A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Search and Selection of Studies
2.3. Assessment of Reporting Quality
2.4. Explanatory Variables
2.4.1. Journal Endorsement of CONSORT
2.4.2. Funding Type
2.4.3. Journal Impact Factor
2.4.4. Continent Where the Study Was Conducted
2.4.5. Other Exploratory Variables
2.5. Outcome Variable
2.6. Sample Size Estimation
2.7. Data Analysis
2.8. Ethical Considerations and Reporting
3. Results
3.1. Study Search and Selection
3.2. Overall Quality of Reporting
3.3. Evolution in Reporting Quality
3.4. Factors Associated with Adequate Reporting
4. Discussion
5. Strengths and Limitations
6. Conclusions and Recommendations
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Appendix A. Data Extraction Form
Study Number | ||||
---|---|---|---|---|
Journal Endorsement of CONSORT | Yes | No | ||
Journal impact factor | IF < 10 | 10 < IF < 20 | IF > 20 | |
Continent of trial | ||||
Number of trial centers | Single center | multicenter | ||
Source of funding | Industrial | Non-industrial | No funding | |
Year of publication | 1990–2000 | 2001–2010 | 2011–2018 |
Section | Item No. | Checklist Item | Yes | No | Score |
---|---|---|---|---|---|
Title and Abstract | 1a | Identification as a randomized trial in the title | |||
1b | Structured summary of trial design, methods, results, and conclusions | ||||
Background and objectives | 2a | Scientific background and explanation of rationale | |||
2b | Specific objectives or hypotheses | ||||
Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | |||
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | ||||
Participants | 4a | Eligibility criteria for participants | |||
4b | Settings and locations where the data were collected | ||||
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | |||
Outcomes | 6a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | |||
6b | Any changes to trial outcomes after the trial commenced, with reasons | ||||
Section | Item No. | Checklist Item | Yes | No | Score |
Sample size | 7a | How sample size was determined | |||
7b | When applicable, explanation of any interim analyses and stopping guidelines | ||||
Sequence generation | 8a | Method used to generate the random allocation sequence | |||
8b | Type of randomization; details of any restriction (such as blocking and block size) | ||||
Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | |||
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | |||
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | |||
11b | If relevant, description of the similarity of interventions | ||||
Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | |||
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | ||||
Participant flow | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | |||
13b | For each group, losses and exclusions after randomization, together with reasons | ||||
13c | Flow diagram | ||||
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | |||
14b | Why the trial ended or was stopped | ||||
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | |||
Numbers analysed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | |||
Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | |||
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | ||||
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | |||
Harms | 19 | All-important harms or unintended effects in each group | |||
Limitations | 20 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | |||
Generalizability | 21 | Generalizability of the trial findings | |||
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | |||
Registration | 23 | Registration number and name of trial registry | |||
Protocol | 24 | Where the full trial protocol can be accessed, if available | |||
Funding | 25 | Sources of funding and other support role of funders |
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A. Search String Used for the PubMed Database | |
---|---|
# | Search |
1 | Tuberculosis OR TB OR PTB |
2 | Vaccine OR Vaccines OR Vaccination |
3 | Placebo OR control |
4 | “randomized controlled trials” OR randomization OR RCT OR controlled trials OR Comparative |
5 | (((Tuberculosis OR TB OR PTB) AND (Vaccine OR Vaccines OR Vaccination)) AND (Placebo OR control)) AND (“randomized controlled trials” OR randomization OR RCT OR controlled trials OR Comparative) |
6 | (((Tuberculosis OR TB OR PTB) AND (Vaccine OR Vaccines OR Vaccination)) AND (Placebo OR control)) AND (“randomized controlled trials” OR randomization OR RCT OR controlled trials OR Comparative) Filters: Humans |
7 | (((Tuberculosis OR TB OR PTB) AND (Vaccine OR Vaccines OR Vaccination)) AND (Placebo OR control)) AND (“randomized controlled trials” OR randomization OR RCT OR controlled trials OR Comparative) Filters: Humans, from 1990–2020 |
8 | (((Tuberculosis OR TB OR PTB) AND (Vaccine OR Vaccines OR Vaccination)) AND (Placebo OR control)) AND (“randomized controlled trials” OR randomization OR RCT OR controlled trials OR Comparative) Filters: Humans, from 1990–2018 |
B. Search String Used for the Cochrane Central Register of Controlled Trials | |
# | Search |
1 | MeSH descriptor: [Tuberculosis] explode all tress |
2 | MeSH descriptor: [Vaccines] explode all tress |
3 | MeSH descriptor: [Vaccination] explode all tress |
4 | #2 OR #3 |
5 | #1 AND #4 |
Characteristic | Categories Used for the Characteristic | Crude Odds Ratio * (95% CI) | p Value | Adjusted Odds Ratio ** (95% CI) | p Value |
---|---|---|---|---|---|
Impact factor | <10 | Reference | Reference | ||
10 to 20 | 6.44 (1.24 to 33.58) | 0.027 | 9.4 (1.30 to 67.83) | 0.026 | |
>20 | 4.29 (1.01 to 18.20) | 0.048 | 2.89 (0.30 to 27.80) | 0.35 | |
Type of Funding | Industrial funding | Reference | Reference | ||
Non-industrial funding | 0.28 (0.12 to 0.65) | 0.003 | 0.55 (0.18 to 1.67) | 0.29 | |
No funding | 0.09 (0.023 to 0.33) | <0.001 | 0.23 (0.45 to 1.26) | 0.09 | |
Type of journal | Non-CONSORT endorsing | Reference | Reference | ||
CONSORT endorsing | 2.33 (1.04 to 5.26) | 0.041 | 1.85 (0.59 to 5.84) | 0.28 | |
Year of publication | 1990–2000 | Reference | Reference | ||
2001–2010 | 5.99 (0.67 to 54.04) | 0.110 | 4.89 (0.38 to 62.45) | 0.22 | |
2011–2018 | 25.24 (3.23 to 197.22) | 0.002 | 25.8 (2.25 to 297.20) | 0.009 | |
Continent of study | Africa | Reference | Reference | ||
Asia | 0.44 (0.12 to 1.61) | 0.218 | 1.45 (0.22 to 9.56) | 0.69 | |
Europe | 0.52 (0.22 to 1.25) | 0.144 | 0.65 (0.22 to 1.93) | 0.44 | |
North America | |||||
South America | 1 (0.059 to 16.79) | 1.000 | 0.24 (0.007 to 8.40) | 0.43 | |
Number of centers | Single center | Reference | |||
Multiple centers | 1.344 (0.64 to 2.81) | 0.432 |
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Ngah, V.D.; Mazingisa, A.V.; Zunza, M.; Wiysonge, C.S. A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials. Vaccines 2020, 8, 770. https://doi.org/10.3390/vaccines8040770
Ngah VD, Mazingisa AV, Zunza M, Wiysonge CS. A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials. Vaccines. 2020; 8(4):770. https://doi.org/10.3390/vaccines8040770
Chicago/Turabian StyleNgah, Veranyuy D., Akhona V. Mazingisa, Moleen Zunza, and Charles S. Wiysonge. 2020. "A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials" Vaccines 8, no. 4: 770. https://doi.org/10.3390/vaccines8040770
APA StyleNgah, V. D., Mazingisa, A. V., Zunza, M., & Wiysonge, C. S. (2020). A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials. Vaccines, 8(4), 770. https://doi.org/10.3390/vaccines8040770