FC-C7M13U1 Research and Biomedicine Concepts in Ehealth
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Research and Biomedicine Concepts in eHealth Foundational Curriculum: Cluster 7: Patient and Device Integration/Research and Biomedicine Module 13: Research, Biomedicine, and Device Development Unit 1: Research and Biomedicine Concepts in eHealth FC-C7M13U1 Curriculum Developers: Angelique Blake, Rachelle Blake, Pauliina Hulkkonen, Sonja Huotari, Milla Jauhiainen, Johanna Tolonen, and Alpo Vӓrri This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and 39/60 innovation programme under Grant Agreement No. 727552 1 EUUSEHEALTHWORK Unit Objectives • Describe eHealth research and state its importance • Describe the research process, including citing resources, tracking work, and referencing or repeating the process if and when needed, using health IT/eHealth tools when available • Convey the importance of developing precise and relevant questions for research • Describe probability theory and the applicability of probability theory in IT supported health research to foster better patient care and robust outcomes This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 2 EUUSEHEALTHWORK Unit Objectives (cont’d) • Identify various requestors, major sources, uses and users of health care data for research purposes • Differentiate between primary and secondary research • Name eight best practices in healthcare research techniques that utilize health IT/eHealth tools • State the validation and verification principles for research data and information using health IT/eHealth • Explain the basic principles in biomedicine • Describe the use of eHealth in biomedicine This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 3 EUUSEHEALTHWORK eHealth in Research • The term "health research," sometimes also called "medical research" or "clinical research," refers to research that is done to learn more about human health • Health research also aims to find better ways to prevent and treat disease. Health research is an important way to help improve the care and treatment of people globally. • eHealth research can be defined as the use of electronic and mobile health applications, information and communication technologies to assess, monitor, and improve health within a research context This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 4 EUUSEHEALTHWORK The Importance of eHealth in Research • Extensive data can readily be collected using eHealth research • Potential errors in eHealth research and health care can be reduced and/or avoided and the effectiveness of programs can be maximized by incorporating users’ perspectives (how individuals interact with technologies and healthcare systems) into eHealth research and intervention design • Finally, researchers can utilize electronic data to maximize and tailor behavioral interventions This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 5 EUUSEHEALTHWORK eHealth Research Process Generally, health research will proceed according to the following process. Step order and specific step names may vary, depending on the subject matter and researcher. Steps are usually part of most formal healthcare research that involves eHealth, both basic and applied: 1. Define Subject Define Develop Collect Data 2. Literature Review Subject Study Plan 3. Define Terms and Concepts 4. Clarify the Scope of the Study Literature Define Analyse Data 5. Define the Study Population Review Population 6. Develop the Instrumentation Plan/Study Plan Define Report/ Clarify Scope 7. Collect Data Terms Disseminate 8. Analyse/Interpret Data 9. Report and Disseminate Results This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 6 EUUSEHEALTHWORK eHealth Research Process (cont’d) 1. Define Subject - Subject area identification/formulation of the topic: Consists of defining the subject area of one's interest and following that subject area to conduct subject related research. This can be done using various eHealth mechanisms. 2. Literature Review/Hypothesis: A review of the available literature is necessary to review information available about the subject area. Then, a testable prediction can be made which designates the relationship between two or more variables. A systematic review involves a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence. This step is simplified with eHealth tools, such as the Internet. Citing resources is an important part of this step. This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 7 EUUSEHEALTHWORK eHealth Research Process (cont’d) 3. Define terms and concepts: In this step, the details of the study, including terms and concepts, are laid out in a clear fashion so that they make sense to both researchers and study participants. eHealth can be used to disseminate the terms and concepts to all participants. Items that need to be considered include: a. Sampling b. Statistical issues c. Qualitative/Quantitative Research d. Collaborations e. Intellectual Property 4. Clarify the scope of the study: Specific details are developed in regards to defining the variables and how they will be measured/assessed in the study. These details can be compiled in an electronic specifications document. This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 8 EUUSEHEALTHWORK eHealth Research Process (cont’d) 5. Define the study population: The candidates for the members of the study are selected based on criteria determined in the literature review and scope clarification. Electronic consent forms can be obtained. 6. Develop the Instrumentation Plan/Study Plan: This step involves determining what data will be collected, how it will be represented to participants, and what the order and priority will be. It includes preparing samples, gathering information from or about these samples by using specific research instruments, and insuring instruments used for data collection are valid and reliable. eHealth can simplify this process. 7. Collect data: Involves actually studying the population according to the instrumentation/study plan, performing questionnaires, collecting lab data, dispensing medications and noting effects, etc. In this step, individual components of data are collected. EHRs and other eHealth applications can be used to collect data. Tracking data collected and work done is an important part of this step. This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 9 EUUSEHEALTHWORK eHealth Research Process (cont’d) 8. Analyse/Interpret Data: This step involves breaking down the individual pieces of data to draw conclusions about the information, either in components or as a whole. The analysis can be represented through tables, figures, or pictures, and then described in words. eHealth tools such as data analysis software and data warehouses can be used to analyse data. Retracing of steps may be necessary to validate results. 9. Report and Disseminate: It is important to remember to disseminate your findings outside of academia and to those who have participated or who may benefit from your research. This may be in the form of a research report, dissertation or thesis, lay summary, paper for publication, press release or poster presentation, etc. This work is produced by the EU*US eHealth Work Project. This project has received funding from the European Union’s Horizon 2020 research and FC-C7M13U1 innovation programme under Grant Agreement No. 727552 10 EUUSEHEALTHWORK Relevant Questions To Develop Hypotheses for Research • Relevant questions to develop hypotheses for research can be formulated based on literature review: research questions should be written according to what direction any previous research leads you • Examples of broad clinical research questions (From Vanderbilt School of Nursing): 1. Does the administration of pain medication at time of surgical incision reduce the need for pain medication twenty-four hours after surgery? 2. Which maternal factors are associated with obesity in toddlers? 3. What elements of a peer support intervention prevent suicide in high school females? • Depending on the research the question may be very exact or broader • Usually the ethical permissions require research questions to be set before the study • Studies of clinical care might have broader questions than testing a certain drug