External validity of a randomized controlled trial on the treatment of severe infections caused by MRSA

BMJ Open

Volumn 5, Issue 9, 2015, Pages

  Paul, Mical ^a,b   Bronstein, Ella ^b   Yahav, Dafna ^a,b   Goldberg, Elad ^a,b   Bishara, Jihad ^a,b   Leibovici, Leonard ^a,b  

^a RABIN MEDICAL CENTER   (Israel)

^b TEL AVIV UNIVERSITY   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

COTRIMOXAZOLE; VANCOMYCIN; ANTIINFECTIVE AGENT;

AGED; ANTIBIOTIC THERAPY; ARTICLE; DISEASE SEVERITY; DRUG TREATMENT FAILURE; EXTERNAL VALIDITY; FEMALE; HOSPITAL PATIENT; HUMAN; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION; MORTALITY; NONHUMAN; OBSERVATIONAL STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME; COGNITION; COMPARATIVE STUDY; CONTROLLED STUDY; DAILY LIFE ACTIVITY; MICROBIOLOGY; MIDDLE AGED; ODDS RATIO; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SEVERITY OF ILLNESS INDEX; STAPHYLOCOCCAL INFECTIONS; TREATMENT FAILURE; VALIDATION STUDY; VERY ELDERLY;

ACTIVITIES OF DAILY LIVING; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; COGNITION; FEMALE; HUMANS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MIDDLE AGED; ODDS RATIO; PATIENT SELECTION; SEPSIS; SEVERITY OF ILLNESS INDEX; STAPHYLOCOCCAL INFECTIONS; TREATMENT FAILURE; TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION; VANCOMYCIN;

EID: 84947771487     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008838     Document Type: Article

References (16)

1. Fischer L, Knaebel HP, Golcher H, et al. To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541) apply?-assessment of external validity. BMC Surg 2012; 12: 2
2. Claessens YE, Aegerter P, Boubaker H, et al. Are clinical trials dealing with severe infection fitting routine practices? Insights from a large registry. Crit Care 2013; 17: R89
3. 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: 1-13
4. Hurley JC. Profound effect of study design factors on ventilatorassociated pneumonia incidence of prevention studies: benchmarking the literature experience. J Antimicrob Chemother 2008; 61: 1154-61
5. Avni T, Shiver-Ofer S, Leibovici L, et al. Participation of elderly adults in randomized controlled trials addressing antibiotic treatment of pneumonia. J Am Geriatr Soc 2015; 63: 233-43
6. Paul M, Bishara J, Yahav D, et al. Trimethoprim-sulfamethoxazole versus vancomycin for severe infections caused by meticillin resistant Staphylococcus aureus: randomised controlled trial. BMJ 2015; 350: h2219
7. Scheld WM, Keeley JM, Field MR, et al. Co-trimoxazole versus nafcillin in the therapy of experimental meningitis due to Staphylococcus aureus. J Antimicrob Chemother 1987; 19: 647-58
8. De Gorgolas M, Aviles P, Verdejo C, et al. Treatment of experimental endocarditis due to methicillin-susceptible or methicillin-resistant Staphylococcus aureus with trimethoprim-sulfamethoxazole, and antibiotics that inhibit cell wall synthesis. Antimicrob Agents Chemother 1995; 39: 953-7
9. Baethke R, Golde G, Gahl G. Sulphamethoxazole/trimethoprim: pharmacokinetic studies in patients with chronic renal failure. Eur J Clin Pharmacol 1972; 4: 233-40
10. Van Spall HG, 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: 1233-40
11. Faden RR, Beauchamp TL, Kass NE. Informed consent, comparative effectiveness, and learning health care. N Engl J Med 2014; 370: 766-8
12. Shaw D. HEAT-PPCI sheds light on consent in pragmatic trials. Lancet 2014; 384: 1826-7
13. Paul M, Shani V, Muchtar E, et al. Systematic review, and meta-analysis of the efficacy of appropriate empiric antibiotic therapy for sepsis. Antimicrob Agents Chemother 2010; 54: 4851-63
14. Nayak RK, Wendler D, Miller FG, et al. Pragmatic randomized trials without standard informed consent? A national survey. Ann Intern Med 2015; 163: 356-64
15. Cho MK, Magnus D, Constantine M, et al. Attitudes toward risk, and informed consent for research on medical practices: a cross-sectional survey. Ann Intern Med 2015; 162: 690-6
16. Goldberg E, Paul M, Talker O, et al. Co-trimoxazole versus vancomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteraemia: a retrospective cohort study. J Antimicrob Chemother 2010; 65: 1779-83