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Potential participants were approached either by email or face to face by clinicians from four professional groups (who agreed to contact colleagues for this purpose) and invited to participate, and an information statement about the study and consent form were provided.
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The information pack will contain a cover letter, information statement about the study, and ask the person to contact the research team if they were interested in participating.
Participants were given a written information statement about the research and had the opportunity to discuss the study with the researcher before giving their informed consent to participate.
Information statements about the RCT are included in the information pack posted to each family prior to attending the assessment clinic.
Prior to commencement of the research, participants were given an information statement and consent form and also had information about the study explained verbally.
All study participants will be provided with an explanatory statement containing information about the study, what participation involves and the contact details of the Monash University Ethics Committee, so that they are able to report any concerns or complaints about the study.
Before the first session and randomization, they receive a letter with additional written information about the study, a statement of consent and the baseline questionnaire.
The questionnaire was accompanied by a cover letter that included salient information about the study and an explicit statement on the voluntary nature of participation.
The information package contains a study information statement for the Support Person detailing the research and what participation would involve.
Parents were given written and verbal information about the study and a statement of informed consent was signed by the parents of all enrolled children.
Similar to the successful CONSORT initiative for randomised trials and the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com