Snapshot: Trial Types in Precision Medicine.

Integrating precision diagnostics into personalized treatments requires understanding how biomarkers relate to clinical outcomes. Various clinical data collection methods exist, each with strengths and weaknesses. Interventional data are high quality but narrowly focused. Real-world data (RWD) provide broader information but with variable quality. Master protocols allow better efficiency in data collection. The master observational trial bridges the gap between interventional and retrospective RWD collection methods. To view this SnapShot, open or download the PDF

MRI of the lung (3/3)-current applications and future perspectives

BACKGROUND: MRI of the lung is recommended in a number of clinical indications. Having a non-radiation alternative is particularly attractive in children and young subjects, or pregnant women. METHODS: Provided there is sufficient expertise, magnetic resonance imaging (MRI) may be considered as the preferential modality in specific clinical conditions such as cystic fibrosis and acute pulmonary embolism, since additional functional information on respiratory mechanics and regional lung perfusion is provided. In other cases, such as tumours and pneumonia in children, lung MRI may be considered an alternative or adjunct to other modalities with at least similar diagnostic value. RESULTS: In interstitial lung disease, the clinical utility of MRI remains to be proven, but it could provide additional information that will be beneficial in research, or at some stage in clinical practice. Customised protocols for chest imaging combine fast breath-hold acquisitions from a "buffet" of sequences. Having introduced details of imaging protocols in previous articles, the aim of this manuscript is to discuss the advantages and limitations of lung MRI in current clinical practice. CONCLUSION: New developments and future perspectives such as motion-compensated imaging with self-navigated sequences or fast Fourier decomposition MRI for non-contrast enhanced ventilation- and perfusion-weighted imaging of the lung are discussed. Main Messages • MRI evolves as a third lung imaging modality, combining morphological and functional information. • It may be considered first choice in cystic fibrosis and pulmonary embolism of young and pregnant patients. • In other cases (tumours, pneumonia in children), it is an alternative or adjunct to X-ray and CT. • In interstitial lung disease, it serves for research, but the clinical value remains to be proven. • New users are advised to make themselves familiar with the particular advantages and limitations

Decentralised Clinical Guidelines Modelling with Lightweight Coordination Calculus

Background: Clinical protocols and guidelines have been considered as a major means to ensure that cost-effective services are provided at the point of care. Recently, the computerisation of clinical guidelines has attracted extensive research interest. Many languages and frameworks have been developed. Thus far, however,an enactment mechanism to facilitate decentralised guideline execution has been a largely neglected line of research. It is our contention that decentralisation is essential to maintain a high-performance system in pervasive health care scenarios. In this paper, we propose the use of Lightweight Coordination Calculus (LCC) as a feasible solution. LCC is a light-weight and executable process calculus that has been used successfully in multi-agent systems, peer-to-peer (p2p) computer networks, etc. In light of an envisaged pervasive health care scenario, LCC, which represents clinical protocols and guidelines as message-based interaction models, allows information exchange among software agents distributed across different departments and/or hospitals. Results: We outlined the syntax and semantics of LCC; proposed a list of refined criteria against which the appropriateness of candidate clinical guideline modelling languages are evaluated; and presented two LCC interaction models of real life clinical guidelines. Conclusions: We demonstrated that LCC is particularly useful in modelling clinical guidelines. It specifies the exact partition of a workflow of events or tasks that should be observed by multiple "players" as well as the interactions among these "players". LCC presents the strength of both process calculi and Horn clauses pair of which can provide a close resemblance of logic programming and the flexibility of practical implementation

Hyperthermia combined with chemotherapy - Biological rationale, clinical application, and treatment results

There is substantial evidence from preclinical data that the antitumor cytotoxicity of selected chemotherapeutic agents either alone or combined with radiation can be enhanced by appropriate heat exposure (40-44 degrees C) of cells or tumor tissues. Based upon these results the integration of hyperthermia as an additional treatment modality, given simultaneously with systemic chemotherapy or in combination with radiochemotherapy, is currently tested at the clinic. Regional hyperthermia combined with chemotherapy or radiochemotherapy showed impressive results (phase II studies) at clinical relevant temperatures in locally advanced tumors of different entities in terms of objective response rate, local tumor control and relapse-free survival. Clinical protocols of well-designed phase III trials on combined treatment modalities integrating hyperthermia are rather limited but for some tumors confirm its clinical benefit. In general, the clinical approach to use hyperthermia has gained much more interest within in the field of medical oncology. One of the major reason is the substantial technical improvements made with the available commercial equipment for local or regional heating, especially in case of deep-seated lesions or systemic heating. Further testing of the potential of hyperthermia combined with chemotherapy or radiochemotherapy in prospective randomized trials are warranted. At this time, hyperthermia as an adjunct to conventional treatment strategies is recommended in the setting of clinical protocols. The results of prospective trials should answer the question for which types of local advanced or metastatic tumors hyperthermia becomes standard as part of a multi-modal treatment strategy

Electronic Report Generation Web Service evaluated within a Telemedicine System

This work presents a generic tool based on a client-server architecture that generates electronic reports helping the evaluation process of any information system. For the specific evaluation of telemedicine systems the defined reports cover four dimensions: auditory of the system; evolution of clinical protocols; results from the questionnaires for user acceptance and quality of life; and surveillance of clinical variables. The use of a Web Service approach allows multiplatform use of the developed electronic report service and the modularity followed in the implementation enables easy system evolution and scalability

Influence of study design on digital pathology image quality evaluation : the need to define a clinical task

Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors’ success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria of image quality. Further research is needed to assess whether and for which purposes (e.g., preclinical testing) task-aware pIQ ratings could substitute cIQ for a given clinical task

Enhancing research quality and reporting: why the Journal of Comorbidity is now publishing study protocols

The Journal of Comorbidity was launched in 2011 and has since become established as a high-quality journal that publishes open-access, peer-reviewed articles, with a focus on advancing the clinical management of patients with comorbidity/multimorbidity. To further enhance research quality and reporting of studies in this field, the journal is now offering authors the opportunity to publish a summary of their study protocols – a move designed to generate interest and raise awareness in ongoing clinical research and to enable researchers to detail their methodologies in order that replication by scientific peers is possible

Practice Issues for Evaluation and Management of the Suicidal Left Ventricular Assist Device Patient

There is a high prevalence of depression among left ventricular assist device patients, who present with an increased risk of suicidality given access to means via the device either with nonadherence or disconnection. Suicidality via device nonadherence/disconnection is an underresearched clinical issue, as paradoxically this life-saving procedure can also provide a method of lethal means to patients with significant mental health concerns. A case study is used to highlight the course of an attempted suicide by ventricular assistive device nonadherence. Clinical implications and recommendations for practice include a thorough psychological evaluation presurgery, monitoring quality of life and coping styles before and after placement, psychological testing, outlining specific suicide protocols, psychiatric care considerations for patients with highly specialized medical devices, and related ethical concerns