Background
Methods
Study design and setting
Rating the reporting quality
Item | Description |
---|---|
1. Title or Abstract | The title or the abstract states the study is a randomized controlled trial. |
2. Introduction | Appropriate description of the scientific background and explanation of the rationale. |
Methods: | |
3. Participants | Eligibility criteria for participants are clearly described. |
4. Interventions | Precise details of the interventions intended in each group are provided. |
5. Outcomes | Clear definition of primary and secondary outcome measures is provided. |
6. Objectives | Specific objectives or research question or hypotheses are stated. |
7. Sample size | Clear description on how the sample size was determined is given. |
8. Randomization sequence generation | The method used to generate the random allocation sequence is stated. |
9. Randomization implementation | The separation of generator of the allocation sequence and executor is described. |
10. Statistical methods | Statistical methods used to compare groups for primary outcomes, subgroup analyses or adjusted analyses were properly described. |
Results: | |
11. Participants flow | Number of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for primary outcome are given. |
12. Recruitment | Dates defining the periods of recruitment and follow-up are provided. |
13. Baseline data | Baseline demographic and clinical characteristics of each group are properly described. |
14. Outcomes and estimation | For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95% CI) is provided. |
15. Adverse events | All important adverse events or side effects in each intervention group are described. |
Rating the framing of the research question
Data abstraction
Statistical Analysis
Results
Framing of the research question
All articles n = 89 | |||
---|---|---|---|
Element of the research question | n | % | 95% CI |
P: Patients
| 73 | 82 | 74 - 90 |
I: Intervention
| 83 | 93 | 88 - 98 |
C: Comparator
| 47 | 52 | 42 - 63 |
O: Outcome
| 65 | 73 | 63 - 82 |
T: Time
| 26 | 29 | 19- 38 |
Complete PICOT
| 16 | 18 | 10 - 27 |
Complete PICO
| 30 | 33 | 24 - 44 |
Association between framing of the research question and reporting quality
Independent Variable | Median | Q1-Q3 | Multivariable Model | Univariate Models | ||||
---|---|---|---|---|---|---|---|---|
OQSa
| IRR | 95% CI | p value | IRR | 95% CI | p value | ||
PICOT
| 9 | 8 - 10 | 1.021b
| 1.012 - 1.029 | < 0.0001 | 1.018 | 1.006 - 1.029 | 0.0032 |
Funding Source
| ||||||||
Othersc
| 9 | 8 - 11 | 1 | - | - | 1 | - | - |
Completely funded by industry | 10 | 9 - 10 | 1.022 | 0.999 - 1.046 | 0.0638 | 1.058 | 1.010 - 1.108 | 0.0177 |
Journal of Publication
| ||||||||
Othersc
| 9 | 7 - 10 | 1 | - | - | 1 | - | - |
J Clin Endocrinol Metab | 9 | 8 - 11 | 1.055 | 0.985 - 1.130 | 0.1280 | 1.074 | 0.986 - 1.171 | 0.1027 |
Sample Size
| 9 | 8 - 10 | 1.073d
| 1.026 - 1.123 | 0.0020 | 1.095 | 1.011 - 1.185 | 0.0250 |
Independent Variable | Median | Q1-Q3 | Multivariable Model | Univariate Models | ||||
---|---|---|---|---|---|---|---|---|
KSa
| IRR | 95% CI | p value | IRR | 95% CI | p value | ||
PICOT
| 0 | 0 - 1 | 1.142b
| 1.079 - 1.210 | < 0.0001 | 1.142 | 1.058 - 1.232 | 0.0006 |
Funding Source
| ||||||||
Othersc
| 0 | 0 - 1 | 1 | - | - | 1 | - | - |
Completely funded by industry | 1 | 0 - 1 | 1.074 | 0.747 - 1.544 | 0.7013 | 1.112 | 0.761 - 1.623 | 0.5834 |
Journal of Publication
| ||||||||
Othersc
| 0 | 0 - 1 | 1 | - | - | 1 | - | - |
J Clin Endocrinol Metab | 0 | 0 - 1 | 0.881 | 0.533 - 1.455 | 0.6205 | 0.924 | 0.515 - 1.658 | 0.7919 |
Sample Size
| 0 | 0 - 1 | 1.255d
| 0.936 - 1.684 | 0.1292 | 1.222 | 0.922 - 1.619 | 0.1623 |
Independent Variable | Median | Q1-Q3 | Multivariable Model | Univariate Models | ||||
---|---|---|---|---|---|---|---|---|
OQS1a
| IRR | 95% CI | p value | IRR | 95% CI | p value | ||
Structured RQ
| ||||||||
Not complete PICOc
| 9 | 7 - 10 | 1 | - | - | 1 | - | - |
Complete PICO | 10 | 9 - 11 | 1.095 | 1.059 - 1.132 | < 0.0001 | 1.104 | 1.084 - 1.125 | < 0.0001 |
Funding Source
| ||||||||
Othersc
| 9 | 8 - 11 | 1 | - | - | 1 | - | - |
Completely funded by industry | 10 | 9 - 10 | 1.256 | 1.006 - 1.046 | 0.0113 | 1.074 | 0.986 - 1.171 | 0.1027 |
Journal of Publication
| ||||||||
Othersc
| 9 | 7 - 10 | 1 | - | - | 1 | - | - |
J Clin Endocrinol Metab | 9 | 8 - 11 | 1.039 | 0.962 - 1.121 | 0.3325 | 1.074 | 0.986 - 1.171 | 0.1027 |
Sample Size
| 9 | 8 - 10 | 1.066d
| 1.012 - 1.123 | 0.0169 | 1.095 | 1.011 - 1.185 | 0.0250 |
Independent Variable | Median | Q1-Q3 | Multivariable Model | Univariate Models | ||||
---|---|---|---|---|---|---|---|---|
KSa
| IRR | 95% CI | p value | IRR | 95% CI | p value | ||
Structured RQ
| ||||||||
Not complete PICOc
| 0 | 0 - 1 | 1 | - | - | 1 | - | - |
Complete PICO | 1 | 0 - 1 | 1.530 | 1.311 - 1.786 | < 0.0001 | 1.510 | 1.398 - 1.632 | < 0.0001 |
Funding Source
| ||||||||
Othersc
| 0 | 0 - 1 | 1 | - | - | 1 | - | - |
Completely funded by industry | 1 | 0 - 1 | 1.088 | 0.775 - 1.528 | 0.6249 | 1.112 | 0.761 - 1.623 | 0.5834 |
Journal of Publication
| ||||||||
Othersc
| 0 | 0 - 1 | 1 | - | - | 1 | - | - |
J Clin Endocrinol Metab | 0 | 0 - 1 | 0.808 | 0.466 - 1.400 | 0.4473 | 0.924 | 0.515 - 1.658 | 0.7919 |
Sample Size
| 0 | 0 - 1 | 1.216d
| 0.876 - 1.689 | 0.2421 | 1.222 | 0.922 - 1.619 | 0.1623 |