What is the clinical effectiveness of endoscopy undertaken by nurses

1. 1 Centre for Health Improvement Research and Evaluation University of Wales Swansea. 2 University of Wales Bangor3 University of York. Good morning everone. First of all I wish to thank MA for inviting me to present today and attend this Celtic event. Good morning everone. First of all I wish to thank MA for inviting me to present today and attend this Celtic event.

3. Objectives Compare the clinical and cost effectiveness of upper and lower GI endoscopies undertaken by nurses by measuring acceptability to patients quality of the process outcome for and value to patients resources consumed by NHS and patients

4. Study design MRC approach to the evaluation of complex interventions in health care Pragmatic randomised controlled trial Zelen’s randomisation and Patient’s informed of endoscopist Intervention Upper (OGD) or lower GI endoscopy (Flexi) Participating sites 23 Hospitals (16 in England, 6 in Scotland and 1 Wales) Participating Endoscopists 67 doctors and 30 nurses We adopted the MRC approach to the evaluation of complex interventions. We treated nurse endoscopy and the resulting sequence of events as an alternative health care intervention to medical endoscopy and its sequelae.We adopted the MRC approach to the evaluation of complex interventions. We treated nurse endoscopy and the resulting sequence of events as an alternative health care intervention to medical endoscopy and its sequelae.

5. Patients >18 years Inclusion criteria (OGD) Dyspeptic symptoms Weight loss Anorexia Anaemia Exclusion criteria Dysphagia Planned therapy Dual procedure Another trial Thought unable to comply Hospital criteria Inclusion criteria (Flexi) Bleeding PR Change in bowel habit Exclusion criteria Planned therapy Dual procedure Another trial Thought unable to comply Hospital criteria Patients over the 18 years of age referred for diagnostic endoscopy were considered for the study. Patients who are likely to require therapeutic procedures were excluded.Patients over the 18 years of age referred for diagnostic endoscopy were considered for the study. Patients who are likely to require therapeutic procedures were excluded.

6. Outcome measures Outcome and value to patients – GI specific and generic QOL Acceptability – Preference, anxiety and satisfaction Operator performance Video recordings Duration of procedure Data from clinical records (Hospital & GP) at 1 year (Drugs, diagnosis, investigations, missed diagnosis, complications Need for assistance Quality of endoscopy reporting

7. Outcome measures  Gastrointestinal symptom rating questionnaire (GSRQ)1 (Recorded at baseline, 1 month and 1 year) SF-36, State-Trait Anxiety Index (STAI) (Recorded at baseline, one day, 1 month and 1 year) Gastrointestinal Endoscopy Satisfaction Questionnaire – GESQ2 (recorded at one day only) Participant outcome was analysed by intention to scope Operator performance was analysed by actual endoscopist

8. Results

9. Trial patients: baseline characteristics 1

10. Trial patients: baseline characteristics 2

11. GSRQ Upper GI symptoms This graph shows that there is substantial improvement in patients symptoms at one month and one year following endoscopy. After adjusting for the baseline score, age et there were no significant different between the two gropus.This graph shows that there is substantial improvement in patients symptoms at one month and one year following endoscopy. After adjusting for the baseline score, age et there were no significant different between the two gropus.

12. Lower GI symptoms The same goes for the Lower GI symptomsThe same goes for the Lower GI symptoms

13. Patients’ quality of life - SF-36 SF 36 scores improved on 5 of the 8 subscales and the summary scales in both the groups at each time point but there were no difference between the groups.SF 36 scores improved on 5 of the 8 subscales and the summary scales in both the groups at each time point but there were no difference between the groups.

14. Patients’ anxiety scores - STAI There were no signficant difference in the patients anxiety scores between the two groups.There were no signficant difference in the patients anxiety scores between the two groups.

15. Patient satisfaction: GESQ There was a significant difference in patient satisfaction after endoscopy with the largest diference was information after endoscopy followed by ….There was a significant difference in patient satisfaction after endoscopy with the largest diference was information after endoscopy followed by ….

16. Trial patients changing endoscopists 227 patients changed endoscopits after randomisation and almost all of the changes were du to the non availability of endoscopist rather than due to patient preference227 patients changed endoscopits after randomisation and almost all of the changes were du to the non availability of endoscopist rather than due to patient preference

17. Patient preference – First ranked option When asked at 1 year whether they would recommend endoscopy to a friend an overwhelming majority recommended endoscopy whether performed by a doctor or a nurseWhen asked at 1 year whether they would recommend endoscopy to a friend an overwhelming majority recommended endoscopy whether performed by a doctor or a nurse

18. Diagnosis No difference in major diagnosis OGD 30% reported as normal by Doctors vs 18.2% by nurses Flexible sigmoidoscopy 45% reported as normal by Doctors vs 34%

19. Investigations post procedure More biopsies taken by nurses 50% vs. 31% by doctors for OGD; p<0.001 35% vs. 27% for FS; p=0.006 No difference in GI investigations post procedure at case notes review at 1 year.

20. New GI Diagnoses within 12 months of endoscopy

21. Midazolam use

22. Performance in OGD Objective scale – Technique, safety and thoroughness of examination Validation Inter and Intra-rater reliability Good factor structure Valid 3 scorers, blinded to centre and endoscopist Random sample of 188 videos (10 videos per endoscopist, 10 doctors and 10 nurses)

23. OGD video scores

24. Quality of withdrawal of Flexible sigmoidoscopy

25. Duration of examination by doctors and nurses The actual examination time excludes any time taken for biopsies. The mean duration of actual procedure by the doctor group was 3 minutes and 36 seconds and by the nurse group was 4 minute and 49 seconds. There was no difference between the two groups in the distance the endoscope was inserted into the colon, or duration of examination for OGD [mean = 18.8 minutes for doctors versus 19.8 min, 95% confidence interval (CI) for the difference of -1.0 from –5.8 to 3.8] or sigmoidoscopy (mean = 27.8 minutes for doctors vs 24.2 min, 95% CI for the difference of +3.0 from -0.5 to 7.6). The actual examination time excludes any time taken for biopsies. The mean duration of actual procedure by the doctor group was 3 minutes and 36 seconds and by the nurse group was 4 minute and 49 seconds. There was no difference between the two groups in the distance the endoscope was inserted into the colon, or duration of examination for OGD [mean = 18.8 minutes for doctors versus 19.8 min, 95% confidence interval (CI) for the difference of -1.0 from –5.8 to 3.8] or sigmoidoscopy (mean = 27.8 minutes for doctors vs 24.2 min, 95% CI for the difference of +3.0 from -0.5 to 7.6).

26. Other clinical process No significant difference quality of endoscopy reporting (against BSG standards) Immediate and delayed complications

27. Summary There were no significant difference between groups in outcome at one day, one month and one year except that patients were more satisfied with nurses after one day. Nurses were also more thorough in examining stomach and oesophagus Quality of life scores were slightly better in patients scoped by doctors (not statistically significant) Diagnostic endoscopy can be undertaken safely and effectively by nurses

28. We wish to thant all local collaboratorsWe wish to thant all local collaborators

30. Prof J G Williams Dr W Y Cheung Dr D Durai Prof I T Russell Ms A Farrin Mr G Richardson Dr K Bloor Mr D V Ford Mr S Coulton Dr F Ali Dr E Praveen Dr M Rahman Dr Siwan Thomas Gibson Prof Quereshi Dr B Saunders Dr A Pal Ms E Gregory Ms A Seagrove Ms V Wordsworth The study team. The funding body. Thank you for listening.The study team. The funding body. Thank you for listening.