To improve the content of protocols of randomised controlled trials, the standard protocol items for randomized trials (SPIRIT) initiative is currently developing guidelines for the core information to be included in trial protocols.
The items assessed for trials, observational studies, and systematic reviews are shown in Table 1.
The findings would have been more convincing if the trials had been designed, analyzed, and interpreted following the standard protocol items for clinical trials.
In collaboration with journal editors, trialists, methodologists, and ethicists, we have launched the SPIRIT (standard protocol items for randomised trials) initiative to establish evidence based recommendations for the key content of trial protocols.
This is reflected in overlapping content of the CONSORT-PRO [20] and PRO-specific guidance for protocols currently in development: SPIRIT-PRO extension (Standardised Protocol Items for Randomised Trials) [23, 24].
The protocol employs relevant standard protocol items for clinical trials according to the SPIRIT 2013 statement [ 10], and follows the CONSORT statement [ 11] for transparent reporting.
The protocol employs relevant standard protocol items for clinical trials according to the SPIRIT 2013 statement [ 44] and follows the CONSORT statement [ 45] for transparent reporting.
The protocol adheres to the SPIRIT 2013 Statement, which defines standard protocol items for clinical trials [ 21], and the CONSORT guidelines for non-pharmacological interventions [ 22, 23].
Data were extracted using an ad hoc form with key items for each trial: study design, patients' characteristics (sex, age and duration of disease evolution), patient inclusion criteria, drugs and doses used, treatment duration and ACR response and safety parameters.
An obvious example of this is a situation where all the 12 relevant quality items for a randomized trial (24) are considered, but no trial meets any of these or all trials include fatal flaws (e.g. more than 50% loss to follow-up).
