bluuebunny/crossref_metadata_2025 huggingface dataset:
Pars plana vitrectomy in management of giant retinal tear and retinal detachment following iris-fixated anterior chamber phakic intraocular lens implantation
Authors: Sen Sagnik , Ravani Raghav Dinesh , Kakkar Prateek , Kumar Atul
Published: December 2018

This case report describes a 26-year-old man presenting with a giant retinal tear (GRT) with retinal detachment (RD) following implantation of iris-fixated anterior chamber phakic intraocular lens (AC-PIOL) for high myopia and occurrence of intraoperative aberrations during vitrectomy due to the presence of AC-PIOL in situ. Posterior chamber PIOL have been well reported to be associated with GRT with RD. Very few reports exist of GRT with RD following AC-PIOL. Moreover, the presence of iris-fixated AC-PIOL, in this case, led to the formation of ghost images intraoperatively especially during crucial steps like induction of posterior vitreous detachment which has never been reported.
Impact of a structured patient support program on adherence and persistence in basal insulin therapy for type 2 diabetes
Authors: Zhou Fang Liz , Yeaw Jason , Karkare Swapna U , DeKoven Mitch , Berhanu Paulos , Reid Timothy
Published: December 2018

Objective

Treatment adherence and persistence are essential to achieving therapeutic goals in diabetes and may be improved by patient support programs (PSPs). The COACH Program was launched in 2015 with the goal of supporting patients with diabetes who are prescribed insulin glargine 300 U/mL (Gla-300). The study objective was to assess the program’s impact on persistence and adherence with therapy among patients with type 2 diabetes.

Research design and methods

A retrospective 12-month analysis was conducted to compare treatment adherence and persistence in patients treated with Gla-300 who actively participated in the COACH PSP versus those who did not enroll using COACH engagement and claims data for the identification period from February 1, 2016 to July 31, 2016. COACH (n=544) and non-COACH (n=544) participants were matched on selected baseline characteristics.

Results

COACH participants were more likely to be adherent to (68.0% vs 61.4%, p= 0.0201; OR: 1.81, p=0.0002) and persistent (48.5% vs 42.1%, p= 0.0309; discontinuation HR: 0.60, p<0.0001) with Gla-300 than non-COACH patients during the 12-month follow-up after controlling for clinical confounders. Additionally, both insulin-naive and basal insulin switcher COACH participants, respectively, were more likely to be adherent (OR: 2.25, p=0.0082 and OR: 1.662, p=0.0364) and persistent (discontinuation HR: 0.53, p=0.0054 and HR: 0.67, p=0.0492) than non-COACH patients. Finally, COACH participants with greater level of engagement showed better persistence.

Conclusion

These data demonstrate that participation and engagement with COACH PSPs are associated with improved persistence and adherence to Gla-300 among patients with type 2 diabetes.
Observational study of clinical characteristics of dome-shaped macula in Chinese Han with high myopia at Zhongshan Ophthalmic Centre
Authors: Zhao Xiujuan , Ding Xiaoyan , Lyu Cancan , Li Shiyi , Lian Yu , Chen Xiaohong , Tanumiharjo Silvia , Zhang Aiyuan , Lu Jinge , Liang Xiaoling , Jin Chenjin , Lu Lin
Published: December 2018

Purpose

To evaluate the prevalence of dome-shaped macula (DSM) in highly myopic eyes among Chinese Han and to detect the correlation with myopic maculopathy and macular complications.

Methods

A total of 736 Chinese Han patients (1384 eyes) with high myopia (refractive error≤6.0 diopters or axial length ≥26.5 mm) are reviewed based on information entered into a high-myopia database at Zhongshan Ophthalmic Centre. Subfoveal choroidal thickness (SFCT) and parafoveal choroidal thickness (PFCT) are measured. The prevalence of DSM in patients with myopic maculopathy is categorised from C0 to C4. Clinical features, including macular complications, SFCT and PFCT, are compared between myopic eyes with and without DSM.

Results

Among the 1384 eyes, 149 (10.77%) show DSM. In highly myopic eyes without macular complications, the best corrected visual acuity is significantly worse in patients with DSM (p=0.002), and the ratio between subfoveal and parafoveal choroidal thickness (S/PCT) is significantly elevated in patients with DSM (p=0.021). The proportion of foveal schisis (17.24% vs 62.86%) is much lower in eyes with DSM compared with those without DSM. However, the proportions of extrafoveal schisis (39.66% vs 5.37%), foveal serous retinal detachment (SRD) (5.17% vs 0) and epiretinal membrane (ERM) (24.14% vs 10.74%) are much higher in eyes with DSM. The proportion of DSM was lower in C0 and C1, but higher proportion of DSM was found in C3 and C4.

Conclusions

DSM is found in 10.77% of highly myopic eyes among Chinese Han. DSM might be a protective mechanism for foveal schisis and a risk factor for extrafoveal schisis, SRD and ERM.
Use of C-reactive protein to tailor antibiotic use: a systematic review and meta-analysis
Authors: Petel Dara , Winters Nicholas , Gore Genevieve C , Papenburg Jesse , Beltempo Marc , Lacroix Jacques , Fontela Patricia S
Published: December 2018

Background and objectives

C-reactive protein (CRP) has been proposed to guide the use of antibiotics. However, study results are controversial regarding the benefits of such a strategy. We synthesised the evidence of CRP-based algorithms on antibiotic treatment initiation and on antibiotic treatment duration in adults, children and neonates, as well as their safety profile.

Design

Systematic review and meta-analysis.

Data sources

MEDLINE, EMBASE, CENTRAL and CINAHL from inception to 20 July 2017.

Eligibility criteria for selecting studies

We included randomised controlled trials (RCTs), non-RCTs and cohort studies (prospective or retrospective) investigating CRP-guided antibiotic use in adults, children and neonates with bacterial infection.

Data extraction and synthesis

Two researchers independently screened all identified studies and retrieved the data. Outcomes were duration of antibiotic use, antibiotic initiation, mortality, infection relapse and hospitalisation. We assessed the quality of the included studies using the Cochrane Collaboration’s tool (RCTs), and A Cochrane Risk Of Bias Assessment Tool: for Non-Randomized Studies of Interventions and the Newcastle-Ottawa scale (non-RCTs). We analysed our results using descriptive statistics and random effects models.

Results

Of 11 165 studies screened, 15 were included. In five RCTs in adult outpatients, the risk difference for antibiotic treatment initiation in the CRP group was −7% (95% CI: −10% to –4%), with no difference in hospitalisation rate. In neonates, CRP-based algorithms shortened antibiotic treatment duration by −1.45 days (95% CI −2.61 to –0.28) in two RCTs, and by −1.15 days (95% CI −2.06 to –0.24) in two cohort studies, with no differences in mortality or infection relapse.

Conclusion

The use of CRP-based algorithms seems to reduce antibiotic treatment duration in neonates, as well as to decrease antibiotic treatment initiation in adult outpatients. However, further high-quality studies are still needed to assess safety, particularly in children outside the neonatal period.

PROSPERO registration number

CRD42016038622
Patient work from a context and time use perspective: a mixed-methods study protocol
Authors: Yin Kathleen , Harms Teresa , Ho Kenneth , Rapport Frances , Vagholkar Sanjyot , Laranjo Liliana , Coiera Enrico , Gershuny Jonathan , Lau Annie Y S
Published: December 2018

Introduction

Self-management is widely promoted but less attention is focused on the work required from patients. To date, many individuals struggle to practise self-management. ‘Patient work’, a concept that examines the ‘work’ involved in self-management, is an approach to understanding the tasks, effort, time and context from patient perspective. The purpose of our study is to use a novel approach combining non-obstructive observations via digital devices with in-depth qualitative data about health behaviours and motivations, to capture the full range of patient work experienced by people with type 2 diabetes and chronic comorbidities. It aims to yield comprehensive insights about ‘what works’ in self-management, potentially extending to populations with other chronic health conditions.

Methods and analysis

This mixed-methods observational study involves a (1) prestudy interview and questionnaires, (2) a 24-hour period during which participants wear a camera and complete a time-use diary, and a (3) poststudy interview and study feedback. Adult participants living with type 2 diabetes with at least one chronic comorbidity will be recruited using purposive sampling to obtain a balanced gender ratio and of participants using insulin and those using only oral medication. Interviews will be analysed using thematic analysis. Data captured by digital devices, diaries and questionnaires will be used to analyse the duration, time, context and patterns of health-related behaviours.

Ethics and dissemination

The study was approved by the Macquarie University Human Research Ethics Committee for Medical Sciences (reference number 5201700718). Participants will carry a wallet-sized card that explains the purpose of the study to third parties, and can remove the camera at any stage. Before the poststudy interview begins, participants will view the camera images in private and can delete any images. Should any images be used in future publications or presentations, identifying features such as human faces and names will be obscured.
Impact of the SIGN head injury guidelines and NHS 4-hour emergency target on hospital admissions for head injury in Scotland: an interrupted times series
Authors: Marincowitz Carl , Lecky Fiona E , Morris Eleanor , Allgar Victoria , Sheldon Trevor A
Published: December 2018

Objectives

Head injury is a common reason for emergency department (ED) attendance. Around 1% of patients have life-threatening injuries, while 80% of patients are discharged. National guidelines (Scottish Intercollegiate Guidelines Network (SIGN)) were introduced in Scotland with the aim of achieving early identification of those with acute intracranial lesions yet safely reducing hospital admissions.

This study aims to assess the impact of these guidelines and any effect the national 4-hour ED performance target had on hospital admissions for head injury.

Setting

All Scottish hospitals between April 1998 and March 2016.

Participants

Patients admitted to hospital for head injury or traumatic brain injury (TBI) diagnosed by CT imaging identified using administrative Scottish Information Services Division data. There are 275 hospitals in Scotland. In 2015/2016, there were 571 221 emergency hospital admissions in Scotland.

Interventions

The SIGN head injury guidelines introduced in 2000 and 2009. The 4-hour ED target introduced in 2004.

Outcomes

The monthly rate of hospital admissions for head injury and traumatic brain injury.

Study design

An interrupted time series analysis.

Results

The first guideline was associated with a reduction in monthly admissions of 0.14 (95% CI 0.09 to 4.83) per 100 000 population. The 4-hour target was associated with a monthly increase in admissions of 0.13 (95% CI 0.06 to 0.20) per 100 000 population. The second guideline reduced monthly admissions by 0.09 (95% CI−0.13 to −0.05) per 100 000 population. These effects varied between age groups.

The guidelines were associated with increased admissions for patients with injuries identified by CT imaging—guideline 1: 0.06 (95% CI 0.004 to 0.12); guideline 2: 0.05 (95% CI 0.04 to 0.06) per 100 000 population.

Conclusion

Increased CT imaging of head injured patients recommended by SIGN guidelines reduced hospital admissions. The 4-hour ED target and the increased identification of TBI by CT imaging acted to undermine this effect.
Differences in family planning outcomes between military and general populations in Kinshasa, Democratic Republic of the Congo: a cross-sectional analysis
Authors: Akilimali Pierre , Anglewicz Philip , Engale Henri Nzuka , Kurhenga Gilbert Kabanda , Hernandez Julie , Kayembe Patrick , Bertrand Jane
Published: December 2018

Objectives

To examine family planning outcomes among women living in military camps in Kinshasa, Democratic Republic of the Congo, and compare these outcomes with a representative sample of non-military women in Kinshasa.

Participants

Women of reproductive ages, 15–49 years. We compare two populations: women living in military camps and the general (non-military) population in Kinshasa.

Study design

For sampling, we used a two-stage cluster sampling design, where we first randomly selected enumeration areas (EA), and then randomly selected women within each EA (separately for each of the two populations). We administered a survey on contraceptive use and family planning to all participating women. We use bivariate and multivariate analysis to compare these populations for a range of family planning outcomes.

Results

We find many statistically significant differences between women in military camps and general female population of Kinshasa. Although they do not have more children, women in military camps are less likely to be using contraception (all methods OR 0.24, 95% CI 0.11 to 0.53; modern methods OR 0.25, 95% CI 0.08 to 0.79; traditional methods OR 0.41, 95% CI 0.24 to 0.71) and less knowledgeable about many family planning methods (less likely to have heard of implants (OR 0.23, 95% CI 0.11 to 0.48), injectables (OR 0.19, 95% CI 0.08 to 0.44), condoms (OR 0.23, 95% CI 0.12 to 0.47), withdrawal (OR 0.05, 95% CI 0.02 to 0.17) and rhythm (OR 0.12, 95% CI 0.03 to 0.44) methods), while at the same time they are more likely to want to limit their births (OR 5.17, 95% CI 2.52 to 10.62), and less likely to have obtained their preferred family planning method (OR 0.14, 95% CI 0.03 to 0.64).

Conclusions

Women in military camps in Kinshasa appear to be an important and underserved population with regard to family planning. Our results suggest that women in military camps have limited access to modern family planning methods.
Conversion therapies and access to transition-related healthcare in transgender people: a narrative systematic review
Authors: Wright Talen , Candy Bridget , King Michael
Published: December 2018

Objectives

Conversion is a term for treatments that seek to suppress or change a person’s sexual orientation or gender. Our review focuses on transgender and gender-diverse (TGD) people. Our aims were to (1) describe the frequency, nature and structure of conversion practices; (2) document difficulties in accessing transition-related healthcare and (3) evaluate the mental health consequences of such practices and access barriers.

Method

Systematic review and narrative synthesis using the Critical Appraisals Skills Programme and Joanne Briggs Institute critical appraisal tools. Data sources include Embase, MEDLINE, PsychINFO, PsychARTICLES and Web of Science between 1990 and June 2017.

Participants

Studies were included that (1) document use of conversion therapies or access barriers to transition-related healthcare; and/or (2) describe how such therapeutic practices and access barriers have been applied and/or (3) evaluate the mental health impacts of such therapies and difficulties accessing transition-related healthcare. Two reviewers screened papers for eligibility. Data were then grouped according to the objectives. Narratives and themes were presented per study.

Results

Seven studies met inclusion criteria. Four reports were on ‘realignment’, involving case studies or case series. Two involved psychoanalysis, one self-exposure therapy and one open-ended play psychotherapy. All four studies concerning ‘realignment’ were of poor methodological quality. The other three studies explored access barriers from the view point of TGD youth, their parents and healthcare providers. All papers reported access barriers, such as inability to access puberty-delaying medications. The papers concerning barriers to access were of good methodological quality.

Conclusion

We found limited published evidence on use, nature, structure and/or health consequences of conversion therapies and access barriers to transition in TGD people. However, reports of restriction to access may indicate a more widespread problem. Research is needed into TGD people’s experiences of conversion therapy and access barriers to transition-related healthcare

Trial registration number

CRD42017062149.
Description and assessment of trustability of motives for self-exclusion reported by online poker gamblers in a cohort using account-based gambling data
Authors: Luquiens Amandine , Vendryes Delphine , Aubin Henri-Jean , Benyamina Amine , Gaiffas Stéphane , Bacry Emmanuel
Published: December 2018

Objective

Self-exclusion is one of the main responsible gambling tools. The aim of this study was to assess the reliability of self-exclusion motives in self-reports to the gambling service provider.

Settings

This is a retrospective cohort using prospective account-based gambling data obtained from a poker gambling provider.

Participants

Over a period of 7 years we included all poker gamblers self-excluding for the first time, and reporting a motive for their self-exclusion (n=1996). We explored two groups: self-excluders who self-reported a motive related to addiction and those who reported a commercial motive.

Results

No between-group adjusted difference was found on gambling summary variables. Sessions in the two groups were poorly discriminated one from another on four different machine-learning models. More than two-thirds of the gamblers resumed poker gambling after a first self-exclusion (n=1368), half of them within the first month. No between-group difference was found for the course of gambling after the first self-exclusion. 60.1% of first-time self-excluders self-excluded again (n=822). Losses in the previous month were greater before second self-exclusions than before the first.

Conclusions

Reported motives for self-exclusion appear non-informative, and could be misleading. Multiple self-exclusions seem to be more the rule than the exception. The process of self-exclusion should therefore be optimised from the first occurrence to protect heavy gamblers.
Chemoprevention in BRCA1 mutation carriers (CIBRAC): protocol for an open allocation crossover feasibility trial assessing mechanisms of chemoprevention with goserelin and anastrozole versus tamoxifen and acceptability of treatment
Authors: Campbell Aideen M , Morris Melanie , Gallagher Rebecca , Boyd Ruth , Carson Hazel , Harkin D Paul , Wielogorska Ewa , Elliott Christopher , Savage Kienan I , McIntosh Stuart A
Published: December 2018

Introduction

BRCA1 mutation carriers have a significant lifetime risk of breast cancer, with their primary risk-reduction option being bilateral mastectomy. Preclinical work from our laboratory demonstrated that in BRCA1-deficient breast cells, oestrogen and its metabolites are capable of driving DNA damage and subsequent genomic instability, which are well-defined early events in BRCA1-related cancers. Based on this, we hypothesise that a chemopreventive approach which reduces circulating oestrogen levels may reduce DNA damage and genomic instability, thereby providing an alternative to risk-reducing surgery.

Methods and analysis

12 premenopausal women with pathogenic BRCA1 mutations and no previous risk-reducing surgery will be recruited from family history clinics. Participants will be allocated 1:1 to two arms. All will undergo baseline breast biopsies, blood and urine sampling, and quality of life questionnaires. Group A will receive goserelin 3.6 mg/28 days by subcutaneous injection, plus oral anastrozole 1 mg/day, for 12 weeks. Group B will receive oral tamoxifen 20 mg/day for 12 weeks. Following treatment, both groups will provide repeat biopsies, blood and urine samples, and questionnaires. Following a 1-month washout period, the groups will cross over, group A receiving tamoxifen and group B goserelin and anastrozole for a further 12 weeks. After treatment, biopsies, blood and urine samples, and questionnaires will be repeated. DNA damage will be assessed in core biopsies, while blood and urine samples will be used to measure oestrogen metabolite and DNA adduct levels.

Ethics and dissemination

This study has ethical approval from the Office for Research Ethics Committees Northern Ireland (16/NI/0055) and the Medicines and Healthcare products Regulatory Agency (MHRA) (reference: 32485/0032/001–0001). The investigational medicinal products used in this trial are licensed and in common use, with well-documented safety information. Dissemination of results will be via high-impact journals and relevant national/international conferences. A copy of the results will be offered to the participants and be made available to patient support groups.

Trial registration number

EudraCT: 2016-001087-11; Pre-results.
Cohort study of a specialist social worker intervention on hospital use for patients at risk of long stay
Authors: Osborne Sonya , Harrison Gai , O’Malia Angela , Barnett Adrian Gerard , Carter Hannah E , Graves Nicholas
Published: December 2018

Background

Long-stay patients in acute hospitals commonly present with complex psychosocial needs and use high levels of hospital resources.

Objective

To determine whether a specialist social worker-led model of care was associated with a reduction in length of stay for medically stable patients with complex psychosocial needs who were at risk of long stay, and to determine the economic value of this model relative to the decision makers’ willingness to pay for bed days released.

Design

A prospective, matched cohort study with historical controls.

Setting

A large, tertiary teaching and referral hospital in metropolitan Southeast Queensland, Australia.

Methods

Length of hospital stay for a cohort of patients seen under the specialist social worker-led model of care was compared with a matched control group of patients admitted to the hospital prior to the introduction of the new model of care using a multistate model with the social worker model of care as an intermediate event. Costs associated with the model of care were calculated and an estimate of the ‘cost per bed day’ was produced.

Results

The model of care reduced mean length of stay by 33 days. This translated to 9999 bed days released over 12 months. The cost to achieve this was estimated to be $A229 000 over 12 months. The cost per bed day released was $23, which is below estimates of hospital decision makers’ willingness to pay for a bed day to be released for an alternate use.

Conclusions

The specialist social worker-led model of care was associated with a reduced length of stay at a relatively low cost. This is likely to represent a cost-effective use of hospital resources. The limitations of our historic control cohort selection mean that results should be interpreted with caution. Further research is needed to confirm these findings.
Health behaviours of Australian fly-in, fly-out workers and partners during on-shift and off-shift days: an ecological momentary assessment study
Authors: Rebar Amanda L , Alfrey Kristie-Lee , Gardner Benjamin , Vandelanotte Corneel
Published: December 2018

Objectives

Fly-in, fly-out (FIFO) work involves long commutes, living on-site for consecutive days and returning home between shifts. This unique type of work requires constant transitioning between the roles and routines of on-shift versus off-shift days. This study aims to examine health behaviour patterns of FIFO workers and FIFO partners during on-shift and off-shift time frames.

Design

This study used ecological momentary assessment and multilevel modelling to examine daily health behaviours.

Setting

FIFO workers and FIFO partners from across Australia responded to daily online surveys for up to 7 days of on-shift and up to 7 days of off-shift time frames.

Participants

Participants included 64 FIFO workers and 42 FIFO worker partners.

Results

Workers and partners reported poorer sleep and nutrition quality for on-shift compared with off-shift days. Both workers and partners exercised less, smoked more cigarettes, took more physical health medication and drank less alcohol during on-shift compared with off-shift days.

Conclusions

FIFO organisations should consider infrastructure changes and support services to enhance opportunities for quality sleep and nutrition, sufficient exercise, moderate alcohol consumption and cigarette cessation for workers on-site and their partners at home.
Catheter-related infections: does the spectrum of microbial causes change over time? A nationwide surveillance study
Authors: Buetti Niccolò , Lo Priore Elia , Atkinson Andrew , Widmer Andreas F , Kronenberg Andreas , Marschall Jonas
Published: December 2018

Objectives

To estimate the incidence and epidemiology of catheter-related bloodstream infections (CRBSIs) on a national scale by using prospective epidemiological data from the SwissAntibiotic Resistance Surveillance System(ANRESIS).

Design

Observational study.

Setting

National surveillance from 2008 to 2015 of acute hospitals in Switzerland.

Participants

We included acute Swiss hospitals that sent blood cultures and catheter tip culture results on a regular basis during the entire study period to the ANRESIS database.

Outcome measure

A catheter-related bloodstream infection (termed ‘modified CRBSI’, mCRBSI) was defined as isolating the same microorganism with identical antibiogram from ≥1 blood cultures (performed ±7 days around the catheter removal) as the one recovered from the catheter tip. Incidence rates of mCRBSI were calculated per 1000 admissions.

Results

From 2008 to 2015, the mCRBSI incidence rate decreased from 0.83 to 0.58 episodes/1000 admissions (−6% per year, p<0.001). Coagulase-negative staphylococci,Staphylococcus aureusand fungi all exhibited decreasing trends, while rates of enterococci and Gram-negative bacteria remained stable.

Conclusions

The overall incidence of mCRBSI in Switzerland is decreasing; however, the incidence of mCRBSI due to Enterococci and Gram-negative micro-organisms did not change over time. These pathogens may grow in importance in catheter-related infections, which would have clinical implications for the choice of empirical treatment.
Feasibility and tolerability of bone impact microindentation testing: a cross-sectional, population-based study in Australia
Authors: Rufus-Membere Pamela , Holloway-Kew Kara L , Diez-Perez Adolfo , Kotowicz Mark A , Pasco Julie A
Published: December 2018

Objectives

The OsteoProbe measures Bone Material Strength Index (BMSi) of cortical bone in living humans using impact microindentation (IMI). Research using this minimally invasive technique is expanding yet, to-date, there have been no reports about its feasibility in the research setting. In this study, we assessed the feasibility and tolerability of using the OsteoProbe in men enrolled in the Geelong Osteoporosis Study.

Design

Cross-sectional analysis of data collected in a population-based study.

Setting

Barwon Statistical Division, southeastern Australia, 2016–2018.

Methods

For 252 of 345 consecutive participants (ages 33–96 years), BMSi was measured using the OsteoProbe at the mid-tibia. Immediately following measurement, each participant used a Visual Analogue Scale (0–10) to rate the level of discomfort that was anticipated and experienced, their initial reluctance towards the measurement and their willingness to repeat measurement.

Results

Reasons for non-measurement in 92 men were needle phobia (n=8), discomfort after first indentation (n=5), skin infections (n=21), excessive soft tissues around the mid-tibia region (n=56), inability to provide informed consent (n=2). Among 252 men who had IMI measures, the expectation for pain during measurement was low (1.54±1.56), as was actual pain experienced (0.38±0.71). Reluctance to undergo measurement was low (0.34±0.93). All participants indicated a willingness to have the measurement performed again. Mean (±SD) BMSi was 83.0±6.4 (range 62.3–93.0).

Conclusion

In this study, the procedure was well accepted by participants suggesting that IMI testing with the OsteoProbe is feasible in a research setting.
Hepatitis C and pregnancy outcomes: a systematic review protocol
Authors: Parent Stephanie , Salters Kate , Awendila Lindila , Ti Lianping
Published: December 2018

Introduction

Many women living with hepatitis C (HCV) are of childbearing age. While the risk of vertical HCV transmission has been well established, the impact of HCV on pregnancy outcomes are equivocal, with some studies reporting risks of preterm birth, low gestational weight, gestational diabetes and hypertension, while other studies report no such risks. With the shift of the HCV treatment landscape to more effective, tolerable and shorter medications, understanding pregnancy outcomes of women living with HCV are an important consideration in order to provide a baseline from which to consider the usefulness and safety of HCV treatment for this population. The objective of this systematic review will be to investigate pregnancy outcomes associated with maternal HCV infection.

Methods and analysis

This systematic review will incorporate articles relevant to pregnancy outcomes among women living with HCV (eg, gestational diabetes and caesarean delivery). Articles will be retrieved from academic databases including MEDLINE, EMBASE, CINAHL, clinicaltrial.gov and the Cochrane Library and hand searching of conference proceedings and reference lists. A database search will not be restricted by date, and conference abstract will be restricted to the past 2 years. The Newcastle-Ottawa Quality Assessment Scale will be used to assess the quality of the retrieved studies. Data will be extracted and scored independently by two authors. A narrative account will synthesise the findings to answer the objectives of this review.

Ethics and dissemination

This systematic review will synthesise the literature on the pregnancy outcomes of women living with HCV. Results from this review will be disseminated to clinical audiences, community groups and policy-makers, and may support clinicians and decision-makers in developing guidelines to promote best outcomes for this population.
Stigmatisation and body image impairment in dermatological patients: protocol for an observational multicentre study in 16 European countries
Authors: Dalgard Florence J , Bewley Anthony , Evers Andrea W , Gieler Uwe , Lien Lars , Sampogna Francesca , Ständer Sonja , Tomas-Aragones Lucia , Vulink Ninke , Kupfer Jörg
Published: December 2018

Introduction

Patients with common skin diseases may have substantial psychosocial comorbidity and reduced quality of life. This study aims at exploring further the psychosocial burden of skin diseases by assessing stigmatisation and body image problems in a large sample of patients with skin disease across Europe.

Methods and analysis

The study is an observational cross-sectional multicentre study across 16 European countries comparing stigmatisation and body image in patients with skin disease compared with controls. Consecutive patients will be recruited in outpatient clinics and will complete validated questionnaires prior to clinical examination by a dermatologist at each recruitment site. In addition to sociodemographic background information, the outcomes will be: mood disorders assessed by short versions of the Patient Health Questionnaire and the General Anxiety Disorder Assessment; general health assessed by the EuroQol-Visual Analogue Scale; stigmatisation experience assessed by the Perceived Stigmatisation Questionnaire; stress assessed by the Perceived Stress Scale and body image assessed by the Dysmorphic Concern Questionnaire. The main criteria for eligibility are to be 18 years old or more. The analysis will include comparison between patients and controls for the main outcomes using t-tests, analyses of covariance and multivariate logistic regression models adjusting for potential confounding factors.

Ethics and dissemination

The study protocol is approved by the University of Giessen and by the local Ethical Committee in each recruitment centre. Informed consent will be given by each participant. The results of the study will be disseminated by publications in international peer-reviewed journals and presented at international conferences and general public conferences. Results will influence support intervention and management of patients with skin disease across Europe.

Trial registration number

DRKS00012745; Pre-results.
Are anxiety levels associated with the decision to participate in a Swedish colorectal cancer screening programme? A nationwide cross-sectional study
Authors: Wangmar Johanna , von Vogelsang Ann-Christin , Hultcrantz Rolf , Fritzell Kaisa , Wengström Yvonne , Jervaeus Anna
Published: December 2018

Objectives

Colorectal cancer (CRC) screening programmes are commonly challenged by low uptake, limiting their potential to reduce CRC burden. We aimed to investigate anxiety levels related to the decision to participate or not in CRC screening among screening participants and non-participants. Further to explore associations between higher anxiety levels related to the decision and individuals’ characteristics.

Design

A nationwide cross-sectional study conducted with individuals included in a national randomised controlled CRC screening trial, the Screening of Swedish Colons (SCREESCO).

Participants

A total of 1409 individuals, 60–62 years, recruited from SCREESCO during 2015–2016 participated in the study; 1256 had participated in CRC screening (faecal immunochemical test: n=958; colonoscopy: n=298) and 153 had declined screening participation.

Measures

Anxiety levels were assessed with the State-Trait Anxiety Inventory (STAI) S-Anxiety Scale. Health literacy (HL) was assessed with the Swedish Functional and Communicative and Critical Health Literacy Scales.

Results

Altogether, 79% of survey participants reported lower anxiety levels regarding their CRC screening decision (STAI S-Anxiety <40). Anxiety levels did not differ between screening participants and non-participants (mean STAI S-Anxiety score=34.1 vs 33.9, p=0.859). The odds of reporting higher anxiety levels increased by female sex (OR=1.37; CI 1.04 to 1.80; p=0.025) and previous faecal sampling (OR=1.53; CI 1.14 to 2.05; p=0.004), and decreased if living with partner (OR=0.65; CI 0.48 to 0.88; p=0.005), working (OR=0.72; CI 0.53 to 0.96; p=0.027) or having sufficient HL (functional: OR=0.49; CI 0.33 to 0.73, p≤0.001; communicative and critical: OR=0.55; CI 0.38 to 0.82; p=0.003).

Conclusions

Anxiety levels did not differ between screening participants and non-participants. Higher anxiety scores were associated with certain characteristics. Interventions accounting for these characteristics can be applied to reduce anxiety and facilitate programme acceptance.

Trial registration number

NCT02078804; Results.
Directing research funds to the right research projects: a review of criteria used by research organisations in Australia in prioritising health research projects for funding
Authors: Tuffaha Haitham W , El Saifi Najwan , Chambers Suzanne K , Scuffham Paul A
Published: December 2018

Objectives

Healthcare budgets are limited, and therefore, research funds should be wisely allocated to ensure high-quality, useful and cost-effective research. We aimed to critically review the criteria considered by major Australian organisations in prioritising and selecting health research projects for funding.

Methods

We reviewed all grant schemes listed on the Australian Competitive Grants Register that were health-related, active in 2017 and with publicly available selection criteria on the funders’ websites. Data extracted included scheme name, funding organisation, selection criteria and the relative weight assigned to each criterion. Selection criteria were grouped into five representative domains: relevance, appropriateness, significance, feasibility (including team quality) and cost-effectiveness (ie, value for money).

Results

Thirty-six schemes were included from 158 identified. One-half of the schemes were under the National Health and Medical Research Council. The most commonly used criteria were research team quality and capability (94%), research plan clarity (94%), scientific quality (92%) and research impact (92%). Criteria considered less commonly were existing knowledge (22%), fostering collaboration (22%), research environment (19%), value for money (14%), disease burden (8%) and ethical/moral considerations (3%). In terms of representative domains, relevance was considered in 72% of the schemes, appropriateness in 92%, significance in 94%, feasibility in 100% and cost-effectiveness in 17%. The relative weights for the selection criteria varied across schemes with 5%–30% for relevance, 20%–60% for each appropriateness and significance, 20%–75% for feasibility and 15%–33% for cost-effectiveness.

Conclusions

In selecting research projects for funding, Australian research organisations focus largely on research appropriateness, significance and feasibility; however, value for money is most often overlooked. Research funding decisions should include an assessment of value for money in order to maximise return on research investment.
Supraciliary microstent implantation for open-angle glaucoma: multicentre 3-year outcomes
Authors: Grisanti Swaantje , Grisanti Salvatore , Garcia-Feijoo Julian , Dick H Burkhard , Munoz-Negrete Francisco Jose , Arrondo Elena , Ianchulev Tsontcho
Published: December 2018

Objective

To describe the safety and effectiveness of CyPass supraciliary microstent implantation alone in eyes with open-angle glaucoma (OAG) followed up for up to 3 years.

Methods and analysis

This registry study included subjects with primary or secondary OAG who underwent CyPass Micro-Stent implantation alone at 12 sites in four European countries to reduce intraocular pressure (IOP) and/or use of IOP-lowering medications. The primary safety outcome was the incidence of adverse events. Secondary efficacy outcomes included mean changes from baseline in IOP and IOP-lowering medications. Eyes were subgrouped into those with low (< 21 mm Hg) and high (>21 mm Hg) baseline IOP.

Results

This study included 225 eyes of 178 patients, with mean baseline IOP of 22.6 ± 6.7 mm Hg and a mean 2.2 ± 1.2 medications per eye. Common ocular adverse events included device obstruction (10.2%), IOP elevation>10 mm Hg during follow-up (8.9%), retinal complications (4.4%) and loss of > 2 lines of best-corrected visual acuity (2.7%). Seventy-one eyes (31.6%) required secondary glaucoma surgery, with trabeculectomy (33 eyes) and second microstent implantation (13 eyes) being most common. At months 6–36, mean IOP reductions ranged from 4.4 to 5.1 mm Hg (15.8%–19.5%) and mean medication reductions from 0.2 to 1.2 (9.1%–54.5%). Mean IOP reduction was greater in eyes with higher than lower baseline IOP. Both subgroups showed reductions of 0.5–1.0 medication at 12–18 months.

Conclusion

CyPass microstent implantation demonstrated a safety profile consistent with other minimally invasive glaucoma surgeries and effectively lowered IOP for up to 3 years in eyes with OAG.
Incidence of mortality due to rebound toxicity after ‘treat and release’ practices in prehospital opioid overdose care: a systematic review
Authors: Greene Jennifer Anne , Deveau Brent J , Dol Justine S , Butler Michael B
Published: December 2018

Introduction

Death due to opioid overdose was declared a public health crisis in Canada in 2015. Traditionally, patients who have overdosed on opioids that are managed by emergency medical services (EMS) are treated with the opioid antagonist naloxone, provided ventilatory support and subsequently transported to hospital. However, certain EMS agencies have permitted patients who have been reversed from opioid overdose to refuse transport, if the patient exhibits capacity to do so. Evidence on the safety of this practice is limited. Therefore, our intent was to examine the available literature to determine mortality and serious adverse events within 48 hours of EMS treat and release due to suspected rebound opioid toxicity after naloxone administration.

Methods

A systematic search was performed on 11 May 2017 in PubMed, Cochrane Central, Embase and CINHAL. Studies that reported on the outcome of patients treated with prehospital naloxone and released at the scene were included. Analyses for incidence of mortality and adverse events at the scene were conducted. Risk of bias and assessment of publication bias was also done.

Results

1401 records were screened after duplicate removal. Eighteen full-text studies were reviewed with seven selected for inclusion. None were found to be high risk of bias. In most studies, heroin was the source of the overdose. Mortality within 48 hours was infrequent with only four deaths among 4912 patients ﴾0.081%﴿ in the seven studies. Only one study reported on adverse events and found no incidence of adverse events from their sample of 71 released patients.

Conclusion

Mortality or serious adverse events due to suspected rebound toxicity in patients released on scene post-EMS treatment with naloxone were rare. However, studies involving longer-acting opioids were rare and no study involved fentanyl.
Phenotype and function of HBV-specific T cells is determined by the targeted epitope in addition to the stage of infection
Authors: Hoogeveen Ruben C , Robidoux Maxwell P , Schwarz Tatjana , Heydmann Laura , Cheney James A , Kvistad Daniel , Aneja Jasneet , Melgaço Juliana G , Fernandes Carlos A , Chung Raymond T , Boonstra Andre , Kim Arthur Y , Baumert Thomas F , Timm Jörg , Lewis-Ximenez Lia L , Tonnerre Pierre , Lauer Georg M
Published: December 2018

Objective

Chronic HBV infection affects more than 250 million people worldwide and remains a global healthcare problem in part because we lack curative treatment. Sustained viral control requires HBV-specific T cells, but these become functionally impaired in chronic infection. Clinical evidence indicates that functional cure of HBV infection by the host immune response is feasible. Developing T cell-based therapies able to achieve functional cure will require identification of the requirements for a successful T cell response against HBV and the relative contribution of individual T cell specificities to HBV control.

Design

The phenotype and function of HBV-specific T cells were studied directly ex vivo using fluorochrome-labelled multimers. We studied multiple HBV-specific T cell specificities targeting different HBV proteins in individuals with either an acute self-limiting or chronic HBV infection.

Results

We detected strong T cell responses targeting multiple HBV viral proteins in acute self-limiting and low-frequency core and polymerase-specific T cells in chronic infection. Expression of the T cell inhibitory receptor PD-1, as well as T cell differentiation, T cell function and T cell regulation differed by stages and outcomes of infection. In addition, these features differed significantly between T cells targeting different HBV specificities.

Conclusion

HBV-specific T cells with different target specificities are characterised by distinct phenotypical and functional profiles. These results have direct implications for the design of immunological studies in HBV infection, and are potentially relevant for informing immunotherapeutic approaches to induce functional cure.
Inhibition of glutamine synthetase in monocytes from patients with acute-on-chronic liver failure resuscitates their antibacterial and inflammatory capacity
Authors: Korf Hannelie , du Plessis Johannie , van Pelt Jos , De Groote Sofie , Cassiman David , Verbeke Len , Ghesquière Bart , Fendt Sarah-Maria , Bird Matthew J , Talebi Ali , Van Haele Matthias , Feio-Azevedo Rita , Meelberghs Lore , Roskams Tania , Mookerjee Rajeshwar P , Mehta Gautam , Jalan Rajiv , Gustot Thierry , Laleman Wim , Nevens Frederik , van der Merwe Schalk Willem
Published: December 2018

Objective

Acute-on-chronic liver failure (ACLF) is associated with dysfunctional circulating monocytes whereby patients become highly susceptible to bacterial infections. Here, we identify the pathways underlying monocyte dysfunction in ACLF and we investigate whether metabolic rewiring reinstates their phagocytic and inflammatory capacity.

Design

Following phenotypic characterisation, we performed RNA sequencing on CD14+CD16−monocytes from patients with ACLF and decompensated alcoholic cirrhosis. Additionally, anin vitromodel mimicking ACLF patient-derived features was implemented to investigate the efficacy of metabolic regulators on monocyte function.

Results

Monocytes from patients with ACLF featured elevated frequencies of interleukin (IL)-10-producing cells, reduced human leucocyte antigen DR isotype (HLA-DR) expression and impaired phagocytic and oxidative burst capacity. Transcriptional profiling of isolated CD14+CD16−monocytes in ACLF revealed upregulation of an array of immunosuppressive parameters and compromised antibacterial and antigen presentation machinery. In contrast, monocytes in decompensated cirrhosis showed intact capacity to respond to inflammatory triggers. Culturing healthy monocytes in ACLF plasma mimicked the immunosuppressive characteristics observed in patients, inducing a blunted phagocytic response and metabolic program associated with a tolerant state. Metabolic rewiring of the cells using a pharmacological inhibitor of glutamine synthetase, partially restored the phagocytic and inflammatory capacity ofin vitrogenerated- as well as ACLF patient-derived monocytes. Highlighting its biological relevance, the glutamine synthetase/glutaminase ratio of ACLF patient-derived monocytes positively correlated with disease severity scores.

Conclusion

In ACLF, monocytes feature a distinct transcriptional profile, polarised towards an immunotolerant state and altered metabolism. We demonstrated that metabolic rewiring of ACLF monocytes partially revives their function, opening up new options for therapeutic targeting in these patients.
Mental resilience training
Authors: Precious Duncan , Lindsay A
Published: December 2018

This paper will explain the concept behind mental resilience training (MRT) and how the training package was developed and implemented within the British ArmyInfantry Training Centre (ITC) Catterick between 2014 and 2016. MRT is a mindfulness-based psychological skills training package that integrates cognitive behavioural and mindfulness based principles and techniques, which have been proven to improve stress regulation, emotional and cognitive control and self-confidence in military personnel. MRT is based on an extensive evidence base that has demonstrated that psychological skills training delivers tangible improvements in performance in elite sport and in healthcare, business and military contexts. The initial trials at the ITC Catterick have delivered tangible improvements in infantry recruits’ use of psychological skills within real-life training contexts.
Authority without identity: defending advance directives via posthumous rights over one’s body
Authors: Persad Govind
Published: December 2018

This paper takes a novel approach to the active bioethical debate over whether advance medical directives have moral authority in dementia cases. Many have assumed that advance directives would lack moral authority if dementia truly produced a complete discontinuity in personal identity, such that the predementia individual is a separate individual from the postdementia individual. I argue that even if dementia were to undermine personal identity, the continuity of the body and the predementia individual’s rights over that body can support the moral authority of advance directives. I propose that the predementia individual retains posthumous rights over her body that she acquired through historical embodiment in that body, and further argue that claims grounded in historical embodiment can sometimes override or exclude moral claims grounded in current embodiment. I close by considering how advance directives grounded in historical embodiment might be employed in practice and what they would and would not justify.