Effectiveness and safety of treatments used for the management of patent ductus arteriosus (PDA) in preterm infants: A protocol for a systematic review and network meta-analysis

BMJ Open

Volumn 6, Issue 7, 2016, Pages

  Mitra, Souvik ^a,b   Florez, Ivan D ^a,c   Tamayo, Maria E ^c   Aune, Dagfinn ^d   Mbuagbaw, Lawrence ^a   Veroniki, Areti Angeliki ^e   Thabane, Lehana ^a  

^a MCMASTER UNIVERSITY   (Canada)

^b DALHOUSIE UNIVERSITY   (Canada)

^c UNIVERSIDAD DE ANTIOQUIA   (Colombia)

^d IMPERIAL COLLEGE LONDON   (United Kingdom)

^e ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

IBUPROFEN; INDOMETACIN; PARACETAMOL; PROSTAGLANDIN SYNTHASE INHIBITOR;

BIRTH WEIGHT; BRAIN HEMORRHAGE; CHRONIC LUNG DISEASE; CLINICAL PROTOCOL; COCHRANE LIBRARY; COMPARATIVE EFFECTIVENESS; ECHOCARDIOGRAPHY; EMBASE; ENTERIC FEEDING; GASTROINTESTINAL HEMORRHAGE; GESTATIONAL AGE; HUMAN; INFANT; INTERVENTION STUDY; LEUKOMALACIA; MEDLINE; META ANALYSIS; NECROTIZING ENTEROCOLITIS; NEWBORN MORTALITY; OLIGURIA; OUTCOME ASSESSMENT; PATENT DUCTUS ARTERIOSUS; PERIVENTRICULAR LEUKOMALACIA; PREMATURITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SYSTEMATIC REVIEW; BAYES THEOREM; INFANT MORTALITY; NETWORK META-ANALYSIS; NEWBORN; ORAL DRUG ADMINISTRATION; PRACTICE GUIDELINE;

ACETAMINOPHEN; ADMINISTRATION, ORAL; BAYES THEOREM; CYCLOOXYGENASE INHIBITORS; DUCTUS ARTERIOSUS, PATENT; HUMANS; IBUPROFEN; INDOMETHACIN; INFANT; INFANT MORTALITY; INFANT, NEWBORN; INFANT, PREMATURE; NETWORK META-ANALYSIS; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84979987740     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011271     Document Type: Review

References (56)

1. Gournay V. The ductus arteriosus: physiology, regulation, functional and congenital anomalies. Arch Cardiovasc Dis 2011;104:578-85.
2. Clyman RI, Couto J, Murphy GM. Patent ductus arteriosus: are current neonatal treatment options better or worse than no treatment at all? Semin Perinatol 2012;36:123-9: Elsevier.
3. Dollberg S, Lusky A, Reichman B, et al. Patent ductus arteriosus, indomethacin and necrotizing enterocolitis in very low birth weight infants: a population-based study. J Pediatr Gastroenterol Nutr 2005;40:184-8.
4. Brown ER. Increased risk of bronchopulmonary dysplasia in infants with patent ductus arteriosus. J Pediatr 1979;95:865-6.
5. Lipman B, Serwer GA, Brazy JE. Abnormal cerebral hemodynamics in preterm infants with patent ductus arteriosus. Pediatrics 1982;69:778-81.
6. Mitra S, Rønnestad A, Holmstrøm H. Management of patent ductus arteriosus in preterm infants-where do we stand? Congenit Heart Dis 2013;8:500-12.
7. Meyers RL, Lln GAE, Clyman RI. Patent ductus arteriosus, indomethacin, intestinal distension: effects on intestinal blood flow and oxygen consumption. Pediatr Res 1991;29:564-74.
8. Corazza MS, Davis RF, Merritt TA, et al. Prolonged bleeding time in preterm infants receiving indomethacin for patent ductus arteriosus. J Pediatr 1984;105:292-6.
9. Miller SP, Mayer EE, Clyman RI, et al. Prolonged indomethacin exposure is associated with decreased white matter injury detected with magnetic resonance imaging in premature newborns at 24 to 28 weeks' gestation at birth. Pediatrics 2006;117:1626-31.
10. Van Bel F, Van de Bor M, Stijnen T, et al. Cerebral blood flow velocity changes in preterm infants after a single dose of indomethacin: duration of its effect. Pediatrics 1989;84:802-7.
11. van Bel F, Guit GL, Schipper J, et al. Indomethacin-induced changes in renal blood flow velocity waveform in premature infants investigated with color Doppler imaging. J Pediatr 1991;118:621-6.
12. Ohlsson A, Walia R, Shah SS. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. Cochrane Database Syst Rev 2013;4:CD003481.
13. Zecca E, Romagnoli C, De Carolis MP, et al. Does ibuprofen increase neonatal hyperbilirubinemia? Pediatrics 2009;124: 480-4.
14. Bellini C, Campone F, Serra G. Pulmonary hypertension following L-lysine ibuprofen therapy in a preterm infant with patent ductus arteriosus. CMAJ 2006;174:1843-4.
15. Amendolia B, Lynn M, Bhat V, et al. Severe pulmonary hypertension with therapeutic l-lysine ibuprofen in 2 preterm neonates. Pediatrics 2012;129:e1360-e3.
16. Dang D, Wang D, Zhang C, et al. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS ONE 2013;8:e77888.
17. Oncel MY, Yurttutan S, Degirmencioglu H, et al. Intravenous paracetamol treatment in the management of patent ductus arteriosus in extremely low birth weight infants. Neonatology 2013;103:166-9.
18. Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low-birth-weight infants. Cochrane Database Syst Rev 2015;3:CD010061.
19. Streiner DL. Placebo-controlled trials: when are they needed? Schizophr Res 1999;35:201-10.
20. Higgins JPT, Altman DG (eds). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions. Chichester (UK): John Wiley & Sons, 2011.
21. Jansen JP, Crawford B, Bergman G, et al. Bayesian meta-analysis of multiple treatment comparisons: an introduction to mixed treatment comparisons. Value in Health 2008;11:956-64.
22. Jonas DE, Wilkins TM, Bangdiwala S, et al. Findings of Bayesian mixed treatment comparison meta-analyses: comparison and exploration using real-world trial data and simulation. AHRQ Methods Effective Health Care 2013;13:EHC039-EF.
23. Jones L, Craven P, Attia J, et al. Network meta-analysis of indomethacin versus ibuprofen versus placebo for PDA in preterm infants. Arch Dis Child Fetal Neonatal Ed 2011;96:F45-52.
24. Shamseer L, Moher D, Clarke M, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;349:g7647.
25. Hutton B, Salanti G, Caldwell DM, et al. The PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-analyses of Health Care Interventions: checklist and explanations. Ann Intern Med 2015;162:777-84. (cited 20 October 2015). http://hiru.mcmaster.ca/hiru/HIRU-Hedges-MEDLINE-Strategies.aspx
26. Moher D, Liberati A, Tetzlaff J, et al. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 2009;6:e1000097.
27. Akl EA, Sun X, Busse JW, et al. Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid. J Clin Epidemiol 2012;65:262-7.
28. Cornell JE, Mulrow CD, Localio R, et al. Random-effects meta-analysis of inconsistent effects: a time for change. Ann Intern Med 2014;160:267-70.
29. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7:177-88.
30. Lambert PC, Sutton AJ, Burton PR, et al. How vague is vague? A simulation study of the impact of the use of vague prior distributions in MCMC using WinBUGS. Stat Med 2005;24: 2401-28.
31. Turner RM, Davey J, Clarke MJ, et al. Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews. Int J Epidemiol 2012;41:818-27.
32. Rhodes KM, Turner RM, Higgins JP. Predictive distributions were developed for the extent of heterogeneity in meta-analyses of continuous outcome data. J Clin Epidemiol 2015;68:52-60.
33. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539-58.
34. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ 2003;327:557-60.
35. Egger M, Smith GD, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34. 1997-09-13 07:00:00.
36. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994:1088-101.
37. Mills EJ, Thorlund K, Ioannidis JP. Demystifying trial networks and network meta-analysis. BMJ 2013;346:f2914.
38. White IR, Barrett JK, Jackson D, et al. Consistency and inconsistency in network meta-analysis: model estimation using multivariate meta-regression. Res Synth Methods 2012;3: 111-25.
39. Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997;50:683-91.
40. Veroniki AA, Vasiliadis HS, Higgins JP, et al. Evaluation of inconsistency in networks of interventions. Int J Epidemiol 2013;42:332-45.
41. Riley RD, Higgins JP, Deeks JJ. Interpretation of random effects meta-analyses. BMJ 2011;342:d549.
42. Higgins J, Thompson SG, Spiegelhalter DJ. A re-evaluation of random-effects meta-analysis. J R Stat Soc Ser A Stat Soc 2009;172:137-59.
43. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 2011;64:163-71.
44. Gelman A, Rubin DB. Inference from iterative simulation using multiple sequences. Stat Sci 1992:457-72.
45. Thomas A, O'Hara B, Ligges U, et al. Making BUGS open. R News 2006;6:12-7.
46. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383-94.
47. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64:401-6.
48. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol 2011;64:407-15.
49. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol 2011;64:1283-93.
50. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol 2011;64:1294-302.
51. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol 2011;64:1277-82.
52. Donegan S, Williamson P, Gamble C, et al. Indirect comparisons: a review of reporting and methodological quality. PLoS ONE 2010;5: e11054.
53. Baker SG, Kramer BS. The transitive fallacy for randomized trials: if A bests B and B bests C in separate trials, is A better than C? BMC Med Res Methodol 2002;2:13.
54. Cipriani A, Higgins JP, Geddes JR, et al. Conceptual and technical challenges in network meta-analysis. Ann Intern Med 2013;159:130-7.
55. Puhan MA, Schünemann HJ, Murad MH, et al. A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis. BMJ 2014;349: g5630.
56. Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health 2014;17:157-73.