Worldwide, both the incidence and death rates of pancreatic cancer are increasing. Evaluation of pancreatic cancer burden and its global, regional, and national patterns is crucial to policy making ...and better resource allocation for controlling pancreatic cancer risk factors, developing early detection methods, and providing faster and more effective treatments.
Vital registration, vital registration sample, and cancer registry data were used to generate mortality, incidence, and disability-adjusted life-years (DALYs) estimates. We used the comparative risk assessment framework to estimate the proportion of deaths attributable to risk factors for pancreatic cancer: smoking, high fasting plasma glucose, and high body-mass index. All of the estimates were reported as counts and age-standardised rates per 100 000 person-years. 95% uncertainty intervals (UIs) were reported for all estimates.
In 2017, there were 448 000 (95% UI 439 000–456 000) incident cases of pancreatic cancer globally, of which 232 000 (210 000–221 000; 51·9%) were in males. The age-standardised incidence rate was 5·0 (4·9–5·1) per 100 000 person-years in 1990 and increased to 5·7 (5·6–5·8) per 100 000 person-years in 2017. There was a 2·3 times increase in number of deaths for both sexes from 196 000 (193 000–200 000) in 1990 to 441 000 (433 000–449 000) in 2017. There was a 2·1 times increase in DALYs due to pancreatic cancer, increasing from 4·4 million (4·3–4·5) in 1990 to 9·1 million (8·9–9·3) in 2017. The age-standardised death rate of pancreatic cancer was highest in the high-income super-region across all years from 1990 to 2017. In 2017, the highest age-standardised death rates were observed in Greenland (17·4 15·8–19·0 per 100 000 person-years) and Uruguay (12·1 10·9–13·5 per 100 000 person-years). These countries also had the highest age-standardised death rates in 1990. Bangladesh (1·9 1·5–2·3 per 100 000 person-years) had the lowest rate in 2017, and São Tomé and Príncipe (1·3 1·1–1·5 per 100 000 person-years) had the lowest rate in 1990. The numbers of incident cases and deaths peaked at the ages of 65–69 years for males and at 75–79 years for females. Age-standardised pancreatic cancer deaths worldwide were primarily attributable to smoking (21·1% 18·8–23·7), high fasting plasma glucose (8·9% 2·1–19·4), and high body-mass index (6·2% 2·5–11·4) in 2017.
Globally, the number of deaths, incident cases, and DALYs caused by pancreatic cancer has more than doubled from 1990 to 2017. The increase in incidence of pancreatic cancer is likely to continue as the population ages. Prevention strategies should focus on modifiable risk factors. Development of screening programmes for early detection and more effective treatment strategies for pancreatic cancer are needed.
Bill & Melinda Gates Foundation.
Understanding how prevalence, incidence, and mortality of motor neuron diseases change over time and by location is crucial for understanding the causes of these disorders and for health-care ...planning. Our aim was to produce estimates of incidence, prevalence, and disability-adjusted life-years (DALYs) for motor neuron diseases for 195 countries and territories from 1990 to 2016 as part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2016.
The motor neuron diseases included in this study were amyotrophic lateral sclerosis, spinal muscular atrophy, hereditary spastic paraplegia, primary lateral sclerosis, progressive muscular atrophy, and pseudobulbar palsy. Incidence, prevalence, and DALYs were estimated using a Bayesian meta-regression model. We analysed 14 165 site-years of vital registration cause of death data using the GBD 2016 cause of death ensemble model. The 84 risk factors quantified in GBD 2016 were tested for an association with incidence or death from motor neuron diseases. We also explored the relationship between Socio-demographic Index (SDI; a compound measure of income per capita, education, and fertility) and age-standardised DALYs of motor neuron diseases.
In 2016, globally, 330 918 (95% uncertainty interval UI 299 522–367 254) individuals had a motor neuron disease. Motor neuron diseases have caused 926 090 (881 566–961 758) DALYs and 34 325 (33 051–35 364) deaths in 2016. The worldwide all-age prevalence was 4·5 (4·1–5·0) per 100 000 people, with an increase in age-standardised prevalence of 4·5% (3·4–5·7) over the study period. The all-age incidence was 0·78 (95% UI 0·71–0·86) per 100 000 person-years. No risk factor analysed in GBD showed an association with motor neuron disease incidence. The largest age-standardised prevalence was in high SDI regions: high-income North America (16·8, 95% UI 15·8–16·9), Australasia (14·7, 13·5–16·1), and western Europe (12·9, 11·7–14·1). However, the prevalence and incidence were lower than expected based on SDI in high-income Asia Pacific.
Motor neuron diseases have low prevalence and incidence, but cause severe disability with a high fatality rate. Incidence of motor neuron diseases has geographical heterogeneity, which is not explained by any risk factors quantified in GBD, suggesting other unmeasured risk factors might have a role. Between 1990 and 2016, the burden of motor neuron diseases has increased substantially. The estimates presented here, as well as future estimates based on data from a greater number of countries, will be important in the planning of services for people with motor neuron diseases worldwide.
Bill & Melinda Gates Foundation.
AZAR eye and vision cohort study Somi, Mohammad Hossein; Nikniaz, Zeinab; Ostadrahimi, Alireza ...
Scientific reports,
05/2023, Letnik:
13, Številka:
1
Journal Article
Recenzirano
Odprti dostop
According to World Health Organization (WHO), currently, 2.2 billion people are living with visual impairment worldwide, of which almost half could have been prevented. There are both modifiable and ...unmodifiable factors leading to visual disability and, ultimately, blindness. Several population-based studies in different parts of Iran have tried to determine these factors concerning their specific population and environment-related characteristics. AZAR Eye and Vision cohort is the second-largest cohort study in the whole country. AZAR Eye and Vision cohort is the ophthalmologic branch of AZAR cohort which is the largest eye cohort study in the country, which is trying to determine the prevalence and incidence of visual impairment, blindness, and other major ophthalmologic conditions and their associated risk factors in East Azerbaijan province located in Iran, a middle eastern country. A recently emerging phenomenon is the drying of the ultra-salty lake of Urmia located in the West Azerbaijan province which is a direct neighbor of our studied population and has caused recurrent salt storms in the immediate near areas. This phenomenon could adversely affect visual health via different conditions which our study will elucidate. The enrollment phase took place between 2014 and 2017 and 11,208 participants were enrolled out of 15,000 participants in the primary cohort. The resurvey phase will begin five years after the enrollment phase. In this phase, 30% of the participants are randomly selected to be reexamined and complete questionnaires. The participants showing any issues such as diabetes and being a glaucoma suspect will be included in the resurvey phase, too. Data categories gathered include demographics, lifestyle factors, past medical and drug histories, and a diet quality and quantity questionnaire including 130 edible items. Urine, hair, nail, and 25-ml blood samples, were collected from the participants. Then they were referred to an optometrist to complete an ophthalmologic questionnaire and undergo eye examination and lensometry. Then they underwent slit-lamp examinations and pictures were taken of the lens and fundus. People with suspected visual impairment were referred to an ophthalmology clinic. The data are processed and a four-level quality check is performed on each block. The most common visual impairment is cataracts. This study's most important aim is to evaluate the effect of local environmental and ethnic factors on eye diseases in this specific population.
Although a preventable and treatable disease, tuberculosis causes more than a million deaths each year. As countries work towards achieving the Sustainable Development Goal (SDG) target to end the ...tuberculosis epidemic by 2030, robust assessments of the levels and trends of the burden of tuberculosis are crucial to inform policy and programme decision making. We assessed the levels and trends in the fatal and non-fatal burden of tuberculosis by drug resistance and HIV status for 195 countries and territories from 1990 to 2016.
We analysed 15 943 site-years of vital registration data, 1710 site-years of verbal autopsy data, 764 site-years of sample-based vital registration data, and 361 site-years of mortality surveillance data to estimate mortality due to tuberculosis using the Cause of Death Ensemble model. We analysed all available data sources, including annual case notifications, prevalence surveys, population-based tuberculin surveys, and estimated tuberculosis cause-specific mortality to generate internally consistent estimates of incidence, prevalence, and mortality using DisMod-MR 2.1, a Bayesian meta-regression tool. We assessed how the burden of tuberculosis differed from the burden predicted by the Socio-demographic Index (SDI), a composite indicator of income per capita, average years of schooling, and total fertility rate.
Globally in 2016, among HIV-negative individuals, the number of incident cases of tuberculosis was 9·02 million (95% uncertainty interval UI 8·05–10·16) and the number of tuberculosis deaths was 1·21 million (1·16–1·27). Among HIV-positive individuals, the number of incident cases was 1·40 million (1·01–1·89) and the number of tuberculosis deaths was 0·24 million (0·16–0·31). Globally, among HIV-negative individuals the age-standardised incidence of tuberculosis decreased annually at a slower rate (–1·3% –1·5 to −1·2) than mortality did (–4·5% –5·0 to −4·1) from 2006 to 2016. Among HIV-positive individuals during the same period, the rate of change in annualised age-standardised incidence was −4·0% (–4·5 to −3·7) and mortality was −8·9% (–9·5 to −8·4). Several regions had higher rates of age-standardised incidence and mortality than expected on the basis of their SDI levels in 2016. For drug-susceptible tuberculosis, the highest observed-to-expected ratios were in southern sub-Saharan Africa (13·7 for incidence and 14·9 for mortality), and the lowest ratios were in high-income North America (0·4 for incidence) and Oceania (0·3 for mortality). For multidrug-resistant tuberculosis, eastern Europe had the highest observed-to-expected ratios (67·3 for incidence and 73·0 for mortality), and high-income North America had the lowest ratios (0·4 for incidence and 0·5 for mortality).
If current trends in tuberculosis incidence continue, few countries are likely to meet the SDG target to end the tuberculosis epidemic by 2030. Progress needs to be accelerated by improving the quality of and access to tuberculosis diagnosis and care, by developing new tools, scaling up interventions to prevent risk factors for tuberculosis, and integrating control programmes for tuberculosis and HIV.
Bill & Melinda Gates Foundation.
Data about the global, regional, and country-specific variations in the levels and trends of colorectal cancer are required to understand the impact of this disease and the trends in its burden to ...help policy makers allocate resources. Here we provide a status report on the incidence, mortality, and disability caused by colorectal cancer in 195 countries and territories between 1990 and 2017.
Vital registration, sample vital registration, verbal autopsy, and cancer registry data were used to generate incidence, death, and disability-adjusted life-year (DALY) estimates of colorectal cancer at the global, regional, and national levels. We also determined the association between development levels and colorectal cancer age-standardised DALY rates, and calculated DALYs attributable to risk factors that had evidence of causation with colorectal cancer. All of the estimates are reported as counts and age-standardised rates per 100 000 person-years, with some estimates also presented by sex and 5-year age groups.
In 2017, there were 1·8 million (95% UI 1·8–1·9) incident cases of colorectal cancer globally, with an age-standardised incidence rate of 23·2 (22·7–23·7) per 100 000 person-years that increased by 9·5% (4·5–13·5) between 1990 and 2017. Globally, colorectal cancer accounted for 896 000 (876 300–915 700) deaths in 2017, with an age-standardised death rate of 11·5 (11·3–11·8) per 100 000 person-years, which decreased between 1990 and 2017 (−13·5% –18·4 to −10·0). Colorectal cancer was also responsible for 19·0 million (18·5–19·5) DALYs globally in 2017, with an age-standardised rate of 235·7 (229·7–242·0) DALYs per 100 000 person-years, which decreased between 1990 and 2017 (−14·5% –20·4 to −10·3). Slovakia, the Netherlands, and New Zealand had the highest age-standardised incidence rates in 2017. Greenland, Hungary, and Slovakia had the highest age-standardised death rates in 2017. Numbers of incident cases and deaths were higher among males than females up to the ages of 80–84 years, with the highest rates observed in the oldest age group (≥95 years) for both sexes in 2017. There was a non-linear association between the Socio-demographic Index and the Healthcare Access and Quality Index and age-standardised DALY rates. In 2017, the three largest contributors to DALYs at the global level, for both sexes, were diet low in calcium (20·5% 12·9–28·9), alcohol use (15·2% 12·1–18·3), and diet low in milk (14·3% 5·1–24·8).
There is substantial global variation in the burden of colorectal cancer. Although the overall colorectal cancer age-standardised death rate has been decreasing at the global level, the increasing age-standardised incidence rate in most countries poses a major public health challenge across the world. The results of this study could be useful for policy makers to carry out cost-effective interventions and to reduce exposure to modifiable risk factors, particularly in countries with high incidence or increasing burden.
Bill & Melinda Gates Foundation.
ObjectivesHyperinsulinaemia and insulin resistance are proposed as contributors to the incidence of cardiometabolic phenotypes (CMPs) with unhealthy metabolic status. This study analysed the ...association between dietary insulin load (DIL) and Dietary Insulin Index (DII) with CMPs in the AZAR cohort population.DesignThis study was a cross-sectional analysis of the AZAR Cohort Study, beginning in 2014 and continuing to this date.SettingThe AZAR cohort is a part of an Iranian screening programme named the Persian cohort and involves participants living in the Shabestar region, Iran for at least 9 months.ParticipantsA total of 15 006 participants agreed to partake in the study. We excluded participants with missing data (n=15), daily energy intake lower than 800 kcal (n=7) or higher than 8000 kcal (n=17), and cancer (n=85). Finally, 14 882 individuals remained.Primary and secondary outcome measuresThe gathered information included the participants' demographic, dietary, anthropometric and physical activity data.ResultsThe frequency of DIL and DII significantly decreased from the first to fourth quartiles in metabolically unhealthy participants (p≤0.001). The mean values of DIL and DII were greater in metabolically healthy participants than in unhealthy ones (p<0.001). The results of the unadjusted model showed that the risks of unhealthy phenotypes in the fourth DIL quartile decreased by 0.21 (0.14–0.32) and 0.37 (0.33–0.43), respectively, compared with the first quartile. The same model showed the same risks for DII decreased by 0.18 (0.11–0.28) and 0.39 (0.34–0.45), respectively. The results in both genders were the same as all participants combined.ConclusionsDII and DIL were correlated with a decreased OR of unhealthy phenotypes. We suggest the reason may be either a lifestyle change in metabolically unhealthy participants or elevated insulin secretion not being as detrimental as previously thought. Further studies can confirm these speculations.
The incidence and associated risk factors for premature death were investigated in a population-based cohort study in Iran.
A total of 7245 participants (3216 men), aged 30-70 years, were included. ...We conducted Cox proportional hazards models to identify the risk factors for premature death. For each risk factor, hazard ratio (HR), 95% confidence intervals (95% CI) and population attributable fraction (PAF) were calculated.
After a median follow-up of 13.8 years, 262 premature deaths (153 in men) occurred. Underlying causes of premature deaths were cardiovascular disease (CVD) (n = 126), cancer (n = 51), road injuries (n = 15), sepsis and pneumonia (n = 9) and miscellaneous reasons (n = 61). The age-standardized incident rate of premature death was 2.35 per 1000 person years based on WHO standard population. Hypertension HR 1.40, 95% CI (1.07-1.83), diabetes (2.53, 1.94-3.29) and current smoking (1.58, 1.16-2.17) were significant risk factors for premature mortality; corresponding PAFs were 12.3, 22.4 and 9.2%, respectively. Overweight (body mass index (BMI): 25-29.9 kg/m
) (0.65, 0.49-0.87) and obesity (BMI ≥30 kg/m
) (0.67, 0.48-0.94) were associated with decreased premature mortality. After replacing general adiposity with central adiposity, we found no significant risk for the latter (0.92, 0.71-1.18). Moreover, when we excluded current smokers, those with prevalent cancer/cardiovascular disease and those with survival of less than 3 years, the inverse association between overweight (0.59, 0.39-0.88) and obesity (0.67, 0.43-1.04), generally remained unchanged; although, diabetes still showed a significant risk (2.62, 1.84-3.72).
Controlling three modifiable risk factors including diabetes, hypertension and smoking might potentially reduce mortality events by over 40%, and among these, prevention of diabetes should be prioritized to decrease burden of events. We didn't confirm a negative impact of overweight and obesity status on premature mortality events.
Oesophageal cancer is a common and often fatal cancer that has two main histological subtypes: oesophageal squamous cell carcinoma and oesophageal adenocarcinoma. Updated statistics on the incidence ...and mortality of oesophageal cancer, and on the disability-adjusted life-years (DALYs) caused by the disease, can assist policy makers in allocating resources for prevention, treatment, and care of oesophageal cancer. We report the latest estimates of these statistics for 195 countries and territories between 1990 and 2017, by age, sex, and Socio-demographic Index (SDI), using data from the Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD).
We used data from vital registration systems, vital registration-samples, verbal autopsy records, and cancer registries, combined with relevant modelling, to estimate the mortality, incidence, and burden of oesophageal cancer from 1990 to 2017. Mortality-to-incidence ratios (MIRs) were estimated and fed into a Cause of Death Ensemble model (CODEm) including risk factors. MIRs were used for mortality and non-fatal modelling. Estimates of DALYs attributable to the main risk factors of oesophageal cancer available in GBD were also calculated. The proportion of oesophageal squamous cell carcinoma to all oesophageal cancers was extracted by use of publicly available data, and its variation was examined against SDI, the Healthcare Access and Quality (HAQ) Index, and available risk factors in GBD that are specific for oesophageal squamous cell carcinoma (eg, unimproved water source and indoor air pollution) and for oesophageal adenocarcinoma (gastro-oesophageal reflux disease).
There were 473 000 (95% uncertainty interval 95% UI 459 000–485 000) new cases of oesophageal cancer and 436 000 (425 000–448 000) deaths due to oesophageal cancer in 2017. Age-standardised incidence was 5·9 (5·7–6·1) per 100 000 population and age-standardised mortality was 5·5 (5·3–5·6) per 100 000. Oesophageal cancer caused 9·78 million (9·53–10·03) DALYs, with an age-standardised rate of 120 (117–123) per 100 000 population. Between 1990 and 2017, age-standardised incidence decreased by 22·0% (18·6–25·2), mortality decreased by 29·0% (25·8–32·0), and DALYs decreased by 33·4% (30·4–36·1) globally. However, as a result of population growth and ageing, the total number of new cases increased by 52·3% (45·9–58·9), from 310 000 (300 000–322 000) to 473 000 (459 000–485 000); the number of deaths increased by 40·0% (34·1–46·3), from 311 000 (301 000–323 000) to 436 000 (425 000–448 000); and total DALYs increased by 27·4% (22·1–33·1), from 7·68 million (7·42–7·97) to 9·78 million (9·53–10·03). At the national level, China had the highest number of incident cases (235 000 223 000–246 000), deaths (213 000 203 000–223 000), and DALYs (4·46 million 4·25–4·69) in 2017. The highest national-level age-standardised incidence rates in 2017 were observed in Malawi (23·0 19·4–26·5 per 100 000 population) and Mongolia (18·5 16·4–20·8 per 100 000). In 2017, age-standardised incidence was 2·7 times higher, mortality 2·9 times higher, and DALYs 3·0 times higher in males than in females. In 2017, a substantial proportion of oesophageal cancer DALYs were attributable to known risk factors: tobacco smoking (39·0% 35·5–42·2), alcohol consumption (33·8% 27·3–39·9), high BMI (19·5% 6·3–36·0), a diet low in fruits (19·1% 4·2–34·6), and use of chewing tobacco (7·5% 5·2–9·6). Countries with a low SDI and HAQ Index and high levels of indoor air pollution had a higher proportion of oesophageal squamous cell carcinoma to all oesophageal cancer cases than did countries with a high SDI and HAQ Index and with low levels of indoor air pollution.
Despite reductions in age-standardised incidence and mortality rates, oesophageal cancer remains a major cause of cancer mortality and burden across the world. Oesophageal cancer is a highly fatal disease, requiring increased primary prevention efforts and, possibly, screening in some high-risk areas. Substantial variation exists in age-standardised incidence rates across regions and countries, for reasons that are unclear.
Bill & Melinda Gates Foundation.
BackgroundPast research has shown how fires, heat and hot substances are important causes of health loss globally. Detailed estimates of the morbidity and mortality from these injuries could help ...drive preventative measures and improved access to care.MethodsWe used the Global Burden of Disease 2017 framework to produce three main results. First, we produced results on incidence, prevalence, years lived with disability, deaths, years of life lost and disability-adjusted life years from 1990 to 2017 for 195 countries and territories. Second, we analysed these results to measure mortality-to-incidence ratios by location. Third, we reported the measures above in terms of the cause of fire, heat and hot substances and the types of bodily injuries that result.ResultsGlobally, there were 8 991 468 (7 481 218 to 10 740 897) new fire, heat and hot substance injuries in 2017 with 120 632 (101 630 to 129 383) deaths. At the global level, the age-standardised mortality caused by fire, heat and hot substances significantly declined from 1990 to 2017, but regionally there was variability in age-standardised incidence with some regions experiencing an increase (eg, Southern Latin America) and others experiencing a significant decrease (eg, High-income North America).ConclusionsThe incidence and mortality of injuries that result from fire, heat and hot substances affect every region of the world but are most concentrated in middle and lower income areas. More resources should be invested in measuring these injuries as well as in improving infrastructure, advancing safety measures and ensuring access to care.
We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to ...severely ill.
This is a single center, open label, randomized, controlled, parallel group, clinical trial that will be conducted at Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences.
Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9
to April 14
2020. Patients will be randomly assigned to the intervention groups or the control group with the following eligibility criteria: ≥ 18 years of age AND (oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24) AND at least one of the following: Contactless infrared forehead thermometer temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission, and time of onset of the symptoms should be acute (Days ≤ 14). Although Hydroxychloroquine will be administered in a single dose, patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes) will be excluded. Other exclusion criteria include using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β 1b, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results and refusal to participate. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services.
COVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra).
Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. Secondary outcomes include mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. If any patient dies, we have reached an important secondary outcome. SpO2 Improvement between the last and first day of hospitalization, using pulse-oximetry. Duration of hospitalization from date of randomization until the date of hospital discharge or date of death from any cause, whichever comes first. Incidence of new mechanical ventilation uses from date of randomization until the last day of the study. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Statistical analysis will be performed by R version 3.6.1 software. We will use Kaplan-Meier to analyze the time to clinical improvement (compared with a log-rank test). Hazard ratios with 95% confidence intervals will be calculated using the Cox proportional-hazards model in crude and adjusted analysis.
Eligible patients will be randomly assigned in a 1:1:1 ratio to receive either Interferon Beta 1a, Interferon Beta 1b or standard care only. Patients will be randomly allocated to three therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases.
The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement.
Of the 60 patients who underwent randomization, 20 patients were assigned to receive Interferon beta-1a, 20 patients were assigned to receive Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone.
Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on 9
April 2020 and the end date was on 14
April 2020. Last point of data collection will be the last day on which all of the 60 participants have had an outcome of clinical improvement or death, completing the study's follow-up time window.
This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020).
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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