Confirmation of Values and Preferences When Considering a Musculoskeletal Diagnostic Test: A Scenario-Based Study
Phase: NA
Conditions: Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS), Lateral Epicondylitis, Osteoarthritis, Trigger Digit, Dupuytren Contracture, Rotator Cuff Tendinopathy, De Quervain Disease
Sponsor: University of Texas at Austin

Confirmation of Values and Preferences When Considering a Musculoskeletal 
Diagnostic Test: A Scenario-Based Study 
 
2 September 2025 
 
ID: STUDY00004831(2) 
NCT ID: Not yet assigned 
 
 
 
Emily H. Jaarsma & David Ring 
 
Research to be conducted at Dell Medical School, University of Texas at Austin, United States 
 
 
 
 

 
Hypotheses 
Primary null hypothesis:  
There is no difference in the likelihood of choosing to proceed with a diagnostic test between 
patients exposed to randomized discussions that include versus do not include a structured 
diagnostic Advance Care Planning (ACP) discussion. 
 
Secondary null hypotheses:  
• There is no difference in the degree of patient confidence that a diagnostic test has more 
potential for benefit than harm between patients exposed to scenarios with and without 
a diagnostic ACP-style discussion. 
• There is no difference in the perceived difficulty of the diagnostic decision between 
patients exposed to scenarios with and without a diagnostic ACP-style discussion. 
• Patients’ preferred level of involvement in diagnostic decision-making does not 
moderate the association between exposure to a diagnostic ACP-style discussion and 
decision outcomes (i.e., test acceptance, confidence, or difficulty making decision). 
 
 
Authors: Emily Jaarsma, David Ring, *Other authors to be determined as per ongoing 
commitment and engagement with study 
Target journal: TBD 
IRB approval required: Blanket 
ClinicalTrials.gov: Yes, not yet completed 
 
Background and Rationale 
Background 
Most musculoskeletal diagnoses can be made with a high probability based on interview and 
examination alone.(1,2) This is in part due to the fact that there is a single common 
pathophysiology at most anatomical areas, many of them associated with human aging, and in 
part because symptoms and signs are often characteristic and can confirm the diagnosis with a 
high probability that is not notably increased by diagnostic tests. One example is the diagnosis 
of carpal tunnel syndrome, where the probability of diagnosis based on characteristic signs and 
symptoms is not appreciably improved by electrodiagnostic testing.(3)   
 
Following Bayes theorem, diagnostic tests are best used to confirm a likely but still somewhat 
uncertain diagnosis or to disconfirm an unlikely, but possible and potentially concerning 
diagnosis.(2) Ordering a test in a context of complete uncertainty often has more potential for 
harm than benefit due to misleading results or misinterpretation of expected results.  For 
instance, an adult over age 40 with new knee pain after a minor event and no fracture or 
ligamentous injury is almost certain to have symptoms from knee osteoarthritis, which most 
humans develop with age.(4) An MRI interpreted as “meniscal tear”, when the correct diagnosis 
is osteoarthritis of the knee, might lead to overdiagnosis and overtreatment with iatrogenic, 
financial, and psychological harm. Psychological harm takes the form of false hope, uncertainty, 

and anxiety about the role of these tests in health, especially when it is not clear why the test is 
being obtained or the potential benefits and potential harms of testing. (5) Despite this, 
patients often expect diagnostic tests and imagine they are a necessary step towards solving the 
problem.(6,7) Patients and non-specialists may think that testing is necessary for diagnosis, 
whereas specialists tend to make diagnoses without tests and reserve tests for planning 
operative interventions.  
 
People are not accustomed to thinking about the potential harms of diagnostic testing.  More 
information seems inherently good and it can be difficult to understand the misinformation and 
harm that can be associated diagnostic tests and their interpretation. Likewise, clinicians may 
assume that reassurance must be tied to diagnostic testing. Yet, evidence suggests that a 
negative test result is rarely effective in alleviating worry and that the quality of the patient-
clinician relationship is instead far more important.(8-10) Thoughtful and healthful use of 
diagnostic testing depends, in part, on trust between clinician and patient.(5) 
 
 
Rationale 
Advance Care Planning (ACP) is often considered in terms of end-of-life care among people with 
terminal or life-threatening illness.(5,11) During ACP, clinicians help patients ground their 
understanding of the illness and explore what tests and treatments matter most to them (their 
values). The motivation for ACR is that, in the midst of the emotion of serious illness, people 
might be more likely to make choices contrary to their values.(12) Having carefully considered 
and mapped out one’s values and plans prior to serious illness can help with calm, confident 
navigation of difficult decisions amid serious illness. While this approach has been traditionally 
centered around end-of-life care, there is emerging interest in extending this approach to care 
throughout medicine, including plans for decisions regarding visits, tests, and treatments for 
non-life-threatening illness. In the field of musculoskeletal care, there is evidence that 
personalized treatment approaches are associated with alleviation of symptoms and enhanced 
patient confidence in self-management and understanding regarding their condition.(13) For 
instance, in patients with ongoing musculoskeletal symptoms such as low back pain and 
symptoms diagnosed as fibromyalgia, individualized approaches to care in which patients are 
active participants in their treatment decisions, can enhance patient satisfaction, quality of life, 
treatment adherence and self-efficacy (as measured via Patient Activation Measure).(13-16) In 
most cases, musculoskeletal diagnostic tests are not considered in time sensitive situations. 
Most of the pathophysiologies under consideration are idiopathic or senescent and the tests 
and treatments are optional (discretionary).  There may be value in adding a step prior to 
ordering a test, where both the patient and clinician take time to explore what matters most to 
the patient and how they plan to weigh potential harms and benefits of testing.   
 
This study aims to explore how patients respond to brief hypothetical scenarios regarding 
potential musculoskeletal diagnostic tests, and whether a simulated ACP-style discussion 
embedded within the scenario affects patient preferences and confidence in understanding 
potential harms and benefits.  
 

Proposed methods 
Study design: Randomized, scenario-based study 
 
Recruitment methods: Participants will be recruited from an outpatient musculoskeletal 
specialty clinic. After obtaining verbal consent, all participants will be asked to complete a short 
survey on a tablet or other electronic device via the REDCap platform (Vanderbilt University, 
United States).   
 
Intervention: Patients will be invited to enroll prior to their musculoskeletal specialty care visit. 
Participants will be randomized (using an online random number generator) to receive one of 
two clinical vignettes, each involving a commonly considered diagnostic test for a non-traumatic 
musculoskeletal condition: 
• Group 1 – Patients will engage in a structured ACP-style discussion facilitated by a 
trained researcher using branching scripted prompts and recorded via verbal-to-text 
transcription technology (Appendix 1) 
• Group 2 – Patients will receive the same clinical vignette, including mention of 
consideration for an optional diagnostic test. Instead of a structured ACP-style 
discussion, they will be presented with a brief, standardized informational statement 
regarding diagnostic tests. This statement will describe what the test involves, what it 
may reveal and any general risks or limitations (Appendix 1) 
 
The ACP-style discussion (intervention) will simulate the process of decision-making about 
diagnostic testing but will not involve actual test ordering, nor necessarily reflect diagnostic 
tests currently being considered for the participant. This will be clearly communicated to all 
participants. 
 
Inclusion Criteria:  
• Adults (18+ years) 
• English literacy 
• Seeking musculoskeletal specialty care  
• Diagnosis of non-traumatic musculoskeletal condition (including but not limited to: 
carpal tunnel syndrome, lateral epicondylitis, osteoarthritis, trigger digit, Dupuytren’s, 
De Quervain, or rotator cuff tendinopathy) 
 
Exclusion criteria: 
• Cognitive or physical impairment or severe psychiatric illness that would interfere with 
participation in the scenario-based discussion or completion of the survey 
instruments 
 
Measured variables 
Response variables (Appendix 2): 

• Enthusiasm for proposed hypothetical diagnostic test (11-point Likert scale from, 0=I 
would definitely decline this test, 5=I am not sure if I would accept this test, 10=I would 
definitely proceed with this test) 
• Decisional conflict regarding the diagnostic test, assessed using the ‘SURE’ scale (0-4 
score; higher scores indicate greater certainty and lower decisional conflict) (Appendix 2)  
 
Explanatory variables: 
Exposure to diagnostic ACP discussion (yes/no) 
Preferred level of involvement in diagnostic decision-making (Appendix 3) 
Musculoskeletal diagnosis 
Scenario test modality (XR, MRI, ultrasound, CT) 
New/return status 
Age (continuous) 
Gender 
Education level 
Self-reported race  
Self-reported ethnicity 
Insurance status 
Work status 
Annual household income 
Social health measure 
3 items quantifying unhelpful thoughts regarding symptoms 
3 item quantifying feelings of distress regarding symptoms 
ANCHOR (agency measure) 
 
Statistical analysis 
Independent t-tests (or Mann-Whitney U tests, depending on data distribution) will be used to 
compare mean enthusiasm for the proposed diagnostic test (primary outcome, measured on an 
11-point Likert scale from 0 = definitely decline to 10 = definitely proceed) between study arms. 
Similarly, group differences in decisional conflict (secondary outcome, measured using the SURE 
scale) will also be analyzed using independent t-tests or Mann-Whitney U tests. 
 
Multivariable linear regression analysis will be used to assess associations between outcomes 
and explanatory variables (including age, gender, education level, musculoskeletal diagnosis, 
and test modality). Statistical significance will be set at p < 0.05. 
 
To assess whether patients’ preferred level of involvement in diagnostic decision-making 
moderates the association between exposure to a structured diagnostic Advance Care Planning 
(ACP)-style discussion and decision outcomes (test acceptance and decisional conflict), 
interaction terms between ACP exposure and preferred decision-making role will be included in 
the regression models. Significant interaction effects will be interpreted as evidence of 
moderation. Subgroup or stratified analyses may also be performed to further explore 
differential effects across levels of preferred decision-making involvement. 
 

Sample size calculation  
For the primary outcome (enthusiasm for diagnostic test, 0-10), assuming a moderate effect 
(Cohen’s d=0.40; 1-point mean difference with SD~2.5), a two-sample t-test (two-sided α=0.05, 
80% power) requires 98 participants per arm (196 total). Allowing for 10 percent attrition and 
incomplete data, we plan to recruit 220 participants in total. 
 
For the secondary outcome (SURE score), this sample size provides ≥80% power to detect 0.5-
point differences. Analyses of moderation (between preferred involvement in decision-making 
and exposure to ACP-style discussion or decision outcomes) will be considered exploratory 
given expected power constraints for small interaction effects. 
 
 
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Appendix 1 – Scenario Structure (Example Layout) 
 
Please consider the following hypothetical situation:  
Your clinician is considering an imaging test [XR/MRI/CT/USS scan] for you. 
 
Group 1: We’re going to simulate a discussion between you and the clinician treating you about 
whether or not the test is right for you. You can think about your own symptoms if that helps. 
Would that be okay?  

• “What are you hoping the test might do for us?” 
• "What is the best thing that happen when you do a test?” 
• “What is the worst thing that can happen when you do a test?” 
• “What is the likelihood that the results of this test will improve your health?” 
• “In what ways could the test harm your health?” 
• “What matters to you most as we decide whether or not to move forward with this 
test?” 
• "What else do you need to feel ready to decide about whether or not to get this test?” 
 
 
Group 2: Please read the following information regarding diagnostic tests. 
• Imaging tests are not usually necessary to make a diagnosis.  
• Imaging tests are primarily used to confirm a likely diagnosis and to help plan surgery.  
• People tend to think of imaging tests are completely harmless, but there are risks of 
misdiagnosis, overdiagnosis, mistreatment, and overtreatment.  
• Imaging tests should therefore be considered carefully as they do have a potential for 
harm.  
 
 
 
Appendix 2 – Diagnostic Testing Preference Questions 
 
Decision to proceed with diagnostic test: 
 
How enthusiastic are you about proceeding with the proposed (hypothetical) imaging test?  
Slider scale with 0 = I would definitely decline this test, 5= I am not sure if I would accept or 
decline this test, 10 = I would definitely proceed with this test  
 
 
Short-form decision conflict scale (SURE): 
 
S 
Are you sure that this is the best choice for you? 
Yes/No 
U 
Do you feel you clearly understand the potential 
benefits and harms of the test? 
Yes/No 
R 
Are you clear about which risks and benefits matter 
most to you? 
Yes/No 
 
E 
Do you feel you have enough support and advice to 
make a choice? 
Yes/No 
 
 

 
Appendix 3 – Question to assess patient preferred level of involvement in diagnostic decision-
making  
 
In general, how involved do you like to be in the decision about whether or not to have a test? 
 
• I prefer my doctor to make the decision alone 
• I prefer the doctor to make the final decision, but consider my opinion 
• I prefer to make the decision together 
• I prefer to make the final decision, after considering the doctor's opinion 
• I prefer to make the decision alone