ARIA 2016: Care pathways implementing emerging technologies for predictive medicine in rhinitis and asthma across the life cycle.

The Allergic Rhinitis and its Impact on Asthma (ARIA) initiative commenced during a World Health Organization workshop in 1999. The initial goals were (1) to propose a new allergic rhinitis classification, (2) to promote the concept of multi-morbidity in asthma and rhinitis and (3) to develop guidelines with all stakeholders that could be used globally for all countries and populations. ARIA-disseminated and implemented in over 70 countries globally-is now focusing on the implementation of emerging technologies for individualized and predictive medicine. MASK [MACVIA (Contre les Maladies Chroniques pour un Vieillissement Actif)-ARIA Sentinel NetworK] uses mobile technology to develop care pathways for the management of rhinitis and asthma by a multi-disciplinary group and by patients themselves. An app (Android and iOS) is available in 20 countries and 15 languages. It uses a visual analogue scale to assess symptom control and work productivity as well as a clinical decision support system. It is associated with an inter-operable tablet for physicians and other health care professionals. The scaling up strategy uses the recommendations of the European Innovation Partnership on Active and Healthy Ageing. The aim of the novel ARIA approach is to provide an active and healthy life to rhinitis sufferers, whatever their age, sex or socio-economic status, in order to reduce health and social inequalities incurred by the disease.

MACVIA-ARIA Sentinel NetworK for allergic rhinitis (MASK-rhinitis): the new generation guideline implementation.

Several unmet needs have been identified in allergic rhinitis: identification of the time of onset of the pollen season, optimal control of rhinitis and comorbidities, patient stratification, multidisciplinary team for integrated care pathways, innovation in clinical trials and, above all, patient empowerment. MASK-rhinitis (MACVIA-ARIA Sentinel NetworK for allergic rhinitis) is a simple system centred around the patient which was devised to fill many of these gaps using Information and Communications Technology (ICT) tools and a clinical decision support system (CDSS) based on the most widely used guideline in allergic rhinitis and its asthma comorbidity (ARIA 2015 revision). It is one of the implementation systems of Action Plan B3 of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA). Three tools are used for the electronic monitoring of allergic diseases: a cell phone-based daily visual analogue scale (VAS) assessment of disease control, CARAT (Control of Allergic Rhinitis and Asthma Test) and e-Allergy screening (premedical system of early diagnosis of allergy and asthma based on online tools). These tools are combined with a clinical decision support system (CDSS) and are available in many languages. An e-CRF and an e-learning tool complete MASK. MASK is flexible and other tools can be added. It appears to be an advanced, global and integrated ICT answer for many unmet needs in allergic diseases which will improve policies and standards.

How reliable is visual assessment of the electrically elicited stapedius reflex threshold during cochlear implant surgery, compared with tympanometry?

OBJECTIVES: To assess the reliability of visually assessed thresholds of the electrically elicited stapedius reflex, recorded during cochlear implant surgery, compared with intra-operative tympanometric threshold assessment. Intra-operatively recorded electrically elicited stapedius reflex thresholds vary considerably, and differ from those measured post-operatively by means of impedance changes (i.e. using tympanometry). Thus, any confounding effect of different intra-operative techniques and visual assessment inaccuracies should be excluded. METHODS: Both techniques (i.e. visual observation and tympanometry) were performed intra-operatively in six patients, and threshold values were compared. RESULTS: Recorded electrically elicited stapedius reflex thresholds were very similar for both techniques. Visually assessed thresholds were slightly higher in some cases and lower in others, compared with tympanometric thresholds. DISCUSSION: There was almost no difference between reflex thresholds measured with the two different techniques under the same intra-operative conditions. Therefore, we conclude that differences between intra- and post-operative thresholds are not due to the use of different measuring techniques. The main reason for such differences is probably the influence of intra-operative narcotics on reflex thresholds.

Assessment of asthma control and its impact on optimal treatment strategy.

Achieving and maintaining optimal asthma control is a major asthma management goal advocated by the Global Initiative for Asthma (GINA). Recent evidence suggests that while asthma control is clearly achievable in most asthmatics, not all asthmatics attain optimal asthma control. The difficulty is compounded further because patients, physicians and regulatory bodies have different perceptions of what is meant by asthma control. The challenge therefore remains as to how best to assess asthma control and define management strategies to ensure that this control is achieved and maintained. Despite the availability of several patient-based tools for assessing asthma control, these are mostly employed in a research setting or in selected specialist clinics. A symptom-based treatment approach also may have its limitations because patients can be poor judges of disease symptoms and severity and under-estimation may lead to inadequate treatment of airway inflammation and airway hyperresponsiveness (AHR) when treatment is administered as on-demand reliever therapy, since the effect of treatment on these underlying features occurs over a longer time course. The clinical benefits of sustained maintenance treatment for at least 3 months has been documented in recent studies of salmeterol/fluticasone propionate combination, which have demonstrated correlations between reduction in airway inflammation/AHR and reduction in exacerbation rates. In view of the putative limitations of a purely symptom-based asthma management plan, we suggest that treatment should be focussed on management of all aspects of the disease rather than management of symptoms alone, with a practical approach being treatment for a minimum of 3 months with an optimal dose to ensure maximal effects are seen on asthma control, airway inflammation, lung function, and remodelling.

Health-economic analyses of subcutaneous specific immunotherapy for grass pollen and mite allergy.

OBJECTIVE: To investigate the health and monetary consequences of treating allergy with specific immunotherapy (SIT) compared with symptomatic treatment/standard care among patients with grass pollen or mite allergy. METHODS: We performed an economic analysis based on 253 grass- and/or mite allergic patients who started SIT from 1.1.1996 to 1.1.2002 at the Allergy Unit, Aarhus University Hospital and at a specialist practice in Aarhus. Relevant data were collected before, during and after SIT treatment from the national health service based on each patient's personal identification number and medical records and from a specifically designed questionnaire. A cost-benefit analysis including direct and indirect costs before, during and after SIT was performed. In addition direct costs were related to the clinical effect (improvement in well-being) in the form of a cost-effectiveness analysis. RESULTS: The direct cost per patient/year before SIT (equivalent to standard care) was DKK 2,580. The investment in SIT was DKK 27,545 (in present values) per patient over a 4-year period. After SIT the cost was reduced to DKK 1,072 per patient/year. In the long term, prospective introduction of SIT incurred additional present-value direct costs of DKK 13,676 per patient treated and DKK 2,784 per patient/year of improved well-being. However, when indirect costs were included in the economic evaluation SIT was shown to be net beneficial. CONCLUSION: This study reveals that SIT is associated with initial resource investments and subsequent resource savings in the long term compared with standard care. When all consequences are measured in monetary terms, and assuming that sick days are associated with a loss of productivity, this analysis suggests that SIT increases societal welfare. This conclusion also holds if there is no loss of productivity.

Assessment of patient performance of the HandiHaler compared with the metered dose inhaler four weeks after instruction.

The HandiHaler is a novel breath-actuated dry powder system designed for the delivery of tiotropium 18microg daily in the treatment of COPD. We compared patient ability to use the HandiHaler or metered dose inhaler (MDI) device correctly 4 weeks after receiving brief instructions and device demonstration. A single-blind study was conducted in COPD patients in two centers in Denmark. ALL patients (n = 151) received one placebo capsule via the HandiHaler daily and ipratropium (20 microg) two actuations via the MDI q.i.d. Mean FEV1 for all patients was 1.25 + 0.54 (46% predicted). Twelve instructions establishing proper device use were evaluated for the MDI and Handihaler. Error scores were analyzed by number of patients with less, equal or more errors when using HandiHaler compared to MDI in the total efficacy population (n = 139) and according to those who had not previously used an MDI for at least 12 months (MDI beginners) (n = 74) and those who had used an MDI (MDI experienced) (n = 65). Four weeks after device instruction, a higher proportion of patients in the total population (P < 0.01) had fewer errors with the HandiHaler (35.3%) compared to the MDI (15.1%). The number of errors was equal in 50% of patients. Similar findings were observed in the subgroup of patients who were MDI beginners (42% vs. 11%, P < 0.01) with non-significant trends in favor of the HandiHaler in those patients who were MDI experienced (29.7% vs. 18.9%, P = 0.096). Similar results in favor of HandiHaler were noted across different age and sex strata. The proportion of patients correctly using the device on the first of three attempts was 59.7% and 54.7% for the HandiHaler and MDI, respectively (P = 0.399). In summary, use of the HandiHaler can be easily taught with fewer errors compared to the MDI. Furthermore, patient performance using the HandiHaler was superior to that with an MDI despite prior MDI experience and more frequent usage.

Intranasal corticosteroids for allergic rhinitis: superior relief?

Whether first-line pharmacological treatment of allergic rhinitis should be antihistamines or intranasal corticosteroids has been discussed for several years. First-generation antihistamines are rarely used in the treatment of allergic rhinitis, mainly because of sedative and anticholinergic adverse effects. On the basis of clinical evidence of efficacy, no second-generation antihistamine seems preferable to another. Similarly, comparisons of topical and oral antihistamines have been unable to demonstrate superior efficacy for one method of administration over the other. Current data documents no striking differences in efficacy and safety parameters between intranasal corticosteroids. When the efficacy of antihistamines and intranasal corticosteroids are compared in patients with allergic rhinitis, present data favours intranasal corticosteroids. Interestingly, data do not show antihistamines as superior for the treatment of conjunctivitis. Safety data from comparative studies in patients with allergic rhinitis do not indicate differences between antihistamines and intranasal corticosteroids. Combining antihistamines and intranasal corticosteroids in the treatment of allergic rhinitis does not provide any additional effect to intranasal corticosteroids alone. On the basis of current data, intranasal corticosteroids seem to offer superior relief in allergic rhinitis than antihistamines.

Pending resolution: the question of who owns DNA.

With the emergence of the Human Genome Project and its private counterparts, the U.S. Patent and Trademark Office has begun receiving applications for the patenting of genes and genetic sequences. Earlier patent decisions regarding similar scientific advances limited patents to organisms "made by the hand of man," which would seem to remove discovered genes from patent protection. But many applicants have been successful in attaining patents for genes based on their ability to demonstrate the ultimate utility of the gene, for instance in medicine. One controversy regarding genomic patenting, however, is that patents apparently have been granted for mere gene fragments devoid of much demonstrable utility. Furthermore, critics fear that gene patenting will retard research by squelching scientists' ability to share findings freely.

Settling for less? Tobacco industry.

In November 1998, a coalition of state negotiators and five tobacco companies reached an agreement in which the cigarette makers would pay out the biggest financial settlement in history, $206 billion over the next 25 years to 46 states, to compensate for the medical treatment of patients suffering from tobacco-related health problems. Critics of the settlement say the tobacco companies are getting off the hook too easily, and that the deal's public health provisions are unacceptably riddled with loopholes. But the attorneys general who negotiated the settlement defended it as a good deal-but clearly not as a panacea. Ultimately, they feel, Congress should pass legislation to provide essential reforms, including full Food and Drug Administration authority over tobacco.

Outcome of long-term enteral feeding.

In the past two decades, many technical advances have made tube enteral feeding much more comfortable and acceptable to patients and their families. This has greatly expanded the use of this therapy, both in clinical conditions where it was traditionally prescribed and in many other diagnoses. This expanded use raises important questions about how much enteral nutrition is being used, the medical outcome in different clinical conditions, and the quality of life experienced by long-term therapy users. This article addresses these outcome issues for patients in the nonhospital setting.

Assessment of the allergic reaction in seasonal rhinitis: acoustic rhinometry is a sensitive and objective method.

BACKGROUND: Seasonal allergic rhinitis constitutes an excellent in vivo model of an allergic mucosal inflammatory reaction. This offers the opportunity of studying the fundamentals of allergic inflammation in addition to improvement of knowledge on the basal pathophysiological mechanisms of the disease. So far, monitoring methods of disease activity and treatment efficacy have mainly been based upon subjective assessments, illustrating the impact of introducing reliable objective methods. OBJECTIVE: To investigate the allergic inflammatory reaction of seasonal rhinitis through different objective methods and evaluate these as indicators of disease activity and treatment efficacy. METHODS: Functional parameters, i.e. acoustic rhinometry and nasal metacholine challenge, and biological markers, i.e. blood eosinophil count, eosinophil cationic protein in serum (s-ECP) and nasal lavage fluid (n-ECP), were assessed before and at peak pollen season in 27 patients with grass pollen induced rhinitis. Patients were randomized to either nasal corticosteroid or placebo treatment and recorded nasal symptom scores. RESULTS: Acoustic rhinometry revealed a significant difference in favour of steroid treatment (P < 0.05) comparing nasal volumes before and during season. This difference primarily relied upon a decrease in the placebo group (P = 0.05). A reduction from baseline of s-ECP in the steroid group (P < 0.01) was obtained. N-ECP demonstrated a difference between treatment groups, although not significant. Symptom scores increased in all patients during the pollen season, although this was only significant in the placebo treated patients (P < 0.01). The remaining methods applied did not demonstrate further differences, either within or between treatment groups. CONCLUSION: Our results demonstrate acoustic rhinometry to be a sensitive and objective method of assessment of nasal obstruction. Furthermore, acoustic rhinometry and s-ECP reflect the impact of nasal steroid therapy on seasonal allergic rhinitis.

Using data to design systems of care adults with chronic illness.

Increased Medicare risk contracts led to rising concern with readmission rates among the senior population with chronic illness at Carondelet Health Network. Using readily available data, Carondelet providers and administrators created intervention and evaluation strategies to redesign chronic care services to reduce increased readmissions. The strategies showed health plans can develop such strategies without waiting for sophisticated information systems to be put in place.

Development and operation of a program to obtain volunteer bone marrow donors unrelated to the patient.

Because of recent increases in bone marrow transplantation, the lack of available matched sibling donors has become a problem. This study investigated the feasibility of obtaining volunteer bone marrow donors unrelated to the patient. A program was developed to inform potential donors and obtain their consent for listing in a bone marrow donor registry. Sixty-six percent of whole blood or apheresis donors agreed to participate in the program. There were no demographic differences between those who accepted or declined to participate. Religion, experiences with medical practices, and the attitude of the potential donor's spouse were important factors in the decision to participate. A search for donors was initiated for 127 patients. Thirty searches were not completed, primarily because of patient-related problems. A total of 713 HLA-A and -B antigen-identical donors was located for 63 of the 97 (65%) patients. A total of 40 HLA-A, -B, and -DR antigen-identical donors was located for 18 of these 63 patients. Six of these 18 patients then had one or more donors (total, 9) whose lymphocytes did not react in mixed lymphocyte culture. Thus, using the file of 2147 donors, an HLA-identical donor was located for 6 percent of the 97 patients. None of these patients has yet received a transplant; in four cases this was due to patient-related and in two cases donor-related reasons. The cost to establish the donor program averaged $33.46 (1984) per donor for donors already typed for HLA-A and -B antigens. This experience indicated that, given thorough information about bone marrow donation and transplantation, a majority of blood and apheresis donors will volunteer to donate bone marrow, without feeling pressure to do so. A relatively small donor file provided donors for 6 percent of patients. The long-term value of bone marrow transplantation using unrelated donors and the optimum size of the donor file remain to be established.