scholarly journals Clinical Effectiveness and Cost-Effectiveness of Sugammadex for Reversal of Neuromuscular Block: A Rapid Health Technology Assessment

2018 ◽  
Vol 21 ◽  
pp. S6
Author(s):  
P Men ◽  
X Gu ◽  
H Zhang ◽  
S Zhai
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Neuromuscular Block ◽  
Clinical Effectiveness ◽  
Health Technology

scholarly journals Study of the use of antidepressants for depression in dementia: the HTA-SADD trial – a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine

2013 ◽  
Vol 17 (7) ◽  
pp. 1-166 ◽  
Author(s):  
S Banerjee ◽  
J Hellier ◽  
R Romeo ◽  
M Dewey ◽  
M Knapp ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Double Blind ◽  
Data Set ◽  
Double Blind Placebo ◽  
The Impact

ObjectiveDepression is common in dementia, causing considerable distress and other negative impacts. Treating it is a clinical priority, but the evidence base is sparse and equivocal. This trial aimed to determine clinical effectiveness of sertraline and mirtazapine in reducing depression 13 weeks post randomisation compared with placebo.DesignMulticentre, parallel-group, double-blind placebo-controlled randomised controlled trial of the clinical effectiveness of sertraline and mirtazapine with 13- and 39-week follow-up.SettingNine English old-age psychiatry services.ParticipantsA pragmatic trial.Eligibility: probable or possible Alzheimer's disease (AD), depression (4+ weeks) and Cornell Scale for Depression in Dementia (CSDD) score of 8+.Exclusions: clinically too critical (e.g. suicide risk); contraindication to medication; taking antidepressants; in another trial; and having no carer.Interventions(1) Sertraline; (2) mirtazapine; and (3) placebo, all with normal care. Target doses: 150 mg of sertraline or 45 mg of mirtazapine daily.Main outcome measuresOutcome: CSDD score.Randomisation: Allocated 1 : 1 : 1 through Trials Unit, independently of trial team. Stratified block randomisation by centre, with randomly varying block sizes; computer-generated randomisation.Blinding: Double blind: medication and placebo identical for each antidepressant. Referring clinicians, research workers, participants and pharmacies were blind. Statisticians blind until analyses completed.ResultsNumbers randomised: 326 participants randomised (111 placebo, 107 sertraline and 108 mirtazapine).Outcome: Differences in CSDD at 13 weeks from an adjusted linear-mixed model: mean difference (95% CI) placebo–sertraline 1.17 (−0.23 to 2.78;p = 0.102); placebo–mirtazapine 0.01 (−1.37 to 1.38;p = 0.991); and mirtazapine–sertraline 1.16 (−0.27 to 2.60;p = 0.112).Harms: Placebo group had fewer adverse reactions (29/111, 26%) than sertraline (46/107, 43%) or mirtazapine (44/108, 41%;p = 0.017); 39-week mortality equal, five deaths in each group.ConclusionsThis is a trial with negative findings but important clinical implications. The data suggest that the antidepressants tested, given with normal care, are not clinically effective (compared with placebo) for clinically significant depression in AD. This implies a need to change current practice of antidepressants being the first-line treatment of depression in AD. From the data generated we formulated the following recommendations for future work. (1) The secondary analyses presented here suggest that there would be value in carrying out a placebo-controlled trial of the clinical effectiveness and cost-effectiveness of mirtazapine in the management of Behavioural and Psychological Symptoms of Dementia. (2) A conclusion from this study is that it remains both ethical and essential for trials of new medication for depression in dementia to have a placebo arm. (3) Further research is required to evaluate the impact that treatments for depression in people with dementia can have on their carers not only in terms of any impacts on their quality of life, but also the time they spend care-giving. (4) There is a need for research into alternative biological and psychological therapies for depression in dementia. These could include evaluations of new classes of antidepressants (such as venlafaxine) or antidementia medication (e.g. cholinesterase inhibitors). (5) Research is needed to investigate the natural history of depression in dementia in the community when patients are not referred to secondary care services. (6) Further work is needed to investigate the cost modelling results in this rich data set, investigating carer burden and possible moderators to the treatment effects. (7) There is scope for reanalysis of the primary outcome in terms of carer and participant CSDD results.Trial registrationEudraCT Number – 2006–000105–38.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 7. See the HTA programme website for further project information.

scholarly journals The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2 × 2 factorial randomised controlled trial

2015 ◽  
Vol 19 (102) ◽  
pp. 1-104 ◽  
Author(s):  
Mark Thursz ◽  
Ewan Forrest ◽  
Paul Roderick ◽  
Christopher Day ◽  
Andrew Austin ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Alcohol Consumption ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Odds Ratio ◽  
Alcoholic Hepatitis ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Research Network ◽  
Research Centre

BackgroundAlcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patients who have been drinking to excess for prolonged periods, which is characterised by jaundice and liver failure. Severe disease is associated with high short-term mortality. Prednisolone and pentoxifylline (PTX) are recommended in guidelines for treatment of severe AH, but trials supporting their use have given heterogeneous results and controversy persists about their benefit.ObjectivesThe aim of the clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis trial was to resolve the clinical dilemma on the use of prednisolone or PTX.DesignThe trial was a randomised, double-blind, 2 × 2 factorial, multicentre design.SettingSixty-five gastroenterology and hepatology inpatient units across the UK.ParticipantsPatients with a clinical diagnosis of AH who had a Maddrey’s discriminant function value of ≥ 32 were randomised into four arms: A, placebo/placebo; B, placebo/prednisolone; C, PTX/placebo; and D, PTX/prednisolone. Of the 5234 patients screened for the trial, 1103 were randomised and after withdrawals, 1053 were available for primary end-point analysis.InterventionsThose allocated to prednisolone were given 40 mg daily for 28 days and those allocated to PTX were given 400 mg three times per day for 28 days.OutcomesThe primary outcome measure was mortality at 28 days. Secondary outcome measures included mortality or liver transplant at 90 days and at 1 year. Rates of recidivism among survivors and the impact of recidivism on mortality were assessed.ResultsAt 28 days, in arm A, 45 of 269 (16.7%) patients died; in arm B, 38 of 266 (14.3%) died; in arm C, 50 of 258 (19.4%) died; and in arm D, 35 of 260 (13.5%) died. For PTX, the odds ratio for 28-day mortality was 1.07 [95% confidence interval (CI) 0.77 to 1.40;p = 0.686)] and for prednisolone the odds ratio was 0.72 (95% CI 0.52 to 1.01;p = 0.056). In the logistic regression analysis, accounting for indices of disease severity and prognosis, the odds ratio for 28-day mortality in the prednisolone-treated group was 0.61 (95% CI 0.41 to 0.91;p = 0.015). At 90 days and 1 year there were no significant differences in mortality rates between the treatment groups. Serious infections occurred in 13% of patients treated with prednisolone compared with 7% of controls (p = 0.002). At the 90-day follow-up, 45% of patients reported being completely abstinent, 9% reported drinking within safety limits and 33% had an unknown level of alcohol consumption. At 1 year, 37% of patients reported being completely abstinent, 10% reported drinking within safety limits and 39% had an unknown level of alcohol consumption. Only 22% of patients had attended alcohol rehabilitation treatment at 90 days and 1 year.ConclusionsWe conclude that prednisolone reduces the risk of mortality at 28 days, but this benefit is not sustained beyond 28 days. PTX had no impact on survival. Future research should focus on interventions to promote abstinence and on treatments that suppress the hepatic inflammation without increasing susceptibility to infection.Trial registrationThis trial is registered as EudraCT 2009-013897-42 and Current Controlled Trials ISRCTN88782125.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 102. See the NIHR Journals Library website for further project information. The NIHR Clinical Research Network provided research nurse support and the Imperial College Biomedical Research Centre also provided funding.

scholarly journals MRI-guided pulmonary vein isolation for atrial fibrillation: what is good enough? An early health technology assessment

Open Heart ◽  
2019 ◽  
Vol 6 (2) ◽  
pp. e001014
Author(s):  
Steven Wenker ◽  
Chris van Lieshout ◽  
Geert Frederix ◽  
Jeroen van der Heijden ◽  
Peter Loh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Pulmonary Vein ◽  
Technology Assessment ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Health Technology ◽  
Mri Guided ◽  
Effectiveness Threshold

Next to anticoagulation, pulmonary vein isolation (PVI) is the most important interventional procedure in the treatment of atrial fibrillation (AF). Despite widespread clinical application of this therapy, patients often require multiple procedures to reach clinical success. In contrast to conventional imaging modalities, MRI allows direct visualisation of the ablation lesion. Therefore, the use of real-time MRI to guide cardiac electrophysiology procedures may increase clinical effectiveness. An essential aspect, from a decision-making point of view, is the effect on costs and the potential cost-effectiveness of new technologies. Generally, health technology assessment (HTA) studies are performed when innovations are close to clinical application. However, early stage HTA can inform users, researchers and funders about the ultimate clinical and economic potential of a future innovation. Ultimately, this can guide funding allocation. In this study, we performed an early HTA evaluate MRI-guided PVIs.MethodsWe performed an economic evaluation using a decision tree with a time-horizon of 1 year. We calculated the clinical effectiveness (defined as the proportion of patients that is long-term free of AF after a single procedure) required for MRI-guided PVI to be cost-effective compared with conventional treatment.ResultsDepending on the cost-effectiveness threshold (willingness to pay for one additional quality-of-life adjusted life year (QALY), interventional MRI (iMRI) guidance for PVI can be cost-effective if clinical effectiveness is 69.8% (at €80 000/QALY) and 77.1% (at €20 000/QALY), compared with 64% for fluoroscopy-guided procedures.ConclusionUsing an early HTA, we established a clinical effectiveness threshold for interventional MRI-guided PVIs that can inform a clinical implementation strategy. If crucial technologies are developed, it seems plausible that iMRI-guided PVIs will be able to reach this threshold.

scholarly journals Health technology assessment in the United Kingdom

2009 ◽  
Vol 25 (S1) ◽  
pp. 178-181 ◽  
Author(s):  
Michael Drummond ◽  
David Banta
Keyword(s):  
Health Care ◽  
United Kingdom ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Excellence ◽  
Present Situation ◽  
Health Technology ◽  
The United Kingdom ◽  
Short Run

Objectives: The aim of this study was to describe generally the development and present situation with health technology assessment (HTA) in the United Kingdom.Methods: The methods used are a review of important materials that have described the development process and present situation, supplemented by some personal experiences.Results: The United Kingdom has been characterized historically as a country with a strong interest in evidence in health care, both clinical trials for efficacy and cost-effectiveness analyses. However, this evidence was not well-linked to the needs of the National Health Services (NHS) before formation of the NHS R&D Programme in 1991, The R&D Programme brought substantial resources into HTA and related activities, with the central aim of improving health care in Britain and increasing value for money. However, policy makers as well as staff of the R&D Programme were dissatisfied with the use of the HTA results in clinical and administrative practice. Therefore, the National Institute of Clinical Excellence (NICE) was formed in 1999. NICE issues guidance intended to influence practical decision making in health care at the national and local levels, based on efficacy information and, in some cases, economic analyses. NICE is now also seeking ways to maximize impacts on practice.Conclusions: The UK experience shows that information on clinical and cost-effectiveness may not be enough to change practice, at least in the short-run. Still, one may conclude that the United Kingdom now has one of the few most important and influential HTA programs in the world.

scholarly journals Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT

2019 ◽  
Vol 23 (62) ◽  
pp. 1-94 ◽  
Author(s):  
Mark T Drayson ◽  
Stella Bowcock ◽  
Tim Planche ◽  
Gulnaz Iqbal ◽  
Guy Pratt ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Febrile Episodes

Background Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection. However, the use of prophylaxis has not been established in myeloma and may be associated with health-care-associated infections (HCAIs), such as Clostridium difficile. There is a need to assess the benefits and cost-effectiveness of the use of antibacterial prophylaxis against any risks in a double-blind, placebo-controlled, randomised clinical trial. Objectives To assess the risks, benefits and cost-effectiveness of prophylactic levofloxacin in newly diagnosed symptomatic myeloma patients. Design Multicentre, randomised, double-blind, placebo-controlled trial. A central telephone randomisation service used a minimisation computer algorithm to allocate treatments in a 1 : 1 ratio. Setting A total of 93 NHS hospitals throughout England, Northern Ireland and Wales. Participants A total of 977 patients with newly diagnosed symptomatic myeloma. Intervention Patients were randomised to receive levofloxacin or placebo tablets for 12 weeks at the start of antimyeloma treatment. Treatment allocation was blinded and balanced by centre, estimated glomerular filtration rate and intention to give high-dose chemotherapy with autologous stem cell transplantation. Follow-up was at 4-week intervals up to 16 weeks, with a further follow-up at 1 year. Main outcome measures The primary outcome was to assess the number of febrile episodes (or deaths) in the first 12 weeks from randomisation. Secondary outcomes included number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond. Results In total, 977 patients were randomised (levofloxacin, n = 489; placebo, n = 488). A total of 134 (27%) events (febrile episodes, n = 119; deaths, n = 15) occurred in the placebo arm and 95 (19%) events (febrile episodes, n = 91; deaths, n = 4) occurred in the levofloxacin arm; the hazard ratio for time to first event (febrile episode or death) within the first 12 weeks was 0.66 (95% confidence interval 0.51 to 0.86; p = 0.002). Levofloxacin also reduced other infections (144 infections from 116 patients) compared with placebo (179 infections from 133 patients; p-trend of 0.06). There was no difference in new acquisitions of C. difficile, methicillin-resistant Staphylococcus aureus and extended-spectrum beta-lactamase Gram-negative organisms when assessed up to 16 weeks. Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use. With a median follow-up of 52 weeks, there was no significant difference in overall survival (p = 0.94). Limitations Short duration of prophylactic antibiotics and cost-effectiveness. Conclusions During the 12 weeks from new diagnosis, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and deaths without increasing HCAIs or carriage. Future work should aim to establish the optimal duration of antibiotic prophylaxis and should involve the laboratory investigation of immunity, inflammation and disease activity on stored samples funded by the TEAMM (Tackling Early Morbidity and Mortality in Myeloma) National Institute for Health Research Efficacy and Mechanism Evaluation grant (reference number 14/24/04). Trial registration Current Controlled Trials ISRCTN51731976. Funding details This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 62. See the NIHR Journals Library website for further project information.

scholarly journals Assessment of Decisions and Cost-Effectiveness Criteria Considered by Seven Health Technology Assessment Agencies

2016 ◽  
Vol 19 (7) ◽  
pp. A752
Author(s):  
R Puig-Peiró ◽  
L Planellas ◽  
A Gilabert Perramon ◽  
M Roset ◽  
C Barrull ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology

scholarly journals HTA AND VALUE - A COMMENTARY

2013 ◽  
Vol 29 (4) ◽  
pp. 374-375
Author(s):  
Michael D. Rawlins
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Therapeutic Interventions ◽  
Value Proposition ◽  
Costs And Benefits ◽  
Societal Costs ◽  
The Subject ◽  
Policy Forum

The notion of value, in the evaluation of the clinical and cost-effectiveness of therapeutic interventions, was the subject of discussion at the HTAi Policy Forum in February 2013. A summary of its discussions and conclusions is published in this issue of the journal. This commentary considers the implications of the proposal that health technology assessment (HTA) agencies should include, in the value proposition, wider societal costs and benefits as well as incorporating innovative promise.

TeCHO+ program in Gujarat: a protocol for health technology assessment

2020 ◽  
Vol 6 (4) ◽  
pp. 209-214
Author(s):  
Somen Saha ◽  
Priya Kotwani ◽  
Apurvakumar Pandya ◽  
Deepak Saxena ◽  
Tapasvi Puwar ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Community Health ◽  
Technology Assessment ◽  
Tracking System ◽  
Newborn Care ◽  
Health Technology ◽  
The State ◽  
Family Welfare ◽  
The Impact

The Health and Family Welfare Department, Government of Gujarat, is implementing a program named Technology for Community Health Operation or TeCHO+ addressing state’s priority health issues. This program envisages replacing the existing mother and child tracking system or e-Mamta application in the state. This program is based on ImTeCHO—Innovative Mobile Technology for Community Health Operations—which was piloted in Jhagadia, Bharuch district of Gujarat in 2013. The program showed improvements not only in terms of coverage of maternal and newborn care packages averting malnutrition but also was cost-effective. This paper details the protocol for health technology assessment to assess the impact of TeCHO+ program on data quality, improvement in service delivery coverage, reduction in morbidity and mortality as well as assess the cost-effectiveness. The study will be conducted in five districts of the state. A mixed-method approach will be adopted. Data will be validated in a phased manner over a period of 3 years along with an assessment of key outcome indicators. Additionally, key informant interviews will be conducted and cost data will be gathered to perform cost-effectiveness analysis. The study will inform policymakers about the impact of TeCHO+ program on quality, access and cost-effectiveness of healthcare services.

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