OBJECTIVE: To perform temporal validation of a risk prediction model for breast cancer-related lymphoedema in the European population.
METHODS: Temporal validation of a previously developed prediction model using a new retrospective cohort of women who had undergone axillary lymph node dissection between June 2018 and June 2020.
METHODS: We reviewed clinical records to identify women who did and did not develop lymphoedema within 2 years of surgery and to gather data regarding the variables included in the prediction model. The model was calibrated by calculating Spearman\'s correlation between observed and expected cases. Its accuracy in discriminating between patients who did versus did not develop lymphoedema was assessed by calculating the area under the receiver operating characteristic curve (AUC).
RESULTS: The validation cohort comprised 154 women, 41 of whom developed lymphoedema within 2 years of surgery. The value of Spearman\'s coefficient indicated a strong correlation between observed and expected cases. Sensitivity of the model was higher than in the derivation cohort, as was the value of the AUC.
CONCLUSIONS: The model shows a good capacity to discriminate women at risk of lymphoedema and may therefore help in developing improved care pathways for individual patients.
UNASSIGNED: Identifying risk factors for lymphoedema secondary to breast cancer treatment is vital given its impact on women\'s physical and emotional well-being.
CONCLUSIONS: What problem did the study address? Risk of BCRL. What were the main findings? The prediction model has a good capacity to discriminate women at risk of lymphoedema. Where and on whom will the research have an impact? In clinical practice with women at risk of BCRL.
UNASSIGNED: STROBE checklist. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: It presents a validated risk prediction model for BCRL.
UNASSIGNED: There was no patient or public contribution in the conduct of this study.

UNASSIGNED: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery.
UNASSIGNED: This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with 99mTc lymphoscintigraphy-one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA.
UNASSIGNED: The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020.
UNASSIGNED: jRCT2031190064; Pre-results.

BACKGROUND: Lymphoedema may cause complex problems that can strongly influence patients\' health-related quality of life (HRQoL). The main purpose of this study was to investigate the impact of lymphoedema on HRQoL in patients with varying forms of lymphoedema.
METHODS: The Lymphoedema Quality of Life Inventory (LyQLI), measuring three domains, physical, psychosocial and practical, and the Short Form 36 Health Survey Questionnaire (SF-36), measuring eight health domains, were sent to 200 lymphoedema patients. Out of those who answered both questionnaires, 88 patients had lymphoedema secondary to cancer treatment and they additionally received the Functional Assessment of Cancer Therapy Scale-General (FACT-G). The relation between continuous variables and the three domains were analysed by Spearman\'s correlation coefficients, and Kruskal-Wallis test was used to analyse categorical variables.
RESULTS: Altogether 129 patients completed the LyQLI and SF-36 and 79 of them also completed FACT-G. Twenty per cent had a high mean score (≥2.0) in at least one domain of the LyQLI, thus having a low HRQoL. Lower HRQoL was found in the practical domain of LyQLI in patients with lower limb lymphoedema compared to patient with lymphoedema in upper limb or head/neck (p = 0.002) and in patients working part-time compared to patients working full-time (p = 0.005). The impact on HRQoL tended to decrease with age, with a significant correlation in the psychosocial domain (rs = 0.194, p = 0.028). Compared with the general Swedish population, patients with lymphoedema scored significantly lower in general health (p = 0.006), vitality (p = 0.002) and social functioning (p = 0.025) assessed by the SF-36. From a cancer-specific view, HRQoL was similar to other Swedish studies using the FACT-G.
CONCLUSIONS: This study indicates that about 20% of the patients with lymphoedema had major impact on their HRQoL. More effort and research is needed to identify, understand and support groups of patients with severe lymphoedema-related problems.