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Table 2 The 35 items which achieved consensus

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

Section Standard Consensus (% agreement with scores 7, 8 or 9)
Title and abstract There should be a structured abstract which clearly states aim, study design, setting, population, intervention, outcomes, conclusion and implications. 95%
Introduction Identify the aspect of care that the new service being implemented aims to address (e.g. implementing a guideline recommendation or evidence-based management). 90%
Critically report the evidence underpinning the new service to be implemented: (e.g. phase III randomised controlled trials, systematic review, guideline recommendations). 100%
Describe the rationale for the new service design. 95%
Report the implementation strategy used and its underpinning theory. 84%
Clearly define the aims of the study, differentiating between implementation (process) objectives and effectiveness (clinical) objectives. 100%
Method (setting) Describe the study setting (including health service, personnel involved, patient and public involvement, demography of patients, etc.). 100%
Give year(s) during which the new service was implemented (i.e. planned, initiated and actively developed) and followed up. 95%
Methods (the new service) Describe the new service (e.g. components/content, frequency, duration, intensity, mode of delivery, materials used) with advice on accessing additional detailed information. Use of a standardised checklist (e.g. TIDieR) is recommended. 100%
Describe the professional backgrounds, roles and training requirements of the personnel involved in delivering the intervention with advice on accessing additional detailed information. 84%
Define the core components of the intervention, and the processes for assessing fidelity to this core content, and what, if any, local adaptation was allowed. 100%
Describe the intervention received by control/comparator group not simply stating ‘usual care’. 95%
Methods (population) Describe sites invited/excluded with reasons. 100%
Describe the population targeted by the intervention and any eligibility criteria. 100%
Report method by which patients are referred to or access the new service. 100%
Methods (randomisation) Description of randomisation (or if not randomised how comparator group was selected). 95%
Methods (data) Describe outcome measurements (specifically describing any that are at population level) distinguishing between process and clinical outcomes and health economic data. 100%
Describe data collection processes (specifically including methods of extracting routine data). 100%
Describe any processes for quality assurance (especially for use of routine data). 84%
Methods (analysis) Describe power calculation and rationale for sample size. 100%
Describe methods of statistical analysis (with reasons for that choice including approach to clustering, handling of missing data, intention to treat analysis, and adjustment for confounders, etc.). 100%
Specify a priori sub-group analyses (e.g. between different sites in a multicentre study, different clinical or demographic populations). 95%
Results (population) Report the number of sites approached, reasons for non-participation and characteristics of participating sites. 89%
Report the total eligible population (e.g. number of people with the relevant condition registered with the practice, or eligible for a service), number approached and any exclusions. 100%
Report participation rate among the eligible population, compare characteristics with the eligible population as a whole and describe any known reasons for non-participation. 95%
Report compliance with/attrition from the service as a process outcome. 95%
Include a CONSORT diagram (modified as necessary) to illustrate the recruitment of sites, provision of service to patients and any sub-groups. 84%
Results (fidelity) Report fidelity to the core components of the planned intervention (including, in multicentre studies, in the different settings). 100%
  Report any modifications or adaptations to the new service during the course of the study. 100%
Results (outcomes) Report outcomes for the whole eligible population before an analysis of any sub-groups. 100%
Report process and clinical outcomes. 100%
If relevant, report impact on use of health service resources (and ideally cost of the intervention). 84%
Report any unintended consequences or adverse effects. 100%
Discussion Interpret findings in the light of the general body of literature and consider implications for health care services (including issues of generalizability, transferability, strategies for facilitating and normalising into routine care). 100%
General Include statement(s) on regulatory approvals (including, as appropriate, ethical approval, confidential use of routine data, governance approval), trial/study registration, funding and conflicts of interest. 89%