Evidence map›Paper›PMID 34514868›Full record

ArticleThe Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association2022

Infant with Clefts Observation Outcomes Instrument (iCOO): A New Outcome for Infants and Young Children with Orofacial Clefts.

Todd C Edwards, Carrie L Heike, Kathleen A Kapp-Simon, Salene M Jones, Brian G Leroux, Laura P Stueckle, Claudia Crilly Bellucci, Janine M Rosenberg, Meredith Albert, Cassandra L Aspinall and 1 more

Abstract read
In one paragraph

Article in The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Proxy- and Patient-Reported Outcome Measures in Cleft Lip and/or Palate Under 8 Years of Age: A Scoping Review.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  2. Observations by Caregivers Using the Infant with Clefts Observation Outcomes Instrument (iCOO): A Comparison of Three Versus Seven-day Daily Diaries.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2024
    Observational
  3. Caregiver Observations of Infant Well-Being Before and After Cleft Lip Surgery.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2024
    Article
  4. Exploration of Caregiver Interrater Agreement and Test-Retest Reliability on the Infant Cleft Observer Outcomes (iCOO).The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Todd C Edwards7284University of Washington, Seattle, WA, USA.ORCID 0000-0001-9990-9318
Carrie L Heike7284University of Washington, Seattle, WA, USA.ORCID 0000-0003-2178-7730
Kathleen A Kapp-SimonShriners Hospital for Children, Chicago, IL, USA.
Salene M JonesFred Hutch, Seattle, WA, USA.
Brian G Leroux7284University of Washington, Seattle, WA, USA.
Laura P StueckleSeattle Children's Research Institute, Seattle, WA, USA.
Claudia Crilly BellucciShriners Hospital for Children, Chicago, IL, USA.
Janine M RosenbergUniversity of Illinois Hospital and Health Science System, Chicago, IL, USA.
Meredith AlbertShriners Hospital for Children, Chicago, IL, USA.
Cassandra L AspinallSeattle Children's Research Institute, Seattle, WA, USA.
Donald L Patrick7284University of Washington, Seattle, WA, USA.

Funding

Patient-Centered Outcomes in Infants and Young Children with Cleft Lip and PalateR01DE024986 · NIDCR · UNIVERSITY OF WASHINGTON · PI EDWARDS, TODD C, HEIKE, CARRIE LYN · 2015 to 2019
$2.5M
NIDCR NIH HHS R01 DE024986
6 · The paper itself

Abstract

objectiveWe evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO).

designCross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery).

settingThree academic craniofacial centers and national online advertisements.

participantsPrimary caregivers with an infant with cleft lip with or without cleft palate (CL  ±  P) scheduled to undergo primary lip repair. There were 133 primary caregivers at baseline, 115 at 2 days postsurgery, and 112 at 2 months postsurgery. MAIN OUTCOME MEASURE(S): Caregiver observation items (

resultsMean age at surgery was 6.0 months (range 2.7-11.8 months). Five of eight iCOO domains have scale scores, with Cronbach's alphas ranging from 0.67 to 0.87. Except for the Facial Skin and Mouth domain, iCOO scales had acceptable intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.84. The internal consistency of the Global Impression items across all domains was 0.90 and had acceptable ICCs (range 0.76-0.91). Sixteen out of 20 (nonscale) items had acceptable ICCs (range 0.66-0.96). As anticipated, iCOO scores 2 days postoperatively were generally lower than baseline and scores 2 months postsurgery were consistent with baseline or higher. The iCOO took approximately 10 min to complete.

conclusionsThe iCOO meets measurement standards and may be used for assessing the impact of cleft-related treatments in clinical research and care. More research is needed on its use in various treatment contexts.

Indexed as

Cleft LipCleft PalateChildChild, PreschoolCross-Sectional StudiesHumansInfantLongitudinal Studiescleftinfantobserver-reported outcomevalidation

Identifiers

PMID34514868
PMCPMC8918060

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.