Next-generation integrated care pathways of allergic rhinitis and asthma multimorbidity as a model for non-communicable diseases

A POLLAR project (eit Health)

Jean Bousquet, Michael Bewick, Wienia CzarlewskiARIA:

EAACI: Ioana AgacheEFA: ERS:

Euforea: Claus Bachert, Wytske Fokkens, Peter HellingsGARD: Nils Billo, Alvaro Cruz, Nikolai Khaltaev, Teresa To, Arzu Yorgancioglu

IPCRG: PinnockPOLLAR: Sylvie Arnavielhe, Anna Bedbrook, Samuel Benveniste, Eve Dupas, Daniel Laune, Jean-Louis

Pépin, Robert PicardProSTEP: Lars Munter, Jim Phillips, David Somekh

Vilnius declaration: Arunas Valiulis,WAO: Ignacio Ansotegui,

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Abbreviations

AIRWAYS ICPs: Integrated care pathways for airway diseasesAR: Allergic rhinitisARIA: Allergic rhinitis and its impact on asthmaGARD: Global Alliance against Chronic Respiratory DiseasesGP: General PractionerGRADE: Grading of Recommendation, Assessment, Development and EvaluationICP: integrated care pathwaysMASK: Mobile Airways Sentinel networkMHealth: mobile healthOTC: Over the counterPOLLAR: Impact of Air Pollution in Asthma and RhinitisSDM: Shared decision makingWHO: World health organization

Introduction

In Western societies, the increased burden and cost of non-communicable disease (chronic diseases) is growing rapidly reflecting the changing demography (1). While there is variation in budgetary allocations to health care in individual countries, most economies are struggling to deliver modern healthcare effectively (2). Budgets will continue to be challenged as demand increases and newer more expensive technologies become available (3, 4). Traditional programmes heavily reliant on specialist and supporting services are becoming unaffordable and innovative solutions are required to alleviate system wide pressures (5, 6).

Integrated Care Pathways (ICPs) are structured multi-disciplinary care plans detailing key steps of patient care for a given clinical problem (7). They promote the translation of guidelines into local protocols and their subsequent application to clinical practice. They may be of particular interest in patients with multimorbidities (8, 9). An ICP forms all or part of the clinical record, documents the care given, and facilitates the evaluation of outcomes for continuous quality improvement (10). They can help empower patients and their carers (health and social). ICPs differ from clinical practice guidelines as they are utilized by a multi-disciplinary team, and focus on the quality and co-ordination of care. Self-care and shared decision making are at the forefront of ICPs.

Rhinitis and asthma multimorbidity can be used as a model for chronic diseases since there is broad agreement on a ‘gold standard’ of care (11-13), but, in practice, adherence to this is poor (14, 15). ICPs have been proposed and new technologies through personally held data on tablet devices, recording ‘symptom load’ should enhance self-management and adherence to guidelines and ICPs. The science of self-care and ICPs through Hand Held Applications is in its infancy but results are encouraging.

A novel ARIA initiative in collaboration with most organizations in the field of allergy and airway diseases including patients is undertaken to propose real-life ICPs centered around the patient using mHealth and environmental exposure with rhinitis as a model of other chronic respiratory diseases and beyond as a model of chronic diseases.

The gaps in allergic rhinitis

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Allergic rhinitis (AR) is the most common chronic disease worldwide. Guidelines have improved the knowledge on rhinitis and made a significant impact on AR management. However, many patients are insufficiently controlled (16) and the costs for society are enormous, in particular due to AR major impact on school and work productivity (17) and allergic or non-allergic multimorbidities are not considered (18). Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline (11, 19, 20) to ICPs using mobile technology in AR and asthma multimorbidity across the life cycle (21).

A large number of AR patients do not consult physicians because they think their symptoms are ‘normal’ and/or trivial. However, AR negatively impacts social life, school and work productivity (20). Many AR patients use over the counter (OTC) drugs (22-25). Only a fraction of patients had a medical consultation. The vast majority of patients who visit GPs or specialists have moderate/severe rhinitis (26-30). Thus, ICPs should consider a multi-disciplinary approach as proposed by AIRWAYS ICPs (Figure 1).

Figure 1: ICPs for rhinitis and asthma multimorbidity (from (31))

Improvement in care pathway design to enhance patient participation, health literacy and self-care through technology assisted ‘patient activation’

Self-management is “making your own decisions about how to organize your work, rather than being led or controlled by a manager”. Self-care is “health care provided by oneself often without the consultation of a medical professional”. Self-medication is the treatment of common health problems with medicines especially designed and labeled for use without medical supervision and approved as safe and effective for such use. Medicines for self-medication are often OTC and are available without a doctor’s prescription through pharmacies. (definitions to be agreed)

Self-care is a necessary continuum with health care professionals, in particular for chronic disease patients who make many day-to-day decisions, or self-manage (32). A lack of adherence to medical advice may make self-care difficult. Effectively engaging patients in their care is essential to improve health outcomes, satisfaction with care, optimize costs, and benefit the clinician experience (33, 34). Self-care is a fundamental pillar of health and social care. Self-management is critical and self-management education complements traditional patient education in primary care to support patients

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to live the best possible quality of life with their chronic condition (32). Self-care is learned, purposeful and continuous (35). The economic imperative to move to “managed self-care” is an important step in a paradigm shift required in care of patients with ICPs (36, 37). Self-care can be divided in unintentional and guided self-care.

The ‘activated’ patient is knowledgeable about their condition(s), understands escalation of treatment options and when to seek pharmacy or medical advice. The aim is not to replace the clinician/patient relationship but to enhance it through developed autonomy and shared decision making (SDM) in order to improve control and optimise costs (38, 39). SDM interventions may be more beneficial to disadvantaged groups than higher literacy/socioeconomic status patients (40). Mobile technology has the potential to profoundly impact self-management and SDM of chronic diseases (41). Wider economic effects of self-care go beyond savings in health systems alone, the major economic return being in the workplace where absenteeism and more importantly presenteeism are reduced and productivity increases.

ARIA appears to be close to the patient’s needs but real-life data obtained using an App in 22 countries have shown that very few patients use guidelines and that they often self-medicate (14). Moreover, patients largely use OTC medications dispensed in pharmacies. However, in the case of AR, many patients have prescribed medications at home and when symptoms occur, they use them. Self-care and SDM centered around the patient should be used more often (42). ARIA has followed a change management (CM) strategy but a new one should be considered to fill the gaps in order to increase the benefits of self-care and SDM in ICPs using the currently-available IT tools. Self-care should be integrated in ICPs to optimize the treatment of AR and asthma multimorbidity. Finally, aeroallergen exposure and pollution impact disease control and medications but there is no ICP in airways diseases taking into account aerobiology. These changes should prepare and support individuals, teams and organizations in making organizational change centered around the patient.

Pharmacist care

Pharmacists are trusted health professionals. Most patients with allergic diseases are seen by pharmacists who are initial point of contact of AR management in most countries. Considering the challenges associated with AR and the identified needs, there is a clear the role for the pharmacist for AR management in practice, through a guided change management process. The role of pharmacists in ICPs for allergic diseases is essential. However, regional (national) differences exist and any recommendation should be targeted to the local situation.

ARIA in the pharmacy is being revised to propose ICPs integrated in a multi-disciplinary approach.

Next-generation guidelines

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” (Institute of Medicine, 1990). These clinical practice guidelines define the role of specific diagnostic and treatment modalities, and, include recommendations based on evidence intended to help HCPs in their practice (43).

ARIA was the first chronic respiratory disease guideline to adopt the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) approach, an advanced evidence

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evaluation methodology (11, 44-46). GRADE-based guidelines are available for AR and their recommendations are similar (11-13). However, they are based on randomized clinical trials that imperfectly reflect patients in real life (47), the assumption that patient regularly use their treatment and their recommendations are not tested with real-life data. Moreover, for many questions, recommendations are uncertain and need to be confirmed in real life.

mHealth, such as apps running on consumer smart devices is becoming increasingly popular and has the potential to profoundly affect healthcare and health outcomes. MASK, the Phase 3 ARIA initiative, is based on the freely available MASK app (the Allergy Diary, Android and iOS platforms) (21). MASK is available in 16 languages and deployed in 23 countries (14, 48-54). Over 18,000 users reporting over 100,000 days of treatment are available. MASK allows to assess treatment patterns in real life. Most patients appear to self-medicate, are non-adherent and do not follow guidelines. Moreover, the Allergy Diary is able to distinguish between AR medications (14).

Next-generation ARIA guidelines should consider to test the ARIA recommendations based on the GRADE approach on real-life data obtained by MASK in order to confirm or refine current GRADE-based recommendations. The first results of MASK confirm the feasibility of the project (14). Adherence to treatment is very low as <5% users record symptoms and medications for a period of 2 weeks suggesting that guidelines should consider both regular and on-demand treatment (14).

Study proposals

POLLAR (Impact of Air Pollution in Asthma and Rhinitis, Horizon 2020 grant) is an EIT-Health grant to better understand, prevent and manage the impact of air pollution and allergen exposure on airway diseases. POLLAR will use the MASK App that was found to be a Good Practice (49-52). One of the POLLAR WP is the development of ICPs integrating aerobiology and air pollution. This will be developed using a step wise approach centered around the patient. The three-step project is a WHO Global Alliance against Chronic Respiratory Diseases (GARD) demonstration project.

Step 1: Background information (March-November 2018): The concept needs to be refined by a small group of experts assessing the current knowledge:

1. Review current evidence on self-care strategies internationally utilising ProStep, UK and Danish experience initially (unintentional and guided).

2. Reflect the views of patients with rhinitis and asthma on self-care and any modifications required to enhance their care, through focus groups (on-line survey).

3. Work with POLLAR in the development of an enhanced Rhinitis ICP App reflecting local air quality measures influencing self-care decisions.

4. Establish best practice across several regions in the EU, possibly commencing in London (healthier London programme) linking the study to policy makers desire to improve air quality and outcomes in their population.

5. Check existing economic models for investing in self-care activation programmes.

Step 2: First meeting (December 3-4, 2018): Development of next-generation ICPs with a focus on self-management

1. Improved self-care (unintentional and guided) in the ICP Rhinitis, through the use of mobile technology with the development of an enhanced technology (Figure 2).

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2. Focus on the role of the pharmacist (Figure 2).

3. Next-generation guidelines considering to test the GRADE-based recommendations on real-life data obtained by MASK in order to confirm or refine the current recommendations (Figure 2).

4. Self-care with the development of a strategic and practical approach to improving patient autonomy and self-management programmes (Figure 2).

5. Integration of new paths of understanding health and change (Figure 2).

6. Deployment to other chronic respiratory diseases (asthma and COPD).

7. Deployment to middle and low-income countries.

8. Initiate the development of an economic model for investing in self-care activation programmes.

Figure 2: Next-generation ICPs for rhinitis and asthma multimorbidity

Step 3: Second meeting (December 2019): Embedding environmental data in next-generation ICPs

Using the results obtained by POLLAR, a second meeting will be held to integrate aerobiology and air pollution data in mobile technology and propose ICPs for the prevention of severe exacerbations and asthma during peaks of allergens and/or pollution. This meeting will also consider the deployment to other chronic diseases (Figure 3).

Figure 3: Embedding aerobiology and air pollution in ICPs

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References

1. Bousquet J, Anto JM, Sterk PJ, Adcock IM, Chung KF, Roca J, et al. Systems medicine and integrated care to combat chronic noncommunicable diseases. Genome Med. 2011;3(7):43.

2. Stenberg K, Lauer JA, Gkountouras G, Fitzpatrick C, Stanciole A. Econometric estimation of WHO-CHOICE country-specific costs for inpatient and outpatient health service delivery. Cost Eff Resour Alloc. 2018;16:11.

3. Crespi-Lofton J, Skelton JB. The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference. J Am Pharm Assoc (2003). 2017;57(5):e15-e27.

4. Gronde TV, Uyl-de Groot CA, Pieters T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS One. 2017;12(8):e0182613.

5. Russell J, Greenhalgh T. Affordability as a discursive accomplishment in a changing National Health Service. Soc Sci Med. 2012;75(12):2463-71.

6. Hunter DJ, Erskine J, Small A, McGovern T, Hicks C, Whitty P, et al. Doing transformational change in the English NHS in the context of "big bang" redisorganisation. J Health Organ Manag. 2015;29(1):10-24.

7. Campbell H, Hotchkiss R, Bradshaw N, Porteous M. Integrated care pathways. BMJ. 1998;316(7125):133-7.

8. Hujala A, Taskinen H, Rissanen S. In: Richardson E, van Ginneken E, editors. How to support integration to promote care for people with multimorbidity in Europe? European Observatory Policy Briefs. Copenhagen (Denmark)2017.

9. Palmer K, Marengoni A, Forjaz MJ, Jureviciene E, Laatikainen T, Mammarella F, et al. Multimorbidity care model: Recommendations from the consensus meeting of the Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Health Policy. 2018;122(1):4-11.

10. Overill S. A practical guide to care pathways. J Integr Care. 1998;2:93-8.11. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al. Allergic Rhinitis

and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126(3):466-76.12. Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Allergic Rhinitis and

its Impact on Asthma (ARIA) Guidelines - 2016 Revision. J Allergy Clin Immunol. 2017.13. Dykewicz MS, Wallace DV, Baroody F, Bernstein J, Craig T, Finegold I, et al. Treatment of seasonal

allergic rhinitis: An evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017;119(6):489-511 e41.

14. Bousquet J, Arnavielhe S, Bedbrook A, Alexis-Alexandre G, Eerd Mv, Murray R, et al. Treatment of allergic rhinitis using mobile technology with real world data: The MASK observational pilot study. Allergy. 2018:sous presse.

15. Gray WN, Netz M, McConville A, Fedele D, Wagoner ST, Schaefer MR. Medication adherence in pediatric asthma: A systematic review of the literature. Pediatr Pulmonol. 2018.

16. De Greve G, Hellings PW, Fokkens WJ, Pugin B, Steelant B, Seys SF. Endotype-driven treatment in chronic upper airway diseases. Clin Transl Allergy. 2017;7:22.

7

17. Vandenplas O, Vinnikov D, Blanc PD, Agache I, Bachert C, Bewick M, et al. Impact of Rhinitis on Work Productivity: A Systematic Review. J Allergy Clin Immunol Pract. 2017.

18. Cingi C, Gevaert P, Mosges R, Rondon C, Hox V, Rudenko M, et al. Multi-morbidities of allergic rhinitis in adults: European Academy of Allergy and Clinical Immunology Task Force Report. Clin Transl Allergy. 2017;7:17.

19. Bousquet J, Van Cauwenberge P, Khaltaev N. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001;108(5 Suppl):S147-334.

20. Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63 Suppl 86:8-160.

21. Bousquet J, Hellings PW, Agache I, Bedbrook A, Bachert C, Bergmann KC, et al. ARIA 2016: Care pathways implementing emerging technologies for predictive medicine in rhinitis and asthma across the life cycle. Clin Transl Allergy. 2016;6:47.

22. ARIA in the pharmacy: management of allergic rhinitis symptoms in the pharmacy. Allergic rhinitis and its impact on asthma. Allergy. 2004;59(4):373-87.

23. Carr WW, Yawn BP. Management of allergic rhinitis in the era of effective over-the-counter treatments. Postgrad Med. 2017;129(6):572-80.

24. Lombardi C, Musicco E, Rastrelli F, Bettoncelli G, Passalacqua G, Canonica GW. The patient with rhinitis in the pharmacy. A cross-sectional study in real life. Asthma Res Pract. 2015;1:4.

25. Fromer LM, Blaiss MS, Jacob-Nara JA, Long RM, Mannion KM, Lauersen LA. Current Allergic Rhinitis Experiences Survey (CARES): Consumers' awareness, attitudes and practices. Allergy Asthma Proc. 2014;35(4):307-15.

26. Bousquet J, Neukirch F, Bousquet PJ, Gehano P, Klossek JM, Le Gal M, et al. Severity and impairment of allergic rhinitis in patients consulting in primary care. J Allergy Clin Immunol. 2006;117(1):158-62.

27. Bousquet J, Annesi-Maesano I, Carat F, Leger D, Rugina M, Pribil C, et al. Characteristics of intermittent and persistent allergic rhinitis: DREAMS study group. Clin Exp Allergy. 2005;35(6):728-32.

28. Bousquet PJ, Devillier P, Tadmouri A, Mesbah K, Demoly P, Bousquet J. Clinical Relevance of Cluster Analysis in Phenotyping Allergic Rhinitis in a Real-Life Study. Int Arch Allergy Immunol. 2015;166(3):231-40.

29. del Cuvillo A, Montoro J, Bartra J, Valero A, Ferrer M, Jauregui I, et al. Validation of ARIA duration and severity classifications in Spanish allergic rhinitis patients - The ADRIAL cohort study. Rhinology. 2010;48(2):201-5.

30. Jauregui I, Davila I, Sastre J, Bartra J, del Cuvillo A, Ferrer M, et al. Validation of ARIA (Allergic Rhinitis and its Impact on Asthma) classification in a pediatric population: the PEDRIAL study. Pediatr Allergy Immunol. 2011;22(4):388-92.

31. Bousquet J, Addis A, Adcock I, Agache I, Agusti A, Alonso A, et al. Integrated care pathways for airway diseases (AIRWAYS-ICPs). Eur Respir J. 2014;44(2):304-23.

32. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002;288(19):2469-75.

33. Krist AH, Tong ST, Aycock RA, Longo DR. Engaging Patients in Decision-Making and Behavior Change to Promote Prevention. Stud Health Technol Inform. 2017;240:284-302.

34. Stacey D, Hill S, McCaffery K, Boland L, Lewis KB, Horvat L. Shared Decision Making Interventions: Theoretical and Empirical Evidence with Implications for Health Literacy. Stud Health Technol Inform. 2017;240:263-83.

35. Conway MA, Pleydell-Pearce CW. The construction of autobiographical memories in the self-memory system. Psychol Rev. 2000;107(2):261-88.

36. Basu R, Ory MG, Towne SD, Jr., Smith ML, Hochhalter AK, Ahn S. Cost-effectiveness of the chronic disease self-management program: implications for community-based organizations. Front Public Health. 2015;3:27.

37. Frakking TT, Waugh J, Teoh HJ, Shelton D, Moloney S, Ward D, et al. Integrated children's clinic care (ICCC) versus a self-directed care pathway for children with a chronic health condition: a multi-centre randomised controlled trial study protocol. BMC Pediatr. 2018;18(1):72.

38. Barry MJ, Edgman-Levitan S. Shared decision making--pinnacle of patient-centered care. N Engl J Med. 2012;366(9):780-1.

39. Florin J, Ehrenberg A, Ehnfors M. Clinical decision-making: predictors of patient participation in nursing care. J Clin Nurs. 2008;17(21):2935-44.

40. Durand MA, Carpenter L, Dolan H, Bravo P, Mann M, Bunn F, et al. Do interventions designed to support shared decision-making reduce health inequalities? A systematic review and meta-analysis. PLoS One. 2014;9(4):e94670.

8

41. Bousquet J, Chavannes NH, Guldemond N, Haahtela T, Hellings PW, Sheikh A. Realising the potential of mHealth to improve asthma and allergy care: how to shape the future. Eur Respir J. 2017;49(5).

42. Hellings PW, Borrelli D, Pietikainen S, Agache I, Akdis C, Bachert C, et al. European Summit on the Prevention and Self-Management of Chronic Respiratory Diseases: report of the European Union Parliament Summit (29 March 2017). Clin Transl Allergy. 2017;7:49.

43. Clinical practice guidelines. National Center for Complementary and alternative medicine (NCCAM). National Institutes of Health. http://nccam.nih.gov/health/providers/clinicalpractice.htm. 2014.

44. Brozek JL, Akl EA, Alonso-Coello P, Lang D, Jaeschke R, Williams JW, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions. Allergy. 2009;64(5):669-77.

45. Brozek JL, Baena-Cagnani CE, Bonini S, Canonica GW, Rasi G, van Wijk RG, et al. Methodology for development of the Allergic Rhinitis and its Impact on Asthma guideline 2008 update. Allergy. 2008;63(1):38-46.

46. Padjas A, Kehar R, Aleem S, Mejza F, Bousquet J, Schunemann HJ, et al. Methodological rigor and reporting of clinical practice guidelines in patients with allergic rhinitis: QuGAR study. J Allergy Clin Immunol. 2014;133(3):777-83 e4.

47. Costa DJ, Amouyal M, Lambert P, Ryan D, Schunemann HJ, Daures JP, et al. How representative are clinical study patients with allergic rhinitis in primary care? J Allergy Clin Immunol. 2011.

48. Bousquet J, Bewick M, Arnavielhe S, Mathieu-Dupas E, Murray R, Bedbrook A, et al. Work productivity in rhinitis using cell phones: The MASK pilot study. Allergy. 2017;72(10):1475-84.

49. Bousquet J, Caimmi DP, Bedbrook A, Bewick M, Hellings PW, Devillier P, et al. Pilot study of mobile phone technology in allergic rhinitis in European countries: the MASK-rhinitis study. Allergy. 2017;72(6):857-65.

50. Bousquet J, Onorato GL, Bachert C, Barbolini M, Bedbrook A, Bjermer L, et al. CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report. Clin Transl Allergy. 2017;7:37.

51. Bousquet J, VandenPlas O, Bewick M, Arnavielhe S, Bedbrook A, Murray R, et al. Work Productivity and Activity Impairment Allergic Specific (WPAI-AS) Questionnaire using Mobile Technology: The MASK study. J Investig Allergol Clin Immunol. 2017:0.

52. Caimmi D, Baiz N, Tanno LK, Demoly P, Arnavielhe S, Murray R, et al. Validation of the MASK-rhinitis visual analogue scale on smartphone screens to assess allergic rhinitis control. Clin Exp Allergy. 2017;47(12):1526-33.

53. Bousquet J, Agache I, Aliberti MR, Angles R, Annesi-Maesano I, Anto JM, et al. Transfer of innovation on allergic rhinitis and asthma multimorbidity in the elderly (MACVIA-ARIA) - EIP on AHA Twinning Reference Site (GARD research demonstration project). Allergy. 2018;73(1):77-92.

54. Bousquet J, Arnavielhe S, Bedbrook A, Fonseca J, Morais Almeida M, Todo Bom A, et al. The Allergic Rhinitis and its Impact on Asthma (ARIA) score of allergic rhinitis using mobile technology correlates with quality of life: The MASK study. Allergy. 2018;73(2):505-10.

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