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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 itemsInterventional trialsInstitutional review boardJohns hopkins medicalAdult intensive critical careQuality in health careQuality of life

Reporting of Factorial Randomized Trials

This article provides an extension of the Consolidated Standards of Reporting Trials 2010 checklist for the reporting of factorial trials.

City ofUnited kingdomBrennanc kahanClinical trials unit at university college londonResearch councilUnited kingdom office for national statisticsUnited kingdom national institute for healthNational institute of health researchBetter researchCare researchTransparency of health researchConsolidated standardsReporting trialsHealth researchSection refTerms used

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 solovyevaInstitute of cancer researchCancer researchStatistics unitStandards of reporting trialsStandard protocol itemsInterventional 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 cityUnited kingdomWest midlandsUnited kingdom generalUnited statesDaiichi sankyoJanssen clovisOxford biotherapeuticsLilly incyteCelgene eisaiSumitomo dainippon pharmaGenentech rocheBristol myers squibbAstra zenecaMerck seronoSanofi aventis

Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care. Developing an intervention is a lengthy process pursued in

Glasgow cityUnited kingdomWest midlandsUnited kingdom generalUnited statesDaiichi sankyoOxford biotherapeuticsJanssen clovisLilly incyteSmith klineCelgene eisaiSumitomo dainippon pharmaGenentech rocheAstra zenecaMerck seronoCanadian arthritis patient alliance