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Mark Connolly Global Market Access Solutions, Switzerland University of Groningen, Netherlands, doctoral candidate

IMPLEMENTATION OF NATIONAL DYSPEPSIA GUIDELINES TO REDUCE PRESCRIBING AND RETURN PATIENTS TO SELF CARE: RESULTS FROM prospective EDUCATIONAL INTERVENTION AND CLINICAL AUDIT & 2 1/2 year follow-up IN ENGLAND . Mark Connolly Global Market Access Solutions, Switzerland

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Mark Connolly Global Market Access Solutions, Switzerland University of Groningen, Netherlands, doctoral candidate

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  1. IMPLEMENTATION OF NATIONAL DYSPEPSIA GUIDELINES TO REDUCE PRESCRIBING AND RETURN PATIENTS TO SELF CARE: RESULTS FROM prospective EDUCATIONAL INTERVENTION AND CLINICAL AUDIT & 2 1/2 year follow-up IN ENGLAND Mark Connolly Global Market Access Solutions, Switzerland University of Groningen, Netherlands, doctoral candidate Study sponsor: Reckitt Benckiser manufacturers of Gaviscon Advance

  2. Background to Study • PPIs are one of the most widely prescribed products on the NHS, although overall costs have been falling since the introduction of generics • PPI Rx volumes continue to increase* • NICE Dyspepsia guidelines suggest (NICE Dyspepsia 2004) • Use empirical PPI for uninvestigated dyspepsia without ALARM symptoms • Reviewed patients with prolonged symptoms annually • Importance of self-care and the role of alginates in the management of NUD and GORD • Encourage step down or step off treatment • A return to self-care with alginates or antacids * NHS, Business Service Authority, Sept 2008

  3. Background to study • NICE guidelines are not explicit regarding the use of an antacid / alginate for step-down and step-off (NICE Dyspepsia Guidelines 2004). • Studies have demonstrated that PPI step-down management is cost-effective (Inadomi, 2003) • Patients can be successfully stepped down and stepped off PPI using educational interventions in combination with alginate (Evans, 2007) • We report here the long-term follow-up to the original study reported by Evans et al. 2007 Inadomi, The Amer J of Gastro 2003;98:1940-1944. Evans, Br. J. Healthcare management 2007; 13:425-430.

  4. Objective • To evaluate the long-term effectiveness of an educational strategy aligned with UK NICE Dyspepsia guidance of “Step Therapy” and returning patients to self care • Step down • Step off

  5. Original study design (Evans, 2007) • Study conducted in Wandsworth PCT involving 9 of 56 GPs practices representing 53,000 patients • Patients on PPIs for >2 months were identified and invited to nurse-led clinic • Educational and treatment intervention • Participants were provided information on causes of dyspepsia and heartburn • Lifestyle advice and alternative treatment options • Participants offered opportunity, depending on their suitability, to lower PPI dose in combination with alginate (Step-down) or discontinue PPI and treat with alginate (step-off)

  6. Original study design (Evans, 2007) • Patients with H.Pylori infection, duodenal or gastric ulcer, grade 3 or 4 oesophagitis, history of oesophageal varices, terminal condition or chronic illness and age <18 or >90 were excluded from participating • Duration of follow-up in original audit was 22 weeks • Study protocol approved by local ethics committee

  7. Initial findings (Evans, 2007) From 9 clinics = Reaudit cohort derived from those agreeing to step therapy

  8. Reaudit protocol • Reaudit conducted between Jan - Feb 2008  • 2.5 years after original audit • 5 of 9 original centres agreed to participate in the reaudit (2 centres moved, 1 centre new manager, 1 lost audit records) • Participating centres based on ability to arrange clinic visit and retention of original audit data • Data collection: Patient consultation and review of historical patient notes since therapy switch • Audit was conducted by nurse advisor

  9. REAUDIT RESULTS

  10. Demographics

  11. Reaudit- Success by therapy change † Newcombe, RG. Statistics in Medicine, 17, 857-872 (1998).

  12. Reaudit : Patients remaining on intervention by surgery † 65 patients enrolled at 4 missing sites

  13. Reaudit- Success by therapy change † Test of single proportion considers 0.5 likelihood of success at 2.5 years. Previous studies have shown persistence on PPI around 27% (van Soest et al. Aliment Pharmacol Ther 2006; 24, 377–385.

  14. Conclusions • Results suggest that an educational intervention in combination with alginate treatment can reduce PPI prescribing • Unable to distinguish whether the educational or alginate component is responsible for the sustained response at 2.5 years • These results fill a gap in the knowledge about how to implement NICE Dyspepsia guidelines

  15. Future work: • Expand the reaudit to include additional centres • Similar audit was conducted in Scotland so will be important to review sustained response of educational intervention • Consider the cost-effectiveness of the educational intervention

  16. Contact information: Mark Connolly Global Market Access Solutions ManagingDirector mark@gmasoln.com

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