EBM Exam 2 -- Ch 8+9+10

What is the result in this PPAARE? "What is the highest level of evidence to determine whether an adult patient with insomnia who is a Hispanic male between 18 and 55 years of age is harmed by medication as compared to sleep hygiene education in terms of adverse effects, complications, interactions, costs, safety, tolerability, and adherence?"

"adverse effects, complications, interactions, costs, safety, tolerability, and adherence"

NNT

# of persons needed to be treated on avg to prevent one more EVENT NNT = 1/ARR (higher ARR = less NNT; lower ARR = more NNT)

NNH

# of persons needed to be treated on avg to produce one more AE NNH = 1/ARI

Tips on how to use your PSR wisely

-Ask your PSR questions regarding the product -Perform your timely independent research -Be aware of direct-to-consumer marketing -Know how to evaluate the package insert

What does the RED / authoritative personality provider makes decisions based on?

-BUSINESS-related DATA from peers -quick decision

What does the GREEN / process-oriented / scientific personality provider makes decisions based on?

-Hard facts -requires a significant presentation of STATS -wants to look over journal data -SLOW decision

what is the objective of prevention studies

-ID of prevention strategies -eval of prevention strategies/programs -efficacy of screening modalities -necessity for population screening

BLUE / amiable -- -sales approach? -sales technique?

-PT statements & positive images to show sick before vs healthy after -discuss before vs after to show better QOL for pts using the tx -offer viable stats, pt photos, glossy charts to tie in pt satisfaction & pos outcomes

Patient- and population-centered communication and approach to care

-Patient/Population and provider build a relationship -care is NEGOTIATED btwn both parties -Patient/Community plays an ACTIVE role in making informed decisions about care

why is the 5E model beneficial for learning?

-active learning is promoted over passive learning -enhanced collaboration -follows scientific inquiry approach to discovery

what is the Nat'l Health Education Standards (NHES)?

-articulate framework for promoting health at the personal, family, and community level for students in K-12 -establishes learning outcomes related to health for admin, teachers, and students

PSR basic professional requirements

-bachelors degree, 3.0 GPA -2 yrs sales experience -interview, background check

what are the benefits of health communication with patients and communities?

-developing health knowledge and skills -enhancing health decisions and actions -improve HC safety and quality -facilitating effectiveness/efficiency of HC delivery

GREEN / process-oriented / scientific -- -sales approach? -sales technique?

-discuss science -provider wants to know how the drug binds BETTER THAN COMPETITOR -show HOW p values & confidence intervals were calculated -provider will usually not trial a product until it has been safely on the market for MIN 2 yrs

pharma rep training

-home study in bio, chem, product marketplace -shadowing -selling practice

pharma payments to physicians

-lunch to office, fancy meals -good proportion of marketing funds goes to doctors -"reminder items" (mugs, pens, pt ed materials, etc) -moderately priced items under $100 -"expensive gifts" (research grants, honoraria for speaking engagements) -free samples, coupons

what are self management procedures

-monitor existing dz (ie BG levels) -take meds -other interventions to maintain/ improve a dz or condition -manage emotions that accompany the illness

what is the role/responsibility of practitioners in advocacy ?

-provide evidence to support their advocacy efforts -Ethical responsibility to engage in advocacy to improve health of pts / pops

What does the YELLOW / compassionate personality provider makes decisions based on?

-pt outcomes and feelings -SLOW decisions

RED / authoritative-- -sales approach? -sales technique?

-pts will be more satisfied w/ the drug aka LESS work for the provider -provide MD reports of higher pt satisfaction w/ this tx -shows clinical results WITH SOLID P VALUES -also shows references from respected leaders of the provider's peer group

What does the BLUE / amiable personality provider makes decisions based on?

-relationship btwn new products & EASE OF USE -quick decision

what are the benefits of health communication with practitioners from other health care disciplines?

-shared decision making -self-management resources based on individual needs -networks for social support -delivery of tailored health info -health literacy -interactions w vulnerable populations -access to web based and mobile health info

YELLOW / compassionate personality-- -sales approach? -sales technique?

-use a graph to illustrate how the SE profile is MORE favorable than competitor / gold standard -describe how this tx will benefit pts OVER other meds avail -presents glossy chart showing lower % SE d/t this tx's less-frequent dosing and ease of use

Elements of a Forest Plot

-vertical dashed line = null effect -squares = sample size and study outcome -horizontal line through square = study confidence interval -diamond = SUMMARY outcome and confidence interval (summary line)

what is 0-1 on the readiness ruler? what is 2-3 on the readiness ruler? what is the f/u question to ask?

0-1= I never think about eliminating an unhealthy behavior or engaging in a healthy behavior 1-2= I sometimes think about eliminating an unhealthy behavior or engaging in a healthy behavior when will you be ready to start considering a change?

IMPORTANT BIOSTATISTICS TERMS

1. Absolute Risk (AR), Increase (ARI), & Reduction (ARR) 2. Relative Risk (RR), Increase (RRI), and Reduction (RRR) 3. Number Needed to Treat (NNT) 4. Number Needed to Harm (NNH) 5. Number Needed to Screen (NNS) 6. Odds Ratio (OR) 7. Hazard Ratio (HR)

Considerations in Prevention

1. Alternative options 2. Standard of care tx, screening, or prevention strategy 3. Gold standard

What 2 things does the MEAN DIFFERENCE need in order to be STATISTICALLY significant (vs MCID)? (MCID= minimal clinically important difference)

1. BETWEEN confidence interval 2. does NOT include 0 ie. MD - 1.70; 95% CI -2.49 to -0.90 (=significant)

What 2 things does the RELATIVE RISK need in order to be STATISTICALLY significant (vs MCID)? (MCID= minimal clinically important difference)

1. BETWEEN confidence interval 2. does NOT include 1 or -1

what are the 3 communication strategies used in the evaluation phase?

1. Celebrate successes, focus on positive outcomes 2. Engage pt to set future goals or actions 3. Ask Qs to revise action plan

Criteria for Selecting or Developing pt ed materials

1. Content is specific to a target pop 2. Info is relevant to pt 3. Literacy level is appropr for pt's level 4. Plain language is used 5. Info presented is accurate & current 6. Format is conducive to reading or listening 7. Illustrations, pictures, & diagrams are provided to support info presented 8. Material is accessible to pt

what is the purpose of communication during the implementation phase? (4 things)

1. EDUCATE client on intervention(s) & self-care 2. Assist in creating a REALISTIC action plan 3. Help w/ strategies to improve ADHERENCE to intervention / action plan 4. Educate on F/U care

Considerations in Tx

1. Efficacy 2. Indications + C/I 3. Cost 4. Time 5. Administration 6. Dosage

NIH 5E Instructional Model

1. Engage 2. Explore 3. Explain 4. Elaborate 5. Evaluate

8 Interprofessional Communication Strategies

1. Establish communication guidelines 2. Interpersonal relationships (demonstrate respect / trust) 3. Understand/ appreciate unique roles / contributions 4. REGULAR COMM to establish team ID & SHARED GOALS 5. SHARE IDEAS & support innovation 6. Support mutual understanding of info 7. ACTIVE LISTENING + mindful of nonverbal 8. RESPECTFUL if conflict

what is the purpose of communication during the evaluation phase?

1. Evaluate outcomes (obj & subj) of tx or intervention 2. Evaluate pt's perspective on self-mgmt procedures 3. Assess adherence to action plan & revise

what is the purpose of communication during assessment phase?

1. Explore client's CC 2. Collect data on health status (review of health history, interview client, clinical exam) 3. Evaluate client's language and cultural influences 4. Evaluate client's health literacy level ▪ 5. Evaluate client's readiness to change and self-efficacy

Characteristics of Treatment studies (2 categories)

1. INTERVENTIONAL & prospective = TX of a diagnosed condition (ie case studies, case series, control trials, RCTs, cohort studies) 2. OBSERVATIONAL & prospective = determine OUTCOME of a pt w/ a diagnosed condition who is already receiving a specific tx (ie cohort studies, systematic reviews, meta-analysis)

Characteristics of Prevention studies

1. INTERVENTIONAL, prospective = PREVENT pts from developing a condition (ie case studies, case series, control trials, RCTs, cohort studies) 2. OBSERVATIONAL, prospective = determine whether pts develop a given condition (ie case studies, case series, cohort studies, systematic reviews, meta-analysis)

3 goals of Interprofessional Communication

1. Info shared btwn pt/ fam/community/team members to ensure SHARED UNDERSTANDING 2. COHESIVE COLLAB TEAM that incl pts + their families to provide comprehensive, high qual care 3. IMPROVE QOL for pts & populations

Characteristics of Harm studies (2 categories)

1. Observational, RETROSPECTIVE = ID harmful exposures (ie case control studies) 2. Observational, PROSPECTIVE = ID harmful exposures (ie cohort studies, systematic reviews, meta-analysis)

what are the communication strategies used in the planning phase? (6 things)

1. PLAIN LANG, NO med jargon 2. LISTEN 3. MINDFUL of pts' + families' needs / preferences 4. EMPATHY 5. Encourage pt Qs & allow adequate TIME for pt-provider interaction 6. RESPECT for pt's decisions

regarding health communication w/ decision-makers, what are 2 types of advocacy and an example of each?

1. Patient advocacy -ex = Correspond w/ insurance company to explain need for tx or med on behalf of a pt 2. Health policy advocacy -ex= Communication w/ legislators who vote on health policies

types of products marketed to HC organizations (NOT just meds!!)

1. Pharmaceuticals 2. Devices for diagnostics 3. Devices for tx 4. Biologics 5. Supplies 6. Training/ education resources

what is the purpose of communication during the planning phase?

1. Present assessment findings during case presentation 2. Explain intervention and self-management options 3. Describe associated benefits and risks of each option 4. Engage in Shared Decision-Making (SDM) to support pt-centered care by aligning pts' decisions w/ their preferences and what matters most to them and their families 5. Present treatment plan and gain informed consent

Traditional communication and approach to care

1. Provider = expert and MAKES DECISIONS about care 2. Patient = PASSIVE listener and complies w/ practitioner's recommendations

personality palette

1. RED = authoritative 2. BLUE = amiable 3. GREEN = process-oriented / scientific 4. YELLOW = compassionate

Considerations in Harm

1. Side-effects 2. Complications 3. Interactions 4. Adherence

Types of Focus Researchable Clinical Questions

1. Therapy/Tx Qs 2. Harm/Etiology Qs 3. Dx/DDx Qs 4. Prognostic Qs 5. Prevention Qs 6. Qualitative Qs

pt education can be applied in which 3 general aspects of care?

1. Treatment 2. Prevention (Primary, Secondary, Tertiary, Quaternary) 3. Harm

in what 5 situations do policies need to be created or improved through modification ?

1. Unmet health needs 2. Unfair distribution of health resources 3. Ineffective or non-enforcement of current policies 4. Harmful proposed policies or laws 5. Threatening conditions to public's health

what are the communication strategies used in the implementation phase?

1. Use plain lang targeted @ pt's health literacy level 2. mindful of culturally sensitive comm 3. interpreter for non-English speaking 4. HONEST comm to gain pt's trust & establish credibility 5. ACTIVE listening strategies 6. Ask Qs to assess pts' understanding of intervention / self-care procedures

what are the steps to creating pt education materials

1. assessment of target population & time/resources req 2. planning -- objective & content 3. pilot testing w target pop 4. evaluation of feedback from pilot 5. improvement to create final version

sales rep role / activities

1. basic professional requirements 2. pharma rep training 3. personality palette 4. performance eval

when creating pt education materials, what are the 3 types of objectives the practitioner can choose? (for a clear vision on WHY this material is being created)

1. cognitive = address change in knowledge 2. affective = state changes in attitudes or values 3. psychomotor = deal w changes to motor skills or other skills

3 pharma marketing goals towards the consumer

1. inform 2. remind 3. persuade

what are the communication strategies used in the assessment phase?

1. open-ended questions 2. Ask health literacy questions or use assessment tool 3. Use Readiness ruler and Self-efficacy ruler

what are the 5 stages of the transtheoretical model?

1. precontemplation 2. contemplation 3. preparation 4. action 5. maintenance

what are the 7 stages of the precaution adoption process?

1. pt unaware of health issue 2. pt gains awareness but is not engaged to change 3. pt realizes they need to make decision to take action or not 4. decision to not take action OR 5. decision to take action 6. acting 7. maintenance

what are the 2 things to provide evidence for in health policy?

1. that here IS a health problem 2. provide solution to problem by a health policy

what 6 components go into a health policy brief

1. title page 2. aim of the health policy change 3. problem 4. health policy options to solve the problem 5. recommendation 6. references

what is 7-8 on the readiness ruler? what is 9-10 on the readiness ruler? what is the f/u question to ask for 7-10?

7-8= i am already eliminating an unhealthy behavior or engaging in a healthy behavior 9-10= my behavior has changed to eliminate an unhealthy behavior or engage in a healthy behavior what is the main barrier to preventing you to change?

FDA Pregnancy Categories

A = no risk in 1st trimester B= risk unconfirmed in humans C= caution advised D = evidence of risk X= risk>benefit

what is Iatrogenesis

ADVERSE EFFECTS of preventive, diagnostic, therapeutic, surgical, & other medical, sanitary, & health procedures, interventions, or programs aka HCP harms pt

what is a key element for quality collaborative care?

Communication among interprofessional team members

what is a responsibility of health practitioners regarding health policy development?

Communication w/ decision-makers to advocate on behalf of clients

what is the hypothesis of a non-inferiority study? what is the null?

Experimental tx IS NOT inferior to current tx Null = Experimental tx IS inferior to current tx

what is the hypothesis of a equivalence study? what is the null? (Also called non-superiority studies)

Experimental tx IS equivalent to current tx Experimental tx IS NOT equivalent to current tx

what is the hypothesis of a Superiority study? what is the null?

Experimental tx IS significantly different than current tx null: Experimental tx IS NOT significantly different than current tx

what do these hazard ratios mean? HR > 1.0 ? HR = 1.0 ? HR < 1.0 ?

HR > 1.0 = GREATER hazard HR = 1.0 = EQUAL hazard HR < 1.0 = LESSER hazard (PREVENTATIVE !!)

what resource can be used to ASSESS a health problem?

Health Policy Analysis

What resources can be CREATED to educate decision makers?

Health Policy Brief, Fact Sheet, or letter/email

Hazard (HR) (--> SURVIVAL CURVE)

How often the AE occurs in 1 group compared to another group OVER TIME (ratio) HR = (ObsA / ExpA) / (ObsB / ExpB) Exp = expectation A = experimental/ exposed B = control/ non-exposed

Quaternary Prevention Studies aim to:

ID pts at risk of OVER-dx/ OVER-medication or EXCESSIVE medical intervention

Dichotomy of Industry and Consumer Needs

Industry= growth, jobs, profit consumer = reliability, access, safety

Statistically Significant Difference

MATHEMATICAL DIFFERENCE driven by variability, sample size, data type, etc

Minimum Clinically Important Difference (MCID)

MINIMUM threshold for Tx to be PERCEIVED AS BENEFICIAL by pts OUTCOMES THAT MATTER

Superiority diagram shows:

NEW/experimental tx IS significantly superior (favors new) OR NEW/experimental tx IS NOT significantly superior (bc overlaps "new & current identical" = not sig)

Medication Assistance Programs

Programs established by drug manufacturers and various other organizations to provide medications to qualified patients who are unable to afford their medications

Relative Risk (aka Risk Ratio) (based on PROBABILITY not odds)

RATIO of Experimental Event Rate (exposed) to Control group Event Rate (UNexposed) RR = EER/CER

odds ratio are a measure of association calculated in what type of studies?

RETROSPECTIVE studies (Studies of harm, Epidemiologic studies)

what do these risk ratios mean? RR > 1.0 ? RR = 1.0 ? RR <1.0 ?

RR > 1.0 = risk is INCR for experimental group RR = 1.0 = risk is EQUAL between groups RR <1.0 = risk is DECR for experimental group

Relative Risk Reduction (RRR)

RRR = CER - EER / CER negative RRR is actually a RRI !!!!

Odds (OR) (retrospective studies)

Ratio of odds of an event occurring in 1 group TO odds of event occurring in another group 𝐴𝐷 /𝐵𝐶

what are Health Policies

Regulations & laws that influence systems, communities, and individuals to promote health & control dzs

What does RESPECT stand for? (used in assessment phase of pt care)

Respect (ask ab) Explanatory model (ask ab) Social context (share) Power Empathy Trust

side effects vs complication

SE= unintended sx from tx, preventative, diagnostic, or screening procedures compl = unintended AEs (ie injury, death)

what are the steps in the SHARE approach to shared decision making?

Seek pt participation Help pts explore /compare tx options Assess pt values/preferences Reach decision w pt Evaluate pt decision

what types of measures can assess either outcomes that matter or surrogate outcomes?

Subjective OR objective A measure can be subjective & assess an outcome that matters. A measure can be objective (e.g., electro-cardiogram) & assess a surrogate.

Body Mass Index (BMI) Fasting Plasma Glucose HbA1c High Blood Pressure These are examples of what type of outcomes?

Surrogate

What 2 things have NO bearing on whether a measure represents an Outcome That Matters OR a Surrogate Outcome.

Tx efficacy and statistical significance

Treatment Algorithm

a decision chart that provides an outline of the tx process

efficacy

ability to produce the desired beneficial effect

secondary outcome measures

add'l endpoints that are evaluated but are not the specific focus of the intervention

FDA Adverse Event Reporting System (FAERS)

an online database administered by US FDA in which researchers report AEs, med errors, product quality complaints available to the public

What is numeracy?

application of numbers and measurement into daily tasks (ie med dosing)

what is the explanatory model?

asking open ended questions to help pts disclose their undderstanding of a dz and its progression

what is CDC's CHANGE Action Guide (Comm Health Assessment and Group Eval)

assess changes needed in policies, systems, and environment

NNS

avg # of persons who must undergo a screening test, followed by the diagnostic test & tx in order to prevent one CASE of the disease NNS = 1/ARR

what are Quick Response (QR) codes?

bar codes that can be scanned with a smartphone or tablet that leads to websites, online videos, phone #s, maps, other health info

what is the RESPECT model designed for?

build trust through comm & relationship strategies w/ the pt

what is health info technology

communication of health info through eHealth, mHealth, and uHealth technology

what is 4-6 on the self efficacy ruler?

confident in ability to make the change

what are Cultural Influences

customs, beliefs, and values specific to racial, ethnic, religious, social, or geographical populations impacting health

what is health literacy

degree to which individuals have capacity to obtain, process, and understand basic health info & services needed to make appropriate health decisions

non-inferiority study

demonstrate that an experimental tx is NOT substantially worse than a control tx

equivalence study

demonstrate that differences between control and experimental tx are not large in either direction (equivalence margin)

what are pt decision aids

designed to stimulate interaction btwn pt andd provider on options and benefits/risks for screening, meds, tx, and surgeries from an evidence based approach

off-label use

drug proves effective for a dz that differs from the one involved in original testing and FDA approval ex= Seroquel (Astra Zeneca drug) FDA appr for schizophrenia /BPD

primary outcome measures

endpoints intended to be directly impacted by the intervention

non-inferiority study diagram shows?

establishes non-inferiority (new tx is not worse than current tx) OR does NOT establish non-inferiority (bc overlaps "equivalence boundary")

clinical practice guidelines

evidence-based resources providing high qual evidence on clinical topics form current systematic reviews and original studies most useful when rated/graded related to strength of the recommendation and qual of evidence used to make the recs

what is the objective of harm studies

explore adverse consequences of tx or the natural progression of dz + harm c/b complications from interactions btwn tx

Nutraceutical

foodstuffs, incl items such as fortified food and dietary suppl, that confer health benefits as well as provide nutritional value Nutraceutical Sales Representative (NSR)

product labels and package inserts (PIs)

front label = main ingred, quantity, strength per dose back label = contents, full ingredients, fillers, allergens, potency of each, warnings, min/max dose PIs include info to use as guideline for proper use and prescribing of meds

mode of administration

how the tx reaches the target locations (ie absorbed through skin)

what is 4-6 on the readiness ruler? what is the f/u question to ask?

i have decided to eliminate an unhealthy behavior what are the benefits in changing?

Superiority study

is one tx superior to: -current/other tx -placebo -diff dose

what are 2 pt education websites designed specifically for consumers

medline plus healthfinder.gov

what is mHealth? what is uHealth?

mobile tech w/ smartphones ubiquitous tech using sensors to monitor health in real time

what is 7-9 on the self efficacy ruler? what is 10 on the self efficacy ruler?

moderately confident in ability to make the change extremely confident in ability to make the change

equivalence study diagram shows:

new tx and current tx ARE equivalent (overlaps equivalence margin = favors new AND current) OR new and current tx are NOT equivalent (does not overlap equiv margin = favors new OR current)

Supplements

non-food substances that provide nutrients NOT FDA approved

what is 0 on the self efficacy ruler? what is 1-3 on the self efficacy ruler?

not confident in ability to make the change slightly confident in ability to make the change

Samples

offer a trial amount of a product

Self-report of Excessive Urination Self-report of Nerve Pain Loss of vision d/t diabetic retinopathy Loss of toe(s) d/t peripheral artery dz Stroke Heart Attack These are examples of what type of outcomes?

outcomes that matter

what did the Institute of Medicine identify as a key factor in providing quality care?

patient-centered & population-centered approach to communication

Health Belief Model (developed in 1950s to influence individuals to take action to engage in healthy behaviors)

people who perceive their vulnerability to a dz and a threat to their health will take action to eliminate the vulnerability / prevent the threat

This is an example of what type of prevention? "An education session and materials are produced that encourage employees to maintain good sleep hygiene habits and educate them about sleep hygiene in order to prevent workers from developing insomnia."

primary

Therapeutics

procedures concerned with the remedial tx or prevention of dz

Primary Prevention Studies aim to:

reduce the INCIDENCE of dz (core task of Public Health)

Secondary Prevention Studies aim to:

reduce the PREVALENCE of dz by shortening the duration of disease

what is the objective of treatment studies

remedial tx in existing dz OR prevention of dz

This is an example of what type of prevention? "A screening program is instituted in the workplace to achieve early detection of sleep disturbances, such as insomnia, in order to reduce the duration of insomnia."

secondary

What is the action in this PPAARE? "What is the highest level of evidence available to determine whether an adult patient with insomnia who is a Hispanic male between 18 and 55 years of age benefits from sleep hygiene education as compared to medication treatment to produce a reduction in sleep onset latency as well as improved quality of life?"

sleep hygiene education

Tertiary Prevention Studies aim to:

soften the IMPACT of a long term dz by reducing associated disabilities

What is health communication?

study & use of communication strategies to inform & influence individual + community decisions that enhance health essential to health promotion + dz prevention/control

what is social cognitive theory

theory of behavior change emphasizes interactions btwn people & their environment -focuses on how we interpret & respond to external events

self efficacy ruler

to determine clients' self efficacy with making a behavior change

direct to consumer marketing

type of advertising presents an Rx drug as a medial solution and encourages viewers to ask their physician to order the medicine if appropriate

teach back method

used during implementation phase of care pts are asked to teach the procedure back to the practitioner by demonstrating the use of equipment or explaining medication dosing

what does this tell us: -PhRMA expends $25 billion dollars in one year to market medications... -employ 1 PSR for every 5 physicians... -one of the top five most profitable industries in the world...

very effective marketing strategies !!!

what does this mean? "The cost of health care is increasing in proportion to the increasing expenditures for prescription medications."

↑ HC cost = ↑ Rx cost ):