Treatment of Selective Mutism: A Best-Evidence Synthesis.

ERIC Educational Resources Information Center

Stone, Beth Pionek; Kratochwill, Thomas R.; Sladezcek, Ingrid; Serlin, Ronald C.

2002-01-01

Presents systematic analysis of the major treatment approaches used for selective mutism. Based on nonparametric statistical tests of effect sizes, major findings include the following: treatment of selective mutism is more effective than no treatment; behaviorally oriented treatment approaches are more effective than no treatment; and no…

Cost-effectiveness of available treatment options for patients suffering from severe COPD in the UK: a fully incremental analysis.

PubMed

Hertel, Nadine; Kotchie, Robert W; Samyshkin, Yevgeniy; Radford, Matthew; Humphreys, Samantha; Jameson, Kevin

2012-01-01

Frequent exacerbations which are both costly and potentially life-threatening are a major concern to patients with chronic obstructive pulmonary disease (COPD), despite the availability of several treatment options. This study aimed to assess the lifetime costs and outcomes associated with alternative treatment regimens for patients with severe COPD in the UK setting. A Markov cohort model was developed to predict lifetime costs, outcomes, and cost-effectiveness of various combinations of a long-acting muscarinic antagonist (LAMA), a long-acting beta agonist (LABA), an inhaled corticosteroid (ICS), and roflumilast in a fully incremental analysis. Patients willing and able to take ICS, and those refusing or intolerant to ICS were analyzed separately. Efficacy was expressed as relative rate ratios of COPD exacerbation associated with alternative treatment regimens, taken from a mixed treatment comparison. The analysis was conducted from the UK National Health Service (NHS) perspective. Parameter uncertainty was explored using one-way and probabilistic sensitivity analysis. Based on the results of the fully incremental analysis a cost-effectiveness frontier was determined, indicating those treatment regimens which represent the most cost-effective use of NHS resources. For ICS-tolerant patients the cost-effectiveness frontier suggested LAMA as initial treatment. Where patients continue to exacerbate and additional therapy is required, LAMA + LABA/ICS can be a cost-effective option, followed by LAMA + LABA/ICS + roflumilast (incremental cost-effectiveness ratio [ICER] versus LAMA + LABA/ICS: £16,566 per quality-adjusted life-year [QALY] gained). The ICER in ICS-intolerant patients, comparing LAMA + LABA + roflumilast versus LAMA + LABA, was £13,764/QALY gained. The relative rate ratio of exacerbations was identified as the primary driver of cost-effectiveness. The treatment algorithm recommended in UK clinical practice represents a cost-effective approach for the management of COPD. The addition of roflumilast to the standard of care regimens is a clinical and cost-effective treatment option for patients with severe COPD, who continue to exacerbate despite existing bronchodilator therapy.

The analysis of cost-effectiveness of implant and conventional fixed dental prosthesis.

PubMed

Chun, June Sang; Har, Alix; Lim, Hyun-Pil; Lim, Hoi-Jeong

2016-02-01

This study conducted an analysis of cost-effectiveness of the implant and conventional fixed dental prosthesis (CFDP) from a single treatment perspective. The Markov model for cost-effectiveness analysis of the implant and CFDP was carried out over maximum 50 years. The probabilistic sensitivity analysis was performed by the 10,000 Monte-Carlo simulations, and cost-effectiveness acceptability curves (CEAC) were also presented. The results from meta-analysis studies were used to determine the survival rates and complication rates of the implant and CFDP. Data regarding the cost of each treatment method were collected from University Dental Hospital and Statistics Korea for 2013. Using the results of the patient satisfaction survey study, quality-adjusted prosthesis year (QAPY) of the implant and CFDP strategy was evaluated with annual discount rate. When only the direct cost was considered, implants were more cost-effective when the willingness to pay (WTP) was more than 10,000 won at 10(th) year after the treatment, and more cost-effective regardless of the WTP from 20(th) year after the prosthodontic treatment. When the indirect cost was added to the direct cost, implants were more cost-effective only when the WTP was more than 75,000 won at the 10(th) year after the prosthodontic treatment, more than 35,000 won at the 20(th) year after prosthodontic treatment. The CFDP was more cost-effective unless the WTP was more than 75,000 won at the 10(th) year after prosthodontic treatment. But the cost-effectivenss tendency changed from CFDP to implant as time passed.

The effect of parent involvement in the treatment of anxiety disorders in children: a meta-analysis.

PubMed

Thulin, Ulrika; Svirsky, Liv; Serlachius, Eva; Andersson, Gerhard; Ost, Lars-Göran

2014-01-01

Among clinicians, it is common practice to include parents in treatment, and it has been taken for granted that parents' involvement in their children's treatment is beneficial for therapy outcome, although research on this issue is far from clear. A meta-analysis was carried out in order to investigate whether parent involvement potentiates the outcome for children with anxiety disorders when treated with cognitive-behavior therapy. Sixteen studies, which directly compared parent-involved treatments with child-only treatments, were included in the meta-analysis. The results showed a small, nonsignificant effect size of - 0.10 in favor of the child-only treatments. There was no indication of publication bias in the analysis. Implications of the results are discussed.

Impact of including or excluding both-armed zero-event studies on using standard meta-analysis methods for rare event outcome: a simulation study

PubMed Central

Cheng, Ji; Pullenayegum, Eleanor; Marshall, John K; Thabane, Lehana

2016-01-01

Objectives There is no consensus on whether studies with no observed events in the treatment and control arms, the so-called both-armed zero-event studies, should be included in a meta-analysis of randomised controlled trials (RCTs). Current analytic approaches handled them differently depending on the choice of effect measures and authors' discretion. Our objective is to evaluate the impact of including or excluding both-armed zero-event (BA0E) studies in meta-analysis of RCTs with rare outcome events through a simulation study. Method We simulated 2500 data sets for different scenarios varying the parameters of baseline event rate, treatment effect and number of patients in each trial, and between-study variance. We evaluated the performance of commonly used pooling methods in classical meta-analysis—namely, Peto, Mantel-Haenszel with fixed-effects and random-effects models, and inverse variance method with fixed-effects and random-effects models—using bias, root mean square error, length of 95% CI and coverage. Results The overall performance of the approaches of including or excluding BA0E studies in meta-analysis varied according to the magnitude of true treatment effect. Including BA0E studies introduced very little bias, decreased mean square error, narrowed the 95% CI and increased the coverage when no true treatment effect existed. However, when a true treatment effect existed, the estimates from the approach of excluding BA0E studies led to smaller bias than including them. Among all evaluated methods, the Peto method excluding BA0E studies gave the least biased results when a true treatment effect existed. Conclusions We recommend including BA0E studies when treatment effects are unlikely, but excluding them when there is a decisive treatment effect. Providing results of including and excluding BA0E studies to assess the robustness of the pooled estimated effect is a sensible way to communicate the results of a meta-analysis when the treatment effects are unclear. PMID:27531725

Observational studies using propensity score analysis underestimated the effect sizes in critical care medicine.

PubMed

Zhang, Zhongheng; Ni, Hongying; Xu, Xiao

2014-08-01

Propensity score (PS) analysis has been increasingly used in critical care medicine; however, its validation has not been systematically investigated. The present study aimed to compare effect sizes in PS-based observational studies vs. randomized controlled trials (RCTs) (or meta-analysis of RCTs). Critical care observational studies using PS were systematically searched in PubMed from inception to April 2013. Identified PS-based studies were matched to one or more RCTs in terms of population, intervention, comparison, and outcome. The effect sizes of experimental treatments were compared for PS-based studies vs. RCTs (or meta-analysis of RCTs) with sign test. Furthermore, ratio of odds ratio (ROR) was calculated from the interaction term of treatment × study type in a logistic regression model. A ROR < 1 indicates greater benefit for experimental treatment in RCTs compared with PS-based studies. RORs of each comparison were pooled by using meta-analytic approach with random-effects model. A total of 20 PS-based studies were identified and matched to RCTs. Twelve of the 20 comparisons showed greater beneficial effect for experimental treatment in RCTs than that in PS-based studies (sign test P = 0.503). The difference was statistically significant in four comparisons. ROR can be calculated from 13 comparisons, of which four showed significantly greater beneficial effect for experimental treatment in RCTs. The pooled ROR was 0.71 (95% CI: 0.63, 0.79; P = 0.002), suggesting that RCTs (or meta-analysis of RCTs) were more likely to report beneficial effect for the experimental treatment than PS-based studies. The result remained unchanged in sensitivity analysis and meta-regression. In critical care literature, PS-based observational study is likely to report less beneficial effect of experimental treatment compared with RCTs (or meta-analysis of RCTs). Copyright © 2014 Elsevier Inc. All rights reserved.

Significant treatment effect of adjunct music therapy to standard treatment on the positive, negative, and mood symptoms of schizophrenic patients: a meta-analysis.

PubMed

Tseng, Ping-Tao; Chen, Yen-Wen; Lin, Pao-Yen; Tu, Kun-Yu; Wang, Hung-Yu; Cheng, Yu-Shian; Chang, Yi-Chung; Chang, Chih-Hua; Chung, Weilun; Wu, Ching-Kuan

2016-01-26

Music therapy (MT) has been used as adjunct therapy for schizophrenia for decades. However, its role is still inconclusive. A recent meta-analysis demonstrated that MT for schizophrenic patients only significantly benefits negative symptoms and mood symptoms rather than positive symptoms. In addition, the association between specific characteristics of MT and the treatment effect remains unclear. The aim of this study was to update the published data and to explore the role of music therapy in adjunct treatment in schizophrenia with a thorough meta-analysis. We compared the treatment effect in schizophrenic patients with standard treatment who did and did not receive adjunct MT through a meta-analysis, and investigated the clinical characteristics of MT through meta-regression. The main finding was that the treatment effect was significantly better in the patients who received adjunct MT than in those who did not, in negative symptoms, mood symptoms, and also positive symptoms (all p < 0.05). This significance did not change after dividing the patients into subgroups of different total duration of MT, amounts of sessions, or frequency of MT. Besides, the treatment effect on the general symptoms was significantly positively associated with the whole duration of illness, indicating that MT would be beneficial for schizophrenic patients with a chronic course. Our meta-analysis highlights a significantly better treatment effect in schizophrenic patients who received MT than in those who did not, especially in those with a chronic course, regardless of the duration, frequency, or amounts of sessions of MT. These findings provide evidence that clinicians should apply MT for schizophrenic patients to alleviate disease severity.

Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials.

PubMed

Machado, L A C; Kamper, S J; Herbert, R D; Maher, C G; McAuley, J H

2009-05-01

Estimates of treatment effects reported in placebo-controlled randomized trials are less subject to bias than those estimates provided by other study designs. The objective of this meta-analysis was to estimate the analgesic effects of treatments for non-specific low back pain reported in placebo-controlled randomized trials. Medline, Embase, Cinahl, PsychInfo and Cochrane Central Register of Controlled Trials databases were searched for eligible trials from earliest records to November 2006. Continuous pain outcomes were converted to a common 0-100 scale and pooled using a random effects model. A total of 76 trials reporting on 34 treatments were included. Fifty percent of the investigated treatments had statistically significant effects, but for most the effects were small or moderate: 47% had point estimates of effects of <10 points on the 100-point scale, 38% had point estimates from 10 to 20 points and 15% had point estimates of >20 points. Treatments reported to have large effects (>20 points) had been investigated only in a single trial. This meta-analysis revealed that the analgesic effects of many treatments for non-specific low back pain are small and that they do not differ in populations with acute or chronic symptoms.

Oseltamivir Treatment for Children with Influenza-Like Illness in China: A Cost-Effectiveness Analysis.

PubMed

Shen, Kunling; Xiong, Tengbin; Tan, Seng Chuen; Wu, Jiuhong

2016-01-01

Influenza is a common viral respiratory infection that causes epidemics and pandemics in the human population. Oseltamivir is a neuraminidase inhibitor-a new class of antiviral therapy for influenza. Although its efficacy and safety have been established, there is uncertainty regarding whether influenza-like illness (ILI) in children is best managed by oseltamivir at the onset of illness, and its cost-effectiveness in children has not been studied in China. To evaluate the cost-effectiveness of post rapid influenza diagnostic test (RIDT) treatment with oseltamivir and empiric treatment with oseltamivir comparing with no antiviral therapy against influenza for children with ILI. We developed a decision-analytic model based on previously published evidence to simulate and evaluate 1-year potential clinical and economic outcomes associated with three managing strategies for children presenting with symptoms of influenza. Model inputs were derived from literature and expert opinion of clinical practice and research in China. Outcome measures included costs and quality-adjusted life year (QALY). All the interventions were compared with incremental cost-effectiveness ratios (ICER). In base case analysis, empiric treatment with oseltamivir consistently produced the greatest gains in QALY. When compared with no antiviral therapy, the empiric treatment with oseltamivir strategy is very cost effective with an ICER of RMB 4,438. When compared with the post RIDT treatment with oseltamivir, the empiric treatment with oseltamivir strategy is dominant. Probabilistic sensitivity analysis projected that there is a 100% probability that empiric oseltamivir treatment would be considered as a very cost-effective strategy compared to the no antiviral therapy, according to the WHO recommendations for cost-effectiveness thresholds. The same was concluded with 99% probability for empiric oseltamivir treatment being a very cost-effective strategy compared to the post RIDT treatment with oseltamivir. In the Chinese setting of current health system, our modelling based simulation analysis suggests that empiric treatment with oseltamivir to be a cost-saving and very cost-effective strategy in managing children with ILI.

Skeletal effects in Angle Class II/1 patients treated with the functional regulator type II : Cephalometric and tensor analysis.

PubMed

Schulz, Simone; Koos, Bernd; Duske, Kathrin; Stahl, Franka

2016-11-01

The purpose of this work was to employ both cephalometric and tensor analysis in characterizing the skeletal changes experienced by patients with Angle Class II/1 malocclusion during functional orthodontic treatment with the functional regulator type II. A total of 23 patients with Class II/1 malocclusion based on lateral cephalograms obtained before and after treatment with the functional regulator type II were analyzed. Another 23 patients with Angle Class II/1 malocclusion who had not undergone treatment were included as controls. Our cephalometric data attest to significant therapeutic effects of the functional regulator type II on the skeletal mandibular system, including significant advancement of the mandible, increases in effective mandibular length with enhancement of the chin profile, and reduction of growth-related bite deepening. No treatment-related effects were observed at the cranial-base and midface levels. In addition, tensor analysis revealed significant stimulation of mandibular growth in sagittal directions, without indications of growth effects on the maxilla. Its growth-pattern findings differed from those of cephalometric analysis by indicating that the appliance did promote horizontal development, which supports the functional orthodontic treatment effect in Angle Class II/1 cases. Tensor analysis yielded additional insights into sagittal and vertical growth changes not identifiable by strictly cephalometric means. The functional regulator type II was an effective treatment modality for Angle Class II/1 malocclusion and influenced the skeletal development of these patients in favorable ways.

Finite Element Analysis of Denosumab Treatment Effects on Vertebral Strength in Ovariectomized Cynomolgus Monkeys.

PubMed

Lee, David C; Varela, Aurore; Kostenuik, Paul J; Ominsky, Michael S; Keaveny, Tony M

2016-08-01

Finite element analysis has not yet been validated for measuring changes in whole-bone strength at the hip or spine in people after treatment with an osteoporosis agent. Toward that end, we assessed the ability of a clinically approved implementation of finite element analysis to correctly quantify treatment effects on vertebral strength, comparing against direct mechanical testing, in cynomolgus monkeys randomly assigned to one of three 16-month-long treatments: sham surgery with vehicle (Sham-Vehicle), ovariectomy with vehicle (OVX-Vehicle), or ovariectomy with denosumab (OVX-DMAb). After treatment, T12 vertebrae were retrieved, scanned with micro-CT, and mechanically tested to measure compressive strength. Blinded to the strength data and treatment codes, the micro-CT images were coarsened and homogenized to create continuum-type finite element models, without explicit porosity. With clinical translation in mind, these models were then analyzed for strength using the U.S. Food and Drug Administration (FDA)-cleared VirtuOst software application (O.N. Diagnostics, Berkeley, CA, USA), developed for analysis of human bones. We found that vertebral strength by finite element analysis was highly correlated (R(2)  = 0.97; n = 52) with mechanical testing, independent of treatment (p = 0.12). Further, the size of the treatment effect on strength (ratio of mean OVX-DMAb to mean OVX-Vehicle, as a percentage) was large and did not differ (p = 0.79) between mechanical testing (+57%; 95% CI [26%, 95%]) and finite element analysis (+51% [20%, 88%]). The micro-CT analysis revealed increases in cortical thickness (+45% [19%, 73%]) and trabecular bone volume fraction (+24% [8%, 42%]). These results show that a preestablished clinical finite element analysis implementation-developed for human bone and clinically validated in fracture-outcome studies-correctly quantified the observed treatment effects of denosumab on vertebral strength in cynomolgus monkeys. One implication is that the treatment effects in this study are well explained by the features contained within these finite element models, namely, the bone geometry and mass and the spatial distribution of bone mass. © 2016 American Society for Bone and Mineral Research. © 2016 American Society for Bone and Mineral Research.

Considerations in the analysis and treatment of dietary effects on behavior: a case study.

PubMed

Bird, B L; Russo, D C; Cataldo, M F

1977-12-01

Scientific and public interest in the effects of diet of behavior disorders has recently increased. This paper argues that (1) the experimental analysis of behavior offers an effective scientific methodology for assessing the effects of dietary substances on behavior problems, and that (2) such analysis permits behavioral consequences to be considered as an alternative treatment to dietary control. A case study of a 9-year-old retarded boy with autistic behaviors is presented. Suspected dietary substances were demonstrated to be effective influences on the child's behavior, whereas a simple behavior modification program improved his problem behaviors. Also discussed are issues and problems which arise in research on dietary effects on behavior and in selection of effective and ethical treatments.

Survival analysis using inverse probability of treatment weighted methods based on the generalized propensity score.

PubMed

Sugihara, Masahiro

2010-01-01

In survival analysis, treatment effects are commonly evaluated based on survival curves and hazard ratios as causal treatment effects. In observational studies, these estimates may be biased due to confounding factors. The inverse probability of treatment weighted (IPTW) method based on the propensity score is one of the approaches utilized to adjust for confounding factors between binary treatment groups. As a generalization of this methodology, we developed an exact formula for an IPTW log-rank test based on the generalized propensity score for survival data. This makes it possible to compare the group differences of IPTW Kaplan-Meier estimators of survival curves using an IPTW log-rank test for multi-valued treatments. As causal treatment effects, the hazard ratio can be estimated using the IPTW approach. If the treatments correspond to ordered levels of a treatment, the proposed method can be easily extended to the analysis of treatment effect patterns with contrast statistics. In this paper, the proposed method is illustrated with data from the Kyushu Lipid Intervention Study (KLIS), which investigated the primary preventive effects of pravastatin on coronary heart disease (CHD). The results of the proposed method suggested that pravastatin treatment reduces the risk of CHD and that compliance to pravastatin treatment is important for the prevention of CHD. (c) 2009 John Wiley & Sons, Ltd.

MRI-Guided Focused Ultrasound Surgery for Uterine Fibroid Treatment: A Cost-Effectiveness Analysis

PubMed Central

Kong, Chung Y.; Omer, Zehra B.; Pandharipande, Pari V.; Swan, J. Shannon; Srouji, Serene; Gazelle, G. Scott; Fennessy, Fiona M.

2015-01-01

Objective To evaluate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids that employs Magnetic Resonance guided Focused Ultrasound (MRgFUS) as a first-line therapy relative to uterine artery embolization (UAE) or abdominal hysterectomy (HYST). Materials and Methods We developed a decision-analytic model to compare the cost-effectiveness of three treatment strategies: MRgFUS, UAE and HYST. Short and long-term utilities specific to each treatment were incorporated, allowing us to account for differences in quality of life across the strategies considered. Lifetime costs and quality-adjusted life-years (QALYs) were calculated for each strategy. An incremental cost-effectiveness analysis was performed, using a societal willingness-to-pay (WTP) threshold of $50,000 per QALY to designate a strategy as cost-effective. Sensitivity analysis was performed on all key model parameters. Results In the base-case analysis, in which treatment for symptomatic fibroids started at age 40, UAE was the most effective and expensive strategy (22.81 QALYs, $22,164), followed by MRgFUS (22.80 QALYs, $19,796) and HYST (22.60 QALYs, $13,291). MRgFUS was cost-effective relative to HYST, with an associated incremental cost-effectiveness ratio (ICER) of $33,110/QALY. MRgFUS was also cost-effective relative to UAE – the ICER of UAE relative to MRgFUS ($270,057) far exceeded the WTP threshold of $50,000/QALY. In sensitivity analysis, results were robust to changes in most parameters, but were sensitive to changes in probabilities of recurrence and symptom relief following certain procedures, and quality of life associated with symptomatic fibroids. Conclusions MRgFUS is cost-effective relative to both UAE and hysterectomy for the treatment of women with symptomatic fibroids. PMID:25055272

Cost-effectiveness of antipsychotics for outpatients with chronic schizophrenia.

PubMed

Obradovic, M; Mrhar, A; Kos, M

2007-12-01

The aim of the present analysis was to evaluate the cost-effectiveness of alternative treatments for outpatients with chronic schizophrenia from the healthcare payer's perspective. Decision analysis was used to evaluate the cost-effectiveness of the following antipsychotic drugs: amisulpride, aripiprazole, haloperidol (oral formulation), haloperidol (depot formulation), olanzapine, quetiapine, risperidone (oral formulation), risperidone (depot formulation) and ziprazidone. Clinical and economic outcomes were modelled over 1-year time horizon. Effectiveness was measured as a percentage of patients in remission. Clinical parameters used in the model included compliance rates, rehospitalisation rates for compliant and non-compliant patients, duration and frequency of hospitalisation, and adverse event rates. One-way sensitivity analysis was performed to test the robustness of the model. The most effective treatment was treatment with olanzapine where 64.1% of patients remained in remission. The least effective treatment was treatment with quetiapine where 32.7% of patients remained in remission. Overall costs ranged from 3,726.78 Euro for haloperidol to 8,157.03 Euro for risperidone in depot formulation. Inpatient costs represented the major part of costs for most of antipsychotic drugs. Typical antipsychotic drugs had substantially smaller outpatient costs (6.5%) compared with atypical antipsychotics (37.9%). In the base case scenario the non-dominated treatment strategies were haloperidol, haloperidol decanoate and olanzapine. Additionally, risperidone can also be considered to be part of the efficient frontier based on the sensitivity analysis results. Among second-generation antipsychotics, which have a better safety profile than first-generation antipsychotics, olanzapine and risperidone showed to be the most cost-effective treatment strategies for outpatient treatment of chronic schizophrenia.

Ratio-of-Mediator-Probability Weighting for Causal Mediation Analysis in the Presence of Treatment-by-Mediator Interaction

ERIC Educational Resources Information Center

Hong, Guanglei; Deutsch, Jonah; Hill, Heather D.

2015-01-01

Conventional methods for mediation analysis generate biased results when the mediator-outcome relationship depends on the treatment condition. This article shows how the ratio-of-mediator-probability weighting (RMPW) method can be used to decompose total effects into natural direct and indirect effects in the presence of treatment-by-mediator…

Ratio-of-Mediator-Probability Weighting for Causal Mediation Analysis in the Presence of Treatment-by-Mediator Interaction

ERIC Educational Resources Information Center

Hong, Guanglei; Deutsch, Jonah; Hill, Heather D.

2015-01-01

Conventional methods for mediation analysis generate biased results when the mediator--outcome relationship depends on the treatment condition. This article shows how the ratio-of-mediator-probability weighting (RMPW) method can be used to decompose total effects into natural direct and indirect effects in the presence of treatment-by-mediator…

Controlled hydrostatic pressure stress downregulates the expression of ribosomal genes in preimplantation embryos: a possible protection mechanism?

PubMed

Bock, I; Raveh-Amit, H; Losonczi, E; Carstea, A C; Feher, A; Mashayekhi, K; Matyas, S; Dinnyes, A; Pribenszky, C

2016-04-01

The efficiency of various assisted reproductive techniques can be improved by preconditioning the gametes and embryos with sublethal hydrostatic pressure treatment. However, the underlying molecular mechanism responsible for this protective effect remains unknown and requires further investigation. Here, we studied the effect of optimised hydrostatic pressure treatment on the global gene expression of mouse oocytes after embryonic genome activation. Based on a gene expression microarray analysis, a significant effect of treatment was observed in 4-cell embryos derived from treated oocytes, revealing a transcriptional footprint of hydrostatic pressure-affected genes. Functional analysis identified numerous genes involved in protein synthesis that were downregulated in 4-cell embryos in response to hydrostatic pressure treatment, suggesting that regulation of translation has a major role in optimised hydrostatic pressure-induced stress tolerance. We present a comprehensive microarray analysis and further delineate a potential mechanism responsible for the protective effect of hydrostatic pressure treatment.

Cost-utility analysis of botulinum toxin type A products for the treatment of cervical dystonia.

PubMed

Kazerooni, Rashid; Broadhead, Christine

2015-02-15

A cost-utility analysis of botulinum toxin type A products for the treatment of cervical dystonia (CD) was conducted. A cost-utility analysis of botulinum toxin type A products was conducted from the U.S. government perspective using a decision-analysis model with a one-year time horizon. Probabilities of the model were taken from several studies using the three botulinum type A products approved by the Food and Drug Administration for the treatment of CD: onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), and incobotulinumtoxinA (Xeomin). The main outcome measurement was successful treatment response with botulinum toxin type A, measured in quality-adjusted life years (QALYs). Response was defined as a patient who experienced improvement of CD symptoms without a severe adverse event. Probabilistic sensitivity analysis was conducted to test robustness of the base-case results. All three botulinum toxin type A agents were cost-effective at a willingness-to-pay threshold of $100,000 per QALY. Xeomin was the most cost-effective with a cost-effectiveness ratio of $27,548 per QALY. Xeomin was dominant over the alternative agents with equivalent efficacy outcomes and lower costs. Dysport had the second lowest cost-effectiveness ratio ($36,678), followed by Botox ($49,337). The probabilistic sensitivity analysis supported the results of the base-case analysis. Dysport was associated with the lowest wastage (2.2%), followed by Xeomin (10%) and Botox (22.9%). A cost-utility analysis found that Xeomin was the more cost-effective botulinum toxin type A product compared with Botox and Dysport for the treatment of CD. Wastage associated with the respective products may have a large effect on the cost-effectiveness of the agents. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

The effect of heat treatments applied to superstructure porcelain on the mechanical properties and microstructure of lithium disilicate glass ceramics.

PubMed

Özdemir, Hatice; Özdoğan, Alper

2018-01-30

The aim of this study was to investigate that heat treatments with different numbers applied to superstructure porcelain whether effects microstructure and mechanical properties of lithium disilicate ceramic (LDC). Eighty disc-shaped specimens were fabricated from IPS e.max Press. Specimens were fired at heating values of porcelain in different numbers and divided four groups (n=5). Initial Vickers hardness were measured and X-ray diffraction (XRD) analysis was performed. Different surface treatment were applied and then Vickers hardness, surface roughness and environmental scanning electron microscopy (ESEM) analysis were performed. Data were analyzed with Varyans analysis and Tukey HSD test (α=0.05). Initial hardness among groups was no significant different (p>0.05), but hardness and surface roughness after surface treatments were significant different (p<0.05). Lithium disilicate (LD) peaks decrease depended on firing numbers. ESEM observations showed that firing number and surface treatments effect microstructure of LDC. Increasing firing numbers and surface treatments effect the microstructure of LDC.

Incorporating Psychological Predictors of Treatment Response into Health Economic Simulation Models: A Case Study in Type 1 Diabetes.

PubMed

Kruger, Jen; Pollard, Daniel; Basarir, Hasan; Thokala, Praveen; Cooke, Debbie; Clark, Marie; Bond, Rod; Heller, Simon; Brennan, Alan

2015-10-01

. Health economic modeling has paid limited attention to the effects that patients' psychological characteristics have on the effectiveness of treatments. This case study tests 1) the feasibility of incorporating psychological prediction models of treatment response within an economic model of type 1 diabetes, 2) the potential value of providing treatment to a subgroup of patients, and 3) the cost-effectiveness of providing treatment to a subgroup of responders defined using 5 different algorithms. . Multiple linear regressions were used to investigate relationships between patients' psychological characteristics and treatment effectiveness. Two psychological prediction models were integrated with a patient-level simulation model of type 1 diabetes. Expected value of individualized care analysis was undertaken. Five different algorithms were used to provide treatment to a subgroup of predicted responders. A cost-effectiveness analysis compared using the algorithms to providing treatment to all patients. . The psychological prediction models had low predictive power for treatment effectiveness. Expected value of individualized care results suggested that targeting education at responders could be of value. The cost-effectiveness analysis suggested, for all 5 algorithms, that providing structured education to a subgroup of predicted responders would not be cost-effective. . The psychological prediction models tested did not have sufficient predictive power to make targeting treatment cost-effective. The psychological prediction models are simple linear models of psychological behavior. Collection of data on additional covariates could potentially increase statistical power. . By collecting data on psychological variables before an intervention, we can construct predictive models of treatment response to interventions. These predictive models can be incorporated into health economic models to investigate more complex service delivery and reimbursement strategies. © The Author(s) 2015.

The Use of Propensity Scores in Mediation Analysis

ERIC Educational Resources Information Center

Jo, Booil; Stuart, Elizabeth A.; MacKinnon, David P.; Vinokur, Amiram D.

2011-01-01

Mediation analysis uses measures of hypothesized mediating variables to test theory for how a treatment achieves effects on outcomes and to improve subsequent treatments by identifying the most efficient treatment components. Most current mediation analysis methods rely on untested distributional and functional form assumptions for valid…

Effectiveness of Global Postural Re-education for Treatment of Spinal Disorders: A Meta-analysis.

PubMed

Lomas-Vega, Rafael; Garrido-Jaut, María Victoria; Rus, Alma; Del-Pino-Casado, Rafael

2017-02-01

The aim of this study was to investigate the effects of global postural re-education (GPR) on the treatment of spinal disorders by performing a systematic review and a meta-analysis. MEDLINE, Scopus, and PEDro databases were searched without language or publication date restrictions. Data on pain and function were used to evaluate the effectiveness of GPR. Randomized controlled trials and controlled clinical trials analyzing the effectiveness of GPR on spinal disorders were selected. The standardized mean difference (SMD) and the corresponding 95% confidence interval (95% CI) were calculated. The meta-analysis was performed using the Comprehensive Meta-analysis 3.3 software. Seven randomized controlled trials and 4 controlled clinical trials were included in the meta-analysis. The results showed a medium improvement on pain (SMD = -0.63; 95% CI, -0.43 to -0.83) and function (SMD = -0.48; 95% CI, -0.25 to -0.72) after GPR treatment. The positive effect, which was greater in patients with ankylosing spondylitis followed by low back pain and neck pain, was more significant during the intermediate follow-up than immediately after treatment. This meta-analysis provides reliable evidence that GPR may be an effective method for treating spinal disorders by decreasing pain and improving function.

Treatment strategies for pelvic organ prolapse: a cost-effectiveness analysis.

PubMed

Hullfish, Kathie L; Trowbridge, Elisa R; Stukenborg, George J

2011-05-01

To compare the relative cost effectiveness of treatment decision alternatives for post-hysterectomy pelvic organ prolapse (POP). A Markov decision analysis model was used to assess and compare the relative cost effectiveness of expectant management, use of a pessary, and surgery for obtaining months of quality-adjusted life over 1 year. Sensitivity analysis was conducted to determine whether the results depended on specific estimates of patient utilities for pessary use, probabilities for complications and other events, and estimated costs. Only two treatment alternatives were found to be efficient choices: initial pessary use and vaginal reconstructive surgery (VRS). Pessary use (including patients that eventually transitioned to surgery) achieved 10.4 quality-adjusted months, at a cost of $10,000 per patient, while VRS obtained 11.4 quality-adjusted months, at $15,000 per patient. Sensitivity analysis demonstrated that these baseline results depended on several key estimates in the model. This analysis indicates that pessary use and VRS are the most cost-effective treatment alternatives for treating post-hysterectomy vaginal prolapse. Additional research is needed to standardize POP outcomes and complications, so that healthcare providers can best utilize cost information in balancing the risks and benefits of their treatment decisions.

Do all psychological treatments really work the same in posttraumatic stress disorder?

PubMed Central

Ehlers, Anke; Bisson, Jonathan; Clark, David M.; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P.; Turner, Stuart; Yule, William

2010-01-01

A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746–758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent. PMID:20051310

Cost-effectiveness of pediatric epilepsy surgery compared to medical treatment in children with intractable epilepsy.

PubMed

Widjaja, Elysa; Li, Bing; Schinkel, Corrine Davies; Puchalski Ritchie, Lisa; Weaver, James; Snead, O Carter; Rutka, James T; Coyte, Peter C

2011-03-01

Due to differences in epilepsy types and surgery, economic evaluations of epilepsy treatment in adults cannot be extrapolated to children. We evaluated the cost-effectiveness of epilepsy surgery compared to medical treatment in children with intractable epilepsy. Decision tree analysis was used to evaluate the cost-effectiveness of surgery relative to medical management. Fifteen patients had surgery and 15 had medical treatment. Cost data included inpatient and outpatient costs for the period April 2007 to September 2009, physician fee, and medication costs. Outcome measure was percentage seizure reduction at one-year follow-up. Incremental cost-effectiveness ratio (ICER) was assessed. Sensitivity analysis was performed for different probabilities of surgical and medical treatment outcomes and costs, and surgical mortality or morbidity. More patients managed surgically experienced Engel class I and II outcomes compared to medical treatment at one-year follow-up. Base-case analysis yielded an ICER of $369 per patient for each percentage reduction in seizures for the surgery group relative to medical group. Sensitivity analysis showed robustness for the different probabilities tested. Surgical treatment resulted in greater reduction in seizure frequency compared to medical therapy and was a cost-effective treatment option in children with intractable epilepsy who were evaluated for epilepsy surgery and subsequently underwent surgery compared to continuing medical therapy. However, larger sample size and long-term follow-up are needed to validate these findings. Copyright © 2011 Elsevier B.V. All rights reserved.

Quality of medical service, patient satisfaction and loyalty with a focus on interpersonal-based medical service encounters and treatment effectiveness: a cross-sectional multicenter study of complementary and alternative medicine (CAM) hospitals.

PubMed

Kim, Chang Eun; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Kim, Me-Riong; Choi, Areum; Park, Ki Byung; Lee, Ho-Joo; Ha, In-Hyuk

2017-03-28

Treatment effectiveness holds considerable importance in the association between service quality and satisfaction in medical service studies. While complementary and alternative medicine (CAM) use grows more prominent, comprehensive evaluations of the quality of medical service at CAM-oriented hospitals are scarce. This study assesses the quality of medical services provided at a CAM-oriented hospital of Korean medicine using the service encounter system approach and analyzes the influence of treatment effectiveness on patient loyalty. A survey study using one-on-one interviews was conducted using a cross-sectional design in outpatients visiting one of fifteen Korean medicine facilities located throughout Korea. A total of 880 surveys were completed from June to July, 2014, and 728 surveys were included in the final analysis after excluding incomplete or incorrect questionnaires. The reliability and validity of the surveys was confirmed using Cronbach's alpha coefficient and confirmatory factor analysis, and a structural equation modeling analysis was performed to verify causality and association between factors (quality of medical service, treatment effectiveness, patient satisfaction, and intent to revisit). The measured factors of physician performance and quality of service procedures had a positive effect on treatment effectiveness. The impression of the facilities and environment directly impacted satisfaction rates for interpersonal-based medical service encounters, while treatment effectiveness positively affected satisfaction regarding quality of medical service. However, treatment effectiveness had a more significant effect on satisfaction compared to facilities and environment, and it indirectly affected satisfaction and directly influenced intent to revisit. Treatment effectiveness and satisfaction both positively influenced intent to revisit. The importance of treatment effectiveness should be recognized when examining quality of medical services, and we hope that these findings may contribute to future studies.

Mindfulness treatment for substance misuse: A systematic review and meta-analysis.

PubMed

Li, Wen; Howard, Matthew O; Garland, Eric L; McGovern, Patricia; Lazar, Michael

2017-04-01

High rates of relapse following substance misuse treatment highlight an urgent need for effective therapies. Although the number of empirical studies investigating effects of mindfulness treatment for substance misuse has increased dramatically in recent years, few reviews have examined findings of mindfulness studies. Thus, this systematic review examined methodological characteristics and substantive findings of studies evaluating mindfulness treatments for substance misuse published by 2015. The review also includes the first meta-analysis of randomized controlled trials of mindfulness treatments for substance misuse. Comprehensive bibliographic searches in PubMed, PsycInfo, and Web of Science, identified 42 pertinent studies. Meta-analytic results revealed significant small-to-large effects of mindfulness treatments in reducing the frequency and severity of substance misuse, intensity of craving for psychoactive substances, and severity of stress. Mindfulness treatments were also effective in increasing rates of posttreatment abstinence from cigarette smoking compared to alternative treatments. Mindfulness treatment for substance misuse is a promising intervention for substance misuse, although more research is needed examining the mechanisms by which mindfulness interventions exert their effects and the effectiveness of mindfulness treatments in diverse treatment settings. Copyright © 2017 Elsevier Inc. All rights reserved.

A method of decision analysis quantifying the effects of age and comorbidities on the probability of deriving significant benefit from medical treatments

PubMed Central

Bean, Nigel G.; Ruberu, Ravi P.

2017-01-01

Background The external validity, or generalizability, of trials and guidelines has been considered poor in the context of multiple morbidity. How multiple morbidity might affect the magnitude of benefit of a given treatment, and thereby external validity, has had little study. Objective To provide a method of decision analysis to quantify the effects of age and comorbidity on the probability of deriving a given magnitude of treatment benefit. Design We developed a method to calculate probabilistically the effect of all of a patient’s comorbidities on their underlying utility, or well-being, at a future time point. From this, we derived a distribution of possible magnitudes of treatment benefit at that future time point. We then expressed this distribution as the probability of deriving at least a given magnitude of treatment benefit. To demonstrate the applicability of this method of decision analysis, we applied it to the treatment of hypercholesterolaemia in a geriatric population of 50 individuals. We highlighted the results of four of these individuals. Results This method of analysis provided individualized quantifications of the effect of age and comorbidity on the probability of treatment benefit. The average probability of deriving a benefit, of at least 50% of the magnitude of benefit available to an individual without comorbidity, was only 0.8%. Conclusion The effects of age and comorbidity on the probability of deriving significant treatment benefits can be quantified for any individual. Even without consideration of other factors affecting external validity, these effects may be sufficient to guide decision-making. PMID:29090189

Therapy of bovine endometritis with prostaglandin F2α: a meta-analysis.

PubMed

Haimerl, P; Heuwieser, W; Arlt, S

2013-05-01

The objective of the conducted meta-analysis was to assess the efficacy of the treatment of bovine endometritis with PGF(2α) by statistical means. Postpartum uterine infections have a high prevalence and a very negative effect on reproductive performance in dairy cattle. Because of a wide discordance between research results, a meta-analysis of the efficacy of the treatment of bovine endometritis with PGF(2α) was conducted. A comprehensive literature search was performed using online databases to reveal a total of 2,307 references. In addition, 5 articles were retrieved by reviewing citations. After applying specific exclusion criteria and evaluating specific evidence parameters, 5 publications, comprising 6 trials, were eligible for being analyzed by means of meta-analysis. Data for each trial were extracted and analyzed using meta-analysis software Review Manager (version 5.1; The Nordic Cochrane Centre, Copenhagen, Denmark). Estimated effect sizes of PGF(2α) were calculated on calving to first service and calving to conception interval. Prostaglandin F(2α) treatment of cows with chronic endometritis had a negative effect on both reproductive performance parameters. Heterogeneity was substantial for calving to first service and calving to conception interval [I(2) (measure of variation beyond chance)=100 and 87%, respectively]; therefore, random-effects models were used. Sensitivity analysis as well as subgroup analysis showed that the performance of randomization was influential in modifying effect size of PGF(2α) treatment. The funnel plot illustrated a publication bias toward smaller studies that reported a prolonged calving to conception interval after a PGF(2α) treatment. We conclude that the investigation of this subject by means of meta-analysis did not reveal an improvement of reproductive performance of cows with endometritis after treatment with PGF(2α). Furthermore, there is a shortage of comparable high quality studies investigating reproductive performance after PGF(2α) treatment of cows with chronic endometritis. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Does Vitamin D Supplementation Enhance Musculoskeletal Performance in Individuals Identified as Vitamin D Deficient through Blood Spot Testing?

NASA Astrophysics Data System (ADS)

Murphy, Kellie A.

This thesis investigated possible changes in performance after one month of vitamin D supplementation in individuals found to be vitamin D deficient or insufficient through blood spot testing. Thirty-two males, ages 18-32, participated. Each subject visited the lab three times in one-month, completing four performance tests each session, including an isometric mid-thigh pull and a vertical jump on a force plate, a isometric 90-degree elbow flexion test using a load cell, and a psychomotor vigilance test on a palm pilot. The initial lab included blood spot tests to find vitamin D levels. In a single blind manner, 16 subjects were assigned vitamin D and 16 the placebo. Repeated measures ANOVA analysis did not reveal any main effects for time (F=2.626, p=0.364), treatment (vitamin D3 vs placebo; F=1.282, p=0.999), or interaction effects for treatment by time (F=0.304, p=0.999) for maximum force production during an isometric mid-thigh pull. Repeated measures ANOVA analysis did not reveal any main effects for time (F=1.323, p=0.999), treatment (vitamin D3 vs placebo; F=0.510, p=0.999), or interaction effects for treatment by time (F= 1.625, p=0.860) for rate of force production during a vertical jump. Repeated measures ANOVA analysis did not reveal any main effects for time (F=0.194, p=0.999), treatment (vitamin D3 vs placebo; F=2.452, p=0.513), or interaction effects for treatment by time (F= 1.179, p=0.999) for maximal force production during a 90-degree isometric elbow flexion. Repeated measures ANOVA analysis did not reveal any main effects for time (F=1.710, p=0.804), treatment (vitamin D3 vs placebo; F=1.471, p=0.94), or interaction effects for treatment by time (F= 0.293, p=0.999) for mean reaction time to random stimuli during the psychomotor vigilance test. Repeated measures ANOVA analysis did not reveal any main effects for time (F=0.530, p=0.999), treatment (vitamin D3 vs placebo; F=0.141, p=0.999), or interaction effects for treatment by time (F=0.784 p=0.999) for incidence of minor lapses during the psychomotor vigilance test.

Systematic Review and Meta-Analysis of Antimicrobial Treatment Effect Estimation in Complicated Urinary Tract Infection

PubMed Central

Li, Gang; Mitrani-Gold, Fanny S.; Kurtinecz, Milena; Wetherington, Jeffrey; Tomayko, John F.; Mundy, Linda M.

2013-01-01

Noninferiority trial design and analyses are commonly used to establish the effectiveness of a new antimicrobial drug for treatment of serious infections such as complicated urinary tract infection (cUTI). A systematic review and meta-analysis were conducted to estimate the treatment effects of three potential active comparator drugs for the design of a noninferiority trial. The systematic review identified no placebo trials of cUTI, four clinical trials of cUTI with uncomplicated urinary tract infection as a proxy for placebo, and nine trials with reports of treatment effect estimates for doripenem, levofloxacin, or imipenem-cilastatin. In the meta-analysis, the primary efficacy endpoint of interest was the microbiological eradication rate at the test-of-cure visit in the microbiological intent-to-treat population. The estimated eradication rates and corresponding 95% confidence intervals (CI) were 31.8% (26.5% to 37.2%) for placebo, 81% (77.7% to 84.2%) for doripenem, 79% (75.9% to 82.2%) for levofloxacin, and 80.5% (71.9% to 89.1%) for imipenem-cilastatin. The treatment effect estimates were 40.5% for doripenem, 38.7% for levofloxacin, 34.7% for imipenem-cilastatin, and 40.8% overall. These treatment effect estimates can be used to inform the design and analysis of future noninferiority trials in cUTI study populations. PMID:23939900

Physical therapy treatments for low back pain in children and adolescents: a meta-analysis

PubMed Central

2013-01-01

Background Low back pain (LBP) in adolescents is associated with LBP in later years. In recent years treatments have been administered to adolescents for LBP, but it is not known which physical therapy treatment is the most efficacious. By means of a meta-analysis, the current study investigated the effectiveness of the physical therapy treatments for LBP in children and adolescents. Methods Studies in English, Spanish, French, Italian and Portuguese, and carried out by March 2011, were selected by electronic and manual search. Two independent researchers coded the moderator variables of the studies, and performed the effect size calculations. The mean effect size index used was the standardized mean change between the pretest and posttest, and it was applied separately for each combination of outcome measures, (pain, disability, flexibility, endurance and mental health) and measurement type (self-reports, and clinician assessments). Results Eight articles that met the selection criteria enabled us to define 11 treatment groups and 5 control groups using the group as the unit of analysis. The 16 groups involved a total sample of 334 subjects at the posttest (221 in the treatment groups and 113 in the control groups). For all outcome measures, the average effect size of the treatment groups was statistically and clinically significant, whereas the control groups had negative average effect sizes that were not statistically significant. Conclusions Of all the physical therapy treatments for LBP in children and adolescents, the combination of therapeutic physical conditioning and manual therapy is the most effective. The low number of studies and control groups, and the methodological limitations in this meta-analysis prevent us from drawing definitive conclusions in relation to the efficacy of physical therapy treatments in LBP. PMID:23374375

Physical therapy treatments for low back pain in children and adolescents: a meta-analysis.

PubMed

Calvo-Muñoz, Inmaculada; Gómez-Conesa, Antonia; Sánchez-Meca, Julio

2013-02-02

Low back pain (LBP) in adolescents is associated with LBP in later years. In recent years treatments have been administered to adolescents for LBP, but it is not known which physical therapy treatment is the most efficacious. By means of a meta-analysis, the current study investigated the effectiveness of the physical therapy treatments for LBP in children and adolescents. Studies in English, Spanish, French, Italian and Portuguese, and carried out by March 2011, were selected by electronic and manual search. Two independent researchers coded the moderator variables of the studies, and performed the effect size calculations. The mean effect size index used was the standardized mean change between the pretest and posttest, and it was applied separately for each combination of outcome measures, (pain, disability, flexibility, endurance and mental health) and measurement type (self-reports, and clinician assessments). Eight articles that met the selection criteria enabled us to define 11 treatment groups and 5 control groups using the group as the unit of analysis. The 16 groups involved a total sample of 334 subjects at the posttest (221 in the treatment groups and 113 in the control groups). For all outcome measures, the average effect size of the treatment groups was statistically and clinically significant, whereas the control groups had negative average effect sizes that were not statistically significant. Of all the physical therapy treatments for LBP in children and adolescents, the combination of therapeutic physical conditioning and manual therapy is the most effective. The low number of studies and control groups, and the methodological limitations in this meta-analysis prevent us from drawing definitive conclusions in relation to the efficacy of physical therapy treatments in LBP.

Using decision analysis to assess comparative clinical efficacy of surgical treatment of unstable ankle fractures.

PubMed

Michelson, James D

2013-11-01

The development of a robust treatment algorithm for ankle fractures based on well-established stability criteria has been shown to be prognostic with respect to treatment and outcomes. In parallel with the development of improved understanding of the biomechanical rationale of ankle fracture treatment has been an increased emphasis on assessing the effectiveness of medical and surgical interventions. The purpose of this study was to investigate the use of using decision analysis in the assessment of the cost effectiveness of operative treatment of ankle fractures based on the existing clinical data in the literature. Using the data obtained from a previous structured review of the ankle fracture literature, decision analysis trees were constructed using standard software. The decision nodes for the trees were based on ankle fracture stability criteria previously published. The outcomes were assessed by calculated Quality-Adjusted Life Years (QALYs) assigned to achieving normal ankle function, developing posttraumatic arthritis, or sustaining a postoperative infection. Sensitivity analysis was undertaken by varying the patient's age, incidence of arthritis, and incidence or infection. Decision analysis trees captured the essential aspects of clinical decision making in ankle fracture treatment in a clinically useful manner. In general, stable fractures yielded better outcomes with nonoperative treatment, whereas unstable fractures had better outcomes with surgery. These were consistent results over a wide range of postoperative infection rates. Varying the age of the patient did not qualitatively change the results. Between the ages of 30 and 80 years, surgery yielded higher expected QALYs than nonoperative care for unstable fractures, and generated lower QALYs than nonoperative care for stable fractures. Using local cost estimates for operative and nonoperative treatment, the incremental cost of surgery for unstable fractures was less than $40,000 per QALY (the usual cutoff for the determination of cost effectiveness) for patients aged up to 90 years. Decision analysis is a useful methodology in developing treatment guidelines. Numerous previous studies have indicated superior clinical outcomes when unstable ankle fractures underwent operative reduction and stabilization. What has been lacking was an examination of the cost effectiveness of such an approach, particularly in older patients who have fewer expected years of life. In light of the evidence for satisfactory outcomes for surgery of severe ankle fractures in older people, the justification for operative intervention is an obvious question that can be asked in the current increasingly cost-conscious environment. Using a decision-tree decision analysis structured around the stability-based ankle fracture classification system, in conjunction with a relatively simple cost effectiveness analysis, this study was able to demonstrate that surgical treatment of unstable ankle fractures in elderly patients is in fact cost effective. The clinical implication of the present analysis is that these existing treatment protocols for ankle fracture treatment are also cost effective when quality of life outcome measures are taken into account. Economic Level II. See Instructions for Authors for a complete description of levels of evidence.

The Effectiveness of Emotional Freedom Techniques in the Treatment of Posttraumatic Stress Disorder: A Meta-Analysis.

PubMed

Sebastian, Brenda; Nelms, Jerrod

Over the past two decades, growing numbers of clinicians have been utilizing emotional freedom techniques (EFT) in the treatment of posttraumatic stress disorder (PTSD), anxiety, and depression. Randomized controlled trials (RCTs) have shown encouraging outcomes for all three conditions. To assess the efficacy of EFT in treating PTSD by conducting a meta-analysis of existing RCTs. A systematic review of databases was undertaken to identify RCTs investigating EFT in the treatment of PTSD. The RCTs were evaluated for quality using evidence-based standards published by the American Psychological Association Division 12 Task Force on Empirically Validated Therapies. Those meeting the criteria were assessed using a meta-analysis that synthesized the data to determine effect sizes. While uncontrolled outcome studies were excluded, they were examined for clinical implications of treatment that can extend knowledge of this condition. Seven randomized controlled trials were found to meet the criteria and were included in the meta-analysis. A large treatment effect was found, with a weighted Cohen׳s d = 2.96 (95% CI: 1.96-3.97, P < .001) for the studies that compared EFT to usual care or a waitlist. No treatment effect differences were found in studies comparing EFT to other evidence-based therapies such as eye movement desensitization and reprocessing (EMDR; 1 study) and cognitive behavior therapy (CBT; 1 study). The analysis of existing studies showed that a series of 4-10 EFT sessions is an efficacious treatment for PTSD with a variety of populations. The studies examined reported no adverse effects from EFT interventions and showed that it can be used both on a self-help basis and as a primary evidence-based treatment for PTSD. Copyright © 2017 Elsevier Inc. All rights reserved.

Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

PubMed

Krebs, Teri S; Johansen, Pål-Ørjan

2012-07-01

Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2.

PubMed

Hoaglin, David C; Hawkins, Neil; Jansen, Jeroen P; Scott, David A; Itzler, Robbin; Cappelleri, Joseph C; Boersma, Cornelis; Thompson, David; Larholt, Kay M; Diaz, Mireya; Barrett, Annabel

2011-06-01

Evidence-based health care decision making requires comparison of all relevant competing interventions. In the absence of randomized controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best treatment(s). Mixed treatment comparisons, a special case of network meta-analysis, combine direct evidence and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than traditional meta-analysis. This report from the International Society for Pharmacoeconomics and Outcomes Research Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on technical aspects of conducting network meta-analyses (our use of this term includes most methods that involve meta-analysis in the context of a network of evidence). We start with a discussion of strategies for developing networks of evidence. Next we briefly review assumptions of network meta-analysis. Then we focus on the statistical analysis of the data: objectives, models (fixed-effects and random-effects), frequentist versus Bayesian approaches, and model validation. A checklist highlights key components of network meta-analysis, and substantial examples illustrate indirect treatment comparisons (both frequentist and Bayesian approaches) and network meta-analysis. A further section discusses eight key areas for future research. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Identifying Effective Psychological Treatments of Insomnia: A Meta-Analysis.

ERIC Educational Resources Information Center

Murtagh, Douglas R. R.; Greenwood, Kenneth M.

1995-01-01

Clarified efficacy of psychological treatments for insomnia through a meta-analysis of 66 outcome studies representing 139 treatment groups. Psychological treatments produced considerable enhancement of both sleep patterns and the subjective experience of sleep. Participants who were clinically referred and who did not regularly use sedatives…

Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

PubMed Central

Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

2015-01-01

Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

Causal mediation analysis with multiple mediators in the presence of treatment noncompliance.

PubMed

Park, Soojin; Kürüm, Esra

2018-05-20

Randomized experiments are often complicated because of treatment noncompliance. This challenge prevents researchers from identifying the mediated portion of the intention-to-treated (ITT) effect, which is the effect of the assigned treatment that is attributed to a mediator. One solution suggests identifying the mediated ITT effect on the basis of the average causal mediation effect among compliers when there is a single mediator. However, considering the complex nature of the mediating mechanisms, it is natural to assume that there are multiple variables that mediate through the causal path. Motivated by an empirical analysis of a data set collected in a randomized interventional study, we develop a method to estimate the mediated portion of the ITT effect when both multiple dependent mediators and treatment noncompliance exist. This enables researchers to make an informed decision on how to strengthen the intervention effect by identifying relevant mediators despite treatment noncompliance. We propose a nonparametric estimation procedure and provide a sensitivity analysis for key assumptions. We conduct a Monte Carlo simulation study to assess the finite sample performance of the proposed approach. The proposed method is illustrated by an empirical analysis of JOBS II data, in which a job training intervention was used to prevent mental health deterioration among unemployed individuals. Copyright © 2018 John Wiley & Sons, Ltd.

The Effects of Psycho-Emotional and Socio-Economic Support for Tuberculosis Patients on Treatment Adherence and Treatment Outcomes – A Systematic Review and Meta-Analysis

PubMed Central

van Hoorn, Rosa; Jaramillo, Ernesto; Collins, David; Gebhard, Agnes; van den Hof, Susan

2016-01-01

Background There is uncertainty about the contribution that social support interventions (SSI) can have in mitigating the personal, social and economic costs of tuberculosis (TB) treatment on patients, and improving treatment outcomes. Objective To identify psycho-emotional (PE) and socio-economic (SE) interventions provided to TB patients and to assess the effects of these interventions on treatment adherence and treatment outcomes. Search strategy We searched PubMed and Embase from 1 January 1990–15 March 2015 and abstracts of the Union World Conference on Lung Health from 2010–2014 for studies reporting TB treatment adherence and treatment outcomes following SSI. Selection criteria Studies measuring the effects of PE or SE interventions on TB treatment adherence, treatment outcomes, and/or financial burden. Data collection and analysis Two reviewers independently assessed titles and abstracts for inclusion of articles. One reviewer reviewed full text articles and the reference list of selected studies. A second reviewer double checked all extracted information against the articles. Main results Twenty-five studies were included in the qualitative analysis; of which eighteen were included in the meta-analysis. Effects were pooled from 11 Randomized Controlled Trials (RCTs), including 9,655 participants with active TB. Meta-analysis showed that PE support (RR 1.37; CI 1.08–1.73), SE support (RR 1.08; CI 1.03–1.13) and combined PE and SE support (RR 1.17; CI 1.12–1.22) were associated with a significant improvement of successful treatment outcomes. Also PE support, SE support and a combination of these types of support were associated with reductions in unsuccessful treatment outcomes (PE: RR 0.46; CI 0.22–0.96, SE: RR 0.78; CI 0.69–0.88 and Combined PE and SE: RR 0.42; CI 0.23–0.75). Evidence on the effect of PE and SE interventions on treatment adherence were not meta-analysed because the interventions were too heterogeneous to pool. No evidence was found to show whether SE reduced the financial burden for TB patients. Discussion and Conclusions Our review and meta-analysis concluded that PE and SE interventions are associated with beneficial effects on TB treatment outcomes. However, the quality of evidence is very low and future well-designed evaluation studies are needed. PMID:27123848

Efficacy of intensive versus nonintensive physiotherapy in children with cerebral palsy: a meta-analysis.

PubMed

Arpino, Carla; Vescio, Maria Fenicia; De Luca, Angela; Curatolo, Paolo

2010-06-01

A commonly used treatment for cerebral palsy in children is so-called 'conventional therapy', which includes physiotherapy or the neurodevelopmental approach. Although more intensive rehabilitative treatment is thought to be more effective than less intensive interventions, this assumption has not been proven. In this study we compared the efficacy of intensive versus nonintensive rehabilitative treatment in children with cerebral palsy. A meta-analysis of the studies published between January 1996 and July 2007 was performed. infants/children/adolescents (1-18 years old); randomized controlled trials using, as outcome measure, the Gross Motor Function Measure score. studies that included therapies not generally used in 'so-called' conventional treatment (i.e. constraint, taping). Treatment effects were combined using the weighted mean difference method. Fixed and random effect meta-analyses were carried out and results were compared. Heterogeneity was also assessed. Funnel plots were examined and the presence of small-study effects was tested. Intensive therapy tended to have a greater effect than nonintensive therapy (1.32; 95% confidence interval: 0.55-2.10). The effect of intensive treatment tended to be apparently stronger for children 2 years of age. Our meta-analysis shows that, in children with cerebral palsy, intensive conventional therapy may improve the functional motor outcome, but the effect size seems to be modest.

Cost-effectiveness analysis of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis.

PubMed

Cardona-Arias, Jaiberth Antonio; López-Carvajal, Liliana; Tamayo Plata, Mery Patricia; Vélez, Iván Darío

2017-05-01

The treatment of cutaneous leishmaniasis is toxic, has contraindications, and a high cost. The objective of this study was to estimate the cost-effectiveness of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis. Effectiveness was the proportion of healing and safety with the adverse effects; these parameters were estimated from a controlled clinical trial and a meta-analysis. A standard costing was conducted. Average and incremental cost-effectiveness ratios were estimated. The uncertainty regarding effectiveness, safety, and costs was determined through sensitivity analyses. The total costs were $66,807 with Glucantime and $14,079 with thermotherapy. The therapeutic effectiveness rates were 64.2% for thermotherapy and 85.1% for Glucantime. The average cost-effectiveness ratios ranged between $721 and $1275 for Glucantime and between $187 and $390 for thermotherapy. Based on the meta-analysis, thermotherapy may be a dominant strategy. The excellent cost-effectiveness ratio of thermotherapy shows the relevance of its inclusion in guidelines for the treatment. © 2017 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Effects of tibolone on fibrinogen and antithrombin III: A systematic review and meta-analysis of controlled trials.

PubMed

Bała, Małgorzata; Sahebkar, Amirhossein; Ursoniu, Sorin; Serban, Maria-Corina; Undas, Anetta; Mikhailidis, Dimitri P; Lip, Gregory Y H; Rysz, Jacek; Banach, Maciej

2017-10-01

Tibolone is a synthetic steroid with estrogenic, androgenic and progestogenic activity, but the evidence regarding its effects on fibrinogen and antithrombin III (ATIII) has not been conclusive. We assessed the impact of tibolone on fibrinogen and ATIII through a systematic review and meta-analysis of available randomized controlled trials (RCTs). The search included PUBMED, Web of Science, Scopus, and Google Scholar (up to January 31st, 2016) to identify controlled clinical studies investigating the effects of oral tibolone treatment on fibrinogen and ATIII. Overall, the impact of tibolone on plasma fibrinogen concentrations was reported in 10 trials comprising 11 treatment arms. Meta-analysis did not suggest a significant reduction of fibrinogen levels following treatment with tibolone (WMD: -5.38%, 95% CI: -11.92, +1.16, p=0.107). This result was robust in the sensitivity analysis and not influenced after omitting each of the included studies from meta-analysis. When the studies were categorized according to the duration of treatment, there was no effect in the subsets of trials lasting either <12months (WMD: -7.64%, 95% CI: -16.58, +1.29, p=0.094) or ≥12months (WMD: -0.62%, 95% CI: -8.40, +7.17, p=0.876). With regard to ATIII, there was no change following treatment with tibolone (WMD: +0.74%, 95% CI: -1.44, +2.93, p=0.505) and this effect was robust in sensitivity analysis. There was no differential effect of tibolone on plasma ATIII concentrations in trials with either <12months (WMD: +2.26%, 95% CI: -3.14, +7.66, p=0.411) or≥12months (WMD: +0.06%, 95% CI: -1.16, +1.28, p=0.926) duration. Consistent with the results of subgroup analysis, meta-regression did not suggest any significant association between the changes in plasma concentrations of fibrinogen (slope: +0.40; 95% CI: -0.39, +1.19; p=0.317) and ATIII (slope: -0.17; 95% CI: -0.54, +0.20; p=0.374) with duration of treatment. In conclusion, meta-analysis did not suggest a significant reduction of fibrinogen and ATIII levels following treatment with tibolone. Copyright © 2017 Elsevier Ltd. All rights reserved.

The National Treatment Improvement Evaluation Study: Retention Analysis.

ERIC Educational Resources Information Center

Orwin, Rob; Williams, Valerie

This study focuses on programmatic factors that predict retention for individuals in drug and alcohol treatment programs through secondary analysis of data from the National Treatment Improvement Evaluation Study (NTIES). It addresses the relationships between completion rates, lengths of stay, and treatment modality. It examines the effect of…

Comparative effect and safety of verapamil in keloid and hypertrophic scar treatment: a meta-analysis.

PubMed

Li, Zhouna; Jin, Zhehu

2016-01-01

Keloids and hypertrophic scars are the most common types of pathological scarring. Traditionally, keloids have been considered as a result of aberrant wound healing, involving excessive fibroblast participation that is characterized by hyalinized collagen bundles. However, the usefulness of this characterization has been questioned. In recent years, studies have reported the appropriate use of verapamil for keloids and hypertrophic scars. Searches were conducted on the databases Medline, Embase, Cochrane, PubMed, and China National Knowledge Infrastructure from 2006 to July 2016. State12.0 was used for literature review, data extraction, and meta-analysis. Treatment groups were divided into verapamil and nonverapamil group. Nonverapamil group includes steroids and intense pulsed light (IPL) therapy. Total effective rates include cure rate and effective rate. Cure: skin lesions were completely flattened, became soft and symptoms disappeared. Efficacy: skin lesions subsided, patient significantly reduced symptoms. Inefficient definition of skin was progression free or became worse. Random-effects model was used for the meta-analysis. Six studies that included 331 patients with keloids and hypertrophic scars were analyzed. Analysis of the total effective rate of skin healing was performed. The total effective rates in the two groups were 54.07% (verapamil) and 53.18% (nonverapamil), respectively. The meta-analysis showed that there was no difference between the two groups. We also compared the adverse reactions between the verapamil treatment group and the steroids treatment group in two studies, and the result indicated that the verapamil group showed less adverse reactions. There were no differences between the application of verapamil and nonverapamil group in keloids and hypertrophic scars treatment. Verapamil could act as an effective alternative modality in the prevention and treatment of keloid and hypertrophic scars. A larger number of studies are required to confirm our conclusion.

Effectiveness of cognitive rehabilitation following acquired brain injury: a meta-analytic re-examination of Cicerone et al.'s (2000, 2005) systematic reviews.

PubMed

Rohling, Martin L; Faust, Mark E; Beverly, Brenda; Demakis, George

2009-01-01

The present study provides a meta-analysis of cognitive rehabilitation literature (K = 115, N = 2,014) that was originally reviewed by K. D. Cicerone et al. (2000, 2005) for the purpose of providing evidence-based practice guidelines for persons with acquired brain injury. The analysis yielded a small treatment effect size (ES = .30, d(+) statistic) directly attributable to cognitive rehabilitation. A larger treatment effect (ES = .71) was found for single-group pretest to posttest outcomes; however, modest improvement was observed for nontreatment control groups as well (ES = .41). Correction for this effect, which was not attributable to cognitive treatments, resulted in the small, but significant, overall estimate. Treatment effects were moderated by cognitive domain treated, time postinjury, type of brain injury, and age. The meta-analysis revealed sufficient evidence for the effectiveness of attention training after traumatic brain injury and of language and visuospatial training for aphasia and neglect syndromes after stroke. Results provide important quantitative documentation of effective treatments, complementing recent systematic reviews. Findings also highlight gaps in the scientific evidence supporting cognitive rehabilitation, thereby indicating future research directions. (c) 2009 APA, all rights reserved.

Adjusting for the Confounding Effects of Treatment Switching-The BREAK-3 Trial: Dabrafenib Versus Dacarbazine.

PubMed

Latimer, Nicholas R; Abrams, Keith R; Amonkar, Mayur M; Stapelkamp, Ceilidh; Swann, R Suzanne

2015-07-01

Patients with previously untreated BRAF V600E mutation-positive melanoma in BREAK-3 showed a median overall survival (OS) of 18.2 months for dabrafenib versus 15.6 months for dacarbazine (hazard ratio [HR], 0.76; 95% confidence interval, 0.48-1.21). Because patients receiving dacarbazine were allowed to switch to dabrafenib at disease progression, we attempted to adjust for the confounding effects on OS. Rank preserving structural failure time models (RPSFTMs) and the iterative parameter estimation (IPE) algorithm were used. Two analyses, "treatment group" (assumes treatment effect could continue until death) and "on-treatment observed" (assumes treatment effect disappears with discontinuation), were used to test the assumptions around the durability of the treatment effect. A total of 36 of 63 patients (57%) receiving dacarbazine switched to dabrafenib. The adjusted OS HRs ranged from 0.50 to 0.55, depending on the analysis. The RPSFTM and IPE "treatment group" and "on-treatment observed" analyses performed similarly well. RPSFTM and IPE analyses resulted in point estimates for the OS HR that indicate a substantial increase in the treatment effect compared with the unadjusted OS HR of 0.76. The results are uncertain because of the assumptions associated with the adjustment methods. The confidence intervals continued to cross 1.00; thus, the adjusted estimates did not provide statistically significant evidence of a treatment benefit on survival. However, it is clear that a standard intention-to-treat analysis will be confounded in the presence of treatment switching-a reliance on unadjusted analyses could lead to inappropriate practice. Adjustment analyses provide useful additional information on the estimated treatment effects to inform decision making. Treatment switching is common in oncology trials, and the implications of this for the interpretation of the clinical effectiveness and cost-effectiveness of the novel treatment are important to consider. If patients who switch treatments benefit from the experimental treatment and a standard intention-to-treat analysis is conducted, the overall survival advantage associated with the new treatment could be underestimated. The present study applied established statistical methods to adjust for treatment switching in a trial that compared dabrafenib and dacarbazine for metastatic melanoma. The results showed that this led to a substantially increased estimate of the overall survival treatment effect associated with dabrafenib. ©AlphaMed Press.

Adjusting for the Confounding Effects of Treatment Switching—The BREAK-3 Trial: Dabrafenib Versus Dacarbazine

PubMed Central

Abrams, Keith R.; Amonkar, Mayur M.; Stapelkamp, Ceilidh; Swann, R. Suzanne

2015-01-01

Background. Patients with previously untreated BRAF V600E mutation-positive melanoma in BREAK-3 showed a median overall survival (OS) of 18.2 months for dabrafenib versus 15.6 months for dacarbazine (hazard ratio [HR], 0.76; 95% confidence interval, 0.48–1.21). Because patients receiving dacarbazine were allowed to switch to dabrafenib at disease progression, we attempted to adjust for the confounding effects on OS. Materials and Methods. Rank preserving structural failure time models (RPSFTMs) and the iterative parameter estimation (IPE) algorithm were used. Two analyses, “treatment group” (assumes treatment effect could continue until death) and “on-treatment observed” (assumes treatment effect disappears with discontinuation), were used to test the assumptions around the durability of the treatment effect. Results. A total of 36 of 63 patients (57%) receiving dacarbazine switched to dabrafenib. The adjusted OS HRs ranged from 0.50 to 0.55, depending on the analysis. The RPSFTM and IPE “treatment group” and “on-treatment observed” analyses performed similarly well. Conclusion. RPSFTM and IPE analyses resulted in point estimates for the OS HR that indicate a substantial increase in the treatment effect compared with the unadjusted OS HR of 0.76. The results are uncertain because of the assumptions associated with the adjustment methods. The confidence intervals continued to cross 1.00; thus, the adjusted estimates did not provide statistically significant evidence of a treatment benefit on survival. However, it is clear that a standard intention-to-treat analysis will be confounded in the presence of treatment switching—a reliance on unadjusted analyses could lead to inappropriate practice. Adjustment analyses provide useful additional information on the estimated treatment effects to inform decision making. Implications for Practice: Treatment switching is common in oncology trials, and the implications of this for the interpretation of the clinical effectiveness and cost-effectiveness of the novel treatment are important to consider. If patients who switch treatments benefit from the experimental treatment and a standard intention-to-treat analysis is conducted, the overall survival advantage associated with the new treatment could be underestimated. The present study applied established statistical methods to adjust for treatment switching in a trial that compared dabrafenib and dacarbazine for metastatic melanoma. The results showed that this led to a substantially increased estimate of the overall survival treatment effect associated with dabrafenib. PMID:26040620

Biosignals Analysis for Kidney Function Effect Analysis of Fennel Aromatherapy

PubMed Central

Kim, Bong-Hyun; Cho, Dong-Uk; Seo, Ssang-Hee

2015-01-01

Human effort in order to enjoy a healthy life is diverse. IT technology to these analyzes, the results of development efforts, it has been applied. Therefore, I use the care and maintenance diagnostic health management and prevention than treatment. In particular, the aromatherapy treatment easy to use without the side effects there is no irritation, are widely used in modern society. In this paper, we measured the aroma effect by applying a biosignal analysis techniques; an experiment was performed to analyze. In particular, we design methods and processes of research based on the theory aroma that affect renal function. Therefore, in this paper, measuring the biosignals and after fennel aromatherapy treatment prior to the enforcement of the mutual comparison, through the analysis, studies were carried out to analyze the effect of fennel aromatherapy therapy on kidney function. PMID:25977696

Distinct Neural-Functional Effects of Treatments With Selective Serotonin Reuptake Inhibitors, Electroconvulsive Therapy, and Transcranial Magnetic Stimulation and Their Relations to Regional Brain Function in Major Depression: A Meta-analysis.

PubMed

Chau, David T; Fogelman, Phoebe; Nordanskog, Pia; Drevets, Wayne C; Hamilton, J Paul

2017-05-01

Functional neuroimaging studies have examined the neural substrates of treatments for major depressive disorder (MDD). Low sample size and methodological heterogeneity, however, undermine the generalizability of findings from individual studies. We conducted a meta-analysis to identify reliable neural changes resulting from different modes of treatment for MDD and compared them with each other and with reliable neural functional abnormalities observed in depressed versus control samples. We conducted a meta-analysis of studies reporting changes in brain activity (e.g., as indexed by positron emission tomography) following treatments with selective serotonin reuptake inhibitors (SSRIs), electroconvulsive therapy (ECT), or transcranial magnetic stimulation. Additionally, we examined the statistical reliability of overlap among thresholded meta-analytic SSRI, ECT, and transcranial magnetic stimulation maps as well as a map of abnormal neural function in MDD. Our meta-analysis revealed that 1) SSRIs decrease activity in the anterior insula, 2) ECT decreases activity in central nodes of the default mode network, 3) transcranial magnetic stimulation does not result in reliable neural changes, and 4) regional effects of these modes of treatment do not significantly overlap with each other or with regions showing reliable functional abnormality in MDD. SSRIs and ECT produce neurally distinct effects relative to each other and to the functional abnormalities implicated in depression. These treatments therefore may exert antidepressant effects by diminishing neural functions not implicated in depression but that nonetheless impact mood. We discuss how the distinct neural changes resulting from SSRIs and ECT can account for both treatment effects and side effects from these therapies as well as how to individualize these treatments. Copyright © 2017 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Effects of Case Western Reserve University's transverse analysis on the quality of orthodontic treatment.

PubMed

Yehya Mostafa, Raweya; Bous, Rany M; Hans, Mark G; Valiathan, Manish; Copeland, Garrison E; Palomo, Juan Martin

2017-08-01

The purpose of this study was to evaluate the effect of using the transverse analysis developed at Case Western Reserve University (CWRU) in Cleveland, Ohio. The hypotheses were based on the following: (1) Does following CWRU's transverse analysis improve the orthodontic results? (2) Does following CWRU's transverse analysis minimize the active treatment duration? A retrospective cohort research study was conducted on a randomly selected sample of 100 subjects. The sample had CWRU's analysis performed retrospectively, and the sample was divided according to whether the subjects followed what CWRU's transverse analysis would have suggested. The American Board of Orthodontics discrepancy index was used to assess the pretreatment records, and quality of the result was evaluated using the American Board of Orthodontics cast/radiograph evaluation. The Mann-Whitney test was used for the comparison. CWRU's transverse analysis significantly improved the total cast/radiograph evaluation scores (P = 0.041), especially the buccolingual inclination component (P = 0.001). However, it did not significantly affect treatment duration (P = 0.106). CWRU's transverse analysis significantly improves the orthodontic results but does not have significant effects on treatment duration. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Diagnosis and Prognostic of Wastewater Treatment System Based on Bayesian Network

NASA Astrophysics Data System (ADS)

Li, Dan; Yang, Haizhen; Liang, XiaoFeng

2010-11-01

Wastewater treatment is a complicated and dynamic process. The treatment effect can be influenced by many variables in microbial, chemical and physical aspects. These variables are always uncertain. Due to the complex biological reaction mechanisms, the highly time-varying and multivariable aspects, the diagnosis and prognostic of wastewater treatment system are still difficult in practice. Bayesian network (BN) is one of the best methods for dealing with uncertainty in the artificial intelligence field. Because of the powerful inference ability and convenient decision mechanism, BN can be employed into the model description and influencing factor analysis of wastewater treatment system with great flexibility and applicability.In this paper, taking modified sequencing batch reactor (MSBR) as an analysis object, BN model was constructed according to the influent water quality, operational condition and effluent effect data of MSBR, and then a novel approach based on BN is proposed to analyze the influencing factors of the wastewater treatment system. The approach presented gives an effective tool for diagnosing and predicting analysis of the wastewater treatment system. On the basis of the influent water quality and operational condition, effluent effect can be predicted. Moreover, according to the effluent effect, the influent water quality and operational condition also can be deduced.

Comparing the effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in the treatment of depression: a systematic review and meta-analysis.

PubMed

Micallef-Trigona, Beppe

2014-01-01

Electroconvulsive therapy (ECT) is the longest standing psychiatric treatment available and has unequivocal benefit in severe depression. However this treatment comes with a number of side effects such as memory impairment. On the other hand, Repetitive Transcranial Magnetic Stimulation (rTMS) is a relatively new form of treatment which has been shown to be efficacious in patients suffering from a number of psychopathologies, including severe depression, with few reported side effects. Due to its potential therapeutic efficacy and lack of side effects, rTMS has gained traction in the treatment of depression, with a number of authors keen to see it take over from ECT. However, it is not clear whether rTMS represents a therapeutic alternative to ECT. This meta-analysis will therefore compare the "gold standard" treatment for severe depression, with the relatively new but promising rTMS. A literature search will be performed with the intention to include all randomised clinical trials. The null hypothesis is that there is no difference in the antidepressant efficacy between the two types of treatment modalities. Statistical analysis of Hamilton Depression Rating Scale (HDRS) scores will be performed.

A Meta-Analysis for the Efficacy of Hypnotherapy in Alleviating PTSD Symptoms.

PubMed

Rotaru, Tudor-Ștefan; Rusu, Andrei

2016-01-01

A systematic review and meta-analysis of the efficacy of hypnotherapy in the treatment of PTSD used literature searches to obtain 47 articles. However, only 6 were experiments testing the efficacy of hypnosis-based treatments. A fixed-effects meta-analysis was applied to postintervention assessment results and 4-week follow-ups. A large effect in favor of hypnosis-based (especially manualized abreactive hypnosis) treatment was found for the studies that reported the posttest results (d = 1.17). The temporal stability of the effect remains strong, as reflected by the 4-week follow-up assessments (d = 1.58) and also by long-term evaluations (e.g., 12 months). Hypnosis appears to be effective in alleviating PTSD symptoms.

Treatment Effect on Recidivism for Juveniles Who Have Sexually Offended: a Multilevel Meta-Analysis.

PubMed

Ter Beek, Ellis; Spruit, Anouk; Kuiper, Chris H Z; van der Rijken, Rachel E A; Hendriks, Jan; Stams, Geert Jan J M

2018-04-01

The current study investigated the effect on recidivism of treatment aimed at juveniles who have sexually offended. It also assessed the potential moderating effect of type of recidivism, and several treatment, participant and study characteristics. In total, 14 published and unpublished primary studies, making use of a comparison group and reporting on official recidivism rates, were included in a multilevel meta-analysis. This resulted in the use of 77 effect sizes, and 1726 participants. A three-level meta-analytic model was used to calculate the combined effect sizes (Cohens d) and to perform moderator analyses. Study quality was assessed with the EPHPP Quality Assessment Tool for Quantitative Studies. A moderate effect size was found (d = 0.37), indicating that the treatment groups achieved an estimated relative reduction in recidivism of 20.5% as compared to comparison groups. However, after controlling for publication bias, a significant treatment effect was no longer found. Type of recidivism did not moderate the effect of treatment, indicating that treatment groups were equally effective for all types of recidivism. Also, no moderating effects of participant or treatment characteristics were found. Regarding study characteristics, a shorter follow up time showed a trend for larger effect sizes, and the effect size calculation based on proportions yielded larger effect sizes than calculation via mean frequency of offending. Implications for future research and clinical practice are discussed.

Combination of pharmacotherapy and psychotherapy in the treatment of chronic depression: A systematic review and meta-analysis

PubMed Central

2012-01-01

Background Chronic depression represents a substantial portion of depressive disorders and is associated with severe consequences. This review examined whether the combination of pharmacological treatments and psychotherapy is associated with higher effectiveness than pharmacotherapy alone via meta-analysis; and identified possible treatment effect modifiers via meta-regression-analysis. Methods A systematic search was conducted in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ISI Web of Science, BIOSIS, PsycINFO, and CINAHL. Primary efficacy outcome was a response to treatment; primary acceptance outcome was dropping out of the study. Only randomized controlled trials were considered. Results We identified 8 studies with a total of 9 relevant comparisons. Our analysis revealed small, but statistically not significant effects of combined therapies on outcomes directly related to depression (BR = 1.20) with substantial heterogeneity between studies (I² = 67%). Three treatment effect modifiers were identified: target disorders, the type of psychotherapy and the type of pharmacotherapy. Small but statistically significant effects of combined therapies on quality of life (SMD = 0.18) were revealed. No differences in acceptance rates and the long-term effects between combined treatments and pure pharmacological interventions were observed. Conclusions This systematic review could not provide clear evidence for the combination of pharmacotherapy and psychotherapy. However, due to the small amount of primary studies further research is needed for a conclusive decision. PMID:22694751

Effects of metformin treatment on serum levels of C-reactive protein and interleukin-6 in women with polycystic ovary syndrome: a meta-analysis

PubMed Central

Wang, Jiao; Zhu, Lingyan; Hu, Kaixiang; Tang, Yunliang; Zeng, Xiangxia; Liu, Jianying; Xu, Jixiong

2017-01-01

Abstract Background: Metformin is effective for the treatment of polycystic ovary syndrome (PCOS), but conflicting results regarding its impact on serum levels of C-reactive protein (CRP) and interleukin-6 (IL-6) in women with PCOS have been reported. To provide high-quality evidence about the effect of treatment with metformin on CRP and IL-6 in PCOS, relevant studies that assessed the serum levels of CRP and IL-6 in women with PCOS receiving metformin treatment were reviewed and analyzed. Methods: A literature search was conducted in the Science Citation Index, PubMed, Embase, and Cochrane Library databases, and personal contact was made with the authors. Random-effects model was used to estimate the standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). To ensure synthesis of the best available evidence, subgroup analysis, sensitivity analysis, meta-regression analysis, and publication bias were performed. Results: Of 216 studies identified, 20 were included in the meta-analysis (7 prospective, nonrandomized studies, and 13 randomized control trials). Data suggest that serum levels of CRP were decreased after metformin treatment in PCOS patients with an SMD (95% CI) of −0.86 [−1.24 to −0.48] and P = .000 (random-effects). However, significant heterogeneity was detected across studies (I2 = 84.6% and P = .000). Unfortunately, the sources of heterogeneity were not found by subgroup analysis and meta-regression analysis. Serum IL-6 concentrations were not significantly changed after metformin treatment in PCOS with an SMD (95% CI) of −0.48 [−1.26 to 0.31] and P > .05 (random-effects). Significant heterogeneity was also detected across studies (I2 = 90.9% and P = .000). The subgroup analysis suggested that treatment-related reductions in serum IL-6 levels were significantly correlated with BMI, whereas the sources of heterogeneity were not found. In addition, we noticed that metformin treatment could decrease BMI in the CRP and IL-6 related studies (SMD = −0.45, 95% CI: −0.68 to −0.23; SMD = −0.44, 95% CI: −0.73 to −0.16). Conclusion: This meta-analysis showed a significant decrease of serum CRP levels, especially in obese women, but no significant changes in IL-6 levels after metformin treatment in women with PCOS. In general, the data support that early metformin therapy may ameliorate the state of chronic inflammation in women with PCOS. Considering the obvious heterogeneity reported in the literature, further well-designed investigations with larger samples are needed to ascertain the long-term effects of metformin on chronic inflammation in PCOS. PMID:28953677

Causal Mediation Analysis: Warning! Assumptions Ahead

ERIC Educational Resources Information Center

Keele, Luke

2015-01-01

In policy evaluations, interest may focus on why a particular treatment works. One tool for understanding why treatments work is causal mediation analysis. In this essay, I focus on the assumptions needed to estimate mediation effects. I show that there is no "gold standard" method for the identification of causal mediation effects. In…

Cost-effectiveness analysis of once-yearly injection of zoledronic acid for the treatment of osteoporosis in Japan.

PubMed

Moriwaki, K; Mouri, M; Hagino, H

2017-06-01

Model-based economic evaluation was performed to assess the cost-effectiveness of zoledronic acid. Although zoledronic acid was dominated by alendronate, the incremental quality-adjusted life year (QALY) was quite small in extent. Considering the advantage of once-yearly injection of zoledronic acid in persistence, zoledronic acid might be a cost-effective treatment option compared to once-weekly oral alendronate. The purpose of this study was to estimate the cost-effectiveness of once-yearly injection of zoledronic acid for the treatment of osteoporosis in Japan. A patient-level state-transition model was developed to predict the outcome of patients with osteoporosis who have experienced a previous vertebral fracture. The efficacy of zoledronic acid was derived from a published network meta-analysis. Lifetime cost and QALYs were estimated for patients who had received zoledronic acid, alendronate, or basic treatment alone. The incremental cost-effectiveness ratio (ICER) of zoledronic acid was estimated. For patients 70 years of age, zoledronic acid was dominated by alendronate with incremental QALY of -0.004 to -0.000 and incremental cost of 430 USD to 493 USD. Deterministic sensitivity analysis indicated that the relative risk of hip fracture and drug cost strongly affected the cost-effectiveness of zoledronic acid compared to alendronate. Scenario analysis considering treatment persistence showed that the ICER of zoledronic acid compared to alendronate was estimated to be 47,435 USD, 27,018 USD, and 10,749 USD per QALY gained for patients with a T-score of -2.0, -2.5, or -3.0, respectively. Although zoledronic acid is dominated by alendronate, the incremental QALY is quite small in extent. Considering the advantage of annual zoledronic acid treatment in compliance and persistence, zoledronic acid may be a cost-effective treatment option compared to alendronate.

Quantifying the bias in the estimated treatment effect in randomized trials having interim analyses and a rule for early stopping for futility.

PubMed

Walter, S D; Han, H; Briel, M; Guyatt, G H

2017-04-30

In this paper, we consider the potential bias in the estimated treatment effect obtained from clinical trials, the protocols of which include the possibility of interim analyses and an early termination of the study for reasons of futility. In particular, by considering the conditional power at an interim analysis, we derive analytic expressions for various parameters of interest: (i) the underestimation or overestimation of the treatment effect in studies that stop for futility; (ii) the impact of the interim analyses on the estimation of treatment effect in studies that are completed, i.e. that do not stop for futility; (iii) the overall estimation bias in the estimated treatment effect in a single study with such a stopping rule; and (iv) the probability of stopping at an interim analysis. We evaluate these general expressions numerically for typical trial scenarios. Results show that the parameters of interest depend on a number of factors, including the true underlying treatment effect, the difference that the trial is designed to detect, the study power, the number of planned interim analyses and what assumption is made about future data to be observed after an interim analysis. Because the probability of stopping early is small for many practical situations, the overall bias is often small, but a more serious issue is the potential for substantial underestimation of the treatment effect in studies that actually stop for futility. We also consider these ideas using data from an illustrative trial that did stop for futility at an interim analysis. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

A meta-analytic review of psychological treatments for tinnitus.

PubMed

Andersson, G; Lyttkens, L

1999-08-01

Meta-analysis is a technique of combining results from different trials in order to obtain estimates of effects across studies. Meta-analysis has, as yet, rarely been used in audiological research. The aim of this paper was to conduct a meta-analysis on psychological treatment of tinnitus. The outcomes of 18 studies, including a total of 24 samples and up to 700 subjects, were included and coded. Included were studies on cognitive/cognitive-behavioural treatment, relaxation, hypnosis, biofeedback, educational sessions and problem-solving. Effect sizes for perceived tinnitus loudness, annoyance, negative affect (e.g. depression) and sleep problems were calculated for randomized controlled studies, pre-post-treatment design studies and follow-up results. Results showed strong to moderate effects on tinnitus annoyance for controlled studies (d = 0.86), pre-post designs (d = 0.5) and at follow-up (d = 0.48). Results on tinnitus loudness were weaker and disappeared at follow-up. Lower effect sizes were also obtained for measures of negative affect and sleep problems. Exploratory analyses revealed that cognitive-behavioural treatments were more effective on ratings of annoyance in the controlled studies. It is concluded that psychological treatment for tinnitus is effective, but that aspects such as depression and sleep problems may need to be targeted in future studies.

Synergistic Effect of Combinatorial Treatment with Curcumin and Mitomycin C on the Induction of Apoptosis of Breast Cancer Cells: A cDNA Microarray Analysis

PubMed Central

Zhou, Qian-Mei; Chen, Qi-Long; Du, Jia; Wang, Xiu-Feng; Lu, Yi-Yu; Zhang, Hui; Su, Shi-Bing

2014-01-01

In order to explore the synergistic mechanisms of combinatorial treatment using curcumin and mitomycin C (MMC) for breast cancer, MCF-7 breast cancer xenografts were conducted to observe the synergistic effect of combinatorial treatment using curcumin and MMC at various dosages. The synergistic mechanisms of combinatorial treatment using curcumin and MMC on the inhibition of tumor growth were explored by differential gene expression profile, gene ontology (GO), ingenuity pathway analysis (IPA) and Signal–Net network analysis. The expression levels of selected genes identified by cDNA microarray expression profiling were validated by quantitative RT-PCR (qRT-PCR) and Western blot analysis. Effect of combinatorial treatment on the inhibition of cell growth was observed by MTT assay. Apoptosis was detected by flow cytometric analysis and Hoechst 33258 staining. The combinatorial treatment of 100 mg/kg curcumin and 1.5 mg/kg MMC revealed synergistic inhibition on tumor growth. Among 1501 differentially expressed genes, the expression of 25 genes exhibited an obvious change and a significant difference in 27 signal pathways was observed (p < 0.05). In addition, Mapk1 (ERK) and Mapk14 (MAPK p38) had more cross-interactions with other genes and revealed an increase in expression by 8.14- and 11.84-fold, respectively during the combinatorial treatment by curcumin and MMC when compared with the control. Moreover, curcumin can synergistically improve tumoricidal effect of MMC in another human breast cancer MDA-MB-231 cells. Apoptosis was significantly induced by the combinatorial treatment (p < 0.05) and significantly inhibited by ERK inhibitor (PD98059) in MCF-7 cells (p < 0.05). The synergistic effect of combinatorial treatment by curcumin and MMC on the induction of apoptosis in breast cancer cells may be via the ERK pathway. PMID:25226537

Use of generalized ordered logistic regression for the analysis of multidrug resistance data.

PubMed

Agga, Getahun E; Scott, H Morgan

2015-10-01

Statistical analysis of antimicrobial resistance data largely focuses on individual antimicrobial's binary outcome (susceptible or resistant). However, bacteria are becoming increasingly multidrug resistant (MDR). Statistical analysis of MDR data is mostly descriptive often with tabular or graphical presentations. Here we report the applicability of generalized ordinal logistic regression model for the analysis of MDR data. A total of 1,152 Escherichia coli, isolated from the feces of weaned pigs experimentally supplemented with chlortetracycline (CTC) and copper, were tested for susceptibilities against 15 antimicrobials and were binary classified into resistant or susceptible. The 15 antimicrobial agents tested were grouped into eight different antimicrobial classes. We defined MDR as the number of antimicrobial classes to which E. coli isolates were resistant ranging from 0 to 8. Proportionality of the odds assumption of the ordinal logistic regression model was violated only for the effect of treatment period (pre-treatment, during-treatment and post-treatment); but not for the effect of CTC or copper supplementation. Subsequently, a partially constrained generalized ordinal logistic model was built that allows for the effect of treatment period to vary while constraining the effects of treatment (CTC and copper supplementation) to be constant across the levels of MDR classes. Copper (Proportional Odds Ratio [Prop OR]=1.03; 95% CI=0.73-1.47) and CTC (Prop OR=1.1; 95% CI=0.78-1.56) supplementation were not significantly associated with the level of MDR adjusted for the effect of treatment period. MDR generally declined over the trial period. In conclusion, generalized ordered logistic regression can be used for the analysis of ordinal data such as MDR data when the proportionality assumptions for ordered logistic regression are violated. Published by Elsevier B.V.

Beyond Autism Treatment: The Application of Applied Behavior Analysis in the Treatment of Emotional and Psychological Disorders

ERIC Educational Resources Information Center

Ross, Robert K.

2007-01-01

The field of applied behavior analysis (ABA) has increasingly come to be associated with the treatment of autism in young children. This phenomenon is largely the result of empirical research demonstrating effective treatment outcomes in this population. The same cannot be said with regard to the treatment of conditions often referred to as…

Effects of sterilization treatments on the analysis of TOC in water samples.

PubMed

Shi, Yiming; Xu, Lingfeng; Gong, Dongqin; Lu, Jun

2010-01-01

Decomposition experiments conducted with and without microbial processes are commonly used to study the effects of environmental microorganisms on the degradation of organic pollutants. However, the effects of biological pretreatment (sterilization) on organic matter often have a negative impact on such experiments. Based on the principle of water total organic carbon (TOC) analysis, the effects of physical sterilization treatments on determination of TOC and other water quality parameters were investigated. The results revealed that two conventional physical sterilization treatments, autoclaving and 60Co gamma-radiation sterilization, led to the direct decomposition of some organic pollutants, resulting in remarkable errors in the analysis of TOC in water samples. Furthermore, the extent of the errors varied with the intensity and the duration of sterilization treatments. Accordingly, a novel sterilization method for water samples, 0.45 microm micro-filtration coupled with ultraviolet radiation (MCUR), was developed in the present study. The results indicated that the MCUR method was capable of exerting a high bactericidal effect on the water sample while significantly decreasing the negative impact on the analysis of TOC and other water quality parameters. Before and after sterilization treatments, the relative errors of TOC determination could be controlled to lower than 3% for water samples with different categories and concentrations of organic pollutants by using MCUR.

A comprehensive guide to fuel management practices for dry mixed conifer forests in the northwestern United States: Inventory and model-based economic analysis of mechanical fuel treatments

Treesearch

Theresa B. Jain; Mike A. Battaglia; Han-Sup Han; Russell T. Graham; Christopher R. Keyes; Jeremy S. Fried; Jonathan E. Sandquist

2014-01-01

Implementing fuel treatments in every place where it could be beneficial to do so is impractical and not cost effective under any plausible specification of objectives. Only some of the many possible kinds of treatments will be effective in any particular stand and there are some stands that seem to defy effective treatment. In many more, effective treatment costs far...

[Mirtazapine versus other antidepressive agents for depression].

PubMed

Knud Larsen, Jens

2012-11-12

A Cochrane analysis compared efficacy and side effects of mirtazapine with other antidepressants. After six weeks of treatment no reliable difference of efficacy between mirtazapine, selective serotonin reuptake inhibitors (SSRI), noradrenaline reuptake inhibitors or tricyclic antidepressants was found. The side effects like increased sleep and weight gain were compared by treatment with mirtazapine and treatment with SSRI antidepressants. The very fact of the sleep effect and the fast onset of action have probably increased the effect size compared with SSRI antidepressants. The results of the Cochrane analysis cannot for certain be generalized to inpatients, as other studies have found tricyclic antidepressants to be especially effective.

A cost-effectiveness comparison of the use of antimicrobial agents for treatment or prophylaxis of travelers' diarrhea.

PubMed

Reves, R R; Johnson, P C; Ericsson, C D; DuPont, H L

1988-11-01

We conducted a decision analysis to compare the cost-effectiveness of antimicrobial agents used for treatment with their use for prophylaxis of travelers' diarrhea. Estimates of the likelihood and the cost of various outcomes were obtained from a panel of experts using the Delphi group opinion technique. Treatment with sulfamethoxazole-trimethoprim for three days was compared with daily prophylaxis with sulfamethoxazole-trimethoprim or doxycycline. The cost-effectiveness of prophylaxis with either agent (75% to 83%) was greater than that of treatment (38%). Treatment would become more cost-effective than prophylaxis when the cumulative risk of acquiring travelers' diarrhea was less than 0.05 episodes per person per week or if the effectiveness of prophylaxis fell below 35% for doxycycline and 46% for sulfamethoxazole-trimethoprim. The most important contributor to the mean cost of travelers' diarrhea in this analysis was the cost associated with a day of incapacitation due to illness. On the basis of the results of this decision analysis, we conclude that prophylaxis of travelers' diarrhea is an option that should be considered for individual situations and recommend further studies of its cost-effectiveness.

Cost-Effectiveness Analysis of Initial Treatment Strategies for Nonembolic Acute Limb Ischemia Using Real-Word Data.

PubMed

Vaidya, Varun; Gangan, Nilesh; Comerota, Anthony; Lurie, Fedor

2017-02-01

Nonembolic acute limb ischemia (ALI) is a condition characterized by a sudden decrease in limb perfusion and requires immediate interventions. There are multiple treatment options available including surgery, catheter-directed thrombolysis (CDT), endovascular procedures, and hybrid treatment (a combination of open and endovascular techniques). Randomized trials provide information only on clinical efficacy, but not on economic outcomes. The objective of the study was to perform the cost-effective analysis comparing different treatment alternatives of ALI. The data were collected from 4r ProMedica community hospitals in the Northwest Ohio from January 2009 to December 2012. Patients were included if they were treated within 14 days of onset of symptoms for nonembolic ALI and were divided into groups of receiving CDT, surgery, endovascular, or hybrid treatments. Demographics, comorbidities, medications taken before admission, and smoking status were collected at baseline for all patients and were compared among the treatment groups. A cost-effectiveness decision tree was developed to calculate expected costs and life years gained associated with available treatment options. A probabilistic sensitivity analysis was also performed to check the robustness of the model. A population of 205 patients with the diagnosis of ALI was included and divided into different treatment groups. There was no major significant difference in baseline characteristics among the studied groups (P > 0.05). The total costs were $17,163.47 for surgery, $20,620.39 for endovascular, $21,277.61 for hybrid, and $30,675.42 for CDT. The life years gained were 17.25 for surgery, 18 for endovascular, 18 for hybrid, and 17 for CDT. CDT was dominated because of the high cost and the low effectiveness, while hybrid treatment was dominated when compared with endovascular treatment because these 2 treatments have similar outcomes. The incremental cost-effectiveness ratio of the endovascular group over the surgery group was found to be $4,609.23 per life year gained. The sensitivity analysis showed that the endovascular treatment was found to be cost-effective under willingness to pay $50,000. This study provides economic evaluation of ALI treatments for a defined clinical population in the real-world setting. Compared with other available alternatives, the endovascular treatment showed to be a cost-effective use of healthcare resources. Copyright © 2016 Elsevier Inc. All rights reserved.

Estimation of treatment effect in a subpopulation: An empirical Bayes approach.

PubMed

Shen, Changyu; Li, Xiaochun; Jeong, Jaesik

2016-01-01

It is well recognized that the benefit of a medical intervention may not be distributed evenly in the target population due to patient heterogeneity, and conclusions based on conventional randomized clinical trials may not apply to every person. Given the increasing cost of randomized trials and difficulties in recruiting patients, there is a strong need to develop analytical approaches to estimate treatment effect in subpopulations. In particular, due to limited sample size for subpopulations and the need for multiple comparisons, standard analysis tends to yield wide confidence intervals of the treatment effect that are often noninformative. We propose an empirical Bayes approach to combine both information embedded in a target subpopulation and information from other subjects to construct confidence intervals of the treatment effect. The method is appealing in its simplicity and tangibility in characterizing the uncertainty about the true treatment effect. Simulation studies and a real data analysis are presented.

Identification of Indirect Effects in a Cognitive Patient Education (COPE) Intervention for Low Back Pain.

PubMed

Mansell, Gemma; Storheim, Kjersti; Løchting, Ida; Werner, Erik L; Grotle, Margreth

2017-12-01

Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery. The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome. This study was a secondary analysis of the COPE randomized controlled trial. Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline - posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis. Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 [95% CI = 0.03 to 0.16]; pain catastrophizing standardized indirect effect = 0.05 [95% CI = 0.01 to 0.12]). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant. This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects. The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term. © Crown copyright 2015

Quantifying the potential impacts of fuel treatments on wildfire suppression costs

Treesearch

Matthew P. Thompson; Nicole M. Vaillant; Jessica R. Haas; Krista M. Gebert; Keith D. Stockmann

2013-01-01

Modeling the impacts and effects of hazardous fuel reduction treatments is a pressing issue within the wildfire management community. Prospective evaluation of fuel treatment effectiveness allows for comparison of alternative treatment strategies in terms of socioeconomic and ecological impacts and facilitates analysis of tradeoffs across land-management objectives....

A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery.

PubMed

Prochaska, Judith J; Delucchi, Kevin; Hall, Sharon M

2004-12-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (> or = 6 months) were summarized with random effects models. Intervention effects for smoking cessation were significant at posttreatment and comparable for participants in addictions treatment and recovery; however, intervention effects for smoking cessation were nonsignificant at long-term follow-up. Smoking cessation interventions provided during addictions treatment were associated with a 25% increased likelihood of long-term abstinence from alcohol and illicit drugs. Short-term smoking cessation effects look promising, but innovative strategies are needed for long-term cessation. Contrary to previous concerns, smoking cessation interventions during addictions treatment appeared to enhance rather than compromise long-term sobriety. Copyright 2004 APA.

A Meta-Analysis of Smoking Cessation Interventions With Individuals in Substance Abuse Treatment or Recovery

ERIC Educational Resources Information Center

Prochaska, Judith J.; Delucchi, Kevin; Hall, Sharon M.

2004-01-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (? 6 months) were summarized with random effects models. Intervention effects for smoking…

Some Effects of Training Preservice Teachers in Science Teaching Strategy Analysis.

ERIC Educational Resources Information Center

Yeany, Russell, Jr.

This study was designed to assess the effectiveness of three treatments for encouraging and training prospective elementary science teachers in the use of inductive/indirect strategies in science teaching. Subjects were randomly assigned to one of four treatment groups: (1) Strategy Analysis Level - subjects were trained in science teaching…

Fuel treatments and fire severity: A meta-analysis

Treesearch

Erik J. Martinson; Philip N. Omi

2013-01-01

We employed meta-analysis and information theory to synthesize findings reported in the literature on the effects of fuel treatments on subsequent fire intensity and severity. Data were compiled from 19 publications that reported observed fire responses from 62 treated versus untreated contrasts. Effect sizes varied widely and the most informative grouping of studies...

Cost-Effectiveness Analysis of Alternative Antiviral Strategies for the Treatment of HBeAg-Positive and HBeAg-Negative Chronic Hepatitis B in the United Kingdom.

PubMed

Bermingham, Sarah L; Hughes, Ralph; Fenu, Elisabetta; Sawyer, Laura M; Boxall, Elizabeth; T Kennedy, Patrick; Dusheiko, Geoff; Hill-Cawthorne, Grant; Thomas, Howard

2015-09-01

Seven drugs are licensed for the treatment of chronic hepatitis B (CHB) in the United Kingdom. Which initial treatment, secondary therapy, and whether antivirals should be given alone or in combination are questions of considerable uncertainty. The aim of this model was to undertake a comprehensive economic evaluation of all antiviral treatments for CHB to recommend the most cost-effective therapeutic sequence. We developed a probabilistic Markov model to compare the cost-effectiveness of all clinically relevant antiviral treatment sequences for nucleos(t)ide-naive adults with hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative CHB. Relative rates of HBeAg seroconversion and viral suppression were obtained from a network meta-analysis. Data on mortality, antiviral drug resistance, durability of response, adverse events, and costs were obtained from published literature. Results are reported in terms of lifetime costs, quality-adjusted life-years (QALYs), and expected net benefit. In the base-case analysis, pegylated interferon alpha-2a (peg-IFN α-2a) followed by tenofovir disoproxil fumarate was most effective and cost-effective in HBeAg-positive patients, with a cost of £7488 per QALY gained compared with no treatment. In HBeAg-negative patients, peg-IFN α-2a followed by entecavir was most effective and cost-effective, with a cost of £6981 per QALY gained. The model was robust to a wide range of sensitivity analyses. Peg-IFN α-2a followed by tenofovir disoproxil fumarate or entecavir is the most effective antiviral treatment strategy for people with both variants of CHB. At a cost of less than £10,000 per QALY gained, these sequences are considered cost-effective in England and Wales. The results of this analysis were used to inform 2013 National Institute for Health and Care Excellence guideline recommendations. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Motivational interviewing to enhance treatment attendance in mental health settings: A systematic review and meta-analysis.

PubMed

Lawrence, P; Fulbrook, P; Somerset, S; Schulz, P

2017-11-01

WHAT IS KNOWN ON THE SUBJECT?: Despite differences between samples, some literature reviews have suggested that MI is effective in enhancing treatment attendance for individuals with mental health issues. Little is known regarding the effects of MI as a pre-treatment on individuals who are not seeking treatment for mental health issues. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: This systematic review of the literature and meta-analysis demonstrates that MI is most beneficial for individuals who are not seeking mental health treatment. MI represents an opportunity for health promotion when patients are unmotivated but may otherwise be amenable to an intervention. MI is effective as a pre-treatment intervention to motivate individuals to attend further post-MI treatment and counselling. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: MI is a process and a useful tool for clinicians in all therapeutic interactions, to motivate their patients to seek further assistance for mental heath issues. Health promotion and encouragement to attend further treatment sessions can be facilitated through telephone contact. Introduction The stages of change model suggests that individuals seeking treatment are in the "preparation" or the "action" stage of change, which is the desired outcome of successful Motivational Interviewing (MI) interventions. MI is known to enhance treatment attendance among individuals with mental health problems. Aim This study examined the published research on MI as a pre-treatment to enhance attendance among individuals treatment-seeking and non-treatment-seeking for mental health issues. Methods Fourteen randomized controlled trials were identified, and MI efficacy was examined dichotomously: attendance or non-attendance for post-MI therapy. Subgroup analysis investigated treatment-seeking and non-treatment-seeking groups. Results Despite wide variations in sample sizes, blinding and monitoring, intervention fidelity was absent in the majority of published studies. Meta-analysis revealed that MI pre-treatment improved attendance relative to comparison groups. Conclusions Individuals not seeking treatment for mental health issues benefited the most from MI. Despite differences in MI treatment intensity, short interventions were as effective as longer interventions, whereas two MI sessions for as little as 15 min were effective in enhancing treatment attendance. Implications for Practice Motivational interviewing is a useful tool for clinicians in all therapeutic interactions to help motivate patients to seek assistance for mental health issues. © 2017 John Wiley & Sons Ltd.

Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis.

PubMed

Malek, Sarah; Sample, Susannah J; Schwartz, Zeev; Nemke, Brett; Jacobson, Peer B; Cozzi, Elizabeth M; Schaefer, Susan L; Bleedorn, Jason A; Holzman, Gerianne; Muir, Peter

2012-10-04

Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 - transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen - non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs.

Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis

PubMed Central

2012-01-01

Background Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Results Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Conclusion Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs. PMID:23035739

[Cost-effectiveness analysis of etanercept compared with other biologic therapies in the treatment of rheumatoid arthritis].

PubMed

Salinas-Escudero, Guillermo; Vargas-Valencia, Juan; García-García, Erika Gabriela; Munciño-Ortega, Emilio; Galindo-Suárez, Rosa María

2013-01-01

to conduct cost-effectiveness analysis of etanercept compared with other biologic therapies in the treatment of moderate or severe rheumatoid arthritis in patients with previous unresponse to immune selective anti-inflammatory derivatives failure. a pharmacoeconomic model based on decision analysis to assess the clinical outcome after giving etanercept, infliximab, adalimumab or tocilizumab to treat moderate or severe rheumatoid arthritis was employed. Effectiveness of medications was assessed with improvement rates of 20 % or 70 % of the parameters established by the American College of Rheumatology (ACR 20 and ACR 70). the model showed that etanercept had the most effective therapeutic response rate: 79.7 % for ACR 20 and 31.4 % for ACR 70, compared with the response to other treatments. Also, etanercept had the lowest cost ($149,629.10 per patient) and had the most cost-effective average ($187,740.40 for clinical success for ACR 20 and $476,525.80 for clinical success for ACR 70) than the other biologic therapies. we demonstrated that treatment with etanercept is more effective and less expensive compared to the other drugs, thus making it more efficient therapeutic option both in terms of means and incremental cost-effectiveness ratios for the treatment of rheumatoid arthritis.

A cost-effectiveness analysis of conservative versus surgical management for the initial treatment of stress urinary incontinence.

PubMed

Richardson, Monica L; Sokol, Eric R

2014-11-01

We sought to determine whether conservative or surgical therapy is more cost effective for the initial treatment of stress urinary incontinence (SUI). We created a decision tree model to compare costs and cost effectiveness of 3 strategies for the initial treatment of SUI: (1) continence pessary, (2) pelvic floor muscle therapy (PFMT), and (3) midurethral sling (MUS). We identified probabilities of SUI after 12 months of use of a pessary, PFMT, or MUS using published data. Parameter estimates included Health Utility Indices of no incontinence (.93) and persistent incontinence (0.7) after treatment. Morbidities associated with MUS included mesh erosion, retention, de novo urge incontinence, and recurrent SUI. Cost data were derived from Medicare in 2012 US dollars. One- and 2-way sensitivity analysis was used to examine the effect of varying rates of pursuing surgery if conservative management failed and rates of SUI cure with pessaries and PFMT. The primary outcome was an incremental cost-effectiveness ratio threshold <$50,000. Compared to PFMT, initial treatment of SUI with MUS was the more cost-effective strategy with an incremental cost-effectiveness ratio of $32,132/quality-adjusted life year. Initial treatment with PFMT was also acceptable as long as subjective cure was >35%. In 3-way sensitivity analysis, subjective cure would need to be >40.5% for PFMT and 43.5% for a continence pessary for the MUS scenario to not be the preferred strategy. At 1 year, MUS is more cost effective than a continence pessary or PFMT for the initial treatment for SUI. Copyright © 2014. Published by Elsevier Inc.

SU-E-T-420: Failure Effects Mode Analysis for Trigeminal Neuralgia Frameless Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Howe, J

2015-06-15

Purpose: Functional radiosurgery has been used successfully in the treatment of trigeminal neuralgia but presents significant challenges to ensuring the high prescription dose is delivered accurately. A review of existing practice should help direct the focus of quality improvement for this treatment regime. Method: Failure modes and effects analysis was used to identify the processes in preparing radiosurgery treatment for TN. The map was developed by a multidisciplinary team including: neurosurgeon, radiation oncology, physicist and therapist. Potential failure modes were identified for each step in the process map as well as potential causes and end effect. A risk priority numbermore » was assigned to each cause. Results: The process map identified 66 individual steps (see attached supporting document). Corrective actions were developed for areas of high risk priority number. Wrong site treatment is at higher risk for trigeminal neuralgia treatment due to the lack of site specific pathologic imaging on MR and CT – additional site specific checks were implemented to minimize the risk of wrong site treatment. Failed collision checks resulted from an insufficient collision model in the treatment planning system and a plan template was developed to address this problem. Conclusion: Failure modes and effects analysis is an effective tool for developing quality improvement in high risk radiotherapy procedures such as functional radiosurgery.« less

Safety and efficacy of cell-based therapy on critical limb ischemia: A meta-analysis.

PubMed

Ai, Min; Yan, Chang-Fu; Xia, Fu-Chun; Zhou, Shuang-Lu; He, Jian; Li, Cui-Ping

2016-06-01

Critical limb ischemia (CLI) is a major health problem worldwide, affecting approximately 500-1000 people per million per annum. Cell-based therapy has given new hope for the treatment of limb ischemia. This study assessed the safety and efficacy of cellular therapy CLI treatment. We searched the PubMed, Embase and Cochrane databases through October 20, 2015, and selected the controlled trials with cell-based therapy for CLI treatment compared with cell-free treatment. We assessed the results by meta-analysis using a variety of outcome measures, as well as the association of mononuclear cell dosage with treatment effect by dose-response meta-analysis. Twenty-five trials were included. For the primary evaluation index, cell-based therapy significantly reduced the rate of major amputation (odds ratio [OR] 0.44, 95% confidence interval [CI] 0.32-0.60, P = 0.000) and significantly increased the rate of amputation-free survival (OR 2.80, 95% CI 1.70-4.61, P = 0.000). Trial sequence analysis indicated that optimal sample size (n = 3374) is needed to detect a plausible treatment effect in all-cause mortality. Cell-based therapy significantly improves ankle brachial index, increases the rate of ulcer healing, increases the transcutaneous pressure of oxygen, reduces limb pain and improves movement ability. Subgroup analysis indicated heterogeneity is caused by type of control, design bias and transplant route. In the dose-response analysis, there was no significant correlation between cell dosage and the therapeutic effect. Cell-based therapy has a significant therapeutic effect on CLI, but randomized double-blind placebo-controlled trials are needed to improve the credibility of this conclusion. Assessment of all-cause mortality also requires a larger sample size to arrive at a strong conclusion. In dose-response analysis, increasing the dosage of cell injections does not significantly improve the therapeutic effects of cell-based therapy. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Investigation of continuous effect modifiers in a meta-analysis on higher versus lower PEEP in patients requiring mechanical ventilation--protocol of the ICEM study.

PubMed

Kasenda, Benjamin; Sauerbrei, Willi; Royston, Patrick; Briel, Matthias

2014-05-20

Categorizing an inherently continuous predictor in prognostic analyses raises several critical methodological issues: dependence of the statistical significance on the number and position of the chosen cut-point(s), loss of statistical power, and faulty interpretation of the results if a non-linear association is incorrectly assumed to be linear. This also applies to a therapeutic context where investigators of randomized clinical trials (RCTs) are interested in interactions between treatment assignment and one or more continuous predictors. Our goal is to apply the multivariable fractional polynomial interaction (MFPI) approach to investigate interactions between continuous patient baseline variables and the allocated treatment in an individual patient data meta-analysis of three RCTs (N = 2,299) from the intensive care field. For each study, MFPI will provide a continuous treatment effect function. Functions from each of the three studies will be averaged by a novel meta-analysis approach for functions. We will plot treatment effect functions separately for each study and also the averaged function. The averaged function with a related confidence interval will provide a suitable basis to assess whether a continuous patient characteristic modifies the treatment comparison and may be relevant for clinical decision-making. The compared interventions will be a higher or lower positive end-expiratory pressure (PEEP) ventilation strategy in patients requiring mechanical ventilation. The continuous baseline variables body mass index, PaO2/FiO2, respiratory compliance, and oxygenation index will be the investigated potential effect modifiers. Clinical outcomes for this analysis will be in-hospital mortality, time to death, time to unassisted breathing, and pneumothorax. This project will be the first meta-analysis to combine continuous treatment effect functions derived by the MFPI procedure separately in each of several RCTs. Such an approach requires individual patient data (IPD). They are available from an earlier IPD meta-analysis using different methods for analysis. This new analysis strategy allows assessing whether treatment effects interact with continuous baseline patient characteristics and avoids categorization-based subgroup analyses. These interaction analyses of the present study will be exploratory in nature. However, they may help to foster future research using the MFPI approach to improve interaction analyses of continuous predictors in RCTs and IPD meta-analyses. This study is registered in PROSPERO (CRD42012003129).

Does a mandibular overdenture improve nutrient intake and markers of nutritional status better than conventional complete denture? A systematic review and meta-analysis

PubMed Central

Yamazaki, Toru; Martiniuk, Alexandra LC; Irie, Koichiro; Sokejima, Shigeru; Lee, Crystal Man Ying

2016-01-01

Objectives The need for denture treatment in public health will increase as the population ages. However, the impact of dentures on nutrition, particularly overdenture treatment, remains unclear although the physical and psychological effects are known. We investigated whether treatment with a mandibular implant supported overdenture improves nutrient intake and markers of nutritional status better than a conventional complete denture in edentulous patients. Design Systematic review and meta-analysis. Methods Medline, EMBASE and the Cochrane Central Register of Controlled Trials were searched for eligible studies published up to April 2016. We included studies which compared the treatment effect of an overdenture to conventional denture on nutrition, in which primary outcomes included changes in intake of macronutrients and/or micronutrients and/or indicators of nutritional status. Two reviewers independently evaluated eligible studies and assessed the risk of bias. We used a fixed effects model to estimate the weighted mean difference (WMD) and 95% CI for change in body mass index (BMI), albumin and serum vitamin B12 between overdenture and conventional denture 6 months after treatment. Results Of 108 eligible studies, 8 studies involving 901 participants were included in the narrative appraisal. Four studies reported changes in markers of nutritional status and nutrient intake after treatment with a prosthetic, regardless of type. In a meta-analysis of 322 participants aged 65 years or older from three studies, pooled analysis suggested no significant difference in change in BMI between an overdenture and conventional denture 6 months after treatment (WMD=−0.18 kg/m2 (95% CI −0.52 to 0.16)), and no significant difference in change in albumin or vitamin B12 between the two treatments. Conclusions The modifying effect of overdenture treatment on nutritional status might be limited. Further studies are needed to evaluate the effectiveness and efficacy of denture treatments. PMID:27489156

A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.

PubMed

Hadjigeorgiou, G M; Doxani, C; Miligkos, M; Ziakas, P; Bakalos, G; Papadimitriou, D; Mprotsis, T; Grigoriadis, N; Zintzaras, E

2013-12-01

The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'. Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2)) using direct and indirect analyses. The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences. This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments. © 2013 John Wiley & Sons Ltd.

Effect of Corticosteroids on Pain Relief Following Root Canal Treatment: A Systematic Review.

PubMed

Iranmanesh, Foad; Parirokh, Masoud; Haghdoost, Ali Akbar; Abbott, Paul V

2017-01-01

Post-operative pain and flare-up may occur in up to 58% of patients following root canal treatment. The aim was to conduct a systematic review and a possible meta-analysis to determine the effect of glucocorticosteroid (GCS) on pain following root canal treatment. Scopus, MEDLINE and CENTRAL databases were searched up to 30 th January 2017 with broad key words. In addition, the reference lists in eligible papers and text books were hand-searched. Assessment of the eligibility of papers and data extraction were performed by two independent reviewers. Of 9891 articles, 18 were recruited as eligible papers. Most of these papers showed pain reducing effect of GCS on post-endodontic pain. Because of wide heterogeneity among the recruited papers, it was not possible to perform meta-analysis. Based on the results of this systematic review, there is a vast heterogeneity amongst articles regarding the use of GCS and their effect on post-operative pain after endodontic treatment. Further investigations with similar methods and materials are needed before meta-analysis on the effect of GCS on post-operative pain following root canal treatment can be performed .

Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: An Economic Analysis

PubMed Central

Tu, Hong Anh; Palimaka, Stefan; Sehatzadeh, Shayan; Blackhouse, Gord; Yap, Belinda; Tsoi, Bernice; Bowen, Jim; O'Reilly, Daria; Holubowich, Corinne; Kaulback, Kellee; Campbell, Kaitryn

2016-01-01

Background Major depressive disorder (MDD, 10% over a person's lifetime) is common and costly to the health system. Unfortunately, many MDD cases are resistant to treatment with antidepressant drugs and require other treatment to reduce or eliminate depression. Electroconvulsive therapy (ECT) has long been used to treat persons with treatment-resistant depression (TRD). Despite its effectiveness, ECT has side effects that make patients intolerant to the treatment, or they refuse to use it. Repetitive transcranial magnetic stimulation (rTMS), which has fewer side effects than ECT and might be an alternative for TRD patients who are ineligible for or unwilling to undergo ECT, has been developed to treat TRD. Objectives This analysis evaluates the cost-effectiveness of rTMS for patients with TRD compared with ECT or sham rTMS and estimates the potential budgetary impact of various levels of implementation of rTMS in Ontario. Review Methods A cost-utility analysis compared the costs and health outcomes of two treatments for persons with TRD in Ontario: rTMS alone compared with ECT alone and rTMS alone compared with sham rTMS. We calculated the six-month incremental costs and quality-adjusted life-years (QALYs) for these treatments. One-way and probabilistic sensitivity analyses were performed to test the robustness of the model's results. A 1-year budget impact analysis estimated the costs of providing funding for rTMS. The base-case analysis examined the additional costs for funding six centres, where rTMS infrastructure is in place. Sensitivity and scenario analyses explored the impact of increasing diffusion of rTMS to centres with existing ECT infrastructure. All analyses were conducted from the Ontario health care payer perspective. Results ECT was cost effective compared to rTMS when the willingness to pay is greater than $37,640.66 per QALY. In the base-case analysis, which had a six-month time horizon, the cost and effectiveness for rTMS was $5,272 and 0.31 quality-adjusted life-years (QALYs). The cost and effectiveness for ECT were $5,960 and 0.32 QALYs. This translates in an incremental cost-effectiveness ratio of $37,640.66 per QALY gained for ECT compared to rTMS. When rTMS is compared with sham rTMS, an additional $2,154.33 would be spent to gain 0.02 QALY. This translates to an ICER of $98,242.37 per QALY gained. Probabilistic sensitivity analysis showed that the probability of rTMS being cost-effective compared to sham rTMS was 2% and 45% at the thresholds of $50,000 and $100,000 per QALY gained, respectively. Conclusions Repetitive transcranial magnetic stimulation may be cost-effective compared to sham treatment in patients with treatment-resistant depression, depending on the willingness-to-pay threshold. PMID:27110317

Effect of dietary intervention treatment on children with iron deficiency anemia in China: a meta-analysis.

PubMed

Sun, Jian; Zhang, Lei; Cui, Jing; Li, Shanshan; Lu, Hongting; Zhang, Yong; Li, Haiming; Sun, Jianping; Baloch, Zulqarnain

2018-05-10

Previous studies have shown beneficial effects of dietary approaches for iron deficiency anemia (IDA) control. This study was design to investigate the effect of dietary intervention treatment on children with iron deficiency anemia. We performed a systematic review of published dietary interventions effect on IDA treatment through meta-analysis. CBM, CNKI, Wanfang database, EMBASE, VIP, PubMed and Web of science database were searched to identify studies published between January, 1980 and December, 2016. Statistical analysis was performed by Revmen5.2 software. Initially we retrieved for 373 studies, and then 6 studies with a total of 676 individuals were included in the analysis according to the inclusion and exclusion criteria for meta-analysis. The overall pooled estimate of odds ratio [(OR), 95% confidence intervals (95% CI)] in the dietary intervention on children with iron deficiency anemia was 6.54 (95% CI: 3.48-12.31, Z = 5.82, p<0.001) and funnel plot is symmetric. Our meta-analysis suggested that dietary interventions are effective in improving the iron deficiency in children with iron deficiency anemia (IDA) and should be considered in the overall strategy of IDA management.

Psychological Treatment of Sexual Offenders Against Children: A Meta-Analytic Review of Treatment Outcome Studies.

PubMed

Grønnerød, Cato; Grønnerød, Jarna Soilevuo; Grøndahl, Pål

2015-07-01

Numerous meta-analyses and reviews have been conducted on the effectiveness of psychological treatment of sexual offenders in reducing recidivism, but no meta-analysis has been done on sexual offenders against children (SOAC) specifically. A moderate treatment effect has been shown in several evaluations of general sexual offenders, while many scholars maintain that the question remains unanswered until an adequate number of effectiveness studies with a strong research design have been carried out. In this meta-analysis, we evaluated 14 studies selected and coded according to Collaborative Outcome Data Committee (CODC) criteria. They included 1,421 adult offenders in psychotherapy and 1,509 nontreated controls, with a minimum average follow-up period of 3 years, published in peer-reviewed journals in 1980 or later. Recidivism was defined as rearrest or reconviction. Study quality was classified into strong, good, weak or rejected. The analysis revealed a treatment effect size of r = .03 for nine studies evaluated as Good or Weak, while all studies yielded an effect size of r = .08, including five studies classified as Rejected. The results show that the available research cannot establish any effect of treatment on SOAC. Despite a large amount of research, only a tiny fraction of studies meet a minimum of scientific standards, and even fewer provide sensible and useful data from which it is possible to draw conclusions. © The Author(s) 2014.

Psychotherapy, Pharmacotherapy, and Their Combination for Adolescents with Major Depressive Disorder: A Meta-Analysis

ERIC Educational Resources Information Center

Singh, Nikita; Reece, John

2014-01-01

This meta-analysis aims to inform clinical practice of treatment strategies for adolescents with major depressive disorder (MDD). The efficacy of three empirically validated treatments was compared to determine the most effective treatment. These were: cognitive-behavioural therapy (CBT), selective serotonin reuptake inhibitor (SSRI)…

Improving Learning in Primary Schools of Developing Countries: A Meta-Analysis of Randomized Experiments

ERIC Educational Resources Information Center

McEwan, Patrick J.

2015-01-01

I gathered 77 randomized experiments (with 111 treatment arms) that evaluated the effects of school-based interventions on learning in developing-country primary schools. On average, monetary grants and deworming treatments had mean effect sizes that were close to zero and not statistically significant. Nutritional treatments, treatments that…

Cost-effectiveness analysis: role and implications.

PubMed

Marsden, G; Wonderling, D

2013-03-01

Cost-effectiveness analysis (CEA) is often misperceived to be a cost-cutting exercise. The intention of CEA is not to identify and implement cheap technologies, but rather those which offer maximum health gain, subject to available funds. Such analysis is crucial for decision making in health care, as tight budget constraints mean spending in one area of healthcare displaces spending elsewhere. Therefore in order to achieve the greatest health gain for the overall population, treatments must be selected which provide the greatest health gain within the available funds. The relevance of CEA in health care systems is explained, using varicose vein treatment in the UK NHS as an example. Treatment for varicose veins is often not commissioned to at a local level, most likely because it is misperceived to be a cosmetic problem. However, this view does not take into account the impact of quality of life. CEA balances costs against a quantitative measure of health related quality of life, and could therefore be used to determine whether it is cost-effective to provide varicose vein treatment. The current literature on the cost-effectiveness of varicose vein treatment is reviewed, and an overview of cost-effectiveness principles is provided. Concepts such as economic modelling, incremental cost-effectiveness ratios (ICERs), net monetary benefit (NMB) and sensitivity analysis are explained, using examples relevant to varicose veins where appropriate. This article explains how, far from cutting costs and sacrificing patient health, CEA provides a useful tool to maximise the health of the population in the face of ever tightening budget constraints. CEA could be used to compare the cost-effectiveness of the various treatment options for varicose veins, and efficiencies realised.

Effects of sulfate chitosan derivatives on nonalcoholic fatty liver disease

NASA Astrophysics Data System (ADS)

Yu, Mingming; Wang, Yuanhong; Jiang, Tingfu; Lv, Zhihua

2014-06-01

Sulfate chitosan derivatives have good solubility and therapeutic effect on the cell model of NAFLD. The aim of this study was to examine the therapeutic effect of sulfate chitosan derivatives on NAFLD. The male Wistar rats were orally fed high fat emulsion and received sulfate chitosan derivatives for 5 weeks to determine the pre-treatment effect of sulfate chitosan derivatives on NAFLD. To evaluate the therapeutic effect of sulfate chitosan derivatives on NAFLD, the rats were orally fed with high concentration emulsion for 5 weeks, followed by sulfate chitosan derivatives for 3 weeks. Histological analysis and biomedical assays showed that sulfate chitosan derivatives can dramatically prevent the development of hepatic steatosis in hepatocyte cells. In animal studies, pre-treatment and treatment with sulfate chitosan derivatives significantly protected against hepatic steatohepatitis induced by high fat diet according to histological analysis. Furthermore, increased TC, ALT, MDA, and LEP in NAFLD were significantly ameliorated by pre-treatment and treatment with sulfate chitosan derivatives. Furthermore, increased TG, AST, and TNF-α in NAFLD were significantly ameliorated by treatment with sulfate chitosan derivatives. Sulfate chitosan derivatives have good pre-treatment and therapeutic effect on NAFLD.

Significant Effect of Valproate Augmentation Therapy in Patients With Schizophrenia

PubMed Central

Tseng, Ping-Tao; Chen, Yen-Wen; Chung, Weilun; Tu, Kun-Yu; Wang, Hung-Yu; Wu, Ching-Kuan; Lin, Pao-Yen

2016-01-01

Abstract Valproate is an anticonvulsant, which is also widely used for treating psychiatric disorders. Some clinical trials have demonstrated benefits of valproate augmentation therapy in schizophrenia. Previous meta-analysis showed inconsistent findings because of limited literature at that time. The aim of this study is to update the newer published data by conducting a meta-analysis of clinical efficacy of valproate augmentation therapy in patients with schizophrenia or schizoaffective disorder. Data sources include electronic research through platform of PubMed. Study eligibility criteria, participants, and interventions were as follows: the inclusion criteria included articles discussing comparisons of the treatment effect in schizophrenic patients treated with antipsychotic augmented with valproate and antipsychotics with/without placebo; articles on clinical trials in humans. The exclusion criteria were case reports or series and nonclinical trials. We compared the effect between antipsychotic treatment with valproate augmentation and antipsychotic monotherapy. Data from clinical trials were pooled by random-effects model, and possible confounding variables were examined through meta-regression and subgroup analysis. Data from 11 articles including 889 patients were included into current meta-analysis. We found patients treated with antipsychotics with valproate augmentation showed significantly more improvement in total psychopathology than those treated with antipsychotics only (P = 0.02). Results from open trials, but not from randomized controlled trials (P = 0.20), showed significant improvement (P = 0.01). In addition, the significance only persisted in the studies conducted with a shorter treatment duration (P < 0.001) rather than longer treatment duration (P = 0.23). There is no difference in the dropout rate between valproate augmentation and antipsychotic treatment only (P = 0.14). We could not perform a detailed meta-analysis for every category of antipsychotics, long-term effect, and safety profiles of valproate augmentation therapy in maintenance treatment, safety in pregnant patients, and subtype of schizophrenia. Our meta-analysis highlights the significantly better treatment effect with valproate augmentation therapy in patients with schizophrenia or schizoaffective disorder, and provides important evidence for supporting the practice of valproate augmentation therapy in these patients. PMID:26825886

A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid: a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial.

PubMed

Chalmers, J R; Wojnarowska, F; Kirtschig, G; Nunn, A J; Bratton, D J; Mason, J; Foster, K A; Whitham, D; Williams, H C

2015-07-01

Bullous pemphigoid (BP) is the most common autoimmune blistering disease in older people, and is associated with significant morbidity and mortality. Oral corticosteroids are usually effective but the side-effects are thought to contribute to the high morbidity and mortality rate. Treatment with oral tetracyclines may be effective but high-quality, randomized controlled trials (RCTs) are needed to confirm this. To compare the effectiveness and safety of two strategies for treating BP. This is a two-arm, parallel group, 52-week RCT comparing doxycycline with prednisolone for initial treatment of BP. Dose is fixed for the initial 6 weeks of treatment (doxycycline 200 mg daily; prednisolone 0.5 mg kg(-1) daily), after which it can be adjusted according to need. A total of 256 patients with BP will be recruited in the U.K. and Germany. The primary outcomes are: (i) effectiveness (assessor-blinded blister count at 6 weeks) and (ii) safety [proportion of patients experiencing ≥ grade 3 adverse events (i.e. severe, life: threatening or fatal) related to trial medication during the year of follow-up]. Primary effectiveness analysis will be an assessment of whether doxycycline can be considered noninferior to prednisolone after 6 weeks of treatment. Primary safety analysis is a superiority analysis at 12 months. Secondary outcomes include longer-term assessment of effectiveness, relapse rates, the proportion of patients experiencing any grade of adverse events related to treatment, quality of life and cost-effectiveness. The trial will provide good evidence for whether the strategy of starting BP treatment with doxycycline is a useful alternative to prednisolone. © 2015 British Association of Dermatologists.

Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships.

PubMed

Rassen, Jeremy A; Brookhart, M Alan; Glynn, Robert J; Mittleman, Murray A; Schneeweiss, Sebastian

2009-12-01

The gold standard of study design for treatment evaluation is widely acknowledged to be the randomized controlled trial (RCT). Trials allow for the estimation of causal effect by randomly assigning participants either to an intervention or comparison group; through the assumption of "exchangeability" between groups, comparing the outcomes will yield an estimate of causal effect. In the many cases where RCTs are impractical or unethical, instrumental variable (IV) analysis offers a nonexperimental alternative based on many of the same principles. IV analysis relies on finding a naturally varying phenomenon, related to treatment but not to outcome except through the effect of treatment itself, and then using this phenomenon as a proxy for the confounded treatment variable. This article demonstrates how IV analysis arises from an analogous but potentially impossible RCT design, and outlines the assumptions necessary for valid estimation. It gives examples of instruments used in clinical epidemiology and concludes with an outline on estimation of effects.

Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships

PubMed Central

Rassen, Jeremy A.; Brookhart, M. Alan; Glynn, Robert J.; Mittleman, Murray A.; Schneeweiss, Sebastian

2010-01-01

The gold standard of study design for treatment evaluation is widely acknowledged to be the randomized controlled trial (RCT). Trials allow for the estimation of causal effect by randomly assigning participants either to an intervention or comparison group; through the assumption of “exchangeability” between groups, comparing the outcomes will yield an estimate of causal effect. In the many cases where RCTs are impractical or unethical, instrumental variable (IV) analysis offers a nonexperimental alternative based on many of the same principles. IV analysis relies on finding a naturally varying phenomenon, related to treatment but not to outcome except through the effect of treatment itself, and then using this phenomenon as a proxy for the confounded treatment variable. This article demonstrates how IV analysis arises from an analogous but potentially impossible RCT design, and outlines the assumptions necessary for valid estimation. It gives examples of instruments used in clinical epidemiology and concludes with an outline on estimation of effects. PMID:19356901

Exploring heterogeneity in clinical trials with latent class analysis

PubMed Central

Abarda, Abdallah; Contractor, Ateka A.; Wang, Juan; Dayton, C. Mitchell

2018-01-01

Case-mix is common in clinical trials and treatment effect can vary across different subgroups. Conventionally, a subgroup analysis is performed by dividing the overall study population by one or two grouping variables. It is usually impossible to explore complex high-order intersections among confounding variables. Latent class analysis (LCA) provides a framework to identify latent classes by observed manifest variables. Distal clinical outcomes and treatment effect can be different across these classes. This paper provides a step-by-step tutorial on how to perform LCA with R. A simulated dataset is generated to illustrate the process. In the example, the classify-analyze approach is employed to explore the differential treatment effects on distal outcomes across latent classes. PMID:29955579

Surrogate marker analysis in cancer clinical trials through time-to-event mediation techniques.

PubMed

Vandenberghe, Sjouke; Duchateau, Luc; Slaets, Leen; Bogaerts, Jan; Vansteelandt, Stijn

2017-01-01

The meta-analytic approach is the gold standard for validation of surrogate markers, but has the drawback of requiring data from several trials. We refine modern mediation analysis techniques for time-to-event endpoints and apply them to investigate whether pathological complete response can be used as a surrogate marker for disease-free survival in the EORTC 10994/BIG 1-00 randomised phase 3 trial in which locally advanced breast cancer patients were randomised to either taxane or anthracycline based neoadjuvant chemotherapy. In the mediation analysis, the treatment effect is decomposed into an indirect effect via pathological complete response and the remaining direct effect. It shows that only 4.2% of the treatment effect on disease-free survival after five years is mediated by the treatment effect on pathological complete response. There is thus no evidence from our analysis that pathological complete response is a valuable surrogate marker to evaluate the effect of taxane versus anthracycline based chemotherapies on progression free survival of locally advanced breast cancer patients. The proposed analysis strategy is broadly applicable to mediation analyses of time-to-event endpoints, is easy to apply and outperforms existing strategies in terms of precision as well as robustness against model misspecification.

Mobile technology boosts the effectiveness of psychotherapy and behavioral interventions: a meta-analysis.

PubMed

Lindhiem, Oliver; Bennett, Charles B; Rosen, Dana; Silk, Jennifer

2015-11-01

We conducted a meta-analysis on the effects of mobile technology on treatment outcome for psychotherapy and other behavioral interventions. Our search of the literature resulted in 26 empirical articles describing 25 clinical trials testing the benefits of smartphone applications, personal digital assistants (PDAs), or text messaging systems either to supplement treatment or substitute for direct contact with a clinician. Overall, mobile technology use was associated with superior treatment outcome across all study designs and control conditions, effect size (ES) = .34, p < .0001. For the subset of 10 studies that looked specifically at the added benefit of mobile technology using a rigorous "Treatment" versus "Treatment + Mobile" design, effect sizes were only slightly more modest (ES = .27) and still significant (p < .05). Overall, the results support the role of mobile technology for the delivery of psychotherapy and other behavioral interventions. © The Author(s) 2015.

Longitudinal assessment of treatment effects on pulmonary ventilation using 1H/3He MRI multivariate templates

NASA Astrophysics Data System (ADS)

Tustison, Nicholas J.; Contrella, Benjamin; Altes, Talissa A.; Avants, Brian B.; de Lange, Eduard E.; Mugler, John P.

2013-03-01

The utitlity of pulmonary functional imaging techniques, such as hyperpolarized 3He MRI, has encouraged their inclusion in research studies for longitudinal assessment of disease progression and the study of treatment effects. We present methodology for performing voxelwise statistical analysis of ventilation maps derived from hyper­ polarized 3He MRI which incorporates multivariate template construction using simultaneous acquisition of IH and 3He images. Additional processing steps include intensity normalization, bias correction, 4-D longitudinal segmentation, and generation of expected ventilation maps prior to voxelwise regression analysis. Analysis is demonstrated on a cohort of eight individuals with diagnosed cystic fibrosis (CF) undergoing treatment imaged five times every two weeks with a prescribed treatment schedule.

The placebo effect and its determinants in fibromyalgia: meta-analysis of randomised controlled trials.

PubMed

Chen, Xi; Zou, Kun; Abdullah, Natasya; Whiteside, Nicola; Sarmanova, Aliya; Doherty, Michael; Zhang, Weiya

2017-07-01

The aims of this study were to determine whether placebo treatment in randomised controlled trials (RCTs) is effective for fibromyalgia and to identify possible determinants of the magnitude of any such placebo effect. A systematic literature search was undertaken for RCTs in people with fibromyalgia that included a placebo and/or a no-treatment (observation only or waiting list) control group. Placebo effect size (ES) for pain and other outcomes was measured as the improvement of each outcome from baseline divided by the standard deviation of the change from baseline. This effect was compared with changes in the no-treatment control groups. Meta-analysis was undertaken to combine data from different studies. Subgroup analysis was conducted to identify possible determinants of the placebo ES. A total of 3912 studies were identified from the literature search. After scrutiny, 229 trials met the inclusion criteria. Participants who received placebo in the RCTs experienced significantly better improvements in pain, fatigue, sleep quality, physical function, and other main outcomes than those receiving no treatment. The ES of placebo for pain relief was clinically moderate (0.53, 95%CI 0.48 to 0.57). The ES increased with increasing strength of the active treatment, increasing participant age and higher baseline pain severity, but decreased in RCTS with more women and with longer duration of fibromyalgia. In addition, placebo treatment in RCTs is effective in fibromyalgia. A number of factors (expected strength of treatment, age, gender, disease duration) appear to influence the magnitude of the placebo effect in this condition.

rpsftm: An R Package for Rank Preserving Structural Failure Time Models

PubMed Central

Allison, Annabel; White, Ian R; Bond, Simon

2018-01-01

Treatment switching in a randomised controlled trial occurs when participants change from their randomised treatment to the other trial treatment during the study. Failure to account for treatment switching in the analysis (i.e. by performing a standard intention-to-treat analysis) can lead to biased estimates of treatment efficacy. The rank preserving structural failure time model (RPSFTM) is a method used to adjust for treatment switching in trials with survival outcomes. The RPSFTM is due to Robins and Tsiatis (1991) and has been developed by White et al. (1997, 1999). The method is randomisation based and uses only the randomised treatment group, observed event times, and treatment history in order to estimate a causal treatment effect. The treatment effect, ψ, is estimated by balancing counter-factual event times (that would be observed if no treatment were received) between treatment groups. G-estimation is used to find the value of ψ such that a test statistic Z(ψ) = 0. This is usually the test statistic used in the intention-to-treat analysis, for example, the log rank test statistic. We present an R package that implements the method of rpsftm. PMID:29564164

rpsftm: An R Package for Rank Preserving Structural Failure Time Models.

PubMed

Allison, Annabel; White, Ian R; Bond, Simon

2017-12-04

Treatment switching in a randomised controlled trial occurs when participants change from their randomised treatment to the other trial treatment during the study. Failure to account for treatment switching in the analysis (i.e. by performing a standard intention-to-treat analysis) can lead to biased estimates of treatment efficacy. The rank preserving structural failure time model (RPSFTM) is a method used to adjust for treatment switching in trials with survival outcomes. The RPSFTM is due to Robins and Tsiatis (1991) and has been developed by White et al. (1997, 1999). The method is randomisation based and uses only the randomised treatment group, observed event times, and treatment history in order to estimate a causal treatment effect. The treatment effect, ψ , is estimated by balancing counter-factual event times (that would be observed if no treatment were received) between treatment groups. G-estimation is used to find the value of ψ such that a test statistic Z ( ψ ) = 0. This is usually the test statistic used in the intention-to-treat analysis, for example, the log rank test statistic. We present an R package that implements the method of rpsftm.

Comparative effect and safety of verapamil in keloid and hypertrophic scar treatment: a meta-analysis

PubMed Central

Li, Zhouna; Jin, Zhehu

2016-01-01

Background Keloids and hypertrophic scars are the most common types of pathological scarring. Traditionally, keloids have been considered as a result of aberrant wound healing, involving excessive fibroblast participation that is characterized by hyalinized collagen bundles. However, the usefulness of this characterization has been questioned. In recent years, studies have reported the appropriate use of verapamil for keloids and hypertrophic scars. Methods Searches were conducted on the databases Medline, Embase, Cochrane, PubMed, and China National Knowledge Infrastructure from 2006 to July 2016. State12.0 was used for literature review, data extraction, and meta-analysis. Treatment groups were divided into verapamil and nonverapamil group. Nonverapamil group includes steroids and intense pulsed light (IPL) therapy. Total effective rates include cure rate and effective rate. Cure: skin lesions were completely flattened, became soft and symptoms disappeared. Efficacy: skin lesions subsided, patient significantly reduced symptoms. Inefficient definition of skin was progression free or became worse. Random-effects model was used for the meta-analysis. Results Six studies that included 331 patients with keloids and hypertrophic scars were analyzed. Analysis of the total effective rate of skin healing was performed. The total effective rates in the two groups were 54.07% (verapamil) and 53.18% (nonverapamil), respectively. The meta-analysis showed that there was no difference between the two groups. We also compared the adverse reactions between the verapamil treatment group and the steroids treatment group in two studies, and the result indicated that the verapamil group showed less adverse reactions. Conclusion There were no differences between the application of verapamil and nonverapamil group in keloids and hypertrophic scars treatment. Verapamil could act as an effective alternative modality in the prevention and treatment of keloid and hypertrophic scars. A larger number of studies are required to confirm our conclusion. PMID:27877046

Identifying Treatment Effect Modifiers in the STarT Back Trial: A Secondary Analysis.

PubMed

Beneciuk, Jason M; Hill, Jonathan C; Campbell, Paul; Afolabi, Ebenezer; George, Steven Z; Dunn, Kate M; Foster, Nadine E

2017-01-01

Identification of patient characteristics influencing treatment outcomes is a top low back pain (LBP) research priority. Results from the STarT Back trial support the effectiveness of prognostic stratified care for LBP compared with current best care, however, patient characteristics associated with treatment response have not yet been explored. The purpose of this secondary analysis was to identify treatment effect modifiers within the STarT Back trial at 4-month follow-up (n = 688). Treatment response was dichotomized using back-specific physical disability measured using the Roland-Morris Disability Questionnaire (≥7). Candidate modifiers were identified using previous literature and evaluated using logistic regression with statistical interaction terms to provide preliminary evidence of treatment effect modification. Socioeconomic status (SES) was identified as an effect modifier for disability outcomes (odds ratio [OR] = 1.71, P = .028). High SES patients receiving prognostic stratified care were 2.5 times less likely to have a poor outcome compared with low SES patients receiving best current care (OR = .40, P = .006). Education level (OR = 1.33, P = .109) and number of pain medications (OR = .64, P = .140) met our criteria for effect modification with weaker evidence (.20 > P ≥ .05). These findings provide preliminary evidence for SES, education, and number of pain medications as treatment effect modifiers of prognostic stratified care delivered in the STarT Back Trial. This analysis provides preliminary exploratory findings about the characteristics of patients who might least likely benefit from targeted treatment using prognostic stratified care for LBP. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

Treatments for bulimia nervosa: a network meta-analysis.

PubMed

Slade, Eric; Keeney, Edna; Mavranezouli, Ifigeneia; Dias, Sofia; Fou, Linyun; Stockton, Sarah; Saxon, Leanne; Waller, Glenn; Turner, Hannah; Serpell, Lucy; Fairburn, Christopher G; Kendall, Tim

2018-05-06

Bulimia nervosa (BN) is a severe eating disorder that can be managed using a variety of treatments including pharmacological, psychological, and combination treatments. We aimed to compare their effectiveness and to identify the most effective for the treatment of BN in adults. A search was conducted in Embase, Medline, PsycINFO, and Central from their inception to July 2016. Studies were included if they reported on treatments for adults who fulfilled diagnostic criteria for BN. Only randomised controlled trials (RCTs) that examined available psychological, pharmacological, or combination therapies licensed in the UK were included. We conducted a network meta-analysis (NMA) of RCTs. The outcome analysed was full remission at the end of treatment. We identified 21 eligible trials with 1828 participants involving 12 treatments, including wait list. The results of the NMA suggested that individual cognitive behavioural therapy (CBT) (specific to eating disorders) was most effective in achieving remission at the end of treatment compared with wait list (OR 3.89, 95% CrI 1.19-14.02), followed by guided cognitive behavioural self-help (OR 3.81, 95% CrI 1.51-10.90). Inconsistency checks did not identify any significant inconsistency between the direct and indirect evidence. The analysis suggested that the treatments that are most likely to achieve full remission are individual CBT (specific to eating disorders) and guided cognitive behavioural self-help, although no firm conclusions could be drawn due to the limited evidence base. There is a need for further research on the maintenance of treatment effects and the mediators of treatment outcome.

New treatments compared to established treatments in randomized trials

PubMed Central

Djulbegovic, Benjamin; Kumar, Ambuj; Glasziou, Paul P; Perera, Rafael; Reljic, Tea; Dent, Louise; Raftery, James; Johansen, Marit; Di Tanna, Gian Luca; Miladinovic, Branko; Soares, Heloisa P; Vist, Gunn E; Chalmers, Iain

2012-01-01

Background The proportion of proposed new treatments that are ’successful’ is of ethical, scientific, and public importance. We investigated how often new, experimental treatments evaluated in randomized controlled trials (RCTs) are superior to established treatments. Objectives Our main question was: “On average how often are new treatments more effective, equally effective or less effective than established treatments?” Additionally, we wanted to explain the observed results, i.e. whether the observed distribution of outcomes is consistent with the ’uncertainty requirement’ for enrollment in RCTs. We also investigated the effect of choice of comparator (active versus no treatment/placebo) on the observed results. Search methods We searched the Cochrane Methodology Register (CMR) 2010, Issue 1 in The Cochrane Library (searched 31 March 2010); MEDLINE Ovid 1950 to March Week 2 2010 (searched 24 March 2010); and EMBASE Ovid 1980 to 2010 Week 11 (searched 24 March 2010). Selection criteria Cohorts of studies were eligible for the analysis if they met all of the following criteria: (i) consecutive series of RCTs, (ii) registered at or before study onset, and (iii) compared new against established treatments in humans. Data collection and analysis RCTs from four cohorts of RCTs met all inclusion criteria and provided data from 743 RCTs involving 297,744 patients. All four cohorts consisted of publicly funded trials. Two cohorts involved evaluations of new treatments in cancer, one in neurological disorders, and one for mixed types of diseases. We employed kernel density estimation, meta-analysis and meta-regression to assess the probability of new treatments being superior to established treatments in their effect on primary outcomes and overall survival. Main results The distribution of effects seen was generally symmetrical in the size of difference between new versus established treatments. Meta-analytic pooling indicated that, on average, new treatments were slightly more favorable both in terms of their effect on reducing the primary outcomes (hazard ratio (HR)/odds ratio (OR) 0.91, 99% confidence interval (CI) 0.88 to 0.95) and improving overall survival (HR 0.95, 99% CI 0.92 to 0.98). No heterogeneity was observed in the analysis based on primary outcomes or overall survival (I2 = 0%). Kernel density analysis was consistent with the meta-analysis, but showed a fairly symmetrical distribution of new versus established treatments indicating unpredictability in the results. This was consistent with the interpretation that new treatments are only slightly superior to established treatments when tested in RCTs. Additionally, meta-regression demonstrated that results have remained stable over time and that the success rate of new treatments has not changed over the last half century of clinical trials. The results were not significantly affected by the choice of comparator (active versus placebo/no therapy). Authors’ conclusions Society can expect that slightly more than half of new experimental treatments will prove to be better than established treatments when tested in RCTs, but few will be substantially better. This is an important finding for patients (as they contemplate participation in RCTs), researchers (as they plan design of the new trials), and funders (as they assess the ’return on investment’). Although we provide the current best evidence on the question of expected ’success rate’ of new versus established treatments consistent with a priori theoretical predictions reflective of ’uncertainty or equipoise hypothesis’, it should be noted that our sample represents less than 1% of all available randomized trials; therefore, one should exercise the appropriate caution in interpretation of our findings. In addition, our conclusion applies to publicly funded trials only, as we did not include studies funded by commercial sponsors in our analysis. PMID:23076962

Cost-effectiveness analysis reveals microsurgical varicocele repair is superior to percutaneous embolization in the treatment of male infertility.

PubMed

Kovac, Jason Ronald; Fantus, Jake; Lipshultz, Larry I; Fischer, Marc Anthony; Klinghoffer, Zachery

2014-09-01

Varicoceles are a common cause of male infertility; repair can be accomplished using either surgical or radiological means. We compare the cost-effectiveness of the gold standard, the microsurgical varicocele repair (MV), to the options of a nonmicrosurgical approach (NMV) and percutaneous embolization (PE) to manage varicocele-associated infertility. A Markov decision-analysis model was developed to estimate costs and pregnancy rates. Within the model, recurrences following MV and NMV were re-treated with PE and recurrences following PE were treated with repeat PE, MV or NMV. Pregnancy and recurrence rates were based on the literature, while costs were obtained from institutional and government supplied data. Univariate and probabilistic sensitivity-analyses were performed to determine the effects of the various parameters on model outcomes. Primary treatment with MV was the most cost-effective strategy at $5402 CAD (Canadian)/pregnancy. Primary treatment with NMV was the least costly approach, but it also yielded the fewest pregnancies. Primary treatment with PE was the least cost-effective strategy costing about $7300 CAD/pregnancy. Probabilistic sensitivity analysis reinforced MV as the most cost-effective strategy at a willingness-to-pay threshold of >$4100 CAD/pregnancy. MV yielded the most pregnancies at acceptable levels of incremental costs. As such, it is the preferred primary treatment strategy for varicocele-associated infertility. Treatment with PE was the least cost-effective approach and, as such, is best used only in cases of surgical failure.

Effectiveness of medical treatment for Cushing's syndrome: a systematic review and meta-analysis.

PubMed

Broersen, Leonie H A; Jha, Meghna; Biermasz, Nienke R; Pereira, Alberto M; Dekkers, Olaf M

2018-05-31

To systematically review the effectiveness of medical treatment for Cushing's syndrome in clinical practice, regarding cortisol secretion, clinical symptom improvement, and quality of life. To assess the occurrence of side effects of these medical therapies. Eight electronic databases were searched in March 2017 to identify potentially relevant articles. Randomized controlled trials and cohort studies assessing the effectiveness of medical treatment in patients with Cushing's syndrome, were eligible. Pooled proportions were reported including 95% confidence intervals. We included 35 articles with in total 1520 patients in this meta-analysis. Most included patients had Cushing's disease. Pooled reported percentage of patients with normalization of cortisol ranged from 35.7% for cabergoline to 81.8% for mitotane in Cushing's disease. Patients using medication monotherapy showed a lower percentage of cortisol normalization compared to use of multiple medical agents (49.4 vs. 65.7%); this was even higher for patients with concurrent or previous radiotherapy (83.6%). Mild side effects were reported in 39.9%, and severe side effects were seen in 15.2% of patients after medical treatment. No meta-analyses were performed for clinical symptom improvement or quality of life due to lack of sufficient data. This meta-analysis shows that medication induces cortisol normalization effectively in a large percentage of patients. Medical treatment for Cushing's disease patients is thus a reasonable option in case of a contraindication for surgery, a recurrence, or in patients choosing not to have surgery. When experiencing side effects or no treatment effect, an alternate medical therapy or combination therapy can be considered.

Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.

PubMed

Nieves, Diana; Puig-Peiró, Ruth; Ferrándiz, Carlos; Plazas, Maria Josep; Brosa, Max

2015-06-01

The aim of this study is to conduct a cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Clarifying Inconclusive Functional Analysis Results: Assessment and Treatment of Automatically Reinforced Aggression

PubMed Central

Saini, Valdeep; Greer, Brian D.; Fisher, Wayne W.

2016-01-01

We conducted a series of studies in which multiple strategies were used to clarify the inconclusive results of one boy’s functional analysis of aggression. Specifically, we (a) evaluated individual response topographies to determine the composition of aggregated response rates, (b) conducted a separate functional analysis of aggression after high rates of disruption masked the consequences maintaining aggression during the initial functional analysis, (c) modified the experimental design used during the functional analysis of aggression to improve discrimination and decrease interaction effects between conditions, and (d) evaluated a treatment matched to the reinforcer hypothesized to maintain aggression. An effective yet practical intervention for aggression was developed based on the results of these analyses and from data collected during the matched-treatment evaluation. PMID:25891269

Observation Versus Initial Treatment for Men With Localized, Low-Risk Prostate Cancer A Cost-Effectiveness Analysis

PubMed Central

Hayes, Julia H.; Ollendorf, Daniel A.; Pearson, Steven D.; Barry, Michael J.; Kantoff, Philip W.; Lee, Pablo A.; McMahon, Pamela M.

2015-01-01

Background Observation is underused among men with localized, low-risk prostate cancer. Objective To assess the costs and benefits of observation versus initial treatment. Design Decision analysis simulating treatment or observation. Data Sources Medicare schedules, published literature. Target Population Men ages 65 and 75 years with newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 μg/L, stage ≤T2a, Gleason score ≤3+3). Time Horizon Lifetime. Perspective Societal. Intervention Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]). Outcome Measures Quality-adjusted life expectancy, costs. Results of Base-Case Analysis Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15 374 ($24 520 vs. $39 894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11 746 ($18 302 vs. $30 048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment. Results of Sensitivity Analysis Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses. Limitation Results depend on outcomes reported in the published literature, which is limited. Conclusion Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios. Primary Funding Source National Cancer Institute, U.S. Department of Defense, Prostate Cancer Foundation, and Blue Shield of California Foundation. PMID:23778902

Effects of physiotherapy treatment on knee osteoarthritis gait data using principal component analysis.

PubMed

Gaudreault, Nathaly; Mezghani, Neila; Turcot, Katia; Hagemeister, Nicola; Boivin, Karine; de Guise, Jacques A

2011-03-01

Interpreting gait data is challenging due to intersubject variability observed in the gait pattern of both normal and pathological populations. The objective of this study was to investigate the impact of using principal component analysis for grouping knee osteoarthritis (OA) patients' gait data in more homogeneous groups when studying the effect of a physiotherapy treatment. Three-dimensional (3D) knee kinematic and kinetic data were recorded during the gait of 29 participants diagnosed with knee OA before and after they received 12 weeks of physiotherapy treatment. Principal component analysis was applied to extract groups of knee flexion/extension, adduction/abduction and internal/external rotation angle and moment data. The treatment's effect on parameters of interest was assessed using paired t-tests performed before and after grouping the knee kinematic data. Increased quadriceps and hamstring strength was observed following treatment (P<0.05). Except for the knee flexion/extension angle, two different groups (G(1) and G(2)) were extracted from the angle and moment data. When pre- and post-treatment analyses were performed considering the groups, participants exhibiting a G(2) knee moment pattern demonstrated a greater first peak flexion moment, lower adduction moment impulse and smaller rotation angle range post-treatment (P<0.05). When pre- and post-treatment comparisons were performed without grouping, the data showed no treatment effect. The results of the present study suggest that the effect of physiotherapy on gait mechanics of knee osteoarthritis patients may be masked or underestimated if kinematic data are not separated into more homogeneous groups when performing pre- and post-treatment comparisons. Copyright © 2010 Elsevier Ltd. All rights reserved.

Measuring the effect of fuel treatments on forest carbon using landscape risk analysis

Treesearch

A.A. Ager; M.A. Finney; A. McMahan; J. Carthcart

2010-01-01

Wildfire simulation modelling was used to examine whether fuel reduction treatments can potentially reduce future wildfire emissions and provide carbon benefits. In contrast to previous reports, the current study modelled landscape scale effects of fuel treatments on fire spread and intensity, and used a probabilistic framework to quantify wildfire effects on carbon...

Propensity score analysis with partially observed covariates: How should multiple imputation be used?

PubMed

Leyrat, Clémence; Seaman, Shaun R; White, Ian R; Douglas, Ian; Smeeth, Liam; Kim, Joseph; Resche-Rigon, Matthieu; Carpenter, James R; Williamson, Elizabeth J

2017-01-01

Inverse probability of treatment weighting is a popular propensity score-based approach to estimate marginal treatment effects in observational studies at risk of confounding bias. A major issue when estimating the propensity score is the presence of partially observed covariates. Multiple imputation is a natural approach to handle missing data on covariates: covariates are imputed and a propensity score analysis is performed in each imputed dataset to estimate the treatment effect. The treatment effect estimates from each imputed dataset are then combined to obtain an overall estimate. We call this method MIte. However, an alternative approach has been proposed, in which the propensity scores are combined across the imputed datasets (MIps). Therefore, there are remaining uncertainties about how to implement multiple imputation for propensity score analysis: (a) should we apply Rubin's rules to the inverse probability of treatment weighting treatment effect estimates or to the propensity score estimates themselves? (b) does the outcome have to be included in the imputation model? (c) how should we estimate the variance of the inverse probability of treatment weighting estimator after multiple imputation? We studied the consistency and balancing properties of the MIte and MIps estimators and performed a simulation study to empirically assess their performance for the analysis of a binary outcome. We also compared the performance of these methods to complete case analysis and the missingness pattern approach, which uses a different propensity score model for each pattern of missingness, and a third multiple imputation approach in which the propensity score parameters are combined rather than the propensity scores themselves (MIpar). Under a missing at random mechanism, complete case and missingness pattern analyses were biased in most cases for estimating the marginal treatment effect, whereas multiple imputation approaches were approximately unbiased as long as the outcome was included in the imputation model. Only MIte was unbiased in all the studied scenarios and Rubin's rules provided good variance estimates for MIte. The propensity score estimated in the MIte approach showed good balancing properties. In conclusion, when using multiple imputation in the inverse probability of treatment weighting context, MIte with the outcome included in the imputation model is the preferred approach.

Jianpi Bushen, a Traditional Chinese Medicine Therapy, Combined with Chemotherapy for Gastric Cancer Treatment: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Yunbo; Zhang, Guijuan; Chen, Xiaoping; Jiang, Xuefeng; Yuan, Naijun; Wang, Yurong; Hao, Xiaoqian

2018-01-01

Objective. To investigate the effects of Jianpi Bushen (JPBS), a traditional Chinese medicine that is used to invigorate the spleen and tonify the kidney, combined with chemotherapy for the treatment of gastric cancer. Methods. Literature retrieval was performed in PubMed, EMBASE, Cochrane Library, MEDLINE, CNKI, Wanfang Data Information Site, and VIP from inception to October 2017. Randomized controlled trials to evaluate the effects of JPBS combined with chemotherapy were identified. The primary reported outcomes were KPS (Karnofsky Performance Status), clinical curative efficiency, immune function, blood system, and nonhematologic system. Review Manager 5.3 (RevMan 5.3) was used for data analysis, and the quality of the studies was also appraised. Results. A total of 26 studies were included with 3098 individuals. The results of the meta-analysis indicated that treatment of gastric cancer with the combination of JPBS and chemotherapy resulted in better outcomes compared to chemotherapy alone. Conclusion. Evidence from the meta-analysis suggested that JPBS combined with chemotherapy has a positive effect on gastric cancer treatment. However, additional rigorously designed and large sample randomized controlled trials are required to confirm the efficacy and safety of this treatment. PMID:29675052

Hypercholesterolemia: a look at low-cost treatment and treatment adherence.

PubMed

Flannery, J; Raulerson, A

2000-11-01

To determine whether a positive cholesterol-lowering effect could be achieved with a psyllium dose of 6 grams per day instead of the usual 10 grams per day as advocated by other researchers. Randomized trial of 46 males and females with hypercholesterolemia; multivariate analysis of variance with repeated measures on 1 factor done on 28 subjects (18 in treatment group, 10 in control group) remaining after 16 weeks of treatment. Lipoprotein analysis at 2, 8, and 16 weeks indicated that a daily dose of 6 grams of psyllium hydrophilic mucilloid did not significantly affect serum total cholesterol nor low-density lipoproteins in either men or women with hypercholesterolemia. The effects of psyllium on hypercholesterolemia appear to be dose dependent. Although it is a low cost option, the addition of psyllium to the diet has unpleasant side-effects, including abdominal distention, flatulence, and discomfort. Because these side effects are troublesome, the lowest effective dose of psyllium may be an important factor in improving treatment adherence.

The effectiveness of sexual offender treatment for juveniles as measured by recidivism: a meta-analysis.

PubMed

Reitzel, Lorraine R; Carbonell, Joyce L

2006-10-01

Published and unpublished data from nine studies on juvenile sexual offender treatment effectiveness were summarized by meta-analysis (N=2986, 2604 known male). Recidivism rates for sexual, non-sexual violent, non-sexual non-violent crimes, and unspecified non-sexual were as follows: 12.53%, 24.73%, 28.51%, and 20.40%, respectively, based on an average 59-month follow-up period. Four included studies contained a control group (n=2288) and five studies included a comparison treatment group (n=698). An average weighted effect size of 0.43 (CI=0.33-0.55) was obtained, indicating a statistically significant effect of treatment on sexual recidivism. However, individual study characteristics (e.g., handling of dropouts and non-equivalent follow-up periods between treatment groups) suggest that results should be interpreted with caution. A comparison of odds ratios by quality of study design indicated that higher quality designs yielded better effect sizes, though the difference between groups was not significant.

A Meta-Analysis of Parent-Involved Treatment for Child Sexual Abuse

ERIC Educational Resources Information Center

Corcoran, Jacqueline; Pillai, Vijayan

2008-01-01

Sexual abuse in children not only occurs with alarming frequency, it also potentially leads to deleterious consequences for victims. Previous narrative reviews have touted the benefits of including the nonoffending caregiver in child sexual treatment. Objective: A meta-analysis is conducted to determine the effects of parent-involved treatment in…

Cost Utility Analysis of Topical Steroids Compared With Dietary Elimination for Treatment of Eosinophilic Esophagitis.

PubMed

Cotton, Cary C; Erim, Daniel; Eluri, Swathi; Palmer, Sarah H; Green, Daniel J; Wolf, W Asher; Runge, Thomas M; Wheeler, Stephanie; Shaheen, Nicholas J; Dellon, Evan S

2017-06-01

Topical corticosteroids or dietary elimination are recommended as first-line therapies for eosinophilic esophagitis, but data to directly compare these therapies are scant. We performed a cost utility comparison of topical corticosteroids and the 6-food elimination diet (SFED) in treatment of eosinophilic esophagitis, from the payer perspective. We used a modified Markov model based on current clinical guidelines, in which transition between states depended on histologic response simulated at the individual cohort-member level. Simulation parameters were defined by systematic review and meta-analysis to determine the base-case estimates and bounds of uncertainty for sensitivity analysis. Meta-regression models included adjustment for differences in study and cohort characteristics. In the base-case scenario, topical fluticasone was about as effective as SFED but more expensive at a 5-year time horizon ($9261.58 vs $5719.72 per person). SFED was more effective and less expensive than topical fluticasone and topical budesonide in the base-case scenario. Probabilistic sensitivity analysis revealed little uncertainty in relative treatment effectiveness. There was somewhat greater uncertainty in the relative cost of treatments; most simulations found SFED to be less expensive. In a cost utility analysis comparing topical corticosteroids and SFED for first-line treatment of eosinophilic esophagitis, the therapies were similar in effectiveness. SFED was on average less expensive, and more cost effective in most simulations, than topical budesonide and topical fluticasone, from a payer perspective and not accounting for patient-level costs or quality of life. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Accounting for Heterogeneity in Relative Treatment Effects for Use in Cost-Effectiveness Models and Value-of-Information Analyses

PubMed Central

Soares, Marta O.; Palmer, Stephen; Ades, Anthony E.; Harrison, David; Shankar-Hari, Manu; Rowan, Kathy M.

2015-01-01

Cost-effectiveness analysis (CEA) models are routinely used to inform health care policy. Key model inputs include relative effectiveness of competing treatments, typically informed by meta-analysis. Heterogeneity is ubiquitous in meta-analysis, and random effects models are usually used when there is variability in effects across studies. In the absence of observed treatment effect modifiers, various summaries from the random effects distribution (random effects mean, predictive distribution, random effects distribution, or study-specific estimate [shrunken or independent of other studies]) can be used depending on the relationship between the setting for the decision (population characteristics, treatment definitions, and other contextual factors) and the included studies. If covariates have been measured that could potentially explain the heterogeneity, then these can be included in a meta-regression model. We describe how covariates can be included in a network meta-analysis model and how the output from such an analysis can be used in a CEA model. We outline a model selection procedure to help choose between competing models and stress the importance of clinical input. We illustrate the approach with a health technology assessment of intravenous immunoglobulin for the management of adult patients with severe sepsis in an intensive care setting, which exemplifies how risk of bias information can be incorporated into CEA models. We show that the results of the CEA and value-of-information analyses are sensitive to the model and highlight the importance of sensitivity analyses when conducting CEA in the presence of heterogeneity. The methods presented extend naturally to heterogeneity in other model inputs, such as baseline risk. PMID:25712447

Accounting for Heterogeneity in Relative Treatment Effects for Use in Cost-Effectiveness Models and Value-of-Information Analyses.

PubMed

Welton, Nicky J; Soares, Marta O; Palmer, Stephen; Ades, Anthony E; Harrison, David; Shankar-Hari, Manu; Rowan, Kathy M

2015-07-01

Cost-effectiveness analysis (CEA) models are routinely used to inform health care policy. Key model inputs include relative effectiveness of competing treatments, typically informed by meta-analysis. Heterogeneity is ubiquitous in meta-analysis, and random effects models are usually used when there is variability in effects across studies. In the absence of observed treatment effect modifiers, various summaries from the random effects distribution (random effects mean, predictive distribution, random effects distribution, or study-specific estimate [shrunken or independent of other studies]) can be used depending on the relationship between the setting for the decision (population characteristics, treatment definitions, and other contextual factors) and the included studies. If covariates have been measured that could potentially explain the heterogeneity, then these can be included in a meta-regression model. We describe how covariates can be included in a network meta-analysis model and how the output from such an analysis can be used in a CEA model. We outline a model selection procedure to help choose between competing models and stress the importance of clinical input. We illustrate the approach with a health technology assessment of intravenous immunoglobulin for the management of adult patients with severe sepsis in an intensive care setting, which exemplifies how risk of bias information can be incorporated into CEA models. We show that the results of the CEA and value-of-information analyses are sensitive to the model and highlight the importance of sensitivity analyses when conducting CEA in the presence of heterogeneity. The methods presented extend naturally to heterogeneity in other model inputs, such as baseline risk. © The Author(s) 2015.

Ketogenic diet for treatment of intractable epilepsy in adults: A meta-analysis of observational studies.

PubMed

Liu, Hongyan; Yang, Yi; Wang, Yunbing; Tang, Hong; Zhang, Fan; Zhang, Yong; Zhao, Yong

2018-03-01

The ketogenic diet (KD) is an effective treatment for children with drug-resistant epilepsy and has been widely used in young children. Adult patients with intractable epilepsy would also benefit from this dietary treatment. However, only a few studies have been published, and the use of the KD in intractable epilepsy in adults has been limited. This meta-analysis summarized the findings of the relevant published studies to identify the efficacy of the KD for the treatment of intractable epilepsy in adults. In this meta-analysis, PubMed, Embase, and Cochrane Library were used for searching studies concerning the effects of the KD and its major subtypes with intractable epilepsy in adults published up to January 10, 2017. The primary outcomes were seizure freedom, seizure reduction by 50% or more, and seizure reduction by <50%. The quality of the methodology of the observational studies was reviewed by using the Newcastle-Ottawa Scale. We identified 402 articles, of which, 16 studies including 338 patients met the inclusion criteria. The results of the meta-analysis showed that the combined efficacy rates of all the symptoms of seizure freedom, seizure reduction by 50% or more, and seizure reduction below 50% in adults with intractable epilepsy were 13%, 53%, and 27%, respectively. The adverse reactions of the KD were mild, whereas low glycemic index diet (LGID) and low-dose fish oil diet (LFOD) may have fewer side effects. Weight loss, high level of low-density lipoprotein, and elevated total cholesterol were most frequent. The meta-analysis indicates that the KD for refractory epilepsy in adults is a well-tolerated treatment and that its side effects are acceptable, which show that the KD is a promising treatment in adult intractable epilepsy. Further research is needed to assess which type of diet or ratio is more effective in the KD treatment.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

PubMed

Barnhoorn, Karlijn; Staal, J Bart; van Dongen, Robert Tm; Frölke, Jan Paul M; Klomp, Frank P; van de Meent, Henk; Adang, Eddy; Nijhuis-van der Sanden, Maria Wg

2018-06-01

To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. Randomized controlled trial with 9 months follow-up. Patients were recruited from hospitals and general practitioners in the region around a university hospital. A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

Effectiveness of Antidepressants and Predictors of Treatment Response for Depressed HIV Patients in Uganda

PubMed Central

Ngo, Victoria K.; Wagner, Glenn J.; Nakasujja, Noeline; Dickens, Akena; Aunon, Frances; Musisi, Seggane

2015-01-01

Antidepressant medication is well-established for the treatment of depression, but little is known about its effectiveness for HIV populations in sub-Saharan Africa. This study examined the effectiveness of antidepressant treatment and predictors of treatment response among depressed HIV patients in Uganda. Data was obtained from two open label trials in which 184 HIV patients were diagnosed with depression and started on antidepressants. Data at treatment baseline and month 6 were compared to assess treatment response, and baseline predictors of response were assessed. 154 completed Month 6, of whom 122 (79%) had responded to treatment and were no longer depressed (Patient Health Questionnaire-9 score < 5). Bivariate analysis found that education, CD4 count, general health functioning, physical health, pain, quality of life, and social support variables were associated with antidepressant treatment response; however, only secondary education and social support independently predicted treatment response in logistic multiple regression analysis. Baseline depression severity was not associated with treatment response. In conclusion, antidepressants are effective in treating both moderate and more severe depression among persons living with HIV in Uganda, and education [O.R. (95% C.I.) = 4.33 (1.33 – 14.11)] and social support [O.R. (95% C.I.) = 1.54 (1.03 – 2.30)] were most predictive of treatment response. PMID:25525053

Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes.

PubMed

Achana, Felix A; Cooper, Nicola J; Bujkiewicz, Sylwia; Hubbard, Stephanie J; Kendrick, Denise; Jones, David R; Sutton, Alex J

2014-07-21

Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately.

The cost-effectiveness of immediate treatment or watch and wait with deferred chemotherapy for advanced asymptomatic follicular lymphoma.

PubMed

Prettyjohns, Matthew; Hoskin, Peter; McNamara, Christopher; Linch, David

2018-01-01

Recent evidence has shown that immediate treatment with rituximab induction, with and without maintenance, substantially reduces the need for further treatment in patients with advanced asymptomatic follicular lymphoma. This analysis estimates the cost-effectiveness of immediate treatment approaches in comparison to a watch and wait approach from the perspective of the UK National Health Service. A Markov decision model was developed to estimate the cost-effectiveness of treatment strategies in patients with asymptomatic follicular lymphoma. The model was populated using effectiveness data from a systematic literature review with the key clinical data sourced from a randomised trial, in which the treatment strategies were compared. Costs were estimated using UK national sources. In comparison to watchful waiting, both rituximab strategies were found to be more effective and cost saving. In comparison to rituximab induction, the addition of rituximab maintenance marginally increased effectiveness but substantially increased costs, resulting in an incremental cost-effectiveness ratio (ICER) of £69 406 per quality-adjusted life year (QALY). In probabilistic sensitivity analysis, rituximab induction was found to have a 68% probability of being cost-effective at a threshold of £20 000 per QALY. In conclusion, active treatment with rituximab induction is a cost-effective strategy to adopt in patients with asymptomatic follicular lymphoma. © 2017 John Wiley & Sons Ltd.

Effect of Cognitive Behavioral Therapy for Anxiety Disorders on Quality of Life: A Meta-Analysis

PubMed Central

Hofmann, Stefan G.; Wu, Jade Q.; Boettcher, Hannah

2014-01-01

OBJECTIVE Although cognitive-behavioral therapy is effective for treating anxiety disorders, little is known about its effect on quality of life. To conduct a meta-analysis of cognitive-behavioral therapy for anxiety disorders on quality of life, we searched for relevant studies in PubMed, PsycINFO and the Cochrane Library, and conducted manual searches. METHOD The search identified 44 studies that included 59 CBT trials, totaling 3,326 participants receiving cognitive-behavioral therapy for anxiety disorders. We estimated the controlled and within-group random effects of the treatment changes on quality of life. RESULTS The pre-post within-group and controlled effect sizes were moderately strong, Hedges’ g = 0.54 and Hedges’ g = 0.56, respectively. Improvements were greater for physical and psychological domains of quality of life than for environmental and social domains. The overall effect sizes decreased with publication year and increased with treatment duration. Face-to-face treatments delivered individually and in groups produced significantly higher effect sizes than internet-delivered treatments. CONCLUSION Cognitive-behavioral therapy for anxiety disorders is moderately effective for improving quality of life, especially in physical and psychological domains. Internet-delivered treatments are less effective in improving quality of life than face-to-face treatments. PMID:24447006

Cost-effectiveness analysis for joint pain treatment in patients with osteoarthritis treated at the Instituto Mexicano del Seguro Social (IMSS): Comparison of nonsteroidal anti-inflammatory drugs (NSAIDs) vs. cyclooxygenase-2 selective inhibitors.

PubMed

Contreras-Hernández, Iris; Mould-Quevedo, Joaquín F; Torres-González, Rubén; Goycochea-Robles, María Victoria; Pacheco-Domínguez, Reyna Lizette; Sánchez-García, Sergio; Mejía-Aranguré, Juan Manuel; Garduño-Espinosa, Juan

2008-11-12

Osteoarthritis (OA) is one of the main causes of disability worldwide, especially in persons >55 years of age. Currently, controversy remains about the best therapeutic alternative for this disease when evaluated from a cost-effectiveness viewpoint. For Social Security Institutions in developing countries, it is very important to assess what drugs may decrease the subsequent use of medical care resources, considering their adverse events that are known to have a significant increase in medical care costs of patients with OA. Three treatment alternatives were compared: celecoxib (200 mg twice daily), non-selective NSAIDs (naproxen, 500 mg twice daily; diclofenac, 100 mg twice daily; and piroxicam, 20 mg/day) and acetaminophen, 1000 mg twice daily. The aim of this study was to identify the most cost-effective first-choice pharmacological treatment for the control of joint pain secondary to OA in patients treated at the Instituto Mexicano del Seguro Social (IMSS). A cost-effectiveness assessment was carried out. A systematic review of the literature was performed to obtain transition probabilities. In order to evaluate analysis robustness, one-way and probabilistic sensitivity analyses were conducted. Estimations were done for a 6-month period. Treatment demonstrating the best cost-effectiveness results [lowest cost-effectiveness ratio $17.5 pesos/patient ($1.75 USD)] was celecoxib. According to the one-way sensitivity analysis, celecoxib would need to markedly decrease its effectiveness in order for it to not be the optimal treatment option. In the probabilistic analysis, both in the construction of the acceptability curves and in the estimation of net economic benefits, the most cost-effective option was celecoxib. From a Mexican institutional perspective and probably in other Social Security Institutions in similar developing countries, the most cost-effective option for treatment of knee and/or hip OA would be celecoxib.

Cost-effectiveness analysis for joint pain treatment in patients with osteoarthritis treated at the Instituto Mexicano del Seguro Social (IMSS): Comparison of nonsteroidal anti-inflammatory drugs (NSAIDs) vs. cyclooxygenase-2 selective inhibitors

PubMed Central

Contreras-Hernández, Iris; Mould-Quevedo, Joaquín F; Torres-González, Rubén; Goycochea-Robles, María Victoria; Pacheco-Domínguez, Reyna Lizette; Sánchez-García, Sergio; Mejía-Aranguré, Juan Manuel; Garduño-Espinosa, Juan

2008-01-01

Background Osteoarthritis (OA) is one of the main causes of disability worldwide, especially in persons >55 years of age. Currently, controversy remains about the best therapeutic alternative for this disease when evaluated from a cost-effectiveness viewpoint. For Social Security Institutions in developing countries, it is very important to assess what drugs may decrease the subsequent use of medical care resources, considering their adverse events that are known to have a significant increase in medical care costs of patients with OA. Three treatment alternatives were compared: celecoxib (200 mg twice daily), non-selective NSAIDs (naproxen, 500 mg twice daily; diclofenac, 100 mg twice daily; and piroxicam, 20 mg/day) and acetaminophen, 1000 mg twice daily. The aim of this study was to identify the most cost-effective first-choice pharmacological treatment for the control of joint pain secondary to OA in patients treated at the Instituto Mexicano del Seguro Social (IMSS). Methods A cost-effectiveness assessment was carried out. A systematic review of the literature was performed to obtain transition probabilities. In order to evaluate analysis robustness, one-way and probabilistic sensitivity analyses were conducted. Estimations were done for a 6-month period. Results Treatment demonstrating the best cost-effectiveness results [lowest cost-effectiveness ratio $17.5 pesos/patient ($1.75 USD)] was celecoxib. According to the one-way sensitivity analysis, celecoxib would need to markedly decrease its effectiveness in order for it to not be the optimal treatment option. In the probabilistic analysis, both in the construction of the acceptability curves and in the estimation of net economic benefits, the most cost-effective option was celecoxib. Conclusion From a Mexican institutional perspective and probably in other Social Security Institutions in similar developing countries, the most cost-effective option for treatment of knee and/or hip OA would be celecoxib. PMID:19014495

Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis.

PubMed

Konijeti, Gauree G; Sauk, Jenny; Shrime, Mark G; Gupta, Meera; Ananthakrishnan, Ashwin N

2014-06-01

Clostridium difficile infection (CDI) is an important cause of morbidity and healthcare costs, and is characterized by high rates of disease recurrence. The cost-effectiveness of newer treatments for recurrent CDI has not been examined, yet would be important to inform clinical practice. The aim of this study was to analyze the cost effectiveness of competing strategies for recurrent CDI. We constructed a decision-analytic model comparing 4 treatment strategies for first-line treatment of recurrent CDI in a population with a median age of 65 years: metronidazole, vancomycin, fidaxomicin, and fecal microbiota transplant (FMT). We modeled up to 2 additional recurrences following the initial recurrence. We assumed FMT delivery via colonoscopy as our base case, but conducted sensitivity analyses based on different modes of delivery. Willingness-to-pay threshold was set at $50 000 per quality-adjusted life-year. At our base case estimates, initial treatment of recurrent CDI using FMT colonoscopy was the most cost-effective strategy, with an incremental cost-effectiveness ratio of $17 016 relative to oral vancomycin. Fidaxomicin and metronidazole were both dominated by FMT colonoscopy. On sensitivity analysis, FMT colonoscopy remained the most cost-effective strategy at cure rates >88.4% and CDI recurrence rates <14.9%. Fidaxomicin required a cost <$1359 to meet our cost-effectiveness threshold. In clinical settings where FMT is not available or applicable, the preferred strategy appears to be initial treatment with oral vancomycin. In this decision analysis examining treatment strategies for recurrent CDI, we demonstrate that FMT colonoscopy is the most cost-effective initial strategy for management of recurrent CDI.

Current treatment of ocular toxoplasmosis in immunocompetent patients: A network meta-analysis.

PubMed

Zhang, Yanxia; Lin, Xiao; Lu, Fangli

2018-04-25

Ocular toxoplasmosis (OT) is the most frequent form of infectious posterior uveitis caused by the protozoan parasite Toxoplasma gondii. To evaluate the available evidence in peer-reviewed publications about the most effective therapy for OT in immunocompetent patients, herein a systematic literature search was conducted using Embase, PubMed, Google Scholar, and the Cochrane Central Register of Controlled Trials (CENTRAL) database from January 1987 to October 2017, with search terms "OT", "retinochoroiditis", "treatment", and "immunocompetent"; search filters "controlled clinical trial", "randomized clinical trial", and "clinical trial". The included studies were performed to evaluate the various treatment modalities of OT. Different treatment regimens were compared with regard to the improvement of visual acuity, the resolution of vitreous inflammation, recurrence, and side-effects. We independently extracted data and assessed eligibility and risk of bias using the preferred reporting items for systematic reviews and meta-analysis, and resolved any disagreement through discussion. A Bayesian network meta-analysis model was used to evaluate the interesting outcomes of all the interventions. Total 10 trials of treatments for OT were found to meet the inclusion criteria. Six trials of treatments including clindamycin, azithromycin, and trimethoprim-sulfamethoxazole (TMP-SMX) were compared with conventional therapy (the combination of pyrimethamine, sulfadiazine, and prednisone) for evaluation of the effect on visual acuity, vitreous inflammation, recurrence of OT, and side-effects. Two trials were compared TMP-SMX with placebo. One trial was compared azithromycin with TMP-SMX. And another trial was compared among treatments with clindamycin, P-S, TMP-SMX, and placebo. Based on our network meta-analysis, therapy with TMP-SMX seems to be an alternative treatment of OT in immunocompetent patients. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality of life and treatment adherence in hypertensive patients: systematic review with meta-analysis

PubMed Central

de Souza, Ana Célia Caetano; Borges, José Wicto Pereira; Moreira, Thereza Maria Magalhães

2016-01-01

ABSTRACT OBJECTIVE To verify the effects of antihypertensive treatment (pharmacological and non-pharmacological) on the health-related quality of life of individuals with hypertension. METHODS We conducted a systematic review with meta-analysis using the following databases: IBECS, LILACS, SciELO, Medline, Cochrane, Science Direct, Scopus and the Brazilian Capes Theses and Dissertations Database. The statistical analysis was performed using Review Manager, version 5.2. The average difference was used for the summarization of meta-analytic effect by the fixed-effect model. Twenty studies were included. RESULTS The summarization of the effect showed an average increase of 2.45 points (95%CI 1.02–3.87; p < 0.0008) in the quality of life of individuals adhering to non-pharmacological treatment for arterial hypertension. Adherence to pharmacological treatment indicated an average increase of 9.24 points (95%CI 8.16–10.33; p < 0.00001) in the quality of life of individuals with arterial hypertension. CONCLUSIONS Non-pharmacological treatment improves the overall quality of life and physical domain of people with arterial hypertension. Adherence to pharmacological treatment has a positive impact on the mental and physical domains of patients, as it did on the overall quality of life score. PMID:28099657

Identifying key sources of uncertainty in the modelling of greenhouse gas emissions from wastewater treatment.

PubMed

Sweetapple, Christine; Fu, Guangtao; Butler, David

2013-09-01

This study investigates sources of uncertainty in the modelling of greenhouse gas emissions from wastewater treatment, through the use of local and global sensitivity analysis tools, and contributes to an in-depth understanding of wastewater treatment modelling by revealing critical parameters and parameter interactions. One-factor-at-a-time sensitivity analysis is used to screen model parameters and identify those with significant individual effects on three performance indicators: total greenhouse gas emissions, effluent quality and operational cost. Sobol's method enables identification of parameters with significant higher order effects and of particular parameter pairs to which model outputs are sensitive. Use of a variance-based global sensitivity analysis tool to investigate parameter interactions enables identification of important parameters not revealed in one-factor-at-a-time sensitivity analysis. These interaction effects have not been considered in previous studies and thus provide a better understanding wastewater treatment plant model characterisation. It was found that uncertainty in modelled nitrous oxide emissions is the primary contributor to uncertainty in total greenhouse gas emissions, due largely to the interaction effects of three nitrogen conversion modelling parameters. The higher order effects of these parameters are also shown to be a key source of uncertainty in effluent quality. Copyright © 2013 Elsevier Ltd. All rights reserved.

The influence of baseline marijuana use on treatment of cocaine dependence: application of an informative-priors bayesian approach.

PubMed

Green, Charles; Schmitz, Joy; Lindsay, Jan; Pedroza, Claudia; Lane, Scott; Agnelli, Rob; Kjome, Kimberley; Moeller, F Gerard

2012-01-01

Marijuana use is prevalent among patients with cocaine dependence and often non-exclusionary in clinical trials of potential cocaine medications. The dual-focus of this study was to (1) examine the moderating effect of baseline marijuana use on response to treatment with levodopa/carbidopa for cocaine dependence; and (2) apply an informative-priors, Bayesian approach for estimating the probability of a subgroup-by-treatment interaction effect. A secondary data analysis of two previously published, double-blind, randomized controlled trials provided complete data for the historical (Study 1: N = 64 placebo), and current (Study 2: N = 113) data sets. Negative binomial regression evaluated Treatment Effectiveness Scores (TES) as a function of medication condition (levodopa/carbidopa, placebo), baseline marijuana use (days in past 30), and their interaction. Bayesian analysis indicated that there was a 96% chance that baseline marijuana use predicts differential response to treatment with levodopa/carbidopa. Simple effects indicated that among participants receiving levodopa/carbidopa the probability that baseline marijuana confers harm in terms of reducing TES was 0.981; whereas the probability that marijuana confers harm within the placebo condition was 0.163. For every additional day of marijuana use reported at baseline, participants in the levodopa/carbidopa condition demonstrated a 5.4% decrease in TES; while participants in the placebo condition demonstrated a 4.9% increase in TES. The potential moderating effect of marijuana on cocaine treatment response should be considered in future trial designs. Applying Bayesian subgroup analysis proved informative in characterizing this patient-treatment interaction effect.

The Influence of Baseline Marijuana Use on Treatment of Cocaine Dependence: Application of an Informative-Priors Bayesian Approach

PubMed Central

Green, Charles; Schmitz, Joy; Lindsay, Jan; Pedroza, Claudia; Lane, Scott; Agnelli, Rob; Kjome, Kimberley; Moeller, F. Gerard

2012-01-01

Background: Marijuana use is prevalent among patients with cocaine dependence and often non-exclusionary in clinical trials of potential cocaine medications. The dual-focus of this study was to (1) examine the moderating effect of baseline marijuana use on response to treatment with levodopa/carbidopa for cocaine dependence; and (2) apply an informative-priors, Bayesian approach for estimating the probability of a subgroup-by-treatment interaction effect. Method: A secondary data analysis of two previously published, double-blind, randomized controlled trials provided complete data for the historical (Study 1: N = 64 placebo), and current (Study 2: N = 113) data sets. Negative binomial regression evaluated Treatment Effectiveness Scores (TES) as a function of medication condition (levodopa/carbidopa, placebo), baseline marijuana use (days in past 30), and their interaction. Results: Bayesian analysis indicated that there was a 96% chance that baseline marijuana use predicts differential response to treatment with levodopa/carbidopa. Simple effects indicated that among participants receiving levodopa/carbidopa the probability that baseline marijuana confers harm in terms of reducing TES was 0.981; whereas the probability that marijuana confers harm within the placebo condition was 0.163. For every additional day of marijuana use reported at baseline, participants in the levodopa/carbidopa condition demonstrated a 5.4% decrease in TES; while participants in the placebo condition demonstrated a 4.9% increase in TES. Conclusion: The potential moderating effect of marijuana on cocaine treatment response should be considered in future trial designs. Applying Bayesian subgroup analysis proved informative in characterizing this patient-treatment interaction effect. PMID:23115553

Budget impact analysis of trastuzumab in early breast cancer: a hospital district perspective.

PubMed

Purmonen, Timo T; Auvinen, Päivi K; Martikainen, Janne A

2010-04-01

Adjuvant trastuzumab is widely used in HER2-positive (HER2+) early breast cancer, and despite its cost-effectiveness, it causes substantial costs for health care. The purpose of the study was to develop a tool for estimating the budget impact of new cancer treatments. With this tool, we were able to estimate the budget impact of adjuvant trastuzumab, as well as the probability of staying within a given budget constraint. The created model-based evaluation tool was used to explore the budget impact of trastuzumab in early breast cancer in a single Finnish hospital district with 250,000 inhabitants. The used model took into account the number of patients, HER2+ prevalence, length and cost of treatment, and the effectiveness of the therapy. Probabilistic sensitivity analysis and alternative case scenarios were performed to ensure the robustness of the results. Introduction of adjuvant trastuzumab caused substantial costs for a relatively small hospital district. In base-case analysis the 4-year net budget impact was 1.3 million euro. The trastuzumab acquisition costs were partially offset by the reduction in costs associated with the treatment of cancer recurrence and metastatic disease. Budget impact analyses provide important information about the overall economic impact of new treatments, and thus offer complementary information to cost-effectiveness analyses. Inclusion of treatment outcomes and probabilistic sensitivity analysis provides more realistic estimates of the net budget impact. The length of trastuzumab treatment has a strong effect on the budget impact.

[Cost-effectiveness Analysis of Panitumumab Plus mFOLFOX6 Compared to Bevacizumab Plus mFOLFOX6 for First-line Treatment of Patients with Wild-type RAS Metastatic Colorectal Cancer--Czech Republic Model Adaptation].

PubMed

Fínek, J; Skoupá, J; Jandová, P

2015-01-01

Pharmacoeconomic assessments are a part of the decision process not only during reimbursement setting, but in clinical practice as well. The presented cost-effectiveness analysis assesses panitumumab+mFOLFOX6 vs. bevacizumab+mFOLFOX6 in 1st line treatment of patients with wildtype RAS metastatic colorectal cancer (mCRC) in the Czech environment. The adaptation of a Markov model considers the healthcare perspective; clinical data (efficacy, healthcare utilization and adverse events) are derived from a head-to-head comparison (PEAK study). Health states included in the model: progression free on treatment, progression (with/ without active treatment), resection of metastases, disease-free after successful resection and death. Actual reimbursement levels were used to estimate costs, published literature to estimate duration of 2nd line treatment. The analysis assumes a lifetime horizon; uncertainty was limited by performing one-way and probabilistic sensitivity analyses. Analysis outcomes are life-years gained (LYG) and quality-adjusted life-years (QALYs). Panitumumab+mFOLFOX6 is more effective and more costly in 1st line patients with wildtype RAS mCRC. Incremental costs per QALY are 837,270 CZK, per LYG 615,022 CZK; however, below the willingness-to-pay threshold applied in the Czech Republic. Panitumumab+mFOLFOX6 is cost-effective in 1st line treatment of patients with wildtype RAS mCRC compared to bevacizumab+mFOLFOX6 in the Czech setting.

Acupuncture and moxibustion for chronic fatigue syndrome in traditional Chinese medicine: a systematic review and meta-analysis.

PubMed

Wang, Taiwu; Xu, Cong; Pan, Keli; Xiong, Hongyan

2017-03-23

As the etiology of chronic fatigue syndrome (CFS) is unclear and the treatment is still a big issue. There exists a wide range of literature about acupuncture and moxibustion (AM) for CFS in traditional Chinese medicine (TCM). But there are certain doubts as well in the effectiveness of its treatment due to the lack of a comprehensive and evidence-based medical proof to dispel the misgivings. Current study evaluated systematically the effectiveness of acupuncture and moxibustion treatments on CFS, and clarified the difference among them and Chinese herbal medicine, western medicine and sham-acupuncture. We comprehensively reviewed literature including PubMed, EMBASE, Cochrane library, CBM (Chinese Biomedical Literature Database) and CNKI (China National Knowledge Infrastructure) up to May 2016, for RCT clinical research on CFS treated by acupuncture and moxibustion. Traditional direct meta-analysis was adopted to analyze the difference between AM and other treatments. Analysis was performed based on the treatment in experiment and control groups. Network meta-analysis was adopted to make comprehensive comparisons between any two kinds of treatments. The primary outcome was total effective rate, while relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics. A total of 31 randomized controlled trials (RCTs) were enrolled in analyses. In traditional direct meta-analysis, we found that in comparison to Chinese herbal medicine, CbAM (combined acupuncture and moxibustion, which meant two or more types of acupuncture and moxibustion were adopted) had a higher total effective rate (RR (95% CI), 1.17 (1.09 ~ 1.25)). Compared with Chinese herbal medicine, western medicine and sham-acupuncture, SAM (single acupuncture or single moxibustion) had a higher total effective rate, with RR (95% CI) of 1.22 (1.14 ~ 1.30), 1.51 (1.31-1.74), 5.90 (3.64-9.56). In addition, compared with SAM, CbAM had a higher total effective rate (RR (95% CI), 1.23 (1.12 ~ 1.36)). In network meta-analyses, similar results were recorded. Subsequently, we ranked all treatments from high to low effective rate and the order was CbAM, SAM, Chinese herbal medicine, western medicine and sham-acupuncture. In the treatment of CFS, CbAM and SAM may have better effect than other treatments. However, the included trials have relatively poor quality, hence high quality studies are needed to confirm our finding.

[Analysis of costs and cost-effectiveness of preferred GESIDA/National AIDS Plan regimens for initial antiretroviral therapy in human immunodeficiency virus infected adult patients in 2013].

PubMed

Blasco, Antonio Javier; Llibre, Josep M; Arribas, José Ramón; Boix, Vicente; Clotet, Bonaventura; Domingo, Pere; González-García, Juan; Knobel, Hernando; López, Juan Carlos; Lozano, Fernando; Miró, José M; Podzamczer, Daniel; Santamaría, Juan Miguel; Tuset, Montserrat; Zamora, Laura; Lázaro, Pablo; Gatell, Josep M

2013-11-01

The GESIDA and National AIDS Plan panel of experts have proposed "preferred regimens" of antiretroviral treatment (ART) as initial therapy in HIV infected patients for 2013. The objective of this study is to evaluate the costs and effectiveness of initiating treatment with these "preferred regimens". An economic assessment of costs and effectiveness (cost/effectiveness) was performed using decision tree analysis models. Effectiveness was defined as the probability of having viral load <50copies/mL at week48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regime was defined as the costs of ART and its consequences (adverse effects, changes of ART regime and drug resistance analyses) during the first 48weeks. The perspective of the analysis is that of the National Health System was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, resistance studies, and determination of HLA B*5701. The setting is Spain and the costs are those of 2013. A sensitivity deterministic analysis was performed, constructing three scenarios for each regimen: baseline, most favourable, and most unfavourable cases. In the baseline case scenario, the cost of initiating treatment ranges from 6,747euros for TDF/FTC+NVP to 12,059euros for TDF/FTC+RAL. The effectiveness ranges between 0.66 for ABC/3TC+LPV/r and ABC/3TC+ATV/r, and 0.87 for TDF/FTC+RAL and ABC/3TC+RAL. Effectiveness, in terms of cost/effectiveness, varies between 8,396euros and 13,930euros per responder at 48weeks, for TDF/FTC/RPV and TDF/FTC+RAL, respectively. Taking ART at official prices, the most effective regimen was TDF/FTC/RPV, followed by the rest of non-nucleoside containing regimens. The sensitivity analysis confirms the robustness of these findings. Copyright © 2013 Elsevier España, S.L. All rights reserved.

CFD Analysis of an Installation Used to Measure the Skin-Friction Penalty of Acoustic Treatments

NASA Technical Reports Server (NTRS)

Spalart, Philippe R.; Garbaruk, Andrey; Howerton, Brian M.

2017-01-01

There is a drive to devise acoustic treatments with reduced skin-friction and therefore fuel-burn penalty for engine nacelles on commercial airplanes. The studies have been experimental, and the effects on skin-friction are deduced from measurements of the pressure drop along a duct. We conduct a detailed CFD analysis of the installation, for two purposes. The first is to predict the effects of the finite size of the rig, including its near-square cross-section and the moderate length of the treated patch; this introduces transient and blockage effects, which have not been included so far in the analysis. In addition, the flow is compressible, so that even with homogeneous surface conditions, it is not homogeneous in the streamwise direction. The second purpose is to extract an effective sand-grain roughness size for a particular liner, which in turn can be used in a CFD analysis of the aircraft, leading to actual predictions of the effect of acoustic treatments on fuel burn in service. The study is entirely based on classical turbulence models, with an appropriate modification for effective roughness effects, rather than directly modeling the liners.

Meta-Analysis: Reduced Risk of Anxiety with Psychostimulant Treatment in Children with Attention-Deficit/Hyperactivity Disorder.

PubMed

Coughlin, Catherine G; Cohen, Stephanie C; Mulqueen, Jilian M; Ferracioli-Oda, Eduardo; Stuckelman, Zachary D; Bloch, Michael H

2015-10-01

Anxiety is a commonly reported side-effect of psychostimulant treatment. Our goal was to quantify the risk of anxiety as a side effect of psychostimulant treatment for attention-deficit/hyperactivity disorder (ADHD). We conducted a PubMed search to identify all double-blind, randomized, placebo-controlled trials examining the efficacy of psychostimulant medications in the treatment of children with ADHD. We used a fixed-effects meta-analysis to examine the risk ratio of anxiety reported as a side effect in children treated with psychostimulants compared with those treated with placebo. We used stratified subgroup analysis and meta-regression to examine the effects of stimulant type, dosage, duration of use, and trial design on the measured risk of anxiety. We identified 23 studies involving 2959 children with ADHD for inclusion in our meta-analysis. The risk of anxiety associated with psychostimulant treatment was significantly lower than that experienced with placebo (relative risk [RR] = 0.86 [95% CI: 0.77, 0.95], z = -2.90, p < 0.05). Higher doses of psychostimulants were associated with a reduced measured risk of anxiety of psychostimulants when compared with placebo (β = -0.0039 [95% CI: -0.00718, -0.00064], z = -2.34, p = 0.019). Meta-analysis suggests that treatment with psychostimulants significantly reduced the risk of anxiety when compared with placebo. This finding does not rule out the possibility that some children experience increased anxiety when treated with psychostimulants, but suggests that those risks are outweighed by the number of children who experience improvement in anxiety symptoms (possibly as a secondary effect of improved control of ADHD symptoms). Clinicians should consider rechallenging children with ADHD who report new-onset or worsening anxiety with psychostimulants, as these symptoms are much more likely to be coincidental rather than caused by psychostimulants.

Do trauma-focussed psychological interventions have an effect on psychotic symptoms? A systematic review and meta-analysis.

PubMed

Brand, Rachel M; McEnery, Carla; Rossell, Susan; Bendall, Sarah; Thomas, Neil

2018-05-01

There is growing recognition of the relationship between trauma, posttraumatic stress disorder (PTSD) and psychosis. There may be overlaps in causal mechanisms involved in the development of PTSD and psychosis following traumatic or adverse events. Trauma-focussed treatments found to be effective in treating PTSD may therefore represent a new direction in the psychological treatment of psychosis. This systematic review examined the literature on trauma-focussed treatments conducted with people with schizophrenia spectrum or psychotic disorders to determine effects on psychotic symptoms. Secondary outcomes were symptoms of PTSD, depression and anxiety. Twenty-five studies were included in the review, with 12 being included in the meta-analysis. Trauma-focussed treatments had a small, significant effect (g=0.31, CI [0.55, 0.06]) on positive symptoms immediately post-treatment, but the significance and magnitude of this effect was not maintained at follow-up (g=0.18, CI [0.42, -0.06]). Trauma-focussed treatments also had a small effect on delusions at both post-treatment (g=0.37, CI [0.87, -0.12]) and follow-up (g=0.38, CI [0.67, 0.10]), but this only reached significance at follow-up. Effects on hallucinations and negative symptoms were small and non-significant. Effects on PTSD symptoms were also small (post-treatment g=0.21, CI [0.70, -0.27], follow up g=0.31, CI [0.62, 0.00]) and only met significance at follow-up. No significant effects were found on symptoms of depression and anxiety. Results show promising effects of trauma-focussed treatments for the positive symptoms of psychosis, however further studies developing and evaluating trauma-focussed treatments for trauma-related psychotic symptoms are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Erlotinib or best supportive care for third-line treatment of advanced non-small-cell lung cancer: a real-world cost-effectiveness analysis.

PubMed

Cromwell, Ian; van der Hoek, Kimberly; Malfair Taylor, Suzanne C; Melosky, Barbara; Peacock, Stuart

2012-06-01

Erlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer (NSCLC) in British Columbia (BC). A cost-effectiveness analysis was conducted to compare costs and effectiveness in patients who received third-line erlotinib to those in a historical patient cohort that would have been eligible had erlotinib been available. In a population of patients who have been treated with drugs for advanced NSCLC, overall survival (OS), progression-to-death survival (PTD) and probability of survival one year after end of second-line (1YS) were determined using a Kaplan-Meier survival analysis. Costs were collected retrospectively from the perspective of the BC health care system. Incremental mean OS was 90 days (0.25 LYG), and incremental mean cost was $11,102 (CDN 2009), resulting in a mean ICER of $36,838/LYG. Univariate sensitivity analysis yielded ICERs ranging from $21,300 to $51,700/LYG. Our analysis suggests that erlotinib may be an effective and cost-effective third-line treatment for advanced NSCLC compared to best supportive care. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Do Patients’ Symptoms and Interpersonal Problems Improve in Psychotherapeutic Hospital Treatment in Germany? - A Systematic Review and Meta-Analysis

PubMed Central

Liebherz, Sarah; Rabung, Sven

2014-01-01

Background In Germany, inpatient psychotherapy plays a unique role in the treatment of patients with common mental disorders of higher severity. In addition to psychiatric inpatient services, psychotherapeutic hospital treatment and psychosomatic rehabilitation are offered as independent inpatient treatment options. This meta-analysis aims to provide systematic evidence for psychotherapeutic hospital treatment in Germany regarding its effects on symptomatic and interpersonal impairment. Methodology Relevant papers were identified by electronic database search and hand search. Randomized controlled trials as well as naturalistic prospective studies (including post-therapy and follow-up assessments) evaluating psychotherapeutic hospital treatment of mentally ill adults in Germany were included. Outcomes were required to be quantified by either the Symptom-Checklist (SCL-90-R or short versions) or the Inventory of Interpersonal Problems (IIP-64 or short versions). Effect sizes (Hedges’ g) were combined using random effect models. Principal Findings Sixty-seven papers representing 59 studies fulfilled inclusion criteria. Meta-analysis yielded a medium within-group effect size for symptom change at discharge (g = 0.72; 95% CI 0.68–0.76), with a small reduction to follow-up (g = 0.61; 95% CI 0.55–0.68). Regarding interpersonal problems, a small effect size was found at discharge (g = 0.35; 95% CI 0.29–0.41), which increased to follow-up (g = 0.48; 95% CI 0.36–0.60). While higher impairment at intake was associated with a larger effect size in both measures, longer treatment duration was related to lower effect sizes in SCL GSI and to larger effect sizes in IIP Total. Conclusions Psychotherapeutic hospital treatment may be considered an effective treatment. In accordance with Howard’s phase model of psychotherapy outcome, the present study demonstrated that symptom distress changes more quickly and strongly than interpersonal problems. Preliminary analyses show impairment at intake and treatment duration to be the strongest outcome predictors. Further analyses regarding this relationship are required. PMID:25141289

Effects of antithyroid drugs on radioiodine treatment: systematic review and meta-analysis of randomised controlled trials.

PubMed

Walter, Martin A; Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat

2007-03-10

To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Meta-analysis. Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively.

Effects of processing treatment and sorbate addition on the flavor characteristics of apple cider.

PubMed

Boylston, Terri D; Wang, Hui; Reitmeier, Cheryll A; Glatz, Bonita A

2003-03-26

Processing treatments used to produce a microbiologically "safe" apple cider were evaluated to determine the impact of these treatments on the overall flavor characteristics. Apple cider with (0.1%) and without (0%) potassium sorbate was subjected to four processing treatments: untreated, irradiated at 2 kGy, irradiated at 4 kGy, and pasteurized. Volatile flavor compounds were isolated from the cider using solid-phase microextraction methods with gas chromatographic analysis. A trained descriptive analysis panel evaluated sensory attributes. The effects of the processing treatment were dependent on the presence of sorbate in the apple cider. Irradiation treatments resulted in a decrease in the content of esters characteristic of apple flavor and an increase in the content of alcohols and aldehydes formed through lipid oxidation reactions. The presence of sorbate reduced the effects of the irradiation treatments on these volatile flavor compounds. Sensory panelists, however, detected higher intensities of undesirable flavor attributes, including "cardboard flavor", and lower intensities of the desirable "apple flavor" in irradiated cider with added sorbate.

Pipeline embolization device versus coiling for the treatment of large and giant unruptured intracranial aneurysms: a cost-effectiveness analysis.

PubMed

Wali, Arvin R; Park, Charlie C; Santiago-Dieppa, David R; Vaida, Florin; Murphy, James D; Khalessi, Alexander A

2017-06-01

OBJECTIVE Rupture of large or giant intracranial aneurysms leads to significant morbidity, mortality, and health care costs. Both coiling and the Pipeline embolization device (PED) have been shown to be safe and clinically effective for the treatment of unruptured large and giant intracranial aneurysms; however, the relative cost-to-outcome ratio is unknown. The authors present the first cost-effectiveness analysis to compare the economic impact of the PED compared with coiling or no treatment for the endovascular management of large or giant intracranial aneurysms. METHODS A Markov model was constructed to simulate a 60-year-old woman with a large or giant intracranial aneurysm considering a PED, endovascular coiling, or no treatment in terms of neurological outcome, angiographic outcome, retreatment rates, procedural and rehabilitation costs, and rupture rates. Transition probabilities were derived from prior literature reporting outcomes and costs of PED, coiling, and no treatment for the management of aneurysms. Cost-effectiveness was defined, with the incremental cost-effectiveness ratios (ICERs) defined as difference in costs divided by the difference in quality-adjusted life years (QALYs). The ICERs < $50,000/QALY gained were considered cost-effective. To study parameter uncertainty, 1-way, 2-way, and probabilistic sensitivity analyses were performed. RESULTS The base-case model demonstrated lifetime QALYs of 12.72 for patients in the PED cohort, 12.89 for the endovascular coiling cohort, and 9.7 for patients in the no-treatment cohort. Lifetime rehabilitation and treatment costs were $59,837.52 for PED; $79,025.42 for endovascular coiling; and $193,531.29 in the no-treatment cohort. Patients who did not undergo elective treatment were subject to increased rates of aneurysm rupture and high treatment and rehabilitation costs. One-way sensitivity analysis demonstrated that the model was most sensitive to assumptions about the costs and mortality risks for PED and coiling. Probabilistic sampling demonstrated that PED was the cost-effective strategy in 58.4% of iterations, coiling was the cost-effective strategy in 41.4% of iterations, and the no-treatment option was the cost-effective strategy in only 0.2% of iterations. CONCLUSIONS The authors' cost-effective model demonstrated that elective endovascular techniques such as PED and endovascular coiling are cost-effective strategies for improving health outcomes and lifetime quality of life measures in patients with large or giant unruptured intracranial aneurysm.

Factors in Teacher Adherence to Treatment.

ERIC Educational Resources Information Center

Gum, Louann

Treatment integrity, a measure of how accurately a treatment is carried out, is integral to the concept of effective behavioral analysis and intervention. This study sought to correlate teachers' perceptions of the functional behavior assessment and behavior intervention process (FBA/BIP) with their confidence that the process is an effective and…

Evaluating surrogate endpoints, prognostic markers, and predictive markers: Some simple themes.

PubMed

Baker, Stuart G; Kramer, Barnett S

2015-08-01

A surrogate endpoint is an endpoint observed earlier than the true endpoint (a health outcome) that is used to draw conclusions about the effect of treatment on the unobserved true endpoint. A prognostic marker is a marker for predicting the risk of an event given a control treatment; it informs treatment decisions when there is information on anticipated benefits and harms of a new treatment applied to persons at high risk. A predictive marker is a marker for predicting the effect of treatment on outcome in a subgroup of patients or study participants; it provides more rigorous information for treatment selection than a prognostic marker when it is based on estimated treatment effects in a randomized trial. We organized our discussion around a different theme for each topic. "Fundamentally an extrapolation" refers to the non-statistical considerations and assumptions needed when using surrogate endpoints to evaluate a new treatment. "Decision analysis to the rescue" refers to use the use of decision analysis to evaluate an additional prognostic marker because it is not possible to choose between purely statistical measures of marker performance. "The appeal of simplicity" refers to a straightforward and efficient use of a single randomized trial to evaluate overall treatment effect and treatment effect within subgroups using predictive markers. The simple themes provide a general guideline for evaluation of surrogate endpoints, prognostic markers, and predictive markers. © The Author(s) 2014.

Subclinical hypothyroidism: to treat or not to treat, that is the question! A systematic review with meta-analysis on lipid profile

PubMed Central

Lau, Eva; de Sousa Pinto, Bernardo; Carvalho, Davide

2017-01-01

Previous studies suggested that subclinical hypothyroidism has a detrimental effect on cardiovascular risk factors, and that its effective treatment may have a beneficial impact on overall health. The main purpose of this review and meta-analysis was to assess whether subclinical hypothyroidism treatment is of clinical relevance, based on cardiovascular risk parameters correction. A systemic research of the literature using MEDLINE tool was performed to identify the relevant studies. Only placebo-controlled randomized control trials were included. A quantitative analysis was also performed. This systematic review and meta-analysis of randomized placebo-controlled trials assess the different impact of levothyroxine vs placebo treatment. A significant decrease in serum thyroid-stimulating hormone and total and low-density lipoprotein cholesterol was obtained with levothyroxine therapy (66, 9 and 14%, respectively) and, although modest, this could be significant in terms of reduction of the incidence of coronary artery disease. Other significant results of lipid parameters were not obtained. This systematic review provides a strong evidence-based data in favour of specific changes and beneficial effects of levothyroxine treatment. PMID:28249936

Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation.

PubMed

Thurgar, Elizabeth; Barton, Samantha; Karner, Charlotta; Edwards, Steven J

2016-03-01

Typically occurring on the external genitalia, anogenital warts (AGWs) are benign epithelial skin lesions caused by human papillomavirus infection. AGWs are usually painless but can be unsightly and physically uncomfortable, and affected people might experience psychological distress. The evidence base on the clinical effectiveness and cost-effectiveness of treatments for AGWs is limited. To systematically review the evidence on the clinical effectiveness of medical and surgical treatments for AGWs and to develop an economic model to estimate the cost-effectiveness of the treatments. Electronic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases and Web of Science) were searched from inception (or January 2000 for Web of Science) to September 2014. Bibliographies of relevant systematic reviews were hand-searched to identify potentially relevant studies. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for ongoing and planned studies. A systematic review of the clinical effectiveness literature was carried out according to standard methods and a mixed-treatment comparison (MTC) undertaken. The model implemented for each outcome was that with the lowest deviance information criterion. A de novo economic model was developed to assess cost-effectiveness from the perspective of the UK NHS. The model structure was informed through a systematic review of the economic literature and in consultation with clinical experts. Effectiveness data were obtained from the MTC. Costs were obtained from the literature and standard UK sources. Of 4232 titles and abstracts screened for inclusion in the review of clinical effectiveness, 60 randomised controlled trials (RCTs) evaluating 19 interventions were included. Analysis by MTC indicated that ablative techniques were typically more effective than topical interventions at completely clearing AGWs at the end of treatment. Podophyllotoxin 0.5% solution (Condyline(®), Takeda Pharmaceutical Company Ltd; Warticon(®) solution, Stiefel Laboratories Ltd) was found to be the most effective topical treatment evaluated. Networks for other outcomes included fewer treatments, which restrict conclusions on the comparative effectiveness of interventions. In total, 84 treatment strategies were assessed using the economic model. Podophyllotoxin 0.5% solution first line followed by carbon dioxide (CO2) laser therapy second line if AGWs did not clear was most likely to be considered a cost-effective use of resources at a willingness to pay of £20,000-30,000 per additional quality-adjusted life-year gained. The result was robust to most sensitivity analyses conducted. Limited reporting in identified studies of baseline characteristics for the enrolled population generates uncertainty around the comparability of the study populations and therefore the generalisability of the results to clinical practice. Subgroup analyses were planned based on type, number and size of AGWs, all of which are factors thought to influence treatment effect. Lack of data on clinical effectiveness based on these characteristics precluded analysis of the differential effects of treatments in the subgroups of interest. Despite identification of 60 studies, most comparisons in the MTC are informed by only one RCT. Additionally, lack of head-to-head RCTs comparing key treatments, together with minimal reporting of results in some studies, precluded comprehensive analysis of all treatments for AGWs. The results generated by the MTC are in agreement with consensus opinion that ablative techniques are clinically more effective at completely clearing AGWs after treatment. However, the evidence base informing the MTC is limited. A head-to-head RCT that evaluates the comparative effectiveness of interventions used in clinical practice would help to discern the potential advantages and disadvantages of the individual treatments. The results of the economic analysis suggest that podophyllotoxin 0.5% solution is likely to represent a cost-effective first-line treatment option. More expensive effective treatments, such as CO2 laser therapy or surgery, may represent cost-effective second-line treatment options. No treatment and podophyllin are unlikely to be considered cost-effective treatment options. There is uncertainty around the cost-effectiveness of treatment with imiquimod, trichloroacetic acid and cryotherapy. This study is registered as PROSPERO CRD42013005457. The National Institute for Health Research Health Technology Assessment programme.

Surgical Versus Nonsurgical Treatment for Midshaft Clavicle Fractures in Patients Aged 16 Years and Older: A Systematic Review, Meta-analysis, and Comparison of Randomized Controlled Trials and Observational Studies.

PubMed

Smeeing, Diederik P J; van der Ven, Denise J C; Hietbrink, Falco; Timmers, Tim K; van Heijl, Mark; Kruyt, Moyo C; Groenwold, Rolf H H; van der Meijden, Olivier A J; Houwert, Roderick M

2017-07-01

There is no consensus on the choice of treatment of midshaft clavicle fractures (MCFs). The aims of this systematic review and meta-analysis were (1) to compare fracture healing disorders and functional outcomes of surgical versus nonsurgical treatment of MCFs and (2) to compare effect estimates obtained from randomized controlled trials (RCTs) and observational studies. Systematic review and meta-analysis. The PubMed/MEDLINE, Embase, CENTRAL, and CINAHL databases were searched for both RCTs and observational studies. Using the MINORS instrument, all included studies were assessed on their methodological quality. The primary outcome was a nonunion. Effects of surgical versus nonsurgical treatment were estimated using random-effects meta-analysis models. A total of 20 studies were included, of which 8 were RCTs and 12 were observational studies including 1760 patients. Results were similar across the different study designs. A meta-analysis of 19 studies revealed that nonunions were significantly less common after surgical treatment than after nonsurgical treatment (odds ratio [OR], 0.18 [95% CI, 0.10-0.33]). The risk of malunions did not differ between surgical and nonsurgical treatment (OR, 0.38 [95% CI, 0.12-1.19]). Both the long-term Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores favored surgical treatment (DASH: mean difference [MD], -2.04 [95% CI, -3.56 to -0.52]; Constant-Murley: MD, 3.23 [95% CI, 1.52 to 4.95]). No differences were observed regarding revision surgery (OR, 0.85 [95% CI, 0.42-1.73]). Including only high-quality studies, both the number of malunions and days to return to work show significant differences in favor of surgical treatment (malunions: OR, 0.26 [95% CI, 0.07 to 0.92]; return to work: MD, -8.64 [95% CI, -16.22 to -1.05]). This meta-analysis of high-quality studies showed that surgical treatment of MCFs results in fewer nonunions, fewer malunions, and an accelerated return to work compared with nonsurgical treatment. A meta-analysis of surgical treatments need not be restricted to randomized trials, provided that the included observational studies are of high quality.

A Cost-Effectiveness Analysis of Seminatural Wetlands and Activated Sludge Wastewater-Treatment Systems

NASA Astrophysics Data System (ADS)

Mannino, Ilda; Franco, Daniel; Piccioni, Enrico; Favero, Laura; Mattiuzzo, Erika; Zanetto, Gabriele

2008-01-01

A cost-effectiveness analysis was performed to evaluate the competitiveness of seminatural Free Water Surface (FWS) wetlands compared to traditional wastewater-treatment plants. Six scenarios of the service costs of three FWS wetlands and three different wastewater-treatment plants based on active sludge processes were compared. The six scenarios were all equally effective in their wastewater-treatment capacity. The service costs were estimated using real accounting data from an experimental wetland and by means of a market survey. Some assumptions had to be made to perform the analysis. A reference wastewater situation was established to solve the problem of the different levels of dilution that characterize the inflow water of the different systems; the land purchase cost was excluded from the analysis, considering the use of public land as shared social services, and an equal life span for both seminatural and traditional wastewater-treatment plants was set. The results suggest that seminatural systems are competitive with traditional biotechnological systems, with an average service cost improvement of 2.1-fold to 8-fold, according to the specific solution and discount rate. The main improvement factor was the lower maintenance cost of the seminatural systems, due to the self-regulating, low artificial energy inputs and the absence of waste to be disposed. In this work, only the waste-treatment capacity of wetlands was considered as a parameter for the economic competitiveness analysis. Other goods/services and environmental benefits provided by FWS wetlands were not considered.

A cost-effectiveness analysis of seminatural wetlands and activated sludge wastewater-treatment systems.

PubMed

Mannino, Ilda; Franco, Daniel; Piccioni, Enrico; Favero, Laura; Mattiuzzo, Erika; Zanetto, Gabriele

2008-01-01

A cost-effectiveness analysis was performed to evaluate the competitiveness of seminatural Free Water Surface (FWS) wetlands compared to traditional wastewater-treatment plants. Six scenarios of the service costs of three FWS wetlands and three different wastewater-treatment plants based on active sludge processes were compared. The six scenarios were all equally effective in their wastewater-treatment capacity. The service costs were estimated using real accounting data from an experimental wetland and by means of a market survey. Some assumptions had to be made to perform the analysis. A reference wastewater situation was established to solve the problem of the different levels of dilution that characterize the inflow water of the different systems; the land purchase cost was excluded from the analysis, considering the use of public land as shared social services, and an equal life span for both seminatural and traditional wastewater-treatment plants was set. The results suggest that seminatural systems are competitive with traditional biotechnological systems, with an average service cost improvement of 2.1-fold to 8-fold, according to the specific solution and discount rate. The main improvement factor was the lower maintenance cost of the seminatural systems, due to the self-regulating, low artificial energy inputs and the absence of waste to be disposed. In this work, only the waste-treatment capacity of wetlands was considered as a parameter for the economic competitiveness analysis. Other goods/services and environmental benefits provided by FWS wetlands were not considered.

The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.

PubMed

Roozenbeek, Bob; Lingsma, Hester F; Perel, Pablo; Edwards, Phil; Roberts, Ian; Murray, Gordon D; Maas, Andrew Ir; Steyerberg, Ewout W

2011-01-01

In clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome. Simulation studies have shown that exploiting the ordinal nature of the GOS increases chances of detecting treatment effects. The objective of this study is to quantify the benefits of ordinal analysis in the real-life situation of a large TBI trial. We used data from the CRASH trial that investigated the efficacy of corticosteroids in TBI patients (n = 9,554). We applied two techniques for ordinal analysis: proportional odds analysis and the sliding dichotomy approach, where the GOS is dichotomized at different cut-offs according to baseline prognostic risk. These approaches were compared to dichotomous analysis. The information density in each analysis was indicated by a Wald statistic. All analyses were adjusted for baseline characteristics. Dichotomous analysis of the six-month GOS showed a non-significant treatment effect (OR = 1.09, 95% CI 0.98 to 1.21, P = 0.096). Ordinal analysis with proportional odds regression or sliding dichotomy showed highly statistically significant treatment effects (OR 1.15, 95% CI 1.06 to 1.25, P = 0.0007 and 1.19, 95% CI 1.08 to 1.30, P = 0.0002), with 2.05-fold and 2.56-fold higher information density compared to the dichotomous approach respectively. Analysis of the CRASH trial data confirmed that ordinal analysis of outcome substantially increases statistical power. We expect these results to hold for other fields of critical care medicine that use ordinal outcome measures and recommend that future trials adopt ordinal analyses. This will permit detection of smaller treatment effects.

Meta-Analysis of Rare Binary Adverse Event Data

PubMed Central

Bhaumik, Dulal K.; Amatya, Anup; Normand, Sharon-Lise; Greenhouse, Joel; Kaizar, Eloise; Neelon, Brian; Gibbons, Robert D.

2013-01-01

We examine the use of fixed-effects and random-effects moment-based meta-analytic methods for analysis of binary adverse event data. Special attention is paid to the case of rare adverse events which are commonly encountered in routine practice. We study estimation of model parameters and between-study heterogeneity. In addition, we examine traditional approaches to hypothesis testing of the average treatment effect and detection of the heterogeneity of treatment effect across studies. We derive three new methods, simple (unweighted) average treatment effect estimator, a new heterogeneity estimator, and a parametric bootstrapping test for heterogeneity. We then study the statistical properties of both the traditional and new methods via simulation. We find that in general, moment-based estimators of combined treatment effects and heterogeneity are biased and the degree of bias is proportional to the rarity of the event under study. The new methods eliminate much, but not all of this bias. The various estimators and hypothesis testing methods are then compared and contrasted using an example dataset on treatment of stable coronary artery disease. PMID:23734068

Standardized Effect Size Measures for Mediation Analysis in Cluster-Randomized Trials

ERIC Educational Resources Information Center

Stapleton, Laura M.; Pituch, Keenan A.; Dion, Eric

2015-01-01

This article presents 3 standardized effect size measures to use when sharing results of an analysis of mediation of treatment effects for cluster-randomized trials. The authors discuss 3 examples of mediation analysis (upper-level mediation, cross-level mediation, and cross-level mediation with a contextual effect) with demonstration of the…

The Influence of Direct Instruction on Student Self-appraisals: A Hierarchical Analysis of Treatment and Aptitude-Treatment Interaction Effects.

ERIC Educational Resources Information Center

Corno, Lyn; And Others

1981-01-01

Treatment and aptitude-treatment interaction (ATI) effects were assessed on grade 3 student self-appraisal data relating to self-esteem, attitude, anxiety, and locus of control. In particular, parent instruction in learning skills resulted in significantly higher average scores on student self-esteem and attitude and lower scores on anxiety.…

A cost-effectiveness analysis of "test" versus "treat" patients hospitalized with suspected influenza in Hong Kong.

PubMed

You, Joyce H S; Chan, Eva S K; Leung, Maggie Y K; Ip, Margaret; Lee, Nelson L S

2012-01-01

Seasonal and 2009 H1N1 influenza viruses may cause severe diseases and result in excess hospitalization and mortality in the older and younger adults, respectively. Early antiviral treatment may improve clinical outcomes. We examined potential outcomes and costs of test-guided versus empirical treatment in patients hospitalized for suspected influenza in Hong Kong. We designed a decision tree to simulate potential outcomes of four management strategies in adults hospitalized for severe respiratory infection suspected of influenza: "immunofluorescence-assay" (IFA) or "polymerase-chain-reaction" (PCR)-guided oseltamivir treatment, "empirical treatment plus PCR" and "empirical treatment alone". Model inputs were derived from literature. The average prevalence (11%) of influenza in 2010-2011 (58% being 2009 H1N1) among cases of respiratory infections was used in the base-case analysis. Primary outcome simulated was cost per quality-adjusted life-year (QALY) expected (ICER) from the Hong Kong healthcare providers' perspective. In base-case analysis, "empirical treatment alone" was shown to be the most cost-effective strategy and dominated the other three options. Sensitivity analyses showed that "PCR-guided treatment" would dominate "empirical treatment alone" when the daily cost of oseltamivir exceeded USD18, or when influenza prevalence was <2.5% and the predominant circulating viruses were not 2009 H1N1. Using USD50,000 as the threshold of willingness-to-pay, "empirical treatment alone" and "PCR-guided treatment" were cost-effective 97% and 3% of time, respectively, in 10,000 Monte-Carlo simulations. During influenza epidemics, empirical antiviral treatment appears to be a cost-effective strategy in managing patients hospitalized with severe respiratory infection suspected of influenza, from the perspective of healthcare providers in Hong Kong.

The Treatment of Challenging Behaviour in Intellectual Disabilities: Cost-Effectiveness Analysis

ERIC Educational Resources Information Center

Romeo, R.; Knapp, M.; Tyrer, P.; Crawford, M.; Oliver-Africano, P.

2009-01-01

Background: Antipsychotic drugs are used in the routine treatment of adults with intellectual disabilities (ID) and challenging behaviour in the UK despite limited evidence of their effectiveness. There is no evidence on their cost-effectiveness. Methods: The relative cost-effectiveness of risperidone, haloperidol and placebo in treating…

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Individual patient data meta-analysis of combined treatments versus psychotherapy (with or without pill placebo), pharmacotherapy or pill placebo for adult depression: a protocol.

PubMed

Weitz, Erica; Kleiboer, Annet; van Straten, Annemieke; Hollon, Steven D; Cuijpers, Pim

2017-02-13

There are many proven treatments (psychotherapy, pharmacotherapy or their combination) for the treatment of depression. Although there is growing evidence for the effectiveness of combination treatment (psychotherapy + pharmacotherapy) over pharmacotherapy alone, psychotherapy alone or psychotherapy plus pill placebo, for depression, little is known about which specific groups of patients may respond best to combined treatment versus monotherapy. Conventional meta-analyses techniques have limitations when tasked with examining whether specific individual characteristics moderate the effect of treatment on depression. Therefore, this protocol outlines an individual patient data (IPD) meta-analysis to explore which patients, with which clinical characteristics, have better outcomes in combined treatment compared with psychotherapy (alone or with pill placebo), pharmacotherapy and pill placebo. Study searches are completed using an established database of randomised controlled trials (RCTs) on the psychological treatment of adult depression that has previously been reported. Searches were conducted in PubMed, PsycInfo, Embase and the Cochrane Central Register of Controlled Trials. RCTs comparing combination treatment (psychotherapy + pharmacotherapy) with psychotherapy (with or without pill placebo), pharmacotherapy or pill placebo for the treatment of adult depression will be included. Study authors of eligible trials will be contacted and asked to contribute IPD. Conventional meta-analysis techniques will be used to examine differences between studies that have contributed data and those that did not. Then, IPD will be harmonised and analysis using multilevel regression will be conducted to examine effect moderators of treatment outcomes. Study results outlined above will be published in peer-reviewed journals. Study results will contribute to better understanding whether certain patients respond best to combined treatment or other depression treatments and provide new information on moderators of treatment outcome that can be used by patients, clinicians and researchers. CRD42016039028. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Establishing the Feasibility of Direct Observation in the Assessment of Tics in Children with Chronic Tic Disorders

ERIC Educational Resources Information Center

Himle, Michael B.; Chang, Susanna; Woods, Douglas W.; Pearlman, Amanda; Buzzella, Brian; Bunaciu, Liviu; Piacentini, John C.

2006-01-01

Behavior analysis has been at the forefront in establishing effective treatments for children and adults with chronic tic disorders. As is customary in behavior analysis, the efficacy of these treatments has been established using direct-observation assessment methods. Although behavior-analytic treatments have enjoyed acceptance and integration…

Cost-utility analysis of deferiprone for the treatment of β-thalassaemia patients with chronic iron overload: a UK perspective.

PubMed

Bentley, Anthony; Gillard, Samantha; Spino, Michael; Connelly, John; Tricta, Fernando

2013-09-01

Patients with β-thalassaemia major experience chronic iron overload due to regular blood transfusions. Chronic iron overload can be treated using iron-chelating therapies such as desferrioxamine (DFO), deferiprone (DFP) and deferasirox (DFX) monotherapy, or DFO-DFP combination therapy. This study evaluated the relative cost effectiveness of these regimens over a 5-year timeframe from a UK National Health Service (NHS) perspective, including personal and social services. A Markov model was constructed to evaluate the cost effectiveness of the treatment regimens over 5 years. Based on published randomized controlled trial evidence, it was assumed that all four treatment regimens had a comparable effect on serum ferritin concentration (SFC) and liver iron concentration (LIC), and that DFP was more effective for reducing cardiac morbidity and mortality. Published utility scores for route of administration were used, with subcutaneously administered DFO assumed to incur a greater quality of life (QoL) burden than the oral chelators DFP and DFX. Healthcare resource use, drug costs (2010/2011 costs), and utilities associated with adverse events were also considered, with the effect of varying all parameters assessed in sensitivity analysis. Incremental costs and quality-adjusted life-years (QALYs) were calculated for each treatment, with cost effectiveness expressed as incremental cost per QALY. Assumptions that DFP conferred no cardiac morbidity, mortality, or morbidity and mortality benefit were also explored in scenario analysis. DFP was the dominant strategy in all scenarios modelled, providing greater QALY gains at a lower cost. Sensitivity analysis showed that DFP dominated all other treatments unless the QoL burden associated with the route of administration was greater for DFP than for DFO, which is unlikely to be the case. DFP had >99 % likelihood of being cost effective against all comparators at a willingness-to-pay threshold of £20,000 per QALY. In this analysis, DFP appeared to be the most cost-effective treatment available for managing chronic iron overload in β-thalassaemia patients. Use of DFP in these patients could therefore result in substantial cost savings.

Thin-plate spline analysis of the effects of face mask treatment in children with maxillary retrognathism.

PubMed

Chang, Jenny Zwei-Chieng; Liu, Pao-Hsin; Chen, Yi-Jane; Yao, Jane Chung-Chen; Chang, Hong-Po; Chang, Chih-Han; Chang, Frank Hsin-Fu

2006-02-01

Face mask therapy is indicated for growing patients who suffer from maxillary retrognathia. Most previous studies used conventional cephalometric analysis to evaluate the effects of face mask treatment. Cephalometric analysis has been shown to be insufficient for complex craniofacial configurations. The purpose of this study was to investigate changes in the craniofacial structure of children with maxillary retrognathism following face mask treatment by means of thin-plate spline analysis. Thirty children with skeletal Class III malocclusions who had been treated with face masks were compared with a group of 30 untreated gender-matched, age-matched, observation period-matched, and craniofacial configuration-matched subjects. Average geometries, scaled to an equivalent size, were generated by means of Procrustes analysis. Thin-plate spline analysis was then performed for localization of the shape changes. Face mask treatment induced a forward displacement of the maxilla, a counterclockwise rotation of the palatal plane, a horizontal compression of the anterior border of the symphysis and the condylar region, and a downward deformation of the menton. The cranial base exhibited a counterclockwise deformation as a whole. We conclude that thin-plate spline analysis is a valuable supplement to conventional cephalometric analysis.

The side-effects to CPAP treatment inventory: the development and initial validation of a new tool for the measurement of side-effects to CPAP treatment.

PubMed

Broström, Anders; Arestedt, Kristofer Franzén; Nilsen, Per; Strömberg, Anna; Ulander, Martin; Svanborg, Eva

2010-12-01

Continuous positive airway pressure (CPAP) is the treatment of choice for obstructive sleep apnoea syndrome (OSAS), but side-effects are common. No validated self-rating scale measuring side-effects to CPAP treatment exists today. The aim was to develop the side-effects to CPAP treatment inventory (SECI), and investigate the validity and reliability of the instrument among patients with OSAS. SECI was developed on the basis of: (1) in-depth interviews with 23 patients; (2) examination of the scientific literature and (3) consensus agreement of a multi-professional expert panel. This yielded 15 different types of side-effects related to CPAP treatment. Each side-effect has three sub-questions (scales): perceived frequency (a) and magnitude (b) of the side-effect, as well as its perceived impact on CPAP use (c). A cross-sectional descriptive design was used. A total of 329 patients with OSAS with an average use of CPAP treatment for 39 months (2 weeks to 182 months) were recruited. Data were collected with SECI, and obtained from medical records (clinical variables and data related to CPAP treatment). Construct validity was confirmed with factor analysis (principal component analysis with orthogonal rotation). A logical two-factor solution, the device subscale and symptom subscale, emerged across all three scales. The symptom subscale describing physical and psychological side-effects and the device subscale described mask and device-related side-effects. Internal consistency reliability of the three scales was good (Cronbach's α = 0.74-0.86) and acceptable for the subscales (Cronbach's α = 0.62-0.86). The satisfactory measurement properties of this new instrument are promising and indicate that SECI can be used to measure side-effects to CPAP treatment. © 2010 European Sleep Research Society.

Analysing Time to Event Data in Dementia Prevention Trials: The Example of the GuidAge Study of EGb761.

PubMed

Scherrer, B; Andrieu, S; Ousset, P J; Berrut, G; Dartigues, J F; Dubois, B; Pasquier, F; Piette, F; Robert, P; Touchon, J; Garnier, P; Mathiex-Fortunet, H; Vellas, B

2015-12-01

Time-to-event analysis is frequently used in medical research to investigate potential disease-modifying treatments in neurodegenerative diseases. Potential treatment effects are generally evaluated using the logrank test, which has optimal power and sensitivity when the treatment effect (hazard ratio) is constant over time. However, there is generally no prior information as to how the hazard ratio for the event of interest actually evolves. In these cases, the logrank test is not necessarily the most appropriate to use. When the hazard ratio is expected to decrease or increase over time, alternative statistical tests such as the Fleming-Harrington test, provide a better sensitivity. An example of this comes from a large, five-year randomised, placebo-controlled prevention trial (GuidAge) in 2854 community-based subjects making spontaneous memory complaints to their family physicians, which evaluated whether treatment with EGb761 can modify the risk of developing AD. The primary outcome measure was the time to conversion from memory complaint to Alzheimer's type dementia. Although there was no significant difference in the hazard function of conversion between the two treatment groups according to the preplanned logrank test, a significant treatment-by-time interaction for the incidence of AD was observed in a protocol-specified subgroup analysis, suggesting that the hazard ratio is not constant over time. For this reason, additional post hoc analyses were performed using the Fleming-Harrington test to evaluate whether there was a signal of a late effect of EGb761. Applying the Fleming-Harrington test, the hazard function for conversion to dementia in the placebo group was significantly different from that in the EGb761 treatment group (p = 0.0054), suggesting a late effect of EGb761. Since this was a post hoc analysis, no definitive conclusions can be drawn as to the effectiveness of the treatment. This post hoc analysis illustrates the interest of performing another randomised clinical trial of EGb761 explicitly testing the hypothesis of a late treatment effect, as well as of using of better adapted statistical approaches for long term preventive trials when it is expected that prevention cannot have an immediate effect but rather a delayed effect that increases over time.

Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis.

PubMed

Cattaneo, Carlo; Barone, Paolo; Bonizzoni, Erminio; Sardina, Marco

2017-01-01

Pain, a frequent non-motor symptom in Parkinson's Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients. To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE. This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment. The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the "Bodily discomfort" domain.Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect. These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit.

Influence of Surface Modification on the Microstructure and Thermo-Mechanical Properties of Bamboo Fibers

PubMed Central

Zhang, Xiaoping; Wang, Fang; Keer, Leon M.

2015-01-01

The objective of this study is to investigate the effect of surface treatment on the morphology and thermo-mechanical properties of bamboo fibers. The fibers are subjected to an alkali treatment using 4 wt % sodium hydroxide (NaOH) for 1 h. Mechanical measurements show that the present concentration has an insignificant effect on the fiber tensile strength. In addition, systematic experimental results characterizing the morphological aspects and thermal properties of the bamboo fibers are analyzed by scanning electron microscopy, Fourier transform infrared spectroscopy, thermogravimetric analysis, and differential scanning calorimetry. It is found that an alkali treatment may increase the effective surface area, which is in turn available for superior bonding with the matrix. Fourier transform infrared spectroscopy analysis reveals that the alkali treatment leads to a gradual removal of binding materials, such as hemicellulose and lignin from the bamboo fiber. A comparison of the curve of thermogravimetric analysis and differential scanning calorimetry for the treated and untreated samples is presented to demonstrate that the presence of treatment contributes to a better thermal stability for bamboo fibers. PMID:28793585

Comparing Active Pediatric Obesity Treatments Using Meta-Analysis

ERIC Educational Resources Information Center

Gilles, Allyson; Cassano, Michael; Shepherd, Elizabeth J.; Higgins, Diana; Hecker, Jeffrey E.; Nangle, Douglas W.

2008-01-01

The current meta-analysis reviews research on the treatment of pediatric obesity focusing on studies that have been published since 1994. Eleven studies (22 comparisons, 115 effect sizes, N = 447) were included in the present meta-analysis. Results indicated that comprehensive behavioral interventions may be improved in at least two ways:…

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial)

PubMed Central

2012-01-01

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511

Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

PubMed

Landau, Sabine; Emsley, Richard; Dunn, Graham

2018-06-01

Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of the three processes involving baseline measures of intermediate or clinical outcomes is operating. Necessary assumptions for the change score approach (B) to provide unbiased estimates under either process include the independence of baseline measures and change scores of the intermediate variable. Finally, estimates provided by the analysis of covariance approach (C) were found to be unbiased under all the three processes considered here. When applied to the example, there was evidence of mediation under all methods but the estimate of the indirect effect depended on the approach used with the proportion mediated varying from 57% to 86%. Trialists planning mediation analyses should measure baseline values of putative mediators as well as of continuous clinical outcomes. An analysis of covariance approach is recommended to avoid potential biases due to confounding processes involving baseline measures of intermediate or clinical outcomes, and not simply for increased precision.

Effects of Arthroscopy for Femoroacetabular Impingement Syndrome on Quality of Life and Economic Outcomes.

PubMed

Mather, Richard C; Nho, Shane J; Federer, Andrew; Demiralp, Berna; Nguyen, Jennifer; Saavoss, Asha; Salata, Michael J; Philippon, Marc J; Bedi, Asheesh; Larson, Christopher M; Byrd, J W Thomas; Koenig, Lane

2018-04-01

The diagnosis and treatment of femoroacetabular impingement (FAI) have increased steadily within the past decade, and research indicates clinically significant improvements after treatment of FAI with hip arthroscopy. This study examined the societal and economic impact of hip arthroscopy by high-volume surgeons for patients with FAI syndrome aged <50 years with noncontroversial diagnosis and indications for surgery. Economic and decision analysis; Level of evidence, 2. The cost-effectiveness of hip arthroscopy versus nonoperative treatment was evaluated by calculating direct and indirect treatment costs. Direct cost was calculated with Current Procedural Terminology medical codes associated with FAI treatment. Indirect cost was measured with the patient-reported data of 102 patients who underwent arthroscopy and from the reimbursement records of 32,143 individuals between the ages of 16 and 79 years who had information in a private insurance claims data set contained within the PearlDiver Patient Records Database. The indirect economic benefits of hip arthroscopy were inferred through regression analysis to estimate the statistical relationship between functional status and productivity. A simulation-based approach was then used to estimate the change in productivity associated with the change in functional status observed in the treatment cohort between baseline and follow-up. To analyze cost-effectiveness, 1-, 2-, and 3-way sensitivity analyses were performed on all variables in the model, and Monte Carlo analysis evaluated the impact of uncertainty in the model assumptions. Analysis of indirect costs identified a statistically significant increase of mean aggregate productivity of $8968 after surgery. Cost-effectiveness analysis showed a mean cumulative total 10-year societal savings of $67,418 per patient from hip arthroscopy versus nonoperative treatment. Hip arthroscopy also conferred a gain of 2.03 quality-adjusted life years over this period. The mean cost for hip arthroscopy was estimated at $23,120 ± $10,279, and the mean cost of nonoperative treatment was estimated at $91,602 ± $14,675. In 99% of trials, hip arthroscopy was recognized as the preferred cost-effective strategy. FAI syndrome produces a substantial economic burden on society that may be reduced through the indirect cost savings and economic benefits from hip arthroscopy.

Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada.

PubMed

Moshyk, A; Martel, M-J; Tahami Monfared, A A; Goeree, R

2016-01-01

New regimens for the treatment of chronic hepatitis C virus (HCV) genotype 3 have demonstrated substantial improvement in sustained virologic response (SVR) compared with existing therapies, but are considerably more expensive. The objective of this study was to evaluate the cost-effectiveness of two novel all-oral, interferon-free regimens for the treatment of patients with HCV genotype 3: daclatasvir plus sofosbuvir (DCV + SOF) and sofosbuvir plus ribavirin (SOF + RBV), from a Canadian health-system perspective. A decision analytic Markov model was developed to compare the effect of various treatment strategies on the natural history of the disease and their associated costs in treatment-naïve and treatment-experienced patients. Patients were initially distributed across fibrosis stages F0-F4, and may incur disease progression through fibrosis stages and on to end-stage liver disease complications and death; or may achieve SVR. Clinical efficacy, health-related quality-of-life, costs, and transition probabilities were based on published literature. Probabilistic sensitivity analysis was performed to assess parameter uncertainty associated with the analysis. In treatment-naive patients, the expected quality-adjusted life years (QALYs) for interferon-free regimens were higher for DCV + SOF (12.37) and SOF + RBV (12.48) compared to that of pINF + RBV (11.71) over a lifetime horizon, applying their clinical trial treatment durations. The expected costs were higher for DCV + SOF ($170,371) and SOF + RBV ($194,776) vs pINF + RBV regimen ($90,905). Compared to pINF + RBV, the incremental cost-effectiveness ratios (ICER) were $120,671 and $135,398 per QALYs for DCV + SOF and SOF + RBV, respectively. In treatment-experienced patients, DCV + SOF regimen dominated the SOF + RBV regimen. Probabilistic sensitivity analysis indicated a 100% probability that a DCV + SOF regimen was cost saving in treatment-experienced patients. Daclatasvir plus sofosbuvir is a safe and effective option for the treatment of chronic HCV genotype 3 patients. This regimen could be considered a cost-effective option following a first-line treatment of peg-interferon/ribavirin treatment experienced patients with HCV genotype-3 infection.

Economic Analysis of First-Line Treatment with Erlotinib in an EGFR-Mutated Population with Advanced NSCLC.

PubMed

Vergnenegre, Alain; Massuti, Bartomeu; de Marinis, Filippo; Carcereny, Enric; Felip, Enriqueta; Do, Pascal; Sanchez, Jose Miguel; Paz-Arez, Luis; Chouaid, Christos; Rosell, Rafael

2016-06-01

The cost-effectiveness of first-line tyrosine kinase inhibitor therapy in epidermal growth factor receptor gene (EGFR)-mutated advanced-stage non-small cell lung cancer (NSCLC) is poorly documented. We therefore conducted a cost-effectiveness analysis of first-line treatment with erlotinib versus standard chemotherapy in European patients with advanced-stage EGFR-mutated NSCLC who were enrolled in the European Erlotinib versus Chemotherapy trial. The European Erlotinib versus Chemotherapy study was a multicenter, open-label, randomized phase III trial performed mainly in Spain, France, and Italy. We based our economic analysis on clinical data and data on resource consumption (drugs, drug administration, adverse events, and second-line treatments) collected during this trial. Utility values were derived from the literature. Incremental cost-effectiveness ratios were calculated for the first-line treatment phase and for the overall strategy from the perspective of the three participating countries. Sensitivity analyses were performed by selecting the main cost drivers. Compared with standard first-line chemotherapy, the first-line treatment with erlotinib was cost saving (€7807, €17,311, and €19,364 for Spain, Italy and France, respectively) and yielded a gain of 0.117 quality-adjusted life-years. A probabilistic sensitivity analysis indicated that, given a willingness to pay at least €90,000 for 1 quality-adjusted life-year, the probability that a strategy of first-line erlotinib would be cost-effective was 100% in France, 100% in Italy, and 99.8% in Spain. This economic analysis shows that first-line treatment with erlotinib, versus standard chemotherapy, is a dominant strategy for EGFR-mutated advanced-stage NSCLC in three European countries. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

PubMed Central

Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

2015-01-01

Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

Dabigatran for the Treatment and Secondary Prevention of Venous Thromboembolism; A Cost-Effectiveness Analysis for the Netherlands.

PubMed

Stevanović, J; de Jong, L A; Kappelhoff, B S; Dvortsin, E P; Voorhaar, M; Postma, M J

2016-01-01

Dabigatran was proven to have similar effect on the prevention of recurrence of venous thromboembolism (VTE) and a lower risk of bleeding compared to vitamin K antagonists (VKA). The aim of this study is to assess the cost-effectiveness (CE) of dabigatran for the treatment and secondary prevention in patients with VTE compared to VKAs in the Dutch setting. Previously published Markov model was modified and updated to assess the CE of dabigatran and VKAs for the treatment and secondary prevention in patients with VTE from a societal perspective in the base-case analysis. The model was populated with efficacy and safety data from major dabigatran trials (i.e. RE-COVER, RECOVER II, RE-MEDY and RE-SONATE), Dutch specific costs, and utilities derived from dabigatran trials or other published literature. Univariate, probabilistic sensitivity and a number of scenario analyses evaluating various decision-analytic settings (e.g. the perspective of analysis, use of anticoagulants only for treatment or only for secondary prevention, or comparison to no treatment) were tested on the incremental cost-effectiveness ratio (ICER). In the base-case scenario, patients on dabigatran gained an additional 0.034 quality adjusted life year (QALY) while saving €1,598. Results of univariate sensitivity analysis were quite robust. The probability that dabigatran is cost-effective at a willingness-to-pay threshold of €20,000/QALY was 98.1%. From the perspective of healthcare provider, extended anticoagulation with dabigatran compared to VKAs was estimated at €2,158 per QALY gained. The ICER for anticoagulation versus no treatment in patients with equipoise risk of recurrent VTE was estimated at €33,379 per QALY gained. Other scenarios showed dabigatran was cost-saving. From a societal perspective, dabigatran is likely to be a cost-effective or even cost-saving strategy for treatment and secondary prevention of VTE compared to VKAs in the Netherlands.

Screen or not to screen for peripheral arterial disease: guidance from a decision model.

PubMed

Vaidya, Anil; Joore, Manuela A; Ten Cate-Hoek, Arina J; Ten Cate, Hugo; Severens, Johan L

2014-01-29

Asymptomatic Peripheral Arterial Disease (PAD) is associated with greater risk of acute cardiovascular events. This study aims to determine the cost-effectiveness of one time only PAD screening using Ankle Brachial Index (ABI) test and subsequent anti platelet preventive treatment (low dose aspirin or clopidogrel) in individuals at high risk for acute cardiovascular events compared to no screening and no treatment using decision analytic modelling. A probabilistic Markov model was developed to evaluate the life time cost-effectiveness of the strategy of selective PAD screening and consequent preventive treatment compared to no screening and no preventive treatment. The analysis was conducted from the Dutch societal perspective and to address decision uncertainty, probabilistic sensitivity analysis was performed. Results were based on average values of 1000 Monte Carlo simulations and using discount rates of 1.5% and 4% for effects and costs respectively. One way sensitivity analyses were performed to identify the two most influential model parameters affecting model outputs. Then, a two way sensitivity analysis was conducted for combinations of values tested for these two most influential parameters. For the PAD screening strategy, life years and quality adjusted life years gained were 21.79 and 15.66 respectively at a lifetime cost of 26,548 Euros. Compared to no screening and treatment (20.69 life years, 15.58 Quality Adjusted Life Years, 28,052 Euros), these results indicate that PAD screening and treatment is a dominant strategy. The cost effectiveness acceptability curves show 88% probability of PAD screening being cost effective at the Willingness To Pay (WTP) threshold of 40000 Euros. In a scenario analysis using clopidogrel as an alternative anti-platelet drug, PAD screening strategy remained dominant. This decision analysis suggests that targeted ABI screening and consequent secondary prevention of cardiovascular events using low dose aspirin or clopidogrel in the identified patients is a cost-effective strategy. Implementation of targeted PAD screening and subsequent treatment in primary care practices and in public health programs is likely to improve the societal health and to save health care costs by reducing catastrophic cardiovascular events.

Practical Guidance for Conducting Mediation Analysis With Multiple Mediators Using Inverse Odds Ratio Weighting

PubMed Central

Nguyen, Quynh C.; Osypuk, Theresa L.; Schmidt, Nicole M.; Glymour, M. Maria; Tchetgen Tchetgen, Eric J.

2015-01-01

Despite the recent flourishing of mediation analysis techniques, many modern approaches are difficult to implement or applicable to only a restricted range of regression models. This report provides practical guidance for implementing a new technique utilizing inverse odds ratio weighting (IORW) to estimate natural direct and indirect effects for mediation analyses. IORW takes advantage of the odds ratio's invariance property and condenses information on the odds ratio for the relationship between the exposure (treatment) and multiple mediators, conditional on covariates, by regressing exposure on mediators and covariates. The inverse of the covariate-adjusted exposure-mediator odds ratio association is used to weight the primary analytical regression of the outcome on treatment. The treatment coefficient in such a weighted regression estimates the natural direct effect of treatment on the outcome, and indirect effects are identified by subtracting direct effects from total effects. Weighting renders treatment and mediators independent, thereby deactivating indirect pathways of the mediators. This new mediation technique accommodates multiple discrete or continuous mediators. IORW is easily implemented and is appropriate for any standard regression model, including quantile regression and survival analysis. An empirical example is given using data from the Moving to Opportunity (1994–2002) experiment, testing whether neighborhood context mediated the effects of a housing voucher program on obesity. Relevant Stata code (StataCorp LP, College Station, Texas) is provided. PMID:25693776

Cost-effectiveness analysis of treatment alternatives for beef bulls with preputial prolapse.

PubMed

Kasari, T R; McGrann, J M; Hooper, R N

1997-10-01

To develop an economic model for comparing cost-effectiveness of medical and surgical treatment versus replacement of beef bulls with preputial prolapse. Economic analysis. Estimates determined from medical records of bulls treated for preputial prolapse at our hospital and from information about treatment of bulls published elsewhere. Annual depreciation cost for treatment (ADC(T)) and replacement (ADC(R)) were calculated. Total investment for an injured bull equaled the sum of salvage value, maintenance cost, and expected cost of the treatment option under consideration. Total investment for a replacement bull was purchase price. Net present value of cost was calculated for each year of bull use. Sensitivity analyses were constructed to determine the value that would warrant treatment of an injured bull. The decision to treat was indicated when ADC(T) was less than ADC(R). In our example, it was more cost-effective for owners to cull an injured bull. The ADC(R) was $97 less than ADC(T) for medical treatment ($365 vs $462) and $280 less than ADC(T) for surgical treatment ($365 vs $645). Likewise, net present value of cost values indicated that it was more cost-effective for owners to cull an injured bull. Sensitivity analysis indicated treatment decisions were justified on the basis of replacement value or planned number of breeding seasons remaining for the bull. The model described here can be used by practitioners to provide an objective basis to guide decision making of owners who seek advice on whether to treat or replace bulls with preputial prolapse.

The cost-effectiveness of bevacizumab, ranibizumab and aflibercept for the treatment of age-related macular degeneration-A cost-effectiveness analysis from a societal perspective.

PubMed

van Asten, Freekje; Michels, Charlotte T J; Hoyng, Carel B; van der Wilt, Gert Jan; Klevering, B Jeroen; Rovers, Maroeska M; Grutters, Janneke P C

2018-01-01

The discussion on the use of bevacizumab is still ongoing and often doctors are deterred from using bevacizumab due to legal or political issues. Bevacizumab is an effective, safe and inexpensive treatment option for neovascular age-related macular degeneration (AMD), albeit unregistered for the disease. Therefore, in some countries ophthalmologists use the equally effective but expensive drugs ranibizumab and aflibercept. We describe the economic consequences of this dilemma surrounding AMD treatment from a societal perspective. We modelled cost-effectiveness of treatment with ranibizumab (as-needed), aflibercept (bimonthly) and bevacizumab (as-needed). Effectiveness was estimated by systematic review and meta-analysis. The drug with the most favourable cost-effectiveness profile compared to bevacizumab was used for threshold analyses. First, we determined how much we overspend per injection. Second, we calculated the required effectiveness to justify the current price and the reasonable price for a drug leading to optimal vision. Finally, we estimated how much Europe overspends if bevacizumab is not first choice. Bevacizumab treatment costs €27,087 per year, about €4,000 less than aflibercept and €6,000 less than ranibizumab. With similar effectiveness for all drugs as shown by meta-analysis, bevacizumab was the most cost-effective. Aflibercept was chosen for threshold analyses. Aflibercept costs €943 per injection, but we determined that the maximum price to be cost-effective is €533. Alternatively, at its current price, aflibercept should yield about twice the visual gain. Even when optimal vision can be achieved, the maximum price for any treatment is €37,453 per year. Most importantly, Europe overspends €335 million yearly on AMD treatment when choosing aflibercept over bevacizumab. Bevacizumab is the most cost-effective treatment for AMD, yet is not the standard of care across Europe. The registered drugs ranibizumab and aflibercept lead to large overspending without additional health benefits. Health authorities should consider taking steps to implement bevacizumab into clinical practice as first choice.

Effect of soy isoflavone supplementation on plasma lipoprotein(a) concentrations: A meta-analysis.

PubMed

Simental-Mendía, Luis E; Gotto, Antonio M; Atkin, Stephen L; Banach, Maciej; Pirro, Matteo; Sahebkar, Amirhossein

Soy supplementation has been shown to reduce total and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol. However, contradictory effects of soy isoflavone supplementation on lipoprotein(a) [Lp(a)] have been reported suggesting the need for a meta-analysis to be undertaken. The aim of the study was to investigate the impact of supplementation with soy isoflavones on plasma Lp(a) levels through a systematic review and meta-analysis of eligible randomized placebo-controlled trials. The search included PubMed-Medline, Scopus, ISI Web of Knowledge, and Google Scholar databases (by March 26, 2017), and quality of studies was evaluated according to Cochrane criteria. Quantitative data synthesis was performed using a random-effects model, with standardized mean difference and 95% confidence interval as summary statistics. Meta-regression and leave-one-out sensitivity analysis were performed to assess the modifiers of treatment response. Ten eligible studies comprising 11 treatment arms with 973 subjects were selected for the meta-analysis. Meta-analysis did not suggest any significant alteration of plasma Lp(a) levels after supplementation with soy isoflavones (standardized mean difference: 0.08, 95% confidence interval: -0.05, 0.20, P = .228). The effect size was robust in the leave-one-out sensitivity analysis. In meta-regression analysis, neither dose nor duration of supplementation with soy isoflavones was significantly associated with the effect size. This meta-analysis of the 10 available randomized placebo-controlled trials revealed no significant effect of soy isoflavones treatment on plasma Lp(a) concentrations. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of apixaban versus low molecular weight heparin/vitamin k antagonist for the treatment of venous thromboembolism and the prevention of recurrences.

PubMed

Lanitis, Tereza; Leipold, Robert; Hamilton, Melissa; Rublee, Dale; Quon, Peter; Browne, Chantelle; Cohen, Alexander T

2017-01-23

Prior analyses beyond clinical trials are yet to evaluate the projected lifetime benefit of apixaban treatment compared to low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) for treatment of venous thromboembolism (VTE) and prevention of recurrences. The objective of this study is to assess the cost-effectiveness of initial plus extended treatment with apixaban versus LMWH/VKA for either initial treatment only or initial plus extended treatment. A Markov cohort model was developed to evaluate the lifetime clinical and economic impact of treatment of VTE and prevention of recurrences with apixaban (starting at 10 mg BID for 1 week, then 5 mg BID for 6 months, then 2.5 mg BID for an additional 12 months) versus LMWH/VKA for 6 months and either no further treatment or extended treatment with VKA for an additional 12 months. Clinical event rates to inform the model were taken from the AMPLIFY and AMPLIFY-EXT trials and a network meta-analysis. Background mortality rates, costs, and utilities were obtained from published sources. The analysis was conducted from the perspective of the United Kingdom National Health Service. The evaluated outcomes included the number of events avoided in a 1000-patient cohort, total costs, life-years, quality-adjusted life-years (QALYs), and cost per QALY gained. Initial plus extended treatment with apixaban was superior to both treatment durations of LMWH/VKA in reducing the number of bleeding events, and was superior to initial LMWH/VKA for 6 months followed by no therapy, in reducing VTE recurrences. Apixaban treatment was cost-effective compared to 6-month treatment with LMWH/VKA at an incremental cost-effectiveness ratio (ICER) of £6692 per QALY. When initial LMWH/VKA was followed by further VKA therapy for an additional 12 months (i.e., total treatment duration of 18 months), apixaban was cost-effective at an ICER of £8528 per QALY gained. Sensitivity analysis suggested these findings were robust over a wide range of inputs and scenarios for the model. In the UK, initial plus extended treatment with apixaban for treatment of VTE and prevention of recurrences appears to be economical and a clinically effective alternative to LMWH/VKA, whether used for initial or initial plus extended treatment.

Does a mandibular overdenture improve nutrient intake and markers of nutritional status better than conventional complete denture? A systematic review and meta-analysis.

PubMed

Yamazaki, Toru; Martiniuk, Alexandra Lc; Irie, Koichiro; Sokejima, Shigeru; Lee, Crystal Man Ying

2016-08-03

The need for denture treatment in public health will increase as the population ages. However, the impact of dentures on nutrition, particularly overdenture treatment, remains unclear although the physical and psychological effects are known. We investigated whether treatment with a mandibular implant supported overdenture improves nutrient intake and markers of nutritional status better than a conventional complete denture in edentulous patients. Systematic review and meta-analysis. Medline, EMBASE and the Cochrane Central Register of Controlled Trials were searched for eligible studies published up to April 2016. We included studies which compared the treatment effect of an overdenture to conventional denture on nutrition, in which primary outcomes included changes in intake of macronutrients and/or micronutrients and/or indicators of nutritional status. Two reviewers independently evaluated eligible studies and assessed the risk of bias. We used a fixed effects model to estimate the weighted mean difference (WMD) and 95% CI for change in body mass index (BMI), albumin and serum vitamin B12 between overdenture and conventional denture 6 months after treatment. Of 108 eligible studies, 8 studies involving 901 participants were included in the narrative appraisal. Four studies reported changes in markers of nutritional status and nutrient intake after treatment with a prosthetic, regardless of type. In a meta-analysis of 322 participants aged 65 years or older from three studies, pooled analysis suggested no significant difference in change in BMI between an overdenture and conventional denture 6 months after treatment (WMD=-0.18 kg/m(2) (95% CI -0.52 to 0.16)), and no significant difference in change in albumin or vitamin B12 between the two treatments. The modifying effect of overdenture treatment on nutritional status might be limited. Further studies are needed to evaluate the effectiveness and efficacy of denture treatments. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cost-effectiveness of intensive multifactorial treatment compared with routine care for individuals with screen-detected Type 2 diabetes: analysis of the ADDITION-UK cluster-randomized controlled trial

PubMed Central

Tao, L; Wilson, E C F; Wareham, N J; Sandbæk, A; Rutten, G E H M; Lauritzen, T; Khunti, K; Davies, M J; Borch-Johnsen, K; Griffin, S J; Simmons, R K

2015-01-01

Aims To examine the short- and long-term cost-effectiveness of intensive multifactorial treatment compared with routine care among people with screen-detected Type 2 diabetes. Methods Cost–utility analysis in ADDITION-UK, a cluster-randomized controlled trial of early intensive treatment in people with screen-detected diabetes in 69 UK general practices. Unit treatment costs and utility decrement data were taken from published literature. Accumulated costs and quality-adjusted life years (QALYs) were calculated using ADDITION-UK data from 1 to 5 years (short-term analysis, n = 1024); trial data were extrapolated to 30 years using the UKPDS outcomes model (version 1.3) (long-term analysis; n = 999). All costs were transformed to the UK 2009/10 price level. Results Adjusted incremental costs to the NHS were £285, £935, £1190 and £1745 over a 1-, 5-, 10- and 30-year time horizon, respectively (discounted at 3.5%). Adjusted incremental QALYs were 0.0000, – 0.0040, 0.0140 and 0.0465 over the same time horizons. Point estimate incremental cost-effectiveness ratios (ICERs) suggested that the intervention was not cost-effective although the ratio improved over time: the ICER over 10 years was £82 250, falling to £37 500 over 30 years. The ICER fell below £30 000 only when the intervention cost was below £631 per patient: we estimated the cost at £981. Conclusion Given conventional thresholds of cost-effectiveness, the intensive treatment delivered in ADDITION was not cost-effective compared with routine care for individuals with screen-detected diabetes in the UK. The intervention may be cost-effective if it can be delivered at reduced cost. PMID:25661661

Long-term effectiveness of rivastigmine patch or capsule for mild-to-severe Alzheimer's disease: a meta-analysis.

PubMed

Su, Jiangli; Liu, Yang; Liu, Yu; Ren, Liqun

2015-01-01

To evaluate the long-term effectiveness of rivastigmine patch or capsule on mild to severe Alzheimer's disease (AD). We performed a meta-analysis of 17 studies regarding the treatment effectiveness of rivastigmine patch or capsule on mild-to-severe AD. Significant difference exists between treatment with rivastigmine patch or capsule and placebo groups (p-value < 0.001). In the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) score evaluation, a negative weighted mean difference (WMD) was observed in overall and mild-moderate groups after rivastigmine treatment. And in ADAS-ADL score evaluation, a positive WMD was observed in overall groups after rivastigmine treatment. Moreover, WMD value is lower in patch administration subgroup compared to that of capsule administration subgroup. Rivastigmine treatment shows a positive result of improving the condition of patients with mild-to-severe AD. Patch administration shows a stronger effect on decreasing ADAS-Cog score compared to capsule administration.

[Periodontal treatment for cardiovascular risk factors: a systematic review].

PubMed

Deng, Linkai; Li, Chunjie; Li, Qian; Zhang, Yukui; Zhao, Hongwei

2013-10-01

To evaluate the efficacy of periodontal treatment for the management of cardiovascular risk factors. Eligible studies in Cochrane Controlled Trials Register/CENTRAL, PubMed, EMBASE, and China Biology Medicine disc (CBMdisc) were searched until October 13, 2011. References of the included studies were hand searched. Two reviewers assessed the risk of bias and extracted the data of the included studies in duplicate. Meta-analysis was conducted with Revman 5.1. Six randomized controlled trials involving 682 participants were included. One case had low risk of bias, another one had moderate risk of bias, and the remaining four had high risk of bias. Meta-analysis showed that periodontal treatment has no significant effect on C-reactive protein, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P > 0.05). However, the treatment had a significant effect on high-density lipoprotein cholesterol [MD = 0.05, 95% CI (0.00, 0.09), P = 0.04]. Periodontal treatment has good effects on controlling high-density lipoprotein cholesterol although more randomized controlled trials must be conducted to verify its effectiveness.

Bridging the gap between health and non-health investments: moving from cost-effectiveness analysis to a return on investment approach across sectors of economy.

PubMed

Sendi, Pedram

2008-06-01

When choosing from a menu of treatment alternatives, the optimal treatment depends on the objective function and the assumptions of the model. The classical decision rule of cost-effectiveness analysis may be formulated via two different objective functions: (i) maximising health outcomes subject to the budget constraint or (ii) maximising the net benefit of the intervention with the budget being determined ex post. We suggest a more general objective function of (iii) maximising return on investment from available resources with consideration of health and non-health investments. The return on investment approach allows to adjust the analysis for the benefits forgone by alternative non-health investments from a societal or subsocietal perspective. We show that in the presence of positive returns on non-health investments the decision-maker's willingness to pay per unit of effect for a treatment program needs to be higher than its incremental cost-effectiveness ratio to be considered cost-effective.

Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer.

PubMed

Garrison, Louis P; Lubeck, Deborah; Lalla, Deepa; Paton, Virginia; Dueck, Amylou; Perez, Edith A

2007-08-01

Adding trastuzumab to adjuvant chemotherapy provides significant clinical benefit in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A cost-effectiveness analysis was performed to assess clinical and economic implications of adding trastuzumab to adjuvant chemotherapy, based upon joint analysis of NSABP B-31 and NCCTG N9831 trials. A Markov model with 4 health states was used to estimate the cost utility for a 50-year-old woman on the basis of trial results through 4 years and estimates of long-term recurrence and death based on a meta-analysis of trials. From 6 years onward, rates of recurrence and death were assumed to be the same in both trastuzumab and chemotherapy-only arms. Incremental costs were estimated for diagnostic and treatment-related costs. Analyses were from payer and societal perspectives, and these analyses were projected to lifetime and 20-year horizons. Over a lifetime, the projected cost of trastuzumab per quality-adjusted life year (QALY; discount rate 3%) gained was 26,417 dollars (range 9,104 dollars-69,340 dollars under multiway sensitivity analysis). Discounted incremental lifetime cost was 44,923 dollars, and projected life expectancy was 3 years longer for patients who received trastuzumab (19.4 years vs 16.4 years). During a 20-year horizon, the projected cost of adding trastuzumab to chemotherapy was 34,201 dollars per QALY gained. Key cost-effectiveness drivers were discount rate, trastuzumab price, and probability of metastasis. The cost-effectiveness result was robust to sensitivity analysis. Trastuzumab for adjuvant treatment of early stage breast cancer was projected to be cost effective over a lifetime horizon, achieving a cost-effectiveness ratio below that of many widely accepted oncology treatments. (c) 2007 American Cancer Society.

The Effectiveness of Daily Behavior Report Cards for Children With ADHD: A Meta-Analysis.

PubMed

Iznardo, Michelle; Rogers, Maria A; Volpe, Robert J; Labelle, Patrick R; Robaey, Philippe

2017-11-01

This meta-analysis examined group-design studies investigating the effectiveness of Daily Behavior Report Cards (DBRC) as a school-based intervention to manage the classroom behavior of students with ADHD. A search of three article databases (PsycINFO, ERIC and Medline) identified seven group design evaluations of DBRC interventions. This meta-analysis included a total of 272 participants, with an average age of 7.9 years old. Three of the studies compared a control group to a treatment group with randomized group assignment, one study compared a control group to three treatment groups, two studies compared pre-and post-treatment scores in the same group, and one study compared pre-and post-treatment results of two intervention groups without random assignment. Dependent measures for these studies were teacher ratings (n = 5) and systematic direct observation of student academic and social behaviour (n = 2). Standardized mean differences ( Hedge's g) were calculated to obtain a pooled effect size using fixed effects. DBRCs were associated with reductions teacher-rated ADHD symptoms, with a Hedge's g of 0.36 (95% CI: 0.12-0.60, z=2.93, p ≤ .005) with low heterogeneity (Q-value: 2.40, I 2 = 0.00). This result excluded two studies that used observational coding instead of standardized tests to evaluate the effects of the intervention. A moderator analysis indicated that the effect size for systematic direct observation was large ( Hedge's G = 1.05[95% CI: 0.66-1.44, z=5.25, p ≤ .00]), with very high heterogeneity (Q-value: 46.34, I 2 : 93.53). A second moderator analysis found differences in the effects of DBRCs for comorbid externalizing symptoms with an overall effect size of 0.34 (95%CI: -0.04-0.72, z=1.76 p =0.08) with high heterogeneity (Q-value: 3.98, I 2 : 74.85). DBRCs effectively reduce the frequency and severity of ADHD symptoms in classroom settings. Additionally, they have a significant effect on co-occuring externalizing behaviors. It appears that systematic direct observation may be a more sensitive measure of treatment effects compared to teacher ratings of ADHD symptoms.

Improving aluminum particle reactivity by annealing and quenching treatments: Synchrotron X-ray diffraction analysis of strain

DOE PAGES

McCollum, Jena; Pantoya, Michelle L.; Tamura, Nobumichi

2015-11-06

In bulk material processing, annealing and quenching metals such as aluminum (Al) can improve mechanical properties. On a single particle level, affecting mechanical properties may also affect Al particle reactivity. Our study examines the effect of annealing and quenching on the strain of Al particles and the corresponding reactivity of aluminum and copper oxide (CuO) composites. Micron-sized Al particles were annealed and quenched according to treatments designed to affect Al mechanical properties. Furthermore, synchrotron X-ray diffraction (XRD) analysis of the particles reveals that thermal treatment increased the dilatational strain of the aluminum-core, alumina-shell particles. Flame propagation experiments also show thermalmore » treatments effect reactivity when combined with CuO. An effective annealing and quenching treatment for increasing aluminum reactivity was identified. Our results show that altering the mechanical properties of Al particles affects their reactivity.« less

Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture.

PubMed

Chen, Neal C; Shauver, Melissa J; Chung, Kevin C

2011-11-01

We undertook a cost-utility analysis to compare traditional fasciectomy for Dupuytren with 2 new treatments, needle aponeurotomy and collagenase injection. We constructed an expected-value decision analysis model with an arm representing each treatment. A survey was administered to a cohort of 50 consecutive subjects to determine utilities of different interventions. We conducted multiple sensitivity analyses to assess the impact of varying the rate of disease recurrence in each arm of the analysis as well as the cost of the collagenase injection. The threshold for a cost-effective treatment is based on the traditional willingness-to-pay of $50,000 per quality-adjusted life years (QALY) gained. The cost of open partial fasciectomy was $820,114 per QALY gained over no treatment. The cost of needle aponeurotomy was $96,474 per QALY gained versus no treatment. When we performed a sensitivity analysis and set the success rate at 100%, the cost of needle aponeurotomy was $49,631. When needle aponeurotomy was performed without surgical center or anesthesia costs and with reduced hand therapy, the cost was $36,570. When a complete collagenase injection series was priced at $250, the cost was $31,856 per QALY gained. When the injection series was priced at $945, the cost was $49,995 per QALY gained. At the market price of $5,400 per injection, the cost was $166,268 per QALY gained. In the current model, open partial fasciectomy is not cost-effective. Needle aponeurotomy is cost-effective if the success rate is high. Collagenase injection is cost-effective when priced under $945. Economic and Decision Analysis II. Copyright © 2011 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

PubMed

Marsden, G; Perry, M; Bradbury, A; Hickey, N; Kelley, K; Trender, H; Wonderling, D; Davies, A H

2015-12-01

The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Systematic Review and Meta-Analysis of Patiromer and Sodium Zirconium Cyclosilicate: A New Armamentarium for the Treatment of Hyperkalemia.

PubMed

Meaney, Calvin J; Beccari, Mario V; Yang, Yang; Zhao, Jiwei

2017-04-01

To compare and contrast the efficacy and safety of patiromer and sodium zirconium cyclosilicate (ZS-9) in the treatment of hyperkalemia. A systematic review and meta-analysis of phase II and III clinical trial data was completed. Eight studies (two phase II and four phase III trials with two subgroup analyses) were included in the qualitative analysis, and six studies (two phase II and four phase III trials) were included in the meta-analysis. Significant heterogeneity was found in the meta-analysis with an I 2 value ranging from 80.6-99.6%. A random-effects meta-analysis was applied for all end points. Each clinical trial stratified results by hyperkalemia severity and dosing; therefore, these were considered separate treatment groups in the meta-analysis. For patiromer, a significant -0.70 mEq/L (95% confidence interval [CI] -0.48 to -0.91 mEq/L) change was noted in potassium at 4 weeks. At day 3 of patiromer treatment, potassium change was -0.36 mEq/L (range of standard deviation 0.07-0.30). The primary end point for ZS-9-change in potassium at 48 hours-was -0.67 mEq/L (95% CI -0.45 to -0.89 mEq/L). By 1 hour after ZS-9 administration, change in potassium was -0.17 mEq/L (95% CI -0.05 to -0.30). Analysis of pooled adverse effects from these trials indicates that patiromer was associated with more gastrointestinal upset (7.6% constipation, 4.5% diarrhea) and electrolyte depletion (7.1% hypomagnesemia), whereas ZS-9 was associated with the adverse effects of urinary tract infections (1.1%) and edema (0.9%). Patiromer and ZS-9 represent significant pharmacologic advancements in the treatment of hyperkalemia. Both agents exhibited statistically and clinically significant reductions in potassium for the primary end point of this meta-analysis. Given the adverse effect profile and the observed time-dependent effects, ZS-9 may play more of a role in treating acute hyperkalemia. © 2017 Pharmacotherapy Publications, Inc.

Systematic Review and Meta-Analysis of Patiromer and Sodium Zirconium Cyclosilicate: A New Armamentarium for the Treatment of Hyperkalemia

PubMed Central

Meaney, Calvin J.; Beccari, Mario V.; Yang, Yang; Zhao, Jiwei

2017-01-01

Objective To compare and contrast the efficacy and safety of patiromer and sodium zirconium cyclosilicate (ZS-9) in the treatment of hyperkalemia. Design A systematic review and meta-analysis of phase II and III clinical trial data was completed. Patients or Participants Eight studies (2 phase II and 4 phase III trials with 2 subgroup analyses) were included in the qualitative analysis whereas six studies (2 phase II and 4 phase III trials) were included in the meta-analysis. Measurements and Results There was significant heterogeneity in the meta-analysis with an I2 value ranging from 80.6–99.6%. A random-effects meta-analysis was applied for all endpoints. Each clinical trial stratified results by hyperkalemia severity and dosing; therefore, these were considered separate treatment groups in the meta-analysis. For patiromer, there was a significant −0.70mEq/L (95% confidence interval [CI] −0.48 to −0.91mEq/L) change in potassium at 4 weeks. At day 3 of patiromer treatment, potassium change was −0.36mEq/L (range of standard deviation: 0.07 to 0.30). The primary endpoint for ZS-9-- change in potassium at 48 hours-- was −0.67mEq/L (95% CI −0.45 to −0.89mEq/L). By 1 hour after ZS-9 administration, change in potassium was −0.17mEq/L (95% CI −0.05 to −0.30). Analysis of pooled adverse effects from these trials indicates that patiromer was associated with more gastrointestinal upset (7.6% constipation, 4.5% diarrhea) and electrolyte depletion (7.1% hypomagnesemia), whereas ZS-9 was associated with adverse effects of urinary tract infections (1.1%) and edema (0.9%). Conclusion Patiromer and ZS-9 represent significant pharmacologic advancements in the treatment of hyperkalemia. Both agents exhibited statistically and clinically significant reductions in potassium for the primary endpoint of this meta-analysis. Given the adverse effect profile and the observed time dependent effects, ZS-9 may play more of a role in treating acute hyperkalemia. PMID:28122118

Relative efficacy of topical non-steroidal anti-inflammatory drugs and topical capsaicin in osteoarthritis: protocol for an individual patient data meta-analysis.

PubMed

Persson, Monica S M; Fu, Yu; Bhattacharya, Archan; Goh, Siew-Li; van Middelkoop, Marienke; Bierma-Zeinstra, Sita M A; Walsh, David; Doherty, Michael; Zhang, Weiya

2016-09-29

Pain is the most troubling issue to patients with osteoarthritis (OA), yet current pharmacological treatments offer only small-to-moderate pain reduction. Current guidelines therefore emphasise the need to identify predictors of treatment response. In line with these recommendations, an individual patient data (IPD) meta-analysis will be conducted. The study aims to investigate the relative treatment effects of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical capsaicin in OA and to identify patient-level predictors of treatment response. IPD will be collected from randomised controlled trials (RCTs) of topical NSAIDs and capsaicin in OA. Multilevel regression modelling will be conducted to determine predictors for the specific and the overall treatment effect. Through the identification of treatment responders, this IPD meta-analysis may improve the current understanding of the pain mechanisms in OA and guide clinical decision-making. Identifying and prescribing the treatment most likely to be beneficial for an individual with OA will improve the efficiency of patient management. CRD42016035254.

Treatment Components and Their Relationships with Drug and Alcohol Abstinence.

ERIC Educational Resources Information Center

Orwin, Rob; Ellis, Bruce

This study evaluates the effect of treatment components through a secondary analysis of data from the National Treatment Improvement Evaluation Study (NTIES). The study examines the relationship between treatment components, client-level factors, and treatment outcomes, and how these relationships vary by treatment modality. It seeks to understand…

Analysis of External Treatment Methods and Technical Characteristics of External Treatment

NASA Astrophysics Data System (ADS)

Zhang, Rui; Miao, Mingsan; Bai, Ming

2018-01-01

Chinese medicine external therapy is a treatment method of Chinese medicine with Chinese characteristics. The effect of traditional Chinese medicine external treatment, convenient operation, external treatment and technology has great prospects for development. The traditional Chinese medicine external treatment method and technical characteristics were analyzed.

Treatment effectiveness and fidelity of manual therapy to the knee: A systematic review and meta-analysis.

PubMed

Salamh, Paul; Cook, Chad; Reiman, Michael P; Sheets, Charles

2017-09-01

Manual therapy (MT) is a commonly used treatment for knee osteoarthritis (OA) but to date only one systematic review has explored its effectiveness. The purpos e of the present study was to perform a systematic review and meta-analysis of the literature, to determine the effectiveness and fidelity of studies using MT techniques in individuals with knee OA. Relevant studies were assessed for inclusion. Effectiveness was measured using effect sizes, and methodological bias and treatment fidelity were both explored. Effect sizes were calculated using standardized mean differences (SMD) based on pooled data depending on statistical and clinical heterogeneity, as well as risk of bias. The search captured 2,969 studies; after screening, 12 were included. Four had a low risk of bias and high treatment fidelity. For self-reported function, comparing MT with no treatment resulted in a large effect size (standardized mean difference [SMD] 0.84), as did adding MT to a comparator treatment (SMD 0.78). A significant difference was found for pain when adding MT to a comparator treatment (SMD 0.73). The findings in the present meta-analytical review support the use of MT versus a number of different comparators for improvement in self-reported knee function. Lesser support is present for pain reduction, and no endorsement of functional performance can be made at this time. Copyright © 2016 John Wiley & Sons, Ltd.

Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark W.

2011-01-01

Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies.

PubMed

Brock, Gerald B; McVary, Kevin T; Roehrborn, Claus G; Watts, Steven; Ni, Xiao; Viktrup, Lars; Wong, David G; Donatucci, Craig

2014-02-01

Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction. Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms. A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p <0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p <0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p <0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p <0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p <0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement. Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. Copyright © 2014. Published by Elsevier Inc.

Incremental cost-effectiveness of laser therapy for choroidal neovascularization associated with histoplasmosis.

PubMed

Brown, G C; Brown, M M; Sharma, S; Busbee, B; Brown, H

2000-01-01

Laser photocoagulation has been shown in a large clinical trial to be efficacious in reducing the degree of vision loss occurring secondary to choroidal neovascularization (CNV) associated with ocular histoplasmosis. Nevertheless, data are lacking concerning the impact of the therapy on quality of life and its value to stakeholders in health care. Recently, information concerning the utility value of visual states has become available. Accordingly, the authors undertook to ascertain the cost-effectiveness of laser photocoagulation for the treatment of extrafoveal CNV occurring in eyes with ocular histoplasmosis. Design--A computer simulation, econometric model is presented to evaluate the incremental cost-effectiveness of laser photocoagulation therapy, as compared with the natural course of the disease, for the treatment of patients with extrafoveal CNV associated with ocular histoplasmosis. The model applies long-term visual data from previous clinical trials, utility analysis (which reflects patient perceptions of quality of life), decision analysis with Markov modeling, and present value analysis with discounting to account for the time value of money. Outcome measure--Cost per quality-adjusted life-year gained from treatment. Laser photocoagulation therapy for extrafoveal CNV associated with ocular histoplasmosis costs $4167 1999 US dollars (at a 3% discount rate) for each quality-adjusted life-year gained from treatment. Sensitivity analysis shows that changing the discount rate substantially alters the cost-effectiveness, with a value of $1339 at a 0% discount rate and $56,250 at a 10% discount rate. Compared with therapeutic modalities for other disease entities, laser therapy for the treatment of extrafoveal CNV associated with ocular histoplasmosis appears to be a cost-effective treatment from the patient preference-based point of view.

Assessing the treatment effect in a randomized controlled trial with extensive non-adherence: the EVOLVE trial.

PubMed

Kubo, Yumi; Sterling, Lulu Ren; Parfrey, Patrick S; Gill, Karminder; Mahaffey, Kenneth W; Gioni, Ioanna; Trotman, Marie-Louise; Dehmel, Bastian; Chertow, Glenn M

2015-01-01

Intention-to-treat (ITT) analysis is widely used to establish efficacy in randomized clinical trials. However, in a long-term outcomes study where non-adherence to study drug is substantial, the on-treatment effect of the study drug may be underestimated using the ITT analysis. The analyses presented herein are from the EVOLVE trial, a double-blind, placebo-controlled, event-driven cardiovascular outcomes study conducted to assess whether a treatment regimen including cinacalcet compared with placebo in addition to other conventional therapies reduces the risk of mortality and major cardiovascular events in patients receiving hemodialysis with secondary hyperparathyroidism. Pre-specified sensitivity analyses were performed to assess the impact of non-adherence on the estimated effect of cinacalcet. These analyses included lag-censoring, inverse probability of censoring weights (IPCW), rank preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE). The relative hazard (cinacalcet versus placebo) of mortality and major cardiovascular events was 0.93 (95% confidence interval 0.85, 1.02) using the ITT analysis; 0.85 (0.76, 0.95) using lag-censoring analysis; 0.81 (0.70, 0.92) using IPCW; 0.85 (0.66, 1.04) using RPSFTM and 0.85 (0.75, 0.96) using IPE. These analyses, while not providing definitive evidence, suggest that the intervention may have an effect while subjects are receiving treatment. The ITT method remains the established method to evaluate efficacy of a new treatment; however, additional analyses should be considered to assess the on-treatment effect when substantial non-adherence to study drug is expected or observed. Copyright © 2015 John Wiley & Sons, Ltd.

Cost-utility and budget impact analysis of drug treatments in pulmonary arterial hypertension associated with congenital heart diseases in Thailand.

PubMed

Thongsri, Watsamon; Bussabawalai, Thanaporn; Leelahavarong, Pattara; Wanitkun, Suthep; Durongpisitkul, Kritvikrom; Chaikledkaew, Usa; Teerawattananon, Yot

2016-08-01

This study aims to compare the lifetime costs and health outcomes of both first-line and sequential combination treatments with standard treatment for pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD) (PAH-CHD) patients. A cost-utility analysis was performed using a Markov model based on a societal perspective. One-way and probabilistic sensitivity analyses were performed to investigate the effect of parameter uncertainty. As first-line treatments, both beraprost (incremental cost-effectiveness ratio (ICER) = 192,752 and 201,308 Thai baht (THB) per quality-adjusted life year (QALY) gained) and sildenafil (ICER = 249,770 and 226,802 THB per QALY gained) seemed cost-effective for PAH-CHD patients aged ≤30 years in functional classes II and III, respectively, while no treatment was cost-effective for the sequential combination therapy. Sildenafil should be included in the National Drug List of Essential Medicines as the first-line treatment for PAH-CHD, and its price per dose should be negotiated to be reduced by 43-57%.

Impact of fibrates on circulating cystatin C levels: a systematic review and meta-analysis of clinical trials.

PubMed

Sahebkar, Amirhossein; Simental-Mendía, Luis E; Pirro, Matteo; Montecucco, Fabrizio; Carbone, Federico; Banach, Maciej; Barreto, George E; Butler, Alexandra E

2018-06-29

To assess the effect of fibrates on circulating cystatin C levels. Clinical studies evaluating the effect of a fibrate on circulating cystatin C levels were searched in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases. A random-effect model and generic inverse variance method were used for quantitative data synthesis, sensitivity analysis conducted using the leave-one-out method, and weighted random-effects meta-regression performed to evaluate potential confounders on cystatin C levels. This meta-analysis of data from 9 published studies (16 treatment arms) involved a total of 2195 subjects. In a single-arm analysis of clinical trials (without control group; 8 studies comprising 14 treatment arms), fibrate therapy increased circulating cystatin C concentrations (WMD: 0.07 mg/dL, 95% CI: 0.04, 0.10, p <0.001; I 2 = 82.66%). When the analysis was restricted to randomized controlled trials (4 studies comprising 6 treatment arms), again elevation of circulating cystatin C levels was observed (WMD: 0.06 mg/L, 95% CI: 0.03, 0.09, p <0.001; I 2 = 42.98%). Elevated cystatin C levels were only seen with fenofibrate, not other fibrates. The results suggest that fenofibrate treatment adversely affects cystatin C levels and might partially explain the limited efficacy of fenofibrate in reducing cardiovascular events.

Cost-effectiveness analysis of oral anti-viral drugs used for treatment of chronic hepatitis B in Turkey.

PubMed

Kockaya, Guvenc; Kose, Akin; Yenilmez, Fatma Betul; Ozdemir, Oktay; Kucuksayrac, Ece

2015-01-01

All international guidelines suggested that Tenofovir and Entecavir are the primary drugs at the first line therapy for the treatment of chronic hepatitis B (CHB). However, in Turkey these medications reimbursed at the second line therapy according to the Healthcare Implementation Notification. The aim of this study is to compare the cost effectiveness of oral antiviral treatment strategies in CHB for Turkey using lamuvidine, telbuvidine, entecavir, and tenofovir as medications. The analysis was conducted using Markov models. The analysis scenarios based on first line treatment options with Lamuvidine, Telbuvidine, Entecavir, and Tenofovir as the medications. In the analysis, inadequate response or resistance after receiving 12 months of the treatment with Entecavir and Telbivudine were compared to the results found from switching from Entecavir to Tenofovir or from switching from Telbuvidine to Tenofovir. In additional, inadequate response or resistance after receiving 6 months of the treatment for Lamivudine was compared to the results found from switching from Lamivudine to Tenofovir. The study population included men and women, who were 40 years of age. The patients` compliance was estimated 100 % for all of the therapy options. The model duration was constructed to evaluate, treatment strategy duration of 40 years. The cost of medications, examinations/follow-ups and complications were included in the model. Years of Potential Life Lost was used as the health outcome. An incremental cost-effectiveness ratio analysis has been conducted. While the minimum years of life lost was found as 0.22 with tenofovir treatment in 5 years, treatment cost was calculated as 12,169 TL. These values were detected as 0.56 years and 7727 TL, 0.37 years and 12,770 TL, respectively for lamuvidine and telbuvidine treatments. The maximum years of life lost and treatment cost was with lamuvidine treatment were detected as 1.60 years and 18,813 TL and, secondly 0.89 years and 24,007 TL for lamuvidine-tenofovir treatment during 10 years. The minimum years of life lost and cost are 0.54 year and 35,821 TL for tenofovir treatment during 10 years. The minimum years of life lost and cost were determined as 1.21 years and 52,839 TL for tenofovir treatment strategy during 20 years. During 30 years period, tenofovir treatment was found to have the minimum years of life lost (1.73 years) and minimum cost (84,149 TL). When the results of 40 years period were analyzed, years of life lost and costs are 2.06 years and 119,604 TL, 2.13 years and 162,115 TL, 2.13 years and 161,642 TL, 6.52 years and 147,245 TL, 3.20 years and 132,157 TL, 4.10 years and 151,059 TL and 3.05 years and 138,182 TL for tenofovir, entecavir, entecavir-tenofovir, lamuvidine, lamuvidine-tenofovir, telbivudine and telbivudine-tenofovir. In the model presented in this study, in cost effectiveness analysis about CHB treatments, Tenofovir was found to be one of the cost effective methods in comparison with other treatment strategies different time intervals. Beyond this achievement Tenofovir has shown to reduce cumulative treatment cost in first line CHB treatment when compared with regard to 40 year cumulative treatment cost.

Cost-effectiveness of Competing Strategies for Management of Recurrent Clostridium difficile Infection: A Decision Analysis

PubMed Central

Konijeti, Gauree G.; Sauk, Jenny; Shrime, Mark G.; Gupta, Meera; Ananthakrishnan, Ashwin N.

2014-01-01

Background. Clostridium difficile infection (CDI) is an important cause of morbidity and healthcare costs, and is characterized by high rates of disease recurrence. The cost-effectiveness of newer treatments for recurrent CDI has not been examined, yet would be important to inform clinical practice. The aim of this study was to analyze the cost effectiveness of competing strategies for recurrent CDI. Methods. We constructed a decision-analytic model comparing 4 treatment strategies for first-line treatment of recurrent CDI in a population with a median age of 65 years: metronidazole, vancomycin, fidaxomicin, and fecal microbiota transplant (FMT). We modeled up to 2 additional recurrences following the initial recurrence. We assumed FMT delivery via colonoscopy as our base case, but conducted sensitivity analyses based on different modes of delivery. Willingness-to-pay threshold was set at $50 000 per quality-adjusted life-year. Results. At our base case estimates, initial treatment of recurrent CDI using FMT colonoscopy was the most cost-effective strategy, with an incremental cost-effectiveness ratio of $17 016 relative to oral vancomycin. Fidaxomicin and metronidazole were both dominated by FMT colonoscopy. On sensitivity analysis, FMT colonoscopy remained the most cost-effective strategy at cure rates >88.4% and CDI recurrence rates <14.9%. Fidaxomicin required a cost <$1359 to meet our cost-effectiveness threshold. In clinical settings where FMT is not available or applicable, the preferred strategy appears to be initial treatment with oral vancomycin. Conclusions. In this decision analysis examining treatment strategies for recurrent CDI, we demonstrate that FMT colonoscopy is the most cost-effective initial strategy for management of recurrent CDI. PMID:24692533

Comparative Effects of Topical 0.2% Sirolimus for Angiofibromas in Adults and Pediatric Patients with Tuberous Sclerosis Complex.

PubMed

Lee, Young In; Lee, Ju Hee; Kim, Do Young; Chung, Kee Yang; Shin, Jung U

2018-06-20

Recent reports have suggested that the topical formulation of sirolimus is effective in treating facial angiofibromas in tuberous sclerosis complex (TSC). Here, we determined the safety and efficacy of 0.2% topical sirolimus for the treatment of facial angiofibroma and compared its effects based on age. This was a retrospective study which involved 36 TSC patients with facial angiofibromas who were treated with 0.2% sirolimus ointment. Its effect was evaluated using the Facial Angiofibroma Severity Index (FASI). In order to observe its comparative effect based on patient age, a subgroup analysis was performed, between the adult group (> 18 years old) and the pediatric group (≤18 years old). The total FASI as well as its subcategories (erythema, size, and extent) showed statistically significant improvements after the topical treatment with 0.2% sirolimus ointment (FASI before treatment: 7.2 ± 1.1, FASI after treatment: 4.4± 1.4, p < 0.001). Among the subcategories of FASI, the erythema was most significantly reduced with the fastest response to the treatment. In a subgroup analysis, the pediatric group showed significantly greater improvements in FASI (improvement of FASI in the pediatric group = 49.7 ± 12.2%, adult group = 27.9 ± 15.6%, p < 0.001). The serial improvement analysis also showed that the pediatric group achieved a consistently greater improvement in FASI at all visits. Its 1-year application in 3 patients demonstrated a continuous maintenance effect. No significant adverse effects were observed. 0.2% sirolimus ointment is safe and effective for facial angiofibromas. Considering its higher efficacy in younger patients, an early initiation of the treatment is recommended. © 2018 S. Karger AG, Basel.

Treatment evolution and new standards of care: implications for cost-effectiveness analysis.

PubMed

Shechter, Steven M

2011-01-01

Traditional approaches to cost-effectiveness analysis have not considered the downstream possibility of a new standard of care coming out of the research and development pipeline. However, the treatment landscape for patients may change significantly over the course of their lifetimes. To present a Markov modeling framework that incorporates the possibility of treatment evolution into the incremental cost-effectiveness ratio (ICER) that compares treatments available at the present time. . Markov model evaluated by matrix algebra. Measurements. The author evaluates the difference between the new and traditional ICER calculations for patients with chronic diseases facing a lifetime of treatment. The bias of the traditional ICER calculation may be substantial, with further testing revealing that it may be either positive or negative depending on the model parameters. The author also performs probabilistic sensitivity analyses with respect to the possible timing of a new treatment discovery and notes the increase in the magnitude of the bias when the new treatment is likely to appear sooner rather than later. Limitations. The modeling framework is intended as a proof of concept and therefore makes simplifying assumptions such as time stationarity of model parameters and consideration of a single new drug discovery. For diseases with a more active research and development pipeline, the possibility of a new treatment paradigm may be at least as important to consider in sensitivity analysis as other parameters that are often considered.

Cost-effectiveness of rivaroxaban for stroke prevention in atrial fibrillation in the Portuguese setting.

PubMed

Morais, João; Aguiar, Carlos; McLeod, Euan; Chatzitheofilou, Ismini; Fonseca Santos, Isabel; Pereira, Sónia

2014-09-01

To project the long-term cost-effectiveness of treating non-valvular atrial fibrillation (AF) patients for stroke prevention with rivaroxaban compared to warfarin in Portugal. A Markov model was used that included health and treatment states describing the management and consequences of AF and its treatment. The model's time horizon was set at a patient's lifetime and each cycle at three months. The analysis was conducted from a societal perspective and a 5% discount rate was applied to both costs and outcomes. Treatment effect data were obtained from the pivotal phase III ROCKET AF trial. The model was also populated with utility values obtained from the literature and with cost data derived from official Portuguese sources. The outcomes of the model included life-years, quality-adjusted life-years (QALYs), incremental costs, and associated incremental cost-effectiveness ratios (ICERs). Extensive sensitivity analyses were undertaken to further assess the findings of the model. As there is evidence indicating underuse and underprescription of warfarin in Portugal, an additional analysis was performed using a mixed comparator composed of no treatment, aspirin, and warfarin, which better reflects real-world prescribing in Portugal. This cost-effectiveness analysis produced an ICER of €3895/QALY for the base-case analysis (vs. warfarin) and of €6697/QALY for the real-world prescribing analysis (vs. mixed comparator). The findings were robust when tested in sensitivity analyses. The results showed that rivaroxaban may be a cost-effective alternative compared with warfarin or real-world prescribing in Portugal. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Effect of Plasma Treatment on Air and Water-Vapor Permeability of Bamboo Knitted Fabric

NASA Astrophysics Data System (ADS)

Prakash, C.; Ramakrishnan, G.; Chinnadurai, S.; Vignesh, S.; Senthilkumar, M.

2013-11-01

In this paper, the effects of oxygen and atmospheric plasma on air and water-vapor permeability properties of single jersey bamboo fabric have been investigated. The changes in these properties are believed to be related closely to the inter-fiber and inter-yarn friction force induced by the plasma treatments. The outcomes showed that the water-vapor permeability increased, although the air permeability decreased along with the plasma treatments. The SEM images clearly showed that the plasma modified the fiber surface outwardly. The results showed that the atmospheric plasma has an etching effect and increases the functionality of a bamboo surface, which is evident from SEM and FTIR-ATR analysis. These results reveal that atmospheric pressure plasma treatment is an effective method to improve the performance of bamboo fabric. Statistical analysis also indicates that the results are significant for air permeability and water-vapor permeability of the plasma-treated bamboo fabric.

The effect of losartan on progressive aortic dilatation in patients with Marfan's syndrome: a meta-analysis of prospective randomized clinical trials.

PubMed

Gao, Linggen; Chen, Lei; Fan, Li; Gao, Dewei; Liang, Zhiru; Wang, Rong; Lu, Wenning

2016-08-15

To assess the effect of losartan therapy on progressive aortic dilatation and on clinical outcome in patients with Marfan's syndrome (MFS). The meta-analysis was instituted, which included studies identified by a systematic review of MEDLINE of peer-reviewed publications. Echocardiogram or MRI measurements of the aortic root dimension and outcome measures of death, cardiovascular surgery and aortic dissection or rupture were compared between patients who were treated and untreated with losartan therapy. Six randomized trials with 1398 subjects met all the inclusion criteria and were included in the meta-analysis. Compared with non-losartan treatment, losartan therapy significantly decreased the rate of aortic dilatation (SMD=-0.13 with 95% CI -0.25 to 0.00, p=0.04). The clinical outcome beneficial was not observed in the losartan treatment group when compared with no losartan treatment group (odds ratio=1.04 with 95% CI of 0.57-1.87). Given the current results of the meta-analysis and together with the lack of associated side effects, it would be reasonable to use losartan in MFS patients with aortic root dilatation. However, no clinical outcome benefits were observed in the losartan treatment group when compared with no losartan treatment group. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Instrumental Variable Methods for Continuous Outcomes That Accommodate Nonignorable Missing Baseline Values.

PubMed

Ertefaie, Ashkan; Flory, James H; Hennessy, Sean; Small, Dylan S

2017-06-15

Instrumental variable (IV) methods provide unbiased treatment effect estimation in the presence of unmeasured confounders under certain assumptions. To provide valid estimates of treatment effect, treatment effect confounders that are associated with the IV (IV-confounders) must be included in the analysis, and not including observations with missing values may lead to bias. Missing covariate data are particularly problematic when the probability that a value is missing is related to the value itself, which is known as nonignorable missingness. In such cases, imputation-based methods are biased. Using health-care provider preference as an IV method, we propose a 2-step procedure with which to estimate a valid treatment effect in the presence of baseline variables with nonignorable missing values. First, the provider preference IV value is estimated by performing a complete-case analysis using a random-effects model that includes IV-confounders. Second, the treatment effect is estimated using a 2-stage least squares IV approach that excludes IV-confounders with missing values. Simulation results are presented, and the method is applied to an analysis comparing the effects of sulfonylureas versus metformin on body mass index, where the variables baseline body mass index and glycosylated hemoglobin have missing values. Our result supports the association of sulfonylureas with weight gain. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults.

PubMed

McCollister, Kathryn; Yang, Xuan; McKay, James R

2016-01-01

The study conducts a cost-effectiveness analysis (CEA) of a continuing care Telephone Monitoring and Counseling (TMC) intervention for adults diagnosed with cocaine dependence. Participants were randomly assigned to a control condition of intensive outpatient treatment only (treatment-as-usual, or TAU; N=108), or to one of two treatment conditions featuring TMC (N=106) and TMC plus incentives (TMC-plus; N=107). Follow-up assessments were conducted over a 2-year period. Intervention and client costs were collected with the program and client versions of the Drug Abuse Treatment Cost Analysis Program (DATCAP). Effectiveness was measured as the number of days abstinent during follow-up. Secondary analyses consider alternative measures of effectiveness and the reduced societal costs of physical and mental health problems and criminal justice involvement. From the societal perspective, TMC dominates both TAU and TMC-plus as a cost-effective and cost-saving intervention. Results varied by substance-using status, however, with the subgroup of participants in TMC-plus that were using drugs at intake and early in treatment having the greatest number of days of abstinence and generating similar savings during follow-up than the TMC subgroup using drugs at intake. Telephone monitoring and counseling appears to be a cost-effective and potentially cost-saving strategy for reducing substance use among chronic substance users. Providing client incentives added to total intervention costs but did not improve overall effectiveness. Clinical Trials.gov Number: NCT00685659. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

PubMed

Campbell, Aimee N C; Nunes, Edward V; Miele, Gloria M; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E; Turrigiano, Eva; Bailey, Genie L; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L; Carroll, Kathleen M; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A Rebecca

2012-03-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. Copyright © 2011 Elsevier Inc. All rights reserved.

Design and Methodological Considerations of an Effectiveness Trial of a Computer-assisted Intervention: An Example from the NIDA Clinical Trials Network

PubMed Central

Campbell, Aimee N. C.; Nunes, Edward V.; Miele, Gloria M.; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E.; Turrigiano, Eva; Bailey, Genie L.; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L.; Carroll, Kathleen M.; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A. Rebecca

2011-01-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. PMID:22085803

Comparing Effects of Biologic Agents in Treating Patients with Rheumatoid Arthritis: A Multiple Treatment Comparison Regression Analysis.

PubMed

Tvete, Ingunn Fride; Natvig, Bent; Gåsemyr, Jørund; Meland, Nils; Røine, Marianne; Klemp, Marianne

2015-01-01

Rheumatoid arthritis patients have been treated with disease modifying anti-rheumatic drugs (DMARDs) and the newer biologic drugs. We sought to compare and rank the biologics with respect to efficacy. We performed a literature search identifying 54 publications encompassing 9 biologics. We conducted a multiple treatment comparison regression analysis letting the number experiencing a 50% improvement on the ACR score be dependent upon dose level and disease duration for assessing the comparable relative effect between biologics and placebo or DMARD. The analysis embraced all treatment and comparator arms over all publications. Hence, all measured effects of any biologic agent contributed to the comparison of all biologic agents relative to each other either given alone or combined with DMARD. We found the drug effect to be dependent on dose level, but not on disease duration, and the impact of a high versus low dose level was the same for all drugs (higher doses indicated a higher frequency of ACR50 scores). The ranking of the drugs when given without DMARD was certolizumab (ranked highest), etanercept, tocilizumab/ abatacept and adalimumab. The ranking of the drugs when given with DMARD was certolizumab (ranked highest), tocilizumab, anakinra/rituximab, golimumab/ infliximab/ abatacept, adalimumab/ etanercept [corrected]. Still, all drugs were effective. All biologic agents were effective compared to placebo, with certolizumab the most effective and adalimumab (without DMARD treatment) and adalimumab/ etanercept (combined with DMARD treatment) the least effective. The drugs were in general more effective, except for etanercept, when given together with DMARDs.

Comparing Effects of Biologic Agents in Treating Patients with Rheumatoid Arthritis: A Multiple Treatment Comparison Regression Analysis

PubMed Central

Tvete, Ingunn Fride; Natvig, Bent; Gåsemyr, Jørund; Meland, Nils; Røine, Marianne; Klemp, Marianne

2015-01-01

Rheumatoid arthritis patients have been treated with disease modifying anti-rheumatic drugs (DMARDs) and the newer biologic drugs. We sought to compare and rank the biologics with respect to efficacy. We performed a literature search identifying 54 publications encompassing 9 biologics. We conducted a multiple treatment comparison regression analysis letting the number experiencing a 50% improvement on the ACR score be dependent upon dose level and disease duration for assessing the comparable relative effect between biologics and placebo or DMARD. The analysis embraced all treatment and comparator arms over all publications. Hence, all measured effects of any biologic agent contributed to the comparison of all biologic agents relative to each other either given alone or combined with DMARD. We found the drug effect to be dependent on dose level, but not on disease duration, and the impact of a high versus low dose level was the same for all drugs (higher doses indicated a higher frequency of ACR50 scores). The ranking of the drugs when given without DMARD was certolizumab (ranked highest), etanercept, tocilizumab/ abatacept and adalimumab. The ranking of the drugs when given with DMARD was certolizumab (ranked highest), tocilizumab, anakinra, rituximab, golimumab/ infliximab/ abatacept, adalimumab/ etanercept. Still, all drugs were effective. All biologic agents were effective compared to placebo, with certolizumab the most effective and adalimumab (without DMARD treatment) and adalimumab/ etanercept (combined with DMARD treatment) the least effective. The drugs were in general more effective, except for etanercept, when given together with DMARDs. PMID:26356639

Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis

PubMed Central

Sobral, Ana Paula Taboada; de Godoy, Camila Leal H; Fernandes, Kristianne P Santos; Bussadori, Sandra Kalil; Ferrari, Raquel Agnelli Mesquita; Monken, Sonia F

2018-01-01

Introduction Epidemiological data show that the signs and symptoms of temporomandibular disorder (TMD) start becoming apparent from 6 years of age, and during adolescence these signs and symptoms are similar to those of adults. The present study aims to estimate the direct costs for treatment of chronic muscle pain with photobiomodulation therapy, occlusal splint and placebo in patients with TMD; to evaluate the effectiveness of photobiomodulation therapy and occlusal splint for treatment of muscle pain in patients with TMD; to analyse the cost-effectiveness of the two proposed treatments for pain; and to describe and compare the results of the analyses of these treatments. Methods and analysis This is a prospective trial of clinical and economic analyses that will include 135 patientswith TMD aged between 15 years and 25 years, randomly assigned to a treatment group: G1 (photobiomodulation), G2 (occlusal splint) and G3 (placebo). The analyses will be based on the cost of each treatment during the 12-month period. The outcome of the analysis of effectiveness will be pain, measured periodically by means of clinical examination of Research Diagnostic Criteria for Temporomandibular Disorders. The cost-effectiveness ratio will be calculated using, as end points, pain and the ratio of the differences in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D. Ethics and dissemination This protocol has been ethically approved by the local medical ethical committee, protocol number 2.014.339. Results will be submitted to international peer-reviewed journals and presented at international conferences. Trial registration number NCT03096301. PMID:29730613

Early Magnesium Treatment After Aneurysmal Subarachnoid Hemorrhage: Individual Patient Data Meta-Analysis.

PubMed

Dorhout Mees, Sanne M; Algra, Ale; Wong, George K C; Poon, Wai S; Bradford, Celia M; Saver, Jeffrey L; Starkman, Sidney; Rinkel, Gabriel J E; van den Bergh, Walter M; van Kooten, F; Dirven, C M; van Gijn, J; Vermeulen, M; Rinkel, G J E; Boet, R; Chan, M T V; Gin, T; Ng, S C P; Zee, B C Y; Al-Shahi Salman, R; Boiten, J; Kuijsten, H; Lavados, P M; van Oostenbrugge, R J; Vandertop, W P; Finfer, S; O'Connor, A; Yarad, E; Firth, R; McCallister, R; Harrington, T; Steinfort, B; Faulder, K; Assaad, N; Morgan, M; Starkman, S; Eckstein, M; Stratton, S J; Pratt, F D; Hamilton, S; Conwit, R; Liebeskind, D S; Sung, G; Kramer, I; Moreau, G; Goldweber, R; Sanossian, N

2015-11-01

Delayed cerebral ischemia (DCI) is an important cause of poor outcome after aneurysmal subarachnoid hemorrhage (SAH). Trials of magnesium treatment starting <4 days after symptom onset found no effect on poor outcome or DCI in SAH. Earlier installment of treatment might be more effective, but individual trials had not enough power for such a subanalysis. We performed an individual patient data meta-analysis to study whether magnesium is effective when given within different time frames within 24 hours after the SAH. Patients were divided into categories according to the delay between symptom onset and start of the study medication: <6, 6 to 12, 12 to 24, and >24 hours. We calculated adjusted risk ratios with corresponding 95% confidence intervals for magnesium versus placebo treatment for poor outcome and DCI. We included 5 trials totaling 1981 patients; 83 patients started treatment<6 hours. For poor outcome, the adjusted risk ratios of magnesium treatment for start <6 hours were 1.44 (95% confidence interval, 0.83-2.51); for 6 to 12 hours 1.03 (0.65-1.63), for 12 to 24 hours 0.84 (0.65-1.09), and for >24 hours 1.06 (0.87-1.31), and for DCI, <6 hours 1.76 (0.68-4.58), for 6 to 12 hours 2.09 (0.99-4.39), for 12 to 24 hours 0.80 (0.56-1.16), and for >24 hours 1.08 (0.88-1.32). This meta-analysis suggests no beneficial effect of magnesium treatment on poor outcome or DCI when started early after SAH onset. Although the number of patients was small and a beneficial effect cannot be definitively excluded, we found no justification for a new trial with early magnesium treatment after SAH. © 2015 American Heart Association, Inc.

Mixed-treatment comparison of anabolic (teriparatide and PTH 1-84) therapies in women with severe osteoporosis.

PubMed

Migliore, A; Broccoli, S; Massafra, U; Bizzi, E; Frediani, B

2012-03-01

The recent development of compounds with anabolic action on bone have increased the range of therapeutic options for the treatment of osteoporosis and the prevention of fractures. Two major PTH analogs, the synthetic full-length 1-84 PTH molecule and the recombinant 1-34 N-terminal fragment (teriparatide), are available for the treatment of osteoporosis in many countries. There have bee no comparative trials on the bone anabolic effects of these compounds. In this study we applied a mixed treatment comparison (MTC) to compare the efficacy of teriparatide versus PTH 1-84 for the prevention of vertebral and non-vertebral fractures in women with severe osteoporosis. With this approach the relative treatment effect of one intervention over another can be obtained in the absence of head-to-head comparison. Among the candidate papers selected for analysis, two randomized controlled trials investigating the effects of teriparatide and PTH 1-84 met the selection criteria and underwent MTC analysis. Based on a fixed-effect MTC model analysis of data from two RCTs, teriparatide (20 µg/day) showed a 70% and 94% probability of being the best treatment for the prevention of vertebral and non-vertebral fractures, respectively. Together with a lack of statistical significance, this study has additional limitations. Some differences in trial procedures and populations exist; another limitation concerns the impossibility of carrying out a randomized-effect model MTC, due to sample exiguity. Furthermore, in order to consider unknown or unmeasured differences of covariates across trials, a random-effects approach would be preferred in order to assess the presence of heterogeneity across comparisons. In contrast, in our analysis a fixed-effect MTC model only was used. Teriparatide is expected to provide a greater efficacy over PTH 1-84 with both vertebral and non-vertebral fracture prevention in postmenopausal women with severe osteoporosis.

Is testosterone replacement therapy in males with hypogonadism cost-effective? An analysis in Sweden.

PubMed

Arver, Stefan; Luong, Ba; Fraschke, Anina; Ghatnekar, Ola; Stanisic, Sanja; Gultyev, Dmitry; Müller, Elvira

2014-01-01

Testosterone replacement therapy (TRT) has been recommended for the treatment of primary and secondary hypogonadism. However, long-term implications of TRT have not been investigated extensively. The aim of this analysis was to evaluate health outcomes and costs associated with life-long TRT in patients suffering from Klinefelter syndrome and late-onset hypogonadism (LOH). A Markov model was developed to assess cost-effectiveness of testosterone undecanoate (TU) depot injection treatment compared with no treatment. Health outcomes and associated costs were modeled in monthly cycles per patient individually along a lifetime horizon. Modeled health outcomes included development of type 2 diabetes, depression, cardiovascular and cerebrovascular complications, and fractures. Analysis was performed for the Swedish health-care setting from health-care payer's and societal perspective. One-way sensitivity analyses evaluated the robustness of results. The main outcome measures were quality-adjusted life-years (QALYs) and total cost in TU depot injection treatment and no treatment cohorts. In addition, outcomes were also expressed as incremental cost per QALY gained for TU depot injection therapy compared with no treatment (incremental cost-effectiveness ratio [ICER]). TU depot injection compared to no-treatment yielded a gain of 1.67 QALYs at an incremental cost of 28,176 EUR (37,192 USD) in the Klinefelter population. The ICER was 16,884 EUR (22,287 USD) per QALY gained. Outcomes in LOH population estimated benefits of TRT at 19,719 EUR (26,029 USD) per QALY gained. Results showed to be considerably robust when tested in sensitivity analyses. Variation of relative risk to develop type 2 diabetes had the highest impact on long-term outcomes in both patient groups. This analysis suggests that lifelong TU depot injection therapy of patients with hypogonadism is a cost-effective treatment in Sweden. Hence, it can support clinicians in decision making when considering appropriate treatment strategies for patients with testosterone deficiency. © 2013 International Society for Sexual Medicine.

Effectiveness of interceptive treatment of class III malocclusions with skeletal anchorage: A systematic review and meta-analysis.

PubMed

Rodríguez de Guzmán-Barrera, Jorge; Sáez Martínez, Carla; Boronat-Catalá, Montserrat; Montiel-Company, Jose María; Paredes-Gallardo, Vanessa; Gandía-Franco, José Luís; Almerich-Silla, José Manuel; Bellot-Arcís, Carlos

2017-01-01

Recently, new strategies for treating class III malocclusions have appeared. Skeletal anchorage appears to reduce the dentoalveolar effects while maximising the orthopaedic effect in growing patients. The purpose of this systematic review and meta-analysis is to examine the effectiveness of bone anchorage devices for interceptive treatment of skeletal class III malocclusions. Searches were made in the Pubmed, Embase, Scopus and Cochrane databases, as well as in a grey literature database, and were complemented by hand-searching. The criteria for eligibility were: patients who had undergone orthodontic treatment with skeletal anchorage (miniplates and miniscrews). Patients with syndromes or craniofacial deformities or who had undergone maxillofacial surgery were excluded. The following variables were recorded for each article: author, year of publication, type of study, sample size, dropouts, demographic variables, treatment carried out, radiographic study (2D or 3D), follow-up time, and quality of the articles on the Newcastle-Ottawa Scale. The means and confidence intervals of the following variables were employed: Wits, overjet, ANB, SNA and SNB. Initially, 239 articles were identified. After removing the duplicates and applying the selection criteria, 9 were included in the qualitative synthesis and 7 in the quantitative synthesis (meta-analysis). It may be concluded that skeletal anchorage is an effective treatment for improving skeletal Class III malocclusion, but when compared with other traditional treatments such as disjunction and face mask, there is no clear evidence that skeletal anchorage improves the results.

Effectiveness of interceptive treatment of class III malocclusions with skeletal anchorage: A systematic review and meta-analysis

PubMed Central

Rodríguez de Guzmán-Barrera, Jorge; Sáez Martínez, Carla; Boronat-Catalá, Montserrat; Montiel-Company, Jose María; Paredes-Gallardo, Vanessa; Gandía-Franco, José Luís; Almerich-Silla, José Manuel; Bellot-Arcís, Carlos

2017-01-01

Recently, new strategies for treating class III malocclusions have appeared. Skeletal anchorage appears to reduce the dentoalveolar effects while maximising the orthopaedic effect in growing patients. The purpose of this systematic review and meta-analysis is to examine the effectiveness of bone anchorage devices for interceptive treatment of skeletal class III malocclusions. Searches were made in the Pubmed, Embase, Scopus and Cochrane databases, as well as in a grey literature database, and were complemented by hand-searching. The criteria for eligibility were: patients who had undergone orthodontic treatment with skeletal anchorage (miniplates and miniscrews). Patients with syndromes or craniofacial deformities or who had undergone maxillofacial surgery were excluded. The following variables were recorded for each article: author, year of publication, type of study, sample size, dropouts, demographic variables, treatment carried out, radiographic study (2D or 3D), follow-up time, and quality of the articles on the Newcastle-Ottawa Scale. The means and confidence intervals of the following variables were employed: Wits, overjet, ANB, SNA and SNB. Initially, 239 articles were identified. After removing the duplicates and applying the selection criteria, 9 were included in the qualitative synthesis and 7 in the quantitative synthesis (meta-analysis). It may be concluded that skeletal anchorage is an effective treatment for improving skeletal Class III malocclusion, but when compared with other traditional treatments such as disjunction and face mask, there is no clear evidence that skeletal anchorage improves the results. PMID:28328995

Prevention, screening and treatment of colorectal cancer: a global and regional generalized cost effectiveness analysis

PubMed Central

2010-01-01

Background Regional generalized cost-effectiveness estimates of prevention, screening and treatment interventions for colorectal cancer are presented. Methods Standardised WHO-CHOICE methodology was used. A colorectal cancer model was employed to provide estimates of screening and treatment effectiveness. Intervention effectiveness was determined via a population state-transition model (PopMod) that simulates the evolution of a sub-regional population accounting for births, deaths and disease epidemiology. Economic costs of procedures and treatment were estimated, including programme overhead and training costs. Results In regions characterised by high income, low mortality and high existing treatment coverage, the addition of screening to the current high treatment levels is very cost-effective, although no particular intervention stands out in cost-effectiveness terms relative to the others. In regions characterised by low income, low mortality with existing treatment coverage around 50%, expanding treatment with or without screening is cost-effective or very cost-effective. Abandoning treatment in favour of screening (no treatment scenario) would not be cost effective. In regions characterised by low income, high mortality and low treatment levels, the most cost-effective intervention is expanding treatment. Conclusions From a cost-effectiveness standpoint, screening programmes should be expanded in developed regions and treatment programmes should be established for colorectal cancer in regions with low treatment coverage. PMID:20236531

Emotional Freedom Techniques for Anxiety: A Systematic Review With Meta-analysis.

PubMed

Clond, Morgan

2016-05-01

Emotional Freedom Technique (EFT) combines elements of exposure and cognitive therapies with acupressure for the treatment of psychological distress. Randomized controlled trials retrieved by literature search were assessed for quality using the criteria developed by the American Psychological Association's Division 12 Task Force on Empirically Validated Treatments. As of December 2015, 14 studies (n = 658) met inclusion criteria. Results were analyzed using an inverse variance weighted meta-analysis. The pre-post effect size for the EFT treatment group was 1.23 (95% confidence interval, 0.82-1.64; p < 0.001), whereas the effect size for combined controls was 0.41 (95% confidence interval, 0.17-0.67; p = 0.001). Emotional freedom technique treatment demonstrated a significant decrease in anxiety scores, even when accounting for the effect size of control treatment. However, there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.

Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan.

PubMed

Okazaki, Masateru; Kobayashi, Hisanori; Shimizu, Hirohito; Ishii, Yutaka; Yajima, Tsutomu; Kanbori, Masayoshi

2018-06-01

Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided into two age groups (younger: < 75 years and elderly: ≥ 75 years), and the safety, effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. During golimumab treatment over 24 weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4 weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75 years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy. Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.

Community-based management versus traditional hospitalization in treatment of drug-resistant tuberculosis: a systematic review and meta-analysis.

PubMed

Williams, Abimbola Onigbanjo; Makinde, Olusesan Ayodeji; Ojo, Mojisola

2016-01-01

Multidrug drug resistant Tuberculosis (MDR-TB) and extensively drug resistant Tuberculosis (XDR-TB) have emerged as significant public health threats worldwide. This systematic review and meta-analysis aimed to investigate the effects of community-based treatment to traditional hospitalization in improving treatment success rates among MDR-TB and XDR-TB patients in the 27 MDR-TB High burden countries (HBC). We searched PubMed, Cochrane, Lancet, Web of Science, International Journal of Tuberculosis and Lung Disease, and Centre for Reviews and Dissemination (CRD) for studies on community-based treatment and traditional hospitalization and MDR-TB and XDR-TB from the 27 MDR-TB HBC. Data on treatment success and failure rates were extracted from retrospective and prospective cohort studies, and a case control study. Sensitivity analysis, subgroup analyses, and meta-regression analysis were used to explore bias and potential sources of heterogeneity. The final sample included 16 studies involving 3344 patients from nine countries; Bangladesh, China, Ethiopia, Kenya, India, South Africa, Philippines, Russia, and Uzbekistan. Based on a random-effects model, we observed a higher treatment success rate in community-based treatment (Point estimate = 0.68, 95 % CI: 0.59 to 0.76, p  < 0.01) compared to traditional hospitalization (Point estimate = 0.57, 95 % CI: 0.44 to 0.69, p  < 0.01). A lower treatment failure rate was observed in community-based treatment 7 % (Point estimate = 0.07, 95 % CI: 0.03 to 0.10; p  < 0.01) compared to traditional hospitalization (Point estimate = 0.188, 95 % CI: 0.10 to 0.28; p  < 0.01). In the subgroup analysis, studies without HIV co-infected patients, directly observed therapy short course-plus (DOTS-Plus) implemented throughout therapy, treatment duration > 18 months, and regimen with drugs >5 reported higher treatment success rate. In the meta-regression model, age of patients, adverse events, treatment duration, and lost to follow up explains some of the heterogeneity of treatment effects between studies. Community-based management improved treatment outcomes. A mix of interventions with DOTS-Plus throughout therapy and treatment duration > 18 months as well as strategies in place for lost to follow up and adverse events should be considered in MDR-TB and XDR-TB interventions, as they influenced positively, treatment success.

How to interpret a healthcare economic analysis.

PubMed

Brown, Melissa M; Brown, Gary C

2005-06-01

The purpose of the review is to present guidelines to help the clinician to interpret healthcare economic analyses and review pertinent recent analysis in the ophthalmic literature. There are four variants of healthcare economic analyses: (1) cost-minimization analysis; (2) cost-benefit analysis; (3) cost-effectiveness analysis and (4) cost-utility analysis. Cost-utility utility analysis has assumed an increasingly important role in healthcare, with increasing number of analyses occurring in the peer-reviewed ophthalmic literature. These include cost-utility analyses of cataract surgery in the first and second eyes, amblyopia treatment, and cost-utility analyses encompassing the vitreoretinal interventions of the following: (1) laser photocoagulation for exudative macular degeneration; (2) laser treatment for diabetic retinopathy; (3) laser photocoagulation for branch retinal vein obstruction; (4) diabetic vitrectomy; (5) treatment of proliferative retinopathy of prematurity and (6) treatment of retinal detachment associated with proliferative vitreoretinopathy. As an increasing number of cost-utility analyses become available they will provide the information system for the practice of value-based medicine, or medicine based upon the patient-perceived value conferred by interventions. Increasing numbers of cost-utility analysis in the ophthalmic literature suggest that ophthalmic interventions, including vitreoretinal interventions, are cost effective. Cost-utility analysis is a major tool in value-based medicine, the practice of medicine based upon the patient-perceived value conferred by healthcare interventions.

Psychological treatment for vaginal pain: does etiology matter? A systematic review and meta-analysis.

PubMed

Flanagan, Esther; Herron, Katherine A; O'Driscoll, Ciarán; Williams, Amanda C de C

2015-01-01

Classification of vaginal pain within medical or psychiatric diagnostic systems draws mainly on the presumed presence or absence (respectively) of underlying medical etiology. A focus on the experience of pain, rather than etiology, emphasizes common ground in the aims of treatment to improve pain and sexual, emotional, and cognitive experience. Thus, exploring how vaginal pain conditions with varying etiology respond to psychological treatment could cast light on the extent to which they are the same or distinct. To examine the combined and relative efficacy of psychological treatments for vaginal pain conditions. A systematic search of EMBASE, MEDLINE, PsycINFO, and CINAHL was undertaken. Eleven randomized controlled trials were entered into a meta-analysis, and standardized mean differences and odds ratios were calculated. Effect sizes for individual psychological trial arms were also calculated. Main outcome measures were pain and sexual function. Equivalent effects were found for psychological and medical treatments. Effect sizes for psychological treatment arms were comparable across vaginal pain conditions. Effectiveness was equivalent regardless of presumed medical or psychiatric etiology, indicating that presumed etiology may not be helpful in selecting treatment. Research recommendations and clinical implications are discussed. © 2014 International Society for Sexual Medicine.

Cost-effectiveness analysis of annual Trichomonas vaginalis screening and treatment in HIV-positive women to prevent HIV transmission.

PubMed

Lazenby, Gweneth Bratton; Unal, Elizabeth Ramsey; Andrews, Annie Lintzenich; Simpson, Kit

2014-06-01

Because of a high incidence of Trichomonas infection among HIV-positive women, annual screening and treatment are recommended. Trichomonas infection is associated with a 2-fold risk of HIV transmission. The objective of this study was to determine if annual screening is cost-effective for the prevention of new HIV cases in susceptible male partners secondary to Trichomonas infection in HIV-positive women. A decision tree analysis was constructed to model the costs of Trichomonas screening, treatment, and follow-up. 200 women cycled through the model for a period of 12 months. One hundred women were unscreened and 100 were screened and treated per recommendations. Annual Trichomonas screening and treatment saves US $553 (US $475- US $645) per woman in the prevention of HIV transmission to male partners. The cost-effectiveness of this strategy was maintained across all assumptions in a sensitivity analysis. Trichomonas screening and treatment for the purpose of decreasing new HIV infections is not only cost-effective but also cost saving in HIV-positive women. If Centers for Disease Control and Prevention treatment guidelines were followed in all HIV-positive women living in the United States, the lifetime cost of new HIV infections prevented would approximate US $159,264,000 and could potentially prevent new HIV cases secondary to female-to-male transmissions.

MDR-TB patients in KwaZulu-Natal, South Africa: Cost-effectiveness of 5 models of care

PubMed Central

Wallengren, Kristina; Reddy, Tarylee; Besada, Donela; Brust, James C. M.; Voce, Anna; Desai, Harsha; Ngozo, Jacqueline; Radebe, Zanele; Master, Iqbal; Padayatchi, Nesri; Daviaud, Emmanuelle

2018-01-01

Background South Africa has a high burden of MDR-TB, and to provide accessible treatment the government has introduced different models of care. We report the most cost-effective model after comparing cost per patient successfully treated across 5 models of care: centralized hospital, district hospitals (2), and community-based care through clinics or mobile injection teams. Methods In an observational study five cohorts were followed prospectively. The cost analysis adopted a provider perspective and economic cost per patient successfully treated was calculated based on country protocols and length of treatment per patient per model of care. Logistic regression was used to calculate propensity score weights, to compare pairs of treatment groups, whilst adjusting for baseline imbalances between groups. Propensity score weighted costs and treatment success rates were used in the ICER analysis. Sensitivity analysis focused on varying treatment success and length of hospitalization within each model. Results In 1,038 MDR-TB patients 75% were HIV-infected and 56% were successfully treated. The cost per successfully treated patient was 3 to 4.5 times lower in the community-based models with no hospitalization. Overall, the Mobile model was the most cost-effective. Conclusion Reducing the length of hospitalization and following community-based models of care improves the affordability of MDR-TB treatment without compromising its effectiveness. PMID:29668748

A matching framework to improve causal inference in interrupted time-series analysis.

PubMed

Linden, Ariel

2018-04-01

Interrupted time-series analysis (ITSA) is a popular evaluation methodology in which a single treatment unit's outcome is studied over time and the intervention is expected to "interrupt" the level and/or trend of the outcome, subsequent to its introduction. When ITSA is implemented without a comparison group, the internal validity may be quite poor. Therefore, adding a comparable control group to serve as the counterfactual is always preferred. This paper introduces a novel matching framework, ITSAMATCH, to create a comparable control group by matching directly on covariates and then use these matches in the outcomes model. We evaluate the effect of California's Proposition 99 (passed in 1988) for reducing cigarette sales, by comparing California to other states not exposed to smoking reduction initiatives. We compare ITSAMATCH results to 2 commonly used matching approaches, synthetic controls (SYNTH), and regression adjustment; SYNTH reweights nontreated units to make them comparable to the treated unit, and regression adjusts covariates directly. Methods are compared by assessing covariate balance and treatment effects. Both ITSAMATCH and SYNTH achieved covariate balance and estimated similar treatment effects. The regression model found no treatment effect and produced inconsistent covariate adjustment. While the matching framework achieved results comparable to SYNTH, it has the advantage of being technically less complicated, while producing statistical estimates that are straightforward to interpret. Conversely, regression adjustment may "adjust away" a treatment effect. Given its advantages, ITSAMATCH should be considered as a primary approach for evaluating treatment effects in multiple-group time-series analysis. © 2017 John Wiley & Sons, Ltd.

Evaluating surrogate endpoints, prognostic markers, and predictive markers — some simple themes

PubMed Central

Baker, Stuart G.; Kramer, Barnett S.

2014-01-01

Background A surrogate endpoint is an endpoint observed earlier than the true endpoint (a health outcome) that is used to draw conclusions about the effect of treatment on the unobserved true endpoint. A prognostic marker is a marker for predicting the risk of an event given a control treatment; it informs treatment decisions when there is information on anticipated benefits and harms of a new treatment applied to persons at high risk. A predictive marker is a marker for predicting the effect of treatment on outcome in a subgroup of patients or study participants; it provides more rigorous information for treatment selection than a prognostic marker when it is based on estimated treatment effects in a randomized trial. Methods We organized our discussion around a different theme for each topic. Results “Fundamentally an extrapolation” refers to the non-statistical considerations and assumptions needed when using surrogate endpoints to evaluate a new treatment. “Decision analysis to the rescue” refers to use the use of decision analysis to evaluate an additional prognostic marker because it is not possible to choose between purely statistical measures of marker performance. “The appeal of simplicity” refers to a straightforward and efficient use of a single randomized trial to evaluate overall treatment effect and treatment effect within subgroups using predictive markers. Conclusion The simple themes provide a general guideline for evaluation of surrogate endpoints, prognostic markers, and predictive markers. PMID:25385934

[Treatment side effects and compliance in patients with depression].

PubMed

Petrova, N N; Kucher, E O

2012-01-01

The impact of treatment side-effects on the compliance was studied in 85 depressive patients with different mental disorders - recurrent depressive disorder, postschizophrenic depression and organic affective disorder. The comparison of objective and subjective evaluations of compliance and a comparative analysis of the level of compliance, with its dependence on the treatment specifics, in different diseases were done. A significant role of efficacy and treatment side-effects was identified. The levels of "mental" and "autonomous" side-effects were highest in the treatment of depression: patients with postschizophrenic depression had the highest risk in respect of maintenance treatment; patients with recurrent depressive disorder and organic (affective) disorder were more tolerant to the treatment side-effects and their treatment, including the maintenance therapy, was rather effective. The compliance of all patients with depression was negatively correlated with the severity of side-effects of pharmacotherapy. The greatest side-effects and the lowest level of compliance were observed in the complex treatment with antidepressants and atypical neuroleptics. The effect of side-effects on the compliance was dependent on their severity and subjective tolerability and, to a lesser extent, on the amount of drugs.

A health-economic analysis of diagnosis and treatment of obstructive sleep apnea with continuous positive airway pressure in relation to cardiovascular disease. The Greek experience.

PubMed

Trakada, Georgia; Economou, Nicholas-Tiberio; Nena, Evangelia; Trakada, Athanasia; Zarogoulidis, Pavlos; Steiropoulos, Paschalis

2015-05-01

Obstructive sleep apnea syndrome (OSAS) is common in adult population and it is associated with increased morbidity and mortality, especially due to cardiovascular disease (CVD). Both diagnosis, based on polysomnography, and treatment with continuous positive airway pressure (CPAP), carry a potentially high cost. The present study aims to analyze the cost-effectiveness of CPAP treatment versus no treatment, in the long-term, as it examines the effect of this treatment on the incidence of CVD. A Markov model was constructed to observe the disease evolution in patients with OSAS based on published evidence. Data on treatment costs were collected from public hospitals in Greece. Within each cycle of the model, each patient may remain free of CVD, may develop CVD, may die due to a cause related to CVD, or may die from other causes. The model begins at the age of 55 years in a severe OSAS patient (apnea-hypopnea index ≥30/h) and lasts for 45 years. Within the limitation of the model, CPAP was found to be a cost-effective strategy versus no treatment, due to the reduction of the cost for the CVD treatment, when the analysis was restricted to the male population. Moreover, CPAP was found to be clinically more effective than no treatment, as it increases life expectancy in both males and females. CPAP was found to be clinically more effective therapy than no treatment in relation to CVD and a cost-effective strategy in males with severe OSAS.

Prevalence of orthodontic treatment need in permanent dentition of Iranian population: A systematic review and meta-analysis of observational studies.

PubMed

Eslamipour, Faezeh; Afshari, Zohreh; Najimi, Arash

2018-01-01

Malocclusion is a common oral health problem and can affect the psychosocial well-being in the long term. Therefore, in the recent decades, demand for orthodontic treatment to correct malocclusion has greatly increased worldwide. This systematic review and meta-analysis was undertaken to assess existing evidence on the prevalence of orthodontic treatment need in Iran. National and international databases were searched for articles on the prevalence of orthodontic treatment need using index of orthodontic treatment need (IOTN) and dental aesthetic index (DAI). The required data were completed by hand-searching. After applying the inclusion and exclusion criteria, the quality of articles was checked by a professional checklist. Data extraction and meta-analysis were performed. A random effects model was employed, and publication bias was checked. From a total of 443 articles that reported orthodontic treatment need in Iran, 24 articles were included in the meta-analysis process. Meta-analysis was performed on components of IOTN and DAI. The pooled prevalence of orthodontic treatment need based on Dental Health Component and Aesthetic Component of IOTN and DAI was 23.8% (19.5%-28.7%), 4.8% (3.3%-7%), and 16.1% (12.3%-20.8%). The results were found to be heterogeneous ( P < 0.05). The results of this study revealed that orthodontic treatment need was not high in the Iranian population. Considering the differing prevalence of orthodontic treatment need based on normative index and self-perceived index, it is essential to improve the people's awareness of malocclusion and its side effects on their oral and general health.

Drug use to resistance exercise-induced fatigue based on diclofenac diethylamine emulgel efficacy analysis.

PubMed

Gu, Qi

2017-05-01

In this paper, the author study on the effect of drug treatment on sports injury, and makes a comparative analysis of drug effects. In sports, the incidence of various types of injuries is increasing, especially in muscle injury. In the experiment, we compared the effects of three different drugs on the treatment and relief of muscle loss. After 3 weeks, the average optical density of desmin in muscle fiber positive region have decreased, as xiaotong plaster (0.4708±0.0126), votalin (0.5124±0.0264) and placebo (0.3856±0.0312). It has a certain effect to promote the repair and regeneration of desmin expression by drugs. Through the analysis of the effect of drug intervention on sports injury repair, we can effectively improve the therapeutic effect of sports injury.

Identification and Sensitivity Analysis for Average Causal Mediation Effects with Time-Varying Treatments and Mediators: Investigating the Underlying Mechanisms of Kindergarten Retention Policy.

PubMed

Park, Soojin; Steiner, Peter M; Kaplan, David

2018-06-01

Considering that causal mechanisms unfold over time, it is important to investigate the mechanisms over time, taking into account the time-varying features of treatments and mediators. However, identification of the average causal mediation effect in the presence of time-varying treatments and mediators is often complicated by time-varying confounding. This article aims to provide a novel approach to uncovering causal mechanisms in time-varying treatments and mediators in the presence of time-varying confounding. We provide different strategies for identification and sensitivity analysis under homogeneous and heterogeneous effects. Homogeneous effects are those in which each individual experiences the same effect, and heterogeneous effects are those in which the effects vary over individuals. Most importantly, we provide an alternative definition of average causal mediation effects that evaluates a partial mediation effect; the effect that is mediated by paths other than through an intermediate confounding variable. We argue that this alternative definition allows us to better assess at least a part of the mediated effect and provides meaningful and unique interpretations. A case study using ECLS-K data that evaluates kindergarten retention policy is offered to illustrate our proposed approach.

Effects of antithyroid drugs on radioiodine treatment: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat

2007-01-01

Objective To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Design Meta-analysis. Data sources Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. Results We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Conclusions Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively. PMID:17309884

[Indicators of statin use as a model for qualitative evaluation of chronic disease management in the Local Health Unit Roma B].

PubMed

Ciaralli, Fabrizio; Summaria, Francesco; Mustilli, Marina; Vasselli, Loredana; D'Urso, Antonio; Degrassi, Flori

2010-01-01

In chronic diseases the adherence and persistence to therapeutic treatments are often lower than guidelines said. This leads to a worse therapeutic effect of the treatments and to a misuse in healthcare costs. Our study evaluates the impact of a pharmacoutilization analysis model, derived from the administrative database of the Local Health Unit Roma B. In particularly we calculate some indicators of adherence, persistence, occasional treatment and switch in patients on statins secondary prevention treatment (patients discharged from Hospital with Acute Myocardial Infarction diagnosis). The model that we developed would be successfully used in the cost-effective analysis of other drugs.

Anti-proliferative effect of biogenic gold nanoparticles against breast cancer cell lines (MDA-MB-231 & MCF-7)

NASA Astrophysics Data System (ADS)

K. S., Uma Suganya; Govindaraju, K.; Ganesh Kumar, V.; Prabhu, D.; Arulvasu, C.; Stalin Dhas, T.; Karthick, V.; Changmai, Niranjan

2016-05-01

Breast cancer is a major complication in women and numerous approaches are being developed to overcome this problem. In conventional treatments such as chemotherapy and radiotherapy the post side effects cause an unsuitable effect in treatment of cancer. Hence, it is essential to develop a novel strategy for the treatment of this disease. In the present investigation, a possible route for green synthesis of gold nanoparticles (AuNPs) using leaf extract of Mimosa pudica and its anticancer efficacy in the treatment of breast cancer cell lines is studied. The synthesized nanoparticles were found to be effective in killing cancer cells (MDA-MB-231 & MCF-7) which were studied using various anticancer assays (MTT assay, cell morphology determination, cell cycle analysis, comet assay, Annexin V-FITC/PI staining and DAPI staining). Cell morphological analysis showed the changes occurred in cancer cells during the treatment with AuNPs. Cell cycle analysis revealed apoptosis in G0/G1 to S phase. Similarly in Comet assay, there was an increase in tail length in treated cells in comparison with the control. Annexin V-FITC/PI staining assay showed prompt fluorescence in treated cells indicating the translocation of phosphatidylserine from the inner membrane. PI and DAPI staining showed the DNA damage in treated cells.

Treating Depression during Pregnancy and the Postpartum: A Preliminary Meta-Analysis

ERIC Educational Resources Information Center

Bledsoe, Sarah E.; Grote, Nancy K.

2006-01-01

Objectives: This meta-analysis evaluates treatment effects for nonpsychotic major depression during pregnancy and postpartum comparing interventions by type and timing. Methods: Studies for decreasing depressive severity during pregnancy and postpartum applying treatment trials and standardized measures were included. Standardized mean differences…

Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.

PubMed

López-Tarjuelo, Juan; Bouché-Babiloni, Ana; Santos-Serra, Agustín; Morillo-Macías, Virginia; Calvo, Felipe A; Kubyshin, Yuri; Ferrer-Albiach, Carlos

2014-11-01

Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator. A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed. Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320. FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The effect of substitution of sodium chloride with potassium chloride on the physicochemical, microbiological, and sensory properties of Halloumi cheese.

PubMed

Kamleh, R; Olabi, A; Toufeili, I; Najm, N E O; Younis, T; Ajib, R

2012-03-01

This study investigated the effect of salt reduction and partial replacement with KCl on the microbiological and sensory characteristics of fresh and matured Halloumi cheese. Halloumi samples were matured for 8 wk and moisture, fat, protein, pH, lactic acid, sodium, and potassium contents determined. Instrumental textural characteristics of the samples were measured using a texture analyzer. Microbiological analyses included counts of total bacteria, lactic acid bacteria, yeasts and molds, total coliforms, and psychrophilic bacteria. Descriptive sensory analysis was carried out by a 9-member panel, and acceptability testing was conducted with 72 panelists. Salt treatment had a significant effect on the pH, sodium, and potassium contents of the cheeses, whereas age by salt treatment interaction had a significant effect on the pH, lactic acid, and potassium contents of the samples. No major trends could be discerned from the texture profile analysis. All tested microorganisms increased with storage but in general did not differ between treatments and were, in certain instances, lower than levels reported in the literature for other cheeses. Descriptive analysis revealed a significant difference between salt treatments for bitterness, crumbliness, and moistness, whereas age of cheese was significant for saltiness and squeakiness. Salt treatment had no significant effect on any of the acceptability variables for all Halloumi samples. Copyright © 2012 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

The effect of telehealth systems and satisfaction with health expenditure among patients with metabolic syndrome.

PubMed

Uei, Shu-Lin; Tsai, Chung-Hung; Kuo, Yu-Ming

2016-04-29

Telehealth cost analysis has become a crucial issue for governments in recent years. In this study, we examined cases of metabolic syndrome in Hualien County, Taiwan. This research adopted the framework proposed by Marchand to establish a study process. In addition, descriptive statistics, a t test, analysis of variance, and regression analysis were employed to analyze 100 questionnaires. The results of the t$ test revealed significant differences in medical health expenditure, number of clinical visits for medical treatment, average amount of time spent commuting to clinics, amount of time spent undergoing medical treatment, and average number of people accompanying patients to medical care facilities or assisting with other tasks in the past one month, indicating that offering telehealth care services can reduce health expenditure. The statistical analysis results revealed that customer satisfaction has a positive effect on reducing health expenditure. Therefore, this study proves that telehealth care systems can effectively reduce health expenditure and directly improve customer satisfaction with medical treatment.

[Cost-effectiveness considerations in the treatment of osteoporosis].

PubMed

Moriwaki, Kensuke

2015-10-01

Osteoporotic fractures are associated with increased morbidity and mortality, and impose a huge financial burden on healthcare systems. Preventing osteoporotic fractures in the elderly therefore represents an important issue in terms of health economics. To date, the efficacy and cost-effectiveness of osteoporosis treatments have been studied extensively. In this article, the basic idea of health economic evaluation was introduced and articles of cost-effectiveness analysis for osteoporosis treatment were reviewed.

Comparative Effectiveness of Treatments for Chronic Low Back Pain: A Multiple Treatment Comparison Analysis.

PubMed

Rihn, Jeffrey A; Radcliff, Kristen; Norvell, Daniel C; Eastlack, Robert; Phillips, Frank M; Berland, Daniel; Sherry, Ned; Freedman, Mitchell; Vaccaro, Alexander R

2017-06-01

A systematic review and network meta-analysis. To determine current treatment options of chronic low back pain (LBP) as defined by randomized controlled trials (RCTs) and to compare effectiveness of those treatments using a mixed-treatment comparison (MTC). It is important to provide an evidence-based assessment of the treatment options that exist for LBP. A systematic search of RCTs was conducted in MEDLINE and the Cochrane Collaboration Library from 1990 to 2014. From the selected studies, we extracted preoperative and postoperative ODI and VAS back pain scores, additional surgeries, and complications. Standard and network meta-analytic techniques were used. Twelve RCTs were included in the analysis: 5 total disk replacement (TDR) versus fusion; 1 TDR versus exercise and cognitive behavioral therapy (CBT); 5 fusion versus exercise and CBT; and 1 fusion versus physical therapy (PT). On the basis of MTC, with respect to ODI change scores, the pooled mean difference favoring fusion over exercise and CBT was 2.0 points (95% CI, -1.2 to 4.8). The pooled mean difference favoring TDR over exercise and CBT was 6.4 points (95% CI, 3.2-9.3). The pooled mean difference favoring fusion over PT was 8.8 points (95% CI, 4.1-13.6). The pooled mean differences favoring TDR over fusion was 4.4 points (95% CI, 2.37-6.63). For PT versus structured exercise with CBT, the pooled mean difference favoring exercise with CBT over PT was 6.8 points (95% CI, 1.5-12.8). For TDR versus PT, the pooled mean difference favoring TDR over PT was 13.2 points (95% CI, 8.0-18.4). Additional surgery rates were similar between treatment options. All 4 treatments provided some benefit to patients with chronic LBP. According to the MTC analysis, TDR may be the most effective treatment and PT the least effective treatment for chronic LBP. This review is based on a limited number of RCT studies and does not support any 1 treatment modality for all patients.

Effects of Safinamide on Pain in Fluctuating Parkinson’s Disease Patients: A Post-Hoc Analysis

PubMed Central

Cattaneo, Carlo; Barone, Paolo; Bonizzoni, Erminio; Sardina, Marco

2016-01-01

Background: Pain, a frequent non-motor symptom in Parkinson’s Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients. Objective: To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE. Methods: This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson’s Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment. Results: The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the “Bodily discomfort” domain. Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect. Conclusions: These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit. PMID:27802242

Pharmacologic Treatment of Repetitive Behaviors in Autism Spectrum Disorders: Evidence of Publication Bias

PubMed Central

Volkmar, Fred R.; Bloch, Michael H.

2012-01-01

OBJECTIVE: The goal of this study was to examine the efficacy of serotonin receptor inhibitors (SRIs) for the treatment of repetitive behaviors in autism spectrum disorders (ASD). METHODS: Two reviewers searched PubMed and Clinicaltrials.gov for randomized, double-blind, placebo-controlled trials evaluating the efficacy of SRIs for repetitive behaviors in ASD. Our primary outcome was mean improvement in ratings scales of repetitive behavior. Publication bias was assessed by using a funnel plot, the Egger’s test, and a meta-regression of sample size and effect size. RESULTS: Our search identified 5 published and 5 unpublished but completed trials eligible for meta-analysis. Meta-analysis of 5 published and 1 unpublished trial (which provided data) demonstrated a small but significant effect of SRI for the treatment of repetitive behaviors in ASD (standardized mean difference: 0.22 [95% confidence interval: 0.07–0.37], z score = 2.87, P < .005). There was significant evidence of publication bias in all analyses. When Duval and Tweedie's trim and fill method was used to adjust for the effect of publication bias, there was no longer a significant benefit of SRI for the treatment of repetitive behaviors in ASD (standardized mean difference: 0.12 [95% confidence interval: –0.02 to 0.27]). Secondary analyses demonstrated no significant effect of type of medication, patient age, method of analysis, trial design, or trial duration on reported SRI efficacy. CONCLUSIONS: Meta-analysis of the published literature suggests a small but significant effect of SRI in the treatment of repetitive behaviors in ASD. This effect may be attributable to selective publication of trial results. Without timely, transparent, and complete disclosure of trial results, it remains difficult to determine the efficacy of available medications. PMID:22529279

Understanding Treatment Effect Estimates When Treatment Effects Are Heterogeneous for More Than One Outcome.

PubMed

Brooks, John M; Chapman, Cole G; Schroeder, Mary C

2018-06-01

Patient-centred care requires evidence of treatment effects across many outcomes. Outcomes can be beneficial (e.g. increased survival or cure rates) or detrimental (e.g. adverse events, pain associated with treatment, treatment costs, time required for treatment). Treatment effects may also be heterogeneous across outcomes and across patients. Randomized controlled trials are usually insufficient to supply evidence across outcomes. Observational data analysis is an alternative, with the caveat that the treatments observed are choices. Real-world treatment choice often involves complex assessment of expected effects across the array of outcomes. Failure to account for this complexity when interpreting treatment effect estimates could lead to clinical and policy mistakes. Our objective was to assess the properties of treatment effect estimates based on choice when treatments have heterogeneous effects on both beneficial and detrimental outcomes across patients. Simulation methods were used to highlight the sensitivity of treatment effect estimates to the distributions of treatment effects across patients across outcomes. Scenarios with alternative correlations between benefit and detriment treatment effects across patients were used. Regression and instrumental variable estimators were applied to the simulated data for both outcomes. True treatment effect parameters are sensitive to the relationships of treatment effectiveness across outcomes in each study population. In each simulation scenario, treatment effect estimate interpretations for each outcome are aligned with results shown previously in single outcome models, but these estimates vary across simulated populations with the correlations of treatment effects across patients across outcomes. If estimator assumptions are valid, estimates across outcomes can be used to assess the optimality of treatment rates in a study population. However, because true treatment effect parameters are sensitive to correlations of treatment effects across outcomes, decision makers should be cautious about generalizing estimates to other populations.

Effect of extended-release niacin on plasma lipoprotein(a) levels: A systematic review and meta-analysis of randomized placebo-controlled trials.

PubMed

Sahebkar, Amirhosssein; Reiner, Željko; Simental-Mendía, Luis E; Ferretti, Gianna; Cicero, Arrigo F G

2016-11-01

Lipoprotein(a) (Lp(a)) is a proatherogenic and prothrombotic lipoprotein. Our aim was to quantify the extended-release nicotinic acid Lp(a) reducing effect with a meta-analysis of the available randomized clinical trials. A meta-analysis and random-effects meta-regression were performed on data pooled from 14 randomized placebo-controlled clinical trials published between 1998 and 2015, comprising 17 treatment arms, which included 9013 subjects, with 5362 in the niacin arm. The impact of ER niacin on plasma Lp(a) concentrations was reported in 17 treatment arms. Meta-analysis suggested a significant reduction of Lp(a) levels following ER niacin treatment (weighted mean difference - WMD: -22.90%, 95% CI: -27.32, -18.48, p<0.001). Results also remained similar when the meta-analysis was repeated with standardized mean difference as summary statistic (WMD: -0.66, 95% CI: -0.82, -0.50, p<0.001). When the studies were categorized according to the administered dose, there was a comparable effect between the subsets of studies with administered doses of <2000mg/day (WMD: -21.85%, 95% CI: -30.61, -13.10, p<0.001) and ≥2000mg/day (WMD: -23.21%, 95% CI: -28.41, -18.01, p<0.001). The results of the random-effects meta-regression did not suggest any significant association between the changes in plasma concentrations of Lp(a) with dose (slope: -0.0001; 95% CI: -0.01, 0.01; p=0.983), treatment duration (slope: -0.40; 95% CI: -0.97, 0.17; p=0.166), and percentage change in plasma HDL-C concentrations (slope: 0.44; 95% CI: -0.48, 1.36; p=0.350). In this meta-analysis of randomized placebo-controlled clinical trials, treatment with nicotinic acid was associated with a significant reduction in Lp(a) levels. Copyright © 2016 Elsevier Inc. All rights reserved.

A comparison of a modified sequential oral sensory approach to an applied behavior-analytic approach in the treatment of food selectivity in children with autism spectrum disorder.

PubMed

Peterson, Kathryn M; Piazza, Cathleen C; Volkert, Valerie M

2016-09-01

Treatments of pediatric feeding disorders based on applied behavior analysis (ABA) have the most empirical support in the research literature (Volkert & Piazza, 2012); however, professionals often recommend, and caregivers often use, treatments that have limited empirical support. In the current investigation, we compared a modified sequential oral sensory approach (M-SOS; Benson, Parke, Gannon, & Muñoz, 2013) to an ABA approach for the treatment of the food selectivity of 6 children with autism. We randomly assigned 3 children to ABA and 3 children to M-SOS and compared the effects of treatment in a multiple baseline design across novel, healthy target foods. We used a multielement design to assess treatment generalization. Consumption of target foods increased for children who received ABA, but not for children who received M-SOS. We subsequently implemented ABA with the children for whom M-SOS was not effective and observed a potential treatment generalization effect during ABA when M-SOS preceded ABA. © 2016 Society for the Experimental Analysis of Behavior.

Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis.

PubMed

Zhang, Yan; Li, Lixiang; Guo, Chuanguo; Mu, Dan; Feng, Bingcheng; Zuo, Xiuli; Li, Yanqing

2016-06-13

Irritable bowel syndrome (IBS) is one of the most common functional gastroenterological diseases, affecting 11.2 % of people worldwide. Previous studies have shown that probiotic treatment may benefit IBS patients. However, the effect of probiotics and the appropriate type, dose, and treatment duration for IBS are still unclear. The aim of the current study was to assess the efficacy of different probiotic types, doses and treatment durations in IBS patients diagnosed by Rome III criteria via a meta-analysis of randomized controlled trials (RCTs). Medline, EMBASE, and the Cochrane Central Register of Controlled Trials up to October 2015 were searched. RCTs including comparisons between the effects of probiotics and placebo on IBS patients diagnosed by Rome III criteria were eligible. Dichotomous data were pooled to obtain the relative risk (RR) with a 95 % confidence interval (CI), whereas continuous data were pooled using a standardized mean difference (SMD) with a 95 % CI. Twenty-one RCTs were included in this meta-analysis. Probiotic therapy was associated with more improvement than placebo administration in overall symptom response (RR: 1.82, 95 % CI 1.27 to 2.60) and quality of life (QoL) (SMD: 0.29, 95 % CI 0.08 to 0.50), but not in individual IBS symptoms. Single probiotics, a low dose, and a short treatment duration were more effective with respect to overall symptom response and QoL. No differences were detected in individual IBS symptoms in the subgroup analyses. Probiotics are an effective pharmacological therapy in IBS patients. Single probiotics at a low dose and with a short treatment duration appear to be more effective in improving overall symptom response and QoL, but more evidence for these effects is still needed.

Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: evidence from a meta-analysis of 2334 patients from 5 randomised trials

PubMed Central

Laporte, Silvy; Squifflet, Pierre; Baroux, Noémie; Fossella, Frank; Georgoulias, Vassilis; Pujol, Jean-Louis; Douillard, Jean-Yves; Kudoh, Shinzohy; Pignon, Jean-Pierre; Quinaux, Emmanuel; Buyse, Marc

2013-01-01

Objectives To investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in advanced non-small-cell lung cancer (NSCLC). Design Meta-analysis of individual patient data from randomised trials. Setting Five randomised controlled trials comparing docetaxel-based chemotherapy with vinorelbine-based chemotherapy for the first-line treatment of NSCLC. Participants 2331 patients with advanced NSCLC. Primary and secondary outcome measures Surrogacy of PFS for OS was assessed through the association between these endpoints and between the treatment effects on these endpoints. The surrogate threshold effect was the minimum treatment effect on PFS required to predict a non-zero treatment effect on OS. Results The median follow-up of patients still alive was 23.4 months. Median OS was 10 months and median PFS was 5.5 months. The treatment effects on PFS and OS were correlated, whether using centres (R²=0.62, 95% CI 0.52 to 0.72) or prognostic strata (R²=0.72, 95% CI 0.60 to 0.84) as units of analysis. The surrogate threshold effect was a PFS hazard ratio (HR) of 0.49 using centres or 0.53 using prognostic strata. Conclusions These analyses provide only modest support for considering PFS as an acceptable surrogate for OS in patients with advanced NSCLC. Only treatments that have a major impact on PFS (risk reduction of at least 50%) would be expected to also have a significant effect on OS. Whether these results also apply to targeted therapies is an open question that requires independent evaluation. PMID:23485717

Cost-effectiveness analysis evaluating fidaxomicin versus oral vancomycin for the treatment of Clostridium difficile infection in the United States.

PubMed

Stranges, Paul M; Hutton, David W; Collins, Curtis D

2013-01-01

Fidaxomicin is a novel treatment for Clostridium difficile infections (CDIs). This new treatment, however, is associated with a higher acquisition cost compared with alternatives. The objective of this study was to evaluate the cost-effectiveness of fidaxomicin or oral vancomycin for the treatment of CDIs. We performed a cost-utility analysis comparing fidaxomicin with oral vancomycin for the treatment of CDIs in the United States by creating a decision analytic model from the third-party payer perspective. The incremental cost-effectiveness ratio with fidaxomicin compared with oral vancomycin was $67,576/quality-adjusted life-year. A probabilistic Monte Carlo sensitivity analysis showed that fidaxomicin had an 80.2% chance of being cost-effective at a willingness-to-pay threshold of $100,000/quality-adjusted life-year. Fidaxomicin remained cost-effective under all fluctuations of both fidaxomicin and oral vancomycin costs. The decision analytic model was sensitive to variations in clinical cure and recurrence rates. Secondary analyses revealed that fidaxomicin was cost-effective in patients receiving concominant antimicrobials, in patients with mild to moderate CDIs, and when compared with oral metronidazole in patients with mild to moderate disease. Fidaxomicin was dominated by oral vancomycin if CDI was caused by the NAP1/Bl/027 Clostridium difficile strain and was dominant in institutions that did not compound oral vancomycin. Results of our model showed that fidaxomicin may be a more cost-effective option for the treatment of CDIs when compared with oral vancomycin under most scenarios tested. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

A Cost-Effectiveness Analysis of Gemcitabine plus Cisplatin Versus Gemcitabine Alone for Treatment of Advanced Biliary Tract Cancer in Japan.

PubMed

Tsukiyama, Ikuto; Ejiri, Masayuki; Yamamoto, Yoshihiro; Nakao, Haruhisa; Yoneda, Masashi; Matsuura, Katsuhiko; Arakawa, Ichiro; Saito, Hiroko; Inoue, Tadao

2017-12-01

This study assessed the cost-effectiveness of combination treatment with gemcitabine and cisplatin compared to treatment with gemcitabine alone for advanced biliary tract cancer (BTC) in Japan. A monthly transmitted Markov model of three states was constructed based on the Japan BT-22 trial. Transition probabilities among the health states were derived from a trial conducted in Japan and converted to appropriate parameters for our model. The associated cost components, obtained from a receipt-based survey undertaken at the Aichi Medical University Hospital, were those related to inpatient care, outpatient care, and treatment for BTC. Costs for palliative care and treatment of adverse events were obtained from the National Health Insurance price list. We estimated cost-effectiveness per quality-adjusted life year (QALY) at a time horizon of 36 months. An annual discount of 3 % for both cost and outcome was considered. The base case outcomes indicated that combination therapy was less cost-effective than monotherapy when the incremental cost-effectiveness ratio (ICER) was approximately 14 million yen per QALY gained. The deterministic sensitivity analysis of the ICER revealed that the ICER of the base case was robust. A probabilistic analysis conducted with 10,000-time Monte Carlo simulations demonstrated efficacy at the willingness to pay threshold of 6 million yen per QALY gained for approximately 33 % of the population. In Japan, combination therapy is less cost-effective than monotherapy for treating advanced BTC, regardless of the statistical significance of the two therapies. Useful information on the cost-effectiveness of chemotherapy is much needed for the treatment of advanced BTC in Japan.

Researching Sex Bias in the Classroom.

ERIC Educational Resources Information Center

Donlan, Dan

This paper outlines five methods of research on sex bias in the classroom: one-time survey, one class/one treatment, two class/two treatment, one class/random assignment to treatment, and analysis of differentiated effect. It shows how each method could be used in attempting to measure the effect of a unit on Norma Klein's "Mom, the Wolfman and…

Sudden Gains during Psychological Treatments of Anxiety and Depression: A Meta-Analysis

ERIC Educational Resources Information Center

Aderka, Idan M.; Nickerson, Angela; Boe, Hans Jakob; Hofmann, Stefan G.

2012-01-01

Objective: The present study quantitatively reviewed the literature on sudden gains in psychological treatments for anxiety and depression. The authors examined the short- and long-term effects of sudden gains on treatment outcome as well as moderators of these effects. Method: The authors conducted a literature search using PubMed, PsycINFO, the…

Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

ERIC Educational Resources Information Center

Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

2008-01-01

A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

The effectiveness and safety of treatments used for acute diarrhea and acute gastroenteritis in children: protocol for a systematic review and network meta-analysis.

PubMed

Florez, Ivan D; Al-Khalifah, Reem; Sierra, Javier M; Granados, Claudia M; Yepes-Nuñez, Juan J; Cuello-Garcia, Carlos; Perez-Gaxiola, Giordano; Zea, Adriana M; Hernandez, Gilma N; Veroniki, Areti-Angeliki; Guyatt, Gordon H; Thabane, Lehana

2016-01-20

Acute diarrhea and acute gastroenteritis (AD/AGE) are common among children in low- and middle-income countries (LMIC) and high-income countries (HIC). Supportive therapy including maintaining feeding, prevention of dehydration, and use of oral rehydration solution (ORS), is the mainstay of treatment in all children. Several additional treatments aiming to reduce the episode duration have been compared to placebo, but the differences in effectiveness among them are unknown. We will conduct a systematic review of all randomized controlled trials evaluating the use of zinc, vitamin A, probiotics, prebiotics, synbiotics, racecadotril, smectite, and fermented and lactose-free milk/formula for AD/AGE treatment in children. The primary outcomes are diarrhea duration and mortality. Secondary outcomes are diarrhea lasting 3 or 7 days, stool frequency, treatment failure, hospitalizations, and adverse events. We will search MEDLINE, Ovid EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), and LILACS through Ovid, as well as grey literature resources. Two reviewers will independently screen titles and abstracts, review full texts, extract information, and assess the risk of bias (ROB) and the confidence in the estimate (with the grading of recommendations, assessment, development, and evaluation [GRADE] approach). Results will be summarized narratively and statistically. Subgroup analysis according to HIC vs. LMIC, age, nutrition status, and ROB is planned. We will perform a Bayesian network meta-analysis to combine the pooled direct and indirect treatment effect estimates for each outcome, if adequate data is available. This is the first systematic review and network meta-analysis that aims to determine the relative effectiveness of pharmacological and nutritional treatments for reducing the duration of AD/AGE in children. The results will help to reduce the uncertainty of the effectiveness of the interventions, find knowledge gaps, and/or encourage further research for other therapeutic options. PROSPERO registration number: CRD42015023778.

Using forecast modelling to evaluate treatment effects in single-group interrupted time series analysis.

PubMed

Linden, Ariel

2018-05-11

Interrupted time series analysis (ITSA) is an evaluation methodology in which a single treatment unit's outcome is studied serially over time and the intervention is expected to "interrupt" the level and/or trend of that outcome. ITSA is commonly evaluated using methods which may produce biased results if model assumptions are violated. In this paper, treatment effects are alternatively assessed by using forecasting methods to closely fit the preintervention observations and then forecast the post-intervention trend. A treatment effect may be inferred if the actual post-intervention observations diverge from the forecasts by some specified amount. The forecasting approach is demonstrated using the effect of California's Proposition 99 for reducing cigarette sales. Three forecast models are fit to the preintervention series-linear regression (REG), Holt-Winters (HW) non-seasonal smoothing, and autoregressive moving average (ARIMA)-and forecasts are generated into the post-intervention period. The actual observations are then compared with the forecasts to assess intervention effects. The preintervention data were fit best by HW, followed closely by ARIMA. REG fit the data poorly. The actual post-intervention observations were above the forecasts in HW and ARIMA, suggesting no intervention effect, but below the forecasts in the REG (suggesting a treatment effect), thereby raising doubts about any definitive conclusion of a treatment effect. In a single-group ITSA, treatment effects are likely to be biased if the model is misspecified. Therefore, evaluators should consider using forecast models to accurately fit the preintervention data and generate plausible counterfactual forecasts, thereby improving causal inference of treatment effects in single-group ITSA studies. © 2018 John Wiley & Sons, Ltd.

Cost-effectiveness of a barrier-strengthening moisturizing cream as maintenance therapy vs. no treatment after an initial steroid course in patients with atopic dermatitis in Sweden--with model applications for Denmark, Norway and Finland.

PubMed

Hjalte, F; Asseburg, C; Tennvall, G R

2010-04-01

Atopic dermatitis (AD) affects health and quality of life and it has great impact on both health-care costs and costs to the society. The objective of this study was to develop a model to analyse the cost-effectiveness of a barrier-strengthening moisturizing cream as maintenance therapy compared with no treatment after initial treatment with betamethasone valerate in adult patients with AD in Sweden. A further aim was to apply a similar health-economic analysis for Denmark, Norway and Finland. A Markov simulation model was developed including data from three sources: (i) efficacy data from a randomized controlled trial including patients with moderate AD treated with either a moisturizing cream or no treatment, (ii) resource utilization and quality of life data, and (iii) unit prices from official price lists. A societal perspective was used and the analysis was performed according to treatment practice in Sweden. The model simulation was also applied for Denmark, Norway and Finland with inclusion of country-specific unit costs. Sensitivity analyses were performed to test the robustness of the results. The results from the present analyses of treatment for patients with moderate AD indicate that maintenance treatment with a moisturizing cream during eczema-free periods could be cost-effective in a societal perspective. Similar results were obtained for Sweden, Denmark, Norway and Finland. According to the analysis, treatment with a moisturizing cream was found to be a cost-effective option compared with no treatment in eczema-free periods in adult patients with AD in the four Nordic countries.

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).

PubMed

Veronese, Ivan; De Martin, Elena; Martinotti, Anna Stefania; Fumagalli, Maria Luisa; Vite, Cristina; Redaelli, Irene; Malatesta, Tiziana; Mancosu, Pietro; Beltramo, Giancarlo; Fariselli, Laura; Cantone, Marie Claire

2015-06-13

A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres. The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

The Effects of Cognitive Therapy Versus ‘Treatment as Usual’ in Patients with Major Depressive Disorder

PubMed Central

Jakobsen, Janus Christian; Lindschou Hansen, Jane; Storebø, Ole Jakob; Simonsen, Erik; Gluud, Christian

2011-01-01

Background Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy may be an effective treatment option for major depressive disorder, but the effects have only had limited assessment in systematic reviews. Methods/Principal Findings Cochrane systematic review methodology, with meta-analyses and trial sequential analyses of randomized trials, are comparing the effects of cognitive therapy versus ‘treatment as usual’ for major depressive disorder. To be included the participants had to be older than 17 years with a primary diagnosis of major depressive disorder. Altogether, we included eight trials randomizing a total of 719 participants. All eight trials had high risk of bias. Four trials reported data on the 17-item Hamilton Rating Scale for Depression and four trials reported data on the Beck Depression Inventory. Meta-analysis on the data from the Hamilton Rating Scale for Depression showed that cognitive therapy compared with ‘treatment as usual’ significantly reduced depressive symptoms (mean difference −2.15 (95% confidence interval −3.70 to −0.60; P<0.007, no heterogeneity)). However, meta-analysis with both fixed-effect and random-effects model on the data from the Beck Depression Inventory (mean difference with both models −1.57 (95% CL −4.30 to 1.16; P = 0.26, I2 = 0) could not confirm the Hamilton Rating Scale for Depression results. Furthermore, trial sequential analysis on both the data from Hamilton Rating Scale for Depression and Becks Depression Inventory showed that insufficient data have been obtained. Discussion Cognitive therapy might not be an effective treatment for major depressive disorder compared with ‘treatment as usual’. The possible treatment effect measured on the Hamilton Rating Scale for Depression is relatively small. More randomized trials with low risk of bias, increased sample sizes, and broader more clinically relevant outcomes are needed. PMID:21829664

Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes

PubMed Central

2014-01-01

Background Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. Methods The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Results Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Conclusions Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately. PMID:25047164

Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke.

PubMed

Lees, Kennedy R; Khatri, Pooja

2016-08-01

Pooled analysis of individual patient data from stroke trials can deliver more precise estimates of treatment effect, enhance power to examine prespecified subgroups, and facilitate exploration of treatment-modifying influences. Analysis plans should be declared, and preferably published, before trial results are known. For pooling trials that used diverse analytic approaches, an ordinal analysis is favored, with justification for considering deaths and severe disability jointly. Because trial pooling is an incremental process, analyses should follow a sequential approach, with statistical adjustment for iterations. Updated analyses should be published when revised conclusions have a clinical implication. However, caution is recommended in declaring pooled findings that may prejudice ongoing trials, unless clinical implications are compelling. All contributing trial teams should contribute to leadership, data verification, and authorship of pooled analyses. Development work is needed to enable reliable inferences to be drawn about individual drug or device effects that contribute to a pooled analysis, versus a class effect, if the treatment strategy combines ≥2 such drugs or devices. Despite the practical challenges, pooled analyses are powerful and essential tools in interpreting clinical trial findings and advancing clinical care. © 2016 American Heart Association, Inc.

Mobile Technology Boosts the Effectiveness of Psychotherapy and Behavioral Interventions: A Meta-analysis

PubMed Central

Lindhiem, Oliver; Bennett, Charles B.; Rosen, Dana; Silk, Jennifer

2015-01-01

We conducted a meta-analysis on the effects of mobile technology on treatment outcome for psychotherapy and other behavioral interventions. Our search of the literature resulted in 26 empirical articles describing 25 clinical trials testing the benefits of smartphone applications, PDAs, or text messaging systems either to supplement treatment or substitute for direct contact with a clinician. Overall, mobile technology use was associated with superior treatment outcome across all study designs and control conditions, ES = .34, p < .0001. For the subset of 10 studies that looked specifically at the added benefit of mobile technology using a rigorous “Treatment” versus “Treatment + Mobile” design, effect sizes were only slightly more modest (ES = .27) and still significant (p < .05). Overall, the results support the role of mobile technology for the delivery of psychotherapy and other behavioral interventions. PMID:26187164

The effect of antihypertensive treatment on the incidence of stroke and cognitive decline in the elderly: a meta-analysis.

PubMed

Parsons, Christine; Murad, Mohammad Hassan; Andersen, Stuart; Mookadam, Farouk; Labonte, Helene

2016-03-01

To evaluate the effectiveness of antihypertensives in reducing neurocognitive outcomes in elderly patients. We conducted a systematic literature search of randomized trials in which hypertensive patients with a mean age ≥65 years received antihypertensive or control treatment. Outcomes were stroke, transient ischemic attack, cognitive decline and dementia. We included 14 trials for meta-analysis. Compared to placebo, antihypertensive treatment reduced the risk of stroke (RR: 0.67 [95% CI: 0.57-0.79]). Reduced risk was significant for transient ischemic attack, fatal stroke, nonfatal stroke and total stroke. There were insufficient data to compare individual agents. Antihypertensive treatment is associated with a significant reduction in stroke in elderly individuals. Reductions in dementia and cognitive decline were not significant; however, there was short follow-up. Comparative effectiveness evidence is limited.

Clinical and economic evaluation of modulated electrohyperthermia concurrent to dose-dense temozolomide 21/28 days regimen in the treatment of recurrent glioblastoma: a retrospective analysis of a two-centre German cohort trial with systematic comparison and effect-to-treatment analysis

PubMed Central

2017-01-01

Objective To assess the efficacy and cost-effectiveness of modulated electrohyperthermia (mEHT) concurrent to dose-dense temozolomide (ddTMZ) 21/28 days regimen versus ddTMZ 21/28 days alone in patients with recurrent glioblastoma (GBM). Design A cohort of 54 patients with recurrent GBM treated with ddTMZ+mEHT in 2000–2005 was systematically retrospectively compared with five pooled ddTMZ 21/28 days cohorts (114 patients) enrolled in 2008–2013. Results The ddTMZ+mEHT cohort had a not significantly improved mean survival time (mST) versus the comparator (p=0.531) after a significantly less mean number of cycles (1.56 vs 3.98, p<0.001). Effect-to-treatment analysis (ETA) suggests that mEHT significantly enhances the efficacy of the ddTMZ 21/28 days regimen (p=0.011), with significantly less toxicity (no grade III–IV toxicity vs 45%–92%, p<0.0001). An estimated maximal attainable median survival time is 10.10 months (9.10–11.10). Cost-effectiveness analysis suggests that, unlike ddTMZ 21/28 days alone, ddTMZ+mEHT is cost-effective versus the applicable cost-effectiveness thresholds €US$25 000–50 000/quality-adjusted life year (QALY). Budget impact analysis suggests a significant saving of €8 577 947/$11 201 761 with 29.1–38.5 QALY gained per 1000 patients per year. Cost-benefit analysis suggests that mEHT is profitable and will generate revenues between €3 124 574 and $6 458 400, with a total economic effect (saving+revenues) of €5 700 034 to $8 237 432 per mEHT device over an 8-year period. Conclusions Our ETA suggests that mEHT significantly improves survival of patients receiving the ddTMZ 21/28 days regimen. Economic evaluation suggests that ddTMZ+mEHT is cost-effective, budget-saving and profitable. After confirmation of the results, mEHT could be recommended for the treatment of recurrent GBM as a cost-effective enhancer of ddTMZ regimens, and, probably, of the regular 5/28 days regimen. mEHT is applicable also as a single treatment if chemotherapy is impossible, and as a salvage treatment after the failure of chemotherapy. PMID:29102988

Reciprocal effects among changes in weight, body image, and other psychological factors during behavioral obesity treatment: a mediation analysis.

PubMed

Palmeira, António L; Markland, David A; Silva, Marlene N; Branco, Teresa L; Martins, Sandra C; Minderico, Cláudia S; Vieira, Paulo N; Barata, José T; Serpa, Sidónio O; Sardinha, Luis B; Teixeira, Pedro J

2009-02-09

Changes in body image and subjective well-being variables (e.g. self-esteem) are often reported as outcomes of obesity treatment. However, they may, in turn, also influence behavioral adherence and success in weight loss. The present study examined associations among obesity treatment-related variables, i.e., change in weight, quality of life, body image, and subjective well-being, exploring their role as both mediators and outcomes, during a behavioral obesity treatment. Participants (BMI = 31.1 +/- 4.1 kg/m2; age = 38.4 +/- 6.7 y) were 144 women who attended a 12-month obesity treatment program and a comparison group (n = 49), who received a general health education program. The intervention included regular group meetings promoting lasting behavior changes in physical activity and dietary intake. Body image, quality of life, subjective well-being, and body weight were measured at baseline and treatment's end. Mediation was tested by multiple regression and a resampling approach to measure indirect effects. Treatment group assignment was the independent variable while changes in weight and in psychosocial variables were analyzed alternatively as mediators and as dependent variables. At 12 months, the intervention group had greater weight loss (-5.6 +/- 6.8% vs. -1.2 +/- 4.6%, p < .001) and larger decreases in body size dissatisfaction (effect size of 1.08 vs. .41, p < .001) than the comparison group. Significant improvements were observed in both groups for all other psychosocial variables (effect sizes ranging from .31-.75, p < .05). Mediation analysis showed that changes in body image and body weight were concurrently mediators and outcomes of treatment, suggesting reciprocal influences. Weight loss partially mediated the effect of treatment on quality of life and on self-esteem but the reciprocal effect was not observed. Changes in weight and body image may reciprocally affect each other during the course of behavioral obesity treatment. No evidence of reciprocal relationships was found for the other models under analysis; however, weight changes partially explained the effects of treatment on quality of life and self-esteem. Weight and psychosocial changes co-occur during treatment and will probably influence each other dynamically, in ways not yet adequately understood. Results from this study support the inclusion of intervention contents aimed at improving body image in weight management programs.

Effectiveness and Cost-Effectiveness of Antidepressants in Primary Care: A Multiple Treatment Comparison Meta-Analysis and Cost-Effectiveness Model

PubMed Central

Ramsberg, Joakim; Asseburg, Christian; Henriksson, Martin

2012-01-01

Objective To determine effectiveness and cost-effectiveness over a one-year time horizon of pharmacological first line treatment in primary care for patients with moderate to severe depression. Design A multiple treatment comparison meta-analysis was employed to determine the relative efficacy in terms of remission of 10 antidepressants (citalopram, duloxetine escitalopram, fluoxetine, fluvoxamine mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine). The estimated remission rates were then applied in a decision-analytic model in order to estimate costs and quality of life with different treatments at one year. Data Sources Meta-analyses of remission rates from randomised controlled trials, and cost and quality-of-life data from published sources. Results The most favourable pharmacological treatment in terms of remission was escitalopram with an 8- to 12-week probability of remission of 0.47. Despite a high acquisition cost, this clinical effectiveness translated into escitalopram being both more effective and having a lower total cost than all other comparators from a societal perspective. From a healthcare perspective, the cost per QALY of escitalopram was €3732 compared with venlafaxine. Conclusion Of the investigated antidepressants, escitalopram has the highest probability of remission and is the most effective and cost-effective pharmacological treatment in a primary care setting, when evaluated over a one year time-horizon. Small differences in remission rates may be important when assessing costs and cost-effectiveness of antidepressants. PMID:22876296

Effects of Systemic Therapy on Mental Health of Children and Adolescents: A Meta-Analysis.

PubMed

Riedinger, Verena; Pinquart, Martin; Teubert, Daniela

2017-01-01

Systemic therapy is a frequently used form of psychotherapy for the treatment of mental disorders in children and adolescents. The present study reports the results of the first meta-analysis on the effects of systemic treatment of mental disorders and behavior problems in children and adolescents. Based on systematic search in electronic databases (PsycINFO, Psyndex, PubMed, ISI Web of Knowledge, CINAHL), k = 56 randomized, controlled trials met the inclusion criteria. We computed a random-effects meta-analysis. Systemic therapy showed small-to-medium effects in comparison with an untreated control group (posttest: k = 7, g = .59 standard deviation units, follow-up: k = 2, g = .27) and alternative treatment (posttest: k = 43, g = .32, follow-up: k = 38, g = .28). At follow-up, longer interventions produced larger effect sizes. No other moderator effects were identified. Although available randomized, controlled trials show convincing results, their effects refer to a limited number of systemic approaches and mental disorders, and also pertain to adolescents rather than younger children. Thus, more research is needed before more general conclusions about the effects of systemic therapy can be drawn.

Effect size calculation in meta-analyses of psychotherapy outcome research.

PubMed

Hoyt, William T; Del Re, A C

2018-05-01

Meta-analysis of psychotherapy intervention research normally examines differences between treatment groups and some form of comparison group (e.g., wait list control; alternative treatment group). The effect of treatment is normally quantified as a standardized mean difference (SMD). We describe procedures for computing unbiased estimates of the population SMD from sample data (e.g., group Ms and SDs), and provide guidance about a number of complications that may arise related to effect size computation. These complications include (a) incomplete data in research reports; (b) use of baseline data in computing SMDs and estimating the population standard deviation (σ); (c) combining effect size data from studies using different research designs; and (d) appropriate techniques for analysis of data from studies providing multiple estimates of the effect of interest (i.e., dependent effect sizes). Clinical or Methodological Significance of this article: Meta-analysis is a set of techniques for producing valid summaries of existing research. The initial computational step for meta-analyses of research on intervention outcomes involves computing an effect size quantifying the change attributable to the intervention. We discuss common issues in the computation of effect sizes and provide recommended procedures to address them.

Multivariate evaluation of the effectiveness of treatment efficacy of cypermethrin against sea lice (Lepeophtheirus salmonis) in Atlantic salmon (Salmo salar)

PubMed Central

2013-01-01

Background The sea louse Lepeophtheirus salmonis is the most important ectoparasite of farmed Atlantic salmon (Salmo salar) in Norwegian aquaculture. Control of sea lice is primarily dependent on the use of delousing chemotherapeutants, which are both expensive and toxic to other wildlife. The method most commonly used for monitoring treatment effectiveness relies on measuring the percentage reduction in the mobile stages of Lepeophtheirus salmonis only. However, this does not account for changes in the other sea lice stages and may result in misleading or incomplete interpretation regarding the effectiveness of treatment. With the aim of improving the evaluation of delousing treatments, we explored multivariate analyses of bath treatments using the topical pyrethroid, cypermethrin, in salmon pens at five Norwegian production sites. Results Conventional univariate analysis indicated reductions of over 90% in mobile stages at all sites. In contrast, multivariate analyses indicated differing treatment effectiveness between sites (p-value < 0.01) based on changes in the proportion and abundance of the chalimus and PAAM (pre-adult and adult males) stages. Low water temperatures and shortened intervals between sampling after treatment may account for the differences in the composition of chalimus and PAAM stage groups following treatment. Using multivariate analysis, such factors could be separated from those which were attributable to inadequate treatment or chemotherapeutant failure. Conclusions Multivariate analyses for evaluation of treatment effectiveness against multiple life cycle stages of L. salmonis yield additional information beyond that derivable from univariate methods. This can aid in the identification of causes of apparent treatment failure in salmon aquaculture. PMID:24354936

Control of Pteridium aquilinum: Meta-analysis of a Multi-site Study in the UK

PubMed Central

Stewart, Gavin; Cox, Emma; Le Duc, Mike; Pakeman, Robin; Pullin, Andrew; Marrs, Rob

2008-01-01

Background and Aims A great deal of money is spent controlling invasive weeds as part of international and national policies. It is essential that the funded treatments work across the region in which the policies operate. We argue that experiments across multiple sites are required to validate these programs as results from single sites may be misleading. Here, the control of Pteridium aquilinum (bracken) is used as a test example to address the following four questions. (1) Does the effectiveness of P. aquilinum-control treatments vary across sites? (2) Is the best treatment identified in previous research (cutting twice per year) consistent at all sites, and if not why not? (3) Is treatment performance related to P. aquilinum rhizome mass, litter cover or litter depth at the various sites? (4) Does successful P. aquilinum control influence species richness? Methods Pteridium aquilinum‐control treatments were monitored for 10 years using six replicated experiments and analysed using meta-analysis. Meta-regressions were used to explore heterogeneity between sites. Key Results The effectiveness of treatments varied between sites depending on the measure used to assess P. aquilinum performance. In general, cutting twice per year was the most successful treatment but on some sites other, less expensive treatments were as good. The effectiveness of treatments at different sites was not related to rhizome mass, but the effectiveness of most applied treatments were inversely related to post-control litter. Effective treatment was also associated with high species richness. Conclusions It is concluded that successful development of national weed control programs requires multi-site experimental approaches. Here, meta-analyses demonstrate that variation in effectiveness between sites could be explained in part by pre-specified variables. Reliance on data from a single site for policy formulation is therefore clearly dangerous. PMID:18337356

Treatment with GLP1 receptor agonists reduce serum CRP concentrations in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Mazidi, Mohsen; Karimi, Ehsan; Rezaie, Peyman; Ferns, Gordon A

2017-07-01

To undertake a systematic review and meta-analysis of randomized controlled trials of the effect of glucagon-like peptide-1 receptor agonist (GLP-1 RAs) therapy on serum C-reactive protein (CRP) concentrations. PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases were searched for the period up until March 16, 2016. Prospective studies evaluating the impact of GLP-1 RAs on serum CRP were identified. A random effects model (using the DerSimonian-Laird method) and generic inverse variance methods were used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. Heterogeneity was quantitatively assessed using the I 2 index. Random effects meta-regression was performed using unrestricted maximum likelihood method to evaluate the impact of potential moderator. International Prospective Register for Systematic Reviews (PROSPERO) number CRD42016036868. Meta-analysis of the data from 7 treatment arms revealed a significant reduction in serum CRP concentrations following treatment with GLP-1 RAs (WMD -2.14 (mg/dL), 95% CI -3.51, -0.78, P=0.002; I 2 96.1%). Removal of one study in the meta-analysis did not change the result in the sensitivity analysis (WMD -2.14 (mg/dL), 95% CI -3.51, -0.78, P=0.002; I 2 96.1%), indicating that our results could not be solely attributed to the effect of a single study. Random effects meta-regression was performed to evaluate the impact of potential moderator on the estimated effect size. Changes in serum CRP concentration were associated with the duration of treatment (slope -0.097, 95% CI -0.158, -0.042, P<0.001). This meta-analysis suggests that GLP-1 RAs therapy causes a significant reduction in CRP. Copyright © 2016 Elsevier Inc. All rights reserved.

Problems and Issues in Meta-Analysis.

ERIC Educational Resources Information Center

George, Carrie A.

Single studies, by themselves, rarely explain the effect of treatments or interventions definitively in the social sciences. Researchers created meta-analysis in the 1970s to address this need. Since then, meta-analytic techniques have been used to support certain treatment modalities and to influence policymakers. Although these techniques…

Optimizing the selection of small-town wastewater treatment processes

NASA Astrophysics Data System (ADS)

Huang, Jianping; Zhang, Siqi

2018-04-01

Municipal wastewater treatment is energy-intensive. This high energy consumption causes high sewage treatment plant operating costs and increases the energy burden. To mitigate the adverse impacts of China’s development, sewage treatment plants should adopt effective energy-saving technologies. Artificial fortified natural water treatment and use of activated sludge and biofilm are all suitable technologies for small-town sewage treatment. This study features an analysis of the characteristics of small and medium-sized township sewage, an overview of current technologies, and a discussion of recent progress in sewage treatment. Based on this, an analysis of existing problems in municipal wastewater treatment is presented, and countermeasures to improve sewage treatment in small and medium-sized towns are proposed.

Cost-effectiveness analysis of the treatment of large leiomyomas: laparoscopic assisted vaginal hysterectomy versus abdominal hysterectomy.

PubMed

Mittapalli, Raja; Fanning, James; Flora, Robert; Fenton, Bradford W

2007-05-01

The purpose of this study was to perform a cost-effectiveness analysis comparing the treatment of large leiomyomas by laparoscopic assisted vaginal hysterectomy (LAVH) versus abdominal hysterectomy (AH). Twenty consecutive LAVH were compared to 20 consecutive AH for leiomyoma > or = 250 g. Hospital costs were obtained through Healthcare cost accounting system. The 6 principles of cost-effectiveness analysis were used. The groups were similar in respect to age, weight, race, medical comorbidities, blood loss, and operative time. Median uterine weight (513 g) was approximately 20% > for LAVH. Length of stay and pain was significantly less for LAVH. Total hospital cost for AH was approximately 12% less expensive ($4394 vs $5023, P = .18). Because of multiple benefits of LAVH versus AH and no significant difference in cost, we believe LAVH is an acceptable treatment for large leiomyoma.

Anthropometric and quantitative EMG status of femoral quadriceps before and after conventional kinesitherapy with and without magnetotherapy.

PubMed

Graberski Matasović, M; Matasović, T; Markovac, Z

1997-06-01

The frequency of femoral quadriceps muscle hypotrophy has become a significant therapeutic problem. Efforts are being made to improve the standard scheme of kinesitherapeutic treatment by using additional more effective therapeutic methods. Beside kinesitherapy, the authors have used magnetotherapy in 30 of the 60 patients. The total of 60 patients, both sexes, similar age groups and intensity of hypotrophy, were included in the study. They were divided into groups A and B, the experimental and the control one (30 patients each). The treatment was scheduled for the usual 5-6 weeks. Electromyographic quantitative analysis was used to check-up the treatment results achieved after 5 and 6 weeks of treatment period. Analysis of results has confirmed the assumption that magnetotherapy may yield better and faster treatment results, disappearance of pain and decreased risk of complications. The same results were obtained in the experimental group, only one week earlier than in the control group. The EMG quantitative analysis has not proved sufficiently reliable and objective method in the assessment of real condition of the muscle and effects of treatment.

Functional analysis and treatment of elopement for a child with attention deficit hyperactivity disorder.

PubMed

Kodak, Tiffany; Grow, Laura; Northup, John

2004-01-01

We conducted a functional analysis of elopement in an outdoor setting for a child with a diagnosis of attention deficit hyperactivity disorder. A subsequent treatment consisting of noncontingent attention and time-out was demonstrated to be effective in eliminating elopement. Modifications of functional analysis procedures associated with the occurrence of elopement in a natural setting are demonstrated.

Short-term efficacy and safety of low-intensity extracorporeal shock wave therapy in erectile dysfunction: a systematic review and meta-analysis

PubMed Central

Zou, Zi-jun; Tang, Liang-you; Liu, Zhi-hong; Liang, Jia-yu; Zhang, Ruo-chen; Wang, Yu-jie; Tang, Yong-quan; Gao, Rui; Lu, Yi-ping

2017-01-01

ABSTRACT Aim: The role of low-intensity extracorporeal shock wave therapy (LI-ESWT) in erectile dysfunction (ED) is not clearly determined. The purpose of this study is to investigate the short-term efficacy and safety of LI-ESWT for ED patients. Materials and Methods: Relevant studies were searched in Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WANFANG and VIP databases. Effective rate in terms of International Index of Erectile Function-Erectile Function Domain (IIEF-EF) and Erectile Hardness Score (EHS) at about 1XSmonth after LI-ESWT was extracted from eligible studies for meta-analysis to calculate risk ratio (RR) of effective treatment in ED patients treated by LI-ESWT compared to those receiving sham-treatment. Results: Overall fifteen studies were included in the review, of which four randomized controlled trials (RCTs) were for meta-analysis. Effective treatment was 8.31 [95°/o confidence interval (CI): 3.88-17.78] times more effective in the LI-ESWT group (n=176) than in the sham-treatment group (n= 101) at about 1 month after the intervention in terms of EHS, while it was 2.50 (95% CI: 0.74–8.45) times more in the treatment group (n= 121) than in the control group (n=89) in terms of IIEF-EF. Nine-week protocol with energy density of 0.09mJ/mm2 and 1500 pluses seemed to have better therapeutic effect than five-week protocol. No significant adverse event was reported. Conclusion: LI-ESWT, as a noninvasive treatment, has potential short-term therapeutic effect on patients with organic ED irrespective of sensitivity to PDE5is. Owing to the limited number and quality of the studies, more large-scale, well-designed and longterm follow-up time studies are needed to confirm our analysis. PMID:28379665

Short-term efficacy and safety of low-intensity extracorporeal shock wave therapy in erectile dysfunction: a systematic review and meta-analysis.

PubMed

Zou, Zi-Jun; Tang, Liang-You; Liu, Zhi-Hong; Liang, Jia-Yu; Zhang, Ruo-Chen; Wang, Yu-Jie; Tang, Yong-Quan; Gao, Rui; Lu, Yi-Ping

2017-01-01

The role of low-intensity extracorporeal shock wave therapy (LI-ESWT) in erectile dysfunction (ED) is not clearly determined. The purpose of this study is to investigate the short-term efficacy and safety of LI-ESWT for ED patients. Relevant studies were searched in Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WANFANG and VIP databases. Effective rate in terms of International Index of Erectile Function-Erectile Function Domain (IIEF-EF) and Erectile Hardness Score (EHS) at about 1month after LI-ESWT was extracted from eligible studies for meta-analysis to calculate risk ratio (RR) of effective treatment in ED patients treated by LI-ESWT compared to those receiving sham-treatment. Overall fifteen studies were included in the review, of which four randomized controlled trials (RCTs) were for meta-analysis. Effective treatment was 8.31 [95% confidence interval (CI): 3.88-17.78] times more effective in the LI-ESWT group (n=176) than in the sham-treatment group (n=101) at about 1 month after the intervention in terms of EHS, while it was 2.50 (95% CI: 0.74-8.45) times more in the treatment group (n=121) than in the control group (n=89) in terms of IIEF-EF. Nine-week protocol with energy density of 0.09mJ/mm2 and 1500 pluses seemed to have better therapeutic effect than five-week protocol. No significant adverse event was reported. LI-ESWT, as a noninvasive treatment, has potential short-term therapeutic effect on patients with organic ED irrespective of sensitivity to PDE5is. Owing to the limited number and quality of the studies, more large-scale, well-designed and long-term follow-up time studies are needed to confirm our analysis. Copyright® by the International Brazilian Journal of Urology.

Optimization of wastewater treatment alternative selection by hierarchy grey relational analysis.

PubMed

Zeng, Guangming; Jiang, Ru; Huang, Guohe; Xu, Min; Li, Jianbing

2007-01-01

This paper describes an innovative systematic approach, namely hierarchy grey relational analysis for optimal selection of wastewater treatment alternatives, based on the application of analytic hierarchy process (AHP) and grey relational analysis (GRA). It can be applied for complicated multicriteria decision-making to obtain scientific and reasonable results. The effectiveness of this approach was verified through a real case study. Four wastewater treatment alternatives (A(2)/O, triple oxidation ditch, anaerobic single oxidation ditch and SBR) were evaluated and compared against multiple economic, technical and administrative performance criteria, including capital cost, operation and maintenance (O and M) cost, land area, removal of nitrogenous and phosphorous pollutants, sludge disposal effect, stability of plant operation, maturity of technology and professional skills required for O and M. The result illustrated that the anaerobic single oxidation ditch was the optimal scheme and would obtain the maximum general benefits for the wastewater treatment plant to be constructed.

Cost Effectiveness Analysis of Different Management Strategies between Best Supportive Care and Second-line Chemotherapy for Platinum-resistant or Refractory Ovarian Cancer.

PubMed

Luealon, Phanida; Khempech, Nipon; Vasuratna, Apichai; Hanvoravongchai, Piya; Havanond, Piyalamporn

2016-01-01

There is no standard treatment for patients with platinum-resistant or refractory epithelial ovarian cancer. Single agent chemotherapies have evidence of more efficacy and less toxicity than combination therapy. Most are very expensive, with appreciable toxicity and minimal survival. Since it is difficult to make comparison between outcomes, economic analysis of single-agent chemotherapy regimens and best supportive care may help to make decisions about an appropriate management for the affected patients. To evaluate the cost effectiveness of second-line chemotherapy compared with best supportive care for patients with platinum-resistant or refractory epithelial ovarian cancer. A Markov model was used to estimate the effectiveness and total costs associated with treatments. The hypothetical patient population comprised women aged 55 with platinum-resistant or refractory epithelial ovarian cancer. Four types of alternative treatment options were evaluated: 1) gemcitabine followed by BSC; 2) pegylated liposomal doxorubicin (PLD) followed by BSC; 3) gemcitabine followed by topotecan; and 4) PLD followed by topotecan. Baseline comparator of alternative treatments was BSC. Time horizon of the analysis was 2 years. Health care provider perspective and 3% discount rate were used to determine the costs of medical treatment in this study. Quality-adjusted life-years (QALY) were used to measure the treatment effectiveness. Treatment effectiveness data were derived from the literature. Costs were calculated from unit cost treatment of epithelial ovarian cancer patients at various stages of disease in King Chulalongkorn Memorial Hospital (KCMH) in the year 2011. Parameter uncertainty was tested in probabilistic sensitivity analysis by using Monte Carlo simulation. One-way sensitivity analysis was used to explore each variable's impact on the uncertainty of the results. Approximated life expectancy of best supportive care was 0.182 years and its total cost was 26,862 Baht. All four alternative treatments increased life expectancy. Life expectancy of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 0.510, 0.513, 0.566, and 0.570 years, respectively. The total cost of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 113,000, 124,302, 139,788 and 151,135 Baht, respectively. PLD followed by topotecan had the highest expected quality-adjusted life-years but was the most expensive of all the above strategies. The incremental cost-effectiveness ratios (ICER) of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 344,643, 385,322, 385,856, and 420,299 Baht, respectively. All of the second-line chemotherapy strategies showed certain benefits due to an increased life- year gained compared with best supportive care. Moreover, gemcitabine as second-line chemotherapy followed by best supportive care in progressive disease case was likely to be more effective strategy with less cost from health care provider perspective. Gemcitabine was the most cost-effective treatment among all four alternative treatments. ICER is only an economic factor. Treatment decisions should be based on the patient benefit.

Health economic evaluation of patients treated for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter randomized clinical trial of vancomycin and linezolid.

PubMed

Niederman, Michael S; Chastre, Jean; Solem, Caitlyn T; Wan, Yin; Gao, Xin; Myers, Daniela E; Haider, Seema; Li, Jim Z; Stephens, Jennifer M

2014-09-01

Results from studies comparing health care resource use (HCRU), costs of treatment, and cost-effectiveness of linezolid compared with vancomycin therapy in the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published literature. We therefore conducted an analysis to compare the HCRU, costs of treatment, and cost-effectiveness of linezolid compared with vancomycin in the treatment of hospitalized patients with MRSA nosocomial pneumonia using data from a Phase IV clinical trial. The economic effect of moderate to severe adverse events (MSAEs) and the development of renal failure were also evaluated. We performed a post hoc analysis of data from a Phase IV, double-blind, randomized, comparator-controlled, multicenter trial that compared linezolid and vancomycin treatment in patients with MRSA nosocomial pneumonia. HCRU and costs were compared based on treatment, development of MSAEs, and development of renal failure using data from the modified intent-to-treat population. Predictors of costs were evaluated using generalized linear models. A piggyback cost-effectiveness analysis was conducted to assess the incremental cost-effectiveness ratio of linezolid versus vancomycin, given the significantly higher clinical success of linezolid compared with vancomycin found in the trial. Overall, HCRU and costs were similar between the linezolid and vancomycin treatment groups; drug costs were significantly higher and dialysis costs significantly lower for linezolid- compared with vancomycin-treated patients. Total treatment costs were approximately $8000 higher (P = .046) for patients who developed renal failure compared with those who did not. Renal failure occurred more commonly in patients randomized to receive vancomycin (15%) compared with linezolid (4%; P < .001). Region, ventilator-associated pneumonia, clinical failure, and development of renal failure were associated with significantly higher total costs. The point estimate incremental cost-effectiveness ratio for linezolid compared with vancomycin was $16,516 per treatment success, with linezolid dominant in 24% and dominated in <2% of bootstrapped samples. This phase 4 clinical trial conducted in patients with MRSA-confirmed nosocomial pneumonia reveals that linezolid- compared with vancomycin-treated patients had similar HCRU and total overall costs. Fewer patients developed renal failure during the study while taking linezolid compared with vancomycin, and patients with a documented MSAE or renal failure had increased HCRU and costs. In summary, linezolid may be a cost-effective treatment strategy in MRSA-confirmed nosocomial pneumonia. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Cost-effectiveness of hepatitis C virus antiviral treatment for injection drug user populations.

PubMed

Martin, Natasha K; Vickerman, Peter; Miners, Alec; Foster, Graham R; Hutchinson, Sharon J; Goldberg, David J; Hickman, Matthew

2012-01-01

Injecting drug use is the main risk of hepatitis C virus (HCV) transmission in most developed countries. HCV antiviral treatment (peginterferon-α + ribavirin) has been shown to be cost-effective for patients with no reinfection risk. We examined the cost-effectiveness of providing antiviral treatment for injecting drug users (IDUs) as compared with treating ex/non-IDUs or no treatment. A dynamic model of HCV transmission and disease progression was developed, incorporating: a fixed number of antiviral treatments allocated at the mild HCV stage over 10 years, no retreatment after treatment failure, potential reinfection, and three baseline IDU HCV chronic prevalence scenarios (20%, 40%, and 60%). We performed a probabilistic cost-utility analysis estimating long-term costs and outcomes measured in quality adjusted life years (QALYs) and calculating the incremental cost-effectiveness ratio (ICER) comparing treating IDUs, ex/non-IDUs, or no treatment. Antiviral treatment for IDUs is the most cost-effective option in the 20% and 40% baseline chronic prevalence settings, with ICERs compared with no treatment of £ 521 and £ 2,539 per QALY saved, respectively. Treatment of ex/non-IDUs is dominated in these scenarios. At 60% baseline prevalence, treating ex/non-IDUs is slightly more likely to be the more cost-effective option (with an ICER compared with no treatment of £ 6,803), and treating IDUs dominated due to high reinfection. A sensitivity analysis indicates these rankings hold even when IDU sustained viral response rates as compared with ex/non-IDUs are halved. Despite the possibility of reinfection, the model suggests providing antiviral treatment to IDUs is the most cost-effective policy option in chronic prevalence scenarios less than 60%. Further research on how HCV treatment for injectors can be scaled up and its impact on prevalence is warranted. Copyright © 2011 American Association for the Study of Liver Diseases.

Do guided internet-based interventions result in clinically relevant changes for patients with depression? An individual participant data meta-analysis.

PubMed

Karyotaki, Eirini; Ebert, David Daniel; Donkin, Liesje; Riper, Heleen; Twisk, Jos; Burger, Simone; Rozental, Alexander; Lange, Alfred; Williams, Alishia D; Zarski, Anna Carlotta; Geraedts, Anna; van Straten, Annemieke; Kleiboer, Annet; Meyer, Björn; Ünlü Ince, Burçin B; Buntrock, Claudia; Lehr, Dirk; Snoek, Frank J; Andrews, Gavin; Andersson, Gerhard; Choi, Isabella; Ruwaard, Jeroen; Klein, Jan Philipp; Newby, Jill M; Schröder, Johanna; Laferton, Johannes A C; Van Bastelaar, Kim; Imamura, Kotaro; Vernmark, Kristofer; Boß, Leif; Sheeber, Lisa B; Kivi, Marie; Berking, Matthias; Titov, Nickolai; Carlbring, Per; Johansson, Robert; Kenter, Robin; Perini, Sarah; Moritz, Steffen; Nobis, Stephanie; Berger, Thomas; Kaldo, Viktor; Forsell, Yvonne; Lindefors, Nils; Kraepelien, Martin; Björkelund, Cecilia; Kawakami, Norito; Cuijpers, Pim

2018-06-19

Little is known about clinically relevant changes in guided Internet-based interventions for depression. Moreover, methodological and power limitations preclude the identification of patients' groups that may benefit more from these interventions. This study aimed to investigate response rates, remission rates, and their moderators in randomized controlled trials (RCTs) comparing the effect of guided Internet-based interventions for adult depression to control groups using an individual patient data meta-analysis approach. Literature searches in PubMed, Embase, PsycINFO and Cochrane Library resulted in 13,384 abstracts from database inception to January 1, 2016. Twenty-four RCTs (4889 participants) comparing a guided Internet-based intervention with a control group contributed data to the analysis. Missing data were multiply imputed. To examine treatment outcome on response and remission, mixed-effects models with participants nested within studies were used. Response and remission rates were calculated using the Reliable Change Index. The intervention group obtained significantly higher response rates (OR = 2.49, 95% CI 2.17-2.85) and remission rates compared to controls (OR = 2.41, 95% CI 2.07-2.79). The moderator analysis indicated that older participants (OR = 1.01) and native-born participants (1.66) were more likely to respond to treatment compared to younger participants and ethnic minorities respectively. Age (OR = 1.01) and ethnicity (1.73) also moderated the effects of treatment on remission.Moreover, adults with more severe depressive symptoms at baseline were more likely to remit after receiving internet-based treatment (OR = 1.19). Guided Internet-based interventions lead to substantial positive treatment effects on treatment response and remission at post-treatment. Thus, such interventions may complement existing services for depression and potentially reduce the gap between the need and provision of evidence-based treatments. Copyright © 2018. Published by Elsevier Ltd.

Efficacy of face-to-face versus self-guided treatments for disordered gambling: A meta-analysis.

PubMed

Goslar, Martina; Leibetseder, Max; Muench, Hannah M; Hofmann, Stefan G; Laireiter, Anton-Rupert

2017-06-01

Background and aims In the light of growing traditional and novel forms of gambling, the treatment of disordered gambling is gaining increasing importance and practical relevance. Most studies have examined face-to-face treatments. Although trials implementing self-guided treatments have recently been conducted, these options have not yet been systematically examined. The primary objective of this meta-analysis, therefore, was to analyze the efficacy of all types of psychological face-to-face and self-guided treatments. Methods A multilevel literature search yielded 27 randomized controlled studies totaling 3,879 participants to provide a comprehensive comparative evaluation of the short- and long-term efficacies of face-to-face and self-guided treatments for disordered gambling. Results As expected, the results revealed significantly higher effect sizes for face-to-face treatments (16 studies with Hedges's g ranging from 0.67 to 1.15) as compared with self-guided treatments (11 studies with Hedges's g ranging from 0.12 to 0.30) regarding the reduction of problematic gambling behavior. The intensity of treatment moderated the therapy effect, particularly for self-guided treatments. Discussion and Conclusions The results of this meta-analysis favor face-to-face treatments over self-guided treatments for the reduction of disordered gambling. Although the findings broaden the scope of knowledge about psychological treatment modalities for disordered gambling, further research is needed to identify the reasons for these differences with the goal to optimize the treatment for this disabling condition.

A cost-effectiveness analysis of celecoxib compared with diclofenac in the treatment of pain in osteoarthritis (OA) within the Swedish health system using an adaptation of the NICE OA model.

PubMed

Brereton, Nicholas; Pennington, Becky; Ekelund, Mats; Akehurst, Ronald

2014-09-01

Celecoxib for the treatment of pain resulting from osteoarthritis (OA) was reviewed by the Tandvårds- och läkemedelsförmånsverket-Dental and Pharmaceutical Benefits Board (TLV) in Sweden in late 2010. This study aimed to evaluate the incremental cost-effectiveness ratio (ICER) of celecoxib plus a proton pump inhibitor (PPI) compared to diclofenac plus a PPI in a Swedish setting. The National Institute for Health and Care Excellence (NICE) in the UK developed a health economic model as part of their 2008 assessment of treatments for OA. In this analysis, the model was reconstructed and adapted to a Swedish perspective. Drug costs were updated using the TLV database. Adverse event costs were calculated using the regional price list of Southern Sweden and the standard treatment guidelines from the county council of Stockholm. Costs for treating cardiovascular (CV) events were taken from the Swedish DRG codes and the literature. Over a patient's lifetime treatment with celecoxib plus a PPI was associated with a quality-adjusted life year (QALY) gain of 0.006 per patient when compared to diclofenac plus a PPI. There was an increase in discounted costs of 529 kr per patient, which resulted in an incremental cost-effectiveness ratio (ICER) of 82,313 kr ($12,141). Sensitivity analysis showed that treatment was more cost effective in patients with an increased risk of bleeding or gastrointestinal (GI) complications. The results suggest that celecoxib plus a PPI is a cost effective treatment for OA when compared to diclofenac plus a PPI. Treatment is shown to be more cost effective in Sweden for patients with a high risk of bleeding or GI complications. It was in this population that the TLV gave a positive recommendation. There are known limitations on efficacy in the original NICE model.

Modeling analysis on germination and seedling growth using ultrasound seed pretreatment in switchgrass.

PubMed

Wang, Quanzhen; Chen, Guo; Yersaiyiti, Hayixia; Liu, Yuan; Cui, Jian; Wu, Chunhui; Zhang, Yunwei; He, Xueqing

2012-01-01

Switchgrass is a perennial C4 plant with great potential as a bioenergy source and, thus, a high demand for establishment from seed. This research investigated the effects of ultrasound treatment on germination and seedling growth in switchgrass. Using an orthogonal matrix design, conditions for the ultrasound pretreatment in switchgrass seed, including sonication time (factor A), sonication temperature (factor B) and ultrasound output power (factor C), were optimized for germinating and stimulating seedling growth (indicated as plumular and radicular lengths) through modeling analysis. The results indicate that sonication temperature (B) was the most effective factor for germination, whereas output power (C) had the largest effect on seedling growth when ultrasound treatment was used. Combined with the analyses of range, variance and models, the final optimal ultrasonic treatment conditions were sonication for 22.5 min at 39.7°C and at an output power of 348 W, which provided the greatest germination percentage and best seedling growth. For this study, the orthogonal matrix design was an efficient method for optimizing the conditions of ultrasound seed treatment on switchgrass. The electrical conductivity of seed leachates in three experimental groups (control, soaked in water only, and ultrasound treatment) was determined to investigate the effects of ultrasound on seeds and eliminate the effect of water in the ultrasound treatments. The results showed that the electrical conductivity of seed leachates during either ultrasound treatment or water bath treatment was significantly higher than that of the control, and that the ultrasound treatment had positive effects on switchgrass seeds.

Statistical power in parallel group point exposure studies with time-to-event outcomes: an empirical comparison of the performance of randomized controlled trials and the inverse probability of treatment weighting (IPTW) approach.

PubMed

Austin, Peter C; Schuster, Tibor; Platt, Robert W

2015-10-15

Estimating statistical power is an important component of the design of both randomized controlled trials (RCTs) and observational studies. Methods for estimating statistical power in RCTs have been well described and can be implemented simply. In observational studies, statistical methods must be used to remove the effects of confounding that can occur due to non-random treatment assignment. Inverse probability of treatment weighting (IPTW) using the propensity score is an attractive method for estimating the effects of treatment using observational data. However, sample size and power calculations have not been adequately described for these methods. We used an extensive series of Monte Carlo simulations to compare the statistical power of an IPTW analysis of an observational study with time-to-event outcomes with that of an analysis of a similarly-structured RCT. We examined the impact of four factors on the statistical power function: number of observed events, prevalence of treatment, the marginal hazard ratio, and the strength of the treatment-selection process. We found that, on average, an IPTW analysis had lower statistical power compared to an analysis of a similarly-structured RCT. The difference in statistical power increased as the magnitude of the treatment-selection model increased. The statistical power of an IPTW analysis tended to be lower than the statistical power of a similarly-structured RCT.

Lipid remodeling and an altered membrane-associated proteome may drive the differential effects of EPA and DHA treatment on skeletal muscle glucose uptake and protein accretion.

PubMed

Jeromson, Stewart; Mackenzie, Ivor; Doherty, Mary K; Whitfield, Phillip D; Bell, Gordon; Dick, James; Shaw, Andy; Rao, Francesco V; Ashcroft, Stephen P; Philp, Andrew; Galloway, Stuart D R; Gallagher, Iain; Hamilton, D Lee

2018-06-01

In striated muscle, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have differential effects on the metabolism of glucose and differential effects on the metabolism of protein. We have shown that, despite similar incorporation, treatment of C 2 C 12 myotubes (CM) with EPA but not DHA improves glucose uptake and protein accretion. We hypothesized that these differential effects of EPA and DHA may be due to divergent shifts in lipidomic profiles leading to altered proteomic profiles. We therefore carried out an assessment of the impact of treating CM with EPA and DHA on lipidomic and proteomic profiles. Fatty acid methyl esters (FAME) analysis revealed that both EPA and DHA led to similar but substantials changes in fatty acid profiles with the exception of arachidonic acid, which was decreased only by DHA, and docosapentanoic acid (DPA), which was increased only by EPA treatment. Global lipidomic analysis showed that EPA and DHA induced large alterations in the cellular lipid profiles and in particular, the phospholipid classes. Subsequent targeted analysis confirmed that the most differentially regulated species were phosphatidylcholines and phosphatidylethanolamines containing long-chain fatty acids with five (EPA treatment) or six (DHA treatment) double bonds. As these are typically membrane-associated lipid species we hypothesized that these treatments differentially altered the membrane-associated proteome. Stable isotope labeling by amino acids in cell culture (SILAC)-based proteomics of the membrane fraction revealed significant divergence in the effects of EPA and DHA on the membrane-associated proteome. We conclude that the EPA-specific increase in polyunsaturated long-chain fatty acids in the phospholipid fraction is associated with an altered membrane-associated proteome and these may be critical events in the metabolic remodeling induced by EPA treatment.

In vivo non-invasive monitoring of collagen remodelling by two-photon microscopy after micro-ablative fractional laser resurfacing.

PubMed

Cicchi, Riccardo; Kapsokalyvas, Dimitrios; Troiano, Michela; Campolmi, Piero; Morini, Cristiano; Massi, Daniela; Cannarozzo, Giovanni; Lotti, Torello; Pavone, Francesco Saverio

2014-11-01

Non-linear optical microscopy is becoming popular as a non-invasive in vivo imaging modality in dermatology. In this study, combined TPF and SHG microscopy were used to monitor collagen remodelling in vivo after micro-ablative fractional laser resurfacing. Papillary dermis of living subjects, covering a wide age range, was imaged immediately before and forty days after treatment. A qualitative visual examination of acquired images demonstrated an age-dependent remodelling effect on collagen. Additional quantitative analysis of new collagen production was performed by means of two image analysis methods. A higher increase in SHG to TPF ratio, corresponding to a stronger treatment effectiveness, was found in older subjects, whereas the effect was found to be negligible in young, and minimal in middle age subjects. Analysis of collagen images also showed a dependence of the treatment effectiveness with age but with controversial results. While the diagnostic potential of in vivo multiphoton microscopy has already been demonstrated for skin cancer and other skin diseases, here we first successfully explore its potential use for a non-invasive follow-up of a laser-based treatment. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Clinical findings and effect of sodium hydrogen carbonate in patients with glutathione synthetase deficiency.

PubMed

Gündüz, Mehmet; Ünal, Özlem; Kavurt, Sumru; Türk, Emrecan; Mungan, Neslihan Önenli

2016-04-01

Glutathione synthetase (GS) deficiency is a rare inborn error of glutathione (GSH) metabolism manifested by severe metabolic acidosis, hemolytic anemia, neurological problems and massive excretion of pyroglutamic acid (5-oxoproline) in the urine. The disorder has mild, moderate, and severe clinical variants. We aimed to report clinical and laboratory findings of four patients, effect of sodium hydrogen carbonate treatment and long-term follow up of three patients. Urine organic acid analysis was performed with gas chromatography-mass spectrometry. Molecular genetic analysis was performed in three patients, mutation was found in two of them. Enzyme analysis was performed in one patient. Clinical and laboratory findings of four patients were evaluated. One patient died at 4 months old, one patient's growth and development are normal, two patients have developed intellectual disability and seizures in the long term follow up period. Three patients benefited from sodium hydrogen carbonate treatment. The clinical picture varies from patient to patient, so it is difficult to predict the prognosis and the effectiveness of treatment protocols. We reported long term follow up of four patients and demonstrated that sodium hydrogen carbonate is effective for treatment of chronic metabolic acidosis in GS deficieny.

Cost-effectiveness analysis of treatments for metastatic pancreatic cancer based on PRODIGE and MPACT trials.

PubMed

Zhou, Jing; Zhao, Rongce; Wen, Feng; Zhang, Pengfei; Wu, Yifan; Tang, Ruilei; Chen, Hongdou; Zhang, Jian; Li, Qiu

2016-06-02

Fluorouracil, leucovorin, irinotecan, oxaliplatin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GEM-N) have shown a significant survival benefit for the treatment of metastatic pancreatic cancer. The objective of this study was to assess the cost-effectiveness of FOLFIRINOX versus GEM-N for treating metastatic pancreatic cancer based on the PRODIGE and MPACT trials. A decision model was performed to compare FOLFIRINOX with GEM-N. Primary base case data were identified from PRODIGE and MPACT trials. Costs were estimated and incremental cost-effectiveness ratio (ICER) was calculated at West China Hospital, Sichuan University, China. Survival benefits were reported in quality-adjusted life-years (QALY). Finally, sensitive analysis was performed by varying potentially modifiable parameters in the model. The base-case analysis showed that FOLFIRINOX cost $37,203.75 and yielded a survival of 0.67 QALY, and GEM-N cost $32,080.59 and yielded a survival of 0.51 QALY in the entire treatment. Thus, the ICER of FOLFIRINOX versus GEM-N was $32,019.75 per QALY gained. The GEM-N regimen was more cost-effective compared with the FOLFIRINOX regimen for the treatment of metastatic pancreatic cancer from a Chinese perspective.

Cost-effectiveness of the treatment of uncomplicated severe acute malnutrition by community health workers compared to treatment provided at an outpatient facility in rural Mali.

PubMed

Rogers, Eleanor; Martínez, Karen; Morán, Jose Luis Alvarez; Alé, Franck G B; Charle, Pilar; Guerrero, Saul; Puett, Chloe

2018-02-20

The Malian Nutrition Division of the Ministry of Health and Action Against Hunger tested the feasibility of integrating treatment of severe acute malnutrition (SAM) into the existing Integrated Community Case Management package delivered by community health workers (CHWs). This study assessed costs and cost-effectiveness of CHW-delivered care compared to outpatient facility-based care. Activity-based costing methods were used, and a societal perspective employed to include all relevant costs incurred by institutions, beneficiaries and communities. The intervention and control arm enrolled different numbers of children so a modelled scenario sensitivity analysis was conducted to assess the cost-effectiveness of the two arms, assuming equal numbers of children enrolled. In the base case, with unequal numbers of children in each arm, for CHW-delivered care, the cost per child treated was 244 USD and cost per child recovered was 259 USD. Outpatient facility-based care was less cost-effective at 442 USD per child and 501 USD per child recovered. The conclusions of the analysis changed in the modelled scenario sensitivity analysis, with outpatient facility-based care being marginally more cost-effective (cost per child treated is 188 USD, cost per child recovered is 214 USD), compared to CHW-delivered care. This suggests that achieving good coverage is a key factor influencing cost-effectiveness of CHWs delivering treatment for SAM in this setting. Per week of treatment, households receiving CHW-delivered care spent half of the time receiving treatment and three times less money compared with those receiving treatment from the outpatient facility. This study supports existing evidence that the delivery of treatment by CHWs is a cost-effective intervention, provided that good coverage is achieved. A major benefit of this strategy was the lower cost incurred by the beneficiary household when treatment is available in the community. Further research is needed on the implementation costs that would be incurred by the government to increase the operability of these results.

Rifampicin versus streptomycin for brucellosis treatment in humans: A meta-analysis of randomized controlled trials.

PubMed

Meng, Fanjie; Pan, Xiangpo; Tong, Wenzhen

2018-01-01

Brucellosis is a zoonotic disease with a high morbidity in developing countries, but there the optimal treatment is not yet determined. Therefore, the development of a simple and effective treatment is important. The aim of this study was to summarize the available evidences and compare rifampicin with streptomycin in human brucellosis with doxycycline as background regimen. We systematically searched PubMed, EmBase, and the Cochrane Library from their inception up through December 2016. We included studies with a randomized controlled design that evaluated the effect of streptomycin compared with rifampicin in human brucellosis patients who received doxycycline therapy as background regimen. The overall failure and relapse were summarized using random-effects model. Our meta-analysis included 1,383 patients with brucellosis from 14 trials. We found that patients who received rifampicin therapy had a higher risk of overall failure (RR: 2.36; 95% CI: 1.72-3.23; P<0.001) and relapse (RR: 2.74; 95% CI: 1.80-4.19; P<0.001) compared with streptomycin. Results of the sensitivity analysis were consistent with the overall analysis. Subgroup analysis indicated that mean age of the patients and percentage of male participants might influence the treatment effects. Furthermore, no publication bias was detected. The findings of this study indicated that rifampicin therapy significantly increased the risk of overall failure and relapse compared with streptomycin. Hence, it can be recommended to patients with human brucellosis receiving streptomycin therapy.

Cost-effectiveness of early intervention in first-episode psychosis: economic evaluation of a randomised controlled trial (the OPUS study).

PubMed

Hastrup, Lene Halling; Kronborg, Christian; Bertelsen, Mette; Jeppesen, Pia; Jorgensen, Per; Petersen, Lone; Thorup, Anne; Simonsen, Erik; Nordentoft, Merete

2013-01-01

Information about the cost-effectiveness of early intervention programmes for first-episode psychosis is limited. To evaluate the cost-effectiveness of an intensive early-intervention programme (called OPUS) (trial registration NCT00157313) consisting of enriched assertive community treatment, psychoeducational family treatment and social skills training for individuals with first-episode psychosis compared with standard treatment. An incremental cost-effectiveness analysis of a randomised controlled trial, adopting a public sector perspective was undertaken. The mean total costs of OPUS over 5 years (€123,683, s.e. = 8970) were not significantly different from that of standard treatment (€148,751, s.e. = 13073). At 2-year follow-up the mean Global Assessment of Functioning (GAF) score in the OPUS group (55.16, s.d. = 15.15) was significantly higher than in standard treatment group (51.13, s.d. = 15.92). However, the mean GAF did not differ significantly between the groups at 5-year follow-up (55.35 (s.d. = 18.28) and 54.16 (s.d. = 18.41), respectively). Cost-effectiveness planes based on non-parametric bootstrapping showed that OPUS was less costly and more effective in 70% of the replications. For a willingness-to-pay up to €50,000 the probability that OPUS was cost-effective was more than 80%. The incremental cost-effectiveness analysis showed that there was a high probability of OPUS being cost-effective compared with standard treatment.

Cost-effectiveness Analysis of Aripiprazole Once-Monthly for the Treatment of Schizophrenia in the UK.

PubMed

Tempest, Michael; Sapin, Christophe; Beillat, Maud; Robinson, Paul; Treur, Maarten

2015-12-01

Schizophrenia is a severe and debilitating psychiatric disorder. Pharmacological interventions aim to ameliorate symptoms and reduce the risk of relapse and costly hospitalisation. Despite the established efficacy of antipsychotic medication, compliance to treatment is poor, particularly with oral formulation. The emergence of long acting injectable (LAI) antipsychotic formulations in recent years has aimed to counteract the poor compliance rates observed and optimise long term patient outcomes. To estimate the cost-effectiveness of aripiprazole once-monthly 400mg (AOM 400) vs. risperidone long acting injectable (RLAI), paliperidone long acting injectable (PLAI) and olanzapine long acting injectable (OLAI) in the maintenance treatment of chronic, stable schizophrenia patients in the United Kingdom. A Markov model was developed to emulate the treatment pathway of a hypothetical cohort of patients initiating maintenance treatment with LAI antipsychotics. The economic analysis was conducted from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a 10 year time horizon. Efficacy and safety probabilities were derived from mixed treatment comparisons (MTCs) where possible. Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs. The model estimates that AOM 400 improves clinical outcomes by reducing relapses per patient comparative to other LAIs over the model time horizon (2.38, 2.53, 2.70, and 2.67 for AOM 400, RLAI, PLAI and OLAI respectively). In the deterministic analysis, AOM 400 dominated PLAI and OLAI; an incremental cost-effectiveness ratio (ICER) of GBP 3,686 per QALY gained was observed against RLAI. Results from the univariate sensitivity analyses highlighted the probability and cost of relapse as main drivers for cost-effectiveness. In the probabilistic sensitivity analysis, AOM 400 demonstrated a marginally higher probability of being cost-effective (51%) than RLAI, PLAI and OLAI (48%, 1% and 0%, respectively) at a willingness to pay threshold of GBP 20,000. The model was built to accommodate results of an adjusted MTC analysis. Furthermore the model effectively captures repercussions of deteriorating compliance to treatment by incorporating three levels of compliance with elevated risks of relapse for partial compliance and non-compliance. Limitations of the analysis include the limited number of studies incorporated in the MTC, the extrapolation of short term clinical data and the exclusion of the wider societal burden. Comparative to other atypical antipsychotics, AOM 400 represents value for money in the maintenance treatment of chronic, stable schizophrenia; however, in light of the PSA findings and comparable cost-effectiveness (i.e. against RLAI), the product profile and wider benefits of the respective treatments must be taken into account when prescribing antipsychotics. Future research should assess the use of LAI antipsychotics earlier in the disease course of schizophrenia to see whether improved compliance and outcomes shortly following the onset of psychosis has the potential to alter the disease trajectory. Moreover it should be assessed whether changes in the disease trajectory can alleviate cost and resource pressures placed on national health services.

Risk-Stratified Imputation in Survival Analysis

PubMed Central

Kennedy, Richard E.; Adragni, Kofi P.; Tiwari, Hemant K.; Voeks, Jenifer H.; Brott, Thomas G.; Howard, George

2013-01-01

Background Censoring that is dependent on covariates associated with survival can arise in randomized trials due to changes in recruitment and eligibility criteria to minimize withdrawals, potentially leading to biased treatment effect estimates. Imputation approaches have been proposed to address censoring in survival analysis; and while these approaches may provide unbiased estimates of treatment effects, imputation of a large number of outcomes may over- or underestimate the associated variance based on the imputation pool selected. Purpose We propose an improved method, risk-stratified imputation, as an alternative to address withdrawal related to the risk of events in the context of time-to-event analyses. Methods Our algorithm performs imputation from a pool of replacement subjects with similar values of both treatment and covariate(s) of interest, that is, from a risk-stratified sample. This stratification prior to imputation addresses the requirement of time-to-event analysis that censored observations are representative of all other observations in the risk group with similar exposure variables. We compared our risk-stratified imputation to case deletion and bootstrap imputation in a simulated dataset in which the covariate of interest (study withdrawal) was related to treatment. A motivating example from a recent clinical trial is also presented to demonstrate the utility of our method. Results In our simulations, risk-stratified imputation gives estimates of treatment effect comparable to bootstrap and auxiliary variable imputation while avoiding inaccuracies of the latter two in estimating the associated variance. Similar results were obtained in analysis of clinical trial data. Limitations Risk-stratified imputation has little advantage over other imputation methods when covariates of interest are not related to treatment, although its performance is superior when covariates are related to treatment. Risk-stratified imputation is intended for categorical covariates, and may be sensitive to the width of the matching window if continuous covariates are used. Conclusions The use of the risk-stratified imputation should facilitate the analysis of many clinical trials, in which one group has a higher withdrawal rate that is related to treatment. PMID:23818434

Choosing Assessment Instruments for Bulimia Practice and Outcome Research

ERIC Educational Resources Information Center

Sandberg, Katie; Erford, Bradley T.

2013-01-01

Six commonly used instruments for assessment of eating disorders were analyzed. Effect size results from Erford et al.'s (2013) meta-analysis for the treatment of bulimia nervosa were used to compare each scale's ability to measure treatment outcomes for bulimia nervosa. Effect size comparisons indicated higher overall effect sizes using the…

Cost-Effectiveness of Guided Self-Help Treatment for Recurrent Binge Eating

ERIC Educational Resources Information Center

Lynch, Frances L.; Striegel-Moore, Ruth H.; Dickerson, John F.; Perrin, Nancy; DeBar, Lynn; Wilson, G. Terence; Kraemer, Helena C.

2010-01-01

Objective: Adoption of effective treatments for recurrent binge-eating disorders depends on the balance of costs and benefits. Using data from a recent randomized controlled trial, we conducted an incremental cost-effectiveness analysis (CEA) of a cognitive-behavioral therapy guided self-help intervention (CBT-GSH) to treat recurrent binge eating…

Renal Mass Biopsy to Guide Treatment Decisions for Small Incidental Renal Tumors: A Cost-effectiveness Analysis1

PubMed Central

Gervais, Debra A.; Hartman, Rebecca I.; Harisinghani, Mukesh G.; Feldman, Adam S.; Mueller, Peter R.; Gazelle, G. Scott

2010-01-01

Purpose: To evaluate the effectiveness, cost, and cost-effectiveness of using renal mass biopsy to guide treatment decisions for small incidentally detected renal tumors. Materials and Methods: A decision-analytic Markov model was developed to estimate life expectancy and lifetime costs for patients with small (≤4-cm) renal tumors. Two strategies were compared: renal mass biopsy to triage patients to surgery or imaging surveillance and empiric nephron-sparing surgery. The model incorporated biopsy performance, the probability of track seeding with malignant cells, the prevalence and growth of benign and malignant tumors, treatment effectiveness and costs, and patient outcomes. An incremental cost-effectiveness analysis was performed to identify strategy preference under a willingness-to-pay threshold of $75 000 per quality-adjusted life-year (QALY). Effects of changes in key parameters on strategy preference were evaluated in sensitivity analysis. Results: Under base-case assumptions, the biopsy strategy yielded a minimally greater quality-adjusted life expectancy (4 days) than did empiric surgery at a lower lifetime cost ($3466), dominating surgery from a cost-effectiveness perspective. Over the majority of parameter ranges tested in one-way sensitivity analysis, the biopsy strategy dominated surgery or was cost-effective relative to surgery based on a $75 000-per-QALY willingness-to-pay threshold. In two-way sensitivity analysis, surgery yielded greater life expectancy when the prevalence of malignancy and propensity for biopsy-negative cancers to metastasize were both higher than expected or when the sensitivity and specificity of biopsy were both lower than expected. Conclusion: The use of biopsy to guide treatment decisions for small incidentally detected renal tumors is cost-effective and can prevent unnecessary surgery in many cases. © RSNA, 2010 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10092013/-/DC1 PMID:20720070

A Meta-Analysis of Depressive Symptom Outcomes in Randomized, Controlled Trials for PTSD.

PubMed

Ronconi, Julia McDougal; Shiner, Brian; Watts, Bradley V

2015-07-01

Posttraumatic stress disorder (PTSD) often co-occurs with depression. Current PTSD practice guidelines lack specific guidance for clinicians regarding the treatment of depressive symptoms. We conducted a meta-analysis of all randomized, placebo-controlled trials for PTSD therapies focusing on depression outcomes to inform clinicians about effective treatment options for depressive symptoms associated with PTSD. We searched literature databases for randomized, controlled clinical trials of any treatment for PTSD published between 1980 and 2013. We selected articles in which all subjects were adults with a diagnosis of PTSD based on the Diagnostic and Statistical Manual of Mental Disorders criteria, and valid PTSD and depressive symptom measures were reported. The sample consisted of 116 treatment comparisons drawn from 93 manuscripts. Evidence-based PTSD treatments are effective for comorbid depressive symptoms. Existing PTSD treatments work as well for comorbid depressive symptoms as they do for PTSD symptoms.

Analysis of Wastewater Treatment Efficiency in a Soft Drinks Industry

NASA Astrophysics Data System (ADS)

Boguniewicz-Zabłocka, Joanna; Capodaglio, Andrea G.; Vogel, Daniel

2017-10-01

During manufacturing processes, most industrial plants generate wastewater which could become harmful to the environment. Discharge of untreated or improperly treated industrial wastewaters into surface water could, in fact, lead to deterioration of the receiving water body's quality. This paper concerns wastewater treatment solutions used in the soft drink production industry: wastewater treatment plant effectiveness analysis was determined in terms of basic pollution indicators, such as BOD, COD, TSS and variable pH. Initially, the performance of mechanic-biological systems for the treatment of wastewater from a specific beverages production process was studied in different periods, due to wastewater flow fluctuation. The study then showed the positive effects on treatment of wastewater augmentation by methanol, nitrogen and phosphorus salts dosed into it during the treatment process. Results confirm that after implemented modification (methanol, nitrogen and phosphorus additions) pollution removal occurs mostly with higher efficiency.

Hypnosis as an Adjunct to Cognitive-Behavioral Psychotherapy: A Meta-Analysis.

ERIC Educational Resources Information Center

Kirsch, Irving; And Others

1995-01-01

Performed a meta-analysis on 18 studies in which a cognitive-behavioral therapy was compared with the same therapy supplemented by hypnosis. Results indicated that hypnosis substantially enhanced treatment outcome, even though there were few procedural differences between the hypnotic and nonhypnotic treatments. Effects seemed particularly…

After Analysis: A Study of Transference Dreams Following Treatment.

ERIC Educational Resources Information Center

Carlson, Rae

1986-01-01

Examined posttreatment consolidation of experience with a script-theoretic analysis of transference dreams. A content-analytic scheme applied to three during-treatment and three posttreatment dreams showed in posttreatment dreams a significant increase in positive affects, a decrease in negative affects, and more effective initatives by the…

Sustained effects of neurofeedback in ADHD: a systematic review and meta-analysis.

PubMed

Van Doren, Jessica; Arns, Martijn; Heinrich, Hartmut; Vollebregt, Madelon A; Strehl, Ute; K Loo, Sandra

2018-02-14

Neurofeedback (NF) has gained increasing interest in the treatment of attention-deficit/hyperactivity disorder (ADHD). Given learning principles underlie NF, lasting clinical treatment effects may be expected. This systematic review and meta-analysis addresses the sustainability of neurofeedback and control treatment effects by considering randomized controlled studies that conducted follow-up (FU; 2-12 months) assessments among children with ADHD. PubMed and Scopus databases were searched through November 2017. Within-group and between-group standardized mean differences (SMD) of parent behavior ratings were calculated and analyzed. Ten studies met inclusion criteria (NF: ten studies, N = 256; control: nine studies, N = 250). Within-group NF effects on inattention were of medium effect size (ES) (SMD = 0.64) at post-treatment and increased to a large ES (SMD = 0.80) at FU. Regarding hyperactivity/impulsivity, NF ES were medium at post-treatment (SMD = 0.50) and FU (SMD = 0.61). Non-active control conditions yielded a small significant ES on inattention at post-treatment (SMD = 0.28) but no significant ES at FU. Active treatments (mainly methylphenidate), had large ES for inattention (post: SMD = 1.08; FU: SMD = 1.06) and medium ES for hyperactivity/impulsivity (post: SMD = 0.74; FU: SMD = 0.67). Between-group analyses also revealed an advantage of NF over non-active controls [inattention (post: SMD = 0.38; FU: SMD = 0.57); hyperactivity-impulsivity (post: SMD = 0.25; FU: SMD = 0.39)], and favored active controls for inattention only at pre-post (SMD = - 0.44). Compared to non-active control treatments, NF appears to have more durable treatment effects, for at least 6 months following treatment. More studies are needed for a properly powered comparison of follow-up effects between NF and active treatments and to further control for non-specific effects.

Cost-effectiveness of tubal patency tests.

PubMed

Verhoeve, H R; Moolenaar, L M; Hompes, P; van der Veen, F; Mol, B W J

2013-04-01

Guidelines are not in agreement on the most effective diagnostic scenario for tubal patency testing; therefore, we evaluated the cost-effectiveness of invasive tubal testing in subfertile couples compared with no testing and treatment. Cost-effectiveness analysis. Decision analytic framework. Computer-simulated cohort of subfertile women. We evaluated six scenarios: (1) no tests and no treatment; (2) immediate treatment without tubal testing; (3) delayed treatment without tubal testing; (4) hysterosalpingogram (HSG), followed by immediate or delayed treatment, according to diagnosis (tailored treatment); (5) HSG and a diagnostic laparoscopy (DL) in case HSG does not prove tubal patency, followed by tailored treatment; and (6) DL followed by tailored treatment. Expected cumulative live births after 3 years. Secondary outcomes were cost per couple and the incremental cost-effectiveness ratio. For a 30-year-old woman with otherwise unexplained subfertility for 12 months, 3-year cumulative live birth rates were 51.8, 78.1, 78.4, 78.4, 78.6 and 78.4%, and costs per couple were €0, €6968, €5063, €5410, €5405 and €6163 for scenarios 1, 2, 3, 4, 5 and 6, respectively. The incremental cost-effectiveness ratios compared with scenario 1 (reference strategy), were €26,541, €19,046, €20,372, €20,150 and €23,184 for scenarios 2, 3, 4, 5 and 6, respectively. Sensitivity analysis showed the model to be robust over a wide range of values for the variables. The most cost-effective scenario is to perform no diagnostic tubal tests and to delay in vitro fertilisation (IVF) treatment for at least 12 months for women younger than 38 years old, and to perform no tubal tests and start immediate IVF treatment from the age of 39 years. If an invasive diagnostic test is planned, HSG followed by tailored treatment, or a DL if HSG shows no tubal patency, is more cost-effective than DL. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Moderators of fluoxetine treatment response for children and adolescents with comorbid depression and substance use disorders.

PubMed

Hirschtritt, Matthew E; Pagano, Maria E; Christian, Kelly M; McNamara, Nora K; Stansbrey, Robert J; Lingler, Jacqui; Faber, Jon E; Demeter, Christine A; Bedoya, Denise; Findling, Robert L

2012-06-01

Our recent 8-week, randomized, placebo-controlled trial of fluoxetine in adolescents (ages 12-17 years) with comorbid depression and substance use disorder (SUD) did not detect a significant antidepressant treatment effect. The purpose of this secondary analysis was to explore moderators of the effect of fluoxetine in this sample. Static moderators measured at baseline were depression chronicity and hopelessness severity; time-varying moderators measured at baseline and weekly during the 8-week trial period were alcohol and marijuana use severity. Treatment effects on depression outcomes were examined among moderating subgroups in random effects regression models. Subjects assigned to fluoxetine treatment with chronic depression at baseline (p = .04) or no more than moderate alcohol use during the trial (p = .04) showed significantly greater decline in depression symptoms in comparison to placebo-assigned subgroups. The current analysis suggests that youth with chronic depression and no more than moderate alcohol consumption are likely to respond better to treatment with fluoxetine compared with placebo than youth with transient depression and heavy alcohol use. Copyright © 2012 Elsevier Inc. All rights reserved.

Moderators of fluoxetine treatment response for children and adolescents with comorbid depression and substance use disorders

PubMed Central

Hirschtritt, Matthew E.; Pagano, Maria E.; Christian, Kelly M.; McNamara, Nora K.; Stansbrey, Robert J.; Lingler, Jacqui; Faber, Jon E.; Demeter, Christine A.; Bedoya, Denise; Findling, Robert L.

2012-01-01

Our recent 8-week, randomized, placebo-controlled trial of fluoxetine in adolescents (ages 12–17 years) with comorbid depression and substance use disorder (SUD) did not detect a significant antidepressant treatment effect. The purpose of this secondary analysis was to explore moderators of the effect of fluoxetine in this sample. Static moderators measured at baseline were depression chronicity and hopelessness severity; time-varying moderators measured at baseline and weekly during the 8-week trial period were alcohol and marijuana use severity. Treatment effects on depression outcomes were examined among moderating subgroups in random effects regression models. Subjects assigned to fluoxetine treatment with chronic depression at baseline (p = .04) or no more than moderate alcohol use during the trial (p = .04) showed significantly greater decline in depression symptoms in comparison to placebo-assigned subgroups. The current analysis suggests that youth with chronic depression and no more than moderate alcohol consumption are likely to respond better to treatment with fluoxetine compared with placebo than youth with transient depression and heavy alcohol use. PMID:22116008

An Experimental Analysis of Treatment Effects on Consonant Clusters and Ambisyllabic Consonants in Two Adults with Developmental Phonological Problems.

ERIC Educational Resources Information Center

Young, Edna Carter; Thompson, Cynthia K.

1987-01-01

The effects of treatment on errors in consonant clusters and in ambisyllabic consonants were investigated in two adults with histories of developmental phonological problems. Results indicated that treatment, consisting of a sound-referenced rebus approach, affected change in production of trained words as well as generalization to untrained words…

Ecosystem restoration treatments affect soil physical and chemical properties in Appalachian mixed oak forests

Treesearch

Ralph E.J. Boerner; Jennifer a. Brinkman; Daniel A. Yaussy

2007-01-01

This study presents an analysis of the effect of ecosystem restoration treatments on soil properties in the oak forests of southern Ohio. The treatments were (1) prescribed fire, (2) mechanical thinning, (3) fire and thinning, and (4) passive management (control). Fire and thinning resulted in increased mineral soil exposure, with the effect decreasing by the fourth...

Scaling-up essential neuropsychiatric services in Ethiopia: a cost-effectiveness analysis

PubMed Central

Strand, Kirsten Bjerkreim; Chisholm, Dan; Fekadu, Abebaw; Johansson, Kjell Arne

2016-01-01

Introduction There is an immense need for scaling-up neuropsychiatric care in low-income countries. Contextualized cost-effectiveness analyses (CEAs) provide relevant information for local policies. The aim of this study is to perform a contextualized CEA of neuropsychiatric interventions in Ethiopia and to illustrate expected population health and budget impacts across neuropsychiatric disorders. Methods A mathematical population model (PopMod) was used to estimate intervention costs and effectiveness. Existing variables from a previous WHO-CHOICE regional CEA model were substantially revised. Treatments for depression, schizophrenia, bipolar disorder and epilepsy were analysed. The best available local data on epidemiology, intervention efficacy, current and target coverage, resource prices and salaries were used. Data were obtained from expert opinion, local hospital information systems, the Ministry of Health and literature reviews. Results Treatment of epilepsy with a first generation antiepileptic drug is the most cost-effective treatment (US$ 321 per DALY adverted). Treatments for depression have mid-range values compared with other interventions (US$ 457–1026 per DALY adverted). Treatments for schizophrenia and bipolar disorders are least cost-effective (US$ 1168–3739 per DALY adverted). Conclusion This analysis gives the Ethiopian government a comprehensive overview of the expected costs, effectiveness and cost-effectiveness of introducing basic neuropsychiatric interventions. PMID:26491060

The cost-effectiveness of methadone maintenance as a health care intervention.

PubMed

Barnett, P G

1999-04-01

Cost-effectiveness analysis using life-years of survival as the measure of treatment benefit is widely used in the economic evaluation of health care interventions but has not been applied to substance abuse treatment. The cost-effectiveness of methadone maintenance was evaluated to demonstrate the feasibility of applying this method to substance abuse treatment. A literature review was undertaken to determine the effect of methadone treatment on the rate of mortality associated with opiate addiction. Information was also obtained on the average cost and duration of treatment. A two-state Markov model was used to estimate the incremental effect of methadone on the life span and treatment cost of a cohort of 25-year-old heroin users. Providing opiate addicts with access to methadone maintenance has an incremental cost-effectiveness ratio of $5915 per life-year gained (that is, for every year of life that is saved by providing methadone to opiate addicts, an additional $5915 in treatment costs are incurred). One-way sensitivity analysis determined that the ratio was less than $10,000 per-life year over a wide range of modeling assumptions. The ratio determined for methadone is lower than that of many common medical therapies, and well within the $50,000 threshold for judging cost-effectiveness. Even if decision makers do not wish use the same ratio that is applied to the general population, this method allows substance abuse treatment enhancements to be compared to improvements in health services offered to individuals with substance abuse disorders. Future work will require information on the impact of methadone treatment on the cost of health care and public programs, the indirect costs incurred by patients, and adjustments to reflect quality of life.

An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding.

PubMed

Diwakar, L; Roberts, T E; Cooper, N A M; Middleton, L; Jowett, S; Daniels, J; Smith, P; Clark, T J

2016-03-01

To undertake a cost-effectiveness analysis of outpatient uterine polypectomy compared with standard inpatient treatment under general anaesthesia. Economic evaluation carried out alongside the multi-centre, pragmatic, non-inferiority, randomised controlled Outpatient Polyp Treatment (OPT) trial. The UK National Health Service (NHS) perspective was used in the estimation of costs and the interpretation of results. Thirty-one secondary care UK NHS hospitals between April 2008 and July 2011. Five hundred and seven women with abnormal uterine bleeding and hysteroscopically diagnosed endometrial polyps. Outpatient uterine polypectomy versus standard inpatient treatment. Clinicians were free to choose the technique for polypectomy within the allocated setting. Patient-reported effectiveness of the procedure determined by the women's self-assessment of bleeding at 6 months, and QALY gains at 6 and 12 months. Inpatient treatment was slightly more effective but more expensive than outpatient treatment, resulting in relatively high incremental cost-effectiveness ratios. Intention-to-treat analysis of the base case at 6 months revealed that it cost an additional £9421 per successfully treated patient in the inpatient group and £ 1,099,167 per additional QALY gained, when compared with outpatient treatment. At 12 months, these costs were £22,293 per additional effectively treated patient and £445,867 per additional QALY gained, respectively. Outpatient treatment of uterine polyps associated with abnormal uterine bleeding appears to be more cost-effective than inpatient treatment at willingness-to-pay thresholds acceptable to the NHS. HTA-funded OPT trial concluded that outpatient uterine polypectomy is cost-effective compared with inpatient polypectomy. © 2015 Royal College of Obstetricians and Gynaecologists.

Barriers to accessing methamphetamine treatment: A systematic review and meta-analysis.

PubMed

Cumming, Craig; Troeung, Lakkhina; Young, Jesse T; Kelty, Erin; Preen, David B

2016-11-01

Methamphetamine use is associated with a range of poor health, social and justice outcomes. In many parts of the world increased methamphetamine use has been identified as a major public health concern. Methamphetamine treatment programmes have been effective in reducing and ceasing use, however a range of barriers have prevented these programmes being widely adopted by methamphetamine users. This review examines the barriers to accessing meth/amphetamine treatment identified in the literature. Databases were systematically searched using relevant terms for peer-reviewed articles describing original research exploring the barriers to accessing treatment for meth/amphetamine use. Reviews and grey literature were excluded. Eleven studies conducted in 5 countries were included in data synthesis; this involved a systematic review of all 11 studies, and meta-analysis of the prevalence of barriers reported in 6 studies that published sufficient quantitative data. Psychosocial/internal barriers to accessing methamphetamine treatment were most prevalent across studies (10/11 studies). Meta-analysis confirmed the four most commonly endorsed barriers to treatment access across studies all psychosocial barriers were embarrassment or stigma (60%, 95% CI: 54-67%); belief that treatment was unnecessary (59%, 95% CI:54-65%); preferring to withdraw alone without assistance (55%, 95% CI:45-65); and privacy concerns (51%, 95% CI:44-59%). The primary barriers to accessing methamphetamine treatment are psychosocial/internal. Services and treatment models that address these barriers are urgently required. There is a growing need for methamphetamine-appropriate treatment services. Further research evaluating treatment engagement and effectiveness for methamphetamine and polysubstance use, including the development of effective pharmacotherapies is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Immortal time bias in observational studies of time-to-event outcomes.

PubMed

Jones, Mark; Fowler, Robert

2016-12-01

The purpose of the study is to show, through simulation and example, the magnitude and direction of immortal time bias when an inappropriate analysis is used. We compare 4 methods of analysis for observational studies of time-to-event outcomes: logistic regression, standard Cox model, landmark analysis, and time-dependent Cox model using an example data set of patients critically ill with influenza and a simulation study. For the example data set, logistic regression, standard Cox model, and landmark analysis all showed some evidence that treatment with oseltamivir provides protection from mortality in patients critically ill with influenza. However, when the time-dependent nature of treatment exposure is taken account of using a time-dependent Cox model, there is no longer evidence of a protective effect of treatment. The simulation study showed that, under various scenarios, the time-dependent Cox model consistently provides unbiased treatment effect estimates, whereas standard Cox model leads to bias in favor of treatment. Logistic regression and landmark analysis may also lead to bias. To minimize the risk of immortal time bias in observational studies of survival outcomes, we strongly suggest time-dependent exposures be included as time-dependent variables in hazard-based analyses. Copyright © 2016 Elsevier Inc. All rights reserved.

The acute effects of a warm-up including static or dynamic stretching on countermovement jump height, reaction time, and flexibility.

PubMed

Perrier, Erica T; Pavol, Michael J; Hoffman, Mark A

2011-07-01

The purpose of this research was to compare the effects of a warm-up with static vs. dynamic stretching on countermovement jump (CMJ) height, reaction time, and low-back and hamstring flexibility and to determine whether any observed performance deficits would persist throughout a series of CMJs. Twenty-one recreationally active men (24.4 ± 4.5 years) completed 3 data collection sessions. Each session included a 5-minute treadmill jog followed by 1 of the stretch treatments: no stretching (NS), static stretching (SS), or dynamic stretching (DS). After the jog and stretch treatment, the participant performed a sit-and-reach test. Next, the participant completed a series of 10 maximal-effort CMJs, during which he was asked to jump as quickly as possible after seeing a visual stimulus (light). The CMJ height and reaction time were determined from measured ground reaction forces. A treatment × jump repeated-measures analysis of variance for CMJ height revealed a significant main effect of treatment (p = 0.004). The CMJ height was greater for DS (43.0 cm) than for NS (41.4 cm) and SS (41.9 cm) and was not less for SS than for NS. Analysis also revealed a significant main effect of jump (p = 0.005) on CMJ height: Jump height decreased from the early to the late jumps. The analysis of reaction time showed no significant effect of treatment. Treatment had a main effect (p < 0.001) on flexibility, however. Flexibility was greater after both SS and DS compared to after NS, with no difference in flexibility between SS and DS. Athletes in sports requiring lower-extremity power should use DS techniques in warm-up to enhance flexibility while improving performance.

Cost-utility analysis of competing treatment strategies for drug-resistant epilepsy in children with Tuberous Sclerosis Complex.

PubMed

Fallah, Aria; Weil, Alexander G; Wang, Shelly; Lewis, Evan; Baca, Christine B; Mathern, Gary W

2016-10-01

The management of drug-resistant epilepsy in children with Tuberous Sclerosis Complex (TSC) is challenging because of the multitude of treatment options, wide range of associated costs, and uncertainty of seizure outcomes. The most cost-effective approach for children whose epilepsy has failed to improve with first-line medical therapy is uncertain. A review of MEDLINE from 1990 to 2015 was conducted. A cost-utility analysis, from a third-party payer perspective, was performed for children with drug-resistant epilepsy that had failed to improve with 2 antiseizure drugs (ASDs) and that was amenable to resective epilepsy surgery, across a time-horizon of 5years. Four strategies were included: (1) resective epilepsy surgery, (2) vagus nerve stimulator (VNS) implantation, (3) ketogenic diet, and (4) addition of a third ASD (specifically, carbamazepine). The incremental cost per quality-adjusted life year (QALY) gained was analyzed. Given a willingness-to-pay (WTP) of $100,000 per QALY, the addition of a third ASD ($6600 for a gain of 4.14 QALYs) was the most cost-effective treatment strategy. In a secondary analysis, if the child whose epilepsy had failed to improve with 3 ASDs, ketogenic diet, addition of a fourth ASD, and resective epilepsy surgery were incrementally cost-effective treatment strategies. Vagus nerve stimulator implantation was more expensive yet less effective than alternative strategies and should not be prioritized. The addition of a third ASD is a universally cost-effective treatment option in the management of children with drug-resistant epilepsy that has failed to improve with 2 ASDs. For children whose epilepsy has failed to improve with 3 ASDs, the most cost-effective treatment depends on the health-care resources available reflected by the WTP. Copyright © 2016 Elsevier Inc. All rights reserved.

Short-term effects of fuel reduction treatments on herpetofauna from the southeastern United States

Treesearch

Eran S. Kilpatrick; Thomas A. Waldrop; Joseph D. Lanham; Cathryn H. Greenberg; Tom H. Contreras

2010-01-01

Path analysis of fuel reduction treatments on herpetofauna across four southeastern sites of the National Fire and Fire Surrogate Study provided quantitative evidence relating changes in vegetation and fuels to herpetofauna response. Fuel reduction treatments included prescribed burning (B), a mechanical treatment (M), mechanical treatment followed by prescribed...

Cost effectiveness analysis of immunotherapy in patients with grass pollen allergic rhinoconjunctivitis in Germany.

PubMed

Westerhout, K Y; Verheggen, B G; Schreder, C H; Augustin, M

2012-01-01

An economic evaluation was conducted to assess the outcomes and costs as well as cost-effectiveness of the following grass-pollen immunotherapies: OA (Oralair; Stallergenes S.A., Antony, France) vs GRZ (Grazax; ALK-Abelló, Hørsholm, Denmark), and ALD (Alk Depot SQ; ALK-Abelló) (immunotherapy agents alongside symptomatic medication) and symptomatic treatment alone for grass pollen allergic rhinoconjunctivitis. The costs and outcomes of 3-year treatment were assessed for a period of 9 years using a Markov model. Treatment efficacy was estimated using an indirect comparison of available clinical trials with placebo as a common comparator. Estimates for immunotherapy discontinuation, occurrence of asthma, health state utilities, drug costs, resource use, and healthcare costs were derived from published sources. The analysis was conducted from the insurant's perspective including public and private health insurance payments and co-payments by insurants. Outcomes were reported as quality-adjusted life years (QALYs) and symptom-free days. The uncertainty around incremental model results was tested by means of extensive deterministic univariate and probabilistic multivariate sensitivity analyses. In the base case analysis the model predicted a cost-utility ratio of OA vs symptomatic treatment of €14,728 per QALY; incremental costs were €1356 (95%CI: €1230; €1484) and incremental QALYs 0.092 (95%CI: 0.052; 0.140). OA was the dominant strategy compared to GRZ and ALD, with estimated incremental costs of -€1142 (95%CI: -€1255; -€1038) and -€54 (95%CI: -€188; €85) and incremental QALYs of 0.015 (95%CI: -0.025; 0.056) and 0.027 (95%CI: -0.022; 0.075), respectively. At a willingness-to-pay threshold of €20,000, the probability of OA being the most cost-effective treatment was predicted to be 79%. Univariate sensitivity analyses show that incremental outcomes were moderately sensitive to changes in efficacy estimates. The main study limitation was the requirement of an indirect comparison involving several steps to assess relative treatment effects. The analysis suggests OA to be cost-effective compared to GRZ and ALD, and a symptomatic treatment. Sensitivity analyses showed that uncertainty surrounding treatment efficacy estimates affected the model outcomes.

Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis.

PubMed

Wood, Stephen; Rabi, Yacov; Tang, Selphee; Brant, Rollin; Ross, Susan

2017-08-02

Progesterone may be effective in prevention of premature birth in some high risk populations. Women with arrested premature labor are at risk of recurrent labor and maintenance therapy with standard tocolytics has not been successful. Randomized double blinded clinical trial of daily treatment with 200 mg vaginal progesterone in women with arrested premature labor and an updated meta-analysis. The clinical trial was terminated early after 41 women were enrolled. Vaginal progesterone treatment did not change the median gestational age at delivery: 36+2 weeks versus 36+4 weeks, p = .865 nor increase the mean latency to delivery: 44.5 days versus 46.6 days, p = .841. In the updated meta-analysis, progesterone treatment did reduce delivery <37 weeks gestation and increase latency to delivery, but this treatment effect was not evident in the high quality trials: (OR 1.23, 95% CI 0.91, 1.67) and (-0.95 days, 95% CI -5.54, 3.64) respectively. Progesterone is not effective for preventing preterm birth following arrested preterm labor.

Relaxation training for anxiety: a ten-years systematic review with meta-analysis.

PubMed

Manzoni, Gian Mauro; Pagnini, Francesco; Castelnuovo, Gianluca; Molinari, Enrico

2008-06-02

Relaxation training is a common treatment for anxiety problems. Lacking is a recent quantitative meta-analysis that enhances understanding of the variability and clinical significance of anxiety reduction outcomes after relaxation treatment. All studies (1997-2007), both RCT, observational and without control group, evaluating the efficacy of relaxation training (Jacobson's progressive relaxation, autogenic training, applied relaxation and meditation) for anxiety problems and disorders were identified by comprehensive electronic searches with Pubmed, Psychinfo and Cochrane Registers, by checking references of relevant studies and of other reviews. Our primary outcome was anxiety measured with psychometric questionnaires. Meta-analysis was undertaken synthesizing the data from all trials, distinguishing within and between effect sizes. 27 studies qualified for the inclusion in the meta-analysis. As hypothesized, relaxation training showed a medium-large effect size in the treatment of anxiety. Cohen's d was .57 (95% CI: .52 to .68) in the within analysis and .51 (95% CI: .46 to .634) in the between group analysis. Efficacy was higher for meditation, among volunteers and for longer treatments. Implications and limitations are discussed. The results show consistent and significant efficacy of relaxation training in reducing anxiety. This meta-analysis extends the existing literature through facilitation of a better understanding of the variability and clinical significance of anxiety improvement subsequent to relaxation training.

The treatment of perfectionism within the eating disorders: a pilot study.

PubMed

Goldstein, Mandy; Peters, Lorna; Thornton, Christopher E; Touyz, Stephen W

2014-05-01

The aim of this pilot study was to investigate the impact of the direct treatment of perfectionism on the outcome of perfectionism and eating disorder pathology. Sixty-one participants, attending day hospital treatment, participated in a randomised controlled study, in which treatment as usual (TAU) was compared with TAU combined with a clinician-lead cognitive behavioural treatment for perfectionism (TAU+P). Linear mixed model analysis revealed no significant interaction effects but significant main effects for time on variables measuring eating pathology and perfectionism. Outcomes supported the effectiveness of overall treatment but suggested that adding direct treatment of perfectionism did not enhance treatment. The results are discussed in relation to the existing literature on the treatment of perfectionism. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

The COMMAND trial of cognitive therapy to prevent harmful compliance with command hallucinations: predictors of outcome and mediators of change.

PubMed

Birchwood, Max; Dunn, Graham; Meaden, Alan; Tarrier, Nicholas; Lewis, Shon; Wykes, Til; Davies, Linda; Michail, Maria; Peters, Emmanuelle

2017-12-05

Acting on harmful command hallucinations is a major clinical concern. Our COMMAND CBT trial approximately halved the rate of harmful compliance (OR = 0.45, 95% CI 0.23-0.88, p = 0.021). The focus of the therapy was a single mechanism, the power dimension of voice appraisal, was also significantly reduced. We hypothesised that voice power differential (between voice and voice hearer) was the mediator of the treatment effect. The trial sample (n = 197) was used. A logistic regression model predicting 18-month compliance was used to identify predictors, and an exploratory principal component analysis (PCA) of baseline variables used as potential predictors (confounders) in their own right. Stata's paramed command used to obtain estimates of the direct, indirect and total effects of treatment. Voice omnipotence was the best predictor although the PCA identified a highly predictive cognitive-affective dimension comprising: voices' power, childhood trauma, depression and self-harm. In the mediation analysis, the indirect effect of treatment was fully explained by its effect on the hypothesised mediator: voice power differential. Voice power and treatment allocation were the best predictors of harmful compliance up to 18 months; post-treatment, voice power differential measured at nine months was the mediator of the effect of treatment on compliance at 18 months.

Prevalence of orthodontic treatment need in permanent dentition of Iranian population: A systematic review and meta-analysis of observational studies

PubMed Central

Eslamipour, Faezeh; Afshari, Zohreh; Najimi, Arash

2018-01-01

Background: Malocclusion is a common oral health problem and can affect the psychosocial well-being in the long term. Therefore, in the recent decades, demand for orthodontic treatment to correct malocclusion has greatly increased worldwide. This systematic review and meta-analysis was undertaken to assess existing evidence on the prevalence of orthodontic treatment need in Iran. Materials and Methods: National and international databases were searched for articles on the prevalence of orthodontic treatment need using index of orthodontic treatment need (IOTN) and dental aesthetic index (DAI). The required data were completed by hand-searching. After applying the inclusion and exclusion criteria, the quality of articles was checked by a professional checklist. Data extraction and meta-analysis were performed. A random effects model was employed, and publication bias was checked. Results: From a total of 443 articles that reported orthodontic treatment need in Iran, 24 articles were included in the meta-analysis process. Meta-analysis was performed on components of IOTN and DAI. The pooled prevalence of orthodontic treatment need based on Dental Health Component and Aesthetic Component of IOTN and DAI was 23.8% (19.5%–28.7%), 4.8% (3.3%–7%), and 16.1% (12.3%-20.8%). The results were found to be heterogeneous (P < 0.05). Conclusion: The results of this study revealed that orthodontic treatment need was not high in the Iranian population. Considering the differing prevalence of orthodontic treatment need based on normative index and self-perceived index, it is essential to improve the people's awareness of malocclusion and its side effects on their oral and general health. PMID:29497441

Semantic feature analysis treatment for anomia in two fluent aphasia syndromes.

PubMed

Boyle, Mary

2004-08-01

The effect of semantic feature analysis (SFA) treatment on confrontation naming and discourse production was examined in 2 persons, 1 with anomic aphasia and 1 with Wernicke's aphasia. Results indicated that confrontation naming of treated nouns improved and generalized to untreated nouns for both participants, who appeared to have different lexical access impairments. Both participants demonstrated improvement in some aspects of discourse production associated with the confrontation naming SFA treatment. However, there was no change in most manifestations of lexical retrieval difficulty during discourse for either participant. These findings support previous work regarding improved and generalized naming associated with SFA treatment and indicate a need to examine effects of improved confrontation naming on more natural speaking situations.

A multifactorial intervention for frail older people is more than twice as effective among those who are compliant: complier average causal effect analysis of a randomised trial.

PubMed

Fairhall, Nicola; Sherrington, Catherine; Cameron, Ian D; Kurrle, Susan E; Lord, Stephen R; Lockwood, Keri; Herbert, Robert D

2017-01-01

What is the effect of a multifactorial intervention on frailty and mobility in frail older people who comply with their allocated treatment? Secondary analysis of a randomised, controlled trial to derive an estimate of complier average causal effect (CACE) of treatment. A total of 241 frail community-dwelling people aged ≥ 70 years. Intervention participants received a 12-month multidisciplinary intervention targeting frailty, with home exercise as an important component. Control participants received usual care. Primary outcomes were frailty, assessed using the Cardiovascular Health Study criteria (range 0 to 5 criteria), and mobility measured using the 12-point Short Physical Performance Battery. Outcomes were assessed 12 months after randomisation. The treating physiotherapist evaluated the amount of treatment received on a 5-point scale. 216 participants (90%) completed the study. The median amount of treatment received was 25 to 50% (range 0 to 100). The CACE (ie, the effect of treatment in participants compliant with allocation) was to reduce frailty by 1.0 frailty criterion (95% CI 0.4 to 1.5) and increase mobility by 3.2 points (95% CI 1.8 to 4.6) at 12 months. The mean CACE was substantially larger than the intention-to-treat effect, which was to reduce frailty by 0.4 frailty criteria (95% CI 0.1 to 0.7) and increase mobility by 1.4 points (95% CI 0.8 to 2.1) at 12 months. Overall, compliance was low in this group of frail people. The effect of the treatment on participants who comply with allocated treatment was substantially greater than the effect of allocation on all trial participants. Australian and New Zealand Trial Registry ANZCTRN12608000250336. [Fairhall N, Sherrington C, Cameron ID, Kurrle SE, Lord SR, Lockwood K, Herbert RD (2016) A multifactorial intervention for frail older people is more than twice as effective among those who are compliant: complier average causal effect analysis of a randomised trial.Journal of Physiotherapy63: 40-44]. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cheong, S-K; Kim, J

Purpose: The aim of the study is the application of a Failure Modes and Effects Analysis (FMEA) to access the risks for patients undergoing a Low Dose Rate (LDR) Prostate Brachytherapy Treatment. Methods: FMEA was applied to identify all the sub processes involved in the stages of identifying patient, source handling, treatment preparation, treatment delivery, and post treatment. These processes characterize the radiation treatment associated with LDR Prostate Brachytherapy. The potential failure modes together with their causes and effects were identified and ranked in order of their importance. Three indexes were assigned for each failure mode: the occurrence rating (O),more » the severity rating (S), and the detection rating (D). A ten-point scale was used to score each category, ten being the number indicating most severe, most frequent, and least detectable failure mode, respectively. The risk probability number (RPN) was calculated as a product of the three attributes: RPN = O X S x D. The analysis was carried out by a working group (WG) at UPMC. Results: The total of 56 failure modes were identified including 32 modes before the treatment, 13 modes during the treatment, and 11 modes after the treatment. In addition to the protocols already adopted in the clinical practice, the prioritized risk management will be implanted to the high risk procedures on the basis of RPN score. Conclusion: The effectiveness of the FMEA method was established. The FMEA methodology provides a structured and detailed assessment method for the risk analysis of the LDR Prostate Brachytherapy Procedure and can be applied to other radiation treatment modes.« less

Genetic testing in combination with preventive donepezil treatment for patients with amnestic mild cognitive impairment: an exploratory economic evaluation of personalized medicine.

PubMed

Djalalov, Sandjar; Yong, Jean; Beca, Jaclyn; Black, Sandra; Saposnik, Gustavo; Musa, Zahra; Siminovitch, Katherine; Moretti, Myla; Hoch, Jeffrey S

2012-12-01

To evaluate the cost effectiveness of genetic screening for the apolipoprotein (APOE) ε4 allele in combination with preventive donepezil treatment in comparison with the standard of care for amnestic mild cognitive impairment (AMCI) patients in Canada. We performed a cost-effectiveness analysis using a Markov model with a societal perspective and a time horizon of 30 years. For each strategy, we calculated quality-adjusted life-years (QALYs), using utilities from the literature. Costs were also based on the literature and, when appropriate, Ontario sources. One-way and probabilistic sensitivity analyses were performed. Expected value of perfect information (EVPI) analysis was conducted to explore the value of future research. The base case results in our exploratory study suggest that the combination of genetic testing and preventive donepezil treatment resulted in a gain of 0.027 QALYs and an incremental cost of $1,015 (in 2009 Canadian dollars [Can$]), compared with the standard of care. The incremental cost-effectiveness ratio (ICER) for the base case was Can$38,016 per QALY. The ICER was sensitive to the effectiveness of donepezil in slowing the rate of progression to Alzheimer's disease (AD), utility in AMCI patients, and AD and donepezil treatment costs. EVPI analysis showed that additional information on these parameters would be of value. Using presently available clinical evidence, this exploratory study illustrates that genetic testing combined with preventive donepezil treatment for AMCI patients may be economically attractive. Since our results were based on a secondary post hoc analysis, our study alone is insufficient to warrant recommending APOE genotyping in AMCI patients. Future research on the effectiveness of preventive donepezil as a targeted therapy is recommended.

Cost-effectiveness of preoperative nasal mupirocin treatment in preventing surgical site infection in patients undergoing total hip and knee arthroplasty: a cost-effectiveness analysis.

PubMed

Courville, Xan F; Tomek, Ivan M; Kirkland, Kathryn B; Birhle, Marian; Kantor, Stephen R; Finlayson, Samuel R G

2012-02-01

To perform a cost-effectiveness analysis to evaluate preoperative use of mupirocin in patients with total joint arthroplasty (TJA). Simple decision tree model. Outpatient TJA clinical setting. Hypothetical cohort of patients with TJA. A simple decision tree model compared 3 strategies in a hypothetical cohort of patients with TJA: (1) obtaining preoperative screening cultures for all patients, followed by administration of mupirocin to patients with cultures positive for Staphylococcus aureus; (2) providing empirical preoperative treatment with mupirocin for all patients without screening; and (3) providing no preoperative treatment or screening. We assessed the costs and benefits over a 1-year period. Data inputs were obtained from a literature review and from our institution's internal data. Utilities were measured in quality-adjusted life-years, and costs were measured in 2005 US dollars. Incremental cost-effectiveness ratio. The treat-all and screen-and-treat strategies both had lower costs and greater benefits, compared with the no-treatment strategy. Sensitivity analysis revealed that this result is stable even if the cost of mupirocin was over $100 and the cost of SSI ranged between $26,000 and $250,000. Treating all patients remains the best strategy when the prevalence of S. aureus carriers and surgical site infection is varied across plausible values as well as when the prevalence of mupirocin-resistant strains is high. Empirical treatment with mupirocin ointment or use of a screen-and-treat strategy before TJA is performed is a simple, safe, and cost-effective intervention that can reduce the risk of SSI. S. aureus decolonization with nasal mupirocin for patients undergoing TJA should be considered. Level II, economic and decision analysis.

Systematic review and meta-analysis of music interventions in hypertension treatment: a quest for answers.

PubMed

Kühlmann, Anne Y R; Etnel, Jonathan R G; Roos-Hesselink, Jolien W; Jeekel, Johannes; Bogers, Ad J J C; Takkenberg, Johanna J M

2016-04-19

Adverse effects, treatment resistance and high costs associated with pharmacological treatment of hypertension have led to growing interest in non-pharmacological complementary therapies such as music interventions. This meta-analysis aims to provide an overview of reported evidence on the efficacy of music interventions in the treatment of hypertension. A systematic literature search was conducted for publications on the effect of music interventions on blood pressure in adult hypertensive subjects published between January 1990-June 2014. Randomized controlled trials with a follow-up duration ≥28 days were included. Blood pressure measures were pooled using inverse variance weighting. Of the 1689 abstracts reviewed, 10 randomized controlled trials were included. Random-effects pooling of the music intervention groups showed a trend toward a decrease in mean systolic blood pressure (SBP) from 144 mmHg(95 % CI:137-152) to 134 mmHg(95 % CI:124-144), and in mean diastolic blood pressure (DBP) from 84 mmHg(95 % CI:78-89) to 78 mmHg(95 % CI:73-84). Fixed-effect analysis of a subgroup of 3 trials with valid control groups showed a significant decrease in pooled mean SBP and DBP in both intervention and control groups. A comparison between music intervention groups and control groups was not possible due to unavailable measures of dispersion. This systematic review and meta-analysis revealed a trend towards a decrease in blood pressure in hypertensive patients who received music interventions, but failed to establish a cause-effect relationship between music interventions and blood pressure reduction. Considering the potential value of this safe, low-cost intervention, well-designed, high quality and sufficiently powered randomized studies assessing the efficacy of music interventions in the treatment of hypertension are warranted.

Functional analysis and treatment of elopement for a child with attention deficit hyperactivity disorder.

PubMed Central

Kodak, Tiffany; Grow, Laura; Northup, John

2004-01-01

We conducted a functional analysis of elopement in an outdoor setting for a child with a diagnosis of attention deficit hyperactivity disorder. A subsequent treatment consisting of noncontingent attention and time-out was demonstrated to be effective in eliminating elopement. Modifications of functional analysis procedures associated with the occurrence of elopement in a natural setting are demonstrated. PMID:15293643

Cost-effectiveness analysis of the national implementation of integrated community case management and community-based health planning and services in Ghana for the treatment of malaria, diarrhoea and pneumonia.

PubMed

Escribano Ferrer, Blanca; Hansen, Kristian Schultz; Gyapong, Margaret; Bruce, Jane; Narh Bana, Solomon A; Narh, Clement T; Allotey, Naa-Korkor; Glover, Roland; Azantilow, Naa-Charity; Bart-Plange, Constance; Sagoe-Moses, Isabella; Webster, Jayne

2017-07-05

Ghana has developed two main community-based strategies that aim to increase access to quality treatment for malaria, diarrhoea and suspected pneumonia: the integrated community case management (iCCM) and the community-based health planning and services (CHPS). The aim of the study was to assess the cost-effectiveness of these strategies under programme conditions. A cost-effectiveness analysis was conducted. Appropriate diagnosis and treatment given was the effectiveness measure used. Appropriate diagnosis and treatment data was obtained from a household survey conducted 2 and 8 years after implementation of iCCM in the Volta and Northern Regions of Ghana, respectively. The study population was carers of children under-5 years who had fever, diarrhoea and/or cough in the last 2 weeks prior to the interview. Costs data was obtained mainly from the National Malaria Control Programme (NMCP), the Ministry of Health, CHPS compounds and from a household survey. Appropriate diagnosis and treatment of malaria, diarrhoea and suspected pneumonia was more cost-effective under the iCCM than under CHPS in the Volta Region, even after adjusting for different discount rates, facility costs and iCCM and CHPS utilization, but not when iCCM appropriate treatment was reduced by 50%. Due to low numbers of carers visiting a CBA in the Northern Region it was not possible to conduct a cost-effectiveness analysis in this region. However, the cost analysis showed that iCCM in the Northern Region had higher cost per malaria, diarrhoea and suspected pneumonia case diagnosed and treated when compared to the Volta Region and to the CHPS strategy in the Northern Region. Integrated community case management was more cost-effective than CHPS for the treatment of malaria, diarrhoea and suspected pneumonia when utilized by carers of children under-5 years in the Volta Region. A revision of the iCCM strategy in the Northern Region is needed to improve its cost-effectiveness. Long-term financing strategies should be explored including potential inclusion in the National Health Insurance Scheme (NHIS) benefit package. An acceptability study of including iCCM in the NHIS should be conducted.

Cost-effectiveness of early interventions for non-specific low back pain: a randomized controlled study investigating medical yoga, exercise therapy and self-care advice.

PubMed

Aboagye, Emmanuel; Karlsson, Malin Lohela; Hagberg, Jan; Jensen, Irene

2015-02-01

To evaluate the cost-effectiveness of medical yoga as an early intervention compared with evidence-based exercise therapy and self-care advice for non-specific low back pain. Randomized controlled trial with a cost-effectiveness analysis. A total of 159 participants randomized into the medical yoga group (n = 52), the exercise therapy group (n = 52) and the self-care advice group (n = 55). The health outcome measure EQ-5D was applied to measure quality of life data combined with cost data collected from treatment groups from baseline to 12 months follow-up. Outcome measure was health-related quality of life (HRQL). Incremental cost per quality adjusted life year (QALY) was also calculated. Cost-effectiveness analysis was conducted primarily from the societal and employer perspectives. Medical yoga is cost-effective compared with self-care advice if an employer considers the significant improvement in the HRQL of an employee with low back pain justifies the additional cost of treatment (i.e. in this study EUR 150). From a societal perspective, medical yoga is a cost-effective treatment compared with exercise therapy and self-care advice if an additional QALY is worth EUR 11,500. Sensitivity analysis suggests that medical yoga is more cost-effective than its alternatives. Six weeks of uninterrupted medical yoga thera-py is a cost-effective early intervention for non-specific low back pain, when treatment recommendations are adhered to.

Effect of Metformin on Plasma Fibrinogen Concentrations: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

PubMed

Simental-Mendia, Luis E; Pirro, Matteo; Atkin, Stephen L; Banach, Maciej; Mikhailidis, Dimitri P; Sahebkar, Amirhossein

2018-01-01

Fibrinogen is a key mediator of thrombosis and it has been implicated in the pathogenesis of atherosclerosis. Because metformin has shown a potential protective effect on different atherothrombotic risk factors, we assessed in this meta-analysis its effect on plasma fibrinogen concentrations. A systematic review and meta-analysis was carried out to identify randomized placebo-controlled trials evaluating the effect of metformin administration on fibrinogen levels. The search included PubMed-Medline, Scopus, ISI Web of Knowledge and Google Scholar databases (by June 2, 2017) and quality of studies was performed according to Cochrane criteria. Quantitative data synthesis was conducted using a random-effects model and sensitivity analysis by the leave-one-out method. Meta-regression analysis was performed to assess the modifiers of treatment response. Meta-analysis of data from 9 randomized placebo-controlled clinical trials with 2302 patients comprising 10 treatment arms did not suggest a significant change in plasma fibrinogen concentrations following metformin therapy (WMD: -0.25 g/L, 95% CI: -0.53, 0.04, p = 0.092). The effect size was robust in the leave-one-out sensitivity analysis and remained non-significant after omission of each single study from the meta-analysis. No significant effect of metformin on plasma fibrinogen concentrations was demonstrated in the current meta-analysis. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A Meta-Analysis of Treatments for Panic Disorder.

ERIC Educational Resources Information Center

Clum, George A.; And Others

1993-01-01

Used metanalysis to compare effectiveness of psychological and pharmacological treatments for panic disorder. Percentage of agoraphobic subjects in sample and duration of illness were unrelated to effect size (ES). Psychological coping strategies involving relaxation training, cognitive restructuring, and exposure yielded most consistent ESs;…

Frontage road yield treatment analysis tool (FRYTAT) database: user guide.

DOT National Transportation Integrated Search

2009-08-01

The Texas Department of Transportation (TxDOT) sponsored Project 0-4986, An Assessment of Frontage Road : Yield Treatments, to assess the effectiveness of a wide variety of frontage roadexit ramp and frontage roadU-turn : yield treatments...

Surface Analysis Cluster Tool | Materials Science | NREL

Science.gov Websites

spectroscopic ellipsometry during film deposition. The cluster tool can be used to study the effect of various prior to analysis. Here we illustrate the surface cleaning effect of an aqueous ammonia treatment on a

Meta-analysis: aerobic exercise for the treatment of anxiety disorders.

PubMed

Bartley, Christine A; Hay, Madeleine; Bloch, Michael H

2013-08-01

This meta-analysis investigates the efficacy of exercise as a treatment for DSM-IV diagnosed anxiety disorders. We searched PubMED and PsycINFO for randomized, controlled trials comparing the anxiolytic effects of aerobic exercise to other treatment conditions for DSM-IV defined anxiety disorders. Seven trials were included in the final analysis, totaling 407 subjects. The control conditions included non-aerobic exercise, waitlist/placebo, cognitive-behavioral therapy, psychoeducation and meditation. A fixed-effects model was used to calculate the standardized mean difference of change in anxiety rating scale scores of aerobic exercise compared to control conditions. Subgroup analyses were performed to examine the effects of (1) comparison condition; (2) whether comparison condition controlled for time spent exercising and (3) diagnostic indication. Aerobic exercise demonstrated no significant effect for the treatment of anxiety disorders (SMD=0.02 (95%CI: -0.20-0.24), z = 0.2, p = 0.85). There was significant heterogeneity between trials (χ(2) test for heterogeneity = 22.7, df = 6, p = 0.001). The reported effect size of aerobic exercise was highly influenced by the type of control condition. Trials utilizing waitlist/placebo controls and trials that did not control for exercise time reported large effects of aerobic exercise while other trials report no effect of aerobic exercise. Current evidence does not support the use of aerobic exercise as an effective treatment for anxiety disorders as compared to the control conditions. This remains true when controlling for length of exercise sessions and type of anxiety disorder. Future studies evaluating the efficacy of aerobic exercise should employ larger sample sizes and utilize comparison interventions that control for exercise time. Copyright © 2013. Published by Elsevier Inc.

Effect of oxandrolone therapy on adult height in Turner syndrome patients treated with growth hormone: a meta-analysis.

PubMed

Sheanon, Nicole M; Backeljauw, Philippe F

2015-01-01

Turner syndrome is a chromosomal abnormality in which there is complete or partial absence of the X chromosome. Turner syndrome effects 1 in every 2000 live births. Short stature is a cardinal feature of Turner Syndrome and the standard treatment is recombinant human growth hormone. When growth hormone is started at an early age a normal adult height can be achieved. With delayed diagnosis young women with Turner Syndrome may not reach a normal height. Adjuvant therapy with oxandrolone is used but there is no consensus on the optimal timing of treatment, the duration of treatment and the long term adverse effects of treatment. The objective of this review and meta-analysis is to examine the effect of oxandrolone on adult height in growth hormone treated Turner syndrome patients. Eligible trials were identified by a literature search using the terms: Turner syndrome, oxandrolone. The search was limited to English language randomized-controlled trials after 1980. Twenty-six articles were reviewed and four were included in the meta-analysis. A random effects model was used to calculate an effect size and confidence interval. The pooled effect size of 2.0759 (95 % CI 0.0988 to 4.0529) indicates that oxandrolone has a positive effect on adult height in Turner syndrome when combined with growth hormone therapy. In conclusion, the addition of oxandrolone to growth hormone therapy for treatment of short stature in Turner syndrome improves adult height. Further studies are warranted to investigate if there is a subset of Turner syndrome patients that would benefit most from growth hormone plus oxandrolone therapy, and to determine the optimal timing and duration of such therapy.

A tutorial on Bayesian bivariate meta-analysis of mixed binary-continuous outcomes with missing treatment effects.

PubMed

Gajic-Veljanoski, Olga; Cheung, Angela M; Bayoumi, Ahmed M; Tomlinson, George

2016-05-30

Bivariate random-effects meta-analysis (BVMA) is a method of data synthesis that accounts for treatment effects measured on two outcomes. BVMA gives more precise estimates of the population mean and predicted values than two univariate random-effects meta-analyses (UVMAs). BVMA also addresses bias from incomplete reporting of outcomes. A few tutorials have covered technical details of BVMA of categorical or continuous outcomes. Limited guidance is available on how to analyze datasets that include trials with mixed continuous-binary outcomes where treatment effects on one outcome or the other are not reported. Given the advantages of Bayesian BVMA for handling missing outcomes, we present a tutorial for Bayesian BVMA of incompletely reported treatment effects on mixed bivariate outcomes. This step-by-step approach can serve as a model for our intended audience, the methodologist familiar with Bayesian meta-analysis, looking for practical advice on fitting bivariate models. To facilitate application of the proposed methods, we include our WinBUGS code. As an example, we use aggregate-level data from published trials to demonstrate the estimation of the effects of vitamin K and bisphosphonates on two correlated bone outcomes, fracture, and bone mineral density. We present datasets where reporting of the pairs of treatment effects on both outcomes was 'partially' complete (i.e., pairs completely reported in some trials), and we outline steps for modeling the incompletely reported data. To assess what is gained from the additional work required by BVMA, we compare the resulting estimates to those from separate UVMAs. We discuss methodological findings and make four recommendations. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Chinese Herbal Bath Therapy for the Treatment of Knee Osteoarthritis: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Bo; Zhan, Hongsheng; Chung, Mei; Lin, Xun; Zhang, Min; Pang, Jian; Wang, Chenchen

2015-01-01

Objective. Chinese herbal bath therapy (CHBT) has traditionally been considered to have analgesic and anti-inflammatory effects. We conducted the first meta-analysis evaluating its benefits for patients with knee osteoarthritis (OA). Methods. We searched three English and four Chinese databases through October, 2014. Randomized trials evaluating at least 2 weeks of CHBT for knee OA were selected. The effects of CHBT on clinical symptoms included both pain level (via the visual analog scale) and total effectiveness rate, which assessed pain, physical performance, and wellness. We performed random-effects meta-analyses using mean difference. Results. Fifteen studies totaling 1618 subjects met eligibility criteria. Bath prescription included, on average, 13 Chinese herbs with directions to steam and wash around the knee for 20–40 minutes once or twice daily. Mean treatment duration was 3 weeks. Results from meta-analysis showed superior pain improvement (mean difference = −0.59 points; 95% confidence intervals [CI], −0.83 to −0.36; p < 0.00001) and higher total effectiveness rate (risk ratio = 1.21; 95% CI, 1.15 to 1.28; p < 0.00001) when compared with standard western treatment. No serious adverse events were reported. Conclusion. Chinese herbal bath therapy may be a safe, effective, and simple alternative treatment modality for knee OA. Further rigorously designed, randomized trials are warranted. PMID:26483847

A Bayesian network meta-analysis of whole brain radiotherapy and stereotactic radiotherapy for brain metastasis.

PubMed

Yuan, Xi; Liu, Wen-Jie; Li, Bing; Shen, Ze-Tian; Shen, Jun-Shu; Zhu, Xi-Xu

2017-08-01

This study was conducted to compare the effects of whole brain radiotherapy (WBRT) and stereotactic radiotherapy (SRS) in treatment of brain metastasis.A systematical retrieval in PubMed and Embase databases was performed for relative literatures on the effects of WBRT and SRS in treatment of brain metastasis. A Bayesian network meta-analysis was performed by using the ADDIS software. The effect sizes included odds ratio (OR) and 95% confidence interval (CI). A random effects model was used for the pooled analysis for all the outcome measures, including 1-year distant control rate, 1-year local control rate, 1-year survival rate, and complication. The consistency was tested by using node-splitting analysis and inconsistency standard deviation. The convergence was estimated according to the Brooks-Gelman-Rubin method.A total of 12 literatures were included in this meta-analysis. WBRT + SRS showed higher 1-year distant control rate than SRS. WBRT + SRS was better for the 1-year local control rate than WBRT. SRS and WBRT + SRS had higher 1-year survival rate than the WBRT. In addition, there was no difference in complication among the three therapies.Comprehensively, WBRT + SRS might be the choice of treatment for brain metastasis.

Efficacy and Acceptability of Glycemic Control of Glucagon-Like Peptide-1 Receptor Agonists among Type 2 Diabetes: A Systematic Review and Network Meta-Analysis.

PubMed

Li, Zhixia; Zhang, Yuan; Quan, Xiaochi; Yang, Zhirong; Zeng, Xiantao; Ji, Linong; Sun, Feng; Zhan, Siyan

2016-01-01

To synthesize current evidence of the impact of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on hypoglycemia, treatment discontinuation and glycemic level in patients with type 2 diabetes. Systematic review and network meta-analysis. Literature search (Medline, Embase, the Cochrane library), website of clinical trial, bibliographies of published systematic reviews. Randomized controlled trials with available data comparing GLP-1 RAs with placebo or traditional anti-diabetic drugs in patients with type 2 diabetes. Traditional pairwise meta-analyses within DerSimonian-Laird random effects model and network meta-analysis within a Bayesian framework were performed to calculate odds ratios for the incidence of hypoglycemia, treatment discontinuation, HbA1c<7.0% and HbA1c<6.5%. Ranking probabilities for all treatments were estimated to obtain a treatment hierarchy using the surface under the cumulative ranking curve (SUCRA) and mean ranks. 78 trials with 13 treatments were included. Overall, all GLP-1 RAs except for albiglutide increased the risk of hypoglycemia when compared to placebo. Reduction in the incidence of hypoglycemia was found for all GLP-1 RAs versus insulin (except for dulaglutide) and sulphonylureas. For the incidence of treatment discontinuation, increase was found for exenatide, liraglutide, lixisenatide and taspoglutide versus placebo, insulin and sitagliptin. For glycemic level, decrease was found for all GLP-1 RAs versus placebo. Dulaglutide, exenatide long-acting release (exe_lar), liraglutide and taspoglutide had significant lowering effect when compared with sitagliptin (HbA1c<7.0%) and insulin (HbA1c<6.5%). Finally, according to SUCRAs, placebo, thiazolidinediones and albiglutide had the best decrease effect on hypoglycemia; sulphanylureas, sitagliptin and insulin decrease the incidence of treatment discontinuation most; exe_lar and dulaglutide had the highest impact on glycemic level among 13 treatments. Among 13 treatments, GLP-1 RAs had a significant reduction with glycemic level but a slight increase effect on hypoglycemia and treatment discontinuation. While albiglutide had the best decrease effect on hypoglycemia and treatment discontinuation among all GLP-1 RAs. However, further evidence is necessary for more conclusive inferences on mechanisms underlying the rise in hypoglycemia.

Histological analysis of effects of 24% EDTA gel for nonsurgical treatment of periodontal tissues.

PubMed

de Vasconcellos, Luana Marotta Reis; Ricardo, Lucilene Hernandes; Balducci, Ivan; de Vasconcellos, Luis Gustavo Oliveira; Carvalho, Yasmin Rodarte

2006-12-01

The aim of this study was to investigate, by means of histological and histomorphometric analysis, the effects of 24% ethylenediaminetetraacetic acid (EDTA) gel in periodontal tissue when used in combination with conventional periodontal treatment. Periodontitis was induced in the 2nd upper left permanent molars of 45 male Wistar rats by means of ligature. After 5 weeks, this was removed and debridement was performed. The animals were then randomly divided into 3 groups; group 1: mechanical treatment, group 2: mechanical treatment and EDTA gel application for 2 min, and group 3: mechanical treatment and placebo gel application for 2 min. After the treatment, rinsing was done with 0.9% saline solution for 1 min in all cases, followed by root notching in the deepest part of the pocket. After 4, 10, and 28 days the animals were sacrificed. The averages obtained were evaluated by means of test two-way analysis of variance (ANOVA) and Tukey statistical tests (P < 0.05). The results showed that with respect to the type of treatment employed, there were no statistically significant differences in the vitality of the periodontal tissue. It was concluded that 24% EDTA gel did not interfere with periodontal tissue repair when used in combination with conventional periodontal treatment.

Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis.

PubMed

Martins, Wagner Rodrigues; Blasczyk, Juscelino Castro; Aparecida Furlan de Oliveira, Micaele; Lagôa Gonçalves, Karina Ferreira; Bonini-Rocha, Ana Clara; Dugailly, Pierre-Michel; de Oliveira, Ricardo Jacó

2016-02-01

Temporomandibular joint disorder (TMD) requires a complex diagnostic and therapeutic approach, which usually involves a multidisciplinary management. Among these treatments, musculoskeletal manual techniques are used to improve health and healing. To assess the effectiveness of musculoskeletal manual approach in temporomandibular joint disorder patients. A systematic review with meta-analysis. During August 2014 a systematic review of relevant databases (PubMed, The Cochrane Library, PEDro and ISI web of knowledge) was performed to identify controlled clinical trials without date restriction and restricted to the English language. Clinical outcomes were pain and range of motion focalized in temporomandibular joint. The mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated at every post treatment. The PEDro scale was used to demonstrate the quality of the included studies. From the 308 articles identified by the search strategy, 8 articles met the inclusion criteria. The meta-analysis showed a significant difference (p < 0.0001) and large effect on active mouth opening (SMD, 0.83; 95% CI, 0.42 to 1.25) and on pain during active mouth opening (MD, 1.69; 95% CI, 1.09 to 2.30) in favor of musculoskeletal manual techniques when compared to other conservative treatments for TMD. Musculoskeletal manual approaches are effective for treating TMD. In the short term, there is a larger effect regarding the latter when compared to other conservative treatments for TMD. Copyright © 2015 Elsevier Ltd. All rights reserved.

A generalized matching law analysis of cocaine vs. food choice in rhesus monkeys: effects of candidate 'agonist-based' medications on sensitivity to reinforcement.

PubMed

Hutsell, Blake A; Negus, S Stevens; Banks, Matthew L

2015-01-01

We have previously demonstrated reductions in cocaine choice produced by either continuous 14-day phendimetrazine and d-amphetamine treatment or removing cocaine availability under a cocaine vs. food choice procedure in rhesus monkeys. The aim of the present investigation was to apply the concatenated generalized matching law (GML) to cocaine vs. food choice dose-effect functions incorporating sensitivity to both the relative magnitude and price of each reinforcer. Our goal was to determine potential behavioral mechanisms underlying pharmacological treatment efficacy to decrease cocaine choice. A multi-model comparison approach was used to characterize dose- and time-course effects of both pharmacological and environmental manipulations on sensitivity to reinforcement. GML models provided an excellent fit of the cocaine choice dose-effect functions in individual monkeys. Reductions in cocaine choice by both pharmacological and environmental manipulations were principally produced by systematic decreases in sensitivity to reinforcer price and non-systematic changes in sensitivity to reinforcer magnitude. The modeling approach used provides a theoretical link between the experimental analysis of choice and pharmacological treatments being evaluated as candidate 'agonist-based' medications for cocaine addiction. The analysis suggests that monoamine releaser treatment efficacy to decrease cocaine choice was mediated by selectively increasing the relative price of cocaine. Overall, the net behavioral effect of these pharmacological treatments was to increase substitutability of food pellets, a nondrug reinforcer, for cocaine. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Cost-effectiveness in the management of Dupuytren's contracture. A Canadian cost-utility analysis of current and future management strategies.

PubMed

Baltzer, H; Binhammer, P A

2013-08-01

In Canada, Dupuytren's contracture is managed with partial fasciectomy or percutaneous needle aponeurotomy (PNA). Injectable collagenase will soon be available. The optimal management of Dupuytren's contracture is controversial and trade-offs exist between the different methods. Using a cost-utility analysis approach, our aim was to identify the most cost-effective form of treatment for managing Dupuytren's contracture it and the threshold at which collagenase is cost-effective. We developed an expected-value decision analysis model for Dupuytren's contracture affecting a single finger, comparing the cost-effectiveness of fasciectomy, aponeurotomy and collagenase from a societal perspective. Cost-effectiveness, one-way sensitivity and variability analyses were performed using standard thresholds for cost effective treatment ($50 000 to $100 000/QALY gained). Percutaneous needle aponeurotomy was the preferred strategy for managing contractures affecting a single finger. The cost-effectiveness of primary aponeurotomy improved when repeated to treat recurrence. Fasciectomy was not cost-effective. Collagenase was cost-effective relative to and preferred over aponeurotomy at $875 and $470 per course of treatment, respectively. In summary, our model supports the trend towards non-surgical interventions for managing Dupuytren's contracture affecting a single finger. Injectable collagenase will only be feasible in our publicly funded healthcare system if it costs significantly less than current United States pricing.

Cost-effectiveness of pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: qualitative synthesis of scientific evidence.

PubMed

Catalá-López, Ferrán; Ridao, Manuel; Sanfélix-Gimeno, Gabriel; Peiró, Salvador

2013-01-01

To describe the cost-effectiveness analyses of medications launched in Spain for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents. Systematic review of the literature without meta-analysis. A search was made in, PubMed/MEDLINE, SCOPUS, databases of the Centre for Reviews and Dissemination, and the websites of technology assessment agencies from Canada, the United Kingdom and the Spanish Platform AUnETS. Only full economic evaluations were included, considering at least methylphenidate or atomoxetine as pharmacological treatment alternatives in children and/or adolescents with ADHD. Eleven studies published in 9 articles or reports were included. The most frequent characteristics were: cost-utility analysis (82%), health system perspective (82%), short-term horizon (91%), and private funding (50%). Methylphenidate was included in all studies, and atomoxetine in 4 studies. Methylphenidate and atomoxetine are cost-effective alternatives compared to placebo or no treatment, although incremental cost-effectiveness ratios are variable. The few direct treatment-comparisons between methylphenidate and atomoxetine provided contradictory and potentially biased results. The pharmacological treatment of ADHD in children and adolescents, with the reservations arising from the generalization of results to different settings, is probably cost-effective in the short term. The existing studies do not allow the relative efficiency of different treatments to be established, either in the long-term treatment or in patient subgroups with specific characteristics or comorbidities. Copyright © 2012 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

Comprehensive treatments for social cognitive deficits in schizophrenia: A critical review and effect-size analysis of controlled studies.

PubMed

Kurtz, Matthew M; Gagen, Emily; Rocha, Nuno B F; Machado, Sergio; Penn, David L

2016-02-01

Recent advances in psychosocial treatments for schizophrenia have targeted social cognitive deficits. A critical literature review and effect-size (ES) analysis was conducted to investigate the efficacy of comprehensive programs of social cognitive training in schizophrenia. Results revealed 16 controlled studies consisting of seven models of comprehensive treatment with only three of these treatment models investigated in more than one study. The effects of social cognitive training were reported in 11/15 studies that included facial affect recognition skills (ES=.84) and 10/13 studies that included theory-of-mind (ES=.70) as outcomes. Less than half (4/9) of studies that measured attributional style as an outcome reported effects of treatment, but effect sizes across studies were significant (ESs=.30-.52). The effect sizes for symptoms were modest, but, with the exception of positive symptoms, significant (ESs=.32-.40). The majority of trials were randomized (13/16), selected active control conditions (11/16) and included at least 30 participants (12/16). Concerns for this area of research include the absence of blinded outcome raters in more than 50% of trials and low rates of utilization of procedures for maintaining treatment fidelity. These findings provide preliminary support for the broader use of comprehensive social cognitive training procedures as a psychosocial intervention for schizophrenia. Copyright © 2015 Elsevier Ltd. All rights reserved.

Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major depressive disorder.

PubMed

Jakobsen, Janus Christian

2014-10-01

Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the Hamilton Depression Rating Scale (HDRS) compared with "no intervention" (mean difference -3.01 (95% confidence interval -3.98 to -2.03; p = 0.00001), no significant heterogeneity between trials). Trial sequential analysis confirmed this result. The second systematic review included 12 randomised trials examining the effects of cognitive therapy versus "no intervention" for major depressive disorder. Altogether a total of 669 participants were randomised. All trials had high risk of bias. Meta-analysis showed that cognitive therapy significantly reduced depressive symptoms on the HDRS compared with "no intervention" (four trials; mean difference -3.05 (95% confidence interval, -5.23 to -0.87; p = 0.006)). Trial sequential analysis could not confirm this result. The trial protocol showed that it seemed feasible to conduct a randomised trial with low risks of bias and low risks of random errors examining the effects of "third wave" cognitive therapy versus mentalization-based therapy in a setting in the Danish healthcare system. It turned out to be much more difficult to recruit participants in the randomised trial than expected. We only included about half of the planned participants. The results from the randomised trial showed that participants randomised to "third wave" therapy compared with participants randomised to mentalization-based treatment had borderline significantly lower HDRS scores at 18 weeks in an unadjusted analysis (mean difference -4.14 score; 95% CI -8.30 to 0.03; p = 0.051). In the adjusted analysis, the difference was significant (p = 0.039). Five (22.7%) of the participants randomised to "third wave" cognitive therapy had remission at 18 weeks versus none of the participants randomised to mentalization-based treatment (p = 0.049). Sequential analysis showed that these findings could be due to random errors. No significant differences between the two groups was found regarding Beck's Depression Inventory (BDI II), Symptom Checklist 90 Revised (SCL 90-R), and The World Health Organization-Five Well-being Index 1999 (WHO 5). We concluded that cognitive therapy and psychodynamic therapy might be effective interventions for depression measured on HDRS and BDI, but the review results might be erroneous due to risks of bias and random errors. Furthermore, the effects seem relatively small. The trial protocol showed that it was possible to develop a protocol for a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment with low risks of bias and low risks of random errors. Our trial results showed that "third wave" cognitive therapy might be a more effective intervention for depressive symptoms measured on the HDRS compared with mentalization-based treatment. The two interventions did not seem to differ significantly regarding BDI II, SCL 90-R, and WHO 5. More randomised trials with low risks of bias and low risks of random errors are needed to assess the effects of cognitive therapy, psychodynamic therapy, "third wave" cognitive therapy, and mentalization-based treatment.

Functional assessment and treatment of perseverative speech about restricted topics in an adolescent with Asperger syndrome.

PubMed

Fisher, Wayne W; Rodriguez, Nicole M; Owen, Todd M

2013-01-01

A functional analysis showed that a 14-year-old boy with Asperger syndrome displayed perseverative speech (or "restricted interests") reinforced by attention. To promote appropriate speech in a turn-taking format, we implemented differential reinforcement (DR) of nonperseverative speech and DR of on-topic speech within a multiple schedule with stimuli that signaled the contingencies in effect and who was to select the topic. Both treatments reduced perseverative speech, but only DR of on-topic speech increased appropriate turn taking during conversation. Treatment effects were maintained when implemented by family members and novel therapists. © Society for the Experimental Analysis of Behavior.

Cost-effectiveness analysis of antimuscarinics in the treatment of patients with overactive bladder in Spain: A decision-tree model

PubMed Central

2011-01-01

Background Fesoterodine, a new once daily antimuscarinic, has proven to be an effective, safe, and well-tolerated treatment in patients with overactive bladder (OAB). To date, no analysis has evaluated the economic costs and benefits associated with fesoterodine, compared to antimuscarinics in Spain. The purpose of this analysis was to assess the economic value of OAB treatment with fesoterodine relative to extended release tolterodine and solifenacin, from the societal perspective. Methods The economic model was based on data from two 12-week, randomized, double-blind, and multicenter trials comparing fesoterodine and tolterodine extended released (ER). Treatment response rates for solifenacin were extracted from the published literature. Discontinuation and efficacy were based on the results of a 12-week multinational randomized clinical trial extrapolated to 52 weeks. Changes in health related quality of life were assessed with the King's Health Questionnaire, which was transformed into preference-based utility values. Medical costs included (expressed in € 2010) were antimuscarinics, physician visits, laboratory tests, incontinence pads and the costs of OAB-related comorbidities, fractures, skin infections, urinary tract infections, depression, and nursing home admissions associated with incontinence. Time lost from work was also considered. Univariate sensitivity analyses were also performed. Results At week 12, continents accounted for 50.6%, 40.6% and 47.2% of patients in the fesoterodine, tolterodine, and solifenacin groups, respectively. By week 52, the projected proportions of patients remaining on therapy were 33.1%, 26.5% and 30.8%, respectively. The projected quality- adjusted life years (QALY) gain (compared to baseline) over the 52-week simulation period were 0.01014, 0.00846 and 0.00957, respectively. The overall treatment cost was estimated at €1,937, €2,089 and €1,960 for fesoterodine, tolterodine and solifenacin, respectively. Therefore, treatment with fesoterodine resulted in similar overall costs and greater QALY gain than treatment with either tolterodine or solifenacin. Sensitivity analysis showed that these results were robust to all changes performed. Conclusions The results of this economic analysis suggest that fesoterodine is a cost-effective alternative to tolterodine and solifenacin for the treatment of patients with OAB in Spain. Fesoterodine provides additional health benefits while maintain a similar level of costs being a cost-effective treatment strategy from a societal perspective. PMID:21599928

An objective Bayesian analysis of a crossover design via model selection and model averaging.

PubMed

Li, Dandan; Sivaganesan, Siva

2016-11-10

Inference about the treatment effect in a crossover design has received much attention over time owing to the uncertainty in the existence of the carryover effect and its impact on the estimation of the treatment effect. Adding to this uncertainty is that the existence of the carryover effect and its size may depend on the presence of the treatment effect and its size. We consider estimation and testing hypothesis about the treatment effect in a two-period crossover design, assuming normally distributed response variable, and use an objective Bayesian approach to test the hypothesis about the treatment effect and to estimate its size when it exists while accounting for the uncertainty about the presence of the carryover effect as well as the treatment and period effects. We evaluate and compare the performance of the proposed approach with a standard frequentist approach using simulated data, and real data. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Do depression treatments reduce suicidal ideation? The effects of CBT, IPT, pharmacotherapy, and placebo on suicidality.

PubMed

Weitz, Erica; Hollon, Steven D; Kerkhof, Ad; Cuijpers, Pim

2014-01-01

Many well-researched treatments for depression exist. However, there is not yet enough evidence on whether these therapies, designed for the treatment of depression, are also effective for reducing suicidal ideation. This research provides valuable information for researchers, clinicians, and suicide prevention policy makers. Analysis was conducted on the Treatment for Depression Research Collaborative (TDCRP) sample, which included CBT, IPT, medication, and placebo treatment groups. Participants were included in the analysis if they reported suicidal ideation on the HRSD or BDI (score of ≥1). Multivariate linear regression indicated that both IPT (b=.41, p<.05) and medication (b =.47, p<.05) yielded a significant reduction in suicide symptoms compared to placebo on the HRSD. Multivariate linear regression indicated that after adjustment for change in depression these treatment effects were no longer significant. Moderate Cohen׳s d effect sizes from baseline to post-test differences in suicide score by treatment group are reported. These analyses were completed on a single suicide item from each of the measures. Moreover, the TDCRP excluded participants with moderate to severe suicidal ideation. This study demonstrates the specific effectiveness of IPT and medications in reducing suicidal ideation (relative to placebo), albeit largely as a consequence of their more general effects on depression. This adds to the growing body of evidence that depression treatments, specifically IPT and medication, can also reduce suicidal ideation and serves to further our understanding of the complex relationship between depression and suicide. Copyright © 2014 Elsevier B.V. All rights reserved.

Bayesian bivariate meta-analysis of correlated effects: Impact of the prior distributions on the between-study correlation, borrowing of strength, and joint inferences

PubMed Central

Bujkiewicz, Sylwia; Riley, Richard D

2016-01-01

Multivariate random-effects meta-analysis allows the joint synthesis of correlated results from multiple studies, for example, for multiple outcomes or multiple treatment groups. In a Bayesian univariate meta-analysis of one endpoint, the importance of specifying a sensible prior distribution for the between-study variance is well understood. However, in multivariate meta-analysis, there is little guidance about the choice of prior distributions for the variances or, crucially, the between-study correlation, ρB; for the latter, researchers often use a Uniform(−1,1) distribution assuming it is vague. In this paper, an extensive simulation study and a real illustrative example is used to examine the impact of various (realistically) vague prior distributions for ρB and the between-study variances within a Bayesian bivariate random-effects meta-analysis of two correlated treatment effects. A range of diverse scenarios are considered, including complete and missing data, to examine the impact of the prior distributions on posterior results (for treatment effect and between-study correlation), amount of borrowing of strength, and joint predictive distributions of treatment effectiveness in new studies. Two key recommendations are identified to improve the robustness of multivariate meta-analysis results. First, the routine use of a Uniform(−1,1) prior distribution for ρB should be avoided, if possible, as it is not necessarily vague. Instead, researchers should identify a sensible prior distribution, for example, by restricting values to be positive or negative as indicated by prior knowledge. Second, it remains critical to use sensible (e.g. empirically based) prior distributions for the between-study variances, as an inappropriate choice can adversely impact the posterior distribution for ρB, which may then adversely affect inferences such as joint predictive probabilities. These recommendations are especially important with a small number of studies and missing data. PMID:26988929

Cost-effectiveness of cerebrospinal biomarkers for the diagnosis of Alzheimer's disease.

PubMed

Lee, Spencer A W; Sposato, Luciano A; Hachinski, Vladimir; Cipriano, Lauren E

2017-03-16

Accurate and timely diagnosis of Alzheimer's disease (AD) is important for prompt initiation of treatment in patients with AD and to avoid inappropriate treatment of patients with false-positive diagnoses. Using a Markov model, we estimated the lifetime costs and quality-adjusted life-years (QALYs) of cerebrospinal fluid biomarker analysis in a cohort of patients referred to a neurologist or memory clinic with suspected AD who remained without a definitive diagnosis of AD or another condition after neuroimaging. Parametric values were estimated from previous health economic models and the medical literature. Extensive deterministic and probabilistic sensitivity analyses were performed to evaluate the robustness of the results. At a 12.7% pretest probability of AD, biomarker analysis after normal neuroimaging findings has an incremental cost-effectiveness ratio (ICER) of $11,032 per QALY gained. Results were sensitive to the pretest prevalence of AD, and the ICER increased to over $50,000 per QALY when the prevalence of AD fell below 9%. Results were also sensitive to patient age (biomarkers are less cost-effective in older cohorts), treatment uptake and adherence, biomarker test characteristics, and the degree to which patients with suspected AD who do not have AD benefit from AD treatment when they are falsely diagnosed. The cost-effectiveness of biomarker analysis depends critically on the prevalence of AD in the tested population. In general practice, where the prevalence of AD after clinical assessment and normal neuroimaging findings may be low, biomarker analysis is unlikely to be cost-effective at a willingness-to-pay threshold of $50,000 per QALY gained. However, when at least 1 in 11 patients has AD after normal neuroimaging findings, biomarker analysis is likely cost-effective. Specifically, for patients referred to memory clinics with memory impairment who do not present neuroimaging evidence of medial temporal lobe atrophy, pretest prevalence of AD may exceed 15%. Biomarker analysis is a potentially cost-saving diagnostic method and should be considered for adoption in high-prevalence centers.

Follow-up treatment effects of contingency management and motivational interviewing on substance use: A meta-analysis.

PubMed

Sayegh, Caitlin S; Huey, Stanley J; Zara, Erica J; Jhaveri, Kinnari

2017-06-01

Motivation is an integral factor in substance use treatment and long-term recovery. However, it is unclear what role intrinsic and extrinsic motivation play across different treatment modalities. A meta-analysis (N = 84) was performed to estimate the pooled effect size of Motivational Interviewing (MI; primarily targeting intrinsic motivation) and contingency management (CM; primarily targeting extrinsic motivation) at different follow-up periods. Collapsed across all substance types, CM had a significant effect at 3-month follow-up, only. In contrast, MI had a significant effect at 6-month follow-up, only. CM had small and medium effects on multiple substances at 3-month follow-up (i.e., tobacco, marijuana, stimulants, polysubstances), but not at 6-month follow-up. MI had 1 significant medium effect at 3-month follow-up (i.e., marijuana), but several significant small effects at 6-month follow-up (i.e., alcohol, tobacco, polysubstances). This meta-analysis suggests that both CM and MI promote reductions in a range of substances, even several months after the intervention concludes. Further, these results provide some evidence that extrinsically focused CM may produce medium follow-up effects in the short run, but intrinsically focused MI may produce small but durable follow-up effects. However, this interpretation is complicated by the differences between the MI and CM studies that preclude statistical tests comparing effect sizes, and few studies assessed motivation itself. Future researchers should investigate how motivational dynamics impact lasting outcomes in substance use treatment. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Placebo Response in Repetitive Transcranial Magnetic Stimulation Trials of Treatment of Auditory Hallucinations in Schizophrenia: A Meta-Analysis

PubMed Central

Dollfus, Sonia; Lecardeur, Laurent; Morello, Rémy; Etard, Olivier

2016-01-01

Several meta-analyses have assessed the response of patients with schizophrenia with auditory verbal hallucinations (AVH) to treatment with repetitive transcranial magnetic stimulation (rTMS); however, the placebo response has never been explored. Typically observed in a therapeutic trial, the placebo effect may have a major influence on the effectiveness of rTMS. The purpose of this meta-analysis is to evaluate the magnitude of the placebo effect observed in controlled studies of rTMS treatment of AVH, and to determine factors that can impact the magnitude of this placebo effect, such as study design considerations and the type of sham used. The study included twenty-one articles concerning 303 patients treated by sham rTMS. A meta-analytic method was applied to obtain a combined, weighted effect size, Hedges’s g. The mean weighted effect size of the placebo effect across these 21 studies was 0.29 (P < .001). Comparison of the parallel and crossover studies revealed distinct results for each study design; placebo has a significant effect size in the 13 parallel studies (g = 0.44, P < 10−4), but not in the 8 crossover studies (g = 0.06, P = .52). In meta-analysis of the 13 parallel studies, the 45° position coil showed the highest effect size. Our results demonstrate that placebo effect should be considered a major source of bias in the assessment of rTMS efficacy. These results fundamentally inform the design of further controlled studies, particularly with respect to studies of rTMS treatment in psychiatry. PMID:26089351

Cost-Utility Analysis of Lurasidone Versus Aripiprazole in Adults with Schizophrenia.

PubMed

Rajagopalan, Krithika; Trueman, David; Crowe, Lydia; Squirrell, Daniel; Loebel, Antony

2016-07-01

In 2014, lurasidone, an atypical antipsychotic, was approved for the treatment of schizophrenia in adults. It is an alternative treatment option to aripiprazole, and when compared with aripiprazole, lurasidone was associated with improved symptom reduction and reduced risk of weight gain and relapse. We conducted a cost-utility analysis of lurasidone versus aripiprazole from the perspective of healthcare services, using Scotland and Wales as specific case studies. A 10-year Markov model, incorporating a 6-week acute phase and a maintenance phase across three health states (discontinuation, relapse, death) was constructed. Six-week probabilities of discontinuation and adverse events were based on a published independent mixed-treatment comparison; long-term risks of relapse and discontinuation were from an indirect comparison. Costs included drug therapy, relapse, and outpatient, primary and residential care. Costs and benefits were discounted at 3.5 %. Utility estimates were taken from published literature, and cost effectiveness was expressed as total 10-year incremental costs and quality-adjusted life-years (QALYs). Lurasidone yielded a cost saving of £3383 and an improvement of 0.005 QALYs versus aripiprazole, in Scotland. Deterministic sensitivity analysis demonstrated that results were sensitive to relapse rates, while probabilistic sensitivity analysis suggested that lurasidone had the highest expected net benefit at willingness-to-pay thresholds of £20,000-30,000 per QALY. The probability that lurasidone was a cost-effective treatment strategy was approximately 75 % at all willingness-to-pay thresholds, with similar results being obtained for the Welsh analysis. Our analysis suggests that lurasidone would provide an effective, cost-saving alternative for the healthcare service in the treatment of adult patients with schizophrenia.

Primary treatments for clinically localised prostate cancer: a comprehensive lifetime cost-utility analysis.

PubMed

Cooperberg, Matthew R; Ramakrishna, Naren R; Duff, Steven B; Hughes, Kathleen E; Sadownik, Sara; Smith, Joseph A; Tewari, Ashutosh K

2013-03-01

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Multiple treatment alternatives exist for localised prostate cancer, with few high-quality studies directly comparing their comparative effectiveness and costs. The present study is the most comprehensive cost-effectiveness analysis to date for localised prostate cancer, conducted with a lifetime horizon and accounting for survival, health-related quality-of-life, and cost impact of secondary treatments and other downstream events, as well as primary treatment choices. The analysis found minor differences, generally slightly favouring surgical methods, in quality-adjusted life years across treatment options. However, radiation therapy (RT) was consistently more expensive than surgery, and some alternatives, e.g. intensity-modulated RT for low-risk disease, were dominated - that is, both more expensive and less effective than competing alternatives. To characterise the costs and outcomes associated with radical prostatectomy (open, laparoscopic, or robot-assisted) and radiation therapy (RT: dose-escalated three-dimensional conformal RT, intensity-modulated RT, brachytherapy, or combination), using a comprehensive, lifetime decision analytical model. A Markov model was constructed to follow hypothetical men with low-, intermediate-, and high-risk prostate cancer over their lifetimes after primary treatment; probabilities of outcomes were based on an exhaustive literature search yielding 232 unique publications. In each Markov cycle, patients could have remission, recurrence, salvage treatment, metastasis, death from prostate cancer, and death from other causes. Utilities for each health state were determined, and disutilities were applied for complications and toxicities of treatment. Costs were determined from the USA payer perspective, with incorporation of patient costs in a sensitivity analysis. Differences across treatments in quality-adjusted life years across methods were modest, ranging from 10.3 to 11.3 for low-risk patients, 9.6-10.5 for intermediate-risk patients and 7.8-9.3 for high-risk patients. There were no statistically significant differences among surgical methods, which tended to be more effective than RT methods, with the exception of combined external beam + brachytherapy for high-risk disease. RT methods were consistently more expensive than surgical methods; costs ranged from $19 901 (robot-assisted prostatectomy for low-risk disease) to $50 276 (combined RT for high-risk disease). These findings were robust to an extensive set of sensitivity analyses. Our analysis found small differences in outcomes and substantial differences in payer and patient costs across treatment alternatives. These findings may inform future policy discussions about strategies to improve efficiency of treatment selection for localised prostate cancer. © 2012 BJU International.

The application of Bandura's self-efficacy theory to abstinence-oriented alcoholism treatment.

PubMed

Rollnick, S; Heather, N

1982-01-01

This paper explores the relevance of self-efficacy theory (Bandura, 1977b) to the process of abstinence treatment and the phenomenon of relapse. By distinguishing between the particular efficacy and outcome expectations created in treatment it is possible to clarify some of the problems encountered between clinicians and alcoholics. Bandura's theory also explains why some treatment methods might be more effective than others. Analysis of relapse suggests that while some of the expectations created in treatment might serve to promote abstinence, others might unwittingly precipitate relapse. The understanding of abstinence treatment could be enhanced by the testing of hypotheses which emerge from this analysis.

Significant treatment effect of add-on ketamine anesthesia in electroconvulsive therapy in depressive patients: A meta-analysis.

PubMed

Li, Dian-Jeng; Wang, Fu-Chiang; Chu, Che-Sheng; Chen, Tien-Yu; Tang, Chia-Hung; Yang, Wei-Cheng; Chow, Philip Chik-Keung; Wu, Ching-Kuan; Tseng, Ping-Tao; Lin, Pao-Yen

2017-01-01

Add-on ketamine anesthesia in electroconvulsive therapy (ECT) has been studied in depressive patients in several clinical trials with inconclusive findings. Two most recent meta-analyses reported insignificant findings with regards to the treatment effect of add-on ketamine anesthesia in ECT in depressive patients. The aim of this study is to update the current evidence and investigate the role of add-on ketamine anesthesia in ECT in depressive patients via a systematic review and meta-analysis. We performed a thorough literature search of the PubMed and ScienceDirect databases, and extracted all relevant clinical variables to compare the antidepressive outcomes between add-on ketamine anesthesia and other anesthetics in ECT. Total 16 articles with 346 patients receiving add-on ketamine anesthesia in ECT and 329 controls were recruited. We found that the antidepressive treatment effect of add-on ketamine anesthesia in ECT in depressive patients was significantly higher than that of other anesthetics (p<0.001). This significance persisted in both short-term (1-2 weeks) and moderate-term (3-4 weeks) treatment courses (all p<0.05). However, the side effect profiles and recovery time profiles were significantly worse in add-on ketamine anesthesia group than in control group. Our meta-analysis highlights the significantly higher antidepressive treatment effect of add-on ketamine in depressive patients receiving ECT compared to other anesthetics. However, clinicians need to take undesirable side effects into consideration when using add-on ketamine anesthesia in ECT in depressive patients. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

Practical guidance for conducting mediation analysis with multiple mediators using inverse odds ratio weighting.

PubMed

Nguyen, Quynh C; Osypuk, Theresa L; Schmidt, Nicole M; Glymour, M Maria; Tchetgen Tchetgen, Eric J

2015-03-01

Despite the recent flourishing of mediation analysis techniques, many modern approaches are difficult to implement or applicable to only a restricted range of regression models. This report provides practical guidance for implementing a new technique utilizing inverse odds ratio weighting (IORW) to estimate natural direct and indirect effects for mediation analyses. IORW takes advantage of the odds ratio's invariance property and condenses information on the odds ratio for the relationship between the exposure (treatment) and multiple mediators, conditional on covariates, by regressing exposure on mediators and covariates. The inverse of the covariate-adjusted exposure-mediator odds ratio association is used to weight the primary analytical regression of the outcome on treatment. The treatment coefficient in such a weighted regression estimates the natural direct effect of treatment on the outcome, and indirect effects are identified by subtracting direct effects from total effects. Weighting renders treatment and mediators independent, thereby deactivating indirect pathways of the mediators. This new mediation technique accommodates multiple discrete or continuous mediators. IORW is easily implemented and is appropriate for any standard regression model, including quantile regression and survival analysis. An empirical example is given using data from the Moving to Opportunity (1994-2002) experiment, testing whether neighborhood context mediated the effects of a housing voucher program on obesity. Relevant Stata code (StataCorp LP, College Station, Texas) is provided. © The Author 2015. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis.

PubMed

Nixon, R M; Bansback, N; Brennan, A

2007-03-15

Mixed treatment comparison (MTC) is a generalization of meta-analysis. Instead of the same treatment for a disease being tested in a number of studies, a number of different interventions are considered. Meta-regression is also a generalization of meta-analysis where an attempt is made to explain the heterogeneity between the treatment effects in the studies by regressing on study-level covariables. Our focus is where there are several different treatments considered in a number of randomized controlled trials in a specific disease, the same treatment can be applied in several arms within a study, and where differences in efficacy can be explained by differences in the study settings. We develop methods for simultaneously comparing several treatments and adjusting for study-level covariables by combining ideas from MTC and meta-regression. We use a case study from rheumatoid arthritis. We identified relevant trials of biologic verses standard therapy or placebo and extracted the doses, comparators and patient baseline characteristics. Efficacy is measured using the log odds ratio of achieving six-month ACR50 responder status. A random-effects meta-regression model is fitted which adjusts the log odds ratio for study-level prognostic factors. A different random-effect distribution on the log odds ratios is allowed for each different treatment. The odds ratio is found as a function of the prognostic factors for each treatment. The apparent differences in the randomized trials between tumour necrosis factor alpha (TNF- alpha) antagonists are explained by differences in prognostic factors and the analysis suggests that these drugs as a class are not different from each other. Copyright (c) 2006 John Wiley & Sons, Ltd.

Comparison of efficacy between anti-vascular endothelial growth factor (VEGF) and laser treatment in Type-1 and threshold retinopathy of prematurity (ROP).

PubMed

Li, Zijing; Zhang, Yichi; Liao, Yunru; Zeng, Rui; Zeng, Peng; Lan, Yuqing

2018-01-30

Retinopathy of Prematurity (ROP) is one of the most common causes of childhood blindness worldwide. Comparisons of anti-VEGF and laser treatments in ROP are relatively lacking, and the data are scattered and limited. The objective of this meta-analysis is to compare the efficacy of both treatments in type-1 and threshold ROP. A comprehensive literature search on ROP treatment was conducted using PubMed and Embase up to March 2017 in all languages. Major evaluation indexes were extracted from the included studies by two authors. The fixed-effects and random-effects models were used to measure the pooled estimates. The test of heterogeneity was performed using the Q statistic. Ten studies were included in this meta-analysis. Retreatment incidence was significantly increased for anti-VEGF (OR 2.52; 95% CI 1.37 to 4.66; P = 0.003) compared to the laser treatment, while the incidences of eye complications (OR 0.29; 95% CI 0.10 to 0.82; P = 0.02) and myopia were significantly decreased with anti-VEGF compared to the laser treatment. However, there was no difference in the recurrence incidence (OR 1.86; 95% CI 0.37 to 9.40; P = 0.45) and time between treatment and retreatment (WMD 7.54 weeks; 95% CI 2.00 to 17.08; P = 0.12). This meta-analysis indicates that laser treatment may be more efficacious than anti-VEGF treatment. However, the results of this meta-analysis also suggest that laser treatment may cause more eye complications and increase myopia. Large-scale prospective RCTs should be performed to assess the efficacy and safety of anti-VEGF versus laser treatment in the future.

A Complier Average Causal Effect Analysis of the Stimulant Reduction Intervention using Dosed Exercise Study.

PubMed

Carmody, Thomas; Greer, Tracy L; Walker, Robrina; Rethorst, Chad D; Trivedi, Madhukar H

2018-06-01

Exercise is a promising treatment for substance use disorders, yet an intention-to-treat analysis of a large, multi-site study found no reduction in stimulant use for exercise versus health education. Exercise adherence was sub-optimal; therefore, secondary post-hoc complier average causal effects (CACE) analysis was conducted to determine the potential effectiveness of adequately dosed exercise. The STimulant use Reduction Intervention using Dosed Exercise study was a randomized controlled trial comparing a 12 kcal/kg/week (KKW) exercise dose versus a health education control conducted at nine residential substance use treatment settings across the U.S. that are affiliated with the National Drug Abuse Treatment Clinical Trials Network. Participants were sedentary but medically approved for exercise, used stimulants within 30 days prior to study entry, and received a DSM-IV stimulant abuse or dependence diagnosis within the past year. A CACE analysis adjusted to include only participants with a minimum threshold of adherence (at least 8.3 KKW) and using a negative-binomial hurdle model focused on 218 participants who were 36.2% female, mean age 39.4 years ( SD =11.1), and averaged 13.0 ( SD =9.2) stimulant use days in the 30 days before residential treatment. The outcome was days of stimulant use as assessed by the self-reported TimeLine Follow Back and urine drug screen results. The CACE-adjusted analysis found a significantly lower probability of relapse to stimulant use in the exercise group versus the health education group (41.0% vs. 55.7%, p <.01) and significantly lower days of stimulant use among those who relapsed (5.0 days vs. 9.9 days, p <.01). The CACE adjustment revealed significant, positive effects for exercise. Further research is warranted to develop strategies for exercise adherence that can ensure achievement of an exercise dose sufficient to produce a significant treatment effect.

The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis.

PubMed

Adil, Areej; Godwin, Marshall

2017-07-01

Androgenetic alopecia, or male pattern hair loss, is a hair loss disorder mediated by dihydrotestosterone, the potent form of testosterone. Currently, minoxidil and finasteride are Food and Drug Administration (FDA)-approved, and HairMax LaserComb, which is FDA-cleared, are the only treatments recognized by the FDA as treatments of androgenetic alopecia. This systematic review and meta-analysis assesses the efficacy of nonsurgical treatments of androgenetic alopecia in comparison to placebo for improving hair density, thickness, growth (defined by an increased anagen:telogen ratio), or subjective global assessments done by patients and investigators. A systematic review of randomized controlled trials was conducted. PubMed, Embase, and Cochrane were searched up to December 2016, with no lower limit on the year. We included only randomized controlled trials of good or fair quality based on the US Preventive Services Task Force quality assessment process. A meta-analysis was conducted separately for 5 groups of studies that tested the following hair loss treatments: low-level laser light therapy in men, 5% minoxidil in men, 2% minoxidil in men, 1 mg finasteride in men, and 2% minoxidil in women. All treatments were superior to placebo (P < .00001) in the 5 meta-analyses. Other treatments were not included because the appropriate data were lacking. High heterogeneity in most studies. This meta-analysis strongly suggests that minoxidil, finasteride, and low-level laser light therapy are effective for promoting hair growth in men with androgenetic alopecia and that minoxidil is effective in women with androgenetic alopecia. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Clinical outcomes after estimated versus calculated activity of radioiodine for the treatment of hyperthyroidism: systematic review and meta-analysis.

PubMed

de Rooij, A; Vandenbroucke, J P; Smit, J W A; Stokkel, M P M; Dekkers, O M

2009-11-01

Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal method to determine the activity that is required to achieve long-term euthyroidism. To compare the effect of estimated versus calculated activity of radioiodine in hyperthyroidism. Design Systematic review and meta-analysis. We searched the databases Medline, EMBASE, Web of Science, and Cochrane Library for randomized and nonrandomized studies, comparing the effect of activity estimation methods with dosimetry for hyperthyroidism. The main outcome measure was the frequency of treatment success, defined as persistent euthyroidism after radioiodine treatment at the end of follow-up in the dose estimated and calculated dosimetry group. Furthermore, we assessed the cure rates of hyperthyroidism. Three randomized and five nonrandomized studies, comparing the effect of estimated versus calculated activity of radioiodine on clinical outcomes for the treatment of hyperthyroidism, were included. The weighted mean relative frequency of successful treatment outcome (euthyroidism) was 1.03 (95% confidence interval (CI) 0.91-1.16) for estimated versus calculated activity; the weighted mean relative frequency of cure of hyperthyroidism (eu- or hypothyroidism) was 1.03 (95% CI 0.96-1.10). Subgroup analysis showed a relative frequency of euthyroidism of 1.03 (95% CI 0.84-1.26) for Graves' disease and of 1.05 (95% CI 0.91-1.19) for toxic multinodular goiter. The two main methods used to determine the activity in the treatment of hyperthyroidism with radioiodine, estimated and calculated, resulted in an equally successful treatment outcome. However, the heterogeneity of the included studies is a strong limitation that prevents a definitive conclusion from this meta-analysis.

Effects of placebos without deception compared with no treatment: protocol for a systematic review and meta-analysis.

PubMed

Petkovic, Grace; Charlesworth, James E G; Kelley, John; Miller, Franklin; Roberts, Nia; Howick, Jeremy

2015-11-26

Placebos have long provided a robust control for evaluating active pharmacological preparations, but frequently demonstrate a variable therapeutic effect when delivered in double-blinded placebo-controlled trials. Delivery of placebos as treatment alone has been considered unethical, as it has been thought that deception is essential for their effect. However, recent evidence suggests that clinical benefit can be derived from placebos delivered without deception (unblinded/open-label) manner. Here, we present a protocol for the first systematic review and meta-analysis of studies of the effects of non-deceptive placebos compared with no treatment. This protocol will compare the effect of placebos delivered non-deceptively to no treatment. It will also assess the methods of delivery used for non-deceptive placebos. Studies will be sought through relevant database searches and will include those within disease settings and those among healthy controls. To be included, trials must include both non-deceptive (open-label) placebo and no treatment groups. All data extraction and analysis will be conducted by two independent reviewers. The analysis will evaluate any differences in outcome measures between the non-deceptive placebo and no treatment groups. Outcome measures will be the clinically-relevant outcomes detailed in the primary papers. The delivery methods, such as verbal instructions, which may provide positive expectations and outcomes, of non-deceptive placebos will also be assessed. Each study will be comprehensively assessed for bias. Subgroup analyses will identify any discrepancies among heterogeneous data. This review does not require ethical approval. The completed review will be widely disseminated by publication and social media where appropriate. This protocol has been registered on PROSPERO (2015:CRD42015023347). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cost Effectiveness of Free Access to Smoking Cessation Treatment in France Considering the Economic Burden of Smoking-Related Diseases.

PubMed

Cadier, Benjamin; Durand-Zaleski, Isabelle; Thomas, Daniel; Chevreul, Karine

2016-01-01

In France more than 70,000 deaths from diseases related to smoking are recorded each year, and since 2005 prevalence of tobacco has increased. Providing free access to smoking cessation treatment would reduce this burden. The aim of our study was to estimate the incremental cost-effectiveness ratios (ICER) of providing free access to cessation treatment taking into account the cost offsets associated with the reduction of the three main diseases related to smoking: lung cancer, chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). To measure the financial impact of such a measure we also conducted a probabilistic budget impact analysis. We performed a cost-effectiveness analysis using a Markov state-transition model that compared free access to cessation treatment to the existing coverage of €50 provided by the French statutory health insurance, taking into account the cost offsets among current French smokers aged 15-75 years. Our results were expressed by the incremental cost-effectiveness ratio in 2009 Euros per life year gained (LYG) at the lifetime horizon. We estimated a base case scenario and carried out a Monte Carlo sensitivity analysis to account for uncertainty. Assuming a participation rate of 7.3%, the ICER value for free access to cessation treatment was €3,868 per LYG in the base case. The variation of parameters provided a range of ICER values from -€736 to €15,715 per LYG. In 99% of cases, the ICER for full coverage was lower than €11,187 per LYG. The probabilistic budget impact analysis showed that the potential cost saving for lung cancer, COPD and CVD ranges from €15 million to €215 million at the five-year horizon for an initial cessation treatment cost of €125 million to €421 million. The results suggest that providing medical support to smokers in their attempts to quit is very cost-effective and may even result in cost savings.

Sibling relationship quality and psychopathology of children and adolescents: a meta-analysis.

PubMed

Buist, Kirsten L; Deković, Maja; Prinzie, Peter

2013-02-01

In the current meta-analysis, we investigated the link between child and adolescent sibling relationship quality (warmth, conflict and differential treatment) and internalizing and externalizing problems, and potential moderators of these associations. From 34 studies, we obtained 85 effect sizes, based on 12,257 children and adolescents. Results showed that more sibling warmth, less sibling conflict and less differential treatment were all significantly associated with less internalizing and externalizing problems. Effect sizes for sibling conflict were stronger than for sibling warmth and differential treatment, and associations for internalizing and externalizing problems were similar in strength. Effect sizes were moderated by sibling gender combination (stronger effects for higher percentage brother pairs), age difference between siblings (stronger effects for smaller age differences), and developmental period (stronger effect sizes for children than for adolescents). These results indicate that the sibling context is important when considering psychopathology. In addition to the overwhelming evidence of the impact of parent-child and marital relationships on child and adolescent development, the present meta-analysis is a reminder that the sibling relationship warrants more attention in research as well as in clinical settings. Copyright © 2012 Elsevier Ltd. All rights reserved.

Treatment for preschool children with interpersonal sexual behavior problems: a pilot study.

PubMed

Silovsky, Jane F; Niec, Larissa; Bard, David; Hecht, Debra B

2007-01-01

This pilot study evaluated a 12-week group treatment program for preschool children with interpersonal sexual behavior problems (SBP; N = 85; 53 completed at least 8 sessions). Many children presented with co-occurring trauma symptoms and disruptive behaviors. In intent-to-treat analysis, a significant linear reduction in SBP due to number of treatment sessions attended was found, an effect that was independent of linear reductions affiliated with elapsed time. Under the assumption that treatment can have an incremental impact, more than one third of the variance was accounted for by treatment effects, with female and older children most favorably impacted. Caregivers reported increase in knowledge, satisfaction, and usefulness of treatment. In addition to replication, future research is needed to examine (a) effects of environment change and time on SBP, (b) stability of treatment effects, and (c) best practices to integrate evidence-based treatments for comorbid conditions.

POEM is a cost-effective procedure: cost-utility analysis of endoscopic and surgical treatment options in the management of achalasia.

PubMed

Miller, Heidi J; Neupane, Ruel; Fayezizadeh, Mojtaba; Majumder, Arnab; Marks, Jeffrey M

2017-04-01

Achalasia is a rare motility disorder of the esophagus. Treatment is palliative with the goal of symptom remission and slowing the progression of the disease. Treatment options include per oral endoscopic myotomy (POEM), laparoscopic Heller myotomy (LM) and endoscopic treatments such as pneumatic dilation (PD) and botulinum toxin type A injections (BI). We evaluate the economics and cost-effectiveness of treating achalasia. We performed cost analysis for POEM, LM, PD and BI at our institution from 2011 to 2015. Cost of LM was set to 1, and other procedures are presented as percentage change. Cost-effectiveness was calculated based on cost, number of interventions required for optimal results for dilations and injections and efficacy reported in the current literature. Incremental cost-effectiveness ratio was calculated by a cost-utility analysis using quality-adjusted life year gained, defined as a symptom-free year in a patient with achalasia. Average number of interventions required was 2.3 dilations or two injections for efficacies of 80 and 61 %, respectively. POEM cost 1.058 times the cost of LM, and PD and BI cost 0.559 and 0.448 times the cost of LM. Annual cost per cure over a period of 4 years for POEM, and LM were consistently equivalent, trending the same as PD although this has a lower initial cost. The cost per cure of BI remains stable over 3 years and then doubles. The cost-effectiveness of POEM and LM is equivalent. Myotomy, either surgical or endoscopic, is more cost-effective than BI due to high failure rates of the economical intervention. When treatment is being considered BI should be utilized in patients with less than 2-year life expectancy. Pneumatic dilations are cost-effective and are an acceptable approach to treatment of achalasia, although myotomy has a lower relapse rate and is cost-effective compared to PD after 2 years.

Day Treatment for Emotionally Disturbed Adolescents: Follow-up and Analysis of the Effect of Placement.

ERIC Educational Resources Information Center

Freedman, Marsha

1982-01-01

The philosophy, rationale, and evaluation of the Union County (NJ) Learning Center is presented. The center is an intensive day-treatment program to effect changes that would allow the emotionally disturbed individual to return to the mainstream. (Author/PN)

The Effects of Family Therapies for Adolescent Delinquency and Substance Abuse: A Meta-Analysis

ERIC Educational Resources Information Center

Baldwin, Scott A.; Christian, Sarah; Berkeljon, Arjan; Shadish, William R.

2012-01-01

This meta-analysis summarizes results from k = 24 studies comparing either Brief Strategic Family Therapy, Functional Family Therapy, Multidimensional Family Therapy, or Multisystemic Therapy to either treatment-as-usual, an alternative therapy, or a control group in the treatment of adolescent substance abuse and delinquency. Additionally, the…

A Tutorial on Conducting Meta-Analyses of Clinical Outcome Research.

ERIC Educational Resources Information Center

Robey, Randall R.; Dalebout, Susan D.

1998-01-01

The purpose of this tutorial is to enhance the familiarity and accessibility of meta-analyses in the domains of audiology and speech-language pathology for investigating questions of treatment efficacy and treatment effectiveness. Steps to conducting a meta-analysis are explained and an example of meta-analysis using published data is included.…

Treatment for School Refusal among Children and Adolescents: A Systematic Review and Meta-Analysis

ERIC Educational Resources Information Center

Maynard, Brandy R.; Heyne, David; Brendel, Kristen Esposito; Bulanda, Jeffery J.; Thompson, Aaron M.; Pigott, Terri D.

2018-01-01

Objective: School refusal is a psychosocial problem associated with adverse short- and long-term consequences for children and adolescents. The authors conducted a systematic review and meta-analysis to examine the effects of psychosocial treatments for children and adolescents with school refusal. Method: A comprehensive search process was used…

A Meta-Analysis of Previous Research on the Treatment of Hyperactivity. Final Report.

ERIC Educational Resources Information Center

White, Karl R.; And Others

Using meta-analysis techniques, the study sought to identify, integrate, and synthesize the literature from 61 articles which review the efficacy of various treatments for hyperactive children. The major objectives were to determine if drugs can be used effectively with hyperactive children, what child and intervention characteristics covary with…

Treatment of Autism in Young Children: Behavioral Intervention and Applied Behavior Analysis.

ERIC Educational Resources Information Center

Jensen, Vanessa K.; Sinclair, Leslie V.

2002-01-01

This article discusses the etiology and scope of autism in young children, screening and diagnosis, intervention options, and the use of applied behavior analysis. Supporting evidence of the efficacy of intensive behavioral intervention is cited, and variations in treatments and techniques are reviewed. Barriers to effective services are also…

Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses.

PubMed

Lewis, Ruth A; Williams, Nefyn H; Sutton, Alex J; Burton, Kim; Din, Nafees Ud; Matar, Hosam E; Hendry, Maggie; Phillips, Ceri J; Nafees, Sadia; Fitzsimmons, Deborah; Rickard, Ian; Wilkinson, Clare

2015-06-01

There are numerous treatment approaches for sciatica. Previous systematic reviews have not compared all these strategies together. To compare the clinical effectiveness of different treatment strategies for sciatica simultaneously. Systematic review and network meta-analysis. We searched 28 electronic databases and online trial registries, along with bibliographies of previous reviews for comparative studies evaluating any intervention to treat sciatica in adults, with outcome data on global effect or pain intensity. Network meta-analysis methods were used to simultaneously compare all treatment strategies and allow indirect comparisons of treatments between studies. The study was funded by the UK National Institute for Health Research Health Technology Assessment program; there are no potential conflict of interests. We identified 122 relevant studies; 90 were randomized controlled trials (RCTs) or quasi-RCTs. Interventions were grouped into 21 treatment strategies. Internal and external validity of included studies was very low. For overall recovery as the outcome, compared with inactive control or conventional care, there was a statistically significant improvement following disc surgery, epidural injections, nonopioid analgesia, manipulation, and acupuncture. Traction, percutaneous discectomy, and exercise therapy were significantly inferior to epidural injections or surgery. For pain as the outcome, epidural injections and biological agents were significantly better than inactive control, but similar findings for disc surgery were not statistically significant. Biological agents were significantly better for pain reduction than bed rest, nonopioids, and opioids. Opioids, education/advice alone, bed rest, and percutaneous discectomy were inferior to most other treatment strategies; although these findings represented large effects, they were statistically equivocal. For the first time, many different treatment strategies for sciatica have been compared in the same systematic review and meta-analysis. This approach has provided new data to assist shared decision-making. The findings support the effectiveness of nonopioid medication, epidural injections, and disc surgery. They also suggest that spinal manipulation, acupuncture, and experimental treatments, such as anti-inflammatory biological agents, may be considered. The findings do not provide support for the effectiveness of opioid analgesia, bed rest, exercise therapy, education/advice (when used alone), percutaneous discectomy, or traction. The issue of how best to estimate the effectiveness of treatment approaches according to their order within a sequential treatment pathway remains an important challenge. Copyright © 2015 Elsevier Inc. All rights reserved.

The Direct and Indirect Effects of Paliperidone Extended-release on Depressive Symptoms in Schizoaffective Disorder: A Path Analysis.

PubMed

Turkoz, Ibrahim; Fu, Dong-Jing; Bossie, Cynthia A; Alphs, Larry

2015-01-01

This analysis evaluates improvement in symptoms of depression in patients with schizoaffective disorder administered oral paliperidone extended-release by accounting for the magnitude of direct and indirect (changes in negative and positive symptoms and worsening of extrapyramidal symptoms) treatment effects on depressive symptoms. Data for this post hoc analysis were drawn from two six-week, randomized, placebo-controlled studies of paliperidone extended-release versus placebo in adult subjects with schizoaffective disorder (N=614; NCT00412373, NCT00397033). Subjects with baseline 17-item Hamilton Rating Scale for Depression scores of 16 or greater were included. Structural equation models (path analyses) were used to separate total effects into direct and indirect effects on depressive symptoms. Change from baseline in 17-item Hamilton Rating Scale for Depression score at the Week 6 end point was the dependent variable; changes in Positive and Negative Syndrome Scale positive and negative factors and Simpson-Angus Scale (to evaluate extrapyramidal symptoms) scores were independent variables. At baseline, 332 of 614 (54.1%) subjects had a 17-item Hamilton Rating Scale for Depression score of 16 or greater. Path analysis determined that up to 26.4 percent of the paliperidone extended-release versus placebo effect on depressive symptoms may be attributed to a direct treatment effect, and 45.8 percent and 28.4 percent were mediated indirectly through improvements on positive and negative symptoms, respectively. No effects were identified as mediated through extrapyramidal symptoms changes (-0.7%). RESULTS of this analysis suggest that paliperidone's effect on depressive symptoms in subjects with schizoaffective disorder participating in two six-week, randomized, placebo-controlled studies is mediated through indirect effects (e.g., positive and negative symptom changes) and a direct treatment effect.

Societal costs in displaced transverse olecranon fractures: using decision analysis tools to find the most cost-effective strategy between tension band wiring and locked plating.

PubMed

Francis, Tittu; Washington, Travis; Srivastava, Karan; Moutzouros, Vasilios; Makhni, Eric C; Hakeos, William

2017-11-01

Tension band wiring (TBW) and locked plating are common treatment options for Mayo IIA olecranon fractures. Clinical trials have shown excellent functional outcomes with both techniques. Although TBW implants are significantly less expensive than a locked olecranon plate, TBW often requires an additional operation for implant removal. To choose the most cost-effective treatment strategy, surgeons must understand how implant costs and return to the operating room influence the most cost-effective strategy. This cost-effective analysis study explored the optimal treatment strategies by using decision analysis tools. An expected-value decision tree was constructed to estimate costs based on the 2 implant choices. Values for critical variables, such as implant removal rate, were obtained from the literature. A Monte Carlo simulation consisting of 100,000 trials was used to incorporate variability in medical costs and implant removal rates. Sensitivity analysis and strategy tables were used to show how different variables influence the most cost-effective strategy. TBW was the most cost-effective strategy, with a cost savings of approximately $1300. TBW was also the dominant strategy by being the most cost-effective solution in 63% of the Monte Carlo trials. Sensitivity analysis identified implant costs for plate fixation and surgical costs for implant removal as the most sensitive parameters influencing the cost-effective strategy. Strategy tables showed the most cost-effective solution as 2 parameters vary simultaneously. TBW is the most cost-effective strategy in treating Mayo IIA olecranon fractures despite a higher rate of return to the operating room. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Efficacy of non-surgical treatments for androgenetic alopecia: a systematic review and network meta-analysis.

PubMed

Gupta, Aditya K; Mays, Rachel R; Dotzert, Michelle S; Versteeg, Sarah G; Shear, Neil H; Piguet, Vincent

2018-05-24

Androgenetic alopecia, or male/female pattern baldness, is the most common type of progressive hair loss disorder. The aim of this paper is to review recent advances in non-surgical treatments for androgenetic alopecia and identify the most effective treatments. A network meta-analysis (NMA) was conducted of the available literature of the six most common non-surgical treatment options for treating androgenetic alopecia in both men and women; dutasteride 0.5mg, finasteride 1mg, low level laser therapy (LLLT), minoxidil 2%, minoxidil 5% and platelet rich plasma (PRP). Seventy-eight studies met the inclusion criteria and twenty-two studies had the data necessary for a network meta-analysis. Relative effects show LLLT as the superior treatment. Relative effects show PRP, finasteride 1 mg (male), finasteride 1 mg (female), minoxidil 5%, minoxidil 2% and dutasteride (male) are approximately equivalent in mean change hair count following treatment. Minoxidil 5% and minoxidil 2% reported the most drug-related adverse events (n=45 and n=23, respectively). The quality of evidence of minoxidil 2% vs. minoxidil 5% was high; minoxidil 5% vs. placebo was moderate; dutasteride (male) vs. placebo, finasteride (female) vs placebo, minoxidil 2% vs. placebo, minoxidil 5% vs. LLLT was low and finasteride (male) vs. placebo, LLLT vs. sham, PRP vs. placebo, finasteride vs. minoxidil 2% was very low. Results of this NMA indicate the emergence of novel, non-hormonal therapies as effective treatments for hair loss; however, the quality of evidence is generally low. High quality randomized controlled trials and head to head trials are required to support these findings and aid in the development of more standardized protocols, particularly for PRP. Regardless, this analysis may aid physicians in clinical decision making and highlight the variety of non-surgical hair restoration options for patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Development of frontage road yield treatment analysis tool (FRYTAT) database software.

DOT National Transportation Integrated Search

2009-03-01

The Texas Department of Transportation (TxDOT) sponsored Project 0-4986, An Assessment of Frontage Road : Yield Treatments, to assess the effectiveness of a wide variety of frontage roadexit ramp and frontage roadU-turn : yield treatments...

Proportion of contextual effects in the treatment of fibromyalgia-a meta-analysis of randomised controlled trials.

PubMed

Whiteside, Nicola; Sarmanova, Aliya; Chen, Xi; Zou, Kun; Abdullah, Natasya; Doherty, Michael; Zhang, Weiya

2018-05-01

The objective of this study is to examine the proportion of the total treatment effect that is attributable to contextual effects in randomised controlled trials (RCTs) of treatments for fibromyalgia. A systematic literature search was undertaken in Medline, Web of Science, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Allied and Complementary Medicine in September 2015. The proportion of contextual effect (PCE) was calculated by dividing the improvement in the placebo arm by the improvement in the treatment arm. The measure was log-transformed for each trial and the random effects model was used to pool data. The primary outcome was pain. Secondary outcomes were fibromyalgia impact questionnaire (FIQ) total and fatigue. Heterogeneity was quantified using I 2 . Publication bias was assessed using a funnel plot and Egger's test. Subgroup analysis was undertaken to explore heterogeneity and potential determinants of the PCE. Fifty-one eligible trials (9599 participants) were identified. The PCE was 0.60 (95% CI 0·56 to 0·64) for pain, 0·57 (95% CI 0·53 to 0·61) for FIQ total, and 0·63 (95% CI 0·59 to 0·68) for fatigue. The I 2 was 99.4% for pain, 99.2% for FIQ total, and 97.6% for fatigue. More than half of the treatment effect in fibromyalgia RCTs results from non-specific contextual factors. This suggests that optimising contextual care may enhance treatment effects and improve outcomes. Reporting the total treatment effect and the proportion of contextual effect in trials may help to better translate research evidence into practice.

Orthodontic camouflage versus orthodontic-orthognathic surgical treatment in class II malocclusion: a systematic review and meta-analysis.

PubMed

Raposo, R; Peleteiro, B; Paço, M; Pinho, T

2018-04-01

This systematic review was performed to compare dental, skeletal, and aesthetic outcomes between orthodontic camouflage and surgical-orthodontic treatment, in patients with a skeletal class II malocclusion and a retrognathic mandible who have already finished their growth period. A literature search was conducted, and a modified Downs and Black checklist was used to assess methodological quality. The meta-analysis was conducted using the DerSimonian-Laird random-effects method to obtain summary estimates of the standardized mean differences and corresponding 95% confidence intervals. Nine articles were included in the qualitative synthesis and seven in the meta-analysis. The difference between treatments was not statistically significant regarding SNA angle, linear measurement of the lower lip to Ricketts' aesthetic line, convexity of the skeletal profile, or the soft tissue profile excluding the nose. In contrast, surgical-orthodontic treatment was more effective with regard to ANB, SNB, and ML/NSL angles and the soft tissue profile including the nose. Different treatment effects on overjet and overbite were found according to the severity of the initial values. These results should be interpreted with caution, due to the limited number of studies included and because they were non-randomized clinical trials. Further studies with larger sample sizes and similar pre-treatment conditions are needed. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Expected utility versus expected regret theory versions of decision curve analysis do generate different results when treatment effects are taken into account.

PubMed

Hozo, Iztok; Tsalatsanis, Athanasios; Djulbegovic, Benjamin

2018-02-01

Decision curve analysis (DCA) is a widely used method for evaluating diagnostic tests and predictive models. It was developed based on expected utility theory (EUT) and has been reformulated using expected regret theory (ERG). Under certain circumstances, these 2 formulations yield different results. Here we describe these situations and explain the variation. We compare the derivations of the EUT- and ERG-based formulations of DCA for a typical medical decision problem: "treat none," "treat all," or "use model" to guide treatment. We illustrate the differences between the 2 formulations when applied to the following clinical question: at which probability of death we should refer a terminally ill patient to hospice? Both DCA formulations yielded identical but mirrored results when treatment effects are ignored; they generated significantly different results otherwise. Treatment effect has a significant effect on the results derived by EUT DCA and less so on ERG DCA. The elicitation of specific values for disutilities affected the results even more significantly in the context of EUT DCA, whereas no such elicitation was required within the ERG framework. EUT and ERG DCA generate different results when treatment effects are taken into account. The magnitude of the difference depends on the effect of treatment and the disutilities associated with disease and treatment effects. This is important to realize as the current practice guidelines are uniformly based on EUT; the same recommendations can significantly differ if they are derived based on ERG framework. © 2016 The Authors. Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Expected utility versus expected regret theory versions of decision curve analysis do generate different results when treatment effects are taken into account

PubMed Central

Hozo, Iztok; Tsalatsanis, Athanasios

2016-01-01

Abstract Rationale, aims, and objectives Decision curve analysis (DCA) is a widely used method for evaluating diagnostic tests and predictive models. It was developed based on expected utility theory (EUT) and has been reformulated using expected regret theory (ERG). Under certain circumstances, these 2 formulations yield different results. Here we describe these situations and explain the variation. Methods We compare the derivations of the EUT‐ and ERG‐based formulations of DCA for a typical medical decision problem: “treat none,” “treat all,” or “use model” to guide treatment. We illustrate the differences between the 2 formulations when applied to the following clinical question: at which probability of death we should refer a terminally ill patient to hospice? Results Both DCA formulations yielded identical but mirrored results when treatment effects are ignored; they generated significantly different results otherwise. Treatment effect has a significant effect on the results derived by EUT DCA and less so on ERG DCA. The elicitation of specific values for disutilities affected the results even more significantly in the context of EUT DCA, whereas no such elicitation was required within the ERG framework. Conclusion EUT and ERG DCA generate different results when treatment effects are taken into account. The magnitude of the difference depends on the effect of treatment and the disutilities associated with disease and treatment effects. This is important to realize as the current practice guidelines are uniformly based on EUT; the same recommendations can significantly differ if they are derived based on ERG framework. PMID:27981695

Does fertility treatment increase the risk of uterine cancer? A meta-analysis.

PubMed

Saso, Srdjan; Louis, Louay S; Doctor, Farah; Hamed, Ali Hassan; Chatterjee, Jayanta; Yazbek, Joseph; Bora, Shabana; Abdalla, Hossam; Ghaem-Maghami, Sadaf; Thum, Meen-Yau

2015-12-01

An ongoing debate over the last two decades has focused on whether fertility treatment in women may lead to an increased risk of developing uterine cancer over a period of time. Uterine cancer (including mainly endometrial carcinoma and the less common uterine sarcoma) is the commonest reproductive tract cancer and the fourth commonest cancer in women in the UK. Our objective was to assess the association between fertility drugs used in the treatment of female infertility (both as an independent therapy and during in vitro fertilization cycles) and the development of uterine cancer. A literature search was performed using Medline, Embase, Cochrane Library and Google Scholar databases for comparative studies until December 2014 to investigate a clinical significance of fertility treatment on the incidence of developing uterine cancer. General and MESH search headings, as well as the 'related articles' function were applied. All comparative studies of 'fertility treatment' versus 'non-fertility treatment' reporting the incidence of uterine cancer as an outcome were included. Uterine cancer incorporated the following terms: uterine cancer, uterine body tumours, uterine sarcomas and endometrial cancers. The primary outcome of interest was the uterine cancer incidence in all 'fertility treatment' versus 'non-fertility treatment' patient groups. Secondary outcomes of interest were: (a) uterine cancer incidence in 'IVF' versus 'non-IVF' patient groups; and (b) uterine cancer incidence according to type of fertility drug used. Odds ratio was the summary statistic. Random-effects modelling, graphical exploration and sensitivity analysis were used to evaluate the consistency of the calculated treatment effect. We included six studies in our final analysis, which comprised 776,224 patients in total. Of these, 103,758 had undergone fertility treatment and 672,466 had not. There was 100% agreement between the two reviewers regarding the data extraction. All the studies contained groups that were comparable in age, although the criteria of reporting age varied. Taking all studies into account, the incidence of uterine cancer was 0.14% (150 of 103,758) in the fertility treatment group and 2.22% (14,918 of 672,466) in the non-fertility treatment group. Using the random-effect model to analyze uterine cancer incidence, this difference was not found to be of statistical significance: OR 0.78 (95% CI, 0.39-1.57). The degree of heterogeneity was high (I(2)=68%). The risk for the development of uterine and in particular endometrial cancer posed by infertility and an unopposed oestrogen state is widely recognized. The present analysis aimed to perceive whether standard fertility drugs were also a risk to future uterine cancer development. The treatment does increase the concentrations of unopposed oestrogen for a short periods of time but if successful leads to fertility. This meta-analysis points to a non-deleterious effect of fertility drugs towards the development of uterine cancer, a conclusion strongly supported by our sub-group analysis. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Adjuvant treatment with crude rhubarb for patients with acute organophosphorus pesticide poisoning: A meta-analysis of randomized controlled trials.

PubMed

Wang, Lina; Pan, Shuming

2015-12-01

Crude rhubarb has been used to treat critically ill patients for many years. However, no previous meta-analysis has been investigated the benefits of crude rhubarb in patients with acute organophosphorus pesticide poisoning (AOPP). To summarize the beneficial effects of adjuvant treatment with crude rhubarb in patients with AOPP by conducting a meta-analysis. A literature search of the databases through Pubmed, EMBASE, China National Knowledge Infrastructure, VIP, and Wanfang were performed for studies published up to October 2014. Randomized controlled trials (RCTs) investigating the effects of crude rhubarb as adjuvant treatment for patients with AOPP were included. A total of 12 RCTs with 886 patients were identified. Adjuvant treatment with crude rhubarb was associated with a significantly lower incidence of intermediate syndrome (risk ratio [RR] 0.22; 95% confidence interval [CI] 0.10-0.48), as well as multiple organ dysfunction syndrome (RR 0.34; 95% CI 0.20-0.56). Crude rhubarb as adjuvant treatment reduced the total dose of pralidoxime (mean difference [MD] -5.12 g; 95% CI -8.24 to -2.00) or atropine (MD -94.89 mg; 95% CI -156.22 to -33.57), and hospital length of stay (MD -2.79 days; 95% CI -4.19 to -1.39) compared with the controls. This meta-analysis suggests that crude rhubarb as adjuvant treatment appears to have additional beneficial effects in patients with AOPP. More well-designed trials are needed to confirm our findings due to the methodological flaws of the included trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

Survival After Neoadjuvant and Adjuvant Treatments Compared to Surgery Alone for Resectable Esophageal Carcinoma: A Network Meta-analysis.

PubMed

Pasquali, Sandro; Yim, Guang; Vohra, Ravinder S; Mocellin, Simone; Nyanhongo, Donald; Marriott, Paul; Geh, Ju Ian; Griffiths, Ewen A

2017-03-01

This network meta-analysis compared overall survival after neoadjuvant or adjuvant chemotherapy (CT), radiotherapy (RT), or combinations of both (chemoradiotherapy, CRT) or surgery alone to identify the most effective approach. The optimal treatment for resectable esophageal cancer is unknown. A search for randomized controlled trials reporting on neoadjuvant and adjuvant therapies was conducted. Using a network meta-analysis, treatments were ranked based on their effectiveness for improving survival. In 33 eligible randomized controlled trials, 6072 patients were randomized to receive either surgery alone (N = 2459) or neoadjuvant CT (N = 1332), RT (N = 58), and CRT (N = 1196) followed by surgery or surgery followed by adjuvant CT (N = 542), RT (N = 383), and CRT (N = 102). Twenty-one comparisons were generated. Neoadjuvant CRT followed by surgery compared with surgery alone was the only treatment to significantly improve survival [hazard ratio (HR) = 0.77, 95% confidence interval (CI): 0.68-0.87]. When trials were grouped considering neoadjuvant and adjuvant therapies and surgery alone, neoadjuvant therapies combined with surgery compared with surgery alone showed a survival advantage (HR = 0.83, 95% CI 0.76-0.90), whereas surgery along with adjuvant therapies showed no significant survival advantage (HR = 0.87, 95% CI 0.67-1.14). A subgroup analysis of neoadjuvant therapies showed a superior effectiveness of neoadjuvant CRT and surgery compared with surgery alone (HR = 0.77, 95% CI 0.68-0.87). This network meta-analysis showed neoadjuvant CRT followed by surgery to be the most effective strategy in improving survival of resectable esophageal cancer. Resources should be focused on developing the most effective neoadjuvant CRT regimens for both adenocarcinomas and squamous cell carcinomas of the esophagus.

[Influence of interleukin-1 beta gene polymorphism and childhood maltreatment on antidepressant treatment].

PubMed

Chen, Ying; Zhang, Zhijun; Xu, Zhi; Pu, Mengjia; Geng, Leiyu

2015-12-01

To explore the influence of interleukin-1 beta (IL1B) gene polymorphism and childhood maltreatment on antidepressant treatment. Two hundred and four patients with major depressive disorder (MDD) have received treatment with single antidepressant drugs and were followed up for 8 weeks. Hamilton depression scale-17 (HAMD-17) was used to evaluate the severity of depressive symptoms and therapeutic effect. Childhood maltreatment was assessed using Childhood Trauma Questionnaire, a 28-item Short Form (CTQ-SF). Single nucleotide polymorphism (SNP) of the IL1B gene was determined using a SNaPshot method. Correlation of rs16944 gene polymorphism with response to treatment was analyzed using Unphased 3.0.13 software. The main and interactive effects of SNP and childhood maltreatment on the antidepressant treatment were analyzed using Logistic regression analysis. No significant difference of gender, age, year of education, family history, episode time, and antidepressant agents was detected between the remitters and non-remitters. Association analysis has found that the SNP rs16944 in the IL1B AA genotype carriers antidepressant response was poorer (χ2=3.931, P=0.047). No significant difference was detected in the CTQ scores between the two groups. Genetic and environmental interaction analysis has demonstrated a significant correlation between rs16944 AA genotype and childhood maltreatment and poorer response to antidepressant treatment. The SNP rs16944 in the IL1B gene and its interaction with childhood maltreatment may influence the effect of antidepressant treatment for patients with MDD.

Treatment refusal and premature termination in psychotherapy, pharmacotherapy, and their combination: A meta-analysis of head-to-head comparisons.

PubMed

Swift, Joshua K; Greenberg, Roger P; Tompkins, Kelley A; Parkin, Susannah R

2017-03-01

The purpose of this meta-analysis was to examine rates of treatment refusal and premature termination for pharmacotherapy alone, psychotherapy alone, pharmacotherapy plus psychotherapy, and psychotherapy plus pill placebo treatments. A systematic review of the literature resulted in 186 comparative trials that included a report of treatment refusal and/or premature termination for at least 2 of the 4 treatment conditions. The data from these studies were pooled using a random-effects analysis. Odds Ratio effect sizes were then calculated to compare the rates between treatment conditions, once across all studies and then again for specific client disorder categories. An average treatment refusal rate of 8.2% was found across studies. Clients who were assigned to pharmacotherapy were 1.76 times more likely to refuse treatment compared with clients who were assigned psychotherapy. Differences in refusal rates for pharmacotherapy and psychotherapy were particularly evident for depressive disorders, panic disorder, and social anxiety disorder. On average, 21.9% of clients prematurely terminated their treatment. Across studies, clients who were assigned to pharmacotherapy were 1.20 times more likely to drop out compared with clients who were assigned to psychotherapy. Pharmacotherapy clients with anorexia/bulimia and depressive disorders dropped out at higher rates compared with psychotherapy clients with these disorders. Treatment refusal and dropout are significant problems in both psychotherapy and pharmacotherapy and providers of these treatments should seek to employ strategies to reduce their occurrence. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Pharmacotherapy for residual excessive sleepiness and cognition in CPAP-treated patients with obstructive sleep apnea syndrome: A systematic review and meta-analysis.

PubMed

Avellar, Ariane B C C; Carvalho, Luciane B C; Prado, Gilmar F; Prado, Lucila B F

2016-12-01

Pharmacotherapy has been used as an adjunct to CPAP for treatment of residual excessive sleepiness in patients with a diagnosis of obstructive sleep apnea syndrome (OSAS). However, no studies with a high level of evidence have been conducted to support this practice and confirm its effectiveness. We conducted a meta-analysis to summarize and quantify the effects of pharmacological treatment in adults with OSAS who experience residual excessive sleepiness despite adequate CPAP use. We reviewed clinical trials that compared medications to placebo and evaluated the outcomes residual excessive sleepiness, cognition, and quality of life, as well as treatment effectiveness and safety. The MEDLINE, EMBASE, LILACS, Cochrane Central Register of Controlled Trials - CENTRAL, and PsycINFO electronic databases were searched using highly sensitive search strategies. Trials were only included if measures were taken to ensure effective CPAP treatment. Eight randomized clinical trials were included. Pharmacotherapy with modafinil and armodafinil led to improvement of excessive daytime sleepiness, attention/alertness, and clinical condition as measured with the CGI-C. No improvements in quality of life or other cognitive domains (including memory, executive function, and language) could be confirmed. Pharmacotherapy did not cause any severe adverse effects, but was associated with significant dropout rates as compared with placebo. In conclusion, although our results demonstrate the effectiveness of pharmacological treatment as an adjunct to CPAP, further investigation is necessary to improve confidence in its effects. Many findings on the impact of pharmacotherapy on cognition and quality of life were evaluated through analysis of single studies, with heterogeneity in tests and absence of standardization, which reduced certainty as to whether actual improvement occurred in these outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece.

PubMed

Athanasakis, Kostas; Boubouchairopoulou, Nadia; Tarantilis, Filippos; Tsiantou, Vasiliki; Kontodimas, Stathis; Kyriopoulos, John

2017-05-01

The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24-month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of €30,000 per quality-adjusted life-year (QALY) (€199 and €167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of €10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at €1584 and €1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical field treatment options in all cases for AK treatment. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Polar vectors as a method for evaluating the effectiveness of irritable bowel syndrome treatments: an analysis with pinaverium bromide 100mg plus simethicone 300mg po bid.

PubMed

López-Alvarenga, J C; Sobrino-Cossío, S; Remes-Troche, J M; Chiu-Ugalde, J; Vargas-Romero, J A; Schmulson, M

2013-01-01

Irritable Bowel Syndrome (IBS) is a disorder characterized by abdominal pain or discomfort associated with changes in bowel habit. Currently there are no objective outcome measures for evaluating the effectiveness of treatments for this disorder. To determine the usefulness of a method of analysis that employs polar vectors to evaluate the effectiveness of IBS treatments. Data from a Phase IV clinical study with 1677 active IBS-Rome III patients who received 100mg of pinaverium bromide+300mg of simethicone (PB+S) po bid for a period of four weeks were used for the analysis. Using the Bristol Stool Scale as a reference, the consistency and frequency of each type of bowel movement were recorded weekly in a Bristol Matrix (BM) and the data were expressed as polar vectors. The analysis showed a differential response to the PB+S treatment among the IBS subtypes: in reference to the IBS with constipation subtype, the magnitude of the vector increased from 10.2 to 12.5, reaching maximum improvement at two weeks of treatment (p<0.05, Scheffé). In the IBS with diarrhea and mixed IBS subtypes, the magnitude of the vector decreased from 19 to 14 (p<0.05) and from 16.5 to 13 (p<0.05), respectively, with continuous improvement for a period of four weeks. There was no definable vectorial pattern in the unsubtyped IBS group. Analysis with polar vectors enables treatment response to be measured in different IBS subtypes. All the groups showed improvement with PB+S, but each one had its own characteristic response in relation to vector magnitude and direction. The proposed method can be implemented in clinical studies to evaluate the efficacy of IBS treatments. Copyright © 2012 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

Dielectric barrier discharge-based investigation and analysis of wastewater treatment and pollutant removal.

PubMed

Ramdani, N; Lousdad, A; Tilmatine, A; Nemmich, S

2016-01-01

Current research reveals that the oxidation by ozone is considered as an effective solution and offers irrefutable advantages in wastewater treatment. It is also well known that ozone is used to treat different types of water due to its effectiveness in water purification and for its oxidation potential. This process of ozonation is becoming progressively an alternative technology and is inscribed in a sustainable development perspective in Algeria. In this regards, the present paper investigates the wastewater treatment process by ozone produced by dielectric barrier discharge (DBD) under high potential. Three (DBD) ozone generators of cylindrical form have been used, at a laboratory scale, for treating collected samples from the wastewater treatment plant (WWTP) of the city of Sidi-Bel-Abbes located in the west of Algeria. Our experimental results reveal the efficiency of this type of treatment on the basis of the physicochemical analysis (pH, turbidity, chemical oxygen demand, biological oxygen demand, heavy metals) and microbial analysis downstream of the WWTP, which showed a high rate of elimination of all the parameters.

Analyzing average and conditional effects with multigroup multilevel structural equation models

PubMed Central

Mayer, Axel; Nagengast, Benjamin; Fletcher, John; Steyer, Rolf

2014-01-01

Conventionally, multilevel analysis of covariance (ML-ANCOVA) has been the recommended approach for analyzing treatment effects in quasi-experimental multilevel designs with treatment application at the cluster-level. In this paper, we introduce the generalized ML-ANCOVA with linear effect functions that identifies average and conditional treatment effects in the presence of treatment-covariate interactions. We show how the generalized ML-ANCOVA model can be estimated with multigroup multilevel structural equation models that offer considerable advantages compared to traditional ML-ANCOVA. The proposed model takes into account measurement error in the covariates, sampling error in contextual covariates, treatment-covariate interactions, and stochastic predictors. We illustrate the implementation of ML-ANCOVA with an example from educational effectiveness research where we estimate average and conditional effects of early transition to secondary schooling on reading comprehension. PMID:24795668

Intermittent Cervical Traction for Treating Neck Pain: A Meta-analysis of Randomized Controlled Trials.

PubMed

Yang, Jheng-Dao; Tam, Ka-Wai; Huang, Tsai-Wei; Huang, Shih-Wei; Liou, Tsan-Hon; Chen, Hung-Chou

2017-07-01

A meta-analysis. The aim of this study was to perform a comprehensive search of current literature and conduct a meta-analysis of randomized controlled trials (RCTs) to assess the neck pain relieving effect of intermittent cervical traction (ICT). Neck pain is a common and disabling problem with a high prevalence in general population. It causes a considerable burden on the health care system with a substantial expenditure. ICT is a common component of physical therapy for neck pain in the outpatient clinic. However, the evidence regarding the effectiveness of ICT for neck pain is insufficient. Data were obtained from the PubMed, Cochrane Library, Embase, and Scopus databases from the database inception date to July 02, 2016. RCTs reporting the effects of ICT on neck pain, including those comparing the effects of ICT with those of a placebo treatment, were included. Two reviewers independently reviewed the studies, conducted a risk of bias assessment, and extracted data. The data were pooled in a meta-analysis by using a random-effects model. The meta-analysis included seven RCTs. The results indicated that patients who received ICT for neck pain had significantly lower pain scores than those receiving placebos did immediately after treatment (standardized mean difference = -0.26, 95% confidence interval = -0.46 to -0.07). The pain scores during the follow-up period and the neck disability index scores immediately after treatment and during the follow-up period did not differ significantly. ICT may have a short-term neck pain-relieving effect. Some risks of bias were noted in the included studies, reducing the evidence level of this meta-analysis. Additional high-quality RCTs are required to clarify the long-term effects of ICT on neck pain. 1.

Ictal connectivity in childhood absence epilepsy: Associations with outcome.

PubMed

Tenney, Jeffrey R; Kadis, Darren S; Agler, William; Rozhkov, Leonid; Altaye, Mekibib; Xiang, Jing; Vannest, Jennifer; Glauser, Tracy A

2018-05-01

The understanding of childhood absence epilepsy (CAE) has been revolutionized over the past decade, but the biological mechanisms responsible for variable treatment outcomes are unknown. Our purpose in this prospective observational study was to determine how pretreatment ictal network pathways, defined using a combined electroencephalography (EEG)-functional magnetic resonance imaging (EEG-fMRI) and magnetoencephalography (MEG) effective connectivity analysis, were related to treatment response. Sixteen children with newly diagnosed and drug-naive CAE had 31 typical absence seizures during EEG-fMRI and 74 during MEG. The spatial extent of the pretreatment ictal network was defined using fMRI hemodynamic response with an event-related independent component analysis (eICA). This spatially defined pretreatment ictal network supplied prior information for MEG-effective connectivity analysis calculated using phase slope index (PSI). Treatment outcome was assessed 2 years following diagnosis and dichotomized to ethosuximide (ETX)-treatment responders (N = 11) or nonresponders (N = 5). Effective connectivity of the pretreatment ictal network was compared to the treatment response. Patterns of pretreatment connectivity demonstrated strongest connections in the thalamus and posterior brain regions (parietal, posterior cingulate, angular gyrus, precuneus, and occipital) at delta frequencies and the frontal cortices at gamma frequencies (P < .05). ETX treatment nonresponders had pretreatment connectivity, which was decreased in the precuneus region and increased in the frontal cortex compared to ETX responders (P < .05). Pretreatment ictal connectivity differences in children with CAE were associated with response to antiepileptic treatment. This is a possible mechanism for the variable treatment response seen in patients sharing the same epilepsy syndrome. Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.

Can postoperative GnRH agonist treatment prevent endometriosis recurrence? A meta-analysis.

PubMed

Zheng, Qiaomei; Mao, Hongluan; Xu, Ying; Zhao, Jing; Wei, Xuan; Liu, Peishu

2016-07-01

To investigate whether postoperative GnRH agonist (GnRH-a) treatment can prevent endometriosis recurrence. This meta-analysis searched PubMed, Embase and Cochrane Library for relevant studies published online before June 2015. Seven randomized controlled trials including 328 patients with postoperative GnRH-a treatment and 394 patients in control group were included in the meta-analysis. In the meta-analysis, the recurrence rate of GnRH-a group compared with control group was evaluated with odds ratio (OR) and its 95 % confidence interval (CI). Heterogeneity, small study effect and publication bias were, respectively, assessed using Higgins I (2), sensitivity analysis and funnel plot. Postoperative GnRH-a treatment for endometriosis (pooled OR = 0.71; 95 % CI 0.52-0.96) was superior to expectant or placebo treatment in prevention of the recurrence. The recurrence rate decreased significantly in patients who received 6 months GnRH-a treatment (pooled OR = 0.59, 95 % CI 0.38-0.90), whereas no significant difference of recurrence rate existed between patients with 3 months post-surgical GnRH-a therapy and the control group (pooled OR = 0.87, 95 % CI 0.56-1.34). No significant heterogeneity and small study effect were found in the meta-analysis. However, publication bias did existed in the present meta-analysis. Longer-term (6 months) postoperative administration of GnRH-a can decrease the recurrence risk of endometriosis, whereas 3 months duration of GnRH-a therapy makes no significant difference in preventing the recurrence of endometriosis. Therefore, instead of a 3 month therapy, the duration of the postoperative administration should be longer enough (6 months) to prevent the recurrence of endometriosis.

A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

PubMed

Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

2017-02-01

To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

Repetitive transcranial magnetic stimulation as an alternative therapy for dysphagia after stroke: a systematic review and meta-analysis.

PubMed

Liao, Xiang; Xing, Guoqiang; Guo, Zhiwei; Jin, Yu; Tang, Qing; He, Bin; McClure, Morgan A; Liu, Hua; Chen, Huaping; Mu, Qiwen

2017-03-01

A meta-analysis and systematic review was conducted to investigate the potential effects of repetitive transcranial magnetic stimulation on dysphagia in patients with stroke, including different parameters of frequency and stimulation site. PubMed, Embase, MEDLINE databases and the Cochrane Library, were searched for randomized controlled studies of repetitive transcranial magnetic stimulation treatment of dysphagia published before March 2016. Six clinical randomized controlled studies of a total of 163 stroke patients were included in this meta-analysis. A significant effect size of 1.24 was found for dysphagic outcome (mean effect size, 1.24; 95% confidence interval (CI), 0.67-1.81). A subgroup analysis based on frequency showed that the clinical scores were significantly improved in dysphagic patients with low frequency repetitive transcranial magnetic stimulation treatment ( P < 0.05) as well as high frequency repetitive transcranial magnetic stimulation treatment ( P < 0.05). A stimulation site stratified subgroup analysis implied significant changes in stroke patients with dysphagia for the unaffected hemisphere ( P < 0.05) and the bilateral hemisphere stimulation ( P < 0.05), but not for the affected hemisphere ( P > 0.05). The analysis of the follow-up data shows that patients in the repetitive transcranial magnetic stimulation groups still maintained the therapeutic benefit of repetitive transcranial magnetic stimulation four weeks after the last session of repetitive transcranial magnetic stimulation therapy ( P < 0.05). This meta-analysis indicates that repetitive transcranial magnetic stimulation has a positive effect on dysphagia after stroke. Compared with low-frequency repetitive transcranial magnetic stimulation, high-frequency repetitive transcranial magnetic stimulation may be more beneficial to the patients. This meta-analysis also supports that repetitive transcranial magnetic stimulation on an unaffected - or bilateral - hemisphere has a significant therapeutic effect on dysphagia.

A collaborative sequential meta-analysis of individual patient data from randomized trials of endovascular therapy and tPA vs. tPA alone for acute ischemic stroke: ThRombEctomy And tPA (TREAT) analysis: statistical analysis plan for a sequential meta-analysis performed within the VISTA-Endovascular collaboration.

PubMed

MacIsaac, Rachael L; Khatri, Pooja; Bendszus, Martin; Bracard, Serge; Broderick, Joseph; Campbell, Bruce; Ciccone, Alfonso; Dávalos, Antoni; Davis, Stephen M; Demchuk, Andrew; Diener, Hans-Christoph; Dippel, Diederik; Donnan, Geoffrey A; Fiehler, Jens; Fiorella, David; Goyal, Mayank; Hacke, Werner; Hill, Michael D; Jahan, Reza; Jauch, Edward; Jovin, Tudor; Kidwell, Chelsea S; Liebeskind, David; Majoie, Charles B; Martins, Sheila Cristina Ouriques; Mitchell, Peter; Mocco, J; Muir, Keith W; Nogueira, Raul; Saver, Jeffrey L; Schonewille, Wouter J; Siddiqui, Adnan H; Thomalla, Götz; Tomsick, Thomas A; Turk, Aquilla S; White, Philip; Zaidat, Osama; Lees, Kennedy R

2015-10-01

Endovascular treatment has been shown to restore blood flow effectively. Second-generation medical devices such as stent retrievers are now showing overwhelming efficacy in clinical trials, particularly in conjunction with intravenous recombinant tissue plasminogen activator. This statistical analysis plan utilizing a novel, sequential approach describes a prospective, individual patient data analysis of endovascular therapy in conjunction with intravenous recombinant tissue plasminogen activator agreed upon by the Thrombectomy and Tissue Plasminogen Activator Collaborative Group. This protocol will specify the primary outcome for efficacy, as 'favorable' outcome defined by the ordinal distribution of the modified Rankin Scale measured at three-months poststroke, but with modified Rankin Scales 5 and 6 collapsed into a single category. The primary analysis will aim to answer the questions: 'what is the treatment effect of endovascular therapy with intravenous recombinant tissue plasminogen activator compared to intravenous tissue plasminogen activator alone on full scale modified Rankin Scale at 3 months?' and 'to what extent do key patient characteristics influence the treatment effect of endovascular therapy?'. Key secondary outcomes include effect of endovascular therapy on death within 90 days; analyses of modified Rankin Scale using dichotomized methods; and effects of endovascular therapy on symptomatic intracranial hemorrhage. Several secondary analyses will be considered as well as expanding patient cohorts to intravenous recombinant tissue plasminogen activator-ineligible patients, should data allow. This collaborative meta-analysis of individual participant data from randomized trials of endovascular therapy vs. control in conjunction with intravenous thrombolysis will demonstrate the efficacy and generalizability of endovascular therapy with intravenous thrombolysis as a concomitant medication. © 2015 World Stroke Organization.

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

PubMed

Kimura, Go; Ueda, Takeshi

2017-03-01

A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer—updated results

PubMed Central

Ueda, Takeshi

2017-01-01

Abstract A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28–1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18–0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. PMID:28003320

Effectiveness of Treatment Approaches for Children and Adolescents with Reading Disabilities: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

2014-01-01

Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities, research should intensify the application of blinded randomized controlled trials. PMID:24587110

Anti-inflammatory agents in the treatment of bipolar depression: a systematic review and meta-analysis.

PubMed

Rosenblat, Joshua D; Kakar, Ron; Berk, Michael; Kessing, Lars V; Vinberg, Maj; Baune, Bernhard T; Mansur, Rodrigo B; Brietzke, Elisa; Goldstein, Benjamin I; McIntyre, Roger S

2016-03-01

Inflammation has been implicated in the risk, pathophysiology, and progression of mood disorders and, as such, has become a target of interest in the treatment of bipolar disorder (BD). Therefore, the objective of the current qualitative and quantitative review was to determine the overall antidepressant effect of adjunctive anti-inflammatory agents in the treatment of bipolar depression. Completed and ongoing clinical trials of anti-inflammatory agents for BD published prior to 15 May 15 2015 were identified through searching the PubMed, Embase, PsychINFO, and Clinicaltrials.gov databases. Data from randomized controlled trials (RCTs) assessing the antidepressant effect of adjunctive mechanistically diverse anti-inflammatory agents were pooled to determine standard mean differences (SMDs) compared with standard therapy alone. Ten RCTs were identified for qualitative review. Eight RCTs (n = 312) assessing adjunctive nonsteroidal anti-inflammatory drugs (n = 53), omega-3 polyunsaturated fatty acids (n = 140), N-acetylcysteine (n = 76), and pioglitazone (n = 44) in the treatment of BD met the inclusion criteria for quantitative analysis. The overall effect size of adjunctive anti-inflammatory agents on depressive symptoms was -0.40 (95% confidence interval -0.14 to -0.65, p = 0.002), indicative of a moderate and statistically significant antidepressant effect. The heterogeneity of the pooled sample was low (I² = 14%, p = 0.32). No manic/hypomanic induction or significant treatment-emergent adverse events were reported. Overall, a moderate antidepressant effect was observed for adjunctive anti-inflammatory agents compared with conventional therapy alone in the treatment of bipolar depression. The small number of studies, diversity of agents, and small sample sizes limited interpretation of the current analysis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[The value of lidocaine through different routes of administration in the treatment of tinnitus: a Meta-analysis].

PubMed

Li, Hui; Li, Ming; Zhang, Jianning; Li, Xiangcui; Tan, Junying; Ji, Bobo

2016-01-01

To evaluate the clinical value of lidocain in the treatment of tinnitus through three routes of administration (intravenous, intratympanic and acupoint injection) by analyzing literatures. Articles were collected through Hownet, Wanfang, VIP, Pubmed, SciVerse ScienceDirect, Springer and OVID, etc. The articles were strictly evaluated based on their quality. The Meta-analysis was performed to evaluate the outcomes by RevMan 5. 2 software. A total of 16 articles with 1203 patients were enrolled in the analysis. Their tinnitus history ranged from 7 hours to 20 years. Assessment methods include tinnitus loudness levels, severity scales and subjective feelings. None of articles refer to maintaining time, instead of "short-term", "short" and so on. A total of 133 cases received intravenous injection and the effective rate was 73.4% (98 cases). 50 cases and 332 cases received intratympanic and acupoint injection respectively and their effective rates were 74.0% and 87.7%, respectively. The effective rate ranged from 42.4% to 58.3% in control group. Meta-analysis results indicate that all three routes of lidocaine administrations are more effective than conventional methods (P < 0.05). Different routes of lidocaine administration have a good but short time effects on the tinnitus control. It can effectively reduce the time of tinnitus habituation as a complementary treatment. But its value still needs further evaluation.

Effect of interventions for major depressive disorder and significant depressive symptoms in patients with diabetes mellitus: a systematic review and meta-analysis.

PubMed

van der Feltz-Cornelis, Christina M; Nuyen, Jasper; Stoop, Corinne; Chan, Juliana; Jacobson, Alan M; Katon, Wayne; Snoek, Frank; Sartorius, Norman

2010-01-01

Comorbid depression in diabetes is highly prevalent, negatively impacting well-being and diabetes control. How depression in diabetes is best treated is unknown. This systematic review and meta-analysis aims to establish the effectiveness of existing anti-depressant therapies in diabetes. PubMed, Psycinfo, Embase and Cochrane library. Study eligibility criteria, participants, interventions: randomized controlled trials (RCTs) evaluating the outcome of treatment by psychotherapy, pharmacotherapy or collaborative care of depression in persons with Type 1 and Type 2 diabetes mellitus. risk of bias assessment; data extraction. Synthesis methods: data synthesis, random model meta analysis and publication bias analysis. Meta analysis of 14 RCTs with a total of 1724 patients show that treatment is effective in terms of reduction of depressive symptoms: -0.512; 95% CI -0.633 to -0.390. The combined effect of all interventions on clinical impact is moderate, -0.370; 95% CI -0.470 to -0.271; it is large for psychotherapeutic interventions that are often combined with diabetes self management: -0.581; 95% CI -0.770 to -0.391, n=310 and moderate for pharmacological treatment: -0.467; 95% CI -0.665 to -0.270, n=281. Delivery of collaborative care, which provided a stepped care intervention with a choice of starting with psychotherapy or pharmacotherapy, to a primary care population, yielded an effect size of -0.292; 95% CI -0.429 to -0.155, n=1133; indicating the effect size that can be attained on a population scale. Pharmacotherapy and collaborative care aimed at and succeeded in the reduction of depressive symptoms but, apart from sertraline, had no effect on glycemic control. amongst others, the number of RCTs is small. The treatment of depression in people with diabetes is a necessary step, but improvement of the general medical condition including glycemic control is likely to require simultaneous attention to both conditions. Further research is needed. Copyright 2010 Elsevier Inc. All rights reserved.

A Meta-analysis of the Effectiveness of Albendazole Compared with Metronidazole as Treatments for Infections with Giardia duodenalis

PubMed Central

Solaymani-Mohammadi, Shahram; Genkinger, Jeanine M.; Loffredo, Christopher A.; Singer, Steven M.

2010-01-01

Background Metronidazole is the most commonly used drug for the treatment of giardiasis in humans. In spite of its therapeutic efficacy for giardiasis, low patient compliance, especially in children, side effects, and the emergence of metronidazole-resistant strains may restrict its use. Albendazole has been used to treat Giardia duodenalis infections in recent years. However, efficacy studies in vivo and in vitro have produced diverse results as to its effectiveness. A moderately benign side effect profile, combined with established efficacy against many helminths, renders it promising for treatment of giardiasis in humans. Methodology and Principal Findings We performed a search in the PubMed, Scopus, EMBASE, the ISI Web of Science, LILIACS, and Cochrane Controlled Trials Register for trials published before February 2010 as well as in references of relevant research and review articles. Eight randomized clinical trials (including 900 patients) comparing the effectiveness of albendazole with that of metronidazole were included in meta-analysis. After extracting and validating the data, the pooled risk ratio (RR) was calculated using an inverse-variance random-effects model. Albendazole was found to be equally as effective as metronidazole in the treatment of giardiasis in humans (RR 0.97; 95% CI, 0.93, 1.01). In addition, safety analysis suggested that patients treated with albendazole had a lower risk of adverse effects compared with those who received metronidazole (RR 0.36; 95% CI, 0.10, 1.34), but limitations of the sample size precluded a definite conclusion. Conclusions/Significance The effectiveness of albendazole, when given as a single dose of 400 mg/day for 5 days, was comparable to that of metronidazole. Patients treated with albendazole tended to have fewer side effects compared with those who took metronidazole. Given the safety, effectiveness, and low costs of albendazole, this drug could be potentially used as an alternative and/or a replacement for the existing metronidazole therapy protocols in the treatment of giardiasis in humans. PMID:20485492

[Cost-effectiveness of drotrecogin alpha [activated] in the treatment of severe sepsis in Spain].

PubMed

Sacristán, José A; Prieto, Luis; Huete, Teresa; Artigas, Antonio; Badia, Xavier; Chinn, Christopher; Hudson, Peter

2004-01-01

The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain. A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha (activated) versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer. Most of the information for creating the model was obtained from the PROWESS clinical trial. A two-fold baseline analysis was performed: a) for all patients included in the PROWESS clinical trial and b) for the patients with two or more organ failures. The major variables for clinical assessment were the reduction in mortality and years of life gained (YLG). Cost-effectiveness was expressed as cost per YLG. A sensitivity analysis was applied using 3% and 5% discount rates for YLG and by modifying the patterns of health care, intensive care unit costs, and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha (activated). Treatment with drotrecogin alfa (activated) was associated with a 6.0% drop in the absolute risk of death (p = 0.005) when all of the patients from the PROWESS trial were included and with a 7.3% reduction (p = 0.005) when the analysis was restricted to patients with two or more organ failures. The cost-effectiveness of drotrecogin alfa (activated) was 13,550 euros per YLG with respect to standard care after analysing all of the patients and 9,800 euros per YLG in the group of patients with two or more organ failures. In the sensitivity analysis, the results ranged from 7,322 to 16,493 euros per YLG. The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa (activated), adjustment of survival by initial co-morbidity and the application of discount rates to YLG. Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.

Cost-effectiveness and cost-utility of combination therapy in early rheumatoid arthritis: randomized comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone. COBRA Trial Group. Combinatietherapie Bij Reumatoïde Artritis.

PubMed

Verhoeven, A C; Bibo, J C; Boers, M; Engel, G L; van der Linden, S

1998-10-01

Assessment of the cost-effectiveness and cost-utility of early intervention in rheumatoid arthritis (RA) patients, with combined step-down prednisolone, methotrexate and sulphasalazine, compared to sulphasalazine alone. Multicentre 56 week randomized double-blind trial with full economic analysis of direct costs and utility analysis with rating scale and standard gamble measurement techniques. The combined-treatment group included 76 patients and the sulphasalazine group 78 patients. The mean total costs per patient in the first 56 weeks of follow-up were $5519 for combined treatment and $6511 for treatment with sulphasalazine alone (P = 0.37). Out-patient care, in-patient care and non-health care each contributed about one-third to the total costs. The combined-treatment group appeared to generate savings in the length of hospital stay for RA, non-protocol drugs and costs of home help, but comparisons were not statistically significant. Protocol drugs and monitoring were slightly more expensive in the combined-treatment group. Clinical, radiographic and functional outcomes significantly favoured combined treatment at week 28 (radiography also at week 56). Utility scores also favoured combined treatment. Combined treatment is cost-effective due to enhanced efficacy at lower or equal direct costs.

Recovery of calf muscle strength following acute achilles tendon rupture treatment: a comparison between minimally invasive surgery and conservative treatment.

PubMed

Metz, Roderik; van der Heijden, Geert J M G; Verleisdonk, Egbert-Jan M M; Tamminga, Rob; van der Werken, Christiaan

2009-10-01

The aim of this study was to measure the effect of treatment of acute Achilles tendon ruptures on calf muscle strength recovery. Eighty-three patients with acute Achilles tendon rupture were randomly allocated to either minimally invasive surgery with functional after-treatment or conservative treatment by functional bracing. Calf muscle strength using isokinetic testing was evaluated at 3 months and after 6 or more months posttreatment. To exclusively investigate the effect of treatment on outcome, the authors excluded patients with major complications from the analysis. In 31 of 39 patients in the surgical treatment group and 25 of 34 patients in the conservative treatment group, isokinetic strength tests were performed. In the analysis of differences in mean peak torque, no statistically significant differences were found between surgery and conservative treatment, except for plantar flexion strength at 90 degrees per second at the second measurement, favoring conservative treatment. After 8 to 10 months follow- up, loss of plantar flexion strength was still present in the injured leg in both treatment groups. In conclusion, isokinetic muscle strength testing did not detect a statistically significant difference between minimally invasive surgical treatment with functional after-treatment and conservative treatment by functional bracing of acute Achilles tendon ruptures.

Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data.

PubMed

Feagan, Brian; Sandborn, William J; Rutgeerts, Paul; Levesque, Barrett G; Khanna, Reena; Huang, Bidan; Zhou, Qian; Maa, Jen-Fue; Wallace, Kori; Lacerda, Ana; Thakkar, Roopal B; Robinson, Anne M

2018-04-23

Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD. Subsets of patients meeting specified Simplified Endoscopic Score for CD (SES-CD) inclusion criteria, according to site or central reading, and baseline stool frequency (SF) and/or abdominal pain score (AP) thresholds were evaluated. Various endpoint definitions based on the Crohn's Disease Activity Index (CDAI), its SF and AP components, SES-CD, and composite endpoints were compared between treatment groups. Increased stringency of Week 12 clinical endpoints compared to CDAI<150 to SF≤3.0/1.5&AP≤1.0 reduced PBO response rates by ≥12% and increased treatment effects by ≤10%. Amending the SES-CD endpoint from ≤4 to ≤2 reduced the treatment effect from 24% to 8%. Composite endpoints further diminished response rates and effect sizes. Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.

Effects of naloxone distribution alone or in combination with addiction treatment with or without pre-exposure prophylaxis for HIV prevention in people who inject drugs: a cost-effectiveness modelling study.

PubMed

Uyei, Jennifer; Fiellin, David A; Buchelli, Marianne; Rodriguez-Santana, Ramon; Braithwaite, R Scott

2017-03-01

In the USA, an epidemic of opioid overdose deaths is occurring, many of which are from heroin. Combining naloxone distribution with linkage to addiction treatment or pre-exposure prophylaxis (PrEP) for HIV prevention through syringe service programmes has the potential to save lives and be cost-effective. We estimated the outcomes and cost-effectiveness of five alternative strategies: no additional intervention, naloxone distribution, naloxone distribution plus linkage to addiction treatment, naloxone distribution plus PrEP, and naloxone distribution plus linkage to addiction treatment and PrEP. We developed a decision analytical Markov model to simulate opioid overdose, HIV incidence, overdose-related deaths, and HIV-related deaths in people who inject drugs in Connecticut, USA. Model input parameters were derived from published sources. We compared each strategy with no intervention, as well as simultaneously considering all strategies. Sensitivity analysis was done for all variables. Linkage to addiction treatment was referral to an opioid treatment programme for methadone. Endpoints were survival, life expectancy, quality-adjusted life-years (QALYs), number and percentage of overdose deaths averted, number of HIV-related deaths averted, total costs (in 2015 US$) associated with each strategy, and incremental cost per QALY gained. In the base-case analysis, compared with no additional intervention, the naloxone distribution strategy yielded an incremental cost-effectiveness ratio (ICER) of $323 per QALY, and naloxone distribution plus linkage to addiction treatment was cost saving compared with no additional intervention (greater effectiveness and less expensive). The most efficient strategies (ie, those conferring the greatest health benefit for a particular budget) were naloxone distribution combined with linkage to addiction treatment (cost saving), and naloxone distribution combined with PrEP and linkage to addiction treatment (ICER $95 337 per QALY) at a willingness-to-pay threshold of $100 000. In probabilistic sensitivity analysis, the combination of naloxone distribution, PrEP, and linkage to addiction treatment was the optimal strategy in 37% of iterations and the combination of naloxone distribution and linkage to addiction treatment was the optimal strategy in 34% of iterations. Naloxone distribution through syringe service programmes is cost-effective compared with syringe distribution alone, but when combined with linkage to addiction treatment is cost saving compared with no additional services. A strategy that combines naloxone distribution, PrEP, and linkage to addiction treatment results in greater health benefits in people who inject drugs and is also cost-effective. State of Connecticut Department of Public Health and the National Institute of Mental Health. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license. Published by Elsevier Ltd.. All rights reserved.

Reactions to the Stress-Coping Meta-Analysis.

ERIC Educational Resources Information Center

Glass, Gene V.

1986-01-01

Presents a response to the stress-coping meta-analysis (Matheny, et al) with comments regarding the effectiveness of the taxonomy building and the empirical work. Notes the need for reporting effectiveness of stress-coping treatment across different types of outcomes. (KS)

Balneotherapy for osteoarthritis. A cochrane review.

PubMed

Verhagen, Arianne; Bierma-Zeinstra, Sita; Lambeck, Johan; Cardoso, Jefferson Rosa; de Bie, Rob; Boers, Maarten; de Vet, Henrica C W

2008-06-01

Balneotherapy (or spa therapy, mineral baths) for patients with arthritis is one of the oldest forms of therapy. We assessed effectiveness of balneotherapy for patients with osteoarthritis (OA). We performed a broad search strategy to retrieve eligible studies, selecting randomized controlled trials comparing balneotherapy with any intervention or with no intervention. Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data we refrained from statistical pooling. Seven trials (498 patients) were included in this review: one performed an intention-to-treat analysis, 2 provided data for our own analysis, and one reported a "quality of life" outcome. We found silver-level evidence of mineral baths compared to no treatment (effect sizes 0.34-1.82). Adverse events were not measured or found in included trials. We found silver-level evidence concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments, no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation.

Effectiveness of Phosphodiesterase 5 Inhibitors in the Treatment of Erectile Dysfunction in Patients with Spinal Cord Trauma: Systematic Review and Meta-Analysis.

PubMed

García-Perdomo, Herney Andrés; Echeverría-García, Fernando; Tobías, Aurelio

2017-01-01

To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma. A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed. Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%). PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI. © 2016 S. Karger AG, Basel.

One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.

PubMed

Hua, Hairui; Burke, Danielle L; Crowther, Michael J; Ensor, Joie; Tudur Smith, Catrin; Riley, Richard D

2017-02-28

Stratified medicine utilizes individual-level covariates that are associated with a differential treatment effect, also known as treatment-covariate interactions. When multiple trials are available, meta-analysis is used to help detect true treatment-covariate interactions by combining their data. Meta-regression of trial-level information is prone to low power and ecological bias, and therefore, individual participant data (IPD) meta-analyses are preferable to examine interactions utilizing individual-level information. However, one-stage IPD models are often wrongly specified, such that interactions are based on amalgamating within- and across-trial information. We compare, through simulations and an applied example, fixed-effect and random-effects models for a one-stage IPD meta-analysis of time-to-event data where the goal is to estimate a treatment-covariate interaction. We show that it is crucial to centre patient-level covariates by their mean value in each trial, in order to separate out within-trial and across-trial information. Otherwise, bias and coverage of interaction estimates may be adversely affected, leading to potentially erroneous conclusions driven by ecological bias. We revisit an IPD meta-analysis of five epilepsy trials and examine age as a treatment effect modifier. The interaction is -0.011 (95% CI: -0.019 to -0.003; p = 0.004), and thus highly significant, when amalgamating within-trial and across-trial information. However, when separating within-trial from across-trial information, the interaction is -0.007 (95% CI: -0.019 to 0.005; p = 0.22), and thus its magnitude and statistical significance are greatly reduced. We recommend that meta-analysts should only use within-trial information to examine individual predictors of treatment effect and that one-stage IPD models should separate within-trial from across-trial information to avoid ecological bias. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Systemic antibiotics in the treatment of aggressive periodontitis. A systematic review and a Bayesian Network meta-analysis.

PubMed

Rabelo, Cleverton Correa; Feres, Magda; Gonçalves, Cristiane; Figueiredo, Luciene C; Faveri, Marcelo; Tu, Yu-Kang; Chambrone, Leandro

2015-07-01

The aim of this study was to assess the effect of systemic antibiotic therapy on the treatment of aggressive periodontitis (AgP). This study was conducted and reported in accordance with the PRISMA statement. The MEDLINE, EMBASE and CENTRAL databases were searched up to June 2014 for randomized clinical trials comparing the treatment of subjects with AgP with either scaling and root planing (SRP) alone or associated with systemic antibiotics. Bayesian network meta-analysis was prepared using the Bayesian random-effects hierarchical models and the outcomes reported at 6-month post-treatment. Out of 350 papers identified, 14 studies were eligible. Greater gain in clinical attachment (CA) (mean difference [MD]: 1.08 mm; p < 0.0001) and reduction in probing depth (PD) (MD: 1.05 mm; p < 0.00001) were observed for SRP + metronidazole (Mtz), and for SRP + Mtz + amoxicillin (Amx) (MD: 0.45 mm, MD: 0.53 mm, respectively; p < 0.00001) than SRP alone/placebo. Bayesian network meta-analysis showed additional benefits in CA gain and PD reduction when SRP was associated with systemic antibiotics. SRP plus systemic antibiotics led to an additional clinical effect compared with SRP alone in the treatment of AgP. Of the antibiotic protocols available for inclusion into the Bayesian network meta-analysis, Mtz and Mtz/Amx provided to the most beneficial outcomes. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Progression of motor and nonmotor features of Parkinson's disease and their response to treatment

PubMed Central

Vu, Thuy C.; Nutt, John G.; Holford, Nicholas H. G.

2012-01-01

AIMS (i) To describe the progression of the cardinal features of Parkinson's disease (PD); (ii) to investigate whether baseline PD subtypes explain disease progression; and (iii) to quantify the symptomatic and disease-modifying effects of anti-parkinsonian treatments. METHODS Data were available for 795 PD subjects, initially untreated, followed for up to 8 years. Cardinal features [tremor, rigidity, bradykinesia, and postural instability and gait disorder (PIGD)] were derived from the total unified Parkinson's disease rating scale (total UPDRS), cognitive status from the mini-mental status exam score (MMSE) and depression status from the Hamilton depression scale (HAM-D). Analysis was performed using a nonlinear mixed effects approach with an asymptotic model for natural disease progression. Treatment effects (i.e. symptomatic and disease modifying) were evaluated by describing changes in the natural history model parameters. RESULTS Tremor progressed more slowly (half-time of 3.9 years) than all other motor features (half-time 2–3 years). The MMSE progression was negligible, while HAM-D progressed with a half-time of 5 years. Levodopa had marked symptomatic effects on all features, but low potency for effect on PIGD (ED50 of 1237 mg day−1 compared with 7–24 mg day−1 for other motor and nonmotor features). Other anti-parkinsonian treatments had much smaller symptomatic effects. All treatments had disease-modifying effects on the cardinal features of PD. Baseline PD subtypes only explained small differences in disease progression. CONCLUSIONS This analysis indicates that tremor progresses more slowly than other cardinal features and that PIGD is less treatment responsive in early PD patients. There was no evidence of baseline PD subtypes as a clinically useful predictor of disease progression rate. Anti-parkinsonian treatments have symptomatic and disease-modifying effects on all major features of PD. PMID:22283961

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands

PubMed Central

Nuijten, Mark J. C.; Dubois, Dominique J.; Joseph, Alain; Annemans, Lieven

2015-01-01

Objective: To assess the cost-effectiveness of prucalopride vs. continued laxative treatment for chronic constipation in patients in the Netherlands in whom laxatives have failed to provide adequate relief. Methods: A Markov model was developed to estimate the cost-effectiveness of prucalopride in patients with chronic constipation receiving standard laxative treatment from the perspective of Dutch payers in 2011. Data sources included published prucalopride clinical trials, published Dutch price/tariff lists, and national population statistics. The model simulated the clinical and economic outcomes associated with prucalopride vs. standard treatment and had a cycle length of 1 month and a follow-up time of 1 year. Response to treatment was defined as the proportion of patients who achieved “normal bowel function”. One-way and probabilistic sensitivity analyses were conducted to test the robustness of the base case. Results: In the base case analysis, the cost of prucalopride relative to continued laxative treatment was € 9015 per quality-adjusted life-year (QALY). Extensive sensitivity analyses and scenario analyses confirmed that the base case cost-effectiveness estimate was robust. One-way sensitivity analyses showed that the model was most sensitive in response to prucalopride; incremental cost-effectiveness ratios ranged from € 6475 to 15,380 per QALY. Probabilistic sensitivity analyses indicated that there is a greater than 80% probability that prucalopride would be cost-effective compared with continued standard treatment, assuming a willingness-to-pay threshold of € 20,000 per QALY from a Dutch societal perspective. A scenario analysis was performed for women only, which resulted in a cost-effectiveness ratio of € 7773 per QALY. Conclusion: Prucalopride was cost-effective in a Dutch patient population, as well as in a women-only subgroup, who had chronic constipation and who obtained inadequate relief from laxatives. PMID:25926794

A systematic review and meta-analysis of self-help therapeutic interventions for obsessive-compulsive disorder: Is therapeutic contact key to overall improvement?

PubMed

Pearcy, Caitlin P; Anderson, Rebecca A; Egan, Sarah J; Rees, Clare S

2016-06-01

The presence of obsessive-compulsive disorder (OCD) can result in low quality of life, with significant impairments in social and occupational functioning. An increase in the dissemination of self-help programs has been observed in the treatment of OCD, and has provided improved accessibility to treatment. The present study examined the efficacy of self-help interventions for OCD in the context of therapeutic contact. Randomised controlled trials and quasi-experimental studies were identified through computerised database searches. Self-help format (bibliotherapy, internet-based, computerised), and therapeutic contact were examined for their effect on treatment outcomes. Eighteen studies targeting self-help for OCD met inclusion criteria with 1570 participants. The average post-treatment effect size (Hedges' g) of self-help interventions on primary outcomes was .51 (95% CI: .41 to 0.61). Subgroup analysis revealed large effect sizes for minimal-contact self-help (g = 0.91, 95% CI: 0.66 to 1.17), moderate effect sizes for predominantly self-help (g = 0.68, 95% CI: 0.40 to 0.96), and small effect sizes for self-administered self-help (g = 0.33, 95% CI: .18 to 0.47). A large variation of treatment approaches, amount of therapeutic contact, and risk of bias within each study may account for the large magnitude in effect sizes across studies. Additionally, the long-term follow-up effects of treatment approaches were not examined. A growing body of literature supporting to the use of self-help treatments for OCD is evident, however, further investigation through use of randomised controlled trials is required, particularly the use of stepped care and long-term effectiveness. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effectiveness of the Herbst appliance for patients with Class II malocclusion: a meta-analysis

PubMed Central

Yang, Xin; Zhu, Yafen; Long, Hu; Zhou, Yang; Jian, Fan; Ye, Niansong; Gao, Meiya

2016-01-01

Summary Objective: To systematically investigate review in literature the effects of the Herbst appliance for patients with Class II malocclusion patients. Method: We performed a comprehensive literature survey on PubMed, Web of Science, Embase, CENTRAL, SIGLE, and ClinicalTrial.gov up to December 2014. The selection criteria: randomized controlled trials or clinical controlled trials; using any kind of Herbst appliances to correct Class II division 1 malocclusions; skeletal and/or dental changes evaluated through lateral cephalograms. And the exclusion criteria: syndromic patients; individual case reports and series of cases; surgical interventions. Article screening, data extraction, assessment of risk of bias, and evaluation of evidence quality through GRADE were conducted independently by two well-trained orthodontic doctors. Consensus was made via group discussion of all authors when there is inconsistent information from the two. After that, sensitivity analysis and subgroup analysis were performed to evaluate the robustness of the meta-analysis. Results: Twelve clinical controlled trials meet the above-mentioned criteria, and were included in this analysis. All included studies have eleven measures taken during both active treatment effect and long term effect periods, including four angular ones (i.e., SNA, SNB, ANB, mandibular plane angle) and seven linear ones (i.e. Co-Go, Co-Gn, overjet, overbite, molar relationship, A point-OLp, Pg-OLp) during active treatment effect period were statistically pooled. Meta-analysis and sensitivity analysis demonstrated that all these measures showed consistent results except for SNA, ANB, and overbite. Subgroup analysis showed significant changes in SNA, overbite, and Pg-OLp. Publication bias was detected in SNB, mandibular plane angle, and A point-OLp. Conclusion: The Herbst appliance is effective for patients with Class II malocclusion in active treatment period. Especially, there are obvious changes on dental discrepancy and skeletal changes on Co-Gn. As to its long-term effects, more evidence is needed to draw conclusions. PMID:26306822

Quantifying the potential impacts of fuel treatments on wildfire suppression costs volume

Treesearch

Matthew P. Thompson; Nicole M. Vaillant; Jessica R. Haas; Krista M. Gebert; Keith D. Stockmann

2013-01-01

Modeling the impacts and effects of hazardous fuel reduction treatments is a pressing issue within the wildfire management community. Prospective evaluation of fuel treatments allows for comparison of alternative treatment strategies in terms of socioeconomic and ecological impacts and facilitates analysis of tradeoffs across land management objectives (Stockmann et al...

Counseling Outcomes from 1990 to 2008 for School-Age Youth with Depression: A Meta-Analysis

ERIC Educational Resources Information Center

Erford, Bradley T.; Erford, Breann M.; Lattanzi, Gina; Weller, Janet; Schein, Hallie; Wolf, Emily; Hughes, Meredith; Darrow, Jenna; Savin-Murphy, Janet; Peacock, Elizabeth

2011-01-01

Clinical trials exploring the effectiveness of counseling and psychotherapy in treatment of depression in school-age youth composed this meta-analysis. Results were synthesized using a random effects model for mean difference and mean gain effect size estimates. No effects of moderating variables were evident. Counseling and psychotherapy are…

Scaling-up essential neuropsychiatric services in Ethiopia: a cost-effectiveness analysis.

PubMed

Strand, Kirsten Bjerkreim; Chisholm, Dan; Fekadu, Abebaw; Johansson, Kjell Arne

2016-05-01

There is an immense need for scaling-up neuropsychiatric care in low-income countries. Contextualized cost-effectiveness analyses (CEAs) provide relevant information for local policies. The aim of this study is to perform a contextualized CEA of neuropsychiatric interventions in Ethiopia and to illustrate expected population health and budget impacts across neuropsychiatric disorders. A mathematical population model (PopMod) was used to estimate intervention costs and effectiveness. Existing variables from a previous WHO-CHOICE regional CEA model were substantially revised. Treatments for depression, schizophrenia, bipolar disorder and epilepsy were analysed. The best available local data on epidemiology, intervention efficacy, current and target coverage, resource prices and salaries were used. Data were obtained from expert opinion, local hospital information systems, the Ministry of Health and literature reviews. Treatment of epilepsy with a first generation antiepileptic drug is the most cost-effective treatment (US$ 321 per DALY adverted). Treatments for depression have mid-range values compared with other interventions (US$ 457-1026 per DALY adverted). Treatments for schizophrenia and bipolar disorders are least cost-effective (US$ 1168-3739 per DALY adverted). This analysis gives the Ethiopian government a comprehensive overview of the expected costs, effectiveness and cost-effectiveness of introducing basic neuropsychiatric interventions. © The Author 2015. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

Concentration of polycyclic aromatic hydrocarbons in water samples from different stages of treatment

NASA Astrophysics Data System (ADS)

Pogorzelec, Marta; Piekarska, Katarzyna

2017-11-01

The aim of this study was to analyze the presence and concentration of selected polycyclic aromatic hydrocarbons in water samples from different stages of treatment and to verify the usefulness of semipermeable membrane devices for analysis of drinking water. For this purpose, study was conducted for a period of 5 months. Semipermeable membrane devices were deployed in a surface water treatment plant located in Lower Silesia (Poland). To determine the effect of water treatment on concentration of PAHs, three sampling places were chosen: raw water input, stream of water just before disinfection and treated water output. After each month of sampling SPMDs were changed for fresh ones and prepared for further analysis. Concentrations of fifteen polycyclic aromatic hydrocarbons were determined by high performance liquid chromatography (HPLC). Presented study indicates that the use of semipermeable membrane devices can be an effective tool for the analysis of aquatic environment, including monitoring of drinking water, where organic micropollutants are present at very low concentrations.

Correlation of treatment-emergent adverse events and clinical response to endocrine therapy in early breast cancer: a retrospective analysis of the German cohort of TEAM.

PubMed

Hadji, P; Kieback, D G; Tams, J; Hasenburg, A; Ziller, M

2012-10-01

Previous studies have suggested a correlation between the occurrence of vasomotor or joint symptoms during tamoxifen or aromatase inhibitor treatment and improved clinical response. A retrospective analysis of the German cohort of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial was carried out to assess disease-free survival (DFS) and overall survival (OS) in patients with and without arthralgia/myalgia and/or menopausal symptoms during adjuvant endocrine treatment. A total of 1502 patients were included; 739 patients received tamoxifen followed by exemestane and 763 received exemestane. Patients reporting arthralgia/myalgia and patients reporting menopausal symptoms during endocrine treatment had significantly longer OS and DFS than those not reporting these events. The effect on OS was irrespective of treatment. DFS was significantly improved in exemestane-treated patients reporting arthralgia/myalgia or those reporting menopausal symptoms versus those not reporting these events. This effect on DFS was not observed in patients receiving sequential treatment. A combined analysis of patients reporting either menopausal symptoms or arthralgia/myalgia showed that OS and DFS were significantly improved in patients reporting one of these symptoms versus those not reporting either symptom. The occurrence of arthralgia/myalgia or menopausal symptoms during endocrine treatment is associated with significantly improved OS.

Cost-effectiveness analysis in markets with high fixed costs.

PubMed

Cutler, David M; Ericson, Keith M Marzilli

2010-01-01

We consider how to conduct cost-effectiveness analysis when the social cost of a resource differs from the posted price. From the social perspective, the true cost of a medical intervention is the marginal cost of delivering another unit of a treatment, plus the social cost (deadweight loss) of raising the revenue to fund the treatment. We focus on pharmaceutical prices, which have high markups over marginal cost due to the monopoly power granted to pharmaceutical companies when drugs are under patent. We find that the social cost of a branded drug is approximately one-half the market price when the treatment is paid for by a public insurance plan and one-third the market price for mandated coverage by private insurance. We illustrate the importance of correctly accounting for social costs using two examples: coverage for statin drugs and approval for a drug to treat kidney cancer (sorafenib). In each case, we show that the correct social perspective for cost-effectiveness analysis would be more lenient than researcher recommendations.

Patient preferences for outcomes of depression treatment in Germany: a choice-based conjoint analysis study.

PubMed

Zimmermann, Thomas M; Clouth, Johannes; Elosge, Michael; Heurich, Matthias; Schneider, Edith; Wilhelm, Stefan; Wolfrath, Anette

2013-06-01

In general, treatment efficacy in depressed patients is evaluated mainly based on the core symptoms of depression. However, patients might consider different outcomes. This study used choice-based conjoint analysis (CBC) to evaluate patient preferences for depression treatment outcomes. Adult subjects from Germany, currently or previously on antidepressant treatment, were presented with 18 pairs of hypothetical treatment outcome scenarios, differing in eight attributes (2-3 factor levels each): depressed mood, loss of interest and enjoyment, loss of energy/fatigue, sleep disturbance, feelings of guilt, depression-related pain, treatment duration, side effects after 2 weeks. Attributes and factor levels were defined by literature review, expert consultations, and in-depth subject interviews. Data were analyzed using multinomial logit modeling; individual part-worth utilities were estimated using hierarchical Bayes routines. Two hundred twenty-seven subjects (89.4% currently treated with antidepressants, 30.0% with depression-related pain) completed the survey. They valued the relative importance of outcomes as follows: loss of energy/fatigue 18.5%, side effects after 2 weeks 14.2%, loss of interest and enjoyment 13.5%, depression-related pain 12.0%, sleep disturbance 12.0%, feelings of guilt 11.5%, treatment duration 9.9%, depressed mood 8.5%. Participants were not required to meet ICD-10 or DSM-IV criteria for depression and had heterogeneous disease severity. CBC analysis was able to reveal patient preferences for outcomes of depression treatment. Subjects valued the ability to cope with activities of everyday living highest. They considered being free of depression-related pain and side effects more important than being free of depressed mood. These findings should be considered when making treatment decisions. Copyright © 2012 Elsevier B.V. All rights reserved.

Effectiveness of co-treatment with traditional Chinese medicine and letrozole for polycystic ovary syndrome: a meta-analysis.

PubMed

Ma, Qian-Wen; Tan, Yong

2017-03-01

Polycystic ovary syndrome (PCOS) is an endocrine disease that affects gynecological health. Treatment of PCOS remains a big challenge for clinicians. This meta-analysis was developed to compare the efficacy of co-treatment with traditional Chinese medicine (TCM) and letrozole against letrozole monotherapy in the treatment of PCOS. Randomized controlled trials (RCTs) were electronically retrieved from PubMed, Cochrane Library, China Biomedical Literature Database, China National Knowledge Infrastructure and Wanfang Data; related papers that were not available electronically were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and the valid data were analyzed using Revman software (The Cochrane Collaboration, Copenhagen, Denmark). We included RCTs that compared co-treatment with TCM and letrozole against letrozole monotherapy in women with PCOS, which was defined by anovulation, biochemical or clinical hyperandrogenemia and polycystic ovaries. We included trials from all sources. Two independent reviewers extracted data, and evaluated study quality according to the Cochrane Handbook for Systematic Reviews of Interventions criteria for RCT, including issues of patient randomization, blinding and bias. Eight RCTs, involving a total of 537 patients, were included in the present study. The meta-analysis showed that the cycle ovulation rate, the pregnancy rate and the total effective rate of symptom treatment were higher in treatments combining TCM with letrozole, compared with letrozole monotherapy. Although the rate of luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and the body mass index of the group receiving combined therapy were lower than in letrozole monotherapy, no statistical difference was found in the LH and FSH level between the two groups. Available evidence showed that co-treatment with TCM and letrozole was more effective than letrozole monotherapy in the treatment of PCOS.

Direct Oral Anticoagulants and Vitamin K Antagonists for Treatment of Deep Venous Thrombosis and Pulmonary Embolism in the Outpatient Setting: Comparative Economic Evaluation

PubMed Central

Al Saleh, Abdullah S; Berrigan, Patrick; Anderson, David; Shivakumar, Sudeep

2017-01-01

Background To date, there have been few economic evaluations, from a Canadian perspective, of direct oral anticoagulants (DOACs) for the prevention of recurrent venous thromboembolism (VTE) in patients with acute unprovoked VTE. As a result, there is a lack of consensus about which treatment strategy should be adopted in the clinical setting. Objectives To assess the cost-effectiveness of currently approved anti-coagulant options, in terms of cost per quality-adjusted life-year (QALY) gained, for the prevention of recurrent VTE in patients with unprovoked events managed on an outpatient basis. Methods Microsoft Excel was used to develop a Markov model. Model parameters were determined using published literature, local hospital data, expert opinion, and chart review. The analysis considered the costs associated with pharmaceuticals, laboratory testing, hematologist fees, and treatment of recurrent VTE and major bleeding events. Effectiveness was measured in terms of QALYs, and incremental cost-effectiveness ratios (ICERs) were calculated. Results For treatment lasting 3 months, apixaban represented the most cost-effective DOAC relative to low-molecular-weight heparin (LMWH) + vitamin K antagonist, with an ICER of $7379.66. For 6 months of treatment, apixaban again represented the most cost-effective treatment, with an ICER of $84.08 per QALY gained, and this drug dominated all the other strategies at 12 months. For lifetime treatment, DOACs were unlikely to be cost-effective, given a maximum willingness to pay of $50 000 to $100 000 per QALY. In a probabilistic sensitivity analysis at 6 months, 46.4% of iterations resulted in apixaban having lower costs and better outcomes than LMWH + vitamin K antagonist, and 78.6% of iterations resulted in an ICER below $100 000 Conclusions The findings of this study suggest that apixaban is likely cost-effective for treatment durations of 3, 6, and 12 months. However, for indefinite treatment, DOACs were unlikely to be cost-effective. PMID:28680172

Artificially regenerating longleaf pine on wet sites: preliminary analysis of effects of site preparation treatments on early survival and growth

Treesearch

Benjamin O. Knapp; G. Geoff Wang; Joan L. Walker

2010-01-01

Our study, conducted over two years on poorly drained, sandy sites in Onslow County, NC, compared the effects of eight common site preparation treatments on early survival and growth of planted longleaf pine seedlings. Through two growing seasons, we found survival to be similar across all treatments (p = 0.8806), but root collar diameter was greatest with combinations...

Early growth hormone treatment start in childhood growth hormone deficiency improves near adult height: analysis from NordiNet® International Outcome Study.

PubMed

Polak, Michel; Blair, Jo; Kotnik, Primoz; Pournara, Effie; Pedersen, Birgitte Tønnes; Rohrer, Tilman R

2017-11-01

To investigate the effect of age at growth hormone (GH) treatment start on near adult height (NAH) in children with isolated GH deficiency (GHD). NordiNet® International Outcome Study (IOS) (Nbib960128), a non-interventional, multicentre study, evaluates the long-term effectiveness and safety of Norditropin® (somatropin) (Novo Nordisk A/S) in the real-life clinical setting. Patients ( n  = 172) treated to NAH (height at ≥18 years, or height velocity <2 cm/year at ≥16 (boys) or ≥15 (girls) years) were grouped by age (years) at treatment start (early (girls, <8; boys, <9), intermediate (girls, 8-10; boys, 9-11) or late (girls, >10; boys, >11)) and GHD severity (<3 ng/mL or 3 to ≤10 ng/mL). Multiple regression analysis was used to evaluate the effect of age at treatment start (as a categorical and continuous variable) on NAH standard deviation score (SDS). Age at treatment start had a marked effect on NAH SDS; NAH SDS achieved by patients starting treatment early ( n  = 40 (boys, 70.0%); least squares mean (standard error) -0.76 (0.14)) exceeded that achieved by those starting later (intermediate, n  = 42 (boys, 57.1%); -1.14 (0.15); late, n  = 90 (boys, 68.9%); -1.21 (0.10)). Multiple regression analysis showed a significant association between NAH SDS and age at treatment start ( P  < 0.0242), baseline height SDS (HSDS) ( P  < 0.0001), target HSDS ( P  < 0.0001), and GHD severity ( P  = 0.0012). Most (78.5%) patients achieved a normal NAH irrespective of age at treatment start. Early initiation of GH treatment in children with isolated GHD improves their chance of achieving their genetic height potential. © 2017 The authors.

The effects of teacher anxiety and modeling on the acquisition of a science teaching skill and concomitant student performance

NASA Astrophysics Data System (ADS)

Koran, John J., Jr.; Koran, Mary Lou

In a study designed to explore the effects of teacher anxiety and modeling on acquisition of a science teaching skill and concomitant student performance, 69 preservice secondary teachers and 295 eighth grade students were randomly assigned to microteaching sessions. Prior to microteaching, teachers were given an anxiety test, then randomly assigned to one of three treatments; a transcript model, a protocol model, or a control condition. Subsequently both teacher and student performance was assessed using written and behavioral measures. Analysis of variance indicated that subjects in the two modeling treatments significantly exceeded performance of control group subjects on all measures of the dependent variable, with the protocol model being generally superior to the transcript model. The differential effects of the modeling treatments were further reflected in student performance. Regression analysis of aptitude-treatment interactions indicated that teacher anxiety scores interacted significantly with instructional treatments, with high anxiety teachers performing best in the protocol modeling treatment. Again, this interaction was reflected in student performance, where students taught by highly anxious teachers performed significantly better when their teachers had received the protocol model. These results were discussed in terms of teacher concerns and a memory model of the effects of anxiety on performance.

Evaluation of Hepatoprotective Effect of Curcumin on Liver Cirrhosis Using a Combination of Biochemical Analysis and Magnetic Resonance-Based Electrical Conductivity Imaging

PubMed Central

Kyung, Eun Jung; Kim, Hyun Bum; Hwang, Eun Sang; Lee, Seok; Choi, Bup Kyung; Lim, Sang Moo; Kwon, Oh In

2018-01-01

In oriental medicine, curcumin is used to treat inflammatory diseases, and its anti-inflammatory effect has been reported in recent research. In this feasibility study, the hepatoprotective effect of curcumin was investigated using a rat liver cirrhosis model, which was induced with dimethylnitrosamine (DMN). Together with biochemical analysis, we used a magnetic resonance-based electrical conductivity imaging method to evaluate tissue conditions associated with a protective effect. The effects of curcumin treatment and lactulose treatment on liver cirrhosis were compared. Electrical conductivity images indicated that liver tissues damaged by DMN showed decreased conductivity compared with normal liver tissues. In contrast, cirrhotic liver tissues treated with curcumin or lactulose showed increased conductivity than tissues in the DMN-only group. Specifically, conductivity of cirrhotic liver after curcumin treatment was similar to that of normal liver tissues. Histological staining and immunohistochemical examination showed significant levels of attenuated fibrosis and decreased inflammatory response after both curcumin and lactulose treatments compared with damaged liver tissues by DMN. The conductivity imaging and biochemical examination results indicate that curcumin's anti-inflammatory effect can prevent the progression of irreversible liver dysfunction. PMID:29887757

A double-blind placebo-controlled cross-over clinical trial of DONepezil In Posterior cortical atrophy due to underlying Alzheimer's Disease: DONIPAD study.

PubMed

Ridha, Basil H; Crutch, Sebastian; Cutler, Dawn; Frost, Christopher; Knight, William; Barker, Suzie; Epie, Norah; Warrington, Elizabeth K; Kukkastenvehmas, Riitta; Douglas, Jane; Rossor, Martin N

2018-05-01

The study investigated whether donepezil exerts symptomatic benefit in patients with posterior cortical atrophy (PCA), an atypical variant of Alzheimer's disease. A single-centre, double-blind, placebo-controlled, cross-over clinical trial was performed to assess the efficacy of donepezil in patients with PCA. Each patient received either donepezil (5 mg once daily in the first 6 weeks and 10 mg once daily in the second 6 weeks) or placebo for 12 weeks. After a 2-week washout period, each patient received the other treatment arm during the following 12 weeks followed by another 2-week washout period. The primary outcome was the Mini-Mental State Examination (MMSE) at 12 weeks. Secondary outcome measures were five neuropsychological tests reflecting parieto-occipital function. Intention-to-treat analysis was used. For each outcome measure, carry-over effects were first assessed. If present, then analysis was restricted to the first 12-week period. Otherwise, the standard approach to the analysis of a 2 × 2 cross-over trial was used. Eighteen patients (13 females) were recruited (mean age 61.6 years). There was a protocol violation in one patient, who subsequently withdrew from the study due to gastrointestinal side effects. There was statistically significant (p < 0.05) evidence of a carry-over effect on MMSE. Therefore, the analysis of treatment effect on MMSE was restricted to the first 12-week period. Treatment effect at 6 weeks was statistically significant (difference = 2.5 in favour of donepezil, 95% CI 0.1 to 5.0, p < 0.05). Treatment effect at 12 weeks was close, but not statistically significant (difference = 2.0 in favour of donepezil, 95% CI -0.1 to 4.5, p > 0.05). There were no statistically significant treatment effects on any of the five neuropsychological tests, except for digit span at 12 weeks (higher by 0.5 digits in favour of placebo, 95% CI 0.1 to 0.9). Gastrointestinal side effects occurred most frequently, affecting 13/18 subjects (72%), and were the cause of study discontinuation in one subject. Nightmares and vivid dreams occurred in 8/18 subjects (44%), and were statistically more frequent during treatment with donepezil. In this small study, there was no statistically significant treatment effect of donepezil on the primary outcome measure (MMSE score at 12 weeks) in PCA patients, who appear to be particularly susceptible to the development of nightmares and vivid dreams when treated. Trial registration: Current Controlled Trials ISRCTN22636071 . Retrospectively registered 19 May 2010.

Maximizing resources in the local treatment of prostate cancer: A summary of cost-effectiveness studies.

PubMed

Muralidhar, Vinayak; Nguyen, Paul L

2017-02-01

Prostate cancer is a common diagnosis with several treatment options for the newly diagnosed patient, including radiation, surgery, active surveillance, and watchful waiting. Although tailoring of treatment to individual patient needs is an important goal, the recent passage of the Affordable Care Act has placed renewed interest in cost containment and cost-effectiveness. We sought to conduct a literature review of recent US-based studies to analyze the cost-effectiveness of initial local treatments for localized prostate cancer. We conducted a systematic literature search through PubMed, the Cost-Effectiveness Analysis Registry, and manual cross-referencing of articles. We identified US-based studies with cost analyses starting in 2005 that studied the cost-effectiveness of initial local treatments for localized prostate cancer (surgery, radiation, or observation). There were eight studies that met our inclusion and exclusion criteria. Most studies took the cost perspective of Medicare, and two studies also considered the societal cost in terms of lost patient time. Most studies also used a Markov model with inputs based on the available literature for the effectiveness and toxicity of the different treatment options. The radiation-focused studies tended to find brachytherapy (BT) or stereotactic body radiation therapy (SBRT) to be more cost-effective than intensity-modulated radiation therapy or proton beam therapy. These findings were primarily based on the lower cost of SBRT or BT with roughly equal efficacy and toxicity. The two studies focused on surgery found surgery to be more cost effective than intensity-modulated radiation therapy, at least for low-risk disease, and one study found BT to be more cost-effective than surgery, and watchful waiting to be the most cost-effective option overall. Cost-effectiveness analysis is important because it helps patients, physicians, and policymakers make quantitatively-based decisions, which balance treatment efficacy, toxicity, and costs. Significant methodological heterogeneity in the studies we found limit the ability to compare their results directly, but most found that for favorable-risk prostate cancer, shorter or simpler treatments tended to be more cost-effective, including no treatment (watchful waiting) in one study. Copyright © 2017 Elsevier Inc. All rights reserved.

Greater first year effectiveness drives favorable cost-effectiveness of brand risedronate versus generic or brand alendronate: modeled Canadian analysis

PubMed Central

Papaioannou, A.; Thompson, M. F.; Pasquale, M. K.; Adachi, J. D.

2016-01-01

Summary The RisedronatE and ALendronate (REAL) study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data from real-world clinical practice. Using a published osteoporosis model, the researchers found risedronate to be cost-effective compared to generic or brand alendronate for the treatment of Canadian postmenopausal osteoporosis in patients aged 65 years or older. Introduction The REAL study provides robust data on the real-world performance of risedronate and alendronate. The study used these data to assess the cost-effectiveness of brand risedronate versus generic or brand alendronate for treatment of Canadian postmenopausal osteoporosis patients aged 65 years or older. Methods A previously published osteoporosis model was populated with Canadian cost and epidemiological data, and the estimated fracture risk was validated. Effectiveness data were derived from REAL and utility data from published sources. The incremental cost per quality-adjusted life-year (QALY) gained was estimated from a Canadian public payer perspective, and comprehensive sensitivity analyses were conducted. Results The base case analysis found fewer fractures and more QALYs in the risedronate cohort, providing an incremental cost per QALY gained of $3,877 for risedronate compared to generic alendronate. The results were most sensitive to treatment duration and effectiveness. Conclusions The REAL study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data taken from real-world clinical practice. The analysis supports the cost-effectiveness of risedronate compared to generic or brand alendronate and the use of risedronate for the treatment of osteoporotic Canadian women aged 65 years or older with a BMD T-score ≤−2.5. PMID:18008100

Relaxation training for anxiety: a ten-years systematic review with meta-analysis

PubMed Central

Manzoni, Gian Mauro; Pagnini, Francesco; Castelnuovo, Gianluca; Molinari, Enrico

2008-01-01

Background Relaxation training is a common treatment for anxiety problems. Lacking is a recent quantitative meta-analysis that enhances understanding of the variability and clinical significance of anxiety reduction outcomes after relaxation treatment. Methods All studies (1997–2007), both RCT, observational and without control group, evaluating the efficacy of relaxation training (Jacobson's progressive relaxation, autogenic training, applied relaxation and meditation) for anxiety problems and disorders were identified by comprehensive electronic searches with Pubmed, Psychinfo and Cochrane Registers, by checking references of relevant studies and of other reviews. Our primary outcome was anxiety measured with psychometric questionnaires. Meta-analysis was undertaken synthesizing the data from all trials, distinguishing within and between effect sizes. Results 27 studies qualified for the inclusion in the meta-analysis. As hypothesized, relaxation training showed a medium-large effect size in the treatment of anxiety. Cohen's d was .57 (95% CI: .52 to .68) in the within analysis and .51 (95% CI: .46 to .634) in the between group analysis. Efficacy was higher for meditation, among volunteers and for longer treatments. Implications and limitations are discussed. Conclusion The results show consistent and significant efficacy of relaxation training in reducing anxiety. This meta-analysis extends the existing literature through facilitation of a better understanding of the variability and clinical significance of anxiety improvement subsequent to relaxation training. PMID:18518981

Comparison of curative effect of 131I and antithyroid drugs in Graves' disease: a meta analysis.

PubMed

Yuan, Ju; Lu, Xiuqing; Yue, Yan

2017-03-01

Radioactive 131I is currently reported to be a potential effective intervention for Graves' Disease treatment in China. Whether 131I treatment was associated with effective outcome or reduced risk of side effects, reccurence rate remained unknown. Eligible studies were selected from Chinese VIP, Wangfang, CNKI databases using the keywords "Iodine" and "Graves Disease". Finally, 13 clinical trials met the inclusion criterion and were included this meta-analysis. Our meta-analysis included 1355 patients diagnosed of Graves' Disease with regular anti-thyroid drugs oral administration and 1320 patients with 131I therapy. The results showed that there was significant symptom improvement with radioactive iodine intervention (Odd Ratio (OR)=4.50, 95% CI [3.55, 5.71], P<0.01). 3 studies mentioned side effects, 6 mentioned reccurence rate and another 6 mentioned hypothyroidism. The ORs and 95%CIs for these subgroups were 0.12 [0.06, 0.21], 0.08 [0.05, 0.13] and 2.27 [1.77, 2.92] respectively. It means a significant reduction of side effects and reccurence rate but increased hypothyroidism after 131I intervention in Graves' Disease. Treatment with 131I was associated with better clinical outcome; it reduced side effects and reccurence rate but increased hypothyroidism in Graves' Disease.

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

"I Need to Talk about It": A Qualitative Analysis of Trauma-Exposed Women's Reasons for Treatment Choice

ERIC Educational Resources Information Center

Angelo, Frank N.; Miller, Helen E.; Zoellner, Lori A.; Feeny, Norah C.

2008-01-01

A significant proportion of individuals suffering from posttraumatic stress disorder do not seek or receive effective treatment. Understanding the reasons why an individual chooses to seek treatment or prefers one treatment to another is a critical step to improve treatment seeking. To begin to understand these reasons, we conducted a qualitative…

Comparative Effectiveness of a Bioengineered Living Cellular Construct and Cryopreserved Cadaveric Skin Allograft for the Treatment of Venous Leg Ulcers in a Real-World Setting

PubMed Central

Treadwell, Terry; Sabolinski, Michael L.; Skornicki, Michelle; Parsons, Nathan B.

2018-01-01

Objective: A variety of advanced biological therapies are available for the treatment of chronic wounds such as venous leg ulcers (VLUs), but real-world comparative effectiveness data that can help guide decisions around treatments are currently lacking. Approach: This analysis was designed to compare the effectiveness of a bioengineered living cellular construct (BLCC) to a cryopreserved cadaveric skin allograft (CCSA) for the treatment of VLUs. Treatment records were collected from a large wound care-specific electronic medical record database on 717 patients (799 VLUs) receiving treatment at 177 wound care centers. Ulcers ≥28 days duration, between ≥1 and < 40 cm2 that closed ≤40% within the 28 days before treatment were included. Results: Patient baseline demographics and wound characteristics were comparable between groups. The median time to wound closure was 52% faster with BLCC compared with CCSA (15 weeks vs. 31 weeks). In addition, the proportion of wounds healed were significantly higher for BLCC by 12 weeks (42% vs. 24%) and 24 weeks (65% vs. 41%) (p = 0.0002). Treatment with BLCC increased the probability of healing by 97% compared with CCSA (hazard ratio = 1.97 [95% confidence interval 1.39–2.79], p = 0.0002). Innovation: This is the first real-world comparative effectiveness analysis to evaluate BLCC and CCSA for the treatment of VLUs. Conclusion: Treatment with a bioengineered cellular technology significantly improved the incidence and speed of wound closure compared with a CCSA. PMID:29644144

Evidence-based treatment of atopic dermatitis with topical moisturizers.

PubMed

Micali, Giuseppe; Paternò, Valentina; Cannarella, Rossella; Dinotta, Franco; Lacarrubba, Francesco

2018-06-01

Skin barrier restoration represents the mainstay of the treatment of atopic dermatitis and the use of moisturizers is recommended by several international guidelines. The aim of the study was to investigate through an evidence-based medicine analysis the effectiveness and safety of different moisturizing products available for a non-pharmacological treatment of atopic dermatitis. A total of 92 randomized controlled trials (RCTs) have been identified and analyzed. The results confirm the presence of a reasonable number of studies highlighting moisturizers safety and effectiveness in the treatment of atopic dermatitis by improving disease severity, increasing the time of relapse and reducing the time of flares. Moisturizers containing urea, glycerin or glycyrrhetinic acid seem to show the greater evidence of efficacy being supported by more clinical trials. Among the existing moisturizers, those containing a single agent generally work although the heterogeneity of RCTs does not allow reaching more definitive conclusions. Moisturizers made of a mixture of substances seem to be more effective thanks to the presence of different active substances that may exert a synergistic effect. A meta-analysis of 4 RCTs confirms the efficacy of a medical device containing glycyrrhetinic acid, hyaluronic acid, shea butter, telmesteine, and vitis vinifera in the treatment of atopic dermatitis.

Neural mechanisms associated with treatment decision making: An fMRI study.

PubMed

Abidi, Malek; Bruce, Jared; Le Blanche, Alain; Bruce, Amanda; Jarmolowicz, David P; Csillik, Antonia; Thai, N Jade; Lim, Seung-Lark; Heinzlef, Olivier; de Marco, Giovanni

2018-04-23

Great progress has been made in understanding how people make financial decisions. However, there is little research on how people make health and treatment choices. Our study aimed to examine how participants weigh benefits (reduction in disease progression) and probability of risk (medications' side effects) when making hypothetical treatment decisions, and to identify the neural networks implicated in this process. Fourteen healthy participants were recruited to perform a treatment decision probability discounting task using MRI. Behavioral responses and skin conductance responses (SCRs) were measured. A whole brain analysis were performed to compare activity changes between "mild" and "severe" medications' side effects conditions. Then, orbitofrontal cortex (OFC), ventral striatum (VS), amygdala and insula were chosen for effective connectivity analysis. Behavioral data showed that participants are more likely to refuse medication when side effects are high and efficacy is low. SCRs values were significantly higher when people made medication decisions in the severe compared to mild condition. Functionally, OFC and VS were activated in the mild condition and were associated with increased likehood of choosing to take medication (higher area under the curve "AUC" side effects/efficacy). These regions also demonstrated an increased effective connectivity when participants valued treatment benefits. By contrast, the OFC, insula and amygdala were activated in the severe condition and were associated with and increased likelihood to refuse treatment. These regions showed enhanced effective connectivity when participants were confronted with increased side effects severity. This is the first study to examine the behavioral and neural bases of medical decision making. Copyright © 2018 Elsevier B.V. All rights reserved.

The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

2017-01-01

Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

Opiate treatment for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Cole, M J; Jeffery, H E

2002-01-01

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using an opiate, compared to a sedative or non-pharmacological treatment, for treatment of NAS due to withdrawal from opiates. The evidence for use of different opiates was assessed in subgroup analyses. The standard search strategy of the Cochrane Neonatal Review Group including searches (up to March 2002) of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), MEDLINE (1966-March 2002), previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to opiate or control. Control could include an opiate, sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included control of symptoms, seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using relative risk (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Six studies enrolling a total of 511 infants met inclusion criteria (Carin 1983, Finnegan 1984, Kaltenbach 1986, Kandall 1983, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. The studies enrolled infants of mothers who had used opiates with or without other drugs during pregnancy. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in four studies. Opiate (morphine) vs supportive care only: One study (Khoo 1995) found no significant effect on treatment failure (RR 1.29, 95% CI 0.41, 4.07), a significant increase in hospital stay (MD 15.0 days, 95% CI 8.9, 21.1) and significant reductions in time to regain birthweight (MD -2.8 days, 95% -5.3, -0.3) and duration of supportive care (MD -197.2 minutes/day, 95% CI -274.2, -120.3). Opiate vs phenobarbital: Meta-analysis of three studies found no significant difference in treatment failure (typical RR 0.78, 95% CI 0.46, 1.32). One of these studies (Finnegan 1984) reported that opiate treatment resulted in a significant reduction in treatment failure among infants of mothers who had used only opiates; however, as this was a post-hoc analysis, this result should be interpreted with caution. One study (Kandall 1983) reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate vs diazepam: Meta-analysis of two studies found a significant reduction in treatment failure (RR 0.43, 95% CI 0.23, 0.80) with the use of opiate. No study reported neurodevelopment by allocated treatment group. Opiates, as compared to supportive care only, appear to reduce the time to regain birth weight and reduce the duration of supportive care, but increase the duration of hospital stay; there is no evidence of effect on treatment failure. When compared to phenobarbital, opiates may reduce the incidence of seizures but, overall, there is no evidence of effect on treatment failure. When compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that treatment effects may vary according to whether the population includes infants born to all opiate users (i.e. with or without other drug exposure) or is restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution. Further research is needed.

Effect of a single session of muscle-biased therapy on pain sensitivity: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

Gay, Charles W; Alappattu, Meryl J; Coronado, Rogelio A; Horn, Maggie E; Bishop, Mark D

2013-01-01

Background Muscle-biased therapies (MBT) are commonly used to treat pain, yet several reviews suggest evidence for the clinical effectiveness of these therapies is lacking. Inadequate treatment parameters have been suggested to account for inconsistent effects across studies. Pain sensitivity may serve as an intermediate physiologic endpoint helping to establish optimal MBT treatment parameters. The purpose of this review was to summarize the current literature investigating the short-term effect of a single dose of MBT on pain sensitivity in both healthy and clinical populations, with particular attention to specific MBT parameters of intensity and duration. Methods A systematic search for articles meeting our prespecified criteria was conducted using Cumulative Index to Nursing and Allied Health Literature (CINAHL) and MEDLINE from the inception of each database until July 2012, in accordance with guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analysis. Relevant characteristics from studies included type, intensity, and duration of MBT and whether short-term changes in pain sensitivity and clinical pain were noted with MBT application. Study results were pooled using a random-effects model to estimate the overall effect size of a single dose of MBT on pain sensitivity as well as the effect of MBT, dependent on comparison group and population type. Results Reports from 24 randomized controlled trials (23 articles) were included, representing 36 MBT treatment arms and 29 comparative groups, where 10 groups received active agents, 11 received sham/inert treatments, and eight received no treatment. MBT demonstrated a favorable and consistent ability to modulate pain sensitivity. Short-term modulation of pain sensitivity was associated with short-term beneficial effects on clinical pain. Intensity of MBT, but not duration, was linked with change in pain sensitivity. A meta-analysis was conducted on 17 studies that assessed the effect of MBT on pressure pain thresholds. The results suggest that MBT had a favorable effect on pressure pain thresholds when compared with no-treatment and sham/inert groups, and effects comparable with those of other active treatments. Conclusion The evidence supports the use of pain sensitivity measures by future research to help elucidate optimal therapeutic parameters for MBT as an intermediate physiologic marker. PMID:23403507

Recent advances in behavioral addiction treatments: focusing on mechanisms of change.

PubMed

Longabaugh, Richard; Magill, Molly

2011-10-01

In the latter half of the 20th century, research on behavioral treatments for addictions aimed to develop and test effective treatments. Among the treatments found to be at least moderately effective, direct comparisons failed to reveal consistent superiority of one approach over another. This ubiquitous finding held true despite underlying theories that differed markedly in their proposed causal processes related to patient change. In the 21st century, the focus of treatment research is increasingly on how treatment works for whom rather than whether it works. Studies of active treatment ingredients and mechanisms of behavioral change, while promising, have yielded inconsistent results. Simple mediation analysis may need to be expanded via inclusion of models testing for moderated mediation, mediated moderation, and conditional indirect effects. Examples are offered as to how these more complex models can lead to increased understanding of the conditions under which specific treatment interventions will be effective and mechanisms of change operative in improving behavioral treatments for addictions.

Recent Advances in Behavioral Addiction Treatments: Focusing on Mechanisms of Change

PubMed Central

Longabaugh, Richard; Magill, Molly

2012-01-01

In the latter half of the 20th century, research on behavioral treatments for addictions aimed to develop and test effective treatments. Among treatments found to be at least moderately effective, direct comparisons failed to reveal consistent superiority of one approach over another. This ubiquitous finding held true despite underlying theories that differed markedly in their proposed causal processes related to patient change. In the 21st century the focus of treatment research is increasingly on how treatment works for whom, rather than whether it works. Studies of active treatment ingredients and mechanisms of behavioral change, while promising, have yielded inconsistent results. Simple mediation analysis may need to be expanded by inclusion of models testing for moderated mediation, mediated moderation, and conditional indirect effects. Examples are offered as to how these more complex models can lead to increased understanding of the conditions under which specific treatment interventions will be effective and mechanisms of change operative in improving behavioral treatments for addictions. PMID:21750958

Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials.

PubMed

Fernández-San-Martín, Maria Isabel; Masa-Font, Roser; Palacios-Soler, Laura; Sancho-Gómez, Pilar; Calbó-Caldentey, Cristina; Flores-Mateo, Gemma

2010-06-01

Insomnia is an often seen primary health care problem. Valerian might be an alternative treatment with fewer secondary effects. The aim of this study is to evaluate its effectiveness on insomnia through a meta-analysis of published literature. Search for randomized clinical trials (RCTs) of Valerian preparations compared with a placebo on Medline, the Cochrane Library, Embase and Biosis. sleep-quality improvement (SQ, yes/no), sleep-quality improvement quantified through visual analogical scales (SQS) and the latency time (LT) in minutes until getting to sleep. Three meta-analyses were carried out using inverse-variance weighted random effects models. Heterogeneity was determined with the Q-statistic and was explored through a sub-groups analysis. Publication bias was evaluated using the funnel plot. Eighteen RCTs were selected; eight had a score of 5 on Jadad's scale. The mean differences in LT between the Valerian and placebo treatment groups was 0.70 min (95% CI, -3.44 to 4.83); the standardized mean differences between the groups measured with SQS was -0.02 (95% CI, -0.35 to 0.31); treatment with Valerian showed a relative risk of SQ of 1.37 (95% CI, 1.05-1.78) compared with the placebo group. There was heterogeneity in the three meta-analyses, but it diminished in the sub groups analysis. No publication bias was detected. The qualitative dichotomous results suggest that valerian would be effective for a subjective improvement of insomnia, although its effectiveness has not been demonstrated with quantitative or objective measurements. We recommend future investigations oriented toward improving insomnia with other more promising treatments. Copyright 2010 Elsevier B.V. All rights reserved.

Personalized Medicine Enrichment Design for DHA Supplementation Clinical Trial.

PubMed

Lei, Yang; Mayo, Matthew S; Carlson, Susan E; Gajewski, Byron J

2017-03-01

Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate. We performed a meta-analysis to obtain informative prior distributions and simulated operating characteristics to ensure that overall Type I error rate was close to 0.05 in designs with three different models: independent, hierarchical, and dynamic linear models. We performed simulations and sensitivity analysis to examine the subgroup power of models and compared results to a chi-square test. We performed simulations under two hypotheses: a large overall treatment effect and a small overall treatment effect. Within each hypothesis, we designed three different subgroup effects scenarios where resulting subgroup rates are linear, flat, or nonlinear. When the resulting subgroup rates are linear or flat, dynamic linear model appeared to be the most powerful method to identify the subgroups with a treatment effect. It also outperformed other methods when resulting subgroup rates are nonlinear and the overall treatment effect is big. When the resulting subgroup rates are nonlinear and the overall treatment effect is small, hierarchical model and chi-square test did better. Compared to independent and hierarchical models, dynamic linear model tends to be relatively robust and powerful when the control arm has ordinal risk subgroups.

Using permutation tests to enhance causal inference in interrupted time series analysis.

PubMed

Linden, Ariel

2018-06-01

Interrupted time series analysis (ITSA) is an evaluation methodology in which a single treatment unit's outcome is studied serially over time and the intervention is expected to "interrupt" the level and/or trend of that outcome. The internal validity is strengthened considerably when the treated unit is contrasted with a comparable control group. In this paper, we introduce a robustness check based on permutation tests to further improve causal inference. We evaluate the effect of California's Proposition 99 for reducing cigarette sales by iteratively casting each nontreated state into the role of "treated," creating a comparable control group using the ITSAMATCH package in Stata, and then evaluating treatment effects using ITSA regression. If statistically significant "treatment effects" are estimated for pseudotreated states, then any significant changes in the outcome of the actual treatment unit (California) cannot be attributed to the intervention. We perform these analyses setting the cutpoint significance level to P > .40 for identifying balanced matches (the highest threshold possible for which controls could still be found for California) and use the difference in differences of trends as the treatment effect estimator. Only California attained a statistically significant treatment effect, strengthening confidence in the conclusion that Proposition 99 reduced cigarette sales. The proposed permutation testing framework provides an additional robustness check to either support or refute a treatment effect identified in for the true treated unit in ITSA. Given its value and ease of implementation, this framework should be considered as a standard robustness test in all multiple group interrupted time series analyses. © 2018 John Wiley & Sons, Ltd.

Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators.

PubMed

Olatunji, Bunmi O; Kauffman, Brooke Y; Meltzer, Sari; Davis, Michelle L; Smits, Jasper A J; Powers, Mark B

2014-07-01

The present investigation employed meta-analysis to examine the efficacy of cognitive-behavioral therapy (CBT) for hypochondriasis/health anxiety as well as potential moderators that may be associated with outcome. A literature search revealed 15 comparisons among 13 randomized-controlled trials (RCTs) with a total sample size of 1081 participants that met inclusion criteria. Results indicated that CBT outperformed control conditions on primary outcome measures at post-treatment (Hedges's g = 0.95) and at follow-up (Hedges's g = 0.34). CBT also outperformed control conditions on measures of depression at post-treatment (Hedges's g = 0.64) and at follow-up (Hedges's g = 0.35). Moderator analyses revealed that higher pre-treatment severity of hypochondriasis/health anxiety was associated with greater effect sizes at follow-up visits and depression symptom severity was significantly associated with a lower in effect sizes at post-treatment. Although effect size did not vary as a function of blind assessment, smaller effect sizes were observed for CBT vs. treatment as usual control conditions than for CBT vs. waitlist control. A dose response relationship was also observed, such that a greater number of CBT sessions was associated with larger effect sizes at post-treatment. This review indicates that CBT is efficacious in the treatment of hypochondriasis/health anxiety and identifies potential moderators that are associated with outcome. The implications of these findings for further delineating prognostic and prescriptive indicators of CBT for hypochondriasis/health anxiety are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules.

PubMed

Robertson, David S; Prevost, A Toby; Bowden, Jack

2016-09-30

Seamless phase II/III clinical trials offer an efficient way to select an experimental treatment and perform confirmatory analysis within a single trial. However, combining the data from both stages in the final analysis can induce bias into the estimates of treatment effects. Methods for bias adjustment developed thus far have made restrictive assumptions about the design and selection rules followed. In order to address these shortcomings, we apply recent methodological advances to derive the uniformly minimum variance conditionally unbiased estimator for two-stage seamless phase II/III trials. Our framework allows for the precision of the treatment arm estimates to take arbitrary values, can be utilised for all treatments that are taken forward to phase III and is applicable when the decision to select or drop treatment arms is driven by a multiplicity-adjusted hypothesis testing procedure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

A meta-analysis of hypnosis for chronic pain problems: a comparison between hypnosis, standard care, and other psychological interventions.

PubMed

Adachi, Tomonori; Fujino, Haruo; Nakae, Aya; Mashimo, Takashi; Sasaki, Jun

2014-01-01

Hypnosis is regarded as an effective treatment for psychological and physical ailments. However, its efficacy as a strategy for managing chronic pain has not been assessed through meta-analytical methods. The objective of the current study was to conduct a meta-analysis to assess the efficacy of hypnosis for managing chronic pain. When compared with standard care, hypnosis provided moderate treatment benefit. Hypnosis also showed a moderate superior effect as compared to other psychological interventions for a nonheadache group. The results suggest that hypnosis is efficacious for managing chronic pain. Given that large heterogeneity among the included studies was identified, the nature of hypnosis treatment is further discussed.

Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis.

PubMed

Kirsch, I; Montgomery, G; Sapirstein, G

1995-04-01

A meta-analysis was performed on 18 studies in which a cognitive-behavioral therapy was compared with the same therapy supplemented by hypnosis. The results indicated that the addition of hypnosis substantially enhanced treatment outcome, so that the average client receiving cognitive-behavioral hypnotherapy showed greater improvement than at least 70% of clients receiving nonhypnotic treatment. Effects seemed particularly pronounced for treatments of obesity, especially at long-term follow-up, indicating that unlike those in nonhypnotic treatment, clients to whom hypnotic inductions had been administered continued to lose weight after treatment ended. These results were particularly striking because of the few procedural differences between the hypnotic and nonhypnotic treatments.

The enduring effects of psychodynamic treatments vis-a-vis alternative treatments: A multilevel longitudinal meta-analysis

NASA Astrophysics Data System (ADS)

Kivlighan, D. Martin, III

Although evidence suggests that the benefits of psychodynamic treatments are sustained over time, presently it is unclear whether these sustained benefits are superior to non-psychodynamic treatments. Additionally, the extant literature comparing the sustained benefits of psychodynamic treatments compared to alternative treatments is limited with methodological shortcomings. The purpose of the current study was to conduct a rigorous test of the growth of the benefits of psychodynamic treatments relative to alternative treatments across distinct domains of change (i.e., all outcome measures, targeted outcome measures, non-targeted outcome measures, and personality outcome measures). To do so, the study employed strict inclusion criteria to identify randomized clinical trials that directly compared at least one bona fide psychodynamic treatment and one bona fide non-psychodynamic treatment. Hierarchical linear modeling (Raudenbush, Bryk, Cheong & Congdon, du Toit, 2011) was used to longitudinally model the impact of psychodynamic treatments compared to non-psychodynamic treatments at post-treatment and to compare the growth (i.e., slope) of effects beyond treatment completion. Findings from the present meta-analysis indicated that psychodynamic treatments and non-psychodynamic treatments were equally efficacious at post-treatment and at follow-up for combined outcomes ( k = 20), targeted outcomes (k =19), non-targeted outcomes (k =17), and personality outcomes (k =6). Clinical implications, directions for future research, and limitations are discussed.

Combining synthetic controls and interrupted time series analysis to improve causal inference in program evaluation.

PubMed

Linden, Ariel

2018-04-01

Interrupted time series analysis (ITSA) is an evaluation methodology in which a single treatment unit's outcome is studied over time and the intervention is expected to "interrupt" the level and/or trend of the outcome. The internal validity is strengthened considerably when the treated unit is contrasted with a comparable control group. In this paper, we introduce a robust evaluation framework that combines the synthetic controls method (SYNTH) to generate a comparable control group and ITSA regression to assess covariate balance and estimate treatment effects. We evaluate the effect of California's Proposition 99 for reducing cigarette sales, by comparing California to other states not exposed to smoking reduction initiatives. SYNTH is used to reweight nontreated units to make them comparable to the treated unit. These weights are then used in ITSA regression models to assess covariate balance and estimate treatment effects. Covariate balance was achieved for all but one covariate. While California experienced a significant decrease in the annual trend of cigarette sales after Proposition 99, there was no statistically significant treatment effect when compared to synthetic controls. The advantage of using this framework over regression alone is that it ensures that a comparable control group is generated. Additionally, it offers a common set of statistical measures familiar to investigators, the capability for assessing covariate balance, and enhancement of the evaluation with a comprehensive set of postestimation measures. Therefore, this robust framework should be considered as a primary approach for evaluating treatment effects in multiple group time series analysis. © 2018 John Wiley & Sons, Ltd.

Stepped wedge designs: insights from a design of experiments perspective.

PubMed

Matthews, J N S; Forbes, A B

2017-10-30

Stepped wedge designs (SWDs) have received considerable attention recently, as they are potentially a useful way to assess new treatments in areas such as health services implementation. Because allocation is usually by cluster, SWDs are often viewed as a form of cluster-randomized trial. However, since the treatment within a cluster changes during the course of the study, they can also be viewed as a form of crossover design. This article explores SWDs from the perspective of crossover trials and designed experiments more generally. We show that the treatment effect estimator in a linear mixed effects model can be decomposed into a weighted mean of the estimators obtained from (1) regarding an SWD as a conventional row-column design and (2) a so-called vertical analysis, which is a row-column design with row effects omitted. This provides a precise representation of "horizontal" and "vertical" comparisons, respectively, which to date have appeared without formal description in the literature. This decomposition displays a sometimes surprising way the analysis corrects for the partial confounding between time and treatment effects. The approach also permits the quantification of the loss of efficiency caused by mis-specifying the correlation parameter in the mixed-effects model. Optimal extensions of the vertical analysis are obtained, and these are shown to be highly inefficient for values of the within-cluster dependence that are likely to be encountered in practice. Some recently described extensions to the classic SWD incorporating multiple treatments are also compared using the experimental design framework. Copyright © 2017 John Wiley & Sons, Ltd.

Changes in illness perceptions mediated the effect of cognitive behavioural therapy in severe functional somatic syndromes.

PubMed

Christensen, Sara Sletten; Frostholm, Lisbeth; Ørnbøl, Eva; Schröder, Andreas

2015-04-01

Although there is substantial evidence that cognitive behavioural therapy alleviates symptoms in functional somatic syndromes, the mechanisms of change are less investigated. This study examined whether changes in illness perceptions mediated the effect of cognitive behavioural therapy. We analysed additional data from a randomised controlled trial comparing completers of cognitive behavioural group therapy (46 patients) to an enhanced usual care group (66 patients). Proposed mediators (illness perceptions) and primary (physical health) and secondary (somatic symptoms and illness worry) outcomes were assessed by means of questionnaires at referral, baseline, end of treatment, and 10 and 16 months after randomisation. Multiple mediation analysis determined whether (1) changes in specific illness perceptions during treatment mediated the effect of cognitive behavioural therapy (primary analysis), and (2) whether changes in illness perceptions during the whole trial period were associated with improved outcome (secondary analysis). Improvements in illness perceptions during treatment partially mediated the effect of cognitive behavioural therapy on physical health one year after treatment (sum of indirect effects 1.556, BCa 95% CI (0.006; 3.620)). Improving perceived control was particularly important. Changes in illness perceptions from baseline to 16 months after randomisation were associated with clinically meaningful improvements in physical health, somatic symptoms and illness worry during the same period. Our results suggest that changing patients' illness perceptions is an important process in cognitive behavioural therapy for functional somatic syndromes. Challenging patients' own understanding of their illness may hence be a key element of successful treatment. Copyright © 2014 Elsevier Inc. All rights reserved.

Steroid-antivirals treatment versus steroids alone for the treatment of Bell's palsy: a meta-analysis.

PubMed

Dong, Yabing; Zhu, Yong; Ma, Chuan; Zhao, Huaqiang

2015-01-01

To illustrate whether the steroid-antivirals treatment could acquire a better recovery in patients with Bell's palsy than the steroids alone treatment. We conducted an exhaustive search over Pub med/Medline, Ovid, Elsevier search engines and the Cochrane library thereby collecting the randomized controlled trials in the treatment of patients with Bell's palsy with steroid-antivirals and steroids. The qualities of relevant articles were assessed by GRADE, which was used to present the overall quality of evidence as recommended by the Cochrane Handbook for Systematic Reviews of Interventions. Two investigators evaluated these papers independently, and resolved the disagreements by discussion. At last 8 eligible papers (1816 patients included: 896 treated with steroid-antivirals and 920 treated with steroids alone) match the criteria. Owing to the result (chi(2) = 12.57, P = 0.08, I(2) = 44%) presented by the formal test for heterogeneity, the fixed effect meta-analysis model was chosen. The facial muscle recovery between the steroids-antivirals group and the steroids alone group show significant differences (OR = 1.52, 95% CI: 1.20-1.94), while the statistical outcome of adverse effect shows no statistical significance (OR = 1.28, 95% CI: 0.71-2.31). The present meta-analysis indicates that the steroid-antivirals treatment could improve the recovery rate in patients with Bell's palsy when comparing with the steroid alone treatment. This meta-analysis showed that the steroid-antivirals treatment achieved the better outcomes in patients with Bell's palsy. Clinicians should consider that steroid-antivirals therapy is an alternative choice for the patients with Bell's palsy.

Interventions to improve adherence to treatment for paediatric tuberculosis in low- and middle-income countries: a systematic review and meta-analysis

PubMed Central

Weaver, Meaghann S; Lönnroth, Knut; Howard, Scott C; Roter, Debra L

2015-01-01

Abstract Objective To assess the design, delivery and outcomes of interventions to improve adherence to treatment for paediatric tuberculosis in low- and middle-income countries and develop a contextual framework for such interventions. Methods We searched PubMed and Cochrane databases for reports published between 1 January 2003 and 1 December 2013 on interventions to improve adherence to treatment for tuberculosis that included patients younger than 20 years who lived in a low- or middle-income country. For potentially relevant articles that lacked paediatric outcomes, we contacted the authors of the studies. We assessed heterogeneity and risk of bias. To evaluate treatment success – i.e. the combination of treatment completion and cure – we performed random-effects meta-analysis. We identified areas of need for improved intervention practices. Findings We included 15 studies in 11 countries for the qualitative analysis and of these studies, 11 qualified for the meta-analysis – representing 1279 children. Of the interventions described in the 15 studies, two focused on education, one on psychosocial support, seven on care delivery, four on health systems and one on financial provisions. The children in intervention arms had higher rates of treatment success, compared with those in control groups (odds ratio: 3.02; 95% confidence interval: 2.19–4.15). Using the results of our analyses, we developed a framework around factors that promoted or threatened treatment completion. Conclusion Various interventions to improve adherence to treatment for paediatric tuberculosis appear both feasible and effective in low- and middle-income countries. PMID:26600612

Cost-Effectiveness of Cetuximab as First-line Treatment for Metastatic Colorectal Cancer in the United States.

PubMed

Shankaran, Veena; Ortendahl, Jesse D; Purdum, Anna G; Bolinder, Bjorn; Anene, Ayanna M; Sun, Gordon H; Bentley, Tanya G K

2018-01-01

We conducted a cost-effectiveness analysis incorporating recent phase III clinical trial (FIRE-3) data to evaluate clinical and economic tradeoffs associated with first-line treatments of KRAS wild-type (WT) metastatic colorectal cancer (mCRC). A cost-effectiveness model was developed using FIRE-3 data to project survival and lifetime costs of FOLFIRI plus either cetuximab or bevacizumab. Hypothetical KRAS-WT mCRC patients initiated first-line treatment and could experience adverse events, disease progression warranting second-line treatment, or clinical response and hepatic metastasectomy. Model inputs were derived from FIRE-3 and published literature. Incremental cost-effectiveness ratios (ICERs) were reported as US$ per life year (LY) and quality-adjusted life year (QALY). Scenario analyses considered patients with extended RAS mutations and CALGB/SWOG 80405 data; 1-way and probabilistic sensitivity analyses were conducted. Compared with bevacizumab, KRAS-WT patients receiving first-line cetuximab gained 5.7 months of life at a cost of $46,266, for an ICER of $97,223/LY ($122,610/QALY). For extended RAS-WT patients, the ICER was $77,339/LY ($99,584/QALY). Cetuximab treatment was cost-effective 80.3% of the time, given a willingness-to-pay threshold of $150,000/LY. Results were sensitive to changes in survival, treatment duration, and product costs. Our analysis of FIRE-3 data suggests that first-line treatment with cetuximab and FOLFIRI in KRAS (and extended RAS) WT mCRC patients may improve health outcomes and use financial resources more efficiently than bevacizumab and FOLFIRI. This information, in combination with other studies investigating comparative effectiveness of first-line options, can be useful to clinicians, payers, and policymakers in making treatment and resource allocation decisions for mCRC patients.

Repeated intermittent ulipristal acetate in the treatment of uterine fibroids: a cost-effectiveness analysis.

PubMed

Geale, Kirk; Saridogan, Ertan; Lehmann, Matthieu; Arriagada, Pablo; Hultberg, Marcus; Henriksson, Martin

2017-01-01

There are limited treatment options available for women with moderate to severe symptoms of uterine fibroids (UFs) who wish to avoid surgery. For these women, treatment with standard pharmaceuticals such as contraceptives is often insufficient to relieve symptoms, and patients may require surgery despite their wish to avoid it. Clinical trials demonstrate that ulipristal acetate 5 mg (UPA) is an effective treatment for this patient group, but its cost-effectiveness has not been assessed in this population. A decision-analytic model was developed to simulate a cohort of patients in this population under treatment with UPA followed by surgery as needed compared to treatment with iron and non-steroidal anti-inflammatory drug (NSAID) followed by surgery as needed (best supportive care, BSC). The analysis took the perspective of the National Health Service (NHS) in England, UK, and was based on the published UPA clinical trials. Results were calculated for the long-term costs and quality-adjusted life years (QALYs) for each treatment arm and combined into an incremental cost-effectiveness ratio (ICER) as the primary outcome. The impact of parameter uncertainty on the results was assessed using scenario, deterministic, and probabilistic sensitivity analyses. The results show that treating patients with the UPA strategy, instead of the BSC strategy, results in an additional cost of £1,115 and a gain of 0.087 QALYs, resulting in an ICER of £12,850. Given commonly accepted cost-effectiveness thresholds in England, the use of UPA as a repeated, intermittent treatment for women with moderate to severe symptoms of UF wishing to avoid surgery is likely to be a cost-effective intervention when compared to BSC.

Coping strategies as a mediator of internet-delivered psychosocial treatment: Secondary analysis from a NIDA CTN multisite effectiveness trial.

PubMed

Lévesque, Annie; Campbell, Aimee N C; Pavlicova, Martina; Hu, Mei-Chen; Walker, Robrina; McClure, Erin A; Ghitza, Udi E; Bailey, Genie; Stitzer, Maxine; Nunes, Edward V

2017-02-01

Coping strategies are a predictor of abstinence among patients with substance use disorders. However, little is known regarding the role of coping strategies in the effectiveness of the Community Reinforcement Approach (CRA). Using data from a 12week randomized control trial assessing the effectiveness of the Therapeutic Education System (TES), an internet-delivered version of the CRA combined with contingency management, we tested the role of coping strategies as a mediator of treatment effectiveness. 507 participants entering 10 outpatient addiction treatment programs received either treatment-as-usual (TAU), a counselor-delivered treatment (Arm 1), or reduced TAU plus TES wherein 2h of TAU per week were replaced by TES (Arm 2). Abstinence from drugs and alcohol was evaluated using urine toxicology and self-report. Coping strategies were measured using the Coping Strategies Scale-Brief Version. Mediation analyses were done following Baron and Kenny's and path analysis approaches. The average baseline coping strategies scores were not significantly different between the two treatment arms. Overall, TES intervention was significantly associated with higher coping strategies scores when accounting for baseline scores (F 1,1342 =8.3, p=0.004). Additionally, higher coping strategies scores at week 12 were associated with an increased likelihood of abstinence during the last 4weeks of the treatment, while accounting for treatment assignment and baseline abstinence. The effect of TES intervention on abstinence was no longer significant after controlling for coping strategies scores at week 12. Our results support the importance of coping skills as a partial mediator of the effectiveness of an internet-version of the CRA combined with contingency management. Copyright © 2016. Published by Elsevier Ltd.