Interpretation of the Consolidated Standards of Reporting Trials (CONSORT) guideline for within person trials_Chinese Journal of Evidence-Based Medicine

Authors：

HUA Fang ^1,2,3,4 ,  HE Hong ^1,2

1. The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory of Oral Biomedicine Ministry of Education, School of Stomatology, Wuhan University, Wuhan, 430079, P.R.China;
2. Department of Orthodontics, Hospital of Stomatology, Wuhan University, Wuhan, 430079, P.R.China;
3. Center for Evidence-Based Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, 430079, P.R.China;
4. Cochrane Oral Health Group, Division of Dentistry, The University of Manchester, Manchester, M13 9PL, UK;

Corresponding author：

HE Hong, Email: drhehong@whu.edu.cn

Keywords：

Within person trials; Reporting guideline; CONSORT for WPT; Interpretation

DOI：

10.7507/1672-2531.201804086

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Within person trial is an efficient study design for randomized controlled trials which has been widely used in fields of dentistry, dermatology and ophthalmology. However, due to a series of inherent methodological difficulties, the design, conduct and reporting of within person trials usually requires additional methodological knowledge and considerations from researchers. To standardize and improve the reporting quality of these trials, the BMJ recently published the CONSORT statement extension for within person trials. The present article aimed to provide interpretation of this reporting guideline, and thereby promote its understanding and use among Chinese researchers.

Citation： HUA Fang, HE Hong. Interpretation of the Consolidated Standards of Reporting Trials (CONSORT) guideline for within person trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(9): 1001-1006. doi: 10.7507/1672-2531.201804086 Copy

1.	Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med, 2000, 342(25): 1887-1892.
2.	Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet, 2005, 365(9465): 1159-1162.
3.	Innes NP, Evans DJ, Stirrups DR. Sealing caries in primary molars: randomized control trial, 5-year results. J Dent Res, 2011, 90(12): 1405-1410.
4.	Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent, 2012, 40(9): 766-775.
5.	Sundaram H, Cegielska A, Wojciechowska A, et al. Prospective, randomized, investigator-blinded, split-face evaluation of a topical crosslinked hyaluronic acid serum for post-procedural improvement of skin quality and biomechanical attributes. J Drugs Dermatol, 2018, 17(4): 442-450.
6.	Shi VY, Foolad N, Ornelas JN, et al. Comparing the effect of bleach and water baths on skin barrier function in atopic dermatitis: a split-body randomized controlled trial. Br J Dermatol, 2016, 175(1): 212-214.
7.	He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol, 2014, 157(6): 1170-1178.
8.	Yip YW, Yu MC, Jhanji V. Randomized, contralateral eye study to evaluate the effect of standard and inverted side-cut angle on corneal biomechanical properties during femtosecond laser-assisted in situ keratomileusis. Acta Ophthalmol, 2014, 92(6): e437-e442.
9.	Pandis N, Chung B, Scherer RW, et al. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ, 2017, 357: j2835.
10.	Scherer R, Breck J, Ervin A, et al. Characteristics of randomized trials in ophthalmology using a within-person paired design. Invest Ophthalmol Vis Sci, 2012, 357: 4734.
11.	Lesaffre E, Garcia Zattera MJ, Redmond C, et al. Reported methodological quality of split-mouth studies. J Clin Periodontol, 2007, 34(9): 756-761.
12.	Pandis N, Walsh T, Polychronopoulou A, et al. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod, 2013, 35(6): 783-789.
13.	Lesaffre E, Philstrom B, Needleman I, et al. The design and analysis of split-mouth studies: what statisticians and clinicians should know. Stat Med, 2009, 28(28): 3470-3482.
14.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
15.	Moher D, Hopewell S, Schulz KF, 等. CONSORT 2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(8): 1672-1977.
16.	Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
17.	Hopewell S, Clarke M, Moher D, 等. 期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明: 说明与详述. 中西医结合学报, 2008, 6(3): 221-232.
18.	Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 2014, 348: g1687.
19.	Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
20.	Hua F, Walsh T, Glenny AM, et al. Surveys on reporting guideline usage in dental journals. J Dent Res, 2016, 95(11): 1207-1213.
21.	Shamseer L, Hopewell S, Altman DG, et al. Update on the endorsement of CONSORT by high impact factor journals: a survey of journal "Instructions to Authors" in 2014. Trials, 2016, 17(1): 301.
22.	Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 2012, 11: MR000030.
23.	Hua F, Deng L, Kau CH, et al. Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals. J Am Dent Assoc, 2015, 146(9): 669-678.
24.	Pandis N, Shamseer L, Kokich VG, et al. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting. J Clin Epidemiol, 2014, 67(9): 1044-1048.
25.	Hopewell S, Ravaud P, Baron G, et al. Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ, 2012, 344: e4178.
26.	Campbell MK, Piaggio G, Elbourne DR, et al. CONSORT 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
27.	Boutron I, Altman DG, Moher D, et al. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med, 2017, 167(1): 40-47.
28.	Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276.
29.	张明妍, 杨丰文, 李越, 等. 核心指标集报告规范(COS-STAR)介绍. 中国循证医学杂志, 2017, 17(7): 857-861.
30.	吴沛霞, 胡雁. 患者和公众参与研究的报告规范(GRIPP 2)解读. 中国循证医学杂志, 2018, 18(1): 96-100.
31.	Altman DG, Sauerbrei W, McShane LM. Importance of the distinction between quality of methodology and quality of reporting. HPB (Oxford), 2017, 19(7): 649-650.
32.	董稳航, 李春洁, 项陈洋, 等. 我国口腔颌面外科临床随机对照试验的报告质量评价. 华西口腔医学杂志, 2012, 30(5): 505-508.
33.	张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.

1. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med, 2000, 342(25): 1887-1892.
2. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet, 2005, 365(9465): 1159-1162.
3. Innes NP, Evans DJ, Stirrups DR. Sealing caries in primary molars: randomized control trial, 5-year results. J Dent Res, 2011, 90(12): 1405-1410.
4. Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent, 2012, 40(9): 766-775.
5. Sundaram H, Cegielska A, Wojciechowska A, et al. Prospective, randomized, investigator-blinded, split-face evaluation of a topical crosslinked hyaluronic acid serum for post-procedural improvement of skin quality and biomechanical attributes. J Drugs Dermatol, 2018, 17(4): 442-450.
6. Shi VY, Foolad N, Ornelas JN, et al. Comparing the effect of bleach and water baths on skin barrier function in atopic dermatitis: a split-body randomized controlled trial. Br J Dermatol, 2016, 175(1): 212-214.
7. He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol, 2014, 157(6): 1170-1178.
8. Yip YW, Yu MC, Jhanji V. Randomized, contralateral eye study to evaluate the effect of standard and inverted side-cut angle on corneal biomechanical properties during femtosecond laser-assisted in situ keratomileusis. Acta Ophthalmol, 2014, 92(6): e437-e442.
9. Pandis N, Chung B, Scherer RW, et al. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ, 2017, 357: j2835.
10. Scherer R, Breck J, Ervin A, et al. Characteristics of randomized trials in ophthalmology using a within-person paired design. Invest Ophthalmol Vis Sci, 2012, 357: 4734.
11. Lesaffre E, Garcia Zattera MJ, Redmond C, et al. Reported methodological quality of split-mouth studies. J Clin Periodontol, 2007, 34(9): 756-761.
12. Pandis N, Walsh T, Polychronopoulou A, et al. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod, 2013, 35(6): 783-789.
13. Lesaffre E, Philstrom B, Needleman I, et al. The design and analysis of split-mouth studies: what statisticians and clinicians should know. Stat Med, 2009, 28(28): 3470-3482.
14. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
15. Moher D, Hopewell S, Schulz KF, 等. CONSORT 2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(8): 1672-1977.
16. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
17. Hopewell S, Clarke M, Moher D, 等. 期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明: 说明与详述. 中西医结合学报, 2008, 6(3): 221-232.
18. Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 2014, 348: g1687.
19. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
20. Hua F, Walsh T, Glenny AM, et al. Surveys on reporting guideline usage in dental journals. J Dent Res, 2016, 95(11): 1207-1213.
21. Shamseer L, Hopewell S, Altman DG, et al. Update on the endorsement of CONSORT by high impact factor journals: a survey of journal "Instructions to Authors" in 2014. Trials, 2016, 17(1): 301.
22. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 2012, 11: MR000030.
23. Hua F, Deng L, Kau CH, et al. Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals. J Am Dent Assoc, 2015, 146(9): 669-678.
24. Pandis N, Shamseer L, Kokich VG, et al. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting. J Clin Epidemiol, 2014, 67(9): 1044-1048.
25. Hopewell S, Ravaud P, Baron G, et al. Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ, 2012, 344: e4178.
26. Campbell MK, Piaggio G, Elbourne DR, et al. CONSORT 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
27. Boutron I, Altman DG, Moher D, et al. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med, 2017, 167(1): 40-47.
28. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276.
29. 张明妍, 杨丰文, 李越, 等. 核心指标集报告规范(COS-STAR)介绍. 中国循证医学杂志, 2017, 17(7): 857-861.
30. 吴沛霞, 胡雁. 患者和公众参与研究的报告规范(GRIPP 2)解读. 中国循证医学杂志, 2018, 18(1): 96-100.
31. Altman DG, Sauerbrei W, McShane LM. Importance of the distinction between quality of methodology and quality of reporting. HPB (Oxford), 2017, 19(7): 649-650.
32. 董稳航, 李春洁, 项陈洋, 等. 我国口腔颌面外科临床随机对照试验的报告质量评价. 华西口腔医学杂志, 2012, 30(5): 505-508.
33. 张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.

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Interpretation of the Consolidated Standards of Reporting Trials (CONSORT) guideline for within person trials

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