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Cardiometabolic disorders, inflammation and the incidence of non-alcoholic fatty liver disease: A longitudinal study comparing lean and non-lean individuals

by Ehimen C. Aneni, Gul Jana Saeed, Marcio Sommer Bittencourt, Miguel Cainzos-Achirica, Chukwuemeka U. Osondu, Matthew Budoff, Edison R. Parise, Raul D. Santos, Khurram Nasir

Background

There is limited knowledge about the risk of non-alcoholic fatty liver disease (NAFLD) associated with cardiometabolic disorders in lean persons. This study examines the contribution of cardiometabolic disorders to NAFLD risk among lean individuals and compares to non-lean individuals.

Methods

We analyzed longitudinal data from 6,513 participants of a yearly voluntary routine health testing conducted at the Hospital Israelita Albert Einstein, Brazil. NAFLD was defined as hepatic ultrasound diagnosed fatty liver in individuals scoring below 8 on the alcohol use disorders identification test. Our main exposure variables were elevated blood glucose, elevated blood pressure (BP), presence of atherogenic dyslipidemia (AD, defined as the combination of elevated triglycerides and low HDL cholesterol) and physical inactivity ( Results

Over 15,580 person-years (PY) of follow-up, the incidence rate of NAFLD was 7.7 per 100 PY. In multivariate analysis adjusting for likely confounders, AD was associated with a 72% greater risk of NAFLD (IRR: 1.72 [95% CI:1.32–2.23]). Elevated blood glucose (IRR: 1.71 [95%CI: 1.29–2.28]) and physical inactivity (IRR: 1.46 [95%CI: 1.28–1.66]) were also independently associated with increased risk of NAFLD. In lean individuals, AD, elevated blood glucose and elevated BP were significantly associated with NAFLD although for elevated blood glucose, statistical significance was lost after adjusting for possible confounders. Physical inactivity and elevations in HsCRP were not associated with the risk of NAFLD in lean individuals only. Among lean (and non-lean) individuals, there was an independent association between progressively increasing waist circumference and NAFLD.

Conclusion

Cardiometabolic risk factors are independently associated with NAFLD. However, there are significant differences in the metabolic risk predictors of NAFLD between lean and non-lean individuals. Personalized cardiovascular disease risk stratification and appropriate preventive measures should be considered in both lean and non-lean individuals to prevent the development of NAFLD.

Potentially avoidable causes of hospitalisation in people with dementia: contemporaneous associations by stage of dementia in a South London clinical cohort

Por: Gungabissoon · U. · Perera · G. · Galwey · N. W. · Stewart · R.
Objectives

To estimate the frequency of all-cause and ambulatory care sensitive condition (ACSCs)-related hospitalisations among individuals with dementia. In addition, to investigate differences by stage of dementia based on recorded cognitive function.

Setting

Data from a large London dementia care clinical case register, linked to a national hospitalisation database.

Participants

Individuals aged ≥65 years with a confirmed dementia diagnosis with recorded cognitive function.

Outcome measures

Acute general hospital admissions were evaluated within 6 months of a randomly selected cognitive function score in patients with a clinical diagnosis of dementia. To evaluate associations between ACSC-related hospital admissions (overall and individual ACSCs) and stage of dementia, an ordinal regression was performed, modelling stage of dementia as the dependant variable (to facilitate efficient model selection, with no implication concerning the direction of causality).

Results

Of the 5294 people with dementia, 2993 (56.5%) had at least one hospitalisation during a 12-month period of evaluation, and 1192 (22.5%) had an ACSC-related admission. Proportions with an all-cause or ACSC-related hospitalisation were greater in the groups with more advanced dementia (all-cause 53.9%, 57.1% and 60.9%, p 0.002; ACSC-related 19.5%, 24.0% and 25.3%, p

Conclusions

Potentially avoidable hospitalisations were common in people with dementia, particularly in those with greater cognitive impairment. Our results call for greater attention to the extent of cognitive status impairment, and not just dementia diagnosis, when evaluating measures to reduce the risk of potentially avoidable hospitalisations.

'Striving for freedom or remaining with what is well-known: a focus-group study of self-management among people with type 1 diabetes who have suboptimal glycaemic control despite continuous subcutaneous insulin infusion

Por: Persson · M. · Leksell · J. · Ernersson · A. · Rosenqvist · U. · Hörnsten · A.
Introduction

Continuous subcutaneous insulin infusion (CSII) treatment is beneficial for obtaining glycaemic control for many persons with type 1 diabetes mellitus (T1DM). Still, some individuals do not obtain improved HbA1C levels despite CSII treatment, and there is a lack of evidence regarding how psychosocial factors may influence glycaemic control. Thus, we aimed to explore the attitudes and experiences of self-management among people with T1DM and suboptimal glycaemic control despite CSII treatment.

Research design and methods

A qualitative inductive design was applied, and four FGDs were performed with 37 adult men and women of various ages and duration of T1DM. All participants had suboptimal glycaemic control despite CSII treatment. Transcripts were analysed using qualitative manifest and latent content analysis.

Results and conclusion

The themes Searching for freedom and flexibility and Preferring safety and the well-known illustrated the divergent psychosocial strategies adapted, which both resulted in suboptimal glycaemic control. The technical devices and their effects on glycaemic levels may be challenging to understand and adjust to fit people’s lifestyles. The rapid advances of technology devices in diabetes care can potentially change peoples’ lives, but is the educational support developing as fast? Multifaceted web-based education of high quality, including tailored support with a person-centred focus, is more important than ever before as the need for technical knowledge and understanding may put further disease burdens to patients with T1DM on CSII treatment.

Study protocol: a survey exploring patients and healthcare professionals expectations, attitudes and ethical acceptability regarding the integration of socially assistive humanoid robots in nursing

Por: Mlakar · I. · Kampic · T. · Flis · V. · Kobilica · N. · Molan · M. · Smrke · U. · Plohl · N. · Bergauer · A.
Introduction

Population ageing, the rise of chronic diseases and the emergence of new viruses are some of the factors that contribute to an increasing share of gross domestic product dedicated to health spending. COVID-19 has shown that nursing staff represents the critical part of hospitalisation. Technological developments in robotics and artificial intelligence can significantly reduce costs and lead to improvements in many hospital processes. The proposed study aims to assess expectations, attitudes and ethical acceptability regarding the integration of socially assistive humanoid robots into hospitalised care workflow from patients’ and healthcare professionals’ perspectives and to compare them with the results of similar studies.

Methods/design

The study is designed as a cross-sectional survey, which will include three previously validated questionnaires, the Technology-Specific Expectation Scale (TSES), the Ethical Acceptability Scale (EAS) and the Negative Attitudes towards Robots Scale (NARS). The employees of a regional clinical centre will be asked to participate via an electronic survey and respond to TSES and EAS questionaries. Patients will respond to TSES and NARS questionaries. The survey will be conducted online.

Ethics and dissemination

Ethical approval for the study was obtained by the Medical Ethics Commission of the University Medical Center Maribor. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities and the ecosystem of the Horizon 2020 funded project HosmartAI (grant no. 101016834).

Ethical approval date

06 May 2021.

Estimated start of the study

December 2021.

Association of the Intermountain Risk Score with major adverse health events in patients positive for COVID-19: an observational evaluation of a US cohort

Por: Horne · B. D. · Bledsoe · J. R. · Muhlestein · J. B. · May · H. T. · Peltan · I. D. · Webb · B. J. · Carlquist · J. F. · Bennett · S. T. · Rea · S. · Bair · T. L. · Grissom · C. K. · Knight · S. · Ronnow · B. S. · Le · V. T. · Stenehjem · E. · Woller · S. C. · Knowlton · K. U. · Anderson
Objectives

The Intermountain Risk Score (IMRS), composed using published sex-specific weightings of parameters in the complete blood count (CBC) and basic metabolic profile (BMP), is a validated predictor of mortality. We hypothesised that IMRS calculated from prepandemic CBC and BMP predicts COVID-19 outcomes and that IMRS using laboratory results tested at COVID-19 diagnosis is also predictive.

Design

Prospective observational cohort study.

Setting

Primary, secondary, urgent and emergent care, and drive-through testing locations across Utah and in sections of adjacent US states. Viral RNA testing for SARS-CoV-2 was conducted from 3 March to 2 November 2020.

Participants

Patients aged ≥18 years were evaluated if they had CBC and BMP measured in 2019 and tested positive for COVID-19 in 2020.

Primary and secondary outcome measures

The primary outcome was a composite of hospitalisation or mortality, with secondary outcomes being hospitalisation and mortality separately.

Results

Among 3883 patients, 8.2% were hospitalised and 1.6% died. Subjects with low, mild, moderate and high-risk IMRS had the composite endpoint in 3.5% (52/1502), 8.6% (108/1256), 15.5% (152/979) and 28.1% (41/146) of patients, respectively. Compared with low-risk, subjects in mild-risk, moderate-risk and high-risk groups had HR=2.33 (95% CI 1.67 to 3.24), HR=4.01 (95% CI 2.93 to 5.50) and HR=8.34 (95% CI 5.54 to 12.57), respectively. Subjects aged

Conclusions

IMRS, a simple risk score using very basic laboratory results, predicted COVID-19 hospitalisation and mortality. This included important abilities to identify risk in younger adults with few diagnosed comorbidities and to predict risk prior to SARS-CoV-2 infection.

Association of adolescents independent mobility with road traffic injuries in Karachi, Pakistan: a cross-sectional study

Por: Khan · U. R. · Razzak · J. · Gerdin Wärnberg · M.
Objective

Participation in walking, cycling and taking public transportation without adult supervision is defined as independent mobility of children and adolescents. The association between adolescents’ independent mobility and road traffic injury (RTI) is unclear. The purpose of this study is to determine measures of adolescents’ independent mobility associated with RTIs in an urban lower middle-income setting.

Study design

Cross-sectional survey.

Setting

Schools in Karachi, Pakistan.

Participants

Adolescents aged 10–19 years in grades 6–10 were enrolled from private and public schools.

Outcome

Any self-reported lifetime RTI sustained as a pedestrian, as a cyclist or while in a car or another vehicle that resulted in any first aid at home/school or consultation in a healthcare setting.

Exposure

Self-reported independent mobility was assessed by four variables. (1) Any travel companion from school to home on the survey day, (2) parental permission to cross main roads alone, (3) parental permission to travel by public bus alone and (4) activity/activities outside the home on the previous weekend alone.

Results

Data from 1264 adolescents, 10–19 years old, were included. Most were females (60%). Adolescents who had parental permission to cross main roads alone (adjusted OR (aOR) 1.39; 95% CI 1.04 to 1.86) and who participated in one or more activities outside the home alone on the previous weekend (aOR 2.61; 95% CI 1.42 to 5.13) or participated in a mixture of activities with and without adult accompaniment (aOR 2.50; 95% CI 1.38 to 4.89) had higher odds of RTIs.

Conclusions

Parental permission to cross main roads alone and participation in activity/activities outside the home on the previous weekend alone were two measures of independent mobility associated with higher odds of RTIs among adolescents. The study provides an understanding of the risk posed by adolescents’ independent mobility in road traffic environments.

Prevalence and risk factors associated with chronic kidney disease in Nepal: evidence from a nationally representative population-based cross-sectional study

Por: Poudyal · A. · Karki · K. B. · Shrestha · N. · Aryal · K. K. · Mahato · N. K. · Bista · B. · Ghimire · L. · KC · D. · Gyanwali · P. · Jha · A. K. · Garcia-Larsen · V. · Kuch · U. · Groneberg · D. A. · Sharma · S. K. · Dhimal · M.
Objective

This study aimed to determine population-based prevalence of chronic kidney disease (CKD) and its associated factors in Nepal.

Study design

The study was a nationwide population-based cross-sectional study.

Setting and participants

Cross-sectional survey conducted in a nationally representative sample of 12 109 Nepalese adult from 2016 to 2018 on selected chronic non-communicable diseases was examined. Multistage cluster sampling with a mix of probability proportionate to size and systematic random sampling was used for the selection of individuals aged 20 years and above.

Primary and secondary outcome measures

Primary outcome in this study was population-based prevalence of CKD in Nepal. A participant was considered to have CKD if the urine albumin-to-creatinine ratio was greater than or equal to 30 mg/g and/or estimated glomerular filtration rate is less than 60 mL/min/1.73 m2 at baseline and in follow-up using modification of diet in renal disease study equations. The secondary outcome measure was factors associated with CKD in Nepal. The covariate adjusted association of risk factors and CKD was calculated using multivariable binary logistic regression.

Results

The overall prevalence of CKD in Nepal was 6.0% (95% CI 5.5 to 6.6). Factors independently associated with CKD included older age (adjusted OR (AOR) 2.6, 95% CI 1.9 to 3.6), Dalit caste (AOR 1.6, 95% CI 1.1 to 2.3), hypertension (AOR 2.4, 95% CI 2.0 to 3.0), diabetes mellitus (AOR 3.2, 95% CI 2.5 to 4.1), raised total cholesterol (AOR 1.3, 95% CI 1.0 to 1.6) and increased waist-to-hip ratio (AOR 1.6, 95% CI 1.2 to 2.3).

Conclusion

This nationally representative study shows that the prevalence of CKD in the adult population of Nepal is substantial, and it is independently associated with several cardiometabolic traits. These findings warrant longitudinal studies to identify the causes of CKD in Nepal and effective strategies to prevent it.

Antenatal Doppler screening for fetuses at risk of adverse outcomes: a multicountry cohort study of the prevalence of abnormal resistance index in low-risk pregnant women

Por: Vannevel · V. · Vogel · J. P. · Pattinson · R. C. · Adanu · R. · Charantimath · U. · Goudar · S. S. · Gwako · G. · Kavi · A. · Maya · E. · Osoti · A. · Pujar · Y. · Qureshi · Z. P. · Rulisa · S. · Botha · T. · Oladapo · O. T.
Introduction

Few interventions exist to address the high burden of stillbirths in apparently healthy pregnant women in low- and middle-income countries (LMICs). To establish whether a trial on the impact of routine Doppler screening in a low-risk obstetric population is warranted, we determined the prevalence of abnormal fetal umbilical artery resistance indices among low-risk pregnant women using a low-cost Doppler device in five LMICs.

Methods

We conducted a multicentre, prospective cohort study in Ghana, India, Kenya, Rwanda and South Africa. Trained nurses or midwives performed a single, continuous-wave Doppler screening using the Umbiflow device for low-risk pregnant women (according to local guidelines) between 28 and 34 weeks’ gestation. We assessed the prevalence of abnormal (raised) resistance index (RI), including absent end diastolic flow (AEDF), and compared pregnancy and health service utilisation outcomes between women with abnormal RI versus those with normal RI.

Results

Of 7151 women screened, 495 (6.9%) had an abnormal RI, including 14 (0.2%) with AEDF. Caesarean section (40.8% vs 28.1%), labour induction (20.5% vs 9.0%) and low birth weight (

Conclusion

A single Doppler screening of low-risk pregnant women in LMICs using the Umbiflow device can detect a large number of fetuses at risk of growth restriction and consequent adverse perinatal outcomes. Many perinatal deaths could potentially be averted with appropriate intervention strategies.

Trial registration number

CTRI/2018/07/01486.

Effectiveness and safety of bee venom pharmacopuncture for rheumatoid arthritis: a systematic review protocol

Por: Sung · W.-S. · Kim · J.-H. · Lee · D. H. · Kim · E.-J. · Seo · B.-K. · Hong · S.-U. · Baek · Y.-H. · Lee · K. H. · Kim · J.-H.
Introduction

Rheumatoid arthritis (RA) is the common autoimmune disease with low quality of life. The representative treatment is medication and medication usage has improved through update of clinical guidelines, however, there are still limitations. Bee venom (BV) has been reported to have meaningful therapeutic effects and the possibility of alternative options for RA through several types of studies, but there is no well-organised and recent published systematic review (SR).

Methods

We will search randomised controlled trials about the BV on RA from the inception to 31 May 2022 in various databases, manual research and contacting authors. Electronic databases will include MEDLINE, EMBASE, Cochrane library, China National Knowledge Infrastructure, CiNii, J-STAGE, KoreaMed, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, Korea Institute of Science and Technology Information and Oriental Medicine Advanced Searching Integrated System. With screening and reviewing process, we will identify the eligible studies and extract the needed data. The primary outcome will be the disease activity scores indicating the improvement of RA symptoms (American College of Rheumatology response criteria 20, 50, 70), functions (Health Assessment Questionnaire, Disease Activity Score of 28 joints), joint (Western Ontario and McMaster universities osteoarthritis index), pain (Visual Analogue Scale, Numerical Rating Scale) and effective rate. The secondary outcomes will be the RA-related blood test levels and adverse events. We will perform a meta-analysis by Review Manager software, the assessment of risk of bias by Cochrane Collaboration ‘risk of bias’ and the determination of quality of evidence by Grades of Recommendation, Assessment, Development and Evaluation.

Ethics and dissemination

Our SR will suggest the clinical evidence of the use of BV for RA to patient, clinicians and policymakers. We will publish our results in a peer-review journal.

PROSPERO registration number

CRD42021238058.

Histopathological profile of cervical biopsies in northern Malawi: a retrospective cross-sectional study

Por: Kaseka · P. U. · Kayira · A. · Chimbatata · C. S. · Chisale · M. R. O. · Kamudumuli · P. · Wu · T.-S. J. · Mbakaya · B. C. · Sinyiza · F. W.
Objectives

According to the WHO (2014), cervical cancer is the second most common cancer in women globally. More than 85% of the global cervical cancer morbidity and mortality occur in low-income and middle-income countries and the highest risk region is in Eastern and Southern Africa. Malawi has the highest age-standardised rate of cervical cancer in the world. This study was carried out to determine the histopathological profile of cervical biopsies in a public tertiary hospital in Mzuzu, northern region of Malawi.

Setting

A public tertiary hospital in Mzuzu, northern region of Malawi.

Participants

This was a retrospective study of all cervical biopsy specimen reports received in a public tertiary hospital in northern Malawi over a period of 5 years from July 2013 to June 2018. Demographic, clinical and diagnostic data were obtained from original histopathology reports.

Results

A total of 500 cervical biopsy reports were reviewed during the study period. The mean age of the patients was 41.99±12.5. Age ranged from 15 to 80 years. Cervicitis accounted for 46.0% (n=162) of the total non-malignant lesions seen, followed by cervical intraepithelial neoplasm, at 24.4% (n=86) and endocervical polyp, at 20.5% (n=72). Squamous cell carcinoma (SCC) accounted for 15.6% (n=78) of the total cervical biopsies studied and 85.7% of all total malignant lesions. Adenocarcinoma and undifferentiated carcinoma were 8.8% and 4.4%, respectively of the total malignant diagnosis. All patients with malignant lesions had HIV.

Conclusion

Our study shows that cervicitis and SCC were most common among non-malignant and malignant cervical biopsies, respectively. Since the frequency of cervical cancer is high, there is a need to have well detailed national policies to be put in place to increase detection of preinvasive lesions in order to reduce the prevalence of cervical cancer.

Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP)

Por: Ekqvist · D. · Bornefall · A. · Augustinsson · D. · Sönnerbrandt · M. · Nordvall · M. J. · Fredrikson · M. · Carlsson · B. · Sandstedt · M. · Simonsson · U. S. H. · Alffenaar · J.-W. C. · Paues · J. · Niward · K.
Introduction

Increased dosing of rifampicin and pyrazinamide seems a viable strategy to shorten treatment and prevent relapse of drug-susceptible tuberculosis (TB), but safety and efficacy remains to be confirmed. This clinical trial aims to explore safety and pharmacokinetics-pharmacodynamics of a high-dose pyrazinamide-rifampicin regimen.

Methods and analysis

Adult patients with pulmonary TB admitted to six hospitals in Sweden and subjected to receive first-line treatment are included. Patients are randomised (1:3) to either 6-month standardised TB treatment or a 4-month regimen based on high-dose pyrazinamide (40 mg/kg) and rifampicin (35 mg/kg) along with standard doses of isoniazid and ethambutol. Plasma samples for measurement of drug exposure determined by liquid chromatography tandem-mass spectrometry are obtained at 0, 1, 2, 4, 6, 8, 12 and 24 hours, at day 1 and 14. Maximal drug concentration (Cmax) and area under the concentration-time curve (AUC0-24h) are estimated by non-compartmental analysis. Conditions for early model-informed precision dosing of high-dose pyrazinamide-rifampicin are pharmacometrically explored. Adverse drug effects are monitored throughout the study and graded according to Common Terminology Criteria for Adverse Events V.5.0. Early bactericidal activity is assessed by time to positivity in BACTEC MGIT 960 of induced sputum collected at day 0, 5, 8, 15 and week 8. Minimum inhibitory concentrations of first-line drugs are determined using broth microdilution. Disease severity is assessed with X-ray grading and a validated clinical scoring tool (TBscore II). Clinical outcome is registered according to WHO definitions (2020) in addition to occurrence of relapse after end of treatment. Primary endpoint is pyrazinamide AUC0-24h and main secondary endpoint is safety.

Ethics and dissemination

The study is approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency. Informed written consent is collected before study enrolment. The study results will be submitted to a peer-reviewed journal.

Trial registration number

NCT04694586.

Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRE

Por: Morgano · G. P. · Mbuagbaw · L. · Santesso · N. · Xie · F. · Brozek · J. L. · Siebert · U. · Bognanni · A. · Wiercioch · W. · Piggott · T. · Darzi · A. J. · Akl · E. A. · Verstijnen · I. M. · Parmelli · E. · Saz-Parkinson · Z. · Alonso-Coello · P. · Schünemann · H. J.
Introduction

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable and undesirable people-important health outcomes. However, decision thresholds (DTs) that could help understand the magnitude of intervention effects and serve as reference for interpretation of findings are not yet available.

The objective of this study is an approach to derive and use DTs for EtD judgments about the magnitude of health benefits and harms. We hypothesise that approximate DTs could have the ability to discriminate between the existing four categories of EtD judgments (Trivial, Small, Moderate, Large), support panels of decision-makers in their work, and promote consistency and transparency in judgments.

Methods and analysis

We will conduct a methodological randomised controlled trial to collect the data that allow deriving the DTs. We will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, we will investigate the validity of our DTs by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that our DTs approach would suggest if applied on the same guideline data.

Ethics and dissemination

The Hamilton Integrated Research Ethics Board reviewed this study as a quality improvement study and determined that it requires no further consent. Survey participants will be required to read a consent statement in order to participate in this study at the beginning of the trial. This statement reads: You are being invited to participate in a research project which aims to identify indicative DTs that could assist users of the GRADE EtD frameworks in making judgments. Your input will be used in determining these indicative thresholds. By completing this survey, you provide consent that the anonymised data collected will be used for the research study and to be summarised in aggregate in publication and electronic tools.

PROTOCOL registration number

NCT05237635.

Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial - surgery as first-line treatment

Por: Christensen · T. D. · Bendixen · M. · Skaarup · S. H. · Jensen · J.-U. · Petersen · R. H. · Christensen · M. · Licht · P. · Neckelmann · K. · Bibby · B. M. · Moller · L. B. · Bodtger · U. · Borg · M. H. · Saghir · Z. · Langfeldt · S. · Harders · S. M. W. · Bedawi · E. O. · Naidu · B. · R
Introduction

Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment.

Methods and analysis

A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life.

Ethics and dissemination

All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www.clinicaltrials.gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences.

Trial registration number

NCT04095676.

Scoping review: bladder cancer in Nigeria - what are the gaps in clinical care and research?

Por: Iya · A. M. · Beyer · K. · Kotecha · P. · Kibaru · J. · Abdullahi · M. · Alhassan · S. U. · Mustapha · M. I. · Ahmad · A. · Lawal · Y. · Rabiu Ibrahim · J. · Aminu · A. · Abubakar · A. · Saleh · A. · Bryan · R. T. · Van Hemelrijck · M. · Russell · B.
Objectives

There are currently no national guidelines regarding bladder cancer treatment and clinical care pathways in Nigeria. The aim of this scoping review was to identify any gaps in the knowledge of epidemiology, clinical care and translational research in order to aid the development of a defined clinical care pathway and guide future research.

Methods

A scoping review was conducted by searching Medline, Ovid Gateway, The Cochrane library and Open Grey literature using predefined search terms from date of inception to June 2020. Studies were included if they discussed the epidemiology or treatment pathway of bladder cancer. All data were charted and were analysed in a descriptive manner. A consultation phase was also conducted consisting of a multidisciplinary team of clinicians and bladder cancer survivors.

Results

A total of 19 studies were deemed suitable for inclusion. The themes included the epidemiology of bladder cancer (high prevalence of schistosomiasis), research surrounding the biology of the disease and translational research including potential biomarkers. The consultation phase highlighted some possible sociocultural and infrastructural issues relating to both the diagnosis and treatment of bladder cancer, with poor knowledge of bladder cancer and its symptoms within the general population identified as a key issue.

Conclusion

Even though the factors surrounding the relationship between schistosomiasis and the histopathology of bladder cancer remain unclear, there is potential for screening for schistosomiasis in endemic regions of sub-Saharan Africa. Other key areas for future research include the dissemination of information to the general population surrounding bladder cancer and its symptoms to encourage prompt diagnosis.

Urban scaling of opioid overdose deaths in the USA: a cross-sectional study in three periods between 2005 and 2017

Por: Mullachery · P. H. · Lankenau · S. · Diez Roux · A. V. · Li · R. · Henson · R. M. · Bilal · U.
Objectives

To describe the association between population size, population growth and opioid overdose deaths—overall and by type of opioid—in US commuting zones (CZs) in three periods between 2005 and 2017.

Settings

741 CZs covering the entirety of the US CZs are aggregations of counties based on commuting patterns that reflect local economies.

Participants

We used mortality data at the county level from 2005 to 2017 from the National Center for Health Statistics.

Outcome

Opioid overdose deaths were defined using underlying and contributory causes of death codes from the International Classification of Diseases, 10th revision (ICD-10). We used the underlying cause of death to identify all drug poisoning deaths. Contributory cause of death was used to classify opioid overdose deaths according to the three major types of opioid, that is, prescription opioids, heroin and synthetic opioids other than methadone.

Results

Opioid overdose deaths were disproportionally higher in largely populated CZs. A CZ with 1.0% larger population had 1.10%, 1.10%, and 1.16% higher opioid death count in 2005–2009, 2010–2014, and 2015–2017, respectively. This pattern was largely driven by a high number of deaths involving heroin and synthetic opioids, particularly in 2015–2017. Population growth over time was associated with lower age-adjusted opioid overdose mortality rate: a 1.0% increase in population over time was associated with 1.4% (95% CI: –2.8% to 0.1%), 4.5% (95% CI: –5.8% to –3.2%), and 1.2% (95% CI: –4.2% to 1.8%) lower opioid overdose mortality in 2005–2009, 2010–2014, and 2015–2017, respectively. The association between positive population growth and lower opioid mortality rates was stronger in larger CZs.

Conclusions

Opioid overdose mortality in the USA was disproportionately higher in mid-sized and large CZs, particularly those affected by declines in population over time, regardless of the region where they are located.

Impact of virtual care on health-related quality of life in children with diabetes mellitus: a systematic review protocol

Por: Rajan · R. · Kshatriya · M. · Banfield · L. · Athale · U. · Thabane · L. · Samaan · M. C.
Introduction

Diabetes mellitus is the most common endocrine disorder in children, and the prevalence of paediatric type 1 and type 2 diabetes continue to rise globally. Diabetes clinical care programs pivoted to virtual care with the COVID-19 pandemic-driven social distancing measures. Yet, the impact of virtual care on health-related quality of life in children living with diabetes remains unclear. This protocol reports on the methods that will be implemented to conduct a systematic review to assess the health-related quality of life and metabolic health impacts of virtual diabetes care.

Methods and analysis

We will search MEDLINE, Embase, EMCare, PsycInfo, Web of Science, and the grey literature for eligible studies. We will screen title, abstract, and full-text papers for potential inclusion and assess the risk of bias and the overall confidence in the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. A meta-analysis will be conducted if two studies report similar populations, study designs, methods, and outcomes.

This systematic review will summarise the health-related quality of life outcomes for virtual diabetes care delivery models.

Ethics and dissemination

No ethics approval is required for this systematic review protocol as it does not include patient data. The systematic review will be published in a peer-reviewed journal and presented at international conferences.

PROSPERO registration number

CRD42021235646.

Identifying forms of interventions towards cross border malaria in the Asia-Pacific region: a scoping review protocol

Por: Cintyamena · U. · Murhandarwati · E. E. H. · Elyazar · I. · Probandari · A. · Ahmad · R. A.
Introduction

An ambitious epidemiology strategy has been set by the WHO, targeting malaria elimination for at least 35 countries in 2030. Challenges in preventing malaria cross borders require greater attention to achieve the elimination target. This scoping review aims to identify successful forms of interventions to control malaria transmission across national borders in the Asia-Pacific region.

Methods and analysis

This scoping review will search four electronic databases (PubMed, ScienceDirect, EBSCOhost and ProQuest) limiting the time of publication to the last 10 years. Two independent reviewers will screen all titles and abstracts during the second stage. Study characteristics will be recorded; qualitative data will be extracted and evaluated, while quantitative data will be extracted and summarised. Overall, we will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This scoping review has received ethical approval from the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada. The results will be disseminated through peer-reviewed publications, conference presentations and policy briefs.

Hospital bed occupancy rate is an independent risk factor for COVID-19 inpatient mortality: a pandemic epicentre cohort study

Por: Castagna · F. · Xue · X. · Saeed · O. · Kataria · R. · Puius · Y. A. · Patel · S. R. · Garcia · M. J. · Racine · A. D. · Sims · D. B. · Jorde · U. P.
Introduction

COVID-19 first struck New York City in the spring of 2020, resulting in an unprecedented strain on our healthcare system and triggering multiple changes in public health policy governing hospital operations as well as therapeutic approaches to COVID-19. We examined inpatient mortality at our centre throughout the course of the pandemic.

Methods

This is a retrospective chart review of clinical characteristics, treatments and outcome data of all patients admitted with COVID-19 from 1 March 2020 to 28 February 2021. Patients were grouped into 3-month quartiles. Hospital strain was assessed as per cent of occupied beds based on a normal bed capacity of 1491.

Results

Inpatient mortality decreased from 25.0% in spring to 10.8% over the course of the year. During this time, use of remdesivir, steroids and anticoagulants increased; use of hydroxychloroquine and other antibiotics decreased. Daily bed occupancy ranged from 62% to 118%. In a multivariate model with all year’s data controlling for demographics, comorbidities and acuity of illness, percentage of bed occupancy was associated with increased 30-day in-hospital mortality of patients with COVID-19 (0.7% mortality increase for each 1% increase in bed occupancy; HR 1.007, CI 1.001 to 1.013, p=0.004)

Conclusion

Inpatient mortality from COVID-19 was associated with bed occupancy. Early reduction in epicentre hospital bed occupancy to accommodate acutely ill and resource-intensive patients should be a critical component in the strategic planning for future pandemics.

The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design

Por: Fritsche · L. · Hummel · J. · Wagner · R. · Löffler · D. · Hartkopf · J. · Machann · J. · Hilberath · J. · Kantartzis · K. · Jakubowski · P. · Pauluschke-Fröhlich · J. · Brucker · S. · Hörber · S. · Häring · H.-U. · Roden · M. · Schürmann · A. · Solimena · M. · de Angelis · M.
Introduction

Even well-treated gestational diabetes mellitus (GDM) might still have impact on long-term health of the mother and her offspring, although this relationship has not yet been conclusively studied. Using in-depth phenotyping of the mother and her offspring, we aim to elucidate the relationship of maternal hyperglycaemia during pregnancy and adequate treatment, and its impact on the long-term health of both mother and child.

Methods

The multicentre PREG study, a prospective cohort study, is designed to metabolically and phenotypically characterise women with a 75-g five-point oral glucose tolerance test (OGTT) during, and repeatedly after pregnancy. Outcome measures are maternal glycaemia during OGTTs, birth outcome and the health and growth development of the offspring. The children of the study participants are followed up until adulthood with developmental tests and metabolic and epigenetic phenotyping in the PREG Offspring study. A total of 800 women (600 with GDM, 200 controls) will be recruited.

Ethics and dissemination

The study protocol has been approved by all local ethics committees. Results will be disseminated via conference presentations and peer-reviewed publications.

Trial registration number

The PREG study and the PREG Offspring study are registered with Clinical Trials (ClinicalTrials.gov identifiers: NCT04270578, NCT04722900).

Association of occupational sitting with cardiovascular outcomes and cardiometabolic risk factors: a systematic review with a sex-sensitive/gender-sensitive perspective

Por: Reichel · K. · Prigge · M. · Latza · U. · Kurth · T. · Backe · E.-M.
Objectives

Sedentary behaviour is a modifiable risk factor for cardiovascular health. Although long periods of sedentary behaviour take place at work, evidence of the relationship between such occupational sitting and cardiometabolic health risks remains limited. This systematic review aimed to update the evidence on the associations of occupational sitting with cardiovascular outcomes and cardiometabolic risk factors based on longitudinal studies.

Design

Systematic review.

Setting

Workplace.

Population

Employees aged 18–65 years.

Primary and secondary outcomes

Primary outcomes were cardiovascular diseases and cardiometabolic risk markers. The secondary outcome was all-cause mortality.

Data sources

Ten databases, including PubMed, Web of Science and CINAHL (search January 2018, updated February 2019).

Data extraction and synthesis

Data were screened, extracted and appraised by three independent reviewers following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Results

Studies were markedly heterogeneous in terms of measurement of occupational sitting, cardiometabolic risk factors and cardiovascular morbidity and mortality, so that standards were hardly identifiable and limiting the value of the evidence. The review included 27 high or acceptable quality publications. Of the eight high-quality publications from seven cohorts, three cohort studies found significant associations of occupational sitting with primary outcomes. Additionally, one study described an association with the secondary outcome. Another high-quality publication found an association between occupational sitting and ischaemic heart disease in a subgroup already at risk due to hypertension. For sex/gender analysis, 11 of the 27 high and acceptable quality publications reported sex-stratified results. Five of these found sex differences.

Conclusions

Evidence regarding the association of occupational sitting with cardiometabolic health risks was limited because of the lack of standardised measurements for occupational sitting. Occupational sitting combined with an overall sedentary lifestyle was associated with an elevated relative risk for several cardiometabolic outcomes. There is an urgent need for standardised measurements of occupational sitting to facilitate meta-analysis. Sex/gender aspects of this relationship require further investigation.

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