- WingK, WilliamsonE, CarpenterJR, WiseL, SchneeweissS, SmeethL, et al.Real-world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results. BMJ Open2018;8:e019475. 10.1136/bmjopen-2017-019475
- The Healthcare Commission. Clearing the Air: A National Study Of Chronic Pulmonary Disease. London: The Healthcare Commission; 2006.
- CalverleyPM, AndersonJA, CelliB, FergusonGT, JenkinsC, JonesPW, et al.Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med2007;356:775–89. 10.1056/NEJMoa06307017314337
- TashkinDP, CelliB, SennS, BurkhartD, KestenS, MenjogeS, DecramerM, UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med2008;359:1543–54. 10.1056/NEJMoa080580018836213
- National Institute for Health and Care Excellence. Chronic Obstructive Pulmonary Disease in Over 16s: Diagnosis and Management. 2010. URL: www.nice.org.uk/guidance/cg101 (accessed 26 May 2017).
- FergusonGT, AnzuetoA, FeiR, EmmettA, KnobilK, KalbergC, et al.Maintenance pharmacotherapy of mild and moderate COPD: what is the evidence?Respir Med2011;105:1268–74. 10.1016/j.rmed.2011.02.00521353516
- European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council. 2010. URL: http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf (accessed 2 Jaune 2021).
- SpringS. Guidance for Industry Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. URL: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm (accessed 13 June 2017).
- HerrettE, GallagherAM, BhaskaranK, ForbesH, MathurR, van StaaT, SmeethL. Data resource profile: Clinical Practice Research Datalink (CPRD). Int J Epidemiol2015;44:827–36. 10.1093/ije/dyv09826050254
- HerrettE, ThomasSL, SchoonenWM, SmeethL, HallAJ. Validation and validity of diagnoses in the General Practice Research Database: a systematic review. Br J Clin Pharmacol2010;69:4–14. 10.1111/j.1365-2125.2009.03537.x20078607
- QuintJK, MüllerovaH, DiSantostefanoRL, ForbesH, EatonS, HurstJR, et al.Validation of chronic obstructive pulmonary disease recording in the Clinical Practice Research Datalink (CPRD-GOLD). BMJ Open2014;4:e005540. 10.1136/bmjopen-2014-005540
- MillettER, QuintJK, SmeethL, DanielRM, ThomasSL. Incidence of community-acquired lower respiratory tract infections and pneumonia among older adults in the United Kingdom: a population-based study. PLOS ONE2013;8:e75131. 10.1371/journal.pone.007513124040394
- RothnieKJ, MüllerováH, HurstJR, SmeethL, DavisK, ThomasSL, QuintJK. Validation of the recording of acute exacerbations of COPD in UK primary care electronic healthcare records. PLOS ONE2016;11:e0151357. 10.1371/journal.pone.015135726959820
- NissenF, MoralesDR, MullerovaH, SmeethL, DouglasIJ, QuintJK. Validation of asthma recording in the Clinical Practice Research Datalink (CPRD). BMJ Open2017;7:e017474. 10.1136/bmjopen-2017-017474
- WingK, WilliamsonE, CarpenterJR, WiseL, SchneeweissS, SmeethL, et al.Real world effects of COPD medications: a cohort study with validation against RCT results. Eur Respir J2021;57:2001586. 10.1183/13993003.01586-202033093119
- DouglasI, EvansS, SmeethL. Effect of statin treatment on short term mortality after pneumonia episode: cohort study. BMJ2011;342:d1642. 10.1136/bmj.d164221471172
- WilliamsonE, MorleyR, LucasA, CarpenterJ. Propensity scores: from naive enthusiasm to intuitive understanding. Stat Methods Med Res2012;21:273–93. 10.1177/096228021039448321262780
- WilliamsonEJ, ForbesA. Introduction to propensity scores. Respirology2014;19:625–35. 10.1111/resp.1231224889820
- RootAA, WongAY, Ghebremichael-WeldeselassieY, SmeethL, BhaskaranK, EvansSJ, et al.Evaluation of the risk of cardiovascular events with clarithromycin using both propensity score and self-controlled study designs. Br J Clin Pharmacol2016;82:512–21. 10.1111/bcp.1298327090996
- National Institute for Health and Care Excellence. Chronic Obstructive Pulmonary Disease in Over 16s: Diagnosis and Management. URL: www.nice.org.uk/guidance/ng115 (accessed 3 June 2019).
- ConcatoJ, ShahN, HorwitzRI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med2000;342:1887–92. 10.1056/NEJM20000622342250710861325
- GolderS, LokeYK, BlandM. Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview. PLOS Med2011;8:e1001026. 10.1371/journal.pmed.100102621559325
- DeeksJJ, DinnesJ, D’AmicoR, SowdenAJ, SakarovitchC, SongF, et al.Evaluating non-randomised intervention studies. Health Technol Assess2003;7(27). 10.3310/hta7270
- LawlorDA, Davey SmithG, KunduD, BruckdorferKR, EbrahimS. Those confounded vitamins: what can we learn from the differences between observational versus randomised trial evidence?Lancet2004;363:1724–7. 10.1016/S0140-6736(04)16260-015158637
- VandenbrouckeJP. The HRT controversy: observational studies and RCTs fall in line. Lancet2009;373:1233–5. 10.1016/S0140-6736(09)60708-X19362661
- DanaeiG, RodríguezLA, CanteroOF, LoganR, HernánMA. Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease. Stat Methods Med Res2013;22:70–96. 10.1177/096228021140360322016461
- DouglasIJ, EvansSJ, PocockS, SmeethL. The risk of fractures associated with thiazolidinediones: a self-controlled case-series study. PLOS Med2009;6:e1000154. 10.1371/journal.pmed.100015419787025
- LanganSM, SmeethL, MargolisDJ, ThomasSL. Herpes zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in an older US population: a cohort study. PLOS Med2013;10:e1001420. 10.1371/journal.pmed.100142023585738
- SchneeweissS, SeegerJD, LandonJ, WalkerAM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med2008;358:771–83. 10.1056/NEJMoa070757118287600
- HernánMA, AlonsoA, LoganR, GrodsteinF, MichelsKB, WillettWC, et al.Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology2008;19:766–79. 10.1097/EDE.0b013e3181875e6118854702
- RossouwJE, AndersonGL, PrenticeRL, LaCroixAZ, KooperbergC, StefanickML, et al.Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA2002;288:321–33. 10.1001/jama.288.3.32112117397
- SmeethL, DouglasI, HallAJ, HubbardR, EvansS. Effect of statins on a wide range of health outcomes: a cohort study validated by comparison with randomized trials. Br J Clin Pharmacol2009;67:99–109. 10.1111/j.1365-2125.2008.03308.x19006546
- Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet2002;360:7–22. 10.1016/S0140-6736(02)09327-312114036
- FralickM, KesselheimAS, AvornJ, SchneeweissS. Use of health care databases to support supplemental indications of approved medications. JAMA Intern Med2018;178:55–63. 10.1001/jamainternmed.2017.391929159410
- The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med2008;358:1547–59. 10.1056/NEJMoa080131718378520
- NanniniLJ, LassersonTJ, PooleP. Combined corticosteroid and long-acting beta2-agonist in one inhaler versus long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev2012;9:CD006829. 10.1002/14651858.CD006829.pub2
- SorianoJB, VestboJ, PrideNB, KiriV, MadenC, MaierWC. Survival in COPD patients after regular use of fluticasone propionate and salmeterol in general practice. Eur Respir J2002;20:819–25. 10.1183/09031936.02.0030130212412670
- MapelDW, HurleyJS, RoblinD, RobertsM, DavisKJ, SchreinerR, FrostFJ. Survival of COPD patients using inhaled corticosteroids and long-acting beta agonists. Respir Med2006;100:595–609. 10.1016/j.rmed.2005.08.00616199151
- SuissaS. Inhaled steroids and mortality in COPD: bias from unaccounted immortal time. Eur Respir J2004;23:391–5. 10.1183/09031936.04.0006250415065827
- SuissaS, PatenaudeV, LapiF, ErnstP. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax2013;68:1029–36. 10.1136/thoraxjnl-2012-20287224130228
- ErnstP, GonzalezAV, BrassardP, SuissaS. Inhaled corticosteroid use in chronic obstructive pulmonary disease and the risk of hospitalization for pneumonia. Am J Respir Crit Care Med2007;176:162–6. 10.1164/rccm.200611-1630OC17400730
- SuissaS, Dell’AnielloS, ErnstP. Comparative effectiveness of LABA-ICS versus LAMA as initial treatment in COPD targeted by blood eosinophils: a population-based cohort study. Lancet Respir Med2018;6:855–62. 10.1016/S2213-2600(18)30368-030343028
- BogartM, StanfordRH, LalibertéF, GermainG, WuJW, DuhMS. Medication adherence and persistence in chronic obstructive pulmonary disease patients receiving triple therapy in a USA commercially insured population. Int J Chron Obstruct Pulmon Dis2019;14:343–52. 10.2147/COPD.S18465330863037
- MuellerS, WilkeT, BechtelB, PunekarYS, MitznerK, VirchowJC. Non-persistence and non-adherence to long-acting COPD medication therapy: a retrospective cohort study based on a large German claims dataset. Respir Med2017;122:1–11. 10.1016/j.rmed.2016.11.00827993284
- KyriacouDN, LewisRJ. Confounding by indication in clinical research. JAMA2016;316:1818–19. 10.1001/jama.2016.1643527802529
- YoshidaK, SolomonDH, KimSC. Active-comparator design and new-user design in observational studies. Nat Rev Rheumatol2015;11:437–41. 10.1038/nrrheum.2015.3025800216
- GagneJJ, FiremanB, RyanPB, MaclureM, GerhardT, TohS, et al.Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf2012;21:32–40. 10.1002/pds.231622262591
- NørgaardM, EhrensteinV, VandenbrouckeJP. Confounding in observational studies based on large health care databases: problems and potential solutions – a primer for the clinician. Clin Epidemiol2017;9:185–93. 10.2147/CLEP.S12987928405173
- RCT DUPLICATE – Home. URL: https://aetion.com/company/news/first-rct-duplicate-findings-published-in-circulation/ (accessed 15 October 2021).
- FriedTR, Vaz FragosoCA, RabowMW. Caring for the older person with chronic obstructive pulmonary disease. JAMA2012;308:1254–63. 10.1001/jama.2012.1242223011715
- FergusonGT, BuhlR, BothnerU, HozA, VoßF, AnzuetoA, CalverleyPMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med2018;143:67–73. 10.1016/j.rmed.2018.08.01230261995
- RayR, TombsL, NayaI, ComptonC, LipsonDA, BoucotI. Efficacy and safety of the dual bronchodilator combination umeclidinium/vilanterol in COPD by age and airflow limitation severity: a pooled post hoc analysis of seven clinical trials. Pulm Pharmacol Ther2019;57:101802. 10.1016/j.pupt.2019.10180231096036
- LeeH, RyuJ, ChungSJ, ParkDW, SohnJW, YoonHJ, KimSH. Coexisting COPD increases mortality in patients with corticosteroid-dependent asthma: a nationwide population-based study. Allergy Asthma Immunol Res2020;12:821–31. 10.4168/aair.2020.12.5.82132638562
- HaradaT, YamasakiA, FukushimaT, HashimotoK, TakataM, KodaniM, et al.Causes of death in patients with asthma and asthma-chronic obstructive pulmonary disease overlap syndrome. Int J Chron Obstruct Pulmon Dis2015;10:595–602. 10.2147/COPD.S7749125834418
- SinghD, D’UrzoAD, DonohueJF, KerwinEM. Weighing the evidence for pharmacological treatment interventions in mild COPD; a narrative perspective. Respir Res2019;20:141. 10.1186/s12931-019-1108-931286970
- GartlehnerG, HansenRA, CarsonSS, LohrKN. Efficacy and safety of inhaled corticosteroids in patients with COPD: a systematic review and meta-analysis of health outcomes. Ann Fam Med2006;4:253–62. 10.1370/afm.51716735528
- JonesPW, WillitsLR, BurgePS, CalverleyPM, Inhaled Steroids in Obstructive Lung Disease in Europe study investigators. Disease severity and the effect of fluticasone propionate on chronic obstructive pulmonary disease exacerbations. Eur Respir J2003;21:68–73. 10.1183/09031936.03.0001330312570111
- WolfA, DedmanD, CampbellJ, BoothH, LunnD, ChapmanJ, MylesP. Data resource profile: Clinical Practice Research Datalink (CPRD) Aurum. Int J Epidemiol2019;48:1740–1740g. 10.1093/ije/dyz03430859197
Medications for chronic obstructive pulmonary disease: a historical non-interventional cohort study with validation against RCT results · References
References
Attribution. Kevin Wing; Elizabeth Williamson; James R Carpenter; Lesley Wise; Sebastian Schneeweiss; Liam Smeeth et al. (2021). Medications for chronic obstructive pulmonary disease: a historical non-interventional cohort study with validation against RCT results. NIHR Journals Library. Copyright © 2021 Wing et al. This work was produced by Wing et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Licensed under CC BY 4.0. NCBI Bookshelf NBK573211. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.