Interpretation of SPIRIT extension for N-of-1 trials (SPENT 2019)_Chinese Journal of Evidence-Based Medicine

Authors：

LI Yanfei ^1,2,3 , CHU Xiajing ^1,2,3 , LU Cuncun ⁴ , HAN Jiani ^1,2,3 , ZHENG Zhongli ^1,2,3 ,  LI Xiuxia ^1,2,3 , YANG Kehu ^1,2,3

1. Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
2. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;
3. Evidence Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding author：

LI Xiuxia, Email: yangkh-ebm@lzu.edu.cn

Keywords：

N-of-1 trials; Reporting guideline; Reporting quality; SPIRIT extension for N-of-1 trials (SPENT 2019)

DOI：

10.7507/1672-2531.202112091

Video：

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N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.

Citation： LI Yanfei, CHU Xiajing, LU Cuncun, HAN Jiani, ZHENG Zhongli, LI Xiuxia, YANG Kehu. Interpretation of SPIRIT extension for N-of-1 trials (SPENT 2019). Chinese Journal of Evidence-Based Medicine, 2022, 22(4): 475-482. doi: 10.7507/1672-2531.202112091 Copy

1.	李幼平, 李静, 孙鑫, 等. 循证医学在中国的起源与发展: 献给中国循证医学20周年. 中国循证医学杂志, 2016, 16(1): 2-6.
2.	李江, 田金徽, 石菊芳, 等. 单病例随机对照试验的研究现状与进展. 兰州大学学报(医学版), 2016, 42(3): 52-56.
3.	李江, 田金徽, 杨克虎. 单病例随机对照试验研究现状. 中国循证儿科杂志, 2011, 6(6): 453-455.
4.	翟静波, 李江, 商洪才, 等. 贝叶斯单病例随机对照试验简介. 中国循证医学杂志, 2017, 17(7): 848-851.
5.	Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
6.	Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): Recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
7.	李江, 翟静波, 商洪才, 等. 单病例随机对照试验的证据级别和报告规范. 中国循证医学杂志, 2017, 17(5): 612-615.
8.	Guyatt GH, Keller JL, Jaeschke R, et al. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern Med, 1990, 112(4): 293-299.
9.	Porcino AJ, Shamseer L, Chan AW, et al. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ, 2020, 368: m122.
10.	赵晶晶, 龙泳, 刘学东. 2013临床试验方案规范指南(SPIRIT)及其解读. 中国循证儿科杂志, 2014, 9(5): 381-388.
11.	Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
12.	Dai L, Cheng CW, Tian R, et al. Standard protocol items for clinical trials with traditional chinese medicine 2018: recommendations, explanation and elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med, 2019, 25(1): 71-79.
13.	陈新林, 黄海茵, 张长荣, 等. 2015版CENT声明简介: 单病例随机对照试验报告指南. 中国循证医学杂志, 2016, 16(7): 860-863.
14.	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.
15.	Fielenbach S, Donkers FC, Spreen M, et al. Neurofeedback as a treatment for impulsivity in a forensic psychiatric population with substance use disorder: study protocol of a randomized controlled trial combined with an N-of-1 clinical trial. JMIR Res Protoc, 2017, 6(1): e13.
16.	Kaplan HC, Opipari-Arrigan L, Schmid CH, et al. Evaluating the comparative effectiveness of two diets in pediatric inflammatory bowel disease: a study protocol for a series of N-of-1 trials. Healthcare (Basel), 2019, 7(4): 129.
17.	Stunnenberg BC, Woertman W, Raaphorst J, et al. Combined N-of-1 trials to investigate mexiletine in non-dystrophic myotonia using a Bayesian approach; study rationale and protocol. BMC Neurol, 2015, 15: 43.
18.	Alemayehu C, Mitchell G, Aseffa A, et al. A series of N-of-1 trials to assess the therapeutic interchangeability of two enalapril formulations in the treatment of hypertension in Addis Ababa, Ethiopia: study protocol for a randomized controlled trial. Trials, 2017, 18(1): 470.
19.	Senior HE, McKinlay L, Nikles J, et al. Central nervous system stimulants for secondary attention deficit-hyperactivity disorder after paediatric traumatic brain injury: a rationale and protocol for single patient (n-of-1) multiple cross-over trials. BMC Pediatr, 2013, 13: 89.
20.	Clanchy KM, Tweedy SM, Tate RL, et al. Evaluation of a novel intervention to improve physical activity for adults with whiplash associated disorders: Protocol for a multiple-baseline, single case experimental study. Contemp Clin Trials Commun, 2019, 16: 100455.
21.	Gimeno H, Polatajko HJ, Cornelius V, et al. Protocol for N-of-1 trials with replications across therapists for childhood-onset dystonia rehabilitation: Study 2: Protocole des essais à effectif unique avec répétitions par différents ergothérapeutes pour la réadaptation de la dystonie débutant dans l'enfance: Étude 2. Can J Occup Ther, 2018, 85(3): 255-260.
22.	Nikles J, O'Sullivan JD, Mitchell GK, et al. Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease. Contemp Clin Trials Commun, 2019, 15: 100397.
23.	Simons LE, Harrison LE, O'Brien SF, et al. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun, 2019, 16: 100448.
24.	Herrett E, Williamson E, Beaumont D, et al. Study protocol for statin web-based investigation of side effects (StatinWISE): a series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care. BMJ Open, 2017, 7(12): e016604.
25.	Punja S, Nikles CJ, Senior H, et al. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials, 2016, 17: 375.

1. 李幼平, 李静, 孙鑫, 等. 循证医学在中国的起源与发展: 献给中国循证医学20周年. 中国循证医学杂志, 2016, 16(1): 2-6.
2. 李江, 田金徽, 石菊芳, 等. 单病例随机对照试验的研究现状与进展. 兰州大学学报(医学版), 2016, 42(3): 52-56.
3. 李江, 田金徽, 杨克虎. 单病例随机对照试验研究现状. 中国循证儿科杂志, 2011, 6(6): 453-455.
4. 翟静波, 李江, 商洪才, 等. 贝叶斯单病例随机对照试验简介. 中国循证医学杂志, 2017, 17(7): 848-851.
5. Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
6. Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): Recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
7. 李江, 翟静波, 商洪才, 等. 单病例随机对照试验的证据级别和报告规范. 中国循证医学杂志, 2017, 17(5): 612-615.
8. Guyatt GH, Keller JL, Jaeschke R, et al. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern Med, 1990, 112(4): 293-299.
9. Porcino AJ, Shamseer L, Chan AW, et al. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ, 2020, 368: m122.
10. 赵晶晶, 龙泳, 刘学东. 2013临床试验方案规范指南(SPIRIT)及其解读. 中国循证儿科杂志, 2014, 9(5): 381-388.
11. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
12. Dai L, Cheng CW, Tian R, et al. Standard protocol items for clinical trials with traditional chinese medicine 2018: recommendations, explanation and elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med, 2019, 25(1): 71-79.
13. 陈新林, 黄海茵, 张长荣, 等. 2015版CENT声明简介: 单病例随机对照试验报告指南. 中国循证医学杂志, 2016, 16(7): 860-863.
14. 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.
15. Fielenbach S, Donkers FC, Spreen M, et al. Neurofeedback as a treatment for impulsivity in a forensic psychiatric population with substance use disorder: study protocol of a randomized controlled trial combined with an N-of-1 clinical trial. JMIR Res Protoc, 2017, 6(1): e13.
16. Kaplan HC, Opipari-Arrigan L, Schmid CH, et al. Evaluating the comparative effectiveness of two diets in pediatric inflammatory bowel disease: a study protocol for a series of N-of-1 trials. Healthcare (Basel), 2019, 7(4): 129.
17. Stunnenberg BC, Woertman W, Raaphorst J, et al. Combined N-of-1 trials to investigate mexiletine in non-dystrophic myotonia using a Bayesian approach; study rationale and protocol. BMC Neurol, 2015, 15: 43.
18. Alemayehu C, Mitchell G, Aseffa A, et al. A series of N-of-1 trials to assess the therapeutic interchangeability of two enalapril formulations in the treatment of hypertension in Addis Ababa, Ethiopia: study protocol for a randomized controlled trial. Trials, 2017, 18(1): 470.
19. Senior HE, McKinlay L, Nikles J, et al. Central nervous system stimulants for secondary attention deficit-hyperactivity disorder after paediatric traumatic brain injury: a rationale and protocol for single patient (n-of-1) multiple cross-over trials. BMC Pediatr, 2013, 13: 89.
20. Clanchy KM, Tweedy SM, Tate RL, et al. Evaluation of a novel intervention to improve physical activity for adults with whiplash associated disorders: Protocol for a multiple-baseline, single case experimental study. Contemp Clin Trials Commun, 2019, 16: 100455.
21. Gimeno H, Polatajko HJ, Cornelius V, et al. Protocol for N-of-1 trials with replications across therapists for childhood-onset dystonia rehabilitation: Study 2: Protocole des essais à effectif unique avec répétitions par différents ergothérapeutes pour la réadaptation de la dystonie débutant dans l'enfance: Étude 2. Can J Occup Ther, 2018, 85(3): 255-260.
22. Nikles J, O'Sullivan JD, Mitchell GK, et al. Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease. Contemp Clin Trials Commun, 2019, 15: 100397.
23. Simons LE, Harrison LE, O'Brien SF, et al. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun, 2019, 16: 100448.
24. Herrett E, Williamson E, Beaumont D, et al. Study protocol for statin web-based investigation of side effects (StatinWISE): a series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care. BMJ Open, 2017, 7(12): e016604.
25. Punja S, Nikles CJ, Senior H, et al. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials, 2016, 17: 375.

Chinese Journal of Evidence-Based Medicine

Interpretation of SPIRIT extension for N-of-1 trials (SPENT 2019)

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