scholarly journals ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis

2016 ◽  
Vol 20 (67) ◽  
pp. 1-178 ◽  
Author(s):  
Marie Westwood ◽  
Bram Ramaekers ◽  
Shona Lang ◽  
Nigel Armstrong ◽  
Caro Noake ◽  
...  

BackgroundAllergy is a form of immune-mediated exaggerated sensitivity (hypersensitivity) to a substance that is either inhaled, swallowed, injected or comes into contact with the skin. Foreign substances that provoke allergies are called allergens. It has been claimed that multiplex allergen testing may help in diagnosing the cause of symptoms in patients with an unclear cause of allergy or who are allergic to more than one substance.ObjectivesTo evaluate multiplex allergen testing [devices that can measure the presence of multiple immunoglobulin E (IgE) antibodies in a patient’s blood at the same time], by assessing (1) clinical effectiveness (allergy symptoms, incidence of acute exacerbations, mortality, adverse events of testing and treatment, health-care presentations or admissions, health-related quality of life); (2) effects on treatment (diet, immunotherapy medications, other potential testing); (3) any additional diagnostic information provided by multiplex allergen testing; and (4) cost-effectiveness (cost of different assessment strategies).MethodsFifteen databases were searched from 2005 to April 2015, including MEDLINE (via OvidSp), MEDLINE In-Process Citations, MEDLINE Daily Update, PubMed (National Library of Medicine), EMBASE, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Science Citation Index (SCI), Conference Proceedings Citation Index-Science (CPCI-S), BIOSIS Previews, Latin American and Caribbean Health Sciences Literature (LILACS), National Institute for Health Research (NIHR) HTA programme, and the US Food and Drug Administration (FDA); supplementary searches of conference proceedings and trials registries were performed. Review methods followed published guidance from the Cochrane Collaboration and the Centre for Reviews and Dissemination, University of York, UK. The methodological quality of included studies was assessed using appropriate published tools or a review-specific tool designed by the project team. Studies were summarised in a narrative synthesis. Owing to a lack of data on the clinical effectiveness of multiplex allergen testing, no long-term cost-effectiveness model was developed. A conceptual model structure was developed and cost analyses were performed to examine the short-term costs of various possible diagnostic pathways.ResultsFifteen studies were included in the review. The very limited available data indicated that the addition of multiplex allergen testing [ImmunoCAP®Immuno Solid-phase Allergen Chip (ISAC), Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden] to standard diagnostic work-up can change the clinicians’ views on the diagnosis, management and treatment of patients. There was some indication that the use of ImmunoCAP ISAC testing may be useful to guide decisions on the discontinuation of restrictive diets, the content of allergen-specific immunotherapy (SIT) prescriptions, and whether or not patients should receive SIT. However, none of the studies that we identified reported any information on clinical outcomes subsequent to changes in treatment or management. There was some evidence that ImmunoCAP ISAC may be useful for discriminating allergens that are structurally similar and are recognised by the same IgE antibody (cross-immunoreactive). No data were available for Microtest (Microtest Matrices Ltd, London, UK). Detailed cost analyses suggested that multiplex allergen testing would have to result in a substantial reduction of the proportions of patients receiving single IgE testing and oral food challenge tests in order to be cost-saving in the short term.ConclusionsNo recommendations for service provision can be made based on the analyses included in this report. It is suggested that a consensus-based protocol for the use of multiplex allergen testing be developed. The clinical effectiveness and cost-effectiveness of the proposed protocol should then be assessed by comparing long-term clinical and quality of life outcomes and resource use in patients managed using the protocol with those managed using a standard diagnostic pathway.Study registrationThis study is registered as PROSPERO CRD42015019739.FundingThis project was a Diagnostic Assessment Report commissioned by the NIHR HTA programme on behalf of the National Institute for Health and Care Excellence.

2016 ◽  
Vol 20 (34) ◽  
pp. 1-222 ◽  
Author(s):  
Jonathan Shepherd ◽  
Keith Cooper ◽  
Petra Harris ◽  
Joanna Picot ◽  
Micah Rose

BackgroundJuvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel®, Pfizer), abatacept (Orencia®, Bristol-Myers Squibb), adalimumab (Humira®, AbbVie) and tocilizumab (RoActemra®, Roche) – with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded).Data sourcesElectronic bibliographic databases including MEDLINE, EMBASE, The Cochrane Library and the Database of Abstracts of Reviews of Effects were searched for published studies from inception to May 2015 for English-language articles. Bibliographies of related papers, systematic reviews and company submissions were screened and experts were contacted to identify additional evidence.Review methodsSystematic reviews of clinical effectiveness, health-related quality of life and cost-effectiveness were undertaken in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A cost–utility decision-analytic model was developed to compare the estimated cost-effectiveness of biologic DMARDs versus methotrexate. The base-case time horizon was 30 years and the model took a NHS perspective, with costs and benefits discounted at 3.5%.ResultsFour placebo-controlled randomised controlled trials (RCTs) met the inclusion criteria for the clinical effectiveness review (one RCT evaluating each biologic DMARD). Only one RCT included UK participants. Participants had to achieve an American College of Rheumatology Pediatric (ACR Pedi)-30 response to open-label lead-in treatment in order to be randomised. An exploratory adjusted indirect comparison suggests that the four biologic DMARDs are similar, with fewer disease flares and greater proportions of ACR Pedi-50 and -70 responses among participants randomised to continued biologic DMARDs. However, confidence intervals were wide, the number of trials was low and there was clinical heterogeneity between trials. Open-label extensions of the trials showed that, generally, ACR responses remained constant or even increased after the double-blind phase. The proportions of adverse events and serious adverse events were generally similar between the treatment and placebo groups. Four economic evaluations of biologic DMARDs for patients with JIA were identified but all had limitations. Two quality-of-life studies were included, one of which informed the cost–utility model. The incremental cost-effectiveness ratios (ICERs) for adalimumab, etanercept and tocilizumab versus methotrexate were £38,127, £32,526 and £38,656 per quality-adjusted life year (QALY), respectively. The ICER for abatacept versus methotrexate as a second-line biologic was £39,536 per QALY.LimitationsThe model does not incorporate the natural history of JIA in terms of long-term disease progression, as the current evidence is limited. There are no head-to-head trials of biologic DMARDs, and clinical evidence for specific JIA subtypes is limited.ConclusionsBiologic DMARDs are superior to placebo (with methotrexate where permitted) in children with (predominantly) polyarticular course JIA who have had an insufficient response to previous treatment. Randomised comparisons of biologic DMARDs with long-term efficacy and safety follow-up are needed to establish comparative effectiveness. RCTs for JIA subtypes for which evidence is lacking are also required.Study registrationThis study is registered as PROSPERO CRD42015016459.FundingThe National Institute for Health Research Health Technology Assessment programme.


2013 ◽  
Vol 398 (8) ◽  
pp. 1107-1114
Author(s):  
Katarzyna Blazejczyk ◽  
Andreas Hoene ◽  
Anne Glitsch ◽  
Alexandra Busemann ◽  
Claus Dieter Heidecke ◽  
...  

2020 ◽  
Vol 1 (2) ◽  
pp. 16-24
Author(s):  
Elena S. Akarachkova ◽  
◽  
Anton A. Beliaev ◽  
Dmitrii V. Blinov ◽  
Evgenii V. Bugorskii ◽  
...  

World Health Organization declared COVID-19 outbreak a pandemic on March 11, 2020. Fear of illness, self-isolation/quarantine, and reduced quality of life dramatically increased the prevalence of stress-related disorders in the population. Therefore, it is necessary to implement the preventive health-care measures aimed at short-term and long-term COVID-19 pandemic consequences reduction and promotion of social stability.


Author(s):  
Paria Arfa-Fatollahkhani ◽  
Afsaneh Safar Cherati ◽  
Seyed Amir Hasan Habibi ◽  
Gholam Ali Shahidi ◽  
Ahmad Sohrabi ◽  
...  

AbstractBackgroundThere is growing evidence that exercise modalities have considerable effects on Parkinson’s disease (PD). This trial aimed to provide a more detailed viewpoint of short-term and long-term treadmill training (TT) effects on some motor and non-motor features of PD.MethodsIn this prospective, randomized, single-blind clinical trial, 20 mild to moderate PD patients, admitted in Rasoul-e-Akram hospital in Tehran, Iran, were randomly allocated in case (11) and control (9) groups. Treadmill intervention was performed at moderate intensity with 60% of heart rate reserved (HRR) in two 30-min sessions/week for a duration of 10 weeks. Both the groups were evaluated for three times; at the baseline, 2 months later and then 2 months after the second evaluation. We assigned the Timed Up and Go test (TUG), 6-min walk test (6MW), and the SF-8 healthy questionnaire, for assessment of balance, functional capacity, and Quality of life (QoL), respectively.ResultsBalance and functional capacity were significantly improved in the case group after the intervention (TUG p-value: 0.003, 6MW p-value: 0.003). Moreover, the long-term analysis revealed significant results as well (TUG p-value: 0.001, 6MW p-value: 0.004). Mental condition’s scores of SF-8 in cases were not statistically different in short-term follow-up (F/U). However, analysis illustrated p-value: 0.016 for long-term assessment. The intervention induced significant changes in physical condition’s scores in both of the F/Us (PC p-value: 0.013).ConclusionsThis study provides evidence that a TT of mild to moderate intensity has significant and persistent benefits for the balance, functional capacity, and QoL in PD.


2015 ◽  
Vol 23 (1) ◽  
pp. 65-75
Author(s):  
Yoko Tanaka ◽  
Meryl Brod ◽  
Jeannine R. Lane ◽  
Himanshu Upadhyaya

Objective: To estimate a minimal clinically important difference (MCID) on the adult ADHD Quality of Life (AAQoL) scale. Method: The MCID was determined from data from short-term ( N = 537) and long-term ( N = 440), placebo-controlled atomoxetine trials in adults with ADHD. For the anchor-based approach, change in clinician-rated Clinical Global Impressions–ADHD–Severity (CGI-ADHD-S) scores was used to derive MCID. For the distribution-based approach, baseline-to-endpoint mean ( SD) changes in AAQoL scores corresponding to 0.5 SD were computed. Results: The MCID was similar (approximately 8-point difference) between the short-term and the long-term treatment groups when either the anchor-based or distribution-based approach was used. Conclusion: These results suggest that approximately 8 points in the change from baseline on the AAQoL is a MCID.


2004 ◽  
Vol 22 (5) ◽  
pp. 943-952 ◽  
Author(s):  
Jennifer Cullen ◽  
Marc D. Schwartz ◽  
William F. Lawrence ◽  
Joe V. Selby ◽  
Jeanne S. Mandelblatt

Purpose There are few data on the short-term effects of participating in cancer prevention activities, undergoing genetic risk assessment, or having routine screening. The objective of this article is to systematically review existing research on short-term effects of prevention, genetic counseling and testing, and screening activities on quality of life. Methods We conducted a MEDLINE search for original research studies that were published between January 1, 1985, and December 31, 2002, and conducted in North America or Western Europe. Data were abstracted and summarized using a standardized format. Results We reviewed 210 publications. Most studies focused on psychological states (anxiety, depression), symptoms, or general health status. One hundred thirty-one studies used 51 previously validated noncancer instruments. Many researchers (12.6%) also added cancer-specific measures, such as perceived cancer risk or symptom indices. Only one study measured satisfaction or quality of provider-client communication. While one report examined lost workdays, no other economic consequences of short-term outcomes were evaluated. Among seven studies that assessed short-term outcomes preferences, only four specifically used time trade-off or linear rating scale methods. No study used standard gamble or willingness-to-pay methods. The overwhelming majority of research indicated that short-term effects were transient. Only two studies linked short-term effects to long-term cancer-related health behaviors such as repeat screening. Conclusion There is considerable heterogeneity in short-term outcome measurement. Clinicians need to be aware of potential for short-term, transient adverse effects. The impact of short-term experiences should to be linked to long-term health status and use of services.


Author(s):  
Frank Hulstaert ◽  
Christoph Schwierz ◽  
Frederik Nevens ◽  
Nancy Thiry ◽  
Mohamed Gamil ◽  
...  

Objectives: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B.Methods: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis.Results: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years.Conclusions: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.


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