CAMLE Exam 1 Material

What are the types of biomedical literature?

primary, secondary, and tertiary

These are original research and reports

primary resources

primary resources are BOTH

published and unpublished

primary resources may include

-prospective research (such as randomized controlled trials)

-retrospective research (cohort studies, case series, and case reports)

What all are examples of primary resources?

-prospective trials

-retrospective research

-meta-analyses

-poster/podium presentations about original research

-professional meeting abstracts

randomized controlled trials (RCTs)

prospective trials

what all is included in retrospective research?

cohort studies, case control studies, case series, and case reports

What are the advantages of primary resources?

-new clinical findings (so we have the newest clinical findings, most up-to date)

-provide the most in-depth information

-can be utilized to tailor recommendations to a SPECIFIC PATIENT

-allow practitioners to evaluate the validty and applicability of study results

what are the disadvantages of primary resources?

-require strong literature evaluation skills to analyze and critique the study methodology to determine if results are valid and can be applied to current problem (can be really hard to get through, and difficult to read)

-often time consuming to accurately review

-may lead to misleading conclusions if poor quality study used without context of other research

-may require paid subscription

Which of the following is true about primary resources?

a) they are always high quality and can be applied to any patient

b) unpublished research is not considered a primary resource since it is not easily accessible

c) they provide a quick overview of a topic

d) require strong literature evaluation skills to use appropriately

d

These are searchable databases that enable location and retrieval or primary or tertiary resources

secondary resources

secondary resources will provide access to ______ and some ______ literature found in journals.

primary and some tertiary

various secondary resources may contain literature from different journals, meetings, publications, or other sources --> may need to search multiple secondary resources to ensure complete review of literature

ok

What are examples of secondary resources?

-PubMed

-CINAHL

-Ovoid Medline

-EBSCOhost

-dynamed

-google scholar

-clinical key

COPED GC

_____________ allow searches to be made more specific by using AND, OR, NOT

boolean operators

you can use boolean operators on any secondary resource

ok

Boolean ooperators will allow you to determine how your search is organized

ok

this boolean operator function combines two search terms, returns ONLY citations containing both concepts/terms

AND

this boolean operator combines any citations where EITHER search term is used

OR

using the "or" boolean operator will _______ the number of citations returned

increase

this boolean operator function will eliminate any reference with that term, use with caution

NOT

what are the advantages of secondary resources?

-quick and efficient method for finding primary and tertiary resources

what are disadvantages of secondary resources

-some require paid subscription

-different methods of tailoring search (boolean operators, filters)

-some databases use specific indexing terms --> if correct term not utilized in search, some references may not be included in search (example: MeSH terms)

many of these databases lack pharmacy specific indexing

These are resources that contain SUMMARIZED information to provide a quick and concise overview of a topic

tertiary resources

tertiary resources will synthesize information from other resoruces (may use primary and other tertiary literature)

ok

What are examples of tertiary resources

-textbooks

-systemic reviews

-review articles

-clinical practice guidelines (CPG)

-clinical drug references/compendia (clinical pharmacology, micromedex, lexidrug)

-uptodate

-epocrates

-drug package insert

what are the advantages of tertiary resources

-provide a general overview to quickly familiarize with a topic

-convenience; allow quick and efficient access to information

what are the disadvantages of tertiary resources

-difficult to keep updated, may contain outdated information

-some require paid subscription

-complete or detailed information may be lacking

-may be influenced by bias, incorrect interpretation of the information, or lac of expertise by the authors

original research, both published and unpublished

primary

searchable databases used to locate primary and tertiary literature

secondary

summarize information from other literature to provide and overview of a topic or draw conclusions about the evidence

tertiary

What are examples of alternative resoruces

-consumer health information

centers for disease control and prevention

- myhealthfinder.gov

-mayo clinic

-webmd

-news outlets

-blogs

bottom line for alternative resoruces: online web sources must be evaluated for accuracy, comprehensiveness, timeliness/recently updated

-council patients to take these type of resources with a grain of salt

ok

Which of the following is considered a secondary resource?

a) narrative review article

b) retrospective cohort study

c) google

d) google scholar

d

which of the following is considered a tertiary resource?

a) case series study

b) pubmed

c) systematic review

d) dynamed

c

What type of source is the following journal article: "Exectuve summary of the KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease"

a) primary

b) secondary

c) tertiary

d) alternative

c

which of the following would be most likely to provide the highest quality of evidence when answering a drug information question?

a) randomized clincal trial of sodium polystyrene sulfonate for the treatment of mild hyperkalemia in CKD

b)polysulfonate resins in hyperkalemia: a systematic review

c) medscape publication: don't give kayexalate with other oral drugs, FDA warns

d) prevalence of hyperkalemia in diabetic and nondiabetic patients with CKD: a nestsed case control study

A

prospective is the gold standard that we are looking for, best that you can have. So we want that "randomized" clinical trial.

when to choose a primary resource:

-answering drug information questions for a specific patient population

-answering questions for healthcare providers

-evaluating whether trials included in tertiary resources are applicable/high quality

-use of drugs for an off-label indication

when to choose a secondary resource

-starting a comprehensive literature search

-locating a primary resource

-locating a systematic review or review article

when to choose a tertiary resource

-answering a question from a consumer or patient

-identifying evidence based recommendations for specfiic disease states (CPGs)

-answering medication questions easily located in clinical drug references (dosing, mechanism of action, PK, etc)

You are on your acute care APPE rotation. A doctor asks you the MOA for acetazolamide, a diuretic, that your preceptor recommended for a patient. What type of resource would be most appropriate to answer the question?

a) primary

b) secondary

c) tertiary

d) just ask your preceptor

c

You are looking into the evidence for an off-label indication for a drug. Which resource would be the most likely to provide you information about this question?

a) the package insert

b) micromedex

c) a textbook

d) post-marketing research study

d

These are type of tertiary resources that provides a set of statements of recommendations based on a systematic review of evidence (primary and tertiary literature) regarding a specific topic

clinical practice guidelines

clinical practice guidelines will review potential risks and benefits of various management strategies (e.g. screening, diagnosis, interventions, etc) and provide

recommendations for or against use

clinical practice guidelines are generally develop by ___________ with an expert panel or multidiscinplinary healthcare providers

professional organizations

what is the purpose of clinical practice guidelines

-provide healthcare providers with a systematic aid to make complex medical decisions

-may be used to make decisions about reimbursement for therapies or services

-insurance determination of which medications to cover

-establishing hospital formularies

development of CPGs: should follow _________ approach that is described in methods section of CPG

systematic

development of CPGs: comprehensive literature search/systematic review

ok

development of CPGs: often significant time lag between _______ and _________ in CPG

research and inclusion

________ developed standards for evidence-based clinical practice guidelines

IOM

what does IOM stand for

institute of medicine

IOM: how many standards are there

8

Development and funding process of CPG should be publicly accessible

establishing transparency

COIs of all members of development group must be disclosed, whenever possible COIs should be avoided

management of conflict of interest (COI)

group should be multidisciplinary and balanced, encourage patient and public involvement

guideline development group composition

CPG developers should use systematic review standards from IOM

CPG and systematic review intersection

should provide clear reasoning for each recommendation including available evidence (and its quality). Must rate strength of recommendation and describe any differences in opinion

establishing evidence foundations for and rating strength of recommendations

recommendations should be articulated in a standardized format

articulation of recommendations

external review of CPG performed by relevant stakeholders

conduct an external review

plan for updating review should be documented in CPG, literature should be monitored regularly

establishment of a plan for guideline updates

CPG checklist

1. transparent development and funding process

2. management of conflicts of interest

3. multidisciplinary development group

4. utilizes systematic review of the literature based on IOM standards

5. has grading system for strength of recommendations and quality of evidence

6. Uses standard format for recommendations

7. external review by stakeholders

8. establishes plan for guideline updates

rating systems for quality of evidence and strength of recommendations may vary by guideline

grade system

grade system is most commonly used system for

rating quality of evidence and strength of recommendation

GRADE=

grading of recommendation, assessment, development, and evaluation

what is the process of GRADE

-authors of CPG perform systematic review to gather all available evidence

-for each outcome within the CPG, authors then rate quality of evidence as a whole

-GRADE system applied to describe certainty of quality of evidence

-once reviewing evidence, recommendations created and can be rated as strong or weak in favor or against an intervention

GRADE quality of evidence:

quality of evidence generally based on certainty that the conclusions of the studies are

true

there are ___ levels of evidence-may be titled differently based on guideline

4

what are the different grades

A, B, C, D/E

A:

certainty:

explanation:

type of evidence:

certainty: high

explanation: authors have a lot of confidence that the true effect is similar to estimated effect

type of evidence: well-conducted randomized controlled trials

B

certainty:

explanation:

type of evidence:

certainty: moderate

explanation: authors believe the true effect is probably close to estimated effect

type of evidence: well-conduced cohort or case control studies

C

certainty:

explanation:

type of evidence:

certainty: low

explanation: true effect may be markedly different from estimated effect

type of evidence: poorly conducted trials with methodological flaws, case series, and case reports

D/E

certainty:

explanation:

type of evidence:

certainty: very low

explanation: true effect is probably markedly different from estimated effect

type of evidence: expert opinion or clinical experience

What affects confidence in the evidence?

Increased certainty:

-RCTs

-large magnitude of effect

-clear dose response gradient

What affects confidence in the evidence?

Decreased certainty:

-observational studies

-higher risk of bias

-imprecision

-indirectness (surrogate vs hard outcomes)

-publication bias

once evidence is reviewed, recommendation created and

-direction of recommendation: for or against intervention

strength of recommendation: strong vs weak

Makes recommendations actionable

-weak recommendation may require

shared decision making with patient

strong recommendation suggests that

intervention can be implemented with high confidence.

________ statistics describes the characteristics of people and things, used to describe the characteristics of the study sample

descriptive statistics

can you use descriptive statistics to make comparisons between groups?

no!

_________ statistics makes inferences (aka predictions) about the characteristics of a large group based on data collected from a smaller group

inferential statistics

is inferential statistics a statistical model used to make comparisons between groups?

yes

anything that is measured or manipulated in a study

variables

variables include

independent, dependent, and control variables

a variable can be just about anything

ok

the variable hypothesized to explain an observed clinical phenomenon

independent variables

is the independent variable influenced by other variables in the model?

no

independent variable explains or predicts the values the _________ variable will take

dependent

example of independent variable: patient needs cough to go away.

Independent: cough suppressants in general

the cough suppressant is what controls the cough

ok

when we think about an independent variable, think about how it will explain something

ok

the variable the study investigator is trying to affect or whose variation they are trying to explain

dependent variable

the dependent variables are often called

outcomes

dependent variable is the OUTCOME that we are trying to change.

in our example, we are trying to get the cough to go away

ok

other variables that may be RELATED to the dependent variable/outcome

control variables

control variables have to be held ___________ between groups

constant

control variables have to be held constant between groups to ensure that...

the change in the dependent variable is due to the independent variable

if the control variables are not well controlled, can be called a

confounding variable

if the control variables are different, the outcome may not be because of the independent variable but instead maybe a control variable

ok

pollev: A study is investigating the effect of chocolate consumption on GPA in a cohort of P2 pharmacy students. Other information collected included hours spent studying, number of credit hours, and hair color. Identify the dependent variable:

GPA

pollev: A study is investigating the effect of chocolate consumption on GPA in a cohort of P2 pharmacy students. Other information collected included hours spent studying, number of credit hours, and hair color. Identify the independent variable

chocolate consumptoin

pollev: A study is investigating the effect of chocolate consumption on GPA in a cohort of P2 pharmacy students. Other information collected included hours spent studying, number of credit hours, and hair color. Identify the population we are studying?

P2 pharmacy students