Results Summary
What was the project about?
Imaging tests, such as X-rays and MRIs, can help find health problems. When assessing how well the tests work, accuracy is important. But other benefits and harms, such as having pain from the test or relieving worry by knowing test results, may also matter to patients.
In this study, the research team wanted to learn what effects of imaging tests matter to patients.
What did the research team do?
First, the research team talked with people about their experiences with imaging tests. The team interviewed 77 patients, primary care providers, and imaging test providers. Of these, 77 percent were white, 8 percent were Asian, 5 percent were African American, 5 percent were Hispanic or Latino, and 1 percent each were American Indian or Alaska Native, mixed race, or another race. Also, 77 percent were under age 60, and 61 percent were women. All were receiving or providing care at clinics in Washington or Idaho.
Next, the research team reviewed 89 previous studies about imaging tests for adult patients. The team looked at the types of outcomes reported in these studies.
To identify groups, or domains, of outcomes that matter to patients, the research team met with a different group of people. The group included patients, primary care doctors, imaging test providers, researchers, and imaging industry representatives. Group members looked at and sorted the outcomes from the interviews and previous studies. This group also gave input on other parts of the study.
What were the results?
From the interviews, types of outcomes were
- Physical outcomes, such as pain from holding uncomfortable positions during imaging
- Emotional outcomes, such as anxiety or relief
- Outcomes related to knowledge gained from the test results
- Burden, such as cost or time spent
Most previous studies looked at short-term physical outcomes from imaging, such as radiation exposure or kidney damage. Some studies looked at emotional outcomes. Studies rarely asked patients directly about these outcomes.
At the group meeting, the group sorted the different types of outcomes into four areas:
- Physical effects
- Emotional outcomes
- Information or knowledge gained from the imaging test results
- Burden
What were the limits of the project?
Most people interviewed were white. Results may differ for people of other backgrounds. The research team also didn’t ask patients to rank the importance of outcomes.
Future research could look at which outcomes are most important to patients. Studies could also look at how to use these outcomes to improve testing for patients.
How can people use the results?
Researchers can use the results when assessing imaging tests to look at outcomes that matter to patients.
Professional Abstract
Background
Diagnostic imaging test results inform many healthcare decisions. Most methods and standards used to evaluate tests focus on accuracy, but other outcomes may also be important to patients.
Objective
To develop consensus-based recommendations on patient-centered outcomes for evaluating diagnostic imaging test options
Study Design
| Design Element | Description |
|---|---|
| Design | Empirical analysis |
| Data Sources and Data Sets | 77 semistructured interviews with patients who received imaging tests, primary care providers, and radiology providers from clinics in Washington and Idaho; 89 empirical articles about imaging related to screening, diagnosis, surveillance and monitoring, and staging with adult patients |
| Analytic Approach | Qualitative analysis, systematic review, consensus meeting |
| Outcomes | Types of patient-centered outcomes experienced by interview participants or reported in studies of diagnostic imaging testing; final recommendations from the consensus meeting regarding domains of important patient-centered outcomes to measure |
Methods
This study sought to propose domains to better assess the benefits and harms of imaging tests from a patient perspective. Researchers first conducted interviews with 77 participants, including patients who recently received imaging tests, primary care providers, and radiology providers, about their experiences with and understanding of imaging tests.
Of these participants, 77% were white, 8% were Asian, 5% were African American, 5% were Hispanic or Latino, and 1% each were American Indian or Alaska Native, mixed race, or another race or ethnicity. Also, 77% were under the age of 60, and 61% were female. All interview participants received or provided care at clinics in Washington or Idaho.
Next, researchers conducted a systematic review of 89 empirical articles about imaging screening, diagnosis, surveillance and monitoring, and staging with adult patients. Researchers examined the frequency and types of patient-centered outcomes reported in these studies.
To identify important domains of patient-centered outcomes, an advisory board consisting of patients, primary care providers, radiology providers, researchers, and imaging industry representatives participated in a consensus meeting based on findings from the interviews and systematic review. The board also provided input on study methods, data collection, and data interpretation.
Results
The interviews elicited several types of patient-centered outcomes related to imaging tests, including
- Physical outcomes, such as pain from holding uncomfortable positions during imaging
- Emotional outcomes, such as anxiety or relief
- Outcomes related to knowledge gained from the test
- Outcomes related to burden, including cost and time requirements
Most patient-centered outcomes identified in the systematic review related to immediate or short-term adverse physical effects from the test process itself, such as kidney damage, pain, or level of radiation exposure. The review also identified other types of patient-centered outcomes, including quality of life and emotional effects. Most outcomes in the systematic review were clinician reported rather than patient reported.
In the consensus meeting, participants sorted patient-centered outcomes important in diagnostic imaging tests into four domains:
- Physical effects
- Emotional outcomes
- Information or knowledge yielded by the imaging test
- Test burden
Limitations
Most interview participants were white. Results may differ with participants from other backgrounds. The study identified important patient-centered outcomes but did not prioritize the relative importance of these outcomes.
Conclusions and Relevance
The study identified four domains of patient-centered outcomes that can be used to evaluate diagnostic imaging tests.
Future Research Needs
Future research could determine the relative importance of the patient-centered outcomes identified in this study and how to use the outcomes to inform patient and clinician decision making.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Stories and Videos
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the original report submission included an appendix describing a scoping review of qualitative research on patients’ experiences with imaging testing. The reviewers expressed concern that this scoping review was not well integrated into the rest of the study, and they requested a number of clarifications. The researchers removed the detailed description of the scoping review since it informed the PCORI study but was not part of the original research plan. They incorporated a summary of the results in the discussion section for aim 1, which focused on patients’ experiences with imaging tests and patient-centered outcomes.
- The reviewers commented on the overlap among some of the patient-centered outcome domains that were defined over the course of the study. They asked whether the domains should be redefined or whether the report should address the overlap more directly. The researchers said they felt secure in their definition of domains but acknowledged the overlap and their difficulties in establishing a consistent definition to the test burden domain.
- The reviewers remarked that since the study focused on imaging tests, where the clinicians who order the tests are generally not involved in performing them and often have a limited role in interpreting them, the results of this study may not apply to other types of diagnostic tests. The researchers acknowledged that the study focused on imaging tests, but said they tend to believe that the patient-centered outcomes they proposed will apply to many types of tests to various degrees although further work will be needed to explore this. The researchers explained that they focused on imagining tests because those are some of the most important tests in health care because of their clinical value, frequency of use, and cost.
- The reviewers suggested that the study made a somewhat artificial distinction between consequences of testing due to the test itself versus due to changes the test led to in clinical management. The researchers said this distinction is an area of active discussion and debate in this field, and they considered the issue carefully. They said they consulted with other experts and with their project stakeholders on this issue. The researchers said they chose to focus on the more immediate and direct outcomes from diagnostic tests because they believed that incorporating later effects would dilute understanding about immediate testing outcomes, which was the area they wanted to understand better.
- The reviewers said more work is necessary to evaluate whether the findings from this study apply to an ethnically and socioeconomically diverse population, and they wondered how the findings from this work will be disseminated to different stakeholder groups. The researchers agreed that patient-centered outcomes may vary among different sociodemographic groups and said they plan to disseminate their findings, which will be published in a peer-reviewed journal, by engaging with professional groups, patient and consumer groups, industry, and other stakeholders.