Numerical Rating Scale 11-Pain (also referred to as 11-Point Numerical Rating Scale for Pain Intensity)

Instrument Name: Numerical Rating Scale 11-Pain (also referred to as 11-Point Numerical Rating Scale for Pain Intensity)

Abbreviation: NRS-11-Pain (NRSI)

Points for Consideration:

In an NRS, patients are asked to to indicate a number between 0 and 10 that fits best to their pain intensity (Haefeli and Elfering 2006). The item wording, response scale wording and recall period vary and are often developed to be study specific.

Description of Tool:

The Numerical Rating Scale-11 (NRS-11) is a single item PRO used to measure pain intensity in children. The patient is asked to rate their pain intensity on an 11-point scale ranging from 0="No pain" to 10="Very much pain"or "A pain as bad as it could be" or "The worst pain ever" [descriptors used and recall period vary by study]. Higher scores represent higher pain.

Other Related Tools (if applicable):

None identified

Minimum Qualification Required by COA Administrator: No degree requirement

Comment:

None

Year: 1960

Objective of Development:

None identified

Population of Development: Age range (therapeutic indication):

None identified

Pediatric Population(s) in which COA has been used:

Children aged 6-18; Acute pain; Chronic pain

COA type: PRO

Number of Items 1

Mode of Administration: Self-administered

Data Collection Mode: Paper and verbally administered

Time for Completion: None identified

Response Scales: 11-point scale ranging from 0=

Summary of Scoring:

Available scores: Scores ranging from 0 to 10

Weighting: No

Score Interpretation: Higher score = Higher pain

Evidence of Literature Review: None identified

Evidence of Instrument Review: None identified

Evidence of Clinical or Expert Input: None identified

Evidence of concept elicitation in target patient population: None identified

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period: None identified

Evidence for Selection of Reponse Options: None identified

Evidence of cognitive interviewing of draft instrument in target patient population: None identified

Evidence of Preliminary Scoring of Items and Domains: None identified

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: None identified

Evidence of an item-tracking matrix: None identified

Evidence related to item selection: None identified

Evidence of re-testing the final version: None identified

Internal consistency (Cronbach's alpha): None identified

Evidence of internal consistency: None identified

Test-retest Reliability (ICC):

Bailey B (2010)
Test-retest reliability
- High level of agreement (limits of agreement of -0.9 and 1.2, 95% CI) using the Bland Altman method
- Was a definition of stability applied to identify stable patients: No
- Time frame between the two administrations: 120 (±75) minutes
- Population/Disease: Children aged 8-17 years with abdominal pain; n=44

Inter-rater/ inter-interviewer reliability (kappa):

None identified

Evidence of test-retest or inter-rater reliability: Yes

Concurrent validity (convergent, divergent):

Von Baeyer CL (2009)
Convergent validity
- Correlation coefficient used: Not stated
- Measures: NRS-11; Faces Pain Scale-Revised (FPS-R)
- Results: the correlation of NRS-11 with FPS-R scores was r=0.87; p not stated
- Population/Disease: Children aged 7-17 years (median age=13) who had periooperative pain; n=69

Von Baeyer CL (2009)
Convergent validity
- Correlation coefficient used: Not stated
- Measures: NRS-11; Visual Analog Scale (VAS)
- Results: the correlation of NRS-11 with VAS scores was r=0.89; p not stated
- Population/Disease: Children aged 9-17 years (median age=14) who had pectus excavatum repair surgery; n=29

Von Baeyer CL (2009)
Convergent validity
- Correlation coefficient used: none; differences in the distribution of scores between similar groups (sex and age matched) using chi-square test.
- Measures: NRS; Visual Analog Scale (VAS)
- Results: Distributions of scores on the NRS and VAS were very similar except that scores closer to the no pain anchor were more likely to be selected on the VAS than the NRS (p=0.03)
- Population/Disease: School children aged 11-17 years (median=12 years) who had a recent immunization injection; n=236

Miro J (2009)
Convergent validity
- Correlation coefficient used: Pearson's correlation coefficient (r)
- Measures: NRS-11; FPS-R
- Results: Strong correlations were observed between the NRS-11 and FPS-R (r=0.78, p<0.001)
- Population/Disease: School children aged 8-12 (mean=9.95), who reported having pain somewhere in their body in the last three months; n=175

Miro J (2009)
Convergent validity
- Correlation coefficient used: Pearson's correlation coefficient (r)
- Measures: NRS-11; FPS-R
- Results: Strong correlations were observed between the NRS-11 and FPS-R (r=0.93, p<0.001)
- Population/Disease: Children aged 6-16 (mean=10.46), who had postoperative pain; n=63

Miro J (2009)
Discriminant validity
- Correlation coefficient uesd: Pearson's correlation coefficient (r). Fisher's z-transformations were used to compare the magnitufe of correlation coefficient between ratings on the measures
- Measures: NRS-11 and FPS-R (same construct measured) and the FAS (similar construct), and between the NRS-11 and FDI.
- Results:
The magnitude of ratings on the NRS-11 and the FPS-R was greater than the magnitude of correlation coefficient between the NRS-11 and the FAS (z=3.55, p<0.001).
The magnitude of ratings on the NRS-11 and the FPS-R was greater than the magnitude of the correlation coefficient between the NRS-11 and the FDI (z=7.62, p<0.001).
- Population/Disease: Children aged 8-12 (mean=9.95), who reported having pain somewhere in their body in the last three months; n=164

Miro J (2009)
Discriminant validity
- Correlation coefficient uesd: Pearson's correlation coefficient (r). Fisher's z-transformations were used to compare the magnitufe of correlation coefficient between ratings on the measures.
- Measures NRS-11 and FPS-R (same construct measured) and the FAS (similar construct)
- Results: The magnitude of ratings on the correlatio coefficient between the NRS-11 and the FPS-R was greater than the magnitude of the correlation coefficient between the NRS-11 and the FAS (z=4.74, p<0.01).
Population/Disease: Children aged 6-16 (mean=10.46), who had postoperative pain; n=63

Paige MG (2012)
Convergent validity
- Correlation coefficient used: Pearson's correlation coefficient (r) and Spearman's correlations.
- Measures: NRSI; FPS-R ; Verbal Rating Scale for Pain Intensity (VRSI)
- Results:
The NRSI correlated with the FPS-R (r=0.76, p=0.01)and VRSI (r=0.70, p=0.01) 48-72 hours after surgery.
The NRSI correlated with the VRSI (r=0.82, p=0.01) approximately 2-weeks after discharge from hospital.
- Population/Disease: Children aged 8-18 years (mean=13.8, SD= 2.4) with scoliosis and osteotomy, and who had undergone major surgery; n=83

Paige MG (2012)
Discriminant validity
- Correlation coefficient uesd: Pearson's correlation coefficient (r)
- Measures: NRSI; FDI
- Results:
Moderate correlations were observed between NRSI and FDI scores (r=0.41, p=0.01) 48-72 hours following surgery.
Moderate correlations were observed between NRSI and FDI scores (r=0.41, p=0.01) 2-weeks after discharge from hospital.
- Population/Disease: Children aged 8-18 years (mean=13.8, SD= 2.4) with scoliosis and osteotomy, and who had undergone major surgery; n=83

Ruskin D (2014)
Convergent validity
- Correlation coefficient used: Pearson's correlation coefficient (r); Spearman's rho (r2)
- Measures: NRS; Coloured Analogue Scale (CAS)
- Results: NRS scores correlated significantly (p<0.001) with the CAS at all four pain levels:
Current: r=0.58, n=112
Lowest: r=0.68, n=138
Usual: r=0.68, n=122
Strongest: r=0.58, n=133
- Population/Disease: children aged 8-17 years (mean age=14.1; SD=2.4) with chronic pain; n=143

Ruskin D (2014)
Discriminant validity
- Correlation coefficient used: Magnitiude of the correlation between the NRS and CAS (same contruct) were compared to the correlations between NRS and FAS (affective pain rating) using Fisher's Z-transformation.
- Results: The magnitude of the correlation between the NRS and FAS (r=0.63, p<0.001) was significantly lower than between the NRS and CAS (r=0.41, p<0.001) Z=2.84, p=0.005).
- Population/Disease: Children aged 8-17 years (mean age=14.1; SD=2.4) with chronic pain; n=143

Miro J (2009)
Concurrent validity (criterion)
- Correlation coefficient used: Pearson's correlation coefficient (r)
- Measures: NRS-11; Facial Affective Scale (FAS); Functional Disability Inventory (FDI)
- Results:
Moderate correlations were observed between the NRS-11 and FAS (r=0.58, p<0.001)
Weak correlations were observed between the NRS-11 and FDI (r=0.22, p<0.01)
- Population/Disease: Children aged 8-12 (mean=9.95), who reported having pain somewhere in their body in the last three months; n=175

Miro J (2009)
Concurrent validity (criterion)
- Correlation coefficient used: Pearson's correlation coefficient (r)
- Measures: NRS-11; FAS
- Results:
Moderate correlations were observed between the NRS-11 and FAS (r=0.66, p<0.001)
- Population/Disease: Children aged 6-16 (mean=10.46), who had postoperative pain; n=63

Miro J (2009)
Predictive validity
- Correlation coefficient used: Pearson's correlation coefficient (r)
- Measures: NRS-11; FDI; Quality of Life InventoryTM Version v4.0 (PedsQL)
- Results:
Moderate correlations were observed between the NRS-11 and PedsQL (r=0.46, p<0.01)
Moderate correlations were observed between the NRS-11 and FDI (r=0.39, p<0.01)
- Population/Disease: Children aged 6-16 (mean=10.46), who had postoperative pain; n=61

Known-group validity:

None identified

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: None identified

Evidence of Administration Instructions and Training Provided: None identified

Evidence of concurrent validity: Yes

Evidence of known-groups validity: None identified

Evidence of ability to detect change over time: Yes

Ability to detect change (Responsiveness):

Paige MG (2012)
- Method: Pearson correlations were examined between the NSRI scores 48 to 72 hours post-surgery and 2-weeks following hospital discharge. Paired samples t-test were used to compare changes in mean pain ratings
- Results:
- Correlations between NRSI scores 48 to 72 post-surgery and 2-weeks post-hospital discharge were r=0.45 (p=0.01)
- Scores on the NRSI were significantly higher 48 to 72 hours post-surgery than 2-weeks post hospital discharge (mean change=1.49; t[68]=5.25; p<0.001; effect size =0.68), indicative of decreased pain intensity overtime
- Population/Disease: Children aged 8-18 years (mean=13.8, SD= 2.4) with scoliosis and osteotomy, and who had undergone major surgery; n=83

Bailey B (2010)
- Method: Median NRS-11 pain scores were compared before and after a pain relief intervention
- Results: A large significant difference was observed between NRS-11 scores before and after the pain intervention (NRS-11 before=6.5, NRS-11 after=4.0; W=2, p<0.01)
- Population/Disease: Children aged 8-17 years with abdominal pain (Bailey et al., 2010); n=44

Connelly, M
- Method: Pain intensity measured by the NRS-11 was assessed 5 times a day for three days following surgery using hierarchical linear models
- Results: No significant improvements in pain as measured by the NRS-11 were observed
- Population/disease: Children aged 9-18 undergoing surgical repair of pectus excavatum; n=29

Responder Thresholds:

Bailey B (2010)
- Method: Median difference between first and second assessment when participants considered their pain level to be "a lot worse", "a little worse", "the same". "a little better" and "a lot better
- Results: the Minimun Clinically Significant Difference (MCSD) (representing a change of “a little better” or “a little worse”) for the NRS-11 was 1 out of 10
- Population/Disease: Children aged 8-17 years with abdominal pain; n=44

Voepel-Lewis T (2011)
- Method: Not stated
- Results: MSCD that reflected a change in pain intensity at -1/+1 (“feeling a little better” or “feeling worse,”respectively)
- Population/Disease: Children aged 7-16 years undergoing surgery associated with postoperative pain; n=113

Hirschfeld G (2014)
- Method: Not stated
- Results: A change of 1/10 or a 12.5% decrease on the NRS-11 represents a meaningful change of pain intensity.
- Population/Disease: Adolescents with chronic pain; n=153

Myrvik MP (2015)
- Method: Not stated
- Results: A decrease of 0.9 in the NRS-11 scores represent a clinically significant reduction of pain intensity.
- Population/Disease: Children (mean age=14.65, SD=3.12) with sickle cell disease; n=28

Evidence of responder thresholds: Yes

Miró, J., Castarlenas, E., & Huguet, A. (2009). Evidence for the use of a numerical rating scale to assess the intensity of pediatric pain. European journal of pain, 13(10), 1089-1095. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/19726211/

Von Baeyer, C. L., Spagrud, L. J., McCormick, J. C., Choo, E., Neville, K., & Connelly, M. A. (2009). Three new datasets supporting use of the Numerical Rating Scale (NRS-11) for children’s self-reports of pain intensity. Pain, 143(3), 223-227. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/19359097/

Pagé, M. G., Katz, J., Stinson, J., Isaac, L., Martin-Pichora, A. L., & Campbell, F. (2012). Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. The Journal of Pain, 13(4), 359-369. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/22424915/

Ruskin, D., Lalloo, C., Amaria, K., Stinson, J. N., Kewley, E., Campbell, F., ... & McGrath, P. A. (2014). Assessing pain intensity in children with chronic pain: convergent and discriminant validity of the 0 to 10 numerical rating scale in clinical practice. Pain Research and Management, 19(3), 141-148. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/24712019/

Systematic review: Castarlenas, E., Jensen, M. P., von Baeyer, C. L., & Miró, J. (2017). Psychometric Properties of the Numerical Rating Scale to Assess Self-Reported Pain Intensity in Children and Adolescents: A Systematic Review. The Clinical journal of pain, 33(4), 376–383. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/27518484/ describing the findings from the following articles:
-Bailey, B., Daoust, R., Doyon-Trottier, E., Dauphin-Pierre, S., & Gravel, J. (2010). Validation and properties of the verbal numeric scale in children with acute pain. Pain, 149(2), 216–221. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/20188471/
-Connelly, M., & Neville, K. (2010). Comparative prospective evaluation of the responsiveness of single-item pediatric pain-intensity self-report scales and their uniqueness from negative affect in a hospital setting. The journal of pain, 11(12), 1451–1460. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/20646966/
-Voepel-Lewis, T., Burke, C. N., Jeffreys, N., Malviya, S., & Tait, A. R. (2011). Do 0-10 numeric rating scores translate into clinically meaningful pain measures for children?. Anesthesia and analgesia, 112(2), 415–421. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/21127278/
-Hirschfeld, G., Wager, J., Schmidt, P., & Zernikow, B. (2014). Minimally clinically significant differences for adolescents with chronic pain-variability of ROC-based cut points. The journal of pain, 15(1), 32–39. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/24268356/
-Myrvik, M. P., Drendel, A. L., Brandow, A. M., Yan, K., Hoffmann, R. G., & Panepinto, J. A. (2015). A Comparison of Pain Assessment Measures in Pediatric Sickle Cell Disease: Visual Analog Scale Versus Numeric Rating Scale. Journal of pediatric hematology/oncology, 37(3), 190–194. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/25575295/

Haefeli, M., & Elfering, A. (2006). Pain assessment. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 15 Suppl 1(Suppl 1), S17–S24. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/16320034/

Prolabels search: https://eprovide.mapi-trust.org/advanced-search?search=NRS-pain%20intensity&database=prolabels

Yes

Agency: FDA
Drug: Felctor, diclofenac epolamine
Drug approval date: 20-Jan-2007
Revision date: 02-May-2021
Therapeutic indication: Pain
COA results: Primary endpoint
Age: 6 years and older

Agency: EMA
Drug: Exparel liposomal, bupivacaine
Drug approval date: 15-Nov-2020
Therapeutic indication: Acute Pain
COA results: Primary endpoint
Age: 6 years and older

Yes

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