The future of ARIA guidelines

Transcription

1 The future of ARIA guidelines Evidence- based medicine GRADE Recommenda<ons AND something else? Fit at work with rhini<s

2 MACVIA- ARIA New ARIA guidelines 2- Beyond guidelines

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4 ARIA Develop Integrated Care Pathways for rhini<s/asthma comorbidity 1. ARIA (WHO workshop 1999)

5 1245 cita*ons ISI 3450 cita*ons Google Scolar

6 ARIA ARIA pocket guide 52 transla<ons

7 ARIA

8 Impact of ARIA

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10 ARIA Develop Integrated Care Pathways for rhini<s/asthma comorbidity 1. ARIA (WHO workshop 1999) 2. Revision using GRADE

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12 Quality of guidelines (AGREE II) Padjas et al, J Allergy Clin Immunol 2013

13 ARIA Develop Integrated Care Pathways for rhini<s/asthma comorbidity 1. ARIA (WHO workshop 1999) 2. Revision using GRADE 3. From a guideline to an ICP in asthma and rhini<s co- morbidity

14 From guidelines to ICPs ICPs differ from prac*ce guidelines as they are u*lized by a mul<disciplinary team have a focus on the quality and co- ordina*on of care ICPs need to have a mechanism for recording varia<ons/devia*ons from planned care An ICP is intended to act as a guide to treatment. Clinicians are free to exercise their own professional judgments as appropriate. However, any altera<on to the prac<ce iden<fied within this ICP must be noted as a variance The resul*ng analysis can be used to amend the ICP itself if, for the majority of pa*ents, the prac*ce is different to the pathway

15 Variance analysis in ARIA Any altera<on to the prac<ce iden<fied with the guideline or ICP must be noted as a variance. ARIA classifica<on: severity (mild vs moderate/severe) is linked with quality of life (RQLQ) ARIA classifica<on: Persistence is not associated with RQLQ Persistence is associated with predic*on of efficacy Persistence is associated with dura*on of treatment Persistence is associated with asthma comorbidity Most pa<ents consul<ng in primary or secondary care Have moderate/severe disease Receive ICS + an*histamines

16 ICP in allergic rhinitis Patient with allergic rhinitis symptoms Self- management Incorrect diagnosis Severity OTC medica*on Pharmacist Improvement Failure Primary care Check For asthma YES Incorrect diagnosis Severity Treatment Improvement Failure Specialist Emergency care (asthma)

17 Airways - ICP launch Dr Mike Bewick Deputy Medical Director NHS England 17 Feb 2014

18 ARIA Develop Integrated Care Pathways for rhini<s/ asthma comorbidity 1. ARIA (WHO workshop 1999) 2. Revision using GRADE 3. From a guideline to an ICP in asthma and rhini*s co- morbidity 4. Need to rank interven<ons in stra<fied pa<ents

19 ARIA J Allergy Clin Immunol, May 2016

20 CDSS: allergic rhinitis treatment Assessment of control in untreated symptoma<c pa<ent VAS < 5 Ini<ate treatment ANY 1st Line (An< H1 or INCS or INCS+AZE) VAS 5 Ini<ate treatment Intermicent rhini<s: ANY Persistent rhini<s: INCS or INCS+AZE Re- assess VAS daily up to D3 VAS < 5 VAS 5 Step up and Re- assess VAS daily up to D7 If symptoma<c: con<nue treatment If no symptoms: consider step down treatment VAS < 5 VAS 5 *: consider INCS+AZE if previous treatment ineffec<ve (historical) Consider SIT

21 CDSS: allergic rhinitis treatment Assessment of control in treated symptoma<c pa<ent Intermicent rhini<s No allergen exposure Step- down treatment or STOP VAS < 5 1st Line (An< H1 or INCS or INCS+AZE) Persistent rhini<s or allergen exposure Maintain or step up treatment VAS 5 Step- up treatment INCS or INCS+AZE Re- assess VAS daily up to D7 Re- assess VAS daily up to D3 VAS < 5 VAS 5 VAS < 5 VAS 5 Step up and Re- assess VAS daily If symptoma<c: con<nue treatment If no symptoms: consider step down treatment Consider SIT

22 Systema<c reviews (sources include SPC- PI from regulators such as EMEA and FDA) - RCTs (including pragma<c trials) - Non- randomized studies of interven<ons Direct (head- to- head) comparisons Indirect comparisons Evidence to Decision Frameworks with ranking of an interven<on allowing country (region) adapta<on Guideline panel agreement

23 Most recommenda*ons are s*ll valid in 2016 Oral H1- an*histamines in adolescents and adults Intra- nasal H1- an*histamines Intra- nasal cor*costeroids An*- leukotrienes Intra- nasal ipratropium Intra- nasal or ocular cromoglycate

24 Compara<ve effec<veness review of the treatments for seasonal allergic rhini<s

25 J Allergy Clin Immunol 2016

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27 Systema<c reviews (sources include SPC- PI from regulators such as EMEA and FDA) - RCTs (including pragma<c trials) - Non- randomized studies of interven<ons Direct (head- to- head) comparisons Indirect comparisons Evidence to Decision Frameworks with ranking of an interven<on allowing country (region) adapta<on Guideline panel agreement Health system Availability/affordability of interven<ons Cost/reimbursement HCP views Pa<ents views Social determinants/barriers Step 1 Step 2 Step 3 Care pathway based on evidence to decision frameworks specific to - - Country (region) - Age and sex Pa<ent stra<fica<on - (Social group)

28 Systema<c reviews (sources include SPC- PI from regulators such as EMEA and FDA) - RCTs (including pragma<c trials) - Non- randomized studies of interven<ons Direct (head- to- head) comparisons Indirect comparisons Evidence to Decision Frameworks with ranking of an interven<on allowing country (region) adapta<on Guideline panel agreement Health system Availability/affordability of interven<ons Cost/reimbursement HCP views Pa<ents views Social determinants/barriers Step 1 Step 2 Step 3 Care pathway based on evidence to decision frameworks specific to - - Country (region) - Age and sex Pa<ent stra<fica<on - (Social group) Pa<ent stra<fica<on

29 MACVIA- ARIA New ARIA guidelines 2- MASK

30 The future of ARIA guidelines Evidence- based medicine GRADE Recommenda<ons AND something else? Fit at work with rhini<s

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34 AIRWAYS ICPs (Eur Respir J 2014)

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36 MASK funding

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38 ICP in allergic rhinitis

39 ICP in allergic rhinitis Patient with allergic rhinitis symptoms Self- management Incorrect diagnosis Severity OTC medica*on Pharmacist Improvement Failure Primary care Check For asthma YES Incorrect diagnosis Severity Treatment Improvement Failure Specialist Emergency care (asthma)

40 ICP in allergic rhinitis Patient with allergic rhinitis symptoms Self- management Incorrect diagnosis Severity OTC medica*on Pharmacist Improvement Failure Primary care Check For asthma YES Incorrect diagnosis Severity Treatment Improvement Failure Specialist Emergency care (asthma)

41 Transfer of data to HCP

42 The MACVIA-ARIA future Electronic decision support system

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44 MASK: ICP implementa<on Free (Apple stores and Android) Provides a simple common language for pa*ents and health care professionals A simple and effec*ve tool for precision medicine Stra*fies rapidly uncontrolled pa*ents despite op*mal treatment: reduces *me from first symptoms to AIT The same tool can be used To stra*fy pa*ents to be enrolled in RCTs To perform RCTs To study efficacy of interven*ons in real life To study persistence of the effect when interven*on stopped Can be used in the elderly A tool for healthy work in rhini<s sufferers (EIP on AHA) in rhini*s can be deployed to other chronic diseases

45 The future of ARIA guidelines Evidence- based medicine GRADE Recommenda<ons AND something else? Fit at work with rhini<s

46 On first use, users see a welcome screen, accept terms and conditions of use and are given the opportunity to register and create an account. My Allergy Diary

47 My Allergy Diary: Symptom Control? Indicates a response is required Users touch the line to indicate response and a marker appears in that location The marker can be moved with a finger to mark the line where intended. Once the mark is placed the user then touches next to move on to the next VAS Each VAS is completed once daily

48 MACVIA-ARIA sentinel network Pa<ents selected by allergists - History of allergic symptoms - Posi<ve skin tests (GA 2 LEN bacery) - Component resolved IgE Pollen counts in previous years 2 weeks before expected season SMS to inform pa<ent to start VAS daily monitoring Modelling of future pollen seasons best worst Daily VAS level Increased VAS level best worst SMS to inform all pa<ents of onset of pollen season Daily VAS level monitoring Informa<on to media Analysis of clinical and climatologic data and pollen counts Research Clinical trials Policies and Preven<ve strategies

49 My Allergy Diary: control assessment In case of continued high scores the feedback message will display an appropriate message in red type and a warning icon will mark the graph Prompts users to discuss their diary data with their health care provider Aim: get to green and stay there

50 Pa<ent phenotype and stra<fica<on best worst Daily VAS level Increased VAS level ARIA 2015 Integrated care pathways AIRWAYS- ICP Clinical decision Support system Precise pa<ent phenotype Caracteriza<on of SCUAD pa<ents

51 CDSS: allergic rhinitis treatment Assessment of control in treated symptoma<c pa<ent VAS < 5 VAS 5 Intermicent rhini<s No allergen exposure Step- down treatment or STOP 1st Line (An< H1 or INCS or INCS+AZE) Persistent rhini<s or allergen exposure Maintain or step up treatment Re- assess VAS daily up to D3 preferences and other needs VAS < 5 Step- up treatment INCS or INCS+AZE The therapeu<c strategy will be defined by the physician according to pa<ent s Re- assess VAS daily up to D7 VAS 5 VAS < 5 VAS 5 Step up and Re- assess VAS daily If symptoma<c: con<nue treatment If no symptoms: consider step down treatment Consider SIT

52 From stra<fied pa<ents to trials ARIA 2015 Integrated care pathways ARIA- ICP Stra<fy pa<ents Randomized control trials best worst Daily VAS level Increased VAS level Applicable to all age groups and the elderly Symptoms Medica<ons QOL Clinical decision Support system Assessment of SCUAD Asthma- conjunc<vi<s

53 Valida<on of ARIA 2015 Integrated care pathways ARIA- ICP Clinical decision Support system Treat pa<ent up to control or Maximum therapy Pa<ents treated by physicians «free choice» best worst Daily VAS level Compare the 2 strategies Op<mize treatment Characterize responders