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International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study

Por: Aardoom · M. A. · Kemos · P. · Tindemans · I. · Aloi · M. · Koletzko · S. · Levine · A. · Turner · D. · Veereman · G. · Neyt · M. · Russell · R. K. · Walters · T. D. · Ruemmele · F. M. · Samsom · J. N. · Croft · N. M. · de Ridder · L. · PIBD-SETQuality consortium and PIBD-NET
Introduction

Patients with paediatric-onset inflammatory bowel disease (PIBD) may develop a complicated disease course, including growth failure, bowel resection at young age and treatment-related adverse events, all of which can have significant and lasting effects on the patient’s development and quality of life. Unfortunately, we are still not able to fully explain the heterogeneity between patients and their disease course and predict which patients will respond to certain therapies or are most at risk of developing a more complicated disease course. To investigate this, large prospective studies with long-term follow-up are needed. Currently, no such European or Asian international cohorts exist. In this international cohort, we aim to evaluate disease course and which patients are most at risk of therapy non-response or development of complicated disease based on patient and disease characteristics, immune pathology and environmental and socioeconomic factors.

Methods and analysis

In this international prospective observational study, which is part of the PIBD Network for Safety, Efficacy, Treatment and Quality improvement of care (PIBD-SETQuality), children diagnosed with inflammatory bowel disease

Ethics and dissemination

Medical ethical approval has been obtained prior to patient recruitment for all sites. The results will be disseminated through peer-reviewed scientific publications.

Trial registration number

NCT03571373.

Using liquid chromatography mass spectrometry (LC-MS) to assess the effect of age, high-fat diet, and rat strain on the liver metabolome

by Greg Boyce, Mohammad Shoeb, Vamsi Kodali, Terence Meighan, Jenny R. Roberts, Aaron Erdely, Michael Kashon, James M. Antonini

The goal of this study was to use liquid chromatography mass spectrometry to assess metabolic changes of two different diets in three distinct rat strains. Sprague-Dawley, Fischer 344, and Brown-Norway male rats were maintained on a high-fat, or regular diet for 24 weeks. Liver tissue was collected at 4, 12, and 24 weeks to assess global small molecule metabolite changes using high resolution accurate mass spectrometry coupled to ultra-high-performance liquid chromatography. The results of the global metabolomics analysis revealed significant changes based on both age and diet within all three strains. Principal component analysis revealed that the influence of diet caused a greater variation in significantly changing metabolites than that of age for the Brown Norway and Fisher 344 strains, whereas diet had the greatest influence in the Sprague Dawley strain only at the 4-week time point. As expected, metabolites involved in lipid metabolism were changed in the animals maintained on a high fat diet compared to the regular diet. There were also significant changes observed in the concentration of Tri carboxylic acid cycle intermediates that were extracted from the liver of all three strains based on diet. The results of this study showed that a high fat diet caused significant liver and metabolic changes compared to a regular diet in multiple rat strains. The inbred Fisher 344 and Brown Norway rats were more metabolically sensitive to the diet changes than outbred Sprague Dawley strain. The study also showed that age, as was the case for Sprague Dawley, is an important variable to consider when assessing metabolic changes.

Prevalence, Severity and Mortality associated with COPD and Smoking in patients with COVID-19: A Rapid Systematic Review and Meta-Analysis

by Jaber S. Alqahtani, Tope Oyelade, Abdulelah M. Aldhahir, Saeed M. Alghamdi, Mater Almehmadi, Abdullah S. Alqahtani, Shumonta Quaderi, Swapna Mandal, John R. Hurst

Background

Coronavirus disease 2019 (COVID-19) is an evolving infectious disease that dramatically spread all over the world in the early part of 2020. No studies have yet summarized the potential severity and mortality risks caused by COVID-19 in patients with chronic obstructive pulmonary disease (COPD), and we update information in smokers.

Methods

We systematically searched electronic databases from inception to March 24, 2020. Data were extracted by two independent authors in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Study quality was assessed using a modified version of the Newcastle-Ottawa Scale. We synthesized a narrative from eligible studies and conducted a meta-analysis using a random-effects model to calculate pooled prevalence rates and 95% confidence intervals (95%CI).

Results

In total, 123 abstracts were screened and 61 full-text manuscripts were reviewed. A total of 15 studies met the inclusion criteria, which included a total of 2473 confirmed COVID-19 patients. All studies were included in the meta-analysis. The crude case fatality rate of COVID-19 was 7.4%. The pooled prevalence rates of COPD patients and smokers in COVID-19 cases were 2% (95% CI, 1%–3%) and 9% (95% CI, 4%–14%) respectively. COPD patients were at a higher risk of more severe disease (risk of severity = 63%, (22/35) compared to patients without COPD 33.4% (409/1224) [calculated RR, 1.88 (95% CI, 1.4–2.4)]. This was associated with higher mortality (60%). Our results showed that 22% (31/139) of current smokers and 46% (13/28) of ex-smokers had severe complications. The calculated RR showed that current smokers were 1.45 times more likely [95% CI: 1.03–2.04] to have severe complications compared to former and never smokers. Current smokers also had a higher mortality rate of 38.5%.

Conclusion

Although COPD prevalence in COVID-19 cases was low in current reports, COVID-19 infection was associated with substantial severity and mortality rates in COPD. Compared to former and never smokers, current smokers were at greater risk of severe complications and higher mortality rate. Effective preventive measures are required to reduce COVID-19 risk in COPD patients and current smokers.

Validation of a simplified score for predicting latent rheumatic heart disease progression using a prospective cohort of Brazilian schoolchildren

Por: Bechtlufft · B. M. · Nascimento · B. R. · Sable · C. · Fraga · C. L. · Barbosa · M. M. · Reis · S. D. · Diamantino · A. C. · Meira · Z. M. A. · Castilho · S. R. T. · Arantes · N. F. · Oliveira · K. K. · Silva · J. L. P. · Rezende · B. D. F. · Costa · W. A. A. · Mata · M. D. · Pereira
Objectives

Echocardiographic (echo) screening is an important tool to estimate rheumatic heart disease (RHD) prevalence, but the natural history of screen-detected RHD remains unclear. The PROVAR+ (Programa de RastreamentO da VAlvopatia Reumática) study, which uses non-experts, telemedicine and portable echo, pioneered RHD screening in Brazil. We aimed to assess the mid-term evolution of Brazilian schoolchildren (5–18 years) with echocardiography-detected subclinical RHD and to assess the performance of a simplified score consisting of five components of the World Heart Federation criteria, as a predictor of unfavourable echo outcomes.

Setting

Public schools of underserved areas and private schools in Minas Gerais, southeast Brazil.

Participants

A total of 197 patients (170 borderline and 27 definite RHD) with follow-up of 29±9 months were included. Median age was 14 (12–16) years, and 130 (66%) were woman. Only four patients in the definite group were regularly receiving penicillin.

Primary and secondary outcome measures

Unfavourable outcome was based on the 2-year follow-up echo, defined as worsening diagnostic category, remaining with mild definite RHD or development/worsening of valve regurgitation/stenosis.

Results

Among patients with borderline RHD, 29 (17.1%) progressed to definite, 49 (28.8%) remained stable, 86 (50.6%) regressed to normal and 6 (3.5%) were reclassified as other heart diseases. Among those with definite RHD, 13 (48.1%) remained in the category, while 5 (18.5%) regressed to borderline, 5 (18.5%) regressed to normal and 4 (14.8%) were reclassified as other heart diseases. The simplified echo score was a significant predictor of RHD unfavourable outcome (HR 1.197, 95% CI 1.098 to 1.305, p

Conclusion

The simple risk score provided an accurate prediction of RHD status at 2-year follow-up, showing a good performance in Brazilian schoolchildren, with a potential value for risk stratification and monitoring of echocardiography-detected RHD.

Cross-sectional centiles of blood pressure by age and sex: a four-hospital database retrospective observational analysis

Por: Wong · D. · Gerry · S. · Shamout · F. · Clifton · D. A. · Pimentel · M. A. F. · Watkinson · P. J.
Objectives

National guidelines for identifying physiological deterioration and sepsis in hospitals depend on thresholds for blood pressure that do not account for age or sex. In populations outside hospital, differences in blood pressure are known to occur with both variables. Whether these differences remain in the hospitalised population is unknown. This database analysis study aims to generate representative centiles to quantify variations in blood pressure by age and sex in hospitalised patients.

Design

Retrospective cross-sectional observational database analysis.

Setting

Four near-sea-level hospitals between April 2015 and April 2017

Participants

75 342 adult patients who were admitted to the hospitals and had at least one set of documented vital sign observations within 24 hours before discharge were eligible for inclusion. Patients were excluded if they died in hospital, had no vital signs 24 hours prior to discharge, were readmitted within 7 days of discharge, had missing age or sex or had no blood pressure recorded.

Results

Systolic blood pressure (SBP) for hospitalised patients increases with age for both sexes. Median SBP increases from 122 (CI: 121.1 to 122.1) mm Hg to 132 (CI: 130.9 to 132.2) mm Hg in men, and 114 (CI: 113.1 to 114.4) mm Hg to 135 (CI: 134.5 to 136.2) mm Hg in women, between the ages of 20 and 90 years. Diastolic blood pressure peaked around 50 years for men 76 (CI: 75.5 to 75.9) mm Hg and women 69 (CI: 69.0 to 69.4) mm Hg. The blood pressure criterion for sepsis, systolic

Conclusion

We have quantified variations in blood pressure by age and sex in hospitalised patients that have implications for recognition of deterioration. Nearly 10% of younger women met the blood pressure criterion for sepsis at hospital discharge.

Association between multiple symptoms and quality of life of paediatric patients with cancer in Brazil: a cross-sectional study

Objectives

To identify the association of multiple symptoms and clinical characteristics on quality of life (QoL) of paediatric patients with cancer.

Design

A descriptive, cross-sectional study.

Setting

South American Children’s Hospital for Cancer Treatment (Barretos, São Paulo, Brazil).

Participants

A total of 157 participants, 116 paediatric patients, diagnosed with cancer, undergoing chemotherapy treatment, between 7 and 18 years of age and 41 proxies for patients between 2 and 6 years of age.

Primary outcome measures

The severity and prevalence ofsymptoms were identified through the use of a culturally adapted multi-symptomscreening tool, and the influence these symptoms, in association with clinicalcharacteristics, had on the QOL of Brazilian pediatric cancer patients wasassessed.

Results

Prevalent symptoms identified by all participants were ‘feeling tired’ (98, 62.4%), ‘feeling more or less hungry (do not feel like eating) than you usually do’ (96, 61.1%), ‘changes in taste (flavour of the food)’ (89, 56.7%), ‘throwing up or feeling like you may throw up’ (77, 49%) and ‘changes in how your body (visually) or face looks’ (72, 45.9%). The multivariate analysis for symptom severity as reported by proxies showed that surgery (OR 0.20, 95% CI 0.04 to 0.98, p=0.047) and time of diagnosis (OR 0.14, 95% CI 0.03 to 0.66, p=0.012) were associated with a decreased OR of high severity symptoms.

An analysis of the clinical characteristics associated with Pediatric Quality of Life Inventory (PedsQL) demonstrated no significant effect on QoL in any of the domains evaluated. The association between Symptom Screening in Pediatrics Tool and PedsQL in the self-report version demonstrated a significant negative influence of all symptoms on the QoL.

Conclusions

The prevalence of symptoms experienced among pediatric patients during treatment was high and significantly influenced all aspects of quality of life,especially in the emotional domain.

Prevalence of secondary care multimorbidity in mid-life and its association with premature mortality in a large longitudinal cohort study

Por: Johnston · M. C. · Black · C. · Mercer · S. W. · Prescott · G. J. · Crilly · M. A.
Objectives

Multimorbidity is the coexistence of two or more health conditions in an individual. Multimorbidity in younger adults is increasingly recognised as an important challenge. We assessed the prevalence of secondary care multimorbidity in mid-life and its association with premature mortality over 15 years of follow-up, in the Aberdeen Children of the 1950s (ACONF) cohort.

Method

A prospective cohort study using linked electronic health and mortality records. Scottish ACONF participants were linked to their Scottish Morbidity Record hospital episode data and mortality records. Multimorbidity was defined as two or more conditions and was assessed using healthcare records in 2001 when the participants were aged between 45 and 51 years. The association between multimorbidity and mortality over 15 years of follow-up (to ages 60–66 years) was assessed using Cox proportional hazards regression. There was also adjustment for key covariates: age, gender, social class at birth, intelligence at age 7, secondary school type, educational attainment, alcohol, smoking, body mass index and adult social class.

Results

Of 9625 participants (51% males), 3% had multimorbidity. The death rate per 1000 person-years was 28.4 (95% CI 23.2 to 34.8) in those with multimorbidity and 5.7 (95% CI 5.3 to 6.1) in those without. In relation to the reference group of those with no multimorbidity, those with multimorbidity had a mortality HR of 4.5 (95% CI 3.4 to 6.0) over 15 years and this association remained when fully adjusted for the covariates (HR 2.5 (95% CI 1.5 to 4.0)).

Conclusion

Multimorbidity prevalence was 3% in mid-life when measured using secondary care administrative data. Multimorbidity in mid-life was associated with premature mortality.

Antibiotic use for Australian Aboriginal children in three remote Northern Territory communities

by Timothy Howarth, Raelene Brunette, Tanya Davies, Ross M. Andrews, Bhavini K. Patel, Steven Tong, Federica Barzi, Therese M. Kearns

Objective

To describe antibiotic prescription rates for Australian Aboriginal children aged Design

A retrospective cohort study using electronic health records.

Setting

Three primary health care centres located in the Katherine East region.

Participants

Consent was obtained from 149 mothers to extract data from 196 child records. There were 124 children born between January 2010 and July 2014 who resided in one of the three chosen communities and had electronic health records for their first two years of life.

Main outcome measures

Antibiotic prescription rates, factors associated with antibiotic prescription and factors associated with appropriate antibiotic prescription.

Results

There were 5,675 Primary Health Care (PHC) encounters for 124 children (median 41, IQR 25.5, 64). Of the 5,675 PHC encounters, 1,542 (27%) recorded at least one infection (total 1,777) and 1,330 (23%) had at least one antibiotic prescription recorded (total 1,468). Children had a median five (IQR 2, 9) prescriptions in both their first and second year of life, with a prescription rate of 5.99/person year (95% CI 5.35, 6.63). Acute otitis media was the most common infection (683 records, 38%) and Amoxycillin was the most commonly prescribed antibiotic (797 prescriptions, 54%). Of the 1,468 recorded prescriptions, 398 (27%) had no infection recorded and 116 (8%) with an infection recorded were not aligned with local treatment guidelines.

Conclusion

Prescription rates for Australian Aboriginal children in these communities are significantly higher than that reported nationally for non-Aboriginal Australians. Prescriptions predominantly aligned with treatment guidelines in this setting where there is a high burden of infectious disease.

Knowledge mobilisation in bridging community-practice-academia-policy through meaningful engagement: systematic integrative review protocol focusing on studies conducted on health and wellness among immigrant communities

Por: Turin · T. C. · Chowdhury · N. · Vaska · M. · Rumana · N. · Lasker · M. A. A. · Chowdhury · M. Z. I.
Introduction

Though the importance of knowledge mobilisation has been established globally in health and wellness research, a certain degree of ambiguity remains regarding the meaning and extent of knowledge mobilisation activities and how they have been implemented. In this study, we aim to explore the different descriptions of knowledge mobilisation and the diverse ways mobilisation activities have been realised by different researchers working for the betterment of health and wellness of immigrant communities in their host countries.

Methods and analysis

We aimed to conduct an integrative review to organise the available literature describing knowledge mobilisation pertaining to health and wellness in immigrant communities. We will employ a comprehensive search, using appropriate search-terms, to identify relevant literature and will qualitatively synthesise the information toward fulfilling our objectives. Specific methodological and analytical frameworks related to the integrative review process will guide each step of the process. A librarian designed the systematic search of the academic and grey literature from database inception to December 2019. The databases include MEDLINE (Ovid), Embase, PsycINFO, PubMed, CINAHL and SocINDEX. For grey literature, we will conduct searches in AHS Insite, Google, Google Scholar, OAISter and government websites. A two-stage (title–abstract and full-text) screening will be conducted, including single-citation tracking and hand search of reference lists.

Ethics and dissemination

Ethical approval is not required for this review. We first plan to disseminate the results of our systematic review protocol through meetings with key stakeholders, followed by appropriate publications and presentations at applicable platforms. We also have opted for an integrated knowledge translation or community-engaged knowledge mobilisation approach where we have engaged with community-based citizen researchers from the inception of our research.

Adherence to oral anticoagulants among patients with atrial fibrillation: a systematic review and meta-analysis of observational studies

Por: Salmasi · S. · Loewen · P. S. · Tandun · R. · Andrade · J. G. · De Vera · M. A.
Introduction

Medications cannot exert their effect if not taken as prescribed by patients. Our objective was to summarise the observational evidence on adherence to oral anticoagulants (OACs) among patients with atrial fibrillation (AF).

Methods

In March 2019, we systematically searched PubMed/Medline, Embase, CINAHL and PsycINFO (from inception) for observational studies measuring adherence, its determinants and impacts in patients with AF. Mean adherence measures and corresponding proportions of adherent patients were pooled using random effects models. Factors shown to be independently associated with adherence were extracted as well as the clinical and economic outcomes of adherence.

Results

We included 30 studies. Pooled mean adherence scores of over half a million patients with AF 6 months and 1 year after therapy initiation were 77 (95% CI: 74–79) and 74 (68–79) out of 100, respectively. Drug-specific pooled mean adherence score at 6 months and 1 year were as follows: rivaroxaban: 78 (73–84) and 77 (69–86); apixaban: 77 (75–79) and 82 (74–89); dabigatran: 74 (69–79) and 75 (68–82), respectively. There was inadequate information on warfarin for inclusion in meta-analysis.

Factors associated with increased adherence included: older age, higher stroke risk, once-daily regimen, history of hypertension, diabetes or stroke, concomitant cardiovascular medications, living in rural areas and being an experienced OAC user. Non-adherent patients were more likely to experience stroke and death, and incurred higher medical costs compared with patients with poor adherence.

Conclusions

Our findings show that up to 30% of patients with AF are non-adherent, suggesting an important therapeutic challenge in this patient population.

Developing a multivariable prediction model for functional outcome after reperfusion therapy for acute ischaemic stroke: study protocol for the Targeting Optimal Thrombolysis Outcomes (TOTO) multicentre cohort study

Por: Holliday · E. · Lillicrap · T. · Kleinig · T. · Choi · P. M. C. · Maguire · J. · Bivard · A. · Lincz · L. F. · Hamilton-Bruce · M. A. · Rao · S. R. · Snel · M. F. · Trim · P. J. · Lin · L. · Parsons · M. W. · Worrall · B. B. · Koblar · S. · Attia · J. · Levi · C.
Introduction

Intravenous thrombolysis (IVT) with recombinant tissue plasminogen activator (rt-PA) is the only approved pharmacological reperfusion therapy for acute ischaemic stroke. Despite population benefit, IVT is not equally effective in all patients, nor is it without significant risk. Uncertain treatment outcome prediction complicates patient treatment selection. This study will develop and validate predictive algorithms for IVT response, using clinical, radiological and blood-based biomarker measures. A secondary objective is to develop predictive algorithms for endovascular thrombectomy (EVT), which has been proven as an effective reperfusion therapy since study inception.

Methods and analysis

The Targeting Optimal Thrombolysis Outcomes Study is a multicenter prospective cohort study of ischaemic stroke patients treated at participating Australian Stroke Centres with IVT and/or EVT. Patients undergo neuroimaging using multimodal CT or MRI at baseline with repeat neuroimaging 24 hours post-treatment. Baseline and follow-up blood samples are provided for research use. The primary outcome is good functional outcome at 90 days poststroke, defined as a modified Rankin Scale (mRS) Score of 0–2. Secondary outcomes are reperfusion, recanalisation, infarct core growth, change in stroke severity, poor functional outcome, excellent functional outcome and ordinal mRS at 90 days. Primary predictive models will be developed and validated in patients treated only with rt-PA. Models will be built using regression methods and include clinical variables, radiological measures from multimodal neuroimaging and blood-based biomarkers measured by mass spectrometry. Predictive accuracy will be quantified using c-statistics and R2. In secondary analyses, models will be developed in patients treated using EVT, with or without prior IVT, reflecting practice changes since original study design.

Ethics and dissemination

Patients, or relatives when patients could not consent, provide written informed consent to participate. This study received approval from the Hunter New England Local Health District Human Research Ethics Committee (reference 14/10/15/4.02). Findings will be disseminated via peer-reviewed publications and conference presentations.

The interplay between mindfulness, depression, stress and academic performance in medical students: A Saudi perspective

by Ahmed M. Alzahrani, Ahmed Hakami, Ahmad AlHadi, Mohammed A. Batais, Abdullah A. Alrasheed, Turky H. Almigbal

There is a growing body of research that shows a significant association between mindfulness and mental health. However, studies on Saudi populations are still in their infancy. Mindfulness is a personal tendency to focus on the present time in a non-judgmental manner, including the interior and exterior experience of feelings and events. The first aim of this study is to examine the relationship between mindfulness, stress, depression, and academic performance in a sample of medical students from King Saud University. The second aim is to explore the potential moderation effects of mindfulness on the impact of stress on academic performance and depression in the study population. This cross-sectional study examined 289 medical students who were selected by a stratified random sampling technique and completed validated online questionnaires measuring mindfulness, stress, and depression. The data were analyzed using SAS version 9.2, and R software was used for graphs. Correlation analysis showed that mindfulness is inversely associated with depression and stress, but not with academic performance. Furthermore, multiple logistic regression showed that mindfulness can predict both depression and stress. We also found that two subscales of mindfulness can moderate the relation between stress and depression: non-judging of inner experience and describing. The findings suggest that a higher mindfulness score is associated with lower depression and stress levels and could buffer against depression in a stressful environment. There is a need for further research to investigate the relation of mindfulness with positive psychological outcomes, as well as experimental trials to examine the efficacy of mindfulness training on improving mental wellbeing in our community.

Associations between symptoms of sleep-disordered breathing and maternal sleep patterns with late stillbirth: Findings from an individual participant data meta-analysis

by Robin S. Cronin, Jessica Wilson, Adrienne Gordon, Minglan Li, Vicki M. Culling, Camille H. Raynes-Greenow, Alexander E. P. Heazell, Tomasina Stacey, Lisa M. Askie, Edwin A. Mitchell, John M. D. Thompson, Lesley M. E. McCowan, Louise M. O’Brien

Background and objectives

Sleep-disordered breathing (SDB) affects up to one third of women during late pregnancy and is associated with adverse pregnancy outcomes, including hypertension, diabetes, impaired fetal growth, and preterm birth. However, it is unclear if SDB is associated with late stillbirth (≥28 weeks’ gestation). The aim of this study was to investigate the relationship between self-reported symptoms of SDB and late stillbirth.

Methods

Data were obtained from five case-control studies (cases 851, controls 2257) from New Zealand (2 studies), Australia, the United Kingdom, and an international study. This was a secondary analysis of an individual participant data meta-analysis that investigated maternal going-to-sleep position and late stillbirth, with a one-stage approach stratified by study and site. Inclusion criteria: singleton, non-anomalous pregnancy, ≥28 weeks’ gestation. Sleep data (‘any’ snoring, habitual snoring ≥3 nights per week, the Berlin Questionnaire [BQ], sleep quality, sleep duration, restless sleep, daytime sleepiness, and daytime naps) were collected by self-report for the month before stillbirth. Multivariable analysis adjusted for known major risk factors for stillbirth, including maternal age, body mass index (BMI kg/m2), ethnicity, parity, education, marital status, pre-existing hypertension and diabetes, smoking, recreational drug use, baby birthweight centile, fetal movement, supine going-to-sleep position, getting up to use the toilet, measures of SDB and maternal sleep patterns significant in univariable analysis (habitual snoring, the BQ, sleep duration, restless sleep, and daytime naps). Registration number: PROSPERO, CRD42017047703.

Results

In the last month, a positive BQ (adjusted odds ratio [aOR] 1.44, 95% confidence interval [CI] 1.02–2.04), sleep duration >9 hours (aOR 1.82, 95% CI 1.14–2.90), daily daytime naps (aOR 1.52, 95% CI 1.02–2.28) and restless sleep greater than average (aOR 0.62, 95% CI 0.44–0.88) were independently related to the odds of late stillbirth. ‘Any’ snoring, habitual snoring, sleep quality, daytime sleepiness, and a positive BQ excluding the BMI criterion, were not associated.

Conclusion

A positive BQ, long sleep duration >9 hours, and daily daytime naps last month were associated with increased odds of late stillbirth, while sleep that is more restless than average was associated with reduced odds. Pregnant women may be reassured that the commonly reported restless sleep of late pregnancy may be physiological and associated with a reduced risk of late stillbirth.

Serum ionised calcium and the risk of acute respiratory failure in hospitalised patients: a single-centre cohort study in the USA

Por: Thongprayoon · C. · Cheungpasitporn · W. · Chewcharat · A. · Mao · M. A. · Kashani · K. B.
Objectives

The objective of this study was to evaluate the risk of acute respiratory failure in all hospitalised patients based on admission serum ionised calcium.

Design

A retrospective cohort study.

Setting

A tertiary referral hospital in Rochester, Minnesota, USA.

Participants

All hospitalised patients who had serum ionised calcium measurement within 24 hours of hospital admission from January 2009 to December 2013. Patients who were mechanically ventilated at admission were excluded.

Predictors

Admission serum ionised calcium levels was stratified into six groups: ≤4.39, 4.40–4.59, 4.60–4.79, 4.80–4.99, 5.00–5.19 and ≥5.20 mg/dL.

Primary outcome measure

The primary outcome was the development of acute respiratory failure requiring mechanical ventilation during hospitalisation. Logistic regression analysis was fit to assess the independent risk of acute respiratory failure based on various admission serum ionised calcium, using serum ionised calcium of 5.00–5.19 mg/dL as the reference group.

Results

Of 25 709 eligible patients, with the mean serum ionised calcium of 4.8±0.4 mg/dL, acute respiratory failure requiring mechanical ventilation occurred in 2563 patients (10%). The incidence of acute respiratory failure was lowest when admission serum ionised calcium was 5.00–5.19 mg/dL, with the progressively increased risk of acute respiratory failure with decreased serum ionised calcium. In multivariate analysis with adjustment for potential confounders, the increased risk of acute respiratory failure requiring mechanical ventilation was significantly associated with admission serum ionised calcium of ≤4.39 (OR 2.52; 95% CI 2.12 to 3.00), 4.40–4.59 (OR 1.76; 95% CI 1.49 to 2.07) and 4.60–4.79 mg/dL (OR 1.48; 95% CI 1.27 to 1.72), compared with serum ionised calcium of 5.00–5.19 mg/dL. The risk of acute respiratory failure was not significantly increased when serum ionised calcium was at least 4.80 mg/dL.

Conclusion

The increased risk of acute respiratory failure requiring mechanical ventilation was observed when admission serum ionised calcium was lower than 4.80 mg/dL in hospitalised patients.

Prediction of gestational age with symphysis-fundal height and estimated uterine volume in a pregnancy cohort in Sylhet, Bangladesh

Por: Lee · A. C. C. · Whelan · R. · Bably · N. N. · Schaeffer · L. E. · Rahman · S. · Ahmed · S. · Moin · S. M. I. · Begum · N. · Quaiyum · M. A. · Rosner · B. · Litch · J. A. · Baqui · A. H. · Wylie · B. J.
Objective

To improve the accuracy of the prediction of gestational age (GA) before birth with the standardised measurement of symphysis-fundal height (SFH), estimation of uterine volume, and statistical modelling including maternal anthropometrics and other factors.

Design

Prospective pregnancy cohort study.

Setting

Rural communities in Sylhet, Bangladesh.

Participants

1516 women with singleton pregnancies with early pregnancy ultrasound dating (

Methods

SFH and abdominal girth were measured at subsequent antenatal care (ANC) visits by community health workers at 24 to 28, 32 to 36, and/or >37 weeks gestation. An estimated uterine volume (EUV) was calculated from these measures. Data on pregnancy characteristics and other maternal anthropometrics were also collected.

Primary outcome measure

GA at subsequent ANC visits, as defined by early ultrasound dating.

Results

1486 (98%) women had at least one subsequent ANC visit, 1102 (74%) women had two subsequent ANC visits, and 748 (50%) had three visits. Using the common clinical practice of approximating the GA (in weeks) with the SFH measurement (cm), SFH systematically underestimated GA in late pregnancy (mean difference –4.4 weeks, 95% limits of agreement –12.5 to 3.7). For the classification of GA

Conclusions

We were unable to predict GA with a high degree of accuracy before birth using maternal anthropometric measures and other available maternal characteristics. Efforts to improve GA dating in low- and middle-income countries before birth should focus on increasing coverage and training of ultrasonography.

Trial registration number

NCT01572532

Constructing treatment episodes from concomitant medication logs: a prospective observational study

Por: Kuramoto · L. K. · Sobolev · B. G. · Brasher · P. M. A. · Tang · M. W. · Cragg · J. J.
Objectives

To describe an approach using concomitant medication log records for the construction of treatment episodes. Concomitant medication log records are routinely collected in clinical studies. Unlike prescription and dispensing records, concomitant medication logs collect utilisation data. Logs can provide information about drug safety and drug repurposing.

Design

A prospective multicentre, multicohort observational study.

Setting

Twenty-one clinical sites in the USA, Europe, Israel and Australia.

Participants

415 subjects from the de novo cohort of the Parkinson’s Progression Markers Initiative.

Methods

We construct treatment episodes of concomitant medication use. The proposed approach treats temporal gaps as a stoppage of medication and temporal overlaps as simultaneous use or changes in dose. Log records with no temporal gaps were combined into a single treatment episode.

Results

5723 concomitant medication log records were used to construct 3655 treatment episodes for 65 medications. There were 405 temporal gaps representing a stoppage of medication; 985 temporal overlaps representing simultaneous regimens of the same medication and 2696 temporal overlaps representing a change in dose regimen. The median episode duration was 37 months (IQ interval: 11–73 months).

Conclusions

The proposed approach for constructing treatment episodes offers a method of estimating duration and dose of treatment from concomitant medication log records. The accompanying recommendations guide log data collection to improve their quality for drug safety and drug repurposing.

Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis

Por: Wijn · S. R. W. · Rovers · M. M. · Rongen · J. J. · Osteras · H. · Risberg · M. A. · Roos · E. M. · Hare · K. B. · van de Graaf · V. A. · Poolman · R. W. · Englund · M. · Hannink · G.
Introduction

Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.

Methods and analysis

An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs’ characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.

Ethics and dissemination

All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42017067240.

Designing new diagnostic systems for the early detection of tobacco-associated chronic renal damage in patients of a primary care centre in Salamanca, Spain: an observational, prospective study protocol

Introduction

Tobacco causes kidney damage that can progress to chronic kidney disease. However, the diagnostic parameters used in clinics are not effective in identifying smokers at risk. Our first objective is to more effectively detect subclinical renal damage in smokers. In addition, we hypothesise that tobacco consumption can predispose smokers to renal damage on exposure to other potentially nephrotoxic events (drugs, diagnostic procedures and so on). We will test this hypothesis in our second objective by investigating whether certain predisposition markers (GM2 ganglioside activator protein (GM2AP), transferrin and t-gelsolin) are able to detect smokers who are predisposed to kidney damage. Finally, in our third objective, we will study whether smoking cessation reduces subclinical and/or predisposition to renal damage.

Methods and analysis

For our first objective, a prospective cross-sectional study will be carried out with patients from a primary healthcare centre. The influence of tobacco on renal damage, in patients both with and without additional risk factors, will be studied using a panel of early biomarkers (albuminuria, N-acetyl-beta-D-glucosaminidase, kidney injury molecule-1 and neutrophil gelatinase-associated lipocalin). For our second objective, a prospective longitudinal study will be carried out with patients recruited for our first objective. We will study whether certain predisposition biomarkers (GM2AP, transferrin and t-gelsolin) are able to detect smokers predisposed to renal damage. For our third objective, a prospective longitudinal study will be carried out with patients from a smoking cessation unit. We will study the evolution of the markers described above following smoking cessation.

Ethics and dissemination

The study has been approved by the Clinical Research Ethics Committee of the Healthcare Area of Salamanca. All study participants will sign an informed consent form in compliance with the Declaration of Helsinki and the WHO standards for observational studies. Results will be presented at conferences and submitted to peer-reviewed journals.

Trial registration number

NCT03850756.

A multidisciplinary approach to decreasing length of stay in acute care surgery patients 缩短急症护理手术病人住院时间的多学科方法

Abstract

Aim

To decrease hospital length of stay in acute care surgery patients.

Design

An observational cohort quality improvement project at a single tertiary referral centre.

Methods

A multidisciplinary team of physicians, nurses, case managers, and physical and occupational therapists was created to identify patients at risk for prolonged length of stay and implement weekly multidisciplinary rounding, with a systematic method of tracking progress in real time. The main outcome measure was hospital length of stay. The observed/expected ratios for length of stay 2 years before (2012–2014) and after (2014–2016) the intervention were compared.

Results

A total of 6,120 patients was analysed. Early identification and action on barriers to discharge created a significant decrease in risk‐adjusted acute care surgery patient days per year (96 days) with limited added cost (1–2 hr per week). Patients discharged to home with or without services benefited most.

Conclusion

Decreasing length of stay in acute care surgery patients is possible without adding a significant burden to healthcare providers.

Impact

We describe a comprehensive, multidisciplinary initiative to decrease the length of stay of acute care surgery patients. Institutions can use existing resources in a sustainable manner to create a significant decrease in patient days per year with limited added cost.

Registration

https://osf.io/zfc3t

目的

缩短急症护理手术病人的住院时间。

设计

在一个三级转诊中心开展观察性队列质量改进项目。

方法

组建了一支由医师、护士、病例管理人员、理疗师和职业治疗师组成的多学科团队,以识别有住院时间延长风险的患者,并开展每周多学科凑整,同时采用系统的方法实时跟踪进展。主要评价指标为住院时间。对干预前(2012年‐2014年)和干预后(2014年‐2016年)两年内住院时间的观察/预期比率进行比较。

结果

共对6,120名病人进行了分析。早期确定出院阻碍因素并采取行动,使风险调整后的急症护理手术病人每年的住院天数(96天)显著减少,而且增加的成本有限(每周1‐2小时)。出院回家的病人无论是否接受医疗服务均受益最多。

结论

在不显著增加医疗服务提供者负担的情况下,有可能实现缩短急症护理手术病人的住院时间。

影响

我们描述了一个全面的多学科倡议,以缩短急症护理手术病人的住院时间。机构可凭借可持续的方式利用现有资源,在有限的附加成本下,显著减少病人每年的住院天数。

注册

https://osf.io/zfc3t

A Bayesian approach for detecting a disease that is not being modeled

by John M. Aronis, Jeffrey P. Ferraro, Per H. Gesteland, Fuchiang Tsui, Ye Ye, Michael M. Wagner, Gregory F. Cooper

Over the past decade, outbreaks of new or reemergent viruses such as severe acute respiratory syndrome (SARS) virus, Middle East respiratory syndrome (MERS) virus, and Zika have claimed thousands of lives and cost governments and healthcare systems billions of dollars. Because the appearance of new or transformed diseases is likely to continue, the detection and characterization of emergent diseases is an important problem. We describe a Bayesian statistical model that can detect and characterize previously unknown and unmodeled diseases from patient-care reports and evaluate its performance on historical data.
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