Medical residents in hospitals are often required to be on duty for long hours. In 2003 the organization overseeing graduate medical education adopted common program requirements to restrict resident ...workweeks, including limits to an average of 80 hours over 4 weeks and the longest consecutive period of work to 30 hours in order to protect patients and residents from unsafe conditions resulting from excessive fatigue. "Resident Duty Hours" provides a timely examination of how those requirements were implemented and their impact on safety, education, and the training institutions. An in-depth review of the evidence on sleep and human performance indicated a need to increase opportunities for sleep during residency training to prevent acute and chronic sleep deprivation and minimize the risk of fatigue-related errors. In addition to recommending opportunities for on-duty sleep during long duty periods and breaks for sleep of appropriate lengths between work periods, the committee also recommends enhancements of supervision, appropriate workload, and changes in the work environment to improve conditions for safety and learning. All residents, medical educators, those involved with academic training institutions, specialty societies, professional groups, and consumer/patient safety organizations will find this book useful to advocate for an improved culture of safety. The following are appended: (1) Statement of Task; (2) Comparison of Select Scheduling Possibilities Under Committee Recommendations and Under 2003 Accreditation Council for Graduate Medical Education (ACGME) Duty Hour Rules; (3) International Experiences Limiting Resident Duty Hours; (4) Glossary, Acronyms, and Abbreviations; (5) Committee Member Biographies; and (6) Public Meeting Agendas. An Index is also included. Following a welcome statement by Michael Johns and remarks from study sponsor and committee questions (facilitated by Carolyn Clancy), the agenda for the pubic meeting included the following panels: (Panel 1) The Accreditation Council for Graduate Medical Education's Duty Hours Requirements (Paul Friedmann and Ingrid Philibert); (Panel 2) Impact of Duty Hours Requirements on Education (Steven Weinberger, Tom Whalen, Michael Ehlert, and Sunny Ramchandani); (Panel 3) Work Hours, Patient Safety, and Enforcement (L. Toni Lewis, Peter Lurie, and Ethan Fried); (Panel 4) Sleep and Outcomes Research (Charles Czeisler, Christopher Landrigan, and Kevin Volpp); and (Panel 5) The Federal Role Funding Graduate Medical Education (Miechal Lefkowitz and Barbara K. Chang). Individual chapters contain references.
To examine the effects of past and current night shift work and genetic type 2 diabetes vulnerability on type 2 diabetes odds.
In the UK Biobank, we examined associations of current (
= 272,214) and ...lifetime (
= 70,480) night shift work exposure with type 2 diabetes risk (6,770 and 1,191 prevalent cases, respectively). For 180,704 and 44,141 unrelated participants of European ancestry (4,002 and 726 cases, respectively) with genetic data, we assessed whether shift work exposure modified the relationship between a genetic risk score (comprising 110 single-nucleotide polymorphisms) for type 2 diabetes and prevalent diabetes.
Compared with day workers, all current night shift workers were at higher multivariable-adjusted odds for type 2 diabetes (none or rare night shifts: odds ratio OR 1.15 95% CI 1.05-1.26; some nights: OR 1.18 95% CI 1.05-1.32; and usual nights: OR 1.44 95% CI 1.19-1.73), except current permanent night shift workers (OR 1.09 95% CI 0.93-1.27). Considering a person's lifetime work schedule and compared with never shift workers, working more night shifts per month was associated with higher type 2 diabetes odds (<3/month: OR 1.24 95% CI 0.90-1.68; 3-8/month: OR 1.11 95% CI 0.90-1.37; and >8/month: OR 1.36 95% CI 1.14-1.62;
= 0.001). The association between genetic type 2 diabetes predisposition and type 2 diabetes odds was not modified by shift work exposure.
Our findings show that night shift work, especially rotating shift work including night shifts, is associated with higher type 2 diabetes odds and that the number of night shifts worked per month appears most relevant for type 2 diabetes odds. Also, shift work exposure does not modify genetic risk for type 2 diabetes, a novel finding that warrants replication.
Introduction Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and it is estimated to avert 2 to 3 million deaths each year. The agent in a vaccine ...stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it. In this way, the immune system can more easily recognize and destroy any of these microorganisms in future encounters. Objective of the study. The study was intended to determine factors associated with the incompletion of immunization as scheduled among children going for immunization at Nabweru Health Centre iii, Nansana Municipality. Methodology: The study was a descriptive cross-sectional study that involved collecting data from 100 respondents and the study employed structured questionnaires administered by the researcher and the research assistants to gather relevant data about factors associated with incompletion of immunization as scheduled among children going for immunization at Nabweru Health Centre iii, Nansana Municipality. Children were got using a systemic sampling technique. Results: Out of the 100 respondents, the Majority, 58(58%) of the children were males. The majority, 51(51%) of the respondents were of rural residence. The majority, 61(61%) gave birth at home. The majority, 64(64%) of the respondents were aware of the threat of vaccine-preventable illnesses. The majority, 56(56%) of the respondents noted that the process was a waste of time. Conclusion: The study specifically sought to find out the factors associated with incompletion of immunization among children going for immunization at Nabweru Health Centre iii, Nansana Municipality and found out that there is still a big number of children defaulting immunization as per the immunization schedule. Recommendation: The government through the M.H.O of Nansana should emphasize immunization of all children under 5 by providing all necessary resources as well as educating and encouraging caretakers to take their children for immunization.
ObjectiveObservational studies indicate an association between working nights and miscarriage, but inaccurate exposure assessment precludes causal inference. Using payroll data with exact and ...prospective measurement of night work, the objective was to investigate whether working night shifts during pregnancy increases the risk of miscarriage.MethodsA cohort of 22 744 pregnant women was identified by linking the Danish Working Hour Database (DWHD), which holds payroll data on all Danish public hospital employees, with Danish national registers on births and admissions to hospitals (miscarriage). The risk of miscarriage during pregnancy weeks 4–22 according to measures of night work was analysed using Cox regression with time-varying exposure adjusted for a fixed set of potential confounders.ResultsIn total 377 896 pregnancy weeks (average 19.7) were available for follow-up. Women who had two or more night shifts the previous week had an increased risk of miscarriage after pregnancy week 8 (HR 1.32 (95% CI 1.07 to 1.62) compared with women, who did not work night shifts. The cumulated number of night shifts during pregnancy weeks 3–21 increased the risk of miscarriages in a dose-dependent pattern.ConclusionsThe study corroborates earlier findings that night work during pregnancy may confer an increased risk of miscarriage and indicates a lowest observed threshold level of two night shifts per week.
Chained and tandem schedules are a common method for thinning schedules of reinforcement following functional communication training (FCT) in the treatment of problem behavior. We conducted a ...systematic literature review and meta-analysis of chained and tandem schedules following FCT to describe treatment characteristics and evaluate effects. We identified 38 articles and found reductions in problem behavior across four measures. Results of a random-effects multilevel meta-analysis of rigorous evaluations showed a significant effect of chained or tandem schedules + FCT on problem behavior relative to baseline. We observed resurgence in 77% of cases and 31% of schedule-thinning transitions. Results showed chained schedules resulted in greater reductions in problem behavior relative to tandem schedules. Exploratory moderator analyses suggested extinction, combined reinforcement, and delay and denial tolerance training procedures were associated with greater reductions in problem behavior relative to other treatment characteristics. Implications for practice and future research are discussed.
This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the ...HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 1.49-1.91 for anti-HPV-16 and 4.52 3.97-5.13 for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 1.54-1.93 for anti-HPV-16 and 3.22 2.82-3.68 for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).
The ongoing COVID-19 pandemic warrants accelerated efforts to test vaccine candidates. We aimed to assess the safety and immunogenicity of an inactivated severe acute respiratory syndrome coronavirus ...2 (SARS-CoV-2) vaccine candidate, BBIBP-CorV, in humans.
We did a randomised, double-blind, placebo-controlled, phase 1/2 trial at Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan Province, China. In phase 1, healthy people aged 18–80 years, who were negative for serum-specific IgM/IgG antibodies against SARS-CoV-2 at the time of screening, were separated into two age groups (18–59 years and ≥60 years) and randomly assigned to receive vaccine or placebo in a two-dose schedule of 2 μg, 4 μg, or 8 μg on days 0 and 28. In phase 2, healthy adults (aged 18–59 years) were randomly assigned (1:1:1:1) to receive vaccine or placebo on a single-dose schedule of 8 μg on day 0 or on a two-dose schedule of 4 μg on days 0 and 14, 0 and 21, or 0 and 28. Participants within each cohort were randomly assigned by stratified block randomisation (block size eight) and allocated (3:1) to receive vaccine or placebo. Group allocation was concealed from participants, investigators, and outcome assessors. The primary outcomes were safety and tolerability. The secondary outcome was immunogenicity, assessed as the neutralising antibody responses against infectious SARS-CoV-2. This study is registered with www.chictr.org.cn, ChiCTR2000032459.
In phase 1, 192 participants were enrolled (mean age 53·7 years SD 15·6) and were randomly assigned to receive vaccine (2 μg n=24, 4 μg n=24, or 8 μg n=24 for both age groups 18–59 years and ≥60 years) or placebo (n=24). At least one adverse reaction was reported within the first 7 days of inoculation in 42 (29%) of 144 vaccine recipients. The most common systematic adverse reaction was fever (18–59 years, one 4% in the 2 μg group, one 4% in the 4 μg group, and two 8% in the 8 μg group; ≥60 years, one 4% in the 8 μg group). All adverse reactions were mild or moderate in severity. No serious adverse event was reported within 28 days post vaccination. Neutralising antibody geometric mean titres were higher at day 42 in the group aged 18–59 years (87·7 95% CI 64·9–118·6, 2 μg group; 211·2 158·9–280·6, 4 μg group; and 228·7 186·1–281·1, 8 μg group) and the group aged 60 years and older (80·7 65·4–99·6, 2 μg group; 131·5 108·2–159·7, 4 μg group; and 170·87 133·0–219·5, 8 μg group) compared with the placebo group (2·0 2·0–2·0). In phase 2, 448 participants were enrolled (mean age 41·7 years SD 9·9) and were randomly assigned to receive the vaccine (8 μg on day 0 n=84 or 4 μg on days 0 and 14 n=84, days 0 and 21 n=84, or days 0 and 28 n=84) or placebo on the same schedules (n=112). At least one adverse reaction within the first 7 days was reported in 76 (23%) of 336 vaccine recipients (33 39%, 8 μg day 0; 18 21%, 4 μg days 0 and 14; 15 18%, 4 μg days 0 and 21; and ten 12%, 4 μg days 0 and 28). One placebo recipient in the 4 μg days 0 and 21 group reported grade 3 fever, but was self-limited and recovered. All other adverse reactions were mild or moderate in severity. The most common systematic adverse reaction was fever (one 1%, 8 μg day 0; one 1%, 4 μg days 0 and 14; three 4%, 4 μg days 0 and 21; two 2%, 4 μg days 0 and 28). The vaccine-elicited neutralising antibody titres on day 28 were significantly greater in the 4 μg days 0 and 14 (169·5, 95% CI 132·2–217·1), days 0 and 21 (282·7, 221·2–361·4), and days 0 and 28 (218·0, 181·8–261·3) schedules than the 8 μg day 0 schedule (14·7, 11·6–18·8; all p<0·001).
The inactivated SARS-CoV-2 vaccine, BBIBP-CorV, is safe and well tolerated at all tested doses in two age groups. Humoral responses against SARS-CoV-2 were induced in all vaccine recipients on day 42. Two-dose immunisation with 4 μg vaccine on days 0 and 21 or days 0 and 28 achieved higher neutralising antibody titres than the single 8 μg dose or 4 μg dose on days 0 and 14.
National Program on Key Research Project of China, National Mega projects of China for Major Infectious Diseases, National Mega Projects of China for New Drug Creation, and Beijing Science and Technology Plan.
The development of sleep disorders, and specifically insomnia, has been linked to the exposure to different stressors. In this line, Coronavirus disease 2019 (COVID-19) outbreak caused by the new ...coronavirus SARS-CoV-2, has caused a huge impact on our environment, and has exposed healthcare workers to an unprecedented threat. In this study, we try to assess sleep quality and the development of sleep disorders in health personnel directly dedicated to the care of COVID-19 patients at the height of the pandemic, compared to the general population.
A cross-sectional, anonymized, self-reported questionnaire survey was carried out at the “12 de Octubre” Hospital, in Madrid, Spain, during the outbreak of COVID-19, from March 1st to April 30th 2020. We compared two groups, healthcare workers who have treated directly COVID-19 patients versus non-healthcare workers. The questionnaire included demographic data, sleep related aspects, Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and 17-items Hamilton Rating Scale (HRS).
In total 170 participants completed the questionnaire successfully, 100 healthcare workers and 70 non-healthcare workers. Self-reported insomnia, nightmares, sleepwalking, sleep terrors and PSQI>6 were more frequent in the healthcare group (p < 0,05). Shift work was associated to greater risk when performing multiple logistic regression analysis.
We observed that, during the outbreak of COVID-19, healthcare workers on the front line developed more sleep disturbances than non-healthcare professionals, and they had worse quality of sleep. Special attention should be paid to shift workers. Concrete protection and prevention measures for particularly exposed population should be considered in pandemic situations.
•Health care workers dealing with COVID-19 patients show poorer sleep quality and higher incidence of self-reported insomnia.•Higher incidence of nightmares, sleepwalking and sleep terrors, is also shown in this group.•Shift work may encourage the emergence of these symptoms.•Special protection measures for particularly exposed groups should be considered in health threatening circumstances.
Use of heterologous prime-boost COVID-19 vaccine schedules could facilitate mass COVID-19 immunisation. However, we have previously reported that heterologous schedules incorporating an adenoviral ...vectored vaccine (ChAdOx1 nCoV-19, AstraZeneca; hereafter referred to as ChAd) and an mRNA vaccine (BNT162b2, Pfizer–BioNTech; hereafter referred to as BNT) at a 4-week interval are more reactogenic than homologous schedules. Here, we report the safety and immunogenicity of heterologous schedules with the ChAd and BNT vaccines.
Com-COV is a participant-blinded, randomised, non-inferiority trial evaluating vaccine safety, reactogenicity, and immunogenicity. Adults aged 50 years and older with no or well controlled comorbidities and no previous SARS-CoV-2 infection by laboratory confirmation were eligible and were recruited at eight sites across the UK. The majority of eligible participants were enrolled into the general cohort (28-day or 84-day prime-boost intervals), who were randomly assigned (1:1:1:1:1:1:1:1) to receive ChAd/ChAd, ChAd/BNT, BNT/BNT, or BNT/ChAd, administered at either 28-day or 84-day prime-boost intervals. A small subset of eligible participants (n=100) were enrolled into an immunology cohort, who had additional blood tests to evaluate immune responses; these participants were randomly assigned (1:1:1:1) to the four schedules (28-day interval only). Participants were masked to the vaccine received but not to the prime-boost interval. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentration (measured by ELISA) at 28 days after boost, when comparing ChAd/BNT with ChAd/ChAd, and BNT/ChAd with BNT/BNT. The heterologous schedules were considered non-inferior to the approved homologous schedules if the lower limit of the one-sided 97·5% CI of the GMR of these comparisons was greater than 0·63. The primary analysis was done in the per-protocol population, who were seronegative at baseline. Safety analyses were done among participants receiving at least one dose of a study vaccine. The trial is registered with ISRCTN, 69254139.
Between Feb 11 and Feb 26, 2021, 830 participants were enrolled and randomised, including 463 participants with a 28-day prime-boost interval, for whom results are reported here. The mean age of participants was 57·8 years (SD 4·7), with 212 (46%) female participants and 117 (25%) from ethnic minorities. At day 28 post boost, the geometric mean concentration of SARS-CoV-2 anti-spike IgG in ChAd/BNT recipients (12 906 ELU/mL) was non-inferior to that in ChAd/ChAd recipients (1392 ELU/mL), with a GMR of 9·2 (one-sided 97·5% CI 7·5 to ∞). In participants primed with BNT, we did not show non-inferiority of the heterologous schedule (BNT/ChAd, 7133 ELU/mL) against the homologous schedule (BNT/BNT, 14 080 ELU/mL), with a GMR of 0·51 (one-sided 97·5% CI 0·43 to ∞). Four serious adverse events occurred across all groups, none of which were considered to be related to immunisation.
Despite the BNT/ChAd regimen not meeting non-inferiority criteria, the SARS-CoV-2 anti-spike IgG concentrations of both heterologous schedules were higher than that of a licensed vaccine schedule (ChAd/ChAd) with proven efficacy against COVID-19 disease and hospitalisation. Along with the higher immunogenicity of ChAd/BNT compared with ChAD/ChAd, these data support flexibility in the use of heterologous prime-boost vaccination using ChAd and BNT COVID-19 vaccines.
UK Vaccine Task Force and National Institute for Health Research.
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