Abstract

Evaluation of correlations between observer (physician) versus patient-reported outcomes (ObsROs and PROs) was conducted among a group of patients receiving external beam radiation therapy for gynecological cancer. Concurrent assessments of Common Terminology Criteria for Adverse Events (CTCAE v4), and PRO CTCAE questionnaires were acquired during radiation oncology clinic visits (July 2017 to January 2018) for gynecological cancer patients. Gastrointestinal toxicities (GI: anorexia, nausea, vomiting, and diarrhea) and genitourinary toxicities (GU: urinary incontinence, urinary frequency and dysuria) were prospectively graded by patients and observers during weekly on-treatment visits from week 1 to 5 of radiation therapy. PROs were captured via electronic tablets and ObsROs were collected using assessment forms in the radiation oncology information system. A Pearson’s correlation was used to determine the relationship between ObsROs and PROs. Of the 27 patients treated, 27 had ObsROs, and 23 had concurrent PROs. The capture efficiency over this 6 month trial period was 85%. The median age at diagnosis was 61 years old (22-77 years old). The median total prescription radiation dose was 45Gy (28-45 Gy). 15 patients had pelvis and 8 had extended fields to paraaortic lymph nodes treatment. All the ObsROs ranged from 0-2; while PROs ranged more widely: decrease appetite (0-3), nausea (0-4), vomiting (0-4), diarrhea (0-3), urinary incontinence (0-4), urinary frequency (0-4) and painful urination (0-3). For GI toxicities, anorexia, nausea, vomiting and diarrhea ObsROs were strongly correlated with their respective PROs (anorexia, r =0.88; nausea, r=0.83; vomiting, r=0.87; diarrhea, r=0.65, all p<0.05). For GU toxicities, urinary incontinence, frequency, and dysuria ObsROs were moderately correlated with their respective PROs (urinary incontinence r=0.56; urinary frequency, r=0.64; painful urination r=0.56, all p<0.05). For the GI toxicities management, 19 patients (82%) received bowel movement medications while the remaining 4 patients tolerated well without need for intervention. For GU toxicities management, 3 (13%) patients received urinary symptom treatment. Agreement among ObsPROs and PROs appears to be stronger in GI than in GU outcomes during the treatment. GI toxicities might be more easily observed and also assessed more thoroughly due to the ease of intervention with existing medications. GU toxicities may be less easy to observe and less amenable to treatment, and therefore, remain underreported by physicians. Future healthcare providers may consider PROs to better measure and monitor symptoms and direct therapeutic interventions for patients receiving pelvic radiation.

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