Developing and implementing clinical practice guidelines.

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Quality in Health Care 1995;4:55-64 Effectiveness Bulletin Developing and implementing clinical practice guidelines Jeremy Grimshaw, Nick Freemantle, Sheila Wallace, Ian Russell, Brian Hurwitz, Ian Watt, Andrew Long, Trevor Sheldon This review is based on Effective Health Care, Bulletin No 8 Health Services Research Unit, University of Aberdeen, Aberdeen AB9 2ZD Jeremy Grimshaw, programme director Sheila Wallace, research fellow NHS Centre for Reviews and Dissemination, University of York, York YOl 5DD Nick Freemantle, research fellow Ian Watt, clinical liaison officer Trevor Sheldon, director Department of Health Sciences, University of York, York YOl 5DD Ian Russell, professor of health sciences Department of Primary Health Care, University College, London WClE 6AU Brian Hurwitz, senior lecturer Nuffield Institute for Health, University of Leeds, Leeds LS2 9PL Andrew Long, senior lecturer Correspondence to: Dr J Grimshaw, Health Services Research Unit, University of Aberdeen, Drew Kay Wing, Polwarth Building, Foresterhill, Aberdeen AB9 2ZD The Effective Health Care bulletins have con- centrated on providing systematic reviews of the research evidence on clinical and cost effectiveness to help inform decision makers and clinicians in the NHS. However, providing information by itself is rarely sufficient to stimulate corresponding change in practice. Various implementation strategies can be used to promote the use of research evidence. One approach which has received growing attention and support is the development and implemen- tation of clinical practice guidelines.' 2 These are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances."3 Some previous bulletins argued for the incorporation of the evidence on effectiveness into guidelines,4 5and it has been argued that healthcare commissioners should purchase guidelines or protocols rather than simple procedures.6 This paper examines the evidence on whether practice guidelines can change the behaviour of health professionals and how best to introduce them into clinical practice. The characteristics of high quality guidelines and how purchasers might use guidelines in commissioning are also considered. Evaluating implementation of guidelines Grimshaw and Russell undertook a systematic review of rigorous evaluations of clinical guidelines published between 1976 and 1992.7 In this paper the review has been updated to include another 32 studies either previously unidentified or published up until June 1994. To identify evaluations of clinical guidelines the DHSS-DATA,5 Embase,9 Medline,'0 and SIGLE" databases were searched, all since 1975; published bibliographies of related topics12-26 were searched; and citations in articles were reviewed. Further references were provided by colleagues. Investigations of clinical guidelines were reviewed in depth if they were intended primarily for medical staff, if they used rigorous study designs to evaluate the effectiveness of guidelines in terms of the process of care or outcome for patients, and if they reported sufficient data for statistical analysis. Evaluations were grouped according to a hierarchy of study designs which reflects the reliability with which they are likely to assess implementation of guidelines (table). Generally, randomised controlled trials provide the best evidence of the effectiveness of implementation. However, in behavioural research simple randomised control trials may be more susceptible to a range of biases than in other types of research.27 28 One of the most reliable trial designs for these types of interventions is one in which each participating doctor simultaneously experiences both guidelines for some conditions and the status quo for others in a balanced incomplete block design (for example, Norton and Dempsey29). Although less reliable, randomised controlled trials randomising doctors either individually or in groups and randomised controlled crossover trials (for example, Landgren et al'0) are, with the balanced incomplete block design, considered to provide the most reliable (grade I) evidence. Before and after studies with non-randomised controls, which compare changes in the targeted behaviour with a control group of activities performed by the same doctors but not targeted by guidelines (for example, De Vos Meiring and Wells3") may provide useful though less reliable results. These studies and simple randomised controlled trials in which patients are randomised are considered together as providing grade II evidence. Time series techniques have been used to analyse before and after studies (for example, Kosecoff et al'2). Before and after studies controlled by data from other sites where non-randomised controls are selected in the belief that they may experience changes similar to those of the study populations (for example, Thompson et al") can also be useful. Studies with this design were included if control and study sites were apparently similar; baseline character- istics and performance in control and study sites were similar; and data collection was contemporaneous in study and control sites during both phases of the study. These two designs are considered to provide grade III evidence. Simple uncontrolled before and after studies were not reviewed as secular trends or sudden changes make it impossible to attribute observed changes to the intervention. Do guidelines influence clinical practice? In all, we identified 91 studies which fulfilled the stated criteria, covering a wide range of 55

Transcript of Developing and implementing clinical practice guidelines.

Page 1: Developing and implementing clinical practice guidelines.

Quality in Health Care 1995;4:55-64

Effectiveness Bulletin

Developing and implementing clinical practiceguidelines

Jeremy Grimshaw, Nick Freemantle, Sheila Wallace, Ian Russell, Brian Hurwitz, Ian Watt,Andrew Long, Trevor SheldonThis review is based on Effective Health Care, Bulletin No 8

Health ServicesResearch Unit,University ofAberdeen,Aberdeen AB9 2ZDJeremy Grimshaw,programme directorSheila Wallace, researchfellow

NHS Centre forReviews andDissemination,University ofYork,York YOl 5DDNick Freemantle,research fellowIan Watt, clinical liaisonofficerTrevor Sheldon, director

Department ofHealthSciences, University ofYork, York YOl 5DDIan Russell, professor ofhealth sciences

Department ofPrimary Health Care,University College,London WClE 6AUBrian Hurwitz, seniorlecturerNuffield Institute forHealth, University ofLeeds, Leeds LS2 9PLAndrew Long, seniorlecturerCorrespondence to:Dr J Grimshaw,Health Services ResearchUnit, University ofAberdeen, Drew Kay Wing,Polwarth Building,Foresterhill, AberdeenAB9 2ZD

The Effective Health Care bulletins have con-centrated on providing systematic reviews ofthe research evidence on clinical and costeffectiveness to help inform decision makersand clinicians in the NHS. However, providinginformation by itself is rarely sufficient tostimulate corresponding change in practice.Various implementation strategies can be usedto promote the use of research evidence. Oneapproach which has received growing attentionand support is the development and implemen-tation of clinical practice guidelines.' 2 Theseare "systematically developed statements toassist practitioner and patient decisions aboutappropriate health care for specific clinicalcircumstances."3 Some previous bulletinsargued for the incorporation of the evidence oneffectiveness into guidelines,4 5and it has beenargued that healthcare commissioners shouldpurchase guidelines or protocols rather thansimple procedures.6This paper examines the evidence on

whether practice guidelines can change thebehaviour of health professionals and how bestto introduce them into clinical practice. Thecharacteristics of high quality guidelines andhow purchasers might use guidelines incommissioning are also considered.

Evaluating implementation of guidelinesGrimshaw and Russell undertook a systematicreview of rigorous evaluations of clinicalguidelines published between 1976 and 1992.7In this paper the review has been updated toinclude another 32 studies either previouslyunidentified or published up until June 1994.To identify evaluations of clinical guidelinesthe DHSS-DATA,5 Embase,9 Medline,'0 andSIGLE" databases were searched, all since1975; published bibliographies of relatedtopics12-26 were searched; and citations inarticles were reviewed. Further references wereprovided by colleagues. Investigations ofclinical guidelines were reviewed in depth ifthey were intended primarily for medical staff,if they used rigorous study designs to evaluatethe effectiveness of guidelines in terms of theprocess of care or outcome for patients, and ifthey reported sufficient data for statisticalanalysis.

Evaluations were grouped according to ahierarchy of study designs which reflects thereliability with which they are likely to

assess implementation of guidelines (table).Generally, randomised controlled trialsprovide the best evidence of the effectivenessof implementation. However, in behaviouralresearch simple randomised control trials maybe more susceptible to a range of biases thanin other types of research.27 28 One of the mostreliable trial designs for these types ofinterventions is one in which each participatingdoctor simultaneously experiences bothguidelines for some conditions and the statusquo for others in a balanced incomplete blockdesign (for example, Norton and Dempsey29).Although less reliable, randomised controlledtrials randomising doctors either individuallyor in groups and randomised controlledcrossover trials (for example, Landgren et al'0)are, with the balanced incomplete blockdesign, considered to provide the most reliable(grade I) evidence. Before and after studieswith non-randomised controls, which comparechanges in the targeted behaviour with acontrol group of activities performed by thesame doctors but not targeted by guidelines(for example, De Vos Meiring and Wells3") mayprovide useful though less reliable results.These studies and simple randomisedcontrolled trials in which patients arerandomised are considered together asproviding grade II evidence. Time seriestechniques have been used to analyse beforeand after studies (for example, Kosecoff etal'2). Before and after studies controlled bydata from other sites where non-randomisedcontrols are selected in the belief that they mayexperience changes similar to those of thestudy populations (for example, Thompsonet al") can also be useful. Studies with thisdesign were included if control and study siteswere apparently similar; baseline character-istics and performance in control and studysites were similar; and data collection wascontemporaneous in study and control sitesduring both phases of the study. These twodesigns are considered to provide grade IIIevidence. Simple uncontrolled before and afterstudies were not reviewed as secular trends orsudden changes make it impossible to attributeobserved changes to the intervention.

Do guidelines influence clinical practice?In all, we identified 91 studies which fulfilledthe stated criteria, covering a wide range of

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Grimshaw, Freemantle, Wallace, Russell, Hurwitz, Watt, Long, Sheldon

Ezidence of effectiveness ofguidelines from igorous studies of introducing guidelines

A uthlos Setting Clinical area End user Interventions to promote use ofinvolvement in guidelinesguidelinedevelopment?

Design of trial Effect on Effect onor study process outcome

Studies of clinical care

Grade I evidence: Balanced incomplete block designs, randomized controlled trials randonmising doctors, and crossover tooaksMcDonald1976i4Sanazaro andWorth I9785

IHopkins ct al1980A"

1Linn 198X0

US ambulatory Various medical Nocare conditionsUS hospital care I Paediatric, No

2 surgical, and4 medicalconditions

US emergency Hypotensive Noroom care shock

US hospital care Management of Nobums

McDonald et al US ambulatory Various medical No1980 i care conditions

Sommers et al US ambulatory Unexplained1984"' care anaemia

Norton andDempsey 1985

Palmer et al1985'

Putnam andCurry 19854'

(i) Yes(ii) No

Canadian general Cystitis and Yespractice vaginitis

US ambulatory 4 Medical and Yescare 4 paediatric

conditionsCanadian general 5 Medical (i) Yespractice conditions (ii) No

Winickoff et al US ambulatory Hypertension Nol98542 care

McAlister et al Canadian general Hypertension No1986 ' practice

Wirtschafter et al19864-

Vinicor ct al198745

US community Neonatalhospitals respiratory

distresssyndrome

No

US ambulatory Diabetes mellitus Nocare

Putnam and Canadian general Hypertension (i) YesCurry 1989" practice (ii) No

Mazzuca ct al US ambulatory Diabetes mellitus No1 9904 care

Lomas ct al19914S

Canadian Caesareanobstetric care section

No

Margolis et al Israeli paediatnic 3 Paediatnrc No199249 care conditionsNorth of England UK general 5 Paediatric (i) YesStudy of practice conditions (ii) NoStandards andPerformance inGeneral Practice1992'0Emslie et al UK general Infertilitv Yes19935' practice

Jones et al 199352 UK general Dyspepsia Yespractice

Soumerai et al US hospital care Blood transfusion No19935

Local guidelines implemented by Crossovercomputer generated remindersNational guidelines approved by RCT-Drlocal staff and placed in patientsnotes

Local guidelines distributed by RCT-Drbrief educational programme andimplemented by general remindersNational guidelines distributed by RCT-Drspecific educational programmeand implemented by generalremindersLocal guidelines implemented by Crossovercomputer generated reminderssupported by bibliographiccitations on requestGuidelines implemented by RCT-Draggregated feedback:(i) developed by end users(ii) developed without end usersGuidelines implemented by BIBaggregated feedback on baselinecomplianceGuidelines implemented with BIBaggregated feedback on baselinecomplianceGuidelines distributed by mail and RCT-Drpersonal educational package, andimplemented with aggregatedfeedback on baseline compliance:(i) developed by end users for 2conditions(ii) developed without end users for2 conditionsNational guidelines modified RCT-Drlocally and implemented withpatient specific feedback outwiththe consultation and physicianspecific feedbackProvincial guidelines distributed by RCT-Drmail and implemented withcomputer generated patientspecific feedbackLocal guidelines: RCT-Dr(i) distributed by specificeducational programme(ii) (i) plus implemented withguidelines embedded in papermedical recordLocal guidelines: RCT-Dr

(i) distributed by individualpatient education(ii) distributed by intensivephysician education andimplemented by aggregatedfeedback, hotline to diabeticspecialists, and computergenerated reminder(iii) (i) + (ii)(i) guidelines developed with end RCT-Drusers(ii) guidelines developed withoutend users, distributed by targetedmailingLocal guidelines distributed by RCT-Drseminar and implemented by:(i) computer generated reminder(ii) (i) + clinical materials(iii) (ii) + diabetes patienteducation serviceProvincial consensus development RCT-Drconference guidelines distributedby mailing to targeted cliniciansand implemented by:(i) aggregated feedback(ii) local opinion leaderLocal guidelines implemented by PBIBcomputerised protocolGuidelines implemented by BIBfeedback on baseline compliance:(i) guidelines developed by endusers(ii) guidelines developed withoutend usersGuidelines distributed by mail and RCT-Drimplemented with guidelinesembedded in paper medical recordGuidelines distributed by targeted RCT-Drmailing and implemented by ageneral reminder of the guidelinesLocal guidelines distributed by RCT-Drlecture, printed materials, andeducational outreach visits toindividual doctors

+++

++±+ ++±

+ ++

(i)(ii) ++

++

(i) ++++(ii) +++

+ 0

(i) ()(ii) +

(i) +(ii) +(iii) ++

(i) ()(ii) 0

(i) +(ii) +

(iii) +

(i) 0(ii) ++

(i+

(i) +(ii) 0

(i) ++++(ii) 0

++

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Developing and implementing clinical practice guidelines

Authors Setting Clinical area End user Interventions to promote use of Design of trial Effect on Effect oninvolvement in guidelines or study process outcomeguidelinedevelopment?

Anderson et al US hospital care Prevention of No NIH consensus development RCT-Dr (i) +++199454 deep vein

thrombosis

McDonald1976"5

Coe et al 197756

Restuccia 19825

Rogers et al198258

Barnett et al198359

Thomas et al198360Brownbridge et al198661

Weingarten et al199062

Barnett et al197863

Kosecoff et al198732

Lomas et al198964

Durand-Zaleskiet al 199265

Sherman et al199266

conference national guidelines:(i) distributed by continuingmedical education(ii) distributed by continuingmedical education andimplemented by quality assuranceprogramme

(ii) +++

Grade II evidence: randomised controlled trial randomising patients, and before and after studies controlled by activity not targeted by guidelines

US ambulatory Diabetes and No Local guidelines implemented by RCT-Ptcare other medical computer generated reminders

conditionsUS ambulatory Hypertension Yes Guidelines implemented by RCT-Ptcare computer generated remindersUS hospital care General medical No National guidelines implemented RCT-Pt

conditions by nurse coordinator providing:(i) direct feedback to attending

physician(ii) feedback to physician adviser(iii) feedback at nurse's discretion

US ambulatory Hypertension, Yes Local guidelines implemented by RCT-Ptcare obesity, and renal computer generated reminders

diseaseUS ambulatory Hypertension No Local guidelines implemented by RCT-Ptcare computer generated patient

specific feedbackUS ambulatory Diabetes No Local guidelines implemented by RCT-Ptcare computer generated remindersUK general Hypertension Yes Local guidelines discussed with CBA-Apractice participants and implemented by

paper based or computerisedprotocol

US hospital care Chest pain No Local guidelines implemented with RCT-Ptpatient specific reminder

Grade III evidence: before and after studies controlled by site and time series analyses

US ambulatory Streptococcal Yes Local guidelines "determined" by TSAcare sore throat clinic staff and implemented by

patient specific feedbackUS hospital care Breast cancer, No NIH consensus development TSA

caesarean conference guidelines distributedsection, coronary by publication in professionalartery bypass journals, no further attempt atgrafting implementation

Canadian Caesarean No Provincial consensus development TSAobstetric care section conference guidelines distributed

by publication in professionaljournals and mailing to targetedclinicians, no further attempt atimplementation

French hospital Hypovolaemia No National consensus development TSAcare conference guidelines distributed

by specific educational meetingsand implemented with monthlyfeedback and discussion ofcompliance

US hospital care Localised No NIH consensus development TSAprostatic conference guidelines distributedcarcinoma by publication in professional

journals and mailing to targetedclinicians, no further attempt atimplementation

Studies ofpreventive care

Grade I evidence: Balanced incomplete block designs, randomised controlled trials randomising doctors, and crossover trials

Cohen et al US ambulatory 8 Preventive No Local guidelines distributed by RCT-Dr198267 care tasks intensive educational intervention

and placed in patients' notesMcDonald et al US ambulatory 9 Preventive No Local guidelines implemented by RCT-Dr1984, 199266 66 care tasks and 6 computer generated reminders

laboratory testsWinickoff et al US community Colorectal cancer Yes Local guidelines distributed by Crossover198470 health plan screening specific educational programme

and implemented by comparativefeedback of individual doctorperformance

Cohen et al US ambulatory 13 Preventive No Local guidelines distributed by BIB19857' care tasks mail, residents received credit at

university book shop after readingguidelines

Tierney et al US ambulatory 11 Preventive No Local guidelines distributed by BIB198672 care tasks internal mail and implemented by:

(i) computer generated reminderwithin consultation(ii) patient specific computergenerated feedback

Cheney and US ambulatory 12 Preventive No National guidelines implemented RCT-DrRamsdell 198713 care tasks by age-sex specific checklist placed

in patient's notesCohen et al 1987, US ambulatory Smoking No National guidelines distributed by RCT-Dr198974 75 care cessation specific educational programme

and implemented by:(i) patient specific reminders(ii) nicotine gum(iii) {i -- {i

0

(i) ++(ii) 0(iii) ++

+ ++

++++ ++

++

++

0

0 +++++

0++

0

++ ++

++ _

"Modest"improve-ment incompliance(i) ++(ii) +

++ _

(i) ++++(ii) ++++(iii) +++++

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Grimshaw, Freemantle, Wallace, Russell, Hurwitz, Watt, Long, Sheldon

Authors Setting Clinical area End user Interventions to promote use of Design of trial Effect on Effect oninvolvement in guidelines or studio process outcomeguidelinedevelopment?

Wilson et al Canadian family Smoking No National guidelines: RCT-Dr (i) +++++ (i) 019887 practice cessation

Cummings et al US ambulatory Smoking19897' care cessation

McPhee ct al US ambulatory 7 Preventive198978 care tasks

Turner et a!19908J

McPhee et al19918/)Ornstein et al199181

Cowan et al199282

Dietrich ct al199283

US ambulatory 6 Preventivecare tasks

US familypractice

US ambulatorycare

US ambulatorycare

US ambulatorycare

Headrick et al US ambulatory19928' care

11 Preventivetasks

5 Preventivetasks

No

No

No

No

No

7 Preventive care Notasks

10 Preventive Notasks

Cholesterol

Litzelman et al US ambulaton, 3 Preventive199385 care tasks

Mayefsky and US ambulatoryFoye 199386 care

No

No

Well child care No

(i) implemented by nicotine gum(ii) distributed by specificeducational intervention andimplemented with nicotine gumNational guidelines distributed by RCT-Drspecific educational programmeand implemented with reminders

National guidelines implemented RCT-Drby:

(i) audit and feedback(ii) cancer screening reminders(iii) patient education

National guidelines implemented RCT-Drby computer generated reminder(control group). In addition studygroup patients received reminders

National guidelines implemented RCT-Drby computer generated reminders

National guidelines distributed by RCT-Drintensive educational interventionand implemented by:(i) physician computer generated

reminder(ii) patient reminder(iii..) (i + (ii

National guidelines placed in RCT-Drpatients' notes

National guidelines:(i) distributed by specific

educational intervention(ii) implemented by practicefacilitator(...i) (i) + (ii)

RCT-Dr

National guidelines distributed by RCT-Drlecture and implemented by:(i) guidelines placed in notes(ii) patient specific computergenerated prompts

National guidelines modified RCT-Drlocally and implemented byrequiring physicians to respond tocomputer generated reminders

National guidelines implemented RCT-Drby individual physician feedback

\(i + I., +

(ii) ..... (ii) +

++ +

(i) +(ii) ++(iii) ++

++

++

(i) +(ii) +

(iii) +

+_

(i) ++(ii) ++(iii) ++

(i) +(ii) +

+_

++ _

Grade II evidence: randonmised controlled trial randoinising patients, and before and after studies controlled by activity not targeted by guidelines

US hospital care Antenatal care

Rodnev ct a! US family1 9838' practice

2 Adultimmunizations

McDowell ct al Canadian family Influenza198688 practice vaccination

Prislin et al198684

Becker et al198990

Chambers et al19899'

McDowell et al198992

US familypractice

2 Preventivetasks

US ambulatory 9 Preventivecare tasks

US family Mammographymedicine

Canadian family Blood pressurepractice screening

McDowell et al Canadian family Cervical198983 practice screening

No

No

No

No

No

National guidelines discussed RCT-Ptlocally and implemented bycomputer generated reminders

Local guidelines distributed by CBA-Aeducational programme andimplemented by redesign ofmedical record to encourage twoadult immunisations

National guidelines implemented RCT-Ptby:

(i) computer generated reminderto the doctor(ii) telephone reminder to thepatient(iii) reminder letter to patientLocal guidelines distributed by RCT-Ptspecific educational conference andimplemented by flowsheet placedin patients' notes

National guidelines implemented RCT-Ptby:(i) reminder to physician(ii) reminders to physician andpatient

National guidelines implemented RCT-Ptby computer generated reminders

National guidelines implemented RCT-Ptby:

(i) computer generated reminderto the doctor(ii) telephone reminder to thepatient(iii) reminder letter to patient

No

No

No National guidelines implementedby:

(i) computer generated reminderto the doctor(ii) telephone reminder to thepatient(iii) reminder letter to patient

RCT-Pt

Morgan ct al1 97828

++

++

(i) +±(ii) +++(iii) +++

(i) +(ii) ++

(i) +(ii) +(iii) ++

(i) 0(ii) +++(iii) +++

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Developing and implementing clinical practice guidelines

Authors Setting Clinical area End user Interventions to promote use of Design of trial Effect on Effect oninvolvement in guidelines or study process outcomeguidelinedevelopment?

Rosser et al Canadian family Smoking No National guidelines implemented RCT-Pt199194 practice cessation by:

(i) computer generated reminderto the doctor(ii) telephone reminder to thepatient(iii) reminder letter to patient

Lilford et al UK hospital care Antenatal care Yes Local guidelines implemented by: RCT-Pt19929' (i) structured paper record

(ii) interactive computerisedquestionnaire

Rosser et al Canadian family Tetanus No National guidelines implemented RCT-Pt199296 practice vaccination by:

(i) computer generated reminderto the doctor(ii) telephone reminder to thepatient(iii) reminder letter to patient

Grade III evidence: before and after studies controlled by site and time series analyses

Thompson et al US prepaid Investigations in Yes Local guidelines distributed by CBA-Dr19833 health plan "routine" intensive educational programme

physical and implemented with feedback onexaminations performance

Robie 198897 US ambulatory 6 Preventive No National guidelines distributed by CBA-Drcare tasks lecture implemented by chart

remindersSchreiner et al US ambulatory 4 Preventive No National guidelines implemented CBA-Dr198898 care tasks by patient specific remindersNattinger et al US ambulatory Mammography No National guidelines implemented CBA-Dr198999 care by:

(i) audit and feedback(ii) visit-based intervention(including patient reminder andcompleted request form)

Tape and US ambulatory 8 Preventive No National guidelines distributed by CBA-DrCampbell care tasks continuing medical education and1993100 implemented by flowsheet in paper

record (control group). In addition,study group received computergenerated reminders.

(i) +++(ii) +++++(iii) ++++

(i) +(ii) +

(i) ++(ii) ++(iii) +++

++

(i) ++(ii) ++

Studies ofprescribing, laboratory and radiological investigationsGrade I evidence: balanced incomplete block designs, randomized controlled trials randomising doctors, and crossover trials

Marton et al US ambulatory Biochemistry and No Local guidelines: RCT-Dr (i) 01985101 care drug monitoring (i) distributed by educational (ii) 0

investigations materials (iii) ++++(ii) implemented by individualphysician feedback(iii) (i) + (ii)

Chassin and US hospital care Pelvimetry in Yes Local guidelines distributed by RCT-Dr +++McCue 198610'2 pregnancy educational meetings and mailed

educational materialsLandgren et al Australian Antibiotic No Local guidelines distributed by Crossover +++198830 hospital care prophylaxis in anti-advertising campaign and

surgery implemented with aggregatedfeedback of baseline compliance

Avorn et al US residential Psychoactive No Local guidelines distributed by RCT-Dr ++++1992'°3 care drugs lectures to non-medical staff,

educational materials to all doctors,and educational outreach visits tohigh prescribing doctors

Bearcroft et al UK general Chest x ray No Local guidelines distributed by RCT-Dr +1994'°4 practice examination postOakeshott et al UK general 4 x ray No National guidelines distributed by RCT-Dr ....1994105 practice investigations local department

Grade II evidence: randomised controlled trial randomising patients, and before and after studies controlled by activity not targeted by guidelines

Eisenberg et al US hospital care Biochemistry No Local guidelines implemented by CBA-A 01977106 investigations physician specific feedback about

over utilisationDe Vos Meiring UK general 9 Radiological No Local guidelines distributed by CBA-A ...

and Wells 19903' practice investigations mailing to targeted clinicians, nofurther attempt at implementation

Grade III evidence: before and after studies controlled by site and time series analyses

Brook and US ambulatory Injectable No State guidelines distributed by TSA ....

Williams 1976107 care antibiotic targeted mailing and practice visitsLohr and Brook prescribing and implemented with financial1980108 incentives (payment was denied

unless care complied withguidelines)

Wong et al US hospital care Biochemistry Yes Local guidelines: TSA (i) 01983'°" investigations (i) distributed by mailed (ii) +++++

educational materials(ii) (i) and implemented by changein request form

Fowkes et al UK accident and Skull x ray No National guidelines distributed by TSA ....

1984"1 emergency care examinations for specific educational programme,patients with implemented by structured headhead injuries injury card

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G0ilGnshaw, Freemlantle, Wallace, Ru3ssell, H1luitz, Watt, Long, Sheldon

Au/thors SettiitO (hCli/ 0rca iHtd user I~Itelveltiiols to P)r(Ioi(t ltys of Dcsiigii of toio/ hI/cct on fPect OttI~llvolve}1lent bi gllidelbies or1 tStlICIN Proe'( ss oultcol)167(111,idelbledcvc'/opuiic'iti

Novich ct a!l US hospital care Biochemistrs No Local guidelines implemented by: TSA (i) ++++1985 '. investigations (i) requirement for general (it) ±++++

justification for test(ii) requirement for specificjustification for test

Fosskcs at i/ UK hospital care Biochemistrs and No Local guidelines distributed bs TSA ++++1 98() haematologs specific educational meeting and

ins estigations implemented by swseeklv feedbackFos kes et al UK hospital care PreoperatiC No National guidelines implemented CBA-Dr (i) ++1986' chest X rav by: ii ++

examinations (i) utilisation reviews committee iii +(ii) feedback on individual (is ++compliance(iii) structured chest s ras requestform(iv) review of requests byradiographer

Ray ct all 1 861 US outpatient Diazepam No State guidelines distributed by C BA-Dr ++practice prescribing educational outreach visit

Asorn et a/ US hospital care Dosage of Yes Local guidelines distributed by 'ISA .+++1 988 intravenous lecture and printed materials, in

antibiotics advertisements and posters,implemented through a structuredordering form

Barcford and UK hospital care Haematological No Local guidelines distributed by TSA +++Hasling 1990' tests specific educational programme

and implemented by aggregatedfeedback and cancellation ofinappropriate expensive tests

Clarke and UK accident and Skull X ras No Local guidelines distributed by TSA +++Adams 1990'' emergency care requests in specific educational programme,

patients 55 ith implemented by general remindershead injuries

Escritt et il/ US obstetric care Prophylactic No Local guidelines approved bs TSA +++++199(o0> antibiotics for senior medical staff, distributed by

complicated pamphlet and departmentalcaesarean section meetings, and implemented

through a structured ordering formRaisch eit / US health Anti-ulcer No Local guidelines distributed bs CBA-Dr 01990l"'l maintenance treatment educational outreach visit

organisationGama et 0il UK hospital care Cardiac enzymes No Local guidelines distributed by TSA ++++1992"'' specific educational programmeSoumeraetcici! US hospital care Antibiotics No Local guidelines implemented with TSA +

19931 'a structured ordering form

Designs of trial or study: BIB balanced incomplete block design; PBIB partially balanced incomplete block design; RCT-Dr trial randomized by individual doctor,team, unit, or hospital; RCT-Pt trial randomised by patient; CBA-A before and after studs controlled by untargeted activity; CBA-Dr before and after studs controlledby other doctors; TSA time series analysis.Effect sizes (average effect size of significant results): - not measured; 0 no significant effect; + absolute effect between 0-9" ,; ++ absolute effect between 10 19",;+++ absolute effect between 20-29"/.; ++++ absolute effect between 30-39"/0;+++++ absolute effect >39"'0.

clinical settings and tasks.'8 "' They comprised35 studies of clinical care, 34 of preventivecare, and 22 of prescribing or the use ofradiological or laboratory investigations. Only14 studies were based in the United Kingdom,including four studies of clinical care (commonpaediatric conditions,' infertility managementand referral,'t dyspepsia, ' and hyper-tension't), one study of preventive care(antenatal care"), and nine studies ofinvestigations (of which six were radio-logical).3' 11t 1(' 110 12 113It 1itOf the 87 studies which examined effects on

the process of care, as measured by adherenceto recommendations of practice guidelines, 81reported significant improvements. Twelve ofthe 17 studies which assessed patient outcomereported significant improvements. All 14studies based in the United Kingdom notedsignificant improvements in compliance withguidelines; the only United Kingdom study tomeasure patient outcome also reportedsignificant improvement.>" The evidence fromthose studies considered to provide the mostreliable evidence confirmed these findings: 43out of 44 grade I studies reported significantchanges in process and eight out of 11 showedsignificant changes in outcome. The evidencefrom these rigorous evaluations strongly

suggests that properly developed guidelinescan change clinical practice and may lead tochanges in patient outcome.

Introducing guidelines into practiceAlthough guidelines can be used to help tochange clinical practice, their adoption and useis not automatic and will depend to a greatextent on how they are developed andimplemented. The behavioural factors whichinfluence adherence with guidelines are verycomplex. For example, it is often assumed thatguidelines developed by the clinicians who willultimately use them (end users) improves theirimplementation, owing partly to a perceptionof increased ownership. However only two4i 50of the four studies identified3 ""16A supportedthis. Guidelines produced locally by pro-fessional end users may at times be seen as lesscredible than those produced by locallyrespected clinicians (opinion leaders) ornational experts."3 Some interventions basedon the passive receipt of information (forexample, publication in professional journalsand mailing to relevant groups) influenceprofessionals' awareness32 and knowledge ofguidelines.64 Three studies in the UnitedKingdom of local general practitioners'guidelines for radiological investigations found

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Developing and implementing clinical practice guidelines

improved compliance after targeted mailingwithout any supporting implementationstrategy.31 104 105 However, these approachesare usually insufficient to change professionalbehaviour.

Educational interventions, requiring moreactive participation by professionals (includingtargeted seminars, educational outreach visits,and the involvement of opinion leaders) aremore likely to lead to changes in behaviour.There is some evidence of the effectiveness ofeducational outreach visits by trained staffmeeting professionals in their practice settingsin influencing prescribing behaviour (forexample, Avorn et al'03) and of the role ofopinion leaders (professionals identified bytheir colleagues as influential).48 Because theseinterventions require the investment ofvaluable resources rigorous evaluation of theircost effectiveness is important before theirwidespread use.

Implementation strategies are more likely tobe effective when they operate directly on theconsultation between the professional and thepatient. Such strategies include restructuringmedical records (for example, Emslie et al,5'Cheney and Ramsdell,73 Rodney et al"),patient specific reminders during theconsultation (for example, McDonald eta168 69) and patient mediated interventions (forexample, McPhee et al78) (whose aim is toaffect professional practice through informingpatients). Strategies operating outside theconsultation that have been rigorouslyevaluated include patient specific feedback (forexample, Tierney et al'2) and aggregatedfeedback on compliance with guidelines (forexample, Durand-Zaleski et al65), financialincentives,'07 108 explicit marketing,30 andprofessional peer review."'3

Several studies compared different edu-cational and implementation strategies(table).44 45 47 48 54 57 72 74 76 78 81 83 84 88 90 92-9699 101 109 111 113 This research suggests thateducational interventions requiring activeprofessional participation and implementationstrategies that are closely related to clinicaldecision making are more likely to lead tosuccessful implementation. In other words,implementation strategies which are nearer theend user and integrated into the process ofhealthcare delivery are more likely to beeffective. However, insufficient evidence existsto reach firm conclusions about the relativeeffectiveness of different educational andimplementation strategies in differentcontexts.

Desirable attributes of clinical practiceguidelinesStrong evidence exists that well implementedclinical guidelines can be used to change theprocess and outcome of care. However, this isonly potentially worthwhile if the changesresult in improved quality of care and efficientuse of resources. Guidelines are referred to asvalid if, when followed, they lead toimprovement in patient outcome at acceptablecosts. Validity depends on how well evidenceis identified, synthesised, and incorporated

into the guideline and, therefore, on how andby whom the guideline is developed.'22

AVOIDING BIAS

Guidelines are commonly developed by"expert" panels uninformed by the results offormal systematic literature reviews of theresearch evidence. This approach relies tooheavily on panel members' opinions andknowledge of published work. Unfortunately,published expert recommendations often lagbehind available evidence'23 and may reflectindividual enthusiasms rather than theknowledge base. Such bias may be overcomeif those developing guidelines adopt asystematic approach to identifying andsynthesising evidence.'24 Guidelines based onreviews that identify, synthesis, and interpretevidence systematically are, therefore, morelikely to be valid. Since local groups may lackthe resource and skills needed to developevidence based guidelines'25 care must betaken to ensure that any increased acceptabilityowing to local development of guidelines is notachieved at the expense of their potential toimprove patient outcomes.Many methods can be used to translate

evidence into practice recommendations,including peer groups, nominal groups, Delphitechniques, and consensus conferences.'26-7 Allhave potential biases and there is little evidenceon their relative merits.

CONSIDERING COST EFFECTIVENESS

Practice guidelines should not be solelyconcerned with clinical effectiveness butshould also pay regard to the costs oftreatments if they are to maximiseimprovements in health status.6 128-130 Theyshould explicitly take into account the costs ofinterventions so that the limited resourcesavailable are used efficiently; guidelines thatignore the issue of cost effectiveness mightrecommend practices resulting in largeincreases in cost for little correspondingimprovement in health. Unfortunately,development of guidelines has largely ignoredthe issue of costs. Since costs of treatmentsmay vary across sites the local development ofguidelines will need to consider local factorswhich may influence cost effectiveness.

INDICATING THE EVIDENCE BASE

Guidelines should clearly indicate the basis ofeach recommendation and the degree to whichit is supported by good research evidence. Thetarget patient population and circumstancesunder which the recommendations apply alsoshould be clearly stated. Clarity of definitions,language, and format is also essential.Unfortunately, few published guidelines giveenough details about development for theirvalidity to be confidently assessed.'3' Thosedeveloping guidelines should provide enoughinformation to allow potential users to make aninformed judgment about validity andrelevance to specific circumstances.'32 A guidefor structured guideline abstracts, encouragingthe publication of details of development isnow available.'33

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MAINTAINING VALIDITY

Those developing guidelines should specifyhow their guidelines should be monitored toidentify major changes in knowledge and howthe guidelines should be routinely reviewed toincorporate new knowledge. Guidelines shouldalso be piloted in several sites to ensure theirapplicability and relevance, and the experienceof patients as well as professional users shouldbe taken into account.

Guidelines and commissioningThe evidence discussed in the previoussections shows that properly developed,evidence based guidelines accompanied by aneffective implementation strategy can helppromote cost effective health care. Thereforeclinical practice guidelines may be a usefulfocus for healthcare commissioning.The purchaser's role in this process may

involve identifying the best evidence ofeffectiveness and cost effectiveness or validnational guidelines and prioritising areas forintroducing local guidelines. Purchasers alsohave a role in sponsoring the development oflocal guidelines, incorporating them incontracts and service specifications, andsupporting providers in implementing them.By itself, however, commissioning is unlikely tobe sufficient to implement guidelines.Purchasers also have a role in monitoring andevaluating the development and implemen-tation of local guidelines. This may includesome form of review of utilisation6 or audit tomeasure the extent to which recommendedstandards are actually achieved. Purchasersand providers need to agree on criteria forreviewing practice based on guidelines. Ideally,relevant data on patient outcomes should becollected and analysed routinely to explorehow implementation of guidelines may beinfluencing quality of care.

A limited number of guidelines can beassimilated by healthcare professionals or

provider organizations at any one time. Localactivities should be coordinated to prioritisethe guidelines that professional groups are

asked to implement. Greater priority should begiven to introducing guidelines which addressimportant local need, where rigorous nationalguidelines or research evidence are readilyavailable, and where current practice divergesfrom best practice, thus indicating the potentialfor significant gains in health. Local develop-ment of guidelines should be both adequatelyresourced and multidisciplinary (includingrepresentatives of all key clinical disciplinesand providers and purchasers) as successfullyimplementing guidelines normally requireschanges in the behaviour of more than oneprofessional group.'34 135 Public involvement indeveloping guidelines may enhance implemen-tation, especially when public expectationsinfluence practice. Clinical audit groups may

be well placed to coordinate and resource the

development of local guidelines if encouragedto develop skills in leading and facilitating localgroups developing guidelines.

Clinicians' concerns about the legal status ofguidelines and potential litigation resulting

from non-compliance may be a major barrierto implementing guidelines. However, com-pliance with, or deviation from, a clinicalguideline is unlikely to prove conclusive in amedical negligence action, unless it can beshown that the guideline is so well establishedthat no responsible doctor acting withreasonable skill would fail to comply with it.Therefore, medicolegal issues do not, inprinciple, represent a barrier to implemen-tation. 136

Research issuesGuidelines are not always the most appropriatetool to promote cost effective health care. Itwould be useful to study the optimalcontribution that guidelines can make.Research is needed to identify the most costeffective methods for developing valid andreliable guidelines, which should includeresearch into methods for deriving recommen-dations and incorporating costs. It is alsoimportant to develop valid instruments forcritically appraising guidelines.'3' Research isrequired of the effects of different formats andstyles of guidelines on their adoption and ofbarriers to adopting guidelines. Although someevidence exists on the effectiveness of differenteducational and implementation strategiesthese are still poorly understood in the UnitedKingdom. Future research will be able to buildon the reviews from the new CochraneCollaboration on Effective ProfessionalPractice, which will provide up to date system-atic reviews of the evidence on the effectivenessof different approaches to implementation. 137

We thank the following for their useful comments on a draft ofthe bulletin: Richard Baker, Richard Grol, Allen Hutchinson,Jonathan Lomas, Andy Oxman, and Mary Ann Thompson. TheChief Scientist Office of the Scottish Office Home and HealthDepartment fund the Health Services Research Unit. TheDepartment ofHealth funds the Effective Health Care Bulletinsand the Centre for Reviews and Dissemination. However, theviews expressed are those of the authors and not necessarily thefunding bodies.

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