Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial

payt.helady61 shared this article with you from Inoreader Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial Via BMJ Open recent issues Introduction Optimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM . Methods and analysis This open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0–2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12–14 weeks and 24–26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA 1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale. Ethics and dissemination This study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations. Trial registration number NCT03522870. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Psychotherapies reducing suicidal thoughts and behaviour: study protocol

payt.helady61 shared this article with you from Inoreader Comprehensive database and individual patient data meta-analysis of randomised controlled trials on psychotherapies reducing suicidal thoughts and behaviour: study protocol Via BMJ Open recent issues Introduction Psychotherapy may reduce suicidal thoughts and behaviour, but its effectiveness is not well examined. Furthermore, conventional meta-analyses are unable to test possible effects of moderators affecting this relationship. This protocol outlines the building of a comprehensive database of the literature in this research field. In addition, we will conduct an individual patient data meta-analysis (IPD-MA) to establish the effectiveness of psychotherapy in reducing suicidality, and to examine which factors moderate the efficacy of these interventions. Methods and analysis To build a comprehensive database, randomised controlled trials examining the effect of any psychotherapy targeting any psychiatric disorder on suicidal thoughts or behaviour will be identified by running a systematic search in PubMed, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials from data inception to 12 August 2019. For the IPD-MA, we will focus on adult outpatients with suicidal ideation or behaviour. In addition, as a comparison group we will focus on a control group (waiting-list, care as usual or placebo). A 1-stage IPD-MA will be used to determine the effectiveness of psychotherapy on suicidal ideation, suicide attempts and/or suicide deaths, and to investigate potential patient-related and intervention-related moderators. Subgroup and sensitivity analyses will be conducted to test the robustness of the findings. Additionally, a conventional MA will be conducted to determine the differences between studies that provided IPD and those that did not. IPD-MA may determine the effectiveness of psychotherapy in reducing suicidality and provide insights into the moderating factors influencing the efficacy of psychotherapy. Answering these questions will inform mental healthcare practitioners about optimal treatments for different groups of individuals with suicidal ideation and/or behaviour and consequently help to reduce suicide risk. Ethics and dissemination An ethical approval is not required for this study. The results will be published in a peer-review journal. PROSPERO registration number CRD42020140573 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Adiposity change and mortality in middle-aged to older

payt.helady61 shared this article with you from Inoreader Adiposity change and mortality in middle-aged to older Chinese: an 8-year follow-up of the Guangzhou Biobank Cohort Study Via BMJ Open recent issues Objective To examine the associations of change in body mass index (BMI) and waist circumference (WC) over an average of 4 years with subsequent mortality risk in middle-aged to older Chinese. Design Prospective cohort study based on the Guangzhou Biobank Cohort Study. Setting Community-based sample. Participants 17 773 participants (12 956 women and 4817 men) aged 50+ years. Primary and secondary outcome measures Primary outcome measure was all-cause mortality. Secondary outcome measures were cardiovascular disease (CVD) and cancer mortality. Causes of death were obtained via record linkage, and coded according to the International Classification of Diseases (tenth revision). Results 1424 deaths (53.4% women) occurred in the 17 773 participants (mean age 61.2, SD 6.8 years) during an average follow-up of 7.8 (SD=1.5) years, and 97.7% of participants did not have an intention of weight loss . Compared with participants with stable BMI, participants with BMI loss (>5%), but not gain, had a higher risk of all-cause mortality (HR=1.49, 95% CI 1.31 to 1.71), which was greatest in those who were underweight (HR=2.45, 95% CI 1.31 to 4.59). Similar patterns were found for WC. In contrast, for participants with a BMI of ≥27.5 kg/m2, BMI gain, versus stable BMI, was associated with 89% higher risk of all-cause mortality (HR=1.89, 95% CI 1.25 to 2.88), 72% higher risk of CVD mortality (HR=1.72, 95% CI 0.80 to 3.72) and 2.27-fold risk of cancer mortality (HR=2.27, 95% CI 1.26 to 4.10). Conclusion In older people, unintentional BMI/WC loss, especially in those who were underweight was associated with higher mortality risk. However, BMI gain in those with obesity showed excess risks of all-cause and cancer mortality, but not CVD mortality. Frequent monitoring of changes in body size can be used as an early warning for timely clinical investigations and interventions and is important to inform appropriate health management in older Chinese. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

TReatment with caffeine of the very preterm infant in the delivery room: a feasibility study

payt.helady61 shared this article with you from Inoreader Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study Via BMJ Open recent issues Introduction Early treatment with caffeine in the delivery room has been proposed to decrease the need for mechanical ventilation (MV) by limiting episodes of apnoea and improving respiratory mechanics in preterm infants. Thus, the purpose of this feasibility study is to verify the hypothesis that intravenous or enteral administration of caffeine can be performed in the preterm infant in the delivery room. Methods and analysis In this multicentre prospective study, infants with 25+0–29+6 weeks of gestational age will be enrolled and randomised to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. Caffeine plasma level will be measured at 60±15 min after administration and 60±15 min before the next dose (5 mg/kg). The primary endpoint will be evaluation of the success rate of intravenous and enteral administration of caffeine in the delivery room. Secondary endpoints will be the comparison of success rate of intravenous versus oral administration and the evaluation of the need for MV in treated infants. In the absence of previous references, we arbitrarily decided to study 20 infants treated with intravenous caffeine and 20 infants treated with enteral caffeine. Primary endpoint will be evaluated measuring the success rate of intravenous and enteral caffeine administration which will be co nsidered a success when it is followed by the achievement of the caffeine therapeutic level (8–25 µg/mL) 60±15 min before administration of the second dose. Ethics and dissemination The study has been approved by the Italian Medicines Agency (AIFA: AIFA/RSC/P/32755) and by Comitato Etico Pediatrico Regione Toscana. The results will be published in peer-reviewed academic journals. Trial registration number ClinicalTrials.gov identifier NCT04044976; EudraCT number 2018-003626-91. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Multilevel influences on resilient healthcare in six countries: an international comparative study protocol

payt.helady61 shared this article with you from Inoreader Multilevel influences on resilient healthcare in six countries: an international comparative study protocol Via BMJ Open recent issues Introduction Resilient healthcare (RHC) is an emerging area of theory and applied research to understand how healthcare organisations cope with the dynamic, variable and demanding environments in which they operate, based on insights from complexity and systems theory. Understanding adaptive capacity has been a focus of RHC studies. Previous studies clearly show why adaptations are necessary and document the successful adaptive actions taken by clinicians. To our knowledge, however, no studies have thus far compared RHC across different teams and countries. There are gaps in the research knowledge related to the multilevel nature of resilience across healthcare systems and the team-based nature of adaptive capacity. This cross-country comparative study therefore aims to add knowledge of how resilience is enabled in diverse healthcare systems by examining adaptive capacity in hospital teams in six countries. The study will identify how team, organisational and national healthcare system factors support or hinder the ability of teams to adapt to variability and change. Findings from this study are anticipated to provide insights to inform the design of RHC systems by considering how macro-level and meso-level structures support adaptive capacity at the micro-level, and to develop guidance for organisations and policymakers. Methods and analysis The study will employ a multiple comparative case study design of teams nested within hospitals, in turn embedded within six countries: Australia, Japan, the Netherlands, Norway, Switzerland and the UK. The design will be based on the Adaptive Teams Framework placing adaptive teams at the centre of the healthcare system with layers of environmental, organisational and system level factors shaping adaptive capacity. In each of the six countries, a focused mapping of the macro-level features of the healthcare system will be undertaken by using documentary sources and interviews with key informants operating at the macro-level. A sampling framework will be developed to select two hospitals in each country to ensure variability based on size, location and teaching status. Four teams will be selected in each hospital—one each of a structural, hybrid, responsive and coordinating team. A total of eight teams will be studied in each country, creating a total sample of 48 teams. Data collection methods will be observations, interviews and document analysis. Within-case analysis will be conducted according to a standardised template using a combination of deductive and inductive qualitative coding, and cross-case analysis will be conducted drawing on the Qualitative Comparative Analysis framework. Ethics and dissemination The overall Resilience in Healthcare research programme of which this study is a part has been granted ethical approval by the Norwegian Centre for Research Data (Ref. No. 8643334 and Ref. No. 478838). Ethical approval will also be sought in each country involved in the study according to their respective regulatory procedures. Country-specific reports of study outcomes will be produced for dissemination online. A collection of case study summaries will be made freely available, translated into multiple languages. Brief policy communications will be produced to inform policymakers and regulators about the study results and to facilitate translation into practice. Academic dissemination will occur through publication in journals specialising in health services research. Findings will be presented at academic, policy and practitioner conferences, including the annual RHC Network meeting and other healthcare quality and safety conferences. Presentations at practitioner and academic c onferences will include workshops to translate the findings into practice and influence quality and safety programmes internationally. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Association of food industry ties with findings of studies examining the effect of dairy food intake on cardiovascular disease and mortality: systematic review and meta-analysis

payt.helady61 shared this article with you from Inoreader Association of food industry ties with findings of studies examining the effect of dairy food intake on cardiovascular disease and mortality: systematic review and meta-analysis Via BMJ Open recent issues Objective To determine if the association of dairy foods with cardiovascular disease (CVD) outcomes differs between studies with food industry ties versus those without industry ties. To determine whether studies with or without industry ties differ in their risk of bias. Eligibility criteria We included cohort and case–control studies that estimated the association of dairy foods with CVD outcomes in healthy adults. Information sources We searched eight databases on 1 February 2019 from 2000 to 2019 and hand searched reference lists. Risk of bias We used the Risk of Bias in Non-Randomised Studies-of Exposure tool. Included studies 43 studies (3 case–controls, 40 cohorts). Synthesis of results There was no clear evidence of an association between studies with industry ties (1/14) versus no industry ties (8/29) and the reporting of favourable results, risk ratio (RR)=0.26 (95% CI 0.04 to 1.87; n=43 studies) and studies with industry ties (4/14) versus no industry ties (11/29) and favourable conclusions, RR=0.75 (95% CI 0.29 to 1.95; n=43). Studies with industry sponsorship, (HR=0.78; n=3 studies) showed a decreased magnitude of risk of CVD outcomes compared with studies with no industry sponsorship (HR=0.97; n=18) (ratio of HRs 0.80 (95% CI 0.66 to 0.97); p=0.03). Strengths and limitations of evidence Every study had an overall high risk of bias rating; this was primarily due to confounding. Interpretation There was no clear evidence of an association between studies with food industry ties and the reporting of favourable results and conclusions compared with studies without industry ties. The statistically significant difference in the magnitude of effects identified in industry-sponsored studies compared with non-industry-sponsored studies, however, is important in quantifying industry influence on studies included in dietary guidelines. PROSPERO registration number CRD42019129659. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Home cardiac rehabilitation programme for people with heart failure and their caregivers

payt.helady61 shared this article with you from Inoreader Protocol for an implementation study of an evidence-based home cardiac rehabilitation programme for people with heart failure and their caregivers in Scotland (SCOT:REACH-HF) Via BMJ Open recent issues Introduction Despite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based programmes might improve accessibility. The aim of SCOT: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is to assess the implementation of the REACH-HF home-based CR intervention in the context of the National Health Service (NHS) in Scotland. This paper presents the design and protocol for this observational implementation study. Specific objectives of SCOT:REACH-HF are to: (1) assess service-level facilitators and barriers to the implementation of REACH-HF; (2) compare real-world patient and caregiver outcomes to those seen in a prior clinical trial; and (3) estimate the economic (health and social) impact of implementing REACH-HF in Scotland. Methods and analysis The REACH-HF intervention will be delivered in partnership with four 'Beacon sites' across six NHS Scotland Health Boards, covering rural and urban areas. Health professionals from each site will be trained to facilitate delivery of the 12-week programme to 140 people with heart failure and their caregivers. Patient and caregiver outcomes will be assessed at baseline and 4-month follow-up. Assessments include the Minnesota Living with Heart Failure Questionnaire (MLHFQ), five-dimension EuroQol 5L, Hospital Anxiety and Depression Scale, and the Caregiver Burden Questionnaire. Qualitative interviews will be conducted with up to 20 health professionals involved in programme delivery (eg, cardiac nurses, physiotherapists). 65 facilitator-patient consultations will be audio recorded and assessed for fidelity. Integrative analysis will address key research questions on fidelity, context and CR participant-related outcomes. The SCOT:REACH-HF findings will inform the future potential roll-out of REACH-HF in Scotland. Ethics and dissemination The study has been given ethical approval by the West of Scotland Research Ethics Service (reference 20/WS/0038, approved 25 March 2020). Written informed consent will be obtained from all participants. The study is listed on the ISRCTN registry with study ID ISRCTN53784122. The research team will ensure that the study is conducted in accordance with both General Data Protection Regulations and the University of Glasgow's Research Governance Framework. Findings will be reported to the funder and shared with Beacon Sites, to facilitate service evaluation, planning and good practice. To broaden interest in, and understanding of REACH-HF, we will seek to publish in peer-reviewed scientific journals and present at stakeholder events, national and international conferences. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Effect of Housing First on violence-related traumatic brain injury in adults with experiences of homelessness and mental illness: findings from the At Home/Chez Soi randomised trial, Toronto site

payt.helady61 shared this article with you from Inoreader Effect of Housing First on violence-related traumatic brain injury in adults with experiences of homelessness and mental illness: findings from the At Home/Chez Soi randomised trial, Toronto site Via BMJ Open recent issues Objectives People experiencing homelessness have a high prevalence and incidence of traumatic brain injury (TBI) due to violence. Little is known about the effectiveness of interventions to reduce TBI in this population. This study assessed the effect of Housing First (HF) on violence-related TBI in adults with experiences of homelessness and mental illness. Design Pragmatic randomised trial. Participants 381 participants in the Toronto site of the At Home/Chez randomised trial. Intervention HF participants were provided with scattered-site housing using rent supplements and supports from assertive community treatment or intensive case management teams (n=218, 57.2%). Control participants had access to treatment as usual (TAU) in the community (n=163, 42.8%). Main outcome measures Primary outcomes were an incident physical violence-related TBI event and the number of physical violence-related TBI events during the follow-up period (January 2014 to March 2017). Interval-censored survival time regression and zero-inflated negative binomial regression were used to assess the effect of HF on primary outcomes. Results Among study participants, 9.2% (n=35) had an incident physical violence-related TBI event, and the mean physical violence-related TBI events was 0.16 (SD ±0.6). Compared with TAU participants, HF participants did not have a significantly lower risk of an incident violence-related TBI event (adjusted HR : 0.58 (95% CI, 0.29 to 1.14)), but they had a significantly lower number of physical violence-related TBI events (unadjusted incidence rate ratio (IRR): 0.22 (95% CI, 0.06 to 0.78); adjusted IRR: 0.15 (95% CI, 0.05 to 0.48)). Conclusion HF may be a useful intervention to reduce the burden of TBI due to physical violence among homeless individuals with mental illness. Trial registration number ISRCTN42520374. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis

payt.helady61 shared this article with you from Inoreader Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis Via BMJ Open recent issues Objective Non-alcoholic fatty liver disease (NAFLD) is a global epidemic without effective therapeutic agents in the clinic. This meta-analysis aimed to assess the efficacy of the marketed hepatoprotectant bicyclol at improving blood biomarkers in patients with NAFLD. Design Electronic databases were searched for randomised controlled trials (RCTs) published up to August 2020 using bicyclol to treat NAFLD. The risk of bias, quality of evidence and publication bias were evaluated. Blood biomarkers, including alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), triglyceride (TG) and total cholesterol (TC), were analysed using Review Manager V.5.3 software. Outcomes with significant heterogeneity (I2 ≥75%) were divided into the bicyclol monotherapy subgroup and combination treatment subgroup. Results Twelve RCTs involving 1008 patients were finally included. No serious adverse events were reported in the bicyclol-treated groups. The total effective rate of bicyclol intervention for NAFLD was significantly higher than that of the control group. The decreases in the levels of AST (mean difference (MD) = –15.20; 95% CI –20.51 to –9.90; I2=74%), TBIL (MD = –1.72; 95% CI –2.72 to –0.72; I2=0%) and TC (MD = –0.52; 95% CI –0.70 to –0.34; I2=67%) treated by bicyclol were significantly higher than those in the control group. When a high heterogeneity existed (I2 ≥75%), subgroup analyses were conducted and revealed significantly decreased ALT levels (MD = –34.07; 95% CI –36.70 to –31.43; I2=0%) merely in the bicyclol monotherapy subgroup, while TG level (MD = –0.39; 95% CI –0.45 to –0.33; I2=0%) was decreased in the bicyclol combination therapy subgroup. Conclusions The study presents the evidence of bicyclol monotherapy and/or combination therapy for improving liver function and blood lipid biomarkers in patients with NAFLD. This preliminary study predicts that bicyclol might be an alternative drug for NAFLD therapy in the future. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Cord blood transplantation for adult myeloid malignancies comparing high-dose cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF priming: G-CONCORD study protocol

payt.helady61 shared this article with you from Inoreader Randomised controlled trial of conditioning regimen for cord blood transplantation for adult myeloid malignancies comparing high-dose cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF priming: G-CONCORD study protocol Via BMJ Open recent issues Introduction A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues. To minimise graft failure and relapse after CBT, intensification of conditioning by the addition of high-dose cytosine arabinoside (CA) and concomitant continuous use of granulocyte-colony stimulating factor (G-CSF) are reported to convey a significantly better survival after CBT in some retrospective studies. To confirm the effect of G-CSF plus CA combination, in addition to the standard conditioning regimen, cyclophosphamide (CY)/total body irradiation (TBI), we design a randomised controlled study comparing CA/CY/TBI with versus without G-CSF priming (G-CSF combined conditioned cord blood transplantation [G-CONCORD] study). Methods and analysis This is a multicentre, open-label, randomised phase III study that aimed to compare G-CSF+CA/CY/TBI as a conditioning regimen for CBT with CA/CY/TBI. Patients with acute myeloid leukaemia or myelodysplastic syndrome, aged 16–55 years, are eligible. The target sample size is 160 and the registration period is 4 years. The primary endpoint is the 2-year disease-free survival rate after CBT. The secondary endpoints are overall survival, relapse, non-relapse mortality, acute and chronic graft-versus-host disease, engraftment rate, time to neutrophil recovery, short-term adverse events, incidence of infections and causes of death. This study employs a single one-to-one web-based randomisation between the with-G-CSF versus without-G-CSF groups after patient registration. Combination of high-dose CA and CY/TBI in both groups is used for conditioning. Ethics and dissemination The study protocol was approved by the central review board, Nagoya University Certified Review Board, after the enforcement of the Clinical Trials Act in Japan. The manuscripts presenting data from this study will be submitted for publication in quality peer-reviewed medical journals. Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journals. Trial registration numbers UMIN000029947 and jRCTs041180059. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial

payt.helady61 shared this article with you from Inoreader Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial Via BMJ Open recent issues Introduction Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible. The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated. Methodology All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).< /p> Ethics and dissemination The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses. Trial registration number NCT03210311 Conclusion The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.