A randomized cross-over trial to detect differences in arm volume after low- and heavy-load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema:study protocol

BACKGROUND: In an effort to reduce the risk of breast cancer-related arm lymphedema, patients are commonly advised to avoid heavy lifting, impacting activities of daily living and resistance exercise prescription. This advice lacks evidence, with no prospective studies investigating arm volume changes after resistance exercise with heavy loads in this population. The purpose of this study is to determine acute changes in arm volume after a session of low- and heavy-load resistance exercise among women undergoing adjuvant chemotherapy for breast cancer at risk for arm lymphedema. METHODS/DESIGN: This is a randomized cross-over trial. Participants: Women receiving adjuvant chemotherapy for breast cancer who have undergone axillary lymph node dissection will be recruited from rehabilitation centers in the Copenhagen area. Intervention: Participants will be randomly assigned to engage in a low- (two sets of 15–20 repetition maximum) and heavy-load (three sets of 5–8 repetition maximum) upper-extremity resistance exercise session with a one week wash-out period between sessions. Outcome: Changes in extracellular fluid (L-Dex score) and arm volume (ml) will be assessed using bioimpedance spectroscopy and dual-energy x-ray absorptiometry, respectively. Symptom severity related to arm lymphedema will be determined using a visual analogue scale (heaviness, swelling, pain, tightness). Measurements will be taken immediately pre- and post-exercise, and 24- and 72-hours post-exercise. Sample size: A sample size of 20 participants was calculated based on changes in L-Dex scores between baseline and 72-hours post exercise sessions. DISCUSSION: Findings from this study are relevant for exercise prescription guidelines, as well as recommendations regarding participating in activities of daily living for women following surgery for breast cancer and who may be at risk of developing arm lymphedema. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97332727. Registered 12 February 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2548-y) contains supplementary material, which is available to authorized users

Stakeholder analysis with regard to a recent European restriction proposal on microplastics

Stakeholder involvement is pivotal EU governance. In this paper, we complete a stakeholder analysis of the European Chemicals Agency's recent Annex XV restriction proposal process on intentionally added microplastics. The aim of this study is to map the interests, influence and importance of active stakeholders in order to understand the arguments being put forward by different stakeholders and provide recommendations to policy-makers on how to ensure a balanced consideration of all stakeholder perspectives. Stakeholders were identified through niche media analysis and by scrutinising comments from the public consultation on the restriction proposal. Their importance and influence were mapped using three approaches: "scale from low to high", "psychometric scale" and "qualitative ranking". We identified 205 different stakeholders out of which 77 were industry and trade associations, 25 were large companies and only four were small and medium-sized enterprises. National authorities and researchers did not comment on the restriction proposal, whilst large companies were very active providing comments. Industry trade associations and sports-related non-governmental organizations articulated anxiety about the costs associated with the implementation of the restriction proposal. Among environmental non-governmental organizations, there was consensus that plastics should be handled like other substances under EU's chemical regulation. Primary stakeholders identified exhibited high importance, but varying degrees of influence, while the opposite applied to the major European institutions. Based on our analysis, we recommend that: The European Chemicals Agency implement measures to include "silent" stakeholders and invite guest experts to participate in their committees on Risk Assessment and Socio-Economic Analysis; Researchers should be more active in the public consultation; and that special emphasis should be put on helping small and medium-sized enterprises. With regards to stakeholder consultation, we find that media analysis is a good supplement to stakeholder analysis and that a more objective top-down measure of stakeholder importance and influence is needed

The association of selected multiple sclerosis symptoms with disability and quality of life:a large Danish self-report survey

Abstract Background People with multiple sclerosis (MS) experience a wide range of unpredictable and variable symptoms. The symptomatology of MS has previously been reported in large sample registry studies; however, some symptoms may be underreported in registries based on clinician-reported outcomes and how the symptoms are associated with quality of life (QoL) are often not addressed. The aim of this study was to comprehensively evaluate the frequency of selected MS related symptoms and their associations with disability and QoL in a large self-report study. Methods We conducted a cross-sectional questionnaire survey among all patients at the Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark. The questionnaire included information on clinical and sociodemographic characteristics, descriptors of QoL and disability, as well as prevalence and severity of the following MS symptoms: impaired ambulation, spasticity, chronic pain, fatigue, bowel and bladder dysfunction, and sleep disturbances. Results Questionnaires were returned by 2244/3606 (62%). Participants without MS diagnosis or incomplete questionnaires were excluded, n = 235. A total of 2009 questionnaires were included for analysis (mean age 49.4 years; mean disease duration 11.7 years; and 69% were women). The most frequently reported symptoms were bowel and bladder dysfunction (74%), fatigue (66%), sleep disturbances (59%), spasticity (51%) and impaired ambulation (38%). With exception of fatigue and sleep disturbances, all other symptoms increased in severity with higher disability level. Invisible symptoms (also referred to as hidden symptoms) such as fatigue, pain and sleep disturbances had the strongest associations with the overall QoL. Conclusion We found invisible symptoms highly prevalent, even at mild disability levels. Fatigue, pain and sleep disturbances had the strongest associations with the overall QoL and were more frequently reported in our study compared with previous registry-based studies. These symptoms may be underreported in registries based on clinician reported outcomes, which emphasizes the importance of including standardized patient reported outcomes in nationwide registries to better understand the impact of the symptom burden in MS