Short summary

The aim of this study is to translate, linguistic validate and cultural adapt the patient reported outcome measure Limb-Q Kids into Danish and perform field testing, combined with international psychometric validation and result studies.

Rationale

Lower Limb deformities is a term that includes many conditions such as: Lower limb deficiency, leg length discrepancy, rotational and angular deformities of the hips, knees, ankles, and feet. Pain and physical limitations are often a part of the lives of children with these deformities. The ideal way to assess the impact of these deformities impact on a child's health-related quality of life, is by using a Patient Reported Outcome Measure (PROM). Such a disease-specific PROM is currently under development, called LIMB-Q Kids.

The aim of this study is to perform an advanced translation and cultural adapt (TCA) of the LIMB-Q Kids for use in Danish children. To undertake a TCA of the LIMB-Q Kids, the guidelines from World Health Organization and the Professional Society for Health Economics and Outcomes Research will be used. This process can be divided into: Two independent Forward translations, a reconciliation meeting, a Backward translation, assessment of the Backward translation, an expert meeting, Cognitive interviews with patients and a proof reading. As it is an advanced translation, results from this translation process will influence the development of the original LIMB-Q Kids.

After the translation finalizes, the international field test will be initiated, wherein data from approximately 100 Danish children with lower limb deformities will be collected. These data from the LIMB-Q Kids will be used as a part of an international field study including psychometric validation and result studies, with an aim to further enhance the PROM.

Description of the cohort

The inclusion criteria for the interviews and the field test are children between the ages of 8 and 18, diagnosed with a Lower Limb Deformity. Children with another condition that might affect their HRQoL, such as cognitive disorders which affects the ability to speak as well as other isolated deformities in the hip and foot, will be excluded. The patients will be included from the Department of Orthopaedics, Aarhus University Hospital. The field test might also end up including patients from other sites in Denmark.

Data and biological material

Data collected in this study includes data from the LIMB-Q KIDS questionnaire, information from cognitive Interviews, data from the participants' journals about the deformities in the lower limb combined with the corresponding treatments and information in relation to the participants nationality, education, gender, age and first language.

Collaborating researchers and departments

Department of Plastic Surgey, OUH

• Jens Ahm Sørensen
• Lotte Rod Poulsen

Department of Orthopaedics, Aaarhus University Hospital

• Jan Duedal Rölfing

Department of Orthopaedics, BC Children's Hospital, Vancouver, BC, Canada

• Harpreet Chhina
• Anthony Cooper