{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T18:19:56Z","timestamp":1788545996068,"version":"build-2803163510"},"reference-count":40,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2020,5,29]],"date-time":"2020-05-29T00:00:00Z","timestamp":1590710400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"REDCap","award":["UL1 TR002319"],"award-info":[{"award-number":["UL1 TR002319"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["The Cleft Palate Craniofacial Journal"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To develop an outcomes instrument that assesses observations that can be reliably reported by caregivers and can be used to assess health of infants with a cleft lip or cleft lip and cleft palate (CL\u00b1P) and impacts of treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Cross-sectional, mixed methods study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting:<\/jats:title>\n                    <jats:p>Caregivers and health-care providers were recruited from 3 academic craniofacial centers and national advertisements. Most interviews were conducted by telephone, and surveys were completed online.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants:<\/jats:title>\n                    <jats:p>Caregivers had a child less than 3 years of age with CL\u00b1P and spoke either English or Spanish. Health-care providers were members of a cleft team. Caregivers (n = 492) and health-care professionals (n = 75) participated in at least one component of this study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measure(s):<\/jats:title>\n                    <jats:p>Caregivers and health-care providers participated in tasks related to instrument development: concept elicitation for items within relevant health domains, prioritization of items, and item review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We identified 295 observations of infant well-being across 9 health areas. Research staff and specialists evaluated items for clarity, specificity to CL\u00b1P, and responsiveness to treatment. Caregivers and health-care providers rated the resulting list of 104 observations and developed the final instrument of 65 items.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In this phase of development of the Infant with Clefts Observation Outcomes (iCOO) instrument, items were developed to collect caregiver observations about indicators of children\u2019s health and well-being across multiple domains allowing for psychometric testing, sensitivity to changes associated with treatment, and documentation of the effects of treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1055665620922105","type":"journal-article","created":{"date-parts":[[2020,5,29]],"date-time":"2020-05-29T05:34:25Z","timestamp":1590730465000},"page":"1266-1279","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Development of an Outcome Measure of Observable Signs of Health and Well-Being in Infants With Orofacial Clefts"],"prefix":"10.1177","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2178-7730","authenticated-orcid":false,"given":"Carrie L.","family":"Heike","sequence":"first","affiliation":[{"name":"Seattle Children\u2019s Research Institute, Seattle, WA, USA"},{"name":"Seattle Children\u2019s Hospital, Seattle, WA, USA"},{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith","family":"Albert","sequence":"additional","affiliation":[{"name":"Shriners Hospital for Children, Chicago, IL, USA"},{"name":"University of Illinois at Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassandra L.","family":"Aspinall","sequence":"additional","affiliation":[{"name":"Seattle Children\u2019s Hospital, Seattle, WA, USA"},{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzel","family":"Bautista","sequence":"additional","affiliation":[{"name":"University of Illinois at Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia Crilly","family":"Bellucci","sequence":"additional","affiliation":[{"name":"Shriners Hospital for Children, Chicago, IL, USA"},{"name":"University of Illinois at Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen A.","family":"Kapp-Simon","sequence":"additional","affiliation":[{"name":"Shriners Hospital for Children, Chicago, IL, USA"},{"name":"University of Illinois at Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Solange","family":"Mecham","sequence":"additional","affiliation":[{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald L.","family":"Patrick","sequence":"additional","affiliation":[{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janine","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"University of Illinois Hospital and Health Science System, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babette","family":"Siebold","sequence":"additional","affiliation":[{"name":"Seattle Children\u2019s Research Institute, Seattle, WA, USA"},{"name":"Seattle Children\u2019s Hospital, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura P.","family":"Stueckle","sequence":"additional","affiliation":[{"name":"Seattle Children\u2019s Research Institute, Seattle, WA, USA"},{"name":"Seattle Children\u2019s Hospital, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9990-9318","authenticated-orcid":false,"given":"Todd C.","family":"Edwards","sequence":"additional","affiliation":[{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,5,29]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"crossref","unstructured":"American Cleft Palate-Craniofacial Association. Parameters for evaluation and treatment of patients with cleft lip\/palate or other craniofacial differences. The Cleft Palate-Craniofacial Journal. 2018;55(1):137\u2013156.","DOI":"10.1177\/1055665617739564"},{"key":"e_1_3_3_3_1","doi-asserted-by":"publisher","DOI":"10.1597\/08-075.1"},{"key":"e_1_3_3_4_1","doi-asserted-by":"publisher","DOI":"10.7748\/paed.20.6.20.s22"},{"issue":"2","key":"e_1_3_3_5_1","first-page":"CD003315","article-title":"Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate","volume":"16","author":"Bessell A","year":"2011","unstructured":"Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. Cochrane Database Syst Rev. 2011;16(2):CD003315. doi:10.1002\/14651858.CD003315.pub3.","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_3_3_6_1","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"e_1_3_3_7_1","volume-title":"Ages and Stages Questionnaire","author":"Bricker D","year":"1999","unstructured":"Bricker D, Squires J, Mounts L, Potter L, Nickel R, Twombly E, Farrell J. Ages and Stages Questionnaire. Baltimore, MD: Paul H Brookes; 1999."},{"key":"e_1_3_3_8_1","first-page":"137","volume-title":"Cross-Cultural Research and Methodology Series, Vol. 8. Field Methods in Cross-Cultural Research","author":"Brislin RW","year":"1986","unstructured":"Brislin RW. The wording and translation of research instruments. In: Lonner WJ, Berry JW, ed. Cross-Cultural Research and Methodology Series, Vol. 8. Field Methods in Cross-Cultural Research. Newbury Park, CA: Sage Publications; 1986: 137\u2013164."},{"key":"e_1_3_3_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1389-9457(99)00009-X"},{"key":"e_1_3_3_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mlr.0000254567.79743.e2"},{"key":"e_1_3_3_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/1055665618811526"},{"key":"e_1_3_3_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00455-007-9111-6"},{"key":"e_1_3_3_13_1","doi-asserted-by":"publisher","DOI":"10.4135\/9781483384436"},{"key":"e_1_3_3_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-70"},{"key":"e_1_3_3_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"e_1_3_3_16_1","doi-asserted-by":"publisher","DOI":"10.1597\/09-217"},{"key":"e_1_3_3_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cppeds.2008.02.003"},{"key":"e_1_3_3_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003446-200508001-00004"},{"key":"e_1_3_3_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/PRS.0b013e3181f63fa4"},{"key":"e_1_3_3_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.76.1.70a"},{"key":"e_1_3_3_21_1","doi-asserted-by":"publisher","DOI":"10.1597\/07-236.1"},{"key":"e_1_3_3_22_1","doi-asserted-by":"publisher","DOI":"10.1597\/09-180.1"},{"key":"e_1_3_3_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-3782(98)00032-2"},{"key":"e_1_3_3_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2012-302104"},{"key":"e_1_3_3_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/ppul.22568"},{"issue":"5","key":"e_1_3_3_26_1","first-page":"221","article-title":"How reliable is computerized assessment of readability?","volume":"13","author":"Mailloux SL","year":"1995","unstructured":"Mailloux SL, Johnson ME, Fisher DG, Pettibone TJ. How reliable is computerized assessment of readability? Comput Nurs. 1995;13(5):221\u2013225.","journal-title":"Comput Nurs"},{"issue":"6","key":"e_1_3_3_27_1","doi-asserted-by":"crossref","first-page":"461","DOI":"10.2223\/JPED.1420","article-title":"Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study","volume":"81","author":"Montagnoli LC","year":"2005","unstructured":"Montagnoli LC, Barbieri MA, Bettiol H, Marques IL, de Souza L. Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study. Jornal de pediatria. 2005;81(6):461\u2013465.","journal-title":"Jornal de pediatria"},{"key":"e_1_3_3_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60695-4"},{"key":"e_1_3_3_29_1","doi-asserted-by":"publisher","DOI":"10.1097\/MOO.0b013e3283585685"},{"key":"e_1_3_3_30_1","doi-asserted-by":"publisher","DOI":"10.1054\/bjps.2001.3618"},{"key":"e_1_3_3_31_1","doi-asserted-by":"publisher","DOI":"10.1177\/1055665618793062"},{"key":"e_1_3_3_32_1","doi-asserted-by":"publisher","DOI":"10.1597\/02-119.5.1"},{"key":"e_1_3_3_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/1055665618766978"},{"key":"e_1_3_3_34_1","doi-asserted-by":"publisher","DOI":"10.1037\/hea0000262"},{"key":"e_1_3_3_35_1","doi-asserted-by":"publisher","DOI":"10.2307\/1131921"},{"key":"e_1_3_3_36_1","doi-asserted-by":"publisher","DOI":"10.1597\/1545-1569-35.6.473"},{"issue":"79","key":"e_1_3_3_37_1","article-title":"Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance","volume":"4","author":"US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health","year":"2006","unstructured":"US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006:4:79. doi:10.1186\/1477-7525-4-79.","journal-title":"Health Qual Life Outcomes"},{"key":"e_1_3_3_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2015.08.006"},{"key":"e_1_3_3_39_1","doi-asserted-by":"publisher","DOI":"10.4135\/9781412983655"},{"issue":"4","key":"e_1_3_3_40_1","first-page":"170","article-title":"Velopharyngeal dysfunction","volume":"26","author":"Woo AS","year":"2012","unstructured":"Woo AS. Velopharyngeal dysfunction. Semin Plast Surg. 2012;26(4):170\u2013177. doi:10.1055\/s-0033-1333882.","journal-title":"Semin Plast Surg"},{"key":"e_1_3_3_41_1","doi-asserted-by":"publisher","DOI":"10.1177\/0003489400109S1217"}],"container-title":["The Cleft Palate Craniofacial Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1055665620922105","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1055665620922105","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1055665620922105","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T16:20:11Z","timestamp":1777393211000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1055665620922105"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,29]]},"references-count":40,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1177\/1055665620922105"],"URL":"https:\/\/doi.org\/10.1177\/1055665620922105","relation":{},"ISSN":["1055-6656","1545-1569"],"issn-type":[{"value":"1055-6656","type":"print"},{"value":"1545-1569","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,29]]}}}