Skip to main content
Top
Published in: European Spine Journal 8/2014

01-08-2014 | Original Article

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

Authors: Xiao Chen, Xiao Zhai, Xue Wang, Jiacan Su, Ming Li

Published in: European Spine Journal | Issue 8/2014

Login to get access

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.
Appendix
Available only for authorised users
Literature
2.
go back to reference Force USPST (1989) Guide to clinical preventive services: report of the US Preventive Services Task Force. DIANE Publishing, USA Force USPST (1989) Guide to clinical preventive services: report of the US Preventive Services Task Force. DIANE Publishing, USA
3.
go back to reference 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 273:408–412CrossRef 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 273:408–412CrossRef
4.
go back to reference 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 352:609–613PubMedCrossRef 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 352:609–613PubMedCrossRef
5.
go back to reference Kjaergard LL, Villumsen J, Gluud C (2001) Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 135:982–989PubMedCrossRef Kjaergard LL, Villumsen J, Gluud C (2001) Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 135:982–989PubMedCrossRef
7.
go back to reference Bai Y, Gao J, Zou DW, Li ZS (2009) Methodological reporting of randomized clinical trials in major gastroenterology and hepatology journals in 2006. Hepatology 49:2108–2112PubMedCrossRef Bai Y, Gao J, Zou DW, Li ZS (2009) Methodological reporting of randomized clinical trials in major gastroenterology and hepatology journals in 2006. Hepatology 49:2108–2112PubMedCrossRef
8.
go back to reference Solomon MJ, McLeod RS (1993) Clinical studies in surgical journals—have we improved? Dis Colon Rectum 36:43–48PubMedCrossRef Solomon MJ, McLeod RS (1993) Clinical studies in surgical journals—have we improved? Dis Colon Rectum 36:43–48PubMedCrossRef
9.
go back to reference 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 104:982–989PubMedCrossRef 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 104:982–989PubMedCrossRef
10.
go back to reference Sandler RS (2001) Reporting randomized controlled trials in gastroenterology: the CONSORT statement. Gastroenterology 121:755PubMedCrossRef Sandler RS (2001) Reporting randomized controlled trials in gastroenterology: the CONSORT statement. Gastroenterology 121:755PubMedCrossRef
11.
go back to reference 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 24:1158–1163PubMedCrossRef 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 24:1158–1163PubMedCrossRef
12.
go back to reference 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 31:150–153PubMedCrossRef 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 31:150–153PubMedCrossRef
14.
go back to reference Chalmers TC (1975) Randomization of the first patient. Med Clin N Am 59:1035–1038PubMed Chalmers TC (1975) Randomization of the first patient. Med Clin N Am 59:1035–1038PubMed
15.
16.
go back to reference Agha R, Cooper D, Muir G (2007) The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 5:413–422PubMedCrossRef Agha R, Cooper D, Muir G (2007) The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 5:413–422PubMedCrossRef
17.
go back to reference 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:485–489PubMed 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:485–489PubMed
18.
19.
go back to reference 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 374:1097–1104PubMedCentralPubMedCrossRef 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 374:1097–1104PubMedCentralPubMedCrossRef
20.
go back to reference 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 301:831–841CrossRef 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 301:831–841CrossRef
21.
go back to reference Schulz KF, Grimes DA (2002) Generation of allocation sequences in randomised trials: chance, not choice. Lancet 359:515–519PubMedCrossRef Schulz KF, Grimes DA (2002) Generation of allocation sequences in randomised trials: chance, not choice. Lancet 359:515–519PubMedCrossRef
22.
go back to reference Schulz KF, Grimes DA (2002) Allocation concealment in randomised trials: defending against deciphering. Lancet 359:614–618PubMedCrossRef Schulz KF, Grimes DA (2002) Allocation concealment in randomised trials: defending against deciphering. Lancet 359:614–618PubMedCrossRef
23.
go back to reference 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 330:1057–1058PubMedCentralPubMedCrossRef 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 330:1057–1058PubMedCentralPubMedCrossRef
24.
go back to reference 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 290:921–928CrossRef 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 290:921–928CrossRef
25.
go back to reference 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 13:76PubMedCentralPubMedCrossRef 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 13:76PubMedCentralPubMedCrossRef
26.
go back to reference Miller JN, Colditz GA, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. II: surgical. Stat Med 8:455–466PubMedCrossRef Miller JN, Colditz GA, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. II: surgical. Stat Med 8:455–466PubMedCrossRef
27.
go back to reference 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 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
Metadata
Title
Methodological reporting quality of randomized controlled trials in three spine journals from 2010 to 2012
Authors
Xiao Chen
Xiao Zhai
Xue Wang
Jiacan Su
Ming Li
Publication date
01-08-2014
Publisher
Springer Berlin Heidelberg
Published in
European Spine Journal / Issue 8/2014
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI
https://doi.org/10.1007/s00586-014-3283-1

Other articles of this Issue 8/2014

European Spine Journal 8/2014 Go to the issue