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Block 3 > Prev Med > Flashcards

Prev Med Flashcards

1
Q

evidence based clinical practice vs medicine

A

clinician eval strength of evidence & use it in best clinical practice for pt vs incorporating clinical expertise, best external research evidence, & pt preferences

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2
Q

steps in evidence based clinical practice

A

1) ask focused question
2) find best evidence
3) appraise evidence validity & applicability
4) apply evidence to pt

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3
Q

focused clinical questions: PICOT

A

pt/problem = describe pt demographics, primary problem, coexisting conditions. intervention/prognostic factor/exposure = what do you want to do for pt?. comparison = are there alternatives to compare intervention to?. outcome = what do you hope to improve or accomplish?. time = what time interval is considered?

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4
Q

type of PICOT questions: dx/prevention vs therapy vs prognosis vs harm/etio w/ ideal study type

A

how to pick & interpret dx tests –> prospective, blind = gold standard, randomized trial, cross-sectional vs how to pick tx that does good > harm –> randomized ctrl trial, cohort vs how to estimate pt’s clinical course based on other interventions & dz complications –> cohort, case ctrl vs how to ID causes of dz –> cohort, case ctrl

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5
Q

what to think when appraise for evidence validity vs applicability

A

what were the results & were they valid/truthful? lg tx effect? bias? lg loss to f/u? equal & comparable groups? vs were study pts similar to my pop of interest? were all clinical outcomes considered? are likely txs worth potential harm/costs?

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6
Q

how to apply evidence to your pt

A

shared decision making approach –> integrate evidence w/ clinical expertise, consider pt’s goals & values, consider costs & AE, communicate, monitor results & outcomes

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7
Q

dz vs pt oriented evidence

A

pathophysiologic markers, labs, PE vs directly related to pts’ experience of their illness (mortality, morbidity, QOL)

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8
Q

statistical vs clinical significance

A

observed w/ trivial outcomes vs matter of judgment & depends on mag of effect being studied

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9
Q

narrative vs scoping vs systematic review vs meta analysis

A

comprehensive objective analysis of current knowledge on topic vs looks at emerging evidence & research while still unclear what other specific questions can be addressed vs high lvl overview of primary research on specific research question that identifies & eval all research evidence; method to combine individual studies vs quantitatively measure combined effect of all similar studies

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10
Q

study designs for systematic review

A

analytic studies (RCT, cohort, case ctrl), need to have measures of effect like RR, OR to compare groups, strong design & few flaws; don’t do descriptive studies (case report/series, cross sectional)

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11
Q

attributable risk vs relative risk. absolute risk reduction vs relative risk reduction

A

incidence in exposed minus incidence in unexposed vs compares incidence in exposed to incidence unexposed. excess risk b/w pts undergoing intervention & pts who aren’t (ie. how many pts = spared adverse outcome when taking tx) vs proportion of risk reduction by doing intervention. Lec 1, slides 23-24

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12
Q

number need to tx vs harm

A

of pts dr needs to tx to prevent 1 pt from having adverse outcome in predefined period; 1/ARR vs # of pts who need to be txed for 1 pt to experience adverse outcome in predefined period; 1/invARR. Lec 1, slide 25

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13
Q

what’s clinical research? device research?

A

determines safety & efficacy of meds, devices, diag products, txs intended for human use. determine mechanical fxn, safety, effectiveness & clinical utility of investigational device including biocompatibility, biodegradability, malfxn

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14
Q

class 1 vs 2 vs 3 medical devices. rigors of research required for device depends on?

A

cardiovasc, GI –> stethoscope, enema kit vs cardiovasc, neuro –> EKG, EEG vs ENT, OBGYN –> implantable prosthetics, IUD. class, risk, predicate of device

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15
Q

phase 1 vs 2 vs 3 vs 4 clinical trials

A

exptl drug/tx in sm group to eval tx safety, dose range & side effects vs exptl drug/tx in lg group to eval safety & efficacy vs exptl drug/tx given to lger group for safety, efficacy, side effects & compare to other txs vs FDA approved, post-marketing studies to find additional info on exptl drug/tx’s risks, benefits, best use

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16
Q

why do clinical trials? how to protect ourselves & pts during trials?

A

discover new txs for dzs; detect, dx, reduce chance of developing dz. document & train; clinical data management generates reliable statistically sound data; informed consent, Human Subjects Protection, IRB, FDA

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17
Q

adverse events vs serious AE/ADR vs unexpected ADR

A

unintended & unfavorable s/s torwards pt/subject when using exptl drug vs any dose resulting in death, life-threatening, requiring hosp, disability, congenital defect vs adverse rxn not consistent w/ applicable production formation

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18
Q

common rule of HHS vs IRB vs FDA

A

requires researchers get informed consent from volunteers –> give info about the study, risks, benefits vs ensure researchers follow HHS rules & ethical guidelines vs protects public health by ensuring safety & efficacy of drugs, bio products, med devices

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19
Q

corrective actions to resolve common issues: src documentation

A

orig place where data was recorded; hosp/clinic, EHR/charts/img/labs; memoranda, subjects’ diaries, evals, pharm dispensing records

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20
Q

corrective actions to resolve common issues: product accountability

A

investigational product = preventive, therapeutic, diagnostic or palliative product in clinical trial; can be used in un/approved forms. record investigation product that was used only in clinical trial for participants and adheres to protocol; chain of custody: PI = responsible for accurate accountability log

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21
Q

corrective actions to resolve common issues: consent. regulatory docs.

A

“concise & focused” informed consent document to give subjects info they need to make a decision to volunteer. signature logs, study personnel edu, monitor reports, financial disclosure

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22
Q

Good Clinical Practice

A

int’l ethical & scientific quality standard for designing, conducting, reporting trials that involve human subjects; compliance gives public assurance that rights & safety of pts = protected

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23
Q

how is GCP demonstrated?

A

study registration, GCP training for those involved in conducting trial, Human Subjects Research Training, IRB submission & approval

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24
Q

Good Laboratory Practice

A

guidelines governing process, organization, conditions of lab studies

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25
Q

community health research per NIH vs community based participatory research

A

addresses dzs & conditions disproportionately affecting community’s health; promotes collab b/w healthcare, scientists, & community leaders to facilitate research advances vs equitable, partnered approach to research involving community members, representatives, & researchers

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26
Q

health program vs community interventions

A

planned activities to accomplish specific health related goals vs small pervasive changes applied to subpop (more specific community)

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27
Q

health belief model vs social cog theory vs stages of change model vs theory of reasoned action vs social eco model

A

individuals’ perception of threat, health problem, benefit of avoiding threat, decision to act vs personal & environ factors & human behavior influence e/o vs individuals’ motivation to change problem behavior vs individuals toward behavior of ease or difficulty to change vs change behavior guided by social environ (mult lvls: individual, interpersonal, org, community, policy)

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28
Q

constructs of social cog theory

A

behavior, self-efficacy, expectations, observational learning, modeling, self-reg, rewards/reinforcement

29
Q

stages of change: cog vs behavioral stage

A

focus on beliefs, attitudes, motivation, thoughts; pre/contemplation vs assist pt to make & implement plan; prep, action, maintenance

30
Q

asmptns of stages of change model

A

pt behavior change happen over time thru seq of stages; most pts not prepared to act –> won’t be served effectively by traditional advice; specific counseling strats = emphasized at specific stages; nudge pt from stage to stage; relapse = nml part of change process

31
Q

theory of reasoned action

A

build intention to inc likelihood of behavior by influencing their attitude, perception, dis/approval, action

32
Q

how to promote healthy communities?

A

health edu to implement health promotion & dz prevention programs tailored to target pop

33
Q

program planning in community research

A
  1. social, epi, edu & eco, admin & policy assessment
  2. implementation
  3. process, impact, outcome eval
    Precede-Proceed Model: 1-4 = get info for planning decisions; 5-8 = detail program development, implementation, eval
34
Q

program eval: formative vs process vs outcome vs economic vs impact eval

A

use during developing new program or modifying existing program; see if proposed program = needed & accepted by target pop; useful for any needed mods vs use when starting program or existing program; see how well program is working, accessible, acceptable; gives early warning for problems vs use when made contact w/ 1+ target; see if there’s effect on target vs use when starting program or existing program; see what resrcs = used & there costs/outcomes vs use during existing program or end; see if program reached its main goal; for future funding & policy

35
Q

grounded theory vs ethnography vs phenomenology vs story telling vs focus group vs survey development vs community assessment

A

analysis & making theories of own data collection vs study ppl in their environ –> obs, face/face interview; classic ethnographic research vs reflecting one’s one XP vs shape life events into stories vs 6-8ppl talking abt topics guided by moderator vs match survey design w/ survey objectives; concept should reflect nominal, ordinal, interval or ratio-appropriate type of analysis; give info abt what’s impt to community –> narrows scope of public health project vs ID needs & priorities w/in community, can utilize above methods

36
Q

validity (accuracy) vs reliability (precision). know graph on Lec 4, slide 5

A

systematic error; degree to which data measures what it intends to measure vs nonsystematic/random error; when rpted measurements by diff ppl at diff times get similar results

37
Q

srcs of systematic error

A

selection bias, information bias, confounding

38
Q

what is bias?

A

any systematic error in design, conduct, analysis of study resuting in incorrect/invalid estimate of measure; pos –> overestimate findings, neg –> underestimate findings

39
Q

selection bias. can you fix it & how?

A

from procedures that have diff results from chosen subjects v from eligible ppl in pop; retrospective cohort, case ctrl. nope not during study –> use same criteria for selecting cases & ctrls, get all participants’ records, get high participation rates, take diag & referral patterns of dz

40
Q

selection bias: ctrl selection bias vs self selection bias vs differential selection bias vs loss to f/u bias

A

selecting inappropriate ctrl group vs refusal, nonresponse by pts to participate related to exposure & dz vs tendency to dx, hosp, refer pts differently based on exposure/dz status vs loss to f/u –> systematically diff pop from orig/target pop

41
Q

observation bias. can you fix it & how?

A

during collection of data or after participants entered study. blind interviewers

42
Q

observation bias: recall bias vs interview bias vs procedure bias vs observer expectancy bias

A

ppl who had AE = more likely to recall previous risk factors than ppl who never experienced it vs systematic diff in soliciting, recording, interpreting info vs subjects in diff groups = txed differently based on exposure and/or dz status vs researcher’s belief in efficacy of tx changes outcome of tx

43
Q

overall methods to minimize bias

A
  1. select dzed ctrl group
  2. design structured or self-administered questionnaire
  3. use mult biological measurements/markers
  4. mask interviewers & participants to study’s hypothesis
  5. use standardized methods of outcome
44
Q

criteria for confounding. pos vs neg confounding?

A

X = assoc w/ dz B, X = assoc w/ risk factor A, X = NOT a result of factor A. exaggerates true association vs hides true association

45
Q

design vs analysis phase for ctrlling confounding

A

group or individual matching on suspected confounding factor; restriction –> limit study subjects to those w/ certain characteristics (all young ppl, all men) vs stratification, standardization, adjustment

46
Q

effect modification

A

when 1 group = affected by a 3rd variable (kinda like confounding but that’s across all groups)

47
Q

association vs causation

A

statistical relationship b/w cause & effect; observed but doesn’t mean causation vs change in exposure –> corresponding change in outcome; inferred (ie. difficult to prove causal relationship in epidem)

48
Q

characteristics of cause

A

association, time/temporal relationship (must precede effect ie. event must precede dz or else dz wouldn’t have occurred), direction (asymm relationship b/w cause & effect; pos = presence induce dz, neg = absence induce dz)

49
Q

causal inference. 2 steps?

A

process of how epidemiologists determine causative & preventive dz factors.
1) is result valid & true?
2) assess whether exposure has actually caused dz

50
Q

what’s risk factor?

A

exposure, behavior, attribute that inc probability of dz

51
Q

sufficient cause vs component cause vs necessary cause

A

set of conditions w/o any 1 of which the dz would not have occurred (whole pie) vs any 1 set of conditions that’s necessary for completion of sufficient cause (piece of pie) vs a component cause that’s a member of q sufficient cause

52
Q

types of causal relationships: directly causal association vs indirectly causal association vs noncausal association

A

factor exert its effect in absence of intermediary factors vs factor exerts its effect thru intermediary factors vs relationship b/w 2 variables = stat sig but no causal relationship b/c temporal relationship = incorrect or another factor responsible for cause/effect

53
Q

causal “guidelines” for est causation per Sir Austin Bradford Hill

A

1) temporal relationship
2) strength of assoc
3) dose-response bio gradient
4) replication of findings
5) biologic plausibility
6) analogy
7) reversibility
8) consistency of findings
9) specificity of assoc

54
Q

which checklists are used to guide critique? describe abstract vs intro

A

CONSORT, PRISMA. succinct, accurate summary; context, obj, methods, results, conclusion vs sets up the question, context (researcher’s motivation, study’s contribution, clinical imptance), objective (goal, hypothesis, funding)

55
Q

describe methods 1: study type vs population

A

limitations of study type vs sample size (how it was determined), sampling procedure (recruitment & any selection bias), in/exclusion criteria, case v ctrl for comparability

56
Q

describe methods 2: data collection vs pt safety

A

primary exposure (minimize bias? when/where collected?), outcome (was it appropriately measured?), reduce confounding (randomization, restriction, matching) vs IRB, safety eval (pt safety monitored? when?), power analysis (ability to finding sig diff when real diff exists), statistical stability (p value, 95% CI), associations (rate/risk, RR, OR)

57
Q

describe results vs discussion vs conclusion

A

major results, strength of relationship; do results match what authors said? any new/unanticipated results? bias or confounding? drop out rates? vs address limitations, extrapolation, generalizability/external validity (does other lit dis/agree?), statistical v clinical sig vs implications supported by evidence in data, future research & policy recs

58
Q

cochrane library vs medline vs uptodate

A

systematic reviews, meta analyses vs national lib of med vs by physicians/for physicians, cont updated, peer-reviewed

59
Q

internal/comparability vs external validity/generalizability. effects of each?

A

extent to which study results = true for target pop; reflected by selection/randomization vs extent to which study results = applied to pop not involved. loss to f/u, lack of randomization vs loss to f/u, low response rate, narrow inclusion criteria

60
Q

sensitivity vs specificity. pos predictive value vs neg predictive value

A

rule out; true pos/(true pos + false neg) vs rule in: true neg/(false pos + true neg). probability of pos pt actually have dz; high = pt really has dz vs probability of neg pt actually doesn’t have dz; high = pt really doesn’t have dz

61
Q

what are ROC curves? what does the diagonal line mean?

A

explains relationship b/w sensitivity & specificity; X = 1-sens, Y = sens. relationship b/w true pos & false pos rates for useless test –> gives on additional info than what’s known before test was performed

62
Q

likelihood ratio. advantages? know the strength

A

describes performance of diag test –> probability of test result in ppl w/ dz/ w/o dz. for mult lvls & compared to other data, go beyond test as ab/nml, gather info for range of values, help choose diag test, help calculate post-test probabilities. Study Guide pg 24

63
Q

asmptn of independence

A

validity of final results depends on info in each test & independent from info of preceding test

64
Q

what other tests can we use for validity? –> parallel vs serial/sequential

A

perform several tests all at once and any pos = evidence for dz –> maximizes sensitivity & NPV vs perform several tests consecutively based on preceding results, ALL tests must be pos to rule in dx –> maximizes specificity & PPV

65
Q

define screening. indicate characteristics of good screening test

A

presumptive ID of unrecog dz thru rapid exams/tests/procedures –> ID asx ppl, early detection & tx; NOT a diag test. suitable dz (highly prevalent, progressive, effective tx at early stage), suitable test (simple, fast, cheap, safe), suitable screening program (using specific test on specific pop for specific dz –> reduce morbidity/mortality

66
Q

lead time vs length time vs overdx vs referral bias

A

screened pts live longer b/w dxed earlier in asx phase but time of true onset to death = same (ie. early detection does not mean inc survival) vs screening catches long preclinical periods but dz can have short or long periods vs when excitement of screening leads to more tests & positives –> false pos pts inappropriately impact survival rates vs pts seeking preventive care = healthier than pts who need attn for acute probs

67
Q

ethical considerations for screening

A

cross-cultural differences in health literacy & practices; geographic disparities (insurances, minorities); genetics screen (good for fetus/children; bad if costly/ins, stress, DNA ownership)

68
Q

o Upstream:
o Midstream:
o Downstream:
of community health research

A

-structural/societal determinations (redlining causing neighborhood SES inequality)
-intermediary determinants (need for parks, grocery stores, etc)
-medical intervention & providing care

69
Q

Rules of P’s & N’s

A

● Increased Prevalence = increased PPV , decreased NPV
● Increased specificity = increased PPV
● Decreased prevalence = increased NPV, decreased PPV
● Increased sensitivity = increased NPV

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