Geir V. Berg

The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries. Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval. eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081.

The role of contrast-enhanced ultrasound in the classification of CT-indeterminate renal lesions

Abstract Objective: Focal renal lesions are common incidental findings on computed tomography (CT). For lesions with a cystic appearance, the Bosniak classification system has enabled an important separation of benign and (potentially) malignant cysts, giving a practical guide for management. The purpose of this study was to evaluate contrast-enhanced ultrasound (CEUS) as a problem-solving modality for classification of indeterminate renal lesions detected with CT. Materials and methods: In total, 140 consecutive patients with 148 indeterminate renal lesions were examined with ultrasound combined with CEUS (81 men and 59 women with mean age 63.8 years). Results: Altogether, 146 lesions were classified by CEUS in categories according to the Bosniak classification system, or as solid lesions. Mean lesion diameter was 30 mm (range 5–166 mm). Nine lesions were classified as category I, 32 as category II and 59 as category IIF (“non-surgical lesions”). 48 IIF cysts were followed for a minimum of 2 years (mean 4 years and 8 months): three lesions were upgraded to category III (6%) and 45 were stable category. 19 lesions had a more complex cystic appearance: 12 were classified as category III and seven as category IV cysts. 27 lesions were diagnosed as solid, enhancing tumors. In total, 25 patients with lesions of category III, IV and solid (“surgical lesions”) underwent renal surgery, with malignancy diagnosed in 18. Conclusion: In the common setting of indeterminate renal lesions incidentally detected with a CT exam, CEUS has the potential to classify lesions into “non-surgical” and “surgical” categories, providing a platform for urological decision making, while avoiding radiation exposure.