Include statement(s) on regulatory approvals (including, as appropriate, ethical approval, confidential use of routine data, governance approval), trial/study registration (availability of protocol), funding and conflicts of interest.
| Explanation Ethical considerations, regulatory approvals, funding and conflicts of interest (including commercial interests, involvement of the owner of a product in the implementation or evaluation) should be reported. Registration of trials is a requirement, and increasingly recommended for other study designs.29 76 While not yet routine practice in implementation studies, authors may find it useful to be able to refer to a published protocol (eg, 19 26 43 77). The detailed descriptions required to describe context, implementation strategy and the intervention comprehensively will be challenging within the word count of a journal and a published protocol may provide further detail. |