1. Title

What to write

Indicate that the manuscript concerns an initiative to improve healthcare (broadly defined to include the quality, safety, effectiveness, patient-centredness, timeliness, cost, efficiency, and equity of healthcare, or access to it).

Explanation

The title of a healthcare improvement report should indicate that it is about an initiative to improve safety, value and/or quality in healthcare, and should describe the aim of the project and the context in which it occurred. Because the title of a paper provides the first introduction of the work, it should be both descriptive and simply written to invite the reader to learn more about the project. Both examples given above do this well.

Authors should consider using terms which allow the reader to identify easily that the project is within the field of healthcare improvement, and/or state this explicitly as in the examples below. This information also facilitates the correct assignment of medical subject headings (MeSH) in the National Library of Medicine’s Medline database. In 2015, healthcare improvement-related MeSH terms include: Health Care Quality Access and Evaluation; Quality Assurance; Quality Improvement; Outcome and Process Assessment (Healthcare); Quality Indicators, Health Care; Total Quality Management; Safety Management (http://www.nlm.nih.gov/mesh/MBrowser.html). Sample keywords which might be used in connection with improvement work include Quality, Safety, Evidence, Efficacy, Effectiveness, Theory, Interventions, Improvement, Outcomes, Processes and Value.

Examples

Example 1

Reducing post-caesarean surgical wound infection rate: an improvement project in a Norwegian maternity clinic.1

Example 2

Large scale organizational intervention to improve patient safety in four UK hospitals: mixed method evaluation.2

Training

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References

1.
Dyrkorn OA, Kristoffersen M, Walberg M. Reducing post-caesarean surgical wound infection rate: An improvement project in a norwegian maternity clinic. BMJ Quality & Safety. 2012;21(3):206-210. doi:10.1136/bmjqs-2011-000316
2.
Benning A, Ghaleb M, Suokas A, et al. Large scale organisational intervention to improve patient safety in four UK hospitals: Mixed method evaluation. BMJ. 2011;342(feb03 1):d195-d195. doi:10.1136/bmj.d195

Reuse

Most of the reporting guidelines and checklists on this website were originally published under permissive licenses that allowed their reuse. Some were published with propriety licenses, where copyright is held by the publisher and/or original authors. The original content of the reporting checklists and explanation pages on this website were drawn from these publications with knowledge and permission from the reporting guideline authors, and subsequently revised in response to feedback and evidence from research as part of an ongoing scholarly dialogue about how best to disseminate reporting guidance. The UK EQUATOR Centre makes no copyright claims over reporting guideline content. Our use of copyrighted content on this website falls under fair use guidelines.

Citation

For attribution, please cite this work as:
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 Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411

Reporting Guidelines are recommendations to help describe your work clearly

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines list the information you should describe so that everyone can understand, replicate, and synthesise your work.

Reporting guidelines do not prescribe how research should be designed or conducted. Rather, they help authors transparently describe what they did, why they did it, and what they found.

Reporting guidelines make writing research easier, and transparent research leads to better patient outcomes.

Easier writing

Following guidance makes writing easier and quicker.

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Smoother publishing

Many journals require completed reporting checklists at submission.

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Maximum impact

From nobel prizes to null results, articles have more impact when everyone can use them.

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Who reads research?

You work will be read by different people, for different reasons, around the world, and for decades to come. Reporting guidelines help you consider all of your potential audiences. For example, your research may be read by researchers from different fields, by clinicians, patients, evidence synthesisers, peer reviewers, or editors. Your readers will need information to understand, to replicate, apply, appraise, synthesise, and use your work.

Cohort studies

A cohort study is an observational study in which a group of people with a particular exposure (e.g. a putative risk factor or protective factor) and a group of people without this exposure are followed over time. The outcomes of the people in the exposed group are compared to the outcomes of the people in the unexposed group to see if the exposure is associated with particular outcomes (e.g. getting cancer or length of life).

Source.

Case-control studies

A case-control study is a research method used in healthcare to investigate potential risk factors for a specific disease. It involves comparing individuals who have been diagnosed with the disease (cases) to those who have not (controls). By analysing the differences between the two groups, researchers can identify factors that may contribute to the development of the disease.

An example would be when researchers conducted a case-control study examining whether exposure to diesel exhaust particles increases the risk of respiratory disease in underground miners. Cases included miners diagnosed with respiratory disease, while controls were miners without respiratory disease. Participants' past occupational exposures to diesel exhaust particles were evaluated to compare exposure rates between cases and controls.

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Cross-sectional studies

A cross-sectional study (also sometimes called a "cross-sectional survey") serves as an observational tool, where researchers capture data from a cohort of participants at a singular point. This approach provides a 'snapshot'— a brief glimpse into the characteristics or outcomes prevalent within a designated population at that precise point in time. The primary aim here is not to track changes or developments over an extended period but to assess and quantify the current situation regarding specific variables or conditions. Such a methodology is instrumental in identifying patterns or correlations among various factors within the population, providing a basis for further, more detailed investigation.

Source

Systematic reviews

A systematic review is a comprehensive approach designed to identify, evaluate, and synthesise all available evidence relevant to a specific research question. In essence, it collects all possible studies related to a given topic and design, and reviews and analyses their results.

The process involves a highly sensitive search strategy to ensure that as much pertinent information as possible is gathered. Once collected, this evidence is often critically appraised to assess its quality and relevance, ensuring that conclusions drawn are based on robust data. Systematic reviews often involve defining inclusion and exclusion criteria, which help to focus the analysis on the most relevant studies, ultimately synthesising the findings into a coherent narrative or statistical synthesis. Some systematic reviews will include a [meta-analysis]{.defined data-bs-toggle="offcanvas" href="#glossaryItemmeta_analyses" aria-controls="offcanvasExample" role="button"}.

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Systematic review protocols

TODO

Meta analyses of Observational Studies

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Randomised Trials

A randomised controlled trial (RCT) is a trial in which participants are randomly assigned to one of two or more groups: the experimental group or groups receive the intervention or interventions being tested; the comparison group (control group) receive usual care or no treatment or a placebo. The groups are then followed up to see if there are any differences between the results. This helps in assessing the effectiveness of the intervention.

Source

Randomised Trial Protocols

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Qualitative research

Research that aims to gather and analyse non-numerical (descriptive) data in order to gain an understanding of individuals' social reality, including understanding their attitudes, beliefs, and motivation. This type of research typically involves in-depth interviews, focus groups, or field observations in order to collect data that is rich in detail and context. Qualitative research is often used to explore complex phenomena or to gain insight into people's experiences and perspectives on a particular topic. It is particularly useful when researchers want to understand the meaning that people attach to their experiences or when they want to uncover the underlying reasons for people's behaviour. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis.

Source

Case Reports

TODO

Diagnostic Test Accuracy Studies

Diagnostic accuracy studies focus on estimating the ability of the test(s) to correctly identify people with a predefined target condition, or the condition of interest (sensitivity) as well as to clearly identify those without the condition (specificity).

Prediction Models

Prediction model research is used to test the accurarcy of a model or test in estimating an outcome value or risk. Most models estimate the probability of the presence of a particular health condition (diagnostic) or whether a particular outcome will occur in the future (prognostic). Prediction models are used to support clinical decision making, such as whether to refer patients for further testing, monitor disease deterioration or treatment effects, or initiate treatment or lifestyle changes. Examples of well known prediction models include EuroSCORE II for cardiac surgery, the Gail model for breast cancer, the Framingham risk score for cardiovascular disease, IMPACT for traumatic brain injury, and FRAX for osteoporotic and hip fractures.

Source

Animal Research

TODO

Quality Improvement in Healthcare

Quality improvement research is about finding out how to improve and make changes in the most effective way. It is about systematically and rigourously exploring "what works" to improve quality in healthcare and the best ways to measure and disseminate this to ensure positive change. Most quality improvement effectiveness research is conducted in hospital settings, is focused on multiple quality improvement interventions, and uses process measures as outcomes. There is a great deal of variation in the research designs used to examine quality improvement effectiveness.

Source

Economic Evaluations in Healthcare

TODO

Meta Analyses

A meta-analysis is a statistical technique that amalgamates data from multiple studies to yield a single estimate of the effect size. This approach enhances precision and offers a more comprehensive understanding by integrating quantitative findings. Central to a meta-analysis is the evaluation of heterogeneity, which examines variations in study outcomes to ensure that differences in populations, interventions, or methodologies do not skew results. Techniques such as meta-regression or subgroup analysis are frequently employed to explore how various factors might influence the outcomes. This method is particularly effective when aiming to quantify the effect size, odds ratio, or risk ratio, providing a clearer numerical estimate that can significantly inform clinical or policy decisions.

How Meta-analyses and Systematic Reviews Work Together

Systematic reviews and meta-analyses function together, each complementing the other to provide a more robust understanding of research evidence. A systematic review meticulously gathers and evaluates all pertinent studies, establishing a solid foundation of qualitative and quantitative data. Within this framework, if the collected data exhibit sufficient homogeneity, a meta-analysis can be performed. This statistical synthesis allows for the integration of quantitative results from individual studies, producing a unified estimate of effect size. Techniques such as meta-regression or subgroup analysis may further refine these findings, elucidating how different variables impact the overall outcome. By combining these methodologies, researchers can achieve both a comprehensive narrative synthesis and a precise quantitative measure, enhancing the reliability and applicability of their conclusions. This integrated approach ensures that the findings are not only well-rounded but also statistically robust, providing greater confidence in the evidence base.

Why Don't All Systematic Reviews Use a Meta-Analysis?

Systematic reviews do not always have meta-analyses, due to variations in the data. For a meta-analysis to be viable, the data from different studies must be sufficiently similar, or homogeneous, in terms of design, population, and interventions. When the data shows significant heterogeneity, meaning there are considerable differences among the studies, combining them could lead to skewed or misleading conclusions. Furthermore, the quality of the included studies is critical; if the studies are of low methodological quality, merging their results could obscure true effects rather than explain them.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

Source

Assumptions

Reasons for choosing the activities and tools used to bring about changes in healthcare services at the system level. Source

Context

Physical and sociocultural makeup of the local environment (for example, external environmental factors, organizational dynamics, collaboration, resources, leadership, and the like), and the interpretation of these factors (“sense-making”) by the healthcare delivery professionals, patients, and caregivers that can affect the effectiveness and generalizability of intervention(s). Source

Ethical aspects

The value of system-level initiatives relative to their potential for harm, burden, and cost to the stakeholders. Potential harms particularly associated with efforts to improve the quality, safety, and value of healthcare services include opportunity costs, invasion of privacy, and staff distress resulting from disclosure of poor performance.

Generalizability

The likelihood that the intervention(s) in a particular report would produce similar results in other settings, situations, or environments (also referred to as external validity). Source

Healthcare improvement

Any systematic effort intended to raise the quality, safety, and value of healthcare services, usually done at the system level. We encourage the use of this phrase rather than “quality improvement,” which often refers to more narrowly defined approaches. Source

Inferences

The meaning of findings or data, as interpreted by the stakeholders in healthcare services - improvers, healthcare delivery professionals, and/or patients and families. Source

Initiative

A broad term that can refer to organization-wide programs, narrowly focused projects, or the details of specific interventions (for example, planning, execution, and assessment). Source

Internal validity

Demonstrable, credible evidence for efficacy (meaningful impact or change) resulting from introduction of a specific intervention into a particular healthcare system. Source

Interventions

The specific activities and tools introduced into a healthcare system with the aim of changing its performance for the better. Complete description of an intervention includes its inputs, internal activities, and outputs (in the form of a logic model, for example), and the mechanism(s) by which these components are expected to produce changes in a system's performance. Source #TODO check matches

Opportunity costs

Loss of the ability to perform other tasks or meet other responsibilities resulting from the diversion of resources needed to introduce, test, or sustain a particular improvement initiative. Source

Problem

Meaningful disruption, failure, inadequacy, distress, confusion or other dysfunction in a healthcare service delivery system that adversely affects patients, staff, or the system as a whole, or that prevents care from reaching its full potential. Source

process

The routines and other activities through which healthcare services are delivered. Source

Rationale

Explanation of why particular intervention(s) were chosen and why it was expected to work, be sustainable, and be replicable elsewhere. Source

Systems

The interrelated structures, people, processes, and activities that together create healthcare services for and with individual patients and populations. For example, systems exist from the personal self-care system of a patient, to the individual provider-patient dyad system, to the microsystem, to the macrosystem, and all the way to the market/social/insurance system. These levels are nested within each other. Source

Theory

Any “reason-giving” account that asserts causal relationships between variables (causal theory) or that makes sense of an otherwise obscure process or situation (explanatory theory). Theories come in many forms, and serve different purposes in the phases of improvement work. It is important to be explicit and well-founded about any informal and formal theory (or theories) that are used. Source