Advanced search
Publication Cover
Acta Orthopaedica Volume 91, 2020 - Issue 4
Journal homepage
1,331
Views
3
CrossRef citations to date
0
Altmetric
Articles

Assessing variability and uncertainty in orthopedic randomized controlled trials

Lauri RaittioTampere University, Faculty of Medicine and Health Technology, Tampere; Correspondence[email protected]
&
Aleksi ReitoDepartment of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland
Pages 479-484 | Published online: 22 Apr 2020

  • Abdullah L, Davis D E, Fabricant P D, Baldwin K, Namdari S. Is there truly “no significant difference” underpowered randomized controlled trials in the orthopaedic literature. J Bone Joint Surg Am 2015; 97(24): 2068–73.
  • Altman D G. Statistics and ethics in medical research: misuse of statistics is unethical. BMJ 1980a; 281(6249): 1182–4.
  • Altman D G. Statistics and ethics in medical research, VI: Presentation of results. BMJ 1980b; 281(6254): 1542–4.
  • Altman D G. Why we need confidence intervals. World J Surg 2005; 29(5): 554–6.
  • Altman D G, Bland J M. Absence of evidence is not evidence of absence. BMJ 1995; 311(7003): 485.
  • Anderson A A. Assessing statistical results: magnitude, precision, and model uncertainty. Am Stat 2019; 73(Supl.1): 118–21.
  • Angst F, Aeschlimann A, Angst J. The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol 2017; 82: 128–36.
  • Button K S, Ioannidis J P A, Mokrysz C, Nosek B A, Flint J, Robinson E S J, Munafò M R. Power failure: why small sample size undermines the reliability of neuroscience. Nat Rev Neurosci 2013; 14(5): 365–76.
  • Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009; 338: b1732–b1732.
  • Cook J A, Julious S A, Sones W, Hampson L V, Hewitt C, Berlin J A, Ashby D, Emsley R, Fergusson D A, Walters S J, Wilson E C F, Maclennan G, Stallard N, Rothwell J C, Bland M, Brown L, Ramsay C R, Cook A, Armstrong D, Altman D, Vale L D. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials 2018; 19(1): 606.
  • Dabija D I, Jain N B. Minimal clinically important difference of shoulder outcome measures and diagnoses. Am J Phys Med Rehabil 2019; 98(8) 671–6.
  • de Vet H C W, Terwee C B. The minimal detectable change should not replace the minimal important difference. J Clin Epidemiol 2010; 63(7): 804–5.
  • Gelman A, Greenland S. Are confidence intervals better termed “uncertainty intervals”. BMJ 2019; 366: l5381.
  • Higgins J P T, Green S. Cochrane handbook for systematic reviews of interventions. Vol. 4. New York: Wiley; 2011.
  • International Committee of Medical Journal Editors. I. Uniform requirements for manuscripts submitted to biomedical journals. Ann Intern Med; 1988; 108(2): 258.
  • Jayadevappa R, Cook R, Chhatre S. Minimal important difference to infer changes in health-related quality of life-a systematic review. J Clin Epidemiol 2017; 89: 188–98.
  • Lamberink H J, Otte W M, Sinke M R T, Lakens D, Glasziou P P, Tijdink J K, Vinkers C H. Statistical power of clinical trials increased while effect size remained stable: an empirical analysis of 136,212 clinical trials between 1975 and 2014. J Clin Epidemiol 2018; 102: 123–8.
  • Ostelo R W J G, Deyo R A, Stratford P, Waddell G, Croft P, Von Korff M, Bouter L M, de Vet H C. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine 2008; 33(1): 90–4.
  • Reito A, Raittio L, Helminen O. Revisiting the sample size and statistical power of randomized controlled trials in orthopaedics after 2 decades. JBJS Rev 2020; 8(2): e0079.
  • Rothman K J, Greenland S. Planning study size based on precision rather than power. Epidemiology 2018; 29(5): 599–603.
  • Sabharwal S, Patel N, Holloway I, Athanasiou T. Sample size calculations in orthopaedics randomised controlled trials: revisiting research practices. Acta Orthop Belg 2015; 81(1): 115–22.
  • Schulz K F, Altman D G, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med; 2010; 8(1): 18.
  • Senn S. Delta Force: To what extent is clinical relevance relevant? 2014. https://errorstatistics.com/2014/03/17/stephen-senn-on-how-to-interpret-discrepancies-against-which-a-test-has-high-power-guest-post/ (Accessed February 14, 2020
  • Szucs D, Ioannidis J P A. Empirical assessment of published effect sizes and power in the recent cognitive neuroscience and psychology literature. PLoS Biol 2017; 15(3): e2000797.
  • Teare M D, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters S J. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials 2014; 15(1): 264.
  • Vavken P, Heinrich K M, Koppelhuber C, Rois S, Dorotka R. The use of confidence intervals in reporting orthopaedic research findings. Clin Orthop Relat Res 2009; 467(12): 3334–9
  • Vickers A J. Underpowering in randomized trials reporting a sample size calculation. J Clin Epidemiol 2003; 56(8): 717–20.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.