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Original papers: Steve Simpson, Diane Beavis, Adrian Leddy, Sue Ball, and Ian Johnson Naturalistic audit of NICE criteria for the use of cholinesterase inhibitors Psychiatr Bull 2005; 29: 410-412 [Abstract] [Full text] [PDF]

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Not so NICE guidelines

Sudip Sikdar   (5 December 2005)

MMSE- score of 12 ?

Rashi Negi, Gill Pinner ( clinical Director in Old age psychiatry)   (23 January 2006)

Not so NICE guidelines 5 December 2005
Sudip Sikdar, Consultant Psychiatrist Member of Royal College Of Psychiatrists Send letter to journal: Re: Not so NICE guidelines livsudip{at}yahoo.co.uk Sudip Sikdar	I read with great interest the naturalistic audit of NICE criteria for the use of cholinesterase inhibitors by Simpson et al (Psychiatric Bulletin, November 2005, 29, 410 -415). It seemed to be another example of regulatory bodies being out of touch with those doing the job – or the reverse. I recently conducted a postal survey of opinions of all consultant psychiatrists in the north-west of England on NICE guidelines on restriction on venlafaxine use in depression (Clinical Guidelines 23, NICE 2004). NICE advocated severe restrictions on the use of venlafaxine on grounds of lack of superior efficacy over any other antidepressants, including SSRIs, either in remission or recovery from a depressive episode. It restricted use to treatment resistant depression only. It also recommended that venlafaxine could only be initiated and monitored by psychiatrists or GPs with special interest in psychiatry. A questionnaire with 14 questions related to various recommendations in the guidelines was sent to 375 consultants in the College’s register in the north–west of England. 180 consultants replied (response rate 48%) and 160 completed questionnaires were analysed (Table 1). Data indicated that a significant majority of consultants disagreed with all the important recommendations on venlafaxine restrictions. The survey also highlighted the lack of facilities available to most consultants which were needed to comply with the guidelines. Many consultants stopped prescribing venlafaxine principally due to fear of litigation. All the results remained significant irrespective of the speciality a consultant worked in or the number of years they have worked as a consultant or prescribed venlafaxine. Many commentators have criticised the over-reliance on RCT data to judge day-to-day clinical effectiveness of an intervention (a shortcoming NICE admit themselves in their methodology). In real life, GPs commonly initiate a depressed patient on a SSRI and failure to response leads to referral to secondary care where SNRIs like venlafaxine are frequently prescribed with good effect (86% of the consultants believed that venlafaxine should be used as a 2nd line antidepressant, contrary to NICE recommendation. Equivalent doses of venlafaxine cost double that of a SSRI or another SNRI (average £39 versus £19) and one wonders whether cost implications have been a driving force behind the recommendations (as there is a similar unresolved situation now with anti dementia drugs). The government has given a huge responsibility to NICE to advice UK clinicians in practicing evidence based effective medicine and it should not become another regulatory body. Word count: 405 Reference 1.     Simpson, S., Beavis D., Leddy A. et al. (2005) Naturalistic audit of NICE criteria for the use of cholinesterase inhibitors. Psychiatric Bulletin, 29, 410- 412. 2.     National Institute for Health and Clinical Excellence (NICE, 2004) Management of depression in primary and secondary care, Clinical Guideline 23. www.nice.org.uk/pdf/cg023fullguideline.pdf, last accessed on 1 August 2005.   Declaration of interest: none   Table 1: Survey questionnaire results     Yes No opinion No chi-square(df=2) P value 1 Do you agree with the NICE recommendations on restriction of venlafaxine prescription? 16(10%) 35(21.9%) 109(68.1%) 90.53 <.001 2 From your clinical experience, do you agree with the NICE conclusion of RCTs that venlafaxine is not more potent compared to any other antidepressant? 28(17.5%) 38(23.8) 94(58.8%) 47.45 <.001 3 From your clinical experience, do you agree that venlafaxine is not more potent than a SSRI? 29(18.1%) 27(16.9%) 104(65%) 72.23 <.001 4 Do you agree that venlafaxine should not even be used as a second line antidepressant? 7(4.4%) 14(8.8%) 139(86.8%) 322.25 <.001 5 Do you believe that venlafaxine should only be initiated by psychiatrists or GPs with special interest in mental health? 52(32.5%) 20(12.5%) 88(55%) 106.85 <0.005 6 Do you agree that patients on venlafaxine should only be supervised in secondary care or by GPs with special interest in mental health? 37(23.1%) 18(11.3%) 105(65.6%) 78.46 <.001 7 Do you agree that all patients should have an ECG and have their blood pressure checked before starting venlafaxine? 74(46.3%) 29(18.1%) 57(35.6%) 19.36 =0.13 8 Do you have a blood pressure instrument in your outpatient/community clinic? 93(58.1%) 2(1.3%) 65(40.6%) 81.46 <0.05 9 Do you actually check every patient’s blood pressure before starting venlafaxine? 49(30.6%) 5(3.1%) 106(66.3%) 96.16 <.001 10 Do you have an easy facility to do ECG for every patient you have started on venlafaxine? 47(29.4%) 3(1.9%) 110(68.8%) 108.46 <.001 11 Are you confident of reading an ECG strip? 33(20.6%) 3(1.9%) 124(77.5%) 148.88 <.001 12 If you get ECGs done, is it reported by a cardiologist (SpR, Clinical fellow, Non-career grade) on top of the machine generated printed report? 63(39.4%) 9(5.6%) 88(55%) 61.13 <0.05 13 Do you repeat ECGs after any length of time after starting a patient on venlafaxine? 37(23.1%) 14(8.8%) 109(68.1%) 92.11 <.001 14 Have you actually withheld venlafaxine for any reason on any patient that you would have otherwise started on venlafaxine after the NICE guidelines? (Please state the reasons if the answer is yes).   62(38.8%) 6(3.8%) 92(57.5%) 71.45 <.001
MMSE- score of 12 ? 23 January 2006
Rashi Negi, staff grade psychiatrist in old age psychiatry , Gill Pinner ( clinical Director in Old age psychiatry) Send letter to journal: Re: MMSE- score of 12 ? rashinegi{at}hotmail.com Rashi Negi, et al.	On reading the article by Simpson et al (2005) and the letter submitted by Dr Sarkar with interest, we fully agree with the points they have both raised and share the same concerns regarding NICE criteria for the withdrawal of cholinesterase inhibitors. We would like to raise another important point which is directly relevant to the criteria used by NICE. We are all aware that NICE recommends withdrawing treatment when the MMSE score is less than 12. This places the MMSE as a very important and decisive tool in the prescribing process. This is not necessarily appropriate. The MMSE, despite of the fact that it is a useful screening tool, has many limitations. The conventional cut-off of 24 has sensitivity of 0.63 and specificity 0.96 with an increase in sensitivity at higher scores (Kukull et al, 1994). These scores are affected by variables such as intelligence, age, educational level and sex (Cossa et al, 1997). Furthermore separate items have different sensitivities and may be more discerning than others (Braekhus et al, 1992). The diagnosis and evaluation of a dementia is a clinical process. This requires accurate history taking with collateral information on changes in functioning, behaviour, personality, clinical and cognitive examinations and relevant investigations, and not merely dependant on the MMSE score. However, to withdraw cholinesterase inhibitor treatment, NICE suggest clinicians only need to evaluate change on the MMSE score. This approach has been challenged by many clinicians. Further more, if clinicians follow the criteria stipulated by NICE, there are further weaknesses with a reliance on an MMSE score utilized in many memory clinics. Problems with inter-rater reliability, poor consistency in the practice of administration, especially when it may be delivered by a variety of professionals, in a range of different settings. It is vital in these circumstances that there is multidisciplinary training to maximize consistency across the group. This often does not happen in practice. References Braekhus A, Laake K, Engedal K (1992) The Mini-Mental State Examination: identifying the most efficient variables for detecting cognitive impairment in the elderly, Journal of the American Geriatrics Society, 40(11):1139-45 Cossa FM, Della Sala S, Musicco M, Spinnler H, Ubezio MC (1997) Comparison of two scoring systems of the Mini-Mental State Examination as a screening test for dementia, Journal of Clinical Epidemiology, 50(8):961 -5 Kukull WA, Larson EB, Teri L, Bowen J, McCormick W, Pfanschmidt ML (1994) The Mini-Mental State Examination score and the clinical diagnosis of dementia,.Journal of Clinical Epidemiology, 47(9):1061-7 Simpson S, Beavis D, Leddy A, Ball S, Johnson I (2005) Naturalistic audit of NICE criteria for the use of cholinesterase inhibitors, Psychiatr Bull, 29:410-412