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What influences allied health clinician participation in research in the public hospital setting: a qualitative theory-informed approach

Por: Wenke · R. · Noble · C. · Weir · K. A. · Mickan · S.
Objectives

Using theoretical frameworks from implementation science, we aimed to systematically explore the barriers and enablers to research active allied health professionals (AHP) participating and leading research in the hospital setting.

Design

A qualitative interview study informed by behaviour change theory.

Setting

Single Australian tertiary hospital and health service.

Participants

We recruited a convenience sample of 21 AHPs working within a hospital who were seeking to actively participate in/or lead research within their workplace.

Data collection

Semistructured interviews explored perceived barriers and enablers to research participation, informed by the 14 domains of the theoretical domains framework (TDF). Transcribed interviews were deductively coded and mapped to the TDF. A deeper level of inductive coding was used to identify emergent themes that influenced behaviour change, according to the three key constructs of: capability, opportunity and motivation (COM-B).

Results

Barriers and enablers to research participation were identified within nine predominant domains of the TDF. Most enablers to engaging in research related to the motivation or opportunity constructs of the COM-B. These enablers included positive beliefs about the consequences of research participation, enabling social influences, peer support and motivation for skill development and to inform practice. Predominant barriers related to environmental context and resources (eg, reduced funding or time), emotional responses of being overwhelmed and perceptions of reduced capability.

Conclusion

This study identified key barriers and enablers to behaviour change related to AHPs participating and/or leading research. Motivation and opportunities to participate in research may be enabled by maximising social influence opportunities, reiterating beliefs about positive consequences of research and considering AHP’s emotional responses. Implementation science frameworks may provide a more systematic and holistic understanding of factors which influence research participation including enhancing knowledge, motivation and opportunity.

Potentially addictive drugs dispensing to patients receiving opioid agonist therapy: a register-based prospective cohort study in Norway and Sweden from 2015 to 2017

Por: Vold · J. H. · Aas · C. · Skurtveit · S. · Odsbu · I. · Chalabianloo · F. · Reutfors · J. · Halmoy · A. · Johansson · K. A. · Fadnes · L. T.
Objectives

To compare the use of benzodiazepines, z-hypnotics, gabapentinoids, opioids and centrally acting stimulants (CAS) among patients who had received opioid agonist therapy (OAT) in Norway and Sweden during the period 2015 - 2017.

Design

A register-based prospective cohort study using information about dispensed drugs from the Norwegian Prescription Database and Swedish Prescribed Drug Register.

Setting

Patients who were dispensed OAT opioids from pharmacies.

Participants

A total of 7176 Norwegian and 3591 Swedish patients on OAT were included.

Outcome measures

The number and frequency of potentially addictive drugs dispensed were calculated for the two countries. The mean daily doses of dispensed benzodiazepines and z-hypnotics were summarised by calculating benzodiazepines in diazepam equivalents and z-hypnotics in zopiclone equivalents.

Results

In 2017, 46% of patients in Norway, and 15% in Sweden, were dispensed a benzodiazepine. Moreover, 14% in Norway and 26% in Sweden received z-hypnotics. Gabapentinoids were dispensed to 10% of patients in Norway and 19% of patients in Sweden. In Norway, 6% and 12% of the patients received strong and weak non-OAT opioids, respectively, whereas in Sweden 10% were dispensed strong non-OAT opioids and 5% weak non-OAT opioids . CAS were dispensed to 4% in Norway and 18% in Sweden. The mean daily doses of benzodiazepines were 16 and 17 mg diazepam equivalents in Norway and Sweden, respectively. For z-hypnotics, the mean daily dose was 8 mg zopiclone equivalents in both countries. ‘Benzodiazepines and z-hypnotics’ was the most dispensed drug combination in 2017. Similar results were found in 2015 and 2016.

Conclusions

Nearly half of those patients who were dispensed an OAT opioid in Norway and Sweden were dispensed potentially addictive drugs. The differences identified between Norway and Sweden might be related to differences in eligibility guidelines and restrictions with respect to OAT.

Inferred duration of infectious period of SARS-CoV-2: rapid scoping review and analysis of available evidence for asymptomatic and symptomatic COVID-19 cases

Por: Byrne · A. W. · McEvoy · D. · Collins · A. B. · Hunt · K. · Casey · M. · Barber · A. · Butler · F. · Griffin · J. · Lane · E. A. · McAloon · C. · O'Brien · K. · Wall · P. · Walsh · K. A. · More · S. J.
Objectives

Our objective was to review the literature on the inferred duration of the infectious period of COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, and provide an overview of the variation depending on the methodological approach.

Design

Rapid scoping review. Literature review with fixed search terms, up to 1 April 2020. Central tendency and variation of the parameter estimates for infectious period in (A) asymptomatic and (B) symptomatic cases from (1) virological studies (repeated testing), (2) tracing studies and (3) modelling studies were gathered. Narrative review of viral dynamics.

Information sources

Search strategies developed and the following searched: PubMed, Google Scholar, MedRxiv and BioRxiv. Additionally, the Health Information Quality Authority (Ireland) viral load synthesis was used, which screened literature from PubMed, Embase, ScienceDirect, NHS evidence, Cochrane, medRxiv and bioRxiv, and HRB open databases.

Results

There was substantial variation in the estimates, and how infectious period was inferred. One study provided approximate median infectious period for asymptomatic cases of 6.5–9.5 days. Median presymptomatic infectious period across studies varied over

Conclusions

There are limitations of inferring infectiousness from repeated diagnosis, viral loads and viral replication data alone and also potential patient recall bias relevant to estimating exposure and symptom onset times. Despite this, available data provide a preliminary evidence base to inform models of central tendency for key parameters and variation for exploring parameter space and sensitivity analysis.

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.

Rat bite as a cause of diabetic foot ulcer in sub‐Saharan Africa

Abstract

There have been relatively few reports of foot ulcers in diabetes resulting from rat bite. The findings were derived from people attending a single specialist service in Dar es Salaam for diabetic foot ulcers (DFUs) between 1 January 1999 and 31 December 2016. Details from people presenting for the first time with an ulcer judged to be caused by rat bite were compared with those with from other causes of foot ulcer. There were 426 first recorded foot ulcer episodes (in 179 people) judged to be caused by rat bite. The affected population was significantly younger (mean 55.9 vs 57.5 years, P = .037) and had a lower body mass index (26.5 vs 27.9, P = .008) than controls with other types of foot ulcer. They also presented significantly sooner (7.8 vs 18.2 days, P < .001) and were more likely to heal (85.8 vs 5.5%, P < .001), even though there was also a trend towards an increased risk of death (9.1% vs 5.3%, P = .032). Rat bite is an uncommon cause of DFU, but is not rare. Although the incidence of ulcer healing is higher than in a general foot ulcer population, the incidence of death is also higher.

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.

Physical activity and risk of behavioural and mental health disorders in kindergarten children: analysis of a series of cross-sectional complete enumeration (census) surveys

Por: O'Brien · K. · Agostino · J. · Ciszek · K. · Douglas · K. A.
Objectives

There is mixed evidence on the relationship between physical activity and behavioural and mental health. We aimed to estimate the association between physical activity and risk of behavioural and mental health disorders in early school-aged children.

Design

A series of cross-sectional complete enumeration (census) surveys.

Settings

All primary schools in the Australian Capital Territory, 2014–2016.

Participants

All children enrolled in their first year of full-time primary education (kindergarten) were invited to participate. Of the 16 662 eligible kindergarten children, 15 040 completed the survey for the first time.

Outcome measures

Average daily physical activity participation and prevalence of risk of behavioural and mental health disorders derived from parent-reported data and the Strengths and Difficulties Questionnaire (SDQ). Characteristics associated with SDQ Total difficulties and subscales were estimated using logistic regression.

Results

8340 (61.7%) children met physical activity targets (60 min or more daily) and 709 (4.8%) were at clinically significant risk of behavioural and mental health disorders (Total difficulties).

Known sociodemographic correlates were also those variables associated with high risk of behavioural and mental health disorders (Total difficulties): Aboriginal and Torres Strait Islander status (OR 2.72, 95% CI 1.78–4.16), relative socioeconomic disadvantage (most disadvantaged vs least disadvantaged, OR 1.86, 95% CI 1.38–2.50) and male sex (OR 1.80, 95% CI 1.49–2.17). Average daily physical activity was not significant, despite the highest levels of physical activity (90 min or more daily) being reported in boys, Aboriginal and Torres Strait Islander children and those from more disadvantaged areas.

Conclusions

Our study provides comprehensive cross-sectional data on the relationship between physical activity participation and the risk of behavioural and mental health disorders in a large cohort of early school-aged Australian children. Aboriginal and Torres Strait Islander children, boys and those from the most disadvantaged socioeconomic group were at greatest risk of clinically significant behavioural and mental health disorders.

Returning to daily life: a qualitative interview study on parents of childhood cancer survivors in Germany

Por: Peikert · M. L. · Inhestern · L. · Krauth · K. A. · Escherich · G. · Rutkowski · S. · Kandels · D. · Bergelt · C.
Objectives

To investigate experiences of parents of paediatric cancer survivors in cancer-related changes in the parents’ daily life (work life, family life, partner relationship and social life) during and after intensive cancer treatment and to examine the reintegration process with its impeding and facilitating factors.

Design

The design of this cross-sectional study involves a qualitative content analysis of semistructured interviews.

Setting

Participants were consecutively recruited in clinical settings throughout Germany.

Participants

Forty-nine parents (59% female) of 31 cancer survivors (aged 0–17 at diagnosis of leukaemia or central nervous system tumour) were interviewed approximately 16–24 months after the end of intensive cancer treatment (eg, chemotherapy).

Results

During treatment, more than 70% of parents reported difficulties reconciling paid work, household and family responsibilities and caring for the ill child. Couples spent little time with each other and approximately 25% reported dispute and burden. Many parents did not have enough energy for pursuing any hobbies during treatment. However, over the long term, being faced with the child’s disease also led to strengthened relationships, new priorities, improved communication, increased mutual trust and greater appreciation for daily life. Supportive social networks (family/friends/employers), a strong partner relationship prior to the diagnosis and the use of psychosocial services (eg, family-oriented rehabilitation) had a positive impact. At the time of the interview, most families had adapted well. However, reintegration took time and some parents lacked the energy required to continue life as they did before the diagnosis.

Conclusions

Even though most parents successfully readjusted to a new ‘normality’, reintegrating into daily life after paediatric cancer treatment remains difficult. Professional psychosocial support could help families with the reintegration process. Lastly, clinical staff (eg, physicians, psychologists, social workers) should bear in mind that the burden of parents does not automatically end with the end of intensive cancer treatment.

'Ive always done what I was told by the medical people: a qualitative study of the reasons why older adults attend multifactorial falls risk assessments mapped to the Theoretical Domains Framework

Por: Racine · E. · Soye · A. · Barry · P. · Cronin · F. · Hosford · O. · Moriarty · E. · OConnor · K. A. · Turvey · S. · Timmons · S. · Kearney · P. M. · McHugh · S. M.
Objectives

Multifactorial falls risk assessments reduce the rate of falls in older people and are recommended by international guidelines. Despite their effectiveness, their potential impact is often constrained by barriers to implementation. Attendance is an issue. The aim of this study was to explore why older people attend community-based multifactorial falls risk assessment clinics, and to map these reasons to a theoretical framework.

Design

This is a qualitative study. Semi-structured interviews were conducted and analysed thematically. Each theme and subtheme were then mapped onto the Theoretical Domains Framework (TDF) to identify the determinants of behaviour.

Participants

Older adults (aged 60 and over) who attended community-based multifactorial falls risk assessments.

Results

Sixteen interviews were conducted. Three main themes explained participants’ reasons for attending the multifactorial risk assessment; being that ‘type of person’, being ‘linked in’ with health and community services and having ‘strong social support’. Six other themes were identified, but these themes were not as prominent during interviews. These were knowing what to expect, being physically able, having confidence in and being positive towards health services, imagining the benefits given previous positive experiences, determination to maintain or regain independence, and being ‘crippled’ by the fear of falling. These themes mapped on to nine TDF domains: ‘knowledge’, ‘skills’, ‘social role and identity’, ‘optimism’, ‘beliefs about consequences’, ‘goals’, ‘environmental context and resources’, ‘social influences’ and ‘emotion’. There were five TDF domains that were not relevant to the reasons for attending.

Conclusions

These findings provide theoretically based factors that influence attendance which can be used to inform the development of interventions to improve attendance to falls prevention programmes.

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

Por: Wasmann · K. A. · Wijsman · P. · van Dieren · S. · Bemelman · W. · Buskens · C.
Objective

Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.

Design

Systematic review and meta-analyses.

Data sources

MEDLINE, Embase, PsycINFO and the Cochrane Library.

Eligibility criteria for selecting studies

RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.

Data extraction and synthesis

Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.

Results

In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI –0.178 to 0.364, p=0.502).

Conclusions

Patients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.

PROSPERO registration number

CRD42019094438.

Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial

Por: Shickh · S. · Clausen · M. · Mighton · C. · Gutierrez Salazar · M. · Zakoor · K.-R. · Kodida · R. · Reble · E. · Elser · C. · Eisen · A. · Panchal · S. · Aronson · M. · Graham · T. · Armel · S. R. · Morel · C. F. · Fattouh · R. · Glogowski · E. · Schrader · K. A. · Hamilton · J. G. · Offit
Introduction

Genomic sequencing has rapidly transitioned into clinical practice, improving diagnosis and treatment options for patients with hereditary disorders. However, large-scale implementation of genomic sequencing faces challenges, especially with regard to the return of incidental results, which refer to genetic variants uncovered during testing that are unrelated to the primary disease under investigation, but of potential clinical significance. High-quality evidence evaluating health outcomes and costs of receiving incidental results is critical for the adoption of genomic sequencing into clinical care and to understand the unintended consequences of adoption of genomic sequencing. We aim to evaluate the health outcomes and costs of receiving incidental results for patients undergoing genomic sequencing.

Methods and analysis

We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing in a mixed-methods randomised controlled trial. Two hundred and sixty patients who have previously undergone first or second-tier genetic testing for cancer and received uninformative results will be recruited from familial cancer clinics in Toronto, Ontario. Participants in both arms will receive cancer-related results. Participants in the intervention arm have the option to receive incidental results. Our primary outcome is psychological distress at 2 weeks following return of results. Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years. A subset of participants and providers will complete qualitative interviews about utility of incidental results.

Ethics and dissemination

This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System that provides ethical review and oversight for multiple sites participating in the same clinical trial in Ontario.

Results from the trial will be shared through stakeholder workshops, national and international conferences, and peer-reviewed journals.

Trial registration number

NCT03597165.

Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients

Por: McLean · K. A. · Mountain · K. E. · Shaw · C. A. · Drake · T. M. · Ots · R. · Knight · S. R. · Fairfield · C. J. · Sgro · A. · Skipworth · R. J. E. · Wigmore · S. J. · Potter · M. A. · Harrison · E. M.
Introduction

National data suggest that surgical site infection (SSI) complicates 2%–10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.

Methods and analysis

This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention – use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.

Ethics and dissemination

This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.

Trial registration number

NCT02704897; Pre-results.

Using population-wide administrative and laboratory data to estimate type- and subtype-specific influenza vaccine effectiveness: a surveillance protocol

Por: Scott · A. N. · Buchan · S. A. · Kwong · J. C. · Drews · S. J. · Simmonds · K. A. · Svenson · L. W.
Introduction

The appropriateness of using routinely collected laboratory data combined with administrative data for estimating influenza vaccine effectiveness (VE) is still being explored. This paper outlines a protocol to estimate influenza VE using linked laboratory and administrative data which could act as a companion to estimates derived from other methods.

Methods and analysis

We will use the test-negative design to estimate VE for each influenza type/subtype and season. Province-wide individual-level records of positive and negative influenza tests at the Provincial Laboratory for Public Health in Alberta will be linked, by unique personal health numbers, to administrative databases and vaccination records held at the Ministry of Health in Alberta to determine covariates and influenza vaccination status, respectively. Covariates of interests include age, sex, immunocompromising chronic conditions and healthcare setting. Cases will be defined based on an individual’s first positive influenza test during the season, and potential controls will be defined based on an individual’s first negative influenza test during the season. One control for each case will be randomly selected based on the week the specimen was collected. We will estimate VE using multivariable logistic regression.

Ethics and dissemination

Ethics approval was obtained from the University of Alberta’s Health Research Ethics Board—Health Panel under study ID Pro00075997. Results will be disseminated by public health officials in Alberta.

Prospective longitudinal study of tobacco company adaptation to standardised packaging in the UK: identifying circumventions and closing loopholes

Por: Evans-Reeves · K. A. · Hiscock · R. · Lauber · K. · Gilmore · A. B.
Objectives

UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation.

Design, setting and intervention

A prospective study of the introduction of standardised packaging of tobacco products to the UK.

Participants and outcomes

We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications).

Results

One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco.

Conclusions

Tobacco companies adapted to packaging restrictions by innovating their tobacco products and marketing activities. These findings should enable policy makers globally to close loopholes and increase the potential efficacy of standardised packaging policies.

Biobanking for discovery of novel cardiovascular biomarkers using imaging-quantified disease burden: protocol for the longitudinal, prospective, BioHEART-CT cohort study

Por: Kott · K. A. · Vernon · S. T. · Hansen · T. · Yu · C. · Bubb · K. J. · Coffey · S. · Sullivan · D. · Yang · J. · O'Sullivan · J. · Chow · C. · Patel · S. · Chong · J. · Celermajer · D. S. · Kritharides · L. · Grieve · S. M. · Figtree · G. A.
Introduction

Coronary artery disease (CAD) persists as a major cause of morbidity and mortality worldwide despite intensive identification and treatment of traditional risk factors. Data emerging over the past decade show a quarter of patients have disease in the absence of any known risk factor, and half have only one risk factor. Improvements in quantification and characterisation of coronary atherosclerosis by CT coronary angiography (CTCA) can provide quantitative measures of subclinical atherosclerosis—enhancing the power of unbiased ‘omics’ studies to unravel the missing biology of personal susceptibility, identify new biomarkers for early diagnosis and to suggest new targeted therapeutics.

Methods and analysis

BioHEART-CT is a longitudinal, prospective cohort study, aiming to recruit 5000 adult patients undergoing clinically indicated CTCA. After informed consent, patient data, blood samples and CTCA imaging data are recorded. Follow-up for all patients is conducted 1 month after recruitment, and then annually for the life of the study. CTCA data provide volumetric quantification of total calcified and non-calcified plaque, which will be assessed using established and novel scoring systems. Comprehensive molecular phenotyping will be performed using state-of-the-art genomics, metabolomics, proteomics and immunophenotyping. Complex network and machine learning approaches will be applied to biological and clinical datasets to identify novel pathophysiological pathways and to prioritise new biomarkers. Discovery analysis will be performed in the first 1000 patients of BioHEART-CT, with validation analysis in the following 4000 patients. Outcome data will be used to build improved risk models for CAD.

Ethics and dissemination

The study protocol has been approved by the human research ethics committee of North Shore Local Health District in Sydney, Australia. All findings will be published in peer-reviewed journals or at scientific conferences.

Trial registration number

ACTRN12618001322224.

Passive versus active intra-abdominal drainage following pancreatic resection: does a superior drainage system exist? A protocol for systematic review

Por: Park · L. · Baker · L. · Smith · H. · Davies · A. · Abou Khalil · J. · Martel · G. · Balaa · F. · Bertens · K. A.
Background

Clinically relevant postoperative pancreatic fistula (CR-POPF) is the most common cause of major morbidity following pancreatic resection. Intra-abdominal drains are frequently positioned adjacent to the pancreatic anastomosis or transection margin at the time of surgery to aid in detection and management of CR-POPF. Drains can either evacuate fluid by passive gravity (PG) or be attached to a closed suction (CS) system using negative pressure. There is controversy as to whether one of these two systems is superior. The objective of this review is to identify and compare the incidence of adverse events (AEs) and resource utilisation associated with PG and CS drainage following pancreatic resections.

Methods and analysis

MEDLINE, EMBASE, CINAHL and Cochrane Central Registry of Controlled Trials will be searched from inception to April 2019, to identify interventional and observational studies comparing PG and CS drains following pancreatic resection. The primary outcome is POPF as defined by the International Study Group for Pancreatic Fistula in 2017. Secondary outcomes include postoperative AE, resource utilisation (length of stay, return to emergency department, readmission and reintervention), time to drain removal and quality of life. Study selection, data extraction and risk of bias assessment will be performed independently, by two reviewers. A meta-analysis will be conducted if deemed statistically appropriate. Subgroup analysis by study design will be performed. Study heterogeneity will be calculated with the 2 test and reported as I2 statistics. Statistical analyses will be conducted and displayed using RevMan V.5.3

Ethics and dissemination

Ethics approval is not required. The results of this study will be submitted to relevant conferences for presentation and peer-reviewed journals for publication.

PROSPERO registration number

CRD42019123647.

Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial

Por: Collins · K. A. · Ouedraogo · A. · Guelbeogo · W. M. · Awandu · S. S. · Stone · W. · Soulama · I. · Ouattara · M. S. · Nombre · A. · Diarra · A. · Bradley · J. · Selvaraj · P. · Gerardin · J. · Drakeley · C. · Bousema · T. · Tiono · A.
Introduction

A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.

Methods and analysis

This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.

Ethics and dissemination

The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).

Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.

Trial registration number

NCT03705624.

Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK: protocol of the UKGRIS cluster-randomised registry-based trial

Por: Everett · C. C. · Fox · K. A. · Reynolds · C. · Fernandez · C. · Sharples · L. · Stocken · D. D. · Carruthers · K. · Hemingway · H. · Yan · A. T. · Goodman · S. G. · Brieger · D. · Chew · D. P. · Gale · C. P.
Introduction

For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.

Methods and analysis

The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.

Ethics and dissemination

The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder’s open access policy.

Trial registration number

ISRCTN29731761; Pre-results.

Comparison of ventilatory modes to facilitate liberation from mechanical ventilation: protocol for a systematic review and network meta-analysis

Por: Lewis · K. A. · Chaudhuri · D. · Guyatt · G. · Burns · K. E. A. · Bosma · K. · Ge · L. · Karachi · T. · Piraino · T. · Fernando · S. M. · Ranganath · N. · Brochard · L. · Rochwerg · B.
Introduction

Timely liberation from invasive mechanical ventilation is important to reduce the risk of ventilator-associated complications. Once a patient is deemed ready to tolerate a mode of partial ventilator assist, clinicians can use one of multiple ventilatory modes. Despite multiple trials, controversy regarding the optimal ventilator mode to facilitate liberation remains. Herein, we report the protocol for a systematic review and network meta-analysis comparing modes of ventilation to facilitate the liberation of a patient from invasive mechanical ventilation.

Methods and analysis

We will search MEDLINE, EMBASE, PubMed, the Cochrane Library from inception to April 2019 for randomised trials that report on critically ill adults who have undergone invasive mechanical ventilation for at least 24 hours and have received any mode of assisted invasive mechanical ventilation compared with an alternative mode of assisted ventilation. Outcomes of interest will include: mortality, weaning success, weaning duration, duration of mechanical ventilation, duration of stay in the acute care setting and adverse events. Two reviewers will independently screen in two stages, first titles and abstracts, and then full texts, to identify eligible studies. Independently and in duplicate, two investigators will extract all data, and assess risk of bias in all eligible studies using the Modified Cochrane Risk of Bias tool. Reviewers will resolve disagreement by discussion and consultation with a third reviewer as necessary. Using a frequentist framework, we will perform random-effect network meta-analysis, including all ventilator modes in the same model. We will calculate direct and indirect estimates of treatment effect using a node-splitting procedure and report effect estimates using OR and 95% CI. We will assess certainty in effect estimates using Grading of Recommendations Assessment, Development and Evaluation methodology.

Ethics and dissemination

Research ethics board approval is not necessary. The results will be disseminated through publication in a peer-reviewed journals.

PROSPERO registration number

CRD42019137786

Drink driving and speeding in Sao Paulo, Brazil: empirical cross-sectional study (2015-2018)

Por: Andreuccetti · G. · Leyton · V. · Carvalho · H. B. · Sinagawa · D. M. · Bombana · H. S. · Ponce · J. C. · Allen · K. A. · Vecino-Ortiz · A. I. · Hyder · A. A.
Objectives

To evaluate the prevalence of drink driving and speeding during 2015–2018 in Sao Paulo, Brazil.

Design

Cross-sectional observational study.

Setting

Roads representing the five main regions of the city of Sao Paulo in Brazil, one of the world’s largest urban areas.

Participants

Drivers (N=10 294) stopped at routine roadside breath testing checkpoints and those driving in selected roads for speeding measurement (N=414 664).

Primary and secondary outcome measures

Microwave radar guns were used to measure the speed of vehicles, while the prevalence of drivers under the influence of alcohol was observed in police checkpoints. Data were collected during three consecutive years (2016–2018) following a baseline study established in 2015 using a city-level representative sample of observational data representing all days of the week.

Results

Alcohol-related fatalities kept at a constantly high percentage, with 39% of road traffic deaths involving alcohol in 2016. Drivers testing above the legal breath alcohol concentration limit showed a decreasing trend, from 4.1% (95% CI 2.9% to 5.5%) at baseline to 0.6% (95% CI 0.2% to 1.2%) in the end of 2018 (p

Conclusions

Drink driving rates have reduced, likely due to an increase in drivers refusing breath alcohol tests, while speeding rates have increased significantly by the end of the study period, particularly among motorcycles. Future strategies aiming at reducing road traffic injuries in the major Brazilian city should tailor drink driving and speeding enforcement based on the new evidence provided here.

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