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Morbidity and cost-effectiveness analysis of outpatient analgesia versus general anaesthesia for testicular sperm extraction in men with azoospermia due to defects in spermatogenesis |
Ezeh U I, Shepherd S, Moore H D, Cooke I D |
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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 Performing testicular sperm extraction (TESE) under an outpatient testicular biopsy programme using the analgesic technique of intravenous (i.v.) midazolam (initial dose of 2 mg) sedation and local anaesthetic with lignocaine spray, spermatic cord block with bupivacaine and scrotal infiltration with lignocaine, in men with non-obstructive azoospermia.
Economic study type Cost-effectiveness analysis.
Study population Patients with azoospermia due to primary gonadal failure.
Setting Hospital. The economic study was carried out in Sheffield, UK.
Dates to which data relate No dates were explicitly specified.
Source of effectiveness data The evidence for final outcomes was based on a single study.
Link between effectiveness and cost data Costing appears to have been undertaken prospectively on the same study sample as that used in the effectiveness analysis.
Study sample Power calculations were not used to determine the sample size. The study sample consisted of 40 men with a median (SD) age of 34 (8) years. The first 19 consecutive patients were assigned to the general anaesthesia group with a median age of 33 (range: 25 - 58) years, whilst the subsequent 21 consecutive patients with a median age of 32 (range: 26 - 62) years were allocated to the outpatient group.
Study design This was a non-randomised study with historical controls, carried out in a single centre. The duration of the follow-up was until one week after the operation. The study appears to have had no loss to follow-up. Clinical criteria were used to select the patients with primary gonadal failure, the diagnosis being confirmed by the histology in all cases. Patients in both groups were monitored with a similar protocol. The same surgeon performed the operation in both groups.
Analysis of effectiveness The principle used in the analysis of effectiveness appears to have been intention to treat. The clinical outcomes were sperm retrieval rate, haemodynamic stability, postoperative pain scores, sedation scores, analgesic requirements, frequency of nausea and vomiting, recovery time, late postoperative morbidity (testicular swelling for longer than 48 hours, haematoma, infection, testicular bruising for more than 4 days, pain score in the sub-categories of mild and moderate, days of pain, and medication), time taken to resume normal activities and coitus, and patients' satisfaction. A visual analogue scale (VAS) and categorical verbal score (CVS) were employed to assess the pain scores. The modified Ramsay score was used to assess the sedation scores. A questionnaire was completed by the patients at discharge, regarding postoperative testicular swelling, infection, pain, use of analgesics, and the time following the operation until they resumed daily activities and coitus. Patient groups were comparable in terms of demographic and prognostic features.
Effectiveness results The sperm retrieval rate for the whole study was 70%. Both groups demonstrated haemodynamic stability throughout both the operating and recovery periods, with little or no alteration of the heart and respiratory rates, blood pressure and oxygen saturation. The two groups were significantly different in terms of analgesic requirements: 3 in the outpatient group versus 14 in the general anaesthesia group, (p<0.0225). A significantly larger number of patients were sedated in the general anaesthesia group (p=0.0001), and pain scores were significantly higher in the first 15 minutes postoperatively. Median recovery time was 55 (range: 20 - 65) minutes in the outpatient group versus 180 (range: 106 - 300) minutes in the general anaesthesia group, (p<0.0001). No cases of nausea and vomiting were observed in either group. No symptoms of local anaesthetic toxicity was observed. The postoperative morbidity and time taken to resume normal activities and coitus were similar in both groups. The approval rate was 88% in the outpatient group versus 13% in the general anaesthesia group, (p<0.0001).
Clinical conclusions There was haemodynamic stability in all the patients and there was satisfactory pain control in almost all cases in the outpatient group, making this approach a safe and effective method for testicular biopsy in azoospermic men with gonadal failure. The key to the effectiveness of local anaesthetic in controlling the pain appears to be giving an adequate dose of local anaesthetic, waiting for the onset of its action before making the testicular incision, and maintaining communication with the patient. The study sperm retrieval rate of 70% suggests that the quantity of tissue used for TESE may be as important as the site of biopsy, and supports the hypothesis that spermatogenesis in these men may be distributed uniformly, rather than focally.
Measure of benefits used in the economic analysis No summary benefit measure was identified in the economic analysis, and only separate clinical outcomes were reported.
Direct costs Costs were not discounted due to the short time frame of the cost analysis. Quantities were reported separately from the costs in terms of staff requirement. Cost components were reported separately. The cost analysis covered the costs of consultations, histopathology, haemoglobin, microbiology, and procedural cost including nursing (qualified and unqualified), surgeon's fee, assistant's fee, medical staff (ward), anaesthetist's fee, and use of theatres (consumables, operating theatre assistant, recovery costs, and capital equipment per case), and overhead costs. NHS charge data were used instead of true costs as specific contractual arrangements made the cost data for similar items inappropriately different for the two study groups. The overhead costs were estimated based on 40% of the treatment cost in both groups because of difficulties in obtaining the exact cost. The finance department of the study institution provided the procedural and staff costs. The perspective adopted was that of the UK NHS. The date of the price data was not explicitly specified. The cost analysis did not cover the costs of late postoperative morbidity, analgesic requirement, or time taken to resume normal activity (which were similar in both groups). In addition, the costs associated with investigations performed such as karyotype, at least two semen analyses, and plasma FSH, LH and testosterone concentrations measured, were not considered since they were not directly related to the testicular biopsy.
Sensitivity analysis No sensitivity analysis was conducted.
Estimated benefits used in the economic analysis Cost results The outpatient group had an overall cost of 236.12 versus 577.23 in the general anaesthesia group. The difference in direct costs between the two groups was mainly due to the use of a greater number of nursing staff, an anaesthetic assistant and anaesthetist, as well as higher overhead costs and the costs of consumables in the group who received general anaesthesia.
Synthesis of costs and benefits Costs and benefits were not combined since the use of the intervention was the dominant strategy.
Authors' conclusions The authors concluded that the analgesic technique of i.v. midazolam sedation and local anaesthetic with lignocaine spray, spermatic cord block with bupivacaine and scrotal infiltration with lignocaine provided a cost-effective analgesia for TESE in men with non-obstructive azoospermia.
CRD COMMENTARY - Selection of comparators A justification was given for the choice of the comparator (the use of general anaesthesia). It was considered the most frequently used approach in the context in question at the time of the study.
Validity of estimate of measure of effectiveness The internal validity of the effectiveness results can not be reasonably guaranteed given the non-randomized nature of the study design, the absence of power calculations, the relatively small sample size, and the possibility of historical bias (as the operations on the general anaesthesia group were performed before those for the outpatient group), as acknowledged by the authors. However, it was speculated that bias may have been minimised by the facts that operations were performed by the same surgeon using the same technique and similar operating time, and that the patients were selected consecutively and monitored with a similar protocol. The study groups were found to be comparable in terms of patient demographic and prognostic features. The study sample appears to be representative of the wider study population.
Validity of estimate of measure of benefit The authors did not derive a measure of health benefit. The economic analysis was therefore a cost-consequences design.
Validity of estimate of costs Some quantities were reported separately from the costs. Adequate details of the methods of cost estimation were given. The exclusion of some cost items is unlikely to affect the authors' conclusion. Statistical analysis was not performed on either resource use data or cost data. The price year was not specified. Indirect costs (lost productivity), were not considered in the analysis. However, the study groups were not statistically different in terms of time taken to resume work.
Other issues Given the non-randomised nature of the study design, and the lack of sensitivity analysis, some degree of caution may need to be exercised in the interpretation of the study results. The issue of generalisability to other settings was not addressed. Appropriate comparisons were made with other studies. The study sample consisted of patients with azoospermia due to primary gonadal failure and the authors' comment appears to reflect this.
Implications of the study The haemodynamic stability and lack of adverse reactions to local anaesthetics or midazolam sedation observed among all patients in this study supports the safety of the technique, but further studies with Doppler and larger numbers of patients will be required to explore any long-term relationship between the spermatic cord block and testicular atrophy.
Bibliographic details Ezeh U I, Shepherd S, Moore H D, Cooke I D. Morbidity and cost-effectiveness analysis of outpatient analgesia versus general anaesthesia for testicular sperm extraction in men with azoospermia due to defects in spermatogenesis. Human Reproduction 1999; 14(2): 321-328 Indexing Status Subject indexing assigned by NLM MeSH Adult; Ambulatory Care /economics; Analgesia /economics; Anesthesia, General /economics; Biopsy /methods; Cost-Benefit Analysis; Humans; Male; Morbidity; Oligospermia /etiology; Pain, Postoperative /physiopathology; Patient Satisfaction; Postoperative Complications /epidemiology; Prospective Studies; Specimen Handling /adverse effects /economics; Spermatogenesis /physiology; Spermatozoa; Testis /pathology AccessionNumber 21999000509 Date bibliographic record published 30/09/2000 Date abstract record published 30/09/2000 |
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