Last data update: Dec 02, 2024. (Total: 48272 publications since 2009)
Records 1-19 (of 19 Records) |
Query Trace: Mangan J[original query] |
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Reasons for acceptance or nonparticipation in iAdhere: a trial of latent TB infection treatment
Chapman Hedges KN , Scott N , Belknap R , Goldberg SV , Engle M , Borisov A , Mangan J . Int J Tuberc Lung Dis 2024 28 (11) 521-526 <sec><title>BACKGROUND</title>Understanding the motivations behind clinical trial participation can help enhance recruitment strategies and determine the generalizability of trial results. This study focuses on the reasons for participating in or declining the Tuberculosis Trials Consortium Study 33 (iAdhere), a clinical trial on the treatment of latent tuberculosis infection (LTBI).</sec><sec><title>METHODS</title>A quantitative evaluation was conducted among screened patients to ascertain their reasons for participating or not in the iAdhere trial. The study gathered data from enrolled participants and those who chose not to enroll.</sec><sec><title>RESULTS</title>Among 1,002 enrolled individuals, 290 participants provided 749 reasons for enrolling. The most common reasons included access to shorter treatment regimens (56%), avoiding progression to TB disease (45%), and improving health (21%). Of the 670 eligible persons who chose not to enroll, 551 individuals provided 800 reasons, with the most common being a preference for standard therapy (17%), disinterest in study medication or TB therapy (both 13%), and the inconvenience of daily observed treatment (12%).</sec><sec><title>CONCLUSION</title>The desire for shorter treatment options and preventing active disease motivates participation in LTBI trials. The diverse reasons for declining enrolment suggest the importance of developing targeted recruitment strategies. These findings support exploring shorter treatment regimens and can guide future recruitment efforts.</sec>. |
Process and outcome evaluation of the Centers for Disease Control and Prevention's Think. Test. Treat TB health communications campaign, United States, March-September 2022
Caruso E , Parmer J , Allen L , Maiuri A , Mangan J , Bouwkamp B , DeLuca N . Public Health Rep 2024 333549241268644 OBJECTIVES: The Think. Test. Treat TB health communications campaign aims to increase the awareness of latent tuberculosis infection (LTBI) primarily among people born in the Philippines and Vietnam and other non-US-born groups (consumers) and the health care providers (providers) who serve them. We conducted a process evaluation to assess reach and audience engagement and an outcome evaluation to assess awareness, knowledge, perceptions, and behavioral intentions among audiences of the campaign. METHODS: To evaluate the process, the Centers for Disease Control and Prevention measured exposure to (eg, with impressions [total advertisements]) and engagement with (eg, online clicks) the campaign during its rollout (March-September 2022). After the rollout, to evaluate outcomes, we administered online surveys to consumers and providers who were exposed and not exposed to the campaign. RESULTS: The Think. Test. Treat TB campaign resulted in >33 million impressions, >2000 materials downloaded from the internet, and >33 000 materials shipped. Of 173 consumers who completed the evaluation survey, 123 (71.1%) were exposed to the campaign, with 108 (87.8%) reporting intention to ask their provider about tuberculosis (TB) during their next visit. Of 44 providers who completed the evaluation survey, 24 (54.5%) did not feel that they were the intended audience of the campaign, yet all felt the campaign materials were relevant to their patients, and 42 (95.5%) felt the materials were relevant to providers who serve patients at risk for TB. CONCLUSION: The Think. Test. Treat TB campaign was successful in raising awareness of LTBI among the intended audiences. Continuing engagement with key audiences about LTBI to encourage testing and treatment is integral to eliminate TB in the United States. |
Facilitators and barriers to adolescent participation in a TB clinical trial
Mangan JM , Hedges KNC , Salerno MM , Tatum K , Bouwkamp B , Frick MW , McKenna L , Muzanyi G , Engle M , Coetzee J , Yvetot J , Elskamp M , Lamunu D , Tizora MET , Namutamba D , Chaisson RE , Swindells S , Nahid P , Dorman SE , Kurbatova E . Int J Tuberc Lung Dis 2024 28 (5) 243-248 <sec id="st1"><title>BACKGROUND</title>The inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.</sec><sec id="st2"><title>METHODS</title>Interviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.</sec><sec id="st3"><title>RESULTS</title>Investigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.</sec><sec id="st4"><title>CONCLUSION</title>Proactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial.</sec>. |
Tuberculosis testing and latent tuberculosis infection treatment practices among health care providers - United States, 2020-2022
Caruso E , Mangan JM , Maiuri A , Bouwkamp B , DeLuca N . MMWR Morb Mortal Wkly Rep 2023 72 (44) 1183-1189 CDC recommends testing persons at increased risk for tuberculosis (TB) infection as part of routine health care, using TB blood tests, when possible, and, if a diagnosis of latent TB infection (LTBI) is made, prescribing a rifamycin-based, 3- or 4-month treatment regimen (short-course) to prevent the development of TB disease. In 2022, approximately three quarters (73%) of reported TB cases in the United States occurred among non-U.S.-born persons. To assess TB-related practices among health care providers (HCPs) in the United States, CDC analyzed data from the 2020-2022 Porter Novelli DocStyles surveys. Approximately one half (53.3%) of HCPs reported routinely testing non-U.S.-born patients for TB, and of those who did, 35.7% exclusively ordered recommended blood tests, 44.2% exclusively ordered skin tests, and 20.2% ordered TB skin tests and blood tests. One third (33.0%) of HCPs reported prescribing recommended short-course LTBI treatment regimens, and 4.0% reported doing none of the treatment practices available for patients with LTBI (i.e., prescribing short-course regimens, longer course regimens, or referring patients to a health department). Further efforts are needed to identify and overcome barriers for providers to test for and treat persons at risk for TB. |
Adverse events among persons with TB using in-person vs. electronic directly observed therapy
Salerno MM , Burzynski J , Mangan JM , Hill A , deCastro BR , Goswami ND , Lam CK , Macaraig M , Schluger NW , Vernon AA . Int J Tuberc Lung Dis 2023 27 (11) 833-840 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. |
Cost of Tuberculosis Therapy Directly Observed on Video for Health Departments and Patients in New York City; San Francisco, California; and Rhode Island (2017-2018)
Beeler Asay GR , Lam CK , Stewart B , Mangan JM , Romo L , Marks SM , Morris SB , Gummo CL , Keh CE , Hill AN , Thomas A , Macaraig M , St John K , JAmpie T , Chuck C , Burzynski J . Am J Public Health 2020 110 (11) 1696-1703 Objectives. To assess costs of video and traditional in-person directly observed therapy (DOT) for tuberculosis (TB) treatment to health departments and patients in New York City, Rhode Island, and San Francisco, California.Methods. We collected health department costs for video DOT (VDOT; live and recorded), and in-person DOT (field- and clinic-based). Time-motion surveys estimated provider time and cost. A separate survey collected patient costs. We used a regression model to estimate cost by DOT type.Results. Between August 2017 and June 2018, 343 DOT sessions were captured from 225 patients; 87 completed a survey. Patient costs were lowest for VDOT live ($1.01) and highest for clinic DOT ($34.53). The societal (health department + patient) costs of VDOT live and recorded ($6.65 and $12.64, respectively) were less than field and clinic DOT ($21.40 and $46.11, respectively). VDOT recorded health department cost was not statistically different from field DOT cost in Rhode Island.Conclusions. Among the 4 different modalities, both types of VDOT were associated with lower societal costs when compared with traditional forms of DOT.Public Health Implications. VDOT was associated with lower costs from the societal perspective and may reduce public health costs when TB incidence is high. |
Challenges associated with electronic and in-person directly observed therapy during a randomized trial
Mangan JM , Burzynski J , deCastro BR , Salerno MM , Lam CK , Macaraig M , Reaves M , Kiskadden-Bechtel S , Bowers S , Sathi C , Dias MP , Goswami ND , Vernon A . Int J Tuberc Lung Dis 2023 27 (4) 298-307 BACKGROUND: Electronic directly observed therapy (eDOT) has been proposed as an alternative to traditional in-person DOT (ipDOT) for monitoring TB treatment adherence. Information about the comparative performance and implementation of eDOT is limited.METHODS: The frequency of challenges during DOT, challenge type, and effect on medication observation were documented by DOT method during a crossover, noninferiority randomized controlled trial. A logistic mixed-effects model that adjusted for the study design was used to estimate the percentage of successfully observed doses when challenges occurred.RESULTS: A total of 20,097 medication doses were scheduled for observation with either eDOT (15,405/20,097; 76.7%) or ipDOT (4,692/20,097; 23.3%) for 213 study participants. In total, one or more challenges occurred during 17.3% (2,672/15,405) of eDOT sessions and 15.6% (730/4,692) of ipDOT sessions. Among 4,374 documented challenges, 27.3% (n = 1,192) were characterized as technical, 65.9% (n = 2,881) were patient-related, and 6.9% (n = 301) were program-related. Estimated from the logistic model (n = 6,782 doses, 173 participants), the adjusted percentage of doses successfully observed during problematic sessions was 21.7% (95% CI 11.2-37.8) for eDOT and 4.2% (95% CI 1.1-14.7) for ipDOT.CONCLUSION: Compared to ipDOT, challenges were encountered in a slightly higher percentage of eDOT sessions but were more often resolved to enable successful dose observation during problematic sessions. |
Recommendations for use of video directly observed therapy during tuberculosis treatment - United States, 2023
Mangan JM , Woodruff RS , Winston CA , Nabity SA , Haddad MB , Dixon MG , Parvez FM , Sera-Josef C , Salmon-Trejo LAT , Lam CK . MMWR Morb Mortal Wkly Rep 2023 72 (12) 313-316 U.S. clinical practice guidelines recommend directly observed therapy (DOT) as the standard of care for tuberculosis (TB) treatment (1). DOT, during which a health care worker observes a patient ingesting the TB medications, has typically been conducted in person. Video DOT (vDOT) uses video-enabled devices to facilitate remote interactions between patients and health care workers to promote medication adherence and clinical monitoring. Published systematic reviews, a published meta-analysis, and a literature search through 2022 demonstrate that vDOT is associated with a higher proportion of medication doses being observed and similar proportions of cases with treatment completion and microbiologic resolution when compared with in-person DOT (2-5). Based on this evidence, CDC has updated the recommendation for DOT during TB treatment to include vDOT as an equivalent alternative to in-person DOT. vDOT can assist health department TB programs meet the U.S. standard of care for patients undergoing TB treatment, while using resources efficiently. |
In-person vs electronic directly observed therapy for tuberculosis treatment adherence: A randomized noninferiority trial
Burzynski J , Mangan JM , Lam CK , Macaraig M , Salerno MM , deCastro BR , Goswami ND , Lin CY , Schluger NW , Vernon A . JAMA Netw Open 2022 5 (1) e2144210 IMPORTANCE: Electronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited. OBJECTIVE: To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT. DESIGN, SETTING, AND PARTICIPANTS: This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021. INTERVENTIONS: Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos. MAIN OUTCOMES AND MEASURES: Difference between the percentage of medication doses participants were observed to completely ingest with in-person DOT and with electronic DOT. Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates). RESULTS: There were 173 participants in each crossover period (median age, 40 years [range, 16-86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%-89.9%) vs 89.8% (95% CI, 87.5%-92.1%) with electronic DOT. The percentage difference was -2.6% (95% CI, -4.8% to -0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from -4.9% to -1.9%. CONCLUSIONS AND RELEVANCE: In this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03266003. |
Factors Influencing Risk for COVID-19 Exposure Among Young Adults Aged 18-23 Years - Winnebago County, Wisconsin, March-July 2020.
Wilson RF , Sharma AJ , Schluechtermann S , Currie DW , Mangan J , Kaplan B , Goffard K , Salomon J , Casteel S , Mukasa A , Euhardy N , Ruiz A , Bautista G , Bailey E , Westergaard R , Gieryn D . MMWR Morb Mortal Wkly Rep 2020 69 (41) 1497-1502 On May 13, 2020, the Wisconsin Supreme Court declared the state's Safer at Home Emergency Order (https://evers.wi.gov/Documents/COVID19/EMO28-SaferAtHome.pdf) "unlawful, invalid, and unenforceable,"* thereby increasing opportunities for social and business interactions. By mid-June, Winnebago County,(†) Wisconsin experienced an increase in the number of infections with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), with the largest increase among persons aged 18-23 years (young adults) (1). This age group(§) accounts for 12.5% of the population in the county. To identify factors that influence exposure to COVID-19 among young adults in Winnebago County, characteristics of COVID-19 cases and drivers of behaviors in this age group were examined. During March 1-July 18, 2020, 240 young adults received positive SARS-CoV-2 test results, accounting for 32% of all Winnebago County cases. In 30 key informant interviews, most interviewees reported exposure to misinformation, conflicting messages, or opposing views about the need for and effectiveness of masks. Thirteen young adults described social or peer pressure to not wear a mask and perceived severity of disease outcome for themselves as low but high for loved ones at risk. Having low perceived severity of disease outcome might partly explain why, when not in physical contact with loved ones at risk, young adults might attend social gatherings or not wear a mask (2). Exposure to misinformation and unclear messages has been identified as a driver of behavior during an outbreak (3,4), underscoring the importance of providing clear and consistent messages about the need for and effectiveness of masks. In addition, framing communication messages that amplify young adults' responsibility to protect others and target perceived social or peer pressure to not adhere to public health guidance might persuade young adults to adhere to public health guidelines that prevent the spread of COVID-19. |
Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA Clinical Practice Guideline
Nahid P , Mase SR , Migliori GB , Sotgiu G , Bothamley GH , Brozek JL , Cattamanchi A , Cegielski JP , Chen L , Daley CL , Dalton TL , Duarte R , Fregonese F , Horsburgh CR Jr , Ahmad Khan F , Kheir F , Lan Z , Lardizabal A , Lauzardo M , Mangan JM , Marks SM , McKenna L , Menzies D , Mitnick CD , Nilsen DM , Parvez F , Peloquin CA , Raftery A , Schaaf HS , Shah NS , Starke JR , Wilson JW , Wortham JM , Chorba T , Seaworth B . Am J Respir Crit Care Med 2019 200 (10) e93-e142 Background: The American Thoracic Society, U.S. Centers for Disease Control and Prevention, European Respiratory Society, and Infectious Diseases Society of America jointly sponsored this new practice guideline on the treatment of drug-resistant tuberculosis (DR-TB). The document includes recommendations on the treatment of multidrug-resistant TB (MDR-TB) as well as isoniazid-resistant but rifampin-susceptible TB.Methods: Published systematic reviews, meta-analyses, and a new individual patient data meta-analysis from 12,030 patients, in 50 studies, across 25 countries with confirmed pulmonary rifampin-resistant TB were used for this guideline. Meta-analytic approaches included propensity score matching to reduce confounding. Each recommendation was discussed by an expert committee, screened for conflicts of interest, according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology.Results: Twenty-one Population, Intervention, Comparator, and Outcomes questions were addressed, generating 25 GRADE-based recommendations. Certainty in the evidence was judged to be very low, because the data came from observational studies with significant loss to follow-up and imbalance in background regimens between comparator groups. Good practices in the management of MDR-TB are described. On the basis of the evidence review, a clinical strategy tool for building a treatment regimen for MDR-TB is also provided.Conclusions: New recommendations are made for the choice and number of drugs in a regimen, the duration of intensive and continuation phases, and the role of injectable drugs for MDR-TB. On the basis of these recommendations, an effective all-oral regimen for MDR-TB can be assembled. Recommendations are also provided on the role of surgery in treatment of MDR-TB and for treatment of contacts exposed to MDR-TB and treatment of isoniazid-resistant TB. |
Tuberculosis mortality in the United States: Epidemiology and prevention opportunities
Beavers SF , Pascopella L , Davidow AL , Mangan JM , Hirsch-Moverman YR , Golub JE , Blumberg HM , Webb RM , Royce RA , Buskin SE , Leonard MK , Weinfurter PC , Belknap RW , Hughes SE , Warkentin JV , Welbel SF , Miller TL , Kundipati SR , Lauzardo M , Barry PM , Katz DJ , Garrett DO , Graviss EA , Flood JM . Ann Am Thorac Soc 2018 15 (6) 683-692 RATIONALE: More information on risk factors for death from tuberculosis in the United States could help reduce the tuberculosis mortality rate, which has remained steady for over a decade. Objective(s) To identify risk factors for tuberculosis-related death in adults. METHODS: We performed a retrospective study of 1,304 adults with tuberculosis who died before treatment completion and 1,039 frequency-matched controls who completed tuberculosis treatment in 2005-2006 in thirteen states reporting 65% of U.S. tuberculosis cases. We used in-depth record abstractions and a standard algorithm to classify deaths in persons with tuberculosis as tuberculosis-related or not. We then compared these classifications to causes of death as coded in death certificates. We used multivariable logistic regression to calculate adjusted odds ratios (aOR) for predictors of tuberculosis-related death among adults compared with those who completed tuberculosis treatment. RESULTS: Of 1,304 adult deaths, 942 (72%) were tuberculosis-related, 272 (21%) were not, and 90 (7%) couldn't be classified. Of 847 tuberculosis-related deaths with death certificates available, 378 (45%) did not list tuberculosis as a cause of death. Adjusting for known risks, we identified new risks for tuberculosis-related death during treatment: absence of pyrazinamide in the initial regimen (aOR=3.4, 95% CI=1.9-6.0); immunosuppressive medications (aOR=2.5, 95% CI=1.1-5.6); incomplete TB diagnostic evaluation (aOR=2.2, 95% CI=1.5-3.3), and an alternative non-TB diagnosis prior to TB diagnosis (aOR=1.6, 95% CI=1.2-2.2). Conclusions Most persons who died with tuberculosis had a tuberculosis-related death. Intensive record review revealed tuberculosis as a cause of death more often than did death certificate diagnoses. New tools, such as a TB mortality risk score based on our study findings, may identify TB patients for in-hospital interventions to prevent death. |
Evaluation of the Tuberculosis Infection Control Training Center, Tajikistan, 2014-2015
Scott C , Mangan J , Tillova Z , Jensen PA , Ahmedov S , Ismoilova J , Trusov A . Int J Tuberc Lung Dis 2017 21 (5) 579-585 SETTING: Training center on tuberculosis (TB) infection control (IC) for health care workers in the Central Asian Republics region. OBJECTIVE: To assess the effects of TB IC training courses conducted at the Tuberculosis Infection Control Training Center in Machiton, Tajikistan. DESIGN: Participants who participated in training (n = 89) during the first year of operation (April 2014-February 2015) were invited to participate in a post-training interview. RESULTS: Of the 89 participants, 84 (94%) completed the interview and expressed satisfaction with the training. Eighty (95%) participants reported meeting with workplace leadership to discuss the training. Of these, 69 (85%) reported discussing changes required to meet TB IC standards. Self-reported changes in TB IC practices at work facilities post training included the creation of TB IC committees, designation of a TB IC focal person, TB IC planning, policies to separate infectious patients in waiting rooms, provision of masks for infectious patients, development of cough etiquette policies, improved glove availability, hand hygiene programs, and TB IC posters in waiting rooms. CONCLUSIONS: Participant satisfaction and reported changes in TB IC activities illustrate the potential of these training courses to improve TB IC in the region. Future training courses may be tailored to specific audiences using a structured conceptual framework to impact administration, budgeting, and facilities management of TB IC practices. |
Multidrug-resistant tuberculosis patients' views of interventions to reduce treatment loss to follow-up
Tupasi T , Garfin AMCG , Mangan JM , Orillaza-Chi R , Naval LC , Balane GI , Basilio R , Golubkov A , Joson ES , Lew WJ , Lofranco V , Mantala M , Pancho S , Sarol JN Jr , Blumberg A , Burt D , Kurbatova EV . Int J Tuberc Lung Dis 2017 21 (1) 23-31 SETTING: Patients who initiated treatment for multidrug-resistant tuberculosis (MDR-TB) at 15 Programmatic Management of Drug-resistant Tuberculosis (PMDT) health facilities in the Philippines between July and December 2012. OBJECTIVES: To describe patients' views of current interventions, and suggest changes likely to reduce MDR-TB loss to follow-up. METHODS: In-depth interviews were conducted between April and July 2014 with MDR-TB patients who were undergoing treatment, had finished treatment at the time of the interview (controls), or had been lost to follow-up (LTFU). Responses were thematically analyzed. RESULTS: Interviews were conducted with 182 patients who were undergoing or had completed treatment and 91 LTFU patients. Views and suggestions could be thematically categorized as approaches to facilitate adherence or address barriers to adherence. The top themes were the need for transportation assistance or improvements to the current transportation assistance program, food assistance, and difficulties patients encountered related to their medications. These themes were addressed by respectively 63%, 60%, and 32% of the participants. CONCLUSIONS: A more patient-centered approach is needed to improve MDR-TB treatment adherence. Programs should strive to provide assistance that considers patient preferences, is adequate to cover actual costs or needs, and is delivered in a timely, uninterrupted manner. |
Multidrug-resistant tuberculosis patients lost to follow-up: self-reported readiness to restart treatment
Mangan JM , Tupasi TE , Garfin AM , Lofranco V , Orillaza-Chi R , Basilio R , Naval LC , Balane GI , Joson ES , Burt D , Lew WJ , Mantala M , Pancho S , Sarol JN , Golubkov A , Kurbatova EV . Int J Tuberc Lung Dis 2016 20 (9) 1205-11 SETTING: Multidrug-resistant tuberculosis (MDR-TB) patients lost to follow-up (LTFU) from Programmatic Management of Drug-resistant Tuberculosis facilities in the Philippines. OBJECTIVES: To gain insight into patients' readiness to return to treatment. METHODS: MDR-TB patients who initiated treatment and were categorized as LTFU were identified using TB registers, contacted, and asked to consent to an interview and medical record review. At the conclusion of the interview, patients' readiness to restart treatment was assessed and examined in relation to demographic, clinical, and interview data. Odds ratios were calculated. RESULTS: When asked if they would consider restarting MDR-TB treatment, 3% of the 89 participating patients reported that they had already restarted, 34% indicated that they wanted to restart, 33% had not considered restarting, 28% were undecided, and 2% had decided against restarting. Patients who wanted to restart treatment were more likely to report having borrowed money for TB-related expenses (OR 5.97, 95%CI 1.27-28.18), and were less likely to report being self-employed (OR 0.08, 95%CI 0.01-0.67), or perceive themselves at low or no risk for TB relapse (OR 0.30, 95%CI 0.08-0.96) than patients who did not indicate an interest in restarting treatment. CONCLUSIONS: Efforts to re-engage LTFU patients in care should consider financial barriers, knowledge gaps, and personal adherence challenges in patients. |
Factors associated with loss to follow-up during treatment for multidrug-resistant tuberculosis, the Philippines, 2012-2014
Tupasi TE , Garfin AM , Kurbatova EV , Mangan JM , Orillaza-Chi R , Naval LC , Balane GI , Basilio R , Golubkov A , Joson ES , Lew WJ , Lofranco V , Mantala M , Pancho S , Sarol JN Jr . Emerg Infect Dis 2016 22 (3) 491-502 To identify factors associated with loss to follow-up during treatment for multidrug-resistant (MDR) tuberculosis (TB) in the Philippines, we conducted a case-control study of adult patients who began receiving treatment for rifampin-resistant TB during July 1-December 31, 2012. Among 91 case-patients (those lost to follow-up) and 182 control-patients (those who adhered to treatment), independent factors associated with loss to follow-up included patients' higher self-rating of the severity of vomiting as an adverse drug reaction and alcohol abuse. Protective factors included receiving any type of assistance from the TB program, better TB knowledge, and higher levels of trust in and support from physicians and nurses. These results provide insights for designing interventions aimed at reducing patient loss to follow-up during treatment for MDR TB. |
Evaluation of community-based treatment for drug-resistant tuberculosis in Bangladesh
Cavanaugh JS , Kurbatova E , Alami NN , Mangan J , Sultana Z , Ahmed S , Begum V , Sultana S , Daru P , Ershova J , Golubkov A , Banu S , Heffelfinger JD . Trop Med Int Health 2015 21 (1) 131-139 OBJECTIVE: Drug-resistant tuberculosis (TB) threatens global TB control because it is difficult to diagnose and treat. Community-based programmatic management of drug-resistant TB (cPMDT) has made therapy easier for patients, but data on these models are scarce. Bangladesh initiated cPMDT in 2012, and in 2013 we sought to evaluate program performance. METHODS: In this retrospective review, we abstracted demographic, clinical, microbiologic and treatment outcome data for all patients enrolled in the cPMDT program over six months in three districts of Bangladesh. We interviewed a convenience sample of patients about their experience in the program. RESULTS: Chart review was performed on 77 patients. Sputum smears and cultures were done, on average, once every 1.35 and 1.36 months, respectively. Among 74 initially culture-positive patients, 70 (95%) converted their cultures and 69 (93%) patients converted the cultures before the sixth month. Fifty-two (68%) patients had evidence of screening for adverse events. We found written documentation of musculoskeletal complaints for 16 (21%) patients, gastrointestinal adverse events for 16 (21%), hearing loss for eight (10%) and psychiatric events for four (5%) patients; conversely, on interview of 60 patients, 55 (92%) reported musculoskeletal complaints, 54 (90%) reported nausea, 36 (60%) reported hearing loss, and 36 (60%) reported psychiatric disorders. CONCLUSIONS: The cPMDT program in Bangladesh appears to be programmatically feasible and clinically effective; however, inadequate monitoring of adverse events raises some concern. As the program is brought to scale nationwide, renewed efforts at monitoring adverse events should be prioritized. This article is protected by copyright. All rights reserved. |
Evaluation of the informed consent process of a multicenter tuberculosis treatment trial
Chapman KN , Pevzner E , Mangan JM , Breese P , Lamunu D , Shrestha-Kuwahara R , Nakibali JG , Goldberg SV . AJOB Empir Bioeth 2015 6 (4) 31-43 BACKGROUND: Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. METHODS: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. RESULTS: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. CONCLUSIONS: Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials. |
Development and initial testing of messages to encourage tuberculosis testing and treatment among bacille calmette-guerin (BCG) vaccinated persons
Mangan JM , Galindo-Gonzalez S , Irani TA . J Immigr Minor Health 2013 17 (1) 79-88 Misperceptions surrounding the Bacille Calmette-Guerin (BCG) vaccine can lead some vaccinated individuals to resist being tested and treated for tuberculosis (TB). Educational messages to best explain the risk of TB to BCG-vaccinated, Hispanic persons were systematically developed and tested. First, TB program staff provided messages they considered effective. These were analyzed and validated by TB experts, and then presented in group interviews initially to foreign-born Hispanic persons with a TB diagnosis, and then persons without a prior TB diagnosis. Based on interviewees' feedback, preferred statements were used to develop one long and three short comprehensive messages. One-on-one interviews were conducted with Hispanic persons to assess the saliency of the comprehensive educational messages. Participants preferred messages that were gain or positively-framed and explained that BCG does not confer lifelong protection against TB. Participants confirmed the messages would likely have a positive impact on patient decisions to undergo TB testing and treatment. |
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