RECOMMENDATIONS: This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients' participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population.
CONCLUSIONS: Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.
METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.
DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.
METHODS: We searched Ovid MEDLINE, EMBASE, the Cochrane Library, Web of Science and PubMed databases through to December 2013 using the terms "percutaneous endoscopic gastrostomy", "gastrostomy", "PEG", "nasogastric", "nasogastric tube", "nasogastric feeding" and "intubation". We included randomized controlled trials (RCTs) and non-RCTs which compared PEG with NG feeding in individuals with non-stroke dysphagia.
RESULTS: 9 studies involving 847 participants were included in the final analysis, including two randomized trials. Pooled analysis indicated no significant difference in the risk of pneumonia [relative risk (RR) = 1.18, 95% confidence interval (CI) = 0.87-1.60] and overall complications [relative risk (RR) = 0.80, 95% confidence interval (CI) = 0.63-1.02] between PEG and NG feeding. A meta-analysis was not possible for mortality and nutritional outcomes, but three studies suggested improved mortality outcomes with PEG feeding while two out of three studies reported PEG feeding to be better from a nutritional perspective.
CONCLUSIONS: Firm conclusions could not be derived on whether PEG feeding is beneficial over NG feeding in older persons with non-stroke dysphagia, as previously published literature were unclear or had a high risk of bias. A well-designed and adequately powered RCT, which includes carer strain and quality of life as outcome measures is therefore urgently needed.
BACKGROUND: FPE is a cost-effective and helpful tool for reducing fall occurrences.
EVALUATION: This is a systematic review study using electronic searches via EBSCOHost® platform, ScienceDirect, Scopus and Google Scholar in March 2021. The review protocol was registered with PROSPERO (CRD42021232102). The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement flow chart guided the search strategy. Articles published from January 2010 to March 2021 were included for quality appraisal using the 'Transparent Reporting of Evaluations with Non-randomised Designs' (TREND) and the 'Consolidated Standards of Reporting Trials' (CONSORT) statement for randomised controlled trial studies.
KEY ISSUES: Six FPE studies selected emphasised on personal health status, exercise and environmental risk factors. These studies reported an increase in fall risk awareness or knowledge and a positive change in fall preventive behaviours. Two studies included nurses as educators in FPE.
CONCLUSION: FPE evidently improved awareness or knowledge and preventive fall behaviour change among older adults. Nurses are in great potential in planning and providing FPE for older adults in community settings.
IMPLICATIONS FOR NURSING MANAGEMENT: Expand nurses' roles in fall prevention programmes in community settings by using high-quality and evidence-based educational tools. Highlight the nurse's role and collaborative management in FPE.