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  • 1. Ultrasound-guided foam sclerotherapy for varicose veins Audit support Implementing NICE guidance 2009NICE interventional procedure guidance 314
  • 2. This audit support accompanies the interventional procedure: ‘Ultrasound- guided foam sclerotherapy for varicose veins’ (available online at www.nice.org.uk/IPG314). Issue date: 2009This is a support tool for clinical audit based on the NICE guidance.It is not NICE guidance.National Institute for Health and Clinical ExcellenceMidCity Place, 71 High Holborn, London WC1V 6NA; www.nice.org.uk© National Institute for Health and Clinical Excellence, 2009. All rights reserved. Thismaterial may be freely reproduced for educational and not-for-profit purposes. Noreproduction by or for commercial organisations, or for commercial purposes, isallowed without the express written permission of the Institute.
  • 3. Using audit supportThe audit support document can be used to measure current practice inultrasound-guided foam sclerotherapy for varicose veins against therecommendations in the NICE guideline. Use it for a local audit project, byeither using the whole tool or copying the relevant parts into a local audittemplate.This document provides audit criteria (table 1) based on the guidancedeveloped by the NICE IP guidance programme. Users can cut and paste thesecriteria into their own programmes. The standards (where given) are based onthe evidence available. Where there is insufficient evidence, no standard isgiven. In this situation, a local standard should be determined based on regularmonitoring.Data required for audit of this procedure are given in table 2. This dataset isintended to be collected for each patient (or sometimes each procedure) by theclinical team providing the treatment. To assist with the collection of data tosupport the suggested audit criteria, a tailored data collection tool has also beenprovided (table 3). Suggestions on where you might find relevant informationare included although this may be different in your service. The dataset anddata collection tool can be used or adapted for use by the trust.To ensure that any valuable insight regarding unexpected consequences of thisprocedure is shared among clinicians, each adverse event should bedocumented and details forwarded to the National Patient Safety Agencys(NPSA) National Reporting and Learning System.Links with other national prioritiesThe audit based on this guideline should be considered in conjunction withother national priorities such as:Ultrasound-guided foam sclerotherapy for varicose veins. NICE InterventionalProcedures guidance 217 (2007)Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 3sclerotherapy for varicose veins)
  • 4. Criterion 1 The proportion of patients receiving ultrasound-guided foam sclerotherapy for varicose veins within a given period who have: (A) received written information on the procedure and any possible complications, (B) had a discussion with the clinician about the procedure which is documented in the notes and (C) given written consent to treatment (dataset items A to C, table 2)Exceptions NoneStandard 100%Definitions The DH Good practice in consent initiative produced formal processes and documents for full and informed consent. The correct documents should be used to support the consent process for all investigations and treatments. Specific information regarding the treatment should be provided. If the patient is not capable of providing consent, the information and discussion elements should apply to the patient’s delegated carer/guardian.Criterion 2 The proportion of guardian (s) or carer (s) receiving ultrasound-guided foam sclerotherapy for varicose veins within a given period who have (A) received written information on the procedure and any possible complications, (B) had a discussion with the clinician about the procedure which is documented in the notes and (C) given written consent to treatment (dataset items A to C, table 2)Exceptions NoneStandard 100%Definitions The DH Good practice in consent initiative produced formal processes and documents for full and informed consent. The correct documents should be used to support the consent process for all investigations and treatments. Specific information regarding the treatment should be provided. If the patient is not capable of providing consent, the information and discussion elements should apply to the patient’s delegated carer/guardian. Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 4 sclerotherapy for varicose veins)
  • 5. EFFICACY The percentage of patients who had ultrasound-guided foam sclerotherapy for varicose veins who experienced any of the following:  absence of varicose veins post treatment  evidence of venous occlusion & reabsorption  abolition of venous refluxCriterion3  patient satisfaction  quality of life  other (dataset items D to I, W to AF, table 2)Exceptions NoneStandard 100%Definitions Quality of life could be measured using SF36, VeinsQolSym, the Aberdeen Varicose Vein Severity score questionnaire or Patient Reported Outcomes Measures (PROMs). Abolition of venous reflux could be evaluated using duplex scanning Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 5 sclerotherapy for varicose veins)
  • 6. SAFETY The percentage of patients who had ultrasound-guided foam sclerotherapy for varicose veins who had any of the intraprocedural and procedure-related or post procedural complications:  transient ischaemic attack (TIA)  stroke  deep vein thrombosis (DVT)  arterial thrombosis  migraineCriterion 4  superficial thrombophlbetis  allergic reaction  skin pigmentation  skin ulceration  visual disturbance  further intervention  other (dataset items J to U, table 2)Exceptions NoneStandard 0%Definitions Effectiveness could be measured at 6-mth or 1 year post-procedureNumber of Local alternatives to above criteria (to be used where other datacriterion replaced: addressing the same issue are more readily available)ExceptionsStandardDefinitions Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 6 sclerotherapy for varicose veins)
  • 7. Clinical criteria for ultrasound-guided foam sclerotherapy for varicose veinsTable 2. Dataset: This defines the data items required within the audit criteria given in table 1.Dataset Dataset required per patient Data source Data variable typeitem ref. Consent A Received written information on the procedure and any possible Data collection form or patient record Y/N complications B Had a discussion with the clinician about the procedure which is Data collection form or patient record Y/N documented in the notes C Written consent to treatment obtained Data collection form or patient record Y/N Initial measures of procedure success D Absence of varicose veins post treatment Data collection form or patient record Y/N:Detail E Evidence of venous occlusion and reabsorption Data collection form or patient record Y/N:Detail F Abolition of venous reflux Data collection form or patient record Y/N:Detail G Patient satisfaction Data collection form or patient record Detail: H Quality of life (QoL) Data collection form or patient record Detail: I Other (please specify) Data collection form or patient record Y/N:Detail Adverse events (intraprocedural, procedure-related or post-procedural complications) J Transient Ischaemic Attack (TIA) Data collection form or patient record Y/N:Detail K Stroke Data collection form or patient record Y/N:Detail L Deep Vein Thrombosis (DVT) Data collection form or patient record Y/N:Detail M Arterial thrombosis Data collection form or patient record Y/N:Detail N Migraine Data collection form or patient record Y/N:Detail O Superficial thrombophlbetis Data collection form or patient record Y/N:Detail P Allergic reaction Data collection form or patient record Y/N:Detail Q Skin pigmentation Data collection form or patient record Y/N:Detail R Skin ulceration Data collection form or patient record Y/N:Detail S Visual disturbance Data collection form or patient record Y/N:Detail T Further intervention Data collection form or patient record Y/N:Detail U Other (please specify) Data collection form or patient record Y/N:Detail Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam sclerotherapy for varicose veins) 7
  • 8. Clinical criteria for ultrasound-guided foam sclerotherapy for varicose veins Effectiveness (post-procedural)W Recurrence of varicose veins Data collection form or patient record Y/N:Detail X Evidence of venous occlusion and reabsorption Data collection form or patient record Y/N:Detail Y Abolition of venous reflux Data collection form or patient record Y/N:Detail Z Patient satisfaction Data collection form or patient record Detail:AA Quality of life Data collection form or patient record Detail:AB Other (please specify) Data collection form or patient record Y/N:Detail Effectiveness (longer term)AC Recurrence of varicose veins Data collection form or patient record Y/N:DetailAD Evidence of venous occlusion and reabsorption Data collection form or patient record Y/N:DetailAE Abolition of venous reflux Data collection form or patient record Y/N:DetailAF Patient satisfaction Data collection form or patient record Detail:AG Quality of life Data collection form or patient record Detail:AF Other (please specify) Data collection form or patient record Y/N:Detail Aggregated data / denominatorsa The number of patients who had ultrasound-guided foam sclerotherapy for varicose veins Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam sclerotherapy for varicose veins) 8
  • 9. Clinical criteria for ultrasound-guided foam sclerotherapy for varicose veinsTable 3. Data collection tool: This is the data collection tool developed by NICE to support thecollection of data to undertake the audit. Users can cut and paste these into their programmes orthey can use this template. Complete one form for each patient or procedure.Patient identifier: Sex: Age: Ethnicity: M / FTime period for audit (e.g. 1 year in which patients received this interventional procedure):From: To:Did patient have Yes: No:interventional procedurewithin given time period? (If ‘No’, data collection completed)Criterion Data item Tick/complete box as indicated Consent Written information on the procedure and any A possible complications has been given to patient Yes No 1/2 (or carer/guardian if patient incapacitated) Discussion with clinician about the procedure is B Yes No documented in the notes C Written consent to treatment is obtained Yes No Initial measures of procedure success 3 D Recurrence of varicose veins Yes No 3 E Evidence of venous occlusion and reabsorption Yes No 3 F Abolition of venous reflux Yes No 3 G Patient satisfaction Detail: 3 H Quality of life Detail: 3 I Other (please specify) Yes No Adverse events (intraprocedural and procedure-related or post-procedural) 4 J Transient Ischaemic Attack (TIA) Yes No 4 K Stroke Yes No 4 L Deep Vein Thrombosis (DVT) Yes No 4 M Arterial Thrombosis Yes No 4 N Migraine Yes No 4 O Superficial thrombophlbetis Yes No 4 P Allergic reaction Yes No 4 Q Skin pigmentation Yes No 4 R Skin ulceration Yes No 4 S Visual disturbance Yes No 4 T Further intervention Yes No 4 U Other (please specify) Yes No Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 9 sclerotherapy for varicose veins)
  • 10. Clinical criteria for ultrasound-guided foam sclerotherapy for varicose veins Effectiveness (post-procedural)3 W Recurrence of varicose veins Yes No3 X Evidence of venous occlusion and reabsorption Yes No3 Y Abolition of venous reflux Yes No3 Z Patient satisfaction Detail:3 AA Quality of life Detail:3 AB Other (please specify) Yes No Effectiveness (longer term)3 AC Recurrence of varicose veins Yes No3 AD Evidence of venous occlusion and reabsorption Yes No3 AE Abolition of venous reflux Yes No3 AF Patient satisfaction Detail:3 AG Quality of life Detail:3 AF Other (please specify) Yes No Data collection completed Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 10 sclerotherapy for varicose veins)
  • 11. Further informationClick here for further information on reporting and monitoring the audit ofNICE guidance in your organisation.NICE is committed to promoting through its guidance race and disabilityequality and equality between men and women, and to eliminating all forms ofdiscrimination. One of the ways we do this is by trying to involve as wide arange of people and interest groups as possible in the development of ourguidance on interventional procedures. In particular, we aim to encouragepeople and organisations from groups in the population who might notnormally comment on our guidance to do so. We also ask consultees tohighlight any ways in which draft guidance fails to promote equality or tacklediscrimination and give suggestions for how it might be improved.Supporting implementationA practical guide to implementation, ‘How to put NICE guidance into practice:a guide to implementation for organisations’, is also available on our website(www.nice.org.uk/usingguidance/implementationtools).The guidanceYou can download the guidance documents from www.nice.org.uk/IPG314Interventional procedures guidance – all the recommendations.‘Understanding NICE guidance’ – information for patients and carers.For printed copies of the ‘Understanding NICE guidance’, phone NICEpublications on 0845 003 7783 or email publications@nice.org.uk and quoteN1978 (‘Understanding NICE guidance’).Audit support (NICE interventional procedure guidance 314 –Ultrasound-guided foam 11sclerotherapy for varicose veins)