{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T22:37:36Z","timestamp":1785451056085,"version":"3.56.0"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004321","name":"Shire","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/501100004321","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Health Qual Life Outcomes"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n              <jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Acute infectious conjunctivitis is a common condition most frequently caused by viruses or bacteria. Clinical outcome assessments have been used to assess signs and symptoms of bacterial and viral conjunctivitis, but have not been evaluated for content validity. We aimed to develop content-valid patient- (PRO) and observer-reported outcome (ObsRO) instruments to assess symptoms of ocular discomfort associated with viral or bacterial conjunctivitis in adult and pediatric patients.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Draft items were developed from a previous review of published studies from 2001 to 2015. Patients and caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the past 6\u2009months were recruited. Concept elicitation with open-ended questions explored signs and symptoms, followed by cognitive interviewing to assess clarity and relevance of the draft items. Patients aged \u22658\u2009years were interviewed for the PRO; parents\/caregivers of children aged 1\u201310\u2009years were interviewed for the ObsRO. Interviews were conducted in three rounds to allow changes. Concept saturation was documented using a saturation grid. Cognitive interview data were analyzed iteratively and focused on clarity, relevance and inconsistent interpretation of the instrument\u2019s content.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 23 patients or parents\/caregivers participated (round 1, <jats:italic>n<\/jats:italic>\u00a0=\u200910; round 2, <jats:italic>n<\/jats:italic>\u00a0=\u20096; round 3, <jats:italic>n<\/jats:italic>\u00a0=\u20097). Data saturation was reached by the 16th interview. The most frequent spontaneously reported signs\/symptoms were: discharge, red\/pink eyes, itchiness, swelling\/puffiness, watery eyes, pain, burning and foreign body sensation. Itching, pain\/burning\/stinging and foreign body sensation were most commonly reported as the top three most bothersome symptoms. Interview results indicated that items on pain, itching and foreign body sensation for the PRO and pain or discomfort for the ObsRO were relevant to the patients\u2019 experience of conjunctivitis and were clear and easy to understand.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key viral and bacterial conjunctivitis symptoms in adult and pediatric patients.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12955-019-1223-9","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T20:44:07Z","timestamp":1572468247000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Content validity of a novel patient-reported and observer-reported outcomes assessment to evaluate ocular symptoms associated with infectious conjunctivitis in both adult and pediatric populations"],"prefix":"10.1186","volume":"17","author":[{"given":"Sujata P.","family":"Sarda","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"De La Cruz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emuella M.","family":"Flood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Vanya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Hwang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher N.","family":"Ta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhijit","family":"Narvekar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,10,30]]},"reference":[{"key":"1223_CR1","doi-asserted-by":"publisher","first-page":"1721","DOI":"10.1001\/jama.2013.280318","volume":"310","author":"AA Azari","year":"2013","unstructured":"Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA. 2013;310:1721\u20139.","journal-title":"JAMA"},{"key":"1223_CR2","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1016\/S0002-9394(02)01701-4","volume":"134","author":"SJ Isenberg","year":"2002","unstructured":"Isenberg SJ, Apt L, Valenton M, Del Signore M, Cubillan L, Labrador MA, Chan P, Berman NG. A controlled trial of povidone-iodine to treat infectious conjunctivitis in children. Am J Ophthalmol. 2002;134:681\u20138.","journal-title":"Am J Ophthalmol"},{"key":"1223_CR3","volume-title":"Preferred practice pattern guidelines. Conjunctivitis","author":"AAO_PPP_Panel. American Academy of Ophthalmology Cornea\/External Disease PPP Panel","year":"2018","unstructured":"AAO_PPP_Panel. American Academy of Ophthalmology Cornea\/External Disease PPP Panel. Preferred practice pattern guidelines. Conjunctivitis. San Francisco: American Academy of Ophthalmology; 2018. Available at: \n                    https:\/\/www.aao.org\/preferred-practice-pattern\/conjunctivitis-ppp-2018\n                    \n                  . Accessed 18 June 2018."},{"key":"1223_CR4","first-page":"78","volume":"17","author":"JE Schneider","year":"2014","unstructured":"Schneider JE, Scheibling CM, Segall D. Epidemiology and economic burden of conjunctivitis: a managed care perspective. J Manage Care Med. 2014;17:78\u201383.","journal-title":"J Manage Care Med"},{"key":"1223_CR5","unstructured":"U.S. Food and Drug Administration. Clinical Outcome Assessment Qualification Program. \n                    http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DrugDevelopmentToolsQualificationProgram\/ucm284077.htm\n                    \n                  . Accessed 14 Nov 2018."},{"key":"1223_CR6","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1016\/j.jval.2016.11.005","volume":"20","author":"JH Powers 3rd","year":"2017","unstructured":"Powers JH 3rd, Patrick DL, Walton MK, Marquis P, Cano S, Hobart J, Isaac M, Vamvakas S, Slagle A, Molsen E, et al. Clinician-reported outcome assessments of treatment benefit: report of the ISPOR clinical outcome assessment emerging good practices task force. Value Health. 2017;20:2\u201314.","journal-title":"Value Health"},{"key":"1223_CR7","doi-asserted-by":"publisher","first-page":"1299","DOI":"10.1136\/bjo.2010.188623","volume":"95","author":"MR Wilkins","year":"2011","unstructured":"Wilkins MR, Khan S, Bunce C, Khawaja A, Siriwardena D, Larkin DF. A randomised placebo-controlled trial of topical steroid in presumed viral conjunctivitis. 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BMJ. 2003;327:789.","journal-title":"BMJ"},{"key":"1223_CR14","doi-asserted-by":"publisher","first-page":"376","DOI":"10.1097\/AJP.0000000000000406","volume":"33","author":"E Castarlenas","year":"2017","unstructured":"Castarlenas E, Jensen MP, von Baeyer CL, Miro J. Psychometric properties of the numerical rating scale to assess self-reported pain intensity in children and adolescents: a systematic review. Clin J Pain. 2017;33:376\u201383.","journal-title":"Clin J Pain"},{"key":"1223_CR15","doi-asserted-by":"publisher","first-page":"474838","DOI":"10.1155\/2010\/474838","volume":"2010","author":"R Srouji","year":"2010","unstructured":"Srouji R, Ratnapalan S, Schneeweiss S. Pain in children: assessment and nonpharmacological management. Int J Pediatr. 2010;2010:474838.","journal-title":"Int J Pediatr"}],"container-title":["Health and Quality of Life Outcomes"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-019-1223-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12955-019-1223-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-019-1223-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T00:11:06Z","timestamp":1603930266000},"score":1,"resource":{"primary":{"URL":"https:\/\/hqlo.biomedcentral.com\/articles\/10.1186\/s12955-019-1223-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,30]]},"references-count":15,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["1223"],"URL":"https:\/\/doi.org\/10.1186\/s12955-019-1223-9","relation":{},"ISSN":["1477-7525"],"issn-type":[{"value":"1477-7525","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,30]]},"assertion":[{"value":"12 December 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 September 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 October 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Institutional review board approval for the study protocol, the informed consent form and participant recruitment language was provided by Salus Institutional Review Board (Austin, TX, USA).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SPS is an employee of and owns stock\/stock options in Shire, a Takeda company. MDLC and MV are employees of ICON PLC, which performed contract research on behalf of Shire, a Takeda company. EMF was an employee of ICON PLC at the time this study was conducted. DGH and CNT have been consultants for Shire, a Takeda company. AN was an employee of and owned shares in Shire, a Takeda company, at the time this study was conducted.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"163"}}