11. Analysis

What to write

  1. Qualitative and quantitative methods used to draw inferences from the data

  2. Methods for understanding variation within the data, including the effects of time as a variable

Explanation

Various types of problems addressed by healthcare improvement efforts may make certain types of solutions more or less effective. Not every problem can be solved with one method—-yet a problem often suggests its own best solution strategy. Similarly, the analytical strategy described in a report should align with the rationale, project aims and data constraints. Many approaches are available to help analyse healthcare improvement, including qualitative approaches (eg, fishbone diagrams in root cause analysis, structured interviews with patients/families, Gemba walks) or quantitative approaches (eg, time series analysis, traditional parametrical and non-parametrical testing between groups, logistic regression). Often the most effective analytical approach occurs when quantitative and qualitative data are used together. Examples of this might include value stream mapping where a process is graphically outlined with quantitative cycle times denoted; or a spaghetti map linking geography to quantitative physical movements; or annotations on a statistical process control (SPC) chart to allow for temporal insights between time series data and changes in system contexts.

In the first example by Brady et al,1 family activated medical emergency teams (MET) are evaluated. The combination of three methods—statistical process control, a Pareto chart and χ2 testing—makes for an effective and efficient analysis. The choice of analytical methods is described clearly and concisely. The reader knows what to expect in the results sections and why these methods were chosen. The selection of control charts gives statistically sound control limits that capture variation over time. The control limits give expected limits for natural variation, whereas statistically based rules make clear any special cause variation. This analytical methodology is strongly suited for both the prospective monitoring of healthcare improvement work as well as the subsequent reporting as a scientific paper. Depending on the type of intervention under scrutiny, complementary types of analyses may be used, including qualitative methods.

The MET analysis also uses a Pareto chart to analyse differences in characteristics between clinician-initiated versus family initiated MET activations. Finally, specific comparisons between subgroups, where time is not an essential variable, are augmented with traditional biostatistical approaches, such as χ2 testing. This example, with its one-paragraph description of analytical methods (control charts, Pareto charts and basic biostatistics) is easily understandable and clearly written so that it is accessible to front-line healthcare professionals who might wish to use similar techniques in their work.

Every analytical method also has constraints, and the reason for choosing each method should be explained by authors. The second example, by Timmerman et al,2 presents a more complex analysis of the data processes involved in a multicentre improvement collaborative. The authors provide a clear rationale for selecting each of their chosen approaches. Principles of healthcare improvement analytics are turned inwards to understand more deeply the strengths and weaknesses of the way in which primary data were obtained, rather than interpretation of the clinical data itself. In this example,2 rational subgrouping of participating sites is undertaken to understand how individual sites contribute to variation in the process and outcome measures of the collaborative. Control charts have inherent constraints, such as the requisite number of baseline data points needed to establish preliminary control limits. Recognising this, Timmerman, et al used linear regression to test for the statistical significance in the slopes of aggregate data, and used run charts for graphical representation of the data to enhance understanding.

Donabedian said, “Measurement in the classical sense—implying precision in quantification—cannot reasonably be expected for such a complex and abstract object as quality.”3 In contrast to the what, when and how much of quantitative, empirical approaches to data, qualitative analytical methods strive to illuminate the how and why of behaviour and decision making—be it of individuals or complex systems. In the third example, by Dainty et al, grounded theory is applied to improvement work wherein the data from structured interviews are used to gain insight into and generate hypotheses about the causative or moderating forces in multicentre quality improvement collaboratives, including how they contribute to actual improvement. Themes were elicited using multiple qualitative methods—including a structured interview process, audiotaping with independent transcription, comparison of analyses by multiple investigators, and recurrence frequencies of constructs.3

In all three example papers, the analytical methods selected are clearly described and appropriately cited, affording readers the ability to understand them in greater detail if desired. In the first two, SPC methods are employed in divergent ways that are instructive regarding the versatility of this analytical method. All three examples provide a level of detail which further supports replication.

Examples

Example 1

We used statistical process control with our primary process measure of family activated METs (Medical Emergency Teams) displayed on a u-chart. We used established rules for differentiating special versus common cause variation for this chart. We next calculated the proportion of family-activated versus clinician-activated METs which was associated with transfer to the ICU within 4 h of activation. We compared these proportions using χ2 tests.1

Example 2

The CDMC (Saskatchewan Chronic Disease Management Collaborative) did not establish a stable baseline upon which to test improvement; therefore, we used line graphs to examine variation occurring at the aggregate level (data for all practices combined) and linear regression analysis to test for statistically significant slope (alpha=0.05). We used small multiples, rational ordering and rational subgrouping to examine differences in the level and rate of improvement between practices.

We examined line graphs for each measure at the practice level using a graphical analysis technique called small multiples. Small multiples repeat the same graphical design structure for each ‘slice’ of the data; in this case, we examined the same measure, plotted on the same scale, for all 33 practices simultaneously in one graphic. The constant design allowed us to focus on patterns in the data, rather than the details of the graphs. Analysis of this chart was subjective; the authors examined it visually and noted, as a group, any qualitative differences and unusual patterns.

To examine these patterns quantitatively, we used a rational subgrouping chart to plot the average month to month improvement for each practice on an Xbar-S chart.2

Example 3

Key informant interviews were conducted with staff from 12 community hospital ICUs that participated in a cluster randomized control trial (RCT) of a QI intervention using a collaborative approach. Data analysis followed the standard procedure for grounded theory. Analyses were conducted using a constant comparative approach. A coding framework was developed by the lead investigator and compared with a secondary analysis by a coinvestigator to ensure logic and breadth. As there was close agreement for the basic themes and coding decisions, all interviews were then coded to determine recurrent themes and the relationships between themes. In addition, ‘deviant’ or ‘negative’ cases (events or themes that ran counter to emerging propositions) were noted. To ensure that the analyses were systematic and valid, several common qualitative techniques were employed including consistent use of the interview guide, audiotaping and independent transcription of the interview data, double coding and analysis of the data and triangulation of investigator memos to track the course of analytic decisions.4

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References

1.
Brady PW, Zix J, Brilli R, et al. Developing and evaluating the success of a family activated medical emergency team: A quality improvement report. BMJ Quality & Safety. 2014;24(3):203-211. doi:10.1136/bmjqs-2014-003001
2.
Timmerman T, Verrall T, Clatney L, Klomp H, Teare G. Taking a closer look: Using statistical process control to identify patterns of improvement in a quality-improvement collaborative. BMJ Quality & Safety. 2010;19(6):e19-e19. doi:10.1136/qshc.2008.029025
3.
Donabedian a . Explorations in quality assessment and monitoring. Ann arbour, MI: Health administration press, 1980.
4.
Dainty KN, Scales DC, Sinuff T, Zwarenstein M. Competition in collaborative clothing: A qualitative case study of influences on collaborative quality improvement in the ICU. BMJ Quality & Safety. 2013;22(4):317-323. doi:10.1136/bmjqs-2012-001166

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

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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

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.

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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

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.

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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

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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