{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T19:23:05Z","timestamp":1787599385806,"version":"build-2736575974"},"reference-count":48,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T00:00:00Z","timestamp":1761177600000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009867","name":"Agenzia Sanitaria e Sociale Regionale, Regione Emilia-Romagna","doi-asserted-by":"publisher","award":["E45J19000810002"],"award-info":[{"award-number":["E45J19000810002"]}],"id":[{"id":"10.13039\/501100009867","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,25]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Real-world data and patient-reported outcomes in diabetes in Emilia\u2013Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia\u2013Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The study has a mixed retrospective\/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019\u20132024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0\u20136 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06639100\">NCT06639100<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-102401","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T08:55:59Z","timestamp":1761209759000},"page":"e102401","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Real-world data and patient-reported outcomes in diabetes in Emilia\u2013Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06639100","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Fabrizio","family":"Carinci","sequence":"first","affiliation":[{"name":"Unicamillus International Medical University, UniCamillus, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rossella","family":"Messina","sequence":"additional","affiliation":[{"name":"Local Health Authority (AUSL) of Romagna, Ravenna, Italy, Ravenna, Italy"},{"name":"University of Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Michelini","sequence":"additional","affiliation":[{"name":"Local Health Authority (AUSL) of Reggio Emilia, Reggio Emilia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amelia","family":"Bici","sequence":"additional","affiliation":[{"name":"Local Health Authority (AUSL) of Reggio Emilia, Reggio Emilia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arianna","family":"Berardo","sequence":"additional","affiliation":[{"name":"Local Health Authority (AUSL) of Romagna, Ravenna, Italy, Ravenna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Dei Cas","sequence":"additional","affiliation":[{"name":"University of Parma, Parma, Italy"},{"name":"University Hospital of Parma, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Iezzi","sequence":"additional","affiliation":[{"name":"University Hospital of Parma, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Concetta Tania","family":"Di Iorio","sequence":"additional","affiliation":[{"name":"Serectrix srls, Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Gualdi","sequence":"additional","affiliation":[{"name":"Internet Express, Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaella","family":"Aldigeri","sequence":"additional","affiliation":[{"name":"University of Parma, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3257-6552","authenticated-orcid":false,"given":"Maria Pia","family":"Fantini","sequence":"additional","affiliation":[{"name":"University of Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo C","family":"Bonadonna","sequence":"additional","affiliation":[{"name":"University of Parma, Parma, Italy"},{"name":"University of Verona, Verona, Italy"},{"name":"University Hospital (AOU) of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Massi Benedetti","sequence":"additional","affiliation":[{"name":"HUB for International health ReSearch (HIRS), Perugia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5957-1551","authenticated-orcid":false,"given":"Paolo","family":"Di Bartolo","sequence":"additional","affiliation":[{"name":"Local Health Authority (AUSL) of Romagna, Ravenna, Italy, Ravenna, Italy"},{"name":"University of Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,10,23]]},"reference":[{"key":"2025120415080111000_15.10.e102401.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m799","article-title":"Covid-19: preparedness, decentralisation, and the hunt for patient zero","volume":"368","author":"Carinci","year":"2020","journal-title":"BMJ"},{"key":"2025120415080111000_15.10.e102401.2","unstructured":"World Health Organization . Rapid assessment of service delivery for NCDs during the COVID-19 pandemic. Geneva; 2020. Available: https:\/\/www.who.int\/publications\/m\/item\/rapid-assessment-of-service-delivery-for-ncds-during-the-covid-19-pandemic [accessed 01 Mar 2025]"},{"key":"2025120415080111000_15.10.e102401.3","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1007\/s00592-014-0688-6","article-title":"Trends over 8 years in quality of diabetes care: results of the AMD Annals continuous quality improvement initiative","volume":"52","author":"Rossi","year":"2015","journal-title":"Acta Diabetol"},{"key":"2025120415080111000_15.10.e102401.4","unstructured":"PNRR 2022 . National resilience and recovery plan. Mission 6. Health. 2022. Available: https:\/\/www.italiadomani.gov.it\/content\/sogei-ng\/it\/en\/il-piano\/missioni-pnrr\/salute.html [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.5","unstructured":"Ministero della Salute . Decreto 21 settembre 2022. Approvazione delle linee guida per i servizi di telemedicina - Requisiti funzionali e livelli di servizio. Available: https:\/\/www.gazzettaufficiale.it\/eli\/id\/2022\/11\/02\/22A06184\/sg [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.healthpol.2014.11.016"},{"key":"2025120415080111000_15.10.e102401.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1511701"},{"key":"2025120415080111000_15.10.e102401.8","doi-asserted-by":"crossref","first-page":"744516","DOI":"10.3389\/fcdhc.2021.744516","article-title":"Making Use of Comparable Health Data to Improve Quality of Care and Outcomes in Diabetes: The EUBIROD Review of Diabetes Registries and Data Sources in Europe","volume":"2","author":"Carinci","year":"2021","journal-title":"Front Clin Diabetes Healthc"},{"key":"2025120415080111000_15.10.e102401.9","doi-asserted-by":"crossref","first-page":"2009","DOI":"10.1111\/dme.14286","article-title":"A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach","volume":"37","author":"Nano","year":"2020","journal-title":"Diabet Med"},{"key":"2025120415080111000_15.10.e102401.10","first-page":"235","article-title":"The patient health questionnaire (PHQ) for the screening of psychiatric disorders: a validation study versus the structured clinical interview for DSM-IV axis I (SCID-I)","volume":"9","author":"Mazzotti","year":"2003","journal-title":"Ital J Psychopathol"},{"key":"2025120415080111000_15.10.e102401.11","doi-asserted-by":"publisher","DOI":"10.1186\/2193-1801-3-1"},{"key":"2025120415080111000_15.10.e102401.12","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1002\/pdi.993","article-title":"The 3rd International DAWN Summit: from research and practice to large\u2010scale implementation","volume":"23","author":"Wroe","year":"2006","journal-title":"Pract Diab Int"},{"key":"2025120415080111000_15.10.e102401.13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-051065","article-title":"Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group","volume":"11","author":"Seligman","year":"2021","journal-title":"BMJ Open"},{"key":"2025120415080111000_15.10.e102401.14","unstructured":"OECD . OECD reviews of health care quality: Italy 2014: raising standards. OECD Publishing; 2014. Available: https:\/\/www.oecd.org\/en\/publications\/2015\/01\/oecd-reviews-of-health-care-quality-italy-2014_g1g4b59d.html [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.15","doi-asserted-by":"crossref","DOI":"10.1186\/s41687-018-0061-6","article-title":"How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis","volume":"2","author":"Greenhalgh","year":"2018","journal-title":"J Patient Rep Outcomes"},{"key":"2025120415080111000_15.10.e102401.16","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-008-9396-4"},{"key":"2025120415080111000_15.10.e102401.17","doi-asserted-by":"crossref","DOI":"10.3390\/healthcare12191942","article-title":"Clinical Health Psychology Perspectives in Diabetes Care: A Retrospective Cohort Study Examining the Role of Depression in Adherence to Visits and Examinations in Type 2 Diabetes Management","volume":"12","author":"Messina","year":"2024","journal-title":"Healthcare (Basel)"},{"key":"2025120415080111000_15.10.e102401.18","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1007\/s00592-021-01791-x","article-title":"Is it time to consider depression as a major complication of type 2 diabetes? Evidence from a large population-based cohort study","volume":"59","author":"Messina","year":"2022","journal-title":"Acta Diabetol"},{"key":"2025120415080111000_15.10.e102401.19","doi-asserted-by":"crossref","first-page":"1247","DOI":"10.1007\/s00592-022-01894-z","article-title":"Emergency department accesses for diabetes-related complications during COVID-19 pandemic in people with type 2 diabetes and depression","volume":"59","author":"Messina","year":"2022","journal-title":"Acta Diabetol"},{"key":"2025120415080111000_15.10.e102401.20","doi-asserted-by":"crossref","first-page":"111561","DOI":"10.1016\/j.diabres.2024.111561","article-title":"A multi-state analysis of disease trajectories and mental health transitions in patients with type 2 diabetes: A population-based retrospective cohort study utilizing health administrative data","volume":"209","author":"Lenzi","year":"2024","journal-title":"Diabetes Res Clin Pract"},{"key":"2025120415080111000_15.10.e102401.21","doi-asserted-by":"publisher","DOI":"10.1111\/dme.14157"},{"key":"2025120415080111000_15.10.e102401.22","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-2053"},{"key":"2025120415080111000_15.10.e102401.23","doi-asserted-by":"crossref","unstructured":"Speight J , Hermanns N , Ehrmann D . Data on diabetes-specific distress are needed to improve the quality of diabetes care. Lancet 2021;397. doi:10.1016\/S0140-6736(21)00664-4","DOI":"10.1016\/S0140-6736(21)00633-4"},{"key":"2025120415080111000_15.10.e102401.24","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-023-05926-3"},{"key":"2025120415080111000_15.10.e102401.25","doi-asserted-by":"publisher","DOI":"10.1159\/000029256"},{"key":"2025120415080111000_15.10.e102401.26","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-009-1559-5"},{"key":"2025120415080111000_15.10.e102401.27","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.18.1737"},{"key":"2025120415080111000_15.10.e102401.28","unstructured":"Nobilio L , Leucci AC , Ugolini C , et al . Profili di assistenza e costi del diabete in Emilia-Romagna. Analisi empirica attraverso dati amministrativi, 2010-2016. Collana Dossier n. 264. Agenzia sanitaria e sociale regionale dell\u2019Emilia-Romagna, Bologna; 2018. Available: http:\/\/assr.regione.emilia-romagna.it\/it\/servizi\/pubblicazioni\/dossier\/doss264 [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.29","doi-asserted-by":"crossref","first-page":"2828","DOI":"10.2337\/dci22-0003","article-title":"Using Data to Improve the Management of Diabetes: The Tayside Experience","volume":"45","author":"Siddiqui","year":"2022","journal-title":"Diabetes Care"},{"key":"2025120415080111000_15.10.e102401.30","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-1552"},{"key":"2025120415080111000_15.10.e102401.31","doi-asserted-by":"publisher","DOI":"10.1111\/dme.12239"},{"key":"2025120415080111000_15.10.e102401.32","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.18.6.754"},{"key":"2025120415080111000_15.10.e102401.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.genhosppsych.2010.03.006"},{"key":"2025120415080111000_15.10.e102401.34","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-054650","article-title":"Effect of routinely assessing and addressing depression and diabetes distress on clinical outcomes among adults with type 2 diabetes: a systematic review","volume":"12","author":"McMorrow","year":"2022","journal-title":"BMJ Open"},{"key":"2025120415080111000_15.10.e102401.35","doi-asserted-by":"crossref","first-page":"31","DOI":"10.2202\/1557-4679.1275","article-title":"Sample size requirements for interval estimation of the kappa statistic for interobserver agreement studies with a binary outcome and multiple raters","volume":"6","author":"Donner","year":"2010","journal-title":"Int J Biostat"},{"key":"2025120415080111000_15.10.e102401.36","unstructured":"Rotondi MA . kapIpaSize: Sample Size Estimation Functions for Studies of Interobserver Agreement, R package version 1.2. 2018. Available: https:\/\/CRAN.R-project.org\/package=kappaSize [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.37","unstructured":"R Core Team . R: a language and environment for statistical computing, R foundation for statistical computing. Vienna, Austria, 2021. Available: https:\/\/www.R-project.org\/ [accessed 01 Mar 2025]"},{"key":"2025120415080111000_15.10.e102401.38","unstructured":"NeuBIRO software website. 2025. Available: https:\/\/github.com\/eubirodnetwork\/neubiro [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.39","unstructured":"BIRO Consortium . Best information through regional outcomes. The BIRO Monograph; 2012. Available: http:\/\/www.biroproject.eu\/documents\/downloads\/D14_4_BIRO_Monograph.pdf [Accessed 01 Mar 2025]."},{"key":"2025120415080111000_15.10.e102401.40","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2013-101603"},{"key":"2025120415080111000_15.10.e102401.41","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2009.029918"},{"key":"2025120415080111000_15.10.e102401.42","doi-asserted-by":"publisher","DOI":"10.1093\/eurpub\/cks043"},{"key":"2025120415080111000_15.10.e102401.43","doi-asserted-by":"crossref","unstructured":"Di Iorio CT , Carinci F , Oderkirk J , et al . Assessing data protection and governance in health information systems: a novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA). J Med Ethics 2020. doi:10.1136\/medethics-2019-105948","DOI":"10.1136\/medethics-2019-105948"},{"key":"2025120415080111000_15.10.e102401.44","doi-asserted-by":"crossref","first-page":"166","DOI":"10.3414\/ME15-01-0016","article-title":"Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery","volume":"55","author":"Cunningham","year":"2016","journal-title":"Methods Inf Med"},{"key":"2025120415080111000_15.10.e102401.45","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehad260"},{"key":"2025120415080111000_15.10.e102401.46","doi-asserted-by":"crossref","DOI":"10.1155\/2022\/7414258","article-title":"Adherence to General Diabetes and Foot Care Processes, with Prompt Referral, Are Associated with Amputation-Free Survival in People with Type 2 Diabetes and Foot Ulcers: A Scottish National Registry Analysis","volume":"2022","author":"Meza-Torres","year":"2022","journal-title":"J Diabetes Res"},{"key":"2025120415080111000_15.10.e102401.47","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1007\/s00592-020-01662-x","article-title":"Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis","volume":"58","author":"Meza-Torres","year":"2021","journal-title":"Acta Diabetol"},{"key":"2025120415080111000_15.10.e102401.48","doi-asserted-by":"crossref","DOI":"10.1111\/dme.15514","article-title":"The missing piece: The clinical translation of precision diabetes medicine requires precision mental health care: A call to action from the international PsychoSocial Aspects of Diabetes (PSAD) Study Group","volume":"42","author":"Pouwer","year":"2025","journal-title":"Diabet Med"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-102401","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T23:13:49Z","timestamp":1764890029000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-102401"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":48,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,10,23]]},"published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1136\/bmjopen-2025-102401"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-102401","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]}}}