Evidence map›Paper›PMID 31965369›Full record

ArticleAnnals of surgical oncology2020

Development and Validation of the BREAST-Q Breast-Conserving Therapy Module.

Anne F Klassen, Laura Dominici, Sarah Fuzesi, Stefan J Cano, Dunya Atisha, Tracie Locklear, Madelijn L Gregorowitsch, Elena Tsangaris, Monica Morrow, Tari King and 1 more

2 registry-linked trialsAbstract readValidation Study
In one paragraph

Article in Annals of surgical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04541290 phase1 / phase2completednot on this map

Tacrolimus as Treatment of Breast Cancer-Related Lymphedema

TypeinterventionalSponsorOdense University HospitalRan2020 to 2022Enrolled20ConditionsBreast Cancer LymphedemaArmsProtopic 0.1 % Topical Ointment
NCT05637216 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

TypeinterventionalSponsorShaw Cancer CenterRan2023 to 2027Enrolled43ConditionsRadiation Induced FibrosisArmsLosartan 25 milligram capsule, Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Anne F KlassenMcMaster University, Hamilton, ON, Canada.
Laura DominiciDivision of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Sarah FuzesiMemorial Sloan-Kettering Cancer Center, New York, NY, USA.
Stefan J CanoModus Outcomes, Letchworth Garden City, UK.
Dunya AtishaHenry Ford Health System, Detroit, MI, USA.
Tracie LocklearNorth Carolina Central University, Durham, NC, USA.
Madelijn L GregorowitschDivision of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Elena TsangarisDivision of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Monica MorrowMemorial Sloan-Kettering Cancer Center, New York, NY, USA.
Tari KingDivision of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Andrea L PusicDivision of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. apusic@bwh.harvard.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Elisa de Stanchina · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundIn breast cancer surgery, patient-reported outcome measures are needed to measure outcomes best reported by patients (e.g., psychosocial well-being). This study aimed to develop and validate a new BREAST-Q module to address the unique concerns of patients undergoing breast-conserving therapy (BCT).

methodsPhase 1 involved qualitative and cognitive interviews with women who had BCT and clinical expert input to establish content for the BCT module. A field-test (phase 2) was performed, and Rasch measurement theory (RMT) analysis was used for item reduction and examination of reliability and validity. Validation of the item-reduced scales in a clinical sample (phase 3) was conducted for further assessment of their psychometric properties.

resultsQualitative interviews with 24 women resulted in the addition of 15 new items across multiple existing BREAST-Q scales and the development of two new scales (Adverse Effects of Radiation and Satisfaction With Information-Radiation Therapy). Feedback from 15 patients and 5 clinical experts were used to refine the instructions, response options, and item wording. An RMT analysis of data from 3497 women resulted in item reduction. The final set of scales showed evidence of ordered response option thresholds, good item fit, and good reliability, except for the Adverse Effects of the Radiation Scale. Validity and reliability were further supported by the phase 3 data from 3125 women.

conclusionsThe BREAST-Q BCT module can be used in research and clinical care to evaluate quality metrics and to compare surgical outcomes across all breast cancer surgery patients.

Indexed as

Breast NeoplasmsMastectomy, SegmentalPatient SatisfactionPsychometricsFemaleHumansQuality of LifeReproducibility of ResultsSurveys and Questionnaires

Identifiers

PMID31965369
PMCPMC8174155

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.