Item Wording and Internal Consistency of a Measure of Cohesion: The Group Environment Questionnaire

A common practice for counteracting response acquiescence in psychological measures has been to employ both negatively and positively worded items. However, previous research has highlighted that the reliability of measures can be affected by this practice (Spector, 1992). The purpose of the present study was to examine the effect that the presence of negatively worded items has on the internal reliability of the Group Environment Questionnaire (GEQ). Two samples (N = 276) were utilized, and participants were asked to complete the GEQ (original and revised) on separate occasions. Results demonstrated that the revised questionnaire (containing all positively worded items) had significantly higher Cronbach α values for three of the four dimensions of the GEQ. Implications, alternatives, and future directions are discussed

ParticipACTION: Baseline assessment of the capacity available to the 'New ParticipACTION': A qualitative study of Canadian organizations

Evaluation of the original ParticipACTION campaign effects focused on individual awareness, recall, and understanding. Less studied has been the impact such campaigns have had on the broader organizational capacity to mobilize and advocate for physical activity. With the relaunch of ParticipACTION, the purpose of this study was to qualitatively explore baseline organizational capacity to promote physical activity messages, programs, and services within the Canadian context. Using a purposeful sampling strategy, we conducted semi-structured telephone interviews with 49 key informants representing a range of national, provincial, and local organizations with a mandate to promote physical activity. Interview data were analysed using a thematic analytic approach. Key informants painted a generally positive picture of current organizational capacity to promote physical activity messages, programs, and services in Canada. Will and leadership were clear strengths while infrastructure limitations remained the greatest concern. Some specific challenges included: 1) funding issues: the absence of core funding in a climate of shifting funding priorities; 2) the difficulty of working without a national physical activity policy (lack of leadership); 3) inconsistent provincial and educational sector level policies; and 4) a persistent focus on obesity rather than physical inactivity. The data generated here can be utilized to monitor the future impact of ParticipACTION on enhancing and utilizing this organizational capacity. A range of indicators are suggested that could be used to illustrate ParticipACTION's impact on the broad field of physical activity promotion in the future

ParticipACTION: Awareness of the participACTION campaign among Canadian adults - Examining the knowledge gap hypothesis and a hierarchy-of-effects model

ParticipACTION was a pervasive communication campaign that promoted physical activity in the Canadian population for three decades. According to McGuire's hierarchy-of-effects model (HOEM), this campaign should influence physical activity through intermediate mediators such as beliefs and intention. Also, when such media campaigns occur, knowledge gaps often develop within the population about the messages being conveyed. The purposes of this study were to (a) determine the current awareness of ParticipACTION campaigns among Canadians; (b) confirm if awareness of the ParticipACTION initiative varied as a function of levels of education and household income; and, (c) to examine whether awareness of ParticipACTION was associated with physical activity related beliefs, intentions, and leisure-time physical activity (LTPA) as suggested by the HOEM. Specifically, we tested a model including awareness of ParticipACTION (unprompted, prompted), outcome expectations, self-efficacy, intention, and physical activity status. A population-based survey was conducted on 4,650 Canadians over a period of 6 months from August, 2007 to February, 2008 (response rate = 49%). The survey consisted of a set of additional questions on the 2007 Physical Activity Monitor (PAM). Our module on the PAM included questions related to awareness and knowledge of ParticipACTION. Weighted logistic models were constructed to test the knowledge gap hypotheses and to examine whether awareness was associated with physical activity related beliefs (i.e., outcome expectations, self-efficacy), intention, and LTPA. All analyses included those respondents who were 20 years of age and older in 2007/2008 (N = 4424). Approximately 8% of Canadians were still aware of ParticipACTION unprompted and 82% were aware when prompted. Both education and income were significant correlates of awareness among Canadians. The odds of people being aware of ParticipACTION were greater if they were more educated and reported higher income. Awareness of ParticipACTION was also associated with outcome expectations, self-efficacy, intention, and LTPA status. Awareness of ParticipACTION is associated with LTPA. Knowledge gaps in awareness are associated with level of education and household income. Thus, future promotion campaigns should include specific strategies to target different segments of the population, especially people who are living in deprived conditions with lower levels of education

Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P) Study, a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial.</p> <p>Methods</p> <p>SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment.</p> <p>Results</p> <p>Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome).</p> <p>Conclusions</p> <p>Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible.</p> <p>Trial Registration</p> <p>Clinicaltrials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00688155">NCT00688155</a></p

Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol

Background: Abiraterone acetate plus prednisolone (herein referred to as abiraterone) or enzalutamide added at the start of androgen deprivation therapy improves outcomes for patients with metastatic prostate cancer. Here, we aimed to evaluate long-term outcomes and test whether combining enzalutamide with abiraterone and androgen deprivation therapy improves survival. Methods: We analysed two open-label, randomised, controlled, phase 3 trials of the STAMPEDE platform protocol, with no overlapping controls, conducted at 117 sites in the UK and Switzerland. Eligible patients (no age restriction) had metastatic, histologically-confirmed prostate adenocarcinoma; a WHO performance status of 0–2; and adequate haematological, renal, and liver function. Patients were randomly assigned (1:1) using a computerised algorithm and a minimisation technique to either standard of care (androgen deprivation therapy; docetaxel 75 mg/m2 intravenously for six cycles with prednisolone 10 mg orally once per day allowed from Dec 17, 2015) or standard of care plus abiraterone acetate 1000 mg and prednisolone 5 mg (in the abiraterone trial) orally or abiraterone acetate and prednisolone plus enzalutamide 160 mg orally once a day (in the abiraterone and enzalutamide trial). Patients were stratified by centre, age, WHO performance status, type of androgen deprivation therapy, use of aspirin or non-steroidal anti-inflammatory drugs, pelvic nodal status, planned radiotherapy, and planned docetaxel use. The primary outcome was overall survival assessed in the intention-to-treat population. Safety was assessed in all patients who started treatment. A fixed-effects meta-analysis of individual patient data was used to compare differences in survival between the two trials. STAMPEDE is registered with ClinicalTrials.gov (NCT00268476) and ISRCTN (ISRCTN78818544). Findings: Between Nov 15, 2011, and Jan 17, 2014, 1003 patients were randomly assigned to standard of care (n=502) or standard of care plus abiraterone (n=501) in the abiraterone trial. Between July 29, 2014, and March 31, 2016, 916 patients were randomly assigned to standard of care (n=454) or standard of care plus abiraterone and enzalutamide (n=462) in the abiraterone and enzalutamide trial. Median follow-up was 96 months (IQR 86–107) in the abiraterone trial and 72 months (61–74) in the abiraterone and enzalutamide trial. In the abiraterone trial, median overall survival was 76·6 months (95% CI 67·8–86·9) in the abiraterone group versus 45·7 months (41·6–52·0) in the standard of care group (hazard ratio [HR] 0·62 [95% CI 0·53–0·73]; p&lt;0·0001). In the abiraterone and enzalutamide trial, median overall survival was 73·1 months (61·9–81·3) in the abiraterone and enzalutamide group versus 51·8 months (45·3–59·0) in the standard of care group (HR 0·65 [0·55–0·77]; p&lt;0·0001). We found no difference in the treatment effect between these two trials (interaction HR 1·05 [0·83–1·32]; pinteraction=0·71) or between-trial heterogeneity (I2 p=0·70). In the first 5 years of treatment, grade 3–5 toxic effects were higher when abiraterone was added to standard of care (271 [54%] of 498 vs 192 [38%] of 502 with standard of care) and the highest toxic effects were seen when abiraterone and enzalutamide were added to standard of care (302 [68%] of 445 vs 204 [45%] of 454 with standard of care). Cardiac causes were the most common cause of death due to adverse events (five [1%] with standard of care plus abiraterone and enzalutamide [two attributed to treatment] and one (&lt;1%) with standard of care in the abiraterone trial). Interpretation: Enzalutamide and abiraterone should not be combined for patients with prostate cancer starting long-term androgen deprivation therapy. Clinically important improvements in survival from addition of abiraterone to androgen deprivation therapy are maintained for longer than 7 years. Funding: Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, Janssen, and Astellas