National Institute for Health and Clinical Excellence. Clinical guideline: ADHD PRE-PUBLICATION CHECK

Transcription

1 National Institute for Health and Clinical Excellence Clinical guideline: ADHD PRE-PUBLICATION CHECK Organisation Eli Lilly and Company Limited Eli Lilly and Company Limited Eli Lilly and Company Section Order number in FULL guideline 1 General Comment Appendice s Page Line reported error Response Thank you for the opportunity to review the ADHD guideline for errors. The use of atomoxetine in adults is unlicensed the atomoxetine SPC (section 4.2) states the following: In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, start of treatment with STRATTERA in adults is not appropriate. Whenever atomoxetine is mentioned in the context of treating adults you may want to consider the inclusion of an asterisk next atomoxetine (as used in other NICE guidelines), to reference the SPC wording above The Contents listing needs checking - Appendix 10 is listed 3 times with different page numbers. 1 Thank you. Thank you for your helpful suggestion. We have followed the NICE convention of stating that drugs do not have marketing authorisation in the beginning of the relevant section ( Treatment of adults with ADHD). This is linked to the first recommendation of the section, but is not repeated. We have clarified the footnote to state: At the time of publication (month 2008) Methylphenidate, dexamfetamine, and atomoxetine did not have UK marketing authorisation for use in adults with ADHD. However, atomoxetine is licensed for adults with ADHD when the drug has been started in children. We have also moved recommendation into this section, where it will be covered by this footnote. We did not reference the SPC in the health economics section ( ), as typically only recommendations are footnoted in this way. Thank you; this will be addressed by our copy editor upon final publication.

2 Limited Eli Lilly and Company Limited 4 Appendice s The references are not mentioned in the contents listing. Unable to comment not included. Flynn Pharma Omission of reference to availability of Medikinet (Tablets) for which SPC is available on Electronic Medicines Compendium. This is one of only two immediate release presentations available and licensed in the UK for 5mg, 10mg and 20mg. Flynn Pharma The suffix XL is omitted after the brand name Concerta Flynn Pharma For consistency, after the mention of Medikinet XL, the supplier (Flynn Pharma Ltd) should be identified. Flynn Pharma Table after line 26 Novartis UK 1 General comment Equasym XL is incorrectly identified as Equasym XR. Medikinet XL is omitted from the table, notwithstanding it is available as a 10mg, 20mg, 30mg and uniquely also a 40mg strength. These are equivalent (in a single daily dose) to total daily doses of 10mg, 20mg, 30mg and 40mg IR-MPH respectively. It should also be noted that combinations of Medikinet XL strengths can be used to meet the need for a 50mg and a 60mg daily dose as well. The origin of the table is not clear It might be clearer to refer to OROS-MPH as Concerta XL. It should also be noted that the table shows a dose equivalence of 60mg IR-MPH to 72mg OROS-MPH (Concerta XL)- your attention is drawn to the fact that whereas 60mg IR-MPH is licensed at such a total daily dose (as are Medikinet XL and Equasym XL), Concerta XL is not licensed at daily doses above 54mg (see BNF 55 and Concerta XL SPC) Thank you for the opportunity to review the ADHD Guideline prior to publication. We have not been able to identify any factual errors thus do not have any further comments. 2 Thank you. Medikinet (tablets) added. Supplier information was not identified in the document.. Thank you. Quality p.180 lines 17-26

3 improvement Scotland 'One study of a parent-training intervention was excluded from the analysis as the level of attendance was poor to the extent that any difference between the intervention and control groups might not be attributable to the intervention (BARKLEY2000). In this trial only 13% of parents assigned to parent training attended a minimum of nine out of 14 sessions, and while the majority did attend at least one session (67%) under half (42%) attended a minimum of five sessions. The children in this study also differed somewhat from others as they were younger (mean age 4.9 months) and were included on the basis of a parent measure of disruptive behaviour (14 symptom items for ADHD and eight symptom items for ODD).' Shire Ltd 1 General comment Shire Ltd 2 Table of Comment s For Info Age is as 4.9 months - should be?4.8 years. Some references are cited throughout the text of the document but not appropriately referenced in the Reference section. We have noted below on this Pre-Publication Check Form a number of instances where this occurs, although our list is not intended to be all-inclusive. We have not checked the reverse situation, ie whether listed references in the Reference section have not been cited in the text 6 30 Delete full stop after ADHD ; move 95 up from line 31 Thank you; this will be checked by our copy editor before publication. Thank you. Shire Ltd Correct font of the Shire Ltd Olfson et al., 2003 not cited in the Reference section - Olfson, M., Gameroff, M.J., Marcus, S.C., Jensen, P.S. (2003). National trends in the treatment of attention deficit hyperactivity disorder. Am J Psychiatry, 160(6), Shire Ltd General comment: this section should be appropriately referenced Shire Ltd Several studies have followed, etc. - these studies should be cited in the text and Reference section 3 Thank you; we have added references. Thank you; references have been added.

4 Shire Ltd Longitudinal population studies, etc. - these studies should be cited in the text and Reference section Shire Ltd This statement contradicts the chronicity of ADHD: Nevertheless, it is important to remember that many young people with ADHD will make a good adult adjustment and be free of mental health problems. The statement appears to be inconsistent with the clinical course of the disorder as stated in section 2.3 (Adult ADHD, p. 28, lines 26-31): A recent review of longitudinal follow-up studies of individuals diagnosed with ADHD as children found that by age 25 only 15% retained the full ADHD diagnosis. However, a much larger proportion (65%) fulfilled the DSM criteria for ADHD in partial remission, indicating the persistence of some symptoms associated with clinical impairments (Faraone et al., 2006) Shire Ltd Close space: benefits Shire Ltd (Table 2) B. Impulsivity: The statement as written is inconsistent with the DSM-IV-TR diagnostic criteria: often has difficulty awaiting turn and often interrupts or intrudes on others. Shire Ltd Typographical error: American Psychiatric Association Shire Ltd Close line space Shire Ltd Epstein et al. ( Reference section- citation states published in 2005?) Shire Ltd Goodman ( Reference section- citation states published in 1997?) Thank you; references have been added. We have changed the statement in italics to be clearer. (1) Although ADHD symptoms persist in the majority of cases, it is important to remember that many young people with ADHD will make a good adult adjustment and be free of mental health problems - Epstein, J. N., Johnson, D., & Conners, C. K. (2001). CAADID: Conners adult ADHD diagnostic interview for DSM- IV technical manual. North Towanda, NY: Multihealth Systems, Inc. - Goodman, R. (2001). Psychometric properties of the Strengths and Difficulties Questionnaire. Journal of the American Academy of Child and Adolescent Psychiatry, 40, Shire Ltd Achenbach et al., 2003: Refer to Reference section Reference is included in reference section - Achenbach, T.M, Dumenci, L. & Rescorla, L.A. (2003) DSM-oriented and empirically based approaches to 4

5 Shire Ltd ,34 Refer to Reference section- need to differentiate between two Conners citations Shire Ltd Verhulst & Van der Ende, 2002 not cited in Reference section Shire Ltd Typographical error: Tourette s syndrome (also noted in other sections of the Guideline) Shire Ltd Refer to Reference section- Barkley & Murphy, 1998 Shire Ltd Polancyzk and colleagues, 2007 not cited in Reference section 5 constructing scales from the same item pools. Journal of Clinical Child and Adolescent Psychology, 32, added Conners et al. (1997): Conners, C.K., Conners, K.C., Wells, J.D., Parker, G., Sitarenios, J.M. et al. (1997). A new self-report scale for assessment of adolescent psychopathology: factor structure, reliability, validity, and diagnostic sensitivity, Journal of Abnormal Child Psychology, 25, Verhulst, F. C. & Van der Ende, J. (2002). Rating scales. En M. Rutter & E. Taylor (Eds.), Child and Adolescent Psychiatry (pp ). Oxford: Blackwell. - Polanczyk, G., Silva de Lima, M., Horta, B.H., Biederman, J. & Rohde, L.A. (2007). The worldwide prevalence of ADHD: A systematic review and metaregression analysis. Am J Psychiatry, 164, Shire Ltd Taylor et al., 1991 not cited in Reference section - Taylor, E., Sandberg, S., Thorley, G., et al (1991) The Epidemiology of Childhood Hyperactivity. Oxford: Oxford University Press. Shire Ltd Ornoyet al., 2001 not cited in Reference section - Ornoy, A., Segal, J., Bar- Hamburger, R. & Greenbaum, C. (2001). Developmental outcome of school-age children born to mothers with heroin dependency: Importance of environmental factors.

6 Developmental Medicine & Child Neurology, 43, Shire Ltd Title of reference implies deficiency of Zn, not toxicity Shire Ltd Dietary Interventions is Chapter 9, not Chapter 8 (pages ). Shire Ltd Richardson, 2004 not cited in Reference section - Richardson, A. (2004). Long-chain polyunsaturated fatty acids in childhood developmental and psychiatric disorders. Biomedical and Life Sciences, 39 (12), Shire Ltd Biederman et al, 2002 not cited in Reference section 6 in full guideline to Biederman et al Biederman J, Faraone SV, Keenan K, Benjamin J, Krifcher B, Moore C, Sprich- Buckminster S, Ugaglia K, Jellinek MS, Steingard R, Spencer T, Norman D, Kolodny R, Kraus I, Perrin J, Keller M, Tsuang MT (1992) Further evidence for family-genetic risk factors in attention deficit hyperactivity disorder: patterns of comorbidity in probands and relatives psychiatrically and pediatrically referred samples. Arch Gen Psychiatry 49: to Schachar et al., 1997 Shire Ltd Schachar et al. ( Reference section- citation states published in 1997?) Shire Ltd Preferable that reference reads:..appraisal #98 (NICE, 2006b).. Shire Ltd , 7 Reference should be NICE, 2006b Shire Ltd Duplicate full stop at end of the sentence ( support ) Shire Ltd Bailey 2006 not cited in Reference section - Bailey, S. (2006) ADHD - what's in a name? Paper presented at the British Education Research Association Conference, Warwick, England, September 6-9, ents/ htm [accessed June

7 2008] Shire Ltd Medication section should be appropriately referenced We have referred readers to Chapter 10 for the full trial reports. Shire Ltd This statement requires revision to identify that. these immediate effects are in reference to immediate-release formulations Shire Ltd Pharmacological treatment is Chapter 10, not Chapter 9 Shire Ltd Delete additional space after had a Shire Ltd Punctuation required at end of the statement Shire Ltd This section should be appropriately referenced. Shire Ltd Reference section states Dalsgaard et al 2002 to 2002 in full guideline. Shire Ltd Add in the US after costs Shire Ltd Should be higher than Shire Ltd Reference spelling should be Leibson? to Leibson Shire Ltd Add in the US after 25% Shire Ltd Hankin et al 2001 not cited in Reference section Hankin, C.S. (2001). ADHD and its impact on the family. Drug Benefit Trends, 13 (Suppl C), Shire Ltd footnot Should be data were e Shire Ltd Add Figure 3 to the text Thank you; the reference to Figure 3 has been deleted, as the information in the bullet point is sufficient. Shire Ltd For clarity, we suggest additional words:.concerta XL (at this stage he was taking 108mg daily in the morning, plus.. Shire Ltd ,18,3 References are not cited in Reference section - References added. 2,35 Shire Ltd This sentence should be appropriately referenced Shire Ltd Delete the first are Shire Ltd Green et al, 2004 not cited in Reference section - Green, M.O., O Reilly, J., Itchon & Sigafoos, J. (2004). Persistence of early aberrant behavior in children with developmental disabilities. Research in Developmental Disabilities, 26, Shire Ltd ,20,2 3,28,3 Green et al, 2004 not cited in Reference section 7 - Green, M.O., O Reilly, J., Itchon & Sigafoos, J. (2004).

8 5 Persistence of early aberrant behavior in children with developmental disabilities. Research in Developmental Disabilities, 26, Shire Ltd Typographical error: activities Shire Ltd Efron et al, 1998 not cited in Reference section; add et al to Meaux 8 Efron D., Jarman F.C., Barker, M.J., (1998). Child and parent perceptions of stimulant medication treatment in attention deficit hiperactivity disorder. J Paediatr Child Health, 34(3), Shire Ltd Singh et al. not cited in Reference section It is in the references list in the appendix where the study is located. We will combine both reference lists on publication. Shire Ltd Many studies - should be appropriately referenced We have clarified this. Shire Ltd Taylor et al., should this be 1996 as stated in Reference section? This should be Taylor 1986; reference has been added. Shire Ltd Kessler et al., 2002 not cited in Reference section - Kessler, R.C., McGonagle, K.A., Zhao, S., Nelson, C.B., Hughes, M. et al. (1994). Lifetime and 12- month prevalence of DSM-III-R psychiatric disorders in the United States: Results from the National Comorbidity Survey. Arch Gen Psychiatry, 51, Shire Ltd Rosenman, 2006 not cited in Reference section reference omitted in full guideline. Shire Ltd Duplicate period at end of the statement (after Section 5.14 ) Shire Ltd require not requires Shire Ltd Typographical error: parents Shire Ltd Clarification required: higher juvenile and adult arrest rates compared to what? The comparison is to normal controls (boys) and has been amended Shire Ltd The uterus is not exposed to tobacco smoke. We suggest rewording, thus:..exposure in utero to the consequences of tobacco smoking Shire Ltd Punctuation required at end of the statement Shire Ltd Punctuation required at end of the statement

9 Shire Ltd Feigner criteria should be defined and appropriately referenced Shire Ltd Add % after 6.8 and 15.8 Shire Ltd Typographical errors: consideration and not Shire Ltd This sentence should be appropriately referenced 9 This refers to the Washington University Diagnostic Criteria referred to earlier in the chapter Shire Ltd Identify which Rutter reference is being referenced Shire Ltd Use ADHD rather than ADD for consistency Shire Ltd Punctuation required at end of the statement Shire Ltd Should this be after the age of 7? No. What we mean by Should the age of onset before 7 years be strictly applied? is whether the current criteria of age of onset before 7 years is that it would exclude many children whose onset is later (7 to 12 years of age). The headline questions whether this current criteria of onset should be strictly followed. Shire Ltd Punctuation required at the end of the statement Shire Ltd Typographical error: presence Shire Ltd Remove underline Shire Ltd Typographical error: have Shire Ltd Duplicate full stop at end of the statement (after disorder ) Shire Ltd Typographical error: in Shire Ltd Methylphenidate is indicated in the treatment of to 6 years or older. ADHD in children aged 6 years or older Shire Ltd Should this be 4.9 years (rather than months )? Shire Ltd Table Quality of the data is not defined (e.g., high, 7 moderate or low) Shire Ltd Text is largely repeated on page 192 Shire Ltd Should be: parents not parent s Shire Ltd Feingold theory should be defined and appropriately referenced. Shire Ltd Should the year be 1980? The reference should be Conners 1976 which ha also been added to the reference list. Shire Ltd Richardson & Montgomery 2005 not cited in Reference section Richardson, A.J. & Montgomery, P. (2005). The Oxford Durham study: a randomized,

10 controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics, 115, Shire Ltd Bradley, 1937 not cited in Reference section - Bradley, C. (1937). The behavior of children receiving benzedrine. Am J Psychiatry, 94, Shire Ltd Poulton, 2006 not cited in Reference section - Poulton, A. (2006). Growth and sexual maturation in children and adolescents with attention deficit hyperactivity disorder. Current opinion in pediatrics. 18, Shire Ltd Immediate-release methylphenidate was originally. licensed in the US in 1955 (refer to NDA for Ritalin) Shire Ltd Footnote for 13 is not cited at the bottom of the page footnote number was omitted. Shire Ltd Footnotes for 14 and 15 are not cited at the bottom of the page footnote numbers were omitted. Shire Ltd Figure X requires appropriate identification Table 25. Shire Ltd Is waiting list supposed to be waitlist control? Yes. It has been amended to waitlist control Shire Ltd Footnote for 20 is not cited at the bottom of the page footnote number has been omitted. Shire Ltd Figure X requires appropriate identification Table 27. Shire Ltd and These statements appear to contradict the NICE recommendations regarding pharmacological treatments in children (refer to Section 10.18). Although the clinical data are limited regarding dexamfetamine, it is licensed for the treatment of ADHD. These statements on p304 appear too strong, given that the Technology Appraisal recommends dexamfetamine on the basis of crossover trials Shire Ltd Merge into one sentence: children, although, in order to construct correct text Shire Ltd The date of the reference should be 1976a Shire Ltd / Table Quality of the data is not defined (e.g., high, moderate or low) Shire Ltd Table Etc.: Medication status is not defined in the table 10 Thank you for your comments; we have amended the statements in the evidence summary.

11 36 Shire Ltd Typographical error: trials Shire Ltd Typographical error: trial Shire Ltd 104 Appendix There is no specific mention of behavioural therapy as an option. Given that behavioural therapy is typically first in line, not including those costs gives an inaccurate estimate of total costs. It also appears to create an inaccurate impression that behavioural therapy costs nothing UCB Group 1 UCB has no specific comments on the guideline findings, apart from welcoming the clarity it will bring to those involved managing this difficult condition. This is a standard data extraction form used to extract data from economic studies included in the systematic literature review across all NCC-MH guidelines. Therefore, categories of costs included are general and not specific to treatments covered in this guideline. Where applicable, costs of behavioural therapy reported in economic studies have been extracted under the heading direct treatment. Thank you. 11