EBCR Quiz 2 Content

Tertiary Literature

• takes information from all the different studies that have been performed to try to answer a question and distills it into information that can be easily accessed and referenced

• can be general or specialized

• textbooks, package inserts, systematic reviews, evidence-based guidelines, online resources (Drug databases), compendia

Advantages of tertiary literature

• general information

• provides overview of most important information about a topic

• quick reference guide

• Gold-standard diagnosis/treatment algorithm for disease or condition

Disadvantages of tertiary literature

• can become dated very quickly as new guidelines are relased

• information may be incomplete

• may be errors in transcription or interpretation by others

• author may be biased or lack expertise

Evaluating tertiary literature

• CRAAP

• Currency

  • publication date

  • revision date

• Relevance

• Authority

  • author’s expertise/experience

  • are sources reliable?

• Accuracy

  • blatant errors?

  • can information be verified by reliable source?

• Purpose

  • potential bias?

Primary literature

• original research

• commonly found in journals

How to cite drug databases

1. Author

2. Title of author,

3. Title of database.

4. Publisher/Database owner

5. Year of publication

6. Update date

7. Access date

8. doi/URL

Author(s). Title of article, Title of database. Publisher or database owner; Year of publication. Updated [date]. Accessed [date]. doi/URL

Package inserts

• tertiary literature

• includes review of literature with corresponding references

• developed by pharmaceutical manufacturer who chooses what information to include (possibility of bias)

• must follow FDA requirements and be approved by FDA before used

Package Insert Sections

• table of contents

• highlights of precribing information

• Recent major changes

• indications and usage

  • FDA approved only

  • off-label uses not included

• description of pharmacologic classification and chemical structure

• dosage and administration

• dosage forms and strengths

• contraindications

• storage and handling

• warnings and precautions

• adverse reactions

• drug interactions

• use in specific populations (pregnant, geriatric, children)

• overdosage

• Clinical Pharmacology

  • mechanism of action

  • pharmacokinetics/pharmacodynamics

• nonclinical toxicology

• patient counseling information

  • administration techniques or requirements

  • medication guides

  • risk evaluation and mitigation strategies for some drugs to manage specific serious risk

• boxed warning (if drug or device can cause serious side effects)

• clinical studies

• references

• company contact information

• date of publication and last revision

Use of Package inserts in practice

initial resource when answering drug information request about

• approved uses

• overview of pharmacology, pharmacokinetic, and pharmacodynamic properties

• basic administration and monitoring requirements

• product availability

good resource for basic patient counseling requirements

Disadvantages of package inserts

• not intended to be all-inclusive

• may not be sufficient by itself to address drug information request

Drug Databases

• tertiary literature

• may be subscription based or free/government databases

  • of free databases, government-led are more reliable

Subscription-based drug databases

• clinical pharmacology

• facts and comparisons

• lexicomp

• micromedex

• natmed pro

Free/Government drug databases

• DailyMed (government)

• Drugs.com

• Epocrates

• Medscape

• Physicians’ Desk Reference

• US FDA

Drug databases usually include

• FDA-approved and off-label uses

• dosages, including for special populations

• interactions with other medications/substances

• adverse reactions/side effects

• toxicology

• drug identification

• stability/compatibility/compounding (IV)

• most have dosing/other calculators

Drug Databases for Non-Prescription Therapies

• Handbook of Non-prescription Drugs (now APhA OTC)

• NatMed Pro

• Dietary Supplement Label Database

Will off-label uses be on government databases?

No

Evidence-based clinical practice guidelines

• systematically developed statements to assist practioner and patient make decisions about appropriate healthcare for specific clinical circumstances

• series of recommendations that are developed by reviewing the existing evidence and assessing risks/benefits of health care interventions

Purpose of Evidence-Based Clinical Practice Guidelines

• provide concise summary of expected outcomes for available therapies

• assist practioners inmaking informed, evidence-based decisions for their patients

• provide a standard of care and improve quality of care

Development of Evidence-Based Clinical Guidelines

• developed by variety of organizations

• standards for development by IOM (institute of medicine)

  • establish transparency

  • manage conflicts of interest

  • establish multidisciplinary guideline development

  • conduct systematic review for qualifying evidence

  • establish strength of recommendations

  • articulate recommendations

  • conduct external review

  • establish plan for updates

Sections of Evidence-Based Clinical Guidelines

1. Information about developers

2. Introduction/Methodology

   1. Literature reviewed and how quality of evidence is rated

3. Recommendations (majority)

Quality of Evidence for guidelines

• key aspect of interpretation and use of guidelines

• guide strength of recommendations

• usually categorized as stronger/weaker in tables in introduction/methodology section

Strength of recommendations for guidelines

• amount of confidence one can have that adherence to the recommendation will do more good than harm

• based on quality of evidence

• strength of evidence is described in introduction/methodology

• stronger: based on strong evidence, clinical trials

• weaker: based on observations/expert opinions

Sources of published guidelines

• organization that developed guideline

• peer-reviewed medical literature

• located using secondary resources

• drug databases

Advantages of guidelines

• concise summary of current best evidence when considering health care interventions

• assists in decision-making process

• enhances continuity of care when decisions are made by multiple providers in multiple settings

Disadvantages of guidelines

• may not be updated regularly

• may become outdated

• guidelines published by different organizations may have conflicting information

• not a substitute for clinical judgement

• guidelines may not apply to every patient

Demographic that uses internet for health information the most

Females

25-34

Problems with using internet for health information

• not always accurate and complete

• anyone can publish a website

• quality and reliability of information may vary among websites

• no agency/entity routinely reviews internet sites

• patients may use the internet instead of consulting a healthcare provider

How are pharmacists affected by the internet?

• patients often approach pharmacists with questions about information found on the internet

• pharmacists can help patients evaluate the quality of information found on the internet and recommend websites to use for reliable health information

Websites that generally provide higher-quality health information are maintained by

• governmental agencies (.gov)

• educational entities (.edu)

• professional organizations (.org)

• non-profit organizations (.org)

Websites that have greater risk for bias/inaccuracy are maintained by

commercial entities (.com)

Elements to consider when evaluating internet resources

• content

• currency

• authors

• references

• site design

Evaluating content for internet resources

• Is the information presented at the appropriate level for the audience?

• Is the information accurate and complete?

• Did the authors avoid overly positive words?

• Is the purpose of the site education rather than product promotion?

• Is the text free of grammatical and spelling erros?

• If opinions are present, are they labeled as such?

• Do hyperlinks link to relevant, reputable websites?

Evaluating currency for internet resources

• is the information up to date?

• did the authors include date of last update?

Evaluating authors for internet resources

• are the authors/sources of information identified?

• Do the authors have ethe appropriate background for the type of information presented?

• Is contact information provided?

• are the authors free of bias?

Evaluating References for Internet Resources

• are the references cited completely so information can be verified?

• do the references reflect reputable sources?

Evaluating site design for internet resources

• does the site design allow for easy navigation?

• does the site avoid overly flashy, distracting graphics that can distract from inaccuracies?

• is there a disclaimer that the information is not intended to be used as medical advice ro to replace a healthcare provider’s advice?

HONcode

• tool to assess quality of an internet webstie

• does not evaluate accuracy or completeness of information

• symbol given to sites that apply (voluntary) that meet code of conduct of health on the net foundation

• lack of HONcode does not mean poor quality

When is it appropriate to use internet for health information?

• To find information about very recent topics

• to locate sources of information identified by patients in order to review the information for accuracy/completeness

• to research ingredients of over the counter products, dietary supplements, and herbal products

• providers can recommend websites to patients for information about disease states, medications

Useful Internet resources for patients

• health care organizations and disease society websites

• drug company websites

Useful internet resources for providers

• agency for healthcare research and quality (AHRQ)

• CDC

• Clinicaltrials.gov

• Dietary supplements labels database

• directory of information resources online (DIRLINE)

• US FDA

• National cancer institute

• national center for complementary and alternative medicine

• toxnet

• MD Consult

• Medscaoe

• RxList

Agency for Healthcare Research and Quality (AHRQ)

• link to national guideline clearinghouse and other guidelines

• preventive services section

• guides and resources for treatment options

Center for Disease Control and Prevention (CDC)

• international travel information

• vaccines/immunizations

• diseases/conditions

• preventive care section

• public health

Clinicaltrials.gov

up to date information for locating ongoing clinical trials

Dietary Supplements Labels Database

product label information for supplements

United States Food and Drug Administration (US FDA)

• information about drugs, vaccines, food

• “orange book” listing of products with therapeutic equivalence to other products

• labeling changes and new drug approvals

• medication guides

• drug shortages, safety communications, recalls

• medwatch adverse event reporting program

National Cancer Institute

information on types of cancers, treatment, prevention, causes, screening/testing, coping

National Center for Complementary and Alternative Medicine

• information on herbal supplements

• list of clinical trials involving herbals

• monographs and guidelines for alternative medicines

ToxNet

• databses related to toxicology

• LactMed (database of drugs to which breastfeeding mothers may be exposed)

MD Consult

• access to full text journal articles

• information about medications

• guidelines and patient handouts

Medscape

health-related news

RxList

• drug package inserts

• patient information

National Library of Medicine (NLM)/ Medline Plus

information about drugs and disease states

Thomson Healthcare

Information about prescription drugs

Merck

consumer-based version of merck manual

Department of health and human services

information about common disease states

National Institute of Health (NIH)

efficacy and safety of dietary supplements

American Society of Health-System Pharmacists (ASHP)

patient version of AHFS drug information resource

Secondary Literature

• abstracting or indexing search engines

• facilitate location of primary and tertiary literature

• at minimum, gives title of article, authors, and where you can find more robust sources

• allows us to sift through information and find the articles/information needed

Index

• first characteristic of secondary literature

• included in all secondary literature resources

• list at least 1st author, journal title, article title, and location information

Controlled vocalbulary

• created by some secondary literature

• agree on one word/phrase to use for every major concept

• controlled by database editors who define what is going to be included for each word or phrase, then look through articles and tag those with concept with the subject heading whether or not it uses that specific wording or not

Advantages of controlled vocabulary

• no need to worry about variant spellings or word variations

• easy to understand organization of concept and select broader/narrower terms

• makes searching more efficient/effective

• won’t miss article because you didn’t think of synonym

• vocabulary is structured in hierarchy from broad to narrow to adjust scope of search

Disadvantages of controlled vocabulary

• lag between when article is published and when it’s indexed

• subject to human error and difference in interpretation

• can vary by database

• not available in many databases

Abstract

• included by many secondary sources

• summary of article, usually created by authors or journal

• allows reader to have a better idea about article before reading

Process for Searching Secondary Literature

1. Develop research question

   1. See if tertiary literature can be used to answer any part of research question

2. Identify key concepts

3. Brainstorm synonyms and look up controlled vocabulary

4. Create search strategy for each concept using ORs

5. Combine search statements together using AND

6. Run search in selected database(s)

7. Review search results, examine results that fit topic and look for other terms to use, revise search strategy

8. apply limits if needed

9. record what you did in research notes

10. retrieve/request articles

Questions that can be answered using tertiary literature over secondary

• general information about a drug or condition

• well-documented, well-researched information

• guideline recommendations

• gold standard therapies

quicker to use in rush

Questions that can be answered by primary literature

• specific information

• new, novel drugs, conditions

• more experimental questions

can be more time-intensive

Things to consider when thinking of synonyms

• looking up controlled vocabulary may give ideas for synonyms

• articles in British english may have different spellings

• think about common acronyms

• include both generic and common brand names of drugs

• hypenated words

• words that can be one word or two separate word

• words spelled differently when singular vs plural

Boolean operator OR

• sensitivity

• increase results

• use to join concepts that are similar

• retrieves articles that contain any of concepts

Boolean operator AND

• precision

• narrows search

• join concepts that are different from one another

• tells database that articles should only be retrieved if both concepts are present

Boolean operator NOT

• exclude terms from search result

• use with extreme caution

• may exclude articles you need/want

Proper Parentheses Placement

• Each concept string should be within set of parentheses

• start with () and then add similar terms inside to ensure that right terms are ANDed and ORed

• ex. ((A1 OR A2) AND (B1 OR B2))

• Ex. (A1 OR A1) AND (B1 OR B2)

Quoted phrases

• use quotes to search for a group of words that have a unique meaning when together, such as “end of life” or “Stress reduction”

• may disable other search functions depending on database (PubMed)

Using advanced Search

• title: searches just article titles

• title/abstract: searches words from title or abstract of articles

• journal: articles from specific jounal

• look for search history or advanced search to combine searches together

Truncation

• usually * in most databases

• place asterisk at point in word where variation begins

• can cut down on how many synonyms you need to put in

• not recommended for pubmed

Filters

• help limit search results by date range, study type

• make note of filters to recreate search later

If you have too many results…

• narrow search by adding in more unique concepts

• go back to PICO to find more pieces of question

If you have too few results…

• Make sure you have all the articles by adding in synonyms

• expand question to be broader

If you have wrong results (wrong topics)

• test terms to find culprit and look at search details

• use filters/limits to focus on date range or article type

Health-Specific Secondary Literature to know

• CINAHL (nursing/allied health)

• Embase (like PubMed, has more subject headings and studies from other countries; more tools for searching by drugs, diseases, devices)

• PyschINFO (behavioral health, psychosocial, social sciences)

• PubMed (biomedical literature, life sciences, bioengineering)

General Secondary Literature to Know

• Scopus (Sciences, social sciences, health sciences)

• Web of Science (Biomedical, life sciences, social sciences, arts, humanities)

Construct evidence-based clinical questions with

• PICO (Population, Intervention, Comparison, Outcome)

• In [POPULATION], is. [INTERVENTION] more effective at [OUTCOME] than [COMPARISON]?

PICO: Population

• disease/condition to be treated

• special characteristics to be considered

PICO: Intervention

proposed new treatment

PICO: Comparison

standard treatment/nothing

PICO: Outcome

• how would you measure success?

• improvement in symptoms?

• reduced side-effects/risk?

Generally, when using secondary literature, one should

• avoid “natural language" searches

• use keywords

• add alternate words

5 A’s of Evidence-Based-Practice

• ASK an answerable question

• ACQUIRE the best evidence

• APPRAISE the evidence

• APPLY the evidence

• ASSESS the results

Evidence-Based Practice includes

• best available evidence

• clinical expertise

• patient preference

Where to find controlled vocabulary

• MeSH in PubMed, under Entry Terms

• Lexicomp, under Index Terms

• Emtree (Embase), unse synonyms

PICO terms best suited for search

Population and intervention