QUALITY of INTERVENTIONAL STUDIES

UI Author Year Design * Appropriate Randomization Technique (y/n/nd/NA) Allocation Concealment (y/n/nd/NA) Appropriate Washout Period (y/n/nd/NA) Dropout Rate <20% Blinded Outcome Assessment (y/n/nd) Intention to Treat Analysis (y/n/nd) Appropriate Statistical Analysis ** (y/n) Assessment for Confounding (y/n/nd/NA) Clear Reporting with No Discrepancies (y/n) OVERALL Grade
15213038 Cifuentes 2004 RCT-parallel Y nd Y N Y nd Mostly Y Y B
Adverse Event(s): ** nd
Explanation for Overall Quality Grade (if not Grade A): No mention of intention-to-treat or compliance rate, high dropout rate. Questionable statistics.
Comment Really 2 separate trials. Combining wt maintenance and wt loss in statistical test is of questionable value.
However, they did control for various factors, including the substantial differences in baseline weights.
However, the very small number of subjects may have precluded meaningful adjustment (of 6 variables)

NA=not applicable

*

Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail)

**

Please do not leave blank. Type nd if there was no data on adverse.

Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail)

Please do not leave blank. Type nd if there was no data on adverse.

From: Appendix C, Evidence Tables: A-E

Cover of Vitamin D and Calcium
Vitamin D and Calcium: A Systematic Review of Health Outcomes.
Evidence Reports/Technology Assessments, No. 183.
Chung M, Balk EM, Brendel M, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.