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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

Table 3. Summary of cohort/ cross-sectional study quality assessment system.

Risk of Bias (score)
Criterion High (−1) Medium (0) Low (+1)
1. Study design appropriate? Ambiguously described, obviously bias inducing or unsuitable for the objectives and stated conclusions Possibly restricting but reflected in the scope of the objectives and the stated conclusions Planned to minimise bias and allow generalisability beyond the immediate scope of the objectives
2. Adequate description of study participants? Little or no information given Incl/excl and other criteria such as term/ pre-term/ small for gestational age baby given in some way; at least two useful measures including measure of vitamin D status, ethnicity Incl/excl and other criteria such as term/ pre-term/ small for gestational age baby given in some way; at least three useful measures including measure of vitamin D status, ethnicity with measures of precision
3. How is maternal vitamin D status measured? Dietary intake only or insufficient information Blood levels of circulating 25(OH)-vitamin D Blood levels of circulating 25(OH)-vitamin D, with details of precision, pick up of D2 and D3 and assay used
4. Participants grouped according to Vitamin D status? Subjects divided and analysed in groups based on pre-existing vitamin D thresholds Subjects divided and analysed in groups according to Vitamin D level based on group characteristics Subjects not divided into groups according to Vitamin D level/ or grouped according to at threshold generated from the study
5. Measurements of outcomes reliably ascertained? Inadequately explained or obviously unsuitable Adequate description and reliability/suitability of at least one of the following: instruments, technique/definition/protocol, people, place Detailed description and reliability of one and at least adequate description of the others
6. Measurements of later outcomes objective? Subjective measure, eg bone or muscle pain, wheezing Ascertained from researcher examination Objective measure e.g. DXA, bone biopsy, lung function tests
7. Measures of vitamin D intake/25(OH)-vitamin D level, bone outcomes rounded? Measures categorised or rounded very roughly, or if any clear evidence of rounding exists without explanation in the text Yes, but not by much No information given and no obvious reason to suspect rounding has occurred; or explicitly stated that measurements were not rounded
8. Consideration for the effects of important confounding factors? (e.g. season, sunlight exposure, calcium intake, maternal compliance, infant feeding) One factor controlled for in tables, nothing for the others (NB whether they were measured or not is irrelevant) Most factors controlled for in tables, or fewer if one or more is adjusted for in regression Most factors adjusted for in regression
9. Outcome assessment blind to maternal vitamin D status? N/A (cannot score −1 in this category) No details given Some details or statement given
10. What proportion of the cohort was followed up? % FU is not given, unclear, or low (below 70%) % FU is low to average (70-90%) % FU is high (over 90%)
11. Info on non-participants Very little or no information, or information given that is adequate but suggests a serious potential for bias Adequate information given, or information given that is very clear but suggests a moderate potential for bias Above average information given, none of which suggests a potential for bias
12. Analysis rigorous and appropriate? No statistical analyses carried out (just tables or description) Tables of means & differences given with statistical tests (e.g. t-tests), or some regression but without clear/valid measure of association Regression (or similar technique) used which gives a valid measure of association (e.g. odds ratios, hazard ratios, relative risks)
13. Sample size Extremely ambiguous, not given, or small (under 100) Average (100 to 1000) Large (over 1000)