bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

IntroductionAntithrombotic 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 analysisIn 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 disseminationThis 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 numberNTR4887; 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

ObjectiveTo 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.MethodWe 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.ResultsInterviewees 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.ConclusionsCompeting 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

IntroductionThe 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 analysisThis 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 disseminationThis 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 numberAgence 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

IntroductionCommunity-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 analysisQualitative 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 disseminationThis 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 numberACTRN12615000558527, 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

IntroductionOsteoporosis 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 analysisIn 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 disseminationThis 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 numberNCT02058420; 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

IntroductionCardiopulmonary 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 analysisWe 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 disseminationThe 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 numberNCT02657278.
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

IntroductionLow 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 analysisFirst, 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 disseminationThis 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 numberNCT02356549.
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

ObjectiveTo show how segmentation can enhance risk stratification tools for integrated care, by providing insight into different care usage patterns within the high-risk population.DesignA 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 participantsData were collected from administrative data sets covering primary and secondary care for a random sample of 300 000 English patients.Main measuresThe 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.ResultsWhile 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.DiscussionCluster 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.ConclusionsUsage-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

AimTo investigate effects on men's health and well-being of higher prostate cancer (PCa) investigation and treatment levels in similar populations.ParticipantsPCa survivors in Ireland where the Republic of Ireland (RoI) has a 50% higher PCa incidence than Northern Ireland (NI).MethodA 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.Results3348 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.ConclusionsTreatment 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

IntroductionCurrently 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 analysisThe 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 communicationThe 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 numberNCT02100046, Recruiting.