Evidence map›Paper›PMID 36562144›Full record

ArticleThe Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association2024

Protocol for a Prospective Observational Study of Revision Palatoplasty Versus Pharyngoplasty for Treatment of Velopharyngeal Insufficiency Following Cleft Palate Repair.

Thomas J Sitzman, Adriane L Baylis, Jamie L Perry, Erica M Weidler, M'hamed Temkit, Stacey L Ishman, Raymond W Tse, VPI-OPS Study Consortium

Open access · greenAbstract read
In one paragraph

Article in The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
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

13 citing papers in PubMed, 16 citations in OpenAlex.

  1. Examining Percent Consonants Correct Produced by Preschool Children With and Without Cleft Palate Using the American English Phrase Sample.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  2. What is the Patient Compliance Rate for Nasopharyngoscopy as Documented in Clinical Reports?The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  3. Article
  4. An Exploratory Investigation into the Influence of Nasopharyngoscopy Findings on VPI Surgery Selection.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  5. Can Hypernasality be Reliably Rated Using the American English Phrase Sample as a Part of the Cleft Audit Protocol for Speech-Augmented-Americleft Modification (CAPS-A-AM) Protocol?The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  6. Article
  7. How Do Nasopharyngoscopy Ratings of Sustained Speech Differ From Connected Speech?The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Observational
  8. Examining Factors That Impact Speech Acceptability and Intelligibility in 4- to 7-Year-Old Children With Cleft Palate.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  9. Article
  10. Factors That Limit Evaluation of Velopharyngeal Closure During Nasopharyngoscopy.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2025
    Observational
  11. Article
  12. Article
  13. Sex Differences in Velopharyngeal Anatomy of 9- and 10-Year-Old Children.Journal of speech, language, and hearing research : JSLHR · 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

8 authors at 5 institutions in 1 country.

Thomas J SitzmanDivision of Plastic Surgery, Phoenix Children's Hospital, Phoenix, Arizona, USA.ORCID 0000-0002-2173-923X
Adriane L BaylisDepartment of Plastic and Reconstructive Surgery, Nationwide Children's Hospital, Columbus, Ohio, USA.ORCID 0000-0003-4148-4729
Jamie L PerryDepartment of Communication Sciences and Disorders East Carolina University, Greenville, North Carolina, USA.ORCID 0000-0001-7866-9159
Erica M WeidlerDivision of Plastic Surgery, Phoenix Children's Hospital, Phoenix, Arizona, USA.
M'hamed TemkitDepartment of Clinical Research, Phoenix Children's Hospital, Phoenix, Arizona, USA.
Stacey L IshmanDepartment of Otolaryngology-Head and Neck Surgery, University of Cincinnati, Cincinnati, Ohio, USA.
Raymond W TseDivision of Craniofacial and Plastic Surgery, Department of Surgery, Seattle Children's Hospital, Seattle, Washington, USA.ORCID 0000-0002-0179-9809
VPI-OPS Study Consortium
Phoenix Children's Hospital · USEast Carolina University · USNationwide Children's Hospital · USSeattle Children's Hospital · USUniversity of Cincinnati · US

Funding

Velopharyngeal insufficiency following cleft palate repair: a comparative effectiveness study of existing surgical procedures and identification of criteria to guide a personalized treatment approachU01DE029750 · NIDCR · PHOENIX CHILDREN'S HOSPITAL · PI SITZMAN, THOMAS JAMES · 2020 to 2024
$4.2M
Understanding and Reducing Variation in Outcomes of Cleft Lip and Palate SurgeryK23DE025023 · NIDCR · PHOENIX CHILDREN'S HOSPITAL · PI SITZMAN, THOMAS JAMES · 2016 to 2020
$598k
NIDCR NIH HHS K23 DE025023NIDCR NIH HHS U01 DE029750
6 · The paper itself

Abstract

objectiveTo present the design and methodology for an actively enrolling comparative effectiveness study of revision palatoplasty versus pharyngoplasty for the treatment of velopharyngeal insufficiency (VPI).

designProspective observational multicenter study.

settingTwelve hospitals across the United States and Canada.

participantsIndividuals who are 3-23 years of age with a history of repaired cleft palate and a diagnosis of VPI, with a total enrollment target of 528 participants.

interventionsRevision palatoplasty and pharyngoplasty (either pharyngeal flap or sphincter pharyngoplasty), as selected for each participant by their treatment team. MAIN OUTCOME MEASURE(S): The primary outcome is resolution of hypernasality, defined as the absence of consistent hypernasality as determined by blinded perceptual assessment of a standard speech sample recorded twelve months after surgery. The secondary outcome is incidence of new onset obstructive sleep apnea. Statistical analyses will use propensity score matching to control for demographics, medical history, preoperative severity of hypernasality, and preoperative imaging findings.

resultsStudy recruitment began February 2021. As of September 2022, 148 participants are enrolled, and 78 have undergone VPI surgery. Enrollment is projected to continue into 2025. Collection of postoperative evaluations should be completed by the end of 2026, with dissemination of results soon thereafter.

conclusionsPatients with VPI following cleft palate repair are being actively enrolled at sites across the US and Canada into a prospective observational study evaluating surgical outcomes. This study will be the largest and most comprehensive study of VPI surgery outcomes to date.

Indexed as

Cleft PalateNose DiseasesVelopharyngeal InsufficiencyVoice DisordersHumansMulticenter Studies as TopicObservational Studies as TopicPharynxRetrospective StudiesTreatment Outcomemagnetic resonance imagingnasalitynasopharyngoscopypalatoplastypharyngeal flappharyngoplastyquality of liferesonanceSleep disorderssoft palatespeech perceptionsurgical techniquevelopharyngeal function

Identifiers

PMID36562144
PMCPMC10287832
OpenAlexW4312114187

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.