Using external data to assess the external validity of a randomised controlled trial

References

• Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply”? Lancet Lond Engl. 2005;365(9453):82–93.
   PubMed Web of Science ®Google Scholar
• Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLOS Clin Trial. 2006;1(1):e9.
   PubMedGoogle Scholar
• Paul M, Bronstein E, Yahav D, et al. External validity of a randomised controlled trial on the treatment of severe infections caused by MRSA. BMJ Open. 2015;5(9):e008838.
   PubMed Web of Science ®Google Scholar
• Steg PG, López-Sendón J, de Sa EL, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med. 2007;167(1):68–73.
   PubMedGoogle Scholar
• Claessens Y-E, Aegerter P, Boubaker H, Cub-Rea Network, et al. Are clinical trials dealing with severe infection fitting routine practices? Insights from a large registry. Crit Care. 2013;17(3):R89.
   PubMed Web of Science ®Google Scholar
• Falagas ME, Vouloumanou EK, Sgouros K, et al. Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on antimicrobial agents. Int J Antimicrob Agents. 2010;36(1):1–13.
   PubMed Web of Science ®Google Scholar
• Al-Refaie WB, Vickers SM, Zhong W, et al. Cancer trials versus the real world in the United States. Ann Surg. 2011;254(3):438–443.
   PubMed Web of Science ®Google Scholar
• Buffel Du Vaure C, Dechartres A, Battin C, et al. Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details. BMJ Open. 2016;6(9):e012265.
   PubMed Web of Science ®Google Scholar
• Braslow JT, Duan N, Starks SL, et al. Generalizability of studies on mental health treatment and outcomes, 1981 to 1996. Psychiatr Serv. 2005;56(10):1261–1268.
   PubMed Web of Science ®Google Scholar
• Bradburn MJ, Lee EC, White DA, et al. Treatment effects may remain the same even when trial participants differed from the target population. J Clin Epidemiol. 2020;124:126–138.
   PubMed Web of Science ®Google Scholar
• Huttner A, Kowalczyk A, Turjeman A, et al. Effect of 5-day nitrofurantoin vs single-dose fosfomycin on clinical resolution of uncomplicated lower urinary tract infection in women: a randomized clinical trial. JAMA. 2018;319(17):1781–1789.
   PubMed Web of Science ®Google Scholar
• Van Spall HGC, Toren A, Kiss A, et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297(11):1233–1240.
   PubMed Web of Science ®Google Scholar
• Travers J, Marsh S, Caldwell B, et al. External validity of randomized controlled trials in COPD. Respir Med. 2007;101(6):1313–1320.
   PubMed Web of Science ®Google Scholar
• Travers J, Marsh S, Williams M, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax. 2007;62(3):219–223.
   PubMed Web of Science ®Google Scholar
• Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162(15):1682–1688.
   PubMedGoogle Scholar
• Uijen AA, Bakx JC, Mokkink HGA, et al. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol. 2007;60(4):330–335.
   PubMed Web of Science ®Google Scholar
• Saunders C, Byrne CD, Guthrie B, Scottish Diabetes Research Network Epidemiology Group, et al. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabet Med. 2013;30(3):300–308.
   PubMed Web of Science ®Google Scholar
• Gupta K, Hooton TM, Naber KG, European Society for Microbiology and Infectious Diseases, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: a 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103–e120.
   PubMed Web of Science ®Google Scholar
• Bonkat G, Bartoletti R, Bruyère F, et al. EAU guidelines on urological infections. Eur Assoc Urol. 2017. Available from: https://uroweb.org/guideline/urological-infections/
   PubMedGoogle Scholar
• Gupta K. Short-course nitrofurantoin for the treatment of acute uncomplicated cystitis in women. Arch Intern Med. 2007;167(20):2207.
   PubMedGoogle Scholar
• Lecomte F, et al. Single-dose treatment of cystitis with fosfomycin trometamol (Monuril): analysis of 15 comparative trials on 2,048 patients. Giorn It Ost Gin. 1997;19:399.
   Google Scholar
• Nicolle LE. Pivmecillinam in the treatment of urinary tract infections. J Antimicrob Chemother. 2000;46(90001):35–39.
   Google Scholar
• Huttner A, Verhaegh EM, Harbarth S, et al. Nitrofurantoin revisited: a systematic review and meta-analysis of controlled trials. J Antimicrob Chemother. 2015;70(9):2456–2464.
   PubMed Web of Science ®Google Scholar
• Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci. 2015;16(3):475–485.
   PubMed Web of Science ®Google Scholar
• He Z, Tang X, Yang X, et al. Clinical trial generalizability assessment in the big data era: a review. Clin Transl Sci. 2020;13(4):675–684.
   PubMed Web of Science ®Google Scholar
• Bleidorn J, Gágyor I, Kochen MM, et al. Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?-results of a randomized controlled pilot trial. BMC Med. 2010; 8:30.
   PubMed Web of Science ®Google Scholar
• Christiaens TC, De Meyere M, Verschraegen G, et al. Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. Br J Gen Pract. 2002;52(482):729–734.
   PubMed Web of Science ®Google Scholar
• Vik I, Bollestad M, Grude N, et al. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women—a double-blind, randomized non-inferiority trial. PLoS Med. 2018;15(5):e1002569.
   PubMed Web of Science ®Google Scholar
• Avni T, Shiver-Ofer S, Leibovici L, et al. Participation of elderly adults in randomized controlled trials addressing antibiotic treatment of pneumonia - PubMed. J Am Geriatr Soc. 2015;63(2):233–243.
   PubMed Web of Science ®Google Scholar