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An attempt to reproduce a previous meta-analysis and a new analysis regarding the impact of directly observed therapy on tuberculosis treatment outcomes.

ABSTRACT: Directly observed therapy (DOT) is almost universally used for the treatment of TB. Several meta-analyses using different methods have assessed the effectiveness of DOT compared to self-administered therapy (SAT). The results of these meta-analyses often conflict with some concluding DOT is superior and others that there is little or no difference. Meta-analyses can guide policymaking, but such analyses must be reliable. To assess the validity of a previous meta-analysis, we tried to reproduce it. We encountered problems with the previous analysis that did not allow for a meaningful reproduction. We describe the issues we encountered here. We then performed a new meta-analysis comparing the treatment outcomes of adults given treatment with SAT versus DOT. Outcomes in the new analysis are loss to follow-up, treatment failure, cure, treatment completed, and all-cause mortality. All data, documentation, and code used to generate our results is provided. Our new analysis included four randomized and three observational studies with 1603 and 1626 individuals respectively. The pooled relative risks (RR) are as follows: Lost to follow-up (RR = 1.2, 95% CI 0.9, 1.7), Treatment Failure (RR = 1.1, 95% CI 0.6, 2), Cure (RR = 0.9, 95% CI 0.8, 1.1), Treatment Completion (RR = 1, 95% CI 0.9, 1.1), Mortality (RR = 0.9, 95% CI 0.6, 1.3). Based on data from our new meta-analysis, the magnitude of the difference between DOT and SAT for all reported outcomes is small, and none of the differences are statistically significant.

SUBMITTER: McKay B

PROVIDER: S-EPMC6532908 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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An attempt to reproduce a previous meta-analysis and a new analysis regarding the impact of directly observed therapy on tuberculosis treatment outcomes.

McKay Brian B Castellanos Maria M Ebell Mark M Whalen Christopher C CC Handel Andreas A

PloS one 20190523 5

Directly observed therapy (DOT) is almost universally used for the treatment of TB. Several meta-analyses using different methods have assessed the effectiveness of DOT compared to self-administered therapy (SAT). The results of these meta-analyses often conflict with some concluding DOT is superior and others that there is little or no difference. Meta-analyses can guide policymaking, but such analyses must be reliable. To assess the validity of a previous meta-analysis, we tried to reproduce i ...[more]

PMID: 31120965

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Project description:BackgroundDirectly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT.MethodsWe did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967.FindingsBetween Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved ≥80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5·48, 95% CI 3·10-9·68; p<0·0001). In the restricted analysis, 78 (77%) of 101 patients on VOT achieved the primary outcome compared with 35 (63%) of 56 on DOT (adjusted OR 2·52; 95% CI 1·17-5·54; p=0·017). Stomach pain, nausea, and vomiting were the most common adverse events reported (in 16 [14%] of 112 on VOT and nine [8%] of 114 on DOT).InterpretationVOT was a more effective approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective, and cheaper option for supervision of daily and multiple daily doses than DOT.FundingNational Institute for Health Research.

Project description:Background: Excellent adherence to tuberculosis (TB) treatment is critical to cure TB and avoid the emergence of resistance. Wirelessly observed therapy (WOT) is a novel patient self-management system consisting of an edible ingestion sensor (IS), external wearable patch, and paired mobile device that can detect and digitally record medication ingestions. Our study determined the accuracy of ingestion detection in clinical and home settings using WOT and subsequently compared, in a randomized control trial (RCT), confirmed daily adherence to medication in persons using WOT or directly observed therapy (DOT) during TB treatment.Methods and findings: We evaluated WOT in persons with active Mycobacterium tuberculosis complex disease using IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate). Seventy-seven participants with drug-susceptible TB in the continuation phase of treatment, prescribed daily isoniazid 300 mg and rifampin 600 mg, used IS-Rifamate. The primary endpoints of the trial were determination of the positive detection accuracy (PDA) of WOT, defined as the percentage of ingestions detected by WOT administered under direct observation, and subsequently the proportion of prescribed doses confirmed by WOT compared to DOT. Initially participants received DOT and WOT simultaneously for 2-3 weeks to allow calculation of WOT PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples. Sixty-one participants subsequently participated in an RCT to compare the proportion of prescribed doses confirmed by WOT and DOT. Participants were randomized 2:1 to receive WOT or maximal in-person DOT. In the WOT arm, if ingestions were not remotely confirmed, the participant was contacted within 24 hours by text or cell phone to provide support. The number of doses confirmed was collected, and nonparametric methods were used for group and individual comparisons to estimate the proportions of confirmed doses in each randomized arm with 95% CIs. Sensitivity analyses, not prespecified in the trial registration, were also performed, removing all nonworking (weekend and public holiday) and held-dose days. Participants, recruited from San Diego (SD) and Orange County (OC) Divisions of TB Control and Refugee Health, were 43.1 (range 18-80) years old, 57% male, 42% Asian, and 39% white with 49% Hispanic ethnicity. The PDA of WOT was 99.3% (CI 98.1; 100). Intent-to-treat (ITT) analysis within the RCT showed WOT confirmed 93% versus 63% DOT (p < 0.001) of daily doses prescribed. Secondary analysis removing all nonworking days (weekends and public holidays) and held doses from each arm showed WOT confirmed 95.6% versus 92.7% (p = 0.31); WOT was non-inferior to DOT (difference 2.8% CI [-1.8%, 9.1%]). One hundred percent of participants preferred using WOT. WOT associated adverse events were <10%, consisting of minor skin rash and pruritus associated with the patch. WOT provided longitudinal digital reporting in near real time, supporting patient self-management and allowing rapid remote identification of those who needed more support to maintain adherence. This study was conducted during the continuation phase of TB treatment, limiting its generalizability to the entire TB treatment course.Conclusions: In terms of accuracy, WOT was equivalent to DOT. WOT was superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment and was overwhelmingly preferred by participants. WOT should be tested in high-burden TB settings, where it may substantially support low- and middle-income country (LMIC) TB programs.Trial registration: ClinicalTrials.gov NCT01960257.

Project description:Data regarding tuberculosis (TB) treatment outcomes, proportion of TB/HIV co-infection and associated factors have been released at different TB treatment facilities in Ethiopia and elsewhere in the world as part of the auditing and surveillance service. However, these data are missing for the TB clinic offering directly observed treatment short-course (DOTs) at Debre Tabor General Hospital (DTGH).The authors analysed the records of 985 TB patients registered at the DTGH from September 2008 to December 2016. Data on patients' sex, age, type of TB, and treatment outcomes were extracted from the TB treatment registration logbook. The treatment outcome of patients was categorized according to the National TB and Leprosy Control Program guidelines: cured, treatment completed, treatment failed, died, and not evaluated (transferred out and unknown cases).Around half of the registered patients were males (516, 52.4%). In terms of TB types, 381 (38.7%), 241 (24.5%), and 363 (36.9%) patients had smear-negative pulmonary TB, smear-positive pulmonary TB, and extra pulmonary TB, respectively. Six hundred and seventy-two patients (90.1%) had successful treatment outcomes (cured and treatment completed), while 74 patients (9.9%) had unsuccessful treatment outcomes (death and treatment failure).TB treatment outcome was not associated with age, sex, type and history of TB, or co-infection with HIV (P > 0.05). The proportion of TB/HIV co-infection was at 24.2%, and these were found to be significantly associated with the age groups of 25-34, 35-44 and ≥65 years:(aOR: 0.44; 95% CI: 0.25-0.8), (aOR: 0.39; 95% CI: 0.20-0.70), (aOR: 4.2; 95% CI: 1.30-12.9), respectively.The proportion of patients with successful treatment outcomes was above the World Health Organization target set for Millennium Development Goal of 85% and in line with that of the global milestone target set at > 90% for 2025. Relatively higher proportions of transfer-out cases were recorded in the present study. Similarly, the proportion of TB/HIV co-infection cases was much higher than the national average of 8%.Thus, the health facility under study should develop strategies to record the final treatment outcome of transfer-out cases. In addition, strategies to reduce the burden of TB/HIV co-infection should be strengthened.

Project description:BackgroundHealth facility-based directly observed therapy (HF DOT) is the main strategy for the management of patients with drug-resistant tuberculosis (DR TB) in Uganda, however, this still yields sub-optimal treatment outcomes. We set out to assess the effectiveness of community-based directly observed therapy (CB DOT) for the treatment of DR TB in Uganda.MethodsUsing a previously developed patient-centered model for CB DOT, we assigned community health workers (CHWs) as primary caregivers to patients diagnosed with DR TB. CHWs administered daily DOT to patients in their homes. Once a month, patients received travel vouchers to attend clinic visits for treatment monitoring. We assessed the effectiveness of this model using a quasi-experimental pre and post-study. From December 2020 to March 2022, we enrolled adult DR-TB patients on the CB DOT model. We collected retrospective data from patients who had received care using the HF DOT model during the year before the study started. The adjusted effect of CB DOT versus HF DOT on DR TB treatment success was estimated using modified Poisson regression model with robust cluster variance estimator.ResultsWe analyzed data from 264 DR TB patients (152 HF DOT, 112 CB DOT). The majority were males (67.8%) with a median age of 36 years (IQR 29 to 44 years). Baseline characteristics were similar across the comparison groups, except for educational level, regimen type, and organizational unit with age being borderline. The treatment success rate in the CB DOT group was 12% higher than that in the HF DOT (adjusted prevalence ratio (aPR)= 1.12 [95%CI 1.01, 1.24], P-value=0.03). Males were less likely to achieve treatment success compared to their female counterparts (aPR=0.87 [95% CI 0.78, 0.98], P-value=0.02). A total of 126 (47.7%) of 264 patients reported at least one adverse event. The HF DOT group had a higher proportion of patients with at least one adverse event compared to the CB DOT group (90/152 [59.2%] versus 36/112 [32.1], P-value<0.01). The model was acceptable among patients (93.6%) and health workers (94.1%).ConclusionsCB DOT for DR-TB care is effective and results in better treatment outcomes than HF DOT. The cost-effectiveness of this model of care should be further evaluated.

Project description:The aim of this study was to systematically compare the perioperative outcomes of percutaneous nephrolithotomy in patients with or without previous ipsilateral open renal surgery (POS).Systematic searches of the PubMed, Web of Science and Cochrane Library databases were used to identify relevant studies, and, following literature screening and data extraction, a meta-analysis was performed.17 retrospective cohort studies involving 4833 procedures (4784 patients) were included. No statistically significant differences were observed between patients with or without POS in terms of supracostal access; single/multiple tracts; metal dilator need; time required to access the collecting system; fluoroscopic duration; demand for analgesics; hospital stay; final stone-free rate; and risk of developing certain complications (eg, fever, haemorrhage, haemo/hydro/pneumothorax, blood transfusion, urinary tract infection and sepsis) as well as regarding the risk of total complications. Patients with POS, however, had a greater drop in haemoglobin (weighted mean difference (WMD), 1.78 g/L; 95% CI 1.09 to 2.47; p<0.00001) and higher risk of bleeding that required angiographic embolisation (relative risk (RR), 3.73; 95% CI 1.36 to 10.21; p=0.01). In addition, patients with POS also had a lower initial stone-free rate (RR, 0.96; 95% CI 0.92 to 0.99; p=0.007) and more secondary treatment (RR, 1.61; 95% CI 1.09 to 2.37; p=0.02). Sensitivity analysis produced comparable results except for differences in operative time and initial stone-free rate, which did, however, prove to be statistically insignificant (p=0.16 and 0.69, respectively).Current evidence suggests that percutaneous nephrolithotomy in patients with POS is associated with a significantly greater drop in haemoglobin, higher risk of requiring angiographic embolisation and auxiliary procedures, potentially longer operative time, and lower initial stone-free rate than percutaneous nephrolithotomy in patients without POS.

Project description:BACKGROUND:Tuberculosis (TB) is a leading cause of death among infectious agents, ranking above HIV/AIDS. Though much effort has been done, Ethiopia remained one of those countries which share the greatest burden of TB. Evaluating the TB treatment outcome is one method of TB control measures. Therefore, the aim of the current study was to assess TB treatment outcome and its determinants under directly observed treatment short courses in Adama City, Central Ethiopia. METHOD:An institutional based cross sectional study was conducted in all public and private health facilities of Adama city from March 1st 2016 to December 31st, 2016. The data were entered and analyzed by using SPSS version 21.0 statistical software. The results were presented using descriptive statistics. Univariate and multivariate logistic regression model was used to evaluate the potential determinants of unsuccessful treatment outcome. RESULTS:Among 281 patients evaluated, 90(32%) were cured, 137(48.8%) have completed the treatment, 4(1.4%) were treatment failure, 36(12.8%) were lost to follow up, and 14 (5%) died. The overall treatment success rate was 80.8%. Age 15-24 (Adjusted odds ratio (AOR): 4.97; 95% Confidence interval (CI): 1.13-21.90), distance less than 5 kilometers from treatment center (AOR: 3.1; 95% CI: 1.42-6.77), being seronegative for human immunodeficiency virus (HIV) (AOR: 20.38; 95% CI: 7.80-53.24) were associated with successful TB treatment outcome. CONCLUSION:The treatment outcome of all forms tuberculosis patients in Adama city was unsatisfactory when referred with the national pooled estimate of 86% and WHO 2030 international target of ?90%. Thus, enhancing client supervision, treatment monitoring; and working on provision TB treatment services at nearby health facilities should be a priority concern to improve the success rate of treatment outcome. Further studies are also recommended to explore important factors which were not examined by current study.

Dataset Information

An attempt to reproduce a previous meta-analysis and a new analysis regarding the impact of directly observed therapy on tuberculosis treatment outcomes.

Publications

An attempt to reproduce a previous meta-analysis and a new analysis regarding the impact of directly observed therapy on tuberculosis treatment outcomes.

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