Drug Information Retrieval, Literature Evaluation and Review Flashcards

1
Q

What is Drug Information Retrieval?

A

Drug information retrieval refers to the process of locating, accessing, and obtaining relevant
drug-related data and information to address specific queries or clinical needs.

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2
Q

What is the first step in DI retrieval?

A

The first step in DI retrieval is the definition of the DI query.

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3
Q

How do you define a DI query?

A

Clearly articulate the
question or clinical problem to be addressed. Identify whether the query is related to drug
indications, dosing, adverse effects, interactions, or another topic.

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4
Q

What is the secondary step in DI retrieval?

A

Identify relevant
resources (primary, secondary or tertiary).

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5
Q

What is the third step in DI retrieval?

A

Conduct the search using appropriate tools and
search terms.

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6
Q

Successful retrieval hinges on?

A

Retrieving information from
computerized databases requires familiarity with the database’s structure and search logic.
Successful retrieval hinges on the user’s ability to navigate these systems effectively.

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7
Q

What method can capture in-process citations and non-standard
terminology when trying to retrieve DI?

A

free text searches

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8
Q

A well-rounded search strategy includes various terms to ensure completeness. Give an example of this.

A

For
instance, searching for adolescents might require additional terms like pediatric or child
while understanding their database-specific definitions to avoid confusion.

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9
Q

DI retrieval success
depends on?

A

DI retrieval success
depends on tailoring search strategies to the unique conventions of each database and exploring
both indexed and free text options.

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10
Q

A good example of the standardized term for DI
retrieval is?

A

A good example of the standardized term for DI
retrieval is the Medical Subject Headings (MeSH), which provides a standardized vocabulary for
indexing biomedical literature alongside carefully chosen keywords or search terms.

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11
Q

What is the function of Boolean operators?

A

Boolean
operators (e.g., AND, OR, NOT) further refine searches by defining relationships between terms,
thus enabling users to obtain more targeted and relevant results.

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12
Q

This combination of ____, _____ and ______ transforms a potentially overwhelming
search process into a streamlined and efficient method for accessing high-quality, evidence-based
information.

A

structured
vocabulary, keyword precision, and logical operators

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13
Q

Give an example of a broad and narrow search term using MEDLINE’s MeSH terms

A

users can explore broad topics like cardiovascular
diseases or focus on specific facets such as cardiac tamponade. Each MeSH term may have
associated subheadings (e.g., drug therapy or complications), which can also be subdivided
further, offering precision in targeting specific aspects of a topic. When searching, users can
choose between narrow subheadings (e.g., congenital heart defects: drug therapy) or broader
categories (e.g., congenital heart defects), depending on their informational needs.

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14
Q

MEDLINE provides other search methods such as?

A

MEDLINE provides other search methods, including keyword, journal name, author, or article
title.

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15
Q

What is the difference between a keyword and MeSH terms?

A
  1. Keywords, unlike MeSH terms, are derived from an article’s title, abstract, or indexed terms.
  2. a keyword search may identify irrelevant
    articles, whereas a MeSH term ensures precise matching.
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16
Q

When would a keyword be preferred to a MeSH term?

A

for newly
released drugs that lack assigned MeSH terms, keyword searches become the optimal strategy.

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17
Q

What is the function of Boolean operators?

A

They allow you to combine search terms to refine and structure your query for optimal results.

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18
Q

The three main Boolean operators are:

A

AND, OR and NOT.

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19
Q

What is the function of AND?

A

The operator AND will combine two terms, returning only citations containing both of those
concepts or terms.

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20
Q

What is the function of OR?

A

Combining two terms with the operator OR will result in an equal or
greater number of returns since it will include any citation where either term is used.

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21
Q

What is the function of NOT?

A

The operator NOT would be helpful if a user wants to exclude certain topics, such as a specific disease state.

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22
Q

Let’s illustrate DI retrieval using this example: Is ciprofloxacin effective in treating soft tissue
infections in children?
What are the search terms in the example above?
How can you combine the search terms using Boolean operators?

A

The key search terms are:
1. Ciprofloxacin
2. Soft tissue infections
3. Children

Combining Search Terms Using Boolean Operators

Using AND: Ciprofloxacin AND soft tissue infections AND children

Using OR: (Ciprofloxacin) AND (soft tissue infections OR skin infections OR cellulitis) AND (children OR pediatric OR adolescents)

Using NOT: Ciprofloxacin AND soft tissue infections AND children NOT adults

Final Search String Example:
(Ciprofloxacin) AND (soft tissue infections OR skin infections OR cellulitis) AND (children OR pediatric OR adolescents)

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23
Q

What is Literature evaluation?

A

Literature evaluation refers to the process of critically assessing and analyzing published
scientific and academic materials to determine their validity, relevance, quality, and applicability
to a particular field of study or problem.

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24
Q

Why do pharmacists need literature reviews?

A
  1. Literature evaluation skills are critical
    to determining which articles should change pharmacists’ current practice.
  2. During rounds,
    pharmacists are frequently faced with questions regarding published articles and need to have the skills to decide if the results of published clinical trials should be applied to patient care.
  3. Pharmacists involved with a hospital’s drug and therapeutics committee also must evaluate the
    literature critically to determine if a drug should be included in the hospital formulary.
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25
Literature evaluation is essential for various reasons, including?
1. Identifying issues such as inappropriate study designs 2. Flawed or incorrect methodologies 3. Misinterpretation of findings 4. Selective or inaccurate referencing 5. Unjustified or erroneous conclusions 6. Instances of scientific misconduct 7. Insufficient expertise in study design or statistical analysis by peer reviewers.
26
What is the most significant limitation of tertiary DI resources?
lag time for publication.
27
What are limitations of tertiary DI resources?
1. Author bias 2. Inaccurate information 3. Lack of author expertise
28
Essential considerations in evaluating tertiary literature include:
- Expertise of the author - Purpose of the book (textbook) - Edition and year of publication - References cited - Ease of use - Format – textbook, digital or ebook - Potential bias - Content - Organisation of content
29
For tertiary references that provide a DI focus, the user should consider what?
1. The type of drugs included in the reference (e.g., prescription only, over-the-counter, herbals) 2. The drug’s country of origin. 3. The types of information reported should also be considered (e.g., U.S. Food and Drug Administration- approved uses only or off-label uses as well).
30
What is the purpose of clinical trials?
Clinical trials are conducted to test hypotheses and establish evidence regarding the safety, efficacy, or effectiveness of interventions.
31
What clinical trial design is the gold standard?
randomized controlled trials
32
What is the disadvantage of observational studies?
observational studies, may provide supportive evidence but are less capable of establishing direct causation.
33
Study designs are divided into?
1. Observational 2. Experimental/Interventional 3. Reviews
34
Observational studies are divided into?
Descriptive Analytical
35
Descriptive studies are divided into?
Case reports/case series Cross-sectional
36
Analytical studies are divided into?
Case-control Cohort (Retrospective or Prospective)
37
Experimental/Interventional studies are divided into?
Randomised controlled trials Non-Randomised controlled trials Cluster randomised trials
38
Review studies are divided into?
Narrative Qualitative systematic Quantitative systematic
39
What is the purpose of Randomized Controlled Trial
Participants are randomly assigned to groups to compare interventions, minimizing bias.
40
What is the purpose of Case Report
Detailed report on a single case, providing insights into rare or unique conditions.
41
What is the purpose of Case series
Descriptive study of a series of cases. Reports observations in a series of patients, useful for identifying patterns or generating hypotheses.
42
What is the purpose of Cross-Sectional Study
Examines data at a single point in time to analyze prevalence and relationships of variables/ to understand prevalence of disease characteristics in populations.
43
What is the purpose of Case-Control Study
Compares individuals with a condition (cases) to those without it (controls) to identify risk factors. Determine association between disease states and previous exposure to risk factors.
44
What is the purpose of Cohort Study
Observes a group (cohort) over time to study the relationship between exposure and outcomes. Determine association between risk factors and subsequent development of disease states
45
What is the purpose of Narrative review (nonsystematic review)
Summarize data from multiple studies using nonsystematic, qualitative, and subjective methods
46
What is the purpose of Health outcomes research
Compare outcomes and costs of drug therapies or services
47
What is the purpose of Bioequivalence study
Assess whether products are similar in rate and extent of absorption
48
What is the purpose of Longitudinal Study
Follows participants over an extended period to assess changes and long-term effects.
49
What is the purpose of Post-marketing study
Examine efficacy and/or safety following approval of the drug by a regulatory authority
50
What is bias?
A systematic error that affects the study results positively and negatively. It is something that affects the study results other than the treatment under investigation.
51
The different types of bias often encountered in literature include:
1. One-sided reference bias 2. Positive result bias 3. Sample size bias 4. Withdrawal bias 5. Attention bias 6. Instrument bias 7. Recall bias 8. Selection bias 9. Procedure bias
52
What is One-sided reference bias
occurs when authors limit references to only those works which support their conclusions
53
What is Positive result bias
occurs when authors are likely to submit and publish positive results
54
What is Sample size bias
occurs when samples are too small to prove nothing or too large to prove anything
55
What is Withdrawal bias
occurs when patients who withdraw from a study may differ systematically from those who remain
56
What is Attention bias
occurs when study participants alter their behavior if they know they are being observed
57
What is Instrument bias
occurs due to defects in the calibration or maintenance of measurement instruments leading to systematic deviations in results
58
What is Recall bias
occurs when patients are asked to recall events in the past
59
What is Selection bias
occurs when inclusion and exclusion criteria limit the population to a degree that affects the extrapolation of the data
60
What is Procedure bias
occurs when all the treatment groups do not receive the same diagnostic procedures, leading to increased disease detection in one group.
61
The validity of a clinical trial or study can be classified into two key types
internal validity and external validity
62
What is internal validity?
This refers to the degree to which the study design and execution accurately measure what the trial intended to evaluate. For instance, in a randomized, controlled, double-blind trial, if the investigators are not properly blinded to which participants received Drug A versus Drug B, their knowledge could inadvertently influence the study's outcomes, thereby compromising internal validity.
63
What is external validity?
This pertains to how well the study’s findings can be generalized to other populations or settings. For example, if a clinical trial on patients with type 2 diabetes mellitus (DM) excluded individuals with concomitant hypertension, but most patients with type 2 DM in clinical practice also have hypertension, the findings would have limited external validity and applicability to the typical patient population.
64
What are Confounding variables
Confounding variables are factors associated with both the condition being studied and the potential outcomes, which can introduce bias and affect the validity of the study results.
65
What is the danger of confounding variables?
Confounding factors can mask actual associations or falsely demonstrate an apparent association that does not exist between variables in a study.
65
Issues related to confounding factors are common where?
Issues related to confounding factors are common in observational studies because they are the product of not using a randomization schedule that evenly distributes the confounding factors between the study groups.
66
What is the goal of a controlled clinical trial?
The goal of a controlled clinical trial is to compare the effects of an investigational (intervention) group to a control group, which can be either a placebo (placebo-control) or another intervention (active control).
67
What are the Controlled Clinical Trial Sections?
Abstract Introduction Methods Results Discussion Acknowledgments References/Bibliography
67
Other types of interventions that can be used in a controlled clinical trial include?
different medication dosing regimens, dietary changes, surgery, behavioral processes, exercise programs, diagnostic procedures, radiation therapy, or educational interventions.
68
What is an Abstract
Brief overview of the research project
69
What type of Information Presented in Introduction
Research background What is already known Rationale for study Objective/hypotheses
70
What type of Information Presented in Methods
Study design Study setting Study Population Inclusion and exclusion criteria Intervention and control groups Randomization Blinding Endpoints/outcomes Follow-up procedure Sample size calculations/power analysis Statistical analysis
71
What type of Information Presented in Results
Subject characteristics Subject dropouts/adherence Endpoints quantified Statistical significance Safety assessments
72
What type of Information Presented in Discussion
Interpretation of results Clinical significance Other study results compared Limitations Conclusion/application to practice
73
What type of Information Presented in Acknowledgments
Other contributors Funding source Peer review dates/manuscript acceptance date (not all trials)
74
What type of Information Presented in References/Bibliography
Citations for information included from other resources (e.g., trials and reports)
75
Important considerations for evaluating a clinical trial include?
journal and peer review, publication types, authorship, title, abstract, introduction, methods, study design, patient inclusion/ exclusion criteria, intervention and control groups, institutional board review (health research ethics committee review)/ participants consent, blinding, randomization, randomization techniques, endpoints, follow-up schedule, data collection, sample size, statistical analysis, power analysis, results, result interpretation, discussion, conclusion.
76
What is a CONSORT?
Consolidated Standards of Reporting Trials Statement (CONSORT) The CONSORT comprises a 25-item checklist, which focuses on reporting the trial design, analysis, and interpretation, and a flow diagram for documenting the patients at each stage of the trial.
77
What are the Steps in the literature review process?
1. Define the research question  - You may need to do some exploratory searching of the literature to get a sense of scope, to determine whether you need to narrow or broaden your focus - Identify databases that provide the most relevant sources, and identify relevant terms (controlled vocabularies) to add to your search strategy - Finalize your research question 2. Determine inclusion/exclusion criteria - Think about relevant dates, geographies (and languages), methods, and conflicting points of view 3. Choose databases and conduct the search - Conduct searches in the published literature via the identified databases - Check to see if this topic has been covered in other discipline's databases - Examine the citations of on-point articles for keywords, authors, and previous research (via references) and cited reference searching. 4. Review your results - Save your search results in a citation management tool (such as Zotero, Mendeley or EndNote) - De-duplicate your search results - Make sure that you've found the seminal pieces -- they have been cited many times, and their work is considered foundational  - Check with your supervisor or a librarian to make sure your search has been comprehensive 5. Synthesize the information gathered - Evaluate the strengths and weaknesses of individual sources and evaluate for bias, methodologies, and thoroughness - Group your results in to an organizational structure that will support why your research needs to be done, or that provides the answer to your research question   - Develop your conclusions 6. Analyze the information gathered - Are there gaps in the literature? - Where has significant research taken place, and who has done it? - Is there a consensus or debate on this topic? - Which methodological approaches work best? 7. Write the literature review - Pick an organizational structure, i.e., themes, approaches, concepts, methodologies. - For example: Background, Current Practices, Critics and Proponents, Where/How this study will fit in  - Organize your citations and focus on your research question and pertinent studies - Compile your bibliography/ references
77
Currently, there’s the CONSORT-Outcomes 2022 extension: additional essential checklist items describing outcome-related content not covered by the CONSORT 2010 statement. What additional items were added?
1. Rationale for Selecting Primary Outcome Domain: Explain why the specific primary outcome domain was chosen. 2. Detailed Outcome Description: For each outcome, provide a comprehensive description, including: - Measurement variable - Analysis metric (e.g., change from baseline) - Aggregation method - Assessment time point 3. Minimal Important Change Definition: If applicable, define and justify the minimal important change for the primary outcome. 4. Cut-off Values for Categorical Analysis: Specify the cut-off values used when continuous outcome data are analyzed as categorical data. 5. Time Points for Outcome Analysis: For assessments at multiple time points, indicate which time points were used for the outcome analysis. 6. Composite Outcome Components: Define all individual components included in composite outcomes. 7. Non-Prespecified Outcomes Identification: Identify any outcomes that were not prespecified in the trial protocol or registry. 8. Study Instruments Description: Describe the instruments used to evaluate outcomes, including their reliability, validity, and responsiveness in similar populations. 9. Outcome Assessors' Details: Detail who assessed the outcomes and any necessary qualifications or training to administer the study instruments. 10. Quality Assurance Processes: Describe processes used to ensure the quality of outcome data during and after collection, or state where this information is available. 11. Target Difference Justification: Define and justify the target difference between treatment groups used in sample size calculations. 12. Multiplicity Handling Methods: Describe methods used to account for multiplicity in the analysis or interpretation of primary and secondary outcomes. 13. Outcome Data Exclusion Criteria: Explain any criteria for excluding outcome data from analyses, or state that no data were excluded. 14. Missing Data Handling Methods: Describe methods used to handle and evaluate missing outcome data. 15. Outcome Analysis Population Definition: Define the population used for outcome analysis concerning trial protocol nonadherence. 16. Prespecified Outcome Analyses Results: Include results for all prespecified outcome analyses or indicate where these results are available. 17. Justification for Non-Prespecified Analyses: Provide justification for any analyses performed that were not prespecified.