{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T16:58:13Z","timestamp":1792429093215,"version":"4.5.0"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T00:00:00Z","timestamp":1608681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008799","name":"Gilead Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008799","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010686","name":"Folkh\u00e4lsomyndigheten","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100010686","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Introduction<\/jats:title>\n<jats:p>The use of patient-reported outcomes (PROs) to systematically quantify adverse events (AE) will assist in the improvement of medical care and the QoL of patients living with HIV (PLWH). The aim of this study was to investigate the associations between self-reported side effects and other PROs, demographics and laboratory data, and further evaluate the Health Questionnaire (HQ) as a tool for following trends in patient-reported side effects over time in relation to trends in prescribed third agent in ART.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Materials and methods<\/jats:title>\n<jats:p>The Swedish National Registry InfCareHiv includes an annual self-reported nine-item HQwhich is used in patient-centered HIV care in all Swedish HIV units. In this study, the experience of side effects was addressed. We analyzed 9,476 HQs completed by 4,186 PLWH together with details about their prescribed ART and relevant biomarkers collected during 2011\u20132017. Data were analyzed using descriptive statistics, Pearson\u2019s correlation coefficient and mixed logistic regression.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The cross-sectional analysis of the HQs showed that the frequency of reported side effects decreased from 32% (2011) to 15% (2017). During the same period, there was a shift in ART prescription from efavirenz (EFV) to dolutegravir (DTG) (positive correlation coefficient <jats:italic>r<\/jats:italic> = 0.94, p = 0.0016). Further, PLWH who reported being satisfied with their physical health (OR: 0.47, p = &lt;0.001) or psychological health (OR: 0.70, p = 0.001) were less likely to report side effects than those less satisfied.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Self-reported side effects were found to have a close relationship with the patient\u2019s ratings of their overall health situation and demonstrated a strong correlation with the sharp decline in use of EFV and rise in use of DTG, with reported side effects being halved. This study supports the feasibility of using the HQ as a tool for longitudinal follow up of trends in PROs.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0242710","type":"journal-article","created":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T18:30:20Z","timestamp":1608748220000},"page":"e0242710","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":21,"title":["Longitudinal trends and determinants of patient-reported side effects on ART\u2013a Swedish national registry study"],"prefix":"10.1371","volume":"15","author":[{"given":"\u00c5sa","family":"Mellgren","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars 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phenomenon","volume":"287","author":"AJ Barsky","year":"2002","journal-title":"Jama"},{"issue":"26","key":"pone.0242710.ref008","first-page":"459","article-title":"Nocebo phenomena in medicine: their relevance in everyday clinical practice","volume":"109","author":"W Hauser","year":"2012","journal-title":"Deutsches Arzteblatt international"},{"issue":"8","key":"pone.0242710.ref009","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1080\/02770900802127022","article-title":"Personality influences the reporting of side effects of inhaled corticosteroids in asthma patients","volume":"45","author":"JM Foster","year":"2008","journal-title":"The Journal of asthma: official journal of the Association for the Care of Asthma"},{"issue":"12","key":"pone.0242710.ref010","doi-asserted-by":"crossref","first-page":"1540","DOI":"10.1177\/0269881112458730","article-title":"Warning about side effects can increase their occurrence: an experimental model using placebo treatment for sleep difficulty","volume":"26","author":"B Colagiuri","year":"2012","journal-title":"Journal of psychopharmacology (Oxford, England)"},{"issue":"9","key":"pone.0242710.ref011","doi-asserted-by":"crossref","first-page":"e005992","DOI":"10.1136\/bmjopen-2014-005992","article-title":"A systematic review of qualitative research on the contributory factors leading to medicine-related problems from the perspectives of adult patients with cardiovascular diseases and diabetes mellitus","volume":"4","author":"A Al Hamid","year":"2014","journal-title":"BMJ open"},{"issue":"6","key":"pone.0242710.ref012","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1186\/s13054-014-0643-5","article-title":"A systematic review of adult admissions to ICUs related to adverse drug events","volume":"18","author":"PA Jolivot","year":"2014","journal-title":"Critical care (London, 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Basch","year":"2010","journal-title":"The New England journal of medicine"},{"issue":"23","key":"pone.0242710.ref016","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1093\/jnci\/djp386","article-title":"Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes","volume":"101","author":"E Basch","year":"2009","journal-title":"Journal of the National Cancer Institute"},{"key":"pone.0242710.ref017","unstructured":"Region SAoLaa. Swedish National Quality Registe Stockholm: Vetenskapsr\u00e5det; 2020 [updated 20200416; cited 2020 20201105]. Available from: https:\/\/www.registerforskning.se\/en\/registers-in-sweden\/#National-quality-registers."},{"issue":"11\u201312","key":"pone.0242710.ref018","doi-asserted-by":"crossref","first-page":"788","DOI":"10.3109\/00365540903214322","article-title":"Treatment of HIV infection: Swedish recommendations 2009","volume":"41","author":"F Josephson","year":"2009","journal-title":"Scand J Infect Dis"},{"issue":"6","key":"pone.0242710.ref019","doi-asserted-by":"crossref","first-page":"401","DOI":"10.3109\/00365548.2014.898333","article-title":"Prophylaxis and treatment of HIV-1 infection in pregnancy: Swedish recommendations 2013","volume":"46","author":"L Nav\u00e9r","year":"2014","journal-title":"Scand J Infect Dis"},{"issue":"1","key":"pone.0242710.ref020","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/23744235.2016.1247495","article-title":"Antiretroviral treatment for HIV infection: Swedish recommendations 2016","volume":"49","author":"J Eriksen","year":"2017","journal-title":"Infectious diseases (London, England)"},{"issue":"5","key":"pone.0242710.ref021","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1080\/165019702760279242","article-title":"Life satisfaction in 18- to 64-year-old Swedes: in relation to gender, age, partner and immigrant status","volume":"34","author":"AR Fugl-Meyer","year":"2002","journal-title":"Journal of rehabilitation medicine"},{"key":"pone.0242710.ref022","volume-title":"Interpretive description","author":"SE Thorne","year":"2008"},{"issue":"2","key":"pone.0242710.ref023","doi-asserted-by":"crossref","first-page":"e0171227","DOI":"10.1371\/journal.pone.0171227","article-title":"HIV drug therapy duration; a Swedish real world nationwide cohort study on InfCareHIV 2009\u20132014","volume":"12","author":"A H\u00e4ggblom","year":"2017","journal-title":"PloS one"},{"issue":"5","key":"pone.0242710.ref024","doi-asserted-by":"crossref","first-page":"e0124279","DOI":"10.1371\/journal.pone.0124279","article-title":"Efavirenz-Based Regimens in Antiretroviral-Naive HIV-Infected Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"10","author":"J Kryst","year":"2015","journal-title":"PloS one."},{"issue":"1","key":"pone.0242710.ref025","doi-asserted-by":"crossref","first-page":"e31","DOI":"10.1016\/S2352-3018(16)30206-5","article-title":"Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis","volume":"4","author":"S Kanters","year":"2017","journal-title":"The lancet HIV"},{"issue":"5","key":"pone.0242710.ref026","first-page":"278","article-title":"Patient-reported outcomes in cancer: a review of recent research and policy initiatives","volume":"57","author":"J Lipscomb","year":"2007","journal-title":"CA: a cancer journal for clinicians"},{"issue":"2","key":"pone.0242710.ref027","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1007\/s10461-016-1545-0","article-title":"The Role of ARV Associated Adverse Drug Reactions in Influencing Adherence Among HIV-Infected Individuals: A Systematic Review and Qualitative Meta-Synthesis","volume":"21","author":"H Li","year":"2017","journal-title":"AIDS and behavior"},{"issue":"3","key":"pone.0242710.ref028","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1093\/jac\/dkp232","article-title":"Factors associated with non-adherence to long-term highly active antiretroviral therapy: a 10 year follow-up analysis with correction for the bias induced by missing data","volume":"64","author":"C Protopopescu","year":"2009","journal-title":"The Journal of antimicrobial chemotherapy"},{"issue":"1","key":"pone.0242710.ref029","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1007\/s12160-010-9230-4","article-title":"Improving coping skills for self-management of treatment side effects can reduce antiretroviral medication nonadherence among people living with HIV","volume":"41","author":"MO Johnson","year":"2011","journal-title":"Annals of behavioral medicine: a publication of the Society of Behavioral Medicine"},{"issue":"12","key":"pone.0242710.ref030","doi-asserted-by":"crossref","first-page":"2039","DOI":"10.1080\/03007995.2016.1227776","article-title":"Quality of life of HIV-infected patients who switch antiretroviral medication due to side effects or other reasons","volume":"32","author":"EM Maiese","year":"2016","journal-title":"Current medical research and opinion"},{"issue":"23","key":"pone.0242710.ref031","doi-asserted-by":"crossref","first-page":"3027","DOI":"10.1001\/jama.288.23.3027","article-title":"Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial","volume":"288","author":"SB Detmar","year":"2002","journal-title":"Jama"},{"issue":"4","key":"pone.0242710.ref032","doi-asserted-by":"crossref","first-page":"714","DOI":"10.1200\/JCO.2004.06.078","article-title":"Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial","volume":"22","author":"G Velikova","year":"2004","journal-title":"Journal of clinical oncology: official journal of the American Society of Clinical Oncology"},{"issue":"4","key":"pone.0242710.ref033","doi-asserted-by":"crossref","first-page":"19600","DOI":"10.7448\/IAS.17.4.19600","article-title":"Involvement of HIV patients in treatment-related decisions","volume":"17","author":"M Zanini","year":"2014","journal-title":"Journal of the International AIDS Society"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0242710","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T18:31:22Z","timestamp":1608748282000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0242710"}},"subtitle":[],"editor":[{"given":"Giuseppe Vittorio","family":"De Socio","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2020,12,23]]},"references-count":33,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2020,12,23]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0242710","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,23]]}}}