Former EBM I Literature Review Requirements: Understanding the Rubric

Article Requirement (1 Point)

1. Utilized 1 research article and 1 review article

• You must provide one research article and one review article to meet this requirement. You may use additional professional resources for the paper. You can find more information about the difference between research and review articles here. Your paper will be focused on your research article. Your review article can provide background information for your introduction section. It may also be helpful for your discussion section. Notice the difference in article format for the research article and review article.
• Research articles can be randomized control trials, cohort studies, case control studies, cross-sectional studies, case series or reports, qualitative studies, secondary research, or basic science research.
• Review articles can be narrative reviews, systematic reviews, or meta-analyses.

Quality of Writing (5 Points)

1. No or few spelling and punctuations errors
2. No or few grammatical errors
3. Writing was organized, clear, and concise
   
   Use transitions well to ensure there is flow between the paragraphs. While passive voice is prevalent in the literature, its use adds an extra layer of complexity to writing and can make your writing less clear and concise.
    
4. Paper is 4-5 pages in length

A cover page is optional. A cover page and the literature cited section may be on additional pages beyond the five page limit. Scientific writing is concise and not flowery.

5. Writing is graduate level in mechanics and quality
   
   Graduate level writing requires not only use of evidence, but also the ability to analyze that evidence to increase dialogue about the topic in your field. The use of quotes should enhance your writing, not “carry” the main weight of your paper. Have a strong premise, introduced early, and use most of your paper to strengthen that argument. Also ensure that you have a strong conclusion.

Introduction (4 Points)

1. Objective of paper is clearly defined

Provide a sentence or two discussing the paper the focus of the paper. Why is this topic important?

2. Background information on disease/condition has been included.

Provide a few sentences about the disease / condition. Give basic information about the type of disease, diagnostic tests, common symptoms, common treatments, etc. This information provides the reader with knowledge that is needed to understand the rest of the paper.

• Note: A (narrative) review article can be a good resource for information for the introduction and discussion sections of the paper. The review article could cover the following topics: the disease or condition; one or both drugs; one or both treatments, etc. This article does not need to be a systematic review.

3. Statistical information about the disease/condition provided (such as incidence, prevalence, etc.)

Information could be incidence, prevalence, number of cases in the United States, or other relevant statistics. Is this a common disease / condition? Is it rare? You may find this information in your articles. See the question 19 box of the Tertiary Resources Assignment library guide for a list of resources that may be helpful to find this information: http://libraryguides.neomed.edu/aecontent.php?pid=656625&sid=5439505.

4. Background information on the two drugs or treatments is provided (including information about how the drugs or treatments differ from one another).

Provide a few sentence on the drugs. Discuss things like pharmacologic category, mechanism of action, indications, etc. How do the drugs differ from each other? If the two drugs belong to the same pharmacologic category, how do they differ from one another?

Provide a few sentences describing treatments. How do treatments differ from one another? If the comparison is usual care, what does this entail?

• If you are comparing programs, you must introduce the programs that you are comparing. How do they differ from one another? If the comparison is usual care, what does this entail?
• If writing about a basic science topic, you could discuss drugs, treatments, animals or cell/tissue culture, or methods to be used in the paper.

Research Article (14 Points)

1. Objective of study provided

What was the clinical question? What was the goal of the research study?

2. Hypothesis of study given

Provide a sentence or two on the hypothesis. What does the authors of the study predict that will be the results of the study? If a hypothesis is not given, can you infer what the hypothesis is? If yes, state your inferred hypothesis. If not, state that the authors did not provide a hypothesis.

3. Clinical research design of the study described

What type of study is it? Is it a randomized control study or a cohort study? It is sometimes stated within the article and sometimes it is inferred.

See this article if you need help deciding the research design of your research article:

• Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Types of study in medical research: part 3 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2009;106(15):262-268.
• Other help:
  • Centre for Evidence Based Medicine Oxford: Research Designs
  • Literature Reviews: Types of Clinical Study Designs – Georgia State University Library

4. Type of Blinding

Discuss the type of blinding used (single, double, triple). Blinding is sometimes called masking in a study. Mention if there is no blinding, such as an open-label study. There is a type of blinding called a double dummy study. An explanation for double dummy studies can be found here.

5. Funding source(s)

How was the study funded? It could be governmental funding, funding from a pharmaceutical company, etc. Describe the funding source(s) and whether they are from an academia, governmental, a pharmaceutical company, a foundation, etc. Think about this funding source(s) when writing your discussion. Does the funding source introduce a source of bias?

6. Sample size provided

What was the sample size? What population is this study targeting? Was the research conducted at one site or is it a multi-centered study?

• If a basic science study, mention sample sizes. You should also list the cell line(s) for cell culture studies, or information about the animals that used (for example: mouse strains).

7. Article’s level of evidence

Was the level of evidence for the article? Sometimes articles provide the information. Most of the time you will need to compare the article to one of the level of evidence scales: Oxford Centre for Evidence-based Medicine levels of evidence: https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/  or the American Family Physician's Strength of Recommendation scale: http://www.aafp.org/journals/afp/authors/ebm-toolkit/strength.html.

8. Country in which research was performed
9. Inclusion/exclusion criteria provided

Provide the inclusion and exclusion criteria. If either list is lengthy, provide the most important criteria and refer to the article for the rest of the list.

       10. All primary outcomes and important secondary outcomes provided

List all primary outcomes from the research article. Include secondary outcomes too. If there are numerous secondary outcomes, list the most important secondary outcomes and refer to the article for the rest of the list. They may sometimes be called endpoints in the article.

      11. Methods described

Describe briefly the general methods utilized by the study. Give a brief description of the procedures used in the study, dosages of drugs used, etc.

• Follow-Up: How long were patients in the study followed? How did the study treat individuals who quit the study? Was the study, intention-to-treat, modified intention-to-treat, or per protocol?

      12. Results described

Summarize the results given in the research article. Summarize the results for all primary outcomes and important secondary outcomes.

     13. Student listed statistical tests utilized in the study

List the statistical tests performed in the study. One or two sentences listing the statistical tests utilized in the study is all that is needed. You can also include statistical software applications if it is applicable.

     14. Important statistical results discussed

Discuss the statistical results for all primary outcomes and important secondary outcomes. Provide p-values for statistically significant and non-significant results. Think about what the results mean to the study.

     15. Possible author biases were considered.

     16. Conclusions of authors summarized

Summarize the authors’ conclusions about the article. Your critique will begin in the discussion section.

Discussion (12 points: 2 points each)

1. Research article critiqued

Think about all aspects of the article. Would it be possible for you to repeat the experiment from the description in the article? Think about the individuals included or excluded from the study. The drug dosages used? Thinks about the questions being asked? Are the methods appropriate for answering those questions?

2. Strengths and weaknesses given

These are your thoughts about the strengths and weaknesses of the article. It should be more than just repeating the authors list of strengths and weaknesses. These are examples of discussion points about strengths and weaknesses of a research article:

• Problem/Clinical Question - Is it a clear clinical question? Can the clinical question provided in the article be answered by the study?
• Population - Think about how generalizable is the study to a larger patient population? Is there an appropriate sample size?
• Intervention -
• Comparison
• Outcomes
• Statistics

3. Importance of the topic to medicine/pharmacy

What does this article add to our knowledge of medicine/pharmacy? Is this a new drug or treatment? Is it a new indication for a drug? Why was this study important? Did it bring new knowledge on a topic? How does this study affect patient care for clinicians?

4. POEM versus DOE

Was the research article a POEM or a DOE? POEM stands for Patient Oriented Evidence that Matters and DOE stands for Disease Oriented Medicine. Studies are POEMS if their outcomes are focused on mortality, quality of life, mobility, etc. The outcomes for DOE studies focus on laboratory test results (cardiac biomarkers, blood pressure readings, LDL or HDL, bone density, BMI, etc.).

In some cases, a paper can be both a POEM and a DOE if there are multiple outcomes. In this case, explain how the study outcomes meet both criteria.

See one of the following resources if you need more information about POEMS and DOEs. 

• DOO, POO and You: Getting on the Same Page as your Patients

Frenz D, Beattie J. DOO, POO and you: getting on the same page as your patients. Today's Hospitalist [Internet]. 2014 Jul. Available from: http://www.todayshospitalist.com/index.php?b=articles_read&cnt=1901

• POEMS and DOEs

Office of Medical Education Research and Development - Michigan State University

• Ebell MH, Barry HC, Slawson DC, Shaughnessy AF. Finding POEMs in the medical literature. J Fam Pract. 1999;48(5):350-5. Article available via ILL.

5. Apply results to clinical practice.  Are there other factors that may influence the choice of one or both of these drugs/treatments/programs/interventions?

You can have a drug or treatment do well in a clinical trial but is slowly introduced into clinical care. Think about things like costs, adverse reactions, drug interactions, insurance coverage, etc. What other factors may influence whether a drug or treatment is incorporated into patient care? Could geography or transportation affect accessibility to a treatment or medication?

6. Future trends in medicine/pharmacy

What should be the next steps in researching this drug/treatment/program? You can discuss future experiments that should be conducted. The author may discuss future experiments, programs, etc. that are planned in the future. If not, what research do you think needs to be conducted? Are there suggestions in other articles on the subject that discuss research trends? Give examples. Your response needs to be beyond the standard more research needs to be done on the topic. If your study was basic science research on a drug, think about the clinical trails that will need to be conducted before the drug is approved by the FDA.

Literature Cited Section (4 points: 2 points each)

1. Literature properly cited with the text of the paper
2. Literature properly cited using the National Library of Medicine style within the literature cited section of the paper.

• See the citation guidelines tab for information about citing within the text of the paper.
• You can cite more than two papers in the article. You can use other professional resources such as: journal articles, drug/herbal monographs, websites, etc.
• Your citations must all be National Library of Medicine style. You cannot mix citation styles.

Self-directed Learning (3 points):

1. Student assessed their learning needs and determined a plan to meet those needs.   
2. Student listed the professional resources (primary, secondary, or tertiary) that were utilized to answer the clinical question. Student analyzed and synthesized relevant information from these resources.
3. Student appraised the credibility of the information resources.