Short summary

This is a validation study of the Danish version of Hospital Anxiety and Depression Scale (HADS) in persons with major lower extremity amputations (LEA). To investigate structural validity and internal consistency reliability, we will identify 120 patients with LEA across six orthopedic departments in Denmark representing all five regions. Furthermore, we will assess content validity of HADS using cognitive interviewing following the 'Think aloud' method among 12 patients.

Rationale

One in five patients with major lower extremity amputation (LEA) experience anxiety; up to one-third of the patients have symptoms of depression up to 2-3 years after amputation. Studies have shown that patients with LEA have psychosocial needs, which are not met in healthcare. Screening for anxiety and depression among patients with LEA is therefore recommended in the national guideline for patients with LEA. The screening tool Hospital Anxiety and Depression Scale (HADS) has been found valid among patients with heart failure, but it is currently unknown whether the tool is suitable for patients with LEA. To fulfill patients' psychosocial needs and comply with the Danish clinical guideline, we must ensure that the HADS scale is relevant, comprehensive, and comprehensible for patients with major LEA. Thus, there is a need for investigating content and construct validity as well as internal consistency reliability of HADS among patients with LEA.

Description of the cohort

Data will be collected in Orthopaedic wards at six hospitals representing all regions in Denmark including Aalborg, Aarhus, Kolding, Odense, Holbaek, and Hvidovre Hospitals. Patients having had a major LEA due to vascular diseases will be eligible for participation.

Data and biological material

A methodological study consisting of cognitive interviews with 12 patients with major LEA to assess content validity, and using HADS questionnaire responses from 120 patients with major LEA to assess floor and ceiling effect, construct validity, and internal consistency reliability. The patients will be asked to complete the HADS and optionally an interview before discharge and upon their acceptance of being included in the study.

Collaborating researchers and departments

Department of Orthopedics Aarhus University Hospital

• Associate professor Pia Kjær Kristensen

Department of Orthopaedic Surgery and Traumatology, Odense University Hospital

• Assistant professor Charlotte Myhre Jensen

Clinical Nursing Research Unit, Aalborg University Hospital & Department of Clinical Medicine, Aalborg University

• Associate professor Karin Bundgaard

Department of Orthopedics surgery Holbaek hospital, & REHPA, University of Southern Denmark

• Postdoc Ulla Riis Madsen

Department of Orthopedics surgery & Department of Clinical Research, Copenhagen University Hospital, Hvidovre

• Assistant professor Pia Søe Jensen

Department of Orthopaedic surgery and traumatology, University Hospital Lillebaelt Kolding

• Associate professor Charlotte Abrahamsen