Bayley Scales of Infant and Toddler Development, Third Edition

Instrument Name: Bayley Scales of Infant and Toddler Development, Third Edition

Abbreviation: Bayley-III

Points for Consideration:

Bayley 4 should be used if possible.

Description of Tool:

The Bayley-III is a ClinRO measure designed to assess functional and cognitive abilities in infants from 1 to 42 months. This version of the tool is No longer supported, but may still be used in long-standing trials or natural history studies.

Other Related Tools (if applicable):

Bayley 4

Minimum Qualification Required by COA Administrator: MA or BA

Comment:

The Bayley-III is a revision of the Bayley Scales of Infant Development - Second Edition (BSID-II), developed in 1993

Year: 2005

Objective of Development:

To identify children with developmental delay and to provide information for intervention planning

Population of Development: Age range (therapeutic indication):

1 to 42 months (Generic for Mental Disorders)

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

Congenital, Hereditary and neonatal diseases and Abnormalities; Nervous system diseases; Musculoskeletal diseases; Mental disorders; Cardiovascular diseases; Nutritional and Metabolic Disorders; Virus Diseases; Bacterial Infections and mycoses; Digestive system diseases; Respiratory tract diseases; Immune system diseases; Female Urogenital Diseases and Pregnancy Complications

COA type: PerfO

Number of Items 602

Mode of Administration: Clinician-rated

Data Collection Mode: Paper and pen

Time for Completion: 30 to 90 minutes (depending upon age of child)

Response Scales: Varies by item: Dichotomous: Yes or No; 4 and 6- point verbal rating scale

Summary of Scoring:

Available Scores:
Score by domains range from 1 to 19

Weighting: Not reported

Score Interpretation:
Higher score= Better performance

Evidence of Literature Review: None identified

Evidence of Instrument Review: Yes

Evidence of Clinical or Expert Input: Yes

Evidence of concept elicitation in target patient population: None identified

Evidence of a Saturation Grid: None identified

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period: Present time

Evidence for Selection of Reponse Options: None identified

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

Evidence of Preliminary Scoring of Items and Domains: None identified

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: None identified

Evidence of an item-tracking matrix: None identified

Evidence related to item selection: None identiifed

Evidence of re-testing the final version: None identified

Internal consistency (Cronbach's alpha): Yes

Evidence of internal consistency: Available on Pearson website

Test-retest Reliability (ICC):

Young NL (2009)

Paper-version:
- Intraclass Correlation Coefficient (ICC): 0.987
- Was a definition of stability applied to identify stable patients: No
- Time frame or interval between the two administrations: Mean time: 23 days
- Population/Dise

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

Not reported

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

Concurrent validity (convergent, divergent):

Delaney A (2014)
Correlation coefficient used: Not stated
Measure: Correlation between BSID-III and Vineland Adaptive Behavior Scales (VABS-II) in a group of patients with mucopolysaccharidosis (MPS) IIIA (n= 25) or IIIB (n= 17)
Results:
A correlation was found (p: Not stated) between BSID-III and VABS-II in the MPS IIIA group: r= 0.98
A correlation was found (p: Not stated) between BSID-III and VABS-II in the MPS IIIB group: r= 0.85
Population/Disease: Patients with MPS IIIA or IIIB; n= 42
Age was 75 (±53) months for MPS IIIa group
Age was 156 (±111) months for MPS IIIb group

Known-group validity:

None identified

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: None identified

Evidence of Administration Instructions and Training Provided: Yes

Evidence of concurrent validity: Yes

Evidence of known-groups validity: None identified

Evidence of ability to detect change over time: None identified

Ability to detect change (Responsiveness):

None identified

Responder Thresholds:

None identified

Evidence of responder thresholds: None identified

[Conference Abstract] Delaney KA, Whitley C, Clear M, et al. MPS IIIA and MPS IIIB: a preliminary comparison of disease trajectory, using baseline data from two independent natural history studies. Molecular Genetics and Metabolism. 2014 Feb; 111(2):S35-S36 (https://www.sciencedirect.com/science/article/pii/S1096719213004988?via%3Dihub)

Pearson’s Clinical Assessment group. Bayley Scales of Infant and Toddler Development | Third Edition [Internet]. Bloomington, USA: Pearson; Consulted on March 23rd. Available from: https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-Assessments/Behavior/Adaptive/Bayley-Scales-of-Infant-and-Toddler-Development-%7C-Third-Edition/p/100000123.html#tab-details

Yes

Evrysdi (FDA, 2020):
Results: Of the patients who were treated with the recommended dosage of EVRYSDI 0.2 mg/kg/day, 41% (7/17) were able to sit independently for ≥ 5 seconds (BSID-III, Item 22) after 12 months of treatment. These results indicate a clinically meaningful deviation from the natural history of untreated infantile-onset SMA. As described in the natural history of untreated infantile-onset SMA, patients would Not be expected to attain the ability to sit independently, and No more than 25% of these patients would be expected to survive without permanent ventilation beyond 14 months of age.

Zolgensma (EMA, 2020):
Results: In addition to survival, thirteen patients confirmed the milestone of independent sitting for at least 30 seconds at the 18 month visit (co-primary endpoint, p<0.0001). One patient achieved the milestone of sitting independently for 30 seconds at 16 months of age, but this milestone was Not confirmed at the Month 18 visit. The video-confirmed developmental milestones for patients in Study CL-303 are summarized in Table 4. Three patients did Not achieve any motor milestones (13.6%) and six patients (27.2%) achieved head control as the maximum motor milestone before the 18 months of age final study visit.

[Please see Table 4 in the sub worksheet "Zolgensma_EMA_BSID3"]

Yes

Original Language: English for the USA

Translations:
Bengali for India
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Nancy Bayley

Contact information
Pearson Assessment
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USA

Elizabeth Werner and Dr. Paul Williams from Pearson Research Services
E-mail: research.licensing@pearson.com

*With fees for academic/Non profit research
*With fees for commercial/pharmaceutical companies
*With the signature of a contract/agreement
*Other: Please contact Pearson Assessment, Inc.

Bayley Scales of Infant and Toddler Development, Third Edition © Pearson, 2005. All rights reserved.

Please contact Pearson Assessment, Inc

Bayley Scales of Infant & Toddler Development Ed 3 (pearsonassessments.com)

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