Treatment Success
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Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Anthony D. Bai ◽  
Adam S. Komorowski ◽  
Carson K. L. Lo ◽  
Pranav Tandon ◽  
Xena X. Li ◽  

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.

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1699
Rodrigo Alonso ◽  
Ainara Rodríguez-Achaerandio ◽  
Amaia Aguirre-Quiñonero ◽  
Aitor Artetxe ◽  
Ilargi Martínez-Ballesteros ◽  

The aim of this study was to apply molecular epidemiology, antimicrobial surveillance, and PK/PD analysis to guide the antimicrobial treatment of gonococci infections in a region of the north of Spain. Antibiotic susceptibility testing was performed on all isolates (2017 to 2019, n = 202). A subset of 35 isolates intermediate or resistant to at least two antimicrobials were selected to search for resistance genes and genotyping through WGS. By Monte Carlo simulation, we estimated the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of the antimicrobials used to treat gonorrhea, both indicative of the probability of treatment success. In total, 2.0%, 6.4%, 5.4%, and 48.2% of the isolates were resistant to ceftriaxone, cefixime, azithromycin, and ciprofloxacin, respectively. Twenty sequence types were identified. Detected mutations were related to antibiotic resistance. PK/PD analysis showed high probability of treatment success of the cephalosporins. In conclusion, multiple populations of N. gonorrhoeae were identified. We can confirm that ceftriaxone (even at the lowest dose: 250 mg) and oral cefixime are good candidates to treat gonorrhea. For patients allergic to cephalosporins, ciprofloxacin should be only used if the MIC is known and ≤ 0.125 mg/L; this antimicrobial is not recommended for empirical treatment.

Melese Yeshambaw Teferi ◽  
Ziad El-Khatib ◽  
Minyahil Tadesse Boltena ◽  
Azeb Tarekegn Andualem ◽  
Benedict Oppong Asamoah ◽  

This review aimed to summarize and estimate the TB treatment success rate and factors associated with unsuccessful TB treatment outcomes in Africa. Potentially eligible primary studies were retrieved from PubMed and Google Scholar. The risk of bias and quality of studies was assessed using The Joanna Briggs Institute’s (JBI) appraisal criteria, while heterogeneity across studies was assessed using Cochran’s Q test and I2 statistic. Publication bias was checked using the funnel plot and egger’s test. The protocol was registered in PROSPERO, numbered CRD42019136986. A total of 26 eligible studies were considered. The overall pooled estimate of TB treatment success rate was found to be 79.0% (95% CI: 76–82%), ranging from 53% (95% CI: 47–58%) in Nigeria to 92% (95% CI: 90–93%) in Ethiopia. The majority of unsuccessful outcomes were attributed to 48% (95% CI: 40–57%) death and 47% (95% CI: 39–55%) of defaulter rate. HIV co-infection and retreatment were significantly associated with an increased risk of unsuccessful treatment outcomes compared to HIV negative and newly diagnosed TB patients with RR of 1.53 (95% CI: 1.36–1.71) and 1.48 (95% CI: 1.14–1.94) respectively. TB treatment success rate was 79% below the WHO defined threshold of 85% with significant variation across countries. Countries need to explore contextual underlining factors and more effort is required in providing TB preventive treatment, improve case screening and linkage for TB treatment among HIV high-risk groups and use confirmatory TB diagnostic modality. Countries in Africa need to strengthen counseling and follow-up, socio-economic support for patients at high risk of loss to follow-up and poor treatment success is also crucial for successful TB control programs.

2021 ◽  
Vol 23 (1) ◽  
Bianka Marklein ◽  
Madeleine Jenning ◽  
Zoltán Konthur ◽  
Thomas Häupl ◽  
Franziska Welzel ◽  

2021 ◽  
pp. annrheumdis-2021-220853
Dafne Capelusnik ◽  
Daniel Aletaha

ObjectiveTo perform a comprehensive analysis on predictors of achieving disease activity outcomes by change, response and state measures.MethodsWe used data from three rheumatoid arthritis (RA) trials (one for main analysis, two for validation) to analyse the effect of patient and disease characteristics, core set measure and composite indices on the achievement of different outcomes: response outcomes (% of patients achieving a relative response margin); state outcomes (remission or low disease activity, LDA) and change outcomes (numerical change on metric scales).ResultsWe included patients from the ASPIRE trial (for analysis) and from the ATTRACT and GO-BEFORE trials (for validation). While lower disease activity components at baseline—except acute phase reactants—were associated with achievement of state outcomes (such as LDA by the Simplified Disease Activity Index, SDAI), higher baseline values were associated with change outcomes (such as SDAI absolute change). A multivariate analysis of the identified predictors of state outcomes identified best prediction by a combination of shorter disease duration, male gender and lower disease activity. For prediction of response, no consistently significant predictors were found, again, with exception of C reactive protein, for which higher levels at baseline were associated with better responses.ConclusionPrediction of treatment success is limited in RA. Particularly in early RA, prediction of state targets can be achieved by lower baseline levels of diseases activity. Gender and disease duration may improve the predictability of state targets. In clinical trials, included populations and choice of outcomes can be coordinated to maximise efficiency from these studies.

Georg Authried ◽  
Mathias Svendsen

Chronic nail biting (onychophagia) is a common habit which negatively impacts on the quality of life of those affected, has a negative social impact, and is accompanied with disabling inflammatory processes like gingivitis and paronychia. Habit reversal is a behaviour treatment procedure used to help patients get rid of the habit. The presented case report describes how a six-month period of habit reversal prescribed by the dermatologist was used to treat a 42-year male suffering from life-long onychophagia. During the treatment period, the patient experienced both an improved growth of nails and an improvement in quality of life, but never got fully cured from the habit. Finally, suggestions for an improved treatment success by prescribing habit reversal in specialized onychophagia clinics run by a multidisciplinary team (consisting of e.g., dermatologists, psychiatrists, and psychologists) who ensure regular follow-ups and patient compliance is provided.

2021 ◽  
Vol 15 (09.1) ◽  
pp. 51S-57S
Tetiana Fomenko ◽  
Anna Meteliuk ◽  
Larysa Korinchuk ◽  
Olga Denisiuk ◽  
Garry Aslanyan ◽  

Introduction: Opioid substitution therapy (OST) is one of the pillars of harm reduction strategies for People Who Inject Drugs (PWID). It should be an integral part of tuberculosis (TB) care to increase the uptake, compliance and effectiveness of treatment and also curtail risk behaviors. We aimed to compare TB treatment outcomes in relation to OST among PWID in six regions of Ukraine. Methodology: A retrospective cohort study using routine programmatic data from centers offering integrated TB and OST (December 2016 – May 2020). OST involved use of methadone or buprenorphine. TB treatment outcomes were standardized. Results: Of 228 PWID (85% male) diagnosed with TB, 104 (46%) had drug-sensitive and 124 (64%) drug-resistant TB. The majority had pulmonary TB (95%), 64 (28%) were HCV-positive and 179 (78%) were HIV-positive, 91% of the latter were also on antiretroviral therapy. There were 114 (50%) PWID with TB on OST. For drug-sensitive TB (n=104), treatment success was significantly higher (61%) in those on adjunctive OST than those not on OST (42%, P<0.001). Similarly, for drug-resistant TB (n=124) treatment success was also significantly higher when individuals were on OST (43%) compared to when not on OST (26%, P<0.001). Conclusions: This operational research study shows that OST is associated with significantly improved treatment success in PWID and can contribute to achieving Universal Health Coverage and the WHO Flagship Initiative “Find.Treat.All. #End TB”. We advocate for the scale-up of this intervention in Ukraine.

2021 ◽  
Vol 15 (09.1) ◽  
pp. 66S-74S
Elena Zhdanova ◽  
Olga Goncharova ◽  
Hayk Davtyan ◽  
Sevak Alaverdyan ◽  
Aelita Sargsyan ◽  

Introduction: MDR/RR-TB is a growing problem in Kyrgyzstan. In 2005, the country introduced standard or individualized treatment for 20-24 months. Because of poor treatment outcomes, in 2017 a short treatment with strict eligibility criteria was introduced. The aim of this study was to compare characteristics and treatment outcomes of MDR/RR-TB patients receiving short (9-12 months) treatment in 2017 with those receiving standard or individualized (20-24 months) treatment in 2016/2017. Methodology: A comparative cohort study using routine programmatic data. Characteristics, sputum culture conversion and treatment outcomes were compared between those on short treatment with those on standard/individualized treatment using the chi-square test, crude and adjusted risk ratios (RR and aRR). Results: The study included 274, 82 and 132 patients on standard, individualized and short treatment, respectively. There were more females, fewer migrants/homeless and unemployed and more new TB patients on short treatment compared with the other two groups. A favorable outcome (cure and treatment completed) was significantly higher in short treatment patients (83%) compared with those on standard (50%) or individualized (59%) treatment (p < 0.001). There was higher 1-month sputum culture conversion with short treatment (35%) compared with the other two groups (19% and 24%, p < 0.05). Short treatment (aRR 1.6, 1.4-1.8), female gender (aRR 1.2, 1.1-1.4), not being homeless (aRR 12.9, 4.5-17.3) and having new TB (aRR 1.3, 1.0-1.5) were independently associated with a favorable outcome. Conclusions: The treatment success was higher in selected MDR-TB patients given short treatment in Kyrgyzstan: this regimen should be scaled-up to all MDR-TB patients.

2021 ◽  
Vol 15 (09.1) ◽  
pp. 34S-42S
Tinatin Jomidava ◽  
Mohammed Khogali ◽  
Yuliia Sereda ◽  
Zaza Avaliani ◽  
Malkhaz Davitashvili ◽  

Introduction: Adherence to second-line antituberculosis drug is challenging. A combination of strategies needs to be implemented to achieve adherence. In Georgia an optimized adherence support (OAS) – a package of education, psychosocial support and adherence counselling – was added to the already existing package of adherence support (supervised treatment, adherence incentives, transport cost reimbursement) to improve adherence and increase treatment success. We assessed the additive benefits of OAS on adherence and treatment outcomes. Methodology: This was a before and after cohort study using routine programme data in the National Center for Tuberculosis and Lung Diseases in Tbilisi. All adult rifampicin- and multidrug-resistant tuberculosis (RR/MDR-TB) patients enrolled for treatment under directly observed therapy in the NCTLD during the period before (June 2015 – January 2016) and after (June 2017 – January 2018) were included in the study. Primary outcomes were: i) adequate adherence defined as ≥ 85% of days covered by TB medication during the whole treatment period; ii) final treatment outcomes. Results: Of 221 RR/MDR-TB, most patients were male (76%, N = 167) with a mean age of 41 ± 14 years. Adherence data was available for 111 patients in the ‘before’ and 97 patients in the ‘after’ cohort. Adequate adherence was achieved by 62% (69/111) in the ‘before’ and 70% (68/97) in the ‘after’ cohort (p = 0.290). Overall treatment success was 64% (73/114) and 63% (67/107) in the ‘before’ and ‘after’ cohorts respectively (p = 0.937). Conclusions: Implementation of OAS had modest effect on adherence and had no additive benefits on treatment outcomes among RR/MDR-TB patients on 18-20 months regimen.

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