Psychometric measurement properties of patient-reported and observer-reported outcome measures for spinal mobilisations and manipulation on paediatric subjects with diverse medical conditions: A systematic review

Figures & data

Figure 1. Clinical outcome assessment (COA) categories that were identified by a scoping review on manipulation and mobilization in pediatric populations [2]. Patient-reported and observer-reported outcome measures are reported within this systematic review while clinician-reported and performance-based outcomes are part of larger systematic review project. All outcomes were included in our search however the bolded outcomes were those identified to have psychometric properties for pediatric populations.

Table 1. Characteristics of included studies.

Author (year)	Country of Publication	COA	Medical Conditions Studied	Professional	Age range (years)	Sex ratio (M:F)	Participant number	Psychometric Domain Addressed
Parent et al. [11]	Canada	SQLI	Scoliosis	Physical Therapist	8 to 20	0:95	95	Validity
Feise et al. [12]	US	SQLI	Scoliosis	Chiropractor	0 to 18	14:70	84	Reliability Validity
Staes et al. [13]	Belgium	VAS^¶	Low back problems	Physical Therapist	16 to 18	20:41	61	Reliability
Juniper et al. [14]	Canada	PAQLQ	Asthma	NR	7 to 17	30:22	52	Reliability Validity Responsiveness
Barr et al. [15]	Canada	parental rated crying diary	Excessive crying i.e.,infantile colic	Medical Doctor	5 to 7 weeks	5:5	10	Validity
Abaoud et al. [16]	Saudi Arabia	ATEC	Autism	Teacher	NR	268:95	363	Reliability
Al Backer [17]	Saudi Arabia	ATEC	Autism	Psychologist	3 to 12	33:7	40	Validity
Freire et al. [18]	Brazil	ATEC	Autism	NR	2 to 6	34:8	42	Reliability Validity
Geier et al. [19]	US	ATEC	Autism	NR	2 to 16	49:7	56	Validity
Magiati et al. [20]	UK	ATEC	Autism	NR	2 to 4	22:0	22	Reliability Validity
Mahapatra et al. [21]	US	ATEC	Autism	NR	2 to 12	1181:391	2272	Validity
Memari et al. [22]	Iran	ATEC	Autism	Medical Doctor	6 to 15	111:23	134	Reliability Validity
Sunakarach and Kessomboon [23]	Thailand	ATEC	Autism	Psychiatrist, psychologist and two translators	3 to 18	47:113	160	Reliability Validity
Cheung et al. [24]	Hong Kong	PedsQL	Scoliosis	NR	8 to 18	183:383	566	Validity
Desai et al. [29]	US	PedsQL	Hospitalized children otherwise healthy	Medical Doctor	0 to 18	2465:2172	4637	Validity
Tantilipikorn et al. [26]	Thailand	PedsQL	Cerebral Palsy	Physical Therapist	5 to 18	29:25	Child: 54 Parent: 97	Reliability Validity
Seid et al. [25]	US	PedsQL	Asthma	NR	3 to 14	155:97	252	Reliability Validity Responsiveness
Varni et al. [28]	US	PedsQL	Chronically ill, acutely ill, healthy participants	NR	5 to 18	815:830	963	Reliability Validity

Key: ATEC = Autism Evaluation Treatment Checklist, SQLI = Scoliosis Quality of Life Index, ¶ VAS (0 to 10) = Visual Analog Scale perceived influence of exertion or movement/position on low back problems (with anchors ‘no influence, worst increase in pain’), PedsQL = Pediatric Quality of Life Inventory, PAQLQ = Pediatric Asthma Quality of Life Questionnaire, NR: not reported.

Table 2. Population by clinical outcome assessment.

COA	Age Study Population	Diagnostic Categories (sample size)
Scoliosis Quality of Life Index (SQLI)	0 to 20 years	Idiopathic Adolescent Scoliosis (n = 179)
Visual Analogue Scale^¶ (VAS)	16 to 18 years	Low back problems (n = 61)
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)	7 to 17 years	Asthma (n = 52)
Crying diaries	5 to 7 weeks	Excessively Crying Infants (n = 10) i.e., infantile colic
Autism Treatment Evaluation Checklist (ATEC)	2 to 18 years	Autism Spectrum Disorder (n = 3089)
Pediatric Quality of Life (PedsQL)	3 to 18 years	Cerebral palsy (n = 151) Scoliosis (n = 566) Orthopaedic injuries (n = 48) Acutely ill (n = 4785) Chronically ill (n = 367) Healthy (n = 401) Asthma (n = 252)

Key: ¶ VAS (0 to 10) = Visual Analog Scale perceived influence of exertion or movement/position on low back problems (with anchors “no influence, worst increase in pain”).

Table 3. Summary of findings for each COA included: 1) criteria rating for good measurement property (sufficient (+), insufficient (-), inconsistent (±), indeterminate (?); see gray highlighted ROW) for each measurement property (content validity, structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, cross-cultural validity, criterion validity and responsiveness), 2) overall rating across measurement properties for each COA (sufficient (+), insufficient (–), or indeterminate (?); see gray highlight COLUMN), and 3) certainty of evidence (GRADE). Note that the author(s) with risk of bias score by psychometric property were rated as very good (VG), adequate (A), doubtful (D), or inadequate (I) (i.e., [12] (D)).

COA	Content Validity Structural Validity	Reliability	Validity	Overall Rating across measurement properties	Certainty of Evidence (GRADE)
Criteria Rating	Internal Consistency	Measurement error	Responsiveness
SQLI	Content Validity: NR Structural Validity: NR Internal Consistency: α = 0.89 (1 study, n = 84) Feise et al. [12] (VG)	Test-retest: ICC = 0.80, (1 study, n = 84) Feise et al. [12] (D) Measurement error: - SEM NR - SDC NR - LoA NR	Construct Validity:-Ceiling effect 20 to 50%, (1 study, n = 95), [11] (VG);-Comparison of Quality-of-Life Profile for Spinal Deformities rs = 0.79, (1 study, n = 84) Feise et al. [12] (D) Cross-cultural: NR Criterion Validity: NR Responsiveness: SDC NR, MIC NR, ROC NR	(?) indeterminate	VERY LOW ⊝⊝⊝⊝ downgraded due to limitation in imprecision (−1: total 1 study, n = 50 to 100, no meta-analysis); indirectness (−1: about 20% of population was between 18 to 20 years of age) risk of bias (−1: serious, two studies were identified as doubtful)
Criteria Rating	?|?|+	+ | ?	+|?|?|?
VAS^¶	Content Validity: NR Structural Validity: NR Internal Consistency: NR	Test-retest: k > 0.50, (1 study, n = 61) Staes et al. [13] (D) Measurement error: - SEM NR - SDC NR - LoA NR	Construct Validity: NR Cross-cultural: NR Criterion Validity: NR Responsiveness: SDC NR, MIC NR, ROC NR	(?) indeterminate	VERY LOW ⊝⊝⊝⊝ downgraded due to limitation in risk of bias (−3: There is 1 study of inadequate doubtful quality) imprecision (−1: total 1 study, n = 50–100)
Criteria Rating	?|?|?	- |?	?|?|?|?
PAQLQ	Content Validity: NR Structural Validity: NR Internal Consistency: NR	Inter-rater: NA Test-retest: ICC = 0.95 (1 study, n = 52) Juniper et al. [14] (A) Measurement error: - SEM NR - SDC NR - LoA NR	Construct Validity: Correlation with global rating of change: ρ = 0.40–0.71 (1 study, n = 52) Juniper at al. [14] (A) Cross-cultural: NR Criterion Validity: NR Responsiveness: MIC = 0.42 on a 1 to 7 scale, also available for subscores (1 study, n = 52) Juniper et al. [14] (A)	(?) indeterminate	MODERATE ⊕⊕⊕⊝ downgraded due to limitation in imprecision (−1: total 1 study, n < 100) risk of bias - high quality trials noted
Criteria Rating	?|?|?	+|?	+|?|?|+
Crying Dairies	Content Validity: NR Structural Validity: NR Internal Consistency: NR	Reliability: NR Measurement error: - SEM NR - SDC NR - LoA NR	Construct Validity: Crying hour taped rs = 0.64 (1 study, n = 10) Barr et al. [15] (D) Cross-cultural: NR Criterion Validity: NR Responsiveness: SDC NR, MIC NR, ROC NR	(?) indeterminate	VERY LOW ⊝⊝⊝⊝ downgraded due to limitation in risk of bias (−3: There is only one study of inadequate doubtful quality available) imprecision (−2: total 1 study, n < 50)
Criteria Rating	?|?|?	?|?	?|?|?|?
ATEC	Content Validity: Relevance - researchers made minor necessary adjustments to ensure the adapted version of the ATEC fit within a Saudi cultural context. (1 study, n = 363) Abaoud et al. [16] (A); Comprehensiveness - NR; Comprehensibility: NR; PROM item’s assessed and appropriately worded (1 study, n = 363) Abaoud et al. [16] (A) Structural Validity: exploratory factor analysis supports the univariate nature of the dimensions using Kaiser Criterion (1 study, n = 363) Abaoud et al. [16] (A) Internal Consistency: α = 0.72 to 0.97 and PCC between items and subscales = 0.133 to 0.601 (3 studies, n = 519) Abaoud et al. [16] (A), Memari et al. [22] (VG), Magiati et al. [20] (VG)	Inter-rater: ICC = 0.97 (1 study, n = 160) Sunakarach et al. [23] (A) Test-retest: ICC = 0.89 (1 study, n = 134) Memari et al. [22] (D) ρ = 0.90 (1 study, n = 42) Freire et al. [18] (D) Measurement error: - SEM NR - SDC NR - LoA NR	Construct Validity (5 studies, n = 2544): -Correlation with Childhood Autism Rating scale (3 studies, n = 138): rs = 0.15 Al Backer et al. [17] (VG) rs = 0.71 Geier et al. [19] (VG) ICC = 0.80 Freire Geier et al. [18] (I) -Comparison of Autism Diagnostic interview rs = 0.38 to 0.79 (1 study, n = 134) Memari et al. [22] (D) -Least square means Visit 8 - Visit 1 (1 study, n = 2272) Mahapatra et al. [21] (D) - Discriminative: rs = 0.14 (1 study, n = 363) Abaoud et al. [16] (A) Cross-cultural: NR Criterion Validity: - Predictive: Cutoff 8: Sensitivity 94%, Specificity 62% (1 study, n = 164) Sunakarach et al. [23] (D) Cutoff 49 severely affected child: Sensitivity 96%, Specificity 67%, (1 study, n = 56) Geier et al. [19] (VG) Least squared means by age (1 study, n = 2,472) Mahapatra et al. [21] (D) Responsiveness: SDC NR, MIC NR, ROC NR	(+) sufficient	MODERATE ⊕⊕⊕⊝ downgraded due to limitation in risk of bias (−1: There are multiple studies of doubtful quality available but also several studies of at least adequate)
Criteria Rating	+|+|+	+|?	+|?|+|?
PedsQL	Content Validity: NR Structure Validity: NR Internal Consistency: Child self-report α = 0.67 to 0.91 (3 studies, n = 1983) Tantilipikom et al. [26] (A) Varni et al. [28] (VG) Seid et al. [25] (VG) Parent proxy α = 0.74 to 0.94 (3 studies, n = 2026) Tantilipikom et al. [26] (A) Varni et al. [28] (VG) Seid et al. [25] (VG)	Test-retest: Parent proxy ICC = 0.75 to 0.95 (1 study, n = 97) Tantilipikom et al. [26] (D) Child self-reports ICC = 0.63 to 0.93 (1 study, n = 54) Tantilipikom et al. [26] (D) Measurement error: child self-report: SEM 6.12, parent proxy scale: SEM 5.84 (1 study, n = 252) Seid et al. [25] (D) - SDC NR - LoA NR	Construct Validity (6 studies, n = 7,468): -Compared to known medical complexity Cohen d=0.32–0.40 (1 study, n = 4637) Desai et al. [29] (VG) -Compared healthy, acute/chronic illness, and severity of illness F tests were significant between groups (1 study, n = 1629) Varni et al. [28] (VG) -Comparison of indictors of morbidity: ICC = 0.13 to 0.05 (1 study, n = 963) Varni et al. [28] (VG) -Compared to Scoliosis Research society-22 varied ages: ICC = 0.29 to 0.37 (1 study, n = 566) Cheung et al. [24] (A) Convergent validity -Parent proxy-report and child report: ICC = 0.47 (1 study, n = 252) Seid et al. [25] (A)	(+) sufficient	MODERATE ⊕⊕⊕⊝ downgraded due to limitation in risk of bias (−1: There are multiple studies of inadequate quality)
			-F = 4.84 to 15.05 (2 studies, n = 1881) Varni et al. [28] (VG) Seid et al. [25] (I) -Analysis of sensitivity between subgroups F = 6.63 to 7.57, p = 0.001 (1 study, n = 288) Varni et al. [27] (I) -Parent report: F = 38.90 to 128.30, p = 0.001 (1 study, n = 963) Varni et al. [28] (VG) -Patient report: Factor loading KMO 0.787 (1 study, n = 97)
			Tantilipikom et al. [26] (D) - Discriminative validity Child self-report (total): - asthma vs healthy: t = 0.56 - mild vs severe: t = 0.70 Parent proxy-report: - asthma vs healthy: t = 0.73 - mild vs severe: t = 0.54 (1 study, n = 252) Seid et al. [25] (I) Cross-cultural: NR Criterion Validity: - Predictive Validity (3 studies, n = 5273): -Loss of school days, readmission, Emergency visit (1 study, n = 4637) Desai et al. [29] (I) -Parent report physical health t-test 5.78 Child report physical health t-test 3.18 (1 study, n = 43 and 30) Varni et al. [27] (I) -Ceiling effect 10% (1 study, n = 566) Cheung et al. [24] (A) Responsiveness: -Child self-report Effect Size-1 for all patients Cohen d = 0.58 small (1 study, n = 252) Seid et al. [25] (D) -Parent poxy report Effect Size-1 for all patients Cohen d = 0.62 small (1 study, n = 252) Seid et al. [25] (D)
			-t-test 3.18 (1 study, n = 43 and 30) Varni et al. [27] (I) -Ceiling effect 10% (1 study, n = 566) Cheung et al. [24] (A) Responsiveness: -Child self-report Effect Size-1 for all patients Cohen d = 0.58 small (1 study, n = 252) Seid et al. [25] (D) -Parent poxy report Effect Size-1 for all patients Cohen d = 0.62 small (1 study, n = 252) Seid et al. [25] (D)
Criteria Rating	?|?|+	+|?	-|?|-|?

Key: COA = clinical outcome assessment; criteria rating: “+” = sufficient, “−” = insufficient, “?” = indeterminate, consistent with criteria defined in Table 1 from [30]in Appendix A.; ATEC = Autism Evaluation Treatment Checklist, SQLI = Scoliosis Quality of Life Index, ¶VAS = Visual Analog Scale perceived influence of exertion or movement/position on low back problems (with anchors “no influence, worst increase in pain”), PedsQL = Pediatric Quality of Life Inventory, PAQLQ = Pediatric Asthma Quality of Life Questionnaire, PROM = Patient Reported Outcome Measure, n = sample size; MIC = Minimal important change; PROM = Patient reported outcome measure; ρ = Pearson correlation coefficient (PCC); SDC = Smallest Detectable Change; α = Cronbach’s alpha; r_s = Spearman’s ranked correlation coefficient (rho); ICC = interclass correlation coefficient; k = kappa concordance coefficient (Cohen’s kappa); t = paired t-test; p = p-value level of significance; NR = not reported; Effect Size = the difference between the group means, divided by the pooled standard deviation or Cohen d effect size; RoB = risk of bias; SEM = standard error of measurement, SDC = smallest detectable change (i.e. 1.96 * √2 * SEM as the measurement error of a change score), LoA = limits of agreement.

Table 4. Psychometric properties of patient-reported and observer-reported outcome measures.

Author (year)/ Country	COA	n	Psychometric	RoB	Results
Parent et al. [11] Canada	SQLI	95	Construct Validity	VG	Floor effect 1/95, Ceiling effect 12/22 − 6/22 hitting ceiling effect 20 to 50% of the time
Feise et al. [12] US	SQLI	84	Internal Consistency	VG	Global α = 0.89 (Domains: 0.82 to 0.85)
			Reliability (test-retest)	D	Global ICC = 0.80 (Domains: 0.46 to 0.85)
			Construct Validity	D	Comparison with Quality-of-Life Profile for Spinal Deformities: rs = 0.79 (Domains: 0.46 to 0.81)
					Gwet’s agreement: 0.73 to 0.98
Staes [13] Belgium	VAS^¶ (0 to 10)	61	Reliability (test-retest)	D	k > 0.50
Juniper et al. [14] Canada	PAQLQ	52	Reliability (test-retest)	A	Overall ICC = 0.95 Emotional ICC = 0.89 Activity Limitation ICC = 0.84
			Construct Validity	A	Pearson Correlation Coefficient (ρ) global rating of change: - Symptoms: ρ = 0.44 to 0.71 - Activities: ρ = 0.40 to 0.63 - Emotions: ρ = 0.41 to 0.60
			Responsiveness	A	Minimal Important Difference: Overall: 0.42 Moderate changes quality of life: 1.03 Responsiveness Index: overall 0.59
Barr et al. [15] Canada	Crying Diaries	10	Construct Validity	D	Comparison of crying hours on tape: rs = 0.64
Abaoud et al. [16] Saudi Arabia	ATEC	363	Internal Consistency	A	Correlation between items & subscales total ρ = 0.133 to 0.601 (high internal consistency)
				D	Cronbach’s alpha, Cronbach’s alpha if item deleted, Spearman-Brown’s split-half were computed to establish the checklist’s reliability and the contribution of each item to reliability α = 0.91 1^st subscale α = 0.72 2^nd subscale α = 0.97 3^rd subscale
			Structural Validity	A	exploratory factorial analysis using principal component analysis was performed to check the reliability of the checklist configuration and the one-dimensionality of its four factors; analysis used Kaiser Criterion in which the factor is considered substantial if its latent root is ≤1.0; latent roots for the third and the fourth subscale ranged between 2.08 and 5.9 and 3.6 and 10.19, respectively, this supports the univariate nature of the dimensions.
			Content Validity	I	10 expert referees evaluated for clear word usage, linguistic errors, and suitability with 90% minimal agreement level; the researchers made minor necessary adjustments to ensure the adapted version of the ATEC fit within a Saudi cultural context.
			Construct Validity (discriminate)	A	The correlation between the scores of the total ATEC and educational stages rs = 0.140; p = 0.01
Al Backer [17], Saudi Arabia	ATEC	40	Construct Validity	VG	Comparison to Childhood Autism Rating Scale: rs = 0.15, p = 0.926 meaning that there was no correlation between CARS and ATEC scales
Freire et al. [18] US	ATEC	42	Reliability (test-retest)	D	rs = 0.90
			Construct Validity	I	Comparison of Childhood Autism Rating Scale: ICC = 0.80
Geier et al. [19] US	ATEC	56	Construct Validity	VG	Comparison of Childhood Autism Rating Scale: rs = 0.71
			Construct Validity (predictive)	VG	To predict severely effected child: Cut-off point: total 49 Sensitivity 96%, Specificity 67%
Magiati et al. [20] UK	ATEC	22	Internal Consistency	VG	α: total score: 0.91 to 0.96
				I	Follow-up 1: predicted 46% of the variance between follow-up 1 and follow-up 2: (R^2 = 0.46, p = 0.001); Follow-up 2: outcome ranks (R^2 = 0.64, p = 0.001)
Mahapatra et al. [21]	ATEC	2272	Construct Validity (predictive)	D	Visit 8-Visit 1 Least squared means:
US					− 2 to 3 years: −28.35 (SE 1.30; p < 0.0001)
					− 3 to 6 years: −19.73 (SE 0.72; p < 0.0001)
					− 6 to 12 years: −13.80 (SE 0.96; p < 0.0001)
Memari et al. [22] Iran	ATEC	134	Internal Consistency	VG	α = 0.93 λ = 0.77
			Reliability (test-retest)	D	ICC = 0.89
			Construct Validity	D	Comparison of Autism Diagnostic Interview - Revised: rs = 0.38 to 0.79
Sunakarach and Kessomboon [23] Thailand	ATEC	160	Reliability (inter-rater)	A	ICC = 0.97
			Construct Validity (predictive)	D	Cut-off of 8, to predict mild from moderate to severe: Sensitivity 94%, Specificity 62%, Positive Predictive Value 83%, Negative Predictive Value 81%
Cheung et al. [24] Hong Kong	PedsQL	566	Construct Validity	A	Comparison of Scoliosis Research Society-22 item: − 8 to 12 years old: rs = 0.29 (p < 0.06) (Domains: 0.11 to 0.27)
					− 13 to 18 years old: Total rs = 0.37 (p < 0.01) (Domains: 0.28 to 0.34)
		566	Construct Validity (predictive)	A	Floor and ceiling effects: Total score: − 8 to 12 years old: 0% floor effect, 10.6% ceiling effect
					− 13 to 18 years old: 0% floor effect, 8.7% ceiling effect
Seid et al. [25] US	PedsQL	252	Internal Consistency Measurement Error	VG	α = 0.58 to 0.84 Total scores: - Child α = 0.84 - Parent α = 0.82 SEM: child self-report: 6.12, parent proxy scale: 5.84
			Construct Validity (discriminative)	I	Child self-report total scores: - asthma vs healthy: paired t-test 0.56 - mild vs moderate: paired t-test 0.47 - mild vs severe: paired t-test 0.70 - severe vs mild: paired t-test 0.25 Parent proxy-report: - asthma vs healthy: paired t-test 0.73 - mild vs moderate: paired t-test 0.37 - mild vs severe: paired t-test 0.54 - moderate vs severe: paired t-test 0.19
			Construct Validity (convergent)	A	Parent proxy-report and child-report total score: ICC = 0.47
			Responsiveness	D	Child self-report total: Effect Size for all patients = 0.58, Effect Size for stable patients only = 0.75 Parent proxy-report total: Effect Size for all patients = 0.62, Effect Size for stable patients only = 0.71
Tantilipikorn et al. [26] Thailand	PedsQL	97	Internal Consistency	A	Parent reports α range = 0.74 to 0.94
		54		A	Child self-reports α range = 0.67 to 0.91
		97	Reliability (test-retest)	D	Parent reports ICC range = 0.75 to 0.95
		54	Reliability (test-retest)	D	Child self-reports ICC range = 0.68 to 0.93
		97	Construct Validity	I	Parent reports: Factor Loading KMO = 0.787
Varni et al. [27] US	PedsQL	288	Construct Validity	I	Analysis of sensitivity between subgroups: F = 6.63 to 7.57 between Class I/II, Class III/IV, and healthy participants and they were significant at p = 0.001
		43	Construct Validity (predictive)	I	Parents report: paired t-test = physical health 5.78, psychosocial health 6.29; total score 7.68
		30	Construct Validity (predictive)	I	Child self-report: paired t-test = physical health 3.18, psychosocial health 3.18, total score 3.26
Varni et al. [28] US	PedsQL	1677	Internal Consistency	VG	Parent proxy report: α = 0.90 Child self-report: α = 0.88
		1629	Construct Validity	VG	Analysis between healthy, acute, and chronically ill, have been found to distinguish between healthy children and children with acute and chronic health conditions, and to distinguish severity of illness within chronic health conditions.
		963	Construct Validity	VG	Parents report: F = 38.90 to 128.30 p = 0.001 Child self-report: F = 4.84 to 15.05 p = 0.001
				VG	Comparison of indicators of morbidity and parent/child report: ICC = 0.13 to 0.05

Key: ¶ VAS (0 to 100) = Visual Analog Scale perceived influence of exertion or movement/position on low back problems (with anchors “no influence, worst increase in pain”); SQLI = Scoliosis Quality of Life Index, PedsQL = Pediatric Quality of Life Index, PAQLQ = Pediatric Asthma Quality of Life Questionnaire, ATEC = Autism Treatment Evaluation Checklist, “VG” very good, “A” adequate, “D” doubtful, “I” inadequate; Effect Size = the difference between the group means, divided by the pooled standard deviation or Cohen d effect size; α = Cronbach’s alpha, ICC = Intraclass correlation coefficient, k = Kappa Concordance Coefficient, KMO = Kaiser-Meyer-Olkin Test, r_s = Spearman’s rank correlation coefficient; ρ = Pearson correlation coefficients (PCC); p = p-value level of significance, F = F–statistics, SE = Standard Error, SEM = Standard Error of Measure, λ = Guttman Split Half, R² = Linear Regression.

Box 3. COSMIN steps in evaluating the evidence [30].

Figure 2. The PRISMA diagram for study flow.

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