Considerations for unblinding individual study participants during vaccine trials.

Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or "pseudo unblinding," in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.

Delamanid-containing regimens and multidrug-resistant tuberculosis: A systematic review and meta-analysis.

INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) is a life-threatening condition needing long poly-chemotherapy regimens. As no systematic reviews/meta-analysis is available to comprehensively evaluate the role of delamanid (DLM), we evaluated its effectiveness and safety. METHODS: We reviewed the relevant scientific literature published up to January 20, 2022. The pooled success treatment rate with 95% confidence intervals (CI) was assessed using a random-effect model. We assessed studies for quality and bias, and considered P<0.05 to be statistically significant. RESULTS: After reviewing 626 records, we identified 25 studies that met the inclusion criteria, 22 observational and 3 experimental, with 1276 and 411 patients, respectively. In observational studies the overall pooled treatment success rate of DLM-containing regimens was 80.9% (95% CI 72.6-87.2) with no evidence of publication bias (Begg's test; P >0.05). The overall pooled treatment success rate in DLM and bedaquiline-containing regimens was 75.2% (95% CI 68.1-81.1) with no evidence of publication bias (Begg's test; P >0.05). In experimental studies the pooled treatment success rate of DLM-containing regimens was 72.5 (95% CI 44.2-89.8, P <0.001, I2: 95.1%) with no evidence of publication bias (Begg's test; P >0.05). CONCLUSIONS: In MDR-TB patients receiving DLM, culture conversion and treatment success rates were high despite extensive resistance with limited adverse events.

The impact of the acceleration of COVID-19 vaccine deployment in two border regions in Oman.

Background: Among the challenges to public health systems imposed by coronavirus disease 2019 (COVID-19) have been vaccine scarcity and the prioritization of high-risk groups. Countries have been prompted to accelerate the pace of immunization campaigns against COVID-19 to deploy the immunization umbrella to the largest possible number of target groups. In this paper, we share the perspective of Oman regarding the impact of accelerating the administration of the first dose of the COVID-19 vaccine in one border governorate (Musandam) by comparison to another border governorate (Al-Buraimi) where this approach was not applied. Methods: Daily admissions data (April 10, 2020 to June 24, 2021) and vaccination data (January 1 to June 24, 2021) were collected systematically. For each governorate, the cumulative doses (first and second doses) and vaccination coverage were calculated daily. Results: Within 1 month, first dose vaccination coverage increased from 20% to 58% in Musandam, reducing the incidence of hospital admission by 75%. In comparison, vaccination coverage plateaued at 20% in Al-Buraimi, and the incidence of hospital admission increased by 500%. Conclusions: Given the peculiarity of the geographical location and being the first line of access for imported cases, border regions should be a priority for vaccine deployment as a preventive measure. The two different approaches reported here, implemented in broadly similar cross-border governorates, provide evidence of the significant effect of accelerating the first dose of vaccine in reducing hospitalizations.

Country-specific lockdown measures in response to the COVID-19 pandemic and its impact on tuberculosis control: a global study.

The objective of this study was to describe country-specific lockdown measures and tuberculosis indicators collected during the first year of the COVID-19 pandemic. Data on lockdown/social restrictions (compulsory face masks and hand hygiene; international and local travel restrictions; restrictions to family visits, and school closures) were collected from 24 countries spanning five continents. The majority of the countries implemented multiple lockdowns with partial or full reopening. There was an overall decrease in active tuberculosis, drug-resistant tuberculosis, and latent tuberculosis cases. Although national lockdowns were effective in containing COVID-19 cases, several indicators of tuberculosis were affected during the pandemic.

Seroprevalence of SARS-CoV-2 antibodies in the general population of Oman: results from four successive nationwide sero-epidemiological surveys.

OBJECTIVE: To assess the seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in Oman and longitudinal changes in antibody levels over time within the first 11 months of the coronavirus disease 2019 (COVID-19) pandemic. METHODS: This nationwide cross-sectional study was conducted as a four-cycle serosurvey using a multi-stage stratified sampling method from July to November 2020. A questionnaire was used and included demographics, history of acute respiratory infection and list of symptoms, COVID-19 contact, previous diagnosis or admission, travel history and risk factors. RESULTS: In total, 17,457 participants were surveyed. Thirty percent were female and 66.3% were Omani. There was a significant increase in seroprevalence throughout the study cycles, from 5.5% (4.8-6.2%) in Cycle 1 to 22% (19.6-24.6%) in Cycle 4. There was no difference in seroprevalence between genders, but significant differences were found between age groups. There was a transition of seroprevalence from being higher in non-Omanis than Omanis in Cycle 1 [9.1% (7.6-10.9%) vs 3.2% (2.6-3.9%)] to being higher in Omanis than non-Omanis in Cycle 4 [24.3% (21.0-27.9%) vs 16.8% (14.9-18.9%)]. There was remarkable variation in the seroprevalence of SARS-CoV-2 according to governorate. Close contacts of people with COVID-19 had a 96% higher risk of having the disease [adjusted odds ratio (AOR) 1.96, 95% confidence intervals (CI) 1.64-2.34]. Labourers had 58% higher risk of infection compared with office workers (AOR 1.58, 95% CI 1.04-2.35). CONCLUSION: This study showed a wide variation in the spread of SARS-CoV-2 across governorates in Oman, with higher estimated seroprevalence in migrants in the first two cycles. Prevalence estimates remain low and are insufficient to provide herd immunity.

Challenges and Opportunities for Public Health Service in Oman From the COVID-19 Pandemic: Learning Lessons for a Better Future.

Despite the apparent challenges inflicted by COVID-19 globally, the pandemic provided an opportunity to utilize and expand existing public health capacities for a more adaptive and resilient system during and after each wave of the disease. This paper provides a narrative review of Oman's public health response to the COVID-19 pandemic from January 2020 to July 2021, and the challenges it faced for a more rapid and efficient response. The review demonstrates that the three main pillars influencing the direction of the pandemic and aiding the control are Oman's unified governmental leadership, the move to expand the capacity of the health care system at all levels, and community partnership in all stages of the response including the COVID-19 vaccination campaign. The opportunities identified during response stages in the harmonization of the multisectoral response, streamlining communication channels, addressing vulnerable communities (dormitories, residences at border regions), and providing professional technical leadership provide an excellent precursor for expediting the transformation of Oman's health care system to one with a multisectoral holistic approach. Some of the major challenges faced are the shortage of the public health cadre, lack of a fully integrated digital platform for surveillance, and the scarcity of experts in risk communication and community engagement. A future health system where the center for diseases surveillance and control acts as a nucleus for multisectoral expertise and leadership, which includes community representatives, is crucial to attain optimum health. The destruction inflicted by this prolong COVID-19 pandemic at all levels of human life had valued the importance of investing on preventive and preparedness strategies.

Screening for Tuberculosis in Migrants: A Survey by the Global Tuberculosis Network.

Tuberculosis (TB) does not respect borders, and migration confounds global TB control and elimination. Systematic screening of immigrants from TB high burden settings and-to a lesser degree TB infection (TBI)-is recommended in most countries with a low incidence of TB. The aim of the study was to evaluate the views of a diverse group of international health professionals on TB management among migrants. Participants expressed their level of agreement using a six-point Likert scale with different statements in an online survey available in English, French, Mandarin, Spanish, Portuguese and Russian. The survey consisted of eight sections, covering TB and TBI screening and treatment in migrants. A total of 1055 respondents from 80 countries and territories participated between November 2019 and April 2020. The largest professional groups were pulmonologists (16.8%), other clinicians (30.4%), and nurses (11.8%). Participants generally supported infection control and TB surveillance established practices (administrative interventions, personal protection, etc.), while they disagreed on how to diagnose and manage both TB and TBI, particularly on which TBI regimens to use and when patients should be hospitalised. The results of this first knowledge, attitude and practice study on TB screening and treatment in migrants will inform public health policy and educational resources.

The Impact of Mobility Restriction Strategies in the Control of the COVID-19 Pandemic: Modelling the Relation between COVID-19 Health and Community Mobility Data.

BACKGROUND: Non-pharmaceutical interventions (NPIs), particularly mobility restrictions, are mainstay measures for the COVID-19 pandemic worldwide. We evaluated the effects of Oman's mobility restriction strategies to highlight their efficacy in controlling the pandemic. METHODS: Accessible national data of daily admissions and deaths were collected from 1 April 2020 to 22 May 2021. Google Community Mobility Report (CMR) data were downloaded for the same period. Among six CMR categories, three were used and reduced to one index-the community mobility index (CMI). We used a generalised linear model with a negative binomial distribution combined with a non-linear distributed lag model to investigate the short-term effects of CMI on the number of admitted PCR-confirmed COVID-19 cases and deaths, controlling for public holidays, day of the week, and Eid/Ramadan days. RESULTS: We demonstrated the feasibility of using CMRs in the evaluation and monitoring of different NPIs, particularly those related to movement restriction. The best movement restriction strategy was a curfew from 7 p.m. to 5 a.m. (level 3 of CMI = 8), which had a total reduction of 35% (95% confidence interval (CI); 25-44%) in new COVID-19 admissions in the following two weeks, and a fatality reduction in the following four weeks by 52% (95% CI; 11-75%). CONCLUSION: Evening lockdown significantly affected the course of the pandemic in Oman which lines up with similar studies throughout the world.

The role of children and adolescents in the transmission of SARS-CoV-2 virus within family clusters: A large population study from Oman.

BACKGROUND: In Oman, many extended families tend to live in one household. Some families can include 20-30 individuals with the majority of them being children. This study investigates the role of children in spreading SARS-CoV-2 causing COVID-19 within family clusters in Oman. METHODS: This retrospective study includes data of 1026 SARS-CoV-2 positive children (≤18 years) collected from the national surveillance database for COVID-19 between 1 February 2020 and 30 May 2020. RESULTS: We included 1026 patients. Most, 842 were Omani (82%), 52% male, and 28.5% asymptomatic. Close to the half of symptomatic 419 (40%), patients presented with fever associated with other respiratory symptoms. Fifty pediatric patients were index cases who transmitted the virus to 107 patients in total (86 adults and 21 children) with a mode of 1. There is no statistical significance of all studied risk factors in the transmission of the SARS-CoV-2 virus including age, gender, and cycle threshold (CT) value. CONCLUSIONS: According to this study, children are not to be considered a significant driver of transmission of SARS-CoV-2 in Oman.

The role of supporting services in driving SARS-CoV-2 transmission within healthcare settings: A multicenter seroprevalence study.

OBJECTIVE: To determine the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthcare workers (HCWs) based on risk of exposure to COVID-19 patients. METHOD: This was a SARS-CoV-2 seroprevalence cross-sectional study in risk-stratified HCWs randomly selected from three main district hospitals in Oman. RESULTS: 1078 HCWs were included, with an overall SARS-CoV-2 seroprevalence of 21%. The seropositivity rates in low-, variable-, and high-risk groups were 29%, 18%, and 17%, respectively (p-value < 0.001). The study found higher positivity in males (crude odds ratio [COR] 1.71, 95% confidence interval [CI] 1.28-2.3), and workers residing in high-prevalence areas (COR 2.09, 95% CI 1.42-3.07). Compared with doctors, workers from supporting services, administration staff, and nurses were more likely to test positive for SARS-CoV-2 antibodies (COR 9.81, 95% CI 5.26-18.27; 2.37, 95% CI 1.23-4.58; 2.08 95% CI 1.14-3.81). The overall rate of previously undetected infection was 12%, with higher values in low-risk HCWs. High district prevalence was a driving factor for seropositivity in the low-risk group (adjusted odds ratio [AOR] 2.36, 95% CI 1.0-5.59). CONCLUSION: Low-risk supporting services workers can drive SARS-CoV-2 transmission in hospitals. More attention and innovation within this area will enhance the safety of health care during epidemics/pandemics.

Epidemiological Characteristics of Pandemic Coronavirus Disease (COVID-19) in Oman.

OBJECTIVES: The aim of the current study was to describe COVID-19's epidemiological characteristics in Oman during the initial stages of the outbreak and compare findings with other countries' reports. METHODS: Data were drawn from a descriptive, records-based review of reported cases of COVID-19 collected through the national COVID-19 Surveillance System from February to April 2020. RESULTS: A total of 2,443 confirmed cases were reported during the study period. The overall first-time testing rate for this period was 851.7 per 100,000, the positivity rate was 53.1 (confidence intervals [CI]: 51.0-55.2) and the death rate was 0.32 (CI: 0.20-0.54) per 100,000 population, respectively. The overall national positive ratio was 5.7% and ranged from 2.2-7.1% across various governorates. Muscat Governorate had the highest positive ratio (12.5%). People in the 51-60 year old age group (RR = 1.97), males (RR = 1.24), non-Omanis (RR = 2.33) and those living in Muscat (RR = 2.14) emerged as categories with significant demographic risk for COVID-19 cases when compared to the national average. The mean age was 35.6 ± 13.4. Asymptomatic cases accounted for nearly 16%. CONCLUSION: The overall rate of COVID-19 cases and deaths were low in Oman compared to the rest of the world during the study period.

Knowledge, Attitudes, and Practices (KAP) toward the COVID-19 Vaccine in Oman: A Pre-Campaign Cross-Sectional Study.

Oman is globally acknowledged for its well-structured immunization program with high vaccination coverage. The massive spread of misinformation brought on by the COVID-19 pandemic, as well as the easy access to various media channels, may affect acceptance of a vaccine, despite the inherent trust in the local system. This cross-sectional study evaluated the knowledge, attitudes, and practice (KAP) in Oman toward COVID-19 vaccines. It included 3000 randomly selected adults answering a structured questionnaire via telephone. Participants were 66.7% Omani, 76% male, and 83.7% without comorbidities. Their mean age was 38.27 years (SD ± 10.45). Knowledge of COVID-19's symptoms, mode of transmission, and attitudes toward the disease was adequate; 88.4% had heard of the vaccine, 59.3% would advise others to take it, 56.8% would take it themselves, and 47.5% would take a second dose. Males (CI = 2.37, OR = (2.00-2.81)) and Omani (CI = 1.956, OR = (4.595-2.397)) were more willing to be vaccinated. The history of chronic disease, source of vaccine knowledge, and education level were factors that affected the willingness to accept the vaccine. The Omani community's willingness to take the COVID-19 vaccine can be enhanced by utilizing social media and community influencers to spread awareness about the vaccine's safety and efficacy.