• Intro to Drug Information: already in flashcards

• Intro to the Library

• Ethical & Legal Aspects of Drug Information

• Copyright / Plagiarism / Citations

• Introduction to Primary Literature

• Research Methods

Intro to the Library

What do USF Health Libraries offer?

• 24/7 student study space

• after hours access to Shimberg Library

• Booking a study room or collaborative space

• Access to computer lab and software

• Copier, printing services, and poster printing

• online access to journals and books off-campus

• interlibrary loan services via lliad

• library workshops

• work with a librarian

Who has library building access?

• USF faculty, staff, and students

• all health faculty and students should automatically be added to the card permissions list upon registration for classes each semester

• If you experience problems with card access, please visit WELL front desk or email usfhealthsss@heath.usf.edu

For quick questions, try email, chat, or knowledge base

For complicated questions, set up an appointment

To find books and journals, search the library catalog

General Reference books

• AccessMedicine, AccessPharmacy, AccessSurgery

  • medical book titles, drug information, thousands of images, interactive self-assessments, case files, diagnostic tools, mobile app

• LWW Health Library

  • medical education and pharmacy ebooks from Lippincott williams and Wilkins

• Stat!Ref

  • Full-text cross-searachable reference books, includes Stedman’s Medical Dictionary, MedCalc3000, a unique computerized medical reference and tool set, and more

• Thieme MedOne Education

  • over 110 e-textbooks covering entire medical school curriculum

Library Classes

• Effective Searching and Databases Series

• Writing and Publishing Series

• Promotion and Tenure Series

• Grants Series

• Endnote

• Effective Searching

Copyright/Plagiarism/Citations

What is copyright?

• Copyright: form of protection by US law for original works of authorship (literary, dramatic, musical, artistic, etc)

• Copyright protection exists as soon as work is fixed in tangible form (even a drawing on a napkin)

• Lasts life of author + 70 years of exclusive rights to make copies, distribute, prepare derivatives, perform, and display publicly

• Facts, names, short phrases, and methods are NOT protected by copyright (can be protected by patents)

• Materials in public domain also not protected (copyright expired, forfeit, inapplicable)

  • Ex. Jane Austen’s pride and prejudice (expired)

• Copyright can be given away or forfeit (creative common, cc zero., no rights reserved mark)

• US federal government publications are in public domain

  • Works by third parties under government or state gov may be treated differently

How to use Copyrighted materials

• Put a link to the material

• Quote 

• Fair-use: allows others to use copyrighted material in specific scenarios

  • Depends on purpose and character of work, nature of original material, amount used of copyrighted material vs whole work, effect on original’s market

  • EX. Using short clip from film in documentary

• Special exceptions to copyright

  • Libraries, schools, non-profits

• Creative Commons licenses can tell what activities are allowed

• Request permission from creator

Avoiding Plagiarism

• Plagiarism: act of presenting another’s work or ideas as your own

  • “Kidnapping” someone else’s ideas

• To avoid..

  • Directly quote material

    • When you cannot paraphrase or summarize without losing meaning

    • Can add credibility

    • Do not overuse (don’t parrot)

• Paraphrase

  • Rewording in your own words

• Summary

  • Integrates ideas

  • Shorter in length

• Always cite!

  • Even professor’s lectures

• Don’t cite when it is common knowledge or your own ideas

  • Something everyone would reasonably know (apples grow on trees, George Washington was president)

• Start early, document sources as you go, and research well before starting to write to avoid plagiarism

• Don’t copy and paste from original, don’t procrastinate!

  • Procrastination is biggest cause of plagiarism

• Better to over-cite than take credit from someone else’s ideas

How to Cite Sources

• When should you cite?

  • Did you think of it?

    • If not, cite

  • Is it common knowledge 

    • If not common fact or saying, cite

Why should you cite?

• Avoid plagiarism

• Establish credibility

• Help readers find the original materials

Citation style to use: AMA (also called JAMA)

• Uses numbered endnotes that are placed in your text as superscript numbers with a References list at the end of the text in the order that the citation was used

Parts of a Citation

1. Authors

   1. should list author’s surname followed by initials WITHOUT periods

   2. For 1-2 authors: list all authors in reference list and in-text citations

   3. For 3-6 authors: List all authors in reference list and 1st author followed by et al or “and colleagues” in-text citations

   4. For 7+ authors: List first 3 authors followed by et al. in reference list, list 1st author followed by et al or “and colleagues” in-text citations

2. Article Title & Subtitle

   1. use sentence capitalized (capitalize only first word and proper nouns, do not capitalize after colon)

3. Journal Title (abbreviated)

   1. Capitalize all major words

   2. Italicize titles

   3. Find correct journal title abbreviations using National Library of Medicine Journals list

4. Year of publication/online pre-publication date

   1. For published articles, YEAR followed by semi-colon

   2. For articles online ahead of print/online journal, “Published online Month Date, Year” followed by period

      1. If no volume, issue, or page numbers included, skip

   3. If multiple dates, use MOST RECENT

5. Volume

   1. issues collected into volumes, typically one year’s worth of issues

   2. Year; Volume(issue):startpage-finalpage.

6. Issue

   1. Each publication is an issue

7. Page range/e-locator

   1. Should include the entire range of pages

8. DOI

   1. Digital object identifier

   2. unique permanent number given to each article (and other electronic resources)

   3. if doi is shown within a URL, start with the 10.xx

   4. if no DOI, use URL+access date

Introduction to Primary Literature

Classifications specific to pharmacy:

1. Primary: direct access to data

2. Secondary: abstracting or indexing search engines; facilitate location of primary and tertiary literature

3. Tertiary: indirect access to data; author interpretation of the literature

Primary Literature

• Research methods

• Evaluative (Experimental, Observational) or Descriptive

• Identified via review of secondary and tertiary literature

• Predominantly journal articles

Secondary Literature

• indexing and abstracting services

  • index: citation only

  • abstract: citation plus description of article content

• Facilitates search for tertiary and primary literature

• Content varies per service

Tertiary Literature

• Textbooks (general or specialty)

• Compendia (computer databases)

• Review articles

• Evidence-based guidelines and consensus statements

• package inserts

• internet resources

Alternate/Unclassified Resources

• Expert opinion

• Pharmaceutical industry

• Professional list servs

Primary Literature

• Written accounts of original thought or discovery directly derived from first-hand observation or research

• Introduces new evidence into the existing body of scientific knowledge

• commonly published in medical or health-related journals

  • not all literature in journals is primary

  • not limited to journals

Examples of Primary Literature

• Clinical research studies and reports (randomized controlled trials, cohort studies, case series, case reports)

• Posters presenting original research

Sections of a Primary Literature Article

1. Title/Authors

2. Abstract

   1. Overview of most important aspects of article

   2. Allows reader to quickly determine if he/she wants to read entire article

   3. Should not rely on abstract alone when reading

3. Introduction

   1. Background info and rationale for research

   2. study objectives

4. Methods

   1. Describes how study was conducted

      1. study design

      2. patient selection/recruitment process

      3. interventions used and process for use

      4. how endpoints were measured

      5. how data were collected

      6. planned statistical analyses

5. Results

   1. Description of data/findings

   2. Statistical analysis of data

6. Discussion

   1. Author’s interpretation of the results and the impact of the study

   2. comparison to other studies

   3. trial strengths and limiations

   4. suggested directions for future research

7. Conclusion

   1. summary of what authors feel is the ultimate impact of the study

8. References

Advantages and Disadvantages of Primary Literature

• Advantages:

  • Original, current info

  • Detailed info

  • Open for reader’s own assessment of validity and applicability of study results

• Disadvantages:

  • Conclusion based on one trail may eb misleading without context of other research

  • Reader must have good literature evaluation skills

  • Time-consuming

  • Costly and/or difficult to obtainIntro to Medical Journals

Types of medical journals:

1. General Focus

   1. cover variety of disciplines and medical conditions

   2. ex. New England Journal of Medicine, Journal of the American Medical Association

2. Specialty focus

   1. covers specific medical conditions, organ systems, or patient populations

   2. ex. Diabetes Care, Pediatric

Factors which increase reputability and credibility of journal

• Peer Review

• Editorial Board

• Accept Correspondence

• Affiliated with a professional organization

• low advertisement to text ratio

Impact Factor

• Average number of times the articles in a journal were cited during a period of time

• Rating related to importance the scientific community places on articles published in a journal

• higher impact factor = greater scientific influence

Research Methods

Categories of Research:

1. Evaluative

   1. primary goal: answer a question

      1. Experimental: measure interventions

         1. Clinical trials

         2. Meta-analysis

         3. Pharmacoeconomic (PE)

         4. Health Related Quality of Life (HRQoL)

      2. Observational: examine specific data sources for the purpose of identifying relationships surrounding specific events or outcomes

         1. Cohort

         2. Case-Control

         3. Cross-sectional/Survey

   2. Article sections: Title, Authors, Abstract, Introduction/background, Methods, Results, Discussion, Conclusion, References

2. Descriptive

   1. primary goal is to report individual experiences

      1. typically lack hypothesis or scientific principles

      2. findings often lead to the development of evaluative studies

   2. Cohort, Case-control, cross-sectional, case-report/clinical series,

      1. Overlap with observational research!

   3. Article sections: Title, Authors, Abstract, Introduction/background, Observations (combo of methods and results), Discussion, Conclusion, References

Section Content Overview

1. Introduction/Background

   1. Literature review

   2. Study objective and hypothesis

2. Methods, statistics, and results are inter-related

   1. Methods determine type of results, collected data determines statistical analysis

   2. Results should follow methods and address all planned analysis

3. Discussion: interpret results (no new data/findings), relate to existing literature, address limitations and future research

Methodolgy

• Sample Description

  • Demographics

  • Size

  • Inclusion/Exclusion criteria

• Blinding

  • Single: participants unaware of intervention allocation

  • Double: Both participants and researchers unaware of intervention allocation

  • Open-label: No blinding

• Control group(s)

  • Placebo: physically identical to intervention, no therapeutic effect

  • Active: comparable treatment given

    • seek equivalency, inferiority, or superiority regarding desired effect

• Administration of intervention

  • Parallel: concurrent administration

  • Crossover: Participant serves as their own control

    • receive both interventions with washout period in-between

• Allocation of intervention

  • randomized: computerized process that generates allocations without patterns

  • nonrandomized or random allocation: process that has no randomization or utilizes a distinct pattern

• Number of sites

  • single: one physical location/organization

  • multiple: broad, more diverse practice or several organizations

  • impact patient factors and ability to generalize results to other populations

Outcomes (ECHO)

1. Economic

   1. evaluation of costs and associated consequences

   2. cost effectiveness, cost-benefit, cost-utility, cost-minimization

   3. Costs

      1. Direct:

         1. Medical: monies spent on healthcare

         2. Non-medical: monies spent while obtaining healthcare (ex. time off work, transportation)

      2. Indirect:

         1. Monies lost secondary to morbidity

         2. Monies lost secondary to mortality (death)

      3. Intangible

         1. Related to disease or treatment

         2. Value attributed to pain, suffering, and/or distress

2. Clinical

   1. Biologic and physiologic changes

      1. Lab findings, physical findings

   2. Usually focus on events

      1. disease-related, drug-related, other interventions

3. Humanistic

   1. Effect an intervention has on an individual

   2. Health-related quality of life

   3. Satisfaction

   4. Functional status

      1. Physical, Psychological, Social

   5. Symptoms associated with a disease or treatment

   6. Cultural or ethnicity-related beliefs

   7. Measurement Domains

      1. Instruments: questionnaire or survey

         • General: health profiles, utility analyses

         • Disease-specific

      2. Administration: self or investigator

4. Operational

   1. Assessment of how perceptions or behaviors changed (operationally) as a result of an intervention

   2. impact and implications

      Utility

      1. Many perspectives considered (patient, provider, payer, society)

      2. Clinical practice (formulary management, clinical practice guidelines, justification of services/programs)

      3. Pharmaceutical industry (drug development, pricing)

Clinical Trials

• Purpose: to evaluate cause and effect

• Design: true experiment or quasi-experimental

  • quasi-experimental: groups are not randomly assigned

• Prospective

• Involve some type of intervention

  • laboratory; animal or human

  • Pharmaco-

    • Therapeutic: medication, procedure, physiologic manipulation, behavioral

    • Kinetic: absorption, distribution, metabolism, elimination

    • Dynamic: pathophysiologic

• Methodology

  • Key components: Sample, Blinding, Control group(s), administration parameters, intervention allocation, number of sites, outcome variables

• Analysis

  • predominantly inferential: dealing with data sets

  • set a priori (before study begins)

  • based on type of data (nominal, ordinal, interval/ratio)

  • usually includes alpha value (p-value)

    • reflects type one error (false positives) to support when to accept or reject the null hypothesis

    • traditional level of significance is <0.05

  • may include beta value (power)

    • reflects type two error (false negative) or ability to detect differences between groups

    • used to determine appropriate number of participants in each allocation arm

• Advantages: best way to measure cause and effect

• Disadvantages: time intensive, expensive, may be unethical

Meta-Analysis

• Study of studies

• Does not directly involve patients, an outcome, or intervention

• combination and statistical analysis of results from previously conducted studies (clinical trials, cohort, case-control)

• WILL develop hypothesis

• Similar to a review article in approach but findings are substantiated by the determination of statistical relationships

• By combining data (increasing participants), relationships may be better appreciated

  • Method section will include:

    • Search strategy description

      • detailed description of strategy used to identify studies

      • typically entails both computerized and manual efforts (tertiary lit, secondary lit, alternate resources)

    • Article review process description

      • Description of reviewers

        • minimum 2

      • evaluate and rank articles based on a comparison of method sections

      • blinded to author, title, publication source, and results

    • Inclusion/Exclusion Criteria

      • determined a priori

      • description of required methodologies and data extraction process

      • description of excluded studies will be listed within the text of the document or table

    • Data collation

      • aka pooling: combining results from included studies

      • prior to pooling, investigators will perform statistical analyses to ensure homogeneity

    • Statistical data classification

      • Nominal: comparing effects not participants

      • Variants of chi-square

      • Results usually presented as odds ratios with 95% confidence intervals

    • Additional analyses

      • sensitivity analysis: performed to see whether inclusion of different variables influences circumstances

      • logistic regression: clarify magnitude of significance when confounding variables

• Advantages: If results from individual trails are inconclusive or conflicting, meta-analysis can further evaluate previously identified associations, enhance power, and provide direction for future research initiatives

  • subground analysis, post hoc analysis

• Disadvantages: Retrospective, publication bias (if investigators can only find published studies), internal validity (identified relationships will not be pure), will not confirm cause/effect

Cohort Analyses

• Purpose: to determine the relationship between risk factor exposure and outcome(s)

  • evaluate risk

  • goal: establish causation (not as pure as relationship determined by clinical trial)

  • determine incidence

• Investigators should have some suspicions that the relationship is possible

  • Findings from literature used to support hypothesis

• Usually prospective, may begin with a retrospective review before moving forward

  • Obtain pre-determined baseline information

• Methodology:

  • select a duration of follow-up that is long enough to realize outcome of interest

    • tend to be very long

  • enroll a sufficient number of patients (power)

    • power analysis performed so investigators know number of patients required before study begins

  • Many cohorts include cases (exposed), controls (not exposed)

  • Comparable groups to include in cohort should have similar:

    • Demographics

    • Prior healthcare

    • Monitoring parameters within trial (physical examination, labs, procedures)

      • standardized methods

      • equal access

      • similar evaluation time frames

    • Historians: recall bias

      • inability to recall can introduce bias

    • Compliance

      • can be difficult because of longitudinal nature of cohorts, some may drop-out, withdraw

  • Statistics:

    • Relative Risk

      • A measure of the risk of a certain event happening in one group compared to the risk of the same event happening in another group

        • 1 = identical risk (reference value)

        • <1 = lower risk

        • >1 = higher risk

    • Confidence intervals

      • used to quantify magnitude of relationship

      • wider confidence interval = more likely relationship is due to chance

      • confidence intervals that include 0 are null/void

    • Attributable risk

      • evaluating incidence vs. outcomes

    • statistics differentiate causation from chance occurrence

  • Advantages: investigators determine sample characteristics, evaluation parameters/techniques

  • Disadvantages: May require long duration of follow-up depending on outcome, may be expensive, difficulties may arise with maintaining controlled factors, dropout rates increasing with time, membership bias (difficult to determine whether outcome is secondary to risk factor or to group characteristics), surveillance bias (circumstances associated with investigation affect outcome

Case Control Analyses

• opposite of Cohort

• Purpose: to determine which prior risk factor may be contributing to an observed outcome

  • evaluate risk

  • establish causation

  • examine prevalence

• Retrospective; often used to determine the need for prospective analyses

• Methodology:

  • Before study is undertaken, investigators determine suspected risk factors for an outcome

    • must be literature support/evidence

  • Cases and controls identified by the investigators are matched

    • Cases: with outcome

    • Controls: without outcome

    • Must be comparable groups (demographics, access to healthcare, recall ability should be good)

    • key determinant: how well groups are matched

    • Methods should include description of matching process in regard to Beta or power

    • Common for mismatch between case number vs controls (number of controls may be much higher than cases)

  • Investigators retrospectively review records and perform interviews to determine risk factor exposure

    • both groups may or may not have risk factor exposure

    • Individuals involved with data extraction/interviews are blinded to study intent and patient circumstances to avoid deviation and reduce bias

    • protocols developed to insure appropriate and accurate data collection

  • Predetermine inclusion/exclusion criteria, suspected risk factors, definition of exposure, criteria and statistical methods used to determine existence of relationships

    • avoid data mining

• Statistics

  • Odds ratios or variance

    • The OR represents the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure

    • 1 = identical odds

    • <1 = lower odds

    • >1 = higher odds

  • Confidence intervals (95%)

    • used to quantify magnitude of relationship

  • Regression analysis

    • further quantify relationship between different variables

    • identify best fit line to describe relationship between data points

      • more linear = more likely relationship

      • direction =.postive or negative relationship

• Advantages: investigating rare diseases, evaluating diseases that develop/progress slowly, investigating ethically sensitive issues, less expensive, quicker to perform, able to identify multiple risk factor associations

• Disadvantages: rely on accuracy/completeness of database, risk factor and outcome data collected simultaneously makes identifying relationships challenging, recall/surveillance bias, protopathic bias (making the appropriate risk factor to outcome correlations

Cross-sectional analysis

• purpose: to evaluate an outcome (opinions, environmental circumstances, disease states, or interventions) at a single, specified period in order to determine prevalence and develop ideas for future programming and/or research

• investigators select specific time frame during which data will be collected, then analyze after

• Data collection methods: surveys, other instruments

• Methodology:

  • investigators should describe case/control identification process

  • inclusion/exclusion criteria

  • data selection, collection, and collation process

• Statistics

  • dependent on outcome of interest

• Advantages: quick, less expensive

• Disadvantages: transient effect (since data reflects specific period, challenging to know whether findings are by chance or ongoing), unable to determine cause and effect

Case Report/Case Series

• Case Report: Report the clinical course of a particular patient

• Clinical series: Report the clinical course of multiple patients linked by commonalities

• Typically involves unique or unexpected observation, intervention, procedure, etc.

  • most reported: adverse events, birth defects

• When there is insufficient supportive literature, serve to provide guidance and literature for other practitioners

• No formal study design or presentation format

  • usually blending of introduction, background, and observation sections

• Limited/no statistical analysis

• use of data is restricted, limited ability to make population inferences or generalizations

• may provide direction for future research