Patient-Reported Outcomes in Surgical Oncology: An Overview of Instruments and Scores

Phillips, Joseph D.; Wong, Sandra L.

doi:10.1245/s10434-019-07752-7

Cited by 19 publications

(8 citation statements)

References 92 publications

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“…3 PROMs are an objective measurement tool, even if the outcome they quantify is somewhat subjective; they undergo a rigorous development and validation process in order to make them an objective tool, with reproducible results from which valid conclusions can be drawn. 4 Major cancer organizations, including the Food and Drug Administration and the National Cancer Institute, have made strong recommendations for the inclusion of a PROM approach in routine clinical cancer care.…”

Section: The Importance Of Prommentioning

confidence: 99%

Patient-Reported Outcomes Measures in Abdominal Cancer Surgery and Student-Led Surgical Research

et al. 2021

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Section: The Importance Of Prommentioning

confidence: 99%

Patient-Reported Outcomes Measures in Abdominal Cancer Surgery and Student-Led Surgical Research

et al. 2021

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“…The research is culturally innovative because we will focus on PRO as the primary outcome, thus promoting a growing appreciation of the importance of patient-oriented care in the eld of surgical oncology. 24 Theoretical bene ts of PG, such as an improved hemoglobin level and reduced weight loss, become clinically signi cant only when QoL is improved, which can only be measured using PROs. The primary endpoint (appetite level) will be serologically validated with ghrelin level, which is an appetite-stimulating hormone that is known to decrease after TG.…”

Section: Kunisaki Et Al Conducted a Pgsas Next Survey Study Of Gastri...mentioning

confidence: 99%

Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers

Ikoma¹,

Grotz

Kawakubo

et al. 2023

Preprint

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Background: The current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss, which is caused by a decreased level of ghrelin and anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG. Methods: Enrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared. Discussion: Surgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG. Trial Registration Number: This trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022-00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.

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“…10 Thousands of PRO measures have been developed in medicine, 11 however, in cancer patients, health-reported quality-of-life (HRQoL) and symptom scores are arguably the most important PROs. 12 Contrary to symptom measures, HRQoL is a multidimensional tool ''… encompassing physical and occupational function, psychological state, social interaction and somatic sensation''. 13 HRQoL and symptom PRO measures can be categorized into generic, cancer-specific, or disease-specific questionnaires.…”

mentioning

confidence: 99%

“…13 HRQoL and symptom PRO measures can be categorized into generic, cancer-specific, or disease-specific questionnaires. 12 Generic measures allow the comparison with healthy individuals, while cancer- and disease-type-specific tools aim to measure symptoms and HRQoL in all cancer patients or patients with a specific cancer disease, respectively.…”

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confidence: 99%

Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

Mihaljevic

2021

Ann Surg Oncol

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Background The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated. Methods Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo–Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network. Results Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms ‘poor appetite’, ‘fatigue’, ‘exhaustion’ and ‘sleeping problems’ increased after surgery and climaxed 10–30 days postoperatively. At 3–6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher ‘social functioning’ (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met. Conclusion The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.

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Patient-Reported Outcomes in Surgical Oncology: An Overview of Instruments and Scores

Cited by 19 publications

References 92 publications

Patient-Reported Outcomes Measures in Abdominal Cancer Surgery and Student-Led Surgical Research

Patient-Reported Outcomes Measures in Abdominal Cancer Surgery and Student-Led Surgical Research

Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers

Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

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