Table 1

Selected Standards for Quality Improvement Reporting Excellence (SQUIRE) Guideline items that elicited specific comments from end users (quotes from focus groups and interviews that are illustrative of specific areas of concern in the document)

Item(s) eliciting commentEnd user comments
Item 5.
Intended improvementa) Describes the specific aim of the interventionb) Specifies who and what triggered the decision to make changes, and why now
“Is this where the process of the project goes, or is it in the methods section?” Participant 23, nurse researcher
“We worked with this item and item 6 in several loops, our intended improvement changed because things changed in our work.” Participant 6, healthcare improvement fellow
Item 6.
Study question
State the improvement—related question and any secondary questions that the study of the intervention was designed to answer
“Primary and secondary improvement related question is confusing, what does that mean?… We had a hard time with the [difference between] improvement question and the study question.” Participant 7, healthcare improvement fellow
Methods section
Item 9.
Planning the intervention
Intervention, component parts, factors contributing to choice of intervention, initial plans for intervention implementation
Item 10.
Planning the study of the intervention
Plans for assessing how well intervention was implemented, mechanisms of change and plans for testing, plans for implementing chosen study design, internal and external validity
Item 11.
Methods of evaluation
Instruments and procedures to assess effectiveness of intervention and assessment instruments, methods to assure data quality and accuracy
“One of the things that permeates much of this writing here, the guidelines in this section [methods and results items], is this assumption of a very preconceived linear, extremely methodical approach to studying it. We know that lots of improvement work is messy and emergent…So the guideline, the way the guideline is framed, or written, gives you the sense that if you've been in this messy reality, you are off, you can't use this.”
“…the methods section in general lacks a place for qualitative work such as member checking or triangulation –various ways to measure validity—consider adding words like credibility or trustworthiness…”
“…the initial intervention made us do [things] differently in the next cycle, is that a result, or is that a method?” Participants 2–4, improvement fellowship faculty members
“More about the theory of the intervention should go here. This is something that I have learned more about as a QI professional lately—it has required more professional development for me.” Participant 12, professional healthcare improvement consultant
Results section
Item 13.
The setting, the course of the intervention, degree of success, evolution of the plan, data on change in processes of care, benefits, harms, unexpected results, problems, failures, strength of associations, missing data
“It is odd to describe the setting again here…” Participant 24, healthcare improvement fellow
“I think the question of problems and failures is a different question from outcomes. And I would have a separate section describing my problems and failures. …to specifically identify the problems that they encountered …You know—were the problems related to data collection? Were the problems related to putting reports together that were meaningful? Were the problems reporting to the end users?…” Participant 12, professional healthcare improvement consultant
“People don't know what process measures are.”
“This ‘document degree of success’ [item 13aiii] in implementing intervention components is confusing—do you mean grade the degree of success—and what is the instrument to do that?” Participants 8 and 11, improvement fellowship faculty members
Item 14.
The most important successes and difficulties in implementing intervention components, main changes observed
Item 15.
Relation to other evidence
Compare and contrast study results with relevant findings from other studies
Item 16.
Possible sources of confounding, factors affecting external validity
Item 17.
Reasons for differences observed and outcomes, draw inferences about causal mechanisms, review opportunity cost and financial cost, practical usefulness
Item 18.
Practical usefulness, implications for further studies
“Feels overall unnecessarily complicated—there is duplication.” Participants 1–4, Improvement fellowship faculty members
[regarding item #14] “Are there lists of barriers to implementation that could help with this?” Participant 13, physician researcher
“…context is primarily mentioned in the limitations section. I don't really think that that's right. Context isn't—when we think about QI, context is so central to QI, it's not a limitation, it's a description of what the problem was, what the care setting was…” [regarding item #17] “‘Draw inferences’—how do you measure the strength of the data?”
“…describe what contextual factors we learned may impact effectiveness—I would like clarity on how to measure that…”
“Item 18b [implication for future studies] should be combined with [item] 14, and isn't this the thrust of the whole discussion?” Participants 1, 10 and 11, improvement fellowship faculty members