A Secondary Analysis to Identify Patient-Centered Outcomes in the ACR’s Appropriateness Criteria

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ORIGINAL ARTICLE

HEALTH SERVICES RESEARCH AND POLICY

A Secondary Analysis to Identify Patient-Centered Outcomes in the ACR’s Appropriateness Criteria Q 13

Matthew Thompson, MD, MPH, DPhil a , Victoria Hardy, MSc b, Monica Zigman Suchsland, MPH a, Beth Devine, PhD, PharmD, MBA c, David Kurth, MA, MPH d, Roger Chou, MD e, G. Rebecca Haines, MSM, CPXP d, Jeffrey G. Jarvik, MD, MPH f, for the PROD Research Group Abstract Context: There is a growing body of literature indicating imaging testing can affect patients cognitively, socially, behaviorally, and emotionally. The extent to which these patient-centered outcomes (PCOs) are reported in the imaging literature is unclear. Identifying PCOs may facilitate shared decision making around imaging testing. Objective: To identify PCOs across a spectrum of clinical topics included in the ACR’s Appropriateness Criteria (AC). Methods: We systematically reviewed AC evidence tables for eligible articles of studies conducted in any clinical setting in high-income countries. Included studies reported PCOs occurring as a direct or indirect result of an imaging test performed for any reason (eg, diagnosis, screening, surveillance, or staging). PCOs and the methods used to measure them were extracted through a secondary analysis and descriptive synthesis. Results: Our search identified 89 articles that reported outcomes of radiation exposure (n ¼ 37), downstream testing (n ¼ 20), complications (n ¼ 19), incidental findings (n ¼ 10), quality of life (n ¼ 7), physical discomfort (n ¼ 5), patient values and experiences (n ¼ 4), patient financial and time costs (n ¼ 4), psychosocial outcomes (n ¼ 4), and test duration (n ¼ 2). These outcomes were rarely reported from the patient perspective and were measured using a range of standardized or validated and nonstandardized methods. Conclusions: We identified few PCOs incorporated in the AC. Our findings reflect the historical emphasis of diagnostic research on accuracy, clinical utility, and selected outcomes (eg, adverse events). As radiology moves to a more patient-centered approach, it will be important to measure PCOs reported directly from patients. Keywords: Appropriateness criteria, imaging, patient-centered J Am Coll Radiol 2019;-:---. Copyright
2019 Published by Elsevier Inc. on behalf of American College of Radiology

INTRODUCTION The overriding framework that guides evaluation of diagnostic imaging tests specifies six outcomes: technical efficacy, diagnostic accuracy, diagnostic thinking, therapeutic, patient outcome, and societal efficacy [1,2].

Although there is wide agreement that efficacy studies are critical for determining how a given technology compares with existing reference or “gold standard” tests, limiting evaluation to clinical outcomes alone may be insufficient. Tests can have both direct and indirect

a Department of Family Medicine, University of Washington, Seattle, Washington. b University of Cambridge, Cambridge, England. c The Comparative Health Outcomes, Policy and Economics (CHOICE) Institute, School of Pharmacy, University of Washington, Seattle, Washington. d American College of Radiology, Reston, Virginia. e Oregon Health & Science University, Portland, Oregon. f Departments of Radiology, Neurological Surgery and Health Services, and the Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, Washington.

Corresponding author and reprints: Matthew Thompson, MD, MPH, DPhil, Department of Family Medicine, Box 354696, University of Washington, Seattle, WA 98195-4696; e-mail: [email protected]. Dr Jarvik is a section editor and consultant for UpToDate; has received travel reimbursement from the General Electric-Association of University of Radiologists Radiology Research Academic Fellowship (GERRAF) for service on the faculty advisory board; is a coeditor of Evidenced-Based Neuroradiology published by Springer. David Kurth and Rebecca Haines are employed by the ACR. The other authors state that they have no conflict of interest related to the material discussed in this article. Q2

ª 2019 Published by Elsevier Inc. on behalf of American College of Radiology 1546-1440/19/$36.00 n https://doi.org/10.1016/j.jacr.2019.05.016

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effects on clinical management, as well as other aspects of a patient’s life, such as their emotional well-being, cognition, psychosocial impacts, and health behaviors [3-5]. These patient-centered outcomes (PCOs) could alter the overall balance between risks and benefits of a test and patients’ preferences for different tests. PCO research (PCOR) investigating diagnostic testing is in its infancy. In the context of imaging, PCOR can address outcomes and patients’ experience and deem important when selecting between imaging options. For example, patients have described claustrophobia [6], physical discomfort [6], and discovery of incidental nodules as impactful during MRI [7], and patients undergoing frequent imaging during cancer therapy have highlighted the importance of cumulative radiation exposure [8]. However, along the “test-treatment pathway” [9], diagnostic imaging tests may have many other direct and indirect effects. Collation of information on PCOs for diagnostic testing research is important in supporting the roles that radiologists and referring clinicians play in guiding patients’ decisions. Several radiologic societies have recognized the need to integrate PCOR methods into radiology research and dissemination. A consensus panel convened by the Society of Interventional Radiology ranked identifying patient-centered domains in interventional radiology procedures as the number 1 priority objective [10]. The Association of University Radiologists Radiology Research Alliance Task Force identified four PCOR priority research areas that should align with current radiology research; two priority topics include the assessment of prevention, diagnosis, and treatment options, such as screening regimens, and the communication and dissemination of research [11]. Indeed, the ACR’s Patient and Family-Centered Care initiative [12] highlights effective communication as essential for giving patients the information necessary to make informed choices [13]. To optimize decision making, it is important that providers (ie, referring clinicians and radiologists) are aware of factors related to imaging tests that may be important to patients, so they can be addressed as part of the testing process. In this study, we sought to identify the frequency and type of PCOs reported in studies of diagnostic imaging testing, by conducting a secondary analysis of studies of diagnostic imaging included in the ACR’s Appropriateness Criteria (AC). This study forms part of a program of research called Patient-Centered Research for Standards of Outcomes in Diagnostic Tests (PROD), which aims to inform methods for use of PCOs of diagnostic imaging 2

tests to facilitate more informed decision making around these tests.

METHODS Protocol Development A protocol was developed in conjunction with a Technical Expert Panel, which convened to oversee the conduct of this study. The panel consisted of individuals with expertise in radiology, systematic reviews, imaging industry representatives, members of the ACR, diagnostic methods experts, and patients and patient advocates. The design and reporting of this secondary analysis were informed by Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines [14]. Data Source The ACR systematically reviews published literature to provide evidence to inform expert and consensus-based recommendations. The AC are used by referring physicians, radiologists, and other providers to guide imaging and treatment decisions across multiple clinical areas. Within each clinical area, specific topics are identified with accompanying evidence tables that list studies identified through systematic searches. Each evidence table summarizes the study title and type, sample size, study objectives, and main findings of identified articles: https://acsearch.acr.org/list. Eligibility Criteria We included evidence tables for topics within clinical areas relevant to the PROD study, specifically topics of screening, diagnosis, surveillance and monitoring, staging imaging on adult patients (breast, cardiac, gastrointestinal, musculoskeletal, neurologic, thoracic, urologic, vascular, and women’s health). We excluded pediatrics, radiation oncology, and interventional radiology topics because these are outside the scope of the PROD study, which focused on diagnostic imaging tests in adults. Primary studies cited in eligible evidence tables were included if they reported PCOs of an imaging test used for any purpose. Included studies were conducted in any clinical setting (eg, hospital, ambulatory) in high-income countries and reported in the English language. Clinical topics were excluded if a search strategy was not available on the ACR’s website. We excluded quantitative studies of <20 patients, as well as technical feasibility studies, clinical guidelines, systematic reviews, letters, and abstracts where the full text article was not available. Studies solely reporting any of the following outcomes were also Journal of the American College of Radiology Volume - n Number - n Month 2019

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excluded: diagnostic accuracy, incidence or prevalence, epidemiological associations, sonographic parameters, anatomic or pathologic outcomes.

Identification of PCO There is no widely accepted definition of PCOs specific to diagnostic testing. Therefore, we used PCORI’s definition, which states that PCOs encompass the following: “1) assessment of harms and benefits to inform decision making, highlighting comparisons and outcomes that matter to people; 2) a focus on outcomes that people notice and care about, and 3) the incorporation of a wide variety of settings and diversity of participants” [15]. Our definition was also influenced by Bossuyt and McCaffery’s framework, which describes the diagnostic pathways through which tests may directly influence patient outcomes [3]. We excluded outcomes that we considered downstream consequences due to changes in clinical management from the test. Due to a limited amount of extant research specifying outcomes that are important to patients for imaging tests, we did not have an exhaustive predefined list of PCOs for inclusion, meaning some PCOs were considered and discussed on a case-by-case basis. However, PCOs identified a priori based on previous research included psychosocial, quality of life, incidental findings, downstream testing, testrelated complications, and time (eg, test preparation, testing procedure, or time burden to patients), as well as physical effects of the test or testing process [3,5,16,17]. We included studies where PCOs meeting these criteria were included, regardless of whether or not they were solicited from patients themselves or were primary or secondary outcomes of the study. Search Strategy We systematically reviewed the clinical areas listed on the ACR AC website (https://acsearch.acr.org/list) to identify relevant topics within each clinical area and excluded any that were not relevant to the PROD study or lacked an accompanying search strategy. Evidence tables from eligible topics were then downloaded and hand searched for potentially eligible articles. Full details of the ACR search strategies (including search terms, search dates, selection criteria, and bibliographic databases searched) are available on the ACR website (www.acr.org/ac). We utilized evidence tables from the most recent searches performed by the ACR (range March to December 2017) and last accessed the ACR website AC to corroborate included topics on January 10, 2018. Journal of the American College of Radiology Health Services Research and Policy n Thompson et al

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Screening The article summaries reported within each evidence table were screened for eligibility by at least two authors (M.T., V.H., M.Z.S.). Full texts of articles identified as potentially relevant were retrieved and reviewed using inclusion and exclusion criteria. Final inclusion was determined by consensus between two authors (V.H. and M.Z.S.), with discrepancies resolved by a third (M.T.). The primary reason for exclusion (ie, ineligible clinical area, design, population, outcome, not an imaging test) was recorded, and duplicate articles (ie, those appearing in more than one clinical area) were identified and removed. Data Extraction Two authors (V.H., M.Z.S.) extracted study year, design, clinical topic, imaging modality, imaging purpose, as well as details of the PCO including its definition, and measurement method from each included article to an Excel (Microsoft Corporation, Redmond, Washington, USA) spreadsheet. Extracted data were checked for accuracy (M.T.). The extracted data are presented in the Appendix. Quality Appraisal Each article had a study quality rating assessed by the ACR according to their methodology (Table 1), which is based on elements from the GRADE methodology for Q 3 appraising quality for diagnostic and therapeutic studies [18]. Because our objective was to identify PCOs rather than synthesize data to make recommendations to inform practice, we did not repeat quality appraisal. Analysis Data were analyzed through a descriptive synthesis. Identified PCOs were grouped into categories by the authors. We present our descriptive synthesis by PCO, stratified by imaging modality. RESULTS We reviewed the 254 clinical topics listed on the ACR website as of December 30, 2017. After exclusion of 92 topics not relevant to the PROD study (ie, identified by the ACR as “interventional,” “pediatric,” or “radiology oncology”), 162 topics remained. Of these, 68 had no accompanying search strategy available at the time of the review, and evidence tables for 11 topics appeared in two clinical areas. Evidence tables for the remaining 83 clinical areas were screened, another 14 of which were excluded due to no eligible articles (Fig. 1).

Patient-Centered Outcomes

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Q1

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Table 1. ACR summary quality criteria Study Quality Study Quality Category Category Definition Name 1

2

3

4

Criteria for Diagnostic Studies

The source has The study is all 8 well designed diagnostic and accounts quality for common elements. biases. The source has The study is 6 or 7 moderately diagnostic well designed quality and accounts elements. for most common biases. The study has The source has 3, 4, or 5 important diagnostic study design study quality limitations. elements. The source has The study or 0, 1, or 2 source is not diagnostic useful as study quality primary elements. evidence.

Criteria for Therapeutic Studies The source has 5 or 6 therapeutic study quality elements. The source has 3 or 4 therapeutic study quality elements.

The source has 1 or 2 therapeutic study quality elements. The source has 0 therapeutic study quality elements.

Our review consisted of 69 eligible clinical topics and evidence tables, which included a total of 5,196 article summaries, of which 4,815 were excluded. Of the 381 potentially eligible full-text articles reviewed, 292 were excluded because of ineligible clinical area (n ¼ 29), study design (n ¼ 57), population (n ¼ 9), or outcome (n ¼ 158); because intervention was not an imaging test (n ¼ 12); for a combination of these reasons (n ¼ 15); or because there was no full text available (n ¼ 6). A total of 89 articles were included in the descriptive synthesis (Fig. 1).

Q4

Characteristics of Included Articles The 89 included articles had sample sizes ranging from 23 to 78,353 and covered the following clinical areas: breast (n ¼ 11) [19-29], cardiac (n ¼ 19) [30-48], gastrointestinal (n ¼ 11) [49-58], musculoskeletal (n ¼ 7) [59-65], neurologic (n ¼ 4) [66-69], thoracic (n ¼ 2) [70,71], urologic (n ¼ 19) [72-90], vascular (n ¼ 112) [91-101], and women’s health (n ¼ 4) [102-105] (Table 2). Imaging modalities evaluated were: CT (n ¼ 47) [31-33,35-49,51-54,58,67,70-75,77-80,82-84, 86-88,90,91,93,94,101,103,105], MRI (n ¼ 8) 4

Fig 1. Flowchart of the publication search process that starts at ACR clinical topic, includes reasons for exclusion at each search step, and ends at final count of included articles in the review.

[34,61,69,95,97,99,100,104], mammography (n ¼ 8) [21-28], plain radiography (n ¼ 3) [55,62,63,65], ultrasound (n ¼ 1) [102], and arteriogram (n ¼ 1) [92]. A further 19 studies examined a combination of modalities [19,30,50,55-57,59,60,64,66,68,74,81,85, 89,96,98,106], and two did not report the modality or were unclear [20,107]. Imaging tests were evaluated for the primary purposes of diagnosis (n ¼ 44) [29-33, 37-44,49,55-57,59-61,65,67-69,71,81-88,90,92,93,96, 98-101,105,106], screening (n ¼ 13) [21-28,51,52,70, 102,103], treatment planning (n ¼ 5) [46-48,62,75], monitoring (n ¼ 8) [19,64,72,74,75,91,94,107], patient safety (n ¼ 4) [34,35,95,97], surveillance (n ¼ 1) [73], staging (n ¼ 3) [50,63,89], more than one purpose (n ¼ 4) [53,54,66,104], triage (n ¼ 1) [45], and seven did not report a purpose [36,58,77-80].

Quality of Included Studies The majority of studies included were graded by the ACR quality criteria (Table 1) as ‘The study has important study design limitations” (category 3) (n ¼ 34), or “The study or source is not useful as primary evidence” (category 4) (n ¼ 26) (Appendix). Journal of the American College of Radiology Volume - n Number - n Month 2019

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Table 2. Patient-centered outcomes (PCOs) reported in included studies Imaging Modality

PCO Radiation exposure*

Downstream testing†

Q11

No. of studies

Methods and Data Sources

CT Multiple Plain radiography Total

32 4 1 37

n

CT Mammography Multiple Total

7 8 5 20

n

n

n n n n

Complications‡

Incidental or indeterminate findings§

Arteriogram CT MRI Ultrasound Multiple Total CT

1 9 4 1 4 19

n

9

n

n n

n

n n

Dosing formula Medical record or chart review

Patient report of additional tests by telephone follow-up and unspecified questionnaire Medical record review Expert report Mammography reporting system Institutional annual performance audit records for additional testing or patients recalled for additional tests Clinical observation Medical records or pathology databases Review of adverse events and reactions and documentation in material reaction forms Patient report by telephone or in-person follow-up Medical record or chart review Expert-report Population-based data registry Colonography reporting system

Multiple Total

1 10

n

Quality of lifek

MRI Multiple Total

1 6 7

n

Patient-report of generalized health status by questionnaires (SF 36, EuroQol VascuQol)

Physical discomfort¶

MRI Plain radiography CT Multiple Total CT

1 1 2 1 5 1

n

Patient-report by validated instrument (ie, visual analog scale) Patient verbal disclosure of discomfort during imaging procedure

MRI Multiple Total

2 1 4

n

MRI

1

n

Plain radiography Multiple Total

1 2 4

n

Patient values and experience#

Patient financial and time costs**

n

n

n

n

Patient report of symptom satisfaction, preferences and perceived value of selected tests Experiences of testing procedures Understanding of terminology used in test results by unspecified questionnaires Calculation of relative time expenditure on diagnostic workup to net income Patient report of days absent from work and out of pocket expenses of tests by unspecified questionnaire and telephone follow-up Administrative billing claims records (continued)

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Table 2. Continued PCO ††

Psychosocial

Imaging Modality MRI Multiple Total

No. of studies 3 1 4

Methods and Data Sources n

n

Test duration‡‡

MRI Multiple Total

1 1 2

n

Patient-report of self-efficacy, fear avoidance, depression and anxiety by validated instrument (ie, patient health questionnaire) and unspecified instruments Patient verbal disclosure (of claustrophobia) No clear reporting of methods of data capture and source

*References 29-31, 34-41, 43, 44, 52, 53, 61, 62, 65, 69, 70-72, 79-86, 88, 89, 92, 94, 99, 103, 104. † References 19-27, 38-40, 43, 47, 57, 58, 64, 68, 97, 101. ‡ References 32, 33, 35, 54, 55, 71, 75-78, 83, 87, 90, 91, 93, 95, 98, 100, 105. § References 28, 42, 44-46, 50, 51, 68, 73, 101. k References 17, 57, 58, 62, 66, 85, 96. ¶ References 56, 59, 63, 74, 91. # References 18, 49, 67, 97. **References 57, 58, 60, 67. †† References 66, 67, 97, 102. ‡‡ References 48, 59.

Characteristics of PCOs The most frequent PCOs identified were radiation exposure (n ¼ 37), downstream testing (n ¼ 20), complications (n ¼ 19), indeterminate or incidental findings (n ¼ 10). Additional PCOs identified included quality of life (n ¼ 7), physical discomfort (n ¼ 5), patient values and experiences (n ¼ 4), patient financial and time costs (n ¼ 4), psychosocial outcomes (such as depression, anxiety, self-efficacy, claustrophobia) (n ¼ 4), and test duration (n ¼ 2). Radiation exposure was most commonly reported for CT imaging (36 of 37 studies). These reported ionizing radiation risk to specified anatomical regions or the whole body (expressed as effective radiation dose) from an individual test or series of tests where multiple imaging tests were undertaken. Seven articles aggregated doses to determine cumulative radiation exposure, but only three of these noted the duration of follow-up. Radiation exposure was often estimated, rather than measured directly. Exposure estimations utilized combinations of parameters that varied by study (eg, gender, anatomic area, scanning range). Parameters were entered into, or derived from, dosing formulas facilitated by software (eg, XDose) or preset scanning protocols or formulae (eg, Monte Carlo simulations for anthropomorphic phantoms). “Downstream testing” referred to additional imaging after an initial test and was most often noted for mammography (9 of 20 studies) and CT (8 of 20). Four of the mammography studies used reporting system

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categories (eg, BI-RADS). Seven studies of CT used medical record review to identify subsequent tests or procedures performed at the initial assessment or during follow-up, although only three articles defined the assessment or follow-up period. The need for further testing was based on expert interpretation of incidental findings identified or by the number of subsequent imaging tests conducted until a diagnosis was reached. Complications were most frequently identified for CT (13 of 19 studies) and MRI (7 of 19), and included adverse events or reactions to contrast material (eg, nephrotoxicity). In all 19 articles, these events were identified from clinical observation within a defined time frame based on changes in laboratory tests or medical record review, and three of these articles also included patient reports (eg, report of procedure discomfort). Indeterminate and incidental findings were only found in studies of CT imaging (10 of 10 studies) and referred to additional findings of varying (ie, malignant or benign) or unspecified clinical importance that indicated immediate or deferred investigations or treatment. These outcomes were determined through expert medical notes review to identify the presence and histology of indeterminate and incidental findings, or classify them using established grading conventions (eg, Colonic Reporting and Data System). PCOs reported less frequently included quality of life, physical discomfort, patient values and experiences, patient financial and time costs, psychosocial outcomes, and

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test duration. Patient-reported questionnaires were the most common tool used to capture outcomes of quality of life, emotions (eg, anxiety), patient values and experiences (eg, discomfort during imaging, patient satisfaction, or patient preference), physical discomfort, and psychosocial outcomes (eg, pain, claustrophobia, depression) at defined points after imaging. Validated questionnaires were used to solicit quality of life PCOs. Patient and financial time costs were measured using a mixture of patient report and administrative claims records and calculating the time the patient spent on the diagnostic workup relative to their net income.

DISCUSSION Main Findings Relatively few PCOs are included in studies that underpin the AC recommendations. Across the 69 clinical topics we reviewed, the PCOs identified were predominantly immediate- or short-term health complications from the test process itself (ie, adverse reactions to contrast material), or markers of potential longer-term adverse effects (ie, radiation dose). We found a much smaller body of literature reporting other outcomes, such as the frequency or impact of incidental findings, or outcomes related to emotional or behavioral effects. A small minority of the outcomes were reported from patients themselves. Overall, the quality of evidence reporting the previous outcomes were of low quality. It is perhaps not surprising that the majority of the evidence that guides AC recommendations consists of reports of accuracy or comparative accuracy. Nevertheless, many of the PCOs that we identified could be incorporated within diagnostic accuracy studies relatively easily, such as measuring adverse reactions or radiation dose. The ACR has made a particular effort to try to redress the lack of radiation assessment in the medical literature, by including this information where possible for each AC topic [108]. The paucity of data on other PCOs likely reflects lack of guidance among imaging researchers about what PCOs should be measured, their importance, lack of tools available to measure these, and inadequate reporting. Comparison With Existing Literature Leaders in the field of radiology have advocated for a shift to a more patient-centric approach to the specialty. Some have proposed models of more patient-centered radiology [109], and others have pointed out the need to identify Journal of the American College of Radiology Health Services Research and Policy n Thompson et al

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and quantify PCOs within radiology to demonstrate the overall value of imaging [4]. Although Bossuyt and McCaffery [3] proposed the idea that tests could lead to multiple effects above and beyond impact on medical decision making, few researchers have taken this concept further by specifying which outcomes are important to patients. Nevertheless, patients who have undergone imaging identify several outcomes that they felt were important, including reassurance, anxiety, physical effects, and the knowledge gained from the test [16]. Studies of screening tests also provides examples of the psychological impacts of imaging tests, such as relief from negative tests or anxiety driven by positive (or false-positive) results [110-112]. The importance of identifying both the positive (benefits) and negative (harms) from imaging tests is that patients tend to overestimate the beneficial effects of tests compared with knowledge about their risks [113]. As Gatsonsis Q 5 et al noted, “Those planning test studies should obtain an understanding of the nature and frequency of expected patient relevant outcomes of testing” [114].

Strengths and Limitations We used the AC evidence tables as the data source for this review because they constitute a common source of evidence-based guidelines for a range of imaging tests and clinical conditions. However, it is possible that evidencebased guidelines from other organizations use different strategies to identify and incorporate PCOs to inform their guidelines, therefore our findings may not apply to all areas of testing. Two authors screened each potentially eligible article to capture any ‘hidden’ PCOs. The primary limitation of the AC evidence tables is that their focus is on test accuracy metrics, rather than a broader set of PCOs. The latter are particularly likely to be measured and reported in qualitative studies or surveys. The included studies were highly heterogeneous, prohibiting a quantitative analysis. Another limitation is that the systematic reviews used to generate the AC evidence tables were conducted at different times, did not list all the search terms used, searched only Medline, and did not list reasons for exclusion of studies. Additionally, limiting the generalizability of our study findings is the exclusion criteria such as pediatric studies and Englishonly studies. Finally, we acknowledge that there is no standard definition of PCOs for diagnostic tests, and it could be argued that some of the outcomes we examined are less patient-centric (or less directly patient-centric)

Patient-Centered Outcomes

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than others. For example, the outcome of incidental findings may in reality reflect consequences or impacts of incidental findings (eg, anxiety, consequences of further testing or interventions).

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Implications for Researchers, Clinicians, and Policy Makers PCOR related to diagnostic testing generally, and imaging specifically, is an emerging field of research. It is therefore not surprising that few PCOs are currently found in AC for imaging testing. Achieving PCORI’s goal of “assessing harms and benefits to inform decision making, . . . a focus on outcomes that people notice and care about” [115] will be challenging. First, we need to identify and define PCOs related to imaging testing and explore how these vary, for example, imaging modality, with reasons for testing and other patient characteristics. Initial studies are already helping to answer this gap [16]. Some outcomes are more apparent to patients (eg, emotions), whereas others may be important to patients but invisible to them (eg, radiation exposure). This will facilitate the development of instruments to measure these outcomes and incorporation into evaluations of imaging tests. Measurement of more immediate or direct outcomes of testing will be easier to achieve than longer-term or less direct outcomes. It is also unlikely that every test comparison needs to include PCOs, and it may be possible to use PCOs reported in existing test evaluations. For example, PCOs related to ultrasound scanning may be very similar across most applications of this modality, and only differ (and require more data) in particular clinical situations (eg, pregnancy-related bleeding) or test delivery (eg, transvaginal versus transabdominal scans). Exploring the extent to which PCOs are shared across imaging modalities and test situations will facilitate a rapid acquisition of information about PCOs. Finally, the ultimate goal of identifying and measuring PCOs is to improve patient care. We will need to find ways for patients to understand and use information about PCOs in collaboration with their health care providers as part of shared decision making [116]. New methods will be needed to weight various test attributes, so that the “overall evidence” for a given test is clear. TAKE-HOME POINTS -

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The primary evidence used for current AC includes relatively few PCOs, based on a secondary analysis of 69 clinical topics.

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We found PCOs noted in 89 of the 5,196 articles reviewed. The most common PCOs were focused on radiation exposure, downstream testing, and complications. There was very little evidence on other PCOs such as incidental findings, quality of life, physical discomfort, patient values and experiences, patient financial and time costs, psychosocial outcomes, and test duration. Measuring and using PCOs in imaging test decision making is at an early stage. Future research should define which outcomes are priorities for patients, how these can be measured, and ways to incorporate these into decision making.

ACKNOWLEDGMENTS This study was supported through a Patient Centered Outcomes Research Institute (PCORI) Program Award Q 12 (ME-1503-29245) to derive new methods to incorporate patient-centered outcomes in studies of diagnostic imaging studies (the Patient Centered Outcomes for Diagnostics, or PROD study). We appreciate the input from the PROD Stakeholder Group for input on this study. ADDITIONAL RESOURCES Additional resources can be found online at: https://doi. org/10.1016/10.1016/j.jacr.2019.05.016. REFERENCES

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