Table 2.
CONSORT extension for abstracts and CONSORT-DEFINE for abstract extension checklists—items to include when reporting an early phase dose-finding trial in a journal or conference abstract
| Section or item | CONSORT extension for abstracts | CONSORT-DEFINE for abstracts of EPDF trials |
|---|---|---|
| Title† | Identification as a randomised trial in the title | Identification as an early phase dose-finding (eg, dose escalation or de-escalation, phase 1, phase 1/2 or dose titration) trial in the title or abstract, and, if applicable, randomisation and/or trial acronym |
| Authors* | Contact details for the corresponding author | |
| Trial design† | Description of the trial design (eg, parallel, cluster, non-inferiority) | Description of trial design elements, such as dose escalation or de-escalation strategy, number of treatment groups, allocation ratio if relevant, and details of any prespecified trial adaptations |
| Methods | ||
| Participants | Eligibility criteria for participants and the settings where the data were collected | |
| Interventions† | Interventions intended for each group | Interventions for each dose level within each group |
| Objective† | Specific objective or hypothesis | Specific objectives (eg, relating to safety, pharmacokinetics, pharmacodynamics, recommended dose(s)) |
| Outcome | Clearly defined primary outcome for this report | Clearly defined primary outcome(s) for this report |
| Allocation | How participants were allocated to interventions | |
| Blinding (masking) | Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment | |
| Results | ||
| Numbers allocated | Number of participants randomised to each group | Number of participants allocated to each group |
| Recruitment | Trial status | |
| Numbers analysed | Number of participants analysed in each group | |
| Outcome† | For the primary outcome, a result for each group and the estimated effect size and its precision | For the primary outcome(s), results for each dose within each group, and the estimated effect size and its precision, if applicable |
| Harms | Important adverse events or side effects | |
| Conclusions | General interpretation of the results | |
| Trial registration | Registration number and name of trial register | |
| Funding | Source of funding | |
CONSORT=CONsolidated Standards Of Reporting Trials; DEFINE=Dose-finding Extension; EPDF=early phase dose-finding.
*
This item is specific to conference abstracts.
†
Modified items.