A comparison of stone free rate between a diuretic and a control group of patients undergoing extracorporeal shock wave lithotripsy: a prospective, randomized, double-blind, placebo-controlled trial

Objectives: To compare the stone free rate and treatment success rate between a diuretic group of patients undergoing extracorporeal shock wave lithotripsy (ESWL) and a control placebo group (normal saline solution). Materials and Methods: One hundred and ninety-four patients with solitary renal calculi or ureteric calculi size of 5 mm or over were prospectively randomized into 2 groups. Ninety-seven patients in the first group (diuretic group) underwent ESWL after intravenous injection of furosemide 40 mg, and 97 patients in the second (control) group received normal saline solution 4 ml instead of furosemide prior to ESWL. The treatment protocol included 3,000 shockwaves per patient in each session with the energy beginning at 8 and progressing up to 15 kilovolts. A maximum of 3 ESWL sessions were permitted per patient. The primary outcome was stone free rate, and the secondary outcome was treatment success rate at 3 months after the first ESWL treatment. Results: The stone free rate was 48.5% compared to 50.5% for diuretic group and control group respectively and the treatment success rate was 81.4% compared to 64.9%. The difference in stone free rate was not statistically significantly different (p = 0.87), however the treatment success was, p = 0.01. Conclusion: A combination of diuretic therapy followed by ESWL improves the treatment success rate compared with standard ESWL therapy alone.

The transmission of drug-resistant strains of HIV in heterosexual populations based on genetic sequences

Background China’s National Free Antiretroviral Treatment Program (NFATP) has substantially reduced morbidity and HIV/AIDS incidence since 2003. However, HIV resistance to antiretroviral drugs (ARVs) has been a major challenge for the current treatment of HIV/AIDS in China. Methods In the current study, we established a nested dynamic model to predict the multi-drug resistance dynamics of HIV among the heterosexual population and evaluated the impact of intervention measures on the transmission of drug resistance. We obtained an effective reproductive number R e d from each sub-model held at different stages of the dynamic model. Meanwhile, we applied Bayesian phylogenetic methods to infer the weighted average effective reproductive number R e g from four HIV subtypes that sampled from 912 HIV-positive patients in China. It is an original and innovative method by fitting R e d to R e g by Markov Chain Monte Carlo (MCMC) to generate unknown parameters in R e d. Results By analyzing the HIV gene sequences, we inferred that the most recent common ancestor of CRF01AE, CRF07BC, CRF08BC, and CRFBC dated from 1994, 1990, 1993 and 1990, respectively. The weighted average effective reproductive number R e g dropped from 1.95 in 1994 to 1.73 in 2018. Considering different interventions, we used a macro dynamic model to predict the trend of HIV resistance. The results show that the number of new infections and total drug resistance under the baseline parameter (S1) are 253,422 and 213,250 in 2025, respectively. Comparing with the numbers under the target treatment rate (S2), they were 219,717 and 236,890, respectively. However, under the ideal treatment target (S3, the treatment rate reaches 90% and the treatment success rate reaches 90%), the number of new infections shows a declining trend and will decrease to 46,559 by 2025. Compared with S1 and S2, the total number of resistance also decreased to 160,899 in 2025. Conclusion With the promotion of NFATP in China, HIV resistance to ARVs is inevitable. The strategy of increasing the treatment rate would not only ineffectively curb the epidemic, but also deteriorate drug resistance issue. Whereas, a combination of intervention strategies (the treatment rate reaches 90% and the treatment success rate reaches 90%) can greatly reduce both infection and drug resistance rate than applying one strategy alone.

A.5 Identification of predictors of response to Erenumab in episodic and chronic migraine in a cohort of patients: a preliminary analysis

Background: Erenumab is an antibody anti-calcitonin gene related peptide (CGRP) receptor approved for the treatment of episodic (EM) and chronic migraine (CM). In this study, we aimed to identify the predictors of response to the treatment. Methods: This is an ongoing retrospective cohort study of 120 patients (49 with cervicalgia) with EM or CM treated with Erenumab. The first endpoint was to identify the success rate of this treatment (at least 50% reduction in monthly migraine days during the third month of the treatment). The second endpoint was to identify the predictors of response to Erenumab treatment. Results: Seventy one percent of patients achieved a favorable response (P-value<0.001) to Erenumab. Patients with cervicalgia showed a lower treatment success rate (21.1% with vs 40.8% without cervicalgia) while patients without cervicalgia showed a higher treatment success rate (78. 9% without vs 59.2% with cervicalgia) with a P-value of 0.025 and an odd ratio of 0.388 (95% CI 0.174-0.869, P-value=0.021). A similar trend was observed in patients with occipital neuralgia and obesity (P-value<0.08). Conclusions: The preliminary analysis of this study demonstrates that cervicalgia (and to a lesser extend occipital neuralgia and obesity) is a negative predictor of response to Erenumab in patients with migraine.

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

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.

Tuberculosis Treatment Outcome and Predictors in Africa: A Systematic Review and Meta-Analysis

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.

Treatment Outcomes and Associated Factors in Tuberculosis Patients at Atwima Nwabiagya District, Ashanti Region, Ghana: A Ten-Year Retrospective Study

Introduction. Tuberculosis poses a great threat to public health around the globe and affects persons mostly in their productive age, notwithstanding; everyone is susceptible to tuberculosis (TB) infection. To assess the effectiveness and performance of the tuberculosis control program activities, the percentage of cases with treatment success outcome is key. To control tuberculosis, interrupting transmission through effective treatment cannot be overemphasized. The study was conducted to determine factors associated with TB treatment outcome, in the Atwima Nwabiagya District from 2007–2017. Method. A Retrospective review of routine/standard TB registers was carried out in five directly observed therapy short-course (DOTS) centres at the Atwima Nwabiagya District from January 2007 to December 2017. Demographic characteristics, clinical characteristics, and treatment outcomes were assessed. Bivariate and multivariate logistic regression was conducted to determine the predictors of successful treatment outcome. Results. Of the 891 TB client’s data that was assessed in the district, the treatment success rate was 68.46%. Patients, aged ≤ 20 years (adjusted odds ratio aOR = 4.74 , 95 % CI = 1.75 − 12.83 ) and 51-60 years ( aOR = 1.94 , 95 % CI = 1.12 − 3.39 ), having a pretreatment weight of 35-45 kg ( aOR = 2.54 , 95 % CI = 1.32 − 4.87 ), 46-55 kg ( aOR = 2.75 , 95 % CI = 1.44 − 5.27 ) and 56-65 kg ( aOR = 3.04 , 95 % CI = 1.50 − 6.14 ) were associated with treatment success. However, retreatment patients ( aOR = 0.31 , 95 % CI = 0.11 − 0.84 ) resulted in unsuccessful treatment outcome. Conclusion. Successful treatment outcome among TB patients was about 20.00% and 30.00% lower compared to the national average treatment success rate and WHO target, respectively. Active monitoring, motivation, and counselling of retreatment patients and patients with advanced age are key to treatment success.

Trends of Tuberculosis Treatment Outcomes of Notified Cases in Three Refugee Camps in Sudan: A Four-year Retrospective Analysis, 2014–2017

Background: Refugees are vulnerable to tuberculosis (TB) infection. Tracking of program performance is needed to improve TB care and prevention. The objective of this study was to assess the trends of TB treatment outcomes of notified cases in three refugee camps in Sudan from 2014 to 2017. Methods: This study was a historical cohort study. Sex, age, type of TB, TB patient category, and treatment outcome of all TB cases registered in three refugee camps (Al Kashafa, Shagarab, Wadsherify) from January 1, 2014 to December 31, 2017 were collected from the TB register. Multivariable logistic regression was performed to explore factors for unsuccessful TB treatment. Results: A total of 710 TB cases of which 53.4% were men, 22.1% children (<15 years), and 36.2% extrapulmonary TB (EPTB) were registered. Overall, the TB treatment success rate was 75.7% with a declining trend from 86.2% in 2015 to 63.5% in 2017. On average, 11.4% were lost to follow-up (LTFU), 6.6% died, 5.9% were not evaluated, and in 0.3% the treatment failed. Being 15–24 years old and having EPTB were significantly associated with unsuccessful treatment outcome. Conclusion: The treatment success rate in the refugee camp in 2017 (63.5%) was far lower than the national treatment success rate (78%) and the End TB global target (≥90%) that needs to be improved. LTFU, died, and not evaluated outcomes were high which indicated the necessity to improve the TB treatment program.