Health Care USA Chapter 12

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    Chapter 12

    Research: How Health

    Care Advances

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    CHAPTER OBJECTIVES

    Identify and dene dierent types ofresearch and contributions each makes tohealth and medicine

    Understand the origins and applications ofhealth services research

    Describe functions of the Agency forHealthcare Research & uality and ma!or"uality initiative areas

    Dene ne# $comparative eectivenessresearch% and describe the atient'

    (entered )utcomes Research Institute

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    Research Contr!"tons to#edcal Advances

    *ransition from dependenceon physicians+ clinical

    impressions and anecdotalreports to statistically validndings from controlledstudies

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    Research Interpretaton:Challen$es

    ,olume of reports in popular media-di.cult interpretation/ evaluation ofpotential human applications

    remature report of ndings

    0ensationalism of minor scienticadvances

    1raud

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    T%pes o& Research

    2asic 0cience 3biomedical4

    (linical

    5pidemiological Health 0ervices

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    Basc Scence Research

    2iochemists/ physiologists/geneticists/ pharmacologists

    6uch at cellular level

    Antecedent to clinical advances

    Understanding of gro#th/development/ structures andfunctions of human body andresponse to stimuli

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    Clncal Research

    1ocus on steps in medical careprocess- diagnosis/ treatment/rehabilitation/ palliation

    6uch is e7perimental usingcontrolled clinical trials

    (onducted by all ma!or disciplines-medicine/ nursing/ health relatedprofessions

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    Clncal Trals

    *est ne# treatments/ drugs/ medicaldevices against prevailing standardof care

    6ay use control groups to minimi8esub!ect bias

    Random selection of treatment &control group members furtherreduces bias

    Double'blinded/ placebo controls

    are most rigorous

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    Sa&e$"ards Protectn$Vol"nteer S"!'ects

    eer revie# committees to !udgescientic merit

    Institutional Revie# 2oards revie#ethical considerations

    Informed consents detail- potentialrisks/ side eects/ e7pected benets

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    Epde(olo$% )1*

    5pidemiology 3population4 research-distribution & determinants of health/diseases/ in!uries in human

    populations9 6uch is observational3descriptive or analytical4- (ollects information about natural

    phenomena/ characteristics/ behaviorsof people/ peoples+ locations &environments/ e7posures tocircumstances or events

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    Epde(olo$%:+escrptve St"des Use patient records/ intervie#

    surveys/ databases/ other informationto identify factors determining

    distribution of health and diseaseamong specic populations

    Relatively fast/ ine7pensive: may

    suggest hypotheses or raise"uestions for future study

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    Epde(olo$%: Anal%tcSt"des Under naturally occurring conditions/

    to observe dierences bet#een t#oor more populations #ith dierent

    characteristics or behaviors

    *ry to e7plain biologic phenomena bystatistical association bet#een

    factors that may contribute to asubse"uent occurrence

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    Epde(olo$%: Anal%tc St"d%E,a(ples

    Data about smokers and non'smokersto determine relative risk of anoutcome such as lung cancer

    (ohort studies such as 1raminghamfollo# a cohort to determineassociations among variables such as

    diet/ #eight/ e7ercise and otherbehaviors related to heart diseaseand other outcomes

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    E,per(entalEpde(olo$% )ften follo# analytic studies: most rigorous

    Investigator actively intervenes bymanipulating one variable to observe

    eect on other: control populations ensurethat other/ non'e7perimental variables donot aect outcomes9

    *echnically di.cult

    5thical concerns- unkno#n risks: #ithholdingpotentially benecial drug or treatment amongcontrols

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    Other Applcatons o&Epde(olo$cal #ethods

    Health services planning/ administrationand evaluation

    1orecasting population group health needs

    Assess ade"uacy of health personnel supply Determine outcomes of specic treatments

    in clinical settings

    0tatistical computing advances enableanalysis/ interpretation from massive 3e9g96edicare4 data bases

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    Health Servces Research)1* 6edicare/ 6edicaid/ other subsidy

    programs drove development of H0R

    Revealed cost/ utili8ation data/

    variations in "uality/ indecision/confusion about eective treatments

    need to improve e.ciency/eectiveness of health care & determine#hich treatment options produce bestoutcomes for specic conditions

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    Health Servces Research)2* (ombines perspectives & methods of

    epidemiology/ sociology/ economics& clinical medicine

    Uses process & outcome measuresre;ecting behavioral and economicvariables associated #ith therapeutic

    eectiveness and cost benet

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    Health Servces Research)-* Agency for Health (are olicy &

    Research 3AH(R4- est9 = in U0ublic Health 0ervice/ Department of

    HH0

    Response to ?ennberg studies onclinical variations: promoted

    development of clinically relevantguidelines to assist health carepractitioners in prevention/

    diagnosis/ treatment

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    A$enc% &or Healthcare Polc%and Research. 1/0/1//

    #edcal Treat(ent E3ectvenessPro$ra(:

    identied and analy8ed patient outcomes

    associated #ith alternative practicepatterns and recommended changesthrough patient outcomes researchteams & literature synthesis pro!ects3meta'analyses4

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    Healthcare Research and4"alt% Act o& 1///

    Rena(ed AHCPR to A$enc% &orHealthcare Research 5 4"alt%)AHR4*6 #sson:

    Improve outcomes & "uality ofhealth care services

    Reduce costs

    Address patient safety

    Increase service eectivenessthrough research to promoteclinical & systems improvements /

    disease prevention

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    AHR4 Toda%

    *op priority- providing research ndings& ne# health information to create andensure evidence'base for practice

    guidelines 3

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    Health Servces Research andHealth Polc%

    (ontributions of H0R to olicy

    ?ennberg studies of small areavariation in medical utili8ation

    rospective payment based on DRCs

    Research on inappropriate medicalprocedures

    Resource'based 6D payments

    (oncepts of H6)s and managed care

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    4"alt% I(prove(ent )1*

    5vidence'based clinical "ualityrevie# evolved in Bs follo#ing rior $peer revie#% relied on factual

    kno#ledge and ine7plicable !udgment/intuition of individual physicians aboutindividual patients

    uality assurance focused one7ceptionally poor care/ $bad apples9%uality dened as $absence of mishap/%oensive to physicians/ ineective

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    4"alt% I(prove(ent )2*

    As early as

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    4"alt% I(prove(ent )-*

    *o assess health care practice "uality/early landmark studies used implicit &e7plicit normative or !udgmental

    standards Implicit standards rely on internali8ed!udgments of e7perts

    57plicit standards developed and agreedon in advance of "uality assessment:minimi8e variation & bias resulting frominternali8ed !udgments

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    4"alt% I(prove(ent: E(prcalStandards

    Derived from distributions/ averages/ranges & other measures of datavariability: compare data collected

    from many similar health serviceproviders to identify practicesdeviating from a norm: 59g9/6edicare+s $Hospital (ompare:%

    state'based severity'ad!ustedcardiovascular surgery outcomes byphysician

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    4"alt% I(prove(ent:EvdenceBased #edcne

    $0ystematic application of best availableevidence to evaluate options & decisionsin clinical practice & management9%

    ,ariability in clinical practice/ testcomple7ity/ di.culty in staying current/suggest many clinical decisions notsupported by evidence of eectiveness

    *oday/ cost'control pressures andoutcomes emphasis are stimulatingevidence'based approaches

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    4"alt% I(prove(ent )*

    6edical errors- /BBB hospital patients died annually

    from medical errors: (ongress fundedAHR funded for focus on patient safety

    BBE- atient 0afety and uality

    Improvement Act- est9 atient 0afety)rgani8ations to encourage voluntaryreporting & remediation of risks

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    4"alt% I(prove(ent )7*

    5vidence'based medicine- $0ystematicapplication of best available evidence toevaluate options & decisions in clinicalpractice & management9%

    ,ariability in clinical practice/ testcomple7ity/ di.culty in staying current/suggest many clinical decisions notsupported by evidence of eectiveness

    *oday/ cost'control pressures and outcomesemphasis are stimulating evidence'basedapproaches

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    4"alt% I(prove(ent )0*

    5vidence based medicine/ $cont+d 52 approach considers evidence from

    large/ randomi8ed clinical trials valid:

    dismisses outcomes research usinglarge data les created from insuranceclaims records or other sources becausesub!ects are not randomi8ed9

    $)utcomes research using claims data ise7cellent 99to nd out #hat doctors aredoing/ but Fterrible #ay to nd out

    #hat they should be doing%

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    4"alt% I(prove(ent: O"tco(esResearch

    5valuates health care results in real #orld ofmedical o.ces/ hospitals/ clinics/ homes

    (ontrasts #ith studies of treatments in

    controlled environments uestions !ustication of treatment costs for

    health/ #ell'being of patients/ population

    Insurers/ government/ employers/ consumers

    seek outcomes information to make betterdecisions

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    4"alt% I(prove(ent:O"tco(es Research

    Denes health status in measures ofpatient functional status/ #ell'being/satisfaction #ith care/ not only laboratory

    ndings/ recovery and survival rates- hysical functioning

    Role functioning- health interference #ithactivity

    0ocial functioning- health eects onnormal social activities

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    Co(paratve E3ectvenessResearch )CER*

    ARRA of BB=- G

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    Co(paratve E3ectvenessResearch )CER*

    A(A of B

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    4"alt% I(prove(ent)1-* atient satisfaction- uality perceived by

    patients derives from sub!ective criteriadierent from providers+

    (ompetitive market climate- increasesresearch importance of providercharacteristics/ systems/ communication/facilities and other factors

    6easurement instruments- self'administeredsurveys/ phone intervie#s identify positiveand negative patient perceptions useful forimprovement strategies/ marketing

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    Research Ethcs

    riorities and prot motives driveremedial/ at the e7pense ofpreventive research*a7payer supported research on ne#

    technologies focused on amelioratingdisease- benets for medicine vs9

    community at large ()RI focus on all stakeholders #ith

    ma!or voice of consumers has potentialto shift focus to#ard greater community

    benet9

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    Con8cts o& Interest nResearch Research funding shifted from academic

    institutions to pharmaceutical andmedical device companies creates

    potential for biased ndings olitical/ pharmaceutical manufacturers+

    in;uences result in clinical trial ndingsheld as $trade secrets/% impeding public

    reports on safety and e.cacy $Chost#ritten% publications by medical

    school professors

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    9"t"re Challen$es )1*

    e# focus on dening and improvinghealth of population groups shiftsresearch priorities solely focused on

    disease diagnosis and treatments A(A initiatives such as the ()RI #ill

    re"uire changes in provider behaviors/

    acceptance of ne# information/ ne#reimbursement methods/ ne#resources for information dissemination

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    9"t"re Challen$es )2*

    5thical/ legal/ economic/ religious/professional dilemmas may arise as 2asic science research in genomics

    yields positive breakthroughs (linical advances continue in areas such

    as life'prolonging technology and organ

    transplantation Health services research identies more

    issues in the e"uity of healthcaredistribution and access in the reformed

    system

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    9"t"re Challen$es )-*

    ublic health research must befunded to use the scope of itsdisciplines #ith epidemiology as the

    core/ to increase understanding ofdierences among populations+health/ health behaviors/ health care

    and health systems9