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Methodological reporting quality of randomized controlled trials in three spine journals from 2010 to 2012

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Abstract

Purpose

To elucidate the methodological reporting quality of randomized controlled trials (RCTs) in three spine journals from 2010 to 2012.

Methods

In this study, we summarized the methodological report of RCTs in three major spine journals, including the Spine Journal, Spine and the European Spine Journal from 2010 to 2012. The methodological reporting quality, including the allocation sequence generation, allocation concealment, blinding and sample size calculation, was revealed. Number of patients, funding source, type of intervention and country were also retrieved from each trial. The methodological reporting quality was descriptively reported.

Results

Ninety trials were involved and 57.8 % (52/90) reported adequate allocation sequence generation, 46.7 % (42/90) reported adequate allocation concealment, 34.4 % (31/90) reported adequate blinding and 37.8 % (34/90) reported adequate sample size calculation.

Conclusions

This study shows that the methodological reporting quality of RCTs in the spine field needs further improvement.

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References

  1. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996) Evidence based medicine: what it is and what it isn’t. BMJ 312:71–72

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  2. Force USPST (1989) Guide to clinical preventive services: report of the US Preventive Services Task Force. DIANE Publishing, USA

  3. Schulz KF, Chalmers I, Hayes RJ, Altman DG (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA J Am Med Assoc 273:408–412

    Article  CAS  Google Scholar 

  4. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352:609–613

    Article  CAS  PubMed  Google Scholar 

  5. Kjaergard LL, Villumsen J, Gluud C (2001) Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 135:982–989

    Article  CAS  PubMed  Google Scholar 

  6. http://www.consort-statement.org/

  7. Bai Y, Gao J, Zou DW, Li ZS (2009) Methodological reporting of randomized clinical trials in major gastroenterology and hepatology journals in 2006. Hepatology 49:2108–2112

    Article  PubMed  Google Scholar 

  8. Solomon MJ, McLeod RS (1993) Clinical studies in surgical journals—have we improved? Dis Colon Rectum 36:43–48

    Article  CAS  PubMed  Google Scholar 

  9. Peron J, Pond GR, Gan HK, Chen EX, Almufti R, Maillet D, You B (2012) Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review. J Natl Cancer Inst 104:982–989

    Article  PubMed  Google Scholar 

  10. Sandler RS (2001) Reporting randomized controlled trials in gastroenterology: the CONSORT statement. Gastroenterology 121:755

    Article  CAS  PubMed  Google Scholar 

  11. Bai Y, Wu YF, Wang D, Xia Y, Gao J, Zou DW, Li ZS (2010) Internal validity of randomized controlled trials reported in major gastrointestinal and surgical endoscopy journals in 2008. Surg Endosc 24:1158–1163

    Article  PubMed  Google Scholar 

  12. Robinson KA, Dickersin K (2002) Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. Int J Epidemiol 31:150–153

    Article  PubMed  Google Scholar 

  13. Higgins JPT, Green S (eds) (2008) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration 2011. http://www.cochrane.org/handbook

  14. Chalmers TC (1975) Randomization of the first patient. Med Clin N Am 59:1035–1038

    CAS  PubMed  Google Scholar 

  15. Meakins JL (2006) Evidence-based surgery. Surg Clin N Am 86:1–16 (vii)

    Article  Google Scholar 

  16. Agha R, Cooper D, Muir G (2007) The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 5:413–422

    Article  PubMed  Google Scholar 

  17. Bhandari M, Guyatt GH, Lochner H, Sprague S, Tornetta P 3rd (2002) Application of the Consolidated Standards of Reporting Trials (CONSORT) in the Fracture Care Literature. J Bone Joint Surg Am 84-A:485–489

    PubMed  Google Scholar 

  18. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ 324:1448–1451

    Article  PubMed Central  PubMed  Google Scholar 

  19. Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, Altman DG, Aronson JK, Barkun JS, Campbell WB, Feldman LS, Flum DR, Glasziou P, Maddern GJ, Marshall JC, McCulloch P, Nicholl J, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J (2009) Challenges in evaluating surgical innovation. Lancet 374:1097–1104

    Article  PubMed Central  PubMed  Google Scholar 

  20. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr (2009) Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA J Am Med Assoc 301:831–841

    Article  CAS  Google Scholar 

  21. Schulz KF, Grimes DA (2002) Generation of allocation sequences in randomised trials: chance, not choice. Lancet 359:515–519

    Article  PubMed  Google Scholar 

  22. Schulz KF, Grimes DA (2002) Allocation concealment in randomised trials: defending against deciphering. Lancet 359:614–618

    Article  PubMed  Google Scholar 

  23. Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM (2005) Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ 330:1057–1058

    Article  PubMed Central  PubMed  Google Scholar 

  24. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL (2003) Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA J Am Med Assoc 290:921–928

    Article  Google Scholar 

  25. Rada G, Schunemann HJ, Labedi N, El-Hachem P, Kairouz VF, Akl EA (2013) Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer. BMC Cancer 13:76

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  26. Miller JN, Colditz GA, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. II: surgical. Stat Med 8:455–466

    Article  CAS  PubMed  Google Scholar 

  27. Liberati A, Himel HN, Chalmers TC (1986) A quality assessment of randomized control trials of primary treatment of breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 4:942–951

    CAS  Google Scholar 

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Acknowledgments

We are indebted to the authors of the primary studies.

Conflict of interest

No competing interest declared.

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Authors

Corresponding authors

Correspondence to Jiacan Su or Ming Li.

Additional information

X. Chen and X. Zhai contributed equally to this work.

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Chen, X., Zhai, X., Wang, X. et al. Methodological reporting quality of randomized controlled trials in three spine journals from 2010 to 2012. Eur Spine J 23, 1606–1611 (2014). https://doi.org/10.1007/s00586-014-3283-1

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  • DOI: https://doi.org/10.1007/s00586-014-3283-1

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