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INTRODUCTION: The potential of patient symptoms being monitored longitudinally in radiotherapy (RT) is still unexploited. When novel technologies like online adaptive MR-guided radiotherapy (MRgRT) are evaluated, weekly electronic patient-reported outcomes (ePROs) may add knowledge about the symptom trajectory. This study aimed at evaluating feasibility, usability and acceptance of weekly ePRO among patients receiving pelvic radiotherapy. MATERIALS AND METHODS: In a mixed-methods convergent design, a prospective pilot study enrolled patients referred to pelvic radiotherapy with curative intent. Patients used their own device at home to self-report PRO weekly during and four weeks following radiotherapy and week 8, 12, and 24 (paper-questionnaire as an alternative). Feasibility was extracted from the ePRO software. The Patient Feedback Form and patient interviews were used to explore usability and patient acceptance. Patients were informed that clinicians had no access to PRO responses. RESULTS: In total, 40 patients were included; 32 patients with prostate cancer and 8 with cervical cancer (consent rate 87%), median age 68 (36-76). The majority did digital reporting (93%). 85% of patients responded to ≥80% of the weekly questionnaires with 91% average adherence to weekly completion (60% for follow-up), although lower for patients ≥age 70. Time spent on ePRO (97%) and frequency of reporting (92%) was considered appropriate. Interviews (n = 14) revealed the application was usable and the patients requested real-time feedback from the clinicians. CONCLUSION: Recruitment for ePRO during radiotherapy was feasible and adherence to weekly self-reporting high. The digital application was usable and weekly frequency and time spent acceptable. Real-time feedback from the clinicians is requested by the patients.
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BACKGROUND: A new technology in cancer treatment, the MR-linac, provides online magnetic resonance-guided radiotherapy (MRgRT) that combines real-time visualization of the tumor and surrounding tissue with radiation therapy to deliver treatment more accurately. Online MRgRT makes it possible to minimize treatment volume, potentially reducing acute treatment toxicity. Patient-reported outcomes (PRO) add the patient perspective to evaluating treatment toxicity related to new technology. The objective of this mixed-methods study was to develop and explore the content validity of a set of PRO items to evaluate acute pelvic toxicity to radiotherapy including online MRgRT. METHODS: A literature review and chart audit were conducted to identify symptomatic adverse events (AEs) to be selected from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) library and European Organisation for Research and Treatment of Cancer (EORTC) item library. To validate the content, the item set was applied in a prospective pilot cohort of patients referred for primary pelvic RT with curative intent. Patients reported symptoms weekly during RT (4-8 weeks) and the subsequent 4 weeks. Follow-up reports were collected at 8, 12, and 24 weeks after RT. To ensure symptom coverage clinician-reported toxicity and individual patient interviews were conducted. The symptomatic AEs were included in the final item set if ≥20% of patients reported them. RESULTS: Eighteen acute symptomatic AEs were selected for the initial item set. Forty patients (32 prostate cancer, 8 cervical cancer) were included in the pilot study. Patients with prostate cancer and those with cervical cancer both reported all 18 acute AEs. However, vomiting was not reported by > 20% of patients thus excluded from the item set. Adding a few diagnosis-specific AEs to the final item set was required for both prostate and cervical cancer patients. CONCLUSIONS: A PRO item set for patients with pelvic cancer treated with radiotherapy with a curative intent was developed and content validity explored. In the pilot study, the item set captured the most common acute symptomatic AEs for patients with prostate and cervical cancer related to pelvic RT including online MRgRT. Further validation of the content in broader disease sites would be needed in future studies.
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BACKGROUND: We evaluated a new aseptic method for laparoscopic left colon resection in terms of technical feasibility and outcome. METHODS: Ten pigs were operated on under general anesthesia. Pre- and postoperative body weight, stools, behavior, and need for analgesics were recorded. Fourteen days later, the animals were killed. At autopsy, the degree of intraabdominal adhesions was noted. The anastomoses were sent for histological examination. The entire procedure was performed intracorporeally, and no antibiotics were given. After division of the mesocolon, the segment to be resected was invaginated down through the colon. This was facilitated by a custom-made instrument that was introduced into the bowel via the anus; it consisted of a pull-out device and a modified diathermy wire. The anastomosis was completed at the invagination fold by a row of hernia staples that were covered by an interrupted suture. Then the invaginated bowel was transected by the diathermy wire and delivered through the anus. RESULTS: One animal was killed before completion of the operation because of a colonic perforation. The remaining nine animals had an uneventful and rapid recovery. They ate from the 1st postoperative day and gained weight rapidly. Stools were normal after 2 days (median), and normal behaviour was noted in all animals from the 1st postoperative day. At the postmortem examination, intraabdominal adhesions were observed in two animals. In one case, the adhesions extended from a hematoma in the mesentery to the abdominal wall. There were no adhesions to the anastomosis or the colon. In the other case, the anastomosis adhered to the right uterine tube and a loop of small intestines. CONCLUSIONS: The method is technically feasible, but a modification is suggested for cases where the invagination is impossible. Recovery after the operation is rapid.
