scholarly journals Procalcitonin-Guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations (PRECISION): Study Protocol for a Prospective Randomized Controlled Trial.

2022 ◽  
Author(s):  
Michael van Schaik ◽  
Hans in 't Veen ◽  
Guy Brusselle ◽  
Wim Boersma ◽  
Paul Bresser ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Usual Care ◽  
Bacterial Infections ◽  
Controlled Trial ◽  
Treatment Algorithm ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Antibiotic Administration ◽  
The European Union ◽  
Life Years

Abstract Background: Chronic Obstructive Pulmonary Disease (COPD) is a worldwide prevalent disease. It is estimated to be the 3rd leading cause of death worldwide in 2020, and it is also a leading cause of disability-adjusted life years (DALY’s). COPD accounts for just over 3% of the total health care budget in the European Union. The majority of these costs are attributed to acute exacerbations of COPD (AECOPD). Given the contribution of exacerbations, it is of paramount importance to improve the current treatment of exacerbations to reduce the burden of disease for patients (mortality and DALY’s) and for society (costs). Treatment of AECOPD generally consists of corticosteroids and antibiotics, mostly in one-size fits all fashion. Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give. Biomarkers may aid towards a more personalized treatment of AECOPD by identifying which patient would benefit from antibiotics. Procalcitonin (PCT) is the precursor of calcitonin and is released in response to a bacterial infection. PCT levels are minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infections. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. One meta-analysis suggested that PCT-based protocols may be superior to standard care, but the authors stated that appropriately powered confirmatory trials are necessary. The objective of our study is to assess that at hospitalization for a severe AECOPD, PCT-guided treatment to guide antibiotic administration is non-inferior to usual care, in terms of treatment failure at day 30. Methods: The study is set up as a prospective randomized trial. A total of 693 patients with a severe exacerbation of COPD will be included and randomized between usual care and PCT-guided treatment regarding antibiotic therapy. The primary endpoint will be treatment failure within 30 days after inclusion, the endpoint comprises disease-related mortality and other disease-related adverse events. Discussion: We believe this trial can add to the currently available evidence with PCT being tested in a clinical setting in a treatment algorithm specifically in COPD with the primary objective being treatment failure. Trial registration: Netherlands Trial Register. Registration number: NL9122. Date of registration: 24-11-2020. URL of trial registry record: https://www.trialregister.nl/trial/9122

scholarly journals Electroacupuncture with Usual Care for Patients with Non-Acute Pain after Back Surgery: Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial

2020 ◽  
Vol 12 (12) ◽  
pp. 5033
Author(s):  
NamKwen Kim ◽  
Kyung-Min Shin ◽  
Eun-Sung Seo ◽  
Minjung Park ◽  
Hye-Yoon Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Societal Perspective ◽  
National Health ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Acute Low Back Pain ◽  
Life Years ◽  
Back Surgery ◽  
The Cost

Electroacupuncture (EA) is used to treat pain after back surgery. Although this treatment is covered by national health insurance in Korea, evidence supporting its cost-effectiveness and contribution to the sustainability of the national health care system has yet to be published. Therefore, an economic evaluation, alongside a clinical trial, was conducted to estimate the cost-effectiveness of EA and usual care (UC) versus UC alone to treat non-acute low back pain (LBP). In total, 108 patients were recruited and randomly assigned to treatment groups; 106 were included in the final cost utility analysis. The incremental cost-effectiveness ratio of EA plus UC was estimated as 7,048,602 Korean Rate Won (KRW) per quality-adjusted life years (QALYs) from the societal perspective (SP). If the national threshold was KRW 30 million per QALY, the cost-effectiveness probability of EA plus UC was an estimated 85.9%; and, if the national threshold was over KRW 42,496,372 per QALY, the cost-effectiveness probability would be over 95% percent statistical significance. Based on these results, EA plus UC combination therapy for patients with non-acute LBP may be cost-effective from a societal perspective in Korea.

scholarly journals Impact of pre-enrolment medication use on clinical outcomes in SUMMIT

2019 ◽  
Vol 5 (1) ◽  
pp. 00203-2018 ◽  
Author(s):  
Jørgen Vestbo ◽  
Mark Dransfield ◽  
Julie A. Anderson ◽  
Robert D. Brook ◽  
Peter M.A. Calverley ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Prior Treatment ◽  
Study Entry ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Mortality And Morbidity ◽  
Randomised Study ◽  
The Impact

The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality and exacerbations.We used data on 16 417 patients with moderate COPD and heightened cardiovascular risk and information on prior medications to examine the effects of fluticasone furoate (FF), vilanterol (VI) and combined FF/VI compared to placebo on moderate and severe exacerbation as well as mortality. The study was event-driven with a median study exposure of 1.8 years. This study was registered with ClinicalTrials.gov, number NCT01313676.There were no consistent associations between treatment prior to study entry and the effects of FF, VI or FF/VI on exacerbations during the study. However, patients taking inhaled corticosteroids and one or more bronchodilators prior to study entry seemed to have a better effect of active treatments than of placebo on mortality (hazard ratio for FF/VI 0.65, 95% CI 0.48–0.89). Survival in those randomised to placebo was independent of treatment prior to study enrolment.Prior treatment appears to affect treatment effects on mortality but not exacerbations in a randomised controlled trial of patients with COPD and heightened cardiovascular risk.

scholarly journals Cost-effectiveness, cost-utility and the budget impact of antidepressants versus preventive cognitive therapy with or without tapering of antidepressants

BJPsych Open ◽  
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Nicola S. Klein ◽  
Ben F. M. Wijnen ◽  
Joran Lokkerbol ◽  
Erik Buskens ◽  
Hermien J. Elgersma ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cognitive Therapy ◽  
Clinical Training ◽  
Impact Analysis ◽  
Budget Impact ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cost Utility ◽  
The European Union ◽  
Life Years

BackgroundAs depression has a recurrent course, relapse and recurrence prevention is essential.AimsIn our randomised controlled trial (registered with the Nederlands trial register, identifier: NTR1907), we found that adding preventive cognitive therapy (PCT) to maintenance antidepressants (PCT+AD) yielded substantial protective effects versus antidepressants only in individuals with recurrent depression. Antidepressants were not superior to PCT while tapering antidepressants (PCT/−AD). To inform decision-makers on treatment allocation, we present the corresponding cost-effectiveness, cost-utility and budget impact.MethodData were analysed (n = 289) using a societal perspective with 24-months of follow-up, with depression-free days and quality-adjusted life years (QALYs) as health outcomes. Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were derived to provide information about cost-effectiveness. The budget impact was examined with a health economic simulation model.ResultsMean total costs over 24 months were €6814, €10 264 and €13 282 for AD+PCT, antidepressants only and PCT/−AD, respectively. Compared with antidepressants only, PCT+AD resulted in significant improvements in depression-free days but not QALYs. Health gains did not significantly favour antidepressants only versus PCT/−AD. High probabilities were found that PCT+AD versus antidepressants only and antidepressants only versus PCT/−AD were dominant with low willingness-to-pay thresholds. The budget impact analysis showed decreased societal costs for PCT+AD versus antidepressants only and for antidepressants only versus PCT/−AD.ConclusionsAdding PCT to antidepressants is cost-effective over 24 months and PCT with guided tapering of antidepressants in long-term users might result in extra costs. Future studies examining costs and effects of antidepressants versus psychological interventions over a longer period may identify a break-even point where PCT/−AD will become cost-effective.Declaration of interestC.L.H.B. is co-editor ofPLOS Oneand receives no honorarium for this role. She is also co-developer of the Dutch multidisciplinary clinical guideline for anxiety and depression, for which she receives no remuneration. She is a member of the scientific advisory board of the National Insure Institute, for which she receives an honorarium, although this role has no direct relation to this study. C.L.H.B. has presented keynote addresses at conferences, such as the European Psychiatry Association and the European Conference Association, for which she sometimes receives an honorarium. She has presented clinical training workshops, some including a fee. She receives royalties from her books and co-edited books and she developed preventive cognitive therapy on the basis of the cognitive model of A. T. Beck. W.A.N. has received grants from the Netherlands Organisation for Health Research and Development and the European Union and honoraria and speakers' fees from Lundbeck and Aristo Pharma, and has served as a consultant for Daleco Pharma.

scholarly journals Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029207 ◽  
Author(s):  
Jessica Wright ◽  
Alexis Foster ◽  
Cindy Cooper ◽  
Kirsty Sprange ◽  
Stephen Walters ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Assessment Tools ◽  
Secondary Outcome ◽  
Framework Analysis ◽  
Life Years ◽  
Fidelity Assessment ◽  
Randomised Controlled

IntroductionServices are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.Methods and analysisThe RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.Ethics and disseminationREC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.Trial registration numberISRCTN17993825.

scholarly journals Home-based maintenance tele-rehabilitation reduces the risk for acute exacerbations of COPD, hospitalisations and emergency department visits

2017 ◽  
Vol 49 (5) ◽  
pp. 1602129 ◽  
Author(s):  
Maroula Vasilopoulou ◽  
Andriana I. Papaioannou ◽  
Georgios Kaltsakas ◽  
Zafeiris Louvaris ◽  
Nikolaos Chynkiamis ◽  
...  
Keyword(s):  
Emergency Department ◽  
Usual Care ◽  
Lower Risk ◽  
Controlled Trial ◽  
Emergency Department Visits ◽  
Chronic Obstructive ◽  
Copd Exacerbation ◽  
Copd Exacerbations ◽  
Home Based ◽  
Ed Visits

Pulmonary rehabilitation (PR) remains grossly underutilised by suitable patients worldwide. We investigated whether home-based maintenance tele-rehabilitation will be as effective as hospital-based maintenance rehabilitation and superior to usual care in reducing the risk for acute chronic obstructive pulmonary disease (COPD) exacerbations, hospitalisations and emergency department (ED) visits.Following completion of an initial 2-month PR programme this prospective, randomised controlled trial (between December 2013 and July 2015) compared 12 months of home-based maintenance tele-rehabilitation (n=47) with 12 months of hospital-based, outpatient, maintenance rehabilitation (n=50) and also to 12 months of usual care treatment (n=50) without initial PR.In a multivariate analysis during the 12-month follow-up, both home-based tele-rehabilitation and hospital-based PR remained independent predictors of a lower risk for 1) acute COPD exacerbation (incidence rate ratio (IRR) 0.517, 95% CI 0.389–0.687, and IRR 0.635, 95% CI 0.473–0.853), respectively, and 2) hospitalisations for acute COPD exacerbation (IRR 0.189, 95% CI 0.100–0.358, and IRR 0.375, 95% CI 0.207–0.681), respectively. However, only home-based maintenance tele-rehabilitation and not hospital-based, outpatient, maintenance PR was an independent predictor of ED visits (IRR 0.116, 95% CI 0.072–0.185).Home-based maintenance tele-rehabilitation is equally effective as hospital-based, outpatient, maintenance PR in reducing the risk for acute COPD exacerbation and hospitalisations. In addition, it encounters a lower risk for ED visits, thereby constituting a potentially effective alternative strategy to hospital-based, outpatient, maintenance PR.

scholarly journals Procalcitonin to guide antibiotic administration in COPD exacerbations: a meta-analysis

2017 ◽  
Vol 26 (143) ◽  
pp. 160073 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Victoria Chatzimavridou-Grigoriadou ◽  
Alexandru Corlateanu ◽  
Jørgen Vestbo
Keyword(s):  
Bacterial Infections ◽  
Viral Infections ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Chronic Obstructive ◽  
Antibiotic Administration ◽  
Obstructive Pulmonary Disease ◽  
Copd Exacerbations ◽  
Meta Analyses

Challenges in the differentiation of the aetiology of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have led to significant overuse of antibiotics. Serum procalcitonin, released in response to bacterial infections, but not viral infections, could possibly identify AECOPD requiring antibiotics. In this meta-analysis we assessed the clinical effectiveness of procalcitonin-based protocols to initiate or discontinue antibiotics in patients presenting with AECOPD.Based on a prospectively registered protocol, we reviewed the literature and selected randomised or quasi-randomised trials comparing procalcitonin-based protocols to initiate or discontinue antibiotics versus standard care in AECOPD. We followed Cochrane and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidance to assess risk of bias, quality of evidence and to perform meta-analyses.We included eight trials evaluating 1062 patients with AECOPD. Procalcitonin-based protocols decreased antibiotic prescription (relative risk (RR) 0.56, 95% CI 0.43–0.73) and total antibiotic exposure (mean difference (MD) −3.83, 95% CI (−4.32–−3.35)), without affecting clinical outcomes such as rate of treatment failure (RR 0.81, 0.62–1.06), length of hospitalisation (MD −0.76, −1.95–0.43), exacerbation recurrence rate (RR 0.96, 0.69–1.35) or mortality (RR 0.99, 0.58–1.69). However, the quality of the available evidence is low to moderate, because of methodological limitations and small overall study population.Procalcitonin-based protocols appear to be clinically effective; however, confirmatory trials with rigorous methodology are required.

scholarly journals Cost-effectiveness of therapist-delivered online cognitive–behavioural therapy for depression: randomised controlled trial

2010 ◽  
Vol 197 (4) ◽  
pp. 297-304 ◽  
Author(s):  
Sandra Hollinghurst ◽  
Tim J. Peters ◽  
Surinder Kaur ◽  
Nicola Wiles ◽  
Glyn Lewisand ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Qaly Gain ◽  
Cognitive Behavioural ◽  
Life Years ◽  
Randomised Controlled

BackgroundTherapist-delivered online cognitive–behavioural therapy (CBT) has been found to be effective for depression in primary care.AimsTo determine the cost-effectiveness of online CBT compared with usual care.MethodEconomic evaluation at 8 months alongside a randomised controlled trial. Cost to the National Health Service (NHS), personal costs, and the value of lost productivity, each compared with outcomes based on the Beck Depression Inventory and quality-adjusted life-years (QALYs). Incremental analysis indicated the NHS cost per QALY gain.ResultsOnline CBT was more expensive than usual care, although the outcomes for the CBT group were better. Cost per QALY gain based on complete case data was £17 173, and £10 083 when missing data were imputed.ConclusionsOnline CBT delivered by a therapist in real time is likely to be cost-effective compared with usual care if society is willing to pay at least £20 000 per QALY; it could be a useful alternative to face-to-face CBT.

scholarly journals Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial

2018 ◽  
Vol 52 (4) ◽  
pp. 1800063 ◽  
Author(s):  
Ane Arbillaga-Etxarri ◽  
Elena Gimeno-Santos ◽  
Anael Barberan-Garcia ◽  
Eva Balcells ◽  
Marta Benet ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Text Messages ◽  
Chronic Obstructive ◽  
Efficacy Analysis ◽  
Copd Patients ◽  
Randomised Controlled

There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number). The primary outcome was 12-month change in steps·day−1 measured by accelerometer.Efficacy analysis (with per-protocol analysis set, n=233 classified as adherent to the assigned intervention) showed adjusted (95% CI) 12-month difference +957 (184–1731) steps·day−1 between Urban Training and usual care. Effectiveness analysis (with intention-to-treat analysis set, n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients) showed no differences between groups. Leg muscle pain during walks was more frequently reported in Urban Training than usual care, without differences in any of the other adverse events.Urban Training, combining behavioural strategies with unsupervised outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients, with few safety concerns. However, it was ineffective in the full population including unwilling and self-reported non-adherent patients.

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