Three‐year cost utility analysis of mini versus standard slings: A trial based economic evaluation
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SUBMITTER: Kilonzo M
PROVIDER: S-EPMC10869650 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature
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Project description:BackgroundTelerehabilitation could benefit a large population by increasing adherence to rehabilitation protocols.ObjectiveOur objective was to review and discuss the use of cost-utility approaches in economic evaluations of telerehabilitation interventions.MethodsA review of the literature on PubMed, Scopus, Centres for Review and Dissemination databases (including the HTA database, the Database of Abstracts of Reviews of Effects, and the NHS Economic Evaluation Database), Cochrane Library, and ClinicalTrials.gov (last search on February 8, 2021) was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The inclusion criteria were defined in accordance with the PICOS (population, intervention, comparison, outcomes, and study design) system: the included studies had to evaluate patients in rehabilitation therapy for all diseases and disorders (population) through exercise-based telerehabilitation (intervention) and had to have a control group that received face-to-face rehabilitation (comparison), and these studies had to evaluate effectiveness through gain in quality of life (outcome) and used the design of randomized and controlled clinical studies (study).ResultsWe included 11 economic evaluations, of which 6 concerned cardiovascular diseases. Several types of interventions were assessed as telerehabilitation, consisting in monitoring of rehabilitation at home (monitored by physicians) or a rehabilitation program with exercise and an educational intervention at home alone. All studies were based on randomized clinical trials and used a validated health-related quality of life instrument to describe patients' health states. Four evaluations used the EQ-5D, 1 used the EQ-5D-5L, 2 used the EQ-5D-3L, 3 used the Short-Form Six-Dimension questionnaire, and 1 used the 36-item Short Form survey. The mean quality-adjusted life years gained using telerehabilitation services varied from -0.09 to 0.89. These results were reported in terms of the probability that the intervention was cost-effective at different thresholds for willingness-to-pay values. Most studies showed results about telerehabilitation as dominant (ie, more effective and less costly) together with superiority or noninferiority in outcomes.ConclusionsThere is evidence to support telerehabilitation as a cost-effective intervention for a large population among different disease areas. There is a need for conducting cost-effectiveness studies in countries because the available evidence has limited generalizability in such countries.Trial registrationPROSPERO CRD42021248785; https://tinyurl.com/4xurdvwf.
| S-EPMC10509745 | biostudies-literature
Project description:IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.
| S-EPMC5724064 | biostudies-literature
Project description:PurposeUntil recently, surgery was the only remaining choice for moderate to severe chronic ulcerative colitis patients who failed standard treatment or when it was not tolerated. Anti-TNFα treatment is a new, non-invasive option for the management of ulcerative colitis. The objective of this study was to assess the cost-effectiveness of induction and maintenance treatment up to 1 year of ulcerative colitis with adalimumab/standard care and standard care alone in Poland.MethodsA Markov model was used to estimate the expected costs and effects of adalimumab/standard care and a standard care alone. For each treatment option, the costs and quality adjusted life years were calculated to estimate the incremental cost-utility ratio. The analysis was performed from the perspective of the Polish public payer and society over a 30-year time horizon. Different direct and indirect costs and utility values were assigned to the various model health states.ResultsThe treatment of ulcerative colitis patients with adalimumab/standard care up to 1 year instead of a standard care alone resulted in 0.14 additional years of life with full health (QALYs). The incremental cost-utility ratio of adalimumab/standard care compared to the standard care alone is estimated to be 76,120 €/QALY gained from NHF perspective and 71,457 €/QALY gained from social perspective.ConclusionsThe biologic treatment of ulcerative colitis patients with adalimumab/standard care is more effective but also more costly compared with standard care alone.
| S-EPMC5055904 | biostudies-literature
Project description:Screening for polyomavirus infection after kidney transplantation is recommended by clinical practice guidelines, but cost-effectiveness of this strategy is uncertain. The aim of this study was to estimate the incremental costs and benefits of routine screening for polyomavirus infection compared with no screening in kidney transplant recipients.MethodsProbabilistic Markov models were constructed to compare the health and economic benefits of routine screening for polyomavirus infection using real-time polymerase chain reaction assay. A series of 1-way and probabilistic sensitivity analyses were conducted to define the most influential variables in the model.ResultsMonthly screening for 6 mo followed by 3 monthly screenings until 12 mo after transplant was dominant (lower costs and improved outcomes). Compared with no screening, the incremental benefits of screening were 0.294 life-years saved and 0.232 quality-adjusted life-years saved. Total savings from screening were $6986 Australian dollars ($5057 US dollars). The cost-effectiveness ratios were most sensitive to the costs of transplantation and dialysis, age of transplantation, prevalence of viremia, and probability of death in patients with a history of polyomavirus-associated nephropathy. Probabilistic sensitivity analysis indicated that screening (compared with no screening) was the dominant strategy across all plausible ranges of transition probabilities.ConclusionsScreening for polyomavirus infections 1 year following transplantation appears to save money, improves survival, and improves quality of life in kidney transplant recipients.
| S-EPMC9018998 | biostudies-literature
Project description:BackgroundOlder adults are at greater risk of medication-related harm than younger adults. The Integrated Medication Management model is an interdisciplinary method aiming to optimize medication therapy and improve patient outcomes.ObjectiveWe aimed to investigate the cost effectiveness of a medication optimization intervention compared to standard care in acutely hospitalized older adults.MethodsA cost-utility analysis including 285 adults aged ≥ 70 years was carried out alongside the IMMENSE study. Quality-adjusted life years (QALYs) were derived using the EuroQol 5-Dimension 3-Level Health State Questionnaire (EQ-5D-3L). Patient-level data for healthcare use and costs were obtained from administrative registers, taking a healthcare perspective. The incremental cost-effectiveness ratio was estimated for a 12-month follow-up and compared to a societal willingness-to-pay range of €/QALY 27,067-81,200 (NOK 275,000-825,000). Because of a capacity issue in a primary care resulting in extended hospital stays, a subgroup analysis was carried out for non-long and long stayers with hospitalizations < 14 days or ≥ 14 days.ResultsMean QALYs were 0.023 [95% confidence interval [CI] 0.022-0.025] higher and mean healthcare costs were €4429 [95% CI - 1101 to 11,926] higher for the intervention group in a full population analysis. This produced an incremental cost-effectiveness ratio of €192,565/QALY. For the subgroup analysis, mean QALYs were 0.067 [95% CI 0.066-0.070, n = 222] and - 0.101 [95% CI - 0.035 to 0.048, n = 63] for the intervention group in the non-long stayers and long stayers, respectively. Corresponding mean costs were €- 824 [95% CI - 3869 to 2066] and €1992 [95% CI - 17,964 to 18,811], respectively. The intervention dominated standard care for the non-long stayers with a probability of cost effectiveness of 93.1-99.2% for the whole willingness-to-pay range and 67.8% at a zero willingness to pay. Hospitalizations were the main cost driver, and readmissions contributed the most to the cost difference between the groups.ConclusionsAccording to societal willingness-to-pay thresholds, the medication optimization intervention was not cost effective compared to standard care for the full population. The intervention dominated standard care for the non-long stayers, with a high probability of cost effectiveness.Clinical trial registrationThe IMMENSE trial was registered in ClinicalTrials.gov on 28 June, 2016 before enrolment started (NCT02816086).
| S-EPMC10682290 | biostudies-literature
Project description:IntroductionMajor trauma is a leading cause of death and disability in young adults, especially from massive non-compressible torso haemorrhage. The standard technique to control distal haemorrhage and maximise central perfusion is resuscitative thoracotomy with aortic cross-clamping (RTACC). More recently, the minimally invasive technique of resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed to similarly limit distal haemorrhage without the morbidity of thoracotomy; cost-utility studies on this intervention, however, are still lacking. The aim of this study was to perform a one-year cost-utility analysis of REBOA as an intervention for patients with major traumatic non-compressible abdominal haemorrhage, compared to RTACC within the U.K.'s National Health Service.MethodsA retrospective analysis of the outcomes following REBOA and RTACC was conducted based on the published literature of survival and complication rates after intervention. Utility was obtained from studies that used the EQ-5D index and from self-conducted surveys. Costs were calculated using 2016/2017 National Health Service tariff data and supplemented from further literature. A cost-utility analysis was then conducted.ResultsA total of 12 studies for REBOA and 20 studies for RTACC were included. The mean injury severity scores for RTACC and REBOA were 34 and 39, and mean probability of death was 9.7 and 54%, respectively. The incremental cost-effectiveness ratio of REBOA when compared to RTACC was £44,617.44 per quality-adjusted life year. The incremental cost-effectiveness ratio, by exceeding the National Institute for Health and Clinical Effectiveness's willingness-to-pay threshold of £30,000/quality-adjusted life year, suggests that this intervention is not cost-effective in comparison to RTACC. However, REBOA yielded a 157% improvement in utility with a comparatively small cost increase of 31.5%.ConclusionAlthough REBOA has not been found to be cost-effective when compared to RTACC, ultimately, clinical experience and expertise should be the main factor in driving the decision over which intervention to prioritise in the emergency context.
| S-EPMC6380757 | biostudies-literature
Project description:PurposeStandard corneal collagen cross-linking (S-CXL) is an effective treatment to arrest Keratoconus (KC) progression in children. Less is known on the long-term efficacy of accelerated CXL (A-CXL) in paediatric populations.MethodsA historical cohort analysis of paediatric patients (≤18 years) with KC who underwent S-CXL and A-CXL at two tertiary referral centres in Israel between 2010-2017. Preoperative and 3-year postoperative evaluation included changes in visual acuity (best spectacle corrected [BSCVA]) and uncorrected [UCVA]), refractive errors, and keratometric data.ResultsNinety-three eyes of 93 patients were analysed (A-CXL: n = 39; S-CXL: n = 54). Baseline characteristics were similar between groups. Both groups showed a significant improvement in visual acuity compared to baseline (S-CXL: 0.810-0.602 LogMAR UCVA; A-CXL: 0.890-0.306 LogMAR UCVA, p < 0.05 for both). Improvement in BSCVA and UCVA following A-CXL was non-inferior to S-CXL (< ± 0.2 LogMAR). Kmax decreased by a mean of 0.98 ± 5.56 dioptres following S-CXL (p = 0.02) and by 1.48 ± 8.4 dioptres following A-CXL (p = 0.015). Thinnest pachymetry decreased following both treatments (S-CXL: by 26.8 ± 40.7 µm, p = 0.001, A-CXL: by 10.2 ± 13.4 µm, p = 0.028), the difference between groups was within the non-inferiority margin (< ± 10 µm).ConclusionsPaediatric patients followed for three years after A-CXL showed improved visual function, reduced corneal astigmatism and Kmax, and decreased thinnest corneal thickness. A-CXL was non-inferior to S-CXL at three years in terms of best-corrected and uncorrected visual acuity, thinnest pachymetry, and astigmatism. For Kmax, non-inferiority could not be concluded.
| S-EPMC10102302 | biostudies-literature
Project description:Background: A complex, collaborative pharmaceutical care intervention including medication review and reconciliation demonstrated a statistically significant reduction in the prevalence of discharge medication error and improved quality of prescribing for hospitalised adults. This study sought to assess the cost-effectiveness of this intervention. Methods: A cost-utility analysis was undertaken using a decision-analytic framework. The evaluation was undertaken from the Health Service Executive's perspective, the payer for primary and secondary care settings. Direct costs associated with managing hypothetical harm consequent to intercepted discharge medication error and consequences in terms of quality-adjusted life years loss were key input parameters. Analysis was structured within a decision tree model in Microsoft Excel® populated with consequences as utilities, estimated costs using macro- and micro-costing approaches, and event probabilities generated from the original study. Incremental analysis, one-way and probabilistic sensitivity analyses were performed. Results: The results of analysis for the base-care demonstrated that the intervention dominated standard care with an incremental cost-effectiveness ratio of -€36,537.24/quality-adjusted life year, indicating that the intervention is less costly and more effective. The one-way and probabilistic sensitivity analyses both demonstrated that the intervention dominated standard care. The model was relatively robust to variation in input parameters through one-way sensitivity analysis. The cost of discharge medication error and effect parameters relating to standard care were most sensitive to change. Discussion: The analysis demonstrated the cost-effectiveness of a complex pharmaceutical intervention which will support decision-making regarding implementation. This is the first cost-utility analysis of a complex, collaborative pharmaceutical care intervention, adding to the scant evidence-base in the field.
| S-EPMC10382783 | biostudies-literature
Project description:Background Recent trials comparing catheter ablation to medical therapy in patients with heart failure (HF) with symptomatic atrial fibrillation despite first-line management have demonstrated a reduction in adverse outcomes. We performed an economic evaluation to estimate the cost-utility of catheter ablation as second line therapy in patients with HF with reduced ejection fraction. Methods and Results A Markov model with health states of alive, dead, and alive with amiodarone toxicity was constructed, using the perspective of the Canadian healthcare payer. Patients in the alive states were at risk of HF and non-HF hospitalizations. Parameters were obtained from randomized trials and Alberta health system data for costs and outcomes. A lifetime time horizon was adopted, with discounting at 3.0% annually. Probabilistic and 1-way sensitivity analyses were performed. Costs are reported in 2018 Canadian dollars. A patient treated with catheter ablation experienced lifetime costs of $64 960 and 5.63 quality-adjusted life-years (QALY), compared with $49 865 and 5.18 QALYs for medical treatment. The incremental cost-effectiveness ratio was $35 360/QALY (95% CI, $21 518-77 419), with a 90% chance of being cost-effective at a willingness-to-pay threshold of $50 000/QALY. A minimum mortality reduction of 28%, or a minimum duration of benefit of >1 to 2 years was required for catheter ablation to be attractive at this threshold. Conclusions Catheter ablation is likely to be cost-effective as a second line intervention for patients with HF with symptomatic atrial fibrillation, with incremental cost-effectiveness ratio $35 360/QALY, as long as over half of the relative mortality benefit observed in extant trials is borne out in future studies.
| S-EPMC8483474 | biostudies-literature
Project description:IntroductionDexmedetomidine was shown in two European randomized double-blind double-dummy trials (PRODEX and MIDEX) to be non-inferior to propofol and midazolam in maintaining target sedation levels in mechanically ventilated intensive care unit (ICU) patients. Additionally, dexmedetomidine shortened the time to extubation versus both standard sedatives, suggesting that it may reduce ICU resource needs and thus lower ICU costs. Considering resource utilization data from these two trials, we performed a secondary, cost-minimization analysis assessing the economics of dexmedetomidine versus standard care sedation.MethodsThe total ICU costs associated with each study sedative were calculated on the basis of total study sedative consumption and the number of days patients remained intubated, required non-invasive ventilation, or required ICU care without mechanical ventilation. The daily unit costs for these three consecutive ICU periods were set to decline toward discharge, reflecting the observed reduction in mean daily Therapeutic Intervention Scoring System (TISS) points between the periods. A number of additional sensitivity analyses were performed, including one in which the total ICU costs were based on the cumulative sum of daily TISS points over the ICU period, and two further scenarios, with declining direct variable daily costs only.ResultsBased on pooled data from both trials, sedation with dexmedetomidine resulted in lower total ICU costs than using the standard sedatives, with a difference of €2,656 in the median (interquartile range) total ICU costs-€11,864 (€7,070 to €23,457) versus €14,520 (€7,871 to €26,254)-and €1,649 in the mean total ICU costs. The median (mean) total ICU costs with dexmedetomidine compared with those of propofol or midazolam were €1,292 (€747) and €3,573 (€2,536) lower, respectively. The result was robust, indicating lower costs with dexmedetomidine in all sensitivity analyses, including those in which only direct variable ICU costs were considered. The likelihood of dexmedetomidine resulting in lower total ICU costs compared with pooled standard care was 91.0% (72.4% versus propofol and 98.0% versus midazolam).ConclusionsFrom an economic point of view, dexmedetomidine appears to be a preferable option compared with standard sedatives for providing light to moderate ICU sedation exceeding 24 hours. The savings potential results primarily from shorter time to extubation.Trial registrationClinicalTrials.gov NCT00479661 (PRODEX), NCT00481312 (MIDEX).
| S-EPMC4391080 | biostudies-literature