Evidence map›Paper›PMID 38922461›Full record

ArticleJournal of patient-reported outcomes2024

Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema: the LYMPH-Q Upper Extremity Module.

Manraj N Kaur, Sylvie D Cornacchi, Elena Tsangaris, Lotte Poulsen, Louise M Beelen, Louise Bordeleau, Toni Zhong, Mads Gustaf Jorgensen, Jens Ahm Sorensen, Babak Mehrara and 3 more

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of patient-reported outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Article
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

13 authors.

Manraj N KaurDepartment of Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. mkaur17@bwh.harvard.edu.ORCID 0000-0002-1911-0395
Sylvie D CornacchiDepartment of Pediatrics, 3N27, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 3Z5, Canada.
Elena TsangarisModus Outcomes, CIC 1 Broadway, 14th Floor, Cambridge, MA, 02142, USA.
Lotte PoulsenResearch Unit for Plastic Surgery, Odense University Hospital, J.B. Winsløws Vej 4, Odense C, DK-5000, Denmark.
Louise M BeelenDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Louise BordeleauDepartment of Oncology, Juranvinski Cancer Center, 699 Concession Street, Hamilton, ON, L8V 5C2, Canada.
Toni ZhongDivision of Plastic and Reconstructive Surgery, University Health Network, Toronto General Hospital, 8NU-871, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
Mads Gustaf JorgensenResearch Unit for Plastic Surgery, Odense University Hospital, J.B. Winsløws Vej 4, Odense C, DK-5000, Denmark.
Jens Ahm SorensenResearch Unit for Plastic Surgery, Odense University Hospital, J.B. Winsløws Vej 4, Odense C, DK-5000, Denmark.
Babak MehraraMemorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY, 10065, USA.
Joseph DayanMemorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY, 10065, USA.
Andrea L PusicDepartment of Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.
Anne F KlassenDepartment of Pediatrics, 3N27, McMaster University, 1280 Main Street West, Hamilton, ON, L8N 3Z5, Canada.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Canadian Breast Cancer Foundation 319371Canadian Cancer Society 706256NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundBreast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module.

methodsA multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was demonstrated.

resultsQualitative data from in-depth and cognitive interviews with 15 (age 40-74 years) and 16 (age 38-74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35-72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35-74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies.

conclusionThe LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study's innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema.

Indexed as

Patient Reported Outcome MeasuresQualitative ResearchQuality of LifeUpper ExtremityAdultAgedBreast Cancer LymphedemaBreast NeoplasmsFemaleFocus GroupsHumansInterviews as TopicLymphedemaMiddle AgedPsychometricsReproducibility of ResultsArm swellingBreast cancer-related lymphedemaLymphedemaPatient-reported outcome measurePatient-reported outcomes

Identifiers

PMID38922461
PMCPMC11208340

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Registered trials

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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.