What are the clinical outcome and cost-effectiveness of endoscopy undertaken by nurses when compared with doctors? A Multi-Institution Nurse Endoscopy Trial (MINuET)

OBJECTIVES: To compare the clinical outcome and cost-effectiveness of doctors and nurses undertaking upper and lower gastrointestinal endoscopy. DESIGN: The study was a pragmatic randomised controlled trial. Zelen's randomisation before consent was used to minimise distortion of existing practice in the participating sites. An economic evaluation was conducted alongside the trial, assessing the relative cost-effectiveness of nurses and doctors. SETTING: The study was undertaken in 23 hospitals in England, Scotland and Wales. In six hospitals nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 'centres'. The study was coordinated and managed from Swansea. Randomisation, data management and analysis were undertaken at York. Analysis was by intention-to-scope. PARTICIPANTS: Sixty-seven doctors and 30 nurses took part in the study. Of 4964 potentially eligible patients, 4128 (83%) were randomised. Of these, 1888 (45%) were recruited to the study from 29 July 2002 to 30 June 2003. INTERVENTIONS: The procedures under study were diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy undertaken by nurses or doctors, with or without sedation, using the preparation, techniques and protocols of participating hospitals. MAIN OUTCOME MEASURES: Primary outcome measure was the Gastrointestinal Symptom Rating Questionnaire (GSRQ). The secondary outcome measures were EuroQol (EQ5D), Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ), State-Trait Anxiety Inventory (STAI), cost-effectiveness, immediate and delayed complications, quality of examination by blinded assessment of endoscopic video recordings, quality of procedure reports, patients' preferences for operator 1 year after endoscopy, and new diagnoses at 1 year. RESULTS: The two groups were well matched at baseline for demographic and clinical characteristics. Significantly more patients changed from a planned endoscopy by a doctor to a nurse than vice versa, mainly for staffing reasons. There was no significant difference between the two groups in the primary or secondary outcome measures at 1 day, 1 month or 1 year after endoscopy, with the exception of patient satisfaction at 1 day, which favoured nurses. Nurses were significantly more thorough in the examination of stomach and oesophagus, but no different from doctors in the examination of duodenum and colon. There was no significant difference in costs to the NHS or patients, although doctors cost slightly more. Although quality of life measures showed improvement in some scores in the doctor group, this did not reach traditional levels of statistical significance. Even so, the economic evaluation, taking account of uncertainty in both costs and quality of life, suggests that endoscopy by doctors has an 87% chance of being more cost-effective than endoscopy by nurses. CONCLUSIONS: There is no statistically significant difference between doctors and nurses in their clinical effectiveness in diagnostic endoscopy. However, nurses are significantly more thorough in the examination of oesophagus and stomach, and patients are significantly more satisfied after endoscopy by a nurse. Endoscopy by doctors is associated with better outcome at 1 year at higher cost, but overall is likely to be cost-effective. Further research is needed to evaluate the clinical outcome and cost-effectiveness of nurses undertaking a greater role in other settings, to monitor the cost-effectiveness of nurse endoscopists as they become more experienced and to assess, the effect of increasing the number of nurse endoscopists on waiting times for patients, and the career implications and opportunities for nurses who become trained endoscopists. Evaluation of the clinical outcome and cost-effectiveness of diagnostic endoscopy for all current indications is also needed