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Excluded versus inc...
Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria : relevance to external validity
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- Daitch, Vered (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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- Paul, Mical (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.;Technion Israel Inst Technol, Ruth & Bruce Rappaport Fac Med, Haifa, Israel.
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- Daikos, George L. (author)
- Laikon Gen Hosp, Dept Med 1, Athens, Greece.;Natl & Kapodistrian Univ Athens, Athens, Greece.
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- Durante-Mangoni, Emanuele (author)
- Univ Campania L Vanvitelli, Internal Med, Naples, Italy.;AORN Colli Monaldi Hosp, Naples, Italy.
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- Yahav, Dafna (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Unit Infect Dis, Rabin Med Ctr, Petah Tiqwa, Israel.
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- Carmeli, Yehuda (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, Tel Aviv, Israel.;Natl Inst Antibiot Resistance & Infect Control, Minist Hlth, Tel Aviv, Israel.
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- Benattar, Yael Dishon (author)
- Univ Campania L Vanvitelli, Internal Med, Naples, Italy.;AORN Colli Monaldi Hosp, Naples, Italy.;Univ Haifa, Cheryl Spencer Dept Nursing, Haifa, Israel.
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- Skiada, Anna (author)
- Laikon Gen Hosp, Dept Med 1, Athens, Greece.;Natl & Kapodistrian Univ Athens, Athens, Greece.
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- Andini, Roberto (author)
- Univ Campania L Vanvitelli, Internal Med, Naples, Italy.;AORN Colli Monaldi Hosp, Naples, Italy.
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- Eliakim-Raz, Noa (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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- Nutman, Amir (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Natl Inst Antibiot Resistance & Infect Control, Minist Hlth, Tel Aviv, Israel.
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- Zusman, Oren (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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- Antoniadou, Anastasia (author)
- Natl & Kapodistrian Univ Athens, Athens, Greece.;Attikon Univ, Gen Hosp, Dept Med 4, Athens, Greece.
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- Cavezza, Giusi (author)
- Univ Campania L Vanvitelli, Internal Med, Naples, Italy.;AORN Colli Monaldi Hosp, Naples, Italy.
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- Adler, Amos (author)
- Tel Aviv Sourasky Med Ctr, Microbiol Lab, Tel Aviv, Israel.
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- Dickstein, Yaakov (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.
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- Pavleas, Ioannis (author)
- Laikon Gen Hosp, Intens Care Unit, Athens, Greece.
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- Zampino, Rosa (author)
- Univ Campania L Vanvitelli, Internal Med, Naples, Italy.;AORN Colli Monaldi Hosp, Naples, Italy.
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- Bitterman, Roni (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.;Technion Israel Inst Technol, Ruth & Bruce Rappaport Fac Med, Haifa, Israel.
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- Zayyad, Hiba (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.
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- Koppel, Fidi (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.
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- Zak-Doron, Yael (author)
- Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.
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- Levi, Inbar (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Natl Inst Antibiot Resistance & Infect Control, Minist Hlth, Tel Aviv, Israel.
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- Babich, Tanya (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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- Turjeman, Adi (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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- Ben-Zvi, Haim (author)
- Beilinson Med Ctr, Rabin Med Ctr, Clin Microbiol Lab, Petah Tiqwa, Israel.
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- Friberg, Lena (author)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Mouton, Johan W. (author)
- Erasmus MC, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands.
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- Theuretzbacher, Ursula (author)
- Ctr Antiinfect Agents, Vienna, Austria.
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- Leibovici, Leonard (author)
- Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel.;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel.
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Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Jebotinski 39, Petah Tiqwa, Israel. Rambam Hlth Care Campus, Inst Infect Dis, Haifa, Israel.;Technion Israel Inst Technol, Ruth & Bruce Rappaport Fac Med, Haifa, Israel. (creator_code:org_t)
- 2021-03-31
- 2021
- English.
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In: BMC Infectious Diseases. - : BioMed Central (BMC). - 1471-2334. ; 21
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Abstract
Subject headings
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- Background: Population external validity is the extent to which an experimental study results can be generalized from a specific sample to a defined population. In order to apply the results of a study, we should be able to assess its population external validity. We performed an investigator-initiated randomized controlled trial (RCT) (AIDA study), which compared colistin-meropenem combination therapy to colistin monotherapy in the treatment of patients infected with carbapenem-resistant Gram-negative bacteria. In order to examine the study's population external validity and to substantiate the use of AIDA study results in clinical practice, we performed a concomitant observational trial.Methods: The study was conducted between October 1st, 2013 and January 31st, 2017 (during the RCTs recruitment period) in Greece, Israel and Italy. Patients included in the observational arm of the study have fulfilled clinical and microbiological inclusion criteria but were excluded from the RCT due to receipt of colistin for > 96 h, refusal to participate, or prior inclusion in the RCT. Non-randomized cases were compared to randomized patients. The primary outcome was clinical failure at 14 days of infection onset.Results: Analysis included 701 patients. Patients were infected mainly with Acinetobacter baumannii [78.2% (548/701)]. The most common reason for exclusion was refusal to participate [62% (183/295)]. Non-randomized and randomized patients were similar in most of the demographic and background parameters, though randomized patients showed minor differences towards a more severe infection. Combination therapy was less common in non-randomized patients [31.9% (53/166) vs. 51.2% (208/406), p = 0.000]. Randomized patients received longer treatment of colistin [13 days (IQR 10-16) vs. 8.5 days (IQR 0-15), p = 0.000]. Univariate analysis showed that non-randomized patients were more inclined to clinical failure on day 14 from infection onset [82% (242/295) vs. 75.5% (307/406), p = 0.042]. After adjusting for other variables, non-inclusion was not an independent risk factor for clinical failure at day 14.Conclusion: The similarity between the observational arm and RCT patients has strengthened our confidence in the population external validity of the AIDA trial. Adding an observational arm to intervention studies can help increase the population external validity and improve implementation of study results in clinical practice.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- Population external validity
- Antimicrobial resistance
- Antibiotic treatment
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Daitch, Vered
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Paul, Mical
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Daikos, George L ...
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Durante-Mangoni, ...
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Yahav, Dafna
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Carmeli, Yehuda
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show more...
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Benattar, Yael D ...
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Skiada, Anna
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Andini, Roberto
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Eliakim-Raz, Noa
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Nutman, Amir
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Zusman, Oren
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Antoniadou, Anas ...
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Cavezza, Giusi
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Adler, Amos
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Dickstein, Yaako ...
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Pavleas, Ioannis
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Zampino, Rosa
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Bitterman, Roni
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Zayyad, Hiba
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Koppel, Fidi
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Zak-Doron, Yael
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Levi, Inbar
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Babich, Tanya
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Turjeman, Adi
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Ben-Zvi, Haim
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Friberg, Lena
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Mouton, Johan W.
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Theuretzbacher, ...
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Leibovici, Leona ...
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Uppsala University