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At the completion of the trial, assessment for internal and external symptoms was done by two of the authors (JD and RH).
An independent end point review committee will be in charge of the trial assessment.
The medical practitioners and nurses were specifically trained in the trial assessments and had quality assurance reviews every six months with one of the investigators (DJP).
However, mean PedMIDAS scores in both the topiramate group and the placebo group decreased between baseline and endpoint, and the fact that only two trials [14, 19] used this tool as a trial assessment may be the cause of the heterogeneity.
This trial included assessment of molecular efficacy (correction of CFTR-dependent chloride transport in lungs and nose of treated patients) (CFGTC manuscript in preparation).
Traditionally a non-spatial or field trial assessment is used.
Final endpoints were compliance, loco-regional control, survival (after complete 5-year follow-up), and a concept of trial assessment using the treatment-dependent prognostic index TPI.
Methodological quality of studies was generally poor with only 11 studies rated as adequate using the Clinical Trial Assessment Measure (CTAM).
Fig. 1 Rater proforma for student volunteers' trial assessment of a Healthy Choices Programme session Fig. 2 Teaching needs-supportive rater proforma used in student volunteer training.
The International Headache Society has published guidelines for clinical trial assessment of prophylactic treatment for CM, including guidelines on the selection of outcome measures [11].
These unproven procedures are rarely underpinned by strong scientific evidence and are not tested through rigorous clinical trial assessment, thus making it difficult to support any claims made by the providers other than 'selling hope'.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com