Lymphoedema develops after axillary clearance (ANC) in 25% of patients. This prospective, multi-centre study compared multi-frequency bioimpedance spectroscopy (BIS) with arm volume measurement to: ...(1) determine which test has better diagnostic accuracy, (2) identify factors predicting development of lymphoedema, and its effect on quality-of-life.
Participants (N = 1100) underwent measurements pre and post-ANC surgery for breast cancer. Relative arm volume increase (RAVI) of >10% diagnosed lymphoedema. Predictors of lymphoedema were determined using logistic regression. Optimal diagnostic method was assessed using diagnostic accuracy. Quality-of-life was assessed using the FACT B + 4 questionnaire.
Lymphoedema was diagnosed in 22.8% women using RAVI > 10%, 45.6% using BIS criteria, while 24.5% underwent compression sleeve application by 24 months. BMI > 30 was an independent factor for both development (p = 0.005) and progression (p = 0.015) of lymphoedema. RAVI at 1 month, BMI > 30 and number of involved nodes contributed to a novel scoring model to predict lymphoedema by 36 months. Larger decreases in QoL scores post-surgery occurred in lymphoedema patients (p < 0.001). Progression to moderate lymphoedema occurred in 15% patients after sleeve application.
RAVI measurement was the best diagnostic tool for lymphoedema. BIS alone is not appropriate for lymphoedema screening or diagnosis. BMI > 30 predicted lymphoedema diagnosis and progression.
Chronic oedema (CO) is a major clinical problem worldwide, which has many important secondary consequences for health, activity and participation. Effective treatment planning and organisation of ...services is dependent on an understanding of the condition and its epidemiology. This cross‐sectional study was designed to estimate the point prevalence of CO within the health services of one UK urban population and to determine the proportions that have concurrent leg ulceration.
Patients with CO in all anatomic sites were ascertained by health care professionals in one acute and one community hospital, all relevant outpatient and community nursing services, general practices and all nursing/residential homes in one urban catchment area (Derby City). The presence and distribution of oedema was confirmed through a brief clinical examination. A battery of demographic and clinical details was recorded for each case.
Within the study population of Derby City residents, 971 patients were identified with CO estimated crude prevalence 3·93 per 1000, 95% confidence interval (CI) 3·69–4·19. The prevalence was the highest among those aged 85 or above (28·75 per 1000) and was higher among women (5·37 per 1000) than men (2·48 per 1000). The prevalence among hospital inpatients was 28·5%. Only five (3%) patients in the community population had oedema related to cancer or cancer treatment. Of the 304 patients identified with oedema from the Derby hospitals or community health services, 121 (40%) had a concurrent leg ulcer.
Prevalence statistics and current demographic trends indicate that CO is a major and growing health care problem.
Lymphedema can develop after treatment for breast cancer (BCRL). Lymphedema of the breast is not well studied. Currently, the main techniques used to diagnose and monitor the effectiveness of ...treatment are subjective clinician assessment and patient reports. Eighty-nine women who had undergone breast cancer treatment were recruited with and without breast lymphedema. Blinded clinical assessment determined the presence or absence of breast lymphedema. Measurement of skin thickness by ultrasound scanning, local tissue water by tissue dielectric constant (TDC) and tissue indentation by tonometry was recorded. Breast cancer treatment and demographic details were documented. Descriptive statistics were undertaken to compare sample characteristics, including the Chi-squared test, Odds Ratio (OR) and Relative Risks (RR) calculated. Increased body mass index (BMI), larger bra size, increased number of positive lymph nodes, axillary surgery, chemotherapy and increased Nottingham Prognostic Index (NPI) were all associated with breast lymphedema (
< 0.05). Ultrasound and TDC measurements were significantly higher in the lymphedema group (
< 0.05). Receiver Operator Characteristic (ROC) curves demonstrated that ultrasound and TDC measurements could distinguish between edematous and non-edematous breasts. Threshold levels were produced, which demonstrated good levels of sensitivity and specificity. These findings have the potential to improve the diagnosis of breast lymphedema.
Prognostic information is important for patients with cancer, their families, and clinicians. In practice, survival predictions are made by clinicians based on their experience, judgement, and ...intuition. Previous studies have reported that clinicians' survival predictions are often inaccurate. This study reports a secondary analysis of data from the Prognosis in Palliative care Study II (PiPS2) to assess the accuracy of survival estimates made by doctors and nurses.
Adult patients (n = 1833) with incurable, locally advanced or metastatic cancer, recently referred to palliative care services (community teams, hospital teams, and inpatient palliative care units) were recruited. Doctors (n = 431) and nurses (n = 777) provided independent prognostic predictions and an agreed multi-professional prediction for each patient. Clinicians provided prognostic estimates in several formats including predictions about length of survival and probability of surviving to certain time points. There was a minimum follow up of three months or until death (whichever was sooner; maximum follow-up 783 days). Agreed multi-professional predictions about whether patients would survive for days, weeks or months+ were accurate on 61.9% of occasions. The positive predictive value of clinicians' predictions about imminent death (within one week) was 77% for doctors and 79% for nurses. The sensitivity of these predictions was low (37% and 35% respectively). Specific predictions about how many weeks patients would survive were not very accurate but showed good discrimination (patients estimated to survive for shorted periods had worse outcomes). The accuracy of clinicians' probabilistic predictions (assessed using Brier's scores) was consistently better than chance, improved with proximity to death and showed good discrimination between groups of patients with different survival outcomes.
Using a variety of different approaches, this study found that clinicians predictions of survival show good discrimination and accuracy, regardless of whether the predictions are about how long or how likely patients are to survive. Accuracy improves with proximity to death. Although the positive predictive value of estimates of imminent death are relatively high, the sensitivity of such predictions is relatively low. Despite limitations, the clinical prediction of survival should remain the benchmark against which any innovations in prognostication are judged.
ISRCTN13688211. http://www.isrctn.com/ISRCTN13688211.
Abstract
Background This is a prospective study on 118 patients who underwent lymphaticovenous anastomosis (LVA) due to secondary lower limb lymphedema between January 2018 and October 2020 to ...evaluate patients' quality of life (QOL) using the Quality of Life Measure for Limb Lymphedema (LYMQoL) questionnaire.
Methods The outcome measurement included the LYMQoL leg scoring system tool evaluating the function, appearance, symptom, mood, and overall outcome. In addition, correlation analysis was performed for three factors: based on International Society of Lymphology (ISL) stages, disease duration, and amount of volume reduction.
Results The LYMQoL tool overall satisfaction score significantly increased at all intervals from 4.4 ± 0.2 preoperative to 6.5 ± 0.3 postoperative at 12 months (p < 0.001). Significant findings were seen for each domain scores compared preoperatively and at 12 months: function score (18.6 ± 0.5 to 15.4 ± 0.6), appearance score (17.8 ± 0.5 to 16.0 ± 0.6), symptom score (11.8 ± 0.3 to 8.9 ± 0.4), and mood score (14.5 ± 0.4 to 11.4 ± 0.5; p < 0.05). The correlation analysis between improvement of the overall score and the ISL stage (p = 0.610, correlation coefficient r = − 0.047), disease duration (p = 0.659, r = − 0.041), and amount of limb volume reduction (p = 0.454, r = − 0.070) showed no statistical significance.
Conclusion The QOL of secondary lower limb lymphedema patients was significantly improved after LVA regardless of the severity of disease, duration of disease, and amount of volume reduction after LVA. Understanding the patient-reported outcome measurement will help the surgeons to manage and guide the expectations of the patients.
Lymphoedema is a globally neglected health care problem and a common complication following breast cancer treatment. Lymphoedema is a well-known predisposing factor for cellulitis, but few have ...investigated the risk factors for cellulitis in this patient cohort on an international level. The aim of this study was to identify the frequency of cellulitis in patients with lymphoedema of the arm, including potential risk factors for cellulitis.
An international, multi-centre, cross-sectional study including patients with clinically assessed arm lymphoedema. The primary outcome was the incidence of cellulitis located to the arm with lymphoedema within the last 12 months, and its potential associated risk factors. The secondary outcome was life-time prevalence of cellulitis. Adults with clinically-assessed arm lymphoedema/chronic oedema (all causes) and able to give informed consent were included. End-of-life-patients or those judged as not in the patient's best interest were excluded. Both univariable and multivariable analysis were performed.
A total of 2160 patients were included from Australia, Denmark, France, Ireland, Italy, Japan, Turkey and United Kingdom. Secondary lymphoedema was present in 98% of the patients; 95% of these were judged as related to cancer or its treatment. The lifetime prevalence of cellulitis was 22% and 1-year incidence 11%. Following multivariable analysis, factors associated with recent cellulitis were longer swelling duration and having poorly controlled lymphoedema. Compared to having lymphoedema less than 1 year, the risk increased with duration: 1-2 years (OR 2.15), 2-5 years (OR 2.86), 5-10 years (OR 3.15). Patients with well-controlled lymphoedema had a 46% lower risk of cellulitis (OR 0.54, 95% CI 0.39-0.73, p < 0.001). More advanced stages of lymphoedema were associated with cellulitis even after adjustment for swelling duration and control of swelling by logistic regression (stage II OR 5.44, stage III OR 9.13, p = 0.002), demonstrated in a subgroup analysis.
Patients with advanced arm lymphoedema are at particular risk of developing cellulitis. Prevention of lymphoedema progression is crucial. The results lend towards a positive effect of having well-treated lymphoedema on the frequency of cellulitis.
The Prognosis in Palliative care Study (PiPS) prognostic survival models predict survival in patients with incurable cancer. PiPS-A (Prognosis in Palliative care Study - All), which involved clinical ...observations only, and PiPS-B (Prognosis in Palliative care Study - Blood), which additionally required blood test results, consist of 14- and 56-day models that combine to create survival risk categories: 'days', 'weeks' and 'months+'.
The primary objectives were to compare PIPS-B risk categories against agreed multiprofessional estimates of survival and to validate PiPS-A and PiPS-B. The secondary objectives were to validate other prognostic models, to assess the acceptability of the models to patients, carers and health-care professionals and to identify barriers to and facilitators of clinical use.
This was a national, multicentre, prospective, observational, cohort study with a nested qualitative substudy using interviews with patients, carers and health-care professionals.
Community, hospital and hospice palliative care services across England and Wales.
For the validation study, the participants were adults with incurable cancer, with or without capacity to consent, who had been recently referred to palliative care services and had sufficient English language. For the qualitative substudy, a subset of participants in the validation study took part, along with informal carers, patients who declined to participate in the main study and health-care professionals.
For the validation study, the primary outcomes were survival, clinical prediction of survival and PiPS-B risk category predictions. The secondary outcomes were predictions of PiPS-A and other prognostic models. For the qualitative substudy, the main outcomes were participants' views about prognostication and the use of prognostic models.
For the validation study, 1833 participants were recruited. PiPS-B risk categories were as accurate as agreed multiprofessional estimates of survival (61%;
= 0.851). Discrimination of the PiPS-B 14-day model (
-statistic 0.837, 95% confidence interval 0.810 to 0.863) and the PiPS-B 56-day model (
-statistic 0.810, 95% confidence interval 0.788 to 0.832) was excellent. The PiPS-B 14-day model showed some overfitting (calibration in the large -0.202, 95% confidence interval -0.364 to -0.039; calibration slope 0.840, 95% confidence interval 0.730 to 0.950). The PiPS-B 56-day model was well-calibrated (calibration in the large 0.152, 95% confidence interval 0.030 to 0.273; calibration slope 0.914, 95% confidence interval 0.808 to 1.02). PiPS-A risk categories were less accurate than agreed multiprofessional estimates of survival (
< 0.001). The PiPS-A 14-day model (
-statistic 0.825, 95% confidence interval 0.803 to 0.848; calibration in the large -0.037, 95% confidence interval -0.168 to 0.095; calibration slope 0.981, 95% confidence interval 0.872 to 1.09) and the PiPS-A 56-day model (
-statistic 0.776, 95% confidence interval 0.755 to 0.797; calibration in the large 0.109, 95% confidence interval 0.002 to 0.215; calibration slope 0.946, 95% confidence interval 0.842 to 1.05) had excellent or reasonably good discrimination and calibration. Other prognostic models were also validated. Where comparisons were possible, the other prognostic models performed less well than PiPS-B. For the qualitative substudy, 32 health-care professionals, 29 patients and 20 carers were interviewed. The majority of patients and carers expressed a desire for prognostic information and said that PiPS could be helpful. Health-care professionals said that PiPS was user friendly and may be helpful for decision-making and care-planning. The need for a blood test for PiPS-B was considered a limitation.
The results may not be generalisable to other populations.
PiPS-B risk categories are as accurate as agreed multiprofessional estimates of survival. PiPS-A categories are less accurate. Patients, carers and health-care professionals regard PiPS as potentially helpful in clinical practice.
A study to evaluate the impact of introducing PiPS into routine clinical practice is needed.
Current Controlled Trials ISRCTN13688211.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 25, No. 28. See the NIHR Journals Library website for further project information.
The acronym Limprint stands for Lymphedema IMpact and PRevalence INTernational and was run under the auspices of the International Lymphedema Framework (ILF), a charity dedicated to improving ...provision of care globally. The primary aim was to identify the number of people with chronic edema (chronic edema present for >3 months and due to a range of underlying etiologies and associated risk factors) within diverse health services in nine participating countries and to determine its impact using validated methods. An international protocol and sampling framework, online data capture system, and standard operating procedures were adopted. An international consensus was used to create a core data tool that covered 13 domains. Specialist data on demographics and disability, details of swelling, wounds, cancer, and health-related quality of life were also available for sites. The study protocol was designed to allow flexibility in the types of studies undertaken within complex health care systems. All cases were confirmed using the modified pitting test. Sensitivity and specificity for this method were determined in Japanese and European populations. Following confirmation of a chronic edema case, Lymphologists defined whether it was a primary of a secondary form. The study was designed to provide robust evidence that chronic edema is an important and unrecognized public health problem in health services with significant morbidity. Without evidence of the size and complexity, it will remain considered a rare phenomenon and people affected will be denied access to appropriate treatment that would allow them to have fulfilled and productive lives.
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