Clinical Practice Guidelines in Germany - Design and ...€¦ · Aims, Design and Implementation...

ISTAHC2002Berlin www.aezq.de11

Agency for Quality in Medicine, Cologne Joint Institution of the German Medical Association (GMA) and

the National Ass. of Statutory Health Insurance Physicians (NASHIP)

Agency for Quality in Agency for Quality in MedicineMedicine,, CologneCologne Joint Institution of the German Medical Association (GMA) and

the National Ass. of Statutory Health Insurance Physicians (NASHIP)

ClinicalClinical PracticePractice GuidelinesGuidelinesAimsAims, Design and , Design and ImplementationImplementation

Prof. Dr. Günter Ollenschläger


Clinical Practice Guidelines 2002

Berlin, June 7-8, 2002

Satellite Symposium

German German Guideline Guideline

ClearinghouseClearinghouse

www.cpg2002.de


ContentContent

About AQuMedAbout AQuMed

Rationales of Rationales of Clinical Practice GuidelinesClinical Practice Guidelines

GuidelineGuideline Standards in Europe Standards in Europe –– CouncilCouncil of of Europe CPG Europe CPG Recommendation Recommendation 20012001

Guideline ImplementationGuideline Implementation


Guideline Appraisal GroupsGuideline Appraisal Groups

AQuMed Steering Group (Representatives of German Medical Association and

National Assoc. of Statutory Health Insurance Physicians)

AQuMed Executive

Guideline Appraisal GroupsGuideline Appraisal GroupsGuideline Appraisal GroupsExpert Committees & Panels

Office for CPG Implementation

German Guideline Clearinghouse

Center for Evidence Based Medicine

Patient Information Clearinghouse

Activities and Structure of AQuMed

Office for Quality Progr. Clearing

GGC Steering Group

GMANASHIPNat. Hosp. Ass.Statut. Sickn.F.Priv. Insuran.F.Publ.PensionInsur.Funds

PIC Steering Group

GMANASHIPDisabled People Ass.Health Care Consum. Ass.Self Help Gr.A.

Task Force Patient Safety –Error Prevention

ProgrammeManagement

Research and Development

Training,Education

Communication,Information

Journ. for CME, Qual.Ass. ZaeFQ

Websitewww.aezq.de


Rationales for Quality Activities in German Health Care (TQM, HTA, CPG)

Increasing needIncreasing need,, demanddemand, , costscosts for for healthcarehealthcare as a consequence of

ChangesChanges in thein the volumevolume andand intensityintensity of clinicalof clinical practice practice resulting from Population Population ageingageing New technology andNew technology and knowledgeknowledge ExpectationsExpectations of consumers andof consumers and professionalsprofessionals

PricePrice inflationinflation


Financing and Quality Problems in Health Care Quality Incentives of German Health Care Legislation

Promotion of Promotion of gatekeeping gatekeeping in in ambulatory care ambulatory care

Removal of non Removal of non evidence based technologiesevidence based technologies from from sickness funds benefits cataloguesickness funds benefits catalogue

ImplementationImplementation of TQM in all of TQM in all hospitalshospitals

ImplementationImplementation of of evidenceevidence basedbased guidelinesguidelines for for priority health care problemspriority health care problems

effective since January 2000


German Quality German Quality Implementation ProjectsImplementation Projects EvidenceEvidence--based based Medicine Medicine + Quality Management+ Quality Management

Ongoing Projects Action Guideline Clearinghouse (Physicians / Hospital Ass. and Sickness Funds) HTA Agency

Critical appraisal of interventions and technologies (CPGs + HTA)

Prioritisation Agency Joint Definition of Benefits (Physicians / Hospital Ass. and Sickness Funds)

Need assessment, priority setting;

decision makingPromoting effective practice

(Implement. of CPGs, TQM, EBM, POL, Pat. Information Systems) (Physicians, Hospitals, Scient.Ass., Med.Boards, GMA, NASHIP, GHA, SHI)

Professional education; consumer empowerment,

quality management / assurance


International Guideline Institutions (Selected)

Danmark

Canada

England / Wales

Finland

France

Germany

Italy

Netherlands

New Zealand

Norway

Poland

Scotland

Spain

Sweden

Switzerland

USA

www.dsam.dk, www.dihta.dk

www.cancercare.on.ca/ccopgi

www.nice.org.uk

www.duodecim.fi

www.anaes.fr - www.fnclcc.fr

www.awmf-leitlinien.de - www.leitlinien.de

www.assr.it

www.cbo.nl - www.artsen.net

www.helsetilsynet.no/

www.nzgg.org.nz

qualy.cmj.org.pl/standardy/standardy.htm

www.sign.ac.uk

www.msc.es

www.sbu.se/

www.fmh.ch

www.guideline.gov


Problems of Problems of Guidelines WorldwideGuidelines Worldwide

1.1. Only few mention recommendations'Only few mention recommendations' evidences evidences

2. Most of2. Most of them without informationthem without information on development on development processprocess, , sponsorshipsponsorship / accountability, / accountability, implementation toolsimplementation tools

3.3. CostCost--benefitbenefit--questionsquestions often excludedoften excluded as as topics topics

4.4. Conflicting Conflicting guidelines on relevant guidelines on relevant topicstopics

5. Most of 5. Most of them academic recommthem academic recomm.(non.(non--compliancecompliance in amb.in amb.carecare) )


A p p r a i s e d C P G s ( = F o c u s G r o u p R e c o m m e n d . ) K e y T o p ic s o f a G e r m a n H y p e r t . C P G

C H S ( D T )

C H S ( P r )

J N C 9 7

I C S 9 9

A K Ä 9 8

B H S 9 9

H S A 9 5

V A 9 6

W H O 9 9

N Z 9 7

L ig 9 8

D is e a s e D e f in i t io n

R R - M e a s u r e m e n t

H is t o r y / E x a m in a t io n

C a s e - f in d in g

P r im a r y / S e c . C a r e

In d iv id u a l R is k

B lo o d C h e m is t r y

In d ic a t . /T h e r a p . G o a ls

N o n - d r u g T r e a t m e n t

F o l lo w - u p / M o t iv a t io n

C o m o r b id i t y

P r e v e n t io n

Q u a l i t y A s s u r a n c e

Im p le m e n t a t io n

O p e n Q u e s t io n s

F o r m a l A p p r a is a l ( Y e s - a n s w e r s o f G e r m a n C P G A p p r a is a l C h e c k l is t ) E b M - C P G E B E B E B E B E B E B L I L I F a c t o r 1 .C P G - D e v e lo p . 1 5 1 4 1 4 1 1 1 1 8 7 8 6 6 5 F a c t o r 2 . C P G - C o n te n t 1 6 1 7 1 5 1 6 1 5 1 4 1 6 1 4 1 3 1 4 7 F a c t o r 3 . C P G - A p p l i c a b i l i t y 4 3 5 6 4 6 0 0 2 0 4 F o r m a l Q u a l i t y ( t o t a l ) 3 5 3 4 3 4 3 3 3 0 2 8 2 3 2 2 2 1 2 0 1 6

Differing CPG Recommendations and QualityExample: German Clearing Report on Hypertension 2001


Agree CollaborationAgree Collaboration((Biomed Biomed 2, EU)2, EU)

CouncilCouncil of Europe of Europe CPG CPG RecommendationRecommendation

US US Guideline Guideline ClearinghouseClearinghouse

Intern. Intern. Activities concerningActivities concerning CPG CPG QualityQuality / / UseUse

Research on CPG Research on CPG qualityquality and and useuse

PolicyPolicy Paper on Paper on developdevelop., ., dissemdissem., and ., and use use of of CPGsCPGs

CPG CPG informationinformation, , disseminationdissemination

Promotion of international networking between organisations, research institutions, clearinghouses and other agencies producing evidence-based medical information(CoE Recommend. (2001)13


Clinical Practice Guidelines 2002

Berlin, 7-8 Juni, 2002

Satellite Symposium

German German Guideline Guideline

ClearinghouseClearinghouse

www.cpg2002.de


E t h i c a l , e c o n o m i c ,

a n d l e g a l e n v i r o n m e n t

D e v e l o p m e n t

D i s s e m i n a t i o n

I m p l e m e n t a t i o n

M o n i t o r i n g

E v a l u a t i o n

R e v i e w

T o p i c s e l e c t i o n

G U I D E L I N E S P R O D U C T I O N A N D U S E

P a t i e n t s P r o f e s s i o n a l s P o l i c y m a k e r s

O p t i m a l h e a l t h c a r e

R e s o u r c e s

Recommen- dation on developing a methodology for drawing up guidelines on best medical practices

Rec (01) 13 / 10.10.2001


……recommends that the governments of member states:recommends that the governments of member states:i. i. develop a national policy framework that:develop a national policy framework that:

ensures that the ensures that the national methods for the production and national methods for the production and appraisal of appraisal of CPGsCPGs comply with internationally accepted, current comply with internationally accepted, current state of the art practicesstate of the art practices;;

ensures that policy makers, health care professionals, citizens ensures that policy makers, health care professionals, citizens and patients and patients use the best available evidence to provide use the best available evidence to provide informationinformation to support medical decisions;to support medical decisions;

supports the production, use and timely updating of nationally supports the production, use and timely updating of nationally and locally relevant, evidenceand locally relevant, evidence--based guidelinesbased guidelines……, targeting , targeting important issues in health care;important issues in health care;

Council of Europe Council of Europe RecRec (2001)13 (2001)13 on on developing a methodology for drawing up developing a methodology for drawing up guidelines on best medical practicesguidelines on best medical practices


Recommends that the governments of member states:Recommends that the governments of member states:i. i. develop a national policy framework that :develop a national policy framework that :

ensures that ensures that CPGsCPGs are implemented in an appropriate mannerare implemented in an appropriate manner, , and that and that their effectstheir effects on the clinical process and its results, as on the clinical process and its results, as well as on the legal consequences with regard to the patient andwell as on the legal consequences with regard to the patient and those who provide medical care, those who provide medical care, are monitoredare monitored;;

facilitates the availability and use of facilitates the availability and use of CPGsCPGs, as well as the , as well as the availability of informationavailability of information on their aim, legal status, legal on their aim, legal status, legal implications, health care literature and databases implications, health care literature and databases to citizens, to citizens, patients and professionals in language they can understand and patients and professionals in language they can understand and formats they can use easilyformats they can use easily;;

Council of Europe Council of Europe RecRec (2001)13(2001)13(2)(2)


Recommends that the governments of member states:Recommends that the governments of member states:

ii.ii. promote international networking between organisations, promote international networking between organisations, research institutions, clearinghouses and other agencies that research institutions, clearinghouses and other agencies that are producing evidenceare producing evidence--based medical information; based medical information;

iii.iii. support an active, targeted dissemination of these support an active, targeted dissemination of these recommendations and the explanatory memorandum, paying recommendations and the explanatory memorandum, paying special attention to individuals and organisations involved in special attention to individuals and organisations involved in decisions within health care.decisions within health care.

Council of Europe Council of Europe RecRec (2001)13(2001)13(3)(3)


CPG are CPG are systematically developed statements to assist systematically developed statements to assist important professional and patient decisions about important professional and patient decisions about appropriate health care for specific circumstancesappropriate health care for specific circumstances. .

There has always been a body of opinions providing guidance to There has always been a body of opinions providing guidance to individual professionals. individual professionals. The novel aspect of evidence based The novel aspect of evidence based guidelines is the systematic way in which they are guidelines is the systematic way in which they are developed, and their explicit naturedeveloped, and their explicit nature. .

CPGsCPGs must be developed using state of the art methodology must be developed using state of the art methodology and be critically appraised before implementationand be critically appraised before implementation is is considered.considered.

Definition Definition „„Evidence basedEvidence based GuidelinesGuidelines““


ValidityValidity

Strength of evidence Strength of evidence

Estimated outcomesEstimated outcomes

Reliability/reproducibilityReliability/reproducibility

Clinical applicabilityClinical applicability

Council of Europe Rec. No. R (01) 13Council of Europe Rec. No. R (01) 13

Desirable Attriubutes Desirable Attriubutes of of „„Clinical Practice Clinical Practice GuidelinesGuidelines““ (IOM 1990)(IOM 1990)

Clinical flexibilityClinical flexibility

ClarityClarity

Multidisciplinary processMultidisciplinary process

Scheduled reviewScheduled review

DocumentationDocumentation



Robust CPGs: www.sign.ac.uk


CPGsCPGs have several primary and secondary functions. have several primary and secondary functions.

They canThey can

be used to support health care decisions, be used to support health care decisions,

be referred to in legal proceedings, be referred to in legal proceedings,

be used to provide information about cost be used to provide information about cost effectiveness effectiveness

help to link research, education and practice.help to link research, education and practice.


Functions Functions of of GuidelinesGuidelines


CPG can be used to plan health care for individuals or populations.

They help to make decisions in health care more rational and transparent.

The use of CPGs can improve the consistency of care (reduction of inexplicable variations) and help to achieve better health outcomes.

Council of Europe Rec. NoCouncil of Europe Rec. No. R (01) 13. R (01) 13

Guidelines support health care decisionsGuidelines support health care decisions (1) (1)


PrimaryPrimary GoalGoal of of ClinicalClinical PracticePractice Guidelines Guidelines Definition, Definition, QualityQuality Management of Management of Health Care Health Care

PLAN

ACT DO

CHECK

Evidence basedGuidelines


CPGs can support patients in making informed choices.

A properly developed patient version of a CPG, tailored to the educational and socio-economic status of the lay population in language that they can understand and use, enables patients to make appropriate choices concerning their health problems.

Council of Europe Rec. No.Council of Europe Rec. No. R (01) 13R (01) 13

Guidelines support health care decisionsGuidelines support health care decisions (2) (2)


ImplementationImplementation AidAid: : Patient Information Patient Information ClearinghouseClearinghouse GatewayGateway to to „„Best Best AvailableAvailable““ Patient / Patient / ConsumerConsumer GuidelinesGuidelines

www.patienten-information.de

Appraisal Instr.: www.discern.org.uk


CPGsCPGs are intended to be are intended to be flexibleflexible. .

CPG recommendations can and should be CPG recommendations can and should be tailored tailored to fit individual needsto fit individual needs. .

Deviation from a CPG does not by itself imply Deviation from a CPG does not by itself imply malpractice.malpractice.

(Council of Europe Rec. No. R (01) 13)(Council of Europe Rec. No. R (01) 13)

Guideline CharacteristicsGuideline Characteristics


CPG topics should be selected for development to support and CPG topics should be selected for development to support and assist decision making assist decision making on important issues in health careon important issues in health care..

Prioritisation may be based on the Prioritisation may be based on the epidemiology of health epidemiology of health problems, health inequalities, variations in the provision and problems, health inequalities, variations in the provision and quality of care, emergence of new technologiesquality of care, emergence of new technologies, or other factors , or other factors that create a need for high quality, updated information.that create a need for high quality, updated information.

The existence of presently available evidenceThe existence of presently available evidence--based guidelines based guidelines should be considered.should be considered.

Council of Europe Council of Europe RecRec (2001)13(2001)13Topic SelectionTopic Selection


GuidelineGuideline Topic Topic PrioritisationPrioritisation Procedures Procedures and and MethodsMethods in Germanyin Germany

Specific SearchSpecific Search

refering to health care delivery data, documented problems with health care delivery

Proposal Process Proposal Process

open to scientific medical societies, professional associations of health care providers, health care providers, health care purchasers, patients, other interested parties

StructuredStructured Consensus Consensus Process Process


Prioritisation of Guideline Topics


Topic Selection


Guideline Tutorial


CPG should be produced by CPG should be produced by multiprofessionalmultiprofessional groups in a groups in a systematic, independent and transparent fashion, using systematic, independent and transparent fashion, using appropriate quality criteria.appropriate quality criteria.

End user involvement through a wide review and/or testing of End user involvement through a wide review and/or testing of the pilot version is necessary before adopting a CPG for the pilot version is necessary before adopting a CPG for implementation.implementation.

If If CPGsCPGs are adapted from other countries or areas, they must be are adapted from other countries or areas, they must be rere--edited and reviewed or tested for applicability in the new edited and reviewed or tested for applicability in the new environment.environment.

Council of Europe Council of Europe RecRec (2001)13(2001)13Guidelines DevelopmentGuidelines Development


Council of Europe Council of Europe RecRec (2001)13(2001)13CPG Development in RomaniaCPG Development in Romania

The approach is to use several strategies for developing guideliThe approach is to use several strategies for developing guidelines: nes:

(i) Developing guidelines from first principles (i.e. starting w(i) Developing guidelines from first principles (i.e. starting with a literature review to ith a literature review to identify relevant studies and research); identify relevant studies and research);

(ii) Starting with the results of meta(ii) Starting with the results of meta--analyses of the literature, and updating where analyses of the literature, and updating where necessary; necessary;

(iii) Starting from a foreign guideline and modifying it in the (iii) Starting from a foreign guideline and modifying it in the light of subsequent light of subsequent research findings and according to Romanian conditions. research findings and according to Romanian conditions.

The most often used approach is the third one. Considerable saviThe most often used approach is the third one. Considerable savingsngsin time and cost were achieved by starting from the foreign metain time and cost were achieved by starting from the foreign meta--analysesanalysesand even more by starting with the already developed guidelines.and even more by starting with the already developed guidelines.


Development Steps


Example: GuidelineDevelopment Group


Timescale for Guideline Development

Group c.Lit.search

Meth.apprai

Appropriat.appraisal

Public-ation

Timescale for Guideline Appraisal / Tailoring


Systematic Literature Review


International Guideline Data-Bases searched during the German Clearing Project Tumor Pain (2000)

available via (http://www.leitlinien.de)AHCPR, USA AMA (Alberta Medical Association), CDNAMA (American Medical Association), USAAMA (Australian Medical Association), AUSAm. College fo Preventive Medicine, USAANAES (Ag.Nat.d´Accréd. et d´Év.en Santé), FArzneimittelkommission der dt. Ärzteschaft, DAWMF,DBritish Col. Council on Clinical Practice Guidel.Ca. Task Force on Preventive Health CareCBO (Centraal Begeleidigungsorgaan), NL CDC (Cent. Dis. Control and Prevention), USACMA/CMAJ (Canadian Medical Association), College of Physicians & Surgeons of ManitobaDOH (Department of Health), GBGroup Health Northwest, USAHCFA (Health Care Financing Adm.), USAHealth Canada LCDC, CDNHSTAT (Health Serv. Tech.Ass. Texts), USAICSI (Institute for Clinical Systems Integration)IHS (Inst. Health Sc.)/Univ. of Oxford, GBNederlands Huisartsen Genootschap, NLNew Zealand Guidelines Group, NZNHMRC (Nat. Health, Med. Res.Council), AUSNIH (National Institutes of Health), USANGC (National Guideline Clearinghouse)NSW Health, AUS

SIGN (Scottish Interc. Guidel. Network), GBVirtual Hospital, Univ. of Iowa, USAVPQHC (Ver. Program for Qual.Health Care)WHO (World Health Organization)Wissenschaftlicher Beirat der BÄK, D

AAFP (American Academy of Family Physicians), USAAAP (American Academy of Pediatrics), USAAAPM (American Academy of Physical Medicine & Rehabilitation), USAACP-ASIM (A. Coll. of Physicians – Am. Society of Internal Medicine), USAACS (American Cancer Society), USAAGS (American Geriatrics Society), USAAPS (American Pain Society), USAASA (Am. Society of Anesthesiologists), USAASCO (Am. So. of Clinical Oncology), USACanadian Cancer Society, USACCOPGI (Cancer Care Ontario Practice Guidelines Initiative), CDNDep. of Ped., Loyola Medical Center, USADeutsche Krebsgesellschaft, DFNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer), FNASPGN (North Ame So for Pediatric Gastroenterology and Nutrition), USANBBC (National Breast Cancer Centre), AUSNCI (National Cancer Institute), USARCGP (Royal College of General Pract.), GBTumorzentrum München, DUniv. of Wisconsin Comp. Cancer Center, USA


Formation of Guideline Recommendation


Worksheet Considered Judgement Form


In the absence of sound evidence, the group may In the absence of sound evidence, the group may produce statements about essential care decisions produce statements about essential care decisions using a consensus approach. using a consensus approach.

There remains however the question if the practices There remains however the question if the practices recommended by the guideline have actually been recommended by the guideline have actually been shown to be effective in improving health outcomes. shown to be effective in improving health outcomes.

Council of Europe Council of Europe RecRec (2001)13(2001)13CPG Development CPG Development –– ConsensusConsensus


Study Rating System


Recommend. Grading System


Example:Guideline Extract


Graded Recommendations


Neither is there always a direct link between the level of Neither is there always a direct link between the level of evidence and the strength of the recommendations. evidence and the strength of the recommendations.

When studies have been done on very selected patients, for When studies have been done on very selected patients, for example, the evidence for applying results in the general example, the evidence for applying results in the general population may be considered weaker than otherwise. population may be considered weaker than otherwise.

Sometimes there is very little data to support an important Sometimes there is very little data to support an important decision in health care, and in these cases, experts in the decision in health care, and in these cases, experts in the guideline group may decide the grade of recommendation to be guideline group may decide the grade of recommendation to be higher than the evidence in usual cases would allow. higher than the evidence in usual cases would allow.

Council of Europe Council of Europe RecRec (2001)13(2001)13Levels of Evidence / Strength of Levels of Evidence / Strength of RecommRecomm. .



1

2

3

4

5

A

B

C

D

Science GuidelinesLevel of evidence Grade of recommendation

Modulated by principles of need, applicability, or

cost-effectiveness



Changes in interpreting the evidence may also take place at the Changes in interpreting the evidence may also take place at the implementation stage. implementation stage.

While guidelines should predominantly remain based on While guidelines should predominantly remain based on scientific and professional considerations, there may be a need scientific and professional considerations, there may be a need to modulate and weigh the evidence locally according to value to modulate and weigh the evidence locally according to value judgements, priorities and local conditions. judgements, priorities and local conditions.

Translating guidelines into regional treatment programmes or Translating guidelines into regional treatment programmes or local practice policies may thus mean changes in the content of local practice policies may thus mean changes in the content of recommendationsrecommendations


Funding for CPG dissemination, implementation, evaluation, and Funding for CPG dissemination, implementation, evaluation, and updating must be carefully considered at the same time as theupdating must be carefully considered at the same time as the decision is made to develop the CPG. Funding support may decision is made to develop the CPG. Funding support may vary. The source of support must be transparent.vary. The source of support must be transparent.

CPGsCPGs should should target multiple audiencestarget multiple audiences (professionals, patients, (professionals, patients, and policy makers) and be available in suitable formats for thesand policy makers) and be available in suitable formats for these e different groups.different groups.

CPG clearinghouses or CPG production programmes facilitate CPG clearinghouses or CPG production programmes facilitate the accessibilitythe accessibility of multiple CPG on similar problems and may of multiple CPG on similar problems and may increase CPG quality.increase CPG quality.

Council of Europe Council of Europe RecRec (2001)13(2001)13Guideline DisseminationGuideline Dissemination


Tools for evaluating the quality of existing guidelines should bTools for evaluating the quality of existing guidelines should be e used to decide which guidelines should be implemented.used to decide which guidelines should be implemented.

An internationally coAn internationally co--ordinated research network should study ordinated research network should study the methodology of guidelines evaluation and impact monitoring, the methodology of guidelines evaluation and impact monitoring, including the impact of guidelines on learning process and including the impact of guidelines on learning process and medical knowledge of professionalsmedical knowledge of professionals

Council of Europe Council of Europe RecRec (2001)13(2001)13Evaluation of Guidelines and their Impact Evaluation of Guidelines and their Impact (1)(1)


Example:Indicator Data Set


Evaluation of CPG Implementation:

Diabetes CPGs in Thuringia


Guideline Appraisal Groups

GGC Steering Group

Representatives of member organisations

GGC Executive (Office for Guideline Clearing)Programme Management

Support and coordinationof guideline appraisal

Research and Information

Literature searching, systematicsppraisal methodology, IT

Dissem., Implement.Guideline report publication/ dissemination, networking to

support implementation

Guideline Appraisal GroupsGuideline Appraisal GroupsGuideline Appraisal GroupsGuideline Appraisal Groups

Methodology Development Group

Topic Prioritisation Committee

Implementation Advisory Group

Med. Scient Ass. Joint Committee

Structure of German Guideline Clearinghouse


GermanGerman GuidelineGuideline ClearinghouseClearinghouse:: AimsAims andand ScopesScopes

Setting Setting up up standardsstandards for CPG developmentfor CPG development

National National prioritisationprioritisation of CPG of CPG topics topics

Identification Identification of of „„best best available CPGsavailable CPGs““

ImplementationImplementation of best of best available CPGs available CPGs

EvaluationEvaluation of CPG programmesof CPG programmes

MonitoringMonitoring of the CPGof the CPG‘‘s s quality quality and and „„marketmarket““

GGC Board:GGC Board: GMA, NASHIP, Fed. Hospital Assoc., Fed. Ass. Social Sickness Funds, Stat.Public Pension Insurance Funds


WellWell--planned monitoring of guideline effects is planned monitoring of guideline effects is essential, and especially the impact of guidelines on essential, and especially the impact of guidelines on health outcomes needs further development and health outcomes needs further development and evaluation.evaluation.

Guidelines can include a list of essential indicators that Guidelines can include a list of essential indicators that can be used for evaluating the results of guideline can be used for evaluating the results of guideline implementation.implementation.

Council of Europe Council of Europe RecRec (2001)13(2001)13Evaluation of Guidelines and their Impact Evaluation of Guidelines and their Impact (2)(2)


GermanGerman Clearinghouse for Clearinghouse for Patient Information Patient Information Joint Project of Federal Patient Ass. and AQuMed

Consent on standards for „best“ patient information

Setting joint priorities for PI topics

Identification of „best available PI“ (refering to evidence based literature: Cochrane Reviews, HTA-Reports, CPGs)

Joint Appraisal and certification of PI

PI implementation via consumer groups and physicians


For the most effective implementation of For the most effective implementation of CPGsCPGs, a systematic , a systematic approach to managing the quality of health care and determining approach to managing the quality of health care and determining those responsible is essential.those responsible is essential.

Various guideline dissemination and implementation strategies Various guideline dissemination and implementation strategies should be used in combinations to ensure maximum effect.should be used in combinations to ensure maximum effect.

Professional, organisational, financial, and regulatory incentivProfessional, organisational, financial, and regulatory incentives es and disincentives need to be considered together with other and disincentives need to be considered together with other barriers and facilitators of guideline use at both national and barriers and facilitators of guideline use at both national and local levels (tailored implementation).local levels (tailored implementation).

Council of Europe Council of Europe RecRec (2001)13(2001)13Guideline ImplementationGuideline Implementation (1)(1)


In implementing guidelines, the best interest of the In implementing guidelines, the best interest of the patient should be served and professional patient should be served and professional responsibility and patientsresponsibility and patients’’ rights should be respected.rights should be respected.

Guidelines must become an essential element in the Guidelines must become an essential element in the undergraduate and clinical training of health care undergraduate and clinical training of health care professionals as well as in the continuing professional professionals as well as in the continuing professional development of health care teams.development of health care teams.

Council of Europe Council of Europe RecRec (2001)13(2001)13Guideline ImplementationGuideline Implementation (2)(2)


Implementation


0%10%20%30%40%50%60%70%80%90%

Journ

alsPeer

sBoo

ks

Non-co

mm.Infos

GUIDELINES

Peer Grou

ps

Intern

et

Pharm

aInfo

(very) oftensomet./never

Barriers against CPGs Barriers against CPGs in Germanyin GermanyUser Rate of Information ToolsUser Rate of Information Tools


AwarenessAwareness of of HypertensionHypertension CPGs CPGs by Ambulatory Care Physicians by Ambulatory Care Physicians in Germanyin Germany

HEP Study - Schneider et al. ZaeFQ 2001; 95: 339-344

0

10

20

30

40

50

General practitioners Internists Cardiologists

Res

pond

ents

with

ade

quat

e gu

idel

ine

awar

enes

s (%

)

less than 2 years 2 - 5 years 5 - 10 years 10 -15 years 15 - 20 years more than 20 years

p = 0.005

p < 0.0001

p = 0.136


ImplementationImplementation of of EvidenceEvidence--basedbased InformationInformation How How to to Overcome Barriers Overcome Barriers ??

Evidence-based Information (CPGs, HTA-Reports, Cochrane-Reports etc)

KnowledgeKnowledge

? ? ? GAPGAP

In- and Out-Patient Care,Health Professionals, Patients,

Health Administration, PoliticiansPracticePractice


Implementation Strategies

6464 ISTAHC2002Berlin www.aezq.de

EducationalEducational Tool Tool for for AuthorsAuthors, Editors,, Editors,

and Users ofand Users of

CPGs CPGs ––

Joint Project of

Ass. of Scient. Med. Soc.

and AQuMed

GGC Standards:GGC Standards: Guideline-Manual


Mandatory, Mandatory, nationwide implementationnationwide implementation ofof

guidelineguideline--based quality measures based quality measures for 10 for 10

top priority health care problemstop priority health care problems per per yearyear..

(Social Code Book V of Germany)(Social Code Book V of Germany)

Barriers againstBarriers against UseUse of of CPGsCPGs::Mandatory TopMandatory Top--Down CPG Down CPG ImplementationImplementation


CPGs should …not simply be imposed on professionals by hospital management or third party payers.

That would result in a standardisation of care that leaves insufficient room to do justice to the needs of each individual patient.

Neither are guidelines a simple tool for allocating scarce resources at the population level.

Risks Risks of of CPGsCPGs: : Inadequate Standardisation Inadequate Standardisation of of Health CareHealth Care

Council of Europe - Rec. (01) 13 / 10.10.2001 (Rec. on developing a methodology for drawing up guidelines on best medical practices)


Medicolegal Medicolegal Status of Status of Guidelines Guidelines

Since guidelines are not issued by legislative Since guidelines are not issued by legislative bodies, they are bodies, they are not legal rulesnot legal rules. .

However, the may have or acquire However, the may have or acquire legal significancelegal significance, , for instance when they are incorporated in binding for instance when they are incorporated in binding rules or when they are applied by a court as rules or when they are applied by a court as auxiliary standards to decide a case of professional auxiliary standards to decide a case of professional misconduct or malpractice. misconduct or malpractice.



UseUse of of GuidelinesGuidelines in Court in Court

Basically, guidelines will not provide definite answers even wheBasically, guidelines will not provide definite answers even when n they do not allow for much flexibility in application. A particthey do not allow for much flexibility in application. A particular ular course of action must be judged in the light of the specific heacourse of action must be judged in the light of the specific health lth problem and the specific circumstances of a given patient. problem and the specific circumstances of a given patient.

Sometimes, there can be competing guidelines, for instance Sometimes, there can be competing guidelines, for instance developed in different hospitals or regions.developed in different hospitals or regions.

For all these reasons, the courts will not automatically equate For all these reasons, the courts will not automatically equate compliance with guidelines with good medical practice. compliance with guidelines with good medical practice.



0 10 20 30 40 50 60 70 80 90 100

USPSTF

SIGN

NZG

CATF

ACS

AUS

ACR-S

ACPM

Lebensalter

Keine Mammographie U nur bei CA Verdacht U bei Risiko PatientenJährliches Screening Screening alle 2 Jahre U nur bei Therapieoption

Barriers againstBarriers against UseUse of of CPGsCPGs::ConflictingConflicting CPGCPG RecommendationsRecommendations


Clinical Practice Guidelines Clinical Practice Guidelines in Germany in Germany Status Quo Status Quo

MoreMore thanthan 1000 national 1000 national guidelinesguidelines of of various various quality quality (Editors: (Editors: Scientific Medical Societies Scientific Medical Societies –– n > 120)n > 120)

Legal Legal obligationobligation to to implementimplement 1010 evidence basedevidence based CPGsCPGs per per yearyear ((since since 2001) 2001)

Less thanLess than 30 % of30 % of primary care physicians are awareprimary care physicians are aware ofof keykey CPGsCPGs


MultiprofessionelMultiprofessionel author groupsauthor groups

System. literature search/ reviewSystem. literature search/ review

Use of available best evidenceUse of available best evidence

Structured / transparent conStructured / transparent con-- sensussensus processes for selecting processes for selecting recommendationsrecommendations

Explicit link between Explicit link between recommenrecommen-- dationsdations / underlying evidence/ underlying evidence

Regularly updating of Regularly updating of CPGsCPGs

Goals of German Guideline Clearinghouse:To establish practicable evidence-based CPGs of good quality


Critical Appraisal Critical Appraisal of of CPGs QualityCPGs Quality: : AGREE InstrumentAGREE Instrument wwwwww..agreecollaborationagreecollaboration..orgorg


Implementation Aid : CPG ClearingDisclosure of Best Available CPGs Implementation AidImplementation Aid : : CPG ClearingCPG ClearingDisclosureDisclosure of Best of Best Available CPGs Available CPGs

HypertensionHypertension

TumorTumor PainPain

Low Back PainLow Back Pain

Asthma Asthma bronchialebronchiale

Diabetes mellitus Type 2Diabetes mellitus Type 2

In preparationIn preparation

CHDCHD Heart FailureHeart Failure

DepressionDepression


Appraisal Criteria


Scope and Purpose; Question 3

The patients to whom the guideline is meant to apply are specifically described.

StronglyAgree

4 3 2 1 Strongly Disagree

Context, flexibility; Question 2.3

Is there a satisfactory description of the patients (regarding sex, age, stage of the disease, concurrent diseases) to which the guideline is meant to apply ?

Y = yes N = no uc = unclear na = not applicable

Guideline Appraisal Instruments (Answering Schemes)


SIGN guide to the AGREE instrument

www.sign.ac.uk


Guideline Appraisal Instrument (Comments and Examples)


German Guideline Appraisal ChecklistQuestion - Comments - Examples

Example

Comment

Question


AGREE InstrumentSIGN Examples


Best Best AvailableAvailable Guidelines:Guidelines: Clearing Project Clearing Project „„HypertensionHypertension 20002000““ -- SummarySummary

11 out of 132 identified hypertension CPGs met the formal criteria of German Guideline Appraisal Instrument.

7 out of 11 might be useful as blueprints for German hypertension guideline.

16 key topics for a national hypertension CPG were consented.

Benchmark CPGs: BHS, CanHSF, JNC VI / ICSI


Consultation /Peer Review


Example: Quick Reference Guide


Key Key Points Points for CPGfor CPG‘‘s s AcceptanceAcceptance

Clinical practice guidelines should Clinical practice guidelines should

link link recommendations with underlying evidences recommendations with underlying evidences

deal deal withwith every every day day health care problems health care problems

helphelp professionalsprofessionals in in providingproviding best best medical practicemedical practice at at minimal minimal expensesexpenses

givegive detailed descriptiondetailed description of best of best medical practice processes medical practice processes


Implementation Aid : Electronic –CPG-based Decision Support – f.e. PRODIGY – www.prodigy.nhs.uk - Implementation AidImplementation Aid : : Electronic Electronic ––CPGCPG--based Decision based Decision Support Support –– f.e. PRODIGY f.e. PRODIGY –– www.prodigy.nhs.ukwww.prodigy.nhs.uk --


Fed./ State Parliaments define Legal Framework for Quality in Health Care Selfgov. Bodies define Priority Health Care Topics G.G.Clearinghouse identifies Evidence Based and Practicable Guidelines Selfgov. Bodies define CPG Based Qual.Assur. Regulat. and Budgets

Reg. Selfg.Bod. implement CPG Based Education and TQM Programmes Health Prof. guarantee High Quality Health Care

CPG CPG ImplementationImplementation in Germanyin Germany CPG CPG related related TQM TQM Programs Programs / Budget / Budget IncentivesIncentives


Disease Management in Germany Goal: Effective Chronic Illness Care

(AQuMed Recommendation 02/02)

Disease Management in Germany Goal: Effective Chronic Illness Care


Self-management support: to help patients / families cope with the challenges of living with and managing chronic illness.

Patient support: goes beyond patient education and information; it equips patients with skills in managing their conditions

Decision support to practitioners: includes the effective implementation of evidence-based guidelines

Delivery system: includes well-prepared teams able to efficiently coordinate tasks and utilize key clinical data

Clinical information system: collects information about important elements of care and makes that information available to health care team members.

Wagner et al. Managed Care Quarterl 7 (1999) 56-66.


Disease Management in Germany Program Accreditation Principles

(Federal Ministry of Health 05/02)

Disease Management in Germany Program Accreditation Principles


• Use of evidence-based guidelines, as available, as a basis for program design • Population-based management through identification and stratification of patients who need support to manage their conditions • Support for the physician-patient relationship • Quality interaction between the program and the affected patients and practitioners • Population-based measurement of process and/or outcomes • A QI process that enables an organization to continually learn better ways to provide DM. adapted from NCQA

2002


Disease Management in Germany Program Accreditation Standards


Disease Management in Germany Program Accreditation Standards


Categories: A. Program Content

B. Patient Service

C. Practitioner Service

D. Clinical Systems

E. Measurement and Quality Improvement

F. Program Operation NCQA 2002


Disease Management in Germany Program Accreditation Categories and Standards




A. Program Content

• Using evidence-based guidelines or standards of care in developing program content for patients and practitioners

• Ensuring that all content is consistent with adopted guidelines

• Developing information for patients that assists in self-management

• Developing information for treating practitioners about current guidelines and how program recommendations relate to guidelines and cited evidence






B. Patient Service

• Enlisting and measuring the participation of eligible patients

• Supporting patient self-management with consumer-tested information, coaching, reminders, referrals and feedback on progress

• Providing feedback to patients about their progress toward treatment goals

• Encouraging patient communication with practitioners.






C. Practitioner Service

• Supporting practitioner decisions with evidence-based recommendations on care of chronic conditions and reminders, and feedback on the progress of individual patients

• Providing feedback to practitioners on the condition and progress of their patients






E. Measurement and Quality Improvement

• Measuring quality for each condition managed and across the organization

• Using evaluative data from patients and practitioners to assess their experience with the DM program for quality improvement

• Analyzing performance data and taking action for quality improvement.


PrimaryPrimary GoalGoal of of ClinicalClinical PracticePractice Guidelines Guidelines Definition, Definition, QualityQuality Management of Management of Health Care Health Care

PLAN

ACT DO

CHECK

Evidence basedGuidelines


Results Results andand PerspectivesPerspectives of GGCof GGC

1.1. Joint national Joint national strategystrategy for for CPG CPG develdevel. and . and useuse

2.2. Clearing Report Clearing Report –– a a CME CME resourceresource

3.3. CPGCPG--based based diseasedisease managementmanagement programmesprogrammes

3.3. Guideline Guideline implementation technologiesimplementation technologies

AnnotatedAnnotated CPGCPG retrievalretrieval system (system (wwwwww..leitlinienleitlinien.de).de)

Decision supportDecision support system (system (ProdigyProdigy--ProgramProgram))

4.4. Linking CPGs with Linking CPGs with

Patient Patient informationinformation (Patient Information (Patient Information ClearinghouseClearinghouse))

Clinical measuresClinical measures ((Measures ClearinghouseMeasures Clearinghouse))

National National hospital hospital certificationcertification program program KTQKTQ®®

CME CME programsprograms

Vorführender

Präsentationsnotizen

What are the results of this process so far ? Referring to the Hypertension project we can say, that both editors of the 2 German GLns have declared to rely on the reports recommendation in the future. We are moderating a joint meeting of the 2 national GLn groups, which should result in a joint plan of action to stop conflicting recommendations and to consent on one national GLn on Hypertension. We have established a monitoring group, which will report on that process. We are told that - within a few weeks after publication, the clearing report was identified as a good resource for independent CME. And what are the perspectives of these activities ? We are preparing Implementation Technologies, based on the Hypertension report. We are establishing a clearinghouse for patient information together with consumer groups


http://http://wwwwww..aezqaezq.de.de

Thank you for your Patience !!!

Clinical Practice Guidelines in Germany - Design and ...€¦ · Aims, Design and Implementation...

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