The claudication symptoms questionnaire: Patient directed development and testing

Symptomatic peripheral artery disease (PAD) is defined as calf pain when walking. However, over 70% of patients with PAD suffer from symptoms other than classic claudication pain (atypical symptoms) or are asymptomatic. There is a paucity in understanding the full spectrum of claudication symptoms experienced by patients with PAD. Thus, there is a need to develop tools for a comprehensive evaluation of PAD symptoms. A deeper understanding of claudication symptoms will enable clinical diagnosis of PAD with atypical symptoms.

The Claudication Symptoms Questionnaire (CSQ) was developed and evaluated via phone in patients with PAD at two timepoints. Items were derived from literature and clinical evidence, and the questionnaire was framed using the Theory of Unpleasant Symptoms (TOUS). The CSQ and was evaluated by telephone administration in patients with PAD at two timepoints. The questionnaire begins with an open-ended question, capturing distinctive patient symptom descriptions. Twelve close-ended questions follow, assessing the type and severity of symptoms.

Patients (n = 34) with known claudication due to PAD were enrolled (age 59.7 + 9.5, 58.9% male, 69.4% Black). Cronbach α for the CSQ was satisfactory (α=0.82). Principal component analysis for the CSQ suggested a three-factor solution for 8 of 12 variables (pain, strength, neuropathic). Item-total correlations were adequate (≥0.48). A trend for sex differences was observed with overall higher CSQ scores in women than men (mean difference of 0.36, p = 0.23).

The CSQ has an adequate level of reliability and can identify a wide range of claudication symptoms. Further testing of the CSQ should be completed to fully understand the range of PAD symptoms and elucidate possible sex differences in symptom presentation. Accurate assessment of the spectrum of claudication symptoms will help clinicians diagnose PAD and optimize interventions for symptom management.