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      The importance of adherence in tuberculosis treatment clinical trials and its relevance in explanatory and pragmatic trials

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          Abstract

          Andrew Vernon and co-authors discuss adherence to therapy and its measurement in tuberculosis treatment trials.

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          Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

          Payam Nahid, Susan Dorman, Narges Alipanah … (2016)
          The American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis. For all recommendations, literature reviews were performed, followed by discussion by an expert committee according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. Given the public health implications of prompt diagnosis and effective management of tuberculosis, empiric multidrug treatment is initiated in almost all situations in which active tuberculosis is suspected. Additional characteristics such as presence of comorbidities, severity of disease, and response to treatment influence management decisions. Specific recommendations on the use of case management strategies (including directly observed therapy), regimen and dosing selection in adults and children (daily vs intermittent), treatment of tuberculosis in the presence of HIV infection (duration of tuberculosis treatment and timing of initiation of antiretroviral therapy), as well as treatment of extrapulmonary disease (central nervous system, pericardial among other sites) are provided. The development of more potent and better-tolerated drug regimens, optimization of drug exposure for the component drugs, optimal management of tuberculosis in special populations, identification of accurate biomarkers of treatment effect, and the assessment of new strategies for implementing regimens in the field remain key priority areas for research. See the full-text online version of the document for detailed discussion of the management of tuberculosis and recommendations for practice.
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            Adherence interventions and outcomes of tuberculosis treatment: A systematic review and meta-analysis of trials and observational studies

            Narges Alipanah, Leah G. Jarlsberg, Cecily Miller … (2018)
            Background Incomplete adherence to tuberculosis (TB) treatment increases the risk of delayed culture conversion with continued transmission in the community, as well as treatment failure, relapse, and development or amplification of drug resistance. We conducted a systematic review and meta-analysis of adherence interventions, including directly observed therapy (DOT), to determine which approaches lead to improved TB treatment outcomes. Methods and findings We systematically reviewed Medline as well as the references of published review articles for relevant studies of adherence to multidrug treatment of both drug-susceptible and drug-resistant TB through February 3, 2018. We included randomized controlled trials (RCTs) as well as prospective and retrospective cohort studies (CSs) with an internal or external control group that evaluated any adherence intervention and conducted a meta-analysis of their impact on TB treatment outcomes. Our search identified 7,729 articles, of which 129 met the inclusion criteria for quantitative analysis. Seven adherence categories were identified, including DOT offered by different providers and at various locations, reminders and tracers, incentives and enablers, patient education, digital technologies (short message services [SMSs] via mobile phones and video-observed therapy [VOT]), staff education, and combinations of these interventions. When compared with DOT alone, self-administered therapy (SAT) was associated with lower rates of treatment success (CS: risk ratio [RR] 0.81, 95% CI 0.73–0.89; RCT: RR 0.94, 95% CI 0.89–0.98), adherence (CS: RR 0.83, 95% CI 0.75–0.93), and sputum smear conversion (RCT: RR 0.92, 95% CI 0.87–0.98) as well as higher rates of development of drug resistance (CS: RR 4.19, 95% CI 2.34–7.49). When compared to DOT provided by healthcare providers, DOT provided by family members was associated with a lower rate of adherence (CS: RR 0.86, 95% CI 0.79–0.94). DOT delivery in the community versus at the clinic was associated with a higher rate of treatment success (CS: RR 1.08, 95% CI 1.01–1.15) and sputum conversion at the end of two months (CS: RR 1.05, 95% CI 1.02–1.08) as well as lower rates of treatment failure (CS: RR 0.56, 95% CI 0.33–0.95) and loss to follow-up (CS: RR 0.63, 95% CI 0.40–0.98). Medication monitors improved adherence and treatment success and VOT was comparable with DOT. SMS reminders led to a higher treatment completion rate in one RCT and were associated with higher rates of cure and sputum conversion when used in combination with medication monitors. TB treatment outcomes improved when patient education, healthcare provider education, incentives and enablers, psychological interventions, reminders and tracers, or mobile digital technologies were employed. Our findings are limited by the heterogeneity of the included studies and lack of standardized research methodology on adherence interventions. Conclusion TB treatment outcomes are improved with the use of adherence interventions, such as patient education and counseling, incentives and enablers, psychological interventions, reminders and tracers, and digital health technologies. Trained healthcare providers as well as community delivery provides patient-centered DOT options that both enhance adherence and improve treatment outcomes as compared to unsupervised, SAT alone.
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              A patient-level pooled analysis of treatment-shortening regimens for drug-susceptible pulmonary tuberculosis

              Marjorie Imperial, Payam Nahid, Patrick Phillips … (2018)
              Tuberculosis kills more people than any other infectious disease. Three pivotal trials testing 4-month regimens failed to meet non-inferiority margins; however, approximately four-fifths of participants were cured. Through a pooled analysis of patient-level data with external validation, we identify populations eligible for 4-month treatment, define phenotypes that are hard to treat and evaluate the impact of adherence and dosing strategy on outcomes. In 3,405 participants included in analyses, baseline smear grade of 3+ relative to 6 months to cure all. Regimen duration can be selected in order to improve outcomes, providing a stratified medicine approach as an alternative to the ‘one-size-fits-all’ treatment currently used worldwide.
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                Author and article information

                Journal
                Journal ID (nlm-ta): PLoS Med
                Journal ID (iso-abbrev): PLoS Med
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosmed
                Title: PLoS Medicine
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Print): 1549-1277
                ISSN (Electronic): 1549-1676
                Publication date (Electronic): 10 December 2019
                Publication date Collection: December 2019
                Volume: 16
                Issue: 12
                Electronic Location Identifier: e1002884
                Affiliations
                [1 ] Clinical Research Branch, Division of TB Elimination, NCHHSTP, US Centers for Disease Control & Prevention, Atlanta, Georgia, United States of America
                [2 ] TB Centre, London School of Hygiene & Tropical Medicine, London, United Kingdom
                [3 ] Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa
                [4 ] Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California, United States of America
                [5 ] National Institute for Allergy and Infectious Disease, National Institutes of Health, Washington DC, United States of America
                [6 ] Division of Pulmonary and Critical Care Medicine, University of California, San Francisco at San Francisco General Hospital, San Francisco, California, United States of America
                Author notes

                All the authors work on TB clinical trials; PN, RS, and AV collaborate as part of the TB Trials Consortium, supported by CDC.

                Author information
                http://orcid.org/0000-0003-1105-8534
                http://orcid.org/0000-0003-2811-1311
                Article
                Publisher ID: PMEDICINE-D-19-00393
                DOI: 10.1371/journal.pmed.1002884
                PMC ID: 6903706
                PubMed ID: 31821323
                SO-VID: 4c2ba85b-9191-47d0-b7a4-75cf6c2c4934
                Copyright © © 2019 World Health Organization
                License:

                Licensee Public Library of Science. This is an open access article distributed under the Creative Commons Attribution IGO License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/3.0/igo/. In any use of this article, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.

                History
                Page count
                Figures: 0, Tables: 2, Pages: 10
                Funding
                This work was not supported by any direct funding. The authors were supported by WHO to attend the March 2018 workshop on TB trial design.
                Categories
                Subject: Collection Review
                Subject: Medicine and Health Sciences
                Subject: Infectious Diseases
                Subject: Bacterial Diseases
                Subject: Tuberculosis
                Subject: Medicine and Health Sciences
                Subject: Tropical Diseases
                Subject: Tuberculosis
                Subject: Medicine and Health Sciences
                Subject: Clinical Medicine
                Subject: Clinical Trials
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Drug Research and Development
                Subject: Clinical Trials
                Subject: Research and Analysis Methods
                Subject: Clinical Trials
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Drug Adherence
                Subject: Biology and Life Sciences
                Subject: Physiology
                Subject: Physiological Processes
                Subject: Ingestion
                Subject: Medicine and Health Sciences
                Subject: Physiology
                Subject: Physiological Processes
                Subject: Ingestion
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Fluids
                Subject: Urine
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Fluids
                Subject: Urine
                Subject: Biology and Life Sciences
                Subject: Physiology
                Subject: Body Fluids
                Subject: Urine
                Subject: Medicine and Health Sciences
                Subject: Physiology
                Subject: Body Fluids
                Subject: Urine
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Pharmacokinetics
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Drug Screening
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Pharmacokinetics
                Subject: Drug Metabolism

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