Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi

BACKGROUND: Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI). METHODS: Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9. RESULTS: We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators. Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts. CONCLUSIONS: We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned. REGISTRATION: The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17.