Quality-improvement reports
A report of a study of an improvement in health care tells its reader why the work started, what was done both to improve care and to study that improvement, what was found, and what the findings mean for the usefulness of the intervention and for further studies of improvement.
The SQUIRE checklist
The SQUIRE publication guidelines for improvement studies in health care, in the version published in the BMJ in 2009, give a checklist for these reports. Beyond the title and abstract, the checklist sets each part of the report a question: the introduction answers why the work started, the methods what was done, the results what was found, the discussion what the findings mean, and a closing section whether there were other factors relevant to the conduct and interpretation of the study. It has one item for planning the intervention and another for planning the study of the intervention.
Title and abstract
Give clear and accurate information for finding, indexing and scanning the paper. In the title, indicate that the article concerns the improvement of quality, broadly defined to include the safety, effectiveness, patient-centeredness, timeliness, efficiency and equity of care, state the specific aim of the intervention, and specify the study method used, such as 'A qualitative study' or 'A randomized cluster trial'. In the abstract, summarize precisely all key information from the sections of the text, using the abstract format of the intended publication.
Introduction
Give a brief, nonselective summary of current knowledge of the care problem being addressed and of the characteristics of the organizations in which it occurs. Describe the nature and severity of the specific local problem or system dysfunction that was addressed. Describe the specific aim of the proposed intervention, as changes or improvements in care processes and patient outcomes. Specify who, such as champions and supporters, and what, such as events and observations, triggered the decision to make changes, and why then. State precisely the primary improvement-related question and any secondary questions that the study of the intervention was designed to answer.
Methods
Describe the ethical aspects of implementing and studying the improvement, such as privacy concerns, protection of participants' physical well-being and potential author conflicts of interest, and how the ethical concerns were addressed. Specify how the elements of the local care environment considered most likely to influence change or improvement in the site or sites were identified and characterized. Describe the intervention and its components in enough detail that others could reproduce it, and indicate the main factors that contributed to the choice of that intervention, such as an analysis of the causes of the dysfunction.
Outline the plans for assessing how well the intervention was implemented, meaning the dose or intensity of exposure. Describe the mechanisms by which the intervention's components were expected to cause changes, and the plans for testing whether those mechanisms were effective. Where applicable, identify the study design chosen for measuring the intervention's impact on primary and secondary outcomes, such as observational, quasi-experimental or experimental. Where applicable, explain the plans for implementing the essential aspects of that design as the publication guides for specific designs describe them, such as those at www.equator-network.org.
Describe the qualitative, quantitative or mixed instruments and procedures used to assess the effectiveness of implementation, the contributions of the intervention's components and of context factors to its effectiveness, and the primary and secondary outcomes. Report the efforts to validate and test the reliability of the assessment.
Give the details of the qualitative and quantitative (statistical) methods used to draw inferences from the data. Where applicable, align the unit of analysis with the level at which the intervention was implemented. Specify the degree of variability expected in implementation, the change expected in the primary outcome (the effect size), and the ability of the study design, including its size, to detect such effects. Describe the analytic methods used to demonstrate the effects of time as a variable, such as statistical process control.
Results
Characterize the relevant elements of the setting or settings, such as geography, physical resources and organizational culture. Describe how and why the initial plan evolved and the most important lessons learned from that evolution, particularly the effects of internal feedback from tests of change, which the checklist calls reflexiveness. Present data on the changes observed in the care delivery process and in measures of patient outcomes, such as morbidity, mortality, function, patient and staff satisfaction, service utilization, cost, care and disparities.
Discussion
Summarize the most important successes and difficulties. Compare and contrast the study's results with relevant findings of others, drawing on a broad review of the literature; a summary table may be helpful in building on existing evidence.
Explore possible reasons for differences between the observed and the expected outcomes. Draw inferences about causal mechanisms and the size of the observed changes that are consistent with the strength of the data, paying particular attention to the components of the intervention and the context factors that helped determine its effectiveness or lack of it, and to the types of settings in which the intervention is most likely to be effective. Suggest steps that might be modified to improve future performance, and review issues of opportunity cost and actual financial cost.
Conclude by considering the overall practical usefulness of the intervention and by suggesting the implications of the report for further studies of improvement interventions.
Funding
Describe the funding sources, if any, and the role of the funding organization in the design, implementation, interpretation and publication of the study.