An Examination of the Sport Commitment Model for Athletes With Physical Disabilities.

Sport commitment describes a psychological attachment to a sport that influences one's desire or resolve to continue involvement in it. Studying antecedents believed to influence long term commitment to sport among athletes with a disability will help ensure that participants gain those psychosocial and health outcomes from sport participation that benefit quality of life. Our purposes in this study were: (i) to examine the Sport Commitment Model (SCM) in terms of the magnitude of the contribution of antecedent factors (i.e., enjoyment, personal investment, involvement opportunities, social constraints, involvement alternatives) to sport commitment of athletes with disabilities; and (ii) to examine the model structure (i.e., original SCM, mediation, and direct/indirect model) that best reflects an understanding of the sport commitment antecedents for these athletes. A total of 157 adult athletes (M age = 34.87, SD = 11.78) with physical disabilities from both team and individual sports across the United States, Europe, and Asia completed the Sport Commitment Questionnaire. Data analyses indicated that sport involvement opportunities, followed by personal investment, were the strongest predictors of these athletes' sport commitments (R2 = .66). Based on the principle of parsimony, the original structural equation model (χ2 (215) = 384.95; RMSEA = .07; CFI = .95; SRMR = .06) was deemed better for understanding the mechanism of sport commitment than the mediation or direct/indirect models. We address implications of applying the SCM to athletes with disabilities, and we offer suggestions for future research.

Theory of planned behavior to promote physical activity of adults with physical disabilities: Meta-analytic structural equation modeling.

BACKGROUND: Adults with physical disabilities experience lower physical activity (PA) engagement. The theory of planned behavior (TPB) has been one of dominant theories in understanding and promoting PA. There is no previous meta-analysis examining the use of the TPB on PA of adults with physical disabilities. OBJECTIVE: The purposes of this review were 1) to conduct meta-analysis to examine predictive effects of TPB on PA behavior of adults with physical disabilities and 2) to investigate a possible moderator among components of TPB. METHODS: One-stage meta-analytic structural equation modeling was used to conduct meta-analysis. Type of physical disability was examined as a moderator. RESULTS: Intention had moderate effect on PA (ß = 0.37, p < .001), attitude had a moderate effect on intention (ß = 0.30, p < .001), SN had a non-significant effect on intention (ß = 0.03, p = .75), and PBC had a moderate effect on intention (ß = 0.43, p < .001) and a non-significant direct effect on PA (ß = 0.09, p = .18). The studies conducted with only participants with SCI lowered the predictive effect (ß = -0.12, p = .02) of PBC on PA. CONCLUSIONS: Predictive effects of component of TPB were slightly different from those of individuals without disabilities. Type of physical disability can be a critical factor determining the impact of perceived control on PA behavior. Attitude and PBC can be targets for promoting PA of adults with physical disabilities.

Quality of life and psychological affect related to sport participation in children and youth athletes with physical disabilities: A parent and athlete perspective.

BACKGROUND: Adapted sport, with its recreational, therapeutic, and competitive characteristics is increasingly serving as a forum through which to develop and maintain physical and psychological functioning, promote good health by developing a healthy lifestyle, and enhance health related quality of life (HRQoL) and life satisfaction of persons with disabilities. OBJECTIVE: This study examined the relationship between athlete and parent perceptions of health related quality of life (HRQoL) and the relationship between the athletes' perceived HRQoL and subjective exercise evaluations. METHODS: A total of 70 youth athletes with physical disabilities (Mage = 15, SD = 2.92) and a parent completed the pediatric quality of life inventory (PedsQL). Participants also completed the subjective exercise experience scale (SEES) prior to and immediately after a sport practice. RESULTS: Athletes with disabilities reported higher perceptions of HRQoL than their parents reported for them on physical (t = 4.42, p = .000), emotional (t = 2.78, p = .006) and social (t = 3.26, p = .000) functioning subscales with moderate to high effect sizes (d = .81, .51-1.30, respectively). Positive well-being subscale from the SEES was significantly related to overall HRQoL (r = .49, p = .001) and was a significant predictor (R(2) = .238, F Change = 13.42 (1, 42) p = .001) of overall HRQoL. CONCLUSIONS: Since parents, specifically for younger children, primarily make decisions about program and therapeutic treatments, understanding differences in perceptions of HRQoL between parent and athlete is essential to improving athlete recruitment and structuring program interventions directed at improving HRQoL and emotional well-being of children with disabilities.

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes.

In December 2008, the US Food and Drug Administration (FDA) issued a guidance for industry requiring sponsors to demonstrate that a new antidiabetic therapy being developed to treat type 2 diabetes does not increase cardiovascular (CV) risk to an unacceptable extent. CV events reported during phase 2 and phase 3 trials should be prospectively and independently adjudicated. Before submission of a new drug application or biologics license application, sponsors should compare the incidence of major CV events occurring with the investigational agent versus the control group to show that the upper bound of the 2-sided 95% confidence interval (CI) for the estimated risk ratio is less than 1.8. If the CI includes 1.3, a postmarketing trial will be necessary to definitively show that the upper bound of the 95% CI for the estimated risk ratio is then less than 1.3. In 2012, the European Medicines Agency (EMA) issued an updated guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus that detailed its CV safety assessment requirements. Although similar to the FDA guidance, the EMA guideline does not prospectively define any pre- or postapproval risk margins. This expert perspective, prepared by members of the Cardiac Safety Research Consortium, discusses clinical development strategies, operational issues, and statistical methodological issues to satisfy the FDA's CV safety requirements, and, where appropriate, the EMA guideline. Actual case examples, where applicable, are presented.

The relationships among sport self-perceptions and social well-being in athletes with physical disabilities.

BACKGROUND: Peer relationships account for a significant motivational influence on sport participation among youth athletes with and without disabilities. OBJECTIVE: The primary purpose of this study was to determine if the quality of friendships, physical self-perceptions and general self-worth predicted close friendship, loneliness and social acceptance among 46 athletes with physical disabilities (males = 35, female = 11) between the ages of 12 and 21 (M age = 15.37, SD = 2.45). Second, this study examined descriptive information on the quality of friendships inside and outside of an adapted sport setting, feelings of loneliness, social acceptance, close friendships, athletic competence, physical appearance, and self-worth among youth athletes with physical disabilities. METHODS: Participants completed the Sport Friendship Quality Scale (SFQS), a Loneliness Rating Scale and the Self-Perception Profile for Adolescents (SPPA). RESULTS: Three regression analyses used positive and negative aspects of non-sport friendship quality, positive aspects of sport friendship quality, physical appearance, athletic competence, and self-worth as predictors and accounted for 57%, 41%, and 31% of the variance in loneliness, close friendships, and social acceptance, respectively. Athletic competence and self-worth were the most important predictors of loneliness and close friendships with significant (p < .10) beta weights. No single predictor had a significant beta weight in predicting social acceptance. Negative and positive elements of friendship quality were not important predictors. CONCLUSIONS: These findings highlight the importance of global psychological (i.e., self-worth) and sport specific psychological (i.e., athletic competence) constructs in predicting important social well-being indices (i.e., close friendships & loneliness).

Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease.

Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, lowers blood glucose when administered as monotherapy or in combination with other antihyperglycemic agents. TECOS will evaluate the effects of adding sitagliptin to usual diabetes care on cardiovascular outcomes and clinical safety. TECOS is a pragmatic, academically run, multinational, randomized, double-blind, placebo-controlled, event-driven trial recruiting approximately 14,000 patients in 38 countries who have type 2 diabetes (T2DM), are at least 50 years old, have cardiovascular disease, and have an hemoglobin A1c value between 6.5% and 8.0%. Eligible participants will be receiving stable mono- or dual therapy with metformin, sulfonylurea, or pioglitazone, or insulin alone or in combination with metformin. Randomization is 1:1 to double-blind sitagliptin or matching placebo, in addition to existing therapy in a usual care setting. Follow-up occurs at 4-month intervals in year 1 and then twice yearly until 1300 confirmed primary end points have occurred. Glycemic equipoise between randomized groups is a desired aim. The primary composite cardiovascular endpoint is time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina, with cardiovascular events adjudicated by an independent committee blinded to study therapy. TECOS is a pragmatic-design cardiovascular outcome trial assessing the cardiovascular effects of sitagliptin when added to usual T2DM management.

Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis.

OBJECTIVE: To compare the incidence of cardiovascular events and mortality in patients with type 2 diabetes mellitus treated with sitagliptin or non-sitagliptin comparators. METHODS: A post hoc assessment of cardiovascular safety in 14,611 patients was performed by pooling data from 25 double-blind studies, which randomised patients at baseline to sitagliptin 100 mg/day or a non-sitagliptin comparator (i.e., non-exposed). Included studies were limited to those at least 12 weeks in duration (range: 12 to 104 weeks). Patient-level data were used in this analysis of major adverse cardiovascular events (MACE) including ischaemic events and cardiovascular deaths. Analyses were performed in three cohorts: the entire 25-study cohort, the cohort from placebo-controlled portions of studies (n=19), and the cohort from studies comparing sitagliptin to a sulphonylurea (n=3). RESULTS: In the entire cohort analysis, 78 patients had at least 1 reported MACE-related event, with 40 in the sitagliptin group and 38 in the non-exposed group. The exposure-adjusted incidence rate was 0.65 per 100 patient-years in the sitagliptin group and 0.74 in the non-exposed group (incidence rate ratio = 0.83 [95% confidence interval (CI): 0.53, 1.30]). In the analysis comparing sitagliptin to placebo, the exposure-adjusted incidence rate was 0.80 per 100-patient-years with sitagliptin and 0.76 with placebo (incidence rate ratio = 1.01 [95% CI: 0.55, 1.86]). In the analysis comparing sitagliptin to sulphonylurea, the exposure-adjusted incidence rate was 0.00 per 100 patient-years with sitagliptin and 0.86 with sulphonylurea (incidence rate ratio = 0.00 [95% CI: 0.00, 0.31]). CONCLUSION: A pooled analysis of 25 randomised clinical trials does not indicate that treatment with sitagliptin increases cardiovascular risk in patients with type 2 diabetes mellitus. In a subanalysis, a higher rate of cardiovascular-related events was associated with sulphonylurea relative to sitagliptin.

Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy.

INTRODUCTION: The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy. There is a lack of data regarding the safety of HCQ during pregnancy. AREAS COVERED: In this review, the authors attempt to identify relevant publications by searching MEDLINE, Cochrane database, Ovid-Currents Clinical Medicine, Ovid-Embase:Drugs and Pharmacology, EBSCO, Web of Science and SCOPUS using the search terms HCQ and/or pregnancy. A basis for the mechanism of action of HCQ is provided. EXPERT OPINION: HCQ has been shown by numerous studies over the past 15 years to be efficacious in the treatment of autoimmune diseases, including systemic lupus erythematosus, discoid lupus erythematosus and rheumatoid arthritis. HCQ does not appear to be associated with any increased risk of congenital defects, spontaneous abortions, fetal death, prematurity or decreased numbers of live births in patients with autoimmune diseases. Therefore, in the author's opinion, HCQ is safe for the treatment of autoimmune diseases during pregnancy.

Athletic identity, affect, and peer relations in youth athletes with physical disabilities.

BACKGROUND: Theory-based investigations of the psychosocial aspects of youth participation in disability sport are underresearched, suggesting a need for more scholarly inquiry in this area. We sought to examine athletic identity, affect, and peer relations of youth athletes with physical disabilities and selected relationships among these variables. METHODS: Participants (N=36) completed the Private-Public Athletic Identity Scale, the Positive and Negative Affect Schedule, and the Peer Relations Scale. RESULTS: Participants reported stronger private athletic identity individual item scores (mean ≈ 4.0) compared with a public (mean=2.4) athletic identity and expressed much positive (mean=4.4) affect and low negative affect (mean=1.7). They also expressed strong peer relations (mean=5.0). A significant relationship (r=0.34, p < .05) between positive affect and peer relations existed. CONCLUSIONS: Friendships in and outside of disability sport may contribute to quality of life by promoting positive affective states such as feelings of joy, satisfaction, inspiration, excitement, and enthusiasm. In general, our results supported the potentially positive role that adapted sport can have on the well-being of youth with physical disabilities.

Multidimensional physical self-concept of athletes with physical disabilities.

The purposes of this investigation were first to predict reported PA (physical activity) behavior and self-esteem using a multidimensional physical self-concept model and second to describe perceptions of multidimensional physical self-concept (e.g., strength, endurance, sport competence) among athletes with physical disabilities. Athletes (N = 36, M age = 16.11, SD age = 2.8) completed the Physical Self-Description Questionnaire. Participants reported mostly positive perceptions of self-esteem, global physical self-concept, endurance, body fat, sport competence, strength, flexibility, and physical activity (Ms ranging from 3.9 to 5.6 out of 6). Correlations indicated a number of significant relationships among self-esteem and reported PA and various dimensions of physical self-concept. Using physical self-concept, strength, endurance, and flexibility in the first regression equation and sport competence and endurance simultaneously in the second equation, 47 and 31% of the variance was accounted for in self-esteem and reported PA, respectively. The findings support the value of examining multidimensional physical self-concept as different aspects of the physical self appear to have different influences on reported PA engagement versus self-esteem.

A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet.

Improving the maintenance of weight loss remains a critical challenge for obesity researchers. The present 1-year, randomized, placebo-controlled trial evaluated the safety and efficacy of weight maintenance counseling combined with either placebo or the cannabinoid-1 receptor inverse agonist, taranabant, for sustaining prior weight loss achieved on a low-calorie diet (LCD). Seven hundred eighty-four individuals who had lost ≥ 6% of body weight during six initial weeks of treatment with an 800 kcal/day liquid LCD were randomly assigned to placebo or once-daily taranabant in doses of 0.5, 1, or 2 mg. All participants were provided monthly, on-site behavioral weight maintenance counseling, as well as monthly phone calls. The primary end point was change in body weight from randomization to week 52. The randomized participants lost an average of 9.6 kg (9.5% of initial weight) during the 6-week LCD. The model-adjusted mean change in body weight during the subsequent 1 year was +1.7 kg for placebo, compared with -0.1, -0.6, and -1.2 kg for the taranabant 0.5, 1, and 2 mg doses, respectively (all P values ≤ 0.007 vs. placebo). The incidences of psychiatric-related adverse events, including irritability, were higher for taranabant 1 and 2 mg vs. placebo (P ≤ 0.038). In addition to reporting data on the safety and efficacy of taranabant, this study provides a method for studying the combination of lifestyle modification and pharmacotherapy for weight maintenance after diet-induced weight loss.

Gout and hyperuricemia.

Hyperuricemia is an elevated uric acid level in blood. Gout is a common systemic metabolic disease characterized by deposition of monosodium urate monohydrate crystals with resultant acute intense inflammation of the involved joint. The clinical spectrum ranges from asymptomatic hyperuricemia to intermittent acute episodes of gouty arthritis to chronic tophaceous gout and chronic gouty arthropathy.

Effects of increasing high-density lipoprotein cholesterol and decreasing low-density lipoprotein cholesterol on the incidence of first acute coronary events (from the Air Force/Texas Coronary Atherosclerosis Prevention Study).

Reducing low-density lipoprotein (LDL) cholesterol with statins reduces cardiovascular risk, but the associations between increases in high-density lipoprotein (HDL) cholesterol and cardiovascular risk at different LDL levels have been less well characterized. To evaluate the associations between the 1-year changes in HDL cholesterol and LDL cholesterol with lovastatin and subsequent acute major coronary events (AMCEs), we studied 2,928 patients in the lovastatin arm who were followed for 5.2 years in a post-hoc analysis of the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS). The percentage of HDL cholesterol increase and apolipoproteins at year 1 and the incidence of AMCEs thereafter were assessed stratified by the LDL cholesterol levels. With lovastatin, LDL cholesterol was reduced by 25% on average to 115 mg/dl at year 1, and HDL cholesterol increased 6.0%. Patients with both an increase in HDL cholesterol of > or =7.5% and LDL cholesterol of <115 mg/dl at year 1 had the lowest event rate (3.53/1,000 person-years; p = 0.028). Similar results were found for an increase in HDL cholesterol of > or =7.5% and a decrease in LDL cholesterol of >25%, as well as for apolipoproteins A-I and B. The 1-year percent increase in HDL cholesterol appeared to be associated with a reduction in AMCEs in subsequent follow-up (p = 0.07 with the percentage of HDL cholesterol increase analyzed continuously). Patients with an HDL cholesterol increase of > or =7.5% had an AMCE rate of 5.18 compared with 7.66/1,000 person-years in patients with a lower HDL cholesterol increase (p = 0.08). In conclusion, lovastatin therapy was associated with a greater risk reduction of AMCEs when LDL cholesterol was substantially reduced and the HDL cholesterol increased by > or =7.5%.

Systematic review of hydroxychloroquine use in pregnant patients with autoimmune diseases.

OBJECTIVE: The purpose of this study is to compare the incidence of congenital defects, spontaneous abortions, number of live births, fetal death and pre-maturity in women with autoimmune diseases taking HCQ during pregnancy. METHODS: The authors searched MEDLINE, Cochrane data base, Ovid-Currents Clinical Medicine, Ovid-Embase:Drugs and Pharmacology, EBSCO, Web of Science, and SCOPUS using the search terms HCQ and/or pregnancy. We attempted to identify all clinical trials from 1980 to 2007 regardless of language or publication status. We also searched Cochrane Central Library and http://www.Clinical trials.gov for clinical trials of HCQ and pregnancy. Data were extracted onto standardized forms and were confirmed. RESULTS: The odds ratio (OR) of congenital defects in live births of women taking HCQ during pregnancy was 0.66, 95% confidence intervals (CI) 0.25, 1.75. The OR of a live birth for women taking HCQ during pregnancy was 1.05 (95% CI 0.58, 1.93). The OR of spontaneous abortion in women taking HCQ during pregnancy was 0.92 (95% CI 0.49, 1.72). The OR of fetal deaths in women taking HCQ during pregnancy was 0.97 (95% CI 0.14, 6.54). The OR of pre-mature birth defined as birth before 37 weeks in women taking HCQ during pregnancy was 1.10 (95% CI 0.75, 1.61). CONCLUSION: HCQ is not associated with any increased risk of congenital defects, spontaneous abortions, fetal death, pre-maturity and decreased numbers of live births in patients with auto-immune diseases.

The role of the unblinded sponsor statistician.

In clinical trials sponsored by Merck the unblinded statistician is typically an employee of the company. From a pharmaceutical industry perspective, advantages of this approach include ensuring that the unblinded statistician is knowledgeable regarding the experimental treatments, therapeutic area and study objectives; that the quality of the analysis conforms to rigorous standards; and that the allocation schedule, database and interim results are kept confidential. These advantages are felt to outweigh any potential disadvantages.

The impact of domestic violence on the maternal-child relationship and preschool-age children's functioning.

Although preschool-age children are at risk for witnessing domestic violence, the majority of research has focused on children ages 6 to 12 years. This study examines the mediating role of the mother-child relationship on preschool-age children's functioning in families experiencing domestic violence. Maternal report and behavioral observations of mother-child interactions were used to assess relationship quality. Participants consisted of 103 children and their mothers. The data fit the model well but indicated that some of the correlations were not in the expected direction. Although depressed mothers were struggling with parenting, other mothers appeared to be compensating for the violence by becoming more effective parents. Domestic violence negatively impacted children's behavior with their mothers in interactions but did not influence maternal report of problem behaviors, suggesting that the impact of domestic violence begins very early and in the realm of relationships rather than in mental health.

Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis.

BACKGROUND & AIMS: Epidemiologic data indicate that the risk of nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) clinical events varies based on patients' clinical characteristics. The authors determined risk factors for NSAID-related clinical upper GI events and the event rates, absolute risk reductions, and numbers needed to treat for individual risk factors for a nonselective NSAID and a selective cyclooxygenase 2 inhibitor in a double-blind outcomes trial. METHODS: Eight thousand seventy-six rheumatoid arthritis patients aged >or=50 years (or >or=40 on corticosteroid therapy) were randomly assigned to rofecoxib 50 mg daily or naproxen 500 mg twice daily for a median of 9 months. The development of clinical upper GI events (bleeding, perforation, obstruction, and symptomatic ulcer identified on clinically indicated work-up) was assessed. RESULTS: Significant risk factors included prior upper GI events, age >or=65, and severe rheumatoid arthritis (RR, 2.3-3.9). Patients administered naproxen who had prior upper GI complications or who were aged >or=75 years had 18.84 or 14.46 events per 100 patient-years, and the risk of events remained constant over time. The reduction in events with rofecoxib was similar in high- and low-risk subgroups (RR, 0.31-0.68). The number needed to treat with rofecoxib instead of naproxen to avert 1 GI event was 10-12 in highest risk patients (prior event, age >or=75 years, or severe rheumatoid arthritis), 17-33 in patients with other risk factors, and 42-106 in low-risk patients. CONCLUSIONS: NSAID-related GI events increase dramatically with risk factors such as prior events or older age. Ten to twelve high-risk patients need to be treated with a protective strategy such as the selective cyclooxygenase 2 inhibitor, rofecoxib, to avert a clinical GI event.