Brief Introduction of the CONSORT Extension for Reporting N-of-1 Trials (CENT 2015)_Chinese Journal of Evidence-Based Medicine

Authors：

 CHENXin-lin ¹ , HUANGHai-yin ² , ZHANGChang-rong ³ , WENYi ³ , HOUZheng-kun ³ , HUYue ¹ , MOChuan-wei ¹ , XUQian ¹ ,  LIUFeng-bin ³

1. Basic Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510006, China;
2. Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Chinese Medicine, Shanghai 200437, China;
3. The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510405, China;

Corresponding?author：

LIUFeng-bin, Email: liufb163@163.com

Keywords：

N-of-1 trials; CENT statement; Reporting; Checklist; Diagram

DOI：

10.7507/1672-2531.20160132

Video：

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The CONSORT extension for reporting N-of-1 trials (CENT 2015) is designed to guide N-of-1 and series N-of-1 reporting. This study introduced the terminology (period, block or pair, sequence, washout period, and run-in period), the scope, the checklist and the diagram of CENT 2015 and demonstrated the complete guide frame for N-of-1, and thus to provide reference for relevant studies and improve the reporting quality of N-of-1 in China.

Citation： CHENXin-lin, HUANGHai-yin, ZHANGChang-rong, WENYi, HOUZheng-kun, HUYue, MOChuan-wei, XUQian, LIUFeng-bin. Brief Introduction of the CONSORT Extension for Reporting N-of-1 Trials (CENT 2015). Chinese Journal of Evidence-Based Medicine, 2016, 16(7): 860-863. doi: 10.7507/1672-2531.20160132 Copy

1.	Gabler NB, Duan N, Vohra S, et al. N-of-1 trials in the medical literature:a systematic review. Med Care, 2011, 49(8):761-768.
2.	陳新林, 李先濤, 胡鏡清, 等.復雜干預的設計和評價方法.遼寧中醫藥大學學報, 2013, 15(4):81-83.
3.	Chen X, Chen P. A comparison of four methods for the analysis of N-of-1 trials. PLoS One, 2014, 9(2):e87752.
4.	陳新林, 陳平雁. N-of-1無殘留效應定量數據混合效應模型的模擬研究.中國衛生統計, 2013, 30(3):347-350.
5.	黃海茵, 楊佩蘭, 張譽清, 等.單病例隨機對照試驗在中醫藥研究中的可行性與潛在價值.上海中醫藥雜志, 2012, 46(8):3-8.
6.	陳新林, 李海文, 劉鳳斌, 等.單病例隨機對照試驗的設計和評價方法.中國循證醫學雜志, 2016, 16(2):242-245.
7.	Shamseer L, Sampson M, Bukutu C, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015:Explanation and elaboration. BMJ, 2015, 350:h1793.
8.	Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350:h1738.
9.	Li J, Gao W, Punja S, et al. Reporting quality of N-of-1 trials published between 1985 and 2013:a systematic review. J Clin Epidemiol, 2016, in press.
10.	Tate RL, Perdices M, Rosenkoetter U, et al. Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials:the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychol Rehabil, 2013, 23(5):619-638.
11.	Schulz KF, Altman DG, Moher D. CONSORT 2010 statement:Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2):100-107.
12.	Nonoyama ML, Brooks D, Guyatt GH, et al. Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia. Am J Respir Crit Care Med, 2007, 176(4):343-349.
13.	張昕, 黃李法, 李徐.高血壓腦出血術后患者單病例隨機對照臨床試驗.浙江中醫藥大學學報, 2012, 36(8):871-873.
14.	于大君, 翁維良, 陸芳, 等.慢性腎臟病Ⅲ期單病例隨機對照臨床試驗.中醫雜志, 2012, 53(3):222-224.
15.	劉志剛, 柴程芝, 朱欣佚, 等.葛根湯治療原發性痛經的多基線單病例隨機對照試驗.中華中醫藥雜志, 2015, 30(7):2473-2476.
16.	陳煒煒, 李寧.針刺治療脊髓損傷后下肢痙攣:單病例隨機對照試驗.中國針灸, 2010, 30(6):473-477.

1. Gabler NB, Duan N, Vohra S, et al. N-of-1 trials in the medical literature:a systematic review. Med Care, 2011, 49(8):761-768.
2. 陳新林, 李先濤, 胡鏡清, 等.復雜干預的設計和評價方法.遼寧中醫藥大學學報, 2013, 15(4):81-83.
3. Chen X, Chen P. A comparison of four methods for the analysis of N-of-1 trials. PLoS One, 2014, 9(2):e87752.
4. 陳新林, 陳平雁. N-of-1無殘留效應定量數據混合效應模型的模擬研究.中國衛生統計, 2013, 30(3):347-350.
5. 黃海茵, 楊佩蘭, 張譽清, 等.單病例隨機對照試驗在中醫藥研究中的可行性與潛在價值.上海中醫藥雜志, 2012, 46(8):3-8.
6. 陳新林, 李海文, 劉鳳斌, 等.單病例隨機對照試驗的設計和評價方法.中國循證醫學雜志, 2016, 16(2):242-245.
7. Shamseer L, Sampson M, Bukutu C, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015:Explanation and elaboration. BMJ, 2015, 350:h1793.
8. Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350:h1738.
9. Li J, Gao W, Punja S, et al. Reporting quality of N-of-1 trials published between 1985 and 2013:a systematic review. J Clin Epidemiol, 2016, in press.
10. Tate RL, Perdices M, Rosenkoetter U, et al. Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials:the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychol Rehabil, 2013, 23(5):619-638.
11. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement:Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2):100-107.
12. Nonoyama ML, Brooks D, Guyatt GH, et al. Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia. Am J Respir Crit Care Med, 2007, 176(4):343-349.
13. 張昕, 黃李法, 李徐.高血壓腦出血術后患者單病例隨機對照臨床試驗.浙江中醫藥大學學報, 2012, 36(8):871-873.
14. 于大君, 翁維良, 陸芳, 等.慢性腎臟病Ⅲ期單病例隨機對照臨床試驗.中醫雜志, 2012, 53(3):222-224.
15. 劉志剛, 柴程芝, 朱欣佚, 等.葛根湯治療原發性痛經的多基線單病例隨機對照試驗.中華中醫藥雜志, 2015, 30(7):2473-2476.
16. 陳煒煒, 李寧.針刺治療脊髓損傷后下肢痙攣:單病例隨機對照試驗.中國針灸, 2010, 30(6):473-477.

Chinese Journal of Evidence-Based Medicine

Brief Introduction of the CONSORT Extension for Reporting N-of-1 Trials (CENT 2015)

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