Standards for Reporting Implementation Studies (StaRI) StatementBMJ 2017; 356 doi: https://doi.org/10.1136/bmj.i6795 (Published 06 March 2017) Cite this as: BMJ 2017;356:i6795
All rapid responses
To the Editor,
We were surprised to see the recently published StaRI guidelines for implementation science [Pinnock et al]. StaRI is strikingly similar to SQUIRE 2.0 – the publication guidelines to promote excellence in healthcare improvement reporting1. We are concerned that StaRI may create unintended confusion in the field.
The SQUIRE guidelines represent the input of hundreds of people over a 10 year period of transparent development, evaluation, and revision2-5. We recognize that the StaRI team may have been unaware of the philosophy and development that SQUIRE represents, just as we were unaware of the work of StaRI until its release. We believe the divisions between the science of improvement and implementation science are a false dichotomy. Thus, we will use this forum to briefly outline where the StaRI and SQUIRE converge. We hope this will facilitate a dialogue that can move the field forward as a whole.
The purpose of StaRI and SQUIRE share the same spirit. SQUIRE “provide[s] a framework for the reporting of new knowledge about how to improve healthcare”. StaRI’s purpose is “improve reporting of implementation studies … with the aim of enhancing adoption and sustainability of effective interventions”.
The scope of StaRI and SQUIRE are the same: both cover ‘the range of designs’ used in the field. Additionally, both guidelines indicate that not all items will apply to every study, and should not be required for every manuscript.
A goal for the most recent version of SQUIRE was to create clarity around terminology – favoring plain language over field-specific jargon. It has three key concepts. Authors who use SQUIRE should provide a rationale for their intervention, should study their intervention(s) - not simply report outcomes, and should describe the context of the work. SQUIRE’s three key concepts are recapitulated in StaRI ‘s two defining concepts and 3 overarching components.
In the first defining concept of StaRI, authors are urged to describe the strategy of implementation. Though the authors do not reference TIDIER, these guidelines were released in 2014 and provide a framework for clear reporting of interventions6. SQUIRE directs authors to this tool for the appropriate guidance.
In the second defining concept, StaRI asks authors to report the “impact of the intervention on the health of the target population … [and] even when the evidence is strong, [consider] the possibility that the intervention may be attenuated…”. The items for this include assessments of fidelity, resource use, costs, etc. This is nearly the same as the SQUIRE key concept that invites authors to ‘study their intervention’. The items for StaRI and SQUIRE in this area are similar.
The first of StaRI’s three overarching components is that there must be a hypothesis. This approximates the first key concept of SQUIRE, that there should be a theory or rationale underpinning the proposed interventions7.
The second component of StaRI is the requirement to describe the balance between fidelity to and adaptation of the intervention. It is highly similar to the TIDIER guidelines and also contains elements that SQUIRE places under the heading of ‘the study of the intervention’. This concept is hard to understand and communicate (whether in SQUIRE or StaRI), but at least one publication addresses it8. When we teach about SQUIRE we use the following plain language to describe this concept: ‘did things get better for the reasons you think they did? Were there unintended consequences? What was the impact of the intervention on the people, processes and systems involved?’
The third component of StaRI is the requirement that authors describe context. SQUIRE incorporates items for the description of context in the methods, results and discussion section.
StaRI describes SQUIRE as a publication guideline for quality improvement reports, but this conflates SQUIRE with the classic eight point guideline for quality improvement reports by Moss and Thompson9. SQUIRE is distinguished from Moss and Thompson’s work by having a different purpose, which is to support the reporting of “formal planned empirical studies on the development and testing of improvement interventions”2 and the “reporting of new knowledge about how to improve health care”1. Moss and Thompson’s quality improvement report guideline offers an alternative to the IMRaD format of biomedical reporting, while SQUIRE stays within the IMRaD format.
During the development of SQUIRE 2.0, we noted that the words ‘quality improvement’ had become confusing, because the phrase is associated with specific methodologies that are used in this area of work. SQUIRE is not intended to be restricted to these, but rather applies to any systematic method to improve the quality, safety, and value of healthcare. To resolve the confusion, we retained the SQUIRE acronym to hold on to the guideline’s origins and history, but explicitly moved toward clearer language – SQUIRE’s tag line is now: “promoting excellence in healthcare improvement reporting”. This accurately reflects the intent of the guidelines by leaving space for the many ways and methods that one might use to improve healthcare.
To be sure, some differences between StaRI and SQUIRE remain, especially in the assumptions about timing of iteration and adaptation of interventions. StaRI emphasizes alterations to a specific planned intervention during execution (“implementation cycle”). In SQUIRE the alterations are assumed to most typically occur during both development and execution. SQUIRE does not constrain alterations to a specific time frame.
As we reflect, we are struck by the fact that one field has named itself for the process of making healthcare better (implementation science) while the other has named itself for the hoped for outcome (the science of healthcare improvement). There are more similarities between our work than differences, and we hope this is the beginning of a discussion that can harmonize our science and decrease confusion.
Louise Davies - For the SQUIRE Leadership Team
David P. Stevens
1. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ quality & safety. Sep 14 2015.
2. Davidoff F, Batalden PB, Stevens DP, Ogrinc GS, Mooney SE, Group SD. Development of the SQUIRE Publication Guidelines: evolution of the SQUIRE project. BMJ quality & safety. Nov 2008;34(11):681-687.
3. Davies L, Batalden P, Davidoff F, Stevens D, Ogrinc G. The SQUIRE Guidelines: an evaluation from the field, 5 years post release. BMJ quality & safety. Dec 2015;24(12):769-775.
4. Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project. Qual Saf Health Care. Oct 2005;14(5):319-325.
5. Davies L, Donnelly KZ, Goodman DJ, Ogrinc G. Findings from a novel approach to publication guideline revision: user road testing of a draft version of SQUIRE 2.0. BMJ quality & safety. Apr 2016;25(4):265-272.
6. Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
7. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ quality & safety. Jan 23 2015.
8. Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ quality & safety. May 2015;24(5):325-336.
9. Moss F, Thompson R. A new structure for quality improvement reports. Quality in health care : QHC. Jun 1999;8(2):76.
Competing interests: No competing interests