Psychometric properties of clinician-reported and performance-based outcomes cited in a scoping review on spinal manipulation and mobilization for pediatric populations with diverse medical conditions: a systematic review

ABSTRACT

Introduction

Risks and benefits of spinal manipulations and mobilization in pediatric populations are a concern to the public, policymakers, and international physiotherapy governing organizations. Clinical Outcome Assessments (COA) used in the literature on these topics are contentious. The aim of this systematic review was to establish the quality of clinician-reported and performance-based COAs identified by a scoping review on spinal manipulation and mobilization for pediatric populations across diverse medical conditions.

Method and analysis

Electronic databases, clinicaltrials.gov and Ebsco Open Dissertations were searched up to 21 October 2022. Qualitative synthesis was performed using Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines to select studies, perform data extraction, and assess risk of bias. Data synthesis used Grading of Recommendations, Assessment, Development and Evaluations (GRADE) to determine the certainty of the evidence and overall rating: sufficient (+), insufficient (-), inconsistent (±), or indeterminate (?).

Results

Four of 17 identified COAs (77 studies, 9653 participants) with supporting psychometric research were classified as:

Performance-based outcome measures:

• AIMS – Alberta Infant Motor Scale (n = 51); or:

Clinician-reported outcome measures:

• LATCH – Latch, Audible swallowing, Type of nipple, Comfort, Hold (n = 10),

• Cobb Angle (n = 15),

• Postural Assessment (n = 1).

AIMS had an overall sufficient (+) rating with high certainty evidence, and LATCH had an overall sufficient (+) rating with moderate certainty of evidence. For the Cobb Angle and Postural Assessment, the overall rating was indeterminate (?) with low or very low certainty of evidence, respectively.

Conclusion

The AIMS and LATCH had sufficient evidence to evaluate the efficacy of spinal manipulation and mobilization for certain pediatric medical conditions. Further validation studies are needed for other COAs.

Introduction

Assessing the ethical acceptability of health-related research involving spinal manipulation and mobilization in diverse pediatric populations with varying medical conditions necessitates a crucial risk-benefit analysis. International policymakers, clinicians, and guardians are questioning whether the risks associated with spinal manipulation and mobilization exceed the anticipated benefits. The Australian Government in the state of Victoria has restricted the use of these techniques in infants [1]. The International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT), in collaboration with the International Organisation of Physical Therapists in Paediatrics (IOPTP), has identified a great need to accurately map the scientific evidence and safety issues regarding manipulation and mobilization for infants, children, and adolescents with various conditions. Clinicians are seeking the evidence-basis of this care pathway to make safe clinical judgments, decision-making, and guide their clinical reasoning process. A scoping review [2] for a pediatric population receiving spinal manipulation and mobilization established that there was a diverse listing of Clinical Outcome Assessments (COA) with poor reporting of their psychometric properties; COAs were defined by the United States Food and Drug Administration (FDA) as tools that ‘measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions’ [3]. Healthcare professionals and researchers typically use one or more of the four standardized assessment categories of COA to measure clinical benefit in treatment trials as follows:

• patient-reported – patient’s self report of difficulty in completing a task or of feelings experienced during tasks of daily living.

• clinician-reported – a trained health professional’s observation of a patient’s health condition involving clinical judgment and interpretation of the observable signs, behaviors, or other manifestations.

• observer-reported – a report by a caregiver, guardian, or other observer of patients who cannot report for themselves (e.g., infant); this observation does not include clinical judgment.

• performance-based – a trained observer administers and evaluates a standardized task(s) performed by the patient.

See Figure 1 for those COAs identified by Milne and colleagues [2] in their scoping review.

Figure 1.

Clinical outcome assessment (COA) categories that were identified by a scoping review on spinal manipulation and mobilisation in paediatric populations [2]. Clinician-reported and performance-based outcome assessments were the focus of this report. All listed outcomes were included in our search however the bolded ones were those identified in the literature to have psychometric properties for paediatric populations.

Interpreting the effects of outcomes such as pain, function, motor development, mobility difficulties, and participation in life activities for infants, children, and adolescence before and following spinal manipulation and mobilization is critical. Foundational to the determination of the efficacy, effectiveness, and harm is the use of outcome measures with good measurement properties as established by COSMIN’s [4] including:

• Reliability:internal consistency, test-retest/intra-rater/inter-rater reliability, measurement error;

• Validity

  1. content validity including relevance, comprehensiveness, comprehensibility, outcome measurement items assessed and appropriately worded [5]
  2. structural validity,
  3. hypothesis testing for construct validity,
  4. cross-cultural validity,
  5. criterion validity and

• Responsiveness for each measurement.

Additionally, the interpretability and feasibility of the reported outcome measure is needed to formulate recommendations on the suitability for use in an evaluative application of the construct of interest and study population.

The aim of this systematic review was to evaluate the psychometric properties of clinician-reported and performance-based outcomes that were identified by a scoping review on spinal manipulation and mobilization in pediatrics, aged birth to 18 years across diverse medical conditions. These outcomes are related to the physical functioning, motor development, and mobility of infants, children, and adolescence.

Method

The protocol was registered with Open Science Framework (DOI 10.17605/OSF.IO/RN4UX). This review was part of a larger project designed to depict COAs by subcategories: Part 1. Patient-reported and Observer-reported Outcomes [6]; Part 2. Clinician-reported and Performance-based Outcomes. The review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement [7] and Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guideline for systematic reviews [8].

Eligibility criteria

Type of participants: Pediatric (birth to 18 years of age) patients with medical conditions identified by a scoping review and managed with spinal manipulation and mobilization were considered [2]. These conditions varied and included Enuresis, Otitis Media, Colic, Excessive Crying/Colic, Breastfeeding, Low Back Pain, Headaches, Cerebral Palsy, Neck Pain, Scoliosis, Attention Deficit Disorder, Autism, Torticollis, Asthma, Chronic Respiratory Illness, KISS (kinetic imbalances due to suboccipital strain), and Dysfunctional Voiding and could include healthy participants. If there were greater than 20% of the population older than 18 years old, the study was excluded.

Type of clinical outcome assessment (COA): Clinician-reported and performance-reported COAs were considered eligible for this study.

Type of psychometric outcome: Studies addressed a minimum of one psychometric property from any of the following three domains:

• Validity: content validity (i.e., relevance, comprehensiveness, comprehensibility, outcome measurement items assessed and appropriately worded), structural validity, hypothesis testing for construct validity, cross-cultural validity, criterion validity.

• Reliability: internal consistency, test–retest reliability, intra-rater reliability, inter-rater reliability, measurement error (i.e., standard error measure (SEM), smallest detectable change (SDC) or limit of agreement (LoA)).

• Responsiveness (i.e., SDC, minimal important change (MIC), area under the curve (i.e., ROC – Receiver Operation Curve)).

Information on the interpretability (i.e., floor or ceiling effect) and feasibility of the reported outcome measure was also gathered. Trials where the COA was used as an outcome measure or in validation of another instrument were excluded.

Type of study design: All study designs (i.e., cohort, case-control, cross-sectional, case-series, randomized controlled trials) except for questionnaires, surveys, screening tools, and case reports were included.

Information sources and search strategy

A medical librarian and information specialist (JM) designed, tailored, and performed an electronic search of PUBMED, Embase, and CINAHL from inception to 26 February 2021 with an update to 21 October 2022 without language restriction. However, translation capacity of our research team and colleagues was English, Dutch, German, Spanish, French, Korean, Hungarian, Russian, and Croatian and non-translated studies were recorded. The search strategy was to combine each COA identified by a previously completed scoping review [2] with a modified instrument properties search block for PUBMED created by [9] as well as a measurement property filter: 1) for the Index to Chiropractic Literature created by JM, 2) for EMBASE translated by EP Jansma and 3) for CINAHL developed FS van Etten (COSMIN website). By selectively adding a chiropractic filter and a pediatric filter, we balanced the search strategy between recall and precision. A sample of the search parameters can be found in Box 1. We searched gray literature in clinicaltrials.gov and Ebsco Open Dissertations on 29 March 2021, and references of primary studies were checked by TH.

Box 1.

A sample MEDLINE search strategy and parameters include a search block for psychometric properties and a search block for spinal manipulation and mobilization.

Search block for psychometric properties:

(MH ‘Psychometrics’) or (TI psychometr* or AB psychometr*) or (TI clinimetr* or AB clinimetr*) or (TI clinometr* OR AB clinometr*) or (MH ‘Outcome Assessment’) or (TI outcome assessment or AB outcome assessment) or (TI outcome measure* or AB outcome measure*) or (MH ‘Health Status Indicators’) or (MH ‘Reproducibility of Results’) or (MH ‘Discriminant Analysis’) or ((TI reproducib* or AB reproducib*) or (TI reliab* or AB reliab*) or (TI unreliab* or AB unreliab*)) or ((TI valid* or AB valid*) or (TI coefficient or AB coefficient) or (TI homogeneity or AB homogeneity)) or (TI homogeneous or AB homogeneous) or (TI ‘coefficient of variation’ or AB ‘coefficient of variation’) or (TI ‘internal consistency’ or AB ‘internal consistency’) or (MH ‘Internal Consistency+’) or (MH ‘Reliability+’) or (MH ‘Measurement Error+’) or (MH ‘Content Validity+’) or ‘hypothesis testing’ or ‘structural validity’ or ‘cross-cultural validity’ or (MH ‘Criterion-Related Validity+’) or ‘responsiveness’ or ‘interpretability’ or (TI reliab* or AB reliab*) and ((TI test or AB test) OR (TI retest or AB retest)) or (TI stability or AB stability) or (TI interrater or AB interrater) or (TI inter-rater or AB inter-rater) or (TI intrarater or AB intrarater) or (TI intra-rater or AB intrarater) or (TI intertester or AB intertester) or (TI inter-tester or AB inter-tester) or (TI intratester or AB intratester) or (TI intra-tester or AB intra-tester) or (TI interobserver or AB interobserver) or (TI inter-observer or AB inter-observer) or (TI intraobserver or AB intraobserver) or (TI intra-observer or AB intra-observer) or (TI intertechnician or AB intertechnician) or (TI inter-technician or AB inter-technician) or (TI intratechnician or AB intratechnician) or (TI intra-technician or AB intra-technician) or (TI interexaminer or AB interexaminer) or (TI inter-examiner or AB inter-examiner) or (TI intraexaminer or AB intraexaminer) or (TI intra-examiner or AB intra-examiner) or (TI intra-examiner or AB intraexaminer) or (TI interassay or AB interassay) or (TI inter-assay or AB inter-assay) or (TI intraassay or AB intraassay) or (TI intra-assay or AB intra-assay) or (TI interindividual or AB interindividual) or (TI inter-individual or AB inter-individual) OR (TI intraindividual or AB intraindividual) or (TI intra-individual or AB intra-individual) or (TI interparticipant or AB interparticipant) or (TI inter-participant or AB inter-participant) or (TI intraparticipant or AB intraparticipant) or (TI intra-participant or AB intra-participant) or (TI kappa or AB kappa) or (TI kappa’s or AB kappa’s) or (TI kappas or AB kappas) or (TI repeatab* or AB repeatab*) or (TI responsive* or AB responsive*) or (TI interpretab* or AB interpretab*)

Search block for spinal manipulation and mobilization:

‘spinal manipulation’ OR ‘spinal manipulations’ OR ‘spinal mobilization’ OR ‘spinal mobilizations’ OR ‘spinal mobilization’ OR ‘spinal mobilizations’ OR ‘spinal adjustment’ OR ‘spinal adjustments’ OR ‘spinal manual therapy’ OR ‘high velocity low amplitude thrust’ OR ‘HVLA’ OR ‘musculoskeletal of the spine’ OR ‘spinal musculoskeletal’ OR ‘manual therapy of the spine’ OR ‘cervical manual therapy’ OR ‘thoracic manual therapy’ OR ‘lumbar manual therapy’ OR ‘manual therapy of the lumbar spine’ OR ‘manual therapy of the thoracic spine’ OR ‘manual therapy of the cervical spine’ OR ‘spinal osteopathy’ OR ‘osteopathy of the spine’ OR ‘osteopathy of the cervical spine’ OR ‘osteopathy of the thoracic spine’ OR ‘osteopathy of the lumbar spine’ OR ‘spinal osteopathies’ OR ‘osteopathies of the spine’ OR ‘osteopathies of the cervical spine’ OR ‘osteopathies of the thoracic spine’ OR ‘osteopathies of the lumbar spine’ OR chirop* OR ‘spinal manipulative therapy’ OR ‘spinal manipulative therapies’

Key: TI = Title; AB = abstract; MH = MeSH heading (MeSH is the MEDLINE index).

Study identification and selection

The review manager Covidence (Veritas Health Innovation, Melbourne, Australia) was used for study screening, selection, and data extraction. Pre-piloted forms and two independent reviewers (screening and selection review teams: JP/TH, AB/AG, KO/DC, NM/OA). An initial screening of study title and abstract and full-text selection was performed after a 10-study calibration period and with two additional meetings between the authors to ensure consistency (Kappa values were set at 0.4 moderate to 0.75 good a priori). Disagreements were resolved by discussion and reference to a third reviewer when needed (JP; See Figure 1). For abstracts only, we conducted a second search to determine their publication status.

Data extraction and data items

A standardized data collection form was used by a pair of researchers (review teams: JP/TH, AB/TH, OA/AG) independently extracted data using a standardized pilot-tested form in addition to the COSMIN Risk of Bias checklist including:

• 1. Description and scoring of the assessment tool;

• 2. Population demographic characteristics, medical condition, country, number of participants, age, sex, professional involved;

• 3. Inclusion/exclusion criteria;

• 4. Results addressing psychometrics; and

• 5. Statistical methods used.

Missing data from primary studies were addressed by either consulting the outcome measurement website/administrator when available and the author for key data. We did not check if studies were registered prior to their start.

Risk of bias (RoB) assessment

Using the valid and reliable COSMIN Risk of Bias checklist, two reviewers (review teams JP/AB, TH/OA) independently evaluated the RoB of each included study and resolved uncertainties through discussion [4,8]. Additionally, validation studies for clinician-reported and performance-based measures was conducted [10,11]. The COSMIN checklist uses a 4-point rating scale: very good (VG), adequate (A), doubtful (D), and inadequate (I) (see Box 2. – Step 1). The RoB of research was judged per psychometric property reported, not per study. The overall score for each measurement property on the COSMIN checklist was determined by a ‘worse score counts’ approach.

Box 2.

COSMIN steps in evaluating the evidence [88] and box replicated from Hayton et al. 2024.

Measures of psychometric values

After qualitative evaluation of study population and the psychometric properties, no further quantitative analysis or meta-analysis was completed by psychometric value due to the heterogeneity of study populations and the properties evaluated. Statistics depicted in this paper are directly quoted as the authors presented them. Confidence Intervals (CI) and standard deviations (SD) are presented if they were reported.

Data synthesis and analysis methods

In Table 1, we summarized a descriptive synthesis of findings for the psychometric properties of each COA for identified studies. In Table 4, we detailed the updated criteria of good measurement properties established by COSMIN’s [4]. We rated the results for reliability (internal consistency, test-retest/intra-rater/inter-rater reliability, measurement error), validity (a. content validity including relevance, comprehensiveness, comprehensibility, outcome measurement item’s assessed, and appropriately worded [9]; b. structural validity, c. hypothesis testing for construct validity, cross-cultural validity, and criterion validity), responsiveness for each measurement property as sufficient (+), insufficient (–), or indeterminate (?) (see Box 2. – Step 2; see Appendix A for definitions) [4; 88]. A qualitative summary using COSMIN defined criteria for an OVERALL RATING was completed on measurement properties; this was based on our reviewer’s consensus judgment as sufficient (+), insufficient (−), inconsistent (±), or indeterminate (?) (see Box 2. – Step 3). The interpretability (Appendix B) and feasibility (Appendix C) were reported as per COSMIN guidelines.

Table 1.

Characteristics of included studies.

Author (Year)	Country of Publication	Outcome Measure	Disorder Studied	Professional	Age Range	Sex Ratio (Male : Female)	n	Psychometric Addressed
Aimsamrarn et al. [12]	Thailand	AIMS	Healthy participants	Physiotherapist	1 to 18 months	22:08	30	Reliability, Validity
Albuquerque et al. [13]	Brazil	AIMS	Pre-term infants	NR	3 to 16 months (corrected age)	57:51	108	Reliability, Validity
Almeida et al. [14]	Brazil	AIMS	Healthy premature infants	Physiotherapist	0 to 18 months	25:21	88	Reliability, Validity
Bartlett and Fanning [15]	Canada	AIMS	Pre-term infants	Physiotherapist	8 months (corrected age)	28:32	60	Reliability, Validity
Blanchard et al. [16]	United States	AIMS	Healthy participants	Physiotherapist	0 to 12 months	NR	14	Reliability
Boonzaaijer et al. [17]	Netherlands	AIMS	Healthy participants	Physiotherapist	16 to 54 weeks	24:24	48	Reliability, Validity
Campbell and Kolobe [18]	United States	AIMS	Healthy participants and infants at risk for developmental disability	NR	9 to 18 weeks	47:43	90	Validity
Campbell et al. [19]	United States	AIMS	Healthy and preterm participants.	Physiotherapist	<12 months	52:44	96	Validity
Campos et al. [20]	Brazil	AIMS	Healthy participants	NR	37 to 41 weeks gestation	NR	43	Validity
Chiquetti et al. [21]	Brazil	AIMS	Healthy participants	NR	17 weeks (corrected age)	349:301	650	Validity
Darrah [22]	Canada	AIMS	At risk infants developmental delay	Physiotherapist	4 to 18 months	65:60	125	Validity
Darrah et al. [23]	Canada	AIMS	Healthy participants	Physiotherapist	4 to 8 months	87:77	164	Validity
Darrah et al. [24]	Canada	AIMS	Healthy participants	Physiotherapist	2 weeks to 18 months	20:25	45	Reliability
Darrah et al. [25]	Canada	AIMS	Healthy and preterm participants.	Physiotherapist	2 weeks to 18 months	338:312	650	Validity
Dumas et al. [26]	United States	AIMS	Chronically ill infants	Physiotherapist	3 to 450 days	26:27	53	Validity
Fauls et al. [27]	Australia	AIMs	Children requiring physiotherapy	Physiotherapist	0 to 5 years	50:34	84	Validity
Fetters and Tronick [28]	United States	AIMS	Healthy participants	Physiotherapist	4 to 15 months	16:23	39	Validity
Fleuren et al. [29]	Netherlands	AIMS	Healthy participants	Physiotherapist	0 to 12 months	63:37	118	Reliability Validity
Ga and Kwon [30]	Korea	AIMS	Healthy participants	Physiotherapist	4 to 60 months	119:107	226	Reliability Validity
Harris et al. [31]	Canada	AIMS	At risk and healthy infants	Physiotherapist	4 to 6.5 months	73:71	At risk: 86 Typical: 58 Total: 114	Validity
Heineman et al. [32]	Netherlands	AIMS	NICU infants	Medical Doctor	4 to 18 months	49:31	80	Validity
Heineman et al. [33]	Netherlands	AIMS	Pre-term Infants	NR	25 to 43 weeks gestation	34:25	205	Validity
Hoskens et al. [34]	Belgium	AIMS	Healthy participants	Physiotherapist	19 days to 18 months	62:60	122	Validity
Jeng et al. [35]	Taiwan	AIMS	Pre-term infants	Physiotherapist	24 to 36 weeks	Reliability: 27:18 Validity: 21:20	45 41	Reliability Validity
Krosschell et al. [36]	United States	AIMS	Muscular dystrophy	Physiotherapist	NR	NR	23	Reliability
Lackovic et al. [37]	Serbia	AIMS	Healthy participants	Medical Doctor	0 to 14 months	34:26	60	Reliability
Lefebvre et al. [38]	Canada	AIMS	Pre-term infants	Physiotherapist	26.3 weeks (SD 1.4)	91:69	160	Validity
Morales-Monforte et al. [39]	Spain	AIMS	At risk infants developmental delay	Physiotherapist	24 to 41 weeks gestation	27:23	50	Reliability, Validity
Pai-Jun and Campbell [40]	United States	AIMS	Healthy participants.	Physiotherapist	3 to 12 months	NR	97	Validity
Pin et al. [41]	Australia	AIMS	Pre-term infants	Physiotherapist	<18 months	NR	62	Reliability
Pin et al. [42]	Hong Kong	AIMS	Pre-term infants	Physiotherapist	4 to 12 months	15:16	31	Validity
Piper et al. [43]	Canada	AIMS	Healthy participants	Physiotherapist	0 to 18 months	285:221	221 291 Total: 506	Reliability, Validity
Rizzi et al. [44]	Italy	AIMS	Neurologically compromised infants	NR	0 to 18 months	46:40	86	Validity
Saccani and Valentini [45],	Brazil	AIMS	Healthy participants	NR	0 to 18 months	407:378	795	Validity
Quezada-Villalobos et al. [46]	Chile	AIMS	Preterm and term infants at risk motor control problems	NR	10 to 16 months	Full term: 48:47 Preterm: 10:10	115	Reliability
Siegle and de Sá [47]	Brazil	AIMS	Babies exposed to HIV	NR	0 to 18 months	42:33	75	Validity
Silva et al. [48]	Brazil	AIMS	Healthy participants	Nurse	123 to 196 days	26:24	50	Reliability
Snyder et al. [90]	United States	AIMS	At risk infants developmental delay	Physiotherapist	2 months, 19 days to 16 months, 23 days	16:19	35	Reliability, Validity
Spittle et al. [49]	Australia	AlMS	Preterm infants	Osteopath	<1 year	47:40	87	Validity
Suir et al. [50]	Netherlands	AIMS	Healthy participants	Physiotherapist	2 weeks to 19 months	263:236	499	Reliability Validity
Syrengelas et al. [51]	Greece	AIMS	Full term and preterm infants	NR	1 to 19 months	Preterm 251:152 Full-term 584:454	Preterm: 403 Full-term: 1038 Total: 1441	Validity
Syrengelas et al. [52]	Greece	AIMS	Healthy participants	Physiotherapist	7 d to 18 months	250:174	424	Reliability, Validity
Tse et al. [53]	Canada	AIMS	Healthy and at-risk infants	Other person employed in childcare, early intervention, and health care	4 to 6.5 months	60:61	At risk: 72 Typical:49 Total: 121	Reliability, Validity
Tupsila et al. [54]	Thailand	AIMS	Healthy participants	Physiotherapist	0 to 14 months	314:260	574	Validity
Valentini and Saccani [55]	Brazil	AIMS	Healthy participants	Physiotherapist	0 to 18 months	291:270	561	Reliability Validity
Valentini and Saccani [56]	Brazil	AIMS	Healthy participants	Physiotherapist	1 to 18 months	394:372	766	Reliability, Validity
van Hus et al. [57]	Netherlands	AIMS	Healthy participants	Physiotherapist	<12 months	63:53	116	Validity
van Schie et al. [58]	Netherlands	AIMS	Healthy Participants	Physiotherapist	0 to 2 years	20:12	32	Validity
Wang et al. [59]	China	AIMS	Developmental delay	Physiotherapist	0 to 9 months	29:21	50	Reliability, Validity
Yeh et al. [60]	Taiwan	AIMS	Healthy participants	Physiotherapist	25 to 39 weeks	18:11	29	Validity
Adams and Hewell [61]	United States	LATCH	Healthy breastfed infants and their mothers	Lactation Consultant	Mothers: 20 to 29 years Infants: NR	NR	35 dyads	Reliability
Altuntas et al. [62]	Turkey	LATCH	Healthy participants	NR	NR	NR	46 feeds	Reliability, Validity
Báez León et al. [91]	Spain	LATCH	Breastfeeding, healthy participants	Nurse	Mothers: 32 years; Infants: 37 to 41 weeks gestation	NR	20 dyads	Reliability
Chapman et al. [63]	United States	LATCH	Healthy infants, obese/overweight mothers	Medical Doctor	Mother: 29 years (SD 5.5) Infant: 39.3 weeks (SD 1.2)	NR	45 dyads	Reliability
DaConceição et al. [64]	Brazil	LATCH	Healthy participants	Lactation Consultant	Mothers: 34 year Infant: 39 weeks	Infant: 88:72	160 dyads	Validity
DaConceição et al. [65]	Brazil	LATCH	Healthy participants	Lactation Consultant	NR	NR	160 dyads	Reliability, Validity
Dolgun et al. [66]	Turkey	LATCH	Healthy infants and their mothers	Mother/ translator	Mothers: 19 to 45 years Infants: < 6 months	Infant: 66:61	127 dyads	Reliability, Validity
Kumar et al. [67]	United States	LATCH	Breastfeeding healthy participants	Lactation Consultant	Neonate/Infant: 1 day to 6 weeks	Infant: 134:114	250 dyads	Validity
Lau et al. [68]	Singapore	LATCH	Healthy participants	Trained Research Assistant	Neonate: 48 to 72 hours	Infant: 477:430	907 dyads	Reliability, Validity
Riordan and Koehn [69]	United States	LATCH	Healthy participants	Nurse	infant: full gestation/40 weeks	NR	28 feeds, 13 dyads	Reliability
Adam et al. [70]	Australia	Cobb Angle	Scoliosis	Medical Doctor	NR	NR	12	Reliability
Al-Bashir et al. [71]	India, Jordan, United States	Cobb Angle	Scoliosis	Medical Doctor	10 to 18 years	14:14	28	Validity
Allen et al. [72]	Canada	Cobb Angle	Adolescent idiopathic scoliosis	Medical Doctor	NR	NR	22	Reliability,Validity
Brink [73]	Netherlands	Cobb Angle	Idiopathic scoliosis	Medical Doctor	10 to 17 years	10:90	33	Reliability
De Carvalho et al. [74]	France	Cobb Angle	Scoliosis	Medical Doctor	NR	NR	20	Reliability, Validity
Gstoettner et al. [75]	Austria	Cobb Angle	Scoliosis	Medical Doctor	NR	NR	48	Reliability
Kumar et al. [76]	India	Cobb Angle	Adolescent idiopathic scoliosis	Medical Doctor	NR (adolescents implied)	NR	20	Reliability
Livanelioglu et al. [77]	Turkey	Cobb Angle	Scoliosis	Physiotherapist	9 to 18 years	9:42	51	Reliability, Validity
Loder et al. [78]	United States	Cobb Angle	Scoliosis	Medical Doctor	<10 years	17:47	64	Reliability
Marchetti et al. [79]	Brazil	Cobb Angle	Scoliosis	Medical Doctor	5 to 18 years	42:48	90	Reliability, Validity
Mehta et al. [80]	Korea	Cobb Angle	Scoliosis	Medical Doctor	<7 to > 10 years	NR	318	Reliability
Pruijs et al. [81]	Netherlands	Cobb Angle	Scoliosis	Medical Doctor	8.1 to 21.2 years	6:35	41	Reliability, Validity
Safari et al. [82]	Iran	Cobb Angle	Scoliosis	NR	4 to 40 years	NR	14	Reliability
Stokes and Aronsson [83]	United States	Cobb Angle	Scoliosis	Medical Doctor	NR	NR	27	Reliability
Xiaohua et al. [84]	United States	Cobb Angle	Scoliosis	Chiropractor	NR	NR	20	Reliability
Watson and Mac Donncha [85]	Ireland	Posture Assessment	Healthy participants	NR	15 to 17 years	114:00	114	Reliability

Key: AIMS = Alberta Infant Motor Scale; LATCH = Latch, Key: Audible Swallow, Type of Nipple, Comfort, Hold; HIV = human immunodeficiency virus; NICU = neonatal intensive care unit; SD = standard deviation; NR = not reported; n = sample size, dyad = mother and infant pair.

Table 4.

Summary of results for Alberta Infant motor Scale (AIMS).

Author (year)	Country of Origin	n	Psychometric	COSMIN Score RoB	Results
Aimsamrarn et al. [12]	Thailand	30	Reliability (Intra-rater)	I	Assessor 1 ICC = 0.99 (95% CI: 0.98 to 0.99)
				I	Assessor 2 ICC = 0.98 (95% CI: 0.92 to 0.99)
			Reliability (Inter-rater)	I	ICC = 0.98 (95% CI: 0.98 to 0.99)
		30	Construct Validity	D	With comparison to the BSID – II ρ = 0.969, P < 0.01
Albuquerque et al. [13]	Brazil	108	Reliability (Intra-rater)	VG	ICC = 0.99 (95% CI 0.98 to 1.00)
			Reliability (Inter-rater)	VG	ICC = 0.99 (95% CI 0.99 to 1.00)
			Predictive Validity	I	R2 = 0.93, R2 = 0.92 after ceiling effect considered.
					5th percentile cut-off: Sensitivity 51.5%, Specificity 98.4%, Positive Predictive Value 889.5%, Negative Predictive Value 88.6%
					10th percentile cut-off: Sensitivity 75.8% Specificity 92.9%, Positive Predictive Value 73.5%, Negative Predictive Value 93.6%
Almeida et al. [14]	Brazil	88	Reliability (Inter-rater)	VG	ICC = 0.99
			Construct Validity	VG	When compared to BSID: Total population: rs = 0.95, R2 = 0.90
					6m: rs = 0.74, R2 = 0.55
					12m rs = 0.89, R2 = 0.79
Bartlett and Fanning [15],	Canada	7	Reliability (Inter-rater)	D	ICC = 0.95 (95% CI: 0.73 to 0.99)
		5		D	ICC = 0.98 (95% CI: 0.87 to 0.99)
		60	Criterion Validity	VG	total and subscale score for three subgroups were significantly different (F = 11.03, df 59, P<0.001) subgroups were normal, suspect, and abnormal.
Blanchard et al. [16]	USA	14	Reliability (Inter-rater)	D	total score: ICC = 0.98 to 0.99
Boonzaaijer et al. [17]	Netherlands	48	Reliability(Inter-rater) Measurement Error	VG	ICC = 0.99, SEM = 0.92
			Reliability (Intra-rater) Measurement Error	VG	ICC = 0.99, SEM = 0.96
			Concurrent Validity	VG	Comparison between live and home video: ICC = 0.99 (95% CI 0.89 to 0.99) SEM = 1.41 (95% CI: 1.63 to 0.80)
Campbell and Kolobe [18],	United States	90	Construct Validity	VG	Comparison with TIMP: Raw scores: rs = 0.64 (p < 0.0001)
					percentiles: rs = 0.60 (p < 0.0001)
Campbell et al. [19]	USA	96	Construct Validity	VG	With comparison to TIMP: ICC = 0.20 to 0.67 p < 0.001
Campos et al. [20]	Brazil	43	Construct Validity	I	With comparison to BSID – II: 5th percentile cut-off: Sensitivity 100%, Specificity 78.37%, k = 0.5
					10th percentile cut-off: Sensitivity 100%, Specificity 48.64%, k = 0.2
Chiquetti et al. [21]	Brazil	650	Construct Validity	D	Weak to moderate correlation with TIMP t = 0.24
Darrah [22]	Canada	12	Reliability (Inter-rater)	VG	Total score: ICC = 0.98
		125	Predictive Validity	VG	Abnormal vs suspicious: 4th month: Sensitivity 87.5%, Specificity 78.0%, Positive Predictive Value 36.8%, Negative Predictive Value 97.7%, 8th month: Sensitivity 100%, Specificity 90.8%, Positive Predictive Value 61.5%, Negative Predictive Value 100%
			Construct Validity	VG	Comparison with BSID II 4th month: ICC = 0.42, 8th month: ICC = 0.5
Darrah et al. [23]	Canada	164	Predictive Validity	VG	Abnormal vs Normal/Suspicious: 4th month (10th percentile cut-off): Sensitivity 77.3%, Specificity 81.7%, Positive Predictive Value 39.5%, Negative Predictive Value 95.8%
					8th month (5th percentile cut-off): Sensitivity 86.4%, Specificity 93%, Positive Predictive Value 65.5%, Negative Predictive Value 97.8%
					Abnormal/Suspicious vs Normal 4th month (10th percentile cut-off): Sensitivity 58.3%, Specificity 82.8%, Positive Predictive Value 48.8%, Negative Predictive Value 87.6%
					8th month (5th percentile cut-off): Sensitivity 63.9%, Specificity 95.3%, Positive Predictive Value 79.3%, Negative Predictive Value 90.4%
Darrah et al. [24]	Canada	45	Reliability (Inter-rater)	D	ICC > 0.99
Darrah et al. [25]	Canada	650	Construct Validity	VG	Comparison of original and contemporary norms: ICC = 0.99
Dumas et al. [26]	United States	53	Construct Validity	A	Comparison of the PEDI = CAT: rs = 0.32 P = 0.02 (fair association)
Fauls et al. [27]	Australia	37	Construct Validity	VG	Comparison of ASQ-3-GM rs = 0.697
Fetters and Tronick [28],	United States	39	Construct Validity	D	High false positives at 4 months. Improved specificity/sensitivity at 7 months
Fleuren et al. [29]	Netherlands	118	Reliability (Inter-rater)	A	total score: rs = 0.99
			Cultural Validity	VG	significantly more Dutch children score below the cut off scores of 10% (29% of Dutch children) and 5% (17% of Dutch children)
Ga and Kwon [30]	Korea	226	Reliability (Inter-rater)	I	97.7% between three testers
		226	Construct Validity	VG	Sensitivity of Korean ASQ-3-GM 76.3 to 90.2% when compared to less than 10th percentile cut off of AIMS
Harris et al. [31]	Canada	144	Construct Validity	VG	Comparison of BSID – II: 4 to 6 months evaluation: rs = 0.36
					10 to 12 months evaluation: rs = 0.4
					2 to 3 years comparison: rs = 0.55
		144	Predictive Validity	VG	4 to 6.5 month (cut-off less than 5th percentile): Sensitivity 12.3%, Specificity 94.3%, Positive Predictive Value 58.3%, Negative Predictive Value 62.1 %
Heineman et al. [32]	Netherlands	80	Construct Validity	VG	With comparison to IMP performance domain: Total score (corrected age) rs = 0.91 (95% CI 0.68 to 0.94)
					total score (raw scores) rs = 0.94, p < 0.005
Heineman et al. [33]	Netherlands	205	Construct Validity	VG	With comparison to IMP: Fair to moderate correlation (rs = 0.37 to 0.54 through the ages)
Hoskens et al. [34]	Belgium	122	Construct Validity	D	With comparison to BSID – III: rs = 0.59 to 0.98 (p < 0.001) overall rs = 0.98
Jeng et al. [35]	Taiwan	45	Reliability (Intra-rater)	A	0 to 3 months ICC = 0.85 to 0.98, SEM = 0.17 to 0.55 4 to 7 months ICC = 0.90 to 0.98, SEM = 0.32 to 1.24 >8 months ICC = 0.97 to 0.99, SEM = 0.01 to 0.73
			Reliability (Inter-rater)	A	0 to 3 months ICC = 0.73 to 0.97, SEM = 0.16 to 0.68 4 to 7 months ICC = 0.75 to 0.98, SEM = 0.4 to 1.24 >8 months ICC = 0.98 to 0.99 SEM = 0.01 to 0.59
		41	Construct Validity	VG	with comparison to BSID: 6 months rs = 0.78 12 months rs = 0.90 (p < 0.0001)
Krosschell et al. [36]	United States	23	Reliability (Inter-rater)	VG	2014 training: ICC = 0.95 (95% CI 0.76 to 1.00)
					2015 training: ICC = 0.98 (95% CI 0.93 to 1.00)
Lackovic et al. [37]	Serbia	60	Internal consistency	I	α 3 months = 0.93 to 0.941
					7 months = 0.997 to 0.998
					14 months = 0.996 to 0.998
			Reliability (Test – retest)	I	α = 0.940 to 0.998
			Reliability (Inter-rater)	I	total ICC = 0.75
Lefebvre et al. [38]	Canada	160	Predictive Validity	VG	Predictive Validity: 4 month AIMS ability to predict BSID < 85 Sensitivity 0.66% (95% CI 0.55 to 0.77), Specificity 0.53% (95% CI 0.45 to 0.64), Positive Predictive Value 0.55% (95% CI 0.45 to 0.65), Negative Predictive Value 0.65% (95% CI 0.54 to 0.76)
					BSID < 70: Sensitivity 0.78% (95% CI 0.61 to 0.95), Specificity 0.48% (95% CI 0.4 to 0.56), Positive Predictive Value 0.20% (95% CI 0.12 to 0.29), Negative Predictive Value 0.93% (95% CI 0.87 to 0.99)
					10 to 12 months AIMS
					BSID < 85 Sensitivity 0.44% (95% CI 0.32 to 0.57) Specificity 0.82% (95% CI 0.73 to 0.90), Positive Predictive Value 0.67% (95% CI 0.52 to 0.81), Negative Predictive Value 0.64% (95% CI 0.54 to 0.73)
					BSID < 70: Sensitivity 0.65% (95% CI 0.42 to 0.87), Specificity 0.75% (95% CI 0.67 to 0.82) Positive Predictive Value 0.26% (95% CI 0.13 to 0.39), Negative Predictive Value 0.94% (95% CI 0.89 to 0.97)
Pai-Jun and Campbell [40]	United States	97	Structural Validity	D	Rasch ability measure for infants: 51.05 (SD = 8.28) in non-extreme scoring infants. Infit mean square: 0.92 Outfit mean square: 0.63
Morales-Monforte et al. [39]	Spain	50	Reliability (Intra-rater)	D	ICC > 0.98
			Reliability (Inter-rater)	D	ICC = 0.98 (95% CI 0.82 to 1.00)
			Internal Consistency	VG	KR 20 scales: 0.88 to 0.99
			Construct Validity	VG	With comparison to BISD – III rs = 0 to 3 months 0.973, 4 to 8 months 0.693 9 to 18 months: 0.957
Pin et al. [41]	Australia	62	Reliability (Intra-rater)	VG	ICC = 0.99
			Reliability (Inter-rater)	VG	ICC = 0.85 to 0.97
Pin et al. [42]	Hong Kong	31	Construct Validity	A	Sub items: rs = 0.315 to 0.621 (3 areas with significant differences: 4 months supine, 12 months standing score and total score)
Piper et al. [43]	Canada	221	Reliability (Inter-rater)	A	rs = 0.996
		138 291 PT;6 International experts	Reliability (Test-retest) Content	A A	rs = 0.993 Relevance - stemmed from functional sequences and variations that occur in early motor development. Comprehensiveness − 84 items reviewed and rated by pediatric physiotherapists in Alberta and 291 members of the Paediatric Division of the Canadian Physiotherapy Association. 6 international experts to revise the 84 items to 59 items. Comprehensibility – tested for feasibility with 97 low risk normal infants; 15 minutes, no handling, minimal space, and equipment required.
		506	Construct Validity	A	when compared to BSID: rs = 0.98
				A	when compared to PDGMS: rs = 0.97
Quezada-Villalobos et al. [46]	Chile	115	Reliability (Inter-rater)	VG	Total score: ICC = 0.94 SEM of total = 3.1 points
Rizzi et al. [44]	Italy	86	Construct Validity	VG	With comparison to IMP: total rs = 0.076, Performance domain: rs = 0.89 (p < 0.001)
			Predictive Validity	VG	AUC = 0.85 (p < 0.001, 95% CI 0.77 to 0.94)
Saccani and Valentini [45]	Brazil	795	Cultural Validity	A	Comparison of Brazilian and Canadian norms: t-test: <± 2.614 (p < 0.0001)
				I	No significant differences between genders
Siegle and de Sá [47]	Brazil	75	Construct Validity	A	with comparison to BSITD 1 month: rs = 0.57 (95% CI 0.20 to 0.82), 2 months rs = 0.44 (95% CI 0.29 to 0.63), 3 months: rs = 0.03 (5% CI −0.43 to 0.48), 4 months: rs = 0.53 (95% CI 0.23 to 0.74) 4 months: rs = 0.53 (95% CI 0.23 to 0.74), 8 months: rs = 0.51 (95% CI 0.16 to 0.74), 12 months: rs = 0.59 (95% CI 0.32 to 0.78)
Silva et al. [48]	Brazil	50	Reliability (Intra-rater)	VG	ICC = 0.55 to 0.95 for categories (prone, supine, sitting and standing)
Snyder et al. [86]	United States	35	Reliability (Inter-rater)	VG	ICC = 0.98 (95% CI 0.96 to 0.99)
			Construct Validity	VG	Comparison of PDGMS-2 rs= 0.90 to 0.97
Spittle et al. [87]	Australia	87	Predictive Validity	VG	Accuracy for predicting motor impairment was good. Motor impairment on the MABC-2 (scores < or = 5th and < or = 15th) was most accurately predicted by the AIMS at 4 months, whereas cerebral palsy was most accurately predicted by the NSMDA at 12 months. Best accuracy was achieved when combining NSMDA and AIMS at 4 months as follows: MABC</= 15th Accuracy 80 (95% CI 70, 88); MABC </= 5th Accuracy 84 (95% CI 74, 91); Cerebral Palsy Accuracy 92 (95% CI 84 to 97).
Suir et al. [50]	Netherlands	499	Reliability (Inter-rater)	I	% agreement = 97.80%
			Cultural Validity	D	(Dutch) = 1.18 x (Canada), 7% proportion explained variance
Syrengelas et al. [52]	Greece	424	Reliability (Inter-rater)	D	ICC = 0.99 (95% CI 0.99 to 0.99)
			Cultural Validity	I	No significant difference with Canada norms x 2 to 3 months, no significant differences in the 5th and 90th percentile
Syrengelas et al. [51]	Greece	1441	Construct Validity	A	Total AIMS score significantly lower for premature infants (p < 0.0001) at each age category
					The rate of mean increase did not differ between premature and full-term infants.
Tse et al. [53]	Canada	121	Reliability (Inter-rater)	I	ICC = 0.72 to 0.98 for HINT and AIMS (not sub divided)
			Construct Validity	VG	With comparison to HINT 4 to 6.5m ρ = 0.831 (n = 121)
					10 to 12.5 months ρ = − 0.84 (n = 109)
Tupsila et al. [54]	Thailand	574	Cultural Validity	VG	Thai scores lower for 01, 1–2, 2–3 and 3–4 months, with a moderate to large effect size, from 6–14 Thai scores were higher. Overall Thai infant scores were significantly higher with a moderate effect size.
Valentini and Saccani [55]	Brazil	561	Reliability (Inter-rater)	D	ICC = 0.86 to 0.99
			Reliability (Intra-rater)	D	ICC = 0.915 to 0.993
			Reliability (Test-retest)	D	rs = 0.85 p < 0.001
			Internal Consistency	VG	α = 0.88
			Construct Validity		correlation with DSCB: w = 0.319, k = 0.309, McNemar-Bower test: 0.047
			Predictive Validity	I	Comparison to DSCB ICC = 0.96 (95% CI 0.89 to 0.99, p < 0.0001)
Valentini and Saccani [56]	Brazil	766	Internal Consistency	VG	Total score: α = 0.90 (subscales: 0.84 to 0.92)
			Content Validity	D	Language Clarity: k = 0.51 to 0.87 Pertinence: k = 0.82 to 0.93
			Reliability: Test-retest Inter-rater Intra-rater Construct Concurrent Validity Discriminant Validity Predictive Validity	VG VG VG VG VG VG	rs = 0.98 ICC = 0.86 to 0.99 ICC = 0.91 to 0.99 Comparison to CBDS classification moderate positive and significant correlation rs = 0.34, p = 0.03 Full-term vs preterm groups significant difference between for the raw score (t = - 4.84, p < 0.001) and percentile (t = -1.99, p < 0.05). predictive power (p < 0.001) was limited to the group of infants aged from 3 months to 9 months.
van Hus et al. [57]	Netherlands	116	Construct Validity	I	With comparison to the PDGMS rs = 0.726 p < 0.001)
van Schie et al. [58]	Netherlands	32	Predictive Validity	D	Predicting motor and mental outcome after perinatal hypoxic ischemic encephalopathy: Sensitivity 100% (95% CI 87 to 100), Specificity 80% (95% CI 48 to 80), Positive Predictive Value: 92 (95% CI 80 to 92), Negative Predictive Value (95% CI 0 to 40)
Wang et al. [59]	China	50	Reliability (Inter-rater)	VG	ICC = 0.99 (95% CI 0.98 to 0.99)
			Construct Validity	VG	With comparison to PDGMS −2: ICC > 0.90 for all subscale except RE ICC = 0.75
					k = AIMS 5th percentile cut-off 0.580 to 0.724 moderate
Yeh et al. [60]	Taiwan	29	Construct Validity	VG	Consistency of GMA results between the home and clinic recorded videos was very good (k = 0.869; P < 0.05).

Key: COSMIN RoB Score: very good (VG), adequate (A), doubtful (D), and inadequate (I); ASQ-3- GM = Ages and Stages Questionnaire; AIMS = Alberta Infant Motor Scale; AUC = area under curve; BSITD = Bayley Scale of Infant and Toddler Development; BSID – II = Bayley Score of Infant Development − 2nd Edition; BSID = Bayley Score of Infant Development; CBDS = Child Behaviour Development Scale; CI = confidence interval; DSCB = Development Scale of Child Behaviour; GMA = General Movement Assessment; HINT= Harris Infant Neuromotor Test; α = Cronbach’s alpha; ρ = Pearson’s correlation coefficient (PCC); r_s = Spearman’s ranked correlation coefficient (rho); ICC = interclass correlation coefficient; k = Cohen’s kappa; R² = Linear Regression; TIMP = Test of Infant Motor Performance; IMP = Infant Motor Profile; MABC-2 = Movement Assessment Battery for Children 2 Edition; n = sample size; NSMDA = Neuro-Sensory Motor Development Assessment; PDGMS-2 = Peabody Development Gross Motor Scale 2nd Edition; PEDI-CAT = Pediatric Evaluation of Disability Inventory Computer Adaptive Test; SD = standard deviation; SEM = standard error of measurement.

Certainty assessment

The adapted GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was used to summarize the evidence across the psychometric elements as follows: 1. high, 2. moderate, 3. low, and 4. very low certainty (see Box 2. – Step 4 [4; –] page 32–36 [92,93].

Results

Of 2361 records left following deduplication, 248 were retrieved for full-text review, we selected 95 studies which met the inclusion criteria of which 77 studies concerned clinician-reported or performance-based outcomes (Figure 2)

Figure 2.

The PRISMA diagram for study flow.

Included studies

We included 77 studies and 9789 participants analyzed: AIMS – Alberta Infant Motor Skill (n = 51 studies), LATCH – Latch, Audible swallowing, Type of nipple, Comport, Hold (n = 10 studies), Cobb Angle (n = 15 studies), Postural Assessment (n = 1 study). Table 1 cites the included studies by outcome measure and describes their characteristics, while Table 2 details the population’s age and medical condition by outcome measure. Most studies assessed a spectrum of psychometric properties, and one COA (AIMS) was comprehensive (see Tables 4 to 7 for a detailed description). Most studies used convenience samples drawn from community and government supported healthcare centers, schools, and daycares. The ages of the participants reflected the purpose of the outcome measure used. Two studies [81,82] utilizing Cobb angles did consider participants as older than 18 years. The sex of the participants was distributed evenly except for postural assessment where males were exclusively studied. Of the full-text articles screened, nine studies cited in Appendix D, addressed the validity and reliability of the Cobb angle using alternative methods from that sited in the scoping review. Convenience samples drawn from community and government supported healthcare centers, schools, and daycares were predominately use. Gender varied by the diagnoses studied.

Table 2.

Population per outcome measure.

Outcome Measure	Age of Population Studied	Medical Condition
AIMS	0–5 years old (51 studies 10,215 participants)	Neurologically compromised (145 participants) At risk (undefined) (582 participants) Preterm (<38 weeks’ gestation) (1437 participants) Chronically ill (107 participants) Exposed to human immunodeficiency virus (HIV, 75 participants) Typical (7869 participants).
LATCH	Neonates, Infants and mothers (10 studies, 1717 paired participants, 46 undetermined feeds)	Healthy infants
Cobb Angle	Children/Adolescents (15 studies, 808 participants)	Idiopathic adolescent scoliosis
Postural Assessment	Adolescents (1 study, 114 participants)	Healthy participants

Key: AIMS = Alberta Infant Motor Scale; LATCH = Latch, Audible Swallow, Type of Nipple, Comfort, Hold; HIV = human immunodeficiency virus.

Table 5.

Summary of results for LATCH.

Author (year)	Country of Origin	n	Psychometric	COSMIN Score RoB	Results
Adams and Hewell [61]	USA	25	Reliability (Inter-rater)	D	Percent agreements: 75 to 100 % between lactation consultant and researcher
					Between professional and mother rs = 0.53
Altuntas et al. [62]	Turkey	46	Reliability	D	Total score: rs = 0.85 to 0.91 (Domains: 0.65 to 0.90)
			Construct Validity	A	Correlation with IBFAT: rs = 0.71
					Correlation with MBA: rs = 0.88
Báez León et al. [94]	Spain	20	Reliability (Inter-rater)	VG	Totals; time (1) rs = 0.894 (2) rs = 0.453 (3) rs = 0.729
Chapman et al. [63]	USA	45	Reliability (Inter-rater)	A	Day 2: ICC 0.79 (95% CI 0.7 to 0.86)
					Day 4: ICC 0.78 (95% CI 0.67 to 0.86)
					Day 7: ICC 0.89 (95% CI 0.83 to 0.93)
DaConceição et al. [64]	Brazil	160	Internal Consistency	D	α global score: 0.25 to 0.32
			Reliability (Inter-rater)	A	ICC = 0.96
DaConceição et al. [65]	Brazil	160	Criterion Validity Cross-Cultural Validity	AI	applied in two specialist nurses simultaneously in the evaluation of 160 feeds in order to validate the reliability of the instrument ICC 0.96 Original version of the translation to Portuguese and back translation of the original instrument and evaluated by the judges CVI: > 0.90 (60%) evaluation of judges concordance coefficient AC 2 Gwett, 0.93 (95% CI 0.91 to 0.96).
Dolgun et al. [66]	Turkey	127	Construct Validity	VG	Comparison of BBAT rs = 0.76
Kumar et al. [67]	USA	250	Predictive Validity	VG	9 or higher during 16 to 24 hours period after birth: Sensitivity 75% Specificity 63% 1.7 times more likely to be solely breastfeeding at 6 weeks. 0 to 8 hours, 6 or more: Sensitivity 92.8% Specificity 30.0% Relative Risk: 2.3 8 to 16 hours: 7 or more: Sensitivity 89%, Specificity 34%, Relative Risk 1.8
Lau et al. [68]	Singapore	907	Structural Validity	VG	Exploratory Factor Analysis resulted in removal of C (Comfort) Confirmatory Factor Analysis 4-item: Goodness-of fit (GFI): 0.994 to 0.995, Adjusted Goodness of Fit (AGFI): 0.971 to 0.976, Incremental Fit Index (IFI): 0.993 to 0.995, Tucker-Lewis Index (TLI): 0.979 to 0.985, Comparative Fit Index (CFI): 0.993 to 0.995, Root Means Square Error of Approximation (RMSEA) = 0.042 to 0.044 5-item: GFI: 0.961 to 0.980, AGFI = 0.883 to 0.941, IFI: 0.889 to 0.957, TLI = 0.772 to 0.957, CFI: 0.886 to 0.956, RMESA: 0.086 to 0.125
			Internal Consistency	VG	α: 4-item: 0.74
					α: 5-item: 0.70
			Predictive Validity	VG	Predicting exclusive or nonexclusive breast-feeding success: 4 items: vaginally delivered (cut off 3.5 and 5.5): Sensitivity 94 to 95%, Specificity 0 to 2%, Positive Predictive Value: 25%, Negative Predictive Value 20 to 47%, Likelihood Ratio = 0.96
Riordan and Koehn [69],	USA	28	Reliability (Inter-rater) Construct validity	VGD	r = 0.11 to 0.46 percent agreement: 0.37 to 0.95 correlation with IBFAT: r = 0.69 correlation with MBA: r = 0.68

Key: COSMIN Risk of Bias (RoB) Score: very good (VG), adequate (A), doubtful (D), and inadequate (I); USA = United States of America; SD = standard deviation; α = Cronbach’s alpha; ρ = Pearson’s correlation coefficient; r_s = Spearman’s ranked correlation coefficient (rho); ICC = interclass correlation coefficient; AGFI = adjusted Goodness of Fit; BBAT = Bristol Breast-feeding Assessment Tool; CFI = Comparative Fit Index; CVI = Content Validity Index; GFI = Goodness-of fit; IBFAT = Infant Breast-Feeding Assessment Tool; IFI = Incremental Fit Index; MBA = Mother-Baby Assessment; n = sample size; RMSFA = Root Means Square Error of Approximation; TLI = Tucker-Lewis Index.

Table 6.

Summary of results for Cobb angle.

Author (year)	Country of Origin	n	Psychometric	COSMIN score RoB	Results
Adam et al. [70]	Australia	12	Reliability (Intra-rater)	I	Error ± 7.7 degrees for single reading ±5.9 degrees for multiple readings.
Allen et al. [72]	Canada	22	Reliability (Intra-rater)	D	Manual method: ICC = 0.95Semiautomated: ICC = 0.92 to 0.94
					Automated: ICC = 0.91 to 0.92
			Reliability (Inter-rater)	D	Manual method: ICC = 0.93 to 0.95 (95% CI 0.83 to 0.98)
					Semiautomated: ICC = 0.0.89 to 0.93 (95% CI 0.76 to 0.97)
					Automated: ICC = 0.83 to 0.96 (95% CI 0.63 to 0.98)
			Construct Validity	D	Correlation between manual and automated: ICC = 0.30 (95% CI 0 to 0.6)
					Correlation between semiautomated and automated: ICC = 0.30 (95% CI 0 to 0.6)
					Correlation between manual and semiautomated: ICC = 0.70 (95% CI 0.4 to 0.9) Outliers removed
Al-Bashir et al. [71]	India, Jordan, USA	28	Reliability Construct Validity	I VG	Mean standard deviations: manual: 5.28 degrees Computer algorithm: 2.64 Correlation between manual and computer algorithm: rs = 0.80
Brink et al. [73]	Netherlands	33	Reliability (Inter-rater)	D	Automated: ICC = 0.94 (95% CI 0.85 to 0.95) Manual Spinous Process (SP) angle: ICC = 0.86 (95% CI 0.68 to 0.94) Manual Transverse Process (TP) angle: ICC = 0.84 (95% CI 0.64 to 0.94)
			Reliability (Intra-rater)	D	Automated: ICC = 0.97 Manual SP angle: ICC = 0.96 Manual TP angle: ICC = 0.94
De Carvalho et al. [74]	France	20	Reliability (Inter-rater)	D	30 cm × 90cm: rs = 0.886 ICC = 0.94 (95% CI 0.92 to 0.95)
					14 cm × 42 cm: rs = 0.888 ICC = 0.93 (95% CI 0.91 to 0.95)
			Reliability (Intra-rater)	D	30 cm x 90 cm: rs = 0.0.932 ICC = 0.95 to 0.99
					14 cm × 42 cm: rs = 0.0.832 ICC = 0.91 to 0.98
			Construct Validity	I	Comparison between small films and plain-films measurements ICC = 0.95 (95% CI 0.96 to 0.97); The graphic study of agreement proposed by Altman and Bland showed discordance higher than 10 between 30 to 90 cm radiographs and small radiograph measurements for 16 of 640 measurements.
Gstoettner et al. [75]	Austria	48	Reliability (Inter-rater)	A	Manual set: ICC = 0.96 (95% CI 0.96 to 0.97)
					Digital set: ICC = 0.93 (95% CI 0.92 to 0.93)
			Reliability (Intra-rater)	A	Manual set: ICC = 0.97 (95% CI 0.94 to 0.83)
			Reliability (Intra-rater)	A	Manual set: ICC = 0.97 (95% CI 0.94 to 0.83)
					Digital set: ICC = 0.96 (95% CI 0.90 to 0.98)
Kumar et al. [76]	India	20	Reliability (Inter-rater)	A	Average 4 degrees SD ICC > 0.9
			Reliability (Intra-rater)	A	Average 2 degrees SD ICC > 0.9
Livanelioglu et al. [77]	Turkey	51	Reliability (Inter-rater)	A	ICC = 0.96 (95% CI: 0.93 to 0.97)
			Construct Validity	VG	Comparison of Cobb1 to smart mouse1: rs = 0.93 (95% CI 0.88 to 0.96)
					Comparison of Cobb1 to smart mouse2: rs = 0.87 (95% CI: 0.77 to 0.92)
Loder et al. [78]	USA	64	Reliability (Inter-rater)	I	±7 to 7.9 degrees
			Reliability (Intra-rater)	I	±6.1 to 6.9 degrees
Marchetti et al. [79]	Other: Brazil	tsp: 90	Reliability (Inter-rater)	A	Thoracic spine: ICC = 0.77 (95% CI: 0.67 to 0.84) SEM: 4.8 degrees, MDC: 9.3 degrees
		lsp: 89			Lumbar spine: ICC = 0.87 (95% CI: 0.76 to 0.89) SEM: 3.8 degrees MDC: 7.5 degrees
			Reliability (Intra-rater)	I	Thoracic spine: ICC = 0.75 (95% CI: 0.68 to 0.82) SEM: 5.2 degrees, MDC: 10.2 deg
					Lumbar spine: ICC = 0.76 (95% CI: 0.69 to 0.82) SEM: 4.3 degrees, MDC: 8.5 deg
			Construct Validity	D	Compared to measuring apex angle and linear measurements: Thoracic spine: rs = 0.791 p < 0.001)
					Lumbar spine: rs = 0.689, p < 0.001)
Mehta et al. [80]	Korea	318	Reliability (Inter-rater)	D	rs = 0.986 (both endplate and pedicle measurement)
			Reliability (Intra-rater)		Endplate measurement rs = 0.980
				D	Pedicle measurement rs = 0.986
Pruijs et al. [81]	Netherlands	41	Reliability	I	Measurement error, 40 degrees of freedom, Range 6 to 48 degrees SD 3.67 degrees
Safari et al. [82]	Iran	14	Construct Validity	I	“New” semi-automated method compared to gold standard difference in mean was 4 degrees
Stokes and Aronsson [83],	USA	27	Reliability (Inter-rater)	I	2.3 to 2.7 degrees
			Reliability (Intra-rater)	I	1.8 to 2.4 degrees
Xiaohua et al. [84]	USA	20	Reliability (Inter-rater)	D	Manual method: ICC = 0.92
					Digital method: ICC = 0.97

Key: COSMIN RoB Score: very good (VG), adequate (A), doubtful (D), and inadequate (I); USA = United States of America; ICC = interclass correlation coefficient; SD = standard deviation; p = probability level; r_s = Spearman’s ranked correlation coefficient (rho); ICC = interclass correlation coefficient; MDC = minimal detectable change; SEM = standard error of measurement.

Table 7.

Summary of results for postural assessment.

Author (Year)	Country of Origin	n	Psychometric	COSMIN RoB	Results
Watson and Mac Donncha [85],	Ireland	114	Reliability (Intra-rater) Reliability (inter-rater)	I I	10-items for Bland and Altman plot % agreement = 86.6% to 100% 10-items for Bland and Altman plot % agreement = 93.3 to 100%

Key: COSMIN RoB Score: very good (VG), adequate (A), doubtful (D), and inadequate (I); n = sample size.

Excluded studies

We excluded 169 studies for the following reasons: 1) the participants were adults; 2) the COA was not on the pre-identified list from the scoping review; 3) more than 20% of the population under research was over 18 years of age; and 4) psychometric properties did not address reliability, validity, responsiveness, and information related to the interpretability and feasibility of the reported outcome measure.

Risk of bias

The quality of research was judged per psychometric property reported, not per study. Research quality was judged to be adequate or very good in 31% for reliability and 43% for validity with the most common sources of bias being poor statistical analysis, unclear methodology, and small population numbers (see Table 3).

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. Allen 208 (D)).

COA	Content Validity Structural Validity	Reliability	Validity (Construct, Cross-cultural, Criterion)
Criteria Rating	Internal Consistency	Measurement Error	Responsiveness	Overall Rating across Measurement Properties	Certainty of Evidence (GRADE)
AIMS	Content Validity: -Relevance founded on functional sequences in early motor development. Piper (1992)¶ (A); -Pertinence: (k) = 0.82 to 0.93 (1 study, n = 766) Valentini (2012) (D) -Comprehensiveness 84-items reduced to 56-items by 291 PTs and 6 international experts. Piper (1992)¶ (A) -Comprehensibility feasibility tested(1 study, n = 291 PT and 6 experts) Piper (1992)¶ (A) - PROM item’s assessed and appropriately worded: assessed clarity k = 0.51 to 0.87 (1 study, n = 766) Valentini (2012) (D) Structural Validity: Rasch Analysis = 51.05 (SD 8.28) (1 study, n = 97) Pai-jun (2004) (D) Internal Consistency: α = 0.88 to 0.99, (4 studies, n = 1437), Lackovic (2020) (I), Morales-Monforte (2017) (VG), Valentini (2011) (VG), Valentini (2012) (VG)	Test-retest: α = 0.85 to 0.998 (4 study, n = 1525)Lackovic (2020) (I), Valentini (2012) (VG), Piper (1992) (A), Valentini (2011) (D) Intra-rater: ICC = 0.55 to 0.99, (8 studies, n = 1720) Aimsamrarn (2019) (I)Albuquerque (2018) (VG), Boonzaaijer (2017) (VG), Jeng (2000) (A), Morales-Monforte (2017) (D), Pin (2010) (VG), Silva (2013) (VG), Valentini (2011) (D), Valentini (2021) (VG) Inter-rater: ICC = 0.55 to 0.99, (23 studies, n = 2962) Aimsamrarn (2019) (I), Albuquerque (2018) (VG), Almeida (2008) (VG), Bartlett (2003) (D), Blanchard (2004) (D), Boonzaaijer (2017) (VG), Darrah (1996) (VG), Darrah (1998b) (D), Fleuren (2007) (A), Jeng (2000) (A), Krosschell (2018) (VG), Ga (2011) (I), Lackovic (2020) (I), Morales-Monforte (2017) (D), Pin (2010) VG, Piper (1992) (A), Quezada-Villalobos (2010) (VG), Snyder (2008) (VG), Suir (2019) (I) Syrengelas (2010) (A), Tse (2008) (I), Valentini (2011) (D), Wang (2018) (VG) Measurement error:- SEM = 0.92 to 0.96 (1 study, n = 48) Boonzaaijer 2017 (VG) - SEM varied by age (1 study, n = 45) Jeng 2000 (A) - SDC NR - LoA NR	Construct Validity: -Comparison of ASQ-3-GM rs = 0.697 (1 study, n = 37) Fauls (2020) (VG) -Comparison to BSID or BSID-II or BSID-III or BSITD had varied results rs = 0.36 to 0.969(10 studies, n = 879) Aimsamrarn (2019) (D), Almeida (2008) (VG), Campos (2006) (I), Darrah (1996) (VG), Harris (2010) (VG), Hoskens (2018) (D), Jeng (2000) (VG), Morales-Monforte (2017) (VG), Piper (1992) (A), Siegle (2018) (A) -Comparison with CBDS classification rs = 0.34 (1 study, n = 766) Valentini (2012) (VG) -Comparison with DSCB k = 0.309 (1 study, n = 561) Valentini (2011) (I) -Consistency of GMA results between the home and clinic recorded videos k = 0.869 (1 study, n = 29) Yeh (2020) (VG) -Comparison to HINTat 4 to 6 months rs = 0.831 or 10 to 12.5 months, rs = - 0.84 (1 study, n = 121) Tse (208) (VG) -Comparison to PDGMS or PDGMS-2 rs = 0.72 to 0.97 or ICC > 0.90 (4 studies, n = 287) Piper (1992) (A), Snyder (2008) (VG), van Hus (2013) (I), Wang (2018) (VG)	(+) sufficient	High ⊕⊕⊕⊕
			-Comparison to TIMP or IMP rs = 0.64 to 0.91 or rs = 0.37 to 0.54 through the various ages (5 study, n = 1111) Campbell (2000) (VG), Chiquetti (2020) (D), Heineman (2013) (VG), Heineman (2013) (VG), Rizzi (2021) (VG) -Comparison to TIMP at 30, 60 and 90 days: ICC = 0.20 to 0.67 (1 study, n = 96) Campbell (2002) (VG) -Comparison of the PEDI-CAT: rs = 0.32 (1 study, n = 53) Dumas (2015) (A) -Comparison sub-items at varied ages and positions significant differences identified (1 study, n = 31) Pin (2020) (A) -Comparison premature vs other age categories p < 0.0001 (1 study, n = 1441)Syrengelas (2016) (A) -Comparison of original and contemporary norms: ICC = 0.99 (1 study, n = 650) Darrah (2014) (VG) Cross-cultural Validity: -Significantly more Dutch children score below the cut off scores (1 study, n = 118) Fleuren (2007) (VG) -Comparison of Brazilian and Canadian norms: t-test: < 2.614 -Comparison of Greece and Canadian norms: no significant difference -Comparison of Thai score and Canadian norms: significantly higher (3 study, n = 2110) Saccani (2012) (A), Syrengelas (2010) (I), Tupsila (2020) (VG)
			Criterion Validity:-Predictive validity -10th percentile cut-off had varied results Sensitivity 75.8%, Specificity 92.9% (4 study, n = 642) Albuquerque (2018) (I), Darrah (1998) (VG), Ga (2022) (VG), Harris (2020) (VG) -Abnormal vs suspicious: 8th month: varied results, Sensitivity 100%, Specificity 90.8% (2 study, n = 125+164) Darrah (1996) (VG), Darrah (1998) (VG) -High false positive rate at 4 month, improved at 7 months (1 study, n = 39) Fetters (2000) (D) -Predict BSID of various levels <85; <70 at 4 months or 10 to 12 months (see 7) (1 study, n = 160) Lefebvre (2016) (VG) -Predict DSCB ICC = 0,96 (1 study, n = 561) Valentini (2011) (I) -Predict IMPAUC = 0.85 (1 study, n = 86) Rizzi (2021) (VG) -Predict MAABC-2 scores or NSMDA at 4 or 12 months: Accuracy 80 to 92% (1 study, n = 87), Spittle (2015) (VG) -Predicting motor and mental outcome after perinatal hypoxicischaemic encephalopathy Sensitivity 100%, Specificity 80%, van Schie (2010) (D) -Predictive power limited to group of infants aged 3 months vs 9 months p < 0.001 (1 study, n = 766) Valentini (2012) (VG) -Concurrent validity-3 subgroups different F = 11.03, df 59, p < 0.001 (1 study, n = 60)Bartlett (2003) (VG) -Comparison live and home video ICC = 0.99 (1 study, n = 48) Boonzaaijer (2017) (VG) Responsiveness: SDC N R; MIC N R; ROC NR
Criteria Rating	+|+|+	+|+	+|+|+|?
LATCH	Content Validity: NR Structural Validity: Exploratory Factor Analysis resulted in removal of C (Comfort), Confirmatory Factor Analysis 4-items GFI 0.994 to 0.995 (1 study, n = 907) Lau (2016) (VG) Internal Consistency: 5-item α = 0.25 to 0.70, 4-item α = 0.74 (2 studies, n = 1067) Da Conceicao (2017) (D), Lau (2016) (VG)	Inter-rater: ICC = 0.79 to 0.96, (7 studies, n = 484) Adams (1997) (D), Altuntas (2014) (D), Baez Leon (2008) (VG), Chapman (2016) (A), Da Conceicao (2017) (A), Da Conceicao (2018) (A), Riordan (1997) (VG) Test-retest: NR Measurement error: SEM NR; SDC NR; LoA NR	Construct Validity: -Comparison on Infant Breast-Feeding Assessment Tool rs = 0.69 to 0.71, (2 studies, n = 74) Altuntas (2014) (A), Riordan (1997) (D) -Mother-Baby Assessment rs = 0.88, (2 studies, n = 74) Altuntas (2014) (A), Riordan (1997) (D) -Bristol Breast-feeding Assessment Tool rs = 0.76, (1 study, n = 127), Dolgun (2018) (VG) Cross-cultural Validity: Forward and back translation to Portuguese CVI >0.90 (60%)(1 study, n = 160) Da Conceicao (2018) (I) Criterion Validity: -Predictive -9 or higher during 16 to 24 hours period after birth: Sensitivity 75%, Specificity 63% (1 study, n = 250) Kumar (2006) (VG) -Predicting exclusive or nonexclusive breast-feeding success: 4 items: (cut off 3.5 and 5.5): Sensitivity 94 to 95%, Specificity 0 to 2%, Likelihood Ratio = 0.96, ROC analysis confirmed high sensitivity (1 study, n = 907) Lau (2016) (VG) Responsiveness: SDC NR; MIC NR; ROC NR	(+) sufficient	MODERATE ⊕⊕⊕⊝ downgraded due to imprecision (-1: total 10 studies, n < 100; no meta-analysis)
CriteriaRating	?|+|+	+|?	+|-|+|?
Cobb Angle	Content Validity: NA Structural Validity: NA Internal Consistency: NA	Intra-rater: ICC = 0.92 to 0.97, or rs = 0.980 (10 studies, n = 654) Adam (2005) (I), Allen (2008) (D), Brink (2018) (D), DeCarvalho (2007) (D), Gstoettner (2007) (A), Kumar (2009) (A), Lodar (2004) (I), Marchetti (2017) (I), Mehta (2009) (D), Stokes (2006) (I) Inter-rater: ICC = 0.75 to 0.96, or rs = 0.986 (11 studies, n = 713) Allen (2008) (D), Brink (2018) (D), DeCarvalho (2007) (D), Gstoettner (2007) (A), Kumar (2009) (A), Livanelioglu (2016) (A), Lodar (2004) (I), Marchetti (2017) (A), Mehta (2009) (D), Stokes (2006) (I), Xiaohua (2013) (D) Test-retest: NA Measurement error:- SEM 40 degrees of freedom(1 study, n = 41) Pruijs 1995 (I) - SEM 4.8 degrees thoracic and SEM 3.8 degrees lumbar (1 study, n = 90) Marchetti (2017) (A) - MDC thoracic spine 9.3 degrees and MDC lumbar spine 7.5 degrees (1 study, n = 90) Marchetti (2017) (A) - LoA NR	Construct Validity: -Comparison manual and automated ICC = 0.30 -Comparison manual and semiautomated (outliers removed) ICC = 0.70 (1 study, n = 22) Allen (2008) (D) -Comparison manual and computer algorithm rs = 0.80 (1 study, n = 28) Al-Bashir (2019) (VG) -Comparison between small films and plain-films measurements ICC = 0.95 (1 study, n = 20) De Carvalho (2007) (I) -Comparison of Cobb1 to smart mouse1 or smart mouse2: rs = 0.93 and 0.87 (1 study, n = 51) Livanelioglu (2016) (VG) -Compared to measuring apex angle and linear measurements: Thoracic spine: rs = 0.79 (1 study, n = 90) Marchetti (2017) (D) -“New” semi-automated method compared to gold standard difference in mean was 4 degrees (1 study, n = 14) Safari (2019) (I) Cross-cultural Validity: NA Criterion Validity: NA Responsiveness: SDC NR; MIC NR; ROC NR	(?) indeterminate	LOW ⊕⊝⊝⊝downgraded due to limitation in inconsistency (-1: numerous studies are rated doubtful or inadequate in study design); indirectness (-1: about 20% of population was between 18 to 40 years of age)
Criteria Rating	NA|NA|NA	+|+	+|NA|NA|?
Postural Assess-ment	Content Validity: NR Structural Validity: NA Internal Consistency: NA	Intra-rater:10-items for Bland and Altman agreement 86.6 to 100%, (1 study, n = 114)Watson (2000) (I) Inter-rater:10-items for Bland and Altman agreement 93.3 to 100%, (1 study, n = 114)Watson (2000) (I) Measurement error: SEM NR; SDC NR; LoA NR	Construct Validity: NR Cross-cultural Validity: NR Criterion Validity: NR Responsiveness:- SDC NR; MIC NR; ROC NR	(?) indeterminate	VERY LOW ⊝⊝⊝⊝ downgraded due to limitation in risk of bias (-2: COSMIN score= inadequate, only agreement was assessed; poor statistical analysis) indirectness (-1: biased population) imprecision (-1: one study with sample size n = 114)
CriteriaRating	?|NA|NA	?|?	?|?|?|?

Key: ¶ Piper and Darrah 1994 (text book) detail theories of motor development and construction of a Motor Assessment Tool for the Developing Infant. COA = clinical outcome assessment; Criteria Rating: “+” = sufficient, “−” = insufficient, “?” = indeterminate, consistent with criteria defined in Table 1 from [88]AIMS = Alberta Infant Motor Scale; BSID = Bayley Score of Infant Development; CBDS = Child Behavior Development Scale; CVI = Content Validity Index; DSCB = Development Scale of Child Behaviour; GFI = Goodness of Fit Index; GMA = General Movement Assessment; LATCH = “L” identifies how well the infant latches onto the breast. “A” identifies the amount of audible swallowing noted. “T” identifies the mother’s nipple type. “C” identifies the mother’s level of comfort. “H” indicates the amount of help the mother needs to hold her infant to the breast; LoA = Limits of Agreement; MIC = Minimal important change; α = Cronbach’s alpha; ρ = Pearson’s correlation coefficient; r_s = Spearman’s ranked correlation coefficient (rho); ICC = interclass correlation coefficient; k = Cohen’s kappa; MABC-2 = Movement Assessment Battery for Children 2 Edition; n = sample size; NSMDA = Neuro-Sensory Motor Development Assessment; NA = not applicable; NR = not reported; PDGMS = Peabody Development Gross Motor Scale; PEDI-CAT = Pediatric Evaluation of Disability Inventory Computer Adaptive Test; ROC = receiver operation curve; SDC = smallest detectable change; SEM = standard error of measurement; TIMP = Test of Infant Motor Performance.

Main results by clinical outcome assessment

Table 3 summarizes the main findings with overall ratings by COA and the GRADE with certainty of evidence and related reasons of downgrading. The main psychometric properties can be found in Table 4 for AIMS, Table 5 for LATCH, Table 6 for Cobb angle, and Table 7 for Postural.

Performance-based outcomes

• Alberta Infant Motor Scale (AIMS)

The Alberta Infant Motor Scale has a predictive purpose to classify motor learning. It is an observational assessment scale that assesses gross motor maturation and skills in infants from ages 0 to 18 months with typical development or those with developmental delay or atypical patterns. It measures weight bearing, posture, and antigravity movements of infants. Fifty-one studies examined the psychometric properties of AIMS (Table 4). Population studies included healthy, preterm, chronically ill, neurologically compromised, and infants exposed to HIV (human immunodeficiency virus). Content validity (two studies, n = 1057) was assessed for relevance, comprehensiveness, comprehensibility, and appropriate wording. Forty-six properties of the validity domain were studied, including construct, predictive, criterion, concurrent, structural, and cultural validity. With the exception to one outlier [47], there is a moderate to strong correlation with other outcome measures intended to evaluate motor performance of infants. Thirty-eight properties of the reliability domain were studied. If >0.70 is considered a significant ICC value, then all studies show an acceptable inter-rater reliability. Apart from one outlier [48], the range showed acceptable inter-rater reliability ICC = 0.85 to 0.99. High certainty evidence supports the use of AIMS with responsiveness needing further research. The overall rating was sufficient (+). There were greater number of large studies of lower risk of bias across all psychometric domains exploring different aspects of reliability. Construct validity explored numerous hypotheses with large trials (see Table 3).

Clinician-reported outcomes

• LATCH

The quality of breastfeeding is evaluated using the evaluative measure LATCH [95]; each letter of the acronym indicates an area of assessment. ‘L’ identifies how well the infant latches onto the breast. ‘A’ identifies the amount of audible swallowing noted. ‘T’ identifies the mother’s nipple type. ‘C’ identifies the mother’s level of comfort. ‘H’ indicates the amount of help the mother needs to hold her infant to the breast. Structural validity using confirmatory factor analysis on 4-items removing one item C (Comfort). Internal consistency improved with four items (α = 0.74) versus five items (α = 0.25 to 0.70) as well. Six further elements of validity and seven of inter-rater reliability were studied (Table 5) in a population of healthy newborns and infants. The certainty of evidence was judged to be moderately downgraded due to imprecision (−1: total 10 studies, n < 100; no meta-analysis). The overall rating was sufficient (+) (see Table 3).

• Cobb Angle

Cobb Angle has a discriminative purpose used with scoliosis. It is a standard measurement to determine the presence of and track the advancement of scoliosis. Of 15 studies (see Table 6), six assessed validity and 12 various aspects of reliability. All studies correlated different novel methods of digital measurements versus a traditional reading but did not directly address the validity of measuring the Cobb angle as an indication of disease severity. The certainty of the evidence was low downgraded due to limitation in inconsistency (−1: numerous studies are rated doubtful or inadequate in study design) and indirectness (−1: about 20% of population was between 18 to 40 years of age). The overall rating of the Cobb Angle was indeterminate (?) (see Table 3).

• Postural Assessment

A postural assessment can involve observation of static posture for symmetry and alignment of anatomic landmarks. It may be visual or use a palpation assessment. The patient is directed to stand with feet shoulder-width apart and arms relaxed to the sides. One study (Watson and Mac Donncha, 2020; Table 7) examined intra-rater and inter-rater reliability of postural assessment in male adolescents using a photographic method. The certainty of the evidence was very low downgraded due to limitations in risk of bias (−2), imprecision (−1), and indirectness (−1). We could not find reports on validity or responsiveness. The overall rating of postural assessment was indeterminate (?) (see Table 3).

Discussion

We evaluated the psychometric properties on four of 18 pre-identified COAs used to determine the effectiveness of spinal manipulation and mobilization for various medical conditions in a pediatric population [2]. One performance-based outcome (AIMS) and one clinician-reported outcome measures (LATCH) had sufficient information; AIMS had high certainty evidence, and LATCH had moderate, but both lacked sufficient assessment on responsiveness.

Overall completeness and applicability of evidence

The context and purpose of this systematic review was to determine if the included COAs can and should be used to evaluate the effectiveness of spinal manipulation or mobilization for various medical conditions in a pediatric population. We questioned if the identified COAs were fit for this purpose. Whilst we determined that one performance-based outcome and one clinician-reported outcome measure have high to moderate levels of certainty, respectively, they both lacked assessment on responsiveness. The COA may have poor responsiveness to detect change, and a treatment effect may not be detected, when one exists, in other words, leading to a false-negative result or to a failed trial. Additionally, the greatest level of certainty is to use a COA that was developed and assessed in the target patient population in which it will be used. The construct underpinning the clinical reasoning in performing a manipulation and mobilization in diverse medical conditions remains unclear.

The AIMS is a well-researched performance-based outcome tool used to determine motor development in infants [23]. We have high certainty that it is a reliable and valid tool that gives appropriate results for the staging of infants’ motor development. One randomized control study that utilized AIMS as a chosen outcome measure was identified through a scoping review. The effect of manual therapy on non-synostotic plagiocephaly were examined [96]. It is beyond the scope of the paper to determine if manipulation or mobilization is an effective treatment technique for plagiocephaly; however, the scientific basis of this construct is in debate [97]. Considering the objective of this study, AIMS was an appropriate outcome measure for assessing motor development; however, since responsiveness is not reported, it may be inadequate in this medical condition.

It has been suggested that chiropractic manipulation is an effective treatment option to improve breastfeeding due to mechanical restriction of the infant’s cervical spine and temporomandibular joint [98–100]. Fry [101] completed a literature review regarding the role of chiropractic care and breastfeeding. Chiropractic care was identified to be beneficial if there was a biomechanical limitation to breastfeeding. Successful treatment was aimed at the cranial sutures, temporomandibular joint, and cervical spine, particularly the atlantoaxial joint. Again, the scientific basis of this construct of thinking is lacking, and it is hard to find evidence for the relation between, for example, movement of the cranial sutures and breastfeeding. One randomized control study was identified by the scoping review [2]. Mother-infant dyads were randomized to either a group with a lactation consultation and sham osteopathic treatment or a group with a lactation consultation and osteopathic treatment [102]. The biological rationale does not seem plausible that manipulation or mobilization should have a positive effect on breastfeeding and is without any evidence. The LATCH tool was presented by Jensen and colleagues [95] as a clinician-reported outcome that assesses the quality of the LATCH, audible swallowing, nipple type, comfort, and hold to measure the effectiveness of breastfeeding. Research from this review demonstrates that LATCH has a moderate certainty of evidence for reliability and validity. Regarding responsiveness, there was no evidence found. It is beyond the scope of this paper to draw conclusions regarding the effectiveness of treatment utilizing manipulation or mobilization, to improve the infant’s biomechanics of breastfeeding. It is unclear if the LATCH is an appropriate tool to measure responsiveness to changes in breastfeeding.

Quality of the evidence

A thorough methodological assessment of included studies using the robust and validated COSMIN checklist across a variety of outcome measures identified that the limitations in the retrieved articles were poor statistical analysis, poor methodological reporting, and low sample size. A thoughtful and strategic approach to instrument selection in clinical trials is a unique challenge.

Potential biases in the review process

Our medical information specialist was unable to limit the search parameters to the medical conditions discussed in the scoping review due to the vague definition of medical conditions within the identified studies in the scoping review [2]. Additionally, we did have language restrictions, our search included only English, Spanish, Dutch, French, and German articles. We maximized the inter-rater reliability for the COSMIN score by organizing group consensus discussions on three occasions during the review process to ensure calibration and interpretation of checklist items.

Agreements and disagreements with other studies or reviews

No other systematic reviews assessing the psychometric properties of LATCH and posture assessment were identified for pediatric conditions. We found reviews on the measurement of the Cobb angle, but these reviews did not mention a pediatric population. Three systematic reviews regarding the AIMS agreed with our review [49,103,104]. They concluded that the AIMS was valid and reliable but was not ideal for use with preterm infants and lacked predictive value. Spittle et al. [89] concluded that the AIMS was good at predicting motor impairment of corrected age preterm infants, with the most consistent results at 4 months. Albuquerque et al. also found a small ceiling effect. Kjølbye et al. [105] differed from our review in that they also stated that AIMS was valid for staging motor skills as confirmed with Peabody Developmental Gross Motor Scale and with Bayley Score of Infant Development. None of the reviews found data on responsiveness, similar to our findings.

Conclusion

The AIMS has a high and LATCH moderate certainty of evidence and demonstrated sufficient measurement properties to be used in clinical practice. Neither had sufficiently assessed responsiveness.

High-quality research assessing the psychometric properties of diagnostic and evaluative tools utilized with pediatric populations is needed to fill the gap for those utilizing spinal manipulation or mobilization to manage a variety of medical conditions in infants, children, and adolescents. Furthermore, a focus on responsiveness is needed.

Biographies

Tricia Hayton is a private practitioner in Oakville, Ontario, Canada. She was a graduate student of the OMPT program at McMaster University and completed this work as part of her research requirements.

Anita Gross is an Associate Clinical Professor at McMaster University on the School of Rehabilitation Sciences leading their advanced orthopedic musculoskeletal-manipulative physical therapy (OMPT) program. She is a lecturer in the Master’s of Clinical Science program in Manipulative Therapy at Western University and the Canadian Physiotherapy Association AIM program. She is the chair of the IFOMPT/IOPTP Taskforce on Pediatric Manipulation informing PT policy with systematic reviews and evidence gap maps. She is a clinician scientist and educator. She has over 150 peer reviewed publications, has been principal/co-investigator on 30 grants and has been an invited speaker at 20 international conferences. She coordinates the Cervical Overview Group, an International Network that conducts and maintains Cochrane systematic reviews on neck pain and participates in randomized clinical trials on back pain (Welback). She works in private practice OMPT and is a Fellow of the Canadian Academy of Manipulative Physiotherapy (FCAMPT).

Annalie Basson is a clinician and part-time lecturer at the University of Witwatersrand, Johannesburg, South Africa working in private practice in Pretoria.

Ken Olson is the president and co-owner of the physical therapy private practice Northern Rehab Physical Therapy Specialists in DeKalb, Illinois and is adjunct faculty for Northern Illinois University. He is a Past-President of both the International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) and the American Academy of Orthopaedic Manual Physical Therapists (AAOMPT).

Oliver Ang primary research interests are innovative interventions using digital technologies to address cervical disorders and contextual factors, particularly therapeutic alliance, in physical therapy treatments. He is currently involved in the Spinal Manipulation and Patient Self-Management for Preventing Chronic Back Pain (PACBACK), the Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT) and Partners4Pain studies, funded by the US National Institute of Health (NIH). He is a member of the validity assessment team of the Cervical Overview Group.

Nikki Milne works as an Associate Professor of Physiotherapy (Paediatrics) at Bond University where she has worked for the past 16 years. Prior to starting work in the academic setting Nikki worked as a Paediatric physiotherapist for NSW Health which led to her research interests in child health and wellbeing and paediatric curriculum. Nikki has a special interest in child health, learning and paediatric physiotherapy and is passionate about the inclusion of paediatric curriculum in entry-level physiotherapy programs, to ensure that all graduates of accredited entry-level programs have knowledge and skills to safely and effectively work with children.

Jan Pool has worked as Associate Professor Institute of Human Movement Studies, Faculty of Health Care and as a Coordinator/Head of Master Program Physical Therapy division; Orthopedic Manual Therapy. He was senior researcher of Research Group Lifestyle and Health, HU University of Applied Sciences Utrecht, Utrecht, The Netherlands. He worked as a manual therapist for over 30 years in a private clinic. His scientific interest culminated in a master degree in epidemiology in 2003 and a doctorate in medicine in 2007 both at the Free University Amsterdam. He wrote numerous articles on the topics neck pain, chronic pain and manipulative therapy and has a special interest in clinimetry. He was a member of the board of the Dutch Association of Manual therapy in The Netherlands (NVMT), from 1990 till 1998. From 2000-2016 he was a member of the Standard Committee of the International Federation of Manipulative Physical Therapy (IFOMPT).Jan became a member of the Spinal Manipulation Taskforce in 2020.

Funding Statement

The work was supported by the Canadian Academy of Manipulative Therapy Student Research Fund.

Disclosure statement

No authors have declared any conflict of interest.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10669817.2023.2269038