J Reconstr Microsurg 2020; 36(09): 625-633
DOI: 10.1055/s-0040-1713669
Original Article

Content Validity of the LIMB-Q: A Patient-Reported Outcome Instrument for Lower Extremity Trauma Patients

Lily R. Mundy
1  Department of Surgery, Division of Plastic and Reconstructive Surgery, Duke University, Durham, North Carolina
,
Anne Klassen
2  Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
,
Amanda R. Sergesketter
1  Department of Surgery, Division of Plastic and Reconstructive Surgery, Duke University, Durham, North Carolina
,
Andrew Jordan Grier
3  Department of Orthopaedic Surgery, Section of Orthopaedic Trauma, Duke University, Durham, North Carolina
,
Matthew J. Carty
4  Department of Surgery, Division of Plastic Surgery, Brigham and Women's Hospital, Boston, Massachusetts
,
Scott T. Hollenbeck
1  Department of Surgery, Division of Plastic and Reconstructive Surgery, Duke University, Durham, North Carolina
,
Andrea L. Pusic
4  Department of Surgery, Division of Plastic Surgery, Brigham and Women's Hospital, Boston, Massachusetts
5  Patient Reported Outcomes, Value & Experience Center, Brigham and Women's Hospital, Boston, Massachusetts
,
Mark J. Gage
3  Department of Orthopaedic Surgery, Section of Orthopaedic Trauma, Duke University, Durham, North Carolina
› Author Affiliations
Funding L.R.M, M.J.G., A.K., S.T.H., A.R.S., and J.G. reports grants from Foundation of Orthopedic Trauma during the conduct of the study; other from Allergan and Q-Portfolio outside the submitted work. A.L.P. reports, in addition, has a patent QPROMS with royalties paid. This study has been aided by a grant from the Foundation of Orthopedic Trauma and a grant from the Duke Surgical Center for Outcomes Research via the Duke Musculoskeletal Program.

Abstract

Background Limb-threatening lower extremity traumatic injuries can be devastating events with a multifaceted impact on patients. Therefore, evaluating patient-reported outcomes (PROs) in addition to traditional surgical outcomes is important. However, currently available instruments are limited as they were not developed specific to lower extremity trauma patients and lack content validity. The LIMB-Q is being developed as a novel PRO instrument to meet this need, with the goal to measure all relevant concepts and issues impacting amputation and limb-salvage patients after limb-threatening lower extremity trauma.

Methods This is a qualitative interview-based study evaluating content validity for the LIMB-Q. Patients aged 18 years and older who underwent amputation, reconstruction, or amputation after failed reconstruction were recruited using purposeful sampling to maximize variability of participant experiences. Expert opinion was solicited from a variety of clinical providers and qualitative researchers internationally. Preliminary items and scales were modified, added, or removed based on participant and expert feedback after each round of participant interviews and expert opinion.

Results Twelve patients and 43 experts provided feedback in a total of three rounds, with changes to the preliminary instrument made between each round. One scale was dropped after round one, one scale was added after round two, and only minor changes were needed after round three. Modifications, additions and removal of items, instructions, and response options were made after each round using feedback gathered.

Conclusion The LIMB-Q was refined and modified to reflect feedback from patients and experts in the field. Content validity for the LIMB-Q was established. Following a large-scale field test, the LIMB-Q will be ready for use in research and clinical care.



Publication History

Received: 11 January 2020

Accepted: 13 May 2020

Publication Date:
02 July 2020 (online)

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