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					                                                               NHS Sheffield
                                                         Framework of NICE Guidance
                                                                 July 2009

Guideline   Title                  Summary                                                                       Implications                          Review         Local
No                                                                                                                                                      Date          Action
TA173       Tenofovir isoproxil     This guidance does not apply to people with chronic hepatitis B who         NICE state that this guidance        March
            for the treatment        also have hepatitis C, hepatitis D or HIV.                                  applies to acute care and that       2012
            of chronic                                                                                           it does not impact on PbR.
            hepatitis B               Tenofovir disoproxil, within its marketing authorisation, is
                                       recommended as an option for the treatment of people with chronic         NICE state that implementing
                                       HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral            this guidance is unlikely to
                                       treatment is indicated.                                                   result in a significant change in
                                                                                                                 resource use in the NHS
TA174       Rituximab for the         Rituximab in combination with fludarabine and cyclophosphamide is         NICE state that this guidance        December
            first-line treatment       recommended as an option for the first-line treatment of chronic          is for acute care.                   2010
            of chronic                 lymphocytic leukaemia in people for whom fludarabine in
            lymphocytic                combination with cyclophosphamide is considered appropriate.              Drugs affecting the immune
            leukaemia                 Rituximab in combination with chemotherapy agents other than              response are currently
                                       fludarabine and cyclophosphamide is not recommended for the first-        excluded from PbR and
                                                                                                                 remain subject to local
                                       line treatment of chronic lymphocytic leukaemia.
                                                                                                                 negotiation and agreement.

                                                                                                                 NICE state the net cost of
                                                                                                                 implementing this guidance is
                                                                                                                 £22,400 per 100,000
                                                                                                                 population
TA175       Gefitinib for the      NICE is unable to recommend the use in the NHS of gefitinib for the second-   Not applicable                       January
            second-line            line treatment of locally advanced or metastatic non-small-cell lung cancer                                        2100 (sic)
            treatment of           because no evidence submission was received from the manufacturer or
            locally advanced       sponsor of the technology.
            or metastatic non-
            small-cell lung
            cancer
            (terminated
            appraisal)
CG89        When to suspect        The following topics were outside the scope of this guideline and have        NICE state that this guidance          t.b.c.
            child                  therefore not been covered:                                                   is for all health professionals in
            maltreatment            risk factors for child maltreatment, which are well recognised (for         all sectors.
                                       example, parental or carer drug or alcohol misuse, parental or carer




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                                                              NHS Sheffield
                                                        Framework of NICE Guidance
                                                                July 2009

Guideline   Title                Summary                                                                          Implications                       Review    Local
No                                                                                                                                                    Date     Action
                                     mental health problems, intrafamilial violence or history of violent         NICE state that this guidance
                                     offending, previous child maltreatment in members of the family, known       may have significant resource
                                     maltreatment of animals by the parent or carer, vulnerable and               impact on both the initial costs
                                     unsupported parents or carers, pre-existing disability in the child)         of investigating suspected
                                    protection of the unborn child                                               child maltreatment and any
                                    children who have died as a result of child maltreatment                     interventions delivered. These
                                    diagnostic assessment and investigations (for example, X-rays)               upfront direct costs may be
                                    treatment and care of the child if maltreatment is suspected                 offset by significant
                                    how healthcare professionals should proceed once they suspect                downstream savings.
                                     maltreatment                                                                 However, for reasons outlined
                                    healthcare professionals’ competency, training and behaviour                 above, it is not possible to
                                    service organisation                                                         quantify the costs or savings.
                                    child protection procedures
                                    communication of suspicions to parents or carers, or the child or young
                                     person
                                    education and information for parents or carers, or the child or young
                                     person.

                                 The following terms are used to describe children of different ages:
                                  infant (under 1 year)
                                  child (under 13 years)
                                  young person (13–17 years).

                                 N.B. It is not possible to summarise the guidance any further from the
                                 QRG (www.nice.org.uk/nicemedia/pdf/CG89QuickRefGuide.pdf). The
                                 following are the areas covered:

                                 Physical features
                                 Abrasions, bites (human), bruises, burns, cold injuries, cuts, eye injuries,
                                 fractures, hypothermia, intra-abdominal injuries, intracranial injuries,
                                 intrathoracic injuries, lacerations, ligature marks, oral injuries,
                                 petechiae, retinal haemorrhage, scalds, scars, spinal injuries, strangulation,
                                 subdural haemorrhage, teeth marks




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                                                               NHS Sheffield
                                                         Framework of NICE Guidance
                                                                 July 2009

Guideline   Title                 Summary                                                                            Implications      Review     Local
No                                                                                                                                      Date      Action
                                  Sexual abuse
                                  Anal symptoms and signs, anogenital injuries, dysuria, foreign bodies, genital
                                  symptoms and signs, pregnancy, sexual exploitation, sexualised behaviour
                                  (also see Emotional, behavioural, interpersonal and social functioning),
                                  sexually transmitted infections (STIs), vaginal discharge

                                  Neglect
                                  Abandonment, bites (animal), clothing, dirty child, failure to thrive, faltering
                                  growth, footwear, head lice, health promotion, health reviews, home
                                  conditions, immunisation, lack of provision, lack of supervision, medication
                                  adherence, parental interaction with medical services, persistent infestations,
                                  poor hygiene, scabies, screening, smelly child, sunburn, tooth decay

                                  Emotional, behavioural, interpersonal and social functioning
                                  Age-inappropriate behaviour, aggression, body rocking, change in emotional
                                  or behavioural state, cutting, dissociation, drug taking, eating and feeding
                                  behaviour, encopresis, fearful, runaway behaviour, self-esteem, self-harm,
                                  sexual behaviour, smearing (faeces), wetting

                                  Clinical presentations
                                  Apparent life-threatening event, attendance at medical services (also see
                                  Neglect), hypernatraemia, ingestion (also see Neglect), nasal bleeding, near
                                  drowning, poisoning, poor school attendance

                                  Fabricated or induced illness

                                  Parent– or carer–child interactions
                                  Domestic abuse (exposure to), emotional unavailability and
                                  unresponsiveness, expectations (age-inappropriate), hostility, isolation,
                                  marital disputes (using child), rejection, scapegoating, socialisation
                                  (inappropriate), wetting (response to)
IPG305      Sinus tarsi            Current evidence on the safety and efficacy of sinus tarsi implant               Acute care only     -
            implant insertion         insertion for mobile flatfoot is inadequate in quality and quantity.
            for mobile flatfoot       Therefore this procedure should only be used with special arrangements
                                      for clinical governance, consent and audit or research.




bc50b1fd-0938-4217-921d-c4fb5e0e9654.doc                                                                                                     Page 3
                                                               NHS Sheffield
                                                         Framework of NICE Guidance
                                                                 July 2009

Guideline   Title                 Summary                                                                           Implications      Review     Local
No                                                                                                                                     Date      Action
                                     Clinicians wishing to undertake sinus tarsi implant insertion for mobile
                                      flatfoot should take the following actions.
                                        o Inform the clinical governance leads in their Trusts.
                                        o Ensure that patients and/or their parents/carers understand the
                                           uncertainty about the procedure’s safety and efficacy in relation to
                                           symptom relief, quality of life, and long-term outcomes; that the
                                           success of the procedure may be dependent on the aetiology of their
                                           flatfoot; that there may be a need for adjunctive or subsequent
                                           procedures; and that the implant may need to be removed. Patients
                                           and parents or carers should be provided with clear written
                                           information.
                                        o Audit and review clinical outcomes of all patients having sinus tarsi
                                           implant insertion for mobile flatfoot.
                                     Sinus tarsi implant insertion is not appropriate for most children with
                                      mobile flatfoot. The procedure may be used in selected children with
                                      persistent mobile flatfoot due to neuromuscular disorder, skeletal
                                      dysplasia or systemic ligamentous laxity, whose treatment is supervised
                                      by a multidisciplinary team. The procedure may be indicated rarely in
                                      highly selected adult patients.
                                     NICE encourages further research into sinus tarsi implant insertion for
                                      mobile flatfoot. Research studies should define patient selection criteria,
                                      address uncertainties about using the procedure in children and in
                                      adults, include descriptions of adjunctive procedures, and provide long-
                                      term outcome data. Studies comparing outcomes of the procedure with
                                      the natural history of mobile flatfoot would be useful. NICE may review
                                      the procedure upon publication of further evidence.
IPG306      Prosthetic               Current evidence on the safety and efficacy of prosthetic intervertebral      Acute care only     -
            intervertebral disc       disc replacement appears adequate to support the use of this procedure.
            replacement               However, there is little evidence on outcomes beyond 2–3 years and
                                      collection of long-term data is therefore particularly important.
                                     Clinicians wishing to undertake prosthetic intervertebral disc
                                      replacement should take the following actions.
                                       o Ensure that patients understand the uncertainty about the procedure’s
                                          longterm efficacy and provide them with clear written information.




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                                                              NHS Sheffield
                                                        Framework of NICE Guidance
                                                                July 2009

Guideline   Title                 Summary                                                                         Implications      Review     Local
No                                                                                                                                   Date      Action
                                       o Audit and review clinical outcomes of all patients having prosthetic
                                         intervertebral disc replacement.
                                     Publication of longer-term efficacy outcomes will be useful in reducing
                                      the current uncertainty. The Institute may review the procedure upon
                                      publication of further evidence.
IPG307      Intramuscular             The evidence on intramuscular diaphragm stimulation for ventilator-        Acute care only     -
            diaphragm                  dependent chronic respiratory failure due to neurological disease raises
            stimulation for            no major safety concerns; however, current evidence on its efficacy is
            ventilator-                inadequate in quantity. Therefore, this procedure should only be used
            dependent                  with special arrangements for clinical governance, consent, and audit
            chronic                    or research.
            respiratory failure       Clinicians wishing to undertake intramuscular diaphragm stimulation for
            due to                     ventilator-dependent chronic respiratory failure due to neurological
            neurological               disease should take the following actions.
            disease                    o Inform the clinical governance leads in their Trusts.
                                       o Ensure that patients and their carers understand the uncertainty
                                          about the procedure’s efficacy and provide them with clear written
                                          information.
                                       o Audit and review clinical outcomes of all patients having
                                          intramuscular diaphragm stimulation for ventilator-dependent chronic
                                          respiratory failure due to neurological disease.
                                      Patient selection should be carried out by a multidisciplinary team
                                       experienced in the care of patients with long-term ventilation needs and
                                       in conventional phrenic nerve pacing.
                                      The procedure should be carried out only by laparoscopic surgeons
                                       and neurophysiologists with specific training in intramuscular
                                       diaphragm stimulation.
IPG308      Image-guided              Current evidence on the safety and efficacy of image-guided                Acute care only     -
            radiofrequency             radiofrequency (RF) excision biopsy of breast lesions is inadequate in
            excision biopsy            quantity and quality, and there are concerns about the possibility of
            of breast lesions          false-negative biopsy results. Therefore, this procedure should only be
                                       used with special arrangements for clinical governance, consent and
                                       audit or research.
                                      Clinicians wishing to undertake image-guided RF excision biopsy of




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                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               July 2009

Guideline   Title                Summary                                                                        Implications   Review    Local
No                                                                                                                              Date     Action
                                      breast lesions should take the following actions.
                                      o Inform the clinical governance leads in their Trusts.
                                      o Ensure that patients and their carers understand the uncertainty
                                        about the procedure’s safety and efficacy and provide them with clear
                                        written information.
                                      o Audit and review clinical outcomes of all patients having image-
                                        guided RF excision biopsy of breast lesions.
                                     NICE encourages further research into imageguided RF excision
                                      biopsy of breast lesions. Research should be in the form of diagnostic
                                      studies aimed at quantifying the risk of false-negative results
                                      associated with the procedure. NICE may review the procedure on
                                      publication of further evidence.




bc50b1fd-0938-4217-921d-c4fb5e0e9654.doc                                                                                            Page 6

				
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