The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.

The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.

When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.

Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group.

To Prepare
  • Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
  • Reflect on situations in which children should be prescribed drugs for off-label use.
  • Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.
By Day 5 of Week 11

Write a 1-page narrative in APA format that addresses the following:

  • Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
  • Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

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Write a 4-6-page analysis of a current problem or issue in health care, including a proposed solution and possible ethical implications.

Write a 4-6-page analysis of a current problem or issue in health care, including a proposed solution and possible ethical implications.

Introduction

In your health care career, you will be confronted with many problems that demand a solution. By using research skills, you can learn what others are doing and saying about similar problems. Then you can analyze the problem and the people and systems it affects. You can examine potential solutions and their ramifications. This assessment allows you to practice this approach with a real-world problem.

Demonstration of Proficiency

By successfully completing this assessment, you will demonstrate your proficiency in the course competencies through the following assessment scoring guide criteria:

  • Competency 1: Apply information literacy and library research skills to obtain scholarly information in the field of health care.
    • Use scholarly information to describe and explain a health care problem or issue and identify possible causes for it.
  • Competency 2: Apply scholarly information through critical thinking to solve problems in the field of health care.
    • Analyze a health care problem or issue by describing the context, explaining why it is important and identifying populations affected by it.
    • Discuss potential solutions for a health care problem or issue and describe what would be required to implement a solution.
  • Competency 3: Apply ethical principles and academic standards to the study of health care.
    • Analyze the ethical implications if a potential solution to a health care problem or issue was implemented.
  • Competency 4: Write for a specific audience, in appropriate tone and style, in accordance with Capella’s writing standards.
    • Write clearly and logically, with correct use of spelling, grammar, punctuation, and mechanics.
    • Write following APA style for in-text citations, quotes, and references.

Instructions

Note: The requirements outlined below correspond to the grading criteria in the scoring guide. At a minimum, be sure to address each point. In addition, you are encouraged to review the performance-level descriptions for each criterion to see how your work will be assessed.

  1. Describe the health care problem or issue you selected for use in Assessment 2 (from the Assessment Topic Areas | Transcript media piece) and provide details about it.
    • Explore your chosen topic. For this, you should use the first four steps of the Socratic Problem-Solving Approach to aid your critical thinking. This approach was introduced in Assessment 2.
    • Identify possible causes for the problem or issue.
  2. Use scholarly information to describe and explain the health care problem or issue and identify possible causes for it.
    • Identify at least three scholarly or academic peer-reviewed journal articles about the topic.
      • You may find the How Do I Find Peer-Reviewed Articles? library guide helpful in locating appropriate references.
      • You may use articles you found while working on Assessment 2 or you may search the Capella library for other articles.
      • You may find the applicable Undergraduate Library Research Guide helpful in your search.
    • Review the Think Critically About Source Quality to help you complete the following:
      • Assess the credibility of the information sources.
      • Assess the relevance of the information sources.
  3. Analyze the health care problem or issue.
    • Describe the setting or context for the problems or issues.
    • Describe why the problem or issue is important to you.
    • Identify groups of people affected by the problem or issue.
    • Provide examples that support your analysis of the problem or issue.
  4. Discuss potential solutions for the health care problem or issue.
    • Describe what would be required to implement a solution.
    • Describe potential consequences of ignoring the problem or issue class=”ice-no-decoration” data-ice-class=”848587″>.
    • Provide the pros and cons for one of the solutions you are proposing.
  5. Analyze the ethical implications if the potential solution (the one for which you provide pros and cons) were to be implemented.
    • Provide examples from the literature to support the points you are making.
    • Discuss the pros and cons of implementing the proposed solution from an ethical principle point of view.
    • Describe what would be required to implement the proposed solution.

Example Assessment: You may use the following to give you an idea of what a Proficient or higher rating on the scoring guide would look like:

  • Assessment 3 Example [PDF].

Additional Requirements

Your assessment should also meet the following requirements:

  • Length: 4–6 typed, double-spaced pages, not including the title page and reference page.
  • Font and font size: Times New Roman, 12 point.
  • APA template: Use the APA Style Paper Template [DOCX] as the paper format and the APA Style Paper Tutorial [DOC] for guidance.
  • Written communication: Write clearly and logically, with correct use of spelling, grammar, punctuation, and mechanics.
  • Using outside sources: Integrate information from outside sources into academic writing by appropriately quoting, paraphrasing, and summarizing, following APA style.
  • References: Integrate information from outside sources to include at least three scholarly or academic peer-reviewed journal articles and three in-text citations within the paper.
  • APA format: Follow current APA guidelines for in-text citations of outside sources in the body of your paper and also on the reference page.

Organize your paper using the following structure and headings:

  • Title page. A separate page.
  • Introduction. A brief one-paragraph statement about the purpose of the paper.
  • Elements of the problem/issue. Identify the elements of the problem or issue or question.
  • Analysis. Analyze, define, and frame the problem or issue.
  • Considering options. Consider solutions, responses, or answers.
  • Solution. Choose a solution, response, or answer.
  • Ethical implications. Ethical implications of implementing the solution.
  • Implementation. Implementation of the potential solution.

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You see another nurse practitioner writing a prescription for her husband, who is not a patient of the nurse practitioner.

Assigned scenario

You see another nurse practitioner writing a prescription for her husband, who is not a patient of the nurse practitioner. The prescription is for a narcotic. You can’t decide whether or not to report the incident.

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Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

Evidence level and quality rating:

Article title: Number:

Author(s): Publication date:

Journal:

Setting: Sample (composition and size):

Does this evidence address my EBP question?

Yes

No-Do not proceed with appraisal of this evidence

Is this study:

QuaNtitative (collection, analysis, and reporting of numerical data)

Measurable data (how many; how much; or how often) used to formulate facts, uncover patterns in

research, and generalize results from a larger sample population; provides observed effects of a

program, problem, or condition, measured precisely, rather than through researcher interpretation of

data. Common methods are surveys, face-to-face structured interviews, observations, and reviews of

records or documents. Statistical tests are used in data analysis.

Go to Section I: QuaNtitative

QuaLitative (collection, analysis, and reporting of narrative data)

Rich narrative documents are used for uncovering themes; describes a problem or condition from the

point of view of those experiencing it. Common methods are focus groups, individual interviews

(unstructured or semi structured), and participation/observations. Sample sizes are small and are

determined when data saturation is achieved. Data saturation is reached when the researcher identifies

that no new themes emerge and redundancy is occurring. Synthesis is used in data analysis. Often a

starting point for studies when little research exists; may use results to design empirical studies. The

researcher describes, analyzes, and interprets reports, descriptions, and observations from participants.

Go to Section II: QuaLitative

Mixed methods (results reported both numerically and narratively)

Both quaNtitative and quaLitative methods are used in the study design. Using both approaches, in

combination, provides a better understanding of research problems than using either approach alone.

Sample sizes vary based on methods used. Data collection involves collecting and analyzing both

quaNtitative and quaLitative data in a single study or series of studies. Interpretation is continual and

can influence stages in the research process.

Go to Section III: Mixed Methods

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

Section I: QuaNtitative

Level of Evidence (Study Design)

Is this a report of a single research study?  Yes  No

Go to B

1. Was there manipulation of an independent variable?  Yes  No

2. Was there a control group?  Yes  No

3. Were study participants randomly assigned to the intervention and control groups?  Yes  No

If Yes to questions 1, 2, and 3, this is a randomized controlled trial (RCT) or experimental study.

LEVEL I

If Yes to questions 1 and 2 and No to question 3 or Yes to question 1 and No to questions 2 and 3, this is quasi-experimental. (Some degree of investigator control, some manipulation of an independent variable, lacks random assignment to groups, and may have a control group).

LEVEL II

If No to questions 1, 2, and 3, this is nonexperimental. (No manipulation of independent variable; can be descriptive, comparative, or correlational; often uses secondary data).

LEVEL III

Study Findings That Help Answer the EBP Question

Skip to the Appraisal of QuaNtitative Research Studies section

A

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

Section I: QuaNtitative (continued)

Is this a summary of multiple sources of research

evidence?  Yes

Continue

 No

Use Appendix F

1. Does it employ a comprehensive search strategy and rigorous appraisal method?

If this study includes research, nonresearch, and experiential evidence, it is an integrative review (see Appendix F).

 Yes

Continue

 No

Use Appendix F

2. For systematic reviews and systematic reviews with meta-analysis

(see descriptions below):

a. Are all studies included RCTs? LEVEL I

b. Are the studies a combination of RCTs and quasi-experimental,

or quasi-experimental only? LEVEL II

c. Are the studies a combination of RCTs, quasi-experimental, and

nonexperimental, or non- experimental only? LEVEL III

A systematic review employs a search strategy and a rigorous appraisal method, but does not

generate an effect size.

A meta-analysis, or systematic review with meta-analysis, combines and analyzes results from

studies to generate a new statistic: the effect size.

Study Findings That Help Answer the EBP Question

Skip to the Appraisal of Systematic Review (With or Without a Meta-Analysis) section

B

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

 

Appraisal of QuaNtitative Research Studies

Does the researcher identify what is known and not known about the problem and how the study will address any gaps in knowledge?

 Yes  No

Was the purpose of the study clearly presented?  Yes  No

Was the literature review current (most sources within the past five years or a seminal study)?  Yes  No

 

Was sample size sufficient based on study design and rationale?  Yes  No

If there is a control group:

 Were the characteristics and/or demographics similar in both the control and intervention groups?

 Yes  No

N/A

 If multiple settings were used, were the settings similar?  Yes  No

N/A

 Were all groups equally treated except for the intervention group(s)?  Yes  No

N/A

Are data collection methods described clearly?  Yes  No

Were the instruments reliable (Cronbach’s [alpha] > 0.70)?  Yes  No N/A

Was instrument validity discussed?  Yes  No N/A

If surveys or questionnaires were used, was the response rate > 25%?  Yes  No

N/A

Were the results presented clearly?  Yes  No

If tables were presented, was the narrative consistent with the table content?  Yes  No

N/A

Were study limitations identified and addressed?  Yes  No

Were conclusions based on results?  Yes  No

Complete the Quality Rating for QuaNtitative Studies section

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

Appraisal of Systematic Review (With or Without Meta-Analysis)

Were the variables of interest clearly identified?  Yes  No

Was the search comprehensive and reproducible?

 Key search terms stated  Yes  No

 Multiple databases searched and identified  Yes  No

 Inclusion and exclusion criteria stated  Yes  No

Was there a flow diagram that included the number of studies eliminated at each level of review?  Yes  No

Were details of included studies presented (design, sample, methods, results, outcomes, strengths, and limitations)?  Yes  No

Were methods for appraising the strength of evidence (level and quality) described?  Yes  No

Were conclusions based on results?  Yes  No

 Results were interpreted  Yes  No

 Conclusions flowed logically from the interpretation and systematic review question  Yes  No

Did the systematic review include a section addressing limitations and how they were addressed?  Yes  No

Complete the Quality Rating for QuaNtitative Studies section (below)

Quality Rating for QuaNtitative Studies

Circle the appropriate quality rating below:

A High quality: Consistent, generalizable results; sufficient sample size for the study design; adequate control; definitive conclusions; consistent recommendations based on comprehensive literature review that includes thorough reference to scientific evidence.

B Good quality: Reasonably consistent results; sufficient sample size for the study design; some control, and fairly definitive conclusions; reasonably consistent recommendations based on fairly comprehensive literature review that includes some reference to scientific evidence.

C Low quality or major flaws: Little evidence with inconsistent results; insufficient sample size for the study design; conclusions cannot be drawn.

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

Section II: QuaLitative

Level of Evidence (Study Design)

 

Is this a report of a single research study?

 

 Yes this is Level III

 

 No go to II B

Study Findings That Help Answer the EBP Question

Complete the Appraisal of Single QuaLitative Research Study section (below)

Appraisal of a Single QuaLitative Research Study

Was there a clearly identifiable and articulated:

 Purpose? ❑ Yes ❑ No

 Research question? ❑ Yes ❑ No

 Justification for method(s) used? ❑ Yes ❑ No

 Phenomenon that is the focus of the research? ❑ Yes ❑ No

Were study sample participants representative? ❑ Yes ❑ No

Did they have knowledge of or experience with the research area? ❑ Yes ❑ No

Were participant characteristics described? ❑ Yes ❑ No

Was sampling adequate, as evidenced by achieving saturation of data? ❑ Yes ❑ No

Data analysis:

 Was a verification process used in every step by checking and confirming with participants the trustworthiness of analysis and interpretation?

 

❑ Yes

 

❑ No

 Was there a description of how data were analyzed (i.e., method), by computer or manually?

❑ Yes ❑ No

Do findings support the narrative data (quotes)? ❑ Yes ❑ No

Do findings flow from research question to data collected to analysis undertaken? ❑ Yes ❑ No

Are conclusions clearly explained? ❑ Yes ❑ No

A

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

 

 

 

Skip to the Quality Rating for QuaLitative Studies section

For summaries of multiple quaLitative research studies

(meta-synthesis), was a comprehensive search strategy and

rigorous appraisal method used?

 Yes Level III

 No go to Appendix F

Study Findings That Help Answer the EBP Question

Complete the Appraisal of Meta-Synthesis Studies section (below)

Appraisal of Meta-Synthesis Studies

Were the search strategy and criteria for selecting primary studies clearly defined? ❑ Yes ❑ No

Were findings appropriate and convincing? ❑ Yes ❑ No

Was a description of methods used to:  Compare findings from each study?

❑ Yes ❑ No

 Interpret data? ❑ Yes ❑ No

Did synthesis reflect: ❑ Yes ❑ No

 New insights? ❑ Yes ❑ No

 Discovery of essential features of phenomena? ❑ Yes ❑ No

 A fuller understanding of the phenomena? ❑ Yes ❑ No

Was sufficient data presented to support the interpretations? ❑ Yes ❑ No

Complete the Quality Rating for QuaLititative Studies section (below)

B

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

1 https://www.york.ac.uk/crd/SysRev/!SSL!/WebHelp/6_4_ASSESSMENT_OF_QUALITATIVE_RESEARCH.htm 2 Adapted from Polit & Beck (2017).

 

Quality Rating for QuaLitative Studies

Circle the appropriate quality rating below:

No commonly agreed-on principles exist for judging the quality of quaLitative studies. It is a subjective

process based on the extent to which study data contributes to synthesis and how much information is

known about the researchers’ efforts to meet the appraisal criteria.

For meta-synthesis, there is preliminary agreement that quality assessments should be made before synthesis to screen out poor-quality studies1.

A/B High/Good quality is used for single studies and meta-syntheses2.

The report discusses efforts to enhance or evaluate the quality of the data and the overall inquiry in

sufficient detail; and it describes the specific techniques used to enhance the quality of the inquiry.

Evidence of some or all of the following is found in the report:

 Transparency: Describes how information was documented to justify decisions, how data were reviewed by others, and how themes and categories were formulated.

 Diligence: Reads and rereads data to check interpretations; seeks opportunity to find multiple sources to corroborate evidence.

 Verification: The process of checking, confirming, and ensuring methodologic coherence.

 Self-reflection and self-scrutiny: Being continuously aware of how a researcher’s experiences, background, or prejudices might shape and bias analysis and interpretations.

 Participant-driven inquiry: Participants shape the scope and breadth of questions; analysis and interpretation give voice to those who participated.

 Insightful interpretation: Data and knowledge are linked in meaningful ways to relevant literature.

C Lower-quality studies contribute little to the overall review of findings and have few, if any, of the

features listed for High/Good quality.

 

http://www.york.ac.uk/crd/SysRev/!SSL!/WebHelp/6_4_ASSESSMENT_OF_QUALITATIVE_RESEARCH.htm
http://www.york.ac.uk/crd/SysRev/!SSL!/WebHelp/6_4_ASSESSMENT_OF_QUALITATIVE_RESEARCH.htm

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

Section III: Mixed Methods

Level of Evidence (Study Design)

You will need to appraise both the quaNtitative and quaLitative parts of the study independently, before appraising the study in its entirety.

1. Evaluate the quaNitative part of the study using Section I. Level Quality

Insert here the level of evidence and overall quality for this part:

2. Evaluate the quaLitative part of the study using Section II. Level Quality

Insert here the level of evidence and overall quality for this part:

3. To determine the level of evidence, circle the appropriate study design:

 Explanatory sequential designs collect quaNtitative data first, followed by the quaLitative data; and their purpose is to explain quaNtitative results using quaLitative findings. The level is determined based on the level of the quaNtitative part.

 Exploratory sequential designs collect quaLitative data first, followed by the quaNtitative data; and their purpose is to explain quaLitative findings using the quaNtitative results. The level is determined based on the level of the quaLitative part, and it is always Level III.

 Convergent parallel designs collect the quaLitative and quaNtitative data concurrently for the purpose of providing a more complete understanding of a phenomenon by merging both datasets. These designs are Level III.

 Multiphasic designs collect quaLitative and quaNtitative data over more than one phase, with each phase informing the next phase. These designs are Level III.

Study Findings That Help Answer the EBP Question

Complete the Appraisal of Mixed Methods Studies section (below)

 

 

Johns Hopkins Nursing Evidence-Based Practice

 

Appendix E Research Evidence Appraisal Tool

©2017 The Johns Hopkins Hospital/ Johns Hopkins University School of Nursing

 

 

 

3 National Collaborating Centre for Methods and Tools. (2015). Appraising Qualitative, Quantitative, and Mixed Methods Studie s included in Mixed Studies Reviews: The MMAT. Hamilton, ON: McMaster University. (Updated 20 July, 2015) Retrieved from http://www.nccmt.ca/ resources/search/232

 

 

 

Appraisal of Mixed Methods Studies3

Was the mixed-methods research design relevant to address the quaNtitative

and quaLitative research questions (or objectives)? ❑ Yes ❑ No ❑ N/A

Was the research design relevant to address the quaNtitative and quaLitative

aspects of the mixed-methods question (or objective)? ❑ Yes ❑ No ❑ N/A

For convergent parallel designs, was the integration of quaNtitative and

quaLitative data (or results) relevant to address the research question or

objective?

❑ Yes ❑ No ❑ N/A

For convergent parallel designs, were the limitations associated with the

integration (for example, the divergence of quaLitative and quaNtitative data or

results) sufficiently addressed?

❑ Yes ❑ No ❑ N/A

Complete the Quality Rating for Mixed-Method Studies section (below)

Quality Rating for Mixed-Methods Studies

Circle the appropriate quality rating below

A High quality: Contains high-quality quaNtitative and quaLitative study components; highly relevant study design; relevant integration of data or results; and careful consideration of the limitations of the chosen approach.

B Good quality: Contains good-quality quaNtitative and quaLitative study components; relevant study design; moderately relevant integration of data or results; and some discussion of limitations of integration.

C Low quality or major flaws: Contains low quality quaNtitative and quaLitative study components; study design not relevant to research questions or objectives; poorly integrated data or results; and no consideration of limits of integration.

 

http://www.nccmt.ca/

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