Observational study reporting (lite) — v1.0.0
Released: 2026-02-02 · Hash: sha256:0cf1d935cb14756602a6ae0ba10b6c569fa14fdd7b062abd3831433ea8eb1073
Title & Abstract
| Criterion | Text |
|---|---|
| must OBS-01 | Make the study design explicit (e.g., cohort/case-control/cross-sectional) in the title or abstract. |
| should OBS-02 | Abstract summarizes objectives, setting, participants, exposures/predictors, outcomes, key analyses, and main results with quantitative estimates. |
Introduction
| Criterion | Text |
|---|---|
| must OBS-10 | State the scientific background and the specific objectives (and prespecified hypotheses, if any). |
Methods
| Criterion | Text |
|---|---|
| must OBS-20 | Describe the key elements of the study design early, including the setting, locations, and relevant dates (recruitment, exposure window, follow-up, data collection). |
| must OBS-21 | Describe participant eligibility criteria and selection methods (and follow-up procedures, if applicable). |
| must OBS-22 | Define all key variables: outcomes, exposures, predictors, confounders, and effect modifiers; include diagnostic criteria where relevant. |
| should OBS-23 | Describe data sources and measurement methods for each variable, including efforts to ensure comparability across groups. |
| should OBS-24 | Describe steps taken to identify and reduce potential biases (selection, information, confounding). |
| should OBS-25 | Explain the study size rationale (sample size, precision targets, feasibility constraints, or available data). |
| must OBS-26 | Describe statistical methods, including confounding control, subgroup/interaction analyses (if any), missing data handling, and sensitivity/robustness checks. |
Results
| Criterion | Text |
|---|---|
| must OBS-30 | Report participant numbers at each stage (eligible, included, analyzed) and reasons for non-participation; include a flow diagram if helpful. |
| must OBS-31 | Provide participant descriptive data (key demographics/clinical variables) and indicate missingness for key variables. |
| must OBS-32 | Report outcome event counts or summary measures over time (as applicable), with denominators. |
| must OBS-33 | Report main effect estimates with measures of precision (e.g., confidence intervals) and clarify which confounders were adjusted for. |
| may OBS-34 | Report additional analyses (e.g., subgroup analyses, alternative model specifications, sensitivity analyses) with rationale. |
Discussion
| Criterion | Text |
|---|---|
| must OBS-40 | Discuss key limitations and potential sources of bias (direction and likely magnitude where feasible). |
| should OBS-41 | Provide an overall interpretation in the context of evidence and discuss generalisability (external validity). |
Other
| Criterion | Text |
|---|---|
| must OBS-50 | Disclose ethics approval/consent (if applicable), funding and competing interests, and provide a data/code availability statement. |