{"doi":"10.5588/ijtld.22.0594","title":"Adverse events among persons with TB using in-person vs. electronic directly observed therapy","abstract":"BACKGROUND: We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA. METHODS: Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE. RESULTS: Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49–1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0–2.0). No participants switched DOT methods due to AERs or monitoring concerns. CONCLUSION: Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted.","journal":"The International Journal of Tuberculosis and Lung Disease","year":2023,"id":386933,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9619,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":867241,"name":"Joseph Burzynski","orcid":"0000-0002-7109-7669","position":1,"is_corresponding":false},{"id":867242,"name":"Joan M. Mangan","orcid":"0000-0001-6770-086X","position":2,"is_corresponding":false},{"id":868010,"name":"A. Ross Hill","orcid":null,"position":3,"is_corresponding":false},{"id":867245,"name":"B. Rey deCastro","orcid":"0000-0002-1610-5849","position":4,"is_corresponding":false},{"id":607693,"name":"Neela D. Goswami","orcid":"0000-0003-4508-9144","position":5,"is_corresponding":false},{"id":867243,"name":"Chee Kin Lam","orcid":"0000-0002-4821-4898","position":6,"is_corresponding":false},{"id":867244,"name":"Michelle Macaraig","orcid":"0000-0002-2891-9903","position":7,"is_corresponding":false},{"id":105380,"name":"Neil W. Schluger","orcid":"0000-0003-0162-2082","position":8,"is_corresponding":false},{"id":346884,"name":"Andrew Vernon","orcid":"0000-0003-1105-8534","position":9,"is_corresponding":false},{"id":1150367,"name":"M. M. Salerno","orcid":null,"position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T01:18:04.706547Z","pmid":"37880884","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}