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1 근거중심의학소개 Evidence-Based Medicine 고려대의대예방의학교실 안형식

2 근거중심의학의발전과정 McMaster 의과대학임상역학, PBL 논문비평 (critical appraisal) 로시작 Sackett, Haynes 등이기여 년대에 CMAJ, JAMA 시리즈 ; 비판적문헌평가와근거의강도에 (A,B,C,D,E.) 의해분류하는방법전개.

3 발전과정 비판적평가 의개념 환자의최적진료를위해비판적평가로부터나온정보를사용 EBM 으로발전 영국 NHS 등에서의료체계발전의주요목표와방법으로채택 Evidence-based health care, nursing, mental health, clinical practice

6 의학지식의발전속도 무작위임상시험의증가

7 의료행위의과학적근거에대한접근 Cochrane, Kerr White(1976) ; 의료서비스의 15% 만이과학적근거가있음 Smith(BMJ editor 1991) ; 15% OTA, NIH 의조사 ; 10-21% 진료의과학적근거에대한실증적연구 의료의질적수준과비용문제에대한관심

Much of Care Today is Not Based on Scientific Evidence Less than 20% of AHA/ACC heart disease management recommendations are based on a high level of evidence and over 40% are based on

8 Much of Care Today is Not Based on Scientific Evidence Less than 20% of AHA/ACC heart disease management recommendations are based on a high level of evidence and over 40% are based on the lowest level of evidence AND proportion of recommendations with high evidence levels has not increased over time Robert Califf, IOM Meeting on Evidence-based Medicine, December 2007

9 근거와실제의료와의차이 1954 년담배와폐암과의관련성논문 1965 년경고문 ( 미국 ) 1978 년경고문시작 1996 년건강증진법 1997 년담뱃값인상

10 근거와실제의료와의차이 암검진률 당뇨병 / 고혈압추적관리 심장질환의예방 천식환자의흡입스테로이드사용 외과영역의예방적항생제사용

11 의사연령별 ICS 처방률 (%) 대 40대 (88,501) (101,628) 50대 (21,631) 60 대 (4,836) 대이상 (2,147) 흡입 / 전체 흡입 / 스테로이드

12 Publication to Implementation Antman EM, Lau J, Kupelnick B, Mosteller F, and Chalmers TC.JAMA, 268:240-8, 1992

13 논문출판후진료적용까지의시간 thrombolytic therapy : 13 년 태아폐성숙촉진을위한코티코스테로이드적용 : 10 년

14 의과대학졸업년도와의학지식수준 R = -o.54 최신고혈압치료에대한지식수준 P < 의과대학졸업이후시간 ( 년 )

15 의학지식을얻는정보원 % n=712

16 의사의의학지식습득 제약회사판촉 약품광고 연수교육 동료조언 교과서 문헌의참조 많은시간, 노력기억소요

17 CME 의효과? Davis D A, et al. 의사퍼포먼스의변화. CME 의효과에대한체계적고찰. JAMA 1995; 274: Sibley J C. CME 효과에대한무작위연구. N Engl J Med 1982; 306: 결론 : 전통적인 CME 는의사의행동변화를가져오는데전혀효과가없음.

18 지식과실제진료와의차이 Evidence Practice Gap Gap 근거지식 실제진료

19 근거중심의학 ; 정의 가장좋은최신의근거를 (current best evidence) 공정하고, 명백하고현명하게사용하여 (conscientious, explicit and judicious use) 개개의환자에대한의사결정을하는것 (in making decision about care of individual patients)

20 EBM 문헌수 EBM 문헌의증가 Year

21 EBM 의세가지접근 의사스스로근거중심의학의방법론습득 검토된근거중심의이차문헌생성 근거중심의체계적분석과진료지침

22 EBM 방법론 - 문헌평가과정 1. 질문만들기 : PICO 2. 근거검색 3. 근거에대한비판적평가 * 타당도 * 효과 ( 편익의크기 ) * 적용성 4. 임상적판단과환자의가치의통합 5. 효과와효율의평가 * 기록의유지 : 과정의향상

23 Medline 에서 RCT 를찾는검색전략 (Cochrane HSSS ; Highly Sensitive Search Strategy)

24 타당성 - 문헌평가 타당도 ; 연구결과는사실과가까운가? 체계적오류 (systematic bias) 는없는가? 치료진단고찰 RCT? 추적관찰? 맹검 비교? 방법론?

25 치료문헌의평가기준 임상시험의결과는타당한가? 1. 치료에대한환자배정은무작위적이며무작위배정표는비밀이었는가? 2. 환자에대한추적관찰은충분히길고완전한가? 3. 환자는모두애초에무작위배정된군에따라분석되었는가? 4. 이중맹검법이시행되었는가? 5. 각군은시험의대상이되는치료법외에는모든측면에서동일하게취급되었는가? 6. 각군은임상시험의시작단계에서는유사하였는가? 해당연구의타당성있는결과가임상적으로중요한가? 1. 치료효과는어느정도인가? 2. 치료효과에대한추정은얼마나정밀한가?

27 근거수준의평가 수준내용 여러가지의잘설계된무작위임상시험의결과에대한 하나이상의체계적인고찰에서얻어진강력한근거 하나이상의적절하게설계된무작위임상시험의결과에서얻어진강력한근거 잘설계된무작위할당이없는임상시험, 단일군의사전 - 사후연구, 코호트연구, 시계열혹은짝지은환자대조군연구에서얻어진근거 하나이상의대상군이나연구단위에서시행된잘설계된비실험적연구에서얻어진근거 임상적근거에기초한존경받는권위자의의견, 기술적연구혹은전문가위원회의보고

28 무작위배정의이점 1. 무작위배정 : 대상자를무작위번호에따라 치료군 / 비치료군으로할당함 2. 잠재적교란변수의최소화 : 연구그룹간알려진것과알려지지않은교란변수들의균등배분

29 A Brief History of Hormone Therapy 1942: FDA approved Estrogen for treatment of menopausal symptoms Prescriptions (Millions) Observational Studies suggest Benefits > Risks E associated with fewer fractures; higher BMD OCs associated with E associated with lower blood clots, heart attacks E associated CHD E associated with Feminine with uterine higher breast cancer forever cancer E+P 2000: Br CA CEE in men: blood Progestins lower E+P > E clots, heart attacks protect uterus CHD only ESTROGEN PROGESTIN : PEPI E vs E+P 1997: HERS- E+P blood clots 1998: HERS 1 st yr = heart attacks; no 4yr benefit 2001: AHA position

30 National Institutes of Health National Heart, Lung, and Blood Institute Women s Health Initiative (WHI) Clinical Trials and Observational Study Presentations by WHI Principal Investigators

31 Oestrogen + progestin 의예방효과, 1992 ( WHI 및 HERS 연구이전 ) Oestrogen + progestin versus usual care

32 Oestrogen + progestin 의예방효과 ( WHI 및 HERS 연구이후 )

33 관찰연구의결과가 RCT 에서입증 되지않은경우 뇌말라리아에서 dexamethasone 의효과 허혈성뇌졸중에서 EC/IC 우회수술 척추골절에서 NaF 의효과 폐경기여성에서에스트로젠투여 (ERT) 가관상동맥질환위험성감소 당뇨병을가진고혈압환자에서이뇨제투여의효과

34 RCT 에서입증된치료 심장질환과 Statin 고혈압환자의장기약물복용과장기적인합병증 대장암, 자궁경부암등일부질환의조기암검진 당뇨환자의혈당강하와합병증 (?)

35 RCT 를통한검증영역의확대 보건교육 보험료본인부담율 공중보건

36 의료서비스의과학적근거 질문 근거중심의료를가능하게주요요인? 요인 양질의연구의존재여부?

37 외국근거의국내적용가능성 주요한건강문제에대한국가간, 민족간차이. 외국과상이한문화적, 제도적으로차이 외국의고찰에는국내연구반영되지않아국내에축적된자료를적용하지못함. 국내에직접적용에한계점을가짐.

38 국가별 Systematic Review 발표수 (2004) UK US Australia Canada Netherlands New Zealand Germany 0% 5% 10% 15% 20% 25% 30%

39 문제점 모든질환에대하여같은비중의 RCT 와 SR 이존재하는것이다.

40 1) 질환 ; 암종별 Systematic Review 수 Systemic Review Stomach Colorectal Breast Cervix

41 1) 질환 ; 암종별 RCT 수 (SR 에인용된것 ) 30,000 25,000 20,000 25,915 20,558 15,000 11,639 Count Clinical tial 10,000 8,340 5, ,882 3, Stomach Colorectal Breast Cervix

42 1) 질환과 SR 수와질병부담과의관계 Number of published systematic reviews and global burden of disease: database analysis; George H Swingler, Jimmy Volmink, John P A Ioannidis; BMJ VOLUME NOVEMBER 2003 bmj.com

43 3) 연구의질개발도상국에서출간된 RCT 의질적인수준 Number, topic and quality of RCTs published Random allocation 51% (435) Quasi-random methods of allocation 49% (423) Concealment of treatment allocation 46% (200) Blinding of observers assessing outcomes 28% (123) All the allocated test subjects 28% (123) The follow-up period was more than 1year 4% (17) Less than 6 days 16% (71) Randomised trials in the South African Medical Journal, ; Pienaar ED, Volmink J, Zwarenstein M, Swingler GH.; S Afr Med J 2002; 92:

44 연구생성과활용의국가간, 지역간 문화간차이 ( 별 )? There are cultural and geographical bias in the availability and relevance of published health literature

46 체계적분석 (systematic review) 체계적인문헌수집 엄격한문헌평가방법론 대개메타분석시행 종합추정치 (pooled estimate) 제시

47 MI 환자에게 Beta blocker 를투여하 여심부전을예방할수있는가? 1981 년도문헌검색

48 We conclude that long-term treatment with timolol in patients surviving acute myocardial infarction reduces mortality and the rate of reinfarction. The Norwegian Multicentre Study Group 개별임상시험결론 The mortality and hospital readmission rates were not significantly different in the two groups. Repnolds and Whitlock Until the results of further trials are reported long-term beta-adrenoceptor blockade is recommended after uncomplicated anterior myocardial infarction. Multicentre International Study The trial was designed a 50% reduction in mortality and this was not shown. The nonfatal reinfarction rate was similar in both groups. Baber et al

49 종설 (Review) 결론 It seems perfectly reasonable to treat patients who have survived an infarction with timolol. European Heart Journal (1981) We still have no clear evidence that beta-blockers improve long-term survival after infarction despite almost 20 years of clinical trials. BMJ (1981)

50 서술형고찰 (narrative review) 문헌수집과정이주관적 (49/50 가수집과정기술안됨 Murrow) 체계적문헌평가과정없음 문헌의숫자계산 ; 표본수, 효과크기, 연구설계등이반영안됨 저자의주관적판단 - 오류의가능성

51 체계적분석 (systematic review) 체계적인문헌수집 엄격한문헌평가방법론 대개메타분석시행 종합추정치 (pooled estimate) 제시

52 beta blocker for myocardial infarction

53 P<0.05

Archie Cochrane(1909-1988) Effectiveness and Efficiency ; 의료의과학적근거의중요성 RCT 자료통합의중요성강조 It is surely a great criticism of our profession that we

55 Archie Cochrane( ) Effectiveness and Efficiency ; 의료의과학적근거의중요성 RCT 자료통합의중요성강조 It is surely a great criticism of our profession that we have not organised a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomised controlled trials. (1979)

56 Cochrane Systematic Reviews (1022; another 500 in preparation) Database of Abstracts of Reviews of Effectiveness (1895) Registry of Randomised Controlled Trials (218,355)

59 ~3800 reviews ~1900 protocols CENTRAL ~575,000 trials

61 진료지침 ; 정의 특정임상상황에서 적절한의료서비스를행하기위하여 의료제공자와환자의결정을돕기위해 체계적으로개발된도구 Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances

62 근거수준의평가 수준내용 여러가지의잘설계된무작위임상시험의결과에대한 하나이상의체계적인고찰에서얻어진강력한근거 하나이상의적절하게설계된무작위임상시험의결과에서얻어진강력한근거 잘설계된무작위할당이없는임상시험, 단일군의사전 - 사후연구, 코호트연구, 시계열혹은짝지은환자대조군연구에서얻어진근거 하나이상의대상군이나연구단위에서시행된잘설계된비실험적연구에서얻어진근거 임상적근거에기초한존경받는권위자의의견, 기술적연구혹은전문가위원회의보고

63 권고의등급 수준내용 A B C D E 임상의사가환자에게서비스를제공할것을강력하게추천 임상의사가환자에게서비스를제공할것을추천 임상의사가환자에게서비스를제공할것을추천하지않음 임상의사가증상이없는환자에게서비스를제공하지않도록추천 임상의사가환자에게서비스를제공하지않도록추천하거나추천의근거가불충분하다는결론을내린다. USPSTF 의추천

Secretariat, DK Finnish Medical Society Duodecim, FIN Finnish Office for HTA FINOHTA, FIN French Nat.Agency for Accred.

64 J.Briggs Inst.for Evid.Based Nursing&Midwifery, AUS National Institute of Clinical Studies NICS, AUS Austrian Ass.for Quality in Healthcare, A Belgian Center for Evidence based Medicine, B Flemish College of General Practitioners, B Program in Evidence-based Care, Cancer Care Ontario, CDN Danish Guidelines Secretariat, DK Finnish Medical Society Duodecim, FIN Finnish Office for HTA FINOHTA, FIN French Nat.Agency for Accred., Eval in Healthcare ANAES, F French National Federation of Cancer Research Centres, F German Association of Scientific Medical Societies AWMF, D Berlin Chamber of Physicians, D German Agency for Quality in Medicine Ä ZQ, D Royal College of Surgeons in Ireland RCSI, IRL Iceland Directorate of Health, ISL Italian Evidence-Based Medicine Group GIMBE, I Regional Health Agency Emilia-Romagna, I Malaysian Ministry of Health, MAL New Zealand Accident Compensation Corporation, NZ New Zealand Guidelines Group, NZ Norwegian Directorate for Health and Social Affairs, NO Polish Institute for EbM, PL Polish Soc.for Quality Promotion in Healthcare, PL Portuguese Institute for Quality in Healthcare, POR Slovene Guidelines Group, SLO Basque HTA Office OSTEBA, E Josep Laporte Library Foundation, Barcelona, E Swedish Board of Health and Welfare (Socialstyrelsen), S Clinical Epidemiology Center Lausanne, CH Swiss Medical Association FMH, CH Dutch Association of Comprehensive Cancer Centres, NL Dutch College of General Practitioners, NL Dutch Institute for Healthcare Improvement CBO, NL National Institute for Clinical Excellence NICE, UK Centre for Reviews & Dissemination York, UK Scottish Intercollegiate Guidelines Network, UK Sowerby Centre for Health Informatics at Newcastle, UK Agency for Health Research & Quality AHRQ, USA National Kidney Foundation, USA AGREE Collaboration, INT World Health Organisation Geneva WHO, INT Membership April 2003

67 양질의진료지침 근거중심적개발방법 진료결과향상 실행및보급가능성

68 근거중심진료지침의조건 체계적인문헌수집 엄격한문헌평가방법론 양적, 객관적인결과종합 - 메타분석, 추정치등 일정기준에따른권고제시

69 Adaptation ( 수용개정, 개작 ) 특정나라나조직의기존지침을지역상황에맞게적용하거나활용함 진료지침신규개발 (de Novo) 대신, 기존의진료지침을지역상황에맞게수정함. 지침개발에필요한비용, 인력시간의절약 같은주제에다수의국제적지침존재 체계적인개발방법이보편화되면서, 지침개발과정이투명하고근거가명시됨

70 지식의실행의필요성 의사의지식 EBM 지식전환 Knowledge translation 진료의실행 환자진료에적용 EBP (Evidence-Based Practice)

71 진료지침의보급 조사된 26개임상진료지침중 모두인쇄물로배포, 인터넷이나 CD로배포된것은없음 학술대회발표 (11개) 학회지게재 (4개) 진료지침에대해교육 ( 5개 ) 활용도조사 (5개 )

72 진료지침의딜레마 Fundamental Provider Gap 진료지침은 : 양질의진료를도와주는도구인가? 외부규제의도구인가? 진료비심사기준 법적인문제

73 진료지침에대한의견 환례가달라임상적결정에유용하지않음 59.3 의사의자율성손상 62.6 의료서비스비용억제 58.7 의사의지식향상에도움 86.4 진료방향결정할때도움 86.7 의료서비스의질향상

74 주요보급방법및전략 교육자료배부 (dissemination of educational material) 교육집담회 (educational conference) 합의도출과정 (consensus) 교육자방문 (educational outreach visit) 의견지도자 (opinion leader) 감사와피드백 (audit and feedback) 리마인더 (reminders) 마케팅 (marketing)

75 Systematic reviews 의결과 대체적으로 효과없음 혼재된결과 대체적으로효과적 자료배부감시와피드백리마인더 단순교육의견 leaders 교육방문 다중중재방법 Bero et al (1998). BMJ Grimshaw et al (2002). Medical Care

81 고찰의대체적결과 단순보급은큰효과없음. 적극적접근 (reminders, educational outreach) 이효과적이지만, 비용소요됨. 장애요인을파악하고이를변화시키려는중재가효과적임. Multi-faceted interventions 이 single interventions 보다효과적임. 효율성, 비용에대하여서는알려진것이없다.

82 진료지침의발전방향 FROM 전문가들의산발적노력비공식합의 TO 국가적프로그램 근거중심 단일학제 다학제적 개발중심 실제사용중심 단발성 주기적개정 책자 인터넷 임상가대상 환자의참여와환자용지침개발

83 Framework for the use of evidence to solve clinical problems Audit, quality improvement Clinical Problem Observations associations, prognosis Basic mechanisms of disease Clinical Care Implementation of research Basic Research Physiology, biochemistry pharmacology Effective treatments or diagnostic tests Guidelines Clinical expertise Applied Research Clinical trials, comparative studies Systematic reviews Potential treatments or diagnostic tests

84 EBM 에대한논란

85 환자개인에대한의사결정 과학적근거 환자의 상황 취향 가치 권리

86 임상경험이무시된진료 : evidence-tyrannized medicine 과학적연구결과가무시된진료 eminence-based, eloquence-based, confidence-based, providence-based..medicine

87 사회적관점과 EBM 과학적근거 : 효과 자원제약 효율 가치 형평

88 EBM 활성화를위한방안 의학정보에대한접근도향상 연구정보의보완활용도제고 근거중심의학지원자원 EBM center, Cochrane network 지침개발보급활용, 유인책 의학교육

89 의료인교육 전문가의내재적동기 학부교육 진료현장에서의교육

The Clinician’s Lament: How Can I Keep Up With the Literature?

The Clinician’s Lament: How Can I Keep Up With the Literature? Evidence-Based Medicine ; 10-890 ; Medline, Embase, Cochrane library, Best Evidence (Ellis ) ( ) 40% 49% 18% 18% ( ) ( ) ( ) , R = -o.54 P < 0.001 () : 20,000 : 17,000 Medline : 4000 : 600 : 400,000