1. WORLA Background & Aim W Harrison, 1 M Temple, 1 Victoria McClure, 1 S Harris, 1 A Tomkinson 1. Surgical Instrument Surveillance Programme (SISP), Temple of Peace and Health, Cardiff, Wales 2. University Hospital Wales, Heath Park, Cardiff THE IMPORTANCE OF MEASURING CLINICALLY RELEVANT OUTCOMES Results Background Single-use Instrument Surveillance Programme (SISP) established 2002. Collaboration between Welsh Assembly Government, Welsh Otorhinolaryngology Association (WORLA), National Public Health Service (NPHS), Welsh Health Supplies and The Surgical Materials Testing Laboratory (SMTL). To ensure safe surgery in Wales, free of risk from vCJD, the surveillance team provide a system to monitor the highly specified single-use adenotonsillectomy instruments developed. Aim To determine how verifiable and reliable postoperative bleeding was as an outcome to measure safety for surveillance purposes. Paper based surveillance system in place utilising core dataset 1. All hospital Trusts in Wales (NHS and private) have participated since 2003. Number of procedures (tonsillectomy, adenotonsillectomy, adenoidectomy), related postoperative complications and performance of highly specified instruments are monitored. Method Currently 19,235 procedures and 458 complication records in the SISP database. Only major haemorrhage complications were deemed as reliable outcome measures (above 80% data capture). Minor haemorrhage complication capture were widely variable (35-70%). Variability attributed to differences in local practice. R1 and R2 rates only include operation complications identified from completing a complication form. One or more bleeds may be included in the figures. The two rates are distinct. R1 bleeds have immediate consequences, are high risk to the patient and occur within the hospital, e.g. delay or cancellation of surgery. R2 bleeds occur within the community, resulting in delayed return to hospital most likely to emergency theatre. Post-operative haemorrhage repairs indicated on 2 nd operation forms (without a corresponding complication form) are also key. Overall rate includes either a major haemorrhage reported on a complication form (R1 or R2) and may also include post- operative haemorrhage repair. Only one occurrence of bleeding recorded per patient. Conclusion Bleed rate (%) = (no. of complications / (no. of tonsillectomy operations + no. of adenotonsillectomy procedures)*100 Reporting of major haemorrhage is an acceptable measure of a clinically relevant outcome. R1 and R2 rates should be calculated separately and provide an insight into the pattern of bleeds at a hospital level. Use of a patient specific bleed rate is suitable for estimating overall bleeds occurring in Trusts and all Wales and has been adopted for tonsillectomy surveillance in Wales. Verifiable data was achieved through collaboration work with ENT surgeons, specifically by agreeing definitions and output. This scheme highlights the importance of a long term approach to determine suitable outcome measures. Investigation of best practice is essential to achieve reliable data. References 1.National Prospective Tonsillectomy Audit (2004) Tonsillectomy technique as a risk factor for postoperative haemorrhage. Lancet 364, 697-702 Post-operative complications were compared for all Wales annually (2003-2007) as outcome measures. Minor and major haemorrhage complications verified with Patient Episode Database for Wales (PEDW). Details of complication data collection is shown in Figure 1. Generates second operation Complete 2nd Operation and Instrument Forms (Complication indicated on Operation Form as post-operative Haemorrhage Repair) Complication noted after tonsillectomy/adenotonsillectomy operation Complete Complication Form EITHER R1 Theatre return within 24hrs post primary operation MAJOR COMPLICATION (R) Return to theatre for cessation of bleed R2 Theatre return more than 24hrs and up to 28 days post primary operation N1 Within 24hrs of post primary operation N2 More than 24hrs and up to 28 days post primary operation MINOR COMPLICATION (N) No surgical revision required eg. pain Figure 1 Complication Data Collection R1 and R2 complications Figure 2 Major haemorrhage rates (R1 & R2) for 2003-07 R1 varied from 0.9% at beginning of surveillance (2003) to 0.5% for 2007; R2 varied from 0.7% to 0.5% same time period. Surgical Instrument Surveillance Programme Overall patient specific bleed rate Figure 3 Post-operative haemorrhage repair numbers for 2003-07 Numbers accounted for 22% of all major haemorrhages recorded. SMTL Figure 4 Overall patient specific bleed rates for 2003-07 Rates decreased from 1.7% to 1.4% from 2003 to 2007. * Data available from Mar 2003 ** Some hospitals did not participate in reporting complications * Data available from Mar 2003 ** Some hospitals did not participate in reporting complications