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Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity

Por: McGuinty · M. · Angel · J. B. · Cooper · C. L. · Cowan · J. · MacPherson · P. A. · Kumar · A. · Murthy · S. · Sy · R. · Dennehy · M. · Tremblay · N. · Byrareddy · S. N. · Cameron · D. W.
Introduction

Continuous antiretroviral therapy (ART) suppresses HIV plasma viral load (pVL) to very low levels, which allows for some immune recovery. Discontinuation of ART leads to pVL rebound from reservoirs of persistence and latency, and progressive immunodeficiency. One promising but controversial strategy targeting CD4+ T lymphocytes with a monoclonal antibody (mAb) against α4β7 integrin has shown promise through sustained virological remission of pVL (SVR) in SIV239-infected rhesus macaques. We propose to assess the safety and tolerability of vedolizumab, a licensed humanised mAb against human α4β7 integrin, in healthy HIV-infected adults on ART. This study will also assess, by analytical treatment interruption (ATI), whether vedolizumab treatment can induce SVR beyond ART and vedolizumab treatment.

Methods and analysis

The HIV-ART-vedolizumab-ATI (HAVARTI) trial is a single-arm, dose-ranging pilot trial in healthy HIV-positive adult volunteers receiving ART. Twelve consenting persons will be enrolled in sequential groups of 4 to each serial dosing vedolizumab regimen (300 mg, 150 mg, 75 mg). The primary outcomes are: (1) to assess the safety and tolerability of seven serial infusions of vedolizumab at each of three doses; (2) to identify the immunovirological measures, including pVL and T-cell kinetics, that characterise HIV/ART cases before, during, after vedolizumab treatment and ATI; and (3) to seek SVR of pVL after ATI. Secondary outcomes will include immune reconstitution and pVL suppression as well as immune reconstitution and long-term safety following re-initiation of ART in the absence of SVR.

Ethics and dissemination

The study protocol was approved by the Ottawa Health Science Network-REB and by the Health Canada Therapeutic Products Directorate. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open access journal within a year of study completion.

Trial registration number

ClinicalTrials.gov NCT03147859; https://clinicaltrials.gov/ct2/show/NCT03147859

Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial

Por: Kawaguchi · A. · Bernier · G. · Adler · A. · Emeriaud · G. · Jouvet · P. A.
Introduction

Chest physiotherapy (CPT) and intrathoracic percussion ventilation have been recognised as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proven to be sufficient.

Method and analyses

This study aims to examine the tolerance, feasibility and physiological effects in airway clearance by using a novel extrathoracic non-invasive oscillating transducer device (NIOD) in critically ill children. A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children’s Hospital will be applied. Children under 24 months old, for whom CPT is prescribed for airway clearance, will be included. The study consists of two stages; (1) Stage 1 ‘Frequency Level’: we will apply two different frequencies of the NIOD (40 Hz vs 60 Hz) for 12 min each, on each patient 3 hours apart, and (2) Stage 2 ‘NIOD versus CPT’: we will implement NIOD and CPT alternatingly for 3 hours apart. The order of the procedures will be randomly allocated for each case. We will compare the average changes of tidal lung volume measured by a 3D imaging system and regional lung functions using electrical impedance tomography, between the two different frequencies and between the NIOD periods and the CPT periods. We will also examine tolerance by seeing COMFORT Scales and related complications during the procedures. We estimate necessary sample size as 6 for each arm (Total 12 cases) for stage 1 and 48 cases for Stage 2, with power of 0.8 and alpha of 0.05.

Ethics and dissemination

This study has been approved by the Health Research Ethics Board of University of Montreal, Canada (REB number: 2020-2471). We will disseminate our findings through peer-reviewed publications and conference presentations in paediatric or/and critical care fields.

Trial registration number

ClinicalTrials.gov Registry (NCT03821389).

Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol

Por: Angkurawaranon · C. · Papachristou Nadal · I. · Mallinson · P. A. C. · Pinyopornpanish · K. · Quansri · O. · Rerkasem · K. · Srivanichakorn · S. · Techakehakij · W. · Wichit · N. · Pateekhum · C. · Hashmi · A. H. · Hanson · K. · Khunti · K. · Kinra · S.
Introduction

Type 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.

Methods and analysis

21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021.

Ethics and dissemination

Ethical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries.

Trial registration number

NCT03938233.

Age differences in clinical features and outcomes in patients with COVID-19, Jiangsu, China: a retrospective, multicentre cohort study

Por: Luo · H. · Liu · S. · Wang · Y. · Phillips-Howard · P. A. · Ju · S. · Yang · Y. · Wang · D.
Objectives

To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China.

Design and setting

Retrospective, multicentre cohort study performed at 24 hospitals in Jiangsu, China.

Participants

625 patients with COVID-19 enrolled between 10 January and 15 March 2020.

Results

Of the 625 patients (median age, 46 years; 329 (52.6%) men), 37 (5.9%) were children (18 years or younger), 261 (41.8%) young adults (19–44 years), 248 (39.7%) middle-aged adults (45–64 years) and 79 (12.6%) elderly adults (65 years or older). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease and diabetes comorbidities increased with age (trend test, p2 test, p=0.0008, 0.0146 and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both p2 test p2 test p2 test p

Conclusions

Elderly (≥65 years) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure and the longest hospital stay, which may be due partly to their having a higher incidence of comorbidities and poor immune responses to COVID-19.

Alpha-crystallin mutations alter lens metabolites in mouse models of human cataracts

by Cheryl Frankfater, Stephanie L. Bozeman, Fong-Fu Hsu, Usha P. Andley

Cataracts are a major cause of blindness worldwide and commonly occur in individuals over 70 years old. Cataracts can also appear earlier in life due to genetic mutations. The lens proteins, αA- and αB-crystallins, are chaperone proteins that have important roles maintaining protein solubility to prevent cataract formation. Mutations in the CRYAA and CRYAB crystallin genes are associated with autosomal dominant early onset human cataracts. Although studies about the proteomic and genomic changes that occur in cataracts have been reported, metabolomics studies are very limited. Here, we directly investigated cataract metabolism using gas-chromatography-mass spectrometry (GC-MS) to analyze the metabolites in adult Cryaa-R49C and Cryab-R120G knock-in mouse lenses. The most abundant metabolites were myo-inositol, L-(+)-lactic acid, cholesterol, phosphate, glycerol phosphate, palmitic and 9-octadecenoic acids, α-D-mannopyranose, and β-D-glucopyranose. Cryaa-R49C knock-in mouse lenses had a significant decrease in the number of sugars and minor sterols, which occurred in concert with an increase in lactic acid. Cholesterol composition was unchanged. In contrast, Cryab-R120G knock-in lenses exhibited increased total amino acid content including valine, alanine, serine, leucine, isoleucine, glycine, and aspartic acid. Minor sterols, including cholest-7-en-3-ol and glycerol phosphate were decreased. These studies indicate that lenses from Cryaa-R49C and Cryab-R120G knock-in mice, which are models for human cataracts, have unique amino acid and metabolite profiles.

Managing hypertension in frail oldest-old—The role of guideline use by general practitioners from 29 countries

by Céline Roulet, Zsofia Rozsnyai, Katharina Tabea Jungo, Milly A. van der Ploeg, Carmen Floriani, Donata Kurpas, Shlomo Vinker, Sanda Kreitmayer Pestic, Ferdinando Petrazzuoli, Kathryn Hoffmann, Rita P. A. Viegas, Christian Mallen, Athina Tatsioni, Hubert Maisonneuve, Claire Collins, Heidrun Lingner, Rosy Tsopra, Yolanda Mueller, Rosalinde K. E. Poortvliet, Jacobijn Gussekloo, Sven Streit

Background

The best management of hypertension in frail oldest-old (≥80 years of age) remains unclear and we still lack guidelines that provide specific recommendations. Our study aims to investigate guideline use in general practitioners (GPs) and to examine if guideline use relates to different decisions when managing hypertension in frail oldest-old.

Design/Setting

Cross-sectional study among currently active GPs from 29 countries using a case-vignettes survey.

Methods

GPs participated in a survey with case-vignettes of frail oldest-olds varying in systolic blood pressure (SBP) levels and cardiovascular disease (CVD). GPs from 26 European countries and from Brazil, Israel and New Zealand were invited. We compared the percentage of GPs reporting using guidelines per country and further stratified on the most frequently mentioned guidelines. To adjust for patient characteristics (SBP, CVD and GPs’ sex, years of experience, prevalence of oldest-old and location of their practice), we used a mixed-effects regression model accounting for clustering within countries.

Results

Overall, 2,543 GPs from 29 countries were included. 59.4% of them reported to use guidelines. Higher guideline use was found in female (p = 0.031) and less-experienced GPs (p Conclusion

Many GPs reported using guidelines to manage hypertension in frail oldest-old patients, however guideline users did not decide differently from non-users concerning hypertension treatment decisions. Instead of focusing on the fact if GPs use guidelines or not, we as a scientific community should put an emphasis on what guidelines suggest in frail and oldest-old patients.

Attitude and beliefs about the social environment associated with chemsex among MSM visiting STI clinics in the Netherlands: An observational study

by Ymke J. Evers, Jill J. H. Geraets, Geneviève A. F. S. Van Liere, Christian J. P. A. Hoebe, Nicole H. T. M. Dukers-Muijrers

Background

Drug use during sex, ‘chemsex’, is common among men who have sex with men (MSM) and related to sexual and mental health harms. This study assessed associations between chemsex and a wide range of determinants among MSM visiting STI clinics to increase understanding of characteristics and beliefs of MSM practicing chemsex.

Methods

In 2018, 785 MSM were recruited at nine Dutch STI clinics; 368 (47%) fully completed the online questionnaire. All participants reported to have had sex in the past six months. Chemsex was defined as using cocaine, crystal meth, designer drugs, GHB/GBL, ketamine, speed or XTC/MDMA during sex in the past six months. Associations between chemsex and psychosocial determinants, socio-demographics, sexual behaviour and using tobacco or alcohol were assessed by multivariable logistic regression analyses.

Results

Chemsex was reported by 44% of MSM (161/368) and was not associated with socio-demographics. Independent determinants were ‘believing that the majority of friends/sex partners use drugs during sex’ (descriptive norm) (aOR: 1.95, 95%CI: 1.43–2.65), ‘believing that sex is more fun when using drugs’ (attitude) (aOR: 2.06, 95%CI: 1.50–2.84), using tobacco (aOR: 2.65, 95%CI: 1.32–5.32), multiple sex partners (aOR: 2.69, 95%CI: 1.21–6.00), group sex (aOR: 4.65, 95%CI: 1.54–14.05) and using online dating platforms (aOR: 2.73, 95%CI: 1.13–6.62).

Conclusion

MSM are likely to find themselves in distinct social networks where it is the norm to use drugs when having sex and pleasure is linked to chemsex. Health services should acknowledge the social influence and pleasurable experiences to increase acceptability of strategies aimed at minimizing the possible harms of chemsex.

PyDSLRep: A domain-specific language for robotic simulation in V-Rep

by Andrés C. Jiménez, John P. Anzola, Vicente García-Díaz, Rubén González Crespo, Liping Zhao

Calculating forward and inverse kinematics for robotic agents is one of the most time-intensive tasks when controlling the robot movement in any environment. This calculation is then encoded to control the motors and validated in a simulator. The feedback produced by the simulation can be used to correct the code or to implement the code can be implemented directly in the robotic agent. However, the simulation process executes instructions that are not native to the robotic agents, extending development time or making it preferable to validate the code directly on the robot, which in some cases might result in severe damage to it. The use of Domain-Specific Languages help reduce development time in simulation tasks. These languages simplify code generation by describing tasks through an easy-to-understand language and free the user to use a framework or programming API directly for testing purposes. This article presents the language PyDSLRep, which is characterized by the connection and manipulation of movement in mobile robotic agents in the V-Rep simulation environment. This language is tested in three different environments by twenty people, against the framework given by V-Rep, demonstrating that PyDSLRep reduces the average development time by 45.22%, and the lines of code by 76.40% against the Python framework of V-Rep.

Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial

Por: Eisenhauer · C. M. · Brito · F. A. · Yoder · A. M. · Kupzyk · K. A. · Pullen · C. H. · Salinas · K. E. · Miller · J. · Hageman · P. A.
Introduction

Men who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men’s access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.

Methods and analysis

A 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40–69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.

Ethics and dissemination

This protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594–17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.

Trial registration number

NCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

Severe Asthma Toolkit: an online resource for multidisciplinary health professionals--needs assessment, development process and user analytics with survey feedback

Por: Maltby · S. · Gibson · P. G. · Reddel · H. K. · Smith · L. · Wark · P. A. B. · King · G. G. · Upham · J. W. · Clark · V. L. · Hew · M. · Owens · L. · Oo · S. · James · A. L. · Thompson · B. · Marks · G. B. · McDonald · V. M.
Objectives

Severe asthma imposes a significant burden on individuals, families and the healthcare system. New treatment and management approaches are emerging as effective options for severe asthma. Translating new knowledge to multidisciplinary healthcare professionals is a priority. We developed ‘The Severe Asthma Toolkit’ (https://toolkit.severeasthma.org.au) to increase awareness of severe asthma, provide evidence-based resources and support decisionmaking by healthcare providers.

Setting

Roundtable discussions and a survey of Australians clinicians were conducted to determine clinician preferences, format and content for a severe asthma resource.

Participants

A reference group from stakeholder and consumer bodies and severe asthma experts provided advice and feedback. A multidisciplinary team of international experts was engaged to develop content. Written content was based on up-to-date literature. Peer and editorial review were performed to finalise content and inform web design. Website design focused on user experience, navigation, engagement, interactivity and tailoring of content for a clinical audience.

Results

A web-based resource was developed. Roundtable discussions and a needs assessment survey identified the need for dedicated severe asthma management resources to support skills training. The end-product, which launched 26 March 2018, includes an overview of severe asthma, diagnosis and assessment, management, medications, comorbidities, living with severe asthma, establishing a clinic, paediatrics/adolescents and clinical resources. Analytics indicate access by users worldwide (32 169 users from 169 countries). User survey results (n=394) confirm access by the target audience (72% health professionals), who agreed the toolkit increased their knowledge (73%) and confidence in managing severe asthma (66%), and 75% are likely to use the resource in clinic.

Conclusions

The Severe Asthma Toolkit is a unique, evidence-based internet resource to support healthcare professionals providing optimal care for people with severe asthma. It is a comprehensive, accessible and independent resource developed by leading severe asthma experts to improve clinician knowledge and skills in severe asthma management.

Does breast reduction surgery improve health-related quality of life? A prospective cohort study in Australian women

Objectives

To assess the health burden of breast hypertrophy and the comparative effectiveness of breast reduction surgery in improving health-related quality of life.

Design

Prospective cohort study.

Setting

A major public tertiary care hospital in Australia.

Participants

Women with symptomatic breast hypertrophy who underwent breast reduction surgery were followed for 12 months. A comparison control cohort comprised women with breast hypertrophy who did not undergo surgery.

Interventions

Bilateral breast reduction surgery for women in the surgical cohort.

Main outcome measures

The primary outcome measure was health-related quality of life measured preoperatively and at 3, 6 and 12 months postoperatively using the Short Form-36 (SF-36) questionnaire. Secondary outcome measures included post-surgical complications.

Results

209 patients in the surgical cohort completed questionnaires before and after surgery. 124 patients in the control hypertrophy cohort completed baseline and 12-month follow-up questionnaires. At baseline, both groups had significantly lower scores compared with population norms across all scales (p

Conclusion

Breast reduction significantly improved quality of life in women with breast hypertrophy. This increase was most pronounced within 3 months of surgery and sustained at 12-month follow-up. This improvement in quality of life is comparable to other widely accepted surgical procedures. Furthermore, women benefit from surgery regardless of factors including body mass index and resection weight.

Physical activity interventions for adults who are visually impaired: a systematic review and meta-analysis

Por: Sweeting · J. · Merom · D. · Astuti · P. A. S. · Antoun · M. · Edwards · K. · Ding · D.
Objectives

Compared with sighted individuals, people with visual impairment have a higher prevalence of chronic conditions and lower levels of physical activity. This review aims to systematically review physical activity interventions for those with a visual impairment and to assess their effectiveness.

Design

A systematic review of articles reporting physical activity interventions in visually impaired individuals was conducted. Medline, EMBASE, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus and the Physiotherapy Evidence Database were searched in August 2018. Meta-analyses were conducted on randomised controlled trials with the same outcome measure.

Setting

Most interventions were conducted in a group setting, with some including an at-home, self-directed component.

Participants

Following identification of a recent systematic review of physical activity interventions in children, our review focused on adults aged 18 years and older with a visual impairment.

Primary and secondary outcome measures

Outcomes included measures of balance, mobility, mental well-being (eg, quality of life), number of falls, muscle strength, flexibility and gait.

Results

Eighteen papers from 17 studies met inclusion criteria. Physical activity components include falls prevention and/or balance-based activities, walking, tai chi, Alexander Technique, Yoga, dance, aerobics and core stability training. Significant results in favour of the intervention were reported most commonly in measures of functional capacity (9/17 studies) and in falls/balance-related outcomes (7/13 studies). The studies identified were generally small and diverse in study design, and risk of bias was high across several categories for most studies. Meta-analyses indicated non-significant effects of the included interventions on the Timed Up and Go, Chair Sit Test and Berg Balance Scale.

Conclusions

Physical activity interventions in individuals with visual impairment incorporating activities such as tai chi, Yoga and dance can have positive results, particularly in physical measures such as mobility and balance. However, when performing a meta-analysis of randomised controlled trials, the evidence for effectiveness is less clear. More studies with larger sample sizes, stronger designs and longer follow-up periods are needed.

PROSPERO registration number

CRD42018103638.

Forging a new identity: a qualitative study exploring the experiences of UK-based physician associate students

Por: Brown · M. E. L. · Laughey · W. · Tiffin · P. A. · Finn · G. M.
Objective

To explore student physician associates’ (PAs) experiences of clinical training to ascertain the process of their occupational identity formation.

Setting

The role of the PA is relatively new within the UK. There has been a rapid expansion in training places driven by National Health Service (NHS) workforce shortages, with the Department of Health recently announcing plans for the General Medical Council to statutorily regulate PAs. Given such recent changes and the relative newness of their role, PAs are currently establishing their occupational identity. Within adjacent fields, robust identity development improves well-being and career success. Thus, there are implications for recruitment, retention and workplace performance. This qualitative study analyses the views of student PAs to ascertain the process of PA occupational identity formation through the use of one-to-one semistructured interviews. A constructivist grounded theory approach to data analysis was taken. Research was informed by communities of practice and socialisation theory.

Participants

A theoretical sample of 19 PA students from two UK medical schools offering postgraduate PA studies courses.

Results

A conceptual model detailing student PA identity formation is proposed. Factors facilitating identity formation include clinical exposure and continuity. Barriers to identity formation include ignorance and negativity regarding the PA role. Difficulties navigating identity formation and lacking support resulted in identity dissonance.

Conclusions

Although similarities exist between PA and medical student identity formation, unique challenges exist for student PAs. These include navigating a new role and poor access to PA role models. Given this, PA students are turning to medicine for their identity. Educators must provide support for student PA identity development in line with this work’s recommendations. Such support is likely to improve the job satisfaction and retention of PAs within the UK NHS.

Prevalence and correlates of alcohol and tobacco use among key populations in Togo in 2017: a cross-sectional study

Por: Bitty-Anderson · A. M. · Gbeasor-Komlanvi · F. A. · Johnson · P. · Sewu · E. K. · Dagnra · C. A. · Salou · M. · Blatome · T. J. · Jaquet · A. · Coffie · P. A. · Ekouevi · D. K.
Objectives

The aim of this study was to estimate alcohol and tobacco use prevalence and their correlates among female sex workers (FSW), men who have sex with men (MSM) and drug users (DU) in Togo.

Design, setting and participants

A cross-sectional bio-behavioural study was conducted among 2115 MSM, FSW and DU in 2017 using a respondent-driven sampling method, in the eight biggest towns of Togo. Selection criteria for the MSM were being male and having had oral or anal intercourse with a man in the previous 12 months; for FSW, being a female and having exchanged sex for money in the previous 12 months; and for DU, consuming heroin, cocaine or hashish for MSM, FSW and DU, respectively. All participants had to be at least 18 years old and residing in the territory for the past 3 months.

Results

The prevalence of alcohol consumption, hazardous/harmful consumption and binge drinking was 64.8%, 38.4% and 45.5%, respectively. Current tobacco use was reported by 30.6% of participants and HIV prevalence was estimated at 12.5%. DU were more likely to engage in binge drinking compared with other key populations (adjusted odds ratio (aOR)=2.0; 95% CI 1.4 to 2.8; p=0.001). Participants who were identified as having hazardous/harmful alcohol consumption had almost three times the odds of tobacco consumption than those with no risky consumption (aOR=2.6; 95% CI 2.0 to 3.4; p=0.001). Hazardous/harmful alcohol consumption was three times more likely among participants with severe psychological distress compared with those with no psychological distress (aOR=3.3, 95% CI 2.2 to 5.1; p=0.001).

Conclusion

Findings from this study demonstrate the need for the integration of mental health and substance abuse reduction interventions into HIV prevention programme, particularly those geared towards key populations.

The Upper Gastrointestinal Cancer Registry (UGICR): a clinical quality registry to monitor and improve care in upper gastrointestinal cancers

Por: Maharaj · A. D. · Holland · J. F. · Scarborough · R. O. · Evans · S. M. · Ioannou · L. J. · Brown · W. · Croagh · D. G. · Pilgrim · C. H. C. · Kench · J. G. · Lipton · L. R. · Leong · T. · McNeil · J. J. · Nikfarjam · M. · Aly · A. · Burton · P. R. · Cashin · P. A. · Chu · J. · Duong · C.
Purpose

The Upper Gastrointestinal Cancer Registry (UGICR) was developed to monitor and improve the quality of care provided to patients with upper gastrointestinal cancers in Australia.

Participants

It supports four cancer modules: pancreatic, oesophagogastric, biliary and primary liver cancer. The pancreatic cancer (PC) module was the first module to be implemented, with others being established in a staged approach. Individuals are recruited to the registry if they are aged 18 years or older, have received care for their cancer at a participating public/private hospital or private clinic in Australia and do not opt out of participation.

Findings to date

The UGICR is governed by a multidisciplinary steering committee that provides clinical governance and oversees clinical working parties. The role of the working parties is to develop quality indicators based on best practice for each registry module, develop the minimum datasets and provide guidance in analysing and reporting of results. Data are captured from existing data sources (population-based cancer incidence registries, pathology databases and hospital-coded data) and manually from clinical records. Data collectors directly enter information into a secure web-based Research Electronic Data Capture (REDCap) data collection platform. The PC module began with a pilot phase, and subsequently, we used a formal modified Delphi consensus process to establish a core set of quality indicators for PC. The second module developed was the oesophagogastric cancer (OGC) module. Results of the 1 year pilot phases for PC and OGC modules are included in this cohort profile.

Future plans

The UGICR will provide regular reports of risk-adjusted, benchmarked performance on a range of quality indicators that will highlight variations in care and clinical outcomes at a health service level. The registry has also been developed with the view to collect patient-reported outcomes (PROs), which will further add to our understanding of the care of patients with these cancers.

Developing a cerebral palsy-specific preference-based measure for a six-dimensional classification system (CP-6D): protocol for a valuation study

Por: Bahrampour · M. · Norman · R. · Byrnes · J. · Downes · M. · Scuffham · P. A.
Introduction

Cerebral palsy (CP) is a lifelong condition. The CP quality of life (CPQOL) instrument is a frequently used disease-specific instrument to assess health-related quality of life (HRQoL) in people with CP, but it cannot be used to generate quality-adjusted life years (QALY) which are the basis of cost utility analysis (CUA). Generic utility instruments (such as the EQ-5D or SF-6D) that are used to value HRQOL may be insensitive to small but important health changes in children with CP. This study aims to generate a preference-based scoring algorithm for the CP six dimensions (CP-6D), a classification system developed from the CPQOL.

Methods and analysis

A discrete choice experiment with duration (DCEtto) will be administrated to value health states described by the CP-6D classification system. These health states will be presented to members of Australian general population and parents of children with CP via an online survey. Conditional logit regression will be used to produce the utility algorithm for CP-6D.

Ethics and dissemination

The Griffith University Human Research Ethics Committee approved for the study (reference HREC/number 2018/913). The developed algorithm can be applied to previous and future economic evaluation of interventions and treatments targeting people with CP which have used either the CPQOL or CP-6D.

Outcomes of disease prevention and management interventions in food pantries and food banks: a scoping review

Por: Long · C. R. · Rowland · B. · Steelman · S. C. · McElfish · P. A.
Objective

Food insecurity affects millions of Americans and is associated with a range of adverse health outcomes. Food insecure individuals often obtain food from food pantries/banks, prompting health researchers to implement disease prevention/management interventions at these sites. This review examined the existing peer-reviewed research on disease prevention/management interventions implemented in food pantries/banks.

Design

Scoping review.

Data sources

Databases searched included MEDLINE, Web of Science, CINAHL and Cochrane. Search strategies included Medical Subject Headings and key terms, including food pantry, food bank, food shelf, food aid and related concepts.

Eligibility criteria

Studies were included if they described an intervention involving food pantries/banks where at least one biometric indicator was included as an outcome variable. Articles focused solely on the quality of foods distributed, the diet quality of food pantry/bank clients or government food aid programmes were excluded.

Data extraction and synthesis

Extracted data included publication details, intervention type, study design, participant characteristics, study outcomes, and barriers and facilitators of intervention implementation.

Results

A total of 3317 articles were assessed for eligibility. Six studies met the predefined inclusion criteria. The studies employed a range of intervention approaches to manage or prevent a number of chronic diseases, including obesity, type 2 diabetes and HIV. The studies examined a range of biometric outcomes, including body mass index, glycated haemoglobin and blood pressure. Information about the food pantries/banks where the interventions were conducted was lacking. The studies documented multiple barriers and facilitators related to costs, sustainability and organisational capacity.

Conclusions

To our knowledge, this is the first review to examine disease prevention and management interventions conducted in food pantries and food banks. Given the high number of households who obtain food from food pantries/banks and the chronic health conditions associated with food insecurity, this review highlights the need for more high-quality research in this setting.

Knowledge acquisition and retention following Saving Childrens Lives course for healthcare providers in Botswana: a longitudinal cohort study

Por: Meaney · P. A. · Joyce · C. L. · Setlhare · S. · Smith · H. E. · Mensinger · J. L. · Zhang · B. · Kalenga · K. · Kloeck · D. · Kgosiesele · T. · Jibril · H. · Mazhani · L. · de Caen · A. · Steenhoff · A. P.
Objectives

Millions of children die every year from serious childhood illnesses. Most deaths are avertable with access to quality care. Saving Children’s Lives (SCL) includes an abbreviated high-intensity training (SCL-aHIT) for providers who treat serious childhood illnesses. The objective of this study was to examine the impact of SCL-aHIT on knowledge acquisition and retention of providers.

Setting

76 participating centres who provide primary and secondary care in Kweneng District, Botswana.

Participants

Doctors and nurses expected by the District Health Management Team to provide initial care to seriously ill children, completed SCL-aHIT between January 2014 and December 2016, submitted demographic data, course characteristics and at least one knowledge assessment.

Methods

Retrospective, cohort study. Planned and actual primary outcome was adjusted acquisition (change in total knowledge score immediately after training) and retention (change in score at 1, 3 and 6 months), secondary outcomes were pneumonia and dehydration subscores. Descriptive statistics and linear mixed models with random intercept and slope were conducted. Relevant institutional review boards approved this study.

Results

211 providers had data for analysis. Cohort was 91% nurses, 61% clinic/health postbased and 45% pretrained in Integrated Management of Childhood Illness (IMCI). A strong effect of SCL-aHIT was seen with knowledge acquisition (+24.56±1.94, p

Conclusions

aHIT for care of the seriously ill child significantly increased provider knowledge and loss of knowledge occurred over time. IMCI training did not significantly impact overall knowledge acquisition nor retention, while professional status impacted overall score and lost to follow-up impacted retention.

What were the impacts of the Committee on Safety of Medicines warning and publication of the NICE guidelines on trends in child and adolescent antidepressant prescribing in primary care? A population based study

Por: Tiffin · P. A. · Mediavilla · J. L. · Close · H. · Kasim · A. S. · Welsh · P. · Paton · L. W. · Mason · J. M.
Objectives

To assess the impact of both the Committee on Safety of Medicines (CSM) warning (December 2003) and the National Institute for Health and Care Excellence (NICE) guidance (September 2005) on antidepressant prescription rates in children and adolescents within the UK primary care service.

Setting

Population based study of primary care antidepressant prescribing using the Clinical Practice Research Datalink (CPRD).

Participants

Under-18s presenting to primary care with a depressive disorder or related diagnostic code recorded in the CPRD.

Primary outcome measure

Antidepressant prescription rates per month per 100 000 depressed 4–17 year olds.

Results

Following the CSM warning, the prior trend towards increased prescribing rates for selective serotonin reuptake inhibitors (SSRIs) in children was significantly reversed (β for change in trend –12.34 (95% CI –18.67 to –6.00, p

Conclusions

Despite a strong emphasis on psychosocial interventions for child and adolescent depression, it may be that the NICE guidelines inadvertently encouraged further antidepressant prescribing, at least for those SSRIs cited. Although the guidelines gave cautions and caveats for the use of antidepressants, practitioners may have interpreted these recommendations as endorsing their use in young people with depression and related conditions. However, more accurate prevalence trend estimates for depression in this age group, and information on the use of psychosocial interventions would be needed to rule out other reasons underlying this increase in prescribing.

Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial

Por: Casey · J. D. · Vaughan · E. R. · Lloyd · B. D. · Bilas · P. A. · Hall · E. J. · Toporek · A. H. · Buell · K. G. · Brown · R. M. · Richardson · R. K. · Rooks · J. C. · Wang · L. · Lindsell · C. J. · Ely · E. W. · Self · W. H. · Bernard · G. R. · Rice · T. W. · Semler · M. W. · the Pragma
Introduction

Following extubation from invasive mechanical ventilation, nearly one in seven critically ill adults requires reintubation. Reintubation is independently associated with increased mortality. Postextubation respiratory support (non-invasive ventilation or high-flow nasal cannula applied at the time of extubation) has been reported in small-to-moderate-sized trials to reduce reintubation rates among hypercapnic patients, high-risk patients without hypercapnia and low-risk patients without hypercapnia. It is unknown whether protocolised provision of postextubation respiratory support to every patient undergoing extubation would reduce the overall reintubation rate, compared with usual care.

Methods and analysis

The Protocolized Post-Extubation Respiratory Support (PROPER) trial is a pragmatic, cluster cross-over trial being conducted between 1 October 2017 and 31 March 2019 in the medical intensive care unit of Vanderbilt University Medical Center. PROPER compares usual care versus protocolized post-extubation respiratory support (a respiratory therapist-driven protocol that advises the provision of non-invasive ventilation or high-flow nasal cannula based on patient characteristics). For the duration of the trial, the unit is divided into two clusters. One cluster receives protocolised support and the other receives usual care. Each cluster crosses over between treatment group assignments every 3 months. All adults undergoing extubation from invasive mechanical ventilation are enrolled except those who received less than 12 hours of mechanical ventilation, have ‘Do Not Intubate’ orders, or have been previously reintubated during the hospitalisation. The anticipated enrolment is approximately 630 patients. The primary outcome is reintubation within 96 hours of extubation.

Ethics and dissemination

The trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number

NCT03288311.

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