Details:
The first step of the EBP process is to develop a question from the nursing practice problem of interest.

Select a practice problem of interest to use as the focus of your research.

Start with the patient and identify the clinical problems or issues that arise from clinical care.

Following the PICOT format, write a PICOT statement in your selected practice problem area of interest, which is applicable to your proposed capstone project.

The PICOT statement will provide a framework for your capstone project (the project students must complete during their final course in the RN-BSN program of study).

Conduct a literature search to locate research articles focused on your selected practice problem of interest. This literature search should include both quantitative and qualitative peer-reviewed research articles to support your practice problem.

Select six peer-reviewed research articles which will be utilized through the next 5 weeks as reference sources. Be sure that some of the articles use qualitative research and that some use quantitative research. Create a reference list in which the six articles are listed. Beneath each reference include the article’s abstract. The completed assignment should have a title page and a reference list with abstracts.

Suggestions for locating qualitative and quantitative research articles from credible sources:

1. Use a library database such as CINAHL Complete for your search.
2. Using the advanced search page check the box beside “Research Article” in the “Limit Your Results” section.
3. When setting up the search you can type your topic in the top box, then add quantitative or qualitative as a search term in one of the lower boxes. Research articles often are described as qualitative or quantitative.

To narrow/broaden your search, remove the words qualitative and quantitative and include words that narrow or broaden your main topic. For example: Diabetes and pediatric and dialysis. To determine what research design was used, review the abstract and the methods section of the article. The author will provide a description of data collection using qualitative or quantitative methods.

Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.

This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.

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                                                    Process and Regulations of Fast Track

    New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.

                                                                    Medical Conditions

    In order to be able to obtain faster approval via the Fast Track protocol, the drug agent must meet a number of requirements. Specific medical conditions are not indicated, but it is prescribed that the effect of the drug should be aimed at treating a life-threatening or dangerous disease, such as heart failure (Papadimitriou & Butler, 2017). A prerequisite is either to improve the outcome of existing treatment, such as a reduction in mortality or disability, or a significant reduction in the toxicity of therapy (Woo & Robinson, 2015). In addition, medical conditions that do not have developed a pharmacological treatment, such as some rare and orphan diseases, are also eligible for faster approval from the FDA via the Fast Track protocol. Therefore, due to this possibility, patients will more quickly gain access to the most modern therapy and increase the chances of a more favorable outcome of treatment.                                                   

                                                                           References

Papadimitriou, L., & Butler, J. (2017). “Fast Track” Development and Approval Process for Heart Failure Therapeutics. Clinical Pharmacology & Therapeutics, 102(2), 184-186.

Woo, T. M., & Robinson, M. V. (2015). Pharmacotherapeutics for advanced practice nurse prescribers. FA Davis.

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The FDA made it possible for critically needed medications to be introduced to the US market promptly using the “Fast Track” procedure.  “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Vaggelas & Seimetz, 2019).  With fast track, FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met (Vaggelas & Seimetz, 2019).  To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use (Darrow, Avorn, & Kesselheim, 2018).

The medical conditions that warrant “Fast Track” drugs are serious or life-threatening conditions and those conditions that result in unmet medical needs (Darrow et al., 2018).  Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.  Stroke, epilepsy, brain disorders, depression, AIDS, Alzheimer’s, heart failure, diabetes, and cancer are examples of serious conditions.  Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (Darrow et al., 2018).

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2018). The FDA breakthrough-drug designation-four years of experience. N Engl J Med, 378(15), 1444-1453.

Vaggelas, A., & Seimetz, D. (2019). Expediting drug development: FDA’s new regenerative medicine advanced therapy designation. Therapeutic Innovation & Regulatory Science, 53(3), 364-373. doi: 10.1177/2168479018779373

E-visits from the Patient and Provider Perspective

Read the Case Study in “Guided Exercise 10H: Patient Requests an E-Visit” on page 432 in your textbook. Then, use the instructions for “Guided Exercise 10H” (beginning with Step 2 on page 433) and “Critical Thinking Exercise 10J” (beginning on page 436) to complete these exercises in the MyHealthProfessionsLab located in Blackboard. You do not have to complete step 10 in either exercise because you are not actually submitting the work in the lab. After completing these exercises, respond to the following questions.

1. What is meant by patient-centered medical care? Define this term and give examples.

2. Why would a patient choose an E-visit instead of an in-office visit?

3. Howarevirtualofficevisitsconducted?

4. HowisEHRusedtoprovidepatient-careinanE-visit?Basedonyourexperienceintheseexercises,wouldyou

prefer an E-visit? Why, or why not?

5. Do virtual office visits have the same privacy standards as in-office visits? Based on these exercises and what you

have read about E-visits in Chapter 10, would you have any hesitation to utilize a virtual office visit?

Your response must be at least two pages in length, and you must use at least your textbook as a source, but other sources may be used if needed. Any information from a source must be cited and referenced in APA style, and your paper should be formatted in accordance to APA guidelines.

Information about accessing the grading rubric for this assignment is provided below.

Discussion 2 Question:

This week, you should be locating sources for your Signature Assignment project. What problems are you having locating sources for your project? Is the wording of an article hard to comprehend? What sites have you found helpful? Please locate at least two scholarly sources for your project and describe the information you found in these sources that you intend to use for your presentation.

Your initial posting should be at least 400 words in length and utilize at least two scholarly sources other than the textbook.

Discussion # 8

Identify a state health policy and the tools used to implement the policy. How do you think the political climate has affected the choice of policy tools and the behavioral assumptions by policymakers?  How have professional nursing organizations been involved in this policy issue? If they have not, what recommendations would you make for them to participate?  Develop a few talking points to inform other health care professionals regarding this issue.