scholarly journals P-P21 Endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by unresectable cancer: systematic review of clinical and cost effectiveness

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Fiona Beyer ◽  
Stephen Rice ◽  
Giovany Orozco-Leal ◽  
Madeleine Still ◽  
Hannah O'Keefe ◽  
...  

Abstract Background Early evidence suggests using radiofrequency ablation (RFA) as an adjunct to stenting may improve outcomes in patients with malignant biliary obstruction. RFA can be deployed either at the initial stent insertion or to clear tumour ingrowth in a previously placed stent. Methods To assess the clinical and cost effectiveness and potential risks of RFA for malignant biliary obstruction. MEDLINE, EMBASE, Cochrane Library, Scopus, CINAHL, HTA and DARE, 3 websites and 7 trial registers were searched from 2008 to 2021. Study inclusion criteria were: malignant biliary obstruction; intervention as endoscopic RFA, either to fit a stent (primary RFA) or to clear a blocked stent (secondary RFA); primary outcomes were survival, quality of life or procedure-related adverse events. Risk of bias was assessed using the RoB 2.0 and ROBINS-I tools. Primary analysis was meta-analysis of the hazard ratio of mortality. Results 68 studies (1742 patients) were identified but only 2 randomised trials, 1 retrospective case-control study and 3 retrospective cohort studies reported a hazard ratio of death for primary RFA compared to stent-only control. The pooled hazard ratio of mortality for primary RFA compared to stent-only was 0.34 (95% confidence interval (CI) 0.21 to 0.55). There was moderate heterogeneity (I2 = 53%) however studies were consistently in favour of primary RFA. There was insufficient evidence available to analyse effectiveness in secondary RFA. No evidence relating to quality of life. There was no evidence of increased risk of cholangitis (risk ratio 1.15, 95% CI 0.63 to 2.12) or pancreatitis (risk ratio 1.34, 95% CI 0.55 to 3.25), but there was an increase in cholecystitis (risk ratio 11.47, 95% CI 2.28 to 57.66). Inconsistencies in standard reporting and study design were noted e.g. adverse outcomes and lack of standardised comparator groups. RFA was estimated to cost £2,659 and produced 0.18 QALYs more than no RFA on average. With an ICER of £14,392/QALY, RFA was likely to be cost-effective at a threshold of £20,000/QALY. The source of the vast majority of decision uncertainty lay in the effect of RFA on stent patency. Conclusions Primary RFA is associated with increased survival and appears cost-effective. The evidence for the impact of secondary RFA on survival and of quality of life is limited. There was no increase in the risk of post-ERCP cholangitis or pancreatitis but increased risk of cholecystitis. High quality RCTs to investigate primary and secondary RFA are needed with accurate documentation of quality of life, adverse event rates and survival.

2015 ◽  
Vol 31 (5) ◽  
pp. 289-296 ◽  
Author(s):  
Amanda C. Shepherd ◽  
Marta Ortega-Ortega ◽  
Manj S. Gohel ◽  
David Epstein ◽  
Louise C. Brown ◽  
...  

Objectives: Although the clinical benefits of endovenous thermal ablation are widely recognized, few studies have evaluated the health economic implications of different treatments. This study compares 6-month clinical outcomes and cost-effectiveness of endovenous laser ablation (EVLA) compared with radiofrequency ablation (RFA) in the setting of a randomized clinical trial.Methods: Patients with symptomatic primary varicose veins were randomized to EVLA or RFA and followed up for 6 months to evaluate clinical improvements, health related quality of life (HRQOL) and cost-effectiveness.Results: A total of 131 patients were randomized, of which 110 attended 6-month follow-up (EVLA n = 54; RFA n = 56). Improvements in quality of life (AVVQ and SF-12v2) and Venous Clinical Severity Scores (VCSS) achieved at 6 weeks were maintained at 6 months, with no significant difference detected between treatment groups. There were no differences in treatment failure rates. There were small differences in favor of EVLA in terms of costs and 6-month HRQOL but these were not statistically significant. However, RFA is associated with less pain at up to 10 days.Conclusions: EVLA and RFA result in comparable and significant gains in quality of life and clinical improvements at 6 months, compared with baseline values. EVLA is more likely to be cost-effective than RFA but absolute differences in costs and HRQOL are small.


2016 ◽  
Vol 6 (1) ◽  
Author(s):  
Wen-Wen Yue ◽  
Shu-Rong Wang ◽  
Feng Lu ◽  
Xiao-Long Li ◽  
Hui-Xiong Xu ◽  
...  

Abstract This study is to compare the health-related quality of life (HRQoL) and cost-effectiveness of radiofrequency ablation (RFA) and open thyroidectomy (OT) for benign thyroid nodules (BTNs) treatment. HRQoL and utility were assessed for 404 BTN patients immediately before treatments (RFA:OT = 137:267) and at 6-month visit. A cost-effectiveness analysis was performed from societal perspective in the China context. Resource use (hospitalization, sick leaves) was collected. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for RFA and OT. Sensitivity analyses of costs of RFA were performed. At 6-month visit, patients treated with RFA had significantly better HRQoL than patients treated with OT on general health (68.5 versus 66.7, P = 0.029), vitality (71.3 versus 67.5, P < 0.001) and mental health (80.9 versus 79.3, P = 0.038). RFA was more effective than OT in terms of quality-adjusted life-years (QALYs; 0.01QALY/patient) but more expensive (US$823/patient). The probability that RFA would be cost effective at a US$50,000/QALY threshold was 15.5% in China, and it would be increased to 88.4% when price of the RFA device was lowered by 30%. RFA exhibited a significant improvement of HRQoL relative to OT, but is unlikely to be cost effective at its current price in short time.


BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023881 ◽  
Author(s):  
Filipa Sampaio ◽  
Marianne Bonnert ◽  
Ola Olén ◽  
Erik Hedman ◽  
Maria Lalouni ◽  
...  

ObjectiveTo assess whether exposure-based internet-delivered cognitive–behavioural therapy (internet-CBT) is a cost-effective treatment for adolescents with irritable bowel syndrome (IBS) compared with a waitlist control, from a societal perspective, based on data from a randomised trial.DesignWithin-trial cost-effectiveness analysis.SettingParticipants were recruited from the whole of Sweden via primary, secondary and tertiary care clinics reached through news media and advertising.ParticipantsAdolescents (aged 13–17) with a diagnosis of IBS.InterventionsParticipants were randomised to either an exposure-based internet-CBT, including 10 weekly modules for adolescents and five modules for parents, or a waitlist.Outcome measuresThe main health outcome was the quality-adjusted life-year (QALY) estimated by mapping Pediatric Quality-of-Life Inventory (PedsQL) scores onto EQ-5D-3L utilities. The secondary outcome was the point improvement on the PedsQL scale. Data on health outcomes and resource use were collected at baseline and 10 weeks post-treatment. Resource use was measured using the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) . Incremental cost-effectiveness ratios (ICER) were calculated as the difference in average costs by the difference in average outcomes between groups.ResultsThe base-case results showed that internet-CBT costs were on average US$170.24 (95% CI 63.14 to 315.04) more per participant than the waitlist. Adolescents in the internet-CBT group showed small QALY gains (0.0031; 95% CI 0.0003 to 0.0061), and an average improvement of 5.647 points (95% CI 1.82 to 9.46) on the PedsQL compared with the waitlist. Internet-CBT yielded an ICER of $54 916/QALY gained and a probability of cost-effectiveness of 74% given the Swedish willingness-to-pay threshold. The ICER for the outcome PedsQL was US$85.29/point improvement.ConclusionsOffering internet-CBT to adolescents with IBS improves health-related quality of life and generates small QALY gains at a higher cost than a waitlist control. Internet-CBT is thus likely to be cost-effective given the strong efficacy evidence, small QALY gains and low cost.Trial registration numberNCT02306369; Results.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20573-e20573 ◽  
Author(s):  
G. Bernardo ◽  
R. Palumbo ◽  
M. Frascaroli ◽  
A. Bernardo ◽  
A. Losurdo ◽  
...  

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.


2012 ◽  
Vol 75 (4) ◽  
pp. AB376
Author(s):  
Yukiko Ito ◽  
Hiroyuki Isayama ◽  
Takeshi Tsujino ◽  
Takashi Sasaki ◽  
Hirofumi Kogure ◽  
...  

2015 ◽  
Vol 19 (40) ◽  
pp. 1-188 ◽  
Author(s):  
Alison McMillan ◽  
Daniel J Bratton ◽  
Rita Faria ◽  
Magda Laskawiec-Szkonter ◽  
Susan Griffin ◽  
...  

BackgroundThe therapeutic and economic benefits of continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnoea syndrome (OSAS) have been established in middle-aged people. In older people there is a lack of evidence.ObjectiveTo determine the clinical efficacy of CPAP in older people with OSAS and to establish its cost-effectiveness.DesignA randomised, parallel, investigator-blinded multicentre trial with within-trial and model-based cost-effectiveness analysis.MethodsTwo hundred and seventy-eight patients, aged ≥ 65 years with newly diagnosed OSAS [defined as oxygen desaturation index at ≥ 4% desaturation threshold level for > 7.5 events/hour and Epworth Sleepiness Scale (ESS) score of ≥ 9] recruited from 14 hospital-based sleep services across the UK.InterventionsCPAP with best supportive care (BSC) or BSC alone. Autotitrating CPAP was initiated using standard clinical practice. BSC was structured advice on minimising sleepiness.Coprimary outcomesSubjective sleepiness at 3 months, as measured by the ESS (ESS mean score: months 3 and 4) and cost-effectiveness over 12 months, as measured in quality-adjusted life-years (QALYs) calculated using the European Quality of Life-5 Dimensions (EQ-5D) and health-care resource use, information on which was collected monthly from patient diaries.Secondary outcomesSubjective sleepiness at 12 months (ESS mean score: months 10, 11 and 12) and objective sleepiness, disease-specific and generic quality of life, mood, functionality, nocturia, mobility, accidents, cognitive function, cardiovascular risk factors and events at 3 and 12 months.ResultsTwo hundred and seventy-eight patients were randomised to CPAP (n = 140) or BSC (n = 138) over 27 months and 231 (83%) patients completed the trial. Baseline ESS score was similar in both groups [mean (standard deviation; SD) CPAP 11.5 (3.3), BSC 11.4 (4.2)]; groups were well balanced for other characteristics. The mean (SD) in ESS score at 3 months was –3.8 (0.4) in the CPAP group and –1.6 (0.3) in the BSC group. The adjusted treatment effect of CPAP compared with BSC was –2.1 points [95% confidence interval (CI) –3.0 to –1.3 points;p < 0.001]. At 12 months the effect was –2.0 points (95% CI –2.8 to –1.2 points;p < 0.001). The effect was greater in patients with increased CPAP use or higher baseline ESS score. The number of QALYs calculated using the EQ-5D was marginally (0.005) higher with CPAP than with BSC (95% CI –0.034 to 0.044). The average cost per patient was £1363 (95% CI £1121 to £1606) for those allocated to CPAP and £1389 (95% CI £1116 to £1662) for those allocated to BSC. On average, costs were lower in the CPAP group (mean –£35; 95% CI –£390 to £321). The probability that CPAP was cost-effective at thresholds conventionally used by the NHS (£20,000 per QALY gained) was 0.61. QALYs calculated using the Short Form questionnaire-6 Dimensions were 0.018 higher in the CPAP group (95% CI 0.003 to 0.034 QALYs) and the probability that CPAP was cost-effective was 0.96. CPAP decreased objective sleepiness (p = 0.02), increased mobility (p = 0.03) and reduced total and low-density lipoprotein cholesterol (p = 0.05,p = 0.04, respectively) at 3 months but not at 12 months. In the BSC group, there was a fall in systolic blood pressure of 3.7 mmHg at 12 months, which was not seen in the CPAP group (p = 0.04). Mood, functionality, nocturia, accidents, cognitive function and cardiovascular events were unchanged. There were no medically significant harms attributable to CPAP.ConclusionIn older people with OSAS, CPAP reduces sleepiness and is marginally more cost-effective than BSC over 12 months. Further work is required in the identification of potential biomarkers of sleepiness and those patients at increased risk of cognitive impairment. Early detection of which could be used to inform the clinician when in the disease cycle treatment is needed to avert central nervous system sequelae and to assist patients decision-making regarding treatment and compliance. Treatment adherence is also a challenge in clinical trials generally, and adherence to CPAP therapy in particular is a recognised concern in both research studies and clinical practice. Suggested research priorities would include a focus on optimisation of CPAP delivery or support and embracing the technological advances currently available. Finally, the improvements in quality of life in trials do not appear to reflect the dramatic changes noted in clinical practice. There should be a greater focus on patient centred outcomes which would better capture the symptomatic improvement with CPAP treatment and translate these improvements into outcomes which could be used in health economic analysis.Trial registrationCurrent Controlled Trials ISRCTN90464927.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 40. See the NIHR Journals Library website for further project information.


2020 ◽  
Author(s):  
Hongyang Chen ◽  
Chunxian Zhu ◽  
Leimin Sun

Abstract Background: Malignant biliary obstruction was typically diagnosed at an advanced stage due to painless jaundice. Stent placement is the therapy of choice in this set of patients. Radiofrequency ablation is an ablative therapy which has been well recognized for treating malignant biliary strictures. This meta-analysis aims to help to better understand the safety and efficacy of biliary Radiofrequency ablation combined with stent placement. Methods: Five databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and China National Knowledge Infrastructure) were searched for randomized controlled trials and observational studies up to April 2020. Results: The mean difference in survival time was 54.87 days (95% confidence interval CI, 34.6-75.14), meaning patients performed with radiofrequency ablation benefit more. Reconstructed Kaplan-Meier data showed improved survival in joint intervention with RFA (hazard ratio, 1.39; 95%CI, 1.34-1.75; P < .001). However, no survival benefit was observed in the extrahepatic distal cholangiocarcinoma. With regard to patency time, the mean difference was 42.88 days (95%CI, 34.02-51.37). Reconstructed Kaplan-Meier data showed improved survival in the radiofrequency ablation treated group (hazard ratio, 1.629; 95%CI, 1.35-1.96; P < .001). Concerning postoperative complications such as abdominal pain, cholangitis and pancreatitis, our analysis did not show a significant difference between the radiofrequency ablation treatment group and the controls. Conclusion: Radiofrequency ablation plus stent resulted in improved survival and stent patency, with longer median survival and patency time than stent alone.


Author(s):  
Danielle M. Gillard ◽  
Jeffrey D. Sharon

Abstract Purpose of Review To summarize and critically review recent literature on the relative cost-effectiveness of hearing augmentation versus stapes surgery for the treatment of otosclerosis. Recent Findings Otosclerosis leads to reduced patient quality of life, which can be ameliorated by either stapes surgery, or hearing aid usage. The success of stapes surgery is high, and the risks of serious postoperative complications are low. Hearing aids don’t have the complications of surgery but are associated with long-term costs. Cost-effectiveness models have shown that stapes surgery is a cost-effective method for treating otosclerosis. Summary Both stapes surgery and hearing aids can improve patient-reported quality of life in otosclerosis. Stapes surgery has larger upfront costs and surgical risks, but hearing aids are associated with longer lifetime costs. Stapes surgery is cost-effective for the treatment of otosclerosis.


Sign in / Sign up

Export Citation Format

Share Document