BackgroundA non-inferiority (NI) trial is intended to show that the effect of a new treatment is not worse than the comparator. We conducted a review to identify how NI trials were conducted and reported, and whether the standard requirements from the guidelines were followed.Methodology and Principal FindingsFrom 300 randomly selected articles on NI trials registered in PubMed at 5 February 2009, we included 227 NI articles that referred to 232 trials. We excluded studies on bioequivalence, trials on healthy volunteers, non-drug trials, and articles of which the full-text version could not be retrieved. A large proportion of trials (34.0%) did not use blinding. The NI margin was reported in 97.8% of the trials, but only 45.7% of the trials reported the method to determine the margin. Most of the trials used either intention to treat (ITT) (34.9%) or per-protocol (PP) analysis (19.4%), while 41.8% of the trials used both methods. Less than 10% of the trials included a placebo arm to confirm the efficacy of the new drug and active comparator against placebo, and less than 5.0% were reporting the similarity of the current trial with the previous comparator's trials. In general, no difference was seen in the quality of reporting before and after the release of the CONSORT statement extension 2006 or between the high-impact and low-impact journals.ConclusionThe conduct and reporting of NI trials can be improved, particularly in terms of maximizing the use of blinding, the use of both ITT and PP analysis, reporting the similarity with the previous comparator's trials to guarantee a valid constancy assumption, and most importantly reporting the method to determine the NI margin.

Coronavirus disease 2019 (COVID-19) is a global pandemic. Non-pharmacological interventions, such as lockdown and mass testing, remain as the mainstay of control measures for the outbreak. We aim to evaluate the effectiveness of mass testing, lockdown, or a combination of both to control COVID-19 pandemic. A systematic search on 11 major databases was conducted on June 8, 2020. This review is registered in Prospero (CRD42020190546). We included primary studies written in English which investigate mass screening, lockdown, or a combination of both to control and/or mitigate the COVID-19 pandemic. There are four important outcomes as selected by WHO experts for their decision-making process: incident cases, onward transmission, mortality, and resource use. Among 623 studies, only 14 studies met our criteria. Four observational studies were rated as strong evidence and ten modelling studies were rated as moderate evidence. Based on one modelling study, mass testing reduced the total infected people compared to no mass testing. For lockdown, ten studies consistently showed that it successfully reduced the incidence, onward transmission, and mortality rate of COVID-19. A limited evidence showed that a combination of lockdown and mass screening resulted in a greater reduction of incidence and mortality rate compared to lockdown only. However, there is not enough evidence on the effectiveness of mass testing only.

Since 2010, Indonesian government has initiated a chronic disease management program, Prolanis (Program Pengendalian Penyakit Kronis) targeted for diabetes and hypertension. The program is continued at the commencement of universal health coverage (UHC) in 2014. "This study aimed to report the utilization and cost of the implementation of Prolanis in Indonesia from 2014 to 2016, or two years since the commencement of Indonesian universal health coverage." Secondary data analysis was performed using publicly available data and data obtained from the national health insurance agency (BPJS); while data on disease prevalence were collected from basic national health survey. There was an increase trend of Prolanis participants, from around 11,000 participants in 2014 to more than 250,000 in 2016. More than 70% of participants were adults living in Java, however, the acceptance rate was very low in other area. Across different activities in Prolanis, physical activity was the most participated ones. In comparison to other regions, regions in Java were the most active area. The total expenditure for Prolanis program in 2016 increased almost triple from the annual cost in 2014. However, the cost per person was actually decreased more than 50%. Within two years of UHC implementation, there were increase covered participants and total costs, but cost per individual was decreased and there was significant difference in of cost between Java and outside Java. Further study and routine monitoring-evaluation process by health authority is needed to assess whether the cost difference would affect the service quality.