Title and abstract | 1 | - (A)
(A). Indicate the study's design with a commonly used term in the title or the abstract - (B)
(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 | - (A)
(A). Provide an estimation of drug penetration in source population - (B)
(B). Describe eligibility for, and access to, treatment - (C)
(C). Indicate the time points for assessment of serial follow-up - (D)
(D). Outline calendar trends in availability of biologic/awareness of outcome
| |
Participants | 6 | - (A)
(A). Give the eligibility criteria and the sources and methods of selection of participants. Describe methods of follow-up - (B)
(B). For matched studies, give matching criteria and number of exposed and unexposed
| - (A)
(A). Provide a clear definition of the exposed and non-exposed cohorts. Justify the choice of comparator - (B)
(B). Describe whether treatment is restricted to new starts or encompasses all individuals with ongoing treatment - (C)
(C). Describe the conditions where subjects may change from one cohort to the other - (D)
(D). Describe whether treatment reflects first start until first stop of therapy or multiple treatment episodes. If the latter, discuss definition of duration of exposure and any implications for combining treatment intervals
|
Variables | 7 | Clearly define all outcomes, exposures, predictors, potential confounders and effect modifiers. Give diagnostic criteria, if applicable | Clearly define start and stop of therapy |
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)
(A). Describe all statistical methods, including those used to control for confounding - (B)
(B). Describe any methods used to examine subgroups and interactions - (C)
(C). Explain how missing data were addressed - (D)
(D). If applicable, explain how loss to follow-up was addressed - (E)
(E). Describe any sensitivity analyses
| - (A)
(A). Define and justify the risk window. Whenever possible, categorise as (1) on drug, (2) on drug + lag window or (3) ever treated - (B)
(B). The use of multiple risk attribution models and lag windows is encouraged if appropriate, but needs to be accompanied by a description of numbers and relative risks for each model - (C)
(C). If the same association under study has previously been published, consider using a similar analysis model and definitions for replicative purposes
|
Results |
Participants | 13* | - (A)
(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)
(B). Give reasons for non-participation at each stage - (C)
(C). Consider use of a flow diagram
| |
Descriptive data | 14* | - (A)
(A). Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders - (B)
(B). Indicate number of participants with missing data for each variable of interest - (C)
(C). Summarise follow-up time (eg, average and total amount)
| - (A)
(A). Provide additional information on average treatment duration for both treated and comparison cohorts - (B)
(B). Describe subjects who changed exposure status - (C)
(C). Provide numbers eligible for follow-up, numbers with completed follow-up and numbers remaining on treatment and/or in analysis at relevant time points during follow-up (eg, at yearly intervals). The use of tabular or graphical presentations of numbers exposed, outcomes and relative risks over time is encouraged
|
Outcome data | 15* | Report numbers of outcome events or summary measures over time | Consider the use of a tabular or graphical presentation (Kaplan–Meier, cumulative incidence plot) of the outcome over time for the exposed and comparison cohort |
Main results | 16 | - (A)
(A). Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% CI). Make clear which confounders were adjusted for and why they were included - (B)
(B). Report category boundaries when continuous variables were categorised - (C)
(C). If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period
| - (A)
(A). Present both relative risks and absolute measures such as event rates per person-time, risk differences or numbers needed to treat/numbers needed to harm - (B)
(B). Provide information on crude as well as all adjusted measures of the main effect as well as the intrinsic effects of key confounders - (C)
(C). Present results per time period of follow-up, if applicable, so as to indicate any time dependence of the association between exposure and outcome
|
Other analyses | 17 | Report other analyses done (eg, analyses of subgroups and interactions, and sensitivity analyses) | - (A)
(A). Consider performing analyses to explore possible effect modification - (B)
(B). Consider performing sensitivity analyses for differing definitions of exposure (item 12A) and outcome or different statistical models, if applicable
|
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 | - (A)
(A). Selection factors for treatment should be considered and discussed - (B)
(B). Discuss implication of unmeasured/residual confounding
|
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 | |