Evidence map›Paper›PMID 31054038›Full record

Trial reportAnnals of surgical oncology2019

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

Sheila H Ridner, Mary S Dietrich, Michael S Cowher, Bret Taback, Sarah McLaughlin, Nicolas Ajkay, John Boyages, Louise Koelmeyer, Sarah M DeSnyder, Jamie Wagner and 3 more

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  18. Body mass index increases the risk of breast cancer-related lymphedema at 6-18 months after surgery: a retrospective study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  19. Under recognition and treatment of lymphedema in head and neck cancer survivors - a database study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 2 countries.

Sheila H RidnerVanderbilt University School of Nursing, Vanderbilt University, Nashville, TN, USA. sheila.ridner@vanderbilt.edu.
Mary S DietrichVanderbilt University School of Nursing, Vanderbilt University, Nashville, TN, USA.
Michael S CowherDepartment of Surgery, Alleghany General Hospital, Pittsburgh, PA, USA.
Bret TabackDivision of Breast Surgery, Department of Surgery, Columbia University Medical Center, New York, NY, USA.
Sarah McLaughlinSection of Surgical Oncology, Mayo Clinic, Jacksonville, FL, USA.
Nicolas AjkayDepartment of Surgery, University of Louisville, Louisville, KY, USA.
John BoyagesFaculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia.
Louise KoelmeyerFaculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia.
Sarah M DeSnyderDivision of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jamie WagnerUniversity of Kansas Medical Center, Westwood, KS, USA.
Vandana AbramsonIngram Cancer Center, Vanderbilt Medical Center, Nashville, TN, USA.
Andrew MooreSoutheast Health Southeast Cancer Center, Cape Girardeau, MO, USA.
Chirag ShahDepartment of Radiation Oncology, Cleveland Clinic, Taussig Cancer Institute, Cleveland, OH, USA.
Macquarie University · AUVanderbilt University Medical Center · USAllegheny General Hospital · USCleveland Clinic · USColumbia University Irving Medical Center · USMayo Clinic in Florida · USSoutheastHEALTH · USThe University of Texas MD Anderson Cancer Center · USUniversity of Kansas Medical Center · USUniversity of Louisville · USVanderbilt University · US

Funding

NIH HHS NIH/NCATS UL1 TR000445
6 · The paper itself

Abstract

backgroundBreast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS).

methodsPatients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up.

resultsA total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p < 0.001) and longer times to trigger (9.5 vs. 2.8 months, p = 0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction (p = 0.130).

conclusionsInterim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.

Indexed as

AgedAnthropometryArmBreast Cancer LymphedemaBreast NeoplasmsCancer SurvivorsDielectric SpectroscopyFemaleFollow-Up StudiesHumansMiddle AgedPrognosis

Identifiers

PMID31054038
PMCPMC6733825
OpenAlexW2943146268

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.