bluuebunny/crossref_metadata_2025 huggingface dataset:
Exercise-induced biochemical changes and their potential influence on cancer: a scientific review
Authors: Thomas Robert James , Kenfield Stacey A , Jimenez Alfonso
Published: December 2016

Aim

To review and discuss the available international literature regarding the indirect and direct biochemical mechanisms that occur after exercise, which could positively, or negatively, influence oncogenic pathways.

Methods

The PubMed, MEDLINE, Embase and Cochrane libraries were searched for papers up to July 2016 addressing biochemical changes after exercise with a particular reference to cancer. The three authors independently assessed their appropriateness for inclusion in this review based on their scientific quality and relevance.

Results

168 papers were selected and categorised into indirect and direct biochemical pathways. The indirect effects included changes in vitamin D, weight reduction, sunlight exposure and improved mood. The direct effects included insulin-like growth factor, epigenetic effects on gene expression and DNA repair, vasoactive intestinal peptide, oxidative stress and antioxidant pathways, heat shock proteins, testosterone, irisin, immunity, chronic inflammation and prostaglandins, energy metabolism and insulin resistance.

Exercise is one of several lifestyle factors known to lower the risk of developing cancer and is associated with lower relapse rates and better survival. This review highlights the numerous biochemical processes, which explain these potential anticancer benefits.
Concurrent aerobic plus resistance exercise versus aerobic exercise alone to improve health outcomes in paediatric obesity: a systematic review and meta-analysis
Authors: García-Hermoso Antonio , Ramírez-Vélez Robinson , Ramírez-Campillo Rodrigo , Peterson Mark D , Martínez-Vizcaíno Vicente
Published: December 2016

Objective

To determine if the combination of aerobic and resistance exercise is superior to aerobic exercise alone for the health of obese children and adolescents.

Design

Systematic review with meta-analysis.

Data sources

Computerised search of 3 databases (MEDLINE, EMBASE, and Cochrane Controlled Trials Registry).

Eligibility criteria for selecting studies

Studies that compared the effect of supervised concurrent exercise versus aerobic exercise interventions, with anthropometric and metabolic outcomes in paediatric obesity (6–18 years old). The mean differences (MD) of the parameters from preintervention to postintervention between groups were pooled using a random-effects model.

Results

12 trials with 555 youths were included in the meta-analysis. Compared with aerobic exercise alone, concurrent exercise resulted in greater reductions in body mass (MD=−2.28 kg), fat mass (MD=−3.49%; and MD=−4.34 kg) and low-density lipoprotein cholesterol (MD=−10.20 mg/dL); as well as greater increases in lean body mass (MD=2.20 kg) and adiponectin level (MD=2.59 μg/mL). Differences were larger for longer term programmes (>24 weeks).

Concurrent aerobic plus resistance exercise improves body composition, metabolic profiles, and inflammatory state in the obese paediatric population.

Trial registration number

CRD42016039807.
Gestational diabetes mellitus treatment reduces obesity-induced adverse pregnancy and neonatal outcomes: the St. Carlos gestational study
Authors: Assaf-Balut Carla , Familiar Cristina , García de la Torre Nuria , Rubio Miguel A , Bordiú Elena , del Valle Laura , Lara Miriam , Ruiz Teresa , Ortolá Ana , Crespo Irene , Duran Alejandra , Herraiz Miguel A , Izquierdo Nuria , Perez Noelia , Torrejon Maria J , Runkle Isabelle , Montañez Carmen , Calle-Pascual Alfonso L
Published: December 2016

Background

Obesity and gestational diabetes mellitus (GDM) increase the morbidity of the mother and newborn, which could increase further should they coexist. We aimed to determine the risk of adverse pregnancy and neonatal outcomes associated with excess weight (EW), and within this group identify potential differences between those with and without GDM.

Methods

We carried out a post-hoc analysis of the St. Carlos Gestational Study which included 3312 pregnant women, arranged in 3 groups: normal-weight women (NWw) (2398/72.4%), overweight women (OWw) (649/19.6%) and obese women (OBw) (265/8%). OWw and OBw were grouped as EW women (EWw). We analyzed variables related to adverse pregnancy and neonatal outcomes.

Results

The relative risk (95% CI) for GDM was 1.82 (1.47 to 2.25; p<0.0001) for OWw, and 3.26 (2.45 to 4.35; p<0.0001) in OBw. Univariate analysis showed associations of EW to higher rates of prematurity, birth weight >90th centile, newborns admitted to neonatal intensive care unit (NICU), instrumental delivery and cesarean delivery (all p<0.005). Multivariate analysis, adjusted for parity and ethnicity, showed that EW increased the risk of prematurity, admission to NICU, cesarean and instrumental delivery, especially in EWw without GDM. NWw with GDM had a significantly lower risk of admission to NICU and cesarean delivery, compared with NWw without GDM.

Conclusions

EW is detrimental for pregnancy and neonatal outcomes, and treatment of GDM contributes to lowering the risk in EWw and NWw. Applying the same lifestyle changes to all pregnant women, independent of their weight or GDM condition, could improve these outcomes.
Mining routinely collected acute data to reveal non-linear relationships between nurse staffing levels and outcomes
Authors: Leary Alison , Cook Rob , Jones Sarahjane , Smith Judith , Gough Malcolm , Maxwell Elaine , Punshon Geoffrey , Radford Mark
Published: December 2016

Objectives

Nursing is a safety critical activity but not easily quantified. This makes the building of predictive staffing models a challenge. The aim of this study was to determine if relationships between registered and non-registered nurse staffing levels and clinical outcomes could be discovered through the mining of routinely collected clinical data. The secondary aim was to examine the feasibility and develop the use of ‘big data’ techniques commonly used in industry for this area of healthcare and examine future uses.

Setting

The data were obtained from 1 large acute National Health Service hospital trust in England. Routinely collected physiological, signs and symptom data from a clinical database were extracted, imported and mined alongside a bespoke staffing and outcomes database using Mathmatica V.10. The physiological data consisted of 120 million patient entries over 6 years, the bespoke database consisted of 9 years of daily data on staffing levels and safety factors such as falls.

Primary and secondary outcomes

To discover patterns in these data or non-linear relationships that would contribute to modelling. To examine feasibility of this technique in this field.

Results

After mining, 40 correlations (p<0.00005) emerged between safety factors, physiological data (such as the presence or absence of nausea) and staffing factors. Several inter-related factors demonstrated step changes where registered nurse availability appeared to relate to physiological parameters or outcomes such as falls and the management of symptoms. Data extraction proved challenging as some commercial databases were not built for extraction of the massive data sets they contain.

Conclusions

The relationship between staffing and outcomes appears to exist. It appears to be non-linear but calculable and a data-driven model appears possible. These findings could be used to build an initial mathematical model for acute staffing which could be further tested.
Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol
Authors: Dreijer Albert R , Kruip Marieke J H A , Diepstraten Jeroen , Polinder Suzanne , Brouwer Rolf , Leebeek Frank W G , Vulto Arnold G , van den Bemt Patricia M L A
Published: December 2016

Introduction

Antithrombotic therapy carries high risks for patient safety. Antithrombotics belong to the top 5 medications involved in potentially preventable hospital admissions related to medication. To provide a standard for antithrombotic therapy and stress the importance of providing optimal care to patients on antithrombotic therapy, the Landelijke Standaard Ketenzorg Antistolling (LSKA; Dutch guideline on integrated antithrombotic care) was drafted. However, the mere publication of this guideline does not guarantee its implementation. This may require a multidisciplinary team effort. Therefore, we designed a study aiming to determine the influence of hospital-based antithrombotic stewardship on the effect and safety of antithrombotic therapy outcomes during and after hospitalisation.

Methods and analysis

In this study, the effect of the implementation of a multidisciplinary antithrombotic team is compared with usual care using a pre-post study design. The study is performed at the Erasmus University Medical Center Rotterdam and the Reinier de Graaf Hospital Delft. Patients who are or will be treated with antithrombotics are included in the study. We aim to include 1900 patients, 950 in each hospital. Primary outcome is the proportion of patients with a composite end point consisting of ≥1 bleeding or ≥1 thrombotic event from the beginning of antithrombotic therapy (or hospitalisation) until 3 months after hospitalisation. Bleeding is defined according to the International Society of Thrombosis and Haemostasis (ISTH) classification. A thrombotic event is defined as any objectively confirmed arterial or venous thrombosis, including acute myocardial infarction or stroke for arterial thrombosis and deep venous thrombosis or pulmonary embolism or venous thrombosis. An economic evaluation is performed to determine whether the implementation of the multidisciplinary antithrombotic team will be cost-effective.

Ethics and dissemination

This protocol was approved by the Medical Ethical Committee of the Erasmus University Medical Center. The findings of the study will be disseminated through peer-reviewed journals and presented at relevant conferences.

Trial registration number

NTR4887; pre-results.
Views on mandatory reporting of impaired health practitioners by their treating practitioners: a qualitative study from Australia
Authors: Bismark Marie M , Mathews Ben , Morris Jennifer M , Thomas Laura A , Studdert David M
Published: December 2016

Objective

To explore the views and experiences of health sector professionals in Australia regarding a new national law requiring treating practitioners to report impaired health practitioners whose impairments came to their attention in the course of providing treatment.

Method

We conducted a thematic analysis of in-depth, semistructured interviews with 18 health practitioners and 4 medicolegal advisors from Australia's 6 states, each of whom had experience with applying the new mandatory reporting law in practice.

Results

Interviewees perceived the introduction of a mandatory reporting law as a response to failures of the profession to adequately protect the public from impaired practitioners. Mandatory reporting of impaired practitioners was reported to have several benefits: it provides treating practitioners with a ‘lever’ to influence behaviour, offers protections to those who make reports and underscores the duty to protect the public from harm. However, many viewed it as a blunt instrument that did not sufficiently take account of the realities of clinical practice. In deciding whether or not to make a report, interviewees reported exercising clinical discretion, and being influenced by three competing considerations: protection of the public, confidentiality of patient information and loyalty to their profession.

Conclusions

Competing ethical considerations limit the willingness of Australian health practitioners to report impaired practitioner-patients under a mandatory reporting law. Improved understanding and implementation of the law may bolster the public protection offered by mandatory reports, reduce the need to breach practitioner-patient confidentiality and help align the law with the loyalty that practitioners feel to support, rather than punish, their impaired colleagues.
Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE study protocol
Authors: Barasinski Chloé , Vendittelli Françoise
Published: December 2016

Introduction

The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum.

Methods and analysis

This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs.

Ethics and dissemination

This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be useful for counselling pregnant women before and during labour.

Trial registration number

Agence national de sécurité du médicament et des produits de santé (ANSM): 150099B-22 and IDRCB: 2014-A01920-47.ClinicalTrials.gov: NCT02474745. Pre-result stage.
Evaluating factors influencing the delivery and outcomes of an incentive-based behaviour change strategy targeting child obesity: protocol for a qualitative process and impact evaluation
Authors: Enright Gemma , Gyani Alex , Raadsma Simon , Allman-Farinelli Margaret , Rissel Chris , Innes-Hughes Christine , Lukeis Sarah , Rodgers Anthony , Redfern Julie
Published: December 2016

Introduction

Community-based weight management programmes are important in addressing childhood obesity. However, the mechanisms that lead to behaviour change within the programmes are rarely studied within the context of the programmes themselves once they have been implemented. This means that further potential gains in the effectiveness of the programme are often not made and any potential losses of efficacy are often not noticed. Qualitative research alongside randomised controlled trials (RCTs) can tell us the context in which these programmes are implemented and elucidate potential mediators or modifiers of the programmes' effectiveness. The aim of this evaluation is to determine the barriers and enablers to the delivery and impact of an incentive-based behaviour change strategy targeting child obesity to inform future translation.

Methods and analysis

Qualitative analysis, including stakeholder and family interviews, focus groups and a survey, will be used. The research will be conducted in collaboration with policymakers, researchers and community health professionals. Participants will be selected from programme providers, and parents/carers and children participating in an Australian community weight management programme during an RCT examining the effectiveness of incentives for improving behaviour change. A maximum variation sampling method based on participant demographics and group characteristics will be used. Thematic analysis will be carried out inductively based on emergent themes, using NVivo V.9.

Ethics and dissemination

This research is approved by the South West Sydney Human Ethics Committee review body (HREC/14/LPOOL/480). The evaluation will provide information about the contextual and influencing factors related to the outcomes of the RCT. The results will assist researchers, community health practitioners and policymakers regarding the development, implementation and translation of behaviour change strategies in community initiatives for obese children. Insights gained may be applicable to a range of chronic conditions where similar preventive intervention approaches are indicated.

Trial registration number

ACTRN12615000558527, Pre-results.
Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose–response double-blinded placebo-controlled randomised trial
Authors: Shen Chwan-Li , Mo Huanbiao , Yang Shengping , Wang Shu , Felton Carol K , Tomison Michael D , Soelaiman Ima Nirwana
Published: December 2016

Introduction

Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women.

Methods and analysis

In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinaryN-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2’-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. ‘Intent-to-treat’ principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ2analysis and regression will be used for comparisons.

Ethics and dissemination

This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences.

Trial registration number

NCT02058420; results.
Effect of peripheral arterial disease on the onset of lactate threshold during cardiopulmonary exercise test: study protocol
Authors: Key Angela , Ali Tamara , Walker Paul , Duffy Nick , Barkat Mo , Snellgrove Jayne , Torella Francesco
Published: December 2016

Introduction

Cardiopulmonary exercise test (CPET) is widely used in preoperative assessment and cardiopulmonary rehabilitation. The effect of peripheral arterial disease (PAD) on oxygen delivery (VO2) measured by CPET is not known. The aim of this study was to investigate the effect of PAD on VO2measurements during CPET.

Methods and analysis

We designed a prospective cohort study, which will recruit 30 patients with PAD, who will undergo CPET before and after treatment of iliofemoral occlusive arterial disease. The main outcome measure is the difference in VO2at the lactate threshold (LT) between the 2 CPETs. The secondary outcome measure is the relationship between change in VO2at the LT and peak exercise pretreatment and post-treatment and haemodynamic measures of PAD improvement (ankle–brachial index differential). For VO2changes, only simple paired bivariate comparisons, not multivariate analyses, are planned, due to the small sample size. The correlation between ABI and VO2rise will be tested by linear regression.

Ethics and dissemination

The study was approved by the North West-Lancaster Research and Ethics committee (reference 15/NW/0801). Results will be disseminated through scientific journal and scientific conference presentation. Completion of recruitment is expected by the end of 2016, and submission for publication by March 2017.

Trial registration number

NCT02657278.
African-American patients with cancer Talking About Clinical Trials (TACT) with oncologists during consultations: evaluating the efficacy of tailored health messages in a randomised controlled trial—the TACT study protocol
Authors: Brown R F , Davis R , Wilson Genderson M , Grant S , Cadet D , Lessard M , Alpert J , Ward J , Ginder G
Published: December 2016

Introduction

Low rates of accrual of African-American (AA) patients with cancer to therapeutic clinical trials (CTs) represent a serious and modifiable racial disparity in healthcare that impedes the development of promising cancer therapies. Suboptimal physician–patient consultation communication is a barrier to the accrual of patients with cancer of any race, but communication difficulties are compounded with AA patients. Providing tailored health messages (THM) to AA patients and their physician about CTs has the potential to improve communication, lower barriers to accrual and ameliorate health disparities.

Objective

(1) Demonstrate the efficacy of THM to increase patient activation as measured by direct observation. (2) Demonstrate the efficacy of THM to improve patient outcomes associated with barriers to AA participation. (3) Explore associations among preconsultation levels of: (A) trust in medical researchers, (B) knowledge and attitudes towards CTs, (C) patient-family member congruence in decision-making, and (D) involvement/information preferences, and group assignment.

Methods and analysis

First, using established methods, we will develop THM materials. Second, the efficacy of the intervention is determined in a 2 by 2 factorial randomised controlled trial to test the effectiveness of (1) providing 357 AA patients with cancer with THM with 2 different ‘depths’ of tailoring and (2) either providing feedback to oncologists about the patients' trial THM or not. The primary analysis compares patient engaged communication in 4 groups preconsultation and postconsultation.

Ethics and dissemination

This study was approved by the Virginia Commonwealth University Institutional Review Board. To facilitate use of the THM intervention in diverse settings, we will convene ‘user groups’ at 3 major US cancer centres. To facilitate dissemination, we will post all materials and the implementation guide in publicly available locations.

Trial registration number

NCT02356549.
Enhancing risk stratification for use in integrated care: a cluster analysis of high-risk patients in a retrospective cohort study
Authors: Vuik Sabine I , Mayer Erik , Darzi Ara
Published: December 2016

Objective

To show how segmentation can enhance risk stratification tools for integrated care, by providing insight into different care usage patterns within the high-risk population.

Design

A retrospective cohort study. A risk score was calculated for each person using a logistic regression, which was then used to select the top 5% high-risk individuals. This population was segmented based on the usage of different care settings using a k-means cluster analysis. Data from 2008 to 2011 were used to create the risk score and segments, while 2012 data were used to understand the predictive abilities of the models.

Setting and participants

Data were collected from administrative data sets covering primary and secondary care for a random sample of 300 000 English patients.

Main measures

The high-risk population was segmented based on their usage of 4 different care settings: emergency acute care, elective acute care, outpatient care and GP care.

Results

While the risk strata predicted care usage at a high level, within the high-risk population, usage varied significantly. 4 different groups of high-risk patients could be identified. These 4 segments had distinct usage patterns across care settings, reflecting different levels and types of care needs. The 2008–2011 usage patterns of the 4 segments were consistent with the 2012 patterns.

Discussion

Cluster analyses revealed that the high-risk population is not homogeneous, as there exist 4 groups of patients with different needs across the care continuum. Since the patterns were predictive of future care use, they can be used to develop integrated care programmes tailored to these different groups.

Conclusions

Usage-based segmentation augments risk stratification by identifying patient groups with different care needs, around which integrated care programmes can be designed.
Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study
Authors: Gavin Anna T , Donnelly David , Donnelly Conan , Drummond Frances J , Morgan Eileen , Gormley Gerard J , Sharp Linda
Published: December 2016

Aim

To investigate effects on men's health and well-being of higher prostate cancer (PCa) investigation and treatment levels in similar populations.

Participants

PCa survivors in Ireland where the Republic of Ireland (RoI) has a 50% higher PCa incidence than Northern Ireland (NI).

Method

A cross-sectional postal questionnaire was sent to PCa survivors 2–18 years post-treatment, seeking information about current physical effects of treatment, health-related quality of life (HRQoL; EORTC QLQ-C30; EQ-5D-5L) and psychological well-being (21 question version of the Depression, Anxiety and Stress Scale, DASS-21). Outcomes in RoI and NI survivors were compared, stratifying into ‘late disease’ (stage III/IV and any Gleason grade (GG) at diagnosis) and ‘early disease’ (stage I/II and GG 2–7). Responses were weighted by age, jurisdiction and time since diagnosis. Between-country differences were investigated using multivariate logistic and linear regression.

Results

3348 men responded (RoI n=2567; NI n=781; reflecting population sizes, response rate 54%). RoI responders were younger; less often had comorbidities (45% vs 38%); were more likely to present asymptomatically (66%; 41%) or with early disease (56%; 35%); and less often currently used androgen deprivation therapy (ADT; 2%; 28%). Current prevalence of incontinence (16%) and impotence (56% early disease, 67% late disease) did not differ between RoI and NI. In early disease, only current bowel problems (RoI 12%; NI 21%) differed significantly in multivariate analysis. In late disease, NI men reported significantly higher levels of gynaecomastia (23% vs 9%) and hot flashes(41% vs 19%), but when ADT users were analysed separately, differences disappeared. For HRQoL, in multivariate analysis, only pain (early disease: RoI 11.1, NI 19.4) and financial difficulties (late disease: RoI 10.4, NI 7.9) differed significantly between countries. There were no significant between-country differences in DASS-21 or index ED-5D-5L score.

Conclusions

Treatment side effects were commonly reported and increased PCa detection in RoI has left more men with these side effects. We recommended that men be offered a PSA test only after informed discussion.
Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
Authors: Kerckhove Nicolas , Mallet Christophe , Pereira Bruno , Chenaf Chouki , Duale Christian , Dubray Claude , Eschalier Alain
Published: December 2016

Introduction

Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain.

Methods and analysis

The Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome Study Short Form 12 (MOS SF-12) and Leeds questionnaires).

Ethics and communication

The study was approved by an independent ethics committee (CPP Sud-Est VI, France, IRB00008526) and registered by the French competent authority (Agence nationale de sécurité du médicament (ANSM)).

Trial registration number

NCT02100046, Recruiting.
Barriers, facilitators, strategies and outcomes to engaging policymakers, healthcare managers and policy analysts in knowledge synthesis: a scoping review protocol
Authors: Tricco Andrea C , Zarin Wasifa , Rios Patricia , Pham Ba’ , Straus Sharon E , Langlois Etienne V
Published: December 2016

Introduction

Engaging policymakers, healthcare managers and policy analysts in the conduct of knowledge synthesis can help increase its impact. This is particularly important for knowledge synthesis studies commissioned by decision-makers with limited timelines, as well as reviews of health policy and systems research. A scoping review will be conducted to assess barriers, facilitators, strategies and outcomes of engaging these individuals in the knowledge synthesis process.

Methods and analysis

We will follow the Joanna Briggs Institute guidance for scoping reviews. Literature searches of electronic databases (eg, MEDLINE, EMBASE, Cochrane Library, ERIC, PsycINFO) will be conducted from inception onwards. The electronic search will be supplemented by searching for sources that index unpublished/difficult to locate studies (eg, GreyNet International database), as well as through scanning of reference lists of reviews on related topics. All study designs using either qualitative or quantitative methodologies will be eligible if there is a description of the strategies, barriers or facilitators, and outcomes of engaging policymakers, healthcare managers and policy analysts in the knowledge synthesis process. Screening and data abstraction will be conducted by 2 team members independently after a calibration exercise across the team. A third team member will resolve all discrepancies. We will conduct frequency analysis and thematic analysis to chart and characterise the literature, identifying data gaps and opportunities for future research, as well as implications for policy.

Ethics and dissemination

This project was commissioned by the Alliance for Health Policy and Systems Research, WHO. The results will be used by Alliance Review Centers of health policy and systems research in low-income and middle-income countries that are conducting knowledge synthesis to inform health policymaking and decision-making. Our results will also be disseminated through conference presentations, train-the-trainer events, peer-reviewed publication and a 1-page policy brief that will be posted on the authors' websites.
The associations between work–life balance behaviours, teamwork climate and safety climate: cross-sectional survey introducing the work–life climate scale, psychometric properties, benchmarking data and future directions
Authors: Sexton J Bryan , Schwartz Stephanie P , Chadwick Whitney A , Rehder Kyle J , Bae Jonathan , Bokovoy Joanna , Doram Keith , Sotile Wayne , Adair Kathryn C , Profit Jochen
Published: December 2016

Background

Improving the resiliency of healthcare workers is a national imperative, driven in part by healthcare workers having minimal exposure to the skills and culture to achieve work–life balance (WLB). Regardless of current policies, healthcare workers feel compelled to work more and take less time to recover from work. Satisfaction with WLB has been measured, as has work–life conflict, but how frequently healthcare workers engage in specific WLB behaviours is rarely assessed. Measurement of behaviours may have advantages over measurement of perceptions; behaviours more accurately reflect WLB and can be targeted by leaders for improvement.

Objectives

1. To describe a novel survey scale for evaluating work–life climate based on specific behavioural frequencies in healthcare workers.

2. To evaluate the scale's psychometric properties and provide benchmarking data from a large healthcare system.

3. To investigate associations between work–life climate, teamwork climate and safety climate.

Methods

Cross-sectional survey study of US healthcare workers within a large healthcare system.

Results

7923 of 9199 eligible healthcare workers across 325 work settings within 16 hospitals completed the survey in 2009 (86% response rate). The overall work–life climate scale internal consistency was Cronbach α=0.790. t-Tests of top versus bottom quartile work settings revealed that positive work–life climate was associated with better teamwork climate, safety climate and increased participation in safety leadership WalkRounds with feedback (p<0.001). Univariate analysis of variance demonstrated differences that varied significantly in WLB between healthcare worker role, hospitals and work setting.

Conclusions

The work–life climate scale exhibits strong psychometric properties, elicits results that vary widely by work setting, discriminates between positive and negative workplace norms, and aligns well with other culture constructs that have been found to correlate with clinical outcomes.
Prevalence of gastrointestinal dysmotility and complications detected by abdominal plain films after lung transplantation: a single-centre cohort study
Authors: Heinrich Henriette , Neuenschwander Anne , Russmann Stefan , Misselwitz Benjamin , Benden Christian , Schuurmans Macé M
Published: December 2016

Introduction and Aims

Gastrointestinal (GI) complications such as gastric retention (GR) and constipation are common after lung transplantation (LT). Abdominal plain films (APFs) are a low-cost diagnostic tool to detect impaired GI function. The goal of our study was to assess the prevalence of GI pathology seen on APF in lung transplant recipients (LTRs) and to identify associated risk factors.

Methods

Retrospective analysis of consecutive LTRs followed up between 2001 and 2013. Demographic, radiographic and clinical data were assessed.

Results

198 patients were included in the study, 166 thereof had more than 1 APF with a mean number of 5 APFs per patient. 163 patients had a detectable radiographic pathology on APF. The proportion of LTR with GR was highest among cystic fibrosis patients (48.5%). Multivariate regression analysis showed a significant association of diabetes with GR with a trend for age and use of opiates as risk factors. Similarly, female sex, advanced age and diabetes showed a trend to be associated with lower GI tract complications. Almost all patients had suffered from at least 1 episode of lower GI dysmotility during a median follow-up of 5.7 years. No clear correlation between GI events and the development of chronic lung allograft dysfunction could be identified.

Conclusions

We found a statistically significant association of diabetes with GR and a progressive increase in the prevalence of GR over time after LT. Lower GI complications affected >80% of LTR and increased over time. Future studies correlating GI transit with APF findings are needed.
Mid-arm circumference can be used to estimate weight of adult and adolescent patients
Authors: Cattermole Giles N , Graham Colin A , Rainer Timothy H
Published: December 2016

Objectives

Many drug and fluid regimens in emergency medicine are weight dependent in adults, but no standard adult weight estimation tools exist. Paediatric weight is often estimated in emergency situations using methods based on age or height when direct measurement is not possible, and recently, methods based on mid-arm circumference (MAC) have also been developed. The aim of this study was to derive and validate an accurate MAC-based method for weight estimation for use in all age groups.

Methods

Data were obtained from the US National Health and Nutrition Examination Survey (NHANES). MAC-based methods of weight estimation were derived in 8498 subjects (5595 adults aged 16–80 years, 2903 children aged 1–15.9 years) from the NHANES 2011–2012 dataset, using linear regression. NHANES 2009–2010 was used for validation in 9022 subjects (6049 adults aged 16–79 years, 2973 children aged 1–15.9 years).

Results

A simplified method of MAC-based weight estimation was derived from linear regression equation: weight in kg=4×MAC (in cm)—50. On validation, results in children aged 1–10.9 years were poor. In adults and children aged 11–15.9 years, over 60%, 90% and 98% of estimates fell, respectively, within 10%, 20% and 30% of actual weights when using the simplified formula.

Conclusions

In this description of a method for estimating weight in adults, we have derived and validated a simplified formula that is at least as precise in adults and adolescents as commonly used paediatric weight estimation tools in children.
Paediatric emergency department-based carbon monoxide detector intervention: a randomised trial
Authors: McKenzie Lara B , Roberts Kristin J , Kaercher Roxanne M , Collins Christy L , Comstock R Dawn , Fernandez Soledad , Abdel-Rasoul Mahmoud , Casavant Marcel J , Mihalov Leslie
Published: December 2016

Background

Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors.

Methods

A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention.

Results

Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit ‘safe’ CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income.

Conclusions

An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector.

Trial registration number

NCT00959478.
Curbing publicly-funded family planning services in Iran: who is affected?
Authors: Erfani Amir
Published: December 2016

Objective

In response to a persistent low fertility rate in the country, the Supreme Leader of Iran in 2012 called for the shift to pronatalist population policies. Consequently, Iran's Parliament proposed a bill to curb the provision of contraceptive knowledge and services as a solution to raising the country's low fertility rate. This study aimed to investigate which groups of women will be adversely affected if the provision of subsidised contraceptive methods [i.e. sterilisation, intrauterine device (IUD) and injections] is curbed.

Methods

This study used recent data from the 2014 Tehran Survey of Fertility (n=3012) conducted among a representative sample of 3012 married women of reproductive age, and used multinomial logistic regression analysis to identify women with a higher likelihood of using government-funded contraceptive methods.

Results

Currently 82% of married women living in Tehran use a contraceptive method. The use of long-acting contraception, namely sterilisation and IUDs, declined from 34% in 2000 to 20% in 2014, and the prevalence of male methods (withdrawal and condoms) increased from 33% to 55% in the same period. Multivariate results showed that women who have a large number of children, want no more children, live in poor districts, and have low education are more likely to use long-acting contraceptive methods than withdrawal and condoms.

Conclusions

Women of low socioeconomic status who want to stop childbearing are the most vulnerable subgroups of the population if the publicly-funded family planning services are curbed.
Shared Decision-Making following Disclosure of Coronary Heart Disease Genetic Risk: Results from a Randomized Clinical Trial
Authors: Jouni Hayan , Haddad Raad A , Marroush Tariq S , Brown Sherry-Ann , Kruisselbrink Teresa M , Austin Erin E , Shameer Khader , Behnken Emma M , Chaudhry Rajeev , Montori Victor M , Kullo Iftikhar J
Published: December 2016

Whether disclosure of genetic risk for coronary heart disease (CHD) influences shared decision-making (SDM) regarding use of statins to reduce CHD risk is unknown. We randomized 207 patients, age 45–65 years, at intermediate CHD risk, and not on statins, to receive the 10-year risk of CHD based on conventional risk factors alone (n=103) or in combination with a genetic risk score (n=104). A genetic counselor disclosed this information followed by a physician visit for SDM regarding statin therapy. A novel decision aid was used in both encounters to disclose the CHD risk estimates and facilitate SDM regarding statin use. Patients reported their decision quality and physician visit satisfaction using validated surveys. There were no statistically significant differences between the two groups in the SDM score, satisfaction with the clinical encounter, perception of the quality of the discussion or of participation in decision-making and physician visit satisfaction scores. Quantitative analyses of a random subset of 80 video-recorded encounters using the OPTION5 scale also showed no significant difference in SDM between the two groups. Disclosure of CHD genetic risk using an electronic health record-linked decision aid did not adversely affect SDM or patients’ satisfaction with the clinical encounter.

Trial registration number

NCT01936675; Results.
MRI audit of complications in intracranial stenosis treated with Wingspan device
Authors: Yeo Leonard L L , Wu Y M , Chen Y L , Yeh C H , Lee T H , Wong H F
Published: December 2016

Objectives

To evaluate the safety and efficacy of the Wingspan device for the treatment of symptomatic intracranial atherosclerotic stenosis (ICAS).

Methods

We audited a prospective ongoing database of consecutive patients who received Wingspan stenting between January 2013 and December 2015. All patients underwent MRI to audit any complications during the early follow-up period. We focused on the clinical demographics, lesion characteristics, treatment results, and periprocedural complications. Functional outcomes were measured with the modified Rankin Scale (mRS) at discharge and after 3 months.

Results

Intracranial stenting was performed in 50 patients (100%). Mean stenosis pre-stenting was 76.5±13.1% and post-stenting residual stenosis was 19.8±13.8%. The overall 30-day rate of procedure-related complications was 6.0% (3/50). Two patients (4%) developed in-stent restenosis, one of whom had a dissection at the middle cerebral artery. Interestingly, on the follow-up MRI scan there was a high incidence of asymptomatic diffusion-weighted imaging (DWI) hyperintensities, 46% (23/50) presumed to be due to microembolic causes. At the 90-day, 180-day, and 1-year follow-up, three patients had further strokes resulting in a total complication rate of 12%. 92% had excellent outcomes (mRS 0–1) and only one patient had deterioration of his mRS score.

Conclusions

ICAS treated by Wingspan stenting using pre-placement balloon angioplasty appears safe and effective with a high technical success rate and favorable outcomes. There is a high incidence of asymptomatic DWI hyperintensites post-procedure, but these do not appear to result in long-term sequelae.