{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T11:12:39Z","timestamp":1782731559964,"version":"3.54.5"},"reference-count":21,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T00:00:00Z","timestamp":1747785600000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013796","name":"Canadian Urological Association Scholarship Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013796","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,4,4]]},"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Existing patient-reported outcome measures (PROMs) do not meet accepted international criteria for measuring health outcomes of hypospadias treatment. This protocol describes the qualitative development (phase I) of a novel PROM to evaluate outcomes of hypospadias treatments.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>Participants aged 7 years and older with hypospadias and caregivers of children under 8 years seeking treatment at Boston Children\u2019s Hospital, Children\u2019s Hospital of Eastern Ontario (CHEO), Children\u2019s Hospital of Philadelphia (CHOP) and McMaster Children\u2019s Hospital), will be invited to participate in concept elicitation and cognitive interviews. Concept elicitation interviews will be in-depth and semi-structured to understand concepts important to patients seeking treatment for hypospadias. Cognitive interviews will be performed concurrently to ensure that the scale items, instructions and response options are relevant, understandable and comprehensive. Cognitive interviews will be complemented by expert input. Concept elicitation and cognitive interview transcripts will be coded line-by-line. Participant quotes will be categorised into top-level domains, themes and subthemes. The primary outcome of this research will be to develop a conceptual model representing the patient experience of hypospadias and a novel PROM.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Ethics approval was obtained from Boston Children\u2019s Hospital\u2019s Institutional Review Board (HHS Registration: IRB00000352; Protocol number IRB-P00042425). CHOP, McMaster and CHEO have reliance agreements with Boston Children\u2019s Hospital. Findings from this research will be disseminated at national and international conferences and published in relevant peer-reviewed journals for the target audience.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-088619","type":"journal-article","created":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T05:25:34Z","timestamp":1747891534000},"page":"e088619","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Protocol for the development of a patient-reported outcome measure for patients with hypospadias"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8523-8610","authenticated-orcid":false,"given":"Melise A","family":"Keays","sequence":"first","affiliation":[{"name":"Boston Children\u2019s Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Tsangaris","sequence":"additional","affiliation":[{"name":"Boston Children\u2019s Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Gulati","sequence":"additional","affiliation":[{"name":"Health Sciences, Carleton University, Ottawa, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Long","sequence":"additional","affiliation":[{"name":"Urology, Children Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"McNamara","sequence":"additional","affiliation":[{"name":"Boston Children\u2019s Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis H","family":"Braga","sequence":"additional","affiliation":[{"name":"Surgery, McMaster Children\u2019s Hospital, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4720-0096","authenticated-orcid":false,"given":"Anne","family":"Klassen","sequence":"additional","affiliation":[{"name":"Paediatrics, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,5,22]]},"reference":[{"key":"2025101814582846000_15.5.e088619.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.f167","article-title":"Patient reported outcome measures could help transform healthcare","volume":"346","author":"Black","year":"2013","journal-title":"BMJ"},{"key":"2025101814582846000_15.5.e088619.2","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e31829b1d84"},{"key":"2025101814582846000_15.5.e088619.3","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2022.20900","article-title":"Patient-Proxy and Societal Perspectives of Quality-of-Life Utilities in Children With Cleft Lip and Palate Managed With Surgical Repair vs No Repair in Ethiopia","volume":"5","author":"Chung","year":"2022","journal-title":"JAMA Netw Open"},{"key":"2025101814582846000_15.5.e088619.4","doi-asserted-by":"publisher","DOI":"10.1542\/peds.100.5.831"},{"key":"2025101814582846000_15.5.e088619.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2019.06.027"},{"key":"2025101814582846000_15.5.e088619.6","doi-asserted-by":"crossref","first-page":"S48","DOI":"10.5489\/cuaj.4386","article-title":"Current hypospadias management: Diagnosis, surgical management, and long-term patient-centred outcomes","volume":"11","author":"Keays","year":"2017","journal-title":"Can Urol Assoc J"},{"key":"2025101814582846000_15.5.e088619.7","doi-asserted-by":"crossref","DOI":"10.3389\/fped.2020.579364","article-title":"Complications Following Primary Repair of Non-proximal Hypospadias in Children: A Systematic Review and Meta-Analysis","volume":"8","author":"Wu","year":"2020","journal-title":"Front Pediatr"},{"key":"2025101814582846000_15.5.e088619.8","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410x.2004.05128.x"},{"key":"2025101814582846000_15.5.e088619.9","doi-asserted-by":"publisher","DOI":"10.1016\/0007-1226(89)90140-9"},{"key":"2025101814582846000_15.5.e088619.10","doi-asserted-by":"publisher","DOI":"10.1093\/jpepsy\/22.3.371"},{"key":"2025101814582846000_15.5.e088619.11","doi-asserted-by":"publisher","DOI":"10.1093\/jpepsy\/jsm098"},{"key":"2025101814582846000_15.5.e088619.12","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1542\/peds.71.3.342","article-title":"Timing of elective hypospadias repair in children","volume":"71","author":"Schultz","year":"1983","journal-title":"Pediatrics"},{"key":"2025101814582846000_15.5.e088619.13","doi-asserted-by":"publisher","DOI":"10.1023\/A:1015291021312"},{"key":"2025101814582846000_15.5.e088619.14","unstructured":"FDA U . 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