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Values and preferences towards medical cannabis among people living with chronic pain: a mixed-methods systematic review

Por: Zeng · L. · Lytvyn · L. · Wang · X. · Kithulegoda · N. · Agterberg · S. · Shergill · Y. · Esfahani · M. A. · Heen · A. F. · Agoritsas · T. · Guyatt · G. H. · Busse · J. W.
Objective

To explore values and preferences towards medical cannabis among people living with chronic pain.

Design

Mixed-methods systematic review.

Data sources

We searched MEDLINE, EMBASE and PsycINFO from inception to 17 March 2020.

Study selection

Pairs of reviewers independently screened search results and included quantitative, qualitative and mixed-methods studies reporting values and preferences towards medical cannabis among people living with chronic pain.

Review methods

We analysed data using meta-narrative synthesis (quantitative findings were qualitised) and tabulated review findings according to identified themes. We used the Grading of Recommendations Assessment, Development and Evaluation approach to assess certainty of evidence.

Results

Of 1838 initial records, 15 studies proved eligible for review. High to moderate certainty evidence showed that patient’s use of medical cannabis for chronic pain was influenced by both positive (eg, support from friends and family) and negative social factors (eg, stigma surrounding cannabis use). Most patients using medical cannabis favoured products with balanced ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD), or high levels of CBD, but not high THC preparations. Many valued the effectiveness of medical cannabis for symptom management even when experiencing adverse events related to concentration, memory or fatigue. Reducing use of prescription medication was a motivating factor for use of medical cannabis, and concerns regarding addiction, losing control or acting strangely were disincentives. Out-of-pocket costs were a barrier, whereas legalisation of medical cannabis improved access and incentivised use.

Low to very low certainty evidence suggested highly variable values towards medical cannabis among people living with chronic pain. Individuals with pain related to life-limiting disease were more willing to use medical cannabis, and preferred oral over inhaled administration.

Conclusions

Our findings highlight factors that clinicians should consider when discussing medical cannabis. The variability of patients’ values and preferences emphasise the need for shared decision making when considering medical cannabis for chronic pain.

Liver dysfunction in idiopathic pulmonary arterial hypertension: prevalence, characteristics and prognostic significance, a retrospective cohort study in China

Por: Luo · C. · Wu · W. · Wu · C. · Qiu · H. · Yuan · P. · Jiang · R. · Zhao · Q. · Gong · S. · Zhang · R. · Li · J. · He · J. · Liu · J. · Wang · L.
Objectives

The aim was to elucidate the relationship between liver function and idiopathic pulmonary arterial hypertension (IPAH).

Design and setting

Retrospective, longitudinal study in urban tertiary care centre in Shanghai, China.

Participants

407 IPAH consecutive incident patients age 18–65 years were retrospectively enrolled from January 2008 to December 2018.

Outcome measurements

The primary endpoint was all-cause mortality. The cut-off value was determined by receiver operating characteristic curve (ROC), which was validated by Cox proportional hazard model was internally validated by bootstrap analysis and used for survival analysis. The Cox model was (internally) validated and cross-validated areas under the curve (AUC) should be reported.

Results

The prevalence of abnormal liver function tests (LFTs) at baseline was 77.6%. Hyperbilirubinaemia is the most common abnormal biochemical liver test: abnormal total bilirubin (TBIL in 51.6% patients). During the follow-up, 160 patients died. Patients with mixed liver dysfunction have worse prognosis than those with normal LFTs or isolated abnormal bilirubin metabolism. Comparing with patients with hepatocellular injury, the survival of patients with abnormal bilirubin metabolism is lower. Multivariable Cox models revealed a positive association between TBIL, -glutamyltransferase (GGT) and mortality showing that each Ig increment in TBIL and GGT was associated with a higher all-cause mortality (TBIL: HR 4. 29 (95% CI 1. 21 to 15. 27), p=0. 02; GGT: HR 2. 76 (95% CI 1. 18 to 6. 45), p=0. 02). A novel formula named Liver Function Predict Index (LFPI) was constructed (LFPI=–0.002*6MWD+1.014*lg GGT+1.458*lg TBIL) to predict prognosis. ROC curve analysis did further identify 2.729 as the best cut-off value for LFPI (AUC 0.75, p

Conclusions

Liver dysfunction is frequent in IPAH, and characterised by a predominantly cholestatic enzyme profile. LFTs abnormalities are associated with worse survival and LFPI was a new and simple predictor for prognosis of IPAH.

Association between maternal pregestational glucose level and adverse pregnancy outcomes: a population-based retrospective cohort study

Por: Zeng · M. · He · Y. · Li · M. · Yang · L. · Zhu · Q. · Liu · J. · Mao · Y. · Chen · Q. · Du · J. · Zhou · W.
Objective

To investigate the association between maternal pregestational blood glucose level and adverse pregnancy outcomes.

Design

Retrospective cohort study.

Setting

This study was conducted in the Chongqing Municipality of China between April 2010 and December 2016.

Participants

A total of 60 222 women (60 360 pregnancies) from all 39 counties of Chongqing who participated in the National Free Preconception Health Examination Project and had pregnancy outcomes were included.

Primary outcome measures

Adverse pregnancy outcomes included spontaneous abortion, induced abortion or labour due to medical reasons, stillbirth, preterm birth (PTB), macrosomia, large for gestational age, low birth weight (LBW) and small for gestational age.

Results

Of the 60 360 pregnancies, rates of hypoglycaemic, normoglycaemia, impaired fasting glycaemia (IFG) and diabetic hyperglycaemic before conception were 5.06%, 89.30%, 4.59% and 1.05%, respectively. Compared with women with normoglycaemia, women with pregestational glucose at the diabetic level (≥7.0 mmol/L) might have a higher rate of macrosomia (6.18% vs 4.16%), whereas pregestational IFG seemed to be associated with reduced risks of many adverse outcomes, including spontaneous abortion, induced abortion due to medical reasons, PTB and LBW. After adjusting for potential confounders, pregestational diabetic hyperglycaemic was remained to be significantly associated with an increased risk of macrosomia (adjusted risk ratio 1.49, 95% CI 1.07 to 2.09). Abnormal maternal glucose levels before pregnancy (either hypoglycaemic or hyperglycaemic) seemed to have no significant negative effect on spontaneous abortion or induced abortion due to medical reasons.

Conclusion

Although without overt diabetes mellitus, women with once diabetic fasting glucose level during their preconception examinations could be associated with an increased risk for macrosomia. Uniform guidelines are needed for maternal blood glucose management during pre-pregnancy care to improve pregnancy outcomes.

Transmission dynamics and the effects of non-pharmaceutical interventions in the COVID-19 outbreak resurged in Beijing, China: a descriptive and modelling study

Por: Cui · X. · Zhao · L. · Zhou · Y. · Lin · X. · Ye · R. · Ma · K. · Jiang · J.-F. · Jiang · B. · Xiong · Z. · Shi · H. · Wang · J. · Jia · N. · Cao · W.
Objective

To evaluate epidemiological characteristics and transmission dynamics of COVID-19 outbreak resurged in Beijing and to assess the effects of three non-pharmaceutical interventions.

Design

Descriptive and modelling study based on surveillance data of COVID-19 in Beijing.

Setting

Outbreak in Beijing.

Participants

The database included 335 confirmed cases of COVID-19.

Methods

To conduct spatiotemporal analyses of the outbreak, we collected individual records on laboratory-confirmed cases of COVID-19 from 11 June 2020 to 5 July 2020 in Beijing, and visitor flow and products transportation data of Xinfadi Wholesale Market. We also built a modified susceptible-exposed-infected-removed model to investigate the effect of interventions deployed in Beijing.

Results

We found that the staff working in the market (52.2%) and the people around 10 km to this epicentre (72.5%) were most affected, and the population mobility entering-exiting Xinfadi Wholesale Market significantly contributed to the spread of COVID-19 (p=0.021), but goods flow of the market had little impact on the virus spread (p=0.184). The prompt identification of Xinfadi Wholesale Market as the infection source could have avoided a total of 25 708 (95% CI 13 657 to 40 625) cases if unnoticed transmission lasted for a month. Based on the model, we found that active screening on targeted population by nucleic acid testing alone had the most significant effect.

Conclusions

The non-pharmaceutical interventions deployed in Beijing, including localised lockdown, close-contact tracing and community-based testing, were proved to be effective enough to contain the outbreak. Beijing has achieved an optimal balance between epidemic containment and economic protection.

In-hospital gastrointestinal bleeding in patients with acute myocardial infarction: incidence, outcomes and risk factors analysis from China Acute Myocardial Infarction Registry

Por: Shi · W. · Fan · X. · Yang · J. · Ni · L. · Su · S. · Yu · M. · Yang · H. · Yu · M. · Yang · Y. · On behalf of China Acute Myocardial Infarction(CAMI) Registry Study Group
Objective

To investigate the incidence of gastrointestinal bleeding (GIB) in patients with acute myocardial infarction (AMI), clarify the association between adverse clinical outcomes and GIB and identify risk factors for in-hospital GIB after AMI.

Design

Retrospective cohort study.

Setting

108 hospitals across three levels in China.

Participants

From 1 January 2013 to 31 August 2014, after excluding 2659 patients because of incorrect age and missing GIB data, 23 794 patients with AMI from 108 hospitals enrolled in the China Acute Myocardial Infarction Registry were divided into GIB-positive (n=282) and GIB-negative (n=23 512) groups and were compared.

Primary and secondary outcome measures

Major adverse cardiovascular and cerebrovascular events (MACCEs) are a composite of all-cause death, reinfarction and stroke. The association between GIB and endpoints was examined using multivariate logistic regression and Cox proportional hazards models. Independent risk factors associated with GIB were identified using multivariate logistic regression analysis.

Results

The incidence of in-hospital GIB in patients with AMI was 1.19%. GIB was significantly associated with an increased risk of MACCEs both in-hospital (OR 2.314; p

Conclusions

GIB is associated with both in-hospital and follow-up MACCEs. Gastrointestinal prophylactic treatment should be administered to patients with AMI who receive primary PCI, thrombolytic therapy or GPIIb/IIIa receptor inhibitor.

Trial registration number

NCT01874691.

Maternal experience of intermittent kangaroo mother care for late preterm infants: a mixed-methods study in four postnatal wards in China

Por: Zhang · B. · Yue · J. · Duan · Z. · Zhao · Y. · Williams · S. · Huang · L. · Zhang · X. · Wu · W. · Zhang · L. · Liu · J. · Zhao · G.
Objective

To describe how mothers of late preterm infants experienced the provision of intermittent kangaroo mother care (KMC) in four postnatal wards in different hospitals in China, under a pilot KMC project.

Design

A concurrent mixed-methods approach incorporating quantitative maternal questionnaires and qualitative semistructured interviews.

Setting

Four postnatal wards in level-III hospitals based in different provinces of Southeast and Northwest China.

Participants

All 752 mothers who provided intermittent KMC to their late preterm newborns in the four participating postnatal wards consented to participate in the study (quantitative component), as well as six nurses, two obstetricians and two mothers from two of the participating postnatal wards (qualitative component).

Outcome measures

Maternal KMC experiences during a hospital stay, patients’ perceptions of KMC initiation, processes, benefits and challenges.

Results

Most mothers had not heard of KMC before being introduced to it in the postnatal ward. On average, mothers and newborns stayed in postnatal wards for 3.6 days; during their stay, mothers provided an average of 3.5 KMC sessions, which is an average of 1.1 sessions a day. Each KMC session lasted an average of 68 min, though there was much variation in the length of a session. Common reasons given for discontinuing a KMC session included restroom use, infant crying and perceived time limitations. Some mothers would have preferred to provide KMC for longer periods of time and nurses encouraged this. Most mothers experienced no difficulty providing KMC, received support from family and medical staff and intended to continue with KMC postdischarge.

Conclusion

In order to improve the maternal experience of KMC, it is recommended that raising awareness of KMC should be included in antenatal care and after birth. Longer periods of KMC provision should be encouraged, greater privacy should be provided for mothers providing KMC in postnatal wards and family members should be encouraged to support KMC.

Role of Dutch internal policy advisors in a hospital quality improvement programme and their influence on nurses role development: a qualitative study

Objective

Nurses are vital in providing and improving quality of care. To enhance the quality improvement (QI) competencies of nurses, hospitals in the Netherlands run developmental programmes generally led by internal policy advisors (IPAs). In this study, we identify the roles IPAs play during these programmes to enhance the development of nurses’ QI competencies and studied how these roles influenced nurses and management.

Design

An exploratory ethnographical study comprising observations, informal conversations, semistructured interviews, focus groups and a strategy evaluation meeting.

Setting

A teaching hospital in an urban region in the Netherlands.

Participants

IPAs (n=7) in collaboration with four teams of nurses (n=131), team managers (n=4), senior managers (n=4) and the hospital director (n=1).

Results

We identified five distinct advisory roles that IPAs perform in the hospital programme: gatekeeper, connector, converter, reflector and implementer. In describing these roles, we provide insights into how IPAs help nurses to develop QI competencies. The IPA’s professional background was a driving force for nurses’ QI role development. However, QI development was threatened if IPAs lost sight of different stakeholders’ interests and consequently lost their credibility. QI role development among nurses was also threatened if the IPA took on all responsibility instead of delegating it timely to managers and nurses.

Conclusions

We have shown how IPAs’ professional background and advisory knowledge connect organisational, managerial and professional aims and interests to enhance professionalisation of nurses.

Association between serum phosphate and mortality in critically ill patients: a large retrospective cohort study

Por: Chen · Y. · Luo · M. · Xu · H. · Zhao · W. · He · Q.
Objectives

This research aims to explore the impact of serum phosphate on the mortality of critically ill patients.

Design

A retrospective large cohort study.

Setting

Our data were extracted from a publicly accessible database named ‘Multiparameter Intelligent Monitoring in Intensive Care Database III’.

Participants

27 131 patients were included by clear definitions of selection and exclusion criteria.

Interventions

We used initial phosphate at admission as a design variable. Patients were divided into six groups with different serum phosphate levels and five groups at different intensive care unit (ICU) departments.

Primary and secondary outcomes

28-day and 90-day mortality were primary outcomes. All-cause mortality and length of stay ICU were secondary outcomes.

Results

Patients with very-high-normal serum phosphate, hypophosphataemia and hyperphosphataemia had worse outcomes. And the relationship between serum phosphate and the probability of 28-day or 90-day mortality had a linear relationship. After adjustment for potential confounders, hypophosphataemia and hyperphosphataemia were not significantly associated with 28-day or 90-day mortality. Nevertheless, at the medical ICU, hyperphosphataemia was associated with increased 28-day or 90-day mortality (HR=0.64, 95% CI 0.48 to 0.84, p=0.0017; HR=0.72, 95% CI 0.57 to 0.91, p=0.0067, respectively), using group 2 (≥2.5 mg/dL and

Conclusions

Patients with very-high-normal serum phosphate also had worse outcomes, it might be necessary to re-evaluate the definitions of the normal reference range for serum phosphate. Hypophosphataemia and hyperphosphataemia are not the independent risk factors of 28-day or 90-day ICU mortality, which leads us to consider whether phosphate monitoring is not a necessary measure in critically ill patients. But hyperphosphataemia was associated with increased 28-day or 90-day mortality at the medical ICU, which emphasises the potential importance of early diagnosis and treatment of hyperphosphataemia for the patients who were admitted to the medical ICU.

Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial

Por: Almeida · A. S. · Ceron · R. O. · Anschau · F. · Kopittke · L. · Lira · K. B. · Delvaux · R. S. · Rode · J. · Rey · R. A. W. · Wittke · E. I. · Rombaldi · A. R.
Introduction

Myocardial protection is essential for successful cardiac surgery, and the search for an ideal cardioplegic solution has continued since its beginning. In this context, Custodiol, del Nido and modified del Nido are single-dose cardioplegic solutions with good safety profiles and great relevance in modern surgical practice. While these solutions have all been evaluated for their impact on patient outcomes independently, limited research exists comparing them directly. Thus, the present study aims to examine the effects of these cardioplegic solutions on myocardial protection and clinical outcomes in adult patients undergoing elective cardiac surgery. The assessment of the increase in myocardial injury biomarkers in patients submitted to all treatment methods may be considered a major strength of our study.

Methods and analysis

This is a clinical trial study protocol that will compare myocardial protection and clinical outcomes among three patient groups based on which cardioplegic solution was used. Patients will be randomised to receive del Nido (n=30), modified del Nido (n=30) or Custodiol (n=30). Myocardial injury biomarkers will be measured at the baseline and 2 hours, 12 hours and 24 hours after the cardiopulmonary bypass. Clinical outcomes will be assessed during the trans operative period and the intensive care unit stay, in addition to other haematological parameters.

Ethics and dissemination

This protocol and its related documents were approved by the Research Ethics Committee of the Hospital Nossa Senhora da Conceicão, Brazil, registered under no. 4.029.545. The findings of this study will be published in a peer-reviewed journal in the related field.

Trial registration number

RBR-7g5s66.

Adolescents and age of consent to HIV testing: an updated review of national policies in sub-Saharan Africa

Por: Barr-DiChiara · M. · Tembo · M. · Harrison · L. · Quinn · C. · Ameyan · W. · Sabin · K. · Jani · B. · Jamil · M. S. · Baggaley · R. · Johnson · C.
Objectives

In sub-Saharan Africa (SSA) where HIV burden is highest, access to testing, a key entry point for prevention and treatment, remains low for adolescents (aged 10–19). Access may be hampered by policies requiring parental consent for adolescents to receive HIV testing services (HTS). In 2013, the WHO recommended countries to review HTS age of consent policies. Here, we investigate country progress and policies on age of consent for HIV testing.

Design

Comprehensive policy review.

Data sources

Policies addressing HTS were obtained through searching WHO repositories and governmental and non-governmental websites and consulting country and regional experts.

Eligibility criteria

HTS policies published by SSA governments before 2019 that included age of consent.

Data extraction and synthesis

Data were extracted on HTS age of consent including exceptions based on risk and maturity. Descriptive analyses of included policies were disaggregated by Eastern and Southern Africa (ESA) and Western and Central Africa (WCA) subregions.

Results

Thirty-nine policies were reviewed, 38 were eligible; 19/38 (50%) permitted HTS for adolescents ≤16 years old without parental consent. Of these, six allowed HTS at ≥12 years old, two at ≥13, two at ≥14, five at ≥15 and four at ≥16. In ESA, 71% (n=15/21) allowed those of ≤16 years old to access HTS, while only 24% (n=6/25) of WCA countries allowed the same. Maturity exceptions including marriage, sexual activity, pregnancy or key population were identified in 18 policies. In 2019, 63% (n=19/30) of policies with clear age-based criteria allowed adolescents of 12–16 years old to access HIV testing without parental consent, an increase from 37% (n=14/38) in 2013.

Conclusions

While many countries in SSA have revised their HTS policies, many do not specify age of consent. Revision of SSA consent to HTS policies, particularly in WCA, remains a priority to achieve the 2025 goal of 95% of people with HIV knowing their status.

Evaluation of microalbuminuria as a prognostic indicator after a TIA or minor stroke in an outpatient setting: the prognostic role of microalbuminuria in TIA evolution (ProMOTE) study

Por: Strain · W. D. · Elyas · S. · Wedge · N. · Mounce · L. · Henley · W. · James · M. · Shore · A. C.
Objective

Transient ischaemic attacks (TIA) and minor strokes are important risk factors for further vascular events. We explored the role of albumin creatinine ratio (ACR) in improving risk prediction after a first event.

Setting

Rapid access stroke clinics in the UK.

Participants

2202 patients attending with TIA or minor stroke diagnosed by the attending stroke physician, able to provide a urine sample to evaluate ACR using a near-patient testing device.

Primary and secondary outcomes

Primary outcome was major adverse cardiac events (MACE: recurrent stroke, myocardial infarction or cardiovascular death) at 90 days. The key secondary outcome was to determine whether urinary ACR could contribute to a risk prediction tool for use in a clinic setting.

Results

151 MACE occurred in 144 participants within 90 days. Participants with MACE had higher ACR than those without. A composite score awarding a point each for age >80 years, previous stroke/TIA and presence of microalbuminuria identified those at low risk and high risk. 90% of patients were at low risk (scoring 0 or 1). Their 90-day risk of MACE was 5.7%. Of the remaining ‘high-risk’ population (scoring 2 or 3) 12.4% experienced MACE over 90 days (p

Conclusion

A risk score comprising age, previous stroke/TIA and microalbuminuria predicts future MACE while identifying those at low risk of a recurrent event. This tool shows promise in the risk stratification of patients to avoid the admission of low-risk patients.

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies

Por: Bäumler · P. · Zhang · W. · Stübinger · T. · Irnich · D.
Objective

Overview on risks of acupuncture-related adverse events (AEs).

Design

Systematic review and meta-analyses of prospective studies.

Data sources

PubMed, Scopus and Embase from inception date to 15 September 2019.

Eligibility criteria for selecting studies

Prospective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German.

Data extraction and synthesis

Two independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses.

Main outcomes

Overall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments.

Results

A total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely.

Conclusion

Acupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs.

PROSPERO registration number

CRD42020151930.

Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED)

Por: Buggy · D. J. · Nolan · R. · Coburn · M. · Columb · M. · Hermanides · J. · Hollman · M. W. · Zarbock · A.
Introduction

Diabetes is common (about 20 million patients in Europe) and patients with diabetes have more surgical interventions than the general population. There are plausible pathophysiological and clinical mechanisms suggesting that patients with diabetes are at an increased risk of postoperative complications. When postoperative complications occur in the general population, they increase major adverse events and subsequently increase 1-year mortality. This is likely to be worse in patients with diabetes. There is variation in practice guidelines in different countries in the perioperative management of patients with diabetes undergoing major surgery and whether this may affect postoperative outcome has not been investigated on a large scale. Neither is it known whether different strata of preoperative glycaemic control affects outcome.

Methods and analysis

A prospective, observational, international, multicentre cohort study, recruiting 5000 patients with diabetes undergoing elective or emergency surgery in at least n=50 centres. Inclusion criteria are any patient with diabetes undergoing surgery under any substantive anaesthetic technique. Exclusion criteria are not being a confirmed diabetic patient and patients with diabetes undergoing procedures under monitored sedation or local anaesthetic infiltration only. Follow-up duration is 30 days after surgery. Primary outcome is days at home at 30 days. Secondary outcomes are Comprehensive Complications Index, Quality of Recovery (QoR-15) score on Day 1 postoperatively, 30-day mortality, length of hospital stay and incidence of specific major adverse events (Myocardial Infarction (MI), Myocardial Injury after Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI), Postoperative Pulmonary Complications (PPC), Cerebrovascular Accident (CVA), Pulmonary Embolism (PE), DVT, surgical site infection, postoperative pulmonary infection). Tertiary outcomes include time to resumption of normal diabetes therapy, incidence of diabetic ketoacidosis or hypoglycaemia, incidence and duration of use of intravenous insulin infusion therapy and change in diabetic management at 30 days.

Ethics and dissemination

This study will adhere to the principles of the Declaration of Helsinki (amendment 2013) by the World Medical Association and the ICH-Good Clinical Practice (GCP) Guidelines E6(R2). Specific national and local regulatory authority requirements will be followed as applicable. Ethical approval has been granted by the Institutional Review Board of the Mater Misericordiae University Hospital, Dublin, Ireland (Reference: 1/378/2167). As enrolment for this study is ongoing, ethical approval from additional centres is being added continuously. The main results of Management and Outcomes of Perioperative Care among European Diabetic Patients and its substudies will be published in peer-reviewed international medical journals and presented at Euroanaesthesia congress and other international and national meetings.

Trial registration number

NCT04511312.

Patterns of sexual violence against adults and children during the COVID-19 pandemic in Kenya: a prospective cross-sectional study

Por: Rockowitz · S. · Stevens · L. M. · Rockey · J. C. · Smith · L. L. · Ritchie · J. · Colloff · M. F. · Kanja · W. · Cotton · J. · Njoroge · D. · Kamau · C. · Flowe · H. D.
Objectives

This study examined patterns of sexual violence against adults and children in Kenya during the COVID-19 pandemic to inform sexual violence prevention, protection, and response efforts.

Design

A prospective cross-sectional research design was used with data collected from March to August 2020.

Setting

Kenya.

Participants

317 adults, 224 children.

Main measures

Perpetrator and survivor demographic data, characteristics of the assault.

Results

Bivariate analyses found that children were more likely than adults to be attacked during daytime (59% vs 44%, p2(5, n=541)=53.3, p

Conclusions

Patterns of sexual violence against adult and child survivors during the COVID-19 pandemic are different, suggesting age-related measures are needed in national emergency plans to adequately address sexual violence during the pandemic and for future humanitarian crises.

Cross-sectional association between long working hours and endoscopic gastritis: the Kangbuk Samsung Health Study

Por: Mun · E. · Lee · Y. · Lee · W. · Park · S.
Objectives

This study aimed to determine the cross-sectional association between long working hours and gastritis diagnosed by endoscopy.

Design

Cross-sectional study.

Setting

Large university hospitals in Seoul and Suwon, South Korea.

Participants

Workers in formal employment who underwent a comprehensive health examination at the Kangbuk Samsung Hospital Total Healthcare Centre clinics in Seoul and Suwon, South Korea, between January 2011 and December 2018. Of the 386 488 participants, 168 391 full-time day workers met the inclusion criteria and were included in the analysis.

Primary outcome measure

Endoscopic gastritis.

Results

The participants were predominantly college graduates or above (88.9%), male (71.2%) and in their 30s (51.1%), and the median age was 36 (IQR 31–42). Approximately 93.2% of participants had positive endoscopic gastritis, and there was a significant association between working hours and positive findings of endoscopic gastritis. The multivariate fully adjusted prevalence ratio (PR) of endoscopic gastritis for participants working >55 hours per week compared with 35–40 hours per week was 1.011 (95% CI 1.007 to 1.015). Furthermore, endoscopic findings were classified into nine subtypes of gastritis, including superficial gastritis, erosive gastritis, atrophic gastritis, intestinal metaplasia and haemorrhagic gastritis increased with longer working hours (p for trends 55 hours per week compared with 35–40 hours per week were 1.019 (95% CI 1.012 to 1.026), 1.025 (95% CI 1.011 to 1.040), 1.017 (95% CI 1.008 to 1.027), 1.066 (95% CI 1.028 to 1.105) and 1.177 (95% CI 1.007 to 1.375), respectively.

Conclusions

Working over 55 hours per week was cross-sectionally associated with positive findings of endoscopic gastritis. The study findings indicated potentially increased risks of superficial gastritis, erosive gastritis, atrophic gastritis, intestinal metaplasia and haemorrhagic gastritis among workers with long working hours (>55 hours per week), supporting the need for further exploration via longitudinal studies.

Electrophysiological ventricular substrate of stroke: a prospective cohort study in the Atherosclerosis Risk in Communities (ARIC) study

Por: Johnson · J. A. · Haq · K. T. · Lutz · K. J. · Peters · K. K. · Paternostro · K. A. · Craig · N. E. · Stencel · N. W. L. · Hawkinson · L. F. · Khayyat-Kholghi · M. · Tereshchenko · L. G.
Objectives

The goal of the study was to determine an association of cardiac ventricular substrate with thrombotic stroke (TS), cardioembolic stroke (ES) and intracerebral haemorrhage (ICH).

Design

Prospective cohort study.

Setting

The Atherosclerosis Risk in Communities (ARIC) study in 1987–1989 enrolled adults (45–64 years), selected as a probability sample from four US communities (Minneapolis, Minnesota; Washington, Maryland; Forsyth, North Carolina; Jackson, Mississippi). Visit 2 was in 1990–1992, visit 3 in 1993–1995, visit 4 in 1996–1998 and visit 5 in 2011–2013.

Participants

ARIC participants with analysable ECGs and no history of stroke were included (n=14 479; age 54±6 y; 55% female; 24% black). Ventricular substrate was characterised by cardiac memory, spatial QRS-T angle (QRS-Ta), sum absolute QRST integral (SAIQRST), spatial ventricular gradient magnitude (SVGmag), premature ventricular contractions (PVCs) and tachycardia-dependent intermittent bundle branch block (TD-IBBB) on 12-lead ECG at visits 1–5.

Outcome

Adjudicated TS included a first definite or probable thrombotic cerebral infarction, ES—a first definite or probable non-carotid cardioembolic brain infarction. Definite ICH was included if it was the only stroke event.

Results

Over a median 24.5 years follow-up, there were 899 TS, 400 ES and 120 ICH events. Cox proportional hazard risk models were adjusted for demographics, cardiovascular disease, risk factors, atrial fibrillation, atrial substrate and left ventricular hypertrophy. After adjustment, PVCs (HR 1.72; 95% CI 1.02 to 2.92), QRS-Ta (HR 1.15; 95% CI 1.03 to 1.28), SAIQRST (HR 1.20; 95% CI 1.07 to 1.34) and time-updated SVGmag (HR 1.19; 95% CI 1.08 to 1.32) associated with ES. Similarly, PVCs (HR 1.53; 95% CI 1.03 to 2.26), QRS-Ta (HR 1.08; 95% CI 1.01 to 1.16), SAIQRST (HR 1.07; 95% CI 1.01 to 1.14) and time-updated SVGmag (HR 1.11; 95% CI 1.04 to 1.19) associated with TS. TD-IBBB (HR 3.28; 95% CI 1.03 to 10.46) and time-updated SVGmag (HR 1.23; 95% CI 1.03 to 1.47) were associated with ICH.

Conclusions

PVC burden (reflected by cardiac memory) is associated with ischaemic stroke. Transient cardiac memory (likely through TD-IBBB) precedes ICH.

Associations between community cultural engagement and life satisfaction, mental distress and mental health functioning using data from the UK Household Longitudinal Study (UKHLS): are associations moderated by area deprivation?

Por: Mak · H. W. · Coulter · R. · Fancourt · D.
Objectives

The association between community cultural engagement and mental health and well-being is well established. However, little is known about whether such associations are influenced by area characteristics. This study therefore examined whether the association between engagement in community cultural assets (attendance at cultural events, visiting museums and heritage sites) and subsequent well-being (life satisfaction, mental distress and mental health functioning) is moderated by neighbourhood deprivation.

Design

Data were drawn from Understanding Society: The UK Household Longitudinal Study waves 2 and 5. Participating households’ addresses were geocoded into statistical neighbourhood zones categorised according to their level of area deprivation.

Setting

General population.

Participants

UK general adult population, with a total sample of 14 783.

Main outcome measures

Life satisfaction was measured with a seven-point scale (1: completely unsatisfied to 7: completely satisfied). Mental distress was measured using the General Health Questionnaire 12. Mental health functioning was measured using 12-item Short Form Health Survey (SF-12).

Results

Using Ordinary Least Squares (OLS) regression, we found that engagement in cultural assets was consistently and positively associated with subsequent life satisfaction and mental health functioning and negatively associated with mental distress. Importantly, such associations were independent of individuals’ demographic background, socioeconomic characteristics and regional location. The results also show that relationships between engagement in community cultural assets and well-being were stronger in more deprived areas.

Conclusions

This study shows that engagement in community cultural assets is associated with better well-being, with some evidence that individuals in areas of high deprivation potentially may benefit more from these engagements. Given that causal mechanisms were not tested, causal claims cannot be generated from the results. However, the results suggest that place-based funding schemes that involve investment in areas of higher deprivation to improve engagement rates should be explored further to see if they can help promote better well-being among residents.

Assessing the capacity of symptom scores to predict COVID-19 positivity in Nigeria: a national derivation and validation cohort study

Por: Elimian · K. O. · Aderinola · O. · Gibson · J. · Myles · P. · Ochu · C. L. · King · C. · Okwor · T. · Gaudenzi · G. · Olayinka · A. · Zaiyad · H. G. · Ohonsi · C. · Ebhodaghe · B. · Dan-Nwafor · C. · Nwachukwu · W. · Abdus-salam · I. A. · Akande · O. W. · Falodun · O. · Arinze · C. · Ezeok
Objectives

This study aimed to develop and validate a symptom prediction tool for COVID-19 test positivity in Nigeria.

Design

Predictive modelling study.

Setting

All Nigeria States and the Federal Capital Territory.

Participants

A cohort of 43 221 individuals within the national COVID-19 surveillance dataset from 27 February to 27 August 2020. Complete dataset was randomly split into two equal halves: derivation and validation datasets. Using the derivation dataset (n=21 477), backward multivariable logistic regression approach was used to identify symptoms positively associated with COVID-19 positivity (by real-time PCR) in children (≤17 years), adults (18–64 years) and elderly (≥65 years) patients separately.

Outcome measures

Weighted statistical and clinical scores based on beta regression coefficients and clinicians’ judgements, respectively. Using the validation dataset (n=21 744), area under the receiver operating characteristic curve (AUROC) values were used to assess the predictive capacity of individual symptoms, unweighted score and the two weighted scores.

Results

Overall, 27.6% of children (4415/15 988), 34.6% of adults (9154/26 441) and 40.0% of elderly (317/792) that had been tested were positive for COVID-19. Best individual symptom predictor of COVID-19 positivity was loss of smell in children (AUROC 0.56, 95% CI 0.55 to 0.56), either fever or cough in adults (AUROC 0.57, 95% CI 0.56 to 0.58) and difficulty in breathing in the elderly (AUROC 0.53, 95% CI 0.48 to 0.58) patients. In children, adults and the elderly patients, all scoring approaches showed similar predictive performance.

Conclusions

The predictive capacity of various symptom scores for COVID-19 positivity was poor overall. However, the findings could serve as an advocacy tool for more investments in resources for capacity strengthening of molecular testing for COVID-19 in Nigeria.

Magnetophoretic and spectral characterization of oxyhemoglobin and deoxyhemoglobin: Chemical versus enzymatic processes

by Mitchell R. H. Weigand, Jenifer Gómez-Pastora, James Kim, Matthew T. Kurek, Richard J. Hickey, David C. Irwin, Paul W. Buehler, Maciej Zborowski, Andre F. Palmer, Jeffrey J. Chalmers

A new method for hemoglobin (Hb) deoxygenation, in suspension or within red blood cells (RBCs) is described using the commercial enzyme product, EC-Oxyrase®. The enzymatic deoxygenation method has several advantages over established deoxygenation methodologies, such as avoiding side reactions that produce methemoglobin (metHb), thus eliminating the need for an inert deoxygenation gas and airtight vessel, and facilitates easy re-oxygenation of Hb/RBCs by washing with a buffer that contains dissolved oxygen (DO). The UV-visible spectra of deoxyHb and metHb purified from human RBCs using three different preparation methods (sodium dithionite [to produce deoxyHb], sodium nitrite [to produce metHb], and EC-Oxyrase® [to produce deoxyHb]) show the high purity of deoxyHb prepared using EC-Oxyrase® (with little to no metHb or hemichrome production from side reactions). The oxyHb deoxygenation time course of EC-Oxyrase® follows first order reaction kinetics. The paramagnetic characteristics of intracellular Hb in RBCs were compared using Cell Tracking Velocimetry (CTV) for healthy and sickle cell disease (SCD) donors and oxygen equilibrium curves show that the function of healthy RBCs is unchanged after EC-Oxyrase® treatment. The results confirm that this enzymatic approach to deoxygenation produces pure deoxyHb, can be re-oxygenated easily, prepared aerobically and has similar paramagnetic mobility to existing methods of producing deoxyHb and metHb.

Development of ACE2 autoantibodies after SARS-CoV-2 infection

by John M. Arthur, J. Craig Forrest, Karl W. Boehme, Joshua L. Kennedy, Shana Owens, Christian Herzog, Juan Liu, Terry O. Harville

Background

Activation of the immune system is implicated in the Post-Acute Sequelae after SARS-CoV-2 infection (PASC) but the mechanisms remain unknown. Angiotensin-converting enzyme 2 (ACE2) cleaves angiotensin II (Ang II) resulting in decreased activation of the AT1 receptor and decreased immune system activation. We hypothesized that autoantibodies against ACE2 may develop after SARS-CoV-2 infection, as anti-idiotypic antibodies to anti-spike protein antibodies.

Methods and findings

We tested plasma or serum for ACE2 antibodies in 67 patients with known SARS-CoV-2 infection and 13 with no history of infection. None of the 13 patients without history of SARS-CoV-2 infection and 1 of the 20 outpatients that had a positive PCR test for SARS-CoV-2 had levels of ACE2 antibodies above the cutoff threshold. In contrast, 26/32 (81%) in the convalescent group and 14/15 (93%) of patients acutely hospitalized had detectable ACE2 antibodies. Plasma from patients with antibodies against ACE2 had less soluble ACE2 activity in plasma but similar amounts of ACE2 protein compared to patients without ACE2 antibodies. We measured the capacity of the samples to inhibit ACE2 enzyme activity. Addition of plasma from patients with ACE2 antibodies led to decreased activity of an exogenous preparation of ACE2 compared to patients that did not have antibodies.

Conclusions

Many patients with a history of SARS-CoV-2 infection have antibodies specific for ACE2. Patients with ACE2 antibodies have lower activity of soluble ACE2 in plasma. Plasma from these patients also inhibits exogenous ACE2 activity. These findings are consistent with the hypothesis that ACE2 antibodies develop after SARS-CoV-2 infection and decrease ACE2 activity. This could lead to an increase in the abundance of Ang II, which causes a proinflammatory state that triggers symptoms of PASC.

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