8. Intervention(s)

What to write

  1. Description of the intervention(s) in sufficient detail that others could reproduce it

  2. Specifics of the team involved in the work

Explanation

In the same way that reports of basic science experiments provide precise details about the quantity, specifications and usage of reagents, equipment, chemicals and materials needed to run an experiment, so too should the description of the healthcare improvement intervention include or reference enough detail that others could reproduce it. Improvement efforts are rarely unimodal and descriptions of each component of the intervention should be included. For additional guidance regarding the reporting of interventions, readers are encouraged to review the TIDieR guidelines: http://www.ncbi.nlm.nih.gov/pubmed/24609605.

 In the first example below1 about the multisite I-PASS study to improve paediatric handoff safety, the authors describe seven different elements of the intervention, including a standardised mnemonic, several educational programmes, a faculty development programme, observation/feedback tools and even the publicity materials used to promote the intervention. Every change that could have contributed to the observed outcome is noted. Each element is briefly described and a reference to a more detailed description provided so that interested readers can seek more information. In this fashion, complete information about the intervention is made available, yet the full details do not overwhelm this report. Note that not all references are to peer-reviewed literature as some are to curricular materials in the website MedEd Portal (https://www.mededportal.org), and others are to online materials.

The online supplementary appendix available with this report summarises key elements of each component which is another option to make details available to readers. The authors were careful to note situations in which the intervention differed across sites. At two sites the written handoff tool was built into word-processing programmes, not the electronic medical record. Since interventions are often unevenly applied or taken up, variation in the application of intervention components across units, sites or clinicians is reported in this section where applicable.

The characteristics of the team that conducted the intervention (for instance, type and level of training, degree of experience, and administrative and/or academic position of the personnel leading workshops) and/or the personnel to whom the intervention was applied should be specified. Often the influence of the people involved in the project is as great as the project components themselves. The second example below,2 from an elegant study of the Hawthorne effect on hand hygiene rates, succinctly describes both the staff that were being studied and characteristics of the intervention personnel: the auditors tracking hand hygiene rates.

Examples

Example 1

We developed the I-PASS Handoff Bundle through an iterative process based on the best evidence from the literature, our previous experience, and our previously published conceptual model. The I-PASS Handoff Bundle included the following seven elements: the I-PASS mnemonic, which served as an anchoring component for oral and written handoffs and all aspects of the curriculum; a 2-hour workshop (to teach TeamSTEPPS teamwork and communication skills, as well as I-PASS handoff techniques), which was highly rated; a 1-hour role-playing and simulation session for practicing skills from the workshop; a computer module to allow for independent learning; a faculty development program; direct-observation tools used by faculty to provide feedback to residents; and a process-change and culture-change campaign, which included a logo, posters, and other materials to ensure program adoption and sustainability. A detailed description of all curricular elements and the I-PASS mnemonic have been published elsewhere and are provided in online supplementary appendix table, available with the full text of this article at NEJM.org. I-PASS is copyrighted by Boston Children’s Hospital, but all materials are freely available.

Each site integrated the I-PASS structure into oral and written handoff processes; an oral handoff and a written handoff were expected for every patient. Written handoff tools with a standardized I-PASS format were built into the electronic medical record programs (at seven sites) or word-processing programs (at two sites). Each site also maintained an implementation log that was reviewed regularly to ensure adherence to each component of the handoff program.1

Example 2

All HCWs (healthcare workers) on the study units, including physicians, nurses and allied health professionals, were invited to participate in the overall study of the RTLS (real-time location system) through presentations by study personnel. Posters describing the RTLS and the study were also displayed on the participating units… Auditors wore white lab coats as per usual hospital practice and were not specifically identified as auditors but may have been recognisable to some HCWs. Auditors were blinded to the study hypothesis and conducted audits in accordance with the Ontario Just Clean Your Hands programme.2

Training

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References

1.
Starmer AJ, Spector ND, Srivastava R, et al. Changes in medical errors after implementation of a handoff program. New England Journal of Medicine. 2014;371(19):1803-1812. doi:10.1056/nejmsa1405556
2.
Srigley JA, Furness CD, Baker GR, Gardam M. Quantification of the hawthorne effect in hand hygiene compliance monitoring using an electronic monitoring system: A retrospective cohort study. BMJ Quality & Safety. 2014;23(12):974-980. doi:10.1136/bmjqs-2014-003080

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.

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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).

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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.

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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

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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.

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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.

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Case Reports

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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.

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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.

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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.

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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