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dc.contributor.authorPersaud, Navindra
dc.contributor.authorBedard, Michael
dc.contributor.authorBoozary, Andrew S.
dc.contributor.authorGlazier, Richard H.
dc.contributor.authorGomes, Tara
dc.contributor.authorHwang, Stephen W.
dc.contributor.authorJüni, Peter
dc.contributor.authorLaw, Michael R.
dc.contributor.authorMamdani, Muhammad M.
dc.contributor.authorManns, Braden J.
dc.contributor.authorMartin, Danielle
dc.contributor.authorMorgan, Steven G.
dc.contributor.authorOh, Paul I.
dc.contributor.authorPinto, Andrew D.
dc.contributor.authorShah, Baiju R.
dc.contributor.authorSullivan, Frank
dc.contributor.authorUmali, Norman
dc.contributor.authorThorpe, Kevin E.
dc.contributor.authorTu, Karen
dc.contributor.authorLaupacis, Andreas
dc.contributor.authorfor the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team
dc.date.accessioned2019-10-21T12:30:02Z
dc.date.available2019-10-21T12:30:02Z
dc.date.issued2020-01
dc.identifier.citationPersaud , N , Bedard , M , Boozary , A S , Glazier , R H , Gomes , T , Hwang , S W , Jüni , P , Law , M R , Mamdani , M M , Manns , B J , Martin , D , Morgan , S G , Oh , P I , Pinto , A D , Shah , B R , Sullivan , F , Umali , N , Thorpe , K E , Tu , K , Laupacis , A & for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team 2020 , ' Effect on treatment adherence of distributing essential medicines at no charge : the CLEAN Meds randomized clinical trial ' , JAMA Internal Medicine , vol. 180 , no. 1 , pp. 27-34 . https://doi.org/10.1001/jamainternmed.2019.4472en
dc.identifier.issn2168-6106
dc.identifier.otherPURE: 262151959
dc.identifier.otherPURE UUID: 97b8474a-4eea-4b4d-926a-d495715242fe
dc.identifier.otherScopus: 85073027638
dc.identifier.otherPubMed: 31589276
dc.identifier.otherWOS: 000508960300006
dc.identifier.urihttp://hdl.handle.net/10023/18722
dc.descriptionThis work is supported by grant 381409 from the Canadian Institutes for Health Research, the Ontario SPOR Support Unit that is supported by the Canadian Institutes of Health Research and the Province of Ontario, the Canada Research Chairs program, and the St Michael’s Hospital Foundation.en
dc.description.abstractImportance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients. Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence. Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle. Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391). Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963.
dc.format.extent8
dc.language.isoeng
dc.relation.ispartofJAMA Internal Medicineen
dc.rightsCopyright © 2019 Persaud N et al. JAMA Internal Medicine. This is an open access article distributed under the terms of the CC-BY License.en
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectInternal Medicineen
dc.subjectNDASen
dc.subjectBDCen
dc.subjectR2Cen
dc.subject~DC~en
dc.subject.lccRA0421en
dc.titleEffect on treatment adherence of distributing essential medicines at no charge : the CLEAN Meds randomized clinical trialen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.1001/jamainternmed.2019.4472
dc.description.statusPeer revieweden


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