Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov

Objectives
Decentralised clinical trial activities—such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply—have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020.

Design
We ascertained the decentralised and on-site conduct for the following operational trial activities: participant outreach, prescreening, screening, obtaining informed consent, asynchronous communication, participant training, IMP supply, IMP adherence monitoring, CT monitoring, staff training and data collection. Results were compared for the public versus private sponsors, regions involved, trial phases and four time periods (the first and second half of 2019 and 2020, respectively).

Setting
Phases 2, 3 and 4 clinical drug trial protocols with a trial start date in 2019 or 2020 available from ClinicalTrials.gov.

Outcome measures
The occurrence of decentralised and on-site conduct of the predefined trial activities reported in CT protocols.

Results
For all trial activities, on-site conduct was more frequently reported than decentralised conduct. Decentralised conduct of the individual trial activities was reported in less than 25.6% of the 254 included protocols, except for decentralised data collection, which was reported in 68.9% of the protocols. More specifically, 81.9% of the phase 3 protocols reported decentralised data collection, compared with 73.3% and 47.0% of the phase 2 and 4 protocols, respectively. For several activities, including prescreening, screening and consenting, upward trends in reporting decentralised conduct were visible over time.

Conclusions
Decentralised methods are used in CTs, mainly for data collection, but less frequently for other activities. Sharing best practices and a detailed description in protocols can drive the adoption of decentralised methods.

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Agosto 2022

Exploring changes in maternal and congenital syphilis epidemiology to identify factors contributing to increases in congenital syphilis in Florida: a two time-period observational study (2013-2014 vs 2018-2019)

Objectives
As, cases of congenital syphilis (CS) and infectious syphilis among women more than doubled in Florida and across the nation during 2013–2019, we sought to understand what may be contributing to these increases in Florida.

Design
A two time-period observational study.

Setting
Pregnant women with reported syphilis infections and their pregnancy outcomes (2013–2014 and 2018–2019) in Florida.

Participants
1213 pregnant women with reported syphilis infections living in Florida and 341 infants meeting the CS case definition.

Outcome measures
We assessed what proportion of the increase in CS was from increases in maternal syphilis infections. We examined maternal demographics, infection characteristics and timing of diagnoses that could explain the increase in CS. Finally, we reviewed if changes in presentation or severity of CS cases occurred.

Results
During 2013–2014, 83 (21%) of 404 pregnant women with syphilis delivered babies with CS. During 2018–2019, 258 (32%) of 809 pregnant women with syphilis delivered babies with CS. Comparing CS prevention rates, it was determined that 65% of the increase in CS was due to the increases in maternal syphilis infections. The proportion of maternal cases staged as primary or secondary increased over time (7%–13%) (p

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Agosto 2022

Temporal trend of first-ever ischaemic stroke incidence from 2010 to 2019 in South Korea: a nationwide retrospective cohort study

Objective
Ischaemic stroke incidence is on the decline globally, but the trend in South Korea is unknown. In this study, the 10-year incidence trends of first-ever ischaemic stroke in South Korea were evaluated.

Design, setting and participants
The National Health Insurance Services medical claim data were used to construct 10 annual cohorts of adults aged 20 years and older, who had not been diagnosed with stroke, to find out the incidence trends of first-ever ischaemic stroke from 2010 to 2019.

Outcome measures
The primary outcomes were crude and age-adjusted incidence rates for 10 years. Crude incidence rates of the age groups and incidence age statistics were calculated. For comparison among the income groups, age-adjusted incidence rates were used. Incidence rates in all the groups were analysed separately by sex.

Results
Age-standardised incidence rates of ischaemic stroke per 100 000 were 101.0 in men, and 67.6 in women in 2010; and 92.2 in men, and 55.0 in women in 2019. By age group, there was a decrease in women over 40 years of age, and men over 60 years of age. The relative difference in stroke incidence rates between medical aid beneficiaries and the highest income group increased from 1.5 to 1.87 over 10 years.

Conclusions
Age-standardised incidence rate of ischaemic stroke has decreased from 2010 to 2019 for both man and women. The incidence rate was stable in the younger age groups and decreased in the older age groups, and the disparities between income groups have widened over the past decade. Stroke prevention strategies are needed for the younger age group and the low-income group. Further research is needed to study the risk factors contributing to the incidence of ischaemic stroke in different groups.

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Agosto 2022

Coronavirus Disease 2019 Pandemic–related Colorectal Cancer Screening Delays Impact Unscreened Older Adults the Most, But Mitigation Strategies Exist

Colorectal cancer (CRC) screening between ages 50 and 75 years is a US Preventive Services Task Force Grade A recommendation.1 The coronavirus disease 2019 (COVID-19) pandemic initially decreased CRC screening participation by as much as 82%,2 and new variants continue to disrupt preventive care. Screening colonoscopy is more vulnerable to pandemic-related delays than the fecal immunochemical test (FIT).2 We estimated the potential clinical impact of pandemic-related interruptions in CRC screening on the US population.

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Agosto 2022

Estimation of smoking-related mortality and its contribution to educational inequalities in life expectancy in Spain: an observational study, 2016-2019

Objective
To estimate smoking-related mortality and its contribution to educational inequalities in life expectancy in Spain.

Design
Nationwide, observational study from 2016 to 2019. Population-attributable fractions were used to estimate age, sex and education-specific cause-of-death smoking-attributable mortality. Life table techniques and decomposition methods were used to estimate potential gains in life expectancy at age 35 and the cause-specific contributions of smoking-related mortality to life expectancy differences across educational groups.

Setting
Spain.

Participants
We use cause-specific mortality data from population registers and smoking prevalence from the National and the European Health Survey for Spain from 2017 and 2019/2020, respectively.

Results
We estimated 219 086 smoking-related deaths during 2016–2019, equalling 13% of all deaths, 83.7% of those in men. In the absence of smoking, potential gains in male life expectancy were higher among the low-educated than the high-educated (3.1 vs 2.1 years). For women, educational differences were less and also in the opposite direction (0.6 vs 0.9 years). The contribution of smoking to life expectancy differences between high-educated and low-educated groups accounted for 1.5 years among men, and –0.2 years among women. For men, the contribution of smoking to these differences was mostly driven by cancer in middle age, cardiometabolic diseases at younger ages and respiratory diseases at older ages. For women, the contribution to this gap, although negligible, was driven by cancer at older ages among the higher educated.

Conclusions
Smoking remains a relevant preventable risk factor of premature mortality in Spain, disproportionately affecting life expectancy of low-educated men.

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Agosto 2022

Rural–Urban Disparities in Mortality and Place of Death for Gastrointestinal Cancer in the United States From 2003 to 2019

Patients with gastrointestinal (GI) cancer experience high symptom burdens and complex needs that challenge healthcare infrastructure at multiple levels beginning with primary care screening and continuing to postsurvival care and end-of-life services. It is unclear whether mortality improvements from national risk factor reduction, screening uptake, and treatment advances apply equally to rural areas where gaps in healthcare funding and access to hospice care exist.1 To determine temporal trends, we investigated rural–urban disparities in age-adjusted mortality rates (AAMRs) per 100,000 and place of death in the United States in individuals dying from GI cancers between 2003 and 2019.

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Agosto 2022

Prevalence and factors associated with self-reported injuries in Nepal: a secondary analysis of the nationally representative cross-sectional STEPS Survey, 2019

Objective
This study aims to determine the prevalence and factors associated with injuries in the adult population of Nepal.

Design and participants
Secondary analysis of the data from the cross-sectional WHO STEPwise Approach to NCD Risk Factor Surveillance (STEPS) Survey Nepal, 2019. A multistage cluster sample of 5593 adults aged 15–69 years who have been the usual residents of the household for at least 6 months. A binary logistic regression model was employed to identify the determinants of injuries.

Setting
Data were derived from the STEPS Survey Nepal, 2019.

Primary and secondary outcome measures
The primary outcome was injured person defined as one who had road traffic injuries (RTIs), had other serious unintentional/accidental injury, or had been seriously injured in a violent incident within the past 12 months. The secondary outcome measure was factors associated with injuries.

Results
Over 11% of the 4996 study participants reported any injuries during the past 12 months. About 3.75% of the participants experienced a RTI, 4.71% had experienced unintentional injuries other than RTI, while 5.33% had been injured in violent incidents. Individuals belonging to the middle wealth quintile (crude OR (COR)=2.95, 95% CI 1.27 to 6.84) were associated with increased odds of RTIs. By occupation, homemaker (COR=0.45, 95% CI 0.24 to 0.84) was protective against these injuries. Likewise, currently married individuals (COR=3.74, 95% CI 1.37 to 10.17), ever married individuals (COR=3.49, 95% CI 1.08 to 11.25) and individuals not in employment (COR=2.13, 95% CI 1.16 to 3.91) were associated with an increased likelihood of sustaining an intentional injury. Injuries were higher among rural participants.

Conclusions
This study provides the baseline population-based estimates of the prevalence of injuries in Nepal. It describes the mechanisms and risk factors of these injuries. It is hoped that this evidence will serve as a stimulus for future studies to elucidate comprehensive national information about injuries.

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Agosto 2022

Prevalence and correlates of self-reported cardiovascular disease in Mongolia: findings from the 2019 Mongolia STEPS cross-sectional survey

Objective
The aim of the study was to estimate the prevalence and correlates of cardiovascular disease (ischaemic heart disease and/or stroke (IHDS)) in Mongolia.

Design
Cross-sectional study.

Setting
National community-based sample of people aged 15–69 years in Mongolia.

Participants
6654 people (15–69 years, mean 41.3) who participated in the 2019 Mongolia STEPS survey.

Primary and secondary outcome measures
Self-reported prevalence of IHDS and biological and social covariates. Determinants of IHDS were estimated with logistic regression.

Results
The prevalence of IHDS was 14.0%, 15.6% among women and 12.3% among men. Older age (45–69 years), being married or cohabiting, and urban residence were positively associated, and male sex was negatively associated, with IHDS. Additionally, experience of threats, hypertension, current tobacco use, passive smoking, sedentary behaviour and high physical activity were positively associated with IHDS.

Conclusions
Almost one in seven people aged 15–69 years had IHDS in Mongolia. Several factors amenable to public health intervention for IHDS were identified, including experience of threats, hypertension, current tobacco use, passive smoking and sedentary behaviour.

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Agosto 2022

Global trends and age-specific incidence and mortality of cervical cancer from 1990 to 2019: an international comparative study based on the Global Burden of Disease

Objective
To describe the trends of incidence and mortality of cervical cancer in different age groups and regions from 1990 to 2019.

Design
An international comparative study based on the Global Burden of Disease (GBD) study estimates.

Participants
Data were publicly available and individuals were not involved.

Methods
We collected detailed information on cervical cancer from the GBD study between 1990 and 2019. Average annual percentage changes (AAPCs) of age-standardised incidence and mortality rate (ASIR and ASMR) in cervical cancer, by age group and region, were calculated to quantify the temporal trends.

Results
Globally, the absolute numbers of incident cases and deaths were increasing, with the most cervical cancer cases and deaths being reported in China, India and Brazil. Although the ASIR and ASMR have declined overall from 1990 to 2019, an increasing or stable trend was also observed in East Asia and Southern sub-Saharan Africa. Particularly, we found that the age-specific AAPC of incidence showed an increasing trend in the age group of 15–49 years globally, and the high Sociodemographic Index region increased the most.

Conclusions
Cervical cancer remains a concerning disease that affects women all over the world, although the ASIR and ASMR are decreasing. Efforts to control the younger trend and to reduce the disparity between regions are imminent.

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Luglio 2022

Medical students exposure to and attitudes towards product promotion and incentives from the pharmaceutical industry in 2019: a national cross-sectional study in France

Objectives
To measure medical students’ exposure to pharmaceutical product promotion and incentives nationwide, and to evaluate students’ attitudes towards the pharmaceutical industry, access to education on promotional strategies and knowledge of institutional policies about drug company-student relationships.

Design
Cross-sectional survey based on a 48-item anonymous questionnaire.

Setting
All 37 French medical schools, from March to April 2019.

Participants
French medical students in their 4th year of study and beyond, having studied exclusively in France.

Main outcome measure
Cumulative frequency of students’ exposure to pharmaceutical product promotion and incentives.

Secondary outcome measures
Exposure within the last 6 months, attitudes regarding interactions with the industry, access to education on pharmaceutical product promotion and incentives and knowledge of institutional policies.

Results
6280 responses were analysed (10.4% out of a total of 60 550 eligible students). 5992 students (96.3% poststratification, 99% CI (96.1% to 96.5%)) had already been exposed to pharmaceutical product promotion and incentives and 4650 (78.1%, 99% CI (77.7% to 78.6%)) within the last 6 months. 5140 students (85.4%, 99% CI (84.8% to 85.8%)) had met a pharmaceutical representative. Regarding attitudes, 2195 students (36.8%, 99% CI (36.0% to 37.5%)) thought receiving a gift could influence their own prescriptions while 3252 (53.6%, 99% CI (53.1% to 54.2%)) thought it could influence their colleagues’ prescriptions. 4533 students (76.0%, 99% CI (75.6% to 76.5%)) reported never having attended any lecture on promotional strategies. Exposure seemed to depend on the year of study and specialty. 5122 (88.1%, 99% CI (87.7% to 88.4%)) did not know whether their faculty had a policy regarding drug company-student interactions.

Conclusion
In France in 2019, medical students’ exposure to pharmaceutical product promotion and incentives remains considerable and starts early during medical training. Education on promotional strategies and institutional policies should be improved to ensure responsible and ethical behaviour in prescribing medications.

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Luglio 2022

Burden of brain and other central nervous system cancer in China, 1990-2019: a systematic analysis of observational data from the global burden of disease study 2019

Objective
To evaluate the trends in disease burden and the epidemiological features of central nervous system (CNS) cancer in China from 1990 to 2019.

Design
A population-based observational study.

Setting
The incidence, prevalence, death and disability-adjusted life years (DALYs) due to CNS cancer in China, stratified by sex, age and provincial region, were collected from the Global Burden of Disease Study 2019.

Participants
Data were publicly available and individuals were not involved.

Results
In 2019, the incident cases of CNS cancer in China were 347 992 (95% UI 262 084–388 896), and the age-standardised rate (ASR) of incidence was 5.69 (95% UI 4.36–6.78) per 100 000 person-years increased by 27.9% compared with that in 1990; meanwhile, CNS cancer caused 63 527 (95% UI 47 793–76 948) deaths in China in 2019, and the ASR of death was 3.5 (95% UI 2.62–4.21) per 100 000 person-years decreased by 9.6%. The ASRs of incidence and prevalence of CNS cancer in China increased more rapidly than the global average; meanwhile, the ASRs of DALYs owing to CNS cancer declined more rapidly. The burden of CNS cancer showed no significant differences between men and women, but was more pronounced in early childhood and old adulthood. The ASRs of incidence and prevalence were higher in high-income provinces, confirmed by the positive correlation with Sociodemographic Index (SDI), with correlation coefficient r of 0.322 and 0.767, respectively (both p

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Luglio 2022