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Unsedated ultrathin EGD is well accepted when compared with conventional sedated EGD: a multicenter randomized trial |
Garcia R T, Cello J P, Nguyen M H, Rogers S J, Rodas A, Trinh H N, Stollman N H, Schlueck G, McQuaid K R |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of unsedated ultrathin oesophagogastroduodenoscopy (UT-EGD) versus sedated conventional EGD (C-EGD) for the diagnosis of pathology of the digestive system.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients undergoing elective, outpatient, diagnostic EGD. Patients aged 18 years or older were eligible for inclusion in the study. The exclusion criteria included patients with active or severe cardiopulmonary disease, coagulopathy, and active gastrointestinal bleeding. Other exclusion criteria were planned sequential endoscopic procedures (e.g. scheduled endoscopy and colonoscopy), planned endoscopic therapy, or anticipation of numerous biopsies.
Setting The setting was tertiary care and the community. The study was conducted in two tertiary care centres and one community-based centre in the USA.
Dates to which data relate Both the effectiveness data and resource use data referred to a period between May 2001 and June 2002. The price year was not explicitly reported. However, it is likely to have been 2001/02.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was carried out prospectively on the same sample of patients as that studied in the effectiveness analysis.
Study sample Power calculations were performed. These determined the required number of patients in each arm to detect a 20% difference in overall patient satisfaction (the primary outcome assessed). This number was estimated to be 40 patients in each arm. Of the 128 eligible patients presenting at the participating centres, 80 (63%) agreed to be randomised and were enrolled in the study. The enrolment was apparently completed when the required number of patients estimated by the power calculations was achieved. Forty patients were allocated to each group. The mean age of the participants was 50 years in the UT-EGD group and 52 years in the C-EGD group. In the UT-EGD group, 38 patients completed the procedure and 2 cases were converted to C-EGD. In the C-EGD group, 38 patients completed the procedure, one case was converted to UT-EGD, and one case failed to complete the procedure and was rescheduled to C-EGD. There was no discussion as to whether the initial study sample was appropriate for the clinical study question. The study was not powered to detect a significant difference in some of the secondary effectiveness outcomes.
Study design The study was a multi-centre, randomised controlled trial. Patients from three medical centres (two tertiary and one community-based) participated in the study. Randomisation was achieved using a permuted block method, stratified by study centre, with concealed allocation using sealed opaque envelopes. Randomisation took place immediately prior to the procedure. The patients, providers and investigators were not blinded to the intervention, as this was not feasible. The patients were asked to complete a questionnaire after the procedure (before discharge) and 24 hours later. Personnel other than endoscopists administered the questionnaires, so that patients did not feel obliged to give favourable answers to their physicians. Seventy-eight patients (98%) completed the post-procedure questionnaire, while 51 (64%) returned the questionnaire completed 24 hours later.
Analysis of effectiveness The analysis of effectiveness was conducted on an intention to treat basis. The primary outcome studied was overall patient satisfaction. The other outcomes assessed were:
patient comfort and preference to repeat EGD in the same manner,
satisfaction of the endoscopists and nursing staff,
technical difficulty of UT-EGD and completion rate,
procedure time and
complications.
Patient satisfaction was assessed using a 10-cm visual analogue scale (VAS). The baseline characteristics of the randomised patients were not significantly different between the two groups.
Effectiveness results The overall, mean satisfaction score (+/- standard deviation, SD), measured on a VAS (range: 1 - 10) immediately after the procedure was 8.7 (+/- 1.8) for the UT-EGD group and 9.1 (+/- 1.3) for the C-EGD group, (p=0.29).
The patients' responses in the 24-hour follow-up questionnaire were similar.
Willingness to repeat the procedure in the same manner was expressed by 36 patients (90%) in the UT-EGD group and 37 (95%) in the C-EGD group immediately after the procedure, (p=0.41). Twenty-four hours later, 24 patients (92%) in the UT-EGD group and 22 (96%) in the C-EGD group were willing to repeat the procedure, (p=0.60).
Patient comfort was reported as being significantly less in the UT-EGD group, (p=0.002).
No statistically significant differences were found within racial or ethnic groups.
The overall satisfaction of the endoscopists and nursing staff with the procedure was equivalent between the two groups.
Recovery and total procedure time were significantly shorter in the UT-EGD group, (p<0.0001 for both).
No serious complications were reported in either group.
Clinical conclusions Patients undergoing UT-EGD were as satisfied as patients undergoing C-EGD, and were just as willing to repeat an UT-EGD. UT-EGD was also faster, equally acceptable to C-EGD by health care professionals, and did not lead to any serious adverse events.
Measure of benefits used in the economic analysis No summary measure of benefit was used in the analysis. In effect, a cost-consequences analysis was performed.
Direct costs It was stated that a provider perspective was adopted in the economic analysis. The costs covered medications and accessories (such as catheters and biopsy forceps), facility maintenance, and personnel and professional fees. Only the unit costs were reported for each cost element. The quantities relating to each procedure were not provided. The costs and the quantities were derived using actual data from the trial. The costs represented the actual costs of operating a fully functioning private ambulatory surgical centre. The costs of medications and accessories were based on negotiated wholesale prices of these items. Facility maintenance costs were calculated on the basis of actual total procedure time, while personnel fees were calculated using the hourly personnel cost. The unit costs for these elements were provided by the Accounting Department of the community-based centre participating in the study. Professional fees were based on Medicare reimbursement rates for 2002. The year to which the other unit costs referred was not reported. No discounting was carried out, which was appropriate as the costs referred to a procedure lasting only one day.
Statistical analysis of costs The costs were treated stochastically, with mean costs and SDs being provided. Statistical tests were used to assess the significance of the cost-difference between UT-EGD and C-EGD.
Indirect Costs The indirect costs were not included in the analysis.
Sensitivity analysis No sensitivity analysis was carried out.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The mean (+/- SD) total procedure cost was $328.6 (+/- 70.3) for UT-EGD and $512.4 (+/- 100.8) for C-EGD. The cost-difference of $183.8 (36.8%) was highly significant, (p<0.0001).
Synthesis of costs and benefits The study was, in effect, a cost-consequences analysis. Therefore, the costs and benefits were not combined.
Authors' conclusions Unsedated ultrathin oesophagogastroduodenoscopy (UT-EGD) was a feasible, acceptable and cost-effective alternative to sedated conventional EGD (C-EGD).
CRD COMMENTARY - Selection of comparators The selection of the comparator was implicitly justified, as it reflected routine practice in the authors' setting. You should consider whether the comparator represents current practice in your own setting.
Validity of estimate of measure of effectiveness The basis of the analysis was a randomised controlled trial, which is the 'gold' standard method for an analysis of effectiveness. The study sample seems to have been representative of the study population. However, the study was not sufficiently powered to detect significant differences in some of the secondary outcomes examined. The patient groups were shown to be comparable at analysis. No further statistical tests to account for potential biases and confounding factors were undertaken. The outcomes were analysed on an intention to treat basis.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit. Therefore, the analysis was categorised as a cost-consequences analysis.
Validity of estimate of costs The perspective adopted in the economic analysis was that of the health care provider. All the categories of cost relevant to this perspective were included in the analysis. The quantities of resources used were not reported, only the unit costs for each cost element. This restricts the generalisability of the results. A statistical analysis of the total costs was performed. With the exception of professional fees, the costs reflected actual costs and not reimbursement rates. The date to which the prices referred was not explicitly reported, which hinders the reproducibility of the results. Discounting was not carried out, which was appropriate as the costs were incurred within one day.
Other issues The authors made appropriate comparisons of their results with those of other studies. They stated that their findings were applicable to outpatients in the USA, where there were significant cultural differences that could potentially affect the patient's acceptability of UT-EGD. The issue of generalisability to other settings was not further discussed. The results appeared to have been reported in full and the authors' conclusions reflected the scope of the analysis.
Implications of the study The authors suggested that, if UT-EGD were to become the standard practice in the USA, the societal implications would be substantial in terms of the availability and acceptability of EGD, and the indirect and direct non-health care costs (e.g. time lost from work by both patients and their escorts, costs of transportation, child and elder care). The authors proposed cost-effectiveness studies of UT-EGD used in various medical conditions. For example, comparisons with empiric treatment in patients with dyspepsia, screening for Barrett's oesophagus in patients with gastroesophageal reflux, and screening for varices in patients with cirrhosis for primary prophylaxis.
Bibliographic details Garcia R T, Cello J P, Nguyen M H, Rogers S J, Rodas A, Trinh H N, Stollman N H, Schlueck G, McQuaid K R. Unsedated ultrathin EGD is well accepted when compared with conventional sedated EGD: a multicenter randomized trial. Gastroenterology 2003; 125(6): 1606-1612 Indexing Status Subject indexing assigned by NLM MeSH Adult; Aged; Aged, 80 and over; Costs and Cost Analysis; Endoscopy, Digestive System /methods; Female; Humans; Hypnotics and Sedatives /pharmacology; Male; Middle Aged AccessionNumber 22004000052 Date bibliographic record published 31/12/2004 Date abstract record published 31/12/2004 |
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