mg and 1.0 mg asimadoline was associated with adequate relief of pain and discomfort, improvement in pain score and number of pain-free days in patients with IBS-D. The 1.0 mg dose was also efficacious in IBS-alternating. There were also weeks with significant reduction in bowel frequency and urgency. Asimadoline has been well tolerated in human trials to date. [source] Market Orientation and R&D Effectiveness in High-Technology Firms: An Empirical Investigation in the Biotechnology Industry,THE JOURNAL OF PRODUCT INNOVATION MANAGEMENT, Issue 3 2010Luigi M. De Luca There seems to be lack of consensus among informed scholars about the importance a of market orientation for high-technology firms. This paper gives a comprehensive review of existing empirical studies on the relationship between market orientation and innovation performance and pinpoints two limitations in this research stream that might be at the origin of such controversy. First, extant research often overlooked key innovation outcomes for high-technology firms, such as those related to research and development (R&D) performance. Second, organizational conditions that can ensure an optimal integration of market knowledge in the innovation process have been less analyzed in the case of these firms. Against this background, the present study contributes to the literature by providing a test of the effect of market orientation on R&D effectiveness and the moderating role of knowledge integration in this relationship, using a sample of Italian biotechnology firms. The study's objectives are addressed in two steps. The first one consists of an in-depth qualitative study based on semistructured interviews in five biotechnology firms. The second step consists of a follow-up survey of 50 biotechnology firms. Results from hierarchical multiple regression analysis show that the different dimensions of a market orientation have diverse effects on R&D effectiveness of high-technology firms: whereas interfunctional coordination has a positive main effect, the effect of customer orientation is moderated by knowledge integration, and competitor orientation has no effect on R&D effectiveness. Post hoc analyses also show two additional results involving a broader set of dependent variables. First, R&D effectiveness mediates the effects of customer orientation and interfunctional coordination on organizational performance. Second, market orientation does not appear to significantly affect R&D efficiency. The present study contributes to current literature in two main respects. First, it adds to previous work on market orientation and innovation by proposing a new dependent variable,R&D effectiveness,which offers a better perspective to understand the impact of market orientation on innovation performance in high-technology contexts. Second, while part of the current debate on the role of market orientation in high-tech markets seems to be polarized by positions that sustain its potential drawbacks or, on the contrary, its advantages, this study's findings on the moderating role of knowledge integration shed light on important contingency factors, such as organizational capabilities. The authors discuss the study's limitations and provide directions for future research. [source] A post hoc analysis of multiple-stimulus preference assessment resultsBEHAVIORAL INTERVENTIONS, Issue 2 2002Richard B. Graff Fifteen individuals with developmental disabilities participated in multiple-stimulus without replacement preference assessments (seven assessment sessions, seven trials each). Twelve of 15 individuals completed a second set of preference assessments 6 months later. Post hoc analyses indicated that in 25 of 27 cases, the same most preferred stimulus was identified in the first three trials as the full seven trials. Additionally, five sessions of three trials each were sufficient to identify the most highly preferred stimulus in 22 of 27 instances. Copyright © 2002 John Wiley & Sons, Ltd. [source] Computer Self-Efficacy and Motivation to Learn in a Self-Directed Online CourseDECISION SCIENCES JOURNAL OF INNOVATIVE EDUCATION, Issue 1 2009Marcia J. Simmering ABSTRACT Despite the increased use of new learning technologies, there is still much to be learned about the role of learner characteristics in online learning. The purpose of this study was to examine how subjects' characteristics normally associated with effective training (i.e., initial motivation to learn and self-efficacy) related to learning in a self-directed online course. From an analysis of 190 respondents, computer and Internet usage prior to the start of class were positively related to individuals' computer self-efficacy and computer self-efficacy was positively related to learning. However, contrary to expectations, computer self-efficacy was not related to initial motivation to learn and motivation to learn was not related to learning in the class. Post hoc analysis of qualitative data enabled a rich explanation of the findings, including an evaluation of the unexpected relationships among the variables of interest and the nature of self-directed courses in virtual learning environments. [source] Depressive symptoms in the first year from diagnosis of Type 2 diabetes: results from the DESMOND trialDIABETIC MEDICINE, Issue 8 2010T. C. Skinner Diabet. Med. 27, 965,967 (2010) Abstract Aims, To describe the course of depressive symptoms during the first year after diagnosis of Type 2 diabetes. Methods,Post hoc analysis of data from a randomized controlled trial of self-management education for 824 individuals newly diagnosed with Type 2 diabetes. Participants completed the Depression scale of the Hospital Anxiety and Depression Scale after diagnosis and at 4, 8 and 12 months follow-up. Participants also completed the Problem Areas in Diabetes scale at 8 and 12 months follow-up. We present descriptive statistics on prevalence and persistence of depressive symptoms. Logistic regression is used to predict possible depression cases, and multiple regression to predict depressive symptomatology. Results, The prevalence of depressive symptoms in individuals recently diagnosed with diabetes (18,22% over the year) was not significantly different from normative data for the general population (12%) in the UK. Over 20% of participants indicated some degrees of depressive symptoms over the first year of living with Type 2 diabetes; these were mostly transient episodes, with 5% (1% severe) reporting having depressive symptoms throughout the year. At 12 months post diagnosis, after controlling for baseline depressive symptoms, diabetes-specific emotional distress was predictive of depressive symptomatology. Conclusions, The increased prevalence of depressive symptoms in diabetes is not manifest until at least 1 year post diagnosis in this cohort. However, there are a significant number of people with persistent depressive symptoms in the early stages of diabetes, and diabetes-specific distress may be contributing to subsequent development of depressive symptoms in people with Type 2 diabetes. [source] Inter-hemispheric inhibition is impaired in mirror dystoniaEUROPEAN JOURNAL OF NEUROSCIENCE, Issue 8 2009S. Beck Abstract Surround inhibition, a neural mechanism relevant for skilled motor behavior, has been shown to be deficient in the affected primary motor cortex (M1) in patients with focal hand dystonia (FHD). Even in unilateral FHD, however, electrophysiological and neuroimaging studies have provided evidence for bilateral M1 abnormalities. Clinically, the presence of mirror dystonia, dystonic posturing when the opposite hand is moved, also suggests abnormal interhemispheric interaction. To assess whether a loss of inter-hemispheric inhibition (IHI) may contribute to the reduced surround inhibition, IHI towards the affected or dominant M1 was examined in 13 patients with FHD (seven patients with and six patients without mirror dystonia, all affected on the right hand) and 12 right-handed, age-matched healthy controls (CON group). IHI was tested at rest and during three different phases of a right index finger movement in a synergistic, as well as in a neighboring, relaxed muscle. There was a trend for a selective loss of IHI between the homologous surrounding muscles in the phase 50 ms before electromyogram onset in patients with FHD. Post hoc analysis revealed that this effect was due to a loss of IHI in the patients with FHD with mirror dystonia, while patients without mirror dystonia did not show any difference in IHI modulation compared with healthy controls. We conclude that mirror dystonia may be due to impaired IHI towards neighboring muscles before movement onset. However, IHI does not seem to play a major role in the general pathophysiology of FHD. [source] Clinical Benefits of Early Triptan Therapy for MigraineHEADACHE, Issue 2002Julio Pascual MD Although triptans have been proven effective for acute treatment of migraine, reserving them for moderate or severe pain may produce suboptimal pain relief and higher rates of recurrence. Recent evidence indicates that early intervention at the onset of pain improves outcomes. Post hoc analysis of a long-term, open-label European study of almotriptan 12.5 mg found that the percentage of attacks rendered pain-free at 2 hours was significantly greater when patients treated mild pain (84%) than when the intervention occurred during moderate or severe pain (53%). A similar pattern emerged with respect to the consistency of pain relief, with a significant advantage for early intervention (88% versus 56%, respectively). A difference in favor of early intervention was also seen with respect to recurrence, need for rescue medication, and adverse events. The recurrence rate was significantly lower in patients treating mild pain (28%) than in those delaying treatment until the pain became moderate or severe (33%), which suggests that achieving pain freedom results in less recurrence. These results were generally replicated in post hoc analysis of a subgroup of patients from a randomized, placebo-controlled trial (the Spectrum Study) of oral sumatriptan 50 mg in migraineurs. This analysis demonstrated that with early intervention, pain was less likely to intensify, fewer attacks required redosing, more attacks remained pain-free 24 hours postdose, and normal function returned more quickly. In sum, early intervention with triptans can improve outcomes, avoiding much of the pain and disability associated with treating moderate or severe attacks. [source] How long should a trial of escitalopram treatment be in patients with major depressive disorder, generalised anxiety disorder or social anxiety disorder?HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2009An exploration of the randomised controlled trial database Abstract Objective To extend the knowledge of course of improvement in patients with major depressive disorder (MDD), social anxiety disorder (SAD) or generalised anxiety disorder (GAD) participating in randomised placebo-controlled trials (RCTs) and to infer the optimal duration of initial escitalopram treatment in clinical practice, after which intervention might be reasonable in case of non-response. Methods Post hoc analysis of pooled clinical trial database for escitalopram in MDD (14 studies), GAD (4 studies) and SAD (2 studies). ,Onset' of action was defined as a 20% or more decrease from baseline score in disorder-specific psychopathological rating scales: ,response' as a 50% or more decrease from baseline score. Results In MDD, the probability of responding at week 8 if no onset was apparent at week 2 was 43%; in patients with an onset of effect the probability was nearly 80%. Similar patterns were observed in GAD and SAD. The chance of responding beyond week 4 in MDD, GAD and SAD was 20% or less if no effect had occurred by week 2. Conclusions The pattern of response in these RCTs suggests that in patients with MDD, GAD or SAD in wider clinical practice, a period of at least 4,weeks is worthwhile before considering further intervention. Copyright © 2009 John Wiley & Sons, Ltd. [source] Do cultural factors predict mammography behaviour among Korean immigrants in the USA?JOURNAL OF ADVANCED NURSING, Issue 12 2009Hanju Lee Abstract Title.,Do cultural factors predict mammography behaviour among Korean immigrants in the USA? Aim., This paper is a report of a study of the correlates of mammogram use among Korean American women. Background., Despite the increasing incidence of and mortality from breast cancer, Asian women in the United States of America report consistently low rates of mammography screening. A number of health beliefs and sociodemographic characteristics have been associated with mammogram participation among these women. However, studies systematically investigating cultural factors in relation to mammogram experience have been scarce. Methods., We measured screening-related health beliefs, modesty and use of Eastern medicine in 100 Korean American women in 2006. Hierarchical logistic regression was used to examine the unique contribution of the study variables, after accounting for sociodemographic characteristics. Findings., Only 51% reported past mammogram use. Korean American women who had previously had mammograms were statistically significantly older and had higher perceived benefit scores than those who had not. Perceived benefits (odds ratio = 6·3, 95% confidence interval = 2·12, 18·76) and breast cancer susceptibility (odds ratio = 3·18, 95% confidence interval = 1·06, 9·59) were statistically significant correlates of mammography experience, whereas cultural factors did not correlate. Post hoc analysis showed that for women with some or good English skills, cultural factors statistically significantly correlated with health beliefs and breast cancer knowledge (P < 0·05). Conclusion., Nurses should consider the inclusion in culturally tailored interventions of more targeted outreach and healthcare system navigation assistance for promoting mammography screening in Korean American women. Further research is needed to unravel the interplay between acculturation, cultural factors and health beliefs related to cancer screening behaviours of Korean American women. [source] Incubation time required for neonatal blood cultures to become positiveJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 12 2006Luke Jardine Aim: We aimed to determine the laboratory detection time of bacteraemia in neonatal blood cultures, and whether this differed by: organism; samples deemed to represent true bacteraemia versus contaminants; and blood cultures collected from an infant <48 h of age (early) or ,48 h of age (late). Methods: A retrospective audit of all positive blood cultures collected from neonates in the Grantley Stable Neonatal Unit, Royal Women's Hospital, Brisbane, between 1 January 2000 and 31 December 2004 was undertaken. The bacteraemia detection method used was the BacTAlert system with Peds bottles. Results: Two hundred and three positive blood cultures were included in the analysis. One hundred and sixteen (57%) were deemed septicaemia, 87 (43%) were deemed contaminants. The median (interquartile range) time to positivity for positive blood cultures deemed septicaemia and contaminants were 15.9 (11.6, 22.2) and 30.2 (20.4, 43.9) h, respectively. Fifty-six (28%) positive blood cultures were collected when infants were <48 h of age and 147 (72%) were collected in infants ,48 h of age. Post hoc analysis revealed that the time to positivity for early septicaemia was 13.7 (11, 16.7) h; early contaminant was 25.2 (19.2, 33.8) h; late septicaemia was 17.2 (12.2, 23.4) h; and late contaminant was 37.9 (21.7, 51.2) h. The time to positivity for: Group B streptococcus was 9.3 (8.2, 11.0) h; Escherichia coli was 11.3 (10.0, 13.5) h; and coagulase-negative staphylococci was 28.9 (20.5, 41.2) h. Conclusion: The incubation time for positive blood cultures significantly differs by organism type and whether they are considered early or late septicaemia versus contaminants. We recommend that: infants who are <48 h of age at the time of blood culture collection, who remain clinically well and have negative cultures 36 h after the initial collection can safely have their antibiotic treatment ceased; infants who are ,48 h of age at the time of collection should continue antibiotic treatment for at least 48 h before cessation is considered. [source] Effect of Transvenous Cardiac Resynchronization Therapy Device Implantation on Cardiac Troponin I ReleasePACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2007TIMUCIN ALTIN M.D. Background: Pacemaker and implantable cardioverter defibrillator (ICD) implantation increases cardiac troponin I (cTnI) levels which indicates myocardial injury. During implantation of a cardiac resynchronization therapy (CRT) device, balloon inflation for coronary sinus (CS) venogram, cannulation of CS side branch, and electrode advancement may interfere with CS drainage and, hence, may decrease the washout of toxic metabolites from the heart. Thus, CRT implantation may further increase cTnI levels. In this study, we investigated the effects of CRT implantation on cTnI release. Methods: We included 10 patients (mean age = 57 ± 15 years) in whom a successful transvenous CRT system was implanted (CRT group). Twenty patients (mean age = 65 ± 10 years) who underwent a transvenous pacemaker or ICD implantation were included as the control group. Blood samples for cTnI were drawn at baseline and at six, 12, 18, and 24 hours thereafter. Results: Baseline median cTnI levels were similar in CRT and control groups (0.03 ng/mL vs 0.02 ng/mL, respectively; P = 0.1). Postoperative cTnI levels during 24 hours were significantly higher in the CRT group (P < 0.05) by two-way repeated measures of analyis of variance. Post hoc analysis revealed that cTnI levels were higher at the 6th, 12th, 18th, and 24th hours compared to baseline levels (P < 0.001, P < 0.001, P < 0.01, and P < 0.01, respectively). There was a significant difference in the area under the curves (AUCs) of cTnI measurements (1.79 hr·ng/mL in the CRT group and 0.78 hr·ng/mL in the control group, P < 0.05). Conclusion: Postoperative cTnI levels were higher after CRT implantation than simple pacemaker/ICD implantation. This may be due to CS manipulation during CRT implantation. [source] Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal DataPAIN MEDICINE, Issue 8 2010R. Norman Harden MD Abstract Objective., To examine the development of analgesic tolerance in patients on oxymorphone extended-release (OxymER). Design.,Post hoc analysis of data from a previously conducted prospective 1 year multi-center open-label extension study in which patients were able to titrate as needed. Patients., Sample of 153 hip and knee osteoarthritis (OA) subjects on OxymER. Primary analyses were limited to study completers (n = 62) due to the large amount of missing data for the noncompleters (n = 91). Outcome Measures., Main outcome measures included OxymER doses (pill counts) and pain intensity ratings using a visual analog scale at monthly visits. Results., There were significant dose increases from weeks 1 to 2 and 2 to 6 (P < 0.05). Doses stabilized around week 6, suggesting the completion of what we defined as "titration." Both doses and pain ratings were stable when this titration phase was excluded from the analysis (P = 0.751; P = 0.056, respectively). Only 28% of the patients had any dose changes following this titration. While there was a significantly greater dose at week 52 compared with week 10 (P = 0.010), the increase in dose became insignificant after excluding four subjects who required two dose increases (P = 0.103). Conclusions., The results showed that most of the titration/dose stabilization changes occurred within the first 10 weeks. A minority (28%) of subjects required dosage increases after this (defined) titration period. Pain reports stabilized statistically after 2 weeks. The findings of this post hoc analysis suggest a lack of opioid tolerance in the majority (72%) of these OA patients who completed this study following a defined titration period on OxymER. Summary., This post hoc analysis of oxymorphone ER consumption in osteoarthritis pain vs pain report showed that most dose changes occurred during an initial "titration period" as defined. Following this titration few subjects increased dose and analgesia remained stable. These findings suggest a lack of longitudinal opioid tolerance in the majority of those OA subjects who completed the trial. [source] Which pulmonary volume should be used in physiotherapy to obtain higher maximal inspiratory pressure in COPD patients?PHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 4 2005Patricia EM Marinho Abstract Background and Purpose Patients with chronic obstructive pulmonary disease (COPD) present pulmonary hyperinflation as the main cause of mechanical disadvantage in respiratory muscles. Measurement of the force generated by those muscles is converted into pressure changes. The aim of the present study was to evaluate the maximal inspiratory pressure (MIP) from the residual volume (RV) and from the functional residual capacity (FRC), in patients with COPD, and to determine which pulmonary volume should be used in physiotherapy so as to obtain higher MIP results. Method An investigation of 18 male patients with stable COPD. Patients were examined using a manual vacuometer to measur the MIP of 20 daily manoeuvres. Ten measurements were taken from the RV and 10 from the FRC, taken alternately with an interval of 1 minute between each measurement, for five consecutive days. Results Increases in MIP were obtained from the RV measurements (mean ± SE) from 59.7 (±5.2) to 66.6 (±5.3) cm H2O (F (4,64) = 3.34; p < 0.015) and from the FRC measurements, from 55.4 (±4.9) to 64.4 (±4,8) cm H2O (F (4,64) = 6.72; p < 0.001). Post hoc analysis showed an increase, over consecutive days, in both RV and FRC. For FRC, an increase was revealed on the second and third days, a fall was found on the fourth day and a new increase was found on the last day. MIP reached different levels, between RV and FRC, on the first (t = 2.888; p = 0.010) and fourth ( t = 2.165; p = 0.045) days. Conclusion In the present study, MIP reached higher levels at FRC during the five days of evaluation, and a learning effect occurred in the patients. Motor units from the respiratory muscles may have been recruited in order to performe the manoeuvres during the days of evaluation. The study suggests that there is good evidence for the use of the FRC as a parameter to find the major MIP value. Copyright © 2005 John Wiley & Sons, Ltd. [source] Epitope-specific immunotherapy of rheumatoid arthritis: Clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial,ARTHRITIS & RHEUMATISM, Issue 11 2009Eva C. Koffeman Objective Induction of immune tolerance to maintain clinical control with a minimal drug regimen is a current research focus in rheumatoid arthritis (RA). Accordingly, we are developing a tolerization approach to dnaJP1, a peptide part of a pathogenic mechanism that contributes to autoimmune inflammation in RA. We undertook this study to test 2 hypotheses: 1) that mucosal induction of immune tolerance to dnaJP1 would lead to a qualitative change from a proinflammatory phenotype to a more tolerogenic functional phenotype, and 2) that immune deviation of responses to an inflammatory epitope might translate into clinical improvement. Methods One hundred sixty patients with active RA and with immunologic reactivity to dnaJP1 were enrolled in a pilot phase II trial. They received oral doses of 25 mg of dnaJP1 or placebo daily for 6 months. Results The dnaJP1 peptide was safe and well-tolerated. In response to treatment with dnaJP1, there was a significant reduction in the percentage of T cells producing tumor necrosis factor , and a corresponding trend toward an increased percentage of T cells producing interleukin-10. Coexpression of a cluster of molecules (programmed death 1 and its ligands) associated with T cell regulation was also found to be a prerequisite for successful tolerization in clinical responders. Analysis of the primary efficacy end point (meeting the American College of Rheumatology 20% improvement criteria at least once on day 112, 140, or 168) showed a difference between treatment groups that became significant in post hoc analysis using generalized estimating equations. Differences in clinical responses were also found between treatment groups on day 140 and at followup. Post hoc analysis showed that the combination of dnaJP1 and hydroxychloroquine (HCQ) was superior to the combination of HCQ and placebo. Conclusion Tolerization to dnaJP1 leads to immune deviation and a trend toward clinical efficacy. Susceptibility to treatment relies on the coexpression of molecules that can down-regulate adaptive immunity. [source] Influence of local geomagnetic storms on arterial blood pressureBIOELECTROMAGNETICS, Issue 6 2004S. Dimitrova Abstract This study attempts to assess the influence of local geomagnetic storms at middle latitudes on some human physiological parameters. The blood pressure (bp), heart rate and general well-being of 86 volunteers were measured, the latter by means of a standardised questionnaire, on work days in autumn, 2001 (1 Oct to 9 Nov), and in spring, 2002 (8 April to 28 May). These timespans were chosen as periods of maximal expected geomagnetic activity (GMA). Altogether, 2799 recordings were obtained and analysed. A four factor analysis of variance (MANOVA) was employed to check the significance of the influence of four factors (local GMA level; sequence of the days of measurements covering up to 3 days before and after geomagnetic storms; sex and the presence of medication) on the physiological parameters under consideration. Post hoc analysis was performed to elicit the significance of differences in the factors' levels. Arterial bp was found to increase with the increase of the GMA level, and systolic and diastolic bp were found to increase significantly from the day before till the second day after the geomagnetic storm. These effects were present irrespective of sex and medication. Bioelectromagnetics 25:408,414, 2004. © 2004 Wiley-Liss, Inc. [source] The Role of Aspirin Resistance in the Treatment of Acute Coronary SyndromesCLINICAL CARDIOLOGY, Issue 1 2008F.A.C.C., Gilead I. Lancaster M.D. F.A.C.P. Abstract The TIMI Risk Score recognizes prior aspirin use as an independent risk factor for adverse outcomes in subjects presenting with an acute coronary syndrome. The etiology of this increased risk awaits clarification, but prior aspirin use may be associated with altered thrombus composition which is more resistant to current treatment modalities as compared to thrombus formation in subjects without prior aspirin use. Post hoc analysis of acute coronary syndrome trials has shown that prior aspirin users treated with unfractionated heparin are at particularly high risk. The addition of glycoprotein IIb/IIIa receptor inhibitor to unfractionated heparin or substitution of low-molecular-weight heparin significantly improves outcomes in prior aspirin users. The prognostic significance of prior aspirin use in acute coronary syndromes has important implications not only in clinical practice, but also in the design and interpretation of clinical trials. Copyright © 2007 Wiley Periodicals, Inc. [source] Treatment of Anemia With Darbepoetin Alfa in Heart FailureCONGESTIVE HEART FAILURE, Issue 3 2010William T. Abraham MD Anemia is common in heart failure (HF) patients. A prespecified pooled analysis of 2 randomized, double-blind, placebo-controlled studies evaluated darbepoetin alfa (DA) in 475 anemic patients with HF (hemoglobin [Hb], 9.0,12.5 g/dL). DA was administered subcutaneously every 2 weeks and titrated to achieve and maintain a target Hb level of 14.0±1.0 g/dL. By week 27, mean (SD) Hb concentrations did not increase with placebo but increased with DA from 11.5 (0.7) to 13.3 (1.3) g/dL. Hazard ratios (HRs) for DA compared with placebo for all-cause death or first HF hospitalization (composite end point), all-cause death, and HF hospitalization by month 12 were 0.67 (95% confidence interval [CI], 0.44,1.03; P=.067), 0.76 (95% CI, 0.39,1.48; P=.419), and 0.66 (95% CI, 0.40,1.07; P=.093), respectively. Incidence of adverse events was similar in both groups. In post hoc analyses, improvement in the composite end point was significantly associated with the mean Hb change from baseline (adjusted HR, 0.40; P=.017) with DA treatment. There was no increased risk of all-cause mortality or first HF hospitalization with DA in patients with reduced renal function or elevated baseline B-type natriuretic peptide, a biomarker of worse HF. These results suggest that DA is well tolerated, corrects HF-associated anemia, and may have favorable effects on clinical outcomes., Congest Heart Fail. 2010;16:87,95. © 2010 Wiley Periodicals, Inc. [source] Cardiovascular drugs as antidiabetic agents: evidence for the prevention of type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 7 2008D. P. Macfarlane Given the long-term health consequences and increasing incidence of type 2 diabetes, there is great interest to potentially prevent or delay its onset. Primary prevention studies have demonstrated that intensive exercise and weight reduction, and to a lesser extent certain antidiabetic agents, can reduce new onset diabetes in at-risk individuals. Results from post hoc analyses and secondary end-point outcomes of large randomized controlled trials of cardiovascular drugs suggest that these may also have beneficial effects, reducing the incidence of new onset diabetes in addition to their proven cardiovascular benefits. Multiple meta-analyses confirm that drugs primarily acting on the renin,angiotensin system (RAS) reduce the incidence of diabetes in the populations studied, perhaps via improved insulin sensitivity and/or effects on pancreatic beta cells. However, results from the recent Diabetes REduction Approaches with Medication study specifically failed to show a significant reduction in the incidence of diabetes with ramipril in individuals with abnormal glucose tolerance at baseline. There is only limited evidence that statins improve glucose tolerance, and although beta-blockers tend to have detrimental effects on glucose tolerance, newer agents with vasodilatory properties may confer benefits. With current guidelines, the use of cardiovascular drugs modifying the RAS will increase in at-risk individuals, but at present, they cannot be recommended to prevent diabetes. [source] Characteristics of Migraine Attacks and Responses to Almotriptan Treatment: A Comparison of Menstrually Related and Nonmenstrually Related MigrainesHEADACHE, Issue 2 2008Merle L. Diamond MD Objectives., To compare the clinical characteristics of menstrually related migraines (MRMs) and nonmenstrually related migraines (nonMRMs) and to investigate the efficacy of almotriptan in the treatment of these migraine subtypes. Design/Methods., These are post hoc analyses of data from the AXERT® Early miGraine Intervention Study (AEGIS), a multicenter, double-blind, parallel-group trial that evaluated adults with IHS-defined migraine with and without aura. Patients were randomized 1 : 1 to treat 3 consecutive headaches with almotriptan 12.5 mg or matching placebo at the first sign of headache typical of their usual migraine, at any level of pain intensity but within 1 hour of onset. MRMs were defined as those occurring ±2 days of the first day of menstrual flow. Post hoc analyses to describe headache characteristics pooled all migraine attacks experienced by patients who reported ,1 menses during the study regardless of assigned treatment group. The post hoc efficacy analyses included outcomes of almotriptan treatment compared with placebo treatment for all migraines in patients with a menstrual record. Results., Of the 275 women in the AEGIS intent-to-treat population, 190 (69.1%; 97 almotriptan, 93 placebo; aged 18-54 years) reported ,1 menses during the trial. Of the 506 migraines reported by these patients, 95 (18.8%) occurred ±2 days of the first day of menstrual flow and were defined as MRM. Aura was associated with 11.7% of MRM and 15.0% of nonMRM. Allodynia-associated symptoms were present with 62.8% of MRM and 57.0% of nonMRM. Prior to treatment, 19.1% of MRM were associated with normal functional ability, 68.1% with disturbed functional ability, and 12.8% required bed rest compared with 18.9%, 68.8%, and 12.3%, respectively, of nonMRM. Pretreatment pain intensity was mild in 40.0%, moderate in 47.4%, and severe in 12.6% of MRM compared with 43.6%, 47.2%, and 9.2%, respectively, of nonMRM. Almotriptan treatment efficacy outcomes for MRM vs nonMRM, respectively, were: 2-hour pain relief, 77.4% vs 68.3%; 2-hour pain free, 35.4% vs 35.9%; and sustained pain free, 22.9% vs 23.8%. Almotriptan was similarly effective in relieving migraine-associated symptoms and improving functional disability associated with both MRM and nonMRM. Conclusions., Prior to treatment, the presence of migraine-associated characteristics including aura, allodynia-associated symptoms, photophobia, phonophobia, and nausea were similar for both MRM and nonMRM attacks. The pretreatment levels of pain intensity and functional disability were likewise similar across the migraine subtypes. Almotriptan was equally effective in the treatment of both MRM and nonMRM attacks and was associated with an adverse event profile that was similar to placebo treatment. [source] Eletriptan for the Acute Treatment of Migraine in Adolescents: Results of a Double-Blind, Placebo-Controlled TrialHEADACHE, Issue 4 2007Paul Winner DO Background.,Eletriptan is a potent 5-HT1B/1D agonist with proven efficacy in the acute treatment of migraine in adults. Objective.,To evaluate the efficacy and tolerability of eletriptan 40 mg versus placebo in adolescent patients (aged 12-17). Methods.,A multicenter, double-blind, parallel-group, placebo-controlled trial was conducted comparing 40 mg of oral eletriptan with placebo for the treatment of migraine in adolescent patients. The primary efficacy endpoint was 2-hour headache response, and a number of secondary endpoints were also evaluated. An exploratory analysis evaluated which clinical and demographic characteristics might be correlated with high placebo response. Results.,Of 274 patients who treated a migraine attack, 267 were evaluated for efficacy (n = 138 eletriptan; n = 129 placebo) at 2 hours post-dose. There was no significant difference in 2-hour headache response for eletriptan 40 mg versus placebo (57% vs 57%), and no significant improvements were observed for any of the outcomes at 1 or 2 hours post-dose. By contrast, there was a significant advantage for eletriptan 40 mg in reducing headache recurrence within 24 hours post-dose (11% vs 25%, P= .028), and post hoc analyses showed statistically significant differences for sustained headache response rates (52% vs 39%; P= .04) and sustained pain-free response rates (22% vs 10%; P= .013). The strongest clinical predictor of placebo response was triptan-naïve status (ie, no previous use of any triptan). Eletriptan 40 mg was well tolerated in this population, and the profile of adverse events was similar to that observed in Phase III trials in adult patients. Conclusions.,The high placebo response rates reported here for 1- and 2-hour outcomes are in accordance with other studies of triptans in adolescent patients. The evaluation of treatment effect in adolescent migraine might benefit from use of more stringent outcome measures, such as headache recurrence, sustained headache response, and sustained pain-free response at 24 hours post-dose. [source] Osteoporosis management: a perspective based on bisphosphonate data from randomised clinical trials and observational databasesINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2009S. Boonen Summary Aims:, The efficacy of treatments for osteoporosis can be evaluated using a variety of study designs. This article aims to comprehensively review the evidence for bisphosphonate anti-fracture efficacy in postmenopausal women, discussing the strengths and limitations associated with each study method. Methods:, Literature analysis included English-language publications reporting results of randomised controlled trials (RCTs), post hoc analyses, meta analyses and observational studies evaluating the efficacy of alendronate (ALN), ibandronate (IBN), risedronate (RIS) and zoledronate (ZOL), with an initial sample size , 100 patients, and follow-up data for at least 1 year. Results:, Primary and secondary analyses of RCT data suggest differences among bisphosphonates with regard to site-specific anti-fracture efficacy and onset of fracture risk reduction. While some observational studies indicate differences in clinical outcomes among these agents, others report similar effectiveness. ALN and RIS data demonstrate sustained fracture protection for up to 10 and 7 years of treatment respectively. The efficacy of IBN and ZOL has been evaluated for up to 3 and 5 years respectively. Conclusions:, Understanding of the benefits of bisphosphonate treatment can be maximised by evaluating complementary data from RCTs and observational database studies. Fracture risk reduction with bisphosphonates is shown in RCTs and in real-world clinical settings. [source] A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezilINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2004Sanford I. Finkel Abstract Objective To examine the safety and efficacy of sertraline augmentation therapy in the treatment of behavioral manifestations of Alzheimer's disease (AD) in outpatients treated with donepezil. Methods and materials Patients with probable or possible AD, and a Neuropsychiatric Inventory (NPI) total score >5 (with a severity score ,2 in at least one domain), were treated with donepezil (5,10,mg) for 8 weeks, then randomly assigned to 12 weeks of double-blind augmentation therapy with either sertraline (50,200,mg) or placebo. Primary efficacy measures were the 12-item Neuropsychiatric Inventory (NPI) and the Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales. Results 24 patients were treated with donepezil+sertraline and 120 patients with donepezil+placebo. There were no statistically significant differences at endpoint on any of the three primary efficacy measures. However, a linear mixed model analysis found modest but statistically significantly greater improvements in the CGI-I score on donepezil+sertraline. Moreover, in a sub-group of patients with moderate-to-severe behavioral and psychological symptoms of dementia, 60% of patients on sertraline vs 40% on placebo (p,=,0.006) achieved a response (defined as ,;50% reduction in a four-item NPI-behavioral subscale). One adverse event (diarrhea) was significantly (p,<,0.05) more common in the donepezil+sertraline group compared to the donepezil+placebo group. Conclusion Sertraline augmentation was well-tolerated in this sample of AD outpatients. In addition, post hoc analyses demonstrated a modest but statistically significant advantage of sertraline over placebo augmentation in mixed model analyses and a clinically and statistically significant advantage in a subgroup of patients with moderate-to-severe behavioral and psychological symptoms of dementia. Copyright © 2004 John Wiley & Sons, Ltd. [source] | |||||||||||||||||||||||||||||||||||||||||||||||||