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Intervention Trials (intervention + trials)
Selected AbstractsThe Relationship between Eligibility Criteria for Participation in Alcohol Brief Intervention Trials and Other Alcohol and Health-Related VariablesTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 3 2001Stephen A. Maisto Ph.D. In clinical trials of brief interventions for alcohol use, individuals typically are defined as eligible for the research through meeting quantity- frequency (QF) of alcohol consumption criteria, alcohol-related problems criteria, or both. The purpose of this study was to evaluate preintervention and posttreatment differences among three groups of research participants eligible for participation in a brief intervention clinical trial by meeting the AUDIT total score criterion only, the QF criterion only, or both. The participants were 301 men and women 21 years of age or older who presented for medical treatment at one of twelve primary care clinics and were screened for participation in the clinical trial. Participants completed an assessment protocol at preintervention and 1, 3, 6, 9, and 12 months postintervention. The analyses showed statistical differences among the three subgroups on three outcome dimensions of alcohol consumption, related consequences and behaviors, and medical complications; for both consumption and complications, the AUDIT + QF participants showed greater severity than participants in either of the other two groups. For consequences, AU DIT + QF participants scored higher than the QF participants on one variable constituting this dimension. The overall subgroup differences were maintained at six months in the consumption and consequences data. The implications of these findings for sensitivity of brief intervention trial design, the discovery of patient moderators of intervention effectiveness, and clinical practice are discussed. [source] 4211: Xanthophylls from blood to retinaACTA OPHTHALMOLOGICA, Issue 2010L BRETILLON Xanthophylls are dietary lipophilic compounds. Among them, lutein and zeaxanthin are the major carotenoids found in the human lens and retina, and referred as macular pigment within the retina. Lutein and zeaxanthin cannot be synthesized endogenously. They may therefore be considered as essential and must be provided by adequate dietary intakes. Lutein and zeaxanthin are present in various food items, mainly in plants and fruits such as green vegetables or yellow-orange fruits, as well as in a few animal sources, such as egg yolk. Epidemiological studies consistently suggest that dietary lutein and zeaxanthin are protective factors against the development of Age-Related Maculopathies and Age-related Macular Degeneration. Intervention trials consisting in supplementing the diet with lutein and zeaxanthin demonstrate the bioavailability of those carotenoids in plasma and, in some of them, their efficacy in increasing the density of the macular pigment. An overview will be presented on the mechanisms of xanthophyll bioavailability in blood and retina. [source] FS13.3 Development of risk reduction strategies for preventing dermatitisCONTACT DERMATITIS, Issue 3 2004Terry Brown Introduction:, A recent survey of the UK printing industry found a prevalence of 11% of occupational contact dermatitis (OCD), much higher than previously identified. Objective:, This pilot study aimed to evaluate risk reduction strategies derived from recommendations of a literature review of preventive intervention studies and a series of focus groups of printers and observations of printers undertaking their normal duties. Methods:, Four interventions were evaluated: (1) Provision of gloves of the correct size/type, plus use of an after-work skin cream; (2) Provision of information; (3) Provision of skin checks; (4) Development of best practice skin care policy. Each intervention was evaluated in two companies over a three-month period, at the end of which printers and managers were interviewed as to the effectiveness and acceptability of each intervention. Results:, Although this pilot study was short, all interventions were acceptable to some extent. The prevalence of frank dermatitis fell over the study period, particularly in intervention (3). Intervention (1) achieved an improvement of awareness in both management and workforce and an increase in the use of both gloves and cream. Intervention (2) highlighted problems of dissemination and the need for relevant information in an appropriate format. However. no single intervention was completely effective. Conclusions:, This qualitative research approach forms an essential first stage to improving understanding of ways in which OCD may be reduced among workers in the printing industry, and points towards the need for further testing of preventive strategies in larger-scale intervention trials, in printing and other industries. [source] Examination stress in Singapore primary schoolchildren: how compliance by subjects can impact on study resultsACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2003G. Parker Objective: Examinations are anecdotally viewed as extremely stressful to Singapore schoolchildren. We test this postulate by obtaining parental ratings of children's emotional stress levels longitudinally in a large representative sample of sixth (P6) and fifth (P5) class primary schoolchildren, respectively, exposed and unexposed to a streaming examination. Method: Children's stress levels were rated monthly by a parent for 10 months. Results: Analyses failed to find evidence of any differential stress impact across P6 and P5 comparison groups, apart from a subset of P6 children whose parents complied with every monthly survey. Conclusion: The streaming examination in the final year of primary school did not emerge as a general stressor to children, but achieved salience within a defined subset of children whose parents were highly study compliant. Study compliance may be a proxy variable of some import, and have wider relevance to other cohort studies and to intervention trials. [source] Whip use and race progress are associated with horse falls in hurdle and steeplechase racing in the UKEQUINE VETERINARY JOURNAL, Issue 5 2004G. L. PINCHBECK Summary Reasons for performing study: Falls during racing present a risk of injury to both horse and jockey and a risk of fatality to horses. Objectives: To use video recordings of races to describe the circumstances surrounding horse falls at hurdle and steeplechase fences and to identify and quantify within-race risk factors for horse falls in National Hunt racing in the UK. Methods: A retrospective, matched, nested case-control study using video recordings of races was conducted on 6 UK racecourses. Cases and controls were matched on both race type and jump number at which the fall occurred. Conditional logistic regression analysis was used to examine the univariable and multivariable relationship between predictor variables and the risk of falling. Results: The risk of falling was significantly associated with whip use and race progress. Horses which were being whipped and progressing through the race were at greater than 7 times the risk of falling compared to horses which were not being whipped and which had no change in position or lost position through the field. Conclusions: This study has identified whip use and the position of the horse with respect to others in the field as potential risk factors for horse falls. Potential relevance: If these findings are confirmed by the use of intervention trials (e.g. with whip-free or restricted whip use races), modifications could be introduced which would reduce the frequency of horse falls, leading to improved equine welfare. [source] Helicobacter pylori Infection and Iron Stores: A Systematic Review and Meta-analysisHELICOBACTER, Issue 5 2008Khitam Muhsen Abstract Background and Aims:, We carried out a systematic literature review and meta-analysis to evaluate the existing evidence on the association between Helicobacter pylori infection and iron stores. Methods:, Twelve case reports and case series, 19 observational epidemiologic studies and six intervention trials were included in the review. Results:, Although only few studies controlled for multiple potential confounders, most studies reported a positive association, linking between H. pylori and decreased body iron stores in symptomatic and asymptomatic H. pylori -infected subjects. H. pylori infection may be regarded as a risk factor for reduction in body iron stores and also for iron deficiency or iron deficiency anemia, especially in high-risk groups. The results of the meta-analysis of thoroughly designed and analyzed studies revealed an increased risk for iron deficiency anemia; pooled odds ratio (OR) 2.8 (95% confidence interval (CI) 1.9, 4.2) and also for iron deficiency; pooled OR 1.38 (95%CI 1.16,1.65) among H. pylori -infected subjects. The biologic mechanism by which H. pylori induces the alteration in the iron stores is not fully understood, but it seems to involve several pathways, including gastrointestinal blood loss, decrease in the absorption of dietary iron, and enhanced uptake of the iron by the bacterium. Conclusions:,H. pylori is associated with reduced iron stores. Future research is needed to determine whether this relationship is a causal association and to better understand its biologic mechanism. The impact of anti- H. pylori therapy on improvement of iron stores needs to be further evaluated in large and well-controlled trials. [source] Modification of cardiovascular risk in hemodialysis patients: An evidence-based reviewHEMODIALYSIS INTERNATIONAL, Issue 1 2007David W. JOHNSON Abstract Cardiovascular disease accounts for 40% to 50% of deaths in dialysis populations. Overall, the risk of cardiac mortality is 10-fold to 20-fold greater in dialysis patients than in age and sex-matched controls without chronic kidney disease. The aim of this paper is to review critically the evidence that cardiac outcomes in dialysis patients are modified by cardiovascular risk factor interventions. There is limited, but as yet inconclusive controlled trial evidence that cardiovascular outcomes in dialysis populations may be improved by antioxidants (vitamin E or acetylcysteine), ensuring that hemoglobin levels do not exceed 120 g/L (especially in the setting of known cardiovascular disease), prescribing carvedilol in the setting of dilated cardiomyopathy, and by using cinacalcet in uncontrolled secondary hyperparathyroidism. Similarly, there are a number of negative controlled trials, which have demonstrated that statins, high-dose folic acid, angiotensin-converting enzyme inhibitors, multiple risk factor intervention via multidisciplinary clinics, and high-dose or high-flux dialysis are ineffective in preventing cardiovascular disease. Although none of these studies could be considered conclusive, the negative trials to date should raise significant concerns about the heavy reliance of current clinical practice guidelines on extrapolation of findings from cardiovascular intervention trials in the general population. It may be that cardiovascular disease in dialysis populations is less amenable to intervention, either because of the advanced stage of chronic kidney disease or because the pathogenesis of cardiovascular disease in dialysis patients is different from that in the general population. Large, well-conducted, multicenter randomized-controlled trials in this area are urgently required. [source] Efficacy of integrated interventions combining psychiatric care and nursing home care for nursing home residents: a review of the literatureINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2010Janine Collet Abstract Background Nursing home residents needing both psychiatric care and nursing home care for either somatic illness or dementia combined with psychiatric disorders or severe behavioural problems are referred to as Double Care Demanding patients, or DCD patients. Integrated models of care seem to be necessary in order to improve the well-being of these residents. Objectives Two research questions were addressed. First, which integrated interventions combining both psychiatric care and nursing home care in DCD nursing home residents are described in the research literature? And second, which outcomes of integrated interventions combining both psychiatric care and nursing home care in DCD nursing home residents are reported in the literature? Method A critical review of studies was done that involved integrated interventions combining both psychiatric care and nursing home care on psychiatric disorders and severe behavioural problems in nursing home patients. A systematic literature search was performed in a number of international databases. Results Eight intervention trials, including four RCTs (2b level of evidence), were identified as relevant studies for the purpose of this review. Seven studies, three of which were RCTs, showed beneficial effects of a comprehensive, integrated multidisciplinary approach combining medical, psychiatric and nursing interventions on severe behavioural problems in DCD nursing home patients. Conclusions Important elements of a successful treatment strategy for DCD nursing home patients include a thorough assessment of psychiatric, medical and environmental causes as well as programmes for teaching behavioural management skills to nurses. DCD nursing home patients were found to benefit from short-term mental hospital admission. This review underlines the need for more rigorously designed studies to assess the effects of a comprehensive, integrated multidisciplinary approach towards DCD nursing home residents. Copyright © 2009 John Wiley & Sons, Ltd. [source] The interleukin-6 (IL6),174 G/C promoter genotype is associated with the presence of septic shock and the ex vivo secretion of IL6INTERNATIONAL JOURNAL OF IMMUNOGENETICS, Issue 6 2007J. J. W. Tischendorf Summary Septic shock is associated with a high mortality and an excessive activation of immune cascades. Interleukin (IL)-6 has been found to be a key cytokine in the pathogenesis of severe sepsis, but the importance of a regulatory polymorphism within the IL6 promoter has been controversial in these patients. The aim of the study was therefore to systematically investigate the IL6,174 G/C promoter genotype with regard to the presence of shock in patients with sepsis, the IL6 serum levels, and the ex vivo secretion of IL6, respectively. Overall, 112 consecutive subjects with severe sepsis and septic shock according to consensus criteria were enrolled. The ex vivo secretion of IL6 after stimulation with lipopolysaccharide (LPS) in a whole blood assay and the IL6 serum concentrations were determined after admission of the patients. Among the 112 subjects with severe sepsis, 85 patients fulfilled the criteria of septic shock. In these patients, the frequency of the mutated C-allele of the IL6 promoter polymorphism was significantly (P = 0.04) higher compared to that in individuals without shock. IL6 serum concentrations were highest in patients with the GG genotype (mean 2209 pg mL,1), followed by CG genotype (mean 1113 pg mL,1), and lowest in individuals with the CC genotype (mean 256 pg mL,1). Interestingly, a significantly (P = 0.005) higher ex vivo secretion of IL6 is detected in heterozygote individuals (535 pg mL,1) and patients with the IL6 CC genotype (555 pg mL,1) compared to patients with the ,174 GG genotype (276 pg mL,1). In conclusion, the IL6,174 G/C promoter genotype is associated with shock in patients with sepsis. Functionally, the mutated C-allele is correlated with low IL6 serum concentrations, but a high ex vivo secretion after LPS stimulation. These results further indicate a complex regulation of the expression of IL6 during infection and have implications for the design of immune intervention trials. [source] Adding an Alcohol-Related Risk Score to an Existing Categorical Risk Classification for Older Adults: Sensitivity to Group DifferencesJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 3 2007Sandra R. Wilson PhD OBJECTIVES: To evaluate a new alcohol-related risk score for research use. DESIGN: Using data from a previously reported trial of a screening and education system for older adults (Computerized Alcohol-Related Problems Survey), secondary analyses were conducted comparing the ability of two different measures of risk to detect postintervention group differences: the original categorical outcome measure and a new, finely grained quantitative risk score based on the same research-based risk factors. SETTING: Three primary care group practices in southern California. PARTICIPANTS: Six hundred sixty-five patients aged 65 and older. MEASUREMENTS: A previously calculated, three-level categorical classification of alcohol-related risk and a newly developed quantitative risk score. RESULTS: Mean postintervention risk scores differed between the three experimental conditions: usual care, patient report, and combined report (P<.001). The difference between the combined report and usual care was significant (P<.001) and directly proportional to baseline risk. The three-level risk classification did not reveal approximately 57.3% of the intervention effect detected by the risk score. The risk score also was sufficiently sensitive to detect the intervention effect within the subset of hypertensive patients (n=112; P=.001). CONCLUSION: As an outcome measure in intervention trials, the finely grained risk score is more sensitive than the trinary risk classification. The additional clinical value of the risk score relative to the categorical measure needs to be determined. [source] Cooperative Dementia Care Clinics: A New Model for Managing Cognitively Impaired PatientsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2006Mary Lessig BS Cooperative health care clinics (CHCCs), or shared medical appointments, are a healthcare innovation that can improve access and expand physicians' capacity to manage common geriatric conditions. This report describes a pilot program and working model for extending CHCCs to patients with dementia. Three cooperative dementia care clinics (CDCCs) met monthly for up to 1 year, drawing participants from a dementia clinic roster of patients and caregivers who had required continued specialty care for at least 3 months. Twenty-six of 33 eligible patient,caregiver dyads expressed interest, and 21 enrolled; five whose clinical status changed during the year withdrew and were replaced with new members. Brief introductory socialization, individualized clinical management, and an educational focus selected from problems of patients and caregivers were common to all sessions. Most participants required several types of clinical intervention and educational support. One group ended after reaching a natural termination point, and two others are ongoing at the request of participants. CDCCs can be a viable approach to increasing dementia care capacity in health systems. Formal service intervention trials to evaluate the generalizability and comparative effectiveness and economic viability of this model versus usual care are an appropriate next step. [source] An expanded role for dietitians in maximising retention in nutrition and lifestyle intervention trials: implications for clinical practiceJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2010L. M. Delahanty Abstract The demand for clinical trials targeting lifestyle intervention has increased as a result of the escalation in obesity, diabetes mellitus and cardiovascular disease. Little is published about the strategies that dietitians have used to successfully screen potential study volunteers, implement interventions and maximise adherence and retention in large multicentre National Institutes of Health funded nutrition and lifestyle intervention clinical trials. This paper discusses an expanded role for the contributions of dietitians as members of an interdisciplinary team based on research experiences in the Diabetes Control and Complications Trial, Diabetes Prevention Program and Look AHEAD (Action for Health in Diabetes). Many of the strategies and insights discussed are also relevant to effective clinical practice. Dietitians need to broaden their scope of practice so that they are integrated proactively into the screening and intervention phases of large clinical trials to maximise retention and adherence to assigned nutrition, lifestyle and behavioural interventions. The skills of dietitians are a unique fit for this work and it is important that investigators and project managers consider including them in both the screening and intervention phases of such clinical trials to maximise retention results. [source] Chlamydia pneumoniae in atherosclerosisJOURNAL OF INTERNAL MEDICINE, Issue 3 2000P. Saikku Abstract. Saikku P (National Public Health Institute, Oulu, Finland). Chlamydia pneumoniae in atherosclerosis (Minisymposium). J Intern Med 2000; 247: 391,396. Chlamydia pneumoniae is currently the infectious agent most often associated with the inflammation found in atherosclerosis. The seroepidemiological association and the actual presence of pathogen in lesions has been confirmed in numerous studies, in which technical difficulties seem to be the only limitation. Besides animal experiments and intervention trials, we need information of possible pathogenic mechanisms. Recently, several studies have suggested mechanisms by which C. pneumoniae infection could participate in the development of atherosclerosis. [source] Gene-environment interaction and obesityNUTRITION REVIEWS, Issue 12 2008Lu Qi The epidemic of obesity has become a major public health problem. Common-form obesity is underpinned by both environmental and genetic factors. Epidemiological studies have documented that increased intakes of energy and reduced consumption of high-fiber foods, as well as sedentary lifestyle, were among the major driving forces for the epidemic of obesity. Recent genome-wide association studies have identified several genes convincingly related to obesity risk, including the fat mass and obesity associated gene and the melanocortin-4 receptor gene. Testing gene-environment interaction is a relatively new field. This article reviews recent advances in identifying the genetic and environmental risk factors (lifestyle and diet) for obesity. The evidence for gene-environment interaction, especially from observational studies and randomized intervention trials, is examined specifically. Knowledge about the interplay between genetic and environmental components may facilitate the choice of more effective and specific measures for obesity prevention based on the personalized genetic make-up. [source] Update: Effects of Antioxidant and Non-Antioxidant Vitamin Supplementation on Immune FunctionNUTRITION REVIEWS, Issue 5 2007Aimee L. Webb PhD The purpose of this manuscript is to review the impact of supplementation with vitamins E and C, carotenoids, and the B vitamins on parameters of innate and adaptive immune function as reported from clinical trials in humans. There is evidence to support causal effects of supplementation with vitamins E and C and the carotenoids singly and in combination on selected aspects of immunity, including the functional capacity of innate immune cells, lymphocyte proliferation, and the delayed-type hypersensitivity (DTH) response. Controlled intervention trials of B vitamin-containing multivitamin supplements suggest beneficial effects on immune parameters and clinical outcomes in HIV-positive individuals [source] A Potential Role for Vitamin D on HIV Infection?NUTRITION REVIEWS, Issue 5 2006Eduardo Villamor MD Despite advances in the knowledge of vitamin D's potent immunomodulatory activity, its role on HIV disease progression is unknown. Decreased concentrations of 1,,25-hydroxyvitamin D3, or 1,25(OH)2D, the active form of vitamin D, have been reported among HIV-infected people and attributed to defects in renal hydroxylation and increased utilization. A few studies also described low levels of 25-hydroxyvitamin D3, 25(OH)D, the vitamin obtained from solar synthesis and diet. An inverse association between 1,25(OH)2D concentrations and mortality has been reported from a small cohort of HIV-infected adults, and some cross-sectional studies have indicated positive correlations between 1,25(OH)2D and CD4+ cell counts. Additional observational studies are needed to confirm the associations between vitamin D status and HIV disease progression. These investigations would provide useful insights on the potential role of vitamin D supplementation to HIV-infected persons and the planning of intervention trials. [source] Psychological Intervention Following Implantation of an Implantable Defibrillator: A Review and Future RecommendationsPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 12 2007SUSANNE S. PEDERSEN Ph.D. Background:The medical benefits of the implantable cardioverter defibrillator (ICD) are unequivocal, but a subgroup of patients experiences emotional difficulties following implantation. For this subgroup, some form of psychological intervention may be warranted. This review provides an overview of current evidence on the efficacy of psychological intervention in ICD patients and recommendations for future research. Methods:We searched the PubMed and PsycInfo databases in the period between January 1980 and April 2007, using a set of a priori determined keywords. Based on the search and a hand search of the reference lists of the included articles, we identified nine studies that fulfilled the inclusion criteria. Results:The majority of studies used a randomized controlled trial design, but studies varied considerably in sample size, response, attrition rate, and type of intervention. However, most interventions were multifactorial, using cognitive behavioral therapy as one of the mainstays of treatment. Overall, psychological interventions seem to have little impact on shocks and heart rate variability. Some studies found a decrease in depressive symptoms and gains in quality of life, but the most notable effects are seen in improved exercise capacity and reductions in anxiety. Effect sizes for changes in anxiety in the intervention group ranged from small to large compared to small in the usual care group, using Cohen's effect size index. Conclusions:Preliminary evidence from small-scale intervention trials suggests that psychological intervention is worthwhile in ICD patients. Nevertheless, large-scale, well-designed trials are warranted to substantiate these findings. A multifactorial approach using a cognitive behavioral component paired with exercise training is likely to be the most successful. [source] Type 1 diabetes intervention trialsPEDIATRIC DIABETES, Issue 1 2001Massimo Pietropaolo This and the following article address the current controversies for the application of studies to predict and prevent type 1 diabetes, based on currently available methodologies. This article outlines the position of the proponent; the following article outlines the position of the opponent. The intent is to illuminate by intellectual debate. [source] arNOX activity of saliva as a non-invasive measure of coenzyme Q10 response in human trialsBIOFACTORS, Issue 1-4 2008D. James Morré arNOX is a coenzyme Q10 -inhibited, aging-related ECTO-NOX protein of the cell surface also present in sera. It is capable of Superoxide generation measured as Superoxide dismutase-inhibited reduction of ferricytochrome c and is a potential contributor to atherogenic risk. Here, we report an arNOX activity of saliva of older individuals also inhibited by coenzyme Q10. The activity first appears after age 30 to a near maximum at about age 55. Those surviving beyond age 55 usually have reduced arNOX activities. Our studies demonstrate significant (25 to 30%) reduction of arNOX levels with coenzyme Q10 supplementation of 60 mg (2 × 30 mg) per day for 28 days. Activity correlated with age. Response to coenzyme Q10 increased with age being greatest between ages 60 and 65. Saliva arNOX levels varied in a regular pattern throughout the day so it was important that samples be collected at approximately the same time each day for comparative purposes. The coenzyme Q10 response was reversible and within 12 h after the last intake of coenzyme Q10, the salivary arNOX levels returned to base line. The findings suggest that salivary arNOX provides a convenient and non-invasive method to monitor arNOX levels in clinical coenzyme Q10 intervention trials with the response levels paralleling those seen with serum and cellular arNOX. [source] The antioxidative function, preventive action on disease and utilization of proanthocyanidinsBIOFACTORS, Issue 1-4 2004Toshiaki Ariga Abstract Proanthocyanidins, which belong to a class of polyphenols, are widely distributed throughout the plant kingdom. Most people ingest trace amounts of proanthocyanidins through foods such as red wine and cranberry juice. However, the functional properties of proanthocyanidins have been little understood. Since 1983, we have studied the antioxidative functions, preventive actions on diseases and utilization of proanthocyanidins. The antioxidative activities of proanthocyanidins were found to be much stronger than vitamin C or vitamin E in aqueous systems. The mechanisms for their antioxidative actions were shown to involve radical scavenging, quenching, and enzyme-inhibiting actions. The preventive actions of proanthcyanidins on diseases relating to reactive oxygen species was examined using animal tests. Proanthocyanidin-rich grape seed extract was showed to have preventive actions on diseases such as atherosclerosis, gastric ulcer, large bowel cancer, cataracts and diabetes. In human intervention trials, grape seed extract was shown to have preventive effects on the increase in lipid peroxides in human plasma after exercise and on muscle fatigue after training. The uses and manufacturing techniques of proanthocyanidin products were subsequently developed. The products were launched as antioxidants in food additives, ingredients in nutritional supplements, and cosmetics. [source] Imputation Strategies for Missing Continuous Outcomes in Cluster Randomized TrialsBIOMETRICAL JOURNAL, Issue 3 2008Monica Taljaard Abstract In cluster randomized trials, intact social units such as schools, worksites or medical practices , rather than individuals themselves , are randomly allocated to intervention and control conditions, while the outcomes of interest are then observed on individuals within each cluster. Such trials are becoming increasingly common in the fields of health promotion and health services research. Attrition is a common occurrence in randomized trials, and a standard approach for dealing with the resulting missing values is imputation. We consider imputation strategies for missing continuous outcomes, focusing on trials with a completely randomized design in which fixed cohorts from each cluster are enrolled prior to random assignment. We compare five different imputation strategies with respect to Type I and Type II error rates of the adjusted two-sample t -test for the intervention effect. Cluster mean imputation is compared with multiple imputation, using either within-cluster data or data pooled across clusters in each intervention group. In the case of pooling across clusters, we distinguish between standard multiple imputation procedures which do not account for intracluster correlation and a specialized procedure which does account for intracluster correlation but is not yet available in standard statistical software packages. A simulation study is used to evaluate the influence of cluster size, number of clusters, degree of intracluster correlation, and variability among cluster follow-up rates. We show that cluster mean imputation yields valid inferences and given its simplicity, may be an attractive option in some large community intervention trials which are subject to individual-level attrition only; however, it may yield less powerful inferences than alternative procedures which pool across clusters especially when the cluster sizes are small and cluster follow-up rates are highly variable. When pooling across clusters, the imputation procedure should generally take intracluster correlation into account to obtain valid inferences; however, as long as the intracluster correlation coefficient is small, we show that standard multiple imputation procedures may yield acceptable type I error rates; moreover, these procedures may yield more powerful inferences than a specialized procedure, especially when the number of available clusters is small. Within-cluster multiple imputation is shown to be the least powerful among the procedures considered. (© 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Psychiatric disorders in advanced cancerCANCER, Issue 8 2007Michael Miovic MD Abstract BACKGROUND. Emotional distress and psychiatric disorders are common among patients with advanced cancer. Oncologists play an important role in screening for these conditions, providing first-line treatment and referring patients for further evaluation and treatment when indicated. METHODS. The literature on psycho-oncology was reviewed, focusing on the epidemiology, assessment, and treatment of psychiatric disorders (adjustment disorders, major depression, anxiety and post-traumatic stress, personality disorders, substance abuse, and major mental disorders such as schizophrenia and bipolar disorder) in patients with advanced cancer. Communication skills and the role of the oncologist in dealing with end-of-life issues were also reviewed. Relevant data were summarized from the most recent systematic reviews, epidemiological studies, and intervention trials. Clinical recommendations are provided. RESULTS. About 50% of patients with advanced cancer meet criteria for a psychiatric disorder, the most common being adjustment disorders (11%,35%) and major depression (5%,26%). Both psychosocial and pharmacological treatments are effective for anxiety and depression, although existing studies have methodological limitations. Collaboration with mental health specialists is recommended for patients with personality disorders, major mental illness, and substance abuse problems. Effective communication involves active listening, exploring emotion and meaning, addressing prognosis, and discussing end-of-life issues when relevant. CONCLUSIONS. Treating psychiatric conditions improves quality of life in patients with advanced cancer. Oncologists play a key role in screening for psychiatric disorders, initiating first-line treatments for depression and anxiety, and communicating with patients and caregivers about prognosis and end-of-life issues. Cancer 2007. © 2007 American Cancer Society. [source] Treatment effects, disease recurrence, and survival in obese women with early endometrial carcinoma,CANCER, Issue 12 2006A Gynecologic Oncology Group study Abstract BACKGROUND. The objective was to examine whether rates of disease recurrence, treatment-related adverse effects, and survival differed between obese or morbidly obese and nonobese patients. METHODS. Data from patients who participated in a randomized trial of surgery with or without adjuvant radiation therapy were retrospectively reviewed. RESULTS. Body mass index (BMI) data were available for 380 patients, of whom 24% were overweight (BMI, 25,29.9), 41% were obese (BMI, 30,39.9), and 12% were morbidly obese (BMI, ,40). BMI did not significantly differ based on age, performance status, histology, tumor grade, myometrial invasion, or lymphovascular-space involvement. BMI > 30 was more common in African Americans (73%) than non-African Americans (50%). Patients with a BMI , 40 compared with BMI < 30 (hazards ratio [HR], 0.42; 95% confidence interval [CI], 0.09,1.84; P = .246) did not have lower recurrence rates. Compared with BMI < 30, there was no significant difference in survival in patients with BMI 30,39.9 (HR, 1.48; 95% CI, 0.82,2.70; P = .196); however, there was evidence for decreased survival in patients with BMI , 40 (HR, 2.77; 95% CI, 1.21,6.36; P = .016). Unadjusted and adjusted BMI hazards ratios for African Americans versus non-African Americans in the current study differed, thus suggesting a confounding effect of BMI on race. Eight (67%) of 12 deaths among 45 morbidly obese patients were from noncancerous causes. For patients who received adjuvant radiation therapy, increased BMI was significantly associated with less gastrointestinal (R, ,0.22; P = .003) and more cutaneous (R, 0.17; P = .019) toxicities. RESULTS. In the current study, obesity was associated with higher mortality from causes other than endometrial cancer but not disease recurrence. Increased BMI was also associated with more cutaneous and less gastrointestinal toxicity in patients who received adjuvant radiation therapy. Future recommendations include lifestyle intervention trials to improve survival in obese endometrial cancer patients. Cancer 2006. © 2006 American Cancer Society. [source] Meta-analysis of blood pressure tracking from childhood to adulthood and implications for the design of intervention trialsACTA PAEDIATRICA, Issue 1 2010AM Toschke Abstract Aim:, Blood pressure (BP) is related with cardiovascular disease. BP tracking in childhood and its implication for intervention trials are unknown. Methods:, A systematic review and meta-analysis were conducted to estimate BP tracking. Results:, In 29 independent studies on 27 820 subjects, follow-up length and baseline age were associated with systolic BP tracking (both p < 0.05), while gender, BP measurement method and study place were not (p = 0.215, p = 0.185 and p = 0.391). The overall adjusted systolic BP correlation coefficient was 0.44 between 10 and 11 years and decreased to 0.37 between 10 and 20 years. Comparison of BP changes before and after intervention need a 26% increased sample size for a 10-year follow-up of 10 year olds, while trials comparing BP values at study end only require smaller sample sizes. Conclusion:, Blood pressure tracking from childhood to adulthood affects trials assessing long-term effects on BP and was low-to-moderate. Therefore, regular BP controls are also needed in children with normal BP measurements possibly identifying hypertensive children earlier. A slight short-term intervention effect on BP may not have any long-term effects because of low BP tracking and its decrease by age. [source] Participation in organized weekly physical exercise in obese adolescents reduced daily physical activityACTA PAEDIATRICA, Issue 2 2009Maria Hagströmer Abstract Aim: The aim of this study was to describe the impact of organized weekly exercise for 13 weeks on aerobic fitness, objectively assessed habitual physical activity and body weight in obese adolescents. Methods: After inclusion and diagnostic evaluation, the adolescents were randomized to either an exercise group or to a control group which lasted for 13 weeks and consisted of a variety of group exercise activities. Out of 47 adolescents 31 (66%) could be evaluated, 16 in the exercise group and 15 in the control group. Results: After the intervention, the exercise group had decreased the daily time spent in moderate activity by 17 (32) min/day (p < 0.05), and the average intensity by 60 (96) counts/min (p < 0.05). A tendency for increased time spent in inactivity was found (37 min/day). No differences were seen in the control group for any of the variables measured. Conclusion: The exercise group showed, in contrast to expectations, a reduction in total daily physical activity with organized physical exercise compared to the control group. This may partly explain the failure of many intervention trials. [source] Liver dysfunction in Turner's syndrome: prevalence, natural history and effect of exogenous oestrogenCLINICAL ENDOCRINOLOGY, Issue 2 2008Olympia Koulouri Summary Objectives, Raised liver enzymes are a common feature of Turner's syndrome (TS), but the cause remains unclear. We studied the hepatic function in a large cohort of women with TS and tested the effect of increasing doses of hormone replacement therapy (HRT) on liver function tests (LFTs). Design and patients, LFTs were assessed in three studies. A cross-sectional review of liver function of 125 women (median age: 31 years), a longitudinal study of 30 women (mean follow-up period: 8 years) and a dose,response study of 14 women with TS and 11 controls with hypogonadism, who received oral 17-,-oestradiol (E2) 1, 2 and 4 mg daily in a cyclical formulation for 12 weeks each. Measurements, Clinical features, oestrogen use and metabolic parameters were compared to liver enzymes (,-glutamyl transferase (GGT), alanine aminotransferase (ALT) and alkaline phosphatase (ALP)), albumin and bilirubin. LFTs were also measured during each treatment interval of the dose,response study. Hepatic autoimmunity was sought in the cross-sectional study. Results, When compared to the control population, as opposed to reference ranges, 91% of women with TS demonstrated liver enzyme elevation, with a yearly incidence of 2·1%. LFTs correlated positively with cholesterol (P < 0·001), BMI (P = 0·004) and type of oestrogen therapy (P = 0·04). Increasing doses of HRT resulted in a significant decrease in GGT, ALT, bilirubin and albumin. No evidence of excessive hepatic autoimmunity was found. Conclusion, The prevalence of raised liver enzymes in TS may have been underestimated by the use of reference ranges rather than matched controls. Obesity and hyperlipidaemia are associated with raised LFTs, as well as the use of HRT compared to the oral contraceptive pill (OCP). Exogenous oestrogen both as OCP and HRT improves liver function. Liver dysfunction in TS is likely to be a form of hepatic steatosis and intervention trials are now indicated. [source] Depression and Obesity: Implications for Assessment, Treatment, and ResearchCLINICAL PSYCHOLOGY: SCIENCE AND PRACTICE, Issue 1 2008Melissa A. Napolitano Markowitz, Friedman, and Arent (2008) review the literature on the relationship between obesity and depression and (a) highlight behavioral, cognitive, physiological, and social mechanisms potentially elucidating these links and (b) provide a valuable resource both for clinicians and researchers. This commentary underscores (a) the strengths of the article; (b) additional areas of consideration; (c) implications for treatment; and (d) future clinical and research opportunities. Also included are suggestions for the design and measurement of future longitudinal observational studies, intervention trials, and other conceptual models. Finally, we comment on the responsibility of the scientist practitioner not only to consider evaluating and treating each behavior in isolation, but also to take an inclusive approach and apply the common features of evidence-based treatment for both obesity and depression. [source] | |||||||||||||