The NIH Minimal Dataset for Chronic Low Back Pain

Abstract

Supplemental Digital Content is available in the textLongitudinal validity of the NIH minimal dataset was tested. Responsiveness was established with areas under the ROC curve of 0.84 for the total outcome score and 0.91 for Impact Stratification. Compared to mean baseline scores, an improvement of 14 points on the total outcome score and 7.5 points on Impact Stratification can be interpreted as clinically important.

Trajectories of Disability and Low Back Pain Impact

“… 19 The Impact Stratification has moderate to strong correlation with concurrent measures 19 and is responsive to change. 20 The Impact Stratification was administered at baseline, 12 months’, and 24 months’ follow-up.…”

“… 19 Four items on depression and two items on catastrophizing formed a factor “depression and catastrophizing’ (range 0–100, higher scores represent more feelings of depression and catastrophizing). 20 , 21 The Euroqol-5D (EQ5D), a 5-item questionnaire, was used to measure quality of life. 22 For scoring the EQ5D, the Dutch utility index was used with values ranging from−0.33 to 1.00, with higher values reflecting higher quality of life.…”

“…Patients with mild LBP impact at baseline (8–27 points) had to improve 7.5 points and patients with moderate (28–34 points) and severe (≥35 points) impact had to improve respectively 11.5 and 12.5 points to be considered a responder. 20 For the PDI and Impact Stratification the proportion of responders per follow-up measurement was reported for the total sample and for each individual latent class group.…”

Between Group-Level Minimally Important Change and Individual Treatment Responders

“…But sometimes investigators fail to limit the MIC estimate to those who changed a little and include all those reporting any change on the retrospective rating of change item. This was the case in a sample of 123 adult surgical patients with spinal [6] and in a study of 223 patients with chronic low back pain [7]. Including all those who change rather than focusing on those with minimal but important change lead to MIC estimates that were too large.…”

“…The task force proposed three categories of ISS severity: 8-27 (mild), 28-34 (moderate), and 35-50 (severe). Following guidelines by de Vet et al [29], Dutmer et al [7] estimated a SEM of 5.2 for the ISS based on test-retest reliability. But test-retest reliability estimates can be problematic.…”