A Systematic Integrative Review of Infant Pain Assessment Tools

Table 1. Key Terms Used in Describing the Psychometric Properties of Instruments ^[20]
Term	Definition
Reliability	Reliability refers to how reproducible the results of the measure are under different conditions or by different raters. Instruments must first be reliable. Reliability is not a property that an instrument does or does not possess. It is a matter of degree of reliability given certain populations and certain conditions.
External
Test-retest reliability	Test-retest is usually done with self-rated measures, wherein the measure is given on 2 occasions separated by a short time frame to see if the results are similar.
Interrater reliability	Interrater reliability is the degree of agreement between different observers.
Intrarater reliability	Intrarater reliability is the degree of agreement between the same observer on 2 different occasions.
Internal
Internal Consistency	Internal consistency is based on a single administration of the instrument and examines how the items "fit" together based on the average of the correlation of all the items in the instrument.
Validity	Validity of an instrument is the evidence that the instrument is assessing what it was intended to assess.
Content and face validity	Content and face validity are subjective judgments of whether the instrument appears reasonable, is relevant, and includes the important domains adequately.
Construct validity	Construct validity examines whether the abstract concept or construct has in fact been adequately measured. This is an ongoing process and is simultaneously assessing both the theory and the measure. Construct validity is divided into convergent and discriminant validity. Convergent validity is the degree to which the new instrument rates against related variables or other measures that it should be correlated to based on the construct being examined. Discriminant validity is the degree to which the instrument rates against dissimilar variables with the expectation that unrelated variables or instruments will not be correlated with the new instrument.
Criterion validity	Criterion validity is the new instrument's correlation with another instrument that is classified as the "gold standard." Criterion validity is further divided into concurrent validity, wherein both the new instrument and the gold standard are administered at the same time and the results compared. Another type of criterion validity is predictive validity, wherein the test of the new instrument is how well its results can determine a future result.
Clinical Utility	This refers to the ability to use the results of the instrument in a meaningful, useful way in the clinical setting.
Feasibility	This refers to the ease with which clinicians can apply the instrument in the clinical setting.

Table 2. Unidimensional Pain Assessment Tools
Pain Scale/Year	Population Tested and Dimensions	Validity/Reliability	Clinical Utility/Feasibility
Pain Rating Scale (PRS)^[25] 1994	Initially pilot-tested on 27 infants 1 to 12 months of age; 98 infants 1 to 36 months of age 6 undefined categories of behavior	Discriminant validity (t-test = 11.52, P < 0.0001) Interrater reliability (pilot data = 80.99%); (r = 0.65 to 0.84, P < 0.0001)	None reported
Riley Infant Pain Scale (RIPS)^[26] 1996 Revision of PRS	391 postoperative infants and children 6 categories of behavior (facial, body movement, sleep, verbal/vocal, consolability, response to movement/touch)	Discriminant validity (t-tests = 8.4 and 9.7, P < 0.001) Interrater reliability (ICCs = 0.39-0.87) Internal consistency (Cronbach's alpha from 0.87 to 0.93)	None reported
Neonatal Facial Coding System (NFCS)^[27] 1987	140 well newborns Brow bulge, eye squeeze, nasolabial furrow, open lips, vertical mouth stretch, horizontal mouth stretch, lip purse, taut tongue, chin quiver, (tongue protrusion added in 199028)	Face/content validity Construct validity (10 actions scored but only 7 in analysis; n = 27; [F1, 25] = 12.01, P < 0.002)^[29]; (n = 75 infants; r = 0.79, P < 0.001)^[30] Interrater reliability (reliability coefficient = 0.88)	Developed primarily for research. Feasibility of using the complete NFCS at the bedside established.^[31] Also, interrater reliability and construct validity was further supported.
Maximally Discriminative Facial Movement Coding System (MAX)^[32] 1979 Original copyright 1995 Revised version^[32]	Infants 0 to 2 years Facial movements used to identify emotion and expressions in the forehead/eyebrows/nasal root, eye/nose/cheek, and mouth/lips/chin	Interrater reliability (83%)	Developed primarily for research
The Children's Hospital of Eastern Ontario Pain Scale^[33] 1985	26 children aged 1 to 5 years and 30 children aged 1 to 7 postoperatively 6 categories of behavior (cry, facial, child verbal, torso, touch, legs)	Face/content validity Interrater reliability (n = 26) (90 to 99.5%) Construct validity (n = 30) (r = 0.85, P < 0.05)	No objective Authors report ease of use
Infant Body Coding System (IBCS)^[4,34] 1993 (Portion of original infant pain behavior rating scale)^[34]	56 preterm and full-term newborns Hand/foot movements, arm movements, leg movements, head movements, and torso movements	Face/content validity Interrater reliability (reliability coefficient = 0.83)	None reported
Échelle Douleur Inconfort Nouveau-Né (EDIN) = Neonatal Pain and Discomfort Scale^[35] 2001	76 preterm infants; mean gestational age 31.5 weeks 5 behavioral indicators of prolonged pain: facial activity, body movements, quality of sleep, quality of contact with nurses, and consolability	Construct validity (mean total scores lower after analgesia, 4.7 vs. 9.2, P < 0.0001, paired t-test) Interrater reliability (weighted κ coefficient = 0.59-0.74) Internal consistency (Cronbach's alpha coefficients = 0.86-0.94)	None reported
Clinical Scoring System (CSS)^[36,37,38] 1987 Also referenced as the Postoperative Pain Score (POPS)^[25,26]	23 infants from 1 to 7 months requiring surgery Sleep during preceding hour, facial expression of pain, quality of cry, spontaneous motor activity, spontaneous excitability, flexion of fingers/toes, sucking, global evaluation of tone, consolability, sociability. Tool later revised by removing 3 indicators (sleep, sociability, and sucking)^[26]	Discriminant validity (54% had better pain scores with analgesia compared to 18% without analgesia, P < 0.05)	Limited feasibility for use because the sleep indicator is scored over the previous hour
Modified Postoperative Comfort Score (PCS) 1998 Revision of CSS/POPS^[39]	22 mechanically ventilated preterm infants Sleep, facial expression, sucking, hyperreactivity, agitation, hypertonicity, toes and fingers, consolability (removed quality of cry and sociability and double-scored 2 other variables)	Discriminant validity (in both placebo and fentanyl groups) (comfort scores from bedside assessment increased significantly after 'analgesia' period, P < 0.00001; video assessment of comfort scores increased in the fentanyl group vs placebo, P < 0.05)	Challenges in using the tool clinically are reported.
Behavioral Pain Score^[40] 1994 Modified from other tools^[27,33]	84 mechanically ventilated preterm infants Facial expression, movements, response to handling, consolability, rigidity of the limbs and body	Discriminant validity (pain scores did not differ between meperidine or saline before treatment, but were higher in saline group during treatment, P = 0.001)	None reported
Behavioral Pain Score (BPS)^[41] 1991 Adapted from CHEOPS^[33]	41 chronically ill infants and toddlers between 3 and 36 months of age Facial expression, cry, movements added for total potential score of 8 signifying increased pain	***Discriminant validity. Both placebo and EMLA groups showed increases in score with venipuncture, but changes in score were smaller with EMLA group, P < 0.01)	None reported
Modified Behavioral Pain Scale (MBPS)^[42] 1995	96 healthy infants aged 4 to 6 months Facial expression, cry, gross body movement with score of 0 to 10	Concurrent validity (correlation coefficient between MBPS and visual analogue scores was 0.68, P < 0.001; and 0.74, P < 0.001) Construct validity (post-vaccination scores significantly lower for EMLA group compared to placebo group, P < 0.01) Interrater reliability (ICC = 0.95, P < 0.001)	None reported
Liverpool Infant Distress Scale (LIDS)^[43] 1996	16 newborn infants post-operatively Spontaneous movement, spontaneous excitability, flexion of fingers/toes, tone, facial expression, quantity of crying, quality of crying, sleep pattern and amount	Face/content validity Construct validity (scores higher in group undergoing major surgery but reporting of statistics limited) Interrater reliability (Pearson's Correlation Coefficient, 0.74 to 0.88) Test-retest reliability (Pearson's Correlation Coefficient, 0.81 to 0.96)	Authors note ongoing work to shorten the score to a more clinically applicable scale.
Facial Action Coding System (FACS)^[44] 1978	Derived from an analysis of the anatomical basis of facial movement in adults. Measures only movement of the face coding for 44 different discrete facial actions	Interrater reliability (0.756 to 0.822	None reported. Developed primarily for research.
Baby Facial Action Coding System (Baby FACS)^[45] 1988	12 healthy newborns 44 different discrete facial actions	Interrater reliability (65-85%)	None reported. Developed primarily for research.
Children's and Infants' Postoperative Pain Scale (CHIPPS)^[46] 2000	584 newborns, infants, and young children 5 behavioral indicator scale (cry, facial expression, posture of trunk, posture of legs, and motor restlessness)	Concurrent validity (compared with Toddler-Preschooler Postoperative Pain Scale, identified pain-free or analgesic demand in 87.4%). Interrater reliability (reliability coefficient = 0.93) Internal consistency (Cronbach's alpha = 0.92 for toddlers, and 0.96 for infants)	Authors report ease of use.
Douleur Aigue du Nouveau-né (DAN) Acute Pain Rating Scale for Neonates^[47,48] 1997	42 newborns born between 25 and 41 weeks gestational age Facial expression, limb movements, and vocal expression with scores ranging from 0 to 10	Interrater reliability (Krippendorff r test = 91.2) Internal consistency (Cronbach's alpha = 0.88)	None reported
Unpublished Unidimensional Pain Assessment Tools
Mills Infant/Toddler Pain Index (Creator ~ Mills) Based on observed pain behaviors^[11]	Limb movement, trunk and general body responses, communication, facial expressions, interactions, self-consolation, activities of daily living	None reported	None reported

CHEOPS, Children's Hospital of Eastern Ontario Pain Scale; EMLA, Lidocaine-prilocaine cream.

Table 3. Unpublished Multidimensional Measures
Pain Scale	Year	General Comments
The Infant Pain Evaluation Criteria (IPEC)^[11]	1994	Multidimensional; not published/abstract only
The Wielenga Observation Scale for Pain in Neonates^[11]	1994	Multidimensional; not published/abstract only
The Neonatal Pain Assessment Scale^[11]	1993, 1994	Multidimensional; not published/abstract only
The Pain Assessment Tool^[11]	1997	Multidimensional; not published/abstract only
N-PASS: Neonatal Pain, Agitation, & Sedation Scale^[58]	2000	Validity and reliability testing in progress; abstract only; criteria: crying/irritability, behavior state, facial expression, extremities/tone, and vital signs
The Pain Assessment Inventory for Neonates (PAIN)^[53]	1989	Original work could not be obtained; behavioral and physiological dimensions

Table 4. Published Multidimensional Measures
Pain Scale/Year	Population Tested and Dimensions	Validity/Reliability	Clinical Utility/Feasibility
The Pain Assessment Tool^[49] 1994	pilot study of 20 neonates postoperatively Posture/tone, sleep pattern, expression, color, cry, respirations, heart rate, saturations, blood pressure, nurse's perception	Discriminant validity (limited reporting of statistics but trend toward differences in pain that would be expected between infusion started with or without bolus dose) Content validity (scores reflecting nurses' perceptions of pain)	No objective testing Authors report it was not difficult to use as identified by the pain management group in this setting, but refinements were suggested.
The Neonatal Pain Assessment Tool^[50] 1995	Retrospective chart reviews of infants in intensive care settings and practitioner questionnaires Describe quality improvement approach to documentation and assessment using chart reviews of neonates in intensive care settings and practitioner questionnaires State, cry, activity, heart rate, blood pressure, respiratory rate, and oxygen saturations	Content validity (survey used with experts and chart review conducted)	No objective testing Authors report of refinements to the scale so that a single score is given at the time of each assessment
The Scale for Use in Newborns (SUN)^[51] 1998	33 preterm and term infants during 68 procedures Central nervous system state, breathing, movement, tone, face, heart rate, and mean blood pressure with range of 0 to 4 for each item	Discriminant validity (significant score changes were detected in the before-versus-during treatment stages of various procedures at the P < 0.01 or P < 0.001 level) Reliability (CV = 33% ± 8%, P < 0.001)	No objective testing One author completed the scoring and indicated it was easier to use than the Comfort Scale but not as easy as the NIPS.
The Distress Scale for Ventilated Newborn Infants (DSVNI)^[52] 1996	Initial reporting of tool development Examines facial expression, body movement, color, heart rate, blood pressure, oxygenation, and temperature differential.	Content validity	None reported
The Comfort Scale^[53] 1992	37 participants ranging from newborn to 204 months of age 8-dimensional scale focusing on alertness, calmness/agitation, respiratory response, physical movement, mean arterial pressure, heart rate, muscle tone, and facial expression	Content validity (survey of experts and review of literature) Concurrent validity (r = 0.75, P < 0.01) Internal consistency (coefficient = 0.90) Interrater reliability (r = 0.84, P < 0.01)	No objective testing Administered in approximately 3 minutes according to authors
The CRIES^[54] 1995	24 infants between 32 and 60 weeks gestational age Postoperative measure focusing on crying, requires oxygen to maintain saturation 95%, increased blood pressure and heart rate, expression, and sleep state	Concurrent validity (Spearman Rank Correlation Coefficient between OPS and CRIES was 0.73, P < 0.0001) Discriminant validity (lower pain scores after analgesics, P < 0.0001) Interrater reliability (r = 0.72, P < 0.0001)	No objective testing Authors report ease of use.
The Neonatal Infant Pain Scale (NIPS)^[24] 1993	38 preterm and term infants and 90 procedures observed Facial expression, cry, breathing patterns, arm movement, leg movement, and state of arousal	Interrater reliability (Pearson's correlations 0.92 to 0.97) Internal consistency (Cronbach's alphas 0.87 to 0.95) Content validity (survey) Concurrent validity (correlations 0.53 to 0.84 when compared with visual analogue scale) Construct validity (change in pain scores over time was seen with main effect of time being statistically significant, F = 18.97, P < 0.001)	None reported
The Pain Assessment in Neonates (PAIN) Scale^[55] 2002	196 neonates with gestational ages of 26 to 47 weeks 7 dimensions are facial expression, cry, breathing pattern, extremity movement, state of arousal, oxygen required to maintain a saturation >95%, and increased vital signs from baseline	Construct validity (pain versus no pain procedure, t-test = -7.11, P < 0.001) Criterion validity (correlation between PAIN and NIPS was 0.93, P < 0.001)	None reported
The Pain/Discomfort Scale^[56] or (Objective Pain Scale)^[54] 1987	44 boys aged 18 months to 12 years of age post-surgery Blood pressure, crying, movement, agitation, posture, and complaints of pain (where appropriate by age)	Discriminant validity (specific statistics not reported, but no significant differences between 2 groups receiving pain treatments after surgery; combined scores were lower than the control group scores but did not reach statistical significance)	None reported
The Modified Infant Pain Scale (MIPS)^[57] 1998	40 healthy term infants undergoing elective surgery 13 dimensions including sleep; facial expression, quality of cry; spontaneous motor activity, excitability and responsiveness to stimulation, flexion of fingers and toes, suckling, overall tone, consolability, sociability, and physiologic changes in heart rate, blood pressure, and saturation. Higher scores indicate less pain	Criterion validity (compared with visual analogue scale, P < 0.00001) Interrater reliability (Pearson's correlation = 0.85)	Authors report ease of learning how to use the tool and ability to adapt it into practice
The Premature Infant Pain Profile (PIPP)^[22] 1996	4 data sets (n = 27, 39, 48, & 124) of infants ranging in gestation from 28 to 40 weeks Gestational age, behavioral state, heart rate, oxygen saturation, brow bulge, eye squeeze, and nasolabial furrow.	Internal consistency (correlation coefficients for individual items 0.59 to 0.76; the standardized item alpha for 6 of the items was 0.71) Content validity (experts and literature) Construct validity (scores between no pain and pain situations, paired t-test = 12.24, two-tailed P < 0.0001)	Not reported in original study

CRIES, crying, requires oxygen to maintain saturation greater than 95%, increased vital signs, expression and sleepless

Table 2. Unidimensional Pain Assessment Tools
Pain Scale/Year	Population Tested and Dimensions	Validity/Reliability	Clinical Utility/Feasibility
Pain Rating Scale (PRS)^[25] 1994	Initially pilot-tested on 27 infants 1 to 12 months of age; 98 infants 1 to 36 months of age 6 undefined categories of behavior	Discriminant validity (t-test = 11.52, P < 0.0001) Interrater reliability (pilot data = 80.99%); (r = 0.65 to 0.84, P < 0.0001)	None reported
Riley Infant Pain Scale (RIPS)^[26] 1996 Revision of PRS	391 postoperative infants and children 6 categories of behavior (facial, body movement, sleep, verbal/vocal, consolability, response to movement/touch)	Discriminant validity (t-tests = 8.4 and 9.7, P < 0.001) Interrater reliability (ICCs = 0.39-0.87) Internal consistency (Cronbach's alpha from 0.87 to 0.93)	None reported
Neonatal Facial Coding System (NFCS)^[27] 1987	140 well newborns Brow bulge, eye squeeze, nasolabial furrow, open lips, vertical mouth stretch, horizontal mouth stretch, lip purse, taut tongue, chin quiver, (tongue protrusion added in 199028)	Face/content validity Construct validity (10 actions scored but only 7 in analysis; n = 27; [F1, 25] = 12.01, P < 0.002)^[29]; (n = 75 infants; r = 0.79, P < 0.001)^[30] Interrater reliability (reliability coefficient = 0.88)	Developed primarily for research. Feasibility of using the complete NFCS at the bedside established.^[31] Also, interrater reliability and construct validity was further supported.
Maximally Discriminative Facial Movement Coding System (MAX)^[32] 1979 Original copyright 1995 Revised version^[32]	Infants 0 to 2 years Facial movements used to identify emotion and expressions in the forehead/eyebrows/nasal root, eye/nose/cheek, and mouth/lips/chin	Interrater reliability (83%)	Developed primarily for research
The Children's Hospital of Eastern Ontario Pain Scale^[33] 1985	26 children aged 1 to 5 years and 30 children aged 1 to 7 postoperatively 6 categories of behavior (cry, facial, child verbal, torso, touch, legs)	Face/content validity Interrater reliability (n = 26) (90 to 99.5%) Construct validity (n = 30) (r = 0.85, P < 0.05)	No objective Authors report ease of use
Infant Body Coding System (IBCS)^[4,34] 1993 (Portion of original infant pain behavior rating scale)^[34]	56 preterm and full-term newborns Hand/foot movements, arm movements, leg movements, head movements, and torso movements	Face/content validity Interrater reliability (reliability coefficient = 0.83)	None reported
Échelle Douleur Inconfort Nouveau-Né (EDIN) = Neonatal Pain and Discomfort Scale^[35] 2001	76 preterm infants; mean gestational age 31.5 weeks 5 behavioral indicators of prolonged pain: facial activity, body movements, quality of sleep, quality of contact with nurses, and consolability	Construct validity (mean total scores lower after analgesia, 4.7 vs. 9.2, P < 0.0001, paired t-test) Interrater reliability (weighted κ coefficient = 0.59-0.74) Internal consistency (Cronbach's alpha coefficients = 0.86-0.94)	None reported
Clinical Scoring System (CSS)^[36,37,38] 1987 Also referenced as the Postoperative Pain Score (POPS)^[25,26]	23 infants from 1 to 7 months requiring surgery Sleep during preceding hour, facial expression of pain, quality of cry, spontaneous motor activity, spontaneous excitability, flexion of fingers/toes, sucking, global evaluation of tone, consolability, sociability. Tool later revised by removing 3 indicators (sleep, sociability, and sucking)^[26]	Discriminant validity (54% had better pain scores with analgesia compared to 18% without analgesia, P < 0.05)	Limited feasibility for use because the sleep indicator is scored over the previous hour
Modified Postoperative Comfort Score (PCS) 1998 Revision of CSS/POPS^[39]	22 mechanically ventilated preterm infants Sleep, facial expression, sucking, hyperreactivity, agitation, hypertonicity, toes and fingers, consolability (removed quality of cry and sociability and double-scored 2 other variables)	Discriminant validity (in both placebo and fentanyl groups) (comfort scores from bedside assessment increased significantly after 'analgesia' period, P < 0.00001; video assessment of comfort scores increased in the fentanyl group vs placebo, P < 0.05)	Challenges in using the tool clinically are reported.
Behavioral Pain Score^[40] 1994 Modified from other tools^[27,33]	84 mechanically ventilated preterm infants Facial expression, movements, response to handling, consolability, rigidity of the limbs and body	Discriminant validity (pain scores did not differ between meperidine or saline before treatment, but were higher in saline group during treatment, P = 0.001)	None reported
Behavioral Pain Score (BPS)^[41] 1991 Adapted from CHEOPS^[33]	41 chronically ill infants and toddlers between 3 and 36 months of age Facial expression, cry, movements added for total potential score of 8 signifying increased pain	***Discriminant validity. Both placebo and EMLA groups showed increases in score with venipuncture, but changes in score were smaller with EMLA group, P < 0.01)	None reported
Modified Behavioral Pain Scale (MBPS)^[42] 1995	96 healthy infants aged 4 to 6 months Facial expression, cry, gross body movement with score of 0 to 10	Concurrent validity (correlation coefficient between MBPS and visual analogue scores was 0.68, P < 0.001; and 0.74, P < 0.001) Construct validity (post-vaccination scores significantly lower for EMLA group compared to placebo group, P < 0.01) Interrater reliability (ICC = 0.95, P < 0.001)	None reported
Liverpool Infant Distress Scale (LIDS)^[43] 1996	16 newborn infants post-operatively Spontaneous movement, spontaneous excitability, flexion of fingers/toes, tone, facial expression, quantity of crying, quality of crying, sleep pattern and amount	Face/content validity Construct validity (scores higher in group undergoing major surgery but reporting of statistics limited) Interrater reliability (Pearson's Correlation Coefficient, 0.74 to 0.88) Test-retest reliability (Pearson's Correlation Coefficient, 0.81 to 0.96)	Authors note ongoing work to shorten the score to a more clinically applicable scale.
Facial Action Coding System (FACS)^[44] 1978	Derived from an analysis of the anatomical basis of facial movement in adults. Measures only movement of the face coding for 44 different discrete facial actions	Interrater reliability (0.756 to 0.822	None reported. Developed primarily for research.
Baby Facial Action Coding System (Baby FACS)^[45] 1988	12 healthy newborns 44 different discrete facial actions	Interrater reliability (65-85%)	None reported. Developed primarily for research.
Children's and Infants' Postoperative Pain Scale (CHIPPS)^[46] 2000	584 newborns, infants, and young children 5 behavioral indicator scale (cry, facial expression, posture of trunk, posture of legs, and motor restlessness)	Concurrent validity (compared with Toddler-Preschooler Postoperative Pain Scale, identified pain-free or analgesic demand in 87.4%). Interrater reliability (reliability coefficient = 0.93) Internal consistency (Cronbach's alpha = 0.92 for toddlers, and 0.96 for infants)	Authors report ease of use.
Douleur Aigue du Nouveau-né (DAN) Acute Pain Rating Scale for Neonates^[47,48] 1997	42 newborns born between 25 and 41 weeks gestational age Facial expression, limb movements, and vocal expression with scores ranging from 0 to 10	Interrater reliability (Krippendorff r test = 91.2) Internal consistency (Cronbach's alpha = 0.88)	None reported
Unpublished Unidimensional Pain Assessment Tools
Mills Infant/Toddler Pain Index (Creator ~ Mills) Based on observed pain behaviors^[11]	Limb movement, trunk and general body responses, communication, facial expressions, interactions, self-consolation, activities of daily living	None reported	None reported

CHEOPS, Children's Hospital of Eastern Ontario Pain Scale; EMLA, Lidocaine-prilocaine cream.

Table 3. Unpublished Multidimensional Measures
Pain Scale	Year	General Comments
The Infant Pain Evaluation Criteria (IPEC)^[11]	1994	Multidimensional; not published/abstract only
The Wielenga Observation Scale for Pain in Neonates^[11]	1994	Multidimensional; not published/abstract only
The Neonatal Pain Assessment Scale^[11]	1993, 1994	Multidimensional; not published/abstract only
The Pain Assessment Tool^[11]	1997	Multidimensional; not published/abstract only
N-PASS: Neonatal Pain, Agitation, & Sedation Scale^[58]	2000	Validity and reliability testing in progress; abstract only; criteria: crying/irritability, behavior state, facial expression, extremities/tone, and vital signs
The Pain Assessment Inventory for Neonates (PAIN)^[53]	1989	Original work could not be obtained; behavioral and physiological dimensions

Table 4. Published Multidimensional Measures
Pain Scale/Year	Population Tested and Dimensions	Validity/Reliability	Clinical Utility/Feasibility
The Pain Assessment Tool^[49] 1994	pilot study of 20 neonates postoperatively Posture/tone, sleep pattern, expression, color, cry, respirations, heart rate, saturations, blood pressure, nurse's perception	Discriminant validity (limited reporting of statistics but trend toward differences in pain that would be expected between infusion started with or without bolus dose) Content validity (scores reflecting nurses' perceptions of pain)	No objective testing Authors report it was not difficult to use as identified by the pain management group in this setting, but refinements were suggested.
The Neonatal Pain Assessment Tool^[50] 1995	Retrospective chart reviews of infants in intensive care settings and practitioner questionnaires Describe quality improvement approach to documentation and assessment using chart reviews of neonates in intensive care settings and practitioner questionnaires State, cry, activity, heart rate, blood pressure, respiratory rate, and oxygen saturations	Content validity (survey used with experts and chart review conducted)	No objective testing Authors report of refinements to the scale so that a single score is given at the time of each assessment
The Scale for Use in Newborns (SUN)^[51] 1998	33 preterm and term infants during 68 procedures Central nervous system state, breathing, movement, tone, face, heart rate, and mean blood pressure with range of 0 to 4 for each item	Discriminant validity (significant score changes were detected in the before-versus-during treatment stages of various procedures at the P < 0.01 or P < 0.001 level) Reliability (CV = 33% ± 8%, P < 0.001)	No objective testing One author completed the scoring and indicated it was easier to use than the Comfort Scale but not as easy as the NIPS.
The Distress Scale for Ventilated Newborn Infants (DSVNI)^[52] 1996	Initial reporting of tool development Examines facial expression, body movement, color, heart rate, blood pressure, oxygenation, and temperature differential.	Content validity	None reported
The Comfort Scale^[53] 1992	37 participants ranging from newborn to 204 months of age 8-dimensional scale focusing on alertness, calmness/agitation, respiratory response, physical movement, mean arterial pressure, heart rate, muscle tone, and facial expression	Content validity (survey of experts and review of literature) Concurrent validity (r = 0.75, P < 0.01) Internal consistency (coefficient = 0.90) Interrater reliability (r = 0.84, P < 0.01)	No objective testing Administered in approximately 3 minutes according to authors
The CRIES^[54] 1995	24 infants between 32 and 60 weeks gestational age Postoperative measure focusing on crying, requires oxygen to maintain saturation 95%, increased blood pressure and heart rate, expression, and sleep state	Concurrent validity (Spearman Rank Correlation Coefficient between OPS and CRIES was 0.73, P < 0.0001) Discriminant validity (lower pain scores after analgesics, P < 0.0001) Interrater reliability (r = 0.72, P < 0.0001)	No objective testing Authors report ease of use.
The Neonatal Infant Pain Scale (NIPS)^[24] 1993	38 preterm and term infants and 90 procedures observed Facial expression, cry, breathing patterns, arm movement, leg movement, and state of arousal	Interrater reliability (Pearson's correlations 0.92 to 0.97) Internal consistency (Cronbach's alphas 0.87 to 0.95) Content validity (survey) Concurrent validity (correlations 0.53 to 0.84 when compared with visual analogue scale) Construct validity (change in pain scores over time was seen with main effect of time being statistically significant, F = 18.97, P < 0.001)	None reported
The Pain Assessment in Neonates (PAIN) Scale^[55] 2002	196 neonates with gestational ages of 26 to 47 weeks 7 dimensions are facial expression, cry, breathing pattern, extremity movement, state of arousal, oxygen required to maintain a saturation >95%, and increased vital signs from baseline	Construct validity (pain versus no pain procedure, t-test = -7.11, P < 0.001) Criterion validity (correlation between PAIN and NIPS was 0.93, P < 0.001)	None reported
The Pain/Discomfort Scale^[56] or (Objective Pain Scale)^[54] 1987	44 boys aged 18 months to 12 years of age post-surgery Blood pressure, crying, movement, agitation, posture, and complaints of pain (where appropriate by age)	Discriminant validity (specific statistics not reported, but no significant differences between 2 groups receiving pain treatments after surgery; combined scores were lower than the control group scores but did not reach statistical significance)	None reported
The Modified Infant Pain Scale (MIPS)^[57] 1998	40 healthy term infants undergoing elective surgery 13 dimensions including sleep; facial expression, quality of cry; spontaneous motor activity, excitability and responsiveness to stimulation, flexion of fingers and toes, suckling, overall tone, consolability, sociability, and physiologic changes in heart rate, blood pressure, and saturation. Higher scores indicate less pain	Criterion validity (compared with visual analogue scale, P < 0.00001) Interrater reliability (Pearson's correlation = 0.85)	Authors report ease of learning how to use the tool and ability to adapt it into practice
The Premature Infant Pain Profile (PIPP)^[22] 1996	4 data sets (n = 27, 39, 48, & 124) of infants ranging in gestation from 28 to 40 weeks Gestational age, behavioral state, heart rate, oxygen saturation, brow bulge, eye squeeze, and nasolabial furrow.	Internal consistency (correlation coefficients for individual items 0.59 to 0.76; the standardized item alpha for 6 of the items was 0.71) Content validity (experts and literature) Construct validity (scores between no pain and pain situations, paired t-test = 12.24, two-tailed P < 0.0001)	Not reported in original study

CRIES, crying, requires oxygen to maintain saturation greater than 95%, increased vital signs, expression and sleepless

Sidebar: How is an Instrument Developed and Tested?

The following provides a brief overview of some of the steps involved in developing a new instrument.^[20]

Review research to obtain existing instruments and determine appropriateness of use based on strength of existing instruments, and appropriate generalization to population and setting of need.
If gap is identified and resources are in place to support the process, instrument development can begin.

Understanding the objective(s) of the instrument is a key first step before Phase One begins.

Phase One in instrument development involves content development. Within this phase, there is a process of item generation, item scaling, and item reduction.
- Item generation is the process of outlining all potentially relevant items for the measurement. This can be done, for instance, by coordinating focus groups with patients or panel discussions with expert practitioners/researchers. The goal is to determine the key concepts to describe the phenomena under study.
- Item scaling involves determining how responses to the items will be obtained. For instance, do you need dichotomous or continuous response options?
- Item reduction is the process of determining whether there is a need to remove any of the items to ensure those that remain in the final version are relevant and necessary without being too lengthy. This can be done in a variety of ways, such as statistical testing, as well as pre-testing with a sample of participants and/or a panel of experts to determine appropriate interpretation and clarity of language and format.

Phase Two involves psychometric testing of the instrument to examine its reliability and validity. A series of converging experiments is necessary to test the full scope of these elements. As well, applying the instrument with different participants or in a different context requires re-testing of these properties. Overall, the instrument needs to be clear and comprehensive, avoid redundancy, and typically be written at a grade 6 reading level or lower.

A Systematic Integrative Review of Infant Pain Assessment Tools

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