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When designing an RCT, one must consider its essential methodological components including randomization, allocation, blinding, choice of outcome measures, sample size, loss to follow-up, and crossover.
Some possible explanations for the discrepancies between these findings can be expressed: differing patients' characteristics, heterogeneous insight or QoL measures, sample size and methodological differences.
Major inconsistencies included discrepancies in study objective and/or hypothesis, study design, primary outcome measures, sample size, statistical analysis, results, and standard deviations/confidence intervals.
All of the published abstracts had at least one minor inconsistency (title, authors, research center, outcome presentation, conclusion), while 65% had at least major inconsistencies (study objective, hypothesis, study design, primary outcome measures, sample size, statistical analysis, results, SD/CI).
The following data were abstracted for each study: Author(s), year of publication; country; title; study design; aims, methods and outcome measures; sample size, age and ethnicity of participants; and key findings.
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Evaluating these translated interventions is challenging because of the differences in outcome measures, sample sizes, and study designs.
Common aspects affecting the studies' quality included not reporting reliability and validity of outcome measures, sample sizes not well justified and of those that did calculate sample size, the studies were commonly under powered [ 10, 23- 25].
Based on this estimate, the associated SNP explains ~5% of the total phenotypic variation, and a successful replication study (α = 0.05, power = 80%) would require 234 samples with a single HbA1c measure (sample size calculation).
The information extracted included type of study, summary conclusions, methods used, intervention studied, health issue(s) studied, outcomes measured, sample size, intervention frequency, effectiveness of intervention, study quality, study location, clinical characteristics/setting, mHealth tools used, and project name (if any).
Where bone turnover markers were measured sample sizes were generally smaller than the overall size of the studies.
In the paragraph headed 'Outcome measures and sample size calculations', the current text "A secondary outcome measure is smoking prevalence among the entire year group".
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interventions sample size
estimates sample size
assessment sample size
means sample size
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evaluating sample size
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measures gap size
measures chest size
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measures sample entropy
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com