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Ambulatory cancer care electronic symptom self-reporting (ACCESS) for surgical patients: a randomised controlled trial protocol

Por: Stabile · C. · Temple · L. K. · Ancker · J. S. · Basch · E. · Carter · J. · Miranda · M. · Stein · D. · Stetson · P. D. · Vickers · A. · Simon · B. A. · Pusic · A. L.
Introduction

An increasing proportion of cancer surgeries are ambulatory procedures requiring a stay of 1 day or less in the hospital. Providing patients and their caregivers with ongoing, real-time support after discharge aids delivery of high-quality postoperative care in this new healthcare environment. Despite abundant evidence that patient self-reporting of symptoms improves quality of care, the most effective way to monitor and manage this self-reported information is not known.

Methods and analysis

This is a two-armed randomised, controlled trial evaluating two approaches to the management of patient-reported data: (1) team monitoring, symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback, real-time feedback to patients about expected symptom severity, with patient-activated care as needed.

Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750) complete an electronic survey for up to 30 days after surgery that includes items from a validated instrument developed by the National Cancer Institute, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Information provided to patients in the Enhanced Feedback group is procedure-specific and based on updated PRO-CTCAE data from previous patients. Qualitative interviews are also performed. The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).

Ethics and dissemination

This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. The relationships between the study team and stakeholders will be leveraged to disseminate study findings. Findings will be relevant in designing future coordinated care models targeting improved healthcare quality and patient experience.

Trial registration number

NCT03178045

Training machine learning models to predict 30-day mortality in patients discharged from the emergency department: a retrospective, population-based registry study

Por: Blom · M. C. · Ashfaq · A. · Sant'Anna · A. · Anderson · P. D. · Lingman · M.
Objectives

The aim of this work was to train machine learning models to identify patients at end of life with clinically meaningful diagnostic accuracy, using 30-day mortality in patients discharged from the emergency department (ED) as a proxy.

Design

Retrospective, population-based registry study.

Setting

Swedish health services.

Primary and secondary outcome measures

All cause 30-day mortality.

Methods

Electronic health records (EHRs) and administrative data were used to train six supervised machine learning models to predict all-cause mortality within 30 days in patients discharged from EDs in southern Sweden, Europe.

Participants

The models were trained using 65 776 ED visits and validated on 55 164 visits from a separate ED to which the models were not exposed during training.

Results

The outcome occurred in 136 visits (0.21%) in the development set and in 83 visits (0.15%) in the validation set. The model with highest discrimination attained ROC–AUC 0.95 (95% CI 0.93 to 0.96), with sensitivity 0.87 (95% CI 0.80 to 0.93) and specificity 0.86 (0.86 to 0.86) on the validation set.

Conclusions

Multiple models displayed excellent discrimination on the validation set and outperformed available indexes for short-term mortality prediction interms of ROC–AUC (by indirect comparison). The practical utility of the models increases as the data they were trained on did not require costly de novo collection but were real-world data generated as a by-product of routine care delivery.

Do hospital pressures change following rotavirus vaccine introduction? A retrospective database analysis in a large paediatric hospital in the UK

Por: Heinsbroek · E. · Hungerford · D. · Cooke · R. P. D. · Chowdhury · M. · Cargill · J. S. · Bar-Zeev · N. · French · N. · Theodorou · E. · Standaert · B. · Cunliffe · N. A.
Objective

Hospitals in the UK are under increasing clinical and financial pressures. Following introduction of childhood rotavirus vaccination in the UK in 2013, rotavirus gastroenteritis (RVGE) hospitalisations reduced significantly. We evaluated changes in ‘hospital pressures’ (demand on healthcare resources and staff) following rotavirus vaccine introduction in a paediatric setting in the UK.

Design

Retrospective hospital database analysis between July 2007 and June 2015.

Setting

A large paediatric hospital providing primary, secondary and tertiary care in Merseyside, UK.

Participants

Hospital admissions aged

Methods

Hospital pressures were compared before and after rotavirus vaccine introduction: these included bed occupancy, hospital-acquired infection rate, unplanned readmission rate and outlier rate (medical patients admitted to surgical wards due to lack of medical beds). Interrupted time-series analysis was used to evaluate changes in bed occupancy.

Results

There were 116 871 admissions during the study period. Lower bed occupancy in the rotavirus season in the postvaccination period was observed for RVGE (–89%, 95% CI 73% to 95%), acute gastroenteritis (–63%, 95% CI 39% to 78%) and any infection (–23%, 95% CI 15% to 31%). No significant overall reduction in bed occupancy was observed (–4%, 95% CI –1% to 9%). No changes were observed for the other outcomes.

Conclusions

Rotavirus vaccine introduction was not associated with reduced hospital pressures. A reduction in RVGE hospitalisation without change in overall bed occupancy suggests that beds available were used for a different patient population, possibly reflecting a previously unmet need.

Trials registration number

NCT03271593

Assessing the appropriateness of the management of upper respiratory tract infection in Australian children: a population-based sample survey

Por: Long · J. C. · Williams · H. M. · Jani · S. · Arnolda · G. · Ting · H. P. · Molloy · C. J. · Hibbert · P. D. · Churruca · K. · Ellis · L. A. · Braithwaite · J.
Objective

To assess the proportion of Australian children aged 0–15 years that received care in line with clinical practice guidelines (CPGs) for upper respiratory tract infections (URTIs).

Design

Retrospective medical record review using a multistage sampling strategy.

Setting

General practices, hospital emergency departments and hospital inpatient service providers in three Australian states.

Participants

Children aged up to 15 years who received care for URTI in 2012 and 2013.

Primary and secondary outcome measures

The primary assessment was estimated adherence with 14 indicators of appropriate care as documented in medical records. Indicators were extracted from national and international CPGs and ratified by experts. Secondary assessment was adherence to two bundles of indicators (diagnostic symptoms and medical history taking), where all indicators must be adherent for the bundle to be scored as adherent.

Results

There were 1653 children with one or more assessments of URTI care to CPG adherence. Over half of the children were under 3 years of age, with roughly equal numbers of males and females. Three indicators had fewer than 25 visits so were not reported. Overall adherence ranged from 0.5% for ‘documented advice around antibiotics’ to 88.3% for ‘documentation of medical history’. Adherence with Bundle A (documentation of all three definitive symptoms) was 43.1% (95% CI 32.8% to 54.0%) and Bundle B (documentation of all four indicators of medical history) was 30.2% (95% CI 20.9% to 40.9%).

Conclusions

URTIs in children are common, usually self-limiting, conditions that are allocated considerable resources. The results suggest that there may be a need for more thorough holistic assessment of the patient and improved documentation. Since inappropriate prescription of antibiotics for URTIs is still a known problem in Australia, there is a need for consistent, clear communication around antibiotics’ lack of impact on symptoms and a high association with undesirable side effects.

A theory-based, task-oriented, outdoor walking programme for older adults with difficulty walking outdoors: protocol for the Getting Older Adults Outdoors (GO-OUT) randomised controlled trial

Por: Salbach · N. M. · Barclay · R. · Webber · S. C. · Jones · C. A. · Mayo · N. E. · Lix · L. M. · Ripat · J. · Grant · T. · van Ineveld · C. · Chilibeck · P. D.
Introduction

A theory-based, task-oriented, community walking programme can increase outdoor walking activity among older adults to optimise functional independence, social participation and well-being. The study objective is to determine if there is a difference in the change in outdoor walking activity from baseline to 10 weeks, 5.5 months and 12 months after receiving a 1-day interactive workshop and outdoor walking programme (Getting Older Adults Outdoors (GO-OUT)) compared with the workshop and weekly reminders (WR) in older adults with difficulty walking outdoors.

Methods and analysis

A randomised controlled trial is being conducted in four urban Canadian communities. We will stratify 240 individuals by site and participant type (ie, individual vs spousal/friend pair) and randomise to either the GO-OUT or WR intervention. The GO-OUT intervention involves a 1-day workshop, where participants complete eight interactive stations to build knowledge and skills to walk outside, followed by a 10-week group outdoor walking programme (two 1-hour sessions/week) led by a physiotherapist or kinesiologist in parks. The WR intervention consists of the same workshop and 10 weekly telephone reminders to facilitate outdoor walking. The primary outcome measure is mean outdoor walking time in minutes/week derived from accelerometry and global positioning system data. GO-OUT is powered to detect an effect size of 0.4, given α=0.05, β=0.20, equal number of participants/group and a 20% attrition rate. Secondary outcomes include physical activity, lifespace mobility, participation, health-related quality of life, balance, leg strength, walking self-efficacy, walking speed, walking distance/endurance and mood.

Ethics and dissemination

GO-OUT has received ethics approval at all sites. A Data Safety Monitoring Board will monitor adverse events. We will disseminate findings through lay summaries, conference presentations and journal articles.

Trial registration number

NCT03292510 (Pre-results).

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

Por: Browne · P. D. · den Hollander · B. · Speksnijder · E. M. · van Wering · H. M. · Tjon a Ten · W. · George · E. K. · Groeneweg · M. · Bevers · N. · Wessels · M. M. S. · van den Berg · M. M. · Goede · J. · Teklenburg-Roord · S. T. A. · Frankenhuis · C. · Benninga · M. A. · Vlieger · A
Introduction

The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.

Methods and analysis

To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.

Ethics and dissemination

Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.

Trial registration number

NTR5814.

The impact of general practitioners working in or alongside emergency departments: a rapid realist review

Por: Cooper · A. · Davies · F. · Edwards · M. · Anderson · P. · Carson-Stevens · A. · Cooke · M. W. · Donaldson · L. · Dale · J. · Evans · B. A. · Hibbert · P. D. · Hughes · T. C. · Porter · A. · Rainer · T. · Siriwardena · A. · Snooks · H. · Edwards · A.
Objectives

Worldwide, emergency healthcare systems are under intense pressure from ever-increasing demand and evidence is urgently needed to understand how this can be safely managed. An estimated 10%–43% of emergency department patients could be treated by primary care services. In England, this has led to a policy proposal and £100 million of funding (US$130 million), for emergency departments to stream appropriate patients to a co-located primary care facility so they are ‘free to care for the sickest patients’. However, the research evidence to support this initiative is weak.

Design

Rapid realist literature review.

Setting

Emergency departments.

Inclusion criteria

Articles describing general practitioners working in or alongside emergency departments.

Aim

To develop context-specific theories that explain how and why general practitioners working in or alongside emergency departments affect: patient flow; patient experience; patient safety and the wider healthcare system.

Results

Ninety-six articles contributed data to theory development sourced from earlier systematic reviews, updated database searches (Medline, Embase, CINAHL, Cochrane DSR & CRCT, DARE, HTA Database, BSC, PsycINFO and SCOPUS) and citation tracking. We developed theories to explain: how staff interpret the streaming system; different roles general practitioners adopt in the emergency department setting (traditional, extended, gatekeeper or emergency clinician) and how these factors influence patient (experience and safety) and organisational (demand and cost-effectiveness) outcomes.

Conclusions

Multiple factors influence the effectiveness of emergency department streaming to general practitioners; caution is needed in embedding the policy until further research and evaluation are available. Service models that encourage the traditional general practitioner approach may have shorter process times for non-urgent patients; however, there is little evidence that this frees up emergency department staff to care for the sickest patients. Distinct primary care services offering increased patient choice may result in provider-induced demand. Economic evaluation and safety requires further research.

PROSPERO registration number

CRD42017069741.

Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device

Por: Reis · Z. S. N. · Guimaraes · R. N. · Rego · M. A. S. · Maia de Castro Romanelli · R. · Gaspar · J. d. S. · Vitral · G. L. N. · dos Reis · M. A. A. · Colosimo · E. A. · Neves · G. S. · Vale · M. S. · Nader · P. d. J. H. · de Moura · M. D. R. · de Aguiar · R. A. P. L.
Introduction

Recognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.

Methods and analysis

Research protocol for diagnosis, single­group, single­blinding and single­arm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.

Ethics and dissemination

Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.

Trial registration number

RBR-3f5bm5.

Can the appropriateness of eye care be measured through cross-sectional retrospective patient record review in eye care practices in Australia? The iCareTrack feasibility study

Por: Ho · K. C. · Rahardjo · D. · Stapleton · F. · Wiles · L. · Hibbert · P. D. · White · A. J. R. · Hayen · A. · Jalbert · I.
Objectives

The CareTrack study found that a wide range of appropriateness of care (ie, care in line with evidence-based or consensus-based guidelines) was delivered across many health conditions in Australia. This study therefore aimed to demonstrate the feasibility of using the CareTrack method (a retrospective onsite record review) to measure the appropriateness of eye care delivery.

Design

Cross-sectional feasibility study.

Setting and participants

Two hundred and thirteen patient records randomly selected from eight optometry and ophthalmology practices in Australia, selected through a combination of convenience and maximum variation sampling.

Methods

Retrospective record review designed to assess the alignment between eye care delivered and 93 clinical indicators (Delphi method involving 11 experts) extracted from evidence-based clinical practice guidelines.

Primary outcome measure

Number of eligible patient records, sampling rates and data collection time. This feasibility study also tested the ability of 93 clinical indicators to measure percentage appropriate eye care for preventative, glaucoma and diabetic eye care. A secondary outcome was the percentage of practitioner–patient encounters at which appropriate eye care was received.

Results

A median of 20 records (range 9 to 63) per practice were reviewed. Data collection time ranged from 3 to 5.5 hours (median 3.5). The most effective sampling strategy involved random letter generation followed by sequential sampling. The appropriateness of care was 69% (95% CI 67% to 70%) for preventative eye care, 60% (95% CI 56% to 58%) for glaucoma and 63% (95% CI 57% to 69%) for diabetic eye care.

Conclusions

Appropriateness of eye care can be measured effectively using retrospective record review of eye care practices and consensus-based care indicators.

The economics of physical activity in low-income and middle-income countries: protocol for a systematic review

Por: Ranasinghe · P. D. · Pokhrel · S. · Anokye · N. K.
Introduction

Evidence on the economic costs of physical inactivity and the cost-effectiveness of physical activity interventions in low-income and middle-income countries (LMICs) is sparse, and fragmented where they are available. This is the first review aimed to summarise available evidence on economics of physical activity in LMICs, identify potential target variables for policy, and identify and report gaps in the current knowledge on economics of physical activity in LMICs.

Methods and analysis

Peer-reviewed journal articles of observational, experimental, quasi-experimental and mixed-method studies on economics of physical activity in LMICs will be identified by a search of electronic databases; Scopus, Web of Science and SPORTDiscus. Websites of WHO, the National Institute for Health and Care Excellence international, World Bank and reference lists of included studies will be searched for relevant studies. The study selection process will be a two-stage approach; title and abstract screen for inclusion, followed by a review of selected full-text articles by two independent reviewers. Disagreements will be resolved by consensus and discussion with a third reviewer. Data will be extracted using standardised piloted data extraction forms. Risk of bias will be critically appraised using standard checklists based on study designs. Descriptive synthesis of data is planned. Where relevant, summaries of studies will be classified according to type of economic analysis, country or country category, population, intervention, comparator, outcome and study design. Meta-analysis will be performed where appropriate. This protocol for systematic review is prepared according to the Preferred Reporting Items for Systematic review and Meta-analysis for Protocols –2015 statement.

Ethics and dissemination

Ethical approval is not obtained as original data will not be collected as part of this review. The completed review will be submitted for publication in a peer-reviewed journal and presented at conferences.

PROSPERO registration number

CRD42018099856.

Lack of serological and molecular evidence of arbovirus infections in bats from Brazil

by Cíntia Bittar, Rafael R. G. Machado, Manuela T. Comelis, Larissa M. Bueno, Eliana Morielle-Versute, Matheus R. Beguelini, Renato P. de Souza, Maurício L. Nogueira, Paula Rahal

Viruses are important agents of emerging zoonoses and are a substantial public health issue. Among emerging viruses, an important group are arboviruses, which are characterized by being maintained in nature in cycles involving hematophagous arthropod vectors and a wide range of vertebrate hosts. Recently, bats have received increasing attention as an important source for the emergence of zoonoses and as possible viral reservoirs. Among the arboviruses, there are many representatives of the genera Flavivirus and Alphavirus, which are responsible for important epidemics such as Dengue virus, Zika virus and Chikungunya virus. Due to the importance of analyzing potential viral reservoirs for zoonosis control and expanding our knowledge of bat viruses, this study aimed to investigate the presence of viruses of the Alphavirus and Flavivirus genera in bats. We analyzed serum, liver, lungs and intestine from 103 bats sampled in northeast and southern Brazil via Nested-PCR and the hemagglutination inhibition test. All samples tested in this study were negative for arboviruses, suggesting that no active or past infection was present in the captured bats. These data indicate that the bats examined herein probably do not constitute a reservoir for these viruses in the studied areas. Further studies are needed to clarify the role of bats as reservoirs and sources of infection of these viral zoonoses.
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