172
Views
4
CrossRef citations to date
0
Altmetric
Study Protocol

Maximizing Adherence and Gaining New Information For Your Chronic Obstructive Pulmonary Disease (MAGNIFY COPD): Study Protocol for the Pragmatic, Cluster Randomized Trial Evaluating the Impact of Dual Bronchodilator with Add-On Sensor and Electronic Monitoring on Clinical Outcomes

ORCID Icon, , ORCID Icon, , , , ORCID Icon, , , ORCID Icon, , , ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon show all
Pages 25-35 | Published online: 24 May 2021

References

  • GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1459–1544.
  • Halpin DM, Miravitlles M, Metzdorf N, Celli B. Impact and prevention of severe exacerbations of COPD: a review of the evidence. Int J Chron Obstruct Pulmon Dis. 2017;12:2891–2908. doi:10.2147/COPD.S139470
  • Andreas S, Taube C. Inhaled therapy reduces COPD mortality. ERJ Open Res. 2020;6(4):00634–2020. doi:10.1183/23120541.00634-2020
  • Cecere LM, Slatore CG, Uman JE, et al. Adherence to long-acting inhaled therapies among patients with chronic obstructive pulmonary disease (COPD). COPD. 2012;9(3):251–258. doi:10.3109/15412555.2011.650241
  • van Boven JF, Chavannes NH, van der Molen T, Rutten-van Molken MP, Postma MJ, Vegter S. Clinical and economic impact of non-adherence in COPD: a systematic review. Respir Med. 2014;108(1):103–113. doi:10.1016/j.rmed.2013.08.044
  • Ingebrigtsen TS, Marott JL, Nordestgaard BG, et al. Low use and adherence to maintenance medication in chronic obstructive pulmonary disease in the general population. J Gen Intern Med. 2015;30(1):51–59. doi:10.1007/s11606-014-3029-0
  • Simoni-Wastila L, Wei YJ, Qian J, et al. Association of chronic obstructive pulmonary disease maintenance medication adherence with all-cause hospitalization and spending in a Medicare population. Am J Geriatr Pharmacother. 2012;10(3):201–210. doi:10.1016/j.amjopharm.2012.04.002
  • Agh T, Inotai A, Meszaros A. Factors associated with medication adherence in patients with chronic obstructive pulmonary disease. Respiration. 2011;82(4):328–334. doi:10.1159/000324453
  • George J, Kong DCM, Thoman R, et al. Factors associated with medication non adherence in patients with COPD. Chest. 2005;128(5):3198–3204. doi:10.1378/chest.128.5.3198
  • Laforest L, Denis F, Van Ganse E, et al. Correlates of adherence to respiratory drugs in COPD patients. Prim Care Respir J. 2010;19(2):148–154. doi:10.4104/pcrj.2010.00004
  • Wei L, Yang X, Li J, et al. Effect of pharmaceutical care on medication adherence and hospital admission in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled trial. J Thorac Dis. 2014;6(6):656–662. doi:10.3978/j.issn.2072-1439.2014.06.20
  • Khdour MR, Hawwa AF, Kidney JC, et al. Potential risk factors for medication non-adherence in patients with chronic obstructive pulmonary disease (COPD). Eur J Clin Pharmacol. 2012;68(10):1365–1373. doi:10.1007/s00228-012-1279-5
  • Krauskopf K, Federman AD, Kale MS, et al. Chronic obstructive pulmonary disease illness and medication beliefs are associated with medication adherence. COPD. 2015;12(2):151–164. doi:10.3109/15412555.2014.922067
  • Bosnic-Anticevich S, Chrystyn H, Costello RW, et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes. Int J Chron Obstruct Pulmon Dis. 2016;12:59–71. doi:10.2147/COPD.S117196
  • Melani AS, Canessa P, Coloretti I, et al. Inhaler mishandling is very common in patients with chronic airflow obstruction and long-term home nebuliser use. Respir Med. 2012;106(5):668–676. doi:10.1016/j.rmed.2011.11.016
  • Claudia G, Dieterle T, Breitenstein A-L, et al. Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial. Respir Res. 2018;19(237):1–15. doi:10.1186/s12931-017-0698-3
  • Braido F, Chrystyn H, Baiardini I, et al. “Trying, but failing” – the role of inhaler technique and mode of delivery in respiratory medication adherence. J Allergy Clin Immunol Pract. 2016;4(5):823–832. doi:10.1016/j.jaip.2016.03.002
  • Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease; 2020. Report. Available from: www.goldcopd.org. Accessed June 6, 2020.
  • Garrett G, Costello RW. Personalizing medicine - could the smart inhaler revolutionize treatment for COPD and asthma patients? Expert Opin Drug Deliv. 2019;16(7):675–677. doi:10.1080/17425247.2019.1628017
  • Chen J, Kaye L, Tuffli M, et al. Passive monitoring of short-acting beta-agonist use via digital platform in patients with chronic obstructive pulmonary disease: quality improvement retrospective analysis. JMIR Form Res. 2019;3(4):e13286. doi:10.2196/13286
  • Moore A, Preece A, Sharma R, et al. A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients. Eur Respir J. 2020:2003103. doi:10.1183/13993003.03103-2020
  • Gossec L, Tubach F, Dougados M, Ravaud P. Reporting of adherence to medication in recent randomized controlled trials of 6 chronic diseases: a systematic literature review. Am J Med Sci. 2007;334(4):248–254. doi:10.1097/MAJ.0b013e318068dde8
  • Roche N, Anzueto A, Bosnic Anticevich S, et al. The importance of real-life research in respiratory medicine: manifesto of the Respiratory Effectiveness Group. Eur Respir J. 2019;54(3):1901511. doi:10.1183/13993003.01511-2019
  • Vestbo J, Anderson JA, Calverley PMA, et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009;64(11):939–943. doi:10.1136/thx.2009.113662
  • Dal-Ré R, Janiaud P, Ioannidis JP. Real-world evidence: how pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018;16(1):49. doi:10.1186/s12916-018-1038-2
  • Gamerman V, Cai T, Elsäßer A. Pragmatic randomized clinical trials: best practices and statistical guidance. Health Serv Outcomes Res Methodol. 2019;19(1):23–35. doi:10.1007/s10742-018-0192-5
  • Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328(7441):702–708. doi:10.1136/bmj.328.7441.702
  • Zwarenstein M, Treweek S, Gagnier JJ, et al. Pragmatic trials in healthcare: improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337(nov11 2):a2390. doi:10.1136/bmj.a2390
  • Alexander E, Seyi S, Brooklyn S, et al. Strategies that promote sustainability in quality improvement activities for chronic disease management in healthcare settings: a practical perspective. Qual Prim Care. 2020;28(6):55–60.
  • National General Practice Profiles. Public health England. Available from: https://fingertips.phe.org.uk/profile/general-practice. Accessed November 24, 2019.
  • National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Clinical guideline; December 2018. Available from: https://www.nice.org.uk/guidance/ng115. Accessed November 24, 2019.
  • NHS Health Research Authority. Optimum patient care research database. Available from: https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/optimum-patient-care-research-database/. Accessed November 24, 2019.
  • Chapman KR, Bergeron C, Bhutani M, et al. Do we know the minimal clinically important difference (MCID) for COPD exacerbations? COPD. 2013;10(2):243–249. doi:10.3109/15412555.2012.733463
  • Donner AA. Review of inference procedures for the intraclass correlation coefficient in the one-way random effects model. Int Stat Rev. 1986;54(1):67–82. doi:10.2307/1403259
  • Ernst E, Canter PH. Limitations of “pragmatic” trials. Postgrad Med J. 2005;81(954):203. doi:10.1136/pgmj.2004.026807
  • Meichembaum D, Turk D. Facilitating Treatment Adherence: A Practitioner’s Guidebook. New York: Plenum; 1987.
  • Murphy AW, Esterman A, Pilotto LS. Cluster randomized controlled trials in primary care: an introduction. Eur J Gen Pract. 2006;12(2):70–73. doi:10.1080/13814780600780627
  • Law LM, Wason JM. Design of telehealth trials–introducing adaptive approaches. Int J Med Inform. 2014;83(12):870–880. doi:10.1016/j.ijmedinf.2014.09.002
  • van Boven JF, Tommelein E, Boussery K, et al. Improving inhaler adherence in patients with chronic obstructive pulmonary disease: a cost-effectiveness analysis. Respir Res. 2014;15(1):66. doi:10.1186/1465-9921-15-66
  • Blakey JD, Bender BG, Dima AL, et al. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J. 2018;52(5):1801147. doi:10.1183/13993003.01147-2018
  • Dayer L, Heldenbrand S, Anderson P, Gubbins PO, Martin BC. Smartphone medication adherence apps: potential benefits to patients and providers. J Am Pharm Assoc. 2013;53(2):172–181. doi:10.1331/JAPhA.2013.12202