Purpose: There are few interventions on an individual basis to support community-dwelling people with dementia to continue to fulfill their potential in society and to support their informal caregivers via e-Health. This study explored the effectiveness of the individualized Meeting Centers Support Program (iMCSP) consisting of DemenTalent (people with dementia work as volunteers in a society based on their talents), Dementelcoach (telephone coaching), and STAR e-Learning for caregivers, compared to regular MCSP and No day care support.

Method: An explorative randomized controlled trial with pre/post measurements (M0-M6) and two groups (iMCSP and regular MCSP). In addition, a comparison was made between iMCSP and a reference No day care control group. Standardized questionnaires were administered on self-esteem, neuropsychiatric symptoms, experienced autonomy and quality of life of the person with dementia, and on caregiver's sense of competence, quality of life, and happiness.

Results: The iMCSP interventions resulted in a broader group of participants utilizing the Meeting Centers. Compared to regular MCSP, DemenTalent had a moderate positive effect on neuropsychiatric symptoms, which also proved less severe. Positive affect of participants improved within the DemenTalent and regular MCSP group after six months. Caregivers of DemenTalent participants experienced less emotional impact of neuropsychiatric symptoms. No differences were found in experienced burden, sense of competence, or quality of life in caregivers using iMCSP or regular MCSP. Compared to those receiving No day care support, caregivers of DemenTalent participants and caregivers using Dementelcoach or STAR e-Learning proved happier. Post-hoc analyses, accounting for potential between-group differences in outcome measures at baseline, generally showed results in the same direction. People with dementia and caregivers highly appreciated iMCSP and regular MCSP.

Conclusion: iMCSP can be effectively applied as alternative or additional support via regular Meeting Centers for people with dementia and caregivers who prefer individualized activities/support. DemenTalent decreased the severity of neuropsychiatric symptoms of people with dementia and emotional burden of caregivers. All iMCSP interventions tended to result in caregivers being happier compared to those receiving no support. Larger-scale studies are needed to investigate the effect of iMCSP on other domains of quality of life of participants.

Background: The time to initiate intravenous thrombolysis for acute ischemic stroke is generally limited to within 4.5 hours after the onset of symptoms. Some trials have suggested that the treatment window may be extended in patients who are shown to have ischemic but not yet infarcted brain tissue on imaging.

Methods: We conducted a multicenter, randomized, placebo-controlled trial involving patients with ischemic stroke who had hypoperfused but salvageable regions of brain detected on automated perfusion imaging. The patients were randomly assigned to receive intravenous alteplase or placebo between 4.5 and 9.0 hours after the onset of stroke or on awakening with stroke (if within 9 hours from the midpoint of sleep). The primary outcome was a score of 0 or 1 on the modified Rankin scale, on which scores range from 0 (no symptoms) to 6 (death), at 90 days. The risk ratio for the primary outcome was adjusted for age and clinical severity at baseline.

Results: After 225 of the planned 310 patients had been enrolled, the trial was terminated because of a loss of equipoise after the publication of positive results from a previous trial. A total of 113 patients were randomly assigned to the alteplase group and 112 to the placebo group. The primary outcome occurred in 40 patients (35.4%) in the alteplase group and in 33 patients (29.5%) in the placebo group (adjusted risk ratio, 1.44; 95% confidence interval [CI], 1.01 to 2.06; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 7 patients (6.2%) in the alteplase group and in 1 patient (0.9%) in the placebo group (adjusted risk ratio, 7.22; 95% CI, 0.97 to 53.5; P = 0.05). A secondary ordinal analysis of the distribution of scores on the modified Rankin scale did not show a significant between-group difference in functional improvement at 90 days.

Conclusions: Among the patients in this trial who had ischemic stroke and salvageable brain tissue, the use of alteplase between 4.5 and 9.0 hours after stroke onset or at the time the patient awoke with stroke symptoms resulted in a higher percentage of patients with no or minor neurologic deficits than the use of placebo. There were more cases of symptomatic cerebral hemorrhage in the alteplase group than in the placebo group. (Funded by the Australian National Health and Medical Research Council and others; EXTEND ClinicalTrials.gov numbers, NCT00887328 and NCT01580839.).

Background: Autonomy-supportive implementation intention exercises have been shown to facilitate goal-directed behaviour (Koestner et al., ). The current study explored whether eating self-efficacy moderated the impact of autonomy-framed versus control-framed implementation intentions to reduce high-calorie snack intake.

Methods: The study employed a randomised prospective design, involving two waves of data collection conducted in 2016. At Time 1, UK participants (N = 300) completed an online questionnaire which asked them to report their snacking behaviour over the previous 7 days. Participants were subsequently asked to form either an autonomy-framed implementation intention or a control-framed implementation intention. Seven days later, participants reported their consumption of high-calorie snacks and completed a measure of eating self-efficacy.

Results: Hierarchical multiple regression analysis revealed that eating self-efficacy moderated the effects of implementation intention framing. Autonomy-framed implementation intentions had a greater impact on the avoidance of snacking for high eating self-efficacy participants than did control-framed implementation intentions. In contrast, for low eating self-efficacy participants, control-framed implementation intentions had more impact than did autonomy-framed implementation intentions.

Conclusions: The results suggest that if implementation intentions to promote healthy diet are to be effective, the role of eating self-efficacy should be considered, and the design of interventions adapted accordingly.

Objectives: To investigate how different competing interest (COI) statements affect clinical readers' perceptions of education articles.

Design: Randomised controlled trial.

Setting and participants: Random sample of UK doctors.

Interventions: We created four permutations of each of two clinical reviews (on gout or dyspepsia), which varied only in terms of the COI statement. Volunteers were blinded and randomised to receive one review and asked to complete a questionnaire after reading it. Blinded factorial analyses of variance and analyses of covariance were carried out to assess the influence of each review and type of COI on outcomes.

Primary and secondary outcomes: Confidence in the article's conclusions (primary outcome), its importance, their level of interest in the article and their likelihood to change practice after reading it.

Results: Of 10 889 doctors invited to participate, 1065 (10%) volunteered. Of these, 749 (70%) completed the survey. Analysis of covariance (adjusting for age, sex, job type, years since qualification) showed no significant difference between the groups in participants' confidence in the article (gout: p=0.32, dyspepsia: p=0.78) or their rating of its importance (gout: p=0.09, dyspepsia: p=0.79). For the gout review, participants rated articles with advisory board and consultancies COI as significantly less interesting than those with no COI (p=0.028 with Bonferroni correction). Among participants indicating that they treat the condition and that the article's recommendations differed from their own practice, there was no significant difference in likelihood to change practice between groups (gout: p=0.59, n=59; dyspepsia: p=0.56, n=80).

Conclusions: Doctors' confidence in educational articles was not influenced by the COI statements. Further work is required to determine if doctors do not perceive these COIs as important in educational articles or if they do not pay attention to these statements. More meaningful COI disclosure practices may be needed, which highlight context-specific potential sources of bias to readers.

Trial registration number: NCT02548312; Results.