Confidence interval of risk difference by different statistical methods and its impact on the study conclusion in antibiotic non-inferiority trials

Abstract Background Numerous statistical methods can be used to calculate the confidence interval (CI) of risk differences. There is consensus in previous literature that the Wald method should be discouraged. We compared five statistical methods for estimating the CI of risk difference in terms of CI width and study conclusion in antibiotic non-inferiority trials. Methods In a secondary analysis of a systematic review, we included non-inferiority trials that compared different antibiotic regimens, reported risk differences for the primary outcome, and described the number of successes and/or failures as well as patients in each arm. For each study, we re-calculated the risk difference CI using the Wald, Agresti-Caffo, Newcombe, Miettinen-Nurminen, and skewness-corrected asymptotic score (SCAS) methods. The CIs by different statistical methods were compared in terms of CI width and conclusion on non-inferiority. A wider CI was considered to be more conservative. Results The analysis included 224 comparisons from 213 studies. The statistical method used to calculate CI was not reported in 134 (59.8%) cases. The median (interquartile range IQR) for CI width by Wald, Agresti-Caffo, Newcombe, Miettinen-Nurminen, and SCAS methods was 13.0% (10.8%, 17.4%), 13.3% (10.9%, 18.5%), 13.6% (11.1%, 18.9%), 13.6% (11.1% and 19.0%), and 13.4% (11.1%, 18.9%), respectively. In 216 comparisons that reported a non-inferiority margin, the conclusion on non-inferiority was the same across the five statistical methods in 211 (97.7%) cases. The differences in CI width were more in trials with a sample size of 100 or less in each group and treatment success rate above 90%. Of the 18 trials in this subgroup with a specified non-inferiority margin, non-inferiority was shown in 17 (94.4%), 16 (88.9%), 14 (77.8%), 14 (77.8%), and 15 (83.3%) cases based on CI by Wald, Agresti-Caffo, Newcombe, Miettinen-Nurminen, and SCAS methods, respectively. Conclusions The statistical method used to calculate CI was not reported in the majority of antibiotic non-inferiority trials. Different statistical methods for CI resulted in different conclusions on non-inferiority in 2.3% cases. The differences in CI widths were highest in trials with a sample size of 100 or less in each group and a treatment success rate above 90%. Trial registration PROSPERO CRD42020165040. April 28, 2020.

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Minority Infant Death Rate Is Down Drug And Alcohol Treatment Success Rate Is Up DSHS Scorecard 2003 Results

PsycEXTRA Dataset ◽

10.1037/e333812004-001 ◽

2003 ◽

Author(s):

Keyword(s):

Success Rate ◽

Infant Death ◽

Death Rate ◽

Treatment Success ◽

Alcohol Treatment ◽

Treatment Success Rate ◽

Drug And Alcohol Treatment ◽

Drug And Alcohol

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Effect of using electronic medication monitors on tuberculosis treatment outcomes in China: a longitudinal ecological study

Infectious Diseases of Poverty ◽

10.1186/s40249-021-00818-3 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Ni Wang ◽

Lei Guo ◽

Hemant Deepak Shewade ◽

Pruthu Thekkur ◽

Hui Zhang ◽

...

Keyword(s):

Success Rate ◽

Treatment Outcomes ◽

Treatment Success ◽

Coverage Rate ◽

Treatment Success Rate ◽

County Level ◽

Time Data ◽

Tb Treatment ◽

Random Intercept ◽

Relative Change

Abstract Background In China, an indigenously developed electronic medication monitor (EMM) was designed and used in 138 counties from three provinces. Previous studies showed positive results on accuracy, effectiveness, acceptability, and feasibility, but also found some ineffective implementations. In this paper, we assessed the effect of implementation of EMMs on treatment outcomes. Methods The longitudinal ecological method was used at the county level with aggregate secondary programmatic data. All the notified TB cases in 138 counties were involved in this study from April 2017 to June 2019, and rifampicin-resistant cases were excluded. We fitted a multilevel model to assess the relative change in the quarterly treatment success rate with increasing quarterly EMM coverage rate, in which a mixed effects maximum likelihood regression using random intercept model was applied, by adjusting for seasonal trends, population size, sociodemographic and clinical characteristics, and clustering within counties. Results Among all 69 678 notified TB cases, the treatment success rate was slightly increased from 93.5% [95% confidence interval (CI): 93.0–94.0] in second quarter of 2018 to 94.9% (95% CI: 94.4–95.4) in second quarter of 2019 after implementing EMMs. There was a statistically significant effect between quarterly EMM coverage and treatment success rate after adjusting for potential confounders (P = 0.0036), increasing 10% of EMM coverage rate will lead to 0.2% treatment success rate augment. Besides, an increase of 10% of elderly or bacteriologically confirmed TB will lead to a decrease of 0.4% and 0.9% of the treatment success rate. Conclusions Under programmatic settings, we found a statistically significant effect between increasing coverage of EMM and treatment success rate at the county level. More prospective studies are needed to confirm the effect of using EMM on TB treatment outcomes. We suggest performing operational research on EMMs that provides real-time data under programmatic conditions in the future.

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Relationship between malocclusion severity and treatment success rate in Class II nonextraction therapy

American Journal of Orthodontics and Dentofacial Orthopedics ◽

10.1016/j.ajodo.2008.10.005 ◽

2009 ◽

Vol 135 (3) ◽

pp. 274-275 ◽

Cited By ~ 4

Author(s):

Guilherme Janson ◽

Fabrício Pinelli Valarelli ◽

Rodrigo Hermont Cançado ◽

Marcos Roberto de Freitas ◽

Arnaldo Pinzan

Keyword(s):

Success Rate ◽

Treatment Success ◽

Class Ii ◽

Treatment Success Rate

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Treatment outcome of tuberculosis at Dilla Referral Hospital, Gedeo Zone, southern Ethiopia: A retrospective study

PLoS ONE ◽

10.1371/journal.pone.0249369 ◽

2021 ◽

Vol 16 (4) ◽

pp. e0249369

Author(s):

Endrias Markos Woldesemayat ◽

Zewtir Azeze

Keyword(s):

Risk Factors ◽

Treatment Outcome ◽

Success Rate ◽

Treatment Success ◽

Referral Hospital ◽

Treatment Success Rate ◽

Southern Ethiopia ◽

Hiv Status ◽

Hospital Data ◽

Tb Treatment

Background Tuberculosis (TB) is one of the major public health problems in Ethiopia. Determining treatment outcome of TB cases could help to understand the effectiveness of TB control efforts. The objective of this study was to assess TB treatment outcome and associated factors and determine the risk factors of death among TB cases who were on Directly Observed Treatment Short course (DOTS). Methodology We analyzed a retrospective data for TB cases who were on DOTS at Dilla Referral Hospital from July 2011- June 2016. The study population was TB cases with known HIV status and whose treatment outcome was evaluated at the Hospital. Data were entered, cleaned and analyzed using statistical package SPSS for windows, version 20. Result Out of 899 registered TB cases, 731 included in this analysis. Of these cases, 424 (58.0%) were male and 334 (45.7%) were in the age group of below 25 years. Treatment success rate of TB was 675 (92.3%) and death rate was 18 (2.5%). Treatment outcome showed statistically significant variation by HIV status (P < 0.001). HIV status of the TB cases and pretreatment weight were associated with TB treatment outcome. HIV status of the TB cases was associated with death of the TB cases (Adjusted Odds Ratio (AOR) 5.0; CI 95%: 1.8–13.5). Conclusion TB treatment success rate found in this study was high. Patient’s weight and HIV status were associated with treatment outcome. Moreover, HIV status predicted death of TB cases. Cautious treatment follow-up and defaulter tracing mechanisms for TB cases with these risk factors were suggested.

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The impact of a cash transfer programme on tuberculosis treatment success rate: a quasi-experimental study in Brazil

BMJ Global Health ◽

10.1136/bmjgh-2018-001029 ◽

2019 ◽

Vol 4 (1) ◽

pp. e001029 ◽

Cited By ~ 6

Author(s):

Daniel J Carter ◽

Rhian Daniel ◽

Ana W Torrens ◽

Mauro N Sanchez ◽

Ethel Leonor N Maciel ◽

...

Keyword(s):

Success Rate ◽

Social Protection ◽

Treatment Success ◽

Cash Transfer ◽

Treatment Success Rate ◽

Sensitivity Analyses ◽

Data Set ◽

Tb Treatment ◽

Quasi Experimental ◽

The Impact

BackgroundEvidence suggests that social protection policies such as Brazil’s Bolsa Família Programme (BFP), a governmental conditional cash transfer, may play a role in tuberculosis (TB) elimination. However, study limitations hamper conclusions. This paper uses a quasi-experimental approach to more rigorously evaluate the effect of BFP on TB treatment success rate.MethodsPropensity scores were estimated from a complete-case logistic regression using covariates from a linked data set, including the Brazil’s TB notification system (SINAN), linked to the national registry of those in poverty (CadUnico) and the BFP payroll.ResultsThe average effect of treatment on the treated was estimated as the difference in TB treatment success rate between matched groups (ie, the control and exposed patients, n=2167). Patients with TB receiving BFP showed a treatment success rate of 10.58 percentage points higher (95% CI 4.39 to 16.77) than patients with TB not receiving BFP. This association was robust to sensitivity analyses.ConclusionsThis study further confirms a positive relationship between the provision of conditional cash transfers and TB treatment success rate. Further research is needed to understand how to enhance access to social protection so to optimise public health impact.

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Treatment outcomes in multidrug-resistant tuberculosis according to pyrazinamide susceptibility

The International Journal of Tuberculosis and Lung Disease ◽

10.5588/ijtld.19.0314 ◽

2020 ◽

Vol 24 (2) ◽

pp. 233-239

Author(s):

S. Park ◽

K-W. Jo ◽

T. S. Shim

Keyword(s):

Success Rate ◽

Treatment Outcomes ◽

Treatment Success ◽

Multidrug Resistant ◽

Treatment Success Rate ◽

Aminosalicylic Acid ◽

Resistant Tuberculosis ◽

Multidrug Resistant Tuberculosis ◽

Mdr Tb ◽

Effective Drugs

BACKGROUND: Pyrazinamide (PZA) is an important anti-tuberculosis drug for multidrug-resistant tuberculosis (MDR-TB). However, PZA has recently been demoted within the hierarchy of TB drugs used for MDR-TB.METHODS: We conducted a retrospective cohort study to investigate treatment outcomes for simple MDR-TB (susceptible to both second-line injectable drugs and fluoroquinolones) according to PZA susceptibility.RESULTS: Among 216 pulmonary MDR-TB patients included in the study, 68 (31.5%) were PZA-resistant (PZA-R). The mean age was 41.8 years, and 63.4% were male. Baseline characteristics such as comorbidity, previous TB history, acid-fast bacilli (AFB) smear positivity and cavitation were similar in PZA-susceptible (PZA-S) and PZA-R patients. The number of potentially effective drugs was slightly higher among PZA-S patients than among the PZA-R (5.1 vs. 4.8, respectively; P = 0.003). PZA was more frequently used in PZA-S patients (73.0%) than in the PZA-R (14.7%), while para-aminosalicylic acid was more frequently used in PZA-R than in PZA-S patients (76.5% vs. 50.7%). The treatment success rate was similar in PZA-S (77.7%) and PZA-R (75.0%) patients. PZA resistance was not associated with treatment success in multivariate analysis.CONCLUSIONS: PZA-resistant simple MDR-TB patients had the same treatment success rate as the PZA-susceptible group even without using novel anti-TB drugs.

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Treatment outcomes among multidrug-resistant TB patients in Bahawal Victoria Hospital, Bahawalpur, Pakistan: a retrospective record review

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1093/trstmh/traa040 ◽

2020 ◽

Vol 114 (10) ◽

pp. 733-741

Author(s):

Muhammad Atif ◽

Wajiha Ahmad ◽

Nafees Ahmad ◽

Iram Malik ◽

Sajjad Sarwar

Keyword(s):

Success Rate ◽

Treatment Outcomes ◽

Treatment Success ◽

Binary Logistic Regression ◽

Multidrug Resistant ◽

Treatment Success Rate ◽

Binary Logistic Regression Analysis ◽

Factors Associated ◽

Unsuccessful Treatment ◽

Mdr Tb

Abstract Background This study aims to evaluate the treatment outcomes and factors associated with unsuccessful treatment outcomes among multidrug-resistant TB (MDR-TB) patients. Method This was a retrospective observational study conducted at the Bahawal Victoria Hospital, Bahawalpur, Pakistan. The sociodemographic, clinical and treatment-related data of MDR-TB patients registered at the study site between June 2014 and December 2016 were retrospectively collected. Patients’ treatment outcomes were categorized on the basis of WHO-recommended criteria. Multivariate binary logistic regression analysis was used to find the independent factors associated with unsuccessful treatment outcomes. Results Out of 179 MDR-TB patients, 106 (59.2%) completed their treatment successfully. The remaining 73 patients (40.8%) had unsuccessful treatment outcomes, among whom 45 (25.1%) died, while 18 (10.1%) were lost to follow-up. Factors associated with unsuccessful treatment outcomes included age ≥40 y (AOR 4.310; p = 0.006), unsuccessful interim treatment outcomes (AOR 5.810; p = 0.032), occurrence of adverse events (AOR 0.290; p = 0.029) and ofloxacin resistance (AOR 2.952; p = 0.042). Conclusion The treatment success rate among the selected cohort of MDR-TB patients was less than the target of ≥75% set by the WHO in the End TB Strategy. The lower treatment success rate at the study site requires urgent attention from clinicians and program managers.

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Medication Event Monitoring System for Infectious Tuberculosis Treatment in Morocco: A Retrospective Cohort Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16030412 ◽

2019 ◽

Vol 16 (3) ◽

pp. 412 ◽

Cited By ~ 2

Author(s):

Seup Park ◽

Ilham Sentissi ◽

Seung Gil ◽

Won-Seok Park ◽

ByungKwon Oh ◽

...

Keyword(s):

Success Rate ◽

Monitoring System ◽

Treatment Success ◽

Treatment Success Rate ◽

Control Group ◽

Event Monitoring ◽

Tb Treatment ◽

The Mean ◽

Lost To Follow Up

Non-adherence to tuberculosis (TB) treatment is a barrier to effective TB control. We investigated the effectiveness of a Medication Event Monitoring System (MEMS) as a tailored adherence-promoting intervention in Morocco. We compared patients who received a MEMS (n = 206) with patients who received standard TB care (n = 141) among new active TB patients with sputum smear-positive. The mean total medication days were 141.87 ± 29.5 in the control group and 140.85 ± 17.9 in the MEMS group (p = 0.7147), and the mean age and sex were not different between the two groups (p > 0.05). The treatment success rate was significantly higher in the MEMS group than in the control group (odds ratio (OR): 4.33, 95% confidence interval (CI): 2.13–8.81, p < 0.001), and the lost to follow-up rate was significantly lower in the MEMS group than in the control group (OR: 0.03, 95% CI: 0.05–0.24, p < 0.001) after adjusting for sex, age, and health centers. The mean drug adherence rate in the first month was significantly higher in the MEMS group than in the control group (p = 0.023). MEMS increased TB treatment success rate and decreased the lost to follow-up rate overall for infectious TB patients in a Moroccan rural area.

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