Publications

EnRICH 2019 Output Online Profiles

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EnRICH 2019 Publications since 2012

  1. Onland W, Offringa M, van Kaam A. Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants. Cochrane Database of Systematic Reviews 2012, Issue 4. Art. No.: CD002311. DOI: 10.1002/14651858.CD002311.pub3
  2. Offringa M, Newton R. Prophylactic drug management for febrile seizures in children. Cochrane Database Syst Rev. 2012 Apr 18;4:CD003031. doi: 10.1002/14651858.CD003031.pub2. Review. PMID: 22513908.
  3. de Haan TR, Bijleveld YA, van der Lee JH, Groenendaal F, van den Broek MP, Rademaker CM, van Straaten HL, van Weissenbruch MM, Vermeulen JR, Dijk PH, Dudink J, Rijken M, van Heijst A, Dijkman KP, Gavilanes D, van Kaam AH, Offringa M, Mathôt RA. Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study. BMC Pediatr. 2012 May 22;12:45. doi: 10.1186/1471-2431-12-45. PMID: 22515424.
  4. Wittmeier KD, Craig J, Klassen TP, Offringa M. The mission of StaR Child Health is to improve the quality of the design, conduct, and reporting of pediatric clinical research by promoting the use of modern research standards. Introduction. Pediatrics. 2012 Jun;129 Suppl 3:S111. doi: 10.1542/peds.2012-0055B. No abstract available. PMID: 22661755.
  5. Hartling L, Wittmeier KD, Caldwell P, van der Lee H, Klassen TP, Craig JC, Offringa M; StaR Child Health Group. StaR child health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials. Pediatrics. 2012 Jun;129 Suppl 3:S112-7. doi: 10.1542/peds.2012-0055C. Review. No abstract available. PMID: 22661756.
  6. Caldwell PH, Dans L, de Vries MC, Newman Ba Hons J, Sammons H, Spriggs M Bioeth M, Tambe P, Van’t Hoff W, Woolfall K, Young B, Offringa M; StaR Child Health Group. Standard 1: consent and recruitment. Pediatrics. 2012 Jun; 129 Suppl 3:S118-23. doi: 10.1542/peds.2012-0055D. PMID: 22661757.
  7. *Hartling L, Hamm M, Klassen T, Chan AW, Meremikwu M, Moyer V, Scott S, Moher D, Offringa M; StaR Child Health Group. Standard 2: containing risk of bias. Pediatrics. 2012 Jun;129 Suppl 3:S124-31. doi: 10.1542/peds.2012-0055E. Review. No abstract available. PMID: 22661758.
  8. Ellenberg S, Fernandes RM, Saloojee H, Bassler D, Askie L, Vandermeer B, Offringa M, Van der Tweel I, Altman DG, van der Lee JH; StaR Child Health Group. Standard 3: data monitoring committees. Pediatrics. 2012 Jun;129 Suppl 3:S132-7. doi: 10.1542/peds.2012-0055F. Review. No abstract available. PMID: 22661759.
  9. van der Tweel I, Askie L, Vandermeer B, Ellenberg S, Fernandes RM, Saloojee H, Bassler D, Altman DG, Offringa M, van der Lee JH; StaR Child Health Group. Standard 4: determining adequate sample sizes. Pediatrics. 2012 Jun;129 Suppl 3:S138-45. doi: 10.1542/peds.2012-0055G. Review. No abstract available. PMID: 22661760.
  10. Sinha IP, Altman DG, Beresford MW, Boers M, Clarke M, Craig J, Alberighi OD, Fernandes RM, Hartling L, Johnston BC, Lux A, Plint A, Tugwell P, Turner M, van der Lee JH, Offringa M, Williamson PR, Smyth RL; StaR Child Health Group. Standard 5: selection, measurement, and reporting of outcomes in clinical trials in children. Pediatrics. 2012 Jun;129 Suppl 3:S146-52. doi: 10.1542/peds.2012-0055H. Review. No abstract available. PMID: 22661761.
  11. van Laerhoven H, de Haan TR, Offringa M, Post B, van der Lee JH Prognostic tests in term neonates with hypoxic-ischemic encephalopathy: a systematic review. Pediatrics. 2013 Jan;131(1):88-98. doi: 10..1542/peds.2012-1297 Epub 2012 Dec 17. PMID: 23248219.
  12. Offringa M, Newton R. Prophylactic drug management for febrile seizures in children (Review). Evid Based Child Health. 2013 Jul;8(4):1376-485. doi: 10.1002/ebch.192. PMID: 23877946.
  13. de Kluiver E, Offringa M, Walther FJ, Duvekot JJ, de Laat MW. [Perinatal policy in cases of extreme prematurity; an investigation into the implementation of the guidelines]. Ned Tijdschr Geneeskd. 2013;157(38):A6362. Dutch. PMID: 24080448.
  14. Schoenmaker NJ, Tromp WF, van der Lee JH, Offringa M, Craig JC, Groothoff JW. Quality and consistency of clinical practice guidelines for the management of children on chronic dialysis. Nephrol Dial Transplant. 2013 Dec;28(12):3052-61. doi: 10.1093/ndt/gft303. Epub 2013 Oct 3. PMID: 24097802
  15. Offringa M, Needham AC, Chan WW; StaR Child Health group. StaR Child Health: improving global standards for child health research. Early Hum Dev. 2013 Nov;89(11):861-4. doi: 10.1016/j.earlhumdev.2013.09.011. Epub 2013 Oct 7. PMID: 24113210
  16. Schoenmaker NJ, Haverman L, Tromp WF, van der Lee JH, Offringa M, Adams B, Bouts AH, Collard L, Cransberg K, van Dyck M, Godefroid N, van Hoeck K, Koster-Kamphuis L, Lilien MR, Raes A, Taylan C, Grootenhuis MA, Groothoff JW. Children of non-Western origin with end-stage renal disease in the Netherlands, Belgium and a part of Germany have impaired health-related quality of life compared with Western children. Nephrol Dial Transplant. 2014 Feb;29(2):448-57. doi: 10.1093/ndt/gft436. Epub 2013 Nov 13. PMID: 24235076.
  17. Onland W, Debray TP, Laughon MM, Miedema M, Cools F, Askie LM, Asselin JM, Calvert SA, Courtney SE, Dani C, Durand DJ, Marlow N, Peacock JL, Pillow JJ, Soll RF, Thome UH, Truffert P, Schreiber MD, Van Reempts P, Vendettuoli V, Vento G, van Kaam AH, Moons KG, Offringa M. Clinical prediction models for bronchopulmonary dysplasia: a systematic review and external validation study. BMC Pediatr. 2013 Dec 17;13:207. doi: 10.1186/1471-2431-13-207. Review. PMID: 24345305.
  18. Hulzebos CV, Dijk PH, van Imhoff DE, Bos AF, Lopriore E, Offringa M, Ruiter SA, van Braeckel KN, Krabbe PF, Quik EH, van Toledo-Eppinga L, Nuytemans DH, van Wassenaer-Leemhuis AG, Benders MJ, Korbeeck-van Hof KK, van Lingen RA, Groot Jebbink LJ, Liem D, Mansvelt P, Buijs J, Govaert P, van Vliet I, Mulder TL, Wolfs C, Fetter WP, Laarman C; BARTrial Study Group. The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: a randomized controlled trial–BARTrial. PLoS One. 2014 Jun 13;9(6):e99466. doi: 10.1371/journal.pone.0099466. eCollection 2014. PMID: 24927259.
  19. Van’t Hoff W, Offringa M; Star Child Health group (http://www.starchildhealth.org). StaR Child Health: developing evidence-based guidance for the design, conduct and reporting of paediatric trials. Arch Dis Child. 2015 Feb;100(2):189-192. doi: 10.1136/archdischild-2012-303094. Epub 2014 Sep 26. PMID: 25260517.
  20. Offringa M, Needham AC. Quality Standards for drug trials with children. Clin. Invest. (Lond.) 2014: 4(11), 997–1000, DOI 10.4155/cli.14.83
  21. Needham AC, Kapadia MZ, Offringa M. Ethics review of pediatric multi-center drug trials. Paediatr Drugs. 2015 Feb;17(1):23-30. doi: 10.1007/s40272-014-0098-9. PMID: 25354988.
  22. Askie L, Offringa M. Systematic reviews and meta-analysis. Semin Fetal Neonatal Med. 2015 Dec;20(6):403-9. doi: 10.1016/j.siny.2015.10.002. Epub 2015 Oct 27. Review. PMID: 26515266
  23. Jansen-van der Weide MC, Caldwell PH, Young B, de Vries MC, Willems DL, Van’t Hoff W, Woolfall K, van der Lee JH, Offringa M. Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure. 2015 Oct;136(4):e983-92. doi: 10.1542/peds.2014-3402. PMID: 26416935
  24. Clyburne-Sherin AV, Thurairajah P, Kapadia MZ, Sampson M, Chan WW, Offringa M. Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. 2015 Sep 18;16:417. doi: 10.1186/s13063-015-0954-0.PMID: 26385379
  25. Pullenayegum EM, Platt RW, Barwick M, Feldman BM, Offringa M, Thabane L. Knowledge translation in biostatistics: a survey of current practices, preferences, and barriers to the dissemination and uptake of new statistical methods. Stat Med. 2015 Aug 25. doi: 10.1002/sim.6633. [Epub ahead of print] PMID: 26307183 C
  26. Patel N, Ram D, Swiderska N, Mewasingh LD, Newton RW, Offringa M. Febrile seizures. 2015 Aug 18;351:h4240. doi: 10.1136/bmj.h4240. Review. PMID: 26286537
  27. Hall NJ, Kapadia MZ, Eaton S, Chan WW, Nickel C, Pierro A, Offringa M. Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review. 2015 Jun 17;16:275. doi: 10.1186/s13063-015-0783-1. PMID: 26081254
  28. Fernandes RM, Plint AC, Terwee CB, Sampaio C, Klassen TP, Offringa M, van der Lee JH. Validity of bronchiolitis outcome measures. 2015 Jun;135(6):e1399-408. doi: 10.1542/peds.2014-3557. Epub 2015 May 18. PMID: 25986025
  29. Gorter RR, van der Lee JH, Cense HA, Kneepkens CM, Wijnen MH, In ‘t Hof KH, Offringa M, Heij HA; APAC Study Group. Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study. 2015;157(5):916-23. doi: 10.1016/j.surg.2015.01.008. Epub 2015 Mar 16. PMID: 25791031
  30. Cools F, Offringa M, Askie LM. Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants. Cochrane Database Syst Rev. 2015 Mar 19;3:CD000104. doi: 10.1002/14651858.CD000104.pub4. Review. PMID: 25785789
  31. Kapadia MZ, Askie L, Hartling L, Contopoulos-Ioannidis D, Bhutta ZA, Soll R, Moher D, Offringa M. PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research. BMJ Open. 2016 Apr 18;6(4):e010270. doi: 10.1136/bmjopen-2015-010270. PMID: 27091820
  32. Kelly LE, Davies EH, Saint-Raymond A, Tomasi P, Offringa M. Important issues in the justification of a control treatment in paediatric drug trials. Arch Dis Child. 2016 Oct;101(10):962-7. doi: 10.1136/archdischild-2016-310644.
  33. De Jaegere AP, Deurloo EE, van Rijn RR, Offringa M, van Kaam AH. Individualized lung recruitment during high-frequency ventilation in preterm infants is not associated with lung hyperinflation and air leaks. Eur J Pediatr. 2016 Aug;175(8):1085-90. doi: 0.1007/s00431-016-2744-4. Epub 2016 Jun 21.
  34. Kapadia MZ, Joachim KC, Balasingham C, Cohen E, Mahant S, Nelson K, Maguire JL, Guttmann A, Offringa M. A Core Outcome Set for Children with Feeding Tubes and Neurologic Impairment: A Systematic Review. 2016 Jul;138(1). pii: e20153967. doi: 10.1542/peds.2015-3967
  35. van der Zanden TM, de Wildt SN, Liem Y, Offringa M, de Hoog M; Developing a Paediatric Drug Formulary for the Netherlands.  Arch Dis Child. 2016 Oct 31. pii: archdischild-2016-311674. PMID: 27799154
  36. Kelly LE, Jansson LM, Moulsdale W, Pereira J, Simpson S, Guttman A, Allegaert K, Askie L, Roukema H, Lacaze T, Davis JM, Finnegan L, Williamson P, Offringa M. A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey. Trials. 2016 Nov 8;17(1):536.
  37. Kelly LE, Ito S, Woods D, Nunn AJ, Taketomo C, de Hoog M, Offringa M. A Comprehensive List of Items to be Included on a Pediatric Drug Monograph. J Pediatr Pharmacol Ther. 2017 Jan-Feb;22(1):48-59. doi: 10.5863/1551-6776-22.1.48.
  38. Onland W, De Jaegere APMC, Offringa M, van Kaam A. Systemic corticosteroid regimens for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD010941.
  39. Offringa M, Newton R, Cozijnsen MA, Nevitt SJ. Prophylactic drug management for febrile seizures in children. Cochrane Database of Systematic Reviews 2017, Issue 2. Art. No.: CD003031. DOI: 10.1002/14651858.CD003031.pub3.
  40. Farid-Kapadia M, Askie L, Hartling L, Contopoulos-Ioannidis D, Bhutta ZA, Soll R, Moher D, Offringa M. Do systematic reviews on pediatric topics need special methodological considerations? BMC Pediatr. 2017 Mar 6;17(1):57. doi: 10.1186/s12887-017-0812-1.
  41. Farid-Kapadia M, Joachim KC, Balasingham C, Clyburne-Sherin A, Offringa M. Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported? Two systematic reviews. Syst Rev. 2017 Mar 6;6(1):31. doi: 10.1186/s13643-017-0423-9.
  42. Hall NJ, Eaton S, Abbo O, Arnaud A; Beaudin M; Brindle M; Butter A; Davies D; Jancelewicz T; Johnson K; Keijzer R; Lapidus-Kroll E; Nasr A; Offringa M; Piche N; Rintala R; Skarsgard E; Svensson J; Ungar WJ; Wester T; Willan A; Zani A; St Peter SD; Pierro A. Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial. BMJ Paediatr Open. 2017 May 18;1(1). pii: bmjpo-2017-000028. doi: 10.1136/bmjpo-2017-000028. eCollection 2017. PMID:29637088.
  43. Onland W, Offringa M, van Kaam A. Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD002311.
  44. Groothoff JW, Offringa M, Grootenhuis M, Jager KJ. Long-term consequences of renal insufficiency in children: lessons learned from the Dutch LERIC study. Nephrol Dial Transplant. 2017 Jul 7. doi: 10.1093/ndt/gfx190. [Epub ahead of print] PMID: 28992218
  45. Rokhsefat S, Morra DE, Offringa M, Askie LM, Kelly LE. Trial registration in pediatric surgery trials. J Pediatr Surg. 2017 Oct 23. pii: S0022-3468(17)30704-2. doi: 10.1016 / j.jpedsurg 2017.10.049. [Epub ahead of print] PMID: 29150369]
  46. Costain G, Moore AM, Munroe L, Williams A, Zlotnik Shaul R, Rockman-Greenberg C, Offringa M, Kannu P. Enzyme replacement therapy in perinatal hypophosphatasia: Case report of a negative outcome and lessons for clinical practice. Mol Genet Metab Rep. 2017 Nov 7;14:22-26. doi: 10.1016/j.ymgmr.2017.10.006. eCollection 2018 Mar. PMID: 29159075.
  47. Tedesco D, Farid-Kapadia M, Offringa M, Bhutta ZA, Maldonado Y, Ioannidis JPA, Contopoulos-Ioannidis DG. Comparative Evidence on Harms in Pediatric RCTs from Less Developed versus More Developed Countries Is Limited.  J Clin Epidemiol.2017 Nov 27. pii: S0895-4356(17)30240-8. doi: 10.1016/j.jclinepi.2017.11.016. [Epub ahead of print]
  48. Knaapen M, van der Lee JH, Bakx R, The SL, van Heurn EWE, Heij HA, Gorter RR; APAC collaborative study group. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). BMJ Open. 2017 Nov 15;7(11):e018145. doi: 10.1136/bmjopen-2017-018145. PMID: 2914664
  49. Kelly LE, Caswell K, Short M, Parimi PS, Offringa M, Diacovo T. Response biomarkers in neonatal intervention studies. Pediatr Res. 2017 Aug 21. doi: 10.1038/pr.2017.204. [Epub ahead of print] PMID: 29278643
  50. Potter BK, Hutton B, Clifford TJ, Pallone N, Smith M, Stockler S, Chakraborty P, Barbeau P, Garritty CM, Pugliese M, Rahman A, Skidmore B, Tessier L, Tingley K, Coyle D, Greenberg CR, Korngut L, MacKenzie A, Mitchell JJ, Nicholls S, Offringa M, Schulze A, Taljaard M; Canadian Inherited Metabolic Diseases Research Network. Establishing core outcome sets for phenylketonuria (PKU) and medium-chain Acyl-CoA dehydrogenase (MCAD) deficiency in children: study protocol for systematic reviews and Delphi surveys. 2017 Dec 19;18(1):603. doi: 10.1186/s13063-017-2327-3. PMID: 29258568
  51. Gorter RR, van der Lee JH, Heijsters FACJ, Cense HA, Bakx R, Kneepkens CMF, Wijnen MH, van der Steeg AFW, in ‘t Hof KH, Offringa M, Heij HA, on behalf of the APAC Study Group. Outcome of initially non-operative treatment for acute simple appendicitis in children. J Pediatr Surg.2017 Dec 24. pii: S0022-3468(17)30837-0. doi: 10.1016/j.jpedsurg.2017.12.012. [Epub ahead of print]
  52. Puligandla PS, Skarsgard ED, Offringa M, for The Canadian CDH Collaborative: The Canadian Congenital Diaphragmatic Hernia Collaborative. Diagnosis and management of congenital diaphragmatic hernia: a clinical practice guideline. CMAJ January 29, 2018 190 (4) E103-E112; DOI: https://doi.org/10.1503/cmaj.170206
  53. Ardell S, Offringa M, Ovelman C, Soll R. Prophylactic vitamin K for the prevention of vitamin K deficiency bleeding in preterm neonates. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No.: CD008342. DOI: 10.1002/14651858.CD008342.pub2.
  54. Woods H, Oronsaye E, Bali A, Rajakulasingam Y, Lee T, Umali N, Cohen E, Finkelstein Y, Offringa M, Persaud N. Development of a provisional essential medicines list for children in Canada: consensus process. CMAJ Open. 2018 Mar 26;6(1):E146-E150. doi: 10.9778/cmajo.20170129. PMID:29592851.
  55. Barker CIS, Standing JF, Kelly LE, Hanly Faught L, Needham A, Rieder MJ, de Wildt SN, Offringa M. Pharmacokinetic Studies in Children: recommendations for practice and research. Arch Dis Child. 2018 Jul;103(7):695-702. doi: 10.1136/archdischild-2017-314506. PMID:29674514.
  56. Kelly LE, Sinha Y, Barker CIS, Standing JF, Offringa M. Useful Pharmacodynamic Endpoints in Children: Selection, Measurement and Next Steps. Ped Research 2018 Apr 18. doi: 10.1038/pr.2018.38. [Epub ahead of print] PMID:29667952.
  57. Maarten Janssen Lok, Hiromu Miyake, Alison Hock, Alan Daneman, Agostino Pierro, Martin Offringa. Value of abdominal ultrasound in necrotizing enterocolitis management: a systematic review and meta-analysis. Pediatr Surg Int. 2018 May 2. doi: 10.1007/s00383-018-4259-8. [Epub ahead of print] PMID:29721677.
  58. Yu AM, Balasubramanaiam B, Offringa M, Kelly LE. Reporting of interventions and ‘standard of care’ control arms in pediatric clinical trials: a quantitative analysis. Pediatr Res. 2018 Jun 13. doi: 10.1038/s41390-018-0019-7. PMID:29899384.
  59. Galica J, Chee-a-tow A, Gupta S, et al. Learning best-practices in journalology: course description and attendee insights into the inaugural EQUATOR Canada Publication School.  BMC Proceedings. 2018;12(Suppl 10):18. doi:10.1186/s12919-018-0155-4.
  60. Guillot M, Offringa M, Lacaze-Masmonteil T, Thébaud B. Cell-Based Therapy for Bronchopulmonary Dysplasia in Preterm Infants: Workshop report. Can J Physiol Pharmacol. 2018 Oct 5. doi: 10.1139/cjpp-2018-0342. PMID:30290122
  61. Sadeghirad B, Florez ID, Chang Y, Forutan F, Zeraatkar D, Morgan RL, Shahid S, Bala MM, Beyene J, Offringa M, Adams-Webber T, Sherman PM, El-Gouhary E, Guyatt GH, Johnston BC. Comparative Effectiveness of Prophylactic Therapies for Necrotizing Enterocolitis in Preterm Infants: Protocol for a Network Meta-analysis of Randomized Trials. Int J Prev Med. 2018 Sep 17;9:83. doi: 10.4103/ijpvm.IJPVM_328_17. eCollection 2018. PMID: 30283615.
  62. Kelly LE, Dyson MP, Butcher NJ, Balshaw R, London AJ, Neilson CJ, Junker A, Mahmud SM, Driedger SM, Wang X. Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan. 2018 Oct 19;19(1):572. doi: 10.1186/s13063-018-2934-7. PMID:30340624
  63. Gibb ACN, Crosby MA, McDiarmid C, Urban D, Lam JYK, Wales P, Brockel M, Raval M, Offringa M, Skarsgard E, Wester T, Wong K, de Beer D, Nelson G, Brindle ME. Protocol for Creation of An Enhanced Recovery After Surgery (ERAS®) Guideline for Neonatal Abdominal Surgery Patients: A Knowledge Synthesis and Consensus Generation Approach. BMJ Open.2018 Dec 9;8(12):e023651. doi: 10.1136/bmjopen-2018-023651.
  64. Onland W, Cools F, Kroon A, Rademaker K, Merkus MP, Mohns T, Blom H, Marechal Y, Debeer A, Dijk PH, van Heijst AF, Kramer BW, van Straaten HL, Te Pas AB, Theyskens C, Zonnenberg I, Plaskie K, Offringa M, van Kaam AH, on behalf of the SToP-BPD study group. Targeted Systemic Hydrocortisone for the Prevention of Bronchopulmonary Dysplasia. in press JAMA 2018.
  65. Butcher NJ, Mew E, Saeed L, Monsour A, Chee-a-tow A, Chan A-W, Moher D, Offringa M. Guidance for reporting outcomes in clinical trials: A systematic scoping review protocol. in press BMJ Open 2018 (& Open Science Framework preprint: doi:10.17605/OSF.IO/UGX29).
  66. Monsour A, Mew E, Szatmari P, Patal S, Saeed L, Offringa M, Butcher NJ. Outcome reporting in randomized controlled trials of major depressive disorder treatment in adolescents: a systematic scoping review protocol. in press BMJ Open 2018.