Skip to main content
Erschienen in: Intensive Care Medicine 12/2018

08.11.2018 | Editorial

Innovation and safety in critical care: should we collaborate with the industry? Con

verfasst von: Anders Perner, Jon Henrik Laake, Iwan C. C. van der Horst

Erschienen in: Intensive Care Medicine | Ausgabe 12/2018

Einloggen, um Zugang zu erhalten

Excerpt

Critical care has evolved tremendously over the last half-century and made it possible for thousands of critically ill patients to survive and recover from life-threatening, complex medical and surgical diseases. Despite this success, most interventions delivered to critically ill patients and most technologies used in critical care have been implemented without proper validation. While this development and implementation strategy may not differ from other areas of medicine or society as whole, its consequences appear clearly in the critical care setting. In critical care, interventions and technologies implemented without proper validation have harmed many patients and resulted in an enormous waste of resources. We know this because research programs led by academic networks with limited or no industry involvement have shown neutral or even harmful effects of standard care monitoring or interventions [1, 2]. The risk of us harming our patients is not trivial. In a systematic review of interventions that was shown to affect mortality in critical care trials [2], half of the interventions increased mortality and several of these interventions were in use in clinical practice at the time of testing. …
Literatur
1.
Zurück zum Zitat Rajaram SS, Desai NK, Kalra A, Gajera M, Cavanaugh SK, Brampton W, Young D, Harvey S, Rowan K (2013) Pulmonary artery catheters for adult patients in intensive care. Cochrane Database Syst Rev 2:CD003408 Rajaram SS, Desai NK, Kalra A, Gajera M, Cavanaugh SK, Brampton W, Young D, Harvey S, Rowan K (2013) Pulmonary artery catheters for adult patients in intensive care. Cochrane Database Syst Rev 2:CD003408
2.
Zurück zum Zitat Landoni G, Comis M, Conte M, Finco G, Mucchetti M, Paternoster G, Pisano A, Ruggeri L, Alvaro G, Angelone M, Bergonzi PC, Bocchino S, Borghi G, Bove T, Buscaglia G, Cabrini L, Callegher L, Caramelli F, Colombo S, Corno L, Del SP, Feltracco P, Forti A, Ganzaroli M, Greco M, Guarracino F, Lembo R, Lobreglio R, Meroni R, Monaco F, Musu M, Pala G, Pasin L, Pieri M, Pisarra S, Ponticelli G, Roasio A, Santini F, Silvetti S, Szekely A, Zambon M, Zucchetti MC, Zangrillo A, Bellomo R (2015) Mortality in multicenter critical care trials: an analysis of interventions with a significant effect. Crit Care Med 43:1559–1568CrossRefPubMed Landoni G, Comis M, Conte M, Finco G, Mucchetti M, Paternoster G, Pisano A, Ruggeri L, Alvaro G, Angelone M, Bergonzi PC, Bocchino S, Borghi G, Bove T, Buscaglia G, Cabrini L, Callegher L, Caramelli F, Colombo S, Corno L, Del SP, Feltracco P, Forti A, Ganzaroli M, Greco M, Guarracino F, Lembo R, Lobreglio R, Meroni R, Monaco F, Musu M, Pala G, Pasin L, Pieri M, Pisarra S, Ponticelli G, Roasio A, Santini F, Silvetti S, Szekely A, Zambon M, Zucchetti MC, Zangrillo A, Bellomo R (2015) Mortality in multicenter critical care trials: an analysis of interventions with a significant effect. Crit Care Med 43:1559–1568CrossRefPubMed
3.
Zurück zum Zitat Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP (2017) Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 43:304–377CrossRefPubMed Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP (2017) Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 43:304–377CrossRefPubMed
4.
Zurück zum Zitat Zhang Z, Hong Y, Liu N (2018) Scientific evidence underlying the recommendations of critical care clinical practice guidelines: a lack of high level evidence. Intensive Care Med 44:1189–1191CrossRefPubMed Zhang Z, Hong Y, Liu N (2018) Scientific evidence underlying the recommendations of critical care clinical practice guidelines: a lack of high level evidence. Intensive Care Med 44:1189–1191CrossRefPubMed
6.
Zurück zum Zitat Smithburger PL, Buckley MS, Culver MA, Sokol S, Lat I, Handler SM, Kirisci L, Kane-Gill SL (2015) A multicenter evaluation of off-label medication use and associated adverse drug reactions in adult medical ICUs. Crit Care Med 43:1612–1621CrossRefPubMedPubMedCentral Smithburger PL, Buckley MS, Culver MA, Sokol S, Lat I, Handler SM, Kirisci L, Kane-Gill SL (2015) A multicenter evaluation of off-label medication use and associated adverse drug reactions in adult medical ICUs. Crit Care Med 43:1612–1621CrossRefPubMedPubMedCentral
7.
Zurück zum Zitat Halpern NA, Pastores SM (2015) Critical care medicine beds, use, occupancy, and costs in the United States: a methodological review. Crit Care Med 43:2452–2459CrossRefPubMedPubMedCentral Halpern NA, Pastores SM (2015) Critical care medicine beds, use, occupancy, and costs in the United States: a methodological review. Crit Care Med 43:2452–2459CrossRefPubMedPubMedCentral
8.
Zurück zum Zitat Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S (2017) Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ 356:i6770CrossRefPubMedPubMedCentral Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S (2017) Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ 356:i6770CrossRefPubMedPubMedCentral
9.
Zurück zum Zitat Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L (2017) Industry sponsorship and research outcome. Cochrane Database Syst Rev 2:MR000033PubMed Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L (2017) Industry sponsorship and research outcome. Cochrane Database Syst Rev 2:MR000033PubMed
10.
Zurück zum Zitat McCoy MS, Pagan O, Donohoe G, Kanter GP, Litman RS (2018) Conflicts of interest of public speakers at meetings of the Anesthetic and Analgesic Drug Products Advisory Committee. JAMA Intern Med 178:996–997CrossRefPubMedPubMedCentral McCoy MS, Pagan O, Donohoe G, Kanter GP, Litman RS (2018) Conflicts of interest of public speakers at meetings of the Anesthetic and Analgesic Drug Products Advisory Committee. JAMA Intern Med 178:996–997CrossRefPubMedPubMedCentral
11.
Zurück zum Zitat Norris SL, Holmer HK, Ogden LA, Burda BU (2011) Conflict of interest in clinical practice guideline development: a systematic review. PLoS One 6:e25153CrossRefPubMedPubMedCentral Norris SL, Holmer HK, Ogden LA, Burda BU (2011) Conflict of interest in clinical practice guideline development: a systematic review. PLoS One 6:e25153CrossRefPubMedPubMedCentral
12.
Zurück zum Zitat Andreatos N, Zacharioudakis IM, Zervou FN, Muhammed M, Mylonakis E (2017) Discrepancy between financial disclosures of authors of clinical practice guidelines and reports by industry. Medicine (Baltimore) 96:e5711CrossRef Andreatos N, Zacharioudakis IM, Zervou FN, Muhammed M, Mylonakis E (2017) Discrepancy between financial disclosures of authors of clinical practice guidelines and reports by industry. Medicine (Baltimore) 96:e5711CrossRef
13.
Zurück zum Zitat Hadland SE, Cerda M, Li Y, Krieger MS, Marshall BDL (2018) Association of pharmaceutical industry marketing of opioid products to physicians with subsequent opioid prescribing. JAMA Intern Med 178:861–863CrossRefPubMedPubMedCentral Hadland SE, Cerda M, Li Y, Krieger MS, Marshall BDL (2018) Association of pharmaceutical industry marketing of opioid products to physicians with subsequent opioid prescribing. JAMA Intern Med 178:861–863CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Austad KE, Avorn J, Franklin JM, Campbell EG, Kesselheim AS (2014) Association of marketing interactions with medical trainees’ knowledge about evidence-based prescribing: results from a national survey. JAMA Intern Med 174:1283–1290CrossRefPubMed Austad KE, Avorn J, Franklin JM, Campbell EG, Kesselheim AS (2014) Association of marketing interactions with medical trainees’ knowledge about evidence-based prescribing: results from a national survey. JAMA Intern Med 174:1283–1290CrossRefPubMed
15.
Zurück zum Zitat Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P, CRASH Trial Collaborators (2004) Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet 364:1321–1328CrossRefPubMed Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P, CRASH Trial Collaborators (2004) Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet 364:1321–1328CrossRefPubMed
16.
Zurück zum Zitat CRASH-Trial Collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S (2010) Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 376:23–32CrossRef CRASH-Trial Collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S (2010) Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 376:23–32CrossRef
17.
Zurück zum Zitat The Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1308CrossRef The Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1308CrossRef
18.
Zurück zum Zitat Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ (2009) Intensive versus conventional glucose control in critically ill patients. N Engl J Med 360:1283–1297CrossRefPubMed Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ (2009) Intensive versus conventional glucose control in critically ill patients. N Engl J Med 360:1283–1297CrossRefPubMed
19.
Zurück zum Zitat Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J (2012) Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124–134CrossRefPubMed Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J (2012) Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124–134CrossRefPubMed
20.
Zurück zum Zitat Woman Trial Collaborators (2017) Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet 389:2105–2116CrossRef Woman Trial Collaborators (2017) Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet 389:2105–2116CrossRef
Metadaten
Titel
Innovation and safety in critical care: should we collaborate with the industry? Con
verfasst von
Anders Perner
Jon Henrik Laake
Iwan C. C. van der Horst
Publikationsdatum
08.11.2018
Verlag
Springer Berlin Heidelberg
Erschienen in
Intensive Care Medicine / Ausgabe 12/2018
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-018-5295-5

Weitere Artikel der Ausgabe 12/2018

Intensive Care Medicine 12/2018 Zur Ausgabe

What's New in Intensive Care

Ten false beliefs in neurocritical care

Bei schweren Reaktionen auf Insektenstiche empfiehlt sich eine spezifische Immuntherapie

Insektenstiche sind bei Erwachsenen die häufigsten Auslöser einer Anaphylaxie. Einen wirksamen Schutz vor schweren anaphylaktischen Reaktionen bietet die allergenspezifische Immuntherapie. Jedoch kommt sie noch viel zu selten zum Einsatz.

Hinter dieser Appendizitis steckte ein Erreger

23.04.2024 Appendizitis Nachrichten

Schmerzen im Unterbauch, aber sonst nicht viel, was auf eine Appendizitis hindeutete: Ein junger Mann hatte Glück, dass trotzdem eine Laparoskopie mit Appendektomie durchgeführt und der Wurmfortsatz histologisch untersucht wurde.

Ärztliche Empathie hilft gegen Rückenschmerzen

23.04.2024 Leitsymptom Rückenschmerzen Nachrichten

Personen mit chronischen Rückenschmerzen, die von einfühlsamen Ärzten und Ärztinnen betreut werden, berichten über weniger Beschwerden und eine bessere Lebensqualität.

Mehr Schaden als Nutzen durch präoperatives Aussetzen von GLP-1-Agonisten?

23.04.2024 Operationsvorbereitung Nachrichten

Derzeit wird empfohlen, eine Therapie mit GLP-1-Rezeptoragonisten präoperativ zu unterbrechen. Eine neue Studie nährt jedoch Zweifel an der Notwendigkeit der Maßnahme.

Update AINS

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.