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"Study protocol for Care cOORDInatioN And sympTom managEment (COORDINAT" by Binu Koirala, Sarah Badawi et al.

INTRODUCTION: Sustainable approaches to support care coordination and symptom management needs of critically ill adults living with multimorbidity are needed to combat the challenges and complexity that multimorbidity presents. The study aims to test the feasibility of the Care cOORDInatioN And sympTom managEment (COORDINATE) intervention to improve health outcomes of adults living with multimorbidity. METHODS AND ANALYSIS: A multicomponent nurse-driven intervention was developed using experience-based co-design and human-centred design. Inclusion criteria include (1) age 55 years and older, (2) admitted to an intermediate care unit, (3) presence of two or more chronic health conditions and (4) signed informed consent. Data collection will occur at baseline (time of recruitment predischarge) and 6 weeks and 3 months following hospital discharge. Outcome of interest from this feasibility study is to evaluate the financial, technical and logistic feasibility of a full-scale study inclu ....

Standard Protocol Items , Interventional Trials , Institutional Review Board , Johns Hopkins Medical , Adult Intensive Critical Care , Quality In Health Care , Quality Of Life ,

Combating Youth Type 2 Diabetes Requires a Holistic Approach

Combating Youth Type 2 Diabetes Requires a Holistic Approach
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United Kingdom , Karp Partha Kar , Journal Of Epidemiology Community Health , Interventional Trials , Youth Onset Type , Del Monte , Food Insecurity , Curr Nutr ,

ICR experts develop clinical trial guidelines to support future research

ICR experts develop clinical trial guidelines to support future research
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Olga Solovyeva , Institute Of Cancer Research , Cancer Research , Statistics Unit , Standards Of Reporting Trials , Standard Protocol Items , Interventional Trials ,

Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote gr ....

Glasgow City , United Kingdom , West Midlands , United Kingdom General , United States , Daiichi Sankyo , Janssen Clovis , Oxford Biotherapeutics , Lilly Incyte , Celgene Eisai , Sumitomo Dainippon Pharma , Genentech Roche , Bristol Myers Squibb , Astra Zeneca , Merck Serono , Sanofi Aventis , Cancer Research United Kingdom , International Delphi , United Kingdom Medical Research Council , United Kingdom Research , European Federation Of Pharmaceutical Industries , University Of Maastricht , University Of Birmingham , Takeda Pharmaceuticals , Imperial Biomedical Research Centre , Royal Marsden Institute Of Cancer Research ,