What outcomes have been reported on patients following open lower limb fracture, and how have they been measured?

Abstract

AimsOpen lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years.MethodsSystematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.ResultsA total of 532 eligible studies were identified, reporting 1,803 outcomes with 786 unique outcome terms, which collapsed to 82 standardized outcome headings. Overall 479 individual outcome measurement instruments were identified, including 298 outcome definitions, 27 patient- and 18 clinician-reported outcome measures, and six physical performance measures. The most-reported outcome was ‘bone union/healing’ reported in over 50% of included studies, while health-related quality of life was only measured in 6% of included studies.ConclusionOutcomes reported for people recovering from open lower limb fracture are heterogeneous, liable to outcome reporting bias, and vary widely in the definitions and the measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical functioning, have been neglected. This systematic review identifies the need to unify outcome measures reported on patients recovering from open lower limb fracture; this may be addressed by creating a core outcome set.Cite this article: Bone Joint Res 2023;12(2):138–146.

Development of a core outcome set for open lower limb fracture

“…Information gathering. A systematic review describing outcomes reported in the literature has been previously published; 5 Outcome headings and themes from the systematic review and qualitative analysis, respectively, were brought together to create the inventory of outcomes for open lower limb fracture. The resulting inventory of outcomes consisted of a long list of 150 outcomes categorized using the COMET taxonomy of outcomes to 3 for a schematic of results.…”

“…Outcomes important to healthcare professionals and researchers were identified using a systematic literature review to collect, summarize, and categorize contemporary outcomes reported in clinical studies on skeletally mature patients following open lower limb fracture over ten years from 2009. 5 Outcomes important to patients were identified through a secondary thematic analysis of 25 in-depth interview transcripts that explored the lived experience of recovery following open lower limb fracture. Interview participants were recruited as part of the WOLLF HTA-10/57/20 trial.…”

“…Inconsistency in outcome-reporting and poor-quality studies hamper attempts to evaluate new interventions to improve function, recovery experience, and investigation into the effects of regional variation of treatment on recovery. 5 A core outcome set is an agreed, standardized set of outcomes to be measured and reported, as a minimum, in all trials for a specific population and health condition, and does not preclude the measurement of other outcomes in addition to the core outcome set. 6 Core outcome set projects have been endorsed as a method to reduce outcome heterogeneity, outcome-reporting bias, and to promote better-quality research that is patient-centred through the involvement of key stakeholders.…”

“…Inconsistency in outcome-reporting and poor-quality studies hamper attempts to evaluate new interventions to improve function, recovery experience, and investigation into the effects of regional variation of treatment on recovery. 5 …”

Tibial plateau fractures in older adults are associated with a clinically significant deterioration in health-related quality of life

“…7,21 A recent study of outcomes following open fractures determined that the domains that are important to patients and should therefore be included in a core outcome set for open fractures include 'Walking, gait and mobility', 'Being able to return to life roles', 'Pain or discomfort' and 'Quality of life'. 22 Using COSMIN methodology, this group of six patients, eight healthcare professionals and 11 research methodologists went on to recommend that the EQ-5D five-level (5L) and LEFS should be used in future research trials, audit and clinical assessment, of open fractures. 23 The current study employed both EQ-5D and LEFS, and though it does not include open fractures, TPFs in the elderly are considered complex fractures according to the NICE definition (joints broken into multiple pieces), 4 and it is reasonable to assume that similar domains are important to patients.…”