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Cost-effectiveness of a randomised trial of physical activity in Alzheimer's disease: a secondary analysis exploring patient and proxy-reported health-related quality of life measures in Denmark.

https://arctichealth.org/en/permalink/ahliterature291166
Source
BMJ Open. 2017 Jun 14; 7(6):e015217
Publication Type
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Date
Jun-14-2017
Author
Elizaveta Sopina
Jan Sørensen
Nina Beyer
Steen Gregers Hasselbalch
Gunhild Waldemar
Author Affiliation
Center of Health Economic Research, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
Source
BMJ Open. 2017 Jun 14; 7(6):e015217
Date
Jun-14-2017
Language
English
Publication Type
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Keywords
Aged
Aged, 80 and over
Alzheimer Disease - economics - rehabilitation
Caregivers - psychology
Cost-Benefit Analysis
Denmark
Exercise
Female
Humans
Linear Models
Logistic Models
Male
Middle Aged
Pain Measurement
Psychiatric Status Rating Scales
Quality of Life
Quality-Adjusted Life Years
Abstract
To explore the cost-effectiveness of a supervised moderate-to-high intensity aerobic exercise programme in people diagnosed with Alzheimer's disease (AD) and estimate incremental cost-effectiveness ratios (ICER) using participant-reported and proxy-reported measures of health-related quality of life (HRQoL) DESIGN: A cost-effectiveness analysis of economic and HRQoL data from a randomised trial delivered over 16?weeks.
Memory clinics in Denmark.
200 individuals with mild AD aged 50-90?years gave informed consent to participate in the study. Participants were randomised to control or intervention group.
Control group received treatment as usual. The intervention group performed 1?hour of supervised moderate-to-high intensity aerobic exercise three times weekly for 16?weeks.
Different physical, functional and health measures were obtained at inclusion (baseline) and 4 and 16?weeks after. HRQoL (EuroQol-5 Dimensions-5 Levels/EQ-Visual Analogue Scale) was reported by the participants and the primary caregivers as proxy respondents. Differences in HRQOL as reported by the participant and caregiver were explored as were different values of caregiver time with respite from care tasks.
The intervention cost was estimated at €608 and €496 per participant, with and without transport cost, respectively. Participants and caregivers in the intervention group reported a small, positive non-significant improvement in EQ-5D-5L and EQ-VAS after 16?weeks. The ICER was estimated at €72 000/quality-adjusted life year using participant-reported outcomes and €87000 using caregiver-reported outcomes.
The findings suggest that the exercise intervention is unlikely to be cost-effective within the commonly applied threshold values. The cost of the intervention might be offset by potential savings from reduction in use of health and social care.
https://clinicaltrials.gov/ct2/show/NCT01681602.
Notes
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PubMed ID
28615271 View in PubMed
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Cost-utility analysis of life-long prophylaxis with recombinant factor VIIIFc vs recombinant factor VIII for the management of severe hemophilia A in Sweden.

https://arctichealth.org/en/permalink/ahliterature295028
Source
J Med Econ. 2018 Apr; 21(4):318-325
Publication Type
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Date
Apr-2018
Author
Nathaniel Henry
Jelena Jovanovic
Max Schlueter
Persefoni Kritikou
Koo Wilson
Karl-Johan Myrén
Author Affiliation
a IQVIA , London , UK.
Source
J Med Econ. 2018 Apr; 21(4):318-325
Date
Apr-2018
Language
English
Publication Type
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Keywords
Adolescent
Adult
Aged
Cost-Benefit Analysis
Dose-Response Relationship, Drug
Factor VIII - economics - therapeutic use
Half-Life
Hemophilia A - drug therapy - mortality
Hemorrhage - economics - prevention & control
Humans
Immunoglobulin Fc Fragments - economics - therapeutic use
Male
Markov Chains
Middle Aged
Models, Econometric
Quality of Life
Quality-Adjusted Life Years
Recombinant Fusion Proteins - economics - therapeutic use
Sweden
Young Adult
Abstract
Prophylaxis with recombinant factor VIII (rFVIII) is the standard of care for severe hemophilia A in Sweden. The need for frequent injections with existing rFVIII products may, however, result in poor adherence to prophylaxis, leading to increased bleeding and long-term joint damage. Recombinant FVIIIFc (rFVIIIFc) is an extended half-life fusion protein which can offer prolonged protection and reduced dosing frequency. The objective of this study was to evaluate the cost-utility of prophylaxis with rFVIIIFc in severe hemophilia A from the perspective of the Swedish health system.
A Markov model was built to estimate lifetime costs and benefits of prophylaxis with rFVIIIFc vs rFVIII products. Clinical outcomes were represented by annualized bleeding rate (ABR) and quality of life via disutility applied to bleeding events and injection frequency. Costs included the cost of FVIII for routine prophylaxis and bleed resolution. The pooled comparator was costed by weighting the cost of individual products by their market share.
In the base case, rFVIIIFc was dominant vs the pooled comparator. Savings of SEK 9.0 million per patient resulted from lower factor consumption for prophylaxis and bleed resolution. Fewer bleeds and reduced injection frequency yielded an estimated 0.59 quality-adjusted life years (QALYs). Results were sensitive to drug dosage and robust to variation in other parameters. Probabilistic sensitivity analysis suggested a greater than 85% probability of rFVIIIFc being cost-effective at a willingness-to-pay threshold of 500,000 SEK/QALY.
Due to unavailibilty of patient-level data, treatment benefit was based on a non-adjusted indirect comparison. Dosing and treatment outcomes were assumed to persist over the model duration in the absence of long-term outcome data.
The results suggest that rFVIIIFc may be a cost-effective option for hemophilia A prophylaxis, generating greater quality of life and reduced costs for the Swedish payer compared to more frequently administered rFVIII alternatives.
PubMed ID
29139314 View in PubMed
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Early Vaccine-type Pneumococcal Acute Otitis Media Does not Predispose to Subsequent Otitis When Compared With Early Acute Otitis Media Due to Other Bacterial Etiology.

https://arctichealth.org/en/permalink/ahliterature299210
Source
Pediatr Infect Dis J. 2018 06; 37(6):592-594
Publication Type
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
06-2018
Author
Arto A Palmu
Mika Lahdenkari
Author Affiliation
From the Department of Public Health Solutions, National Institute for Health and Welfare, Tampere, Finland.
Source
Pediatr Infect Dis J. 2018 06; 37(6):592-594
Date
06-2018
Language
English
Publication Type
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Keywords
Child, Preschool
Disease Susceptibility
Double-Blind Method
Female
Finland
Hepatitis B Vaccines - therapeutic use
Humans
Infant
Male
Nasopharynx - microbiology
Otitis Media - etiology - microbiology - prevention & control
Pneumococcal Infections - etiology - prevention & control
Pneumococcal Vaccines - adverse effects - therapeutic use
Streptococcus pneumoniae
Vaccines, Conjugate - administration & dosage - therapeutic use
Abstract
Prevention of acute otitis media (AOM), and especially recurrence and biofilm formation, by pneumococcal conjugate vaccines has been hypothesized to be due to prevention of early episodes triggering the vicious cycle. We tested the specific role of vaccine-type pneumococcal AOM in this hypothesis.
In the phase III randomized, double-blind Finnish otitis media Vaccine Trial conducted in 1995-1999, children received pneumococcal conjugate vaccine 7 or hepatitis B vaccine as control at 2, 4, 6, and 12 months of age and were followed for AOM. Myringotomy with middle ear fluid aspiration was performed in AOM, and samples were cultured. We compared control-vaccinated children with confirmed vaccine-type or 6A-AOM with those with AOM due to other confirmed etiology within 2-6 months of age (early AOM) and followed for subsequent AOM from 6-24 months of age.
Eight hundred thirty-one children were enrolled in the Finnish otitis media control arm. Before 6 months of age, 34 children experienced vaccine-type-AOM, and 40 children experienced AOM of other bacterial etiology. The subsequent AOM incidences were 1.9 (95% CI, 1.5-2.4) and 2.1 (1.7-2.5) in these subgroups, respectively. However, the subsequent incidences were lower if no bacteria were detected at AOM (1.5, 1.2-1.8) or if there was no early AOM (1.1, 1.1-1.2).
Early vaccine-type AOM was not associated with a higher risk of subsequent AOM compared with AOM due to other confirmed bacterial etiology. These data do not support any specific role of vaccine-type pneumococcus in the hypothesis.
PubMed ID
29200185 View in PubMed
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Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial.

https://arctichealth.org/en/permalink/ahliterature294902
Source
Vaccine. 2018 03 27; 36(14):1816-1822
Publication Type
Clinical Trial, Phase III
Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
03-27-2018
Author
Arto A Palmu
Jukka Jokinen
Heta Nieminen
Hanna Rinta-Kokko
Esa Ruokokoski
Taneli Puumalainen
Marta Moreira
Lode Schuerman
Dorota Borys
Terhi M Kilpi
Author Affiliation
National Institute for Health and Welfare, Tampere, Finland. Electronic address: arto.palmu@thl.fi.
Source
Vaccine. 2018 03 27; 36(14):1816-1822
Date
03-27-2018
Language
English
Publication Type
Clinical Trial, Phase III
Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Keywords
Female
Finland - epidemiology
Health Care Costs
Humans
Immunization, Secondary
Incidence
Infant
Infant, Newborn
Male
Outcome Assessment (Health Care)
Pneumococcal Infections - prevention & control
Pneumococcal Vaccines - administration & dosage - economics - immunology
Population Surveillance
Registries
Streptococcus pneumoniae - classification - immunology
Vaccination
Vaccines, Conjugate - administration & dosage - economics - immunology
Abstract
Estimation of the full disease burden caused by Streptococcus pneumoniae is challenging due to the difficulties in assigning the aetiology especially in lower and upper respiratory infections. We estimated the pneumococcal disease burden by using the vaccine-preventable disease incidence (VPDI) of PHiD-CV10 vaccine (GSK) in our clinical trial setting. Finnish Invasive Pneumococcal disease (FinIP) trial was a cluster-randomized, double-blind trial in children 47,000 children were enrolled. In 30,527 vaccinated infants
PubMed ID
29503110 View in PubMed
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