Intra and Inter-Rater Reliability and Convergent Validity of FIT-HaNSA in Individuals with Grade П Whiplash Associated Disorder

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Abstract

Background:

Whiplash-Associated Disorders (WAD) are common following a motor vehicle accident. The Functional Impairment Test - Hand, and Neck/Shoulder/Arm (FIT-HaNSA) assesses upper extremity physical performance. It has been validated in patients with shoulder pathology but not in those with WAD.

Objectives:

Establish the Intra and inter-rater reliability and the known-group and construct validity of the FIT-HaNSA in patients with Grade II WAD (WAD2).

Methods:

Twenty-five patients with WAD2 and 41 healthy controls were recruited. Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), Disabilities of the Arm, Shoulder and Hand (DASH), cervical range of motion (CROM), and FIT-HaNSA were completed at two sessions conducted 2 to 7 days apart by two raters. Intraclass correlation coefficients (ICC) were used to describe Intra and inter-rater reliability. Spearman rank correlation coefficients ( ρ) were used to quantify the associations between scores of the FIT-HaNSA and other measures in the WAD2 group (convergent construct validity).

Results:

The Intra and inter-ICCs for the FIT-HaNSA scores ranged from 0.88 to 0.89 in the control group and 0.78 to 0.85 in the WAD2 group. Statistically significant differences in FIT-HaNSA performance between the two groups suggested known group construct validity ( P < 0.001). The correlations between the NPRS, NDI, DASH, CROM and FIT-HaNSA were generally poor ( ρ < 0.4).

Conclusion:

The study results indicate that the total FIT-HaNSA score has good Intra and inter-rater reliability and the construct validity in WAD2 and healthy controls.

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Most cited references 37

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In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old. Such investigations are often analysed inappropriately, notably by using correlation coefficients. The use of correlation is misleading. An alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability.

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Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale

John T Farrar, James P Young, Linda LaMoreaux … (2001)

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.