Editorial. Choices in clinical trial design

Bob S. Carter MD, PhD and Fred G. Barker II MD
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  • Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts
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Contributor Notes

Correspondence Bob S. Carter: bcarter@mgh.harvard.edu.

ACCOMPANYING ARTICLE DOI: 10.3171/2018.11.JNS182713.

INCLUDE WHEN CITING Published online September 13, 2019; DOI: 10.3171/2019.7.JNS183276.

Disclosures The authors report no conflict of interest.

  • 1

    Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, : Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA 312:15201530, 2014

    • Search Google Scholar
    • Export Citation
  • 2

    Cook JA, Hislop J, Altman DG, Fayers P, Briggs AH, Ramsay CR, : Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers. Trials 16:12, 2015

    • Search Google Scholar
    • Export Citation
  • 3

    Horton R: From star signs to trial guidelines. Lancet 355:10331034, 2000

  • 4

    Karsy M, Guan J, Eli I, Brock AA, Menacho ST, Park MS: The effect of supplementation of vitamin D in neurocritical care patients with hypovitaminosis D: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY). J Neurosurg [epub ahead of print September 13, 2019; DOI: 10.3171/2018.11.JNS182713]

    • Search Google Scholar
    • Export Citation
  • 1

    Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, : Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA 312:15201530, 2014

    • Search Google Scholar
    • Export Citation
  • 2

    Bikle D: Nonclassic actions of vitamin D. J Clin Endocrinol Metab 94:2634, 2009

  • 3

    Brustad N, Eliasen AU, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL: High-dose vitamin D supplementation during pregnancy and asthma in offspring at the age of 6 years. JAMA 321:10031005, 2019

    • Search Google Scholar
    • Export Citation
  • 4

    Guan J, Karsy M, Brock AA, Eli IM, Ledyard HK, Hawryluk GW, : A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting. J Neurosurg 127:17, 2017

    • Search Google Scholar
    • Export Citation
  • 5

    Guan J, Karsy M, Brock AA, Eli IM, Manton GM, Ledyard HK, : Vitamin D status and 3-month Glasgow Outcome Scale scores in patients in neurocritical care: prospective analysis of 497 patients. J Neurosurg 128:16351641, 2018

    • Search Google Scholar
    • Export Citation
  • 6

    Guan J, Karsy M, Eli I, Bisson EF, McNally S, Taussky P, : Increased incidence of hypovitaminosis D among patients requiring treatment for cerebral aneurysms. World Neurosurg 88:1520, 2016

    • Search Google Scholar
    • Export Citation
  • 7

    Ng K, Nimeiri HS, McCleary NJ, Abrams TA, Yurgelun MB, Cleary JM, : Effect of high-dose vs standard-dose vitamin D3 supplementation on progression-free survival among patients with advanced or metastatic colorectal cancer: the SUNSHINE Randomized Clinical Trial. JAMA 321:13701379, 2019

    • Search Google Scholar
    • Export Citation
  • 8

    Ravindra VM, Godzik J, Guan J, Dailey AT, Schmidt MH, Bisson EF, : Prevalence of vitamin D deficiency in patients undergoing elective spine surgery: a cross-sectional analysis. World Neurosurg 83:11141119, 2015

    • Search Google Scholar
    • Export Citation
  • 9

    Thacher TD, Clarke BL: Vitamin D insufficiency. Mayo Clin Proc 86:5060, 2011

  • 10

    Urashima M, Ohdaira H, Akutsu T, Okada S, Yoshida M, Kitajima M, : Effect of vitamin D supplementation on relapse-free survival among patients with digestive tract cancers: the AMATERASU Randomized Clinical Trial. JAMA 321:13611369, 2019

    • Search Google Scholar
    • Export Citation

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