Inclusion of Patient-Reported Outcomes in Clinical Trials
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When evaluating the outcome of an operation, surgeons are traditionally focused on issues of morbidity and mortality. Although it is extremely important to know metrics such as the occurrence of a surgical site infection or death after surgery, measuring the patient perspective is also necessary for determining the success of an operation. A patient-reported outcome (PRO) is defined by the U.S. Food and Drug Administration as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”  An example of a PRO might include a patient’s characterization of postoperative fatigue or their physical function satisfaction after an operation, as both determinations are made by the patients themselves and cannot be directly measured or observed. Studies have shown that clinical or physical assessments are not always reflective of how the patient actually functions or feels, highlighting the importance of incorporating PROs into surgical practice .
R.P.M. is supported by the Agency for Research and Healthcare Quality (K12HS023011) and an Institutional Research Grant from the American Cancer Society (IRG-18-163-24).
- 1.FDA Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
- 5.van de Graaf VA, Noorduyn JCA, Willigenburg NW, et al. Effect of early surgery vs physical therapy on knee function among patients with nonobstructive meniscal tears: the ESCAPE randomized clinical trial. JAMA. 2018;320(13):1328–37. https://doi.org/10.1001/jama.2018.13308.CrossRefPubMedPubMedCentralGoogle Scholar
- 8.Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19(4):539–49. https://doi.org/10.1007/s11136-010-9606-8.CrossRefPubMedPubMedCentralGoogle Scholar
- 11.EQ-5D. EuroQol Group. https://euroqol.org/.
- 12.MD Anderson Symptom Inventory (MDASI). MD Anderson Cancer Center. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory.html.
- 13.Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentralGoogle Scholar