scholarly journals Ten-year follow-up of a randomised trial of drainage, irrigation and fibrinolytic therapy (DRIFT) in infants with post-haemorrhagic ventricular dilatation

2019 ◽  
Vol 23 (4) ◽  
pp. 1-116 ◽  
Author(s):  
Karen Luyt ◽  
Sally Jary ◽  
Charlotte Lea ◽  
Grace J Young ◽  
David Odd ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Treatment Group ◽  
Standard Treatment ◽  
Cost Effective ◽  
Fibrinolytic Therapy ◽  
Decision Analysis Model ◽  
Cognitive Disability ◽  
Analysis Model ◽  
Standard Treatment Group

Background The drainage, irrigation and fibrinolytic therapy (DRIFT) trial, conducted in 2003–6, showed a reduced rate of death or severe disability at 2 years in the DRIFT compared with the standard treatment group, among preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation. Objectives To compare cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age. Design Ten-year follow-up of a randomised controlled trial. Setting Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen). Participants Fifty-two of the original 77 infants randomised. Interventions DRIFT or standard therapy (cerebrospinal fluid tapping). Main outcome measures Primary – cognitive disability. Secondary – vision; sensorimotor disability; emotional/behavioural function; education; neurosurgical sequelae on magnetic resonance imaging; preference-based measures of health-related quality of life; costs of neonatal treatment and of subsequent health care in childhood; health and social care costs and impact on family at age 10 years; and a decision analysis model to estimate the cost-effectiveness of DRIFT compared with standard treatment up to the age of 18 years. Results By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate. A total of 52 children were assessed at 10 years of age (DRIFT, n = 28; standard treatment, n = 24). Imbalances in gender and birthweight favoured the standard treatment group. The unadjusted mean cognitive quotient (CQ) score was 69.3 points [standard deviation (SD) 30.1 points] in the DRIFT group compared with 53.7 points (SD 35.7 points) in the standard treatment group, a difference of 15.7 points, 95% confidence interval (CI) –2.9 to 34.2 points; p = 0.096. After adjusting for the prespecified covariates (gender, birthweight and grade of IVH), this evidence strengthened: children who received DRIFT had a CQ advantage of 23.5 points (p = 0.009). The binary outcome, alive without severe cognitive disability, gave strong evidence that DRIFT improved cognition [unadjusted odds ratio (OR) 3.6 (95% CI 1.2 to 11.0; p = 0.026) and adjusted OR 10.0 (95% CI 2.1 to 46.7; p = 0.004)]; the number needed to treat was three. No significant differences were found in any secondary outcomes. There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059). The neonatal stay (unadjusted mean difference £6556, 95% CI –£11,161 to £24,273) and subsequent hospital care (£3413, 95% CI –£12,408 to £19,234) costs were higher in the DRIFT arm, but the wide CIs included zero. The decision analysis model indicated that DRIFT has the potential to be cost-effective at 18 years of age. The incremental cost-effectiveness ratio (£15,621 per quality-adjusted life-year) was below the National Institute for Health and Care Excellence threshold. The cost-effectiveness results were sensitive to adjustment for birthweight and gender. Limitations The main limitations are the sample size of the trial and that important characteristics were unbalanced at baseline and at the 10-year follow-up. Although the analyses conducted here were prespecified in the analysis plan, they had not been prespecified in the original trial registration. Conclusions DRIFT improves cognitive function when taking into account birthweight, grade of IVH and gender. DRIFT is probably effective and, given the reduction in the need for special education, has the potential to be cost-effective as well. A future UK multicentre trial is required to assess efficacy and safety of DRIFT when delivered across multiple sites. Trial registration Current Controlled Trials ISRCTN80286058. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 4. See the NIHR Journals Library website for further project information. The DRIFT trial and 2-year follow-up was funded by Cerebra and the James and Grace Anderson Trust.

scholarly journals Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial

2020 ◽  
Vol 105 (5) ◽  
pp. 466-473 ◽  
Author(s):  
Karen Luyt ◽  
Sally L Jary ◽  
Charlotte L Lea ◽  
Grace J. Young ◽  
David E Odd ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Fibrinolytic Therapy ◽  
Ventricular Dilatation ◽  
Cognitive Disability ◽  
Randomised Controlled ◽  
Standard Treatment Group

BackgroundProgressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.ObjectiveTo assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.ParticipantsThe RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.InterventionIntraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.Primary outcomeCognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.ResultsOf the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).ConclusionDRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.Trial registration numberISRCTN80286058.

Percutaneous Stenting of Incidental Unilateral Renal Artery Stenosis: Decision Analysis of Costs and Benefits

2003 ◽  
Vol 10 (3) ◽  
pp. 546-556 ◽  
Author(s):  
David A. Axelrod ◽  
A. Mark Fendrick ◽  
Ruth C. Carlos ◽  
Robert J. Lederman ◽  
James B. Froehlich ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Decision Analysis ◽  
Renal Artery ◽  
Incremental Cost ◽  
Renal Artery Stenosis ◽  
Cost Effective ◽  
Artery Stenosis ◽  
Decision Analysis Model ◽  
Analysis Model ◽  
Refractory Hypertension

Purpose: To determine the incremental cost-effectiveness of prophylactic percutaneous transluminal angioplasty with stent placement (PTA-S) in patients with incidentally discovered, asymptomatic renal artery stenosis (RAS) compared to delaying PTA-S until patients develop refractory hypertension or renal insufficiency (therapeutic PTA-S). Methods: The Markov decision analysis model was used to determine the incremental cost per quality adjusted life year (QALY) saved for prophylactic PTA-S as compared to therapeutic PTA-S in a hypothetical cohort of patients with 50% unilateral atherosclerotic RAS followed from age 61 to death. Results: Prophylactic PTA-S compared to therapeutic PTA-S results in more QALYs/patient (10.9 versus 10.3) at higher lifetime costs ($23,664 versus $16,558). The incremental cost effectiveness of prophylactic PTA-S was estimated to be $12,466/QALY. Prophylactic stenting was not cost effective (>$50,000/QALY) if the modeled incidence of stent restenosis exceeded 15%/year and the incidence of progression in the contralateral renal artery was <2% of arteries/year. Conclusions: PTA-S of incidental, asymptomatic unilateral RAS may improve patients' quality of life at an acceptable incremental cost. However, this technology should be used hesitantly until a randomized comparison confirms its effectiveness.

Meta-analysis and cost-effectiveness of second-line antiepileptic drugs for status epilepticus

Neurology ◽  
2019 ◽  
Vol 92 (20) ◽  
pp. e2339-e2348 ◽  
Author(s):  
Iván Sánchez Fernández ◽  
Marina Gaínza-Lein ◽  
Nathan Lamb ◽  
Tobias Loddenkemper
Keyword(s):  
Status Epilepticus ◽  
Cost Effectiveness ◽  
Antiepileptic Drugs ◽  
Meta Analysis ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Convulsive Status Epilepticus ◽  
Decision Analysis Model ◽  
Analysis Model ◽  
The Cost

ObjectiveCompare the cost and effectiveness of nonbenzodiazepine antiepileptic drugs (non-BZD AEDs) for treatment of BZD-resistant convulsive status epilepticus (SE).MethodsDecision analysis model populated with effectiveness data from a systematic review and meta-analysis of the literature, and cost data from publicly available prices. The primary outcome was cost per seizure stopped ($/SS). Sensitivity analyses evaluated the robustness of the results across a wide variation of the input parameters.ResultsWe included 24 studies with 1,185 SE episodes. The most effective non-BZD AED was phenobarbital (PB) with a probability of SS of 0.8 (95% confidence interval [CI]: 0.69–0.88), followed by valproate (VPA) (0.71 [95% CI: 0.61–0.79]), lacosamide (0.66 [95% CI: 0.51–0.79]), levetiracetam (LEV) (0.62 [95% CI: 0.5–0.73]), and phenytoin/fosphenytoin (PHT) (0.53 [95% CI: 0.39–0.67]). In pairwise comparisons, PB was more effective than PHT (p = 0.002), VPA was more effective than PHT (p = 0.043), and PB was more effective than LEV (p = 0.018). The most cost-effective non-BZD AED was LEV (incremental cost-effectiveness ratio [ICER]: $18.55/SS), followed by VPA (ICER: $94.44/SS), and lastly PB (ICER: $847.22/SS). PHT and lacosamide were not cost-effective compared to the other options. Sensitivity analyses showed marked overlap in cost-effectiveness, but PHT was consistently less cost-effective than LEV, VPA, and PB.ConclusionVPA and PB were more effective than PHT for SE. There is substantial overlap in the cost-effectiveness of non-BZD AEDs for SE, but available evidence does not support the preeminence of PHT, neither in terms of effectiveness nor in terms of cost-effectiveness.

Abstract 6234: Cost-Effectiveness Analysis Demonstrates Superiority of Screening Young Athletes with 12-Lead Electrocardiogram versus History and Physical in Preventing Sudden Cardiac Death

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Matthew T Wheeler ◽  
Paul A Heidenreich ◽  
Victor F Froelicher ◽  
Mark A Hlatky ◽  
Euan A Ashley
Keyword(s):  
Cost Effectiveness ◽  
Sudden Cardiac Death ◽  
Incremental Cost ◽  
Cardiac Death ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Decision Analysis Model ◽  
Analysis Model ◽  
Young Athletes ◽  
Life Years

Sudden cardiac death (SCD) is a rare but frightening event among young athletes. The Italian experience demonstrates a reduction in athlete SCD by screening with history, physical, and 12-lead electrocardiogram (ECG). American guideline statements have not recommended ECG for screening athletes due to perceptions of high cost and unclear effectiveness. We sought to model the cost-effectiveness (CE) of history and physical (H&P), ECG plus H&P, and no screening in US high school and college competitive athletes. A decision analysis model was used. Risks, prevalence, and test characteristics were derived from the medical literature. Costs were derived from publicly available datasets. Markov processes were used to simulate the natural histories of screened athletes. One-way sensitivity analyses and Monte Carlo simulation of all variables in the estimated ranges were performed. A societal perspective was used. Screening with an ECG plus H&P has lower overall costs and better outcomes than use of H&P alone. Compared with no screening, H&P saves 0.57 life years (LY) per 1000 athletes screened at an incremental cost of $111 per athlete, yielding a CE ratio of $195,600 per LY saved (simulation based 95% CI $116,000–514,000). ECG plus H&P when compared to no screening saves 2.7 LY per 1000 athletes at an incremental cost of $199 per athlete, for a CE ratio of $74,100 per LY saved (95% CI $46,000–158,000). Probabilistic sensitivity analysis shows that ECG plus H&P is the preferred strategy over H&P in terms of cost-effectiveness in 99.5% of simulations. ECG plus H&P is cost-effective below a threshold value of $100,000 per LY saved in 89% of simulations, while H&P is cost-effective in 1% of simulations. If the reduction in SCD risk per screening-identified, at-risk athlete is below 33%, or if more than 12% of screens are false positive, screening with ECG plus H&P is no longer cost effective. ECG plus H&P is superior to H&P for screening young athletes in our cost-effectiveness model. The incremental cost of adding an ECG, including screening, secondary testing, and subsequent treatment is under $100 per athlete screened. These data should inform the ongoing debate concerning pre-participation screening of US student-athletes.

scholarly journals The cost-effectiveness of ivermectin vs. albendazole in the presumptive treatment of strongyloidiasis in immigrants to the United States

2004 ◽  
Vol 132 (6) ◽  
pp. 1055-1063 ◽  
Author(s):  
P. MUENNIG ◽  
D. PALLIN ◽  
C. CHALLAH ◽  
K. KHAN
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Treatment Strategies ◽  
Cost Effective ◽  
Strongyloides Stercoralis ◽  
The United States ◽  
Decision Analysis Model ◽  
Analysis Model ◽  
Presumptive Treatment ◽  
The Cost

The presumptive treatment of parasitosis among immigrants with albendazole has been shown to save both money and lives, primarily via a reduction in the burden of Strongyloides stercoralis. Ivermectin is more effective than albendazole, but is also more expensive. This coupled with confusion surrounding the cost-effectiveness of guiding therapy based on eosinophil counts has led to disparate practices. We used the newly arrived year 2000 immigrant population as a hypothetical cohort in a decision analysis model to examine the cost-effectiveness of various interventions to reduce parasitosis among immigrants. When the prevalence of S. stercoralis is greater than 2%, the incremental cost-effectiveness ratios of all presumptive treatment strategies were similar. Ivermectin is associated with an incremental cost-effectiveness ratio of $1700 per QALY gained for treatment with 12 mg ivermectin relative to 5 days of albendazole when the prevalence is 10%. Any presumptive treatment strategy is cost-effective when compared with most common medical interventions.

scholarly journals Spironolactone Improves the All-Cause Mortality and Re-Hospitalization Rates in Acute Myocardial Infarction with Chronic Kidney Disease Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Xiang Qu ◽  
Hui Yao ◽  
Changxi Chen ◽  
Shuting Kong ◽  
Lingyue Sun ◽  
...  
Keyword(s):  
Treatment Group ◽  
Dose Group ◽  
Low Dose ◽  
Standard Treatment ◽  
High Dose Group ◽  
High Dose ◽  
Single Center ◽  
All Cause Mortality ◽  
Standard Treatment Group

Background: Mineralocorticoid receptor antagonists (MRA) improve outcomes in chronic kidney disease (CKD) and acute myocardial infarction (AMI) patients. However, the lack of evidence regarding long-term clinical outcomes in the use of MRA, including spironolactone, in patients with AMI combined with CKD.Objectives: This study aimed to investigate whether spironolactone could significantly reduce the risk of all-cause mortality and re-admission in patients with AMI and CKD.Methods: In this single center, observational, retrospective, registry based clinical study, a total of 2,465 AMI patients were initially screened; after excluding patients with estimated glomerular filtration rate more than 60 ml/min/1.73 m2, 360 patients in the standard treatment group and 200 patients in the spironolactone group met the criteria. All enrolled patients follow-up for 30 months. The primary outcomes were all-cause mortality and re-admission. The key safety outcome was hyperkalemia rates during the 30 months follow-up period.Results: 160 (44.4%) and 41 (20.5%) patients in the standard treatment and spironolactone groups died, respectively [hazard ratio (HR): 0.389; 95% confidence interval (CI): 0.276–0.548; p &lt; 0.001]. Re-admission occurred in 217 (60.3%) and 95 (47.5%) patients in the standard treatment and spironolactone groups, respectively (HR: 0.664; 95% CI: 0.522–0.846; p = 0.004). The spironolactone group was divided into two based on the daily dose, low dose group (no more than 40 mg) and high dose group (more than 40 mg); the differences in the mortality rate between low dose group (16.7%) and the standard treatment group (44.4%) (HR: 0.309; 95% CI: 0.228–0.418; p &lt; 0.001) and high dose group (34.1%) (HR: 0.429; 95% CI: 0.199–0.925; p = 0.007) were significant. The differences in re-hospitalization rate between low dose group (43.6%) and the standard treatment group (60.3%) (HR: 0.583; 95% CI: 0.457–0.744; p &lt; 0.001) and high dose group (61.4%) (HR: 0.551; 95% CI: 0.326–0.930; p = 0.007) was significant. Hyperkalemia occurred in 18 (9.0%) and 18 (5.0%) patients in the spironolactone group and standard treatment group, respectively (HR: 1.879; 95% CI: 0.954–3.700; p = 0.068). Whereas, Hyperkalemia occurred in high dose group (20.5%) significantly more often than in the standard treatment group (p &lt; 0.001) and low dose group (5.8%) (p = 0.003).Conclusion: Using MRA, such as spironolactone, may substantially reduce the risk of both all-cause mortality and re-admission in patients with AMI and CKD; the use of low-dose spironolactone has the best efficacy and safety. However, this was a relatively small sample size, single center, observational, retrospective, registry based clinical study and further prospective evaluation in adequately powered randomized trials were needed before further use of spironolactone in AMI with CKD population.

Cost-Effectiveness: Cholinesterase Inhibitors and Memantine in Vascular Dementia

2009 ◽  
Vol 36 (6) ◽  
pp. 735-739 ◽  
Author(s):  
Camilla L. Wong ◽  
Nick Bansback ◽  
Philip E. Lee ◽  
Aslam H. Anis
Keyword(s):  
Cost Effectiveness ◽  
Adverse Events ◽  
Incremental Cost ◽  
Vascular Dementia ◽  
Standard Care ◽  
Cholinesterase Inhibitors ◽  
Cost Effective ◽  
Decision Analysis Model ◽  
Physician Visits ◽  
Cost Effective Treatment

Background:Several randomized controlled trials of cholinesterase inhibitors and memantine in mild to moderate vascular dementia have demonstrated the efficacy of these treatments. However, given these drugs incur considerable cost, the economic argument for their use is less clear.Objective:To determine the incremental cost-effectiveness of cholinesterase inhibitors and memantine for mild to moderate vascular dementia.Design:A decision analysis model using a 24-28 week time horizon was developed. Outcomes of cholinesterase inhibitors and memantine and probabilities of adverse events were extracted from a systematic review. Costs of adverse events, medications, and physician visits were obtained from local estimates. Robustness was tested with probabilistic sensitivity analysis using a Monte Carlo simulation.Interventions:Donepezil 5 mg daily, donepezil 10 mg daily, galantamine 16-24 mg daily, rivastigmine flexible dosing up to 6 mg twice daily, or memantine 10 mg twice daily versus standard care.Main Outcome Measures:Incremental cost-effectiveness ratio (ICER) expressed as cost per unit decrease in the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) subscale.Results:Donepezil 10 mg daily was found to be the most cost-effective treatment with an ICER of $400.64 (95%CI, $281.10-$596.35) per unit decline in the ADAS-cog subscale. All other treatments were dominated by donepezil 10 mg, that is, more costly and less effective.Conclusion:From a societal perspective, treatment with cholinesterase inhibitors or memantine was more effective but also more costly than standard care for mild to moderate vascular dementia. The donepezil 10 mg strategy was the most cost-effective and also dominated the other alternatives.

scholarly journals Outcome of Using Intravenous Immunoglobulin (IVIG) in Critically Ill COVID-19 Patients’: A ‎Retrospective, ‏Multi-Centric Cohort Study

2021 ◽  
Author(s):  
Mohammadreza Salehi ◽  
Mahdi Barkhori Mehni ◽  
Mohammadmehdi Akbarian ◽  
Samrand Fattah Ghazi ◽  
Nasim Khajavi Rad ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Cohort Study ◽  
Treatment Group ◽  
Mortality Rate ◽  
Length Of Stay ◽  
Standard Treatment ◽  
Ivig Treatment ◽  
Icu Length Of Stay ◽  
Duration Of Hospitalization ◽  
Standard Treatment Group

Abstract Background: To access the effect of Intravenous immunoglobulin ‎‎(IVIG) in critically ill corona virus disease 2019 (COVID-19) patients.Method: In this retrospective matched cohort study, records of three tertiary centers with large number of COVID-19 admissions were evaluated and used. Based on treatment options, ‎patients were divided into two groups, standard COVID-19 treatment (109 patients) and IVIG treatment (74 patients) patients. Also, the effect of IVIG in different dosages was evaluated. Patients with IVIG treatment were divided into three groups of ‎low (0.25 gr/kg), medium (0.5 gr/kg), and high (1 gr/kg) dose. Data analysis was performed using independent t-test and ‎One-way analysis of variance (ANOVA) to compare the ‎outcomes between two groups, including duration of hospitalization, intensive care unit (ICU) length of stay, and mortality rate.‎Result: The duration of hospitalization in the IVIG group ‎were significantly longer than standard treatment (13.74 days vs. 11.10 days, p<0.05). There was not a significant difference between the two groups in ICU length of stay, number of intubated patients and duration of mechanical ventilation (P>0.05).‎ Also initial ‎outcomes in IVIG subgroups were compared separately with the standard ‎treatment group. The results indicated that only the duration of hospitalization ‎in the IVIG subgroup with medium dose is significantly longer than the standard ‎treatment group (P<0.01).Conclusion: Using IVIG is not beneficial for COVID-19 patients based on no remarkable differences in duration of hospitalization, ICU length of stay, duration of mechanical ventilation and even mortality rate.

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