Self-reported questionnaires for lymphoedema: a systematic review of measurement properties using COSMIN framework

Paramanandam, Vincent Singh; Lee, Mi-Joung; Kilbreath, Sharon L.; Dylke, Elizabeth

doi:10.1080/0284186x.2020.1862422

Cited by 15 publications

(17 citation statements)

References 65 publications

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“…The LYMPH-ICF-UL has been used in thousands of patients. (37,51,53,(68)(69)(70)(71)(72)(73)(74)(75)(76)(77) This questionnaire assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb LE. It is a validated questionnaire, consisting of 29 items (questions) across five different domains Lymphedema-specific QoL -Lymph-Q: The Lymph-Q Upper Extremity Module is a new PROM developed to assess patient reported outcomes of BCRL in a concept-driven approach.…”

Section: Detailed Description Of the Assessments Prosmentioning

confidence: 99%

The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

Kappos,

Haas,

Schulz

et al. 2024

Preprint

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Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis: The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome lymphedema-specific QoL, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination: This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee Ethikkommission Nordwest- und Zentralschweiz (2023-00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration: The trial is registered at https://clinicaltrials.gov (ID:NCT05890677) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de. The date of first registration was 23.05.2023. Strengths and limitations of this study: -This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL. -The pragmatic design will reflect clinical practice, thereby directly providing applicable results. -A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. -Patient advocates were intensely involved throughout the trial design. -To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting access of the patients to available treatment options. -The assessment of treatment quality (both conservative and surgical) at various sites is challenging due to potential variations resulting from the pragmatic design, which may influence the outcomes of the study.

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Section: Detailed Description Of the Assessments Prosmentioning

confidence: 99%

The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

Kappos,

Haas,

Schulz

et al. 2024

Preprint

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“…Moreover, it is difficult to compare results if measurements are based on different methods. While circumferential measurement seems to be the most common clinical assessment method to determine lymphedema [Smoot et al 2011, Brorson et al 2015, the LYMQOL has recently been recommended for evaluating the HRQoL of people with lymphedema [Paramanandam et al 2021].…”

Section: Quality Of Lifementioning

confidence: 99%

On lymphedema of the lower limbs after treatment of endometrial cancer : with emphasis on incidence, quality of life, risk factors, and health economy

Wedin

2021

Linköping University Medical Dissertations

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“…Lymphedema is a clinical condition stemming from a failure of the lymphatic system in the formation or drainage of lymph. The cause can be congenital or secondary and aggravating factors can contribute to the increase in edema [1]. The combination of therapies is recommended, such as compression mechanisms (stockings and bandages), manual and mechanical lymphatic drainage, exercises and activities of daily living [2].…”

Section: Introductionmentioning

confidence: 99%

Grosgrain Stockings in the Treatment of Primary Congenital Lymphedema

Godoy

Barufi

et al. 2022

ELECTRON J GEN MED

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The aim of the present study was to evaluate grosgrain c stockings in the reduction and maintenance of the results of treatment for lymphedema.Method: A prospective clinical trial was performed with 45 patients who made use of grosgrain stockings as monotherapy for the treatment of lower limb lymphedema with the analysis of the volumetric reduction using bioimpedance at the Clinica Godoy-Brazil. These stockings are hand-crafted and adapted to each patient, with adjustments made as necessary. Results:The mean reduction in volume was from 7.1 to 6.0 L (standard deviation: 1.56 L). This reduction was statistically significant (p-value < 0.0001, paired t-test). A total of 17 (18.8%) of the 90 limbs did not undergo reductions, but rather had discrete numerical increases. However, these increases were not statistically significant in this group of patients (p-value = 0.08, paired t-test). Conclusion:Grosgrain stockings are effective for the treatment of primary congenital lymphedema when used in accordance with the recommended instructions.

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Self-reported questionnaires for lymphoedema: a systematic review of measurement properties using COSMIN framework

Cited by 15 publications

References 65 publications

The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

On lymphedema of the lower limbs after treatment of endometrial cancer : with emphasis on incidence, quality of life, risk factors, and health economy

Grosgrain Stockings in the Treatment of Primary Congenital Lymphedema

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