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The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.
However, further research is needed as we found that the 2 RCTs that did not report any details on their PRO studies (i.e. CONSORT-PRO scores of 0) addressed less than 20% of recommended PRO-specific protocol items.
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 resident assessment protocol items provide a critical link with care planning.
The protocol follows the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013 statement [ 13], which defines standard protocol items for clinical items, and it has been registered with ClinicalTrials.gov (October 24, 2014, identifier: NCT02273934).
This paper outlines the study protocol, in accordance with the SPIRIT guidelines (Standard protocol items; recommendations for interventional trials).
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The most valid adaptive designs are those in which the opportunity to make adaptations is based on prespecified decision rules that are fully documented in the protocol (Item 21b).
Both studies included patients according to predetermined exclusion/inclusion criteria and measurement protocols (items 3, 4).
293 Non-adherence refers to deviation from intervention protocols (Item 11c) or from the follow-up schedule of assessments (Item 13), but does not mean that the participant is "off-study" and no longer in the trial.
Students were also asked to answer a questionaire after the day of the course and after completion of the study protocol grading items from one (poor) to six (very good).
Physiotherapists completed an interview-based protocol with items about sociodemographic and clinical characteristics (pain, motor function and health-related quality of life) of individuals with CP.
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