Standard Protocol Items News Today

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 experienc...

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

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 a...

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, incorpora...

In a global study of outcome reporting in clinical trials, a research team at The Hospital for Sick Children (SickKids) has issued updated guidelines on what should be included in all trial protocols and published clinical trial reports, with the goal to improve their transparency and utility.

This report, the Consolidated Standards of Reporting Trials (CONSORT)–Outcomes 2022 extension, is a consensus statement on the standards for reporting outcomes

This report, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)–Outcomes 2022 extension, is a consensus statement on the standards

In this blog for Clinical Trials Day 2022, we reflect on the Trials journal Structured Study Protocol Template project since its launch in 2019.

These international, consensus-based, patient-reported outcomes (PRO)–specific guidelines aim to lay out the ethical considerations that researchers, research e

Benjamin Speich and colleagues investigate whether rates of trial completion and publication have increased over the past decade, the extent to which non-published trials can be identified in registries, and the association between reporting quality of protocols and premature discontinuation or non-publication of trials.