Post-stroke infections and preventive antibiotics in stroke: Update of clinical evidence

2018 ◽  
Vol 13 (9) ◽  
pp. 913-920 ◽  
Author(s):  
Jan-Dirk Vermeij ◽  
Willeke F Westendorp ◽  
Diederik van de Beek ◽  
Paul J Nederkoorn
Keyword(s):  
Antibiotic Therapy ◽  
Functional Outcome ◽  
Causal Relation ◽  
Meta Analysis ◽  
Cost Effective ◽  
Related Factors ◽  
Post Stroke ◽  
Life Years ◽  
Large Phase ◽  
Immunological Factors

This review provides an update of evidence on post-stroke infections and the use of preventive antibiotics in stroke. Infection is a common complication after stroke, affecting between 15% and 30% of the patients. The predictors for post-stroke infection can be divided into three categories: clinical factors, anatomical (stroke related) factors and immunological factors. The relation between the occurrence of a post-stroke infection and functional outcome remained subject of debate, but it seems likely that the occurrence of these infections has a causal relation with poor functional outcome and mortality. In the first meta-analysis on preventive antibiotic therapy, almost a decade ago, its beneficial effect on post-stroke infection rate was clear; however, the effect on functional outcome remained uncertain because included studies were small and heterogeneous. Afterwards, three large phase-3 RCTs were published and a Cochrane meta-analysis was performed. It has now become clear that, despite the finding that overall infections are reduced, preventive antibiotic therapy in the acute phase of stroke does neither improve functional outcome, nor decrease mortality rates. This does not yet mean that further research on preventive antibiotics in stroke is useless: the pathophysiology and etiology of post-stroke infections are unclear and the use of preventive antibiotics in specific subgroups of stroke patients could still be very effective. This is currently being studied. Besides, preventive antibiotic therapy might be cost-effective by increasing quality-adjusted life years. Thirdly, research for the upcoming years might put more emphasis on the effect of stroke on immunological alterations.

scholarly journals Association between insulin resistance and post-ischaemic stroke outcome in patients without diabetes: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044771
Author(s):  
Jeremiah Hadwen ◽  
Woojin Kim ◽  
Brian Dewar ◽  
Tim Ramsay ◽  
Alexandra Davis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Insulin Resistance ◽  
Ischaemic Stroke ◽  
Functional Outcome ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Stroke Outcome ◽  
Post Stroke ◽  
Meta Analyses

IntroductionInsulin resistance is an independent risk factor for atherosclerosis, coronary artery disease and ischaemic stroke. Currently, insulin resistance is not usually included in post-stroke risk stratification. This systematic review and meta-analysis intends to determine if available scientific knowledge supports an association between insulin resistance and post-stroke outcomes in patients without diabetes.Methods and analysisThe authors will conduct a literature search in Medline, Embase, Web of Science and Cochrane Central. The review will include studies that assess the association between elevated insulin homeostasis model of insulin resistance (HOMA-IR) and post-stroke outcome (functional outcome and recurrent stroke). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines will be used. The primary outcome will be post-stroke functional outcome (Modified Rankin Scale), and the secondary outcome will be recurrent ischaemic stroke. Comparison of outcome will be made between highest and lowest HOMA-IR range (as defined in each article included in this systematic review). Risk of bias will be assessed qualitatively. Meta-analysis will be performed if sufficient homogeneity exists between studies. Heterogeneity of outcomes will be assessed by I².Ethics and disseminationNo human or animal subjects or samples were/will be used. The results will be published in a peer-reviewed journal, and will be disseminated at local and international neurology conferences.PROSPERO registration numberCRD42020173608.

Is Banning Texturized Implants to Prevent Breast Implant-Associated Anaplastic Large Cell Lymphoma a Rational Decision? A Meta-Analysis and Cost-Effectiveness Study

2019 ◽  
Vol 40 (7) ◽  
pp. 721-731 ◽  
Author(s):  
Stefan V Danilla ◽  
Rocio P Jara ◽  
Felipe Miranda ◽  
Francisco Bencina ◽  
Marcela Aguirre ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Cell Lymphoma ◽  
Meta Analysis ◽  
Breast Implant ◽  
Cost Effective ◽  
Large Cell ◽  
Life Years ◽  
Large Cell Lymphoma ◽  
The Cost

Abstract Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emergent disease that threatens patients with texturized breast implants. Major concerns about the safety of these implants are leading to global changes to restrict the utilization of this product. The principal alternative is to perform breast augmentation utilizing smooth implants, given the lack of association with BIA-ALCL. The implications and costs of this intervention are unknown. Objectives The authors of this study determined the cost-effectiveness of smooth implants compared with texturized implants for breast augmentation surgery. Methods A tree decision model was utilized to analyze the cost-effectiveness. Model input parameters were derived from published sources. The capsular contracture (CC) rate was calculated from a meta-analysis. Effectiveness measures were life years, avoided BIA-ALCL, avoided deaths, and avoided reoperations. A sensitivity analysis was performed to test the robustness of the model. Results For avoided BIA-ALCL, the incremental cost was $18,562,003 for smooth implants over texturized implants. The incremental cost-effectiveness ratio was negative for life years, and avoided death and avoided reoperations were negative. The sensitivity analysis revealed that to avoid 1 case of BIA-ALCL, the utilization of smooth implants would be cost-effective for a risk of developing BIA-ALCL equal to or greater than 1:196, and there is a probability of CC with smooth implants equal to or less than 0.096. Conclusions The utilization of smooth implants to prevent BIA-ALCL is not cost-effective. Banning texturized implants to prevent BIA-ALCL may involve additional consequences, which should be considered in light of higher CC rates and more reoperations associated with smooth implants than with texturized implants.

scholarly journals Challenges in synthesising cost-effectiveness estimates

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Gemma E. Shields ◽  
Jamie Elvidge
Keyword(s):  
Cost Effectiveness ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Cost Effective ◽  
Evidence Base ◽  
Decision Makers ◽  
Economic Evaluations ◽  
Quality Adjusted Life Years ◽  
Life Years ◽  
Study Designs

AbstractEconomic evaluations help decision-makers faced with tough decisions on how to allocate resources. Systematic reviews of economic evaluations are useful as they allow readers to assess whether interventions have been demonstrated to be cost effective, the uncertainty in the evidence base, and key limitations or gaps in the evidence base. The synthesis of systematic reviews of economic evaluations commonly takes a narrative approach whereas a meta-analysis is common step for reviews of clinical evidence (e.g. effectiveness or adverse event outcomes). As they are common objectives in other reviews, readers may query why a synthesis has not been attempted for economic outcomes. However, a meta-analysis of incremental cost-effectiveness ratios, costs, or health benefits (including quality-adjusted life years) is fraught with issues largely due to heterogeneity across study designs and methods and further practical challenges. Therefore, meta-analysis is rarely feasible or robust. This commentary outlines these issues, supported by examples from the literature, to support researchers and reviewers considering systematic review of economic evidence.

Health state utility values in schizophrenia: protocol for a systematic review and meta-analysis

2019 ◽  
Vol 22 (4) ◽  
pp. 142-144 ◽  
Author(s):  
David Aceituno ◽  
Mark Pennington ◽  
Barbara Iruretagoyena ◽  
Matthew A Prina ◽  
Paul McCrone
Keyword(s):  
Systematic Review ◽  
Task Force ◽  
Meta Analysis ◽  
Cost Effective ◽  
Health State Utility ◽  
Health State ◽  
Utility Values ◽  
Life Years ◽  
Health State Utility Values

IntroductionCost-effectiveness analyses that use quality-adjusted life-years (QALYs) allow comparing the value for money of interventions across different health problems. Health state utility values (HSUVs) are crucial to calculate QALYs. These are weights attached to a given health state reflecting preferences in health-related quality of life (HRQoL). In schizophrenia, there is extensive evidence about the consequences of this condition on HRQoL. Besides, several interventions have claimed to be cost-effective in terms of QALYs gained. Despite this evidence, a systematic review of HSUVs has not been conducted. Therefore, we aim to synthesise the evidence about HSUVs in schizophrenia.Methods and analysisWe will conduct a systematic review of the literature about HSUVs in people with schizophrenia following the Preferred Reporting Items for Systematic review and Meta-Analysis and the International Society for Pharmacoeconomics and Outcomes Research task force recommendations. The submissions records of eight electronic peer-reviewed databases and three health technology assessment (HTA) agencies will be searched. Quantitative synthesis will be carried out in comparable studies, using random-effects meta-analysis. Heterogeneity will be explored using meta-regression if more than 10 studies per covariate are found. A narrative synthesis and methodological quality of included studies will be also reported.DiscussionThis review will provide a synthesis of the HSUVs estimated for different states experienced by people with schizophrenia. This will inform analysts when calculating QALYs, using values in a more transparent and accountable manner. Finally, it will shed light on evidence gaps and limitations about this measure in mental health.PROSPERO registration numberCRD42019123582.

scholarly journals Cost-Effectiveness of Olaratumab in Combination with Doxorubicin for Patients with Soft Tissue Sarcoma in the United States

Sarcoma ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Santiago Zuluaga-Sanchez ◽  
Lisa M. Hess ◽  
Sorrel E. Wolowacz ◽  
Yulia D’yachkova ◽  
Emma Hawe ◽  
...  
Keyword(s):  
United States ◽  
Cost Effectiveness ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Meta Analysis ◽  
Single Agent ◽  
Cost Effective ◽  
Standard Of Care ◽  
The United States ◽  
Life Years

Background. Standard first-line treatments for advanced soft tissue sarcoma (STS) have changed little for 40 years, and outcomes have been poor. Recently, the United States (US) Food and Drug Administration conditionally approved olaratumab in combination with doxorubicin (Olara + Dox) based on a randomized phase II trial that reported a significant 11.8-month improvement in median survival versus single-agent doxorubicin (Dox). The present study investigated the cost-effectiveness of Olara + Dox compared with Dox and five other standard-of-care regimens from the US payer perspective. Methods. An economic model was constructed to estimate costs and outcomes over patients’ lifetimes from start of therapy. Progression-free and overall survival were based on survival analysis of patient-level data and a meta-analysis. Adverse-event rates were based on trials. Costs were from published sources. Results. Olara + Dox resulted in an estimated additional 1.27 life-years (LYs) compared with Dox, with an increase in total expected lifetime costs of $133,653. The incremental cost-effectiveness ratio (ICER) was estimated at $105,408 per LY gained; in a fully incremental analysis, all other regimens were dominated (higher costs and lower LYs or a higher ICER). Conclusion. Olara + Dox is cost-effective for STS treatment compared with Dox and other standard-of-care regimens at willingness-to-pay thresholds of $150,000 per LY and above.

scholarly journals Economic evaluation of nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039201
Author(s):  
Daan P J Verberne ◽  
Ghislaine A P G van Mastrigt ◽  
Rudolf W H M Ponds ◽  
Caroline M van Heugten ◽  
Mariëlle E A L Kroese
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Social Participation ◽  
Psychosocial Functioning ◽  
Cost Effective ◽  
Secondary Outcome ◽  
Base Case ◽  
Psychosocial Outcome ◽  
Post Stroke ◽  
Life Years

ObjectiveTo examine the cost-effectiveness of nurse-led stroke aftercare addressing psychosocial outcome at 6 months post stroke, compared with care-as-usual.DesignEconomic evaluation within a comparative effectiveness research design.SettingPrimary care (2016–2017) and community settings (2011–2013) in the Netherlands.ParticipantsPersons who suffered from ischaemic or haemorrhagic stroke, or a transient ischaemic attack and were discharged home after visiting the emergency department, hospitalisation or inpatient rehabilitation.InterventionsNurse-led stroke aftercare at 6 months post stroke addressing psychosocial functioning by providing screening, psycho-education, emotional support and referral to specialist care when needed. Care-as-usual concerned routine follow-up care including secondary prevention programmes and a consultation with the neurologist at 6 weeks post stroke.Primary and secondary outcome measuresMain outcome measure of cost-effectiveness was quality-adjusted life years (QALYs) estimated by the quality of life measured by the five-dimensional, three-level EuroQol. Costs were assessed using a cost-questionnaire. Secondary outcomes were mood (Hospital Anxiety and Depression Scale) and social participation (Utrecht Scale for Evaluation of Rehabilitation-Participation) restrictions subscale.ResultsHealth outcomes were significantly better in stroke aftercare for QALYs (Δ=0.05; 95% CI 0.01 to 0.09) and social participation (Δ=4.91; 95% CI 1.89 to 7.93) compared with care-as-usual. Total societal costs were €1208 higher in stroke aftercare than in care-as-usual (95% CI −€3881 to €6057). Healthcare costs were in total €1208 higher in stroke aftercare than in care-as-usual (95% CI −€3881 to €6057). Average costs of stroke aftercare were €91 (SD=€3.20) per person. Base case cost-effectiveness analyses showed an incremental cost-effectiveness ratio of €24 679 per QALY gained. Probability of stroke aftercare being cost-effective was 64% on a €50 000 willingness-to-pay level.ConclusionsNurse-led stroke aftercare addressing psychosocial functioning showed to be a low-cost intervention and is likely to be a cost-effective addition to care-as-usual. It plays an important role by screening and addressing psychosocial problem, not covered by usual care.

scholarly journals Factors contributing to sex differences in functional outcomes and participation after stroke

Neurology ◽  
2018 ◽  
Vol 90 (22) ◽  
pp. e1945-e1953 ◽  
Author(s):  
Hoang T. Phan ◽  
Christopher L. Blizzard ◽  
Mathew J. Reeves ◽  
Amanda G. Thrift ◽  
Dominique A. Cadilhac ◽  
...  
Keyword(s):  
Sex Differences ◽  
Functional Outcome ◽  
Functional Outcomes ◽  
Meta Analysis ◽  
Stroke Severity ◽  
Participation Restriction ◽  
Related Factors ◽  
Stroke Incidence ◽  
Incidence Studies ◽  
Individual Participant

ObjectiveTo examine factors contributing to the sex differences in functional outcomes and participation restriction after stroke.MethodsIndividual participant data on long-term functional outcome or participation restriction (i.e., handicap) were obtained from 11 stroke incidence studies (1993–2014). Multivariable log-binomial regression was used to estimate the female:male relative risk (RR) of poor functional outcome (modified Rankin Scale score >2 or Barthel Index score <20) at 1 year (10 studies, n = 4,852) and 5 years (7 studies, n = 2,226). Multivariable linear regression was used to compare the mean difference (MD) in participation restriction by use of the London Handicap Scale (range 0–100 with lower scores indicating poorer outcome) for women compared to men at 5 years (2 studies, n = 617). For each outcome, study-specific estimates adjusted for confounding factors (e.g., sociodemographics, stroke-related factors) were combined with the use of random-effects meta-analysis.ResultsIn unadjusted analyses, women experienced worse functional outcomes after stroke than men (1 year: pooled RRunadjusted 1.32, 95% confidence interval [CI] 1.18–1.48; 5 years: RRunadjusted 1.31, 95% CI 1.16–1.47). However, this difference was greatly attenuated after adjustment for age, prestroke dependency, and stroke severity (1 year: RRadjusted 1.08, 95% CI 0.97–1.20; 5 years: RRadjusted 1.05, 95% CI 0.94–1.18). Women also had greater participation restriction than men (pooled MDunadjusted −5.55, 95% CI −8.47 to −2.63), but this difference was again attenuated after adjustment for the aforementioned factors (MDadjusted −2.48, 95% CI −4.99 to 0.03).ConclusionsWorse outcomes after stroke among women were explained mostly by age, stroke severity, and prestroke dependency, suggesting these potential targets to improve the outcomes after stroke in women.

scholarly journals P424 Economic evaluation of vedolizumab SC for the treatment of moderate-to-severe ulcerative colitis in Canada

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S387-S387
Author(s):  
A FISCHER ◽  
M Oppe ◽  
S Stypa ◽  
V Lukyanov ◽  
I Petrakis
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Meta Analysis ◽  
Cost Effective ◽  
Future Research ◽  
Base Case ◽  
Public Healthcare ◽  
Payer Perspective ◽  
Life Years ◽  
Public Payer

Abstract Background Vedolizumab intravenous (IV), a gut selective humanised monoclonal antibody, is indicated for the management of moderately to severely active Ulcerative Colitis (UC) and has been shown in the only head-to-head clinical trial within UC to be superior to adalimumab (NCT02497469). Furthermore, the novel vedolizumab subcutaneous (SC) has recently been proven to be an effective treatment of UC (NCT02611830). The objective of this study is to estimate the comparative cost-effectiveness of vedolizumab IV with updated efficacy data, and vedolizumab SC for the first time. Both vedolizumab IV and SC have been compared with other publicly reimbursed biologics for the treatment of patients with moderate-to-severe UC from a Canadian public healthcare payer perspective. Methods A hybrid decision tree/Markov model was developed to simulate the clinical course of UC, translating the disease course into costs and quality-adjusted life-years (QALYs). Comparative efficacy of vedolizumab SC, vedolizumab IV, adalimumab, infliximab IV, and golimumab were sourced from a network meta-analysis. Drug and disease management costs (2019 $CAD) were sourced from Ontario public payer schedules of benefits. Utilities were sourced from the literature. Clinical and economic outcomes were projected over a lifetime and discounted at 1.5% annually. Results Within a mixed bio-naïve/experienced population, vedolizumab SC resulted in slightly more QALYs than vedolizumab IV and dominated adalimumab (Table 1); vedolizumab SC yielded an incremental cost-effectiveness ratio (ICER) of $CAD 6,727 per QALY and $CAD 52,673 per QALY relative to golimumab and to infliximab (for which the price of a biosimilar was used), respectively. Further scenario analysis within bio-naïve populations supported the robustness of the base-case results, demonstrating that vedolizumab SC or vedolizumab IV were either dominant or cost-effective across all scenarios. Conclusion Our analysis suggests that vedolizumab SC and vedolizumab IV are a cost-effective therapeutic alternative relative to other biologics for moderate-to-severe UC in Canada. Future research will expand the analysis across all biologic comparators as they are used in the real world.

Clinical and economic outcomes associated with sequential treatment in patients with advanced renal cell carcinoma (aRCC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4566-4566
Author(s):  
Meredith M. Regan ◽  
David F. McDermott ◽  
Michael B. Atkins ◽  
Apoorva Ambavane ◽  
Shuo Yang ◽  
...  
Keyword(s):  
Kinase Inhibitors ◽  
Meta Analysis ◽  
Discrete Event ◽  
Cost Effective ◽  
Economic Outcomes ◽  
Sequential Treatment ◽  
New Drugs ◽  
Life Years ◽  
Combination Regimens ◽  
Treatment Sequences

4566 Background: Immuno-oncology therapies (IOs) and tyrosine kinase inhibitors (TKIs) are recommended for the treatment of aRCC. As new drugs and combination regimens emerge, there is interest in gaining a deeper understanding of optimal treatment sequencing. We aimed to assess clinical and economic outcomes associated with treatment sequences for untreated aRCC patients with IMDC intermediate/poor risk. Methods: A discrete event simulation model was developed to estimate the total costs and survival (in life-years; LYs) over patients’ lifetimes when receiving sequential treatment with nivolumab + ipilimumab (N+I), sunitinib (SUN), pazopanib (PAZ), or cabozantinib (CAB) as first-line (1L) treatment, and nivolumab (NIVO), axitinib (AXI), PAZ, CAB, or lenvatinib + everolimus (LEN+EVE) as second line (2L). Efficacy inputs were derived from the CheckMate 214 trial and a network meta-analysis based on available literature. Safety and cost data were obtained from literature and publicly available sources. Results: N+I initiating sequences were estimated to provide longer survival in mean LYs and lower mean costs/LY versus sequences with 1L TKIs (table). The estimates of incremental cost-effectiveness ratio (ICER) for N+I initiating sequences with 2L TKI monotherapy were well below the willingness-to-pay threshold of $50,000. Using 2L LEN+EVE, compared with 2L monotherapies, provided an incremental survival gain but at costs/LY close to $100,000. Conclusions: Use of 1L N+I followed by TKI monotherapy is estimated to provide longer survival while being more cost-effective versus TKIs followed by IOs or sequences cycling TKIs, mainly driven by a longer time to 2L treatment and longer treatment-free survival with N+I. Clinical trials with head-to-head comparisons of treatment sequences would be necessary to validate the findings of the study. [Table: see text]

Cost-effectiveness (CE) analysis of pembrolizumab as first-line (1L) treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the United States (US).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18013-e18013
Author(s):  
Karthik Ramakrishnan ◽  
Disha Jain ◽  
Jyotika Gandhi ◽  
Diana Romana Chirovsky ◽  
Rebekah Borse
Keyword(s):  
Meta Analysis ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Cost Effective ◽  
The United States ◽  
Base Case ◽  
Health State ◽  
Life Years ◽  
Cost Effective Treatment ◽  
The Us

e18013 Background: Pembrolizumab received FDA approval in 1L R/M HNSCC as monotherapy (P) in patients with combined positive score (CPS) ≥1, and in combination with platinum + 5-Fluorouracil (5-FU) chemotherapy (P + C) in the total population, based on KEYNOTE 048 (KN048) trial. Taking a US payer perspective, we evaluated the CE of P and P + C versus KN048 trial comparator cetuximab + platinum + 5-FU (EXTREME regimen), and other comparators commonly used in the US (i.e. cisplatin+docetaxel+cetuximab [TPEx regimen], platinum + paclitaxel/taxane [Pt + T] and platinum+5-FU [Pt + F]). Methods: A 3-state partitioned-survival model was used to project costs and outcomes over 20 years with a 3% annual discount rate. For P, P + C and EXTREME, health state occupancy was based on KN048 trial results with long-term parametric extrapolation of progression-free survival (PFS) and overall survival (OS) guided by statistical criteria. A network meta-analysis (NMA) was applied to the P and P + C interventions in KN048 to project the PFS and OS outcomes for other comparators. The time on treatment (ToT) for P, P+C and EXTREME was derived from the KN048 trial, whereas for other comparators, ToT was approximated by PFS. Costs of 1L and subsequent treatments, disease management, adverse event, and terminal care were included. Utilities were derived using the EuroQoL five-dimension data from KN048 and a US value set. Results: CE ratios, total and incremental costs and quality-adjusted life years (QALYs) from the base case analysis are summarized in the table below. P was more effective and less costly (i.e. dominant) versus EXTREME and TPEx. P + C was highly cost-effective versus EXTREME ($1,789/QALY) and TPEx regimen (dominant). CE ratios for both P and P + C versus all comparators were below a $100,000/QALY willingness-to-pay threshold. Probabilistic sensitivity analysis also showed a 100% CE probability for P and P + C at the $100,000/QALY threshold. Conclusions: P and P + C are cost-effective treatment options in the US with CE ratios below $100,000/QALY gained versus commonly used therapies in 1L R/M HNSCC.[Table: see text]

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