Dating service questionnaire 16a

A summary of the relevant methodological articles was provided to each E&E author for use in preparing the initial draft text for up to six checklist items; each draft was also reviewed and revised by a second author.When citing empirical evidence in the E&E, we aimed to reference a systematic review when available.Modelled after other reporting guidelines,17 18 this E&E paper presents each checklist item with at least one model example from an actual protocol, followed by a full explanation of the rationale and main issues to address.This E&E paper provides important information to facilitate full understanding of each checklist item, and is intended to be used in conjunction with the SPIRIT 2013 Statement.14 These complementary tools serve to inform trial investigators about important issues to consider in the protocol as they relate to trial design, conduct, reporting, and organisation.We searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to reviews) up to September 2009, and EMBASE up to August 2007.We searched reference lists, Pub Med “related articles,” and citation searches using SCOPUS to identify additional relevant studies.High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.However, the completeness of trial protocols is often inadequate.

The SPIRIT 2013 Statement addresses the minimum content for interventional trials; additional concepts may be important to describe in protocols for trials of specific designs (eg, crossover trials) or in protocols intended for submission to specific groups (eg, funders, research ethics committees/institutional review boards).The availability of examples for all checklist items indicates the feasibility of addressing each recommended item in the main protocol rather than in separate documents.Examples are quoted verbatim from the trial protocol.This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations.For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance.

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Some examples illustrate a specific component of a checklist item, while others encompass all key recommendations for an item.

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