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					                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                    October 2008

Guideline   Title                          Summary                                                                                  Implications              Review   Local
No                                                                                                                                                             Date    Action
TA160       Alendronate, etidronate,       This guidance relates only to treatments for the primary prevention of fragility         NICE state that this       July
            risedronate, raloxifene and    fractures in postmenopausal women who have osteoporosis. Osteoporosis is                 guidance applies to        2010
            strontium ranelate for the     defined by a T-score1 of – 2.5 standard deviations (SD) or below on dual-energy X-       primary and acute
            primary prevention of          ray absorptiometry (DXA) scanning. However, the diagnosis may be assumed in              care.
            osteoporotic fragility         women aged 75 years or older if the responsible clinician considers a DXA scan to
            fractures in                   be clinically inappropriate or unfeasible.                                               NICE state that
            postmenopausal women           This guidance assumes that women who receive treatment have an adequate                  this guidance
                                           calcium intake and are vitamin D replete.                                                relates only to drug
                                           Unless clinicians are confident that women who receive treatment meet these              therapy for the
                                           criteria, calcium and/or vitamin D supplementation should be considered.                 primary prevention
                                           NICE is developing a clinical guideline on ‘Osteoporosis: assessment of fracture         of fragility fractures
                                           risk and the prevention of osteoporotic fractures in individuals at high risk’ (see      in postmenopausal
                                           www.nice.org.uk). This technology appraisal guidance should be read in the               women who have
                                           context of the clinical guideline when it is available.                                  osteoporosis and
                                           This guidance does not cover the following:                                              have not sustained
                                           – The treatment of women who have sustained a clinically apparent osteoporotic           a fragility fracture.
                                              fragility fracture (for recommendations for the treatment of women with a prior       It is anticipated that
                                              osteoporotic fragility fracture, see the accompanying NICE technology appraisal,      the majority of
                                              ‘Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and             prescribing will be
                                              teriparatide for the secondary prevention of osteoporotic fragility fractures in      within primary
                                              postmenopausal women’ (TA161).                                                        care.
                                           – The use of alendronate, etidronate, risedronate, raloxifene or strontium ranelate
                                              for the primary prevention of osteoporotic fragility fractures in women with normal   NICE have not
                                              bone mineral density (BMD) or osteopenia (that is, women with a T-score               produced any
                                              between – 1 and – 2.5 SD below peak BMD).                                             costing information
                                           – The use of these drugs for the primary prevention of osteoporotic fragility            at this time.
                                              fractures in women who are on long-term systemic corticosteroid treatment.

                                           The latter two groups will be covered within future guidance produced by the
                                           Institute.

                                           1. Alendronate is recommended as a treatment option for the primary prevention
                                              of osteoporotic fragility fractures in the following groups:




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                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                     October 2008

Guideline   Title                          Summary                                                                                    Implications        Review   Local
No                                                                                                                                                         Date    Action
                                                  Women aged 70 years or older who have an independent clinical risk
                                                   factor for fracture (see section 5) or an indicator of low BMD (see section
                                                   6) and who are confirmed to have osteoporosis (that is, a T-score of – 2.5
                                                   SD or below). In women aged 75 years or older who have two or more
                                                   independent clinical risk factors for fracture or indicators of low BMD, a
                                                   DXA scan may not be required if the responsible clinician considers it to be
                                                   clinically inappropriate or unfeasible.
                                               Women aged 65–69 years who have an independent clinical risk factor for
                                                   fracture (see section 5) and who are confirmed to have osteoporosis (that
                                                   is, a T-score of – 2.5 SD or below).
                                               Postmenopausal women younger than 65 years who have an independent
                                                   clinical risk factor for fracture (see section 5) and at least one additional
                                                   indicator of low BMD (see section 6) and who are confirmed to have
                                                   osteoporosis (that is, a T-score of – 2.5 SD or below).
                                              When the decision has been made to initiate treatment with alendronate, the
                                              preparation prescribed should be chosen on the basis of the lowest acquisition
                                              cost available.
                                           2. Risedronate and etidronate are recommended as alternative treatment options
                                              for the primary prevention of osteoporotic fragility fractures in postmenopausal
                                              women:
                                               who are unable to comply with the special instructions for the
                                                   administration of alendronate, or have a contraindication to or are
                                                   intolerant of alendronate (as defined in section 7) and
                                               who also have a combination of T-score, age and number of independent
                                                   clinical risk factors for fracture (see section 5) as indicated in the following
                                                   table.




                                           T-scores (SD) at (or below) which risedronate or etidronate is recommended
                                           when alendronate cannot be taken




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                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                     October 2008

Guideline   Title                          Summary                                                                                    Implications        Review   Local
No                                                                                                                                                         Date    Action
                                            Number of independent clinical risk factors for fracture
                                            (section 5)
                                            Age (years)      0               1                2
                                            65-69            -*              -3.5             -3.0
                                            70-74            -3.5            -3.0             -2.5
                                            75 or older      -3.0            -3.0             -2.5
                                            * treatment with risedronate or etidronate is not
                                            recommended

                                              If a woman aged 75 years or older who has two or more independent clinical
                                              risk factors for fracture or indicators of low BMD has not previously had her
                                              BMD measured, a DXA scan may not be required if the responsible clinician
                                              considers it to be clinically inappropriate or unfeasible.
                                              In deciding between risedronate and etidronate, clinicians and patients need to
                                              balance the overall proven effectiveness profile of the drugs against their
                                              tolerability and adverse effects in individual patients.
                                           3. Strontium ranelate is recommended as an alternative treatment option for the
                                              primary prevention of osteoporotic fragility fractures in postmenopausal
                                              women:
                                               who are unable to comply with the special instructions for the
                                                   administration of alendronate and either risedronate or etidronate, or have
                                                   a contraindication to or are intolerant of alendronate and either risedronate
                                                   or etidronate (as defined in section 7) and
                                               who also have a combination of T-score, age and number of independent
                                                   clinical risk factors for fracture (see section 5) as indicated in the following
                                                   table.

                                           T-scores (SD) at (or below) which strontium ranelate
                                           is recommended when alendronate and either
                                           risedronate or etidronate cannot be taken




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                                                                   SHEFFIELD PCT
                                                              Framework of NICE Guidance
                                                                                                                                                 October 2008

Guideline   Title                          Summary                                                                                Implications            Review   Local
No                                                                                                                                                         Date    Action
                                            Number of independent clinical risk factors for fracture
                                            (section 5)
                                            Age (years)      0               1                2
                                            65-69            -*              -4.5             -4.0
                                            70-74            -4.5            -4.0             -3.5
                                            75 or older      -4.0            -4.0             -3.0
                                            * treatment with strontium ranelate is not recommended

                                           4. Raloxifene is not recommended as a treatment option for the primary
                                              prevention of osteoporotic fragility fractures in postmenopausal women.
                                           5. For the purposes of this guidance, independent clinical risk factors for fracture
                                              are parental history of hip fracture, alcohol intake of 4 or more units per day,
                                              and rheumatoid arthritis.
                                           6. For the purposes of this guidance, indicators of low BMD are low body mass
                                              index (defined as less than 22 kg/m 2), medical conditions such as ankylosing
                                              spondylitis, Crohn’s disease, conditions that result in prolonged immobility, and
                                              untreated menopause*.
                                           7. For the purposes of this guidance, intolerance of alendronate, risedronate or
                                              etidronate is defined as persistent upper gastrointestinal disturbance that is
                                              sufficiently severe to warrant discontinuation of treatment, and that occurs
                                              even though the instructions for administration have been followed correctly.
                                           8. For the purposes of this guidance, primary prevention refers to opportunistic
                                              identification, during visits to a healthcare professional for any reason, of
                                              postmenopausal women who are at risk of osteoporotic fragility fractures and
                                              who could benefit from drug treatment. It does not imply a dedicated screening
                                              programme.
                                           9. Women who are currently receiving treatment with one of the drugs covered by
                                              this guidance, but for whom treatment would not have been recommended
                                              according to sections 1 to 4, should have the option to continue treatment until
                                              they and their clinicians consider it appropriate to stop.

                                           * Rheumatoid arthritis is also a medical condition indicative of low BMD
TA161       Alendronate, etidronate,       This guidance replaces NICE technology appraisal guidance issued in January            NICE state that this      July




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                                                                   SHEFFIELD PCT
                                                              Framework of NICE Guidance
                                                                                                                                                  October 2008

Guideline   Title                          Summary                                                                                Implications              Review   Local
No                                                                                                                                                           Date    Action
            risedronate,                   2005                                                                                   guidance applies to        2010
            raloxifene, strontium          This guidance relates only to treatments for the secondary prevention of fragility     primary and acute
            ranelate and teriparatide      fractures in postmenopausal women who have osteoporosis and have sustained a           care.
            for the secondary              clinically apparent osteoporotic fragility fracture. Osteoporosis is defined by a T-
            prevention of osteoporotic     score1 of – 2.5 standard deviations (SD) or lower on dual-energy X-ray                 NICE state that
            fragility fractures in         absorptiometry (DXA) scanning.                                                         this guidance
            postmenopausal women           However, the diagnosis may be assumed in women aged 75 years or older if the           relates only to drug
                                           responsible clinician considers a DXA scan to be clinically inappropriate or           therapy for the
                                           unfeasible.                                                                            secondary
                                           This guidance assumes that women who receive treatment have an adequate                prevention of
                                           calcium intake and are vitamin D replete. Unless clinicians are confident that         fragility fractures in
                                           women who receive treatment meet these criteria, calcium and/or vitamin D              postmenopausal
                                           supplementation should be considered.                                                  women who have
                                           NICE is developing a clinical guideline on ‘Osteoporosis: assessment of fracture       osteoporosis and
                                           risk and the prevention of osteoporotic fractures in individuals at high risk’ (see    have not sustained
                                           www.nice.org.uk). This technology appraisal guidance should be read in the             a fragility fracture.
                                           context of the clinical guideline when it is available.                                It is anticipated that
                                           This guidance does not cover the following:                                            the majority of
                                           The use of alendronate, etidronate, risedronate, raloxifene, strontium ranelate or     prescribing will be
                                           teriparatide for the secondary prevention of osteoporotic fragility fractures in       within primary care
                                           women with normal bone mineral density (BMD) or
                                           osteopenia (that is, women with a T-score between – 1 and – 2.5 SD below peak          NICE have not
                                           BMD).                                                                                  produced any
                                           The use of these drugs for the secondary prevention of osteoporotic fragility          costing information
                                           fractures in women who are on long-term systemic corticosteroid treatment.             at this time.

                                           These groups will be covered within future guidance produced by the Institute.
                                           NICE technology appraisal guidance 161
                                           1. Alendronate is recommended as a treatment option for the secondary
                                              prevention of osteoporotic fragility fractures in postmenopausal women who are
                                              confirmed to have osteoporosis (that is, a T-score of – 2.5 SD or below). In
                                              women aged 75 years or older, a DXA scan may not be required if the
                                              responsible clinician considers it to be clinically inappropriate or unfeasible.




a6bae252-f812-448b-9b0c-40db8d472dd2.doc                                                                                                                   Page 5
                                                                   SHEFFIELD PCT
                                                              Framework of NICE Guidance
                                                                                                                                                  October 2008

Guideline   Title                          Summary                                                                                 Implications        Review   Local
No                                                                                                                                                      Date    Action
                                              When the decision has been made to initiate treatment with alendronate, the
                                              preparation prescribed should be chosen on the basis of the lowest acquisition
                                              cost available.
                                           2. Risedronate and etidronate are recommended as alternative treatment options
                                              for the secondary prevention of osteoporotic fragility fractures in
                                              postmenopausal women:
                                               who are unable to comply with the special instructions for the administration of
                                                alendronate, or have a contraindication to or are intolerant of alendronate (as
                                                defined in section 6) and
                                               who also have a combination of T-score, age and number of independent
                                                clinical risk factors for fracture (see section 5) as indicated in the following
                                                table.
                                           T-scores (SD) at (or below) which risedronate or
                                           etidronate is recommended when alendronate
                                           cannot be taken

                                            Number of independent clinical risk factors for fracture (section 5)
                                            Age (years)        0                 1                 2
                                            50-54              -*                -3.0              -2.5
                                            55-59              -3.0              -3.0              -2.5
                                            60-64              -3.0              -3.0              -2.5
                                            65-69              -3.0              -2.5              -2.5
                                            70 or older        -2.5              -2.5              -2.5
                                            * treatment with risedronate or etidronate is not recommended

                                           If a women aged 75 years or older has not previously had her BMD measured, a
                                           DXA scan may not be required if the responsible clinician considers it to be
                                           clinically inappropriate or unfeasible.
                                           In deciding between risedronate and etidronate, clinicians and patients need to
                                           balance the overall proven effectiveness profile of the drugs against their
                                           tolerability and adverse effects in individual patients.
                                           3. Strontium ranelate and raloxifene are recommended as alternative treatment




a6bae252-f812-448b-9b0c-40db8d472dd2.doc                                                                                                              Page 6
                                                                   SHEFFIELD PCT
                                                              Framework of NICE Guidance
                                                                                                                                                 October 2008

Guideline   Title                          Summary                                                                                Implications        Review   Local
No                                                                                                                                                     Date    Action
                                             options for the secondary prevention of osteoporotic fragility fractures in
                                             postmenopausal women:
                                              who are unable to comply with the special instructions for the administration of
                                               alendronate and either risedronate or etidronate, or have a contraindication to
                                               or are intolerant of alendronate and either risedronate or etidronate (as
                                               defined in section 6) and
                                              who also have a combination of T-score, age and number of independent
                                               clinical risk factors for fracture (see section 5) as indicated in the following
                                               table.

                                           T-scores (SD) at (or below) which strontium ranelate
                                           or raloxifene is recommended when alendronate and
                                           either risedronate or etidronate cannot be taken

                                            Number of independent clinical risk factors for fracture (section 5)
                                            Age (years)        0                1                  2
                                            50-54              -*               -3.5               -3.5
                                            55-59              -4.0             -3.5               -3.5
                                            60-64              -4.0             -3.5               -3.5
                                            65-69              -4.0             -3.5               -3.0
                                            70-74              -3.0             -3.0               -2.5
                                            75 or older        -3.0             -2.5               -2.5
                                            * treatment strontium ranelate is not recommended

                                             If a woman aged 75 years or older who has one or more independent clinical
                                             risk factors for fracture or indicators of low BMD has not previously had her
                                             BMD measured, a DXA scan may not be required if the responsible clinician
                                             considers it to be clinically inappropriate or unfeasible.
                                             For the purposes of this guidance, indicators of low BMD are low body mass
                                             index (defined as less than 22 kg/m 2), medical conditions such as ankylosing
                                             spondylitis, Crohn’s disease, conditions that result in prolonged immobility, and
                                             untreated premature menopause*.




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                                                                      SHEFFIELD PCT
                                                                 Framework of NICE Guidance
                                                                                                                                                      October 2008

Guideline   Title                          Summary                                                                                     Implications        Review   Local
No                                                                                                                                                          Date    Action
                                                In deciding between strontium ranelate and raloxifene, clinicians and patients
                                                need to balance the overall proven effectiveness profile of these drugs against
                                                their tolerability and other effects in individual patients.0 1 2
                                           4.   Teriparatide is recommended as an alternative treatment option for the
                                                secondary prevention of osteoporotic fragility fractures in postmenopausal
                                                women:
                                                 who are unable to take alendronate and either risedronate or etidronate, or
                                                   have a contraindication to or are intolerant of alendronate and either
                                                   risedronate or etidronate (as defined in section 6), or who have a
                                                   contraindication to, or are intolerant of strontium ranelate (as defined in
                                                   section 7), or who have had an unsatisfactory response (as defined in section
                                                   8) to treatment with alendronate, risedronate or etidronate and
                                                 who are 65 years or older and have a T-score of – 4.0 SD or below, or a T-
                                                   score of – 3.5 SD or below plus more than two fractures, or who are aged 55–
                                                   64 years and have a T-score of – 4 SD or below plus more than two fractures.
                                           5.   For the purposes of this guidance, independent clinical risk factors for fracture
                                                are parental history of hip fracture, alcohol intake of 4 or more units per day, and
                                                rheumatoid arthritis.
                                           6.   For the purposes of this guidance, intolerance of alendronate, risedronate or
                                                etidronate is defined as persistent upper gastrointestinal disturbance that is
                                                sufficiently severe to warrant discontinuation of treatment, and that occurs even
                                                though the instructions for administration have been followed correctly.
                                           7.   For the purposes of this guidance, intolerance of strontium ranelate is defined
                                                as persistent nausea or diarrhoea, either of which warrants discontinuation of
                                                treatment.
                                           8.   For the purposes of this guidance, an unsatisfactory response is defined as
                                                occurring when a woman has another fragility fracture despite adhering fully to
                                                treatment for 1 year and there is evidence of a decline in BMD below her pre-
                                                treatment baseline.
                                           9.   Women who are currently receiving treatment with one of the drugs covered by
                                                this guidance, but for whom treatment would not have been recommended
                                                according to sections 1 to 4, should have the option to continue treatment until
                                                they and their clinicians consider it appropriate to stop.




a6bae252-f812-448b-9b0c-40db8d472dd2.doc                                                                                                                  Page 8
                                                                        SHEFFIELD PCT
                                                                   Framework of NICE Guidance
                                                                                                                                                        October 2008

Guideline   Title                            Summary                                                                                   Implications             Review    Local
No                                                                                                                                                               Date     Action

                                             * Rheumatoid   arthritis is also a medical condition indicative of low BMD.
TA162       Erlotinib for the treatment of   1. Erlotinib is recommended, within its licensed indication, as an alternative to         This guidance             June
            non-small-cell lung cancer          docetaxel as a second-line treatment option for patients with non-small-cell lung      applies to cancer         2010
                                                cancer (NSCLC) only on the basis that it is provided by the manufacturer at an         care only.
                                                overall treatment cost (including administration, adverse events and monitoring
                                                costs) equal to that of docetaxel.                                                     Chemotherapy
                                             2. The decision to use erlotinib or docetaxel (as outlined in section 1) should be        drugs and the
                                                made after a discussion between the responsible clinician and the individual           activity that relates
                                                about the potential benefits and adverse effects of each treatment.                    to delivery (HRG
                                                                                                                                       codes ending with
                                             3. Erlotinib is not recommended for the second-line treatment of locally advanced
                                                                                                                                       98, for example
                                                or metastatic NSCLC in patients for whom docetaxel is unsuitable (that is,
                                                                                                                                       A98) are excluded
                                                where there is intolerance of or contraindications to docetaxel) or for third-line     from PbR and
                                                treatment after docetaxel therapy.                                                     remain subject to
                                             4. People currently receiving treatment with erlotinib, but for whom treatment            local negotiation
                                                would not be recommended according to section 3, should have the option to             and agreement.
                                                continue treatment until they and their clinicians consider it appropriate to stop.
                                                                                                                                       NICE state that as
                                                                                                                                       erlotinib is only
                                                                                                                                       recommended when
                                                                                                                                       the overall
                                                                                                                                       treatment costs are
                                                                                                                                       the same as
                                                                                                                                       docetaxel then there
                                                                                                                                       should be no
                                                                                                                                       significant impact on
                                                                                                                                       resources.
CG75        Metastatic spinal cord           Service configuration and urgency of treatment                                            NICE state this           t.b.c.
            compression                       Every cancer network should ensure that appropriate services are commissioned           guidance applies to
                                               and in place for the efficient and effective diagnosis, treatment, rehabilitation and   primary and acute
                                               ongoing care of patients with MSCC. These services should be monitored regularly        care.
                                               through prospective audit of the care pathway.
                                             Early detection                                                                           NICE also state the




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                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                      October 2008

Guideline   Title                          Summary                                                                                     Implications             Review   Local
No                                                                                                                                                               Date    Action
                                            Inform patients at high risk of developing bone metastases, patients with diagnosed       guidance impacts
                                             bone metastases, or patients with cancer who present with spinal pain about the           on PbR.
                                             symptoms of MSCC. Offer information (for example, in the form of a leaflet) to
                                             patients and their families and carers which explains the symptoms of MSCC, and           NICE state that they
                                             advises them (and their healthcare professionals) what to do if they develop these        estimate a net
                                             symptoms.                                                                                 saving of £8,974 per
                                            Contact the MSCC coordinator urgently (within 24 hours) to discuss the care of            100,000 population
                                             patients with cancer and any of the following symptoms suggestive of spinal               as a result of better
                                             metastases:                                                                               patient outcomes
                                             – pain in the middle (thoracic) or upper (cervical) spine
                                             – progressive lower (lumbar) spinal pain
                                             – severe unremitting lower spinal pain
                                             – spinal pain aggravated by straining (for example, at stool, or when coughing or
                                               sneezing)
                                             – localised spinal tenderness
                                             – nocturnal spinal pain preventing sleep.
                                            Contact the MSCC coordinator immediately to discuss the care of patients with
                                             cancer and symptoms suggestive of spinal metastases who have any of the following
                                             neurological symptoms or signs suggestive of MSCC, and view them as an
                                             oncological emergency:
                                             – neurological symptoms including radicular pain, any limb weakness, difficulty in
                                               walking, sensory loss or bladder or bowel dysfunction
                                             – neurological signs of spinal cord or cauda equina compression.
                                           Imaging
                                            Perform MRI of the whole spine in patients with suspected MSCC, unless there is a
                                             specific contraindication. This should be done in time to allow definitive treatment to
                                             be planned within 1 week of the suspected diagnosis in the case of spinal pain
                                             suggestive of spinal metastases,
                                            and within 24 hours in the case of spinal pain suggestive of spinal metastases and
                                             neurological symptoms or signs suggestive of MSCC, and occasionally sooner if
                                             there is a pressing clinical need for emergency surgery.
                                           Treatment of spinal metastases and MSCC
                                            Patients with severe mechanical pain suggestive of spinal instability, or any
                                             neurological symptoms or signs suggestive of MSCC, should be nursed flat with




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                                                                     SHEFFIELD PCT
                                                                Framework of NICE Guidance
                                                                                                                                                        October 2008

Guideline   Title                          Summary                                                                                       Implications         Review   Local
No                                                                                                                                                             Date    Action
                                             neutral spine alignment (including ‘log rolling’ or turning beds, with use of a slipper
                                             pan for toilet) until bony and neurological stability are ensured and cautious
                                             remobilisation may begin.
                                            Start definitive treatment, if appropriate, before any further neurological deterioration
                                             and ideally within 24 hours of the confirmed diagnosis of MSCC.
                                            Carefully plan surgery to maximise the probability of preserving spinal cord function
                                             without undue risk to the patient, taking into account their overall fitness, prognosis
                                             and preferences.
                                            Ensure urgent (within 24 hours) access to and availability of radiotherapy and
                                             simulator facilities in daytime sessions, 7 days a week for patients with MSCC
                                             requiring definitive treatment or who are unsuitable for surgery.
                                           Supportive care and rehabilitation
                                            Discharge planning and ongoing care, including rehabilitation for patients with
                                             MSCC, should start on admission and be led by a named individual from within the
                                             responsible clinical team. It should involve the patient and their families and carers,
                                             their primary oncology site team, rehabilitation team and community support,
                                             including primary care and specialist palliative care, as required.
IPG275      Laparoscopic                    Current evidence on the safety and efficacy of laparoscopic prostatectomy for benign          Acute care only       -
            prostatectomy for benign         prostatic obstruction (BPO) is inadequate in both quantity and quality. Therefore this
            prostatic obstruction            procedure should only be used with special arrangements for clinical governance,
                                             consent and audit or research.
                                            Clinicians wishing to undertake laparoscopic prostatectomy for BPO should take the
                                             following actions.
                                             – Inform the clinical governance leads in their Trusts.
                                             – Ensure that patients understand the uncertainty about the procedure’s safety
                                                  and efficacy, make them aware of alternative treatment options and provide
                                                  them with clear written information
                                            This procedure should only be carried out by surgeons with special training and
                                             experience in laparoscopic radical prostatectomy. The British Association of
                                             Urological Surgeons (BAUS) has produced training standards: www.baus.org.uk/
                                             baus_subspecialty_sections/section_of_endourology/guidelines_audit_committee.pht
                                             ml
                                            Patients should only be offered this procedure if they would otherwise be considered
                                             for open prostatectomy, rather than transurethral resection, for BPO.




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                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                     October 2008

Guideline   Title                          Summary                                                                                    Implications         Review   Local
No                                                                                                                                                          Date    Action
                                            Clinicians should submit data on all patients who receive this procedure to the BAUS
                                             Cancer Registry & Sections Audit (www.baus.org.uk/baus_subspecialty_sections/
                                             baus_cancer_registry__sections_audit.phtml).
                                            NICE may review the procedure on publication of further evidence.
IPG276      Transabdominal artificial       Current evidence on the safety and efficacy of transabdominal artificial bowel             Acute care only       -
            bowel sphincter                  sphincter implantation for faecal incontinence is based on a small number of patients
            implantation for faecal          and is inadequate in quantity. Therefore this procedure should only be used with
            incontinence                     special arrangements for clinical governance, consent and audit or research.
                                            Clinicians wishing to undertake transabdominal artificial bowel sphincter implantation
                                             for faecal incontinence should take the following actions.
                                             – Inform the clinical governance leads in their Trusts.
                                             – Ensure that patients understand the uncertainty about the procedure’s safety
                                                  and efficacy and provide them with clear written information.
                                            Audit and review clinical outcomes of all patients having transabdominal artificial
                                             bowel sphincter implantation for faecal incontinence.
IPG277      Electrically-stimulated        Current evidence on electrically-stimulated intravesical chemotherapy for                    Acute care only       -
            intravesical chemotherapy      superficial bladder cancer raises no major safety concerns. However, the evidence
            for superficial bladder        is based on methodologically inconsistent studies and the efficacy of the procedure
            cancer                         is uncertain. Therefore, this procedure should only be used in the context of
                                           research.
                                           Further research should take the form of randomised controlled trials (RCTs) with
                                           adequate duration of follow-up, comparing intravesical
                                           chemotherapy with and without the use of electrical stimulation. NICE may review
                                           the procedure upon publication of further evidence.




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