Analysis and reporting of adverse events in randomised controlled trials: a review.
Phillips R, Hazell L, Sauzet O, Cornelius V (2019)
BMJ open 9(2): e024537.
Zeitschriftenaufsatz
| Veröffentlicht | Englisch
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Autor*in
Phillips, Rachel;
Hazell, Lorna;
Sauzet, OdileUniBi;
Cornelius, Victoria
Einrichtung
Abstract / Bemerkung
OBJECTIVE: To ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome.; DESIGN: A review of clinical trials of drug interventions from four high impact medical journals.; DATA SOURCES: Electronic contents table of the BMJ, the Journal of the American Medical Association (JAMA), the Lancet and the New England Journal of Medicine (NEJM) were searched for reports of original RCTs published between September 2015 and September 2016.; METHODS: A prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collection methods, assessment of severity and causality, reporting criteria, analysis methods and presentation of AE data.; RESULTS: We identified 184 eligible reports (BMJ n=3; JAMA n=38, Lancet n=62 and NEJM n=81). Sixty-two per cent reported some form of spontaneous AE collection but only 29% included details of specific prompts used to ascertain AE data. Numbers that withdrew from the trial were well reported (80%), however only 35% of these reported whether withdrawals were due to AEs. Results presented and analysis performed was predominantly on 'patients with at least one event' with 84% of studies ignoring repeated events. Despite a lack of power to undertake formal hypothesis testing, 47% performed such tests for binary outcomes.; CONCLUSIONS: This review highlighted that the collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused. Areas to improve include reducing information loss when analysing at patient level and inappropriate practice of underpowered multiple hypothesis testing. Implementation of standard reporting practices could enable a more accurate synthesis of safety data and development of guidance for statistical methodology to assess causality of AEs could facilitate better statistical practice. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Erscheinungsjahr
2019
Zeitschriftentitel
BMJ open
Band
9
Ausgabe
2
Art.-Nr.
e024537
ISSN
2044-6055
Page URI
https://pub.uni-bielefeld.de/record/2934267
Zitieren
Phillips R, Hazell L, Sauzet O, Cornelius V. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open. 2019;9(2): e024537.
Phillips, R., Hazell, L., Sauzet, O., & Cornelius, V. (2019). Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open, 9(2), e024537. doi:10.1136/bmjopen-2018-024537
Phillips, Rachel, Hazell, Lorna, Sauzet, Odile, and Cornelius, Victoria. 2019. “Analysis and reporting of adverse events in randomised controlled trials: a review.”. BMJ open 9 (2): e024537.
Phillips, R., Hazell, L., Sauzet, O., and Cornelius, V. (2019). Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open 9:e024537.
Phillips, R., et al., 2019. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open, 9(2): e024537.
R. Phillips, et al., “Analysis and reporting of adverse events in randomised controlled trials: a review.”, BMJ open, vol. 9, 2019, : e024537.
Phillips, R., Hazell, L., Sauzet, O., Cornelius, V.: Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ open. 9, : e024537 (2019).
Phillips, Rachel, Hazell, Lorna, Sauzet, Odile, and Cornelius, Victoria. “Analysis and reporting of adverse events in randomised controlled trials: a review.”. BMJ open 9.2 (2019): e024537.
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PMID: 26452709
Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group, Bellomo R, Nichol A, French C, Cooper D, Huet O, Little L, Mak A, Pettila V, Presneill J, Vallance S, Varma D, Wills J, Duranteau J, Vicaut E, Gallula P, Raghavan V, Chamam A, Kambire S, Camelo S, Cook D, Crowther M, Brun-Buisson C, Lauzier F, Howe B, Paul E, Bailey M, Waddy H, Al Kishi M, Kambire S, Camelo S, Skrifvars M, Bendel S, Schilling C, Kerz T, Murray L, McArthur C, Chen Y, Simmonds C, Newby L, Kumar N, Walshe C, O'Rourke J, Schilling C, Given M, Mitchell I, Van Haren F, Rodgers H, Kot M, Henderson S, Mehrtens J, Noble S, De Ryke R, Bailey M, Hutchinson R, France D, Hill G, Richards B, Tallott M, Field J, Skrifvars M, Vartiala H, Eliasson M, Koivikko M, Lefrant JY, Muller L, Roger C, Bengler C, Barbaste P, Ayral A, Lloret S, Elotmani L, Veber B, Gilles-Baray M, Guitard PG, Braud H, Lamacz A, Duranteau J, Harrois A, Figueiredo S, Hamada S, Bussone J, Pasquier MC, Payen D, Lukaszewicz AC, Damoisel C, Kambire S, Bussone J, Pasquier MC, Payen JF, Manhes P, Franconey G, Boucheix P, Martinez L, Kerz T, Harrigan P, Hardie M, Tolfree A, Haddad S, Arabi Y, Al Kishi M, Deeb A, Al Harbi S, Al-Swaidan L, Al Moammar T, Lingling J, Caliwag S, Richi H, Al Jandan A, Bendel S, Rahikainen S, Myllymaki M, Saari P, Tam V, Micallef S, Robinson J, Cole L, Weisbrodt L, Strickland R, Rivett J, Kloeden S, O'Connor S, Cooper D, McAllister R, Stewart S, Harley N, Barge D, Moore E, Jordan A, King P, Finfer S, Yarad E, Bird S, O'Connor A, Thebridge L, Dobb G, Chamberlain J, Barr M, Jenkinson E, Zelesco M, Gattas D, Buhr H, Hutch D, Keir M, Burnett A, Nair P, Reynolds C, Knowles S, Tantau R, Cooper DJ, Board J, Vallance S, McCracken P, Young M, Wills J, Gordon G, Reeves S, Brennan S, Dinsdale R, Andrews L, Mackle D, Hurford S, McGregor S, Nayyar V, Whitehead C, Kong J, Bonovas G., Lancet 386(10012), 2015
PMID: 26452709
Effect of regional versus local anaesthesia on outcome after arteriovenous fistula creation: a randomised controlled trial.
Aitken E, Jackson A, Kearns R, Steven M, Kinsella J, Clancy M, Macfarlane A., Lancet 388(10049), 2016
PMID: 27492881
Aitken E, Jackson A, Kearns R, Steven M, Kinsella J, Clancy M, Macfarlane A., Lancet 388(10049), 2016
PMID: 27492881
Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.
Kaul U, Bangalore S, Seth A, Arambam P, Abhaichand RK, Abhaychand RK, Patel TM, Banker D, Abhyankar A, Mullasari AS, Shah S, Jain R, Kumar PR, Bahuleyan CG; TUXEDO–India Investigators, Kaul U, Gupta RK, Bali HK, Iqbal K, Wander GS, Kumar S, Chopra AK, Jain R, Chandra P, Saran RK, Goel PK, Sharma GL, Gupta R, Roy S, Alexander T, Mullasari A, Mathew R, Bahuleyan CG, C R, Kumar PR, Abhaychand RK, Shetty R, Rajashekar , Verghese K, Singh R, R K, Mohan M, Dani SI, Sathe S, Patel TM, Abhyankar A, Pinto B, Hiremath M, Duggal JS, Banker D, Jagtap P, Bhagwat A, Singh P, Parikh J, Joshi A, Arneja J, Khan AI, Shah S, Potdar A, Rane S, Bhattacharya D., N. Engl. J. Med. 373(18), 2015
PMID: 26466202
Kaul U, Bangalore S, Seth A, Arambam P, Abhaichand RK, Abhaychand RK, Patel TM, Banker D, Abhyankar A, Mullasari AS, Shah S, Jain R, Kumar PR, Bahuleyan CG; TUXEDO–India Investigators, Kaul U, Gupta RK, Bali HK, Iqbal K, Wander GS, Kumar S, Chopra AK, Jain R, Chandra P, Saran RK, Goel PK, Sharma GL, Gupta R, Roy S, Alexander T, Mullasari A, Mathew R, Bahuleyan CG, C R, Kumar PR, Abhaychand RK, Shetty R, Rajashekar , Verghese K, Singh R, R K, Mohan M, Dani SI, Sathe S, Patel TM, Abhyankar A, Pinto B, Hiremath M, Duggal JS, Banker D, Jagtap P, Bhagwat A, Singh P, Parikh J, Joshi A, Arneja J, Khan AI, Shah S, Potdar A, Rane S, Bhattacharya D., N. Engl. J. Med. 373(18), 2015
PMID: 26466202
Antiretroviral Therapy for the Prevention of HIV-1 Transmission
Cohen MS, Chen YQ, McCauley M., 2016
Cohen MS, Chen YQ, McCauley M., 2016
Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children.
Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF., N. Engl. J. Med. 374(5), 2016
PMID: 26840134
Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF., N. Engl. J. Med. 374(5), 2016
PMID: 26840134
Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Years: A Randomized Clinical Trial.
Natalucci G, Latal B, Koller B, Ruegger C, Sick B, Held L, Bucher HU, Fauchere JC; Swiss EPO Neuroprotection Trial Group, Zeilinger G, Pasquier S, Capone A, Buhrer C, Glanzmann R, Schulzke S, Weber P, Scharrer B, Bar W, Keller E, Killer C, Pfister R, Karin K, Huppi PS, Borradori-Tolsa C, Bucher HU, Fauchere JC, Koller B, Wellmann S, Hagmann C, Latal B, Natalucci G., JAMA 315(19), 2016
PMID: 27187300
Natalucci G, Latal B, Koller B, Ruegger C, Sick B, Held L, Bucher HU, Fauchere JC; Swiss EPO Neuroprotection Trial Group, Zeilinger G, Pasquier S, Capone A, Buhrer C, Glanzmann R, Schulzke S, Weber P, Scharrer B, Bar W, Keller E, Killer C, Pfister R, Karin K, Huppi PS, Borradori-Tolsa C, Bucher HU, Fauchere JC, Koller B, Wellmann S, Hagmann C, Latal B, Natalucci G., JAMA 315(19), 2016
PMID: 27187300
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.
Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, Fitzpatrick AM, Jackson DJ, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan WJ, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Wechsler ME, Phipatanakul W; NIH/NHLBI AsthmaNet, Mauger DT, Israel E, Phipatanakul W, Smith L, Solway J, Krishnan J, Pongracic J, Wechsler M, Szefler S, Sorkness C, Lemanske R, Wenzel S, Holguin F, Lazarus S, Cabana M, Castro M, Bacharier L, Kraft M, Martinez F, Peters S, Fitzpatrick A, Busse WW, Butler E, Maiolo J, Misplay S, Skoner D, Smith G, Flexas I, Kumar R, Makhija M, Qamar N, Szychlinski C, Bloss V, Brown M, Chee K, David S, Ehrman CS, Ezmigna D, Goodwin J, Grad R, Hiranratta A, Lopez S, Paco A, Priefert J, Provencio NS, Ryan E, Varela M, Vasquez M, Weese R, Wences J, Decker J, Harrison K, Long D, Meade K, Mok R, Nelson-Purdy C, Ren D, Stessel H, Bartnikas L, Bouzaher A, Burke C, Cavanaugh M, Chen J, Cunningham E, Cunningham A, Friedlander J, Hindi E, Kantor D, Kopel L, Permaul P, Rao D, Rossi M, Schierembergg D, Schneider L, Troung J, Umetsu D, Zhou J, Aujla S, Broyles J, Chong H, Dubin P, Finder J, Green TD, Holt L, Kufen A, Kurland G, Lanzo R, Nash D, Parente J, Smith C, Spahr J, Weiner DJ, Beaty T, Brown SW, Bruce AC, Dodds JC, Douglas S, Freedle K, Simon DM, Whitlock DM, Gleason M, Spears G, Sundstrom DA, White M, Batalla J, Littlefield M, Rutledge B, Seymour D, Brown S, OquendoFlores O, Doty L, Gern B, Merchlinski A, Nelson J, Schmidt J, Texter L, Updegrave A, Zeller J, Zimmerman R Jr, Craven D, DiMarino A, Hart M, Kerns LA, Logan L, Veri L, Codispoti C, Fu J, Li G, Munoz-Mendoza D, Stevens S, Thompson B, Zitzer S, Bowman J, Bowyer V, Gonzales-Vargas J, McKean M, Tran N, Batson C, Davies L, Kelly F, Morales E, Redway A, Spicher M, Kaminski L, Knutson MR, Olson S, Turcsanyi S, Watson T, Wilmoth C, Caldwell W, Dula C, Ellis A, Horner C, Kertz L, Norris T, Rivera-Spoljaric K, Rodriguez O, Strunk R., N. Engl. J. Med. 375(7), 2016
PMID: 27532828
Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, Fitzpatrick AM, Jackson DJ, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan WJ, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Wechsler ME, Phipatanakul W; NIH/NHLBI AsthmaNet, Mauger DT, Israel E, Phipatanakul W, Smith L, Solway J, Krishnan J, Pongracic J, Wechsler M, Szefler S, Sorkness C, Lemanske R, Wenzel S, Holguin F, Lazarus S, Cabana M, Castro M, Bacharier L, Kraft M, Martinez F, Peters S, Fitzpatrick A, Busse WW, Butler E, Maiolo J, Misplay S, Skoner D, Smith G, Flexas I, Kumar R, Makhija M, Qamar N, Szychlinski C, Bloss V, Brown M, Chee K, David S, Ehrman CS, Ezmigna D, Goodwin J, Grad R, Hiranratta A, Lopez S, Paco A, Priefert J, Provencio NS, Ryan E, Varela M, Vasquez M, Weese R, Wences J, Decker J, Harrison K, Long D, Meade K, Mok R, Nelson-Purdy C, Ren D, Stessel H, Bartnikas L, Bouzaher A, Burke C, Cavanaugh M, Chen J, Cunningham E, Cunningham A, Friedlander J, Hindi E, Kantor D, Kopel L, Permaul P, Rao D, Rossi M, Schierembergg D, Schneider L, Troung J, Umetsu D, Zhou J, Aujla S, Broyles J, Chong H, Dubin P, Finder J, Green TD, Holt L, Kufen A, Kurland G, Lanzo R, Nash D, Parente J, Smith C, Spahr J, Weiner DJ, Beaty T, Brown SW, Bruce AC, Dodds JC, Douglas S, Freedle K, Simon DM, Whitlock DM, Gleason M, Spears G, Sundstrom DA, White M, Batalla J, Littlefield M, Rutledge B, Seymour D, Brown S, OquendoFlores O, Doty L, Gern B, Merchlinski A, Nelson J, Schmidt J, Texter L, Updegrave A, Zeller J, Zimmerman R Jr, Craven D, DiMarino A, Hart M, Kerns LA, Logan L, Veri L, Codispoti C, Fu J, Li G, Munoz-Mendoza D, Stevens S, Thompson B, Zitzer S, Bowman J, Bowyer V, Gonzales-Vargas J, McKean M, Tran N, Batson C, Davies L, Kelly F, Morales E, Redway A, Spicher M, Kaminski L, Knutson MR, Olson S, Turcsanyi S, Watson T, Wilmoth C, Caldwell W, Dula C, Ellis A, Horner C, Kertz L, Norris T, Rivera-Spoljaric K, Rodriguez O, Strunk R., N. Engl. J. Med. 375(7), 2016
PMID: 27532828
Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial).
Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahren B, Torffvit O, Attvall S, Ekelund M, Filipsson K, Tengmark BO, Sjoberg S, Pehrsson NG., BMJ 351(), 2015
PMID: 26512041
Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahren B, Torffvit O, Attvall S, Ekelund M, Filipsson K, Tengmark BO, Sjoberg S, Pehrsson NG., BMJ 351(), 2015
PMID: 26512041
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial.
Lincoff AM, Mehran R, Povsic TJ, Zelenkofske SL, Huang Z, Armstrong PW, Steg PG, Bode C, Cohen MG, Buller C, Laanmets P, Valgimigli M, Marandi T, Fridrich V, Cantor WJ, Merkely B, Lopez-Sendon J, Cornel JH, Kasprzak JD, Aschermann M, Guetta V, Morais J, Sinnaeve PR, Huber K, Stables R, Sellers MA, Borgman M, Glenn L, Levinson AI, Lopes RD, Hasselblad V, Becker RC, Alexander JH; REGULATE-PCI Investigators., Lancet 387(10016), 2015
PMID: 26547100
Lincoff AM, Mehran R, Povsic TJ, Zelenkofske SL, Huang Z, Armstrong PW, Steg PG, Bode C, Cohen MG, Buller C, Laanmets P, Valgimigli M, Marandi T, Fridrich V, Cantor WJ, Merkely B, Lopez-Sendon J, Cornel JH, Kasprzak JD, Aschermann M, Guetta V, Morais J, Sinnaeve PR, Huber K, Stables R, Sellers MA, Borgman M, Glenn L, Levinson AI, Lopes RD, Hasselblad V, Becker RC, Alexander JH; REGULATE-PCI Investigators., Lancet 387(10016), 2015
PMID: 26547100
Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial.
Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G., Lancet 387(10036), 2016
PMID: 27080498
Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G., Lancet 387(10036), 2016
PMID: 27080498
Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial.
Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP., Lancet 388(10050), 2016
PMID: 27542302
Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP., Lancet 388(10050), 2016
PMID: 27542302
Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial.
Rodes-Cabau J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C., JAMA 314(20), 2015
PMID: 26551304
Rodes-Cabau J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Cote M, Marsal JR, Rivest D, Marrero A, Houde C., JAMA 314(20), 2015
PMID: 26551304
Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial.
Ruperto N, Pistorio A, Oliveira S, Zulian F, Cuttica R, Ravelli A, Fischbach M, Magnusson B, Sterba G, Avcin T, Brochard K, Corona F, Dressler F, Gerloni V, Apaz MT, Bracaglia C, Cespedes-Cruz A, Cimaz R, Couillault G, Joos R, Quartier P, Russo R, Tardieu M, Wulffraat N, Bica B, Dolezalova P, Ferriani V, Flato B, Bernard-Medina AG, Herlin T, Trachana M, Meini A, Allain-Launay E, Pilkington C, Vargova V, Wouters C, Angioloni S, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO), Apaz MT, Cuttica R, Espada G, Garay Stella M, Russo R, Hoyoux C, Joos R, Wouters C, Bica B, Ferriani Virginia PL, K Oliveira S, Marini R, Dolezalova P, Herlin T, Brochard K, Couillault G, Desjonqueres M, Fischbach M, Job Deslandre C, Pagnier A, Picherot G, Quartier P, Rodiere M, Soler C, Tardieu M, Dressler F, Trachana M, Uziel Y, Barone P, Bracaglia C, Cimaz R, Gerloni V, Corona F, Lepore L, Martino S, Meini A, Ravelli A, Zulian F, Herbigneaux RM, Stanevicha V, Burgos-Vargas R, Cespedes-Cruz A, Guilaisne BA, Ten Cate R, Wulffraat N, Flato B, Vojinovic J, Vargova V, Avcin T, Fasth A, Magnusson B, Pilkington C, Candell Chalom E, Sterba G., Lancet 387(10019), 2015
PMID: 26645190
Ruperto N, Pistorio A, Oliveira S, Zulian F, Cuttica R, Ravelli A, Fischbach M, Magnusson B, Sterba G, Avcin T, Brochard K, Corona F, Dressler F, Gerloni V, Apaz MT, Bracaglia C, Cespedes-Cruz A, Cimaz R, Couillault G, Joos R, Quartier P, Russo R, Tardieu M, Wulffraat N, Bica B, Dolezalova P, Ferriani V, Flato B, Bernard-Medina AG, Herlin T, Trachana M, Meini A, Allain-Launay E, Pilkington C, Vargova V, Wouters C, Angioloni S, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO), Apaz MT, Cuttica R, Espada G, Garay Stella M, Russo R, Hoyoux C, Joos R, Wouters C, Bica B, Ferriani Virginia PL, K Oliveira S, Marini R, Dolezalova P, Herlin T, Brochard K, Couillault G, Desjonqueres M, Fischbach M, Job Deslandre C, Pagnier A, Picherot G, Quartier P, Rodiere M, Soler C, Tardieu M, Dressler F, Trachana M, Uziel Y, Barone P, Bracaglia C, Cimaz R, Gerloni V, Corona F, Lepore L, Martino S, Meini A, Ravelli A, Zulian F, Herbigneaux RM, Stanevicha V, Burgos-Vargas R, Cespedes-Cruz A, Guilaisne BA, Ten Cate R, Wulffraat N, Flato B, Vojinovic J, Vargova V, Avcin T, Fasth A, Magnusson B, Pilkington C, Candell Chalom E, Sterba G., Lancet 387(10019), 2015
PMID: 26645190
Effect of Topical Intranasal Therapy on Epistaxis Frequency in Patients With Hereditary Hemorrhagic Telangiectasia: A Randomized Clinical Trial.
Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR., JAMA 316(9), 2016
PMID: 27599329
Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR., JAMA 316(9), 2016
PMID: 27599329
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
Schulz KF, Altman DG, Moher D; CONSORT Group, Altman DG, Barbour V, Berlin JA, Boutron I, Devereaux PJ, Dickersin K, Elbourne D, Ellenberg S, Gebski V, Goodman S, Gotzsche PC, Groves T, Grunberg S, Haynes B, Hopewell S, James A, Juhn P, Middleton P, Minckler D, Moher D, Montori VM, Mulrow C, Pocock S, Rennie D, Schriger DL, Schulz KF, Simera I, Wager E, Clarke M, Guyatt G., Ann. Intern. Med. 152(11), 2010
PMID: 20335313
Schulz KF, Altman DG, Moher D; CONSORT Group, Altman DG, Barbour V, Berlin JA, Boutron I, Devereaux PJ, Dickersin K, Elbourne D, Ellenberg S, Gebski V, Goodman S, Gotzsche PC, Groves T, Grunberg S, Haynes B, Hopewell S, James A, Juhn P, Middleton P, Minckler D, Moher D, Montori VM, Mulrow C, Pocock S, Rennie D, Schriger DL, Schulz KF, Simera I, Wager E, Clarke M, Guyatt G., Ann. Intern. Med. 152(11), 2010
PMID: 20335313
Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial.
Lingvay I, Perez Manghi F, Garcia-Hernandez P, Norwood P, Lehmann L, Tarp-Johansen MJ, Buse JB; DUAL V Investigators, Perez Manghi F, Visco V, Saavedra S, Vico M, Lapertosa S, D'Emden M, Moses R, Chen R, Forbes M, Gerstman M, Nathow T, Bargiota A, Ioannidis I, Karatzidou K, Pagkalos E, Sambanis C, Tentolouris N, Tigas S, Dudas M, Harcsa E, Ory I, Bako B, Hidvegi T, Sauque Reyna L, Olvera Alvarez I, Morales de Teresa MA, Morales Franco G, Garcia Hernandez PA, Petunina N, Zalevskaya A, Galstyan G, Potin V, Sobolev A, Samoilova Y, Kharakhulakh M, Klimontov V, Nedogoda S, Zyangirova S, Alpenidze D, Khetagurova F, Ipatko I, Martinka E, Lacka J, Rummer K, Truban J, Gajdosikova L, Philippiova A, Behuncik M, Vargova A, Pastrnakova E, Kosikova M, Dzuponova J, Pastrnakova E, Mezquita Raya P, Rivas Fernandez M, Tofe S, de la Cuesta C, Merino Torres JF, Munoz M, Kok JA, Jacovides A, Snyman HH, Pillay D, Farris N, Cannon K, Lynn L, Bedel G, Chaykin L, Corder C, Gaona R, Kirstein J, McKenzie W, Morawski E, Ndukwu I, Risser J, Thurman J, Winslow D, Blaze K, Boden G, Jardula M, Klaff L, Norwood P, Stamps H, Tandron I, Tarshis G, Levinson L, Agaiby J, Ayele E, Hurley S, Inzerello A, Lane J, Uusinarkaus K, Lingvay I., JAMA 315(9), 2016
PMID: 26934259
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