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PAPERS: Nick Freemantle Is NICE delivering the goods? BMJ 2004; 329: 1003-1004 [Full text]

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More recent data on NICE implementation shows a different picture

Michael Rawlins, Andrew Dillon   (29 October 2004)

But what if NICE is wrong?

Robert G Buist   (2 November 2004)

More recent data on NICE implementation shows a different picture 29 October 2004
Michael Rawlins, Chairman National Institute for Clinical Excellence WC1V 6NA, Andrew Dillon Send response to journal: Re: More recent data on NICE implementation shows a different picture	NICE hasn’t recently “woken up” to the issue of implementing its guidance (as Freemantle alleges in his Commentary[1]). The Institute from its inception was acutely aware of the importance of its guidance being incorporated into routine clinical practice[2]. In retrospect it was probably a mistake for NICE not to have been given explicit responsibility for monitoring the implementation of its guidance at the outset[3]. Nevertheless the Institute’s own concerns, from the beginning, led NICE to ask the NHS R&D programme to commision research in this area. In June this year, the Institute launched an implementation support strategy[4], headed by an executive director. In addition, the Healthcare Commission will soon be putting in place an inspection regime specifically for NICE guidance. The study by Sheldon et al[5], and about which Freemantle wrote his Commentary, covers the earliest period of the Institute’s existance; and pre-dates the Direction now requiring trusts to fund NICE’s appraisal guidance[6]. More recent studies – of which Freemantle appears to be unaware – give a somewhat different picture. The most extensive has been that undertaken by Abacus International[7] which covered a larger number of appraisals (28), for a longer period of time (at least a year), and included ones published after the Direction came into force. The results suggest that there was full implementation of 12 appraisals, less than complete implentation of 12 appraisals, and over implementation of 4 appraisals. More reviews are available on our web site[8]. NICE accepts that more needs to be done to secure full implementation of its guidance – hence our implementation support programme. But the facts show that Freemantle’s incomplete Commentary is very wide of the mark. Michael Rawlins, Chairman Andrew Dillon, Chief Executive References 1.Freemantle, N. Is NICE delivering the goods? BMJ 2004;329:1003- 1004, 2.Rawlins, M. In persuit of quality: The National Institute for Clinical Excellence. Lancet 1999; 353: 1079–82 3.Department of Health. A First Class Service.London: Department of Health,1998. 4.National Institute for Clincial Excellence. Supporting the Implementation of NCE Guidance. NICE: London, May 2004 (available from www.nice.org.uk) 5.Sheldon TA, Cullum N, Dawson D, Lankshear A, Lowson K, Watt I, et al. What’s the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients’ notes, and interviews. BMJ 2004;329:999 6.Department of Health. Directions to Primary Care Trusts and NHS trusts in England concerning Arrangements for the Funding of Technology Appraisal Guidance from the National Institute for Clinical Excellence (NICE). Department of Health:London, 2003 7.Abacus International. NICE guidance implementation tracking. NICE: London, 2004 (avaialble from www.nice.org.uk) 8.www.nice.org.uk/implementation Competing interests: None declared
But what if NICE is wrong? 2 November 2004
Robert G Buist, Director of Obstetrics Royal Hospital for Women, Barker St, Randwick, NSW 2031 Send response to journal: Re: But what if NICE is wrong?	The NICE Clinical guideline regarding fetal monitoring in labour gives emphatic advice regarding the lack of need to recommend electronic fetal monitoring in low risk labours; either as an admission test or continuously in labour (1). This view has been taken up and widely promulgated (2). "There is no evidence", my colleagues tell me, "that such monitoring is appropriate", quoting NICE or the guideline underpinning the NICE advice (3). Perhaps. But evidence is like life itself - not so black and white. The Cochrane review examining continuous electronic fetal monitoring in labour (4) draws exactly the same conclusion as the Dublin Randomised Controlled Trial (RCT) of electronic fetal monitoring in labour (5). The reason for this is simple and obvious - the sheer size of the Dublin RCT ensures its total dominance of the Cochrane meta-analysis, and hence, the NICE guideline. Yet how many people have read the Dublin trial? How many note that the study group only included women in whom a normal volume of clear liquor was demonstrated (usually at amniotomy) shortly following admission in labour? How many recall that the patients that were excluded from the trial because of significant meconium staining of the liquor or oligohydramnios (again, usually at amniotomy) had a much higher perinatal mortality than the group studied (11.4 / 1000 versus 2.1 / 1000)? The poor performance of electronic monitoring in reducing adverse outcomes in the Dublin trial can be explained in part by the rarity of such events in the particular group of patients studied (5). Routine early amniotomy is - rightly in my view - not practiced in most UK and Australian units yet NICE - and hence my colleagues - feel comfortable to extrapolate the findings of the Dublin trial to current clinical practice when in this instance our practice is quite different to that in Dublin. The same caveats need to be applied to the more recent large trial examining admission cardiotocographs in Dublin (6). Even women declining an amniotomy in early labour were excluded from the study. So the NICE conclusions should be "that there is no evidence supporting the routine use of electronic fetal monitoring - either continuously or as an admission test -in women who have a normal volume of clear liquor demonstrated on admission in labour." This is a very different interpretation of "the evidence" than that espoused. Detail, perhaps. 1. National Institute for clinical Excellence. Inherited Clinical Guideline C: The use of electronic fetal monitoring: The use and interpretation of cardiotocography in intrapartum fetal surveillance . NICE, May 2001. 2. Goddard, R. Electronic fetal monitoring: Is not necessary for low risk labours. BMJ 2001; 322: 1436 - 37. 3. Royal College of Obstetricians and Gynaecologists. The use of electronic fetal monitoring: the use and interpretation of cardiotocography in intrapartum fetal surveillance. London: RCOG, 2001. 4. Thacker SB, Stroup D, Chang M. Continuous electronic heart rate monitoring for fetal assessment during labor (Cochrane Review). In: The Cochrane Library, Issue 4, 2003. Chichester, UK: John Wiley and Sons, Ltd. 5. Macdonald D, Grant A, Sheridan-Pereira M, Boylan P, Chalmers I. The Dublin randomised controlled trial of intrapartum fetal heart rate monitoring. Am J Obstet Gynecol 1981; 152: 524 - 39. 6. Impey L, Reynolds M, MacQuillan K, Gates S, Murphy J, Shiel O. Admission cardiotocography: a randomised controlled trial. Lancet 2003; 361: 465 - 70. Competing interests: None declared