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Health Informatics
November 2025
Case Study - EBM
In this case study, a seventy-two-year-old woman presents with osteoarthritis of the knees
and moderate hypertension. She is accompanied by her daughter, a hospital lab technician, who
requests a prescription for a COX-2 inhibitor, citing its reduced risk of gastrointestinal (GI)
bleeding compared to other, more traditional NSAIDs. The patient expresses her concern about
the potential increase in monthly out-of-pocket expenses. This case study highlights the
importance of applying the principles of Evidence-Based Medicine (EBM) to guide clinical
decision-making that integrates the best available evidence with patient values and context.
In order to start the EBM process, it is essential to assess what is known and what
additional information is needed. The patient’s age and comorbid hypertension place her at an
increased risk for both GI and cardiovascular complications. Her osteoarthritis most likely causes
pain and functional limitations, but the severity and impact on daily life are factor that needs to
be clarified. A thorough medication history is also necessary to identify potential drug
interactions or contraindications. Additionally, understanding her history of GI symptoms, renal
function, and current health insurance coverage will inform the safety and affordability of
treatment options. Finally, eliciting her treatment preferences and goals will ensure the care
remains patient-centered.
The next step is to create a focused clinical question using the PICO(TT) framework. In
this case, the Population (P) is elderly patients with osteoarthritis: the Intervention (I) is COX-2
inhibitors such as celecoxib: the Comparison (C) is traditional NSAIDs like ibuprofen or
naproxen: the Outcome (O) is reduction in GI bleeding; the Time (T) is over a six-month
treatment period: and the Type of study (T) is randomized controlled trials. The final PICO(TT)
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question is as follows: “In elderly patients with osteoarthritis, do COX-2 inhibitors, compared to
traditional NSAIDs, reduce the risk of gastrointestinal bleeding over six months?” This question
is clinically relevant as it addresses both safety and cost concerns in a high-risk population,
guiding treatment decisions that balance efficacy, adverse effects, and patient preferences.
To collect data, a literature search was conducted using PubMed and JAMA Network
with terms “COX-2 inhibitors vs NSAIDs GI bleeding osteoarthritis elderly RCT.” The selected
article is the CLASS study: Silverstein et al. (2000), “Gastrointestinal toxicity with celecoxib vs
nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis,” published in
JAMA. This randomized controlled trial (RCT) included over 8,000 patients with osteoarthritis
and rheumatoid arthritis, comparing celecoxib to ibuprofen and diclofenac. It was chosen for its
robust design, large sample size, and direct relevance to the patient population and clinical
question.
Critical appraisal of the CLASS study reveals strengths as well as limitations. As an RCT,
it provides high-quality evidence. The study was double-blinded and multicenter, enhancing its
validity. However, it was industry-sponsored and terminated early, which may introduce bias.
Additionally, the inclusion of patients taking aspirin could confound GI outcomes. The results
showed that celecoxib significantly reduced symptomatic ulcers and GI bleeding compared to
traditional NSAIDs, particularly in patients not taking aspirin. Cardiovascular outcomes were not
significantly different during the study period, though longer-term risks remain a consideration.
Applying this evidence to the patient’s care involves balancing benefits, risks, and
preferences. Celecoxib appears to offer a safer GI profile, which is particularly important for
elderly patients. If the patient has a history of GI intolerance or is at high risk for bleeding,
celecoxib may be appropriate. However, her hypertension and cost concerns must be addressed. I
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would review her insurance coverage to determine affordability and discuss the potential
cardiovascular risks associated with COX-2 inhibitors. Shared decision-making would be
emphasized, ensuring that both the patient and her daughter understand the risks, benefits, and
alternatives. If celecoxib is unaffordable, a traditional NSAID combined with a gastroprotective
agent such as a proton pump inhibitor (PPI) could be considered.
Finally, assessing the effectiveness of the chosen approach involves regular follow-up. I
would monitor the patient’s pain relief, functional improvement, and any GI symptoms. Blood
pressure and renal function would be reassessed to ensure safety. A follow-up visit in 4–6 weeks
would allow for evaluation of treatment efficacy, tolerability, and satisfaction, with adjustments
made as needed based on clinical response and patient feedback. In conclusion, this case
illustrates the value of EBM in tailoring treatment to an individual patient’s clinical profile and
their preferences. By systematically assessing, asking, acquiring, appraising, applying, and then
reassessing, clinicians can make informed decisions that optimize outcomes and respect patient
values.
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References:
Duke University Medical Center Library & Archives. (n.d.). Introduction to Evidence-Based
Practice: A Tutorial. Retrieved November 10, 2025, from
https://guides.mclibrary.duke.edu/ebptutorial
Hawkey, C. J. (1999). COX-2 inhibitors. Lancet (London, England), 353(9149), 307–314.
https://doi.org/10.1016/s0140-6736(98)12154-2
Laine, L. (2001). Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient.
Gastroenterology, 120(3), 594–606. https://doi.org/10.1053/gast.2001.21907
Silverstein, F. E., Faich, G., Goldstein, J. L., Simon, L. S., Pincus, T., Whelton, A., ... & Weaver,
A. L. (2000). Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory
drugs for osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized
controlled trial. JAMA, 284(10), 1247–1255.
https://jamanetwork.com/journals/jama/fullarticle/193062
University of Washington Health Sciences Library. (n.d.). Evidence-Based Practice Case
Examples. Retrieved November 10, 2025, from
https://guides.lib.uw.edu/hsl/ebp/examples
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