Van Zwanenberg T

From 1 January 2005 every UK doctor will need a license to practise. Most doctors will be able to secure revalidation of their licence by annual appraisal and by showing that they are compliant with local clinical governance requirements and free of any serious unresolved concerns about their fitness to practise

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Learning in practiceRevalidation: the purpose needs to be clearTim van ZwanenbergFrom 1 January 2005 every UK doctor will need a licence to practise. Most doctors will be able tosecure revalidation of their licence by annual appraisal and by showing that they are compliant withlocal clinical governance requirements and free of any serious unresolved concerns about theirfitness to practiseIn May 2001, the General Medical Council confirmedthat all doctors would have to show regularly that theyremained up to date and fit to practise in their chosenfield. This process was termed revalidation, and itsintroduction was said to be a landmark in the history ofself regulation of the medical profession.The decision was made against a background ofhigh profile cases of medical malpractice andcoincided with the first term of a new governmentwhich had a mandate to modernise the health service.Indeed the years since the 1997 election have beencharacterised by a range of policy developments affect-ing the regulation of doctors in the NHS (see table Aon bmj.com). These have included the contractualneed to participate in annual appraisal and the profes-sional obligation to undergo revalidation.Recent guidance indicates that revalidation may beachieved through participating in annual appraisal.1What then is the purpose of revalidation?The emerging role of revalidationIn late 2001 I did research to analyse the development ofpolicy between May 1997 (the election of the newgovernment) and July 2001 (the publication of thereport of the Bristol Inquiry) with particular respect tothe revalidation of general practitioners. The overall aimof the study was to examine the emerging role of revali-dation in relation to other changes in professional andcontractual regulation.2The three key stakeholders (with political power)directly involved in negotiating the emergent policywere the profession, the government, and the GeneralMedical Council (the profession’s regulator). The mainfocus of my research was on their contribution to policydevelopment, and I used three principal sources of data:x Stakeholders’ key policy documents—those whichaffected or potentially affected the professional or con-tractual regulation of general practitionersx A sample of the responses to the Royal Collegeof General Practitioners’ consultation exercise onrevalidation.x In-depth interviews with 18 key opinion leaders andpolicy makers (box).Beyond the immediate antecedent of the Bristolcase, I concluded that revalidation stemmed from vari-ous causes. Firstly, failure—failure of the systems, whichwere meant to assure the public that the care theyreceived was satisfactory; and failure of the prevailingmedical culture to change with the times. The govern-ment largely attributed these failings to their predeces-sor’s internal market.3 However, by 1998 they were alsoreferring directly to the series of well publicised lapses,which they said had dented public confidence.4 Thesewere then developed into the more general theme ofunacceptable variations in practice,4 and by 1999 thegovernment was being specific in its concern aboutpoorly performing doctors.5A second antecedent, that revalidation was part of aprogressive development of the profession by the pro-fession, was a view particularly emanating from theregulator and the profession. Conversely a number ofthe opinion leaders saw revalidation as part of acomplex political readjustment between the mainstakeholders.In terms of the purpose of revalidation there werethree over-riding themes: securing public trust,promoting continuing professional development, anddetecting poor performance, with recognition that theSummary pointsRevalidation is a watershed in medical selfregulation in the United KingdomStakeholders agreed on the policy in principlebut disagreed on its operationConfusion and unease exist about whetherrevalidation is intended to detect poor performersand its overt link with appraisalUltimately separating revalidation from appraisalmay be sensible; doctors can do this by followingthe “independent route” rather than the“appraisal route” to revalidationTable A summarising the documents affecting relevant policydevelopments is on bmj.comPostgraduateInstitute forMedicine andDentistry, Universityof Newcastle,Newcastle uponTyne NE2 4ABTim vanZwanenbergprofessor ofpostgraduate generalpracticet.d.van-zwanenberg@ncl.ac.ukBMJ 2004;328:684–6684 BMJ VOLUME 328 20 MARCH 2004 bmj.compurpose might be multifaceted. The government iden-tified rebuilding public confidence in the NHS as oneof its main tasks.6 Events, they said, had strained thevital bond of trust between doctors and patients.7All identified the tension inherent in a single proc-ess, which was designed both to improve the many andto detect the few poor performers. Each group ofstakeholders, however, identified both as purposes ofrevalidation. On balance, the detection of poorperformance seemed to be uppermost in the minds ofthe government and the responders to the consulta-tion exercise. There was some support for the idea thatrevalidation would act as a screening device for poorperformers, though doubts about how effective itmight be and whether it should be seen in that way.The government set out to describe how the raft ofpolicies from government and regulator wouldtogether assure the quality of medical practice.6 Theregulator also defined the relation between revalida-tion and various other processes, including appraisal.8Among the responses to the consultation exercisethere were few references to other processes, except tosuggest that revalidation was a duplication. At that timemany of the opinion leaders were unclear about therelation between the new structures and processes—forexample, the role of the National Clinical AssessmentAuthority in relation to the General Medical Council.“It’s just alphabet soup as far as the average patientgoes,” said C Rayner, chair of the Patients Association,in a personal communication.A consensus on revalidation?At one level consensus was reached on the policythroughout, and revalidation was referenced appropri-ately in policy documents. And the consultationexercise also showed that most general practitionerresponders (1569 out of 1946; 81%) were “broadly insupport.”2 Many adverse comments were, however,given even in the supportive responses, includingobjections in principle; anxiety about the process, itsfunding and its effect on general practice; andapprehension about how general practitioners couldbe expected to meet the requirements of revalidationgiven the constraints of the health service.None of the opinion leaders voiced any substantialobjection to revalidation. Concerns were expressed,however, about the process and whether it woulddeliver the desired outcomes. In particular, wouldrevalidation redress unacceptable variation in practiceor prevent high profile medical failure?The future regulation of doctorsStakeholders also expressed disquiet about theimplications for the regulation of doctors in the future.Among the comments to the consultation exercise, inwhich respondents forecasted future consequences,two themes were evident—general pessimism about theeffect on individual doctors and concern aboutpolitical interference nationally and locally. Theopinion leaders saw potential advantages in terms ofguaranteed quality of the medical workforce. The maindisadvantages were the costs of what was seen as ahighly bureaucratic process and the possible negativeimpact on doctors themselves.The stakeholders accepted that at some point arecently revalidated doctor would be found in breachbut had different views on the likely consequences ofthis. One opinion leader thought that sensitivity andreliability tests would come, whereas another saw thepotential for a huge loss of credibility. Expectations hadbeen built up high, and each time there had been areiteration of the problems of poor practice, theGeneral Medical Council was said to have come outand stated, “Don’t worry, revalidation’s coming.”Nevertheless the opinion leaders thought thatprofessional self regulation would endure for the fore-seeable future, though its importance might wane.Equally though the profession and its regulator had todeliver.Where does revalidation sit now?The historian AJP Taylor commented that the greatestdecisions are nearly always the ones most difficult toexplain simply.9 So it is with revalidation. For althoughthe main stakeholders agreed in principle on thepolicy, they reached only partial consensus on thereasons for revalidation, its purpose, its place amongother mechanisms, and its likely effects. Given thisbackground and the recent guidance which overtlylinks revalidation with appraisal, what might be theimplications for the future?Clearly the chief protagonists have seen value inrevalidation, but it has had its critics. Some have arguedthat the purpose is not clear, and needs to be so thatdoctors and patients know what to expect10; others thatOpinion leaders and policy makers interviewedInterviews were in summer of 2001; T = telephoneinterview and F = face to face interviewThe profession• Chairman of council, Royal College of GeneralPractitioners (T)• Chairman, General Practitioners Committee of theBritish Medical Association (F)• Chairman, British Medical Association (F)• Chairman, Academy of Medical Royal Colleges (T)• President, Royal College of General Practitioners (T)The government• Chief medical officer (for England) (F)• Chief executive, Commission for HealthImprovement (T)• Chair, National Clinical Assessment Authority (T)• Chief executive, NHS Confederation (T)• Chair, National Institute for Clinical Excellence (F)• Clinical director of primary care for the NHS (inEngland) (T)The regulator• President, General Medical Council (F)• Lay member, General Medical Council, and Chair,Patients’ Representative Group (T)• Lead for General Medical Council on pilotingrevalidation (F)Other stakeholders• Chair, Patients Association (T)• Deputy chief nursing officer (for England) (T)• Director, College of Health (T)• Editor, British Medical Journal (T)Learning in practice685BMJ VOLUME 328 20 MARCH 2004 bmj.comthe process is not fit for purpose.11–13 In particular thereis confusion about whether revalidation is intended todetect poor performance, and if so, whether the proc-ess will suffice. Formative appraisal and summativerevalidation are seen as uneasy bedfellows.13 14For most doctors the process will entail participa-tion in an appraisal system, which must be aligned withthe headings in Good Medical Practice and qualityassured to the satisfaction of the General MedicalCouncil.15 The Council states that such participationwill be “a powerful indicator of a doctor’s currentfitness to practise,”1 but makes no claim that the proc-ess will be sensitive (identify poor performance),specific (identify educational needs), valid (reflectactual clinical practice), or reliable (behave consistentlyacross cohorts of doctors).16 Where there is any doubtdoctors will be invited to submit more information andmay be subjected to the performance procedures.ConclusionIt is difficult to escape the conclusion that the purposeof revalidation is as a form of professional regulatoryenforcer to ensure the NHS implements appraisal in adesignated manner. This may be enough to encouragedoctors to develop and to seek help early in case of dif-ficulty. Alternatively, doctors relying for their revalida-tion on five appraisals might be tempted to set easilyachievable objectives in their personal developmentplans, rather than risk failing to meet a challenge. Theproblems with this dual purpose have long beenrecognised.17 In Pringle’s view, the most likely outcomeis the worst of all worlds, where the developmental andformative nature of appraisal is lost, and where revali-dation fails to identify poor performers.13Whether patients and the government will be satis-fied remains to be seen, particularly if (and predictablywhen) a recently revalidated doctor is found to havebeen a poor performer. Ultimately it may be more sen-sible to separate revalidation from appraisal. Doctorsthemselves could choose the independent route torevalidation,1 by submitting other evidence of minimalfitness to practise—appropriate tools are beingdeveloped. Or we could move wholesale to such amodel (as in Canada), where a screening tool providesfeedback on performance to all while identifying theminority of doctors at risk of being poor performers.These doctors are then investigated in more depth.18Patients and others might be more convinced by this.12Finally, the impact on doctors and patients shouldnot be underestimated. In just over a decade, the NHShas moved from being an organisation based on hightrust relationships to one where explicit written downstandards, which are monitored, have become the normfor individuals and institutions. Revalidation is part ofthis increased bureaucratic control being applied toprofessional self regulation. It may increase apparentaccountability, but may not foster a culture whichincreases patients’ trust and doctors’ professionalism.19I thank Madeleine Atkins for her supervision, the Royal Collegeof General Practitioners for access to the responses to the con-sultation exercise, and the interviewees for giving their valuabletime so freely.Contributors: TvZ is the sole contributor.Competing interests: TvZ was an informed participant as chairof the UK Committee of General Practice Education Directorsand a member of the Royal College of General PractitionersRevalidation Working Group.Funding: None.1 General Medical Council A licence to practise & revalidation. London: Gen-eral Medical Council, 2003.2 Van Zwanenberg TD. The revalidation of general practitioners: an analysis ofpolicy development between May 1997 and July 2001. University of Newcas-tle, 2002. (Thesis for doctorate of education.)3 Department of Health. The new NHS: modern, dependable. London:Stationery Office, 1997.4 Department of Health. A first class service: quality in the new NHS. London:Stationery Office, 1998.5 Department of Health. Supporting doctors, protecting patients. London:DoH, 1999.6 Department of Health. Assuring the quality of medical practice: implementingsupporting doctors protecting patients. London: DoH, 2001.7 Department of Health. Modernising medical regulation: interim strengtheningof the GMC’s fitness to practise procedures. London: DoH, 2000.8 General Medical Council. Revalidating doctors: ensuring standards, securingthe future. London: GMC, 2000.9 Taylor AJP. English history 1914-1945. Oxford: Oxford University Press,1975.10 Newble D. Purpose of revalidation process must be agreed on. BMJ2001;322:358.11 Wakeford R. GMC’s proposals for revalidation would not be accurate,economical, or fair. BMJ 2000;321:1220.12 Wakeford R. Appraisal makes for effective revalidation. BMJ 2003;327:161.13 Pringle M. Re-evaluating revalidation and appraisal. Br J Gen Pract2003;53:437-8.14 Conlon M. Appraisal: the catalyst of personal development. BMJ2003;327:389-91.15 General Medical Council. Good medical practice. London: GMC, 2001.16 Roberts C, Newble DI, O’Rourke AJ. Portfolio-based assessments inmedical education: are they valid and reliable for summative purposes?Med Educ 2002;36:899-900.17 Irvine D. General practice in the 1990s: a personal view on future devel-opments. Br J Gen Pract 1993;43:121-5.18 Dauphinee D. Revalidation of doctors in Canada. BMJ 1999;319:1188-90.19 van Zwanenberg T. The system responds. In: Harrison J, Innes R and vanZwanenberg T, eds. Rebuilding trust in healthcare. Oxford: Radcliffe Medi-cal Press, 2003.(Accepted 10 September 2003)Corrections and clarificationsDecline in mortality, AIDS, and hospital admissionsin perinatally HIV-1 infected children in theUnited Kingdom and IrelandMis-reading of the alignment in table 3 of this paper(table 2 in the abridged version) by D M Gibb andcolleagues led us to print the hazard ratios for deathand AIDS/death incorrectly for “How the child wasidentified” (BMJ 2003;327:1019-23). The hazardratios for “prospectively from birth” and “after birth”should be inverted: the values for children identifiedafter birth are therefore 1, and for children identifiedprospectively from birth 0.49 (95% confidenceinterval 0.31 to 0.78) and 0.44 (0.30 to 0.64).ABC of smoking cessation: Nicotine replacement therapyThe table showing the formulations and availabilityof nicotine replacement products in this article byAndrew Molyneux contained an error (21 February,pp 454-6). Nicorette nasal spray is licensed as aPharmacy (P) medicine and is available over thecounter at pharmacies; it is not a prescription-onlyproduct, as stated in the table.Effects of low dose ramipril on cardiovascular and renaloutcomes in patients with type 2 diabetes and raisedexcretion of urinary albumin: randomised, double blind,placebo controlled trial (the DIABHYCAR study)A wrong reference number persisted to publicationof the full version of this article by Michel Marreand colleagues (28 February, pp 495-9). In the fifthparagraph of the Discussion, in the sentencestarting “Conversely, only 30% of the diabeticpatients . . .” the reference for the HOPE andMICRO-HOPE studies should be reference 9(not 11, as stated). The references in the abridgedversion are correct.Learning in practice686 BMJ VOLUME 328 20 MARCH 2004 bmj.com

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Revalidation: The purpose needs to be clear

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Revalidation: The purpose needs to be clear

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