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. Author manuscript; available in PMC: 2014 Aug 7.
Published in final edited form as: Health Technol Assess. 2014 Jul;18(45):1–190. doi: 10.3310/hta18450
a. Study basic details
UIN / AN      
Title      
Reviewer      
Date reviewed      
Author      
Journal & year      
Source      
b. Study description
1. Setting      
2. Study design      
3. Outcome measured      
4. Statistical techniques used      
5. Intention to treat analysis. Patients analysed according to the group they were randomized to?      
5. Confounding factors adjusted for      
6. Cohort size      
7. Number of subjects studied for outcome      
8. %follow-up (5 ÷ 6)      
9. Age range (mean age + SD)      
10. Treatment given/ dose/ route of admin/ duration of treatment      
11. Duration of follow-up      
c. Inclusion criteria d. Exclusion criteria
e. Quality assessment – enter a rating and justify with a brief comment
Criterion Score Comment
1. Study design appropriate?
2.Are CONSORT guidelines followed
3. Adequate description of study participants?
4. is randomisation adequate?
5. Is there placebo control and is blinding adequate?
6. Are details of the study medication given
7. Is change in maternal vitamin D status measured?
8.Are details of the assay given?
9. Measurements of outcomes reliably ascertained?
10. Measurements of later outcomes objective?
11. Measures of vitamin D intake/ 25(OH)-vitamin D, bone outcomes eg BMD rounded
12. Consideration for the effects of important confounding factors? (e.g. season, sunlight exposure, calcium intake, maternal compliance, infant feeding)
13. What proportion of the cohort completed the trial
14. info on non-participants
15. Analysis rigorous and appropriate?
16. Sample size
Overall quality rating (sum of scores):
f. Study results – free text, to consider cohort details, associations found, any additional quality comments
g. Screen of references – any additional studies listed which have not already been reviewed?