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The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. ClinicalTrials.gov NCT#: NCT04338360.

40 primary health clinics (PHCs) in four provinces in South Africa, June 2012 -February 2013. To determine whether health care worker (HCW) practice in investigating people with TB symptoms was altered when the initial test for TB was changed from smear microscopy to Xpert MTB/RIF. Cross-sectional substudy at clinics participating in a pragmatic cluster randomised trial, Xpert for TB: Evaluating a New Diagnostic \"XTEND\", which evaluated the effect of Xpert MTB/RIF implementation in South Africa. Consecutive adults exiting PHCs reporting at least one TB symptom (defined as any of cough, weight loss, night sweats and fever) were enrolled. The main outcome was the proportion who self-reported having sputum requested by HCW during the clinic encounter just completed. 3604 adults exiting PHCs (1676 in Xpert arm, 1928 in microscopy arm) were enrolled (median age 38 years, 71.4% female, 38.8% reported being HIV-positive, 70% reported cough). For 1267 participants (35.2%) the main reason for attending the clinic was TB symptom(s). Overall 2130/3604 (59.1%) said they reported their symptom(s) to HCW. 22.7% (818/3604) reported having been asked to give sputum for TB investigation. Though participants in the Xpert vs. microscopy arm were more likely to have sputum requested by HCW, this was not significantly different: overall (26.0% [436/1676] vs 19.8% [382/1928]; adjusted prevalence ratio [aPR] 1.31, [95% CI 0.78-2.20]) and when restricted to those presenting at clinics due to symptoms (49.1% [260/530] vs 29.9% [220/737]; aPR 1.38 [0.89-2.13]) and those reporting being HIV-positive (29.4% [190/647] vs 20.8% [156/749]; aPR 1.38[0.88-2.16]). Those attending clinic due to TB symptoms, were more likely to have sputum requested if they had increasing number of symptoms; longer duration of cough, unintentional weight loss and night sweats and if they reported symptoms to HCW. A large proportion of people exiting PHCs reporting TB symptoms did not get tested. Implementation of Xpert MTB/RIF did not substantially change the probability of testing for TB. Better systems are needed to ensure that opportunities to identify active TB among PHC attendees are not missed.

Personal digital assistants (PDAs) are versatile task organizers that hold promise as assistive technologies for people with cognitive-behavioral challenges. This delayed randomized controlled trial compared two groups of adult workers with autism spectrum disorder (ASD) to determine whether the use of an Apple iPod Touch PDA as a vocational support improves work performance and reduces personal support needs on the job. Baseline data were collected on 50 adults with ASD who were beginning a vocational placement supported by a job coach. Participants were randomized to receive training in the use of a PDA as a vocational aid upon starting their job or after working 12 weeks without PDA support. Workers who received PDA training at the beginning of their job placement required significantly less hours of job coaching support ( p  = 0.013) during their first 12 weeks on the job than those who had not yet received the intervention. Functional performance between the two groups was not significantly different. The significant difference in hours of job coaching support persisted during the subsequent 12 weeks, in which both groups used a PDA ( p  = 0.017).

Background:Housing is an important environmental influence on population health, and there is growing evidence of health effects from indoor environment characteristics such as low indoor temperatures. However, there is relatively little research, and thus little firm guidance, on the cost-effectiveness of public policies to retrospectively improve the standards of houses. The purpose of this study was to value the health, energy and environmental benefits of retrofitting insulation, through assessing a number of forms of possible benefit: a reduced number of visits to GPs, hospitalisations, days off school, days off work, energy savings and CO2 savings.Methods:All these metrics are used in a cluster randomised trial—the “Housing, Insulation and Health Study”—of retrofitting insulation in 1350 houses, in which at least one person had symptoms of respiratory disease, in predominantly low-income communities in New Zealand.Results:Valuing the health gains, and energy and CO2 emissions savings, suggests that total benefits in “present value” (discounted) terms are one and a half to two times the magnitude of the cost of retrofitting insulation.Conclusion:This study points to the need to consider as wide a range of benefits as possible, including health and environmental benefits, when assessing the value for money of an intervention to improve housing quality. From an environmental, energy and health perspective, the value for money of improving housing quality by retrofitting insulation is compelling.

Background Although the Thai government has introduced policies to promote the health of migrants, it is still the case that urban refugees and asylum seekers (URAS) seem to be neglected. This study aimed to explore the degree of healthcare access through the perspective of unmet need in URAS, relative to the Thai population. Methods A cross-sectional survey, using a self-reporting questionnaire adapted from the Thai Health and Welfare Survey (HWS), was performed in late 2019, with 181 URAS completing the survey. The respondents were were randomly selected from the roster of the Bangkok Refugee Center. The data of the URAS survey were combined with data of the Thai population ( n  = 2941) from the HWS. Unmet need for health services was defined as the status of needing healthcare in the past 12 months but failing to receive it. Bivariate analysis was conducted to explore the demographic and unmet need difference between URAS and Thais. Multivariable logistic regression and mixed-effects (ME) model were performed to determine factors associated with unmet need. Results Overall, URAS were young, less educated and living in more economically deprived households, compared with Thais. About 98% of URAS were uninsured by any of the existing health insurance schemes. The prevalence of unmet need among URAS was significantly higher than among Thais in both outpatient (OP) and inpatient (IP) services (54.1% versus 2.1 and 28.0% versus 2.1%, respectively). Being uninsured showed the strongest association with unmet need, especially for OP care. The association between insurance status and unmet need was more pronounced in the ME model, relative to multivariable logistic regression. URAS migrating from Arab nations suffered from unmet need to a greater extent, compared with those originating from non-Arab nations. Conclusion The prevalence of unmet need in URAS was drastically high, relative to the prevalence in Thais. Factors correlated with unmet need included advanced age, lower educational achievement, and, most evidently, being uninsured. Policy makers should consider a policy option to enrol URAS in the nationwide public insurance scheme to create health security for Thai society.

Transgender people are a diverse population affected by a range of negative health indicators across high-income, middle-income, and low-income settings. Studies consistently document a high prevalence of adverse health outcomes in this population, including HIV and other sexually transmitted infections, mental health distress, and substance use and abuse. However, many other health areas remain understudied, population-based representative samples and longitudinal studies are few, and routine surveillance efforts for transgender population health are scarce. The absence of survey items with which to identify transgender respondents in general surveys often restricts the availability of data with which to estimate the magnitude of health inequities and characterise the population-level health of transgender people globally. Despite the limitations, there are sufficient data highlighting the unique biological, behavioural, social, and structural contextual factors surrounding health risks and resiliencies for transgender people. To mitigate these risks and foster resilience, a comprehensive approach is needed that includes gender affirmation as a public health framework, improved health systems and access to health care informed by high quality data, and effective partnerships with local transgender communities to ensure responsiveness of and cultural specificity in programming. Consideration of transgender health underscores the need to explicitly consider sex and gender pathways in epidemiological research and public health surveillance more broadly.

Background Unmet need for family planning in Oromia region was very high (28.9%) compared to other regions in Ethiopia. To address problems associated with unmet need for family planning locally available evidences are essential, however, there were no clear evidences on unmet need for family planning in Tiro Afeta district. This study aims to assess the magnitude and associated factors of unmet need for family planning among currently married women in Tiro Afeta district, South West Ethiopia, 2017. Methods Community based cross sectional study was conducted in April, 2017. A total of 348 currently married women of reproductive age were enrolled from eight villages selected by simple random sampling and using proportional to size allocation. Data were entered using EpiData 3.1 and analyzed by SPSS version 22. Adjusted odds ratios at 95% confidence interval with p -value of < 0.05 were considered as significant variables. Results Unmet need for family planning among currently married women in Tiro Afeta was 26.1%. Factors significantly associated with unmet need for family planning were: never use of family planning before survey (AOR: 5.09, 95% CI: 2.73–9.50); multiparity (AOR: 3.02, 95% CI: 1.56–5.85); perceived husband’s attitude as disapproval (AOR: 2.75, 95% CI: 1.43–5.26); lack of counseling from health workers (AOR: 2.07, 95% CI: 1.11–3.85); and unavailability of Radio and/or Television in the house (AOR: 2.05, 95% CI: 1.15–3.66). Conclusion Unmet need for family planning in Tiro Afeta was higher than national average but lower than Oromia region. Never use of family planning, women’s parity, husband’s attitude towards contraceptives, women counseling and unavailability of Radio and/or Television in the respondent’s home were significantly associated factors with unmet need for family planning. Therefore, the service providers and the district health office should strengthen counseling and partner involvement to reduce unmet need for family planning.

Background Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. Methods/design The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods. Trial registration ClinicalTrials.gov: NCT01926574 .

Expanding access to contraception and ensuring that need for family planning is satisfied are essential for achieving universal access to reproductive healthcare services, as called for in the 2030 Agenda for Sustainable Development. Monitoring progress towards these outcomes is well established for women of reproductive age (15-49 years) who are married or in a union (MWRA). For those who are not, limited data and variability in data sources and indicator definitions make monitoring challenging. To our knowledge, this study is the first to provide data and harmonised estimates that enable monitoring for all women of reproductive age (15-49 years) (WRA), including unmarried women (UWRA). We seek to quantify the gaps that remain in meeting family-planning needs among all WRA. In a systematic analysis, we compiled a comprehensive dataset of family-planning indicators among WRA from 1,247 nationally representative surveys. We used a Bayesian hierarchical model with country-specific time trends to estimate these indicators, with 95% uncertainty intervals (UIs), for 185 countries. We produced estimates from 1990 to 2019 and projections from 2019 to 2030 of contraceptive prevalence and unmet need for family planning among MWRA, UWRA, and all WRA, taking into account the changing proportions that were married or in a union. The model accounted for differences in the prevalence of sexual activity among UWRA across countries. Among 1.9 billion WRA in 2019, 1.11 billion (95% UI 1.07-1.16) have need for family planning; of those, 842 million (95% UI 800-893) use modern contraception, and 270 million (95% UI 246-301) have unmet need for modern methods. Globally, UWRA represented 15.7% (95% UI 13.4%-19.4%) of all modern contraceptive users and 16.0% (95% UI 12.9%-22.1%) of women with unmet need for modern methods in 2019. The proportion of the need for family planning satisfied by modern methods, Sustainable Development Goals (SDG) indicator 3.7.1, was 75.7% (95% UI 73.2%-78.0%) globally, yet less than half of the need for family planning was met in Middle and Western Africa. Projections to 2030 indicate an increase in the number of women with need for family planning to 1.19 billion (95% UI 1.13-1.26) and in the number of women using modern contraception to 918 million (95% UI 840-1,001). The main limitations of the study are as follows: (i) the uncertainty surrounding estimates for countries with little or no data is large; and (ii) although some adjustments were made, underreporting of contraceptive use and needs is likely, especially among UWRA. In this study, we observed that large gaps remain in meeting family-planning needs. The projected increase in the number of women with need for family planning will create challenges to expand family-planning services fast enough to fulfil the growing need. Monitoring of family-planning indicators for all women, not just MWRA, is essential for accurately monitoring progress towards universal access to sexual and reproductive healthcare services-including family planning-by 2030 in the SDG era with its emphasis on 'leaving no one behind.'

Objectives. We estimated national and state trends in opioid agonist medication-assisted treatment (OA-MAT) need and capacity to identify gaps and inform policy decisions. Methods. We generated national and state rates of past-year opioid abuse or dependence, maximum potential buprenorphine treatment capacity, number of patients receiving methadone from opioid treatment programs (OTPs), and the percentage of OTPs operating at 80% capacity or more using Substance Abuse and Mental Health Services Administration data. Results. Nationally, in 2012, the rate of opioid abuse or dependence was 891.8 per 100 000 people aged 12 years or older compared with national rates of maximum potential buprenorphine treatment capacity and patients receiving methadone in OTPs of, respectively, 420.3 and 119.9. Among states and the District of Columbia, 96% had opioid abuse or dependence rates higher than their buprenorphine treatment capacity rates; 37% had a gap of at least 5 per 1000 people. Thirty-eight states (77.6%) reported at least 75% of their OTPs were operating at 80% capacity or more. Conclusions. Significant gaps between treatment need and capacity exist at the state and national levels. Strategies to increase the number of OA-MAT providers are needed.