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Correction: Alcohol consumption of UK members of parliament: cross-sectional survey

Rao R, Bakolis I, Das-Munshi J, et al. Alcohol consumption of UK members of parliament: cross-sectional survey. BMJ Open 2020;10:e034929. doi: 10.1136/bmjopen-2019-034929

This article was previously published with an error.

Affiliations of authors should be:

Rahul Rao1, Ioannis Bakolis2, Jayati Das-Munshi3, Daniel Poulter4, Nicole Votruba5, and Graham Thornicroft5

1Old Age Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, London, UK

2Department of Biostatistics and Health Informatics/Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK

3Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neurosciences, King’s College London, Institute of Psychiatry, London, UK

4House of Commons, London, UK

5Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK

The information ‘Rahul Rao and Ioannis Bakolis are joint first authors.’ was missing.

The line in competing interest ‘GT, IB are supported by the National Institute for Health Research (NIHR) Collaboration...

Trends in disease incidence and survival and their effect on mortality in Scotland: nationwide cohort study of linked hospital admission and death records 2001-2016

Por: Timmers · P. R. H. J. · Kerssens · J. J. · Minton · J. · Grant · I. · Wilson · J. F. · Campbell · H. · Fischbacher · C. M. · Joshi · P. K.
Objectives

Identify causes and future trends underpinning Scottish mortality improvements and quantify the relative contributions of disease incidence and survival.

Design

Population-based study.

Setting

Linked secondary care and mortality records across Scotland.

Participants

1 967 130 individuals born between 1905 and 1965 and resident in Scotland from 2001 to 2016.

Main outcome measures

Hospital admission rates and survival within 5 years postadmission for 28 diseases, stratified by sex and socioeconomic status.

Results

‘Influenza and pneumonia’, ‘Symptoms and signs involving circulatory and respiratory systems’ and ‘Malignant neoplasm of respiratory and intrathoracic organs’ were the hospital diagnosis groupings associated with most excess deaths, being both common and linked to high postadmission mortality. Using disease trends, we modelled a mean mortality HR of 0.737 (95% CI 0.730 to 0.745) from one decade of birth to the next, equivalent to a life extension of ~3 years per decade. This improvement was 61% (30%–93%) accounted for by improved disease survival after hospitalisation (principally cancer) with the remainder accounted for by lowered hospitalisation incidence (principally heart disease and cancer). In contrast, deteriorations in infectious disease incidence and survival increased mortality by 9% (~3.3 months per decade). Disease-driven mortality improvements were slightly greater for men than women (due to greater falls in disease incidence), and generally similar across socioeconomic deciles. We project mortality improvements will continue over the next decade but slow by 21% because much progress in disease survival has already been achieved.

Conclusion

Morbidity improvements broadly explain observed mortality improvements, with progress on prevention and treatment of heart disease and cancer contributing the most. The male–female health gaps are closing, but those between socioeconomic groups are not. Slowing improvements in morbidity may explain recent stalling in improvements of UK period life expectancies. However, these could be offset if we accelerate improvements in the diseases accounting for most deaths and counteract recent deteriorations in infectious disease.

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

Por: Klassen · A. · van Haren · E. L. · Cross · K. · Fan · K. L. · Gibbons · C. · Hoogbergen · M. M. · Longmire · N. M. · Poulsen · L. · Sorensen · J. A. · Squitieri · L. · Tsangaris · E. · van Alphen · T. C. · van Dishoeck · A.-M. · Vasilic · D. · Pusic · A. L.
Introduction

Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.

Methods and analysis

In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.

Ethics and dissemination

This study is coordinated at Brigham and Women’s Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Physical prognostic factors predicting outcome following anterior cruciate ligament reconstruction: protocol for a systematic review

Por: Middlebrook · A. · Bekker · S. · Middlebrook · N. · Rushton · A. B.
Introduction

Injuries of the anterior cruciate ligament (ACL) are a common musculoskeletal complication and can cause significant reduction in patient function and quality of life. Many undergo ACL reconstruction, with high-quality rehabilitation key to successful outcome. Knowledge of physical prognostic factors, such as quadriceps strength, is crucial to inform rehabilitation and has important implications for outcome following ACL reconstruction. However, these factors predicting outcome are poorly defined. Therefore, the aim of this systematic review is to establish physical prognostic factors predictive of outcome in adults following ACL reconstruction. Outcome will be subdivided into two groups of outcome measures, patient-reported and performance-based. Physical prognostic factors of interest will reflect a range of domains and may be modifiable/non-modifiable. Results will help decide most appropriate management and assist in planning and tailoring preoperative and postoperative rehabilitation.

Methods and analysis

This systematic review protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. MEDLINE, CINAHL and EMBASE databases, key journals and grey literature will be searched from inception to July 2019. Prospective cohort studies including participants aged ≥16 years who have undergone ACL reconstruction will be included, with articles focusing on multi-ligament reconstructions and ACL repair surgery, or not published in English excluded. Two independent reviewers will conduct searches, assess study eligibility, extract data, assess risk of bias (Quality in Prognostic Studies tool) and quantify overall quality of evidence (modified Grading of Recommendations, Assessment, Development and Evaluation guidelines). If possible, a meta-analysis will be conducted, otherwise a narrative synthesis will ensue focusing on prognostic factors, risk of bias of included studies and strength of association with outcomes.

Ethics and dissemination

Findings will be published in a peer-reviewed journal, presented at conferences and locally to physiotherapy departments. Ethical approval is not required for this systematic review.

PROSPERO registration number

CRD42019127732.

Unwanted effects of treatments for depression in children and adolescents: a mapping of systematic reviews

Por: Eidet · L. M. · Dahlgren · A. · Elvsashagen · M.
Objectives

To describe the results of a mapping review exploring the coverage of unwanted treatment effects in systematic reviews of the effects of various treatments for moderate to severe depression in children and adolescents.

Setting

Any context or service providing treatment for depression, including interventions delivered in local communities and school settings, as well as services provided in primary or specialist care.

Participants

Children and young people with moderate to severe depression (

Interventions

Systematic reviews published in 2011 or later comparing the effects of any treatment for children and adolescents with moderate to severe depression meeting the Database of Abstracts of Reviews of Effects criteria. The systematic search was performed in April 2018 and updated in December 2018.

Primary outcomes

Any unwanted effects of treatments as defined in the systematic review.

Results

We included 10 systematic reviews covering 19 treatment comparisons. Unwanted effects were assessed for seven of 19. Three comparisons were evaluations of pharmaceutical interventions or combination therapy, reporting effects on ‘suicidal ideation’ and ‘suicide risk’. Two included therapy, reporting ‘self-harm’, and ‘suicidal ideation’, and two comparisons included transcranial magnetic stimulation and electroconvulsive treatment. Unwanted effects evaluated for these treatments were mostly symptoms of physical discomfort such as headache or cramps. For the remaining treatment comparisons evaluating psychological and psychosocial therapies, unwanted effects were not evaluated or found. A limitation of overviews of systematic reviews such as this mapping study is that data extraction is done based on the reporting of results by the review authors and not on the primary studies.

Conclusion

The unwanted effects of widely used treatments for children and young people with depression is unknown. This is a major barrier for evidence informed decision making about treatment choices for children and young people. We suggest that unwanted effects should be a reporting standard in all protocols describing evaluations of treatments, including primary studies as well as systematic reviews.

Translation and cultural adaptation of a prostate cancer screening decision aid: a qualitative study in Portugal

Por: Baptista · S. · Heleno · B. · Pinto · M. · Guimaraes · B. · China · D. · Ramos · J. P. · Teixeira · A. · Taylor · K. L. · Martins · C.
Objectives

To translate and culturally adapt an English language patient decision aid addressing prostate cancer screening, so it can be used by Portuguese men.

Design

Qualitative study. We followed the European Centre for Disease Prevention and Control’s (ECDC) five-step, stakeholder-based approach to adapting health communication materials: (1) selection of materials and process coordinators, (2) early review, (3) translation and back translation, (4) comprehension testing with cognitive semi-structured interviews and (5) proofreading. Content analysis was performed using Ligre software.

Setting and participants

Cognitive interviews with 15 men to refine a decision aid after its translation. Eligible participants were Portuguese native-speaking men aged 55–69 years old recruited from the local community (urban and suburban) of Oporto district through advertisements in social media and senior universities between January and March 2019. A previous diagnosis of prostate cancer was the single exclusion criterion.

Results

Five main themes are presented: informational content, information comprehension, sociocultural appropriateness, feelings and main message and personal perspective concerning prostate cancer screening. Most men found the translated version of the decision aid to be clear, comprehensive and appropriate for its target population, although some suggested that medical terms could be a barrier. The data collected from men’s interviews afforded the researchers the opportunity to clarify concepts and expand existing content.

Conclusions

A decision aid was successfully translated and adapted to the Portuguese cultural setting. Our ECDC based approach can be replicated by other workgroups to translate and culturally adapt decision aids.

Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial

Por: Zolnourian · A. H. · Franklin · S. · Galea · I. · Bulters · D. O.
Introduction

Subarachnoid haemorrhage (SAH) from a ruptured cerebral aneurysm carries high morbidity and mortality. Despite huge advances in techniques to secure the aneurysm, there has been little progress in the treatment of the deleterious effects of the haemorrhage.

Sulforaphane is an Nrf2 inducer with anti-oxidant and anti-inflammatory properties. It has been shown to improve clinical outcome in experimental models of SAH, but is unstable. SFX-01 (Evgen Pharma) is a novel composition comprised of synthetic sulforaphane stabilised within an α-cyclodextrin complex. On ingestion, the complex releases sulforaphane making SFX-01 an ideal vehicle for delivery of sulforaphane.

Methods and analysis

The objective of the study is to assess the safety, pharmacokinetics and efficacy of SFX-01. This is a prospective, multicentre, randomised, double-blind placebo-controlled trial in patients aged 18–80 years with aneurysmal subarachnoid haemorrhage in the previous 48 hours. 90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.

Safety will be assessed using blood tests and adverse event reporting.

Pharmacokinetics will be assessed based on paired blood and cerebrospinal fluid (CSF) sulforaphane levels on day 7. A subgroup will have hourly samples taken during 6 hours post-dosing on days 1 and 7. Pharmacodynamics will be assessed by haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery will be measured by transcranial Doppler ultrasound.

Clinical outcomes will be assessed at days 28, 90 and 180 with modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke. MRI at 6 months including quantitative susceptibility mapping and volumetric T1 will measure iron deposition and cortical volume.

Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity will be primary outcomes and all others secondary.

Ethics and dissemination

Ethical approval was obtained from South Central Hampshire A committee. Outcomes of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT02614742.

Rationale and protocol for the 7- and 8-year longitudinal assessments of eye health in a cohort of young adults in the Raine Study

Por: Lee · S. S.-Y. · Lingham · G. · Yazar · S. · Sanfilippo · P. G. · Charng · J. · Chen · F. K. · Hewitt · A. W. · Ng · F. · Hammond · C. · Straker · L. M. · Eastwood · P. R. · MacGregor · S. · Rose · K. A. · Lucas · R. M. · Guggenheim · J. A. · Saw · S.-M. · Coroneo · M. T. · He · M. · Macke
Introduction

Eye diseases and visual impairment more commonly affect elderly adults, thus, the majority of ophthalmic cohort studies have focused on older adults. Cohort studies on the ocular health of younger adults, on the other hand, have been few. The Raine Study is a longitudinal study that has been following a cohort since their birth in 1989–1991. As part of the 20-year follow-up of the Raine Study, participants underwent a comprehensive eye examination. As part of the 27- and 28-year follow-ups, eye assessments are being conducted and the data collected will be compared with those of the 20-year follow-up. This will provide an estimate of population incidence and updated prevalence of ocular conditions such as myopia and keratoconus, as well as longitudinal change in ocular parameters in young Australian adults. Additionally, the data will allow exploration of the environmental, health and genetic factors underlying inter-subject differential long-term ocular changes.

Methods and analysis

Participants are being contacted via telephone, email and/or social media and invited to participate in the eye examination. At the 27-year follow-up, participants completed a follow-up eye screening, which assessed visual acuity, autorefraction, ocular biometry and ocular sun exposure. Currently, at the 28-year follow-up, a comprehensive eye examination is being conducted which, in addition to all the eye tests performed at the 27-year follow-up visit, includes tonometry, optical coherence tomography, funduscopy and anterior segment topography, among others. Outcome measures include the incidence of refractive error and pterygium, an updated prevalence of these conditions, and the 8-year change in ocular parameters.

Ethics and dissemination

The Raine Study is registered in the Australian New Zealand Clinical Trials Registry. The Gen2 20-year, 27-year and 28-year follow-ups are approved by the Human Research Ethics Committee of the University of Western Australia. Findings resulting from the study will be published in health or medical journals and presented at conferences.

Trial registration number

ACTRN12617001599369; Active, not recruiting.

Accuracy and consequences of using trial-of-antibiotics for TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial

Por: Divala · T. H. · Fielding · K. L. · Sloan · D. J. · French · N. · Nliwasa · M. · MacPherson · P. · Kandulu · C. C. · Chiume · L. · Chilanga · S. · Ndaferankhande · M. J. · Corbett · E. L.
Introduction

Over 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include ‘trial-of-antibiotics’—empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a ‘rule-out’ diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.

Methods and analysis

A three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF (Mycobacterium tuberculosis/rifampicin) and Mycobacterium tuberculosis culture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngeal Streptococcus pneumoniae isolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.

Ethics and dissemination

The study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics – Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.

Trial registration number

The clinical trial is registered with ClinicalTrials.gov, NCT03545373

Hours lying down per day, as a proxy for sedentary behaviour and risk of diabetes in young and middle-aged adults in Norway: an 11-year follow-up of the HUNT study

Por: Asante · E. O. · Sun · Y.-Q. · Nilsen · T. I. L. · Asvold · B. O. · Sorgjerd · E. P. · Mai · X.-M.
Objective

We aimed to examine relationship between hours lying down per day, as a proxy for sedentary behaviour and risk of diabetes in young and middle-aged adults, and to assess if leisure-time physical activity and body mass index (BMI) modified this relationship.

Design

A population-based prospective cohort study.

Setting

Nord-Trøndelag, Norway.

Participants

The cohort included 17 058 diabetes-free adults, at an age of 20–55 years in 1995–1997, who were followed-up to 2006–2008.

Primary outcome measures

Incident diabetes was defined by self-report of diabetes or non-fasting glucose levels greater than 11 mmol/L at the follow-up.

Methods

Multivariable logistic regression models were used to obtain OR with 95% CI for risk of diabetes by the categories of hours lying down (≤7, 8 and ≥9 hours/day).

Results

362 individuals (2.1%) developed diabetes during an average of 11-year follow-up. Individuals who reported lying down ≥9 hours/day had an adjusted OR of 1.35 (95% CI 1.01 to 1.80) for incident diabetes compared with those lying down 8 hours/day. Lying down ≤7 hours/day was not associated with the risk of diabetes. In analysis stratified by physical activity, the ORs associated with lying down ≥9 hours/day were 1.41 (95% CI 1.05 to 1.90) and 0.90 (95% CI 0.23 to 3.55), respectively, among the less active and highly active individuals (pinteraction=0.048). There was little evidence that the association differed by BMI status (pinteraction=0.62).

Conclusions

Prolonged hours lying down per day was associated with an increased risk of diabetes in young and middle-aged adults. The positive association appeared to be modified by physical activity but not by BMI.

Overview of the burden of chronic kidney disease in Mexico: secondary data analysis based on the Global Burden of Disease Study 2017

Objective

To describe the evolution of the burden of chronic kidney disease (CKD) in Mexico by states, sex and subtypes from 1990 to 2017.

Design

Secondary data analysis based on the Global Burden of Disease Study (GBD) 2017.

Participants

Mexico and its 32 states. Data were publicly available and de-identified and individuals were not involved.

Methods

We analysed age-standardised mortality rates, years of life lost (YLL) due to premature death, years lived with disability (YLD) and disability-adjusted life years (DALY), as well as the percentage of change of these indicators between 1990 and 2017.

Results

From 1990 to 2017, the number of deaths, YLL, YLD and DALY due to CKD increased from 12 395 to 65 033, from 330 717 to 1 544 212, from 86 416 to 210 924 and from 417 133 to 1 755 136, respectively. Age-standardised rates went from 28.7 to 58.1 for deaths (% of change 102.3), from 601.2 to 1296.7 for YLL (% of change 115.7), from 158.3 to 175.4 for YLD (% of change 10.9) and from 759.4 to 1472.2 for DALY (% of change 93.8). The highest burden of CKD was for Puebla and the lowest for Sinaloa. It was also greater for men than women. By subtypes of CKD, diabetes and hypertension were the causes that contributed most to the loss of years of healthy life in the Mexican population.

Conclusions

Mexico has experienced exponential and unprecedented growth in the burden of CKD with significant differences by states, sex and subtypes. Data from the GBD are key inputs to guide decision-making and focus efforts towards the reduction of inequities in CKD. These results should be considered a valuable resource that can help guide the epidemiological monitoring of this disease and prioritise the most appropriate health interventions.

Neighbourhood effects on obesity: scoping review of time-varying outcomes and exposures in longitudinal designs

Por: Letarte · L. · Pomerleau · S. · Tchernof · A. · Biertho · L. · Waygood · E. O. D. · Lebel · A.
Context and objectives

Neighbourhood effect research on obesity took off in the early 2000s and was composed of mostly cross-sectional observational studies interested in various characteristics of the built environment and the socioeconomic environment. To limit biases related to self-selection and life course exposures, many researchers apply longitudinal designs in their studies. Until now, no review has specifically and exclusively examined longitudinal studies and the specific designs of these studies. In this review, we intend to answer the following research question: how are the temporal measurements of contextual exposure and obesity outcomes integrated into longitudinal studies that explore how neighbourhood-level built and socioeconomic environments impact adult obesity?

Design

A systematic search strategy was designed to address the research question. The search was performed in Embase, Web of Science and PubMed, targeting scientific papers published before 1 January 2018. The eligible studies reported results on adults, included exposure that was limited to neighbourhood characteristics at the submunicipal level, included an outcome limited to obesity proxies, and reported a design with at least two exposure measurements or two outcome measurements.

Results

This scoping review identified 66 studies that fit the eligibility criteria. A wide variety of neighbourhood characteristics were also measured, making it difficult to draw general conclusions about associations between neighbourhood exposure and obesity. We applied a typology that classified studies by whether exposure and outcome were measured as varying or fixed. Using this typology, we found that 32 studies reported both neighbourhood exposure and obesity outcomes that were varying in time; 28 reported varying outcomes but fixed exposures; and 6 had fixed outcomes and varying exposures.

Conclusion

Our typology illustrates the variety of longitudinal designs that were used in the selected studies. In the light of our results, we make recommendations on how to better report longitudinal designs and facilitate comparisons between studies.

Investigation of an extensive outbreak of HIV infection among children in Sindh, Pakistan: protocol for a matched case-control study

Por: Siddiqui · A. R. · Ali Nathwani · A. · Abidi · S. H. · Mahmood · S. F. · Azam · I. · Sawani · S. · Kazi · A. M. · Hotwani · A. · Memon · S. A. · Soomro · J. · Shaikh · S. A. · Achakzai · B. · Saeed · Q. · Simms · V. · Khan · P. · Ferrand · R. · Mir · F.
Introduction

In April 2019, 14 children were diagnosed with HIV infection by a private healthcare provider in Larkana district, Sindh province, Pakistan. Over the next 3 months, 930 individuals were diagnosed with HIV, >80% below 16 years, the largest ever outbreak of HIV in children in Pakistan. In this protocol paper, we describe research methods for assessing likely modes of HIV transmission in this outbreak and investigate spatial and molecular epidemiology.

Methods and analysis

A matched case–control study will be conducted with 406 cases recruited. Cases will be children aged below 16 years registered for care at the HIV treatment centre at Shaikh Zayed Children Hospital in Larkana City. Controls will be children who are HIV-uninfected (confirmed by a rapid HIV test) matched 1:1 by age (within 1 year), sex and neighbourhood. Following written informed consent from the guardian, a structured questionnaire will be administered to collect data on sociodemographic indices and exposure to risk factors for parenteral, vertical and sexual (only among those aged above 10 years) HIV transmission. A blood sample will be collected for hepatitis B and C serology (cases and controls) and HIV lineage studies (cases only). Mothers of participants will be tested for HIV to investigate the possibility of mother-to-child transmission. Conditional logistic regression will be used to investigate the association of a priori defined risk factors with HIV infection. Phylogenetic analyses will be conducted. Global positioning system coordinates of participants’ addresses will be collected to investigate concordance between the genetic and spatial epidemiology.

Ethics and dissemination

Ethical approval was granted by the Ethics Review Committee of the Aga Khan University, Karachi. Study results will be shared with Sindh and National AIDS Control Programs, relevant governmental and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals.

Effect of face-to-face verbal feedback compared with no or alternative feedback on the objective workplace task performance of health professionals: a systematic review and meta-analysis

Por: Johnson · C. E. · Weerasuria · M. P. · Keating · J. L.
Objective

Verbal face-to-face feedback on clinical task performance is a fundamental component of health professions education. Experts argue that feedback is critical for performance improvement, but the evidence is limited. The aim of this systematic review was to investigate the effect of face-to-face verbal feedback from a health professional, compared with alternative or no feedback, on the objective workplace task performance of another health professional.

Design

Systematic review and meta-analysis.

Methods

We searched the full holdings of Ovid MEDLINE, CENTRAL, Embase, CINAHL and PsycINFO up to 1 February 2019 and searched references of included studies. Two authors independently undertook study selection, data extraction and quality appraisal. Studies were included if they were randomised controlled trials investigating the effect of feedback, in which health professionals were randomised to individual verbal face-to-face feedback compared with no feedback or alternative feedback and available as full-text publications in English. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach. For feedback compared with no feedback, outcome data from included studies were pooled using a random effects model.

Results

In total, 26 trials met the inclusion criteria, involving 2307 participants. For the effect of verbal face-to-face feedback on performance compared with no feedback, when studies at high risk of bias were excluded, eight studies involving 392 health professionals were included in a meta-analysis: the standardised mean difference (SMD) was 0.7 (95% CI 0.37 to 1.03; p

Conclusions

Verbal face-to-face feedback in the health professions may result in a moderate to large improvement in workplace task performance, compared with no feedback. However, the quality of evidence was low, primarily due to risk of bias and publication bias. Further research is needed. In particular, we found a lack of high-quality trials that clearly reported key components likely to influence performance.

Trial registration number

CRD42017081796.

Mixed-methods approach to understanding clinician macrocognition in the design of a clinical decision support tool: a study protocol

Por: Assadi · A. · Laussen · P. · Trbovich · P.
Introduction

The anatomic variants of congenital heart disease (CHD) are multiple. The increased survival of these patients and disposition into communities has led to an increase in their acute presentation to non-CHD experts in primary care clinics and emergency departments. Given the vulnerability and fragility of these patients in the face of acute illness, new clinical decision support systems (CDSS) are urgently needed to better translate the best practice recommendations for the care of these patients. This study aims to understand the perceived confidence and macrocognitive processes of non-CHD experts (emergency medicine physicians) and CHD experts (paediatric cardiac intensivists) when treating children with CHD during acute illness and apply this to optimise the design of a CDSS (MyHeartPass) for these patients.

Methods and analysis

The first phase of the study involves a survey of non-CHD experts and CHD experts to understand their perceived confidence as it relates to treating acutely ill patients with CHD. The second phase is a qualitative cognitive task analysis using critical decision method to characterise and compare the macrocognitive processes used by non-CHD experts and CHD experts during the critical decision making. In phases 3 and 4, heuristic evaluation and usability testing of the CDSS will be completed. These results will be used to inform design changes to the chosen CDSS (MyHeartPass). In the final phase, a within-participant simulation design will be used to study the effect of the CDSS on clinical decision making compared with baseline (without use of CDSS).

Ethics and dissemination

Ethics approval from The Hospital for Sick Children in Toronto, Ontario, Canada has been obtained for all phases. Results will be published in peer-reviewed journals and presented at relevant conferences. On successful completion of these studies, it is anticipated that there will be a controlled implementation of the redesigned CDSS.

Built environment changes and active transport to school among adolescents: BEATS Natural Experiment Study protocol

Por: Mandic · S. · Hopkins · D. · Garcia Bengoechea · E. · Moore · A. · Sandretto · S. · Coppell · K. · Ergler · C. · Keall · M. · Rolleston · A. · Kidd · G. · Wilson · G. · Spence · J. C.
Introduction

Natural experiments are considered a priority for examining causal associations between the built environment (BE) and physical activity (PA) because the randomised controlled trial design is rarely feasible. Few natural experiments have examined the effects of walking and cycling infrastructure on PA and active transport in adults, and none have examined the effects of such changes on PA and active transport to school among adolescents. We conducted the Built Environment and Active Transport to School (BEATS) Study in Dunedin city, New Zealand, in 2014–2017. Since 2014, on-road and off-road cycling infrastructure construction has occurred in some Dunedin neighbourhoods, including the neighbourhoods of 6 out of 12 secondary schools. Pedestrian-related infrastructure changes began in 2018. As an extension of the BEATS Study, the BEATS Natural Experiment (BEATS-NE) (2019–2022) will examine the effects of BE changes on adolescents’ active transport to school in Dunedin, New Zealand.

Methods and analysis

The BEATS-NE Study will employ contemporary ecological models for active transport that account for individual, social, environmental and policy factors. The published BEATS Study methodology (surveys, accelerometers, mapping, Geographic Information Science analysis and focus groups) and novel methods (environmental scan of school neighbourhoods and participatory mapping) will be used. A core component continues to be the community-based participatory approach with the sustained involvement of key stakeholders to generate locally relevant data, and facilitate knowledge translation into evidence-based policy and planning.

Ethics and dissemination

The BEATS-NE Study has been approved by the University of Otago Ethics Committee (reference: 17/188). The results will be disseminated through scientific publications and symposia, and reports and presentations to stakeholders.

Trial registration number

ACTRN12619001335189.

Mixed-method investigation of health consumers perception and experience of participation in patient safety activities

Por: Lee · N.-J. · Ahn · S. · Lee · M.
Objectives

This study aimed to examine the factors influencing patient safety behaviours and to explore health customers’ experiences of patient participation in the healthcare system.

Design

A mixed-method sequential explanatory design was employed using a survey and focus group interviews with health consumers.

Setting

The study was conducted in South Korea using an online survey tool.

Participants

Survey data were collected from 493 Korean adults, aged 19 years or older, who had visited hospitals within the most recent 1 year. Focus group interviews were conducted in two groups of six participants each among those of the survey participants who agreed to participate in focus groups.

Main outcome measures

The survey measured the recognition of the importance of participation, extent of willingness to participate and experience of engaging in patient safety activities using a 4-point Likert scale. Qualitative data were collected through focus group interviews to explore health consumers’ experience of patient participation in hospital care, and the data were analysed using content analysis.

Results

The average score for experience of participation in patient safety behaviours (2.13±0.63) was found to be lower than those of recognition of the importance of participation (3.27±0.51) and willingness to participate (2.62±0.52). By integrating the results of the quantitative and qualitative data analysis, the factors associated with the experience of engaging in healthcare behaviour included patient-related factors, illness-related factors, factors involving relationship between patients and healthcare providers, and healthcare environment factors.

Conclusions

To improve patient participation, it is necessary to create a healthcare environment in which patients can speak comfortably and to provide an education programme reflecting the patients’ needs. Also, healthcare providers must consider patients as partners for patient safety. Shared decision-making procedures and patient-centred care and patient safety policies should be established in hospitals.

Androgen deprivation therapy and the risk of iron-deficiency anaemia among patients with prostate cancer: a population-based cohort study

Por: Wu · F.-J. · Li · I.-H. · Chien · W.-C. · Shih · J.-H. · Lin · Y.-C. · Chuang · C.-M. · Cheng · Y.-D. · Kao · L.-T.
Objectives

The administration of androgen deprivation therapy (ADT) to patients with metastatic prostate cancer might be associated with some adverse effects such as anaemia; however, few studies have been performed in East Asian populations. This study aimed to investigate the association between ADT and iron-deficiency anaemia (IDA) among patients with prostate cancer in a population-based nationwide cohort.

Design

Cohort study.

Setting

Taiwan.

Participants

Data for the cohort study were retrieved from the Taiwan National Health Insurance Research Database. Propensity score matching was used to select 7262 patients with prostate cancer who received ADT as the study group and 3631 patients who did not receive ADT as the control group.

Primary and secondary outcome measures

This study individually tracked patients over a 3-year study period and identified those who were subsequently diagnosed with IDA following the index date.

Results

The incidence rates of IDA in the study and control groups were 1.66 (95% CI CI 1.45 to 1.86) and 1.01 per 100 person-years (95% CI 0.78 to 1.25), respectively. Furthermore, proportional Cox regression revealed an HR of 1.62 (95% CI 1.24 to 2.12) for IDA in the study group after adjusting for patients’ age, monthly income, geographic location, residential urbanisation level and incidence of hyperlipidaemia, diabetes, hypertension, coronary heart disease, inflammatory bowel disease, other cancers and gastrointestinal bleeding.

Conclusion

Compared with its non-use among patients with prostate cancer, ADT use was associated with a higher risk of IDA.

Management of haemorrhoids: protocol of an umbrella review of systematic reviews and meta-analyses

Por: Chen · M. · Tang · T.-C. · He · T.-H. · Du · Y.-J. · Qin · D. · Zheng · H.
Introduction

The prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.

Methods and analysis

We will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2 statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.

Ethics and dissemination

We will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.

PROSPERO registration number

CRD42019140702.

Impact of the test and treat policy on delays in antiretroviral therapy initiation among adult HIV positive patients from six clinics in Johannesburg, South Africa: results from a prospective cohort study

Por: Onoya · D. · Sineke · T. · Hendrickson · C. · Mokhele · I. · Maskew · M. · Long · L. C. · Fox · M.
Objectives

To assess delays to antiretroviral therapy (ART) initiation before and after the Universal Test and Treat (UTT) and the same-day initiation (SDI) of ART policy periods in Johannesburg, South Africa.

Design

Prospective cohort study.

Setting

Patients were recruited from six primary health clinics in Johannesburg.

Participants

Overall, 1029 newly diagnosed HIV positive adults (≥18 years) were consecutively enrolled by referral from the testing counsellor between April and December 2015 (pre-UTT n=146), July and August 2017 (UTT, n=141) and October 2017 and August 2018 (SDI, n=742).

Main outcome measures

Cox proportional hazards regression was used to assess predictors of 30 days ART initiation. Additionally, predictors of immediate ART initiation were evaluated using Poisson regression.

Results

Overall, 30 days ART proportions were 71.9% overall, 36.9% pre-UTT (44.3% of those eligible), 65.9% under UTT and 79.9% under the SDI policy. The median days to ART initiation declined from 21 pre-UTT (IQR: 15–30) to 8 (IQR: 6–16) under UTT and 5 days (IQR: 0–8) under the SDI policy. However, only 150 (20.2%) of the SDI cohort-initiated ART immediately after HIV diagnosis. Living in a two-adult home (adjusted HR (aHR) 1.2 vs living alone, 95% CI 1.0 to 1.5) increased the likelihood of 30-day ART. Missing baseline cluster of differentiation four (CD4) data decreased the likelihood of 30 days ART by 40% (aHR 0.6 vs CD4 10 months, 95% CI 0.1 to 0.4).

Conclusions

The study results highlight a positive move towards earlier ART initiation during the UTT and SDI periods and emphasise a need to increase same-day ART implementation further.

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