Patient-reported outcome measures in advanced/metastatic colorectal cancer: do they fully capture patients’ experience?

Patient-reported outcome measures (PROMs) are important for capturing patient-centric aspects of disease and treatment. This study evaluated PROMs for advanced or metastatic colorectal cancer (mCRC). An initial conceptual model (CM) was developed from the published literature, patient blogs, and clinician interviews. Eighteen patients were interviewed; their experience of advanced/mCRC was explored to refine the CM, and PROMs—selected for concept coverage, content validity, and psychometric strength—were evaluated. Patients reported 96 symptoms, of which 10 were prioritized as salient (reported by >50% of patients with a bother rating ≥5/10); fatigue was the most salient (n = 18/18; 100%), followed by neuropathy, nausea, and diarrhea (for all: n = 16/18; 88.9%). Of 50 impacts reported, seven were salient; depression and impact on work/employment were most salient (both n = 14/18; 77.8%). The final CM reflects a comprehensive analysis of signs, symptoms, and impacts relevant to patients with advanced/mCRC. Patients found the five selected PROMs—EORTC QLQ-CR29, EORTC QLQ-C30, selected EORTC Library items, FACT-G item GP5, and pain NRS—to be clear, relevant, and representative of their experience. This study provides an in-depth view of patients’ experience in advanced/mCRC and could help inform clinical trial protocols, guidelines, and practice. Patient-reported outcomes (PROs) are surveys filled out by patients about their health, without their doctors’ input. PROs show what it’s like for people living with a disease and its treatment. This study focused on patients with advanced or metastatic colorectal cancer (mCRC). The goal was to see how well PRO surveys used in research capture patients’ feelings about symptoms and treatment. Using information from scientific studies, patient blogs, and doctor interviews, researchers made a list of mCRC symptoms and their impact on patients’ lives. They then talked to 18 patients living with mCRC to improve this list. Finally, the patients were asked if commonly used PRO surveys (EORTC QLQ-C30/CRCR29 and additional questions) were relevant for mCRC and easy to understand. Patients reported 96 symptoms; 10 were considered important (mentioned by over half and rated as very burdensome). Fatigue was the most significant, followed by neuropathy (nerve pain), nausea, and diarrhea. Patients also reported 50 impacts on their lives. Patients rated depression and work-related issues as the most important. The original list was updated to include the important symptoms and impacts reported in the study interviews. Also, patients found the commonly used PRO surveys clear and representative of their experience. This study provides valuable insights into symptoms experienced by patients living with mCRC and how these symptoms impact their lives. The PRO surveys appear to be effective tools for measuring patients’ experiences. This information can inform clinical trials, guidelines, and patient care. An in-depth analysis of the signs, symptoms, and impacts relevant to patients with advanced or metastatic CRC was conducted through a targeted literature review, patient blog searches, clinician interviews, and patient interviews.The symptoms and impacts most bothersome to patients were identified, and a comprehensive conceptual model was created to visualize patients’ experience.Cognitive debriefing of selected patient-reported outcome measures (PROMs) demonstrated that the EORTC QLQ-CR29, EORTC QLQ-C30, selected EORTC Library items, FACT-G item GP5, and pain NRS were clear, relevant, and representative of patients’ experience.This identification of appropriate PROMs for use in patients with advanced or metastatic CRC could inform patient-reported outcome strategies in clinical trials. An in-depth analysis of the signs, symptoms, and impacts relevant to patients with advanced or metastatic CRC was conducted through a targeted literature review, patient blog searches, clinician interviews, and patient interviews. The symptoms and impacts most bothersome to patients were identified, and a comprehensive conceptual model was created to visualize patients’ experience. Cognitive debriefing of selected patient-reported outcome measures (PROMs) demonstrated that the EORTC QLQ-CR29, EORTC QLQ-C30, selected EORTC Library items, FACT-G item GP5, and pain NRS were clear, relevant, and representative of patients’ experience. This identification of appropriate PROMs for use in patients with advanced or metastatic CRC could inform patient-reported outcome strategies in clinical trials.