scholarly journals HIS-based support of follow-up documentation – concept and implementation for clinical studies

2011 ◽  
Vol 02 (01) ◽  
pp. 1-17 ◽  
Author(s):  
F. Fritz ◽  
K. Rahbar ◽  
L. Stegger ◽  
M. Schäfers ◽  
M. Dugas ◽  
...  
Keyword(s):  
Clinical Study ◽  
Computer Tomography ◽  
Clinical Studies ◽  
Clinical Information System ◽  
Single Photon ◽  
Photon Emission ◽  
Additional Patient ◽  
Clinical Workflow ◽  
Study Protocols

Summary Objective: Follow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation. Methods: We have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively. Results: A HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week). Conclusion: HIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols.

scholarly journals Robust Step Detection from Different Waist-Worn Sensor Positions: Implications for Clinical Studies

2020 ◽  
Vol 4 (1) ◽  
pp. 50-58
Author(s):  
Matthias  Tietsch ◽  
Amir Muaremi ◽  
Ieuan Clay ◽  
Felix Kluge ◽  
Holger Hoefling ◽  
...  
Keyword(s):  
Clinical Study ◽  
Clinical Studies ◽  
Neurological Diseases ◽  
Human Gait ◽  
Robust Solution ◽  
Step Detection ◽  
Study Protocols ◽  
Study Results ◽  
Wide Range ◽  
The Impact

Analyzing human gait with inertial sensors provides valuable insights into a wide range of health impairments, including many musculoskeletal and neurological diseases. A representative and reliable assessment of gait requires continuous monitoring over long periods and ideally takes place in the subjects’ habitual environment (real-world). An inconsistent sensor wearing position can affect gait characterization and influence clinical study results, thus clinical study protocols are typically highly proscriptive, instructing all participants to wear the sensor in a uniform manner. This restrictive approach improves data quality but reduces overall adherence. In this work, we analyze the impact of altering the sensor wearing position around the waist on sensor signal and step detection. We demonstrate that an asymmetrically worn sensor leads to additional odd-harmonic frequency components in the frequency spectrum. We propose a robust solution for step detection based on autocorrelation to overcome sensor position variation (sensitivity = 0.99, precision = 0.99). The proposed solution reduces the impact of inconsistent sensor positioning on gait characterization in clinical studies, thus providing more flexibility to protocol implementation and more freedom to participants to wear the sensor in the position most comfortable to them. This work is a first step towards truly position-agnostic gait assessment in clinical settings.

scholarly journals Multiple pericardial hematomas: a case report and mini-review in multimodality imaging

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Aninka Saboe ◽  
Ferdy Sanjaya ◽  
Raden Erwin Affandi Soeriadi ◽  
Euis Maryani ◽  
Nuraini Yasmin Kusumawardhani ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiac Imaging ◽  
Single Photon ◽  
Multimodality Imaging ◽  
Photon Emission ◽  
Vena Cava ◽  
Intracardiac Thrombus ◽  
Surgical Closure ◽  
The Right

Abstract Background Pericardial hematoma is blood accumulation in the pericardial space. Although rare, it could arise in various conditions, such as after cardiac surgery. Clinical diagnosis of pericardial hematoma is implausible; thus, cardiac imaging plays a pivotal role in identifying this condition. We presented a case of multiple pericardial hematomas, which was found as an incidental finding in post-cardiac surgery evaluation. We highlighted the diagnostic challenge and the key features of multi-modality cardiac imaging in pericardial hematoma evaluation. Case presentation An asymptomatic, 35-years old male, who underwent surgical closure of secundum atrial septal defect (ASD) one month ago, came for routine transthoracic echocardiography evaluation. An intrapericardiac hematoma was visualized at the right ventricle (RV) 's free wall side. Another mass with an indistinct border was visualized near the right atrium (RA). This mass was suspected as pericardial hematoma differential diagnosed with intracardiac thrombus. Cardiac computed tomography (CT) scan showed both masses have an attenuation of 30–40 HU; however, the mass's border at the RA side was still not clearly delineated. Mild superior vena cava (SVC) compression and multiple mediastinal lymphadenopathies were also detected. These findings are not typical for pericardial hematomas nor intracardiac thrombus; hence another additional differential diagnosis of pericardial neoplasm was considered. We pursued further cardiac imaging modalities because the patient refused to undergo an open biopsy. Single-photon emission computer tomography (SPECT)/CT with Technetium-99 m (Tc-99 m) macro-aggregated albumin (MAA) and Sestamibi showed filling defect without increased radioactivity, thus exclude the intracardiac thrombus. Cardiac magnetic resonance imaging (MRI) reveals intrapericardial masses with low intensity of T1 signal and heterogeneously high intensity on T2 signal weighted imaged and no evidence of gadolinium enhancement, which concluded the diagnosis as subacute pericardial hematomas. During follow-up, the patient remains asymptomatic, and after six months, the pericardial hematomas were resolved. Conclusion Pericardial hematoma should be considered as a cause of pericardial masses after cardiac surgery. When imaging findings are atypical, further multi-modality cardiac imaging must be pursued to establish the diagnosis. Careful and meticulous follow-up should be considered for an asymptomatic patient with stable hemodynamic.

scholarly journals INTEGRATION OF COMPLEMENTARY BIOMARKERS IN PATIENTS WITH FIRST EPISODE PSYCHOSIS: RESEARCH PROTOCOL OF A PROSPECTIVE FOLLOW UP STUDY

2019 ◽  
Author(s):  
Petra ◽  
Martina Rojnic Kuzman ◽  
Porin Makaric ◽  
Dina Bosnjak Kuharic ◽  
Ivana Kekin ◽  
...  
Keyword(s):  
Genome Wide Association Study ◽  
Single Photon ◽  
Single Gene ◽  
Photon Emission ◽  
Blood Perfusion ◽  
First Episode ◽  
Emission Computed Tomography ◽  
Healthy Controls ◽  
Post Mortem

In this project, we recruited a sample of 150 patients with first episode of psychosis with schizophrenia features (FEP) and 100 healthy controls. We assessed the differences between these two groups, as well as the changes between the acute phase of illness and subsequent remission among patients over 18-month longitudinal follow-up. The assessments were divided into four work packages (WP): WP1- psychopathological status, neurocognitive functioning and emotional recognition; WP2- stress response measured by saliva cortisol during a stress paradigm; cerebral blood perfusion in the resting state (with single photon emission computed tomography (SPECT) and during activation paradigm (with Transcranial Ultrasonography Doppler (TCD); WP3-post mortem analysis in histologically prepared human cortical tissue of post mortem samples of subjects with schizophrenia in the region that synaptic alteration was suggested by WP1 and WP2; WP4- pharmacogenetic analysis (single gene polymorphisms and genome wide association study (GWAS). We expect that the analysis of these data will identify a set of markers that differentiate healthy controls from patients with FEP, and serve as an additional diagnostic tool in the first episode of psychosis, and prediction tool which can be then used to help tailoring individualized treatment options. In this paper, we describe the project protocol including aims and methods and provide a brief description of planned post mortem studies and pharmacogenetic analysis.

scholarly journals A New Strategy for Rapid Diagnosis of the Source of Low Back Pain in Patients Scheduled to Undergo Treatment with Cooled Radiofrequency Ablation

Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1822
Author(s):  
Shih-Hsiang Chou ◽  
Cheng-Chang Lu ◽  
Sung-Yen Lin ◽  
Po-Chih Shen ◽  
Zi-Miao Liu ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Radiofrequency Ablation ◽  
Facet Joint ◽  
Single Photon ◽  
Photon Emission ◽  
Rapid Diagnosis ◽  
Low Back ◽  
New Strategy

Objective: The objective of this study was to develop a new strategy for rapid diagnosis of the source of low back pain (LBP) for treatment with cooled radiofrequency ablation (RFA). Materials: Patients suffering from facet joint (FJ) or sacroiliac joint (SIJ) pain for more than 3 months were included. Two methods, Technetium Tc99m methylene diphosphonate single photon emission tomography/computed tomography (99mTc-MDP SPECT/CT) and a modified Fortin finger test were used to identify the source of LBP for treatment with cooled RFA. The visual analog scale (VAS) and Oswestry disability index (ODI) were used to assess the patients’ pain levels and disabilities respectively. These two measures were recorded at baseline and 1-week, 1-month, 3-month, and 6-month follow-up visits. Results: A total of 40 patients with LBP were included in this study. Our results demonstrated that the patients with LBP identified by our new strategy had significant improvements in VAS or ODI score at 1-week to 6-month follow-up visits (p < 0.001) after receiving cooled RFA. Similar results were also found in patients with FJ pain and those with FJ and SIJ pain respectively. Among all the patients, over 70% had greater than or equal to 50% reduction in VAS and ODI scores. No serious adverse events were observed after treatment. Conclusions: This new strategy could be successfully adopted for rapid diagnosis of the source of comprehensive LBP.

scholarly journals NOGA-Guided Analysis of Regional Myocardial Perfusion Abnormalities Treated With Intramyocardial Injections of Plasmid Encoding Vascular Endothelial Growth Factor A-165 in Patients With Chronic Myocardial Ischemia

Circulation ◽  
2005 ◽  
Vol 112 (9_supplement) ◽  
Author(s):  
Mariann Gyöngyösi ◽  
Aliasghar Khorsand ◽  
Sholeh Zamini ◽  
Wolfgang Sperker ◽  
Christoph Strehblow ◽  
...  
Keyword(s):  
Myocardial Perfusion ◽  
Perfusion Defect ◽  
Single Photon ◽  
Photon Emission ◽  
Tracer Uptake ◽  
Emission Computed Tomography ◽  
Single Photon Emission ◽  
Single Photon Emission Computed ◽  
Photon Emission Computed Tomography

Background— The aim of this substudy of the EUROINJECT-ONE double-blind randomized trial was to analyze changes in myocardial perfusion in NOGA-defined regions with intramyocardial injections of plasmid encoding plasmid human (ph)VEGF-A 165 using an elaborated transformation algorithm. Methods and Results— After randomization, 80 no-option patients received either active, phVEGF-A 165 (n=40), or placebo plasmid (n=40) percutaneously via NOGA-Myostar injections. The injected area (region of interest, ROI) was delineated as a best polygon by connecting of the injection points marked on NOGA polar maps. The ROI was projected onto the baseline and follow-up rest and stress polar maps of the 99m-Tc-sestamibi/tetrofosmin single-photon emission computed tomography scintigraphy calculating the extent and severity (expressed as the mean normalized tracer uptake) of the ROI automatically. The extents of the ROI were similar in the VEGF and placebo groups (19.4±4.2% versus 21.5±5.4% of entire myocardium). No differences were found between VEGF and placebo groups at baseline with regard to the perfusion defect severity (rest: 69±11.7% versus 68.7±13.3%; stress: 63±13.3% versus 62.6±13.6%; and reversibility: 6.0±7.7% versus 6.7±9.0%). At follow-up, a trend toward improvement in perfusion defect severity at stress was observed in VEGF group as compared with placebo (68.5±11.9% versus 62.5±13.5%, P =0.072) without reaching normal values. The reversibility of the ROI decreased significantly at follow-up in VEGF group as compared with the placebo group (1.2±9.0% versus 7.1±9.0%, P =0.016). Twenty-one patients in VEGF and 8 patients in placebo group ( P <0.01) exhibited an improvement in tracer uptake during stress, defined as a ≥5% increase in the normalized tracer uptake of the ROI. Conclusions— Projection of the NOGA-guided injection area onto the single-photon emission computed tomography polar maps permits quantitative evaluation of myocardial perfusion in regions treated with angiogenic substances. Injections of phVEGF A 165 plasmid improve, but do not normalize, the stress-induced perfusion abnormalities.

Theta Burst Magnetic Stimulation Improves Parkinson’s-Related Cognitive Impairment: A Randomised Controlled Study

2021 ◽  
Vol 35 (11) ◽  
pp. 986-995
Author(s):  
Weijia He ◽  
Jia-Chi Wang ◽  
Po-Yi Tsai
Keyword(s):  
Cognitive Impairment ◽  
Magnetic Stimulation ◽  
Single Photon ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Photon Emission ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Randomised Controlled ◽  
Theta Burst

Background. Evidence remains mixed as to the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in treating mild cognitive impairment (MCI) in patients with Parkinson’s disease (PD). Objective. In this study, we examined the short- and long-term effects of patterned rTMS. Methods. We randomly assigned 35 patients with PD with MCI to two groups. One group received intermittent theta burst stimulation (iTBS; n = 20), and the other received its sham counterpart (n = 15). The stimulations were applied over the left dorsolateral prefrontal cortex for 10 consecutive weekdays. Measurements based on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Montreal Cognitive Assessment (MoCA) were conducted at three time points: at baseline, immediately after the last intervention and at 3-month follow-up. Each patient received a 99mTc-TRODAT-1 single-photon emission computed tomography (SPECT) brain scan at baseline. Results. The iTBS group exhibited significantly greater improvement than the sham group did in total RBANS and MoCA scores ( p < .001 for both) immediately after intervention and at the 3-month follow-up. Radiotracer uptake in the bilateral basal ganglion in baseline SPECT was positively correlated with response to iTBS conditioning with respect to improvements in MoCA scores ( p = .021). Conclusion. This randomised controlled trial provides evidence that a consecutive iTBS protocol can achieve a persistent and wide-ranging therapeutic effect in patients with PD with MCI.

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