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BACKGROUND: Breast cancer and its treatments produce multiple symptoms that significantly impact patient quality of life (QOL). Distress and impaired function are the most commonly referred symptoms [Cleeland CS, 2007]. Routine cancer care assessment of patient-reported outcomes (PROs), including symptoms, function, and QOL, has been shown to improve symptom management, identification of psychosocial problems, and patient-provider communication. The Symptom Inventory Tool (SIT) is an assessment tool that captures the patients' perceived symptom burden for real-time clinical intervention, taken at the point of no intervention (baseline) and every 21 days or greater. The SIT is comprised of 27 questions utilizing the M.D. Anderson Symptom Inventory tool (MDASI) [Cleeland CS, Cancer 2013], and validated assessment instrument with 8 questions added and a free text box by Cancer Treatment Centers of America (CTCA). CTCA is a national network of five hospitals that specialize in cancer treatment and integrative oncology. PATIENTS & METHODS: Patients reported symptoms intensity using 19-item MD Anderson Symptom Inventory (MDASI) and 8 additional questions created by CTCA (constipation, swelling, mouth soreness, bleeding, sexual interest, family, hope & QOL). Symptoms were rated "at the worst" on an 11-point numeric scale ranging from 0 ('no present") to 10 ("as bad as you can imagine") in the previous 24 hours. SIT became an integral part of patient care at CTCA beginning in 2012. RESULTS: From July 2012 to February 2015, a total of 3,740 outpatients with breast cancer were evaluated at CTCA. A total of 13,852 assessments were analyzed. The assessments consisted of 3,513 completed at baseline, 2,237 completed at the 2nd follow up (FU), and 8,014 completed at 3rd FU or greater. Median age was 50 (range, 17-88), 60% of patients were ER+. Race: White (68%), Black (29%), and other (3%). Disease extension: locoregional (86%) and metastatic (13.6%). The average time since cancer was diagnosed were 35 months, and 50.7% of the patients received prior systemic therapy: chemotherapy (55%), hormone-therapy (41%), and immunotherapy (4%). Mean, standard deviation and inter quartile ranges at baseline assessment are depicted in. Table 1.Patient Reported SymptomBaseline assessment statisticsPercentage of patients with severe symptoms at baseline and reporting a clinically significant change (2 points) at 2nd SIT assessment Mean +/- STDInterquartile range (IQR)Significant decreaseNo changeDistress3.0 +/- 3.0[0.5]695 (31.3%)594 (26.8%)414 (18.7%)Sadness2.5 +/- 2.9[0.4]622 (28%)718 (32.3%)358 (16.1%)Disturbed Sleep3.3 +/- 3.2[0.6]550 (24.8%)517 (23.3%)642 (28.9%)Mood2.6 +/- 2.7[0.4]549 (24.7%)678 (30.5%)447 (20.1%)Pain2.7 +/- 3.0[0.5]523 (23.9%)675 (30.8%)519 (23.7%)*IQR is a measure of variability, based on dividing a data set into quartiles. Quartiles divide a rank-ordered data set into four equal parts CONCLUSIONS: The SIT was successful in identifying symptoms burden and interference with life issues in breast cancer patients. Distress, sadness, disturbed sleep, mood and pain were the most common reported symptoms. Early identification of patient burden symptoms allowed immediate intervention and improvement in approximately a quarter of patients. Citation Format: Alvarez RH, Hartman S, Bosch B, Kendrick D, Cohen L, Fridman J, Ottersen D, Walcott K, Ware S, Castro I, Thomas J, Niu J, Ahn E, Denny D, Markman M. Self-reported symptoms and interference issues in breast cancer patients. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-27.

IntroductionRotator cuff injuries account for up to 70% of pain in the shoulder. However, there remains no consensus on the best surgical treatment for patients with rotator cuff injuries, in terms of the cost-effectiveness and cost–utility of open and arthroscopic methods for rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost–utility of open and arthroscopic procedures for rotator cuff repair.Methods and analysisThe trial is a two-group, parallel-design, randomised controlled trial. A total of 100 patients with symptomatic rotator cuff lesions will be allocated in either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (≤3 cm or >3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation programme after the intervention. The primary outcome measure will be the Constant-Murley Score and the EuroQol-5D-3L score at 48 weeks postsurgery. Secondary outcomes include cost-effectiveness, cost–utility, pain, complications and clinical analysis, using the Simple Shoulder Test, Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through MRI, and complications and failures of the proposed methods. For the cost-effectiveness analysis, we will use the VAS and the Constant-Murley Score as measures of effectiveness. For the cost–utility analysis, we will use the EuroQol-5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years.Ethics and disseminationThe study has been approved by the local research ethics committee of both institutions: Hospital Israelita Albert Einstein and Hospital Alvorada Moema/Hospital Pró-Cardíaco. The results will be published in a peer-reviewed, open access journal.Trial registration numberNCT04146987.

Background: Shoulder pain is one of the most common musculoskeletal conditions in orthopedic practice. Rotator cuff injuries account for up to 70% of pain in the shoulder girdle. However, there is still no consensus on the best surgical treatment of patients with degenerative rotator cuff injuries, considering cost-effectiveness and cost-utility analysis between the open and arthroscopic methods of rotator cuff repair. The objective of this trial is to compare the efficacy, cost-effectiveness and cost-utility of open and arthroscopic procedure for rotator cuff repair. Methods: The trial is a two-group, parallel design, randomized controlled study. A total of 100 patients with symptomatic rotator cuff lesion will be allocated to repair surgery and randomized by either open or arthroscopic technique in a 1:1 ratio, considering smoking (yes or no), lesion size (less than 3 cm or more than 3 cm) and diabetes (present or absent) as stratification factors. All patients will be included in the same rehabilitation program after the intervention. The primary outcome measure will be the Constant-Murley score at 48 weeks post-surgery. Secondary outcomes include cost-effectiveness, cost-utility, pain, complications and clinical analysis, using the EuroQol 5-D3L, the simple shoulder test (SST), Visual Analogue Pain Scale (VAS), integrity of the repair evaluated through magnetic resonance imaging, complications and failures of the proposed methods. Theses outcomes will also be measured continuously for 48 weeks after the intervention. For the cost-effectiveness analyses, we will use the VAS and the Constant-Murley Score as measures of effectiveness; for the cost-utility analyses, we will use the EuroQol- 5D-3L as a measure of utility in terms of incremental cost per quality-adjusted life-years (QALY). Discussion: There are two options of the rotator cuff repair surgery, open and arthroscopic and, both procedure present good clinical results. However, considering that the arthroscopic surgery present supposedly higher costs, is necessary to understand if these costs present a best cost-effectiveness and cost-utility for the patient.Trials registration: ClinicalTrials.gov register: NCT04146987. Registered October 31, 2019