Abstract
Objectives: To compare the clinical outcome and costeffectiveness
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 costeffectiveness
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.
Original language | English |
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Pages (from-to) | 1-193 |
Number of pages | 192 |
Journal | Health technology assessment |
Volume | 10 |
Issue number | 40 |
DOIs | |
Publication status | Published - Oct 2006 |
Keywords
- QUALITY-OF-LIFE
- GASTROESOPHAGEAL-REFLUX DISEASE
- SCREENING FLEXIBLE SIGMOIDOSCOPY
- UPPER GASTROINTESTINAL SYMPTOMS
- IRRITABLE-BOWEL-SYNDROME
- PATIENT SATISFACTION
- COLORECTAL-CANCER
- GI ENDOSCOPY
- HEALTH-CARE
- PREVALENCE