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What are the benefits and risks of sharing patients diagnostic radiological images with them? A cross-sectional study of the perceptions of patients and clinicians in the UK

Por: Cox · W. A. S. · Cavenagh · P. · Bello · F.
Objectives

The objective for this work was to assess clinical experts’ and patients’ opinions on the benefits and risks of sharing patients’ diagnostic radiological images with them.

Setting

This study was conducted outside of the primary and secondary care settings. Clinical experts were recruited at a UK national imaging and oncology conference, and patients were recruited via social media.

Participants

121 clinical experts and 282 patients completed the study. A further 73 patient and 10 clinical expert responses were discounted due to item non-response. Individuals were required to be a minimum of 18 years of age at the time of participation.

Primary and secondary outcome measures

This study was exploratory in nature. As such, the outcomes to be measured for demonstration of the successful completion of this study were generated organically through the process of the investigation itself. These were: (1) the delineation of the benefits available from, and the risks posed by, widening access to diagnostic radiological images; (2) establishment of the level and nature of demand for access to diagnostic radiological images; and (3) the identification of stakeholder requirements for accessing available benefit from diagnostic radiological images.

Results

403 usable questionnaires were returned consisting of responses from clinical experts (n=121) and patients (n=282). Both groups acknowledge the potential benefits of this practice. Examples included facilitating communication, promoting patient engagement and supporting patients in accepting health information shared with them. However, both groups also recognised risks associated with image sharing, such as the potential for patients to be upset or confused by their images.

Conclusions

There is a demand from patients for access to their diagnostic radiological images alongside acknowledgement from clinical experts that there may be benefits available from this. However, due to the acknowledged risks, there is also a need to carefully manage this interaction.

Trial registration number

187752.

Prospective, observational study to evaluate the relation between patient-reported outcomes and component rotation in total knee replacement: protocol for the CRACK study

Por: van Jonbergen · H.-P. · Landman · E. · Horst · M. · Westerbeek · R. · Kleinlugtenbelt · Y.
Introduction

Total knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed results in less than optimal outcomes is lacking. This study aims to assess the relation between knee prosthesis component rotation and patient-reported outcomes in a large group of patients and to determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.

Methods and analysis

In this single-centre, prospective observational cohort study, a total of 500 patients will undergo TKR. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score, the Knee Injury and Osteoarthritis Outcome Score, EQ-5D, visual analogue scale for pain, the American Knee Society Score and the knee joint range of motion. We will assess the relation between femoral, tibial and combined component rotation and patient-reported outcome measures at 8 weeks and 1 year of follow-up, and we will determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.

Ethics and dissemination

Ethical approval for this study has been granted by the Isala Hospital ethics committee. The results will be published in a peer-reviewed journal and presented at relevant meetings.

Trial registration number

NL7635.

Cumulative exposure to ionising radiation from diagnostic imaging tests: a 12-year follow-up population-based analysis in Spain

Por: Lumbreras · B. · Salinas · J. M. · Gonzalez-Alvarez · I.
Objectives

To calculate each patient’s cumulative radiation exposure and the recurrent tests during a 12-year study period, according to sex and age, in routine practice.

Design

Retrospective cohort study.

Setting

A general hospital with a catchment population of 224 751 people, in the Southeast of Spain.

Participants

Population belonged to the catchment area of that hospital in 2007. We collected all consecutive diagnostic imaging tests undergone by this population until 31 December 2018. We excluded: imaging tests that did not involve radiation exposure.

Main outcome measures

The cumulative effective dose and the recurrent imaging tests by sex and age at entry of study.

Results

Of the 224 751 people, 154 520 (68.8%) underwent an imaging test. The population had 1 335 752 imaging tests during the period of study: 1 110 077 (83.0%) plain radiography; 156 848 (11.8%) CT; 63 157 (4.8%) fluoroscopy and 5670 (0.4%) interventional radiography. 25.4% of the patients who had a CT, underwent five or more CTs (5.4% in the 0–20 years age group). The median total cumulative effective dose was 2.10 mSv (maximum 3980.30) and 16.30 mSv (maximum 1419.30 mSv) if we considered only doses associated with CT. Women received more effective dose than men (median 2.38 vs median 1.90, p

Conclusions

Nearly 5% of patients received doses higher than 50 mSv during the 12-year period of study and 2.5% of the patients in the 0–20 years age group, if we considered only doses associated with CT. The rate of recurrent examinations was high, especially in older patients, but also relevant in the 0–20 years age group.

Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)

Por: Hohenhaus · M. · Egger · K. · Klingler · J.-H. · Hubbe · U. · Reisert · M. · Wolf · K.
Introduction

The diagnosis of degenerative cervical myelopathy (DCM) is difficult in numerous patients due to the limited correlation of clinical symptoms, electrophysiology and MRI. This applies especially for early disease stages with mild symptoms or in uncertainty due to comorbidities. Conventional MRI myelopathy signs show a restricted sensitivity to clinical symptoms of at most 60%. It is desirable to select patients for surgical treatment as early as possible before irreversible neurological damage occurs. To improve treatment, a more reliable imaging is necessary. Microdiffusion imaging (MIDI) is an innovative MRI modality to depict tissue alterations within one voxel based on diffusion-weighted imaging (DWI) postprocessing. By separating the affected area into several mesoscopic compartments, pathological changes might be detected more sensitive through this subtle tissue resolution. We hypothesise, that MIDI shows myelopathic alterations more sensitive than conventional MRI and improves the correlation to functional impairment.

Methods and analysis

In this prospective, observational trial, 130 patients with a relevant degenerative cervical spinal stenosis receive MRI including MIDI and a standard clinical and electrophysiological assessment. Special subvoxel diffusion parameters are calculated. Clinical follow-ups are conducted after 3, 6 and with additional MRI and electrophysiology after 12 months. The primary endpoint is the sensitivity of MIDI to detect functional myelopathy defined by clinical and electrophysiological features correlated to conventional MRI myelopathy signs. Twenty healthy subjects will be included as negative control. The results will provide new insights into the development of mesoscopic spinal cord alterations in DCM associated to the clinical course. Aim is to improve the diagnostics of incipient myelopathy through this new modality.

Ethics and dissemination

The study protocol is approved by the Ethics Committee of the University of Freiburg (reference 261/17). The results will be published in a peer-reviewed journal.

Trial registration number

DRKS00012962.

Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V

Por: Ludwig · M. · Chipon · E. · Cohen · J. · Reymond · E. · Medici · M. · Cole · A. · Moreau Gaudry · A. · Ferretti · G.
Introduction

Lung cancer screening in individuals at risk has been recommended by various scientific institutions. One of the main concerns for CT screening is repeated radiation exposure, with the risk of inducing malignancies in healthy individuals. Therefore, lowering the radiation dose is one of the main objectives for radiologists. The aim of this study is to demonstrate that an ultra-low dose (ULD) chest CT protocol, using recently introduced hybrid iterative reconstruction (ASiR-V, GE medical Healthcare, Milwaukee, Wisconsin, USA), is as performant as a standard ‘low dose’ (LD) CT to detect non-calcified lung nodules ≥4 mm.

Methods and analysis

The total number of patients to include is 150. Those are referred for non-enhanced chest CT for detection or follow-up of lung nodule and will undergo an additional unenhanced ULD CT acquisition, the dose of which is on average 10 times lower than the conventional LD acquisition. Total dose of the entire exam (LD+ULD) is lower than the French diagnostic reference level for a chest CT (6.65 millisievert). ULD CT images will be reconstructed with 50% and 100% ASiR-V and LD CT with 50%. The three sets of images will be read in random order by two pair of radiologists, in a blind test, where patient identification and study outcomes are concealed. Detection rate (sensitivity) is the primary outcome. Secondary outcomes will include concordance of nodule characteristics; interobserver reproducibility; influence of subjects’ characteristics, nodule location and nodule size; and concordance of emphysema, coronary calcifications evaluated by visual scoring and bronchial alterations between LD and ULD CT. In case of discordance, a third radiologist will arbitrate.

Ethics and dissemination

The study was approved by the relevant ethical committee. Each study participant will sign an informed consent form.

Trial registration number

NCT03305978; Pre-results.

Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study)

Por: Aid Mellouk · K. · Soulaymani · A. · Gao · F. · Astagneau · P. · Misset · B.

Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France.

Methods and analysis

From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d’Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay).

Ethics and dissemination

No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016–41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.

Ultrasonic strain elastography for detecting abnormalities in the supraspinatus tendon: an intra- and inter-rater reliability study

Por: Brage · K. · Hjarbaek · J. · Kjaer · P. · Ingwersen · K. G. · Juul-Kristensen · B.
Objectives

The reliability of ultrasonic strain elastography (SEL) used to detect abnormalities in the supraspinatus tendon is unclear. Thus, the aim of this study was to investigate the reliability of SEL in the supraspinatus tendon.

Design

An intra-rater and inter-rater reliability study.

Setting

A single-centre study conducted at the University of Southern Denmark.

Participants

Twenty participants with shoulder pain and MRI-verified supraspinatus tendinosis and 20 asymptomatic participants (no MRI).

Primary and secondary outcome measures

Raw values (RAW) and ratios (deltoid muscle (DELT) and gel pad (GEL) as reference tissues) were calculated and mean values of measurements from three regions of the supraspinatus tendon were reported. Colour scale ratings and number of yellow/red lesions from the three areas were also included.

Results

Intra-rater reliability showed intraclass correlation coefficients (ICCs) for RAW, DELT and GEL: 0.97 (minimal detectable change (MDC): 0.28 (6.36% of the mean)), 0.89 (MDC: 2.91 (20.37%)) and 0.73 (MDC: 1.61 (58.82%)), respectively. The ICCs for inter-rater reliability were 0.89 (MDC: 0.47 (10.53%)), 0.78 (MDC: 3.69 (25.51%)) and 0.70 (MDC: 1.75 (62.63%)), respectively.

For colour scale ratings, intra-rater reliability (linear weighted kappa) ranged from 0.76 to 0.79, with the inter-rater reliability from 0.71 to 0.81. For the number of lesions, intra-rater reliability ranged from 0.40 to 0.82 and inter-rater reliability from 0.24 to 0.67.

Conclusions

Intra-rater and inter-rater reliability were excellent for raw values and for ratios with deltoid muscle as the reference tissue, and good for ratios with gel pad as the reference tissue. The reliability of colour scale ratings was substantial-to-almost perfect, and for the number of lesions fair-to-almost perfect.

Although high reliability was found, validity and responsiveness of these elastographic methods needs further investigation.

Ethics approval

The study protocol was approved by the Ethics Committee for the Region of South Denmark (S-20160115) and reported to the Danish Data Protection Agency (2014-41-3266).

Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study

Por: Wang · M. · Liu · H. · Liu · C. · Li · X. · Jin · C. · Sun · Q. · Liu · Z. · Zheng · J. · Yang · J.
Introduction

Punctate white matter lesions (PWML) are prevalent white matter disease in preterm neonates, and may cause motor disorders and even cerebral palsy. However, precise individual-based diagnosis of lesions that result in an adverse motor outcome remains unclear, and an effective method is urgently needed to guide clinical diagnosis and treatment. Advanced radiomics for multiple modalities data can provide a possible look for biomarkers and determine prognosis quantitatively. The study aims to develop and validate a model for prediction of adverse motor outcomes at a corrected age (CA) of 24 months in neonates with PWML.

Methods and analysis

A prospective cohort multicentre study will be conducted in 11 Chinese hospitals. A total of 394 neonates with PWML confirmed by MRI will undergo a clinical assessment (modified Neonatal Behavioural Assessment Scale). At a CA of 18 months, the motor function will be assessed by Bayley Scales of Infant and Toddler Development-III (Bayley-III). Mild-to-severe motor impairments will be confirmed using the Bayley-III and Gross Motor Function Classification System at a CA of 24 months. During the data collection, the perinatal and clinical information will also be recorded. According to the radiomics strategy, the extracted imaging features and clinical information will be combined for exploratory analysis. After using multiple-modelling methodology, the accuracy, sensitivity and specificity will be computed. Internal and external validations will be used to evaluate the performance of the radiomics model.

Ethics and dissemination

This study has been approved by the institutional review board of The First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2015LSK-172). All parents of eligible participants will be provided with a detailed explanation of the study and written consent will be obtained. The results of this study will be published in peer-reviewed journals and presented at local, national and international conferences.

Trial registration number

NCT02637817; 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.

Automatic brain lesion segmentation on standard MRIs of the human head: a scoping review protocol

Por: Gryska · E. A. · Schneiderman · J. · Heckemann · R. A.
Introduction

Automatic brain lesion segmentation from medical images has great potential to support clinical decision making. Although numerous methods have been proposed, significant challenges must be addressed before they will become established in clinical and research practice. We aim to elucidate the state of the art, to provide a synopsis of competing approaches and identify contrasts between them.

Methods and analysis

We present the background and study design of a scoping review for automatic brain lesion segmentation methods for conventional MRI according to the framework proposed by Arksey and O’Malley. We aim to identify common image processing steps as well as mathematical and computational theories implemented in these methods. We will aggregate the evidence on the efficacy and identify limitations of the approaches. Methods to be investigated work with standard MRI sequences from human patients examined for brain lesions, and are validated with quantitative measures against a trusted reference. PubMed, IEEE Xplore and Scopus will be searched using search phrases that will ensure an inclusive and unbiased overview. For matching records, titles and abstracts will be screened to ensure eligibility. Studies will be excluded if a full paper is not available or is not written in English, if non-standard MR sequences are used, if there is no quantitative validation, or if the method is not automatic. In the data charting phase, we will extract information about authors, publication details and study cohort. We expect to find information about preprocessing, segmentation and validation procedures. We will develop an analytical framework to collate, summarise and synthesise the data.

Ethics and dissemination

Ethical approval for this study is not required since the information will be extracted from published studies. We will submit the review report to a peer-reviewed scientific journal and explore other venues for presenting the work.

Role of diffusional kurtosis imaging in grading of brain gliomas: a protocol for systematic review and meta-analysis

Por: Abdalla · G. · Sanverdi · E. · Machado · P. M. · Kwong · J. S. W. · Panovska-Griffiths · J. · Rojas-Garcia · A. · Yoneoka · D. · Yousry · T. · Bisdas · S.
Introduction

Central nervous system (CNS) gliomas are the most common primary intra-axial brain tumours and pose variable treatment response according to their grade, therefore, precise staging is mandatory. Histopathological analysis of surgical tumour samples is still deemed as the state-of-the-art staging technique for gliomas due to the moderate specificity of the available non-invasive imaging modalities. A recently evolved analysis of the tissue water diffusion properties, known as diffusional kurtosis imaging (DKI), is a dimensionless metric, which quantifies water molecules’ degree of non-Gaussian diffusion, hence reflects tissue microenvironment’s complexity by means of non-invasive diffusion-weighted MRI acquisitions. The objective of this systematic review and meta-analysis is to explore the performance of DKI in the presurgical grading of gliomas, both regarding the differentiation between high-grade and low-grade gliomas as well as the discrimination between gliomas and other intra-axial brain tumours.

Methods and analysis

We will search PubMed, Medline via Ovid, Embase and Scopus in July 2018 for research studies published between January 1990 and June 2018 with no language restrictions, which have reported on the performance of DKI in diagnosing CNS gliomas. Robust inclusion/exclusion criteria will be applied for selection of eligible articles. Two authors will separately perform quality assessment according to the quality assessment of diagnostic accuracy studies-2 tool. Data will be extracted in a predesigned spreadsheet. A meta-analysis will be held using a random-effects model if substantial statistical heterogeneity is expected. The heterogeneity of studies will be evaluated, and sensitivity analyses will be conducted according to individual study quality.

Ethics and dissemination

This work will be based on published studies; hence, it does not require institutional review board approval or ethics clearance. The results will be published in peer-reviewed journals.

PROSPERO registration number

CRD42018099192.

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