MCCRSCC Improving Enrollment Capstone Outline
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MCCRSCC Improving Enrollment Capstone Outline
Research Capstone Outline
I am needing a draft of the Capstone Clinical Research Paper.
Topic: A review on how to improve enrollment for 1st time clinical trial pediatric subjects diagnosed with Duchenne Muscular Dystrophy
I have attached all information that has been provided and or completed so far and items that need to be reviewed and incorporarete into this draft including the grading rubric
Please select a Clinical Study Design to present the information from:
Brief Descriptions of Study Designs:
- Qualitative:
These types of research methods involve describing in details specific situation using research tools like
interviews, surveys, and Observations.- Quantitative:
These types of research methods require quantifiable data involving numerical and statistical explanations.- Correlation/Regression Analysis:
This research method involves determining the strength of the relationship between two or more variables (e.g., are violent video games correlated with aggression in children).- Quasi-Experimental:
This research involves the comparison of two groups, one which is influenced by an external source and
another which is not influenced by an external force.- Experimental:
Use of random assignment to place participants in two groups: an experimental group which receives
intervention, and another control group without any intervention. It is using a positive control for you to base it
or compare it in your result.- Meta-Analysis:
This research method is useful for finding out the average impact of several different studies on a hypothesis.- Qualitative:
These types of research methods involve describing in details specific situation using research tools like
interviews, surveys, and Observations.- Quantitative:
These types of research methods require quantifiable data involving numerical and statistical explanations.- Correlation/Regression Analysis:
This research method involves determining the strength of the relationship between two or more variables (e.g.
are violent video games correlated with aggression in children).- Quasi-Experimental:
This research involves the comparison of two groups, one which is influenced by an external source and
another which is not influenced by an external force.- Experimental:
Use of random assignment to place participants in two groups: an experimental group which receives
intervention, and another control group without any intervention. It is using a positive control for you to base it
or compare it in your result.- Meta-Analysis:
This research method is useful for finding out the average impact of several different studies on a hypothesis.Please see the details below for the table of contents:
Chapter Page #
Chapter 1 (Introduction) t
Chapter 2 (Literature Review) u
Chapter 3 (Methods) v
Chapter 4 (Results) w
Chapter 5 (Discussion) x
References y
Appendices zPlease see the following guidance that has been provided:
Capstone Goals and Objectives
- Goals are broad statements of what the capstone hopes to accomplish. They create a setting for the capstone. Specific objectives are statements of the capstone research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). After statement of the primary objective, secondary objectives may be mentioned.
Study Design – **This section may not be applicable to your project
- The scientific integrity of the capstone and the credibility of the study data depend substantially on the study design and methodology. The design of the study should include information on the type of study, the research population, or the sampling frame, and who can take part (e.g., inclusion and exclusion criteria, withdrawal criteria etc.), and the expected duration of the study.
- The same study can be described in several ways, and as complete a description of the study as possible should be provided. For example, you may want to describe the study as being epidemiologic or health policy or health and social behavioral research. It may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc. If experimental, it may be described as a controlled or a non-controlled study (this is not a comprehensive list).
Methodology
- The methodology section is the most important part of the protocol. It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made etc. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.
- Interventions should be described in detail, including a description of the intervention, education, training etc. provided to groups or individuals.
- Describe the procedures to be conducted. For example: a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant’s environment, etc.).
- Standardized and/or documented procedures/techniques should be described and bibliographic references, if not provided earlier should be provided. Instruments which are to be used to collect information (questionnaires, FGD (Focus Group Data) guides, observation recording form, case report forms etc.) must also be provided.
- This week we will review these sections of the methodology chapter. Certain elements may not apply to your paper.
- This section of your paper is a detailed account of exactly what you are going to do or what you did. The key is to be very specific and not miss anything. Think of this as a recipe from a cookbook. What you will write in your paper will tell your readers whether your results are valid, reliable, and could be used with confidence.
- For a capstone, you need to share the rationale behind what you are doing and that each of your choices was a conscious and correct choice.
- Remember – when writing this section, everything changes to future tense. This is what you are going to do!
- Design of Study
- Setting
- People Involved and Resources Needed
- Sample, including Access and Recruitment Methods
Ethical/Safety Considerations **This section may not be applicable to your project
- The protocol should have a description of ethical considerations relating to the study. This should not be limited to providing information on how or from whom the ethics approval will be taken, but this section should document the issues that are likely to raise ethical concerns. It should also describe how you, the investigator, plan to obtain informed consent from the research participants (the informed consent process).
- The safety of research participants is foremost, whether online or in person. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example. It is useful to remember that even administering a research questionnaire can have adverse effects on individuals – think about confidentiality or questions that may upset.
Additional Guidance Provided:
The first thing you will tell the reader is what kind of study or project you are doing and why it is a good fit for your capstone research question. These can be broad approaches such as qualitative, quantitative, mixed methods, or a specific design such as narrative.
Brief Descriptions of Study Designs:
Example: The proposed study will use a quasi-experimental design with electronic surveys administered to participants before and then 6 months following the implementation of the new teaching program.
You can use articles or books to back up your choices on your approach.
Capstone Setting:
Where is your study taking place? You will need to place it within its geographic setting as well as local ( such as a facility or organization).
Provide enough background information about the setting so the reader understands the context in which the study or problem is taking place.
Details can include:
- Population demographics
- Socioeconomic factors
- Environmental factors
- Cultural factors.
If you are doing a quality -improvement project, include all of the facility or organization information that the reader needs to understand the problem. This may include a description of the organizational culture in addition information related to:
- Administration
- Management
- Leadership structures
- Financial data
- Staffing
- Involved populations, such as patients.
Anything that could influence the implementation or outcomes of your project, for better or worse, should be discussed.
People Involved and Resources-
You may need to describe the people who are involved with your project.
- Who are these people?
- Who are the key stakeholders?
- Who is instrumental in moving your project forward?
- Who will ensure you have the resources, including staff and finance that you need to move forward?
- Who will provide you the necessary data (such as admission reports)?
- What are the resources you need to implement or move this project forward?
- Human resources
- Material Resources (this can include computer, software, teaching supplies, etc.)
- Financial
Sample Population
- What population are you drawing your sample from?
- Who is going to participate in your study or project?
- How many participants do you need? Is there a minimum?
- How are you going to get them?
You need to first look at the type of sample design you are going to use ( convenience, purposive, random, consecutive) and why you chose that design.
Next, you need to establish your sampling frame (the general population from which you will recruit your participants). Example: For a study of bereaved parents of estranged children, the sampling frame might be parents attending a grief support group in a particular region of the United States.
Then you must tell us who you want to recruit from that population.
You need to specify exactly who qualifies to participate
- Develop inclusion and exclusion criteria (I/E)
- Characteristics for I/E may include
- Demographics (age, sex, educational level, marital status, ethnicity, occupation)
- Presence or absence of an illness or health condition
- Duration of illness or health condition
- Number of years phenomenon being experience
- Professional role
- Primary language
- Literacy
- Previous experience with intervention
- Location
Example
The study will include a purposive sample of women in western Uganda who have experienced obstetric fistula. Inclusion criteria are women 18 years of age and older with a vesicovaginal or rectovaginal fistula secondary to prolonged obstructed labor. Exclusion criteria will be women who have had their fistula for longer than five years so that the data reflect current sociocultural norms.
Bias in Research
Bias can occur in the planning, data collection, analysis, and publication phases of research. Understanding research bias allows readers to critically and independently review the scientific literature and avoid treatments which are suboptimal or potentially harmful.
As you develop your project, take time to see if you have identified any potential “bias” in your approach, in your population, and in your analysis. How will you approach bias that you identify?
Introduction
- Topic Overview
- Challenges
- Site Concerns and Challenges
- Potential Participant Concerns and Challenges
Literature Review
- Review of existing literature
- Additional of new literature that supports the challenges
- Additional of literature that
Methodology
- Needs to be decided upon
Results
- Proposed recommendations/ focus on techniques to be used
Discussion Conclusion
MCCRSCC Improving Enrollment Capstone Outline
RUBRIC
Excellent Quality
95-100%
Introduction 45-41 points
The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.
Literature Support
91-84 points
The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.
Methodology
58-53 points
Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met.
Average Score
50-85%
40-38 points
More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided.
83-76 points
Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration.
52-49 points
Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met.
Poor Quality
0-45%
37-1 points
The background and/or significance are missing. No search history information is provided.
75-1 points
Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.
48-1 points
There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
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