Abstract

BackgroundValid and reliable patient-reported outcome measures support health professionals in evaluating the results of clinical research and practice. The Copenhagen Neck Functional Disability Scale (CNFDS) has shown promising measurement properties to measure disability in patients with neck pain, but an Italian version of this questionnaire is not available. The objective of this study was to cross-culturally adapt the CNFDS into Italian (CNFDS-I), and to assess its validity and reliability in patients with neck pain.MethodsThe CNFDS-I was developed according to well-established guidelines for cross-cultural adaptation of patient-reported outcome measures. A cross-sectional clinimetric study was conducted to evaluate its validity and reliability. Patients with chronic neck pain (pain > 3 months) participated in this study. The following measurement properties (defined by the COSMIN initiative) were assessed: structural validity (exploratory factor analysis), internal consistency (Cronbach’s α), construct validity [by testing hypotheses on expected correlations with the Neck Disability Index (NDI), the Neck Bournemouth Questionnaire (NBQ), and pain Visual Analogue Scale (VAS)]. Test-retest reliability [Intraclass Correlation Coefficient for agreement (ICCagreement)], and measurement error [Smallest Detectable Change (SDC)] were also assessed in 50 clinically stable patients. Floor/ceiling effects and acceptability were calculated.ResultsOne-hundred and sixty-two patients (mean age = 47.9 ± 14.5 years, 70% female) were included. The CNFDS-I exhibited sufficient unidimensionality (one factor explained 83% of the variability) and internal consistency (α = 0.83). Construct validity was sufficient as all correlations with the other questionnaires were as expected (r = 0.846 with NDI, r = 0.708 with NBQ, r = 0.570 with VAS). Test-retest reliability was excellent (ICCagreement = 0.99, 95% CI from 0.995 to 0.999), while measurement error was equal to 8.31 scale points (27% scale range). No floor/ceiling effects were detected. The average time for filling the questionnaire was two minutes.ConclusionsThe CNFDS-I proved to be a valid and reliable outcome measure to assess disability in patients with chronic neck pain. Head-to-head comparison studies on the CNFDS-I measurement properties against other disability measures for neck pain (e.g. NDI and NBQ) are required to determine the relative merits of these different measures.

Highlights

  • Valid and reliable patient-reported outcome measures support health professionals in evaluating the results of clinical research and practice

  • Authorization to adapt the Copenhagen Neck Functional Disability Scale (CNFDS) into Italian was obtained from the original developer

  • Copenhagen neck functional disability scale The CNFDS consists of 15 items that evaluate the impact of Neck pain (NP) on headache, ability to sleep, concentration, activities related to work, daily activities and leisure activities

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Summary

Introduction

Valid and reliable patient-reported outcome measures support health professionals in evaluating the results of clinical research and practice. Neck pain is a multifactorial condition which can be related to sex, age, bad posture, poor state of health, other comorbidities, repetitive strain injuries, psychological factors, sleep disorder, and lifestyle [5, 6]. Patients with this condition present with a complex dysfunctional framework that clinicians should regularly manage the best possible manner. Within this context, it is useful to measure neck-related disability as perceived and described by the patient over time, irrespective of its etiology; this measurement can allow to monitor the patients’ outcomes, and to study the relationship between this outcome and other health-related and environmental factors [7]

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