Administrative information
Title and structured summary
Item 1a: Title stating the trial design, population, and interventions, with identification as a protocol.
Open Science
Introduction
Methods: Patient and public involvement, trial design
Example
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“Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol” [27].
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Explanation
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The title provides an important means of trial identification. A succinct description that conveys the topic (study population, intervention, comparator) and trial design (e.g., parallel-group randomised trial) – will facilitate retrieval from electronic database or Internet searches and rapid judgement of relevance [28]. It can also be helpful to include the trial framework (e.g., superiority, non-inferiority), objective or primary outcome, and if relevant, the study phase (e.g., phase II) and acronym.
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Summary of key elements to address
Descriptive title stating:
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Trial design (e.g., parallel-group randomised trial)
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Conceptual framework (e.g., superiority, non-inferiority)
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Trial phase (if applicable)
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Population
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Intervention/comparator
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Objective or primary outcome
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“Protocol”