The REal Life EVidence AssessmeNt Tool (RELEVANT): development of a novel quality assurance asset to rate observational comparative effectiveness research studies Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Asthma outcomes workshop: overview. Integrating patient preferences into health outcomes assessment: the multiattribute Asthma Symptom Utility Index. Clinical efficacy of web-based versus standard asthma self-management. A repeated short educational intervention improves asthma control and quality of life Patient related outcomes in a real life prospective follow up study: Allergen immunotherapy increase quality of life and reduce sick days A systematic review of the implementation and impact of asthma protocols Improving Asthma-Related Health Outcomes Among Low-Income, Multiethnic, School-aged Children: Results of a Demonstration Project That Combined Continuous Quality Improvement and Community Health Worker Strategies Assessing the efficacy of a school-based asthma education program for children: a pilot study. A randomized controlled study of a computerized limited education program among young adults with asthma. Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN) [Cost-effectiveness of an intervention based on the Global INitiative for Asthma (GINA) recommendations using a computerized clinical decision support system: a physicians randomized trial]. Effectiveness of Evidence-Based Asthma Interventions Do small group workshops and locally adapted guidelines improve asthma patients' health outcomes? A cluster randomized controlled trial. Obtaining concomitant control of allergic rhinitis and asthma with a nasally inhaled corticosteroid Evaluation of an educational programme for socially deprived asthma patients.
Abstract Background Evidence from observational comparative effectiveness research ( CER ) is ranked below that from r and omized controlled trials in traditional evidence hierarchies . However , asthma observational CER studies represent an important complementary evidence source answering different research questions and are particularly valuable in guiding clinical decision making in real-life patient and practice setting s. Tools are required to assist in quality appraisal of observational CER to enable identification of and confidence in high- quality CER evidence to inform guideline development . Methods The REal Life EVidence AssessmeNt Tool ( RELEVANT ) was developed through a step-wise approach . We conducted an iterative refinement of the tool based on Task Force member expertise and feedback from pilot testing the tool until reaching adequate inter-rater agreement percentages . Two distinct pilots were conducted — the first involving six members of the Respiratory Effectiveness Group ( REG ) and European Academy of Allergy and Clinical Immunology ( EAACI ) joint Task Force for quality appraisal of observational asthma CER ;  the second involving 22 members of REG and EAACI membership . The final tool consists of 21 quality sub-items distributed across seven methodology domains : Background , Design , Measures , Analysis , Results , Discussion /Interpretation , and Conflict of Interest . Eleven of these sub-items are considered critical and named “ primary sub-items ” . Results Following the second pilot , RELEVANT showed inter-rater agreement ≥ 70 % for 94 % of all primary and 93 % for all secondary sub-items tested across three rater groups . For observational CER to be classified as sufficiently high quality for future guideline consideration , all RELEVANT primary sub-items must be fulfilled . The ten secondary sub-items further qualify the relative strengths and weaknesses of the published CER evidence . RELEVANT could also be applicable to general quality appraisal of observational CER across other medical specialties . Conclusions RELEVANT is the first quality checklist to assist in the appraisal of published observational CER developed through iterative feedback derived from pilot implementation and inter-rater agreement evaluation . Developed for a REG-EAACI Task Force quality appraisal of recent asthma CER , RELEVANT also has wider utility to support appraisal of CER literature in general ( including pre-publication ) . It may also assist in manuscript development and in educating relevant stakeholders about key quality markers in observational CER BACKGROUND Allergen immunotherapy ( AIT ) has been thoroughly documented in r and omized controlled trials ( RCTs ) . It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis , allergic asthma and insect sting allergy . However , there is a high degree of clinical and method ological heterogeneity among the endpoints in clinical studies on AIT , for both subcutaneous and sublingual immunotherapy ( SCIT and SLIT ) . At present , there are no commonly accepted st and ards for defining the optimal outcome parameters to be used for both primary and secondary endpoints . METHODS As elaborated by a Task Force ( TF ) of the European Academy of Allergy and Clinical Immunology ( EAACI ) Immunotherapy Interest Group , this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis . RESULTS Based on a thorough literature review , the TF members have outlined recommendations for nine domains of clinical outcome measures . As the primary outcome , the TF recommends a homogeneous combined symptom and medication score ( CSMS ) as a simple and st and ardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner . All outcomes , grouped into nine domains , are review ed . CONCLUSION A st and ardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required . The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis BACKGROUND Asthma clinical research will highly benefit from st and ardization of major outcomes in terms of definition and assessment methodology . This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing . OBJECTIVE National Institutes of Health ( NIH ) institutes and the Agency for Healthcare Research and Quality convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with st and ardized methodology in future asthma clinical research studies . METHODS Each subcommittee utilized comprehensive literature review s and expert opinion to compile a list of asthma outcomes and classified them as either core ( required in future studies ) , supplemental ( to be used according to study aims and st and ardized ) , or emerging ( requiring validation and st and ardization ) . This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011 . RESULTS Outcomes for study participant characterization , as well as for prospect i ve clinical trial intervention and observational studies , were proposed for adults and children , and method ologies for outcome collection and reporting were determined . Furthermore , the workshop identified areas in which new outcomes or instruments for their measurement need to be developed and vali date d. CONCLUSIONS St and ardized outcomes for clinical research in asthma have been proposed . Participating NIH institutes and other federal agencies will consider these recommendations in future clinical research initiatives in asthma STUDY OBJECTIVE To develop and evaluate a brief , easy-to-administer symptom assessment scale for use as a preference-based outcome measure in clinical trials and cost-effectiveness studies in asthma . DESIGN Cross-sectional survey with 2-week reproducibility assessment . SETTING Ambulatory care : university asthma and allergy center . PARTICIPANTS One hundred sixty-one adults with asthma , 59 % female , mean age 35+/-11 years . Mean FEV1 percent predicted was 86+/-17 % . INTERVENTIONS The  11-item Asthma Symptom Utility Index ( ASUI ) .  MEASUREMENTS AND RESULTS Mean ASUI score for this sample was 0.71+/-0.23 , with a range from 0.02 to 1.0 . The ASUI was reproducible ( intraclass correlation coefficient = 0.74 ) and able to distinguish patients known to differ on disease severity according to clinician ratings ( p < 0.001 ) and by an asthma disease severity scale score ( p < 0.001 ) . The instrument was also significantly correlated with FEV1 percent predicted ( r = 0.27 , p < 0.001 ) , the Asthma Quality of Life Question naire ( r = 0.77 , p < 0.001 ) , and the Health Utilities Index Mark 2 ( r = 0.36 , p < 0.001 ) . CONCLUSION The results of this study support the reliability and validity of the ASUI , suggesting it will be a useful , complementary patient outcome measure for clinical trials and cost-effectiveness studies comparing treatment alternatives for persons with asthma BACKGROUND Guided self-management is an important component of asthma care . Most trials have evaluated paper-based strategies . The effectiveness of new communication technologies remains uncertain . OBJECTIVES To compare the feasibility and clinical outcomes of a st and ard paper-based asthma self-management strategy with web-based strategies . METHODS In a crossover trial , 21 patients using inhaled corticosteroids and long-acting B2-agonists ( mean [ SD ] age 29 [ 10 ] years ) were r and omly assigned to use a sequence of web-based and paper-based diary and action plan .  Quality of life , asthma control , lung function , and airway inflammation were assessed using the Asthma Life Quality Question naire ( ALQ ) , Asthma Control Question naire ( ACQ-5 ) , Mini Asthma Quality of Life Question naire ( Mini AQLQ ) , and office spirometry . The ratio of forced expiratory volume in the first second of expiration ( FEV1 ) to peak expiratory flow ( PEF ) rate ( PiKo-1 ) and fraction of exhaled nitric oxide ( FE(NO ) ) were monitored . The main clinical outcomes were asthma control and FE(NO ) . Quality of data and adherence to monitoring tools were the main process outcomes . RESULTS Significant improvements were observed in the AQL and ACQ scores , although lung function did not change . FE(NO ) was significantly reduced only after a web-based strategy but a significant period effect occurred ( P = .006 ) . There were no differences in clinical outcomes between web-based and paper-based management . No intervention-related adverse effects were observed . Adherence seemed higher with the paper-based strategy ( P < .001 ) . However , paper data were unreliable when compared to automatic daily electronic FEV1/PEF records . Twelve patients were very interested in continuing self-management with the web-based approach compared with 2 in using paper tools ( P = .002 ) . CONCLUSIONS Web-based management was feasible , safe , and preferred by patients . Short-term outcomes were at least as good , and data quality was improved We assessed the effectiveness of an asthma educational programme based on a repeated short intervention ( AEP-RSI ) to improve asthma control ( symptom control and future risk ) and quality of life . A total of 230 adults with mild-to-moderate persistent uncontrolled asthma participated in a 1-year cluster r and omised controlled multicentre study . The AEP-RSI was given in four face-to-face sessions at 3-month intervals , and included administration of a written personalised action plan and training on inhaler technique . Centres were r and omised to the AEP-RSI ( intervention ) group or usual clinical practice group . Specialised centres using a st and ard educational programme were the gold st and ard group . A significant improvement in the Asthma Control Test score was observed in all three groups ( p<0.001 ) , but improvements were higher in the intervention and gold st and ard groups than in the usual clinical practice group ( p=0.042 ) , which also showed fewer exacerbations ( mean±sd ; 1.20±2.02 and 0.56±1.5 versus 2.04±2.72 , respectively ) and greater increases in the Mini Asthma Quality of Life Question naire scores ( 0.95±1.04 and 0.89±0.84 versus 0.52±0.97 , respectively ) . The AEP-RSI was effective in improving asthma symptom control , future risk and quality of life .  An educational programme based on a repeated short intervention for asthma is effective and easily to use in practice Background One fourth of the adult population in Europe suffer from respiratory allergy . Subcutaneous-allergen-specific-immunotherapy ( SCIT ) has long-term disease modifying effect on disease specific Health-Related Quality of Life ( HRQoL ) . The purpose of this study was to assess the effect of SCIT on alternative disease outcomes in patients with grass-pollen and /or house dust mite induced allergic rhino-conjunctivitis and /or an asthma diagnosis . Focus was on expressing outcomes in terms of generic quality of life ( Quality -Adjusted-Life-Years ( QALY ) ) and reductions in sick days . Methods The study was a multi-centre study with prospect i ve follow-up . 248 patients were initiated on SCIT .  The disease specific Rhino-conjunctivitis Quality of Life Question naire ( RQLQ ) and two generic ( HRQoL ) instruments 15D and EQ-5D were used at baseline and at follow-up . The outcome measures included change in ; disease severity , RQLQ-scores , number of days with symptoms- and number of sick days per year and finally changes in generic HRQoL and thus , QALY . Disease severity was assessed by specialist doctors ; severity of rhino-conjunctivitis was classified according to the Allergic Rhinitis and its Impact on Asthma ( ARIA ) and asthma severity according to the Global Initiative for Asthma ( GINA guideline ) . The remaining outcome measures were assessed by the patients in question naires at baseline and at follow-up . An intension to treat approach was applied . For missing items imputation of sample mean base-line values or follow-up values were used after specified criteria . The effect of SCIT on rhino-conjunctivitis and /or asthma diagnoses was analysed at follow-up using three logistic regression models . Results The disease severity showed significantly improved disease control . Mean RQLQ-score was reduced from 3.02 at baseline to 2.00 at follow-up . Average annual days with symptoms were reduced from 189 to 145 days whilst annual sick days were reduced from 3.7 to 1.2 days . The 15D-score increased from 0.83 to 0.86 and the EQ-5D-score from 0.70 to 0.77 , which indicated an annual gain per patient of 0.03 - 0.06 QALY . Conclusions Allergic patients suffering from rhino-conjunctivitis alone or rhino-conjunctivitis and asthma experience significantly increased HRQoL and they gain 0.03 - 0.06 QALY , when treated with SCIT for one year . Trial registration The study was registered at Clinical Trials.gov with the identifier : NCT01486498 Background Asthma is one of the most common childhood illnesses . Guideline -driven clinical care positively affects patient outcomes for care . There are several asthma guidelines and reminder methods for implementation to help integrate them into clinical workflow . Our goal is to determine the most prevalent method of guideline implementation ; establish which methods significantly improved clinical care ; and identify the factors most commonly associated with a successful and sustainable implementation . Methods PUBMED ( MEDLINE ) , OVID CINAHL , ISI Web of Science , and EMBASE . Study Selection : Studies were included if they evaluated an  asthma protocol or prompt , evaluated an intervention , a clinical trial of a protocol implementation , and qualitative studies as part of a protocol intervention .  Studies were excluded if they had non-human subjects , were studies on efficacy and effectiveness of drugs , did not include an evaluation component , studied an educational intervention only , or were a case report , survey , editorial , letter to the editor . Results From 14,478 abstract s , we included 101 full-text articles in the analysis . The most frequent study design was pre-post , followed by prospect i ve , population based case series or consecutive case series , and r and omized trials . Paper-based reminders were the most frequent with fully computerized , then computer generated , and other modalities . No study reported a decrease in health care practitioner performance or declining patient outcomes . The most common primary outcome measure was compliance with provided or prescribing guidelines , key clinical indicators such as patient outcomes or quality of life , and length of stay . Conclusions Paper-based implementations are by far the most popular approach to implement a guideline or protocol . The number of publications on asthma protocol reminder systems is increasing . The number of computerized and computer-generated studies is also increasing . Asthma guidelines generally improved patient care and practitioner performance regardless of the implementation method OBJECTIVE . The purpose of this work was to improve asthma-related health outcomes in an ethnically and geographically disparate population of economically disadvantaged school-aged children by using a team-based approach using continuous quality improvement and community health workers . PATIENTS AND METHODS . A demonstration project was conducted with 7 community clinics treating ∼3000 children with asthma 5 to 18 years of age . The overall clinic population with asthma was assessed for care-process changes through r and om cross-sectional chart review s at baseline and 24 months ( N = 560 ) . A subset of patients with either moderate or severe persistent asthma or poorly controlled asthma ( N = 405 ) was followed longitudinally for specific asthma-related clinical outcomes , satisfaction with care , and confidence managing asthma by family interview at baseline and at 12 or 24 months . Patient-centered and care-process outcomes included patient/parent assessment of quality of care and confidence in self-management , asthma action plan review , and documentation of guideline -based indicators of quality of care . Direct clinical outcomes included daytime and nighttime symptoms , use of rescue medications , acute care and emergency department visits , hospitalizations , and missed school days . Each clinic site 's degree of adherence to the intervention model was evaluated and ranked to examine the correlation between model adherence and outcomes . RESULTS . Cross-sectional data showed clinic-wide improvements in the documentation of asthma severity , review of action plans , health services use , and asthma symptoms . At follow-up in the longitudinal sample , fewer patients reported acute visits , emergency department visits , hospitalizations , frequent daytime and nighttime symptoms , and missed school days compared with baseline . More patients reported excellent or very good quality of care and confidence in asthma self-management . Linear regression analysis of the clinical sites ’ model adherence ranks against site-level combined scores estimating overall outcomes , clinical outcomes , and improvements in clinical care processes showed significant linear correlations with R2 ≥ 0.60 . CONCLUSIONS . The demonstration produced major improvements in asthma-related care processes and clinical outcomes . Closer adherence to the demonstration model was directly associated with better outcomes BACKGROUND Asthma diminishes the health-related quality of life for many school-aged children . This study sought to explore the effect of a School-Based Asthma Education Program ( SBAEP ) on quality of life . METHODS Children with asthma who attended grade s 1 - 5 at two selected schools were requested to participate in this pilot study . Participants at one school were provided with a SBAEP , those at another school ( control group ) were provided with written educational material about asthma . The children completed the Paediatric Asthma Quality of Life Question naire ( PAQLQ ) before and one month after the educational interventions . RESULTS There were clinical ly important improvements in the SBAEP group in quality of life , specifically in the symptom subdomain . CONCLUSIONS The " Air Force " SBAEP appears to result in a favourable trend in quality of life for children . A larger scale trial is required following revisions to the program The aim of the study was to assess the effectiveness of a computerized limited asthma education program , design ed to suit young people . The study was conducted with 97 young adults ( 18 - 25 years ) with asthma , 48 were r and omized to the intervention group and 49 to the control group , and they were followed for 12 months . The intervention group completed an interactive computer program of 30-min duration providing information about asthma , mechanisms , trigger factors , allergies and medication use , which was followed by a 30-min discussion with a specialized asthma nurse . The control group followed the routine schedule for asthma out patients . The outcomes of the study were number of hospital admissions , emergency visits , asthma symptoms , knowledge about asthma , lung function and quality of life . No effect was found regarding admission to hospital , emergency visits , prevalence of respiratory symptoms , knowledge of asthma or quality of life . However , forced exhaled volume in 1s ( FEV(1 ) ) increased significantly , mainly among the atopic subjects . In conclusion , an intervention with a limited asthma education program did not show an effect on asthma symptoms , asthma knowledge or quality of life parameters Objective To evaluate the feasibility of a phase 3 r and omised controlled trial ( RCT ) of a website ( Living Well with Asthma ) to support self-management . Design and setting Phase 2 , parallel group , RCT , participants recruited from 20 general practice s across Glasgow , UK . R and omisation through automated voice response , after baseline data collection , to website access for minimum 12 weeks or usual care . Participants Adults ( age≥16 years ) with physician diagnosed , symptomatic asthma ( Asthma Control Question naire ( ACQ ) score ≥1 ) . People with unstable asthma or other lung disease were excluded .  Intervention ‘ Living Well with Asthma ’ is a desktop/laptop compatible interactive website design ed with input from asthma/ behaviour change specialists , and adults with asthma . It aims to support optimal medication management , promote use of action plans , encourage attendance at asthma review s and increase physical activity . Outcome measures Primary outcomes were recruitment/retention , website use , ACQ and mini-Asthma Quality of Life Question naire ( AQLQ ) . Secondary outcomes included patient activation , prescribing , adherence , spirometry , lung inflammation and health service contacts after 12 weeks . Blinding postr and omisation was not possible . Results Recruitment target met . 51 participants r and omised ( 25 intervention group ) . Age range 16–78 years ; 75 % female ; 28 % from most deprived quintile . 45/51 ( 88 % ; 20 intervention group ) followed up . 19 ( 76 % of the intervention group ) used the website , for a mean of 18 min ( range 0–49 ) . 17 went beyond the 2 ‘ core ’ modules . Median number of logins was 1 ( IQR 1–2 , range 0–7 ) . No significant difference in the prespecified primary efficacy measures of ACQ scores ( −0.36 ; 95 % CI −0.96 to 0.23 ; p=0.225 ) , and mini-AQLQ scores ( 0.38 ; −0.13 to 0.89 ; p=0.136 ) . No adverse events . Conclusions Recruitment and retention confirmed feasibility ; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial . Trial registration number IS RCT N78556552 ; Results BACKGROUND AND OBJECTIVE To assess the cost-effectiveness of an intervention based on the Global INitiative for Asthma ( GINA ) recommendations as compared to usual care . SUBJECTS AND METHOD Pragmatic , cluster-r and omised trial . Ten pneumologists and 10 general practitioners were r and omised to an intervention or control group , recruiting 98 and 100 asthma patients , respectively . The intervention consisted of an education program and a clinical decision support system ( CDSS ) providing recommendations based on the GINA . The control group was characterized by usual care . Effectiveness was assessed by the health related quality of life as measured by the St. George 's Respiratory Question naire ( SGRQ ) . Costs were computed from the re source consumption recorded during a 12 months follow-up period , and the cost-effectiveness of the intervention was investigated in an incremental analysis . RESULTS The intervention effect on the SGRQ total score was estimated as a 6.8 point reduction ( 95 % confidence interval , 2.5 - 11.1 ; p = 0.0021 ) , and a significant improvement in the SGRQ subscores and in the symptoms-free periods were also observed . From the social perspective , the mean total costs showed savings of -1,022 Euros ( 95 % confidence interval , -2,165 to 122 ; p = 0.0795 ) in intervention group as compared to usual care . The incremental analysis confirmed that the intervention was cost-effective . CONCLUSIONS The implementation of an asthma management program based in GINA recommendations improved the patient 's health related quality of life and was cost-effective as compared to usual care This study assessed the effectiveness of translating evidence -based asthma interventions into community health centers . BACKGROUND AND OBJECTIVES : Research ers often struggle with the gap between efficacy and effectiveness in clinical research . To bridge this gap , the Community Healthcare for Asthma Management and Prevention of Symptoms ( CHAMPS ) study adapted an efficacious , r and omized controlled trial that result ed in evidence -based asthma interventions in community health centers . METHODS : Children ( aged 5–12 years ; N = 590 ) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk , low-income communities located in Arizona , Michigan , and Puerto Rico . The asthma intervention was tailored to the participant ’s allergen sensitivity and exposure , and it comprised 4 visits over the course of 1 year . Study visits were documented and monitored prospect ively via electronic data capture . Asthma symptoms and health care utilization were evaluated at baseline , and at 6 and 12 months . RESULTS : A total of 314 intervention children and 276 control children were enrolled in the study .  Allergen sensitivity testing ( 96 % ) and home environmental assessment s ( 89 % ) were performed on the majority of intervention children . Overall study activity completion ( eg , intervention visits , clinical assessment s ) was 70 % . Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings ( control , change of −2.28 ; intervention , change of −3.27 ; difference , −0.99 ; P < .001 ) , and this result was consistent with changes found in the rigorous evidence -based interventions . CONCLUSIONS : Evidence -based interventions can be successfully adapted into primary care setting s that serve impoverished , high-risk population s , reducing the morbidity of asthma in these high-need population OBJECTIVE To improve health outcomes of children and adolescents with asthma using a multifaceted intervention for GPs . METHODS The design of the study was a cluster r and omized controlled trial . GPs were r and omized at a practice level in general practice clinics in Melbourne , Australia . Participants were children/adolescents aged 2 - 14 years with asthma and their caregivers identified from the medical records of participating clinics . Question naires were completed by 411 at baseline and 341 at follow-up . The intervention arm ( n = 18 GPs ) participated in a small group asthma education programme and was provided with locally adapted paediatric asthma guidelines . One control arm ( n = 18 GPs ) received only the adapted paediatric asthma guidelines , while the other control arm ( n = 15 GPs ) received an unrelated educational intervention . The outcome measures of the study were  children/adolescents and caregivers completed question naires about asthma management and control , asthma knowledge and quality of life at recruitment and 6 months later . Ownership of a written asthma action plan ( WAAP ) was the primary outcome . RESULTS There was no evidence for changes in ownership of WAAPs between the three study arms . Adolescents in the intervention group reported an improvement in quality of life subscale score ' positive effects ' ( mean difference = 2.64 , P = 0.01 ) , but there was no evidence for an effect of the intervention on other study outcomes among the three study arms . CONCLUSIONS The intervention was associated with some improvement in quality of life  for adolescents . However , overall , the intervention did not translate into increased ownership of WAAPs , control of asthma or improved quality of life Allergic rhinitis ( AR ) and asthma coexist frequently and a dual treatment is recommended by prescribing topical nasal plus oral inhaled corticosteroids . The purpose of this study was to assess the efficacy of a nasally inhaled corticosteroid aim ing at concomitant control of AR and asthma . A controlled trial was conducted among 60 patients with AR and asthma , aged 6–18 years , who were r and omized into two groups . During 8 weeks , the experimental group ( 30 patients ) received exclusively fluticasone propionate hydrofluoroalkane ( FP‐HFA ) inhaled through the nose ( mouth closed ) using a large volume spacer attached to a face mask . The comparison group ( 30 patients ) received a nasal spray of isotonic saline plus oral inhalation of FP‐HFA through a mouthpiece attached to the same spacer . Clinical scores for AR and asthma , nasal inspiratory peak flow ( NIPF ) , and spirometry were assessed by blinded observers . There was a significant improvement in AR scores and NIPF in the experimental group ( P ≤ 0.01 ) up to week 8 , when a worsening was observed after the intervention was interrupted . Asthma symptoms score , forced expiratory volume (FEV)1 , and FEF25−75 % were not statistically different between groups at the baseline visit or along follow‐up visits ( P ≥ 0.20 ) . Prebronchodilator FEV1 ( % predicted value ) improved by 10 % in both groups , comparing values at inclusion with those obtained at the end of follow up . Our results suggest that nasally inhaled FP‐HFA through a spacer may control AR and asthma in children and adolescents . This approach is likely to result in higher compliance , lower costs , and fewer side effects The aim of this study was to evaluate the effectiveness of an asthma education programme in moderate and severe asthma patients in a longitudinal , prospect i ve and r and omized study with a control group . Fifty-three asthmatic patients were studied , 26 of whom were assigned to the  educational group and 27 to the  control group . The educational group attended the programme regularly for a period of 6 months . The programme included information about asthma , instruction on the appropriate use of medication and training in the metered dose inhaler ( MDI ) technique , and information about the identification and control of asthma attacks and the recognition of early signs of exacerbation . The control group was su bmi tted to the routine care provided at the Asthma Clinic , with no formal instruction regarding asthma control . The groups were identical with regard to severity parameters , skills , lung function and quality of life at the beginning of the trial . At the end of the study , the education group showed significant differences when compared with the control group ( education/control ( mean values ) ) with respect to : visits to the asthma emergency room over the previous 6 months , 0.7/2 ( p=0.03 ) ; nocturnal symptoms , 0.3/0.7 ( p=0.04 ) ; score of symptoms , 1.3/2 ( p=0.04 ) . Improvements were also observed in skills and quality of life , knowledge of how to deal with attacks and how to control the environmental triggering factors , 73/35 ( < 0.05 ) ; correct use of the MDI , 8/4 ( 0.001 ) ; underst and ing of the difference between relief and anti-inflammatory medication , 86/20 ( < 0.05 ) ; and in the global limitation quality of life score , 28/50 ( 0.02 ) . It is concluded that the educational programme led to a significant improvement in asthma morbidity and that the implantation of educational programmes is possible for special population s when these programmes are adapted to the socioeconomic profile of the patients , with a significant gain in terms of the reduction of symptoms and improved pulmonary function and quality of life of asthmatics
Results Although highlighting a general lack of high- quality real-life effectiveness observational research on these clinical ly important topics , the analysis provided insights into how identified observational studies might inform asthma guidelines developers and clinicians .
Overall , RELEVANT appeared reliable and easy to use by expert review ers .
Conclusions Using such quality appraisal tools is m and atory to assess whether specific observational real-life effectiveness studies can be used to inform guideline development and /or decision-making in clinical practice
Abstract Introduction A Task Force was commissioned jointly by the European Academy of Allergy and Clinical Immunology ( EAACI ) and the Respiratory Effectiveness Group ( REG ) to develop a  quality assessment tool for real-life observational research to identify high- quality real-life asthma studies that could be considered within future guideline development .