Clinical research study
Lymphedema
Cultural adaption and multicenter validation of the German version of the LYMPH-Q Upper Extremity Module

https://doi.org/10.1016/j.jvsv.2022.01.008Get rights and content

Abstract

Objective

Upper extremity lymphedema is a burdensome disease with significant effects on quality of life, underscoring the importance of quality of life measures for this patient population. Only recently, the LYMPH-Q Upper Extremity Module, a new patient-reported outcome measure, was developed. The aim of the present study was to translate the LYMPH-Q Upper Extremity Module from English to German and perform a comprehensive validation.

Methods

Translation was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research best practice guidelines. To validate the German LYMPH-Q, a multicenter study was conducted. Internal consistency was determined using Cronbach’s α. Reliability was assessed using the intraclass correlation coefficient. To analyze construct validity, the Pearson correlation coefficient between the LYMPH-Q, quickDASH (disabilities of the arm, shoulder, and hand), and short-form 36-item health survey was calculated. Responsiveness was assessed by comparing the pre- and postoperative LYMPH-Q scores in five patients who had undergone lymphatic reconstructive surgery.

Results

Validation was performed using a cohort of 65 patients. The internal consistency of the different domains was good to excellent (α, 0.87-0.97). The intraclass correlation coefficient ranged from 0.74 to 0.92. The domains of the LYMPH-Q correlated significantly with the corresponding domains of the short-form 36-item health survey and quickDASH. Construct validity was good, with 8 of 10 hypotheses confirmed. Significant improvements in function (46.4 ± 13.3 vs 77.8 ± 11.5; P = .03), symptoms (42.0 ± 10.7 vs 70.6 ± 11.6; P = .02), and psychological well-being (40.4 ± 14.6 vs 78.0 ± 17.3; P = .03) were observed after lymphatic reconstructive surgery.

Conclusions

The German version of the LYMPH-Q Upper Extremity Module was shown to be conceptually equivalent to the original English version. It was shown to be a reliable and valid patient-reported outcome measure to assess the physical and psychological impairments in patients with upper extremity lymphedema.

Section snippets

Advanced translation of LMYPH-Q Upper Extremity Module

The use of this questionnaire, developed by Drs Klassen, Pusic and Cano, was allowed under license from Memorial Sloan Kettering Cancer Center (New York, NY). Translation of the LYMPH-Q was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research best practice guidelines.17 A translation was provided by two German natives who spoke English fluently. Afterward, a backward translation was prepared by a third person with English as their mother tongue and

Advanced translation

We found a high level of consensus between the two forward translations. Individual differences were found owing to variations in wording and were discussed with a third translator to reach a consensus. The back translation review identified 27 items, response options, or instructions that had required repeat translation. After retranslation, the German version corresponded well with the meaning of the original English version. Cognitive debriefing interviews were conducted with the four female

Discussion

In the present study, we have provided a comprehensive evaluation of the German version of the LMYPH-Q Upper Extremity Module. The well-established translation process allowed for the development and cultural adaption of the German LYMPH-Q that is conceptually equivalent to the original English version.

The internal consistency of the different domains was considered to be good to excellent and was comparable that of with other available PROMs for UEL such as the Lymph-ICF upper extremity or

Conclusions

The results of the present study have shown that the German version of the LYMPH-Q Upper Extremity Module is conceptually equivalent to the original English version. It provides clinicians and researchers with a rigorously developed PROM for patients with arm lymphedema. Compared with the existing PROMS for UEL, the LYMPH-Q is unique in terms of the range of patient concerns and impairments covered by the six domains.

Author Contributions

Conception and design: LG, HH, NL

Analysis and interpretation: LG, PG, NL

Data collection: LG, FA, CB, HH, EG, SU, SL, SW, NL

Writing the article: LG

Critical revision of the article: LG, FA, CB, HH, EG, SU, SL, SW, PG, NL

Final approval of the article: LG, FA, CB, HH, EG, SU, SL, SW, PG, NL

Statistical analysis: LG

Obtained funding: Not applicable

Overall responsibility: NL

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    • Author conflict of interest: none.

    The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

    Additional material for this article may be found online at www.jvsvenous.org.

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    © 2022 by the Society for Vascular Surgery. Published by Elsevier Inc.