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Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol

Por: Jaber · S. · Rolle · A. · Jung · B. · Chanques · G. · Bertet · H. · Galeazzi · D. · Chauveton · C. · Molinari · N. · De Jong · A.
Introduction

Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.

Methods and analysis

The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57’". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.

Trial registration details

ClinicalTrials.gov Identifier: NCT04079387; Pre-results.

Physicians' norms and attitudes towards substance use in colleague physicians: A cross-sectional survey in the Netherlands

by Pauline Geuijen, Marlies de Rond, Joanneke Kuppens, Femke Atsma, Aart Schene, Hein de Haan, Cornelis de Jong, Arnt Schellekens

Introduction

Substance use disorders (SUD) in physicians often remain concealed for a long time. Peer monitoring and open discussions with colleagues are essential for identifying SUD. However, physicians often feel uncomfortable discussing substance use with a colleague. We explored physicians’ attitudes and norms about substance use (disorders) and their (intended) approach upon a presumption of substance use in a colleague.

Materials and methods

An online cross-sectional survey concerning “Addiction in physicians” was administered by the Royal Dutch Medical Association physician panel. Overall, 1685 physicians (47%) responded. Data were analyzed by logistic regression to explore factors associated with taking action upon a substance use presumption.

Results

Most physicians agreed that SUD can happen to anyone (67%), is not a sign of weakness (78%) and that it is a disease that can be treated (83%). Substance use in a working context was perceived as unacceptable (alcohol at work: 99%, alcohol during a standby duty: 91%, alcohol in the eight hours before work: 77%, and illicit drugs in the eight hours before work: 97%). Almost all respondents (97%) intend to act upon a substance use presumption in a colleague. Of the 29% who ever had this presumption, 65% took actual action. Actual action was associated with male gender and older age (OR = 1.81; 95% CI = 1.20–2.74 and OR = 1.03; 95% CI = 1.01–1.05, respectively).

Conclusions

About one-third of physicians reported experience with a presumption of substance use in a colleague. Whilst most physicians intend to take action upon such a presumption, two-thirds actually do act upon a presumption. To bridge this intention-behavior gap continued medical education on signs and symptoms of SUD and instructions on how to enter a supportive dialogue with a colleague about personal issues, may enhance physicians’ knowledge, confidence, and ethical responsibility to act upon a presumption of substance use or other concerns in a colleague.

Heightened self-reported punishment sensitivity, but no differential attention to cues signaling punishment or reward in anorexia nervosa

by Nienke C. Jonker, Klaske A. Glashouwer, Albert Hoekzema, Brian D. Ostafin, Peter J. de Jong

This study examined whether adolescents with anorexia nervosa (AN) are more sensitive to punishment and less sensitive to reward than a non-eating disorder comparison group. Both self-report and performance measures were used to index reward and punishment sensitivity. Participants were adolescents with AN (n = 69) and an individually matched comparison group with healthy weight (n = 69). They completed the Behavioral Inhibition Scale/Behavioral Activation Scale and the Sensitivity to Punishment and Sensitivity to Reward Questionnaire to index self-reported reward and punishment sensitivity, and performed the Spatial Orientation Task to index attention to cues signaling reward and punishment. There was extremely strong evidence (BF10 > 100), that adolescents with AN reported higher sensitivity to punishment than adolescents without an eating disorder. However, adolescents with AN did not differ from the comparison group on self-reported reward sensitivity, and attention to cues signaling reward or punishment. Adolescents with AN clearly show heightened punishment sensitivity, yet this was not paralleled by a heightened proneness to detect signals of punishment. An important next step would be to examine whether punishment sensitivity is a reliable risk factor for the development or maintenance of AN.

The initiation of Dutch newly qualified hospital-based midwives in practice, a qualitative study

In the Netherlands, a percentage of newly qualified midwives start work in maternity care as a hospital-based midwife, although prepared particularly for working autonomously in the community.

Qualitative instruments involving clients as co-researchers to assess and improve the quality of care relationships in long-term care: an evaluation of instruments to enhance client participation in quality research

Por: Scheffelaar · A. · Bos · N. · Triemstra · M. · de Jong · M. · Luijkx · K. · van Dulmen · S.
Objectives

Enhancing the active involvement of clients as co-researchers is seen as a promising innovation in quality research. The aim of this study was to assess the feasibility and usability of five qualitative instruments used by co-researchers for assessing the quality of care relationships in long-term care.

Design and setting

A qualitative evaluation was performed in three care organisations each focused on one of the following three client groups: frail older adults, people with mental health problems and people with intellectual disabilities. A total of 140 respondents participated in this study. The data comprised observations by researchers and experiences from co-researchers, clients and professionals.

Results

Two instruments scored best on feasibility and usability and can therefore both be used by co-researchers to monitor the quality of care relationships from the client perspective in long-term care.

Conclusions

The selected instruments let co-researchers interview other clients about their experiences with care relationships. The study findings are useful for long-term care organisations and client councils who are willing to give clients an active role in quality improvement.

Did an urban perinatal health programme in Rotterdam, the Netherlands, reduce adverse perinatal outcomes? Register-based retrospective cohort study

Por: de Jonge · H. C. · Lagendijk · J. · Saha · U. · Been · J. V. · Burdorf · A.
Objectives

To study the effect of an urban perinatal health programme in Rotterdam, the Netherlands, on perinatal outcomes.

Design

A retrospective cohort study with difference-in-differences analysis using individual-level perinatal outcome data from the Dutch Perinatal Registry 2003–2014 linked to Central Bureau of Statistics data of migration background and individual disposable household income.

Intervention

The programme consisted of perinatal health promotion, risk selection and risk-guided pregnancy care, and a new primary care child birth centre. The programme was implemented during 2009–2012.

Primary outcome measures

We compared trends in perinatal mortality, preterm delivery and small-for-gestational-age births between targeted urban neighbourhoods in Rotterdam (n=61 415) and all other urban neighbourhoods in the Netherlands (n=881 202). The effect of the programme was modelled as a change in trend of each perinatal outcome in the treatment group post intervention compared with the control population from January 2010 onwards. All analyses were adjusted for maternal age, parity, ethnicity and individual-level low socioeconomic status (SES). We also conducted a stratified analysis by SES.

Results

During 2003–2014, downward trends in perinatal mortality (adjusted OR (aOR) 0.9439 per year, 95% CI 0.9362 to 0.9517), preterm birth (aOR 0.9970 per year, 95% CI 0.9944 to 0.9997) and small-for-gestational-age births (aOR 0.9809 per year, 95% CI 0.9787 to 0.9831) in the entire study population were observed. No demonstrable changes in these trends were found in the intervention group after the programme had started. The stratified analyses by SES showed no changes in trends post intervention in both strata either.

Conclusions

The programme had no demonstrable effects on perinatal outcomes. The intervention may not have reached a sufficient proportion of the population or has provided too little contrast to the widespread attention for inequalities in pregnancy outcomes occurring simultaneously in the Netherlands.

The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study.

Por: Govaert · G. · Hobbelink · M. · Reininga · I. · Bosch · P. · Kwee · T. · de Jong · P. · Jutte · P. · Vogely · H. · Dierckx · R. · Leenen · L. · Glaudemans · A. · IJpma · F.
Introduction

The optimal diagnostic imaging strategy for fracture-related infection (FRI) remains to be established. In this prospective study, the three commonly used advanced imaging techniques for diagnosing FRI will be compared. Primary endpoints are (1) determining the overall diagnostic performances of white blood cell (WBC) scintigraphy, fluorodeoxyglucose positron emission tomography (FDG-PET) and magnetic resonance imaging (MRI) in patients with suspected FRI and (2) establishing the most accurate imaging strategy for diagnosing FRI.

Methods and analysis

This study is a non-randomised, partially blinded, prospective cohort study involving two level 1 trauma centres in The Netherlands. All adult patients who require advanced medical imaging for suspected FRI are eligible for inclusion. Patients will undergo all three investigational imaging procedures (WBC scintigraphy, FDG-PET and MRI) within a time frame of 14 days after inclusion. The reference standard will be the result of at least five intraoperative sampled microbiology cultures, or, in case of no surgery, the clinical presence or absence of infection at 1 year follow-up. Initially, the results of all three imaging modalities will be available to the treating team as per local protocol. At a later time point, all scans will be centrally reassessed by nuclear medicine physicians and radiologists who are blinded for the identity of the patients and their clinical outcome. The discriminative ability of the imaging modalities will be quantified by several measures of diagnostic accuracy.

Ethics and dissemination

Approval of the study by the Institutional Review Board has been obtained prior to the start of this study. The results of this trial will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.

Trial registration number

The IFI trial is registered in the Netherlands Trial Register (NTR7490).

Sensitivity of point-of-care testing C reactive protein and procalcitonin to diagnose urinary tract infections in Dutch nursing homes: PROGRESS study protocol

Por: Kuil · S. D. · Hidad · S. · Fischer · J. C. · Harting · J. · Hertogh · C. M. · Prins · J. M. · van Leth · F. · de Jong · M. D. · Schneeberger · C.
Introduction

Suspected urinary tract infection (UTI) ranks among the most common reasons for antibiotic use in nursing homes. However, diagnosing UTI in this setting is challenging because UTI often presents with non-specific symptomatology. Moreover asymptomatic bacteriuria is common in elderly, which complicates attribution of causality to detection of bacteria in urine. These diagnostic challenges contribute to overuse of antibiotics and emergence of antimicrobial resistance in nursing homes. Given the diagnostic challenges, there is a need for point-of-care (POC) diagnostic tests to support clinical rules for diagnosing UTI. Procalcitonin (PCT) and C reactive protein (CRP) are inflammatory blood markers that have been proven useful to support diagnosis and monitoring of (bacterial) respiratory tract infections and sepsis. While limited studies suggest their usefulness in supporting UTI diagnosis, their utility has not been studied in elderly populations for this purpose.

Methods and analysis

In a 24-month matched prospective study, ‘PROGRESS’ will assess and compare the sensitivity of rapid POC measurements of blood CRP and PCT levels to support clinical rules for diagnosing UTI in nursing home residents. The primary outcome measure is sensitivity of the POC tests to identify patients with true UTI based on the predefined definition, as derived from receiver operating curves.

Ethics and dissemination

This study will be conducted in accordance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The study protocol is approved by the Medical Ethical Committee of Amsterdam UMC location VUmc with reference number 2017.350 and National Central Committee on Research involving Human Subjects with reference number NL62067.029.17.

Trial registration number

NTR6467.

Systematic client feedback to brief therapy in basic mental healthcare: study protocol for a four-centre clinical trial

Por: Bovendeerd · B. · de Jong · K. · Colijn · S. · de Groot · E. · Hafkenscheid · A. · Moerbeek · M. · de Keijser · J.
Introduction

The Partners for Change Outcome Management System (PCOMS) is a client feedback-system built on two brief visual analogue self-report scales. Prior studies of PCOMS have found effects varying from significant positive to negative. Aims of present study are; to test the predicted beneficial impact of PCOMS, while accounting for methodological flaws in prior studies and to clarify under which circumstances the addition of PCOMS to therapy has a beneficial effect.

Methods and analysis

This study focuses on patients applying for brief, time-limited treatments. Four centres will be randomised to either treatment as usual (TAU) or TAU with PCOMS. All participating patients will be assessed four times. The full staff in the experimental condition will be trained in PCOMS. In the second part of this study, all therapists in the PCOMS condition will fill in a questionnaire concerning the influence of regulatory focus, self-efficacy, external or internal feedback orientation and perceived feedback validity of PCOMS. Finally, patients in the PCOMS condition will be asked to give feedback through a structured interview.

The primary outcome measure is the Outcome Questionnaire over the period from beginning to end of therapy. The Mental Health Continuum-Short Form and Consumer Quality Index are also completed. In the primary analysis, outcomes of the two treatment conditions on treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level (within patient, between patients and between therapists) multilevel analysis. The DSM-classification, sex, education level, age of each patient and therapist factors will be included as covariates.

Ethics and dissemination

The Medical Ethics Committee of the University of Twente approved this study (K15-11, METC Twente). Data will be included from 1 January 2016 to 1 July 2019. Study results will be disseminated through peer-reviewed journals and conferences.

Trial registration number

NTR5466; Pre-results.

Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design

Por: van Hamersvelt · R. W. · Isgum · I. · de Jong · P. A. · Cramer · M. J. M. · Leenders · G. E. H. · Willemink · M. J. · Voskuil · M. · Leiner · T.
Introduction

Anatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFRCT] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFRCT and DL for the identification of functionally significant coronary artery stenosis.

Methods and analysis

Seventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFRCT and DL separately and combined for the identification of functionally significant coronary artery stenosis.

Ethics and dissemination

Ethical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.

Trial registration number

NCT03139006; Pre-results.

Informal and formal care preferences and expected willingness of providing elderly care in Germany: protocol for a mixed-methods study

Por: de Jong · L. · Plöthner · M. · Stahmeyer · J. T. · Eberhard · S. · Zeidler · J. · Damm · K.
Introduction

In Germany, the number of elderly people in need of care is expected to increase from 2.4 million in 2015 to 3.2 million in 2030. The subsequent rise in demand for long-term care facilities is unlikely to be met by the current care structures and available staff. Additionally, many Germans still prefer to be cared for at home for as long as possible. In light of recent changes, such as increasing employment rates of women and growing geographical distances of family members, informal caregiving becomes more challenging in the future. The aim of this study is to explore preferences for informal and formal care services in the German general population, as well as the expected willingness of providing elderly care.

Methods and analysis

A mixed-methods approach will be used to explore care preferences and expected willingness of providing elderly care in the German general population. A systematic literature review will be performed to provide an overview of the current academic literature on the topic. Qualitative interviews will be conducted with informal caregivers, care consultants and people with no prior caregiving experiences. A labelled discrete choice experiment will be designed and conducted to quantitatively measure the preferences for informal and formal care in the German general population. People between 18 and 65 years of age will be recruited in cooperation with a (regional) statutory health insurance (AOK Lower Saxony). A mixed multinomial logit regression model and a latent class finite mixture model will be used to analyse the data and test for subgroup differences in care preferences.

Ethics and dissemination

The study has been approved by the Committee for Clinical Ethics of the Medical School in Hannover. Data will be treated confidential to ensure the participants' anonymity. The results will be discussed and disseminated to relevant stakeholders in the field.

Trial registration number

DRKS00012266.

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