Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden

The relationship between pre-treatment clinical profile and treatment outcome in an integrated stuttering program.

Contains fulltext : 51051.pdf (publisher's version ) (Closed access

A cross-cultural, long-term outcome evaluation of the ISTAR Comprehensive Stuttering Program across Dutch and Canadian adults who stutter.

Contains fulltext : 51132.pdf (publisher's version ) (Closed access)There is a need to evaluate the effectiveness of stuttering treatment programs delivered in domestic and international contexts and to determine if treatment delivered internationally is culturally sensitive. Evaluation of the effectiveness of the ISTAR Comprehensive Stuttering Program (CSP) within and across client groups from the Netherlands and Canada revealed generally positive results. At 2 years post-treatment both groups were maintaining statistically significant reductions in stuttering frequency and improvements in attitudes, confidence, and perceptions as measured by the Revised Communication Attitude Inventory (S24), Perceptions of Stuttering Inventory (PSI), and the approach scale of the Self-Efficacy Scaling by Adult Stutterers (SESAS). Data pooled across the groups on these measures gave evidence of a global treatment effect with standardized effect sizes ranging from typical to larger than typical in the behavioural sciences. Only two differences between the groups emerged: differences in speech rate and perception of self. Given that these groups represent two distinct cultures, differences were discussed in terms of whether they could be due to cultural, methodological, or other variables. Overall, results suggest that, the CSP appears to be similarly effective in both cultures and thus, sufficiently sensitive to the culture of Dutch adults who stutter. Educational objectives: The reader will be able to (a) describe a methodology that can be used in a clinical setting to evaluate the long-term effectiveness of stuttering treatment with adults, (b) describe some of the challenges in developing a model of clinically meaningful outcome, (c) explain the rationale for the need for cross-cultural investigations of treatment outcome, and (d) summarize speech and self-report results of the cross-cultural evaluation of an integrated stuttering treatment program