{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T13:15:06Z","timestamp":1777641306720,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"1_suppl","license":[{"start":{"date-parts":[[2024,6,1]],"date-time":"2024-06-01T00:00:00Z","timestamp":1717200000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Food Nutr Bull"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>It is difficult to recognize vitamin B12 deficiency and to evaluate the effect of B12 treatment due to a broad range of variable clinical symptoms overlapping with other diseases and diagnostic biomarkers that quickly normalize during treatment. This poses a risk of delay in diagnosis and a challenge to uniformly monitor the effect of B12 treatment. There is a need for a new clinical outcome measure suitable for clinical practice and clinical evaluation studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The B12 PROM was developed by (1) gathering input from experts and literature review to define a construct and develop a conceptual model, (2) processing input from health care providers, scientists, and patients to develop items and response options, and (3) improving items based on the feedback from laypersons, test interviews, semi-structured cognitive interviews with patients, and forward and backward translation (ENG-NL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The B12 PROM includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and\/or face, Movement, Emotions, Mouth &amp; Abdomen, Urinary tract &amp; Reproductive organs). Cognitive interviews demonstrated good comprehensibility and comprehensiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This study is the first step in the development of a disease-specific PROM for vitamin B12 deficiency to measure the burden of symptoms. Further validation and reliability testing are necessary before the PROM can be applied in clinical practice and research.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03795721241236284","type":"journal-article","created":{"date-parts":[[2024,7,10]],"date-time":"2024-07-10T23:50:06Z","timestamp":1720655406000},"page":"S73-S79","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of a Vitamin B12 Deficiency Patient-Reported Outcome Measure for Clinical Practice and Research"],"prefix":"10.1177","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7222-2240","authenticated-orcid":false,"given":"Kim I. M.","family":"Suijker","sequence":"first","affiliation":[{"name":"B12 Institute Research Foundation, Rotterdam, the Netherlands"},{"name":"Department of Clinical Chemistry, Erasmus MC, University Medical Center, Rotterdam, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0483-2029","authenticated-orcid":false,"given":"Clara H. M.","family":"Plattel","sequence":"additional","affiliation":[{"name":"B12 Institute Research Foundation, Rotterdam, the Netherlands"},{"name":"B12 Research Institute & Treatment Center, Rotterdam, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8590-867X","authenticated-orcid":false,"given":"Catherine H.","family":"Seage","sequence":"additional","affiliation":[{"name":"Cardiff School of Sport & Health Sciences, Cardiff Metropolitan University, Cardiff, Wales, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4253-2190","authenticated-orcid":false,"given":"Nicola","family":"Ward","sequence":"additional","affiliation":[{"name":"Leicester School of Pharmacy, De Montfort University, Leicester, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Delyth H.","family":"James","sequence":"additional","affiliation":[{"name":"Cardiff School of Sport & Health Sciences, Cardiff Metropolitan University, Cardiff, Wales, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jolande Y.","family":"Vis","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry, Erasmus MC, University Medical Center, Rotterdam, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,7,10]]},"reference":[{"key":"bibr1-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g5226"},{"key":"bibr2-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp1113996"},{"key":"bibr3-03795721241236284","doi-asserted-by":"publisher","DOI":"10.12968\/bjon.2014.23.7.376"},{"key":"bibr4-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2016-10-569186"},{"key":"bibr5-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocpiqo.2019.03.002"},{"key":"bibr6-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2008-03-040253"},{"key":"bibr7-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1159\/000347065"},{"key":"bibr8-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V92.4.1191"},{"key":"bibr9-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(03)90096-8"},{"key":"bibr10-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-033687"},{"issue":"3","key":"bibr11-03795721241236284","volume":"3","author":"Wang H","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"key":"bibr12-03795721241236284","unstructured":"US Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Accessed June 21, 2022. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims"},{"key":"bibr13-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.195"},{"key":"bibr14-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9780511996214.004"},{"key":"bibr15-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.013"},{"key":"bibr16-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1097\/00007632-200012150-00014"},{"key":"bibr17-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.40"},{"key":"bibr18-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.2830340204"},{"key":"bibr19-03795721241236284","doi-asserted-by":"publisher","DOI":"10.1097\/00005792-199107000-00001"},{"key":"bibr20-03795721241236284","unstructured":"Mokkink LB, Prinsen C, Patrick DL, et al. COSMIN Study Design checklist for Patient-reported outcome measurement instruments. 2019. Accessed April 26, 2022. https:\/\/www.cosmin.nl\/wp-content\/uploads\/COSMIN-study-designing-checklist_final.pdf#"}],"container-title":["Food and Nutrition Bulletin"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03795721241236284","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03795721241236284","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03795721241236284","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T06:19:58Z","timestamp":1777443598000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03795721241236284"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6]]},"references-count":20,"journal-issue":{"issue":"1_suppl","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1177\/03795721241236284"],"URL":"https:\/\/doi.org\/10.1177\/03795721241236284","relation":{},"ISSN":["0379-5721","1564-8265"],"issn-type":[{"value":"0379-5721","type":"print"},{"value":"1564-8265","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6]]}}}