As an example of the type of work that this Lab performs, consider the following example related to cleft lip/palate (CL/P) care.
Cleft lip and/or palate (CL/P) is among the most common of birth defects, affecting one baby born in the United States every two hours. Children with CL/P may be functionally disabled (with regard to eating, drinking, speaking, breathing, and hearing) and may carry the visible stigma of being “different” unless provided appropriate care. Treatment is necessarily complex and is delivered in stages by a multidisciplinary team across two decades of the child’s life. Despite efforts to standardize team-based treatment protocols, considerable variation persists due to paucity of rigorous outcomes data upon which to justify changes to clinical practice. Therefore, there is a critical need for multi‑site comparative effectiveness research that identifies optimal treatment protocols and for a collaborative quality‑improvement program that promotes dissemination and implementation of these protocols across teams.
To meet these needs, our Lab, in collaboration with others, has directed an international, multidisciplinary effort to develop a standard set of outcome measures for the comprehensive appraisal of cleft care. This standard set is provided open-access and remains guided by a steering committee under the auspices of the International Consortium for Health Outcome Measurement (ICHOM). Because even terminology, phenotypic description, and classification required standardization, our group proposed a practical but accurate method of classification with corresponding CLAP notational system. In response to the adoption of the ICD-10-CM code system in the United States, our Lab, in conjunction with the CDC National Center on Birth Defects and Developmental Disabilities (NCBDDD), created an ICD-10-based code expansion that permits the accurate phenotypic of CL/P phenotypes while remaining compatible with the official ICD-10-CM code base. Presently, our Lab is collaborating with Americleft, ICHOM, the CLEFT-Q group, and others to plan implementation of a prospective system of data collection across many cleft teams in North America and internationally. In order to permit comparison of outcomes data across institutions, data-science methods are used to develop risk-adjustment models, predictive models, and methods for identification (classification) of centers of excellence. The long-term vision of this program project is an ongoing collaborative quality-improvement program for cleft care in North America.
Selected publications related to this work appear below:
Sitzman TJ, Allori AC, and Thorburn G. Measuring outcomes in cleft lip and palate treatment. In Sitzman TJ and Marcus JR (ed.), Clinics in Plastic Surgery. 2014 Apr; 41(2):311-9. doi: 10.1016/j.cps.2013.12.001. pmid: 24607197.
Allori AC, Kelley T, Meara JG, Albert A, Bonanthaya K, Chapman K, Cunningham M, Daskalagiannakis J, de Gier H, Guernsey C, et al. A standard set of outcome measures for the comprehensive appraisal of cleft care. Cleft Palate Craniofac J. 2016 May 25; Epub ahead of print. pmid: 27223626.
Allori AC, Mulliken JB, Meara JG, Shusterman S, Marcus JR. Classification of cleft lip/palate: then and now. Cleft Palate Craniofac J. 2015 Sep 4; Epub ahead of print. pmid: 26339868. doi: 10.1597/14-080.
Aylsworth AS, Allori AC, Pimenta LA, Marcus JR, Harmsen KG, Watkins SE, Ramsey BL, Strauss RP, and Meyer RE. Issues involved in the phenotypic classification of orofacial clefts ascertained through a state birth defects registry for the North Carolina Cleft Outcomes Study. Birth Defects Res A Clin Mol Teratol. 2015 Nov;103(11):899-903. doi: 10.1002/bdra.23415. pmid: 26251069.
Allori AC, Cragan JD, Cassell CH, and Marcus JR. An ICD-10-based expanded code set for use in cleft lip/palate research and surveillance. ACCEPTED to Birth Defects Res Part A.
Allori AC, Cragan JD, Della Porta GC, Mulliken JB, Meara JG, Bruun R, Shusterman S, Cassell CH, Raynor E, Santiago P, and Marcus JR. Clinician's primer to ICD-10-CM coding for cleft lip/palate care. Cleft Palate Craniofac J. 2015 Nov 2; Epub ahead of print. pmid: 26523325.
Selected podium presentations related to this work appear below:
A mulitidisciplinary, mixed-methods approach to comprehensive appraisal of outcomes in cleft care. 73rd Annual Meeting of the American Cleft Palate–Craniofacial Association; Atlanta, GA; April 6, 2016.
Long-term clinical and holistic outcomes in children with cleft lip and/or palate: A multidisciplinary, mixed-methods approach. American College of Surgeons 2015 Clinical Congress; Chicago, IL; October 7, 2015.
Toward realtime patient-centered outcomes assessment and continuous quality improvement: A CleftKit progress report. 71st Annual Meeting of the American Cleft Palate–Craniofacial Association; Indianapolis, IN; March 25-29, 2014.
Comprehensive appraisal of cleft care for outcomes assessment, comparative effectiveness research, and quality assurance and improvement: The CLP360° framework. 12th Annual International Congress for Cleft Lip & Palate and Related Craniofacial Anomalies (Cleft2013); Orlando, FL; May 9, 2013.
A new taxonomy of surgical outcomes for standardized data reporting in cleft care. 12th Annual International Congress for Cleft Lip & Palate and Related Craniofacial Anomalies (Cleft2013); Orlando, FL; May 9, 2013.
Comprehensive appraisal of cleft lip and palate care – Panel I: Challenges and strategies in clinical outcomes research. 69th Annual Meeting of the American Cleft Palate – Craniofacial Association (ACPA); San Jose, CA; April 21, 2012 — Organized and moderated panel; gave opening and concluding lectures.
Comprehensive appraisal of cleft lip and palate care – Panel II: Economic and systems analysis. 69th Annual Meeting of the American Cleft Palate – Craniofacial Association (ACPA); San Jose, CA; April 21, 2012 — Organized and moderated panel; gave opening and concluding lectures, and presentations on health policy and comparative effectiveness research.