Mapping Outcomes and Outcome Measurement Instruments in the Reconstructive Surgical Interventions of Lower-Limb Segmental Bone Defects: A Scoping Review Protocol.

With the introduction of newer reconstructive techniques, the surgical management of segmental bone defects of the lower limb has become increasingly diverse. At the same time, substantial heterogeneity persists in the outcomes and outcome measurement instruments reported across studies, limiting comparison between treatment approaches and synthesis of the evidence base. This variation also raises concerns about whether outcomes are being reported consistently across studies, or whether fragmented outcome selection may introduce bias and impede the development of a coherent understanding of the literature and the reconstructive techniques being evaluated. With this in mind, this protocol outlines a scoping review designed to identify and map the outcomes and OMIs reported in the literature on segmental bone defects of the lower limb. The findings will provide an overview of what has been measured, how it has been measured, and where important inconsistencies or gaps remain.

Contributors

The idea for this scoping review was conceived by ZS, AY, OR,FB,SK.
The protocol was designed and the first draft of the manuscript was prepared by ZS, AY in close discussion with SK, OR.
The search strategy was developed in discussion among all authors, with support from the experienced librarian JFJ.
The data extraction form was discussed by all authors and will be pilot tested by ZS, AY, TM before use.
The second reviewer for the full scoping review will be AY and in case of the need for a third reviewer, this will be SK , OR and FB in this order.
All authors contributed to the critical revision of the protocol manuscript and approved the final version for publication.

Further Study Information

Current Stage: Ongoing
Date: January 2026 - December 2026
Funding source(s): None


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Lower-Limb Segmental Bone Defects

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Researchers

Study Type

- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

A scoping review of the published literature will be conducted to identify and map outcomes and OMIs across relevant study and patient subgroups. Study selection will be undertaken by two independent reviewers using predefined inclusion and exclusion criteria. For included studies, outcomes, their definitions where reported, the OMIs used, and the timing of outcome assessment will be extracted from both structured outcome fields and relevant free-text sections to avoid omission of important data. Outcomes will be recorded verbatim and primarily mapped to the COMET taxonomy, with further subgrouping or interpretive categorisation informed by the PROLLIT conceptual framework where appropriate. Additional frameworks may be used where necessary to support classification of specific outcomes or instruments. Reference lists of included studies and selected secondary sources will be screened (backward citation search), and forward citation searching

(citation tracking) of included studies will be performed using databases to identify additional eligible primary studies. Findings will be synthesized and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

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