11 声明
11.1 声明
臨床論文は、書き方がある程度規定されています。
- International Committee of Medical Journal Editors (ICMJE)
- アメリカ医学会 Manual of Style: A guide for Authors and Editors
- 各ジャーナルの Authors Guideline など
- 研究デザインごとの声明 (Statement)
声明は、EQUATOR Network (https://www.equator-network.org/) が主導し、以下のようなものがあります。
| 研究デザイン | ガイドライン |
|---|---|
| システマティックレビュー メタアナリシス | PRISMA |
| ランダム化比較試験 | CONSORT |
| 非ランダム化比較試験 | TREND |
| 分析疫学的研究 (コホート研究や症例対照研究) | STROBE |
その他、症例報告 (CARE)、質的研究 (SRQR/COREQ)、診断精度研究 (STARD)、研究計画書 (SPIRIT/PRISMA-P) などがあります。
歴史的にみると、1993年ころからランダム化比較試験の標準項目が、1996年ころからメタ分析の標準項目が議論され始めました。1999年に、メタ分析の標準項目 QUOROM、2001年にランダム化比較試験の標準項目 CONSORT ができました。
11.2 チェックリスト
11.2.1 STROBE
| Item No | Recommendation | Page No |
|---|---|---|
| Title and abstract 1 | (a) Indicate the study’s design with a commonly used term in the title or the abstract | |
| (b) Provide in the abstract an informative and balanced summary of what was done and what was found | ||
| Introduction | ||
| Background/rationale 2 | Explain the scientific background and rationale for the investigation being reported | |
| Objectives 3 | State specific objectives, including any prespecified hypotheses | |
| Methods | ||
| Study design 4 | Present key elements of study design early in the paper | |
| Setting 5 | Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection | |
| Participants 6 | (a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up | |
| (b) For matched studies, give matching criteria and number of exposed and unexposed | ||
| Variables 7 | Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable | |
| Data sources/ measurement 8* | For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group | |
| Bias 9 | Describe any efforts to address potential sources of bias | |
| Study size 10 | Explain how the study size was arrived at | |
| Quantitative variables 11 | Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why | |
| Statistical methods 12 | (a) Describe all statistical methods, including those used to control for confounding | |
| (b) Describe any methods used to examine subgroups and interactions | ||
| (c) Explain how missing data were addressed | ||
| (d) If applicable, explain how loss to follow-up was addressed | ||
| (e) Describe any sensitivity analyses | ||
| Results | ||
| Participants 13* | (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed | |
| (b) Give reasons for non-participation at each stage | ||
| (c) Consider use of a flow diagram | ||
| Descriptive data 14* | (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders | |
| (b) Indicate number of participants with missing data for each variable of interest | ||
| (c) Summarise follow-up time (eg, average and total amount) | ||
| Outcome data 15* | Report numbers of outcome events or summary measures over time | |
| Main results 16 | (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included | |
| (b) Report category boundaries when continuous variables were categorized | ||
| (c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period | ||
| Other analyses 17 | Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses | |
| Discussion | ||
| Key results 18 | Summarise key results with reference to study objectives | |
| Limitations 19 | Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias | |
| Interpretation 20 | Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence | |
| Generalisability 21 | Discuss the generalisability (external validity) of the study results | |
| Other information | ||
| Funding 22 | Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based |
*Give information separately for exposed and unexposed groups.