Search

ObjectiveTo determine the cost‐effectiveness of the current ‘gold standard’ operation of transurethral resection of the prostate (TURP) compared to the new laser technique of thulium laser transurethral vaporesection of the prostate (ThuVARP) in men with benign prostatic obstruction (BPO) within the UK National Health Service (NHS).Patients and MethodsThe trial was conducted across seven UK centres (four university teaching hospitals and three district general hospitals). A total of 410 men aged ≥18 years presenting with either bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO, and suitable for surgery, were randomised (whilst under anaesthetic) 1:1 to receive the TURP or ThuVARP procedure. Resource use in relation to the operation, initial inpatient stay, and subsequent use of NHS services was collected for 12 months from randomisation (equivalent to primary effectiveness outcome) using hospital records and patient questionnaires. Resources were valued using UK reference costs. Quality adjusted life years (QALYs) were calculated from the EuroQoL five Dimensions five Levels (EQ‐5D‐5L) questionnaire completed at baseline, 3‐ and 12‐months. Total adjusted mean costs, QALYs and incremental Net Monetary Benefit statistics were calculated: cost‐effectiveness acceptability curves and sensitivity analyses addressed uncertainty.ResultsThe total adjusted mean secondary care cost over the 12 months in the TURP arm (£4244) was £9 (95% CI –£376, £359) lower than the ThuVARP arm (£4253). The ThuVARP operation took on average 21 min longer than TURP. The adjusted mean difference of QALYs (0.01 favouring TURP, 95% CI −0.01, 0.04) was similar between the arms. There is a 76% probability that TURP is the cost‐effective option compared with ThuVARP at the £20 000 per QALY willingness to pay threshold used by National Institute for Health and Care Excellence (NICE).ConclusionOne of the anticipated benefits of the laser surgery, reduced length of hospital stay with an associated reduction in cost, did not materialise within the study. The longer duration of the ThuVARP procedure is important to consider, both from a patient perspective in terms of increased time under anaesthetic, and from a service delivery perspective. TURP remains a highly cost‐effective treatment for men with BPO.

Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery. Methods In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389). Findings Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively. Interpretation TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed.

Background: Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction. Methods: In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389. Findings: Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means −3·12, 95% CI −5·79 to −0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, −0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication. Interpretation: TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed. Funding: UK National Institute for Health Research Health Technology Assessment Programme.

Objectives To evaluate the accuracy of routine data for costing inpatient resource use in a large clinical trial and to investigate costing methodologies. Design Final-year inpatient cost profiles were derived using (1) data extracted from medical records mapped to the National Health Service (NHS) reference costs via service codes and (2) Hospital Episode Statistics (HES) data using NHS reference costs. Trust finance departments were consulted to obtain costs for comparison purposes. Setting 7 UK secondary care centres. Population A subsample of 292 men identified as having died at least a year after being diagnosed with prostate cancer in Cluster randomised triAl of PSA testing for Prostate cancer (CAP), a long-running trial to evaluate the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Results Both inpatient cost profiles showed a rise in costs in the months leading up to death, and were broadly similar. The difference in mean inpatient costs was £899, with HES data yielding ∼8% lower costs than medical record data (differences compatible with chance, p=0.3). Events were missing from both data sets. 11 men (3.8%) had events identified in HES that were all missing from medical record review, while 7 men (2.4%) had events identified in medical record review that were all missing from HES. The response from finance departments to requests for cost data was poor: only 3 of 7 departments returned adequate data sets within 6 months. Conclusions Using HES routine data coupled with NHS reference costs resulted in mean annual inpatient costs that were very similar to those derived via medical record review; therefore, routinely available data can be used as the primary method of costing resource use in large clinical trials. Neither HES nor medical record review represent gold standards of data collection. Requesting cost data from finance departments is impractical for large clinical trials. Trial registration number ISRCTN92187251; Pre-results.

Background There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer. Methods The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years’ median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs. QALYs (quality-adjusted-life-years) were calculated from patient-reported EQ-5D-3L measurements. Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios were calculated; cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty; subgroup analyses considered age and disease-risk. Results Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery). Active monitoring had lower adjusted mean costs (£5913) than radiotherapy (£7361) and surgery (£7519). Radiotherapy was the most likely (58% probability) cost-effective option at the UK NICE willingness-to-pay threshold (£20,000 per QALY). Subgroup analyses confirmed radiotherapy was cost-effective for older men and intermediate/high-risk disease groups; active monitoring was more likely to be the cost-effective option for younger men and low-risk groups. Conclusions Longer follow-up and modelling are required to determine the most cost-effective treatment for localised prostate cancer over a man’s lifetime. Trial registration Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).