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Objective of the audit.doc.doc.doc Objective of the audit.doc.doc.doc Document Transcript

  • Issue date: June 2007 Audit criteria Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade gliomaNICE technology appraisal 121
  • Audit criteria for NICE technology appraisal 121 Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma Objective of the auditThe aim of the audit is to assist NHS trusts to determine whether the serviceis implementing, and is in compliance with, the NICE technology appraisal‘Carmustine implants and temozolomide for the treatment of newly diagnosedhigh-grade glioma’. Patient groups to be included in the audit(i) In respect of temozolomide, people with newly diagnosed glioblastomamultiforme (GBM).(ii) In respect of carmustine implants, people with newly diagnosed high-gradeglioma. Sample for the auditIt is suggested that the audit should cover (i) those people who are newlydiagnosed with GBM over a 6-month period, and (ii) those people who arenewly diagnosed with high-grade glioma, also over a 6-month period.However, even if organisations are unable to commit to an audit of this scalethere is considerable value in undertaking a structured audit of the guidancefor a shorter period of time. Data source for the auditThe audit criteria require data to be collected from a range of sources,including patient records and patient administration systems. Frequency of the auditThe audit should be repeated periodically depending on the trust auditstrategy and the time required to implement any necessary action arising fromthe first audit. This will allow trusts to monitor progress towards fullcompliance. However, the frequency of repeat audits needs to be consideredalongside other priorities for audit.
  • Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: TA121Audit criteria: These are the audit criteria developed by NICE to support the implementation of this guidance. Users can cut and paste theseinto their own programmes or they can use this template.Criterion Criterion Exceptions Definition of terms Data sourceno. and/or general guidance1 The percentage of patients with a WHO performance status Patients who have not Temozolomide is only Patient records of 0 or 1 for whom temozolomide has been considered as been newly diagnosed recommended within an option for the treatment of newly diagnosed with glioblastoma its licensed glioblastoma multiforme (GBM). multiforme (GBM). indications. Patients with a WHO Consideration of performance status of 2– temozolomide as a 4. treatment option should be noted in the patient’s records. The definitions of WHO performance status of 0 and 1 are provided in Appendix C of the NICE guidance. NHS acute trusts/specialist centres Standard = 100% View slide
  • Criterion Criterion Exceptions Definition of terms Data sourceno. and/or general guidance2 The percentage of patients with a WHO performance status Patients with a WHO Temozolomide is not Patient records of 2–4 for whom temozolomide has been provided as a performance status of 0 recommended for this treatment for newly diagnosed glioblastoma multiforme or 1. group of patients (see (GBM). recommendation 1.1 Patients who were of the NICE receiving temozolomide guidance). before the publication of this NICE guidance. NHS acute trusts/specialist centres Standard = 0%3 The percentage of patients in whom 90% or more of the Patients who have not Carmustine implants Patient records tumour has been resected, for whom carmustine implants been newly diagnosed are only have been considered as an option for the treatment of with high-grade glioma. recommended within newly diagnosed high-grade glioma. their licensed Patients with newly indications. diagnosed high-grade glioma in whom less Consideration of than 90% of the tumour carmustine implants has been resected. as a treatment option should be noted in the patient’s records. Maximal resection (>90%) should be confirmed by a postoperative scan. NHS acute trusts/specialist centres Standard = 100% View slide
  • Criterion Criterion Exceptions Definition of terms Data sourceno. and/or general guidance4 The number of patients being treated with carmustine None Specialists centres Patient records implants outside specialist centres. are defined in Pharmacy records recommendation 1.3 of the NICE guidance as generally conforming to guidance in ‘Improving outcomes for people with brain and other central nervous system tumours’ (NICE cancer service guidance 2006; www.nice.org.uk/csg NHS acute trusts/specialist centres braincns). Standard = nil5 The number of patients being treated with carmustine None Patient records implants whose treament is not being supervised by Clinical staff records specialist neurosurgeons who spend at least 50% of their clinical programmed activities in neuro-oncological surgery. NHS acute trusts/specialist centres Standard = nil
  • Criterion Criterion Exceptions Definition of terms Data sourceno. and/or general guidance6 The number of patients being treated with carmustine None Appropriate Patient records implants in centres where specialists do not have access to resources are defined appropriate resources. in recommendation 1.3 of the NICE guidance, and include access to multidisciplinary teams, MRI and image-directed technology. NHS acute trusts/specialist centres Standard = nil7 The percentage of patients with newly diagnosed high- Patients who had Carmustine implants Patient records grade glioma in whom less than 90% of the tumour has received carmustine are not been resected who have received carmustine implants. implants before the recommended for this publication of this NICE group of patients (see guidance. recommendation 1.4 of the NICE guidance). Maximal resection (>90%) should be confirmed by a postoperative scan. NHS acute trusts/specialist centres Standard = 0%No. of Local alternatives to above criteria (to be used where othercriterion data addressing the same issue are more readily available)replaced
  • Appendix: Using the audit criteria to audit implementation ofthe guidanceThe following paragraphs are provided to assist NHS organisations to auditprogress in implementing NICE technology appraisal guidance. Theyrepresent current good practice in audit, but additional guidance can be foundin ‘Principles for best practice in clinical audit’.Auditing implementation of NICE guidanceFollowing dissemination of the guidance to all relevant services and partners,NHS organisations are encouraged to undertake a baseline audit to determinewhether practice is in accordance with the guidance. Where practicable, theaudit should be repeated on a regular basis to monitor implementation and toenable comparisons of practice and results over time.Audit rationale and planningThe Healthcare Commission assesses the performance of NHS organisationsin meeting core and developmental standards set by the Department ofHealth (DH) in Standards for better health. The implementation of NICEguidance will help organisations meet developmental standard D13. StandardC5(a) states that ‘Healthcare organisations ensure that they conform to NICEtechnology appraisals and, where it is available, take into account nationallyagreed guidance when planning and delivering treatment and care’. In orderto assure themselves of compliance NHS trust boards need to receive regularreports on the implementation of NICE guidance, highlighting areas of non-compliance and risk. The audit of this guidance needs to be plannedalongside audits of other NICE guidance, in order to feed into the appropriatereporting cycle.Audit reporting templateAs part of this guidance, NICE has developed recommended audit criteria andhas included these within an audit reporting template. It is recognised thatsome trusts will have their own well-developed systems for reporting auditresults within the organisation and for retaining results to allow progress overtime to be monitored. Where this is the case, NICE would not wish to altercurrent approaches − the reporting template is provided for those trusts thatmight find it useful.Calculation of complianceWhere compliance (%) with the guidance should be calculated as a measure,this is calculated as follows:Number within the population group whose care is consistent with the criterion x 100%Number within the population group to whom the measure applies (that is, thetotal population group less any exceptions)As well as reporting the percentage compliance, it will often be useful to reportthe actual numerator and denominator figures (to give an idea of scale).
  • Review of audit findingsNICE encourages the local discussion of audit findings and, where there is anidentified lack of compliance with the guidance, the development of an actionplan. See ‘How to put NICE guidance into practice: a guide to implementationfor organisations’. Progress against the plan can then be monitored andreported to the trust board to show that progress towards desiredimprovements is being achieved.
  • Definitions used within the audit criteria and audit reporting templateCriterion Measurable element derived from the key priorities for implementation of each piece of guidance. The organisational level to which the criterion applies is shown in parentheses.Exceptions Where implementation of guidance is not appropriate for a particular subgroup of the population, this is clearly stated. Where there are no exceptions, this is also stated.Definition of terms and/or Unambiguous definitions of any terms usedgeneral guidance in the audit criteria to promote consistency of approach and measurement and reduce the risk of non-comparable findings. This may include general guidance specific to that criterion. These definitions do not include any interpretation (or other clarification) of the NICE guidance. Should there be a need to include any such clarification, this will be inserted as a footnote to the audit template. The desired standard is shown in parentheses.Data source Source(s) of data used to gather evidence of implementation.Compliance Percentage compliance within the audited sample (see previous section for calculation).Findings Usually, this will provide added detail around the basic compliance figure − such as showing variation by age, ethnic group − to ensure that an aggregate compliance figure does not mask difficulties being experienced by particular subgroups of the population.Comments This allows free text for comment on audit findings and the local context in which they exist. It can provide the reference to other, more detailed documents including, if necessary, an action plan for improvement.
  • Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: TA121Audit report: This is designed to be completed for each audit to record compliance, findings and comments.Number of audit:Date audit completed:Audit lead/manager:Summary of previous audit results:(where applicable) To be completed by service during auditCriterion Criterion Data source Compliance Findings Commentsno. 1 The percentage of patients with a WHO performance Patient status of 0 or 1 for whom temozolomide has been records considered as an option for the treatment of newly diagnosed glioblastoma multiforme (GBM). NHS acute trusts/specialist centres 2 The percentage of patients with a WHO performance Patient status of 2–4 for whom temozolomide has been records provided as a treatment for newly diagnosed glioblastoma multiforme (GBM). NHS acute trusts/specialist centres 3 The percentage of patients in whom 90% or more of Patient the tumour has been resected, for whom carmustine records implants have been considered as an option for the treatment of newly diagnosed high-grade glioma. NHS acute trusts/specialist centres
  • Number of audit:Date audit completed:Audit lead/manager:Summary of previous audit results:(where applicable) To be completed by service during auditCriterion Criterion Data source Compliance Findings Commentsno. 4 The number of patients being treated with carmustine Patient implants outside specialist centres. records Pharmacy records NHS acute trusts/specialist centres 5 The number of patients being treated with carmustine Patient implants whose treatment is not being supervised by records specialist neurosurgeons who spend at least 50% of Clinical staff their clinical programmed activities in neuro- records oncological surgery. NHS acute trusts/specialist centres 6 The number of patients being treated with carmustine Patient implants in centres where specialists do not have records access to appropriate resources. NHS acute trusts/specialist centres 7 The percentage of patients with newly diagnosed high- Patient grade glioma in whom less than 90% of the tumour has records been resected who have received carmustine implants. NHS acute trusts/specialist centres
  • Number of audit:Date audit completed:Audit lead/manager:Summary of previous audit results:(where applicable) To be completed by service during auditCriterion Criterion Data source Compliance Findings Commentsno.No. of Local alternatives to above criteria (to be used wherecriterion other data addressing the same issue are more readilyreplaced available)
  • Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: TA121History of audits: This is designed for recording the results of consecutive audits, to demonstrate progress over time. Compliance Other findingsNumber of audit: Initial 2 3 Initial 2 3Date audit completed:Audit lead/manager:Criterion Criterionno. 1 The percentage of patients with a WHO performance status of 0 or 1 for whom temozolomide has been considered as an option for the treatment of newly diagnosed glioblastoma multiforme (GBM). NHS acute trusts/specialist centres 2 The percentage of patients with a WHO performance status of 2–4 for whom temozolomide has been provided as a treatment for newly diagnosed glioblastoma multiforme (GBM). NHS acute trusts/specialist centres 3 The percentage of patients in whom 90% or more of the tumour has been resected, for whom carmustine implants have been considered as an option for the treatment of newly diagnosed high-grade glioma. NHS acute trusts/specialist centres 4 The number of patients being treated with carmustine implants outside specialist centres. NHS acute trusts/specialist centres
  • Compliance Other findingsNumber of audit: Initial 2 3 Initial 2 3Date audit completed:Audit lead/manager:Criterion Criterionno. 5 The number of patients being treated with carmustine implants whose treatment is not being supervised by specialist neurosurgeons who spend at least 50% of their clinical programmed activities in neuro-oncological surgery. NHS acute trusts/specialist centres 6 The number of patients being treated with carmustine implants in centres where specialists do not have access to appropriate resources. NHS acute trusts/specialist centres 7 The percentage of patients, with newly diagnosed high-grade glioma, in whom less than 90% of the tumour has been resected who have received carmustine implants. NHS acute trusts/specialist centresNo. of Local alternatives to above criteria (to be used where other data addressing the samecriterion issue are more readily available)replaced