Core Outcome Measures in Effectiveness Trials

A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care

General Information

Care of the patient with cleft lip and/or palate remains complex. Prior attempts at aggregating data to study the effectiveness of specific interventions or overall treatment protocols have been hindered by a lack of data standards. There exists a critical need to better define the outcomes—particularly those that matter most to patients and their families—and to standardize the methods by which these outcomes will be measured. This report summarizes the recommendations of an international, multidisciplinary working group with regard to which outcomes a typical cleft team could track, how those outcomes could be measured and recorded, and what strategies may be employed to sustainably implement a system for prospective data collection. It is only by agreeing on a common, standard set of outcome measures for the comprehensive appraisal of cleft care that intercenter comparisons can become possible. This is important for quality-improvement endeavors, comparative effectiveness research, and value-based healthcare reform.

Alexander C. Allori, M.D., M.P.H., Thomas Kelley, M.D., M.B.A., John G. Meara, M.D., D.M.D., M.B.A., Asteria Albert, M.D., Krishnamurthy Bonanthaya, M.B.B.S., M.D.S., Kathy Chapman, Ph.D., Michael Cunningham, M.D., Ph.D., John Daskalagiannakis, D.D.S., M.Sc., Henrietta de Gier, M.D., Andrew A. Heggie, M.B.B.S., M.D.Sc., Cristina Hernandez, R.N., B.S.N., M.S.H.I., Oksana Jackson, M.D., Yin Jones, Loshan Kangesu, M.B.B.S., M.S., Maarten J. Koudstaal, M.D., Rajiv Kuchhal, Anette Lohmander, S.L.P., Ph.D., Ross E. Long, Jr., D.M.D., M.S., Ph.D., Leanne Magee, Ph.D., Laura Monson, M.D., Elizabeth Rose, M.D., Thomas J. Sitzman, M.D., M.P.H., Jesse A. Taylor, M.D., Guy Thornburn, M.D., M.A., Simon van Eeden, M.Ch.D., M.B.Ch.B., B.D.S., B.Sc., Chris Williams, John O. Wirthlin, D.D.S., M.S.D., Karen W. Wong, M.D., M.Sc.


The Cleft Palate-Craniofacial Journal
Further Study Information

Funding source(s):

Health Area

Disease Category
Child health
Dentistry & oral health

Disease Name
Cleft palate

Target Population

Age Range


Nature / type of Intervention


Delphi process
Literature review

Nominal Group Technique and thematic content analysis.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for practice

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