{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T18:32:46Z","timestamp":1740162766161,"version":"3.37.3"},"reference-count":37,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T00:00:00Z","timestamp":1732147200000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006259","name":"Teva Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006259","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100002567","name":"American Academy of Allergy, Asthma, and Immunology","doi-asserted-by":"crossref","award":["AI-835475"],"award-info":[{"award-number":["AI-835475"]}],"id":[{"id":"10.13039\/100002567","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006093","name":"PCORI","doi-asserted-by":"crossref","award":["PCS-1504-30283"],"award-info":[{"award-number":["PCS-1504-30283"]}],"id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["K23AI125785"],"award-info":[{"award-number":["K23AI125785"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,10,26]]},"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The Person Empowered Asthma Relief (PREPARE) study found that as-needed inhaled corticosteroid (ICS) supplementation combined with participants\u2019 usual controller and rescue therapy reduced asthma exacerbations for Black and Hispanic\/Latinx individuals. We aimed to determine whether treatment assignment to the intervention group (Patient Activated Reliever-Triggered ICS (PARTICS)) versus the control group (usual care) influenced controller therapy based on clinicians\u2019 written prescriptions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Secondary data analysis of electronic health record data of a pragmatic, open-label, patient-level randomised trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Practices treating asthma.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>PREPARE study participants\u2014 Black and Hispanic\/Latinx individuals with asthma.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Effects of adding ICS to rescue therapy among black and Hispanic adults with moderate-to-severe asthma.<\/jats:p><\/jats:sec><jats:sec><jats:title>Outcome measures<\/jats:title><jats:p>For PARTICS therapy impact on patients, each month is the 28-month period (12 months prior to enrolment, the month of enrolment and 15 months after enrolment), a patient was assigned to a controller step based on a six-step classification scheme. A linear mixed effect spline model was completed for before and after enrolment data to determine controller changes over a 28-month period between the two study arms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This analysis included 713 participants. Of these, 49.1% were usual care patients and 50.9% were PARTICS patients. Throughout the study, the majority of patients changed asthma controller medications in both arms. By the end of the study, the usual care patients were at a significantly higher asthma controller medication step (0.20 step higher) than the PARTICS patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Clinicians\u2019 prescribing patterns showed significant changes over time. Compared with usual care patients, PARTICS patients were on lower doses of asthma controller medications by the end of the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02995733\">NCT02995733<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2024-088349","type":"journal-article","created":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T07:46:25Z","timestamp":1732261585000},"page":"e088349","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Electronic health record data analysis on the impact of rescue-triggered inhaled corticosteroids on controller therapy in Black and Latinx individuals from a pragmatic, open-label, patient-level randomised trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct02995733","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6989-2428","authenticated-orcid":false,"given":"Elisabeth","family":"Callen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elliot","family":"Israel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Carlos","family":"Cardet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne L","family":"Fuhlbrigge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Manning","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriela","family":"Gaona","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Staton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1699-5471","authenticated-orcid":false,"given":"Wilson D","family":"Pace","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,11,21]]},"reference":[{"key":"2024121219342207000_14.11.e088349.1","unstructured":"Centers for Disease Control and Prevention . Asthma in the US 2011, Available: https:\/\/www.cdc.gov\/vitalsigns\/asthma\/index.html"},{"key":"2024121219342207000_14.11.e088349.2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6705e1"},{"key":"2024121219342207000_14.11.e088349.3","unstructured":"Healthy Schools Campaign . Five health-related causes of chronic absenteeism 2016. n.d. Available: https:\/\/healthyschoolscampaign.org\/blog\/five-health-related-causes-of-chronic-absenteeism\/"},{"key":"2024121219342207000_14.11.e088349.4","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201810-1944CI"},{"key":"2024121219342207000_14.11.e088349.5","unstructured":"Institute for Clinical and Economic Review . Biologic Therapies for Treatment of Asthma Associated with Type 2 Inflammation: Effectiveness, Value, and Value-Based Price Benchmarks. Final Evidence Report 2018. 2018. Available: https:\/\/icer.org\/assessment\/asthma-2018\/"},{"key":"2024121219342207000_14.11.e088349.6","first-page":"137","article-title":"Single-inhaler combination therapy for maintenance and relief of asthma: a new strategy in disease management","volume":"69","author":"Peters","year":"2009","journal-title":"Drugs (Abingdon Engl)"},{"key":"2024121219342207000_14.11.e088349.7","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200407-884OC"},{"key":"2024121219342207000_14.11.e088349.8","doi-asserted-by":"publisher","DOI":"10.1378\/chest.129.2.246"},{"key":"2024121219342207000_14.11.e088349.9","doi-asserted-by":"publisher","DOI":"10.1185\/030079904X2051"},{"key":"2024121219342207000_14.11.e088349.10","doi-asserted-by":"crossref","DOI":"10.1186\/s12890-017-0401-y","article-title":"Efficacy of budesonide\/formoterol maintenance and reliever therapy compared with higher-dose budesonide as step-up from low-dose inhaled corticosteroid treatment","volume":"17","author":"Jenkins","year":"2017","journal-title":"BMC Pulm Med"},{"key":"2024121219342207000_14.11.e088349.11","doi-asserted-by":"publisher","DOI":"10.1378\/chest.130.6.1733"},{"key":"2024121219342207000_14.11.e088349.12","unstructured":"Global Initiative for Asthma . Global strategy for asthma management and prevention 2021 report, 2020. Available: https:\/\/ginasthma.org\/gina-reports\/"},{"key":"2024121219342207000_14.11.e088349.13","unstructured":"Global Initiative for Asthma . Difficult-to-treat and severe asthma in adolescent and adult patients. Diagnosis and management 2019. 2019. Available: https:\/\/ginasthma.org\/gina-reports\/gina-2020-full-report_-final-_wms"},{"key":"2024121219342207000_14.11.e088349.14","unstructured":"National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group . 2020 focused update to the asthma management guidelines summary from: a report from the national asthma education and prevention program coordinating committee expert panel working group 2020. 2020. Available: https:\/\/www.nhlbi.nih.gov\/health-topics\/all-publications-and-resources\/2020-focused-updates-asthma-management-guidelines"},{"key":"2024121219342207000_14.11.e088349.15","unstructured":"Centers for Disease Control and Prevention . Asthma Attacks in the Past 12 Months by Year 2019, Available: https:\/\/www.cdc.gov\/asthma\/data-visualizations\/health-outcomes.htm#anchor_1569609411376"},{"key":"2024121219342207000_14.11.e088349.16","unstructured":"Centers for Disease Control and Prevention . Asthma Attacks among People with Current Asthma, 2014\u20132017, 2014. Available: https:\/\/www.cdc.gov\/asthma\/asthma_stats\/attacks-current-asthma.htm"},{"key":"2024121219342207000_14.11.e088349.17","first-page":"1","article-title":"National surveillance of asthma: United States, 2001-2010","volume":"3","author":"Moorman","year":"2012","journal-title":"Vital Health Stat"},{"key":"2024121219342207000_14.11.e088349.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2022.04.030"},{"key":"2024121219342207000_14.11.e088349.19","doi-asserted-by":"crossref","first-page":"1106","DOI":"10.1016\/j.jaci.2022.05.026","article-title":"Caribbean Latinx with moderate-severe asthma bear greater asthma morbidity than other Latinx","volume":"150","author":"Cardet","year":"2022","journal-title":"J Allergy Clin Immunol"},{"key":"2024121219342207000_14.11.e088349.20","doi-asserted-by":"crossref","first-page":"1556","DOI":"10.1016\/j.jaci.2016.08.047","article-title":"Asthma in Puerto Ricans: Lessons from a high-risk population","volume":"138","author":"Szentpetery","year":"2016","journal-title":"J Allergy Clin Immunol"},{"key":"2024121219342207000_14.11.e088349.21","doi-asserted-by":"crossref","first-page":"202","DOI":"10.3109\/02770903.2010.528498","article-title":"Asthma Mortality in Puerto Rico: 1980\u20132007","volume":"48","author":"Antonio Bartolomei-D\u00edaz","year":"2011","journal-title":"J Asthma"},{"key":"2024121219342207000_14.11.e088349.22","unstructured":"British Thorasic Society . BTS\/sign british guideline on the management of asthma 2021. n.d. Available: https:\/\/www.brit-thoracic.org.uk\/quality-improvement\/guidelines\/asthma\/"},{"key":"2024121219342207000_14.11.e088349.23","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa042552"},{"key":"2024121219342207000_14.11.e088349.24","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa063861"},{"key":"2024121219342207000_14.11.e088349.25","doi-asserted-by":"publisher","DOI":"10.1001\/2012.jama.10893"},{"key":"2024121219342207000_14.11.e088349.26","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69284-2"},{"key":"2024121219342207000_14.11.e088349.27","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(97)00467-1"},{"key":"2024121219342207000_14.11.e088349.28","article-title":"Interventions for enhancing medication adherence","volume":"2008","author":"Haynes","year":"2008","journal-title":"Cochrane Database Syst Rev"},{"key":"2024121219342207000_14.11.e088349.29","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1016\/S2213-2600(13)70012-2","article-title":"Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial","volume":"1","author":"Papi","year":"2013","journal-title":"Lancet Respir Med"},{"key":"2024121219342207000_14.11.e088349.30","doi-asserted-by":"crossref","first-page":"1505","DOI":"10.1056\/NEJMoa2118813","article-title":"Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma","volume":"386","author":"Israel","year":"2022","journal-title":"N Engl J Med"},{"key":"2024121219342207000_14.11.e088349.31","doi-asserted-by":"crossref","DOI":"10.1016\/j.cct.2020.106246","article-title":"A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American\/Black and Hispanic\/Latinx adults with asthma: Design and methods of the PREPARE trial","volume":"101","author":"Israel","year":"2021","journal-title":"Contemp Clin Trials"},{"key":"2024121219342207000_14.11.e088349.32","unstructured":"Definition and DDLs for the OMOP Common Data Model (CDM) 2022, Available: https:\/\/github.com\/OHDSI\/CommonDataModel"},{"key":"2024121219342207000_14.11.e088349.33","unstructured":"Springer Science & Business Media . Linear mixed models in practice: A SAS-oriented approach. 2012."},{"key":"2024121219342207000_14.11.e088349.34","doi-asserted-by":"crossref","DOI":"10.1007\/s11910-017-0723-4","article-title":"Statistical Approaches to Longitudinal Data Analysis in Neurodegenerative Diseases: Huntington\u2019s Disease as a Model","volume":"17","author":"Garcia","year":"2017","journal-title":"Curr Neurol Neurosci Rep"},{"key":"2024121219342207000_14.11.e088349.35","unstructured":"Raudenbush SW , Bryk AS . Hierarchical linear models: applications and data analysis methods, 2nd edn. Thousand Oaks, CA: Sage Publications, 2002."},{"key":"2024121219342207000_14.11.e088349.36","doi-asserted-by":"crossref","first-page":"2896","DOI":"10.1016\/j.jaip.2021.04.038","article-title":"Effect of COVID-19 on asthma exacerbation","volume":"9","author":"Salciccioli","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2024121219342207000_14.11.e088349.37","unstructured":"American Academy of Asthma aI . Asthma IQ: patient management and outcomes, Available: https:\/\/education.aaaai.org\/AIQMgmtOutcomes"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-088349","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T03:47:31Z","timestamp":1734061651000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-088349"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11]]},"references-count":37,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,11,21]]},"published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1136\/bmjopen-2024-088349"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-088349","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2024,11]]}}}