Modern Information Technology for Cancer Research: What's in IT for Me? An Overview of Technologies and Approaches.

Information technology (IT) can enhance or change many scenarios in cancer research for the better. In this paper, we introduce several examples, starting with clinical data reuse and collaboration including data sharing in research networks. Key challenges are semantic interoperability and data access (including data privacy). We deal with gathering and analyzing genomic information, where cloud computing, uncertainties and reproducibility challenge researchers. Also, new sources for additional phenotypical data are shown in patient-reported outcome and machine learning in imaging. Last, we focus on therapy assistance, introducing tools used in molecular tumor boards and techniques for computer-assisted surgery. We discuss the need for metadata to aggregate and analyze data sets reliably. We conclude with an outlook towards a learning health care system in oncology, which connects bench and bedside by employing modern IT solutions.

Peridural analgesia may affect long-term survival in patients with colorectal cancer after surgery (PACO-RAS-Study): an analysis of a cancer registry.

OBJECTIVE: To determine the effect of peridural analgesia on long-term survival in patients who underwent surgical treatment of colorectal carcinoma. BACKGROUND: Clinical and animal studies suggest a potential benefit of peridural analgesia on morbidity and mortality after cancer surgery. The effect of peridural analgesia on long-term outcome after surgery for colorectal cancer remains undefined. METHODS: From 2003 to 2009, there were 749 patients who underwent surgery for colorectal carcinoma under general anesthesia with or without peridural analgesia. Clinical data were reviewed retrospectively and analyzed with multivariate analysis and Kaplan-Meier plots. RESULTS: There were 442 patients who received peridural analgesia and 307 patients who did not receive peridural analgesia. A substantial survival benefit was observed in patients who received peridural analgesia (5-year survival rate: peridural analgesia, 62%; no peridural analgesia, 54%; P < 0.02). The hazard rate for death was decreased by 27% in patients who received peridural analgesia. When peridural analgesia was included simultaneously in a Cox model with the confounding factors age, American Society of Anesthesiologists classification, and stage, there was a significant survival benefit in patients who received peridural analgesia. In patients with America Society of Anesthesiologists classification 3 to 4, there was significantly greater survival with peridural analgesia than without peridural analgesia (P < 0.009). CONCLUSIONS: Peridural analgesia may improve survival in patients underwent surgery for colorectal carcinoma. The survival benefit with peridural analgesia was greater in patients who had greater medical morbidity.

Small cause - big effect: improvement in interface design results in improved data quality - a multicenter crossover study.

In Germany the core data set for anesthesia version 3.0 was recently introduced for external quality assurance, which includes five surgical tracer procedures. We found a low rate of correctly documented tracers when compared to procedure data (OPS-Codes) documented separately. Examination revealed that the graphical user interface (GUI) contravened the dialogue principles as defined in EN ISO 9241-110. We worked with the manufacturer to implement small improvements and roll out the software. A crossover study was conducted at a university hospital and a municipal hospital chain with five hospitals. All study sites and surgical tracer procedures combined, we found an improvement from 42% to 65% (p<0.001; N=34,610) correctly documented anesthesias. We also saw improvements for most of the observed surgical tracer procedures at all hospitals. Our results show the big effect small changes to the GUI can have on data quality. They also raise the question, if highly flexible and parameterized clinical documentation systems are suited to achieve high usability. Finding the right balance between GUIs designed by usability experts and the flexibility of parameterization by administrators will be a difficult task for the future and subject to further research.

Analysis of Not Structurable Oncological Study Eligibility Criteria for Improved Patient-Trial Matching.

BACKGROUND: Higher enrolment rates of cancer patients into clinical trials are necessary to increase cancer survival. As a prerequisite, an improved semiautomated matching of patient characteristics with clinical trial eligibility criteria is needed. This is based on the computer interpretability, i.e., structurability of eligibility criteria texts. To increase structurability, the common content, phrasing, and structuring problems of oncological eligibility criteria need to be better understood. OBJECTIVES: We aimed to identify oncological eligibility criteria that were not possible to be structured by our manual approach and categorize them by the underlying structuring problem. Our results shall contribute to improved criteria phrasing in the future as a prerequisite for increased structurability. METHODS: The inclusion and exclusion criteria of 159 oncological studies from the Clinical Trial Information System of the National Center for Tumor Diseases Heidelberg were manually structured and grouped into content-related subcategories. Criteria identified as not structurable were analyzed further and manually categorized by the underlying structuring problem. RESULTS: The structuring of criteria resulted in 4,742 smallest meaningful components (SMCs) distributed across seven main categories (Diagnosis, Therapy, Laboratory, Study, Findings, Demographics, and Lifestyle, Others). A proportion of 645 SMCs (13.60%) was not possible to be structured due to content- and structure-related issues. Of these, a subset of 415 SMCs (64.34%) was considered not remediable, as supplementary medical knowledge would have been needed or the linkage among the sentence components was too complex. The main category "Diagnosis and Study" contained these two subcategories to the largest parts and thus were the least structurable. In the inclusion criteria, reasons for lacking structurability varied, while missing supplementary medical knowledge was the largest factor within the exclusion criteria. CONCLUSION: Our results suggest that further improvement of eligibility criterion phrasing only marginally contributes to increased structurability. Instead, physician-based confirmation of the matching results and the exclusion of factors harming the patient or biasing the study is needed.

Finding Options Beyond Standard of Care in Oncology: A Proposal for Workflows Utilizing Knowledge Databases.

With the novel approach of molecularly stratified therapies based on genetic characteristics of individual tumors, the need for databases providing information on molecular alterations and targeted treatment options is increasing rapidly. In Molecular Tumor Boards (MTB) professionals discuss molecular alterations and provide biological context for therapeutic options using external knowledge databases. The identification of informative databases and the information on their specific contents can greatly facilitate and standardize the functioning of a MTB. In this work we present a list of databases which have been deemed useful and relevant for MTB in a clinical setting. We describe workflows to recommend the use of specific databases at different steps in the clinical curation process. Information obtained from these databases is a necessary prerequisite to evaluate molecular alterations and devise rational targeted therapies in MTB.

An Interactive Timeline Visualization for Patient Cohorts in the Oncological Routine: A Use Case on Multiple Myeloma.

With the growing interdisciplinarity of cancer treatment and increasing amounts of data and patients, it is getting increasingly difficult for physicians to capture a patient's medical history as a basis for adequate treatment and to compare different medical histories of similar patients to each other. Furthermore, in order to tackle the etiological mechanisms of cancer, it is crucial to identify patients exhibiting a different disease course than their corresponding cohort. Several timeline visualizations have already been proposed. However, the functions and design of such visualizations are always use case dependent. We constructed a cohort timeline prototype mock-up for a specific oncological use case involving multiple myeloma, where the chronological monitoring of various parameters is crucial for patient diagnosis and treatment. Our proposed cohort timeline is a synthesis between elements described in the literature and our own approaches regarding function and design.

Factors Influencing the Implementation and Distribution of Clinical Decision Support Systems (CDSS).

Clinical Decision Support Systems (CDSS) can have positive effects on quality of care measures, yet have not gained widespread traction in healthcare. This study sought to determine and evaluate barriers and facilitators to CDSS implementation and distribution. Based on 768 systems identified in a literature review we conducted semi-structured telephone interviews with 54 system developers in 16 countries. Qualitative analysis led to the identification of 66 key factors influencing implementation. Central issues evolved around CDSS properties, quality and integration, as well as usability, user related factors, internal marketing, resource issues and collaborations with emphasis partly on topics differing from existing research. Additionally, evidence pointed to regional differences regarding implementation hurdles. Recent regulatory requirements were deemed less of a barrier to system adoption than expected, even though lacking expertise in this area was surprisingly common among interview partners.

Version changes in medical software: proposing minimal requirements for release notes and a version number convention - an operators' point of view.

Medical software--like any other software--is susceptible to errors. To avoid false system behaviour or attenuate its consequences, system operators need to know about changes in the software. The goal of this proposal is to define terms and minimum requirements regarding documentation for a version change from the operator's point of view, especially in the domain of medical software or software as a medical device (SaMD). The results are a classification of version changes (Upgrade: breaks support for a rollback to a prior version, Major Update: either substantial configuration or user education needed, Minor Update: minor configuration or user information needed, Patch: collection of (small) changes that require neither configuration nor user information.). Additionally, minimal requirements for release notes are determined and a document structure recommended.

Balancing the need for big data and patient data privacy--an IT infrastructure for a decentralized emergency care research database.

Emergency rooms of hospitals provide care to a lot of patients and have great impact on their outcome, so researching the quality of care seems important. Research using registries has yielded impressive results in other areas of medicine. However centralized data-storage has its pitfalls, especially regarding data privacy. We therefore drafted an IT infrastructure that uses decentralized storage to ensure data privacy, but still enables data transfer between participating hospitals. It implements an independent information broker to ensure anonymity of patients. Still it provides a way for researchers to request data and hospitals to contribute data on an opt-in basis. Although not an entirely new approach, the emphasis on data privacy throughout the design is a novel aspect providing a better balance between the need for big sample sizes and patient privacy.

Safety first! managing risks for a daisy chain of medical devices connected to the IT-network - first experiences applying IEC 80001-1.

The best way to ensure patient safety is to eliminate errors. To avoid errors and resulting harm from medical devices, there are rules and laws in Germany to ensure a certain quality and process [1,2]. This does not cover scenarios where devices are connected to a data network, forming a medical IT network. Arising risks need to be addressed by operating organizations, such as hospitals. International standard IEC 80001-1 offers a process for this and defines roles and responsibilities [3]. The aim of our study was to assess the application of risk management for a small initial project. We studied a daisy chain of medical devices connected to the IT network. The number of involved proprietary protocols and interface-definitions complicates the risk management, if just for the number of involved manufacturers. Identified risks could all be addressed and did not block the setup's deployment. Risk management creates an extra effort, but can reduce harm and potential financial liabilities. We can recommend starting with small projects to familiarize with the process.