Literature Analysis of the Reporting of Outcome Measurements in Randomized Controlled Trials of Smoking Cessation_Chinese Journal of Evidence-Based Medicine

Authors：

 LIUZhao , WUYuan , YANGJin-sheng , QIShu-lan ,  WANGYing-ying

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China;

Corresponding author：

WANGYing-ying, Email: zml@ibucm.com

Keywords：

Smoking cessation; Outcome measurement; Randomized controlled trial

DOI：

10.7507/1672-2531.20150121

Video：

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Objective Through the analysis on outcome measurements in domestic and overseas randomized controlled trials (RCTs) of smoking cessation, this study aimed to provide references for clinical trial design in the future. Methods We searched CNKI, WanFang Data, VIP, PubMed, EMbase, ScienceDirect and SpringLink databases to collect RCTs regarding smoking cessation from January 1998 to December 2013. Two reviewers screened literature according to the inclusive and exclusive criteria, extracted the data, and analyzed the outcome measurements of included RCTs. Results A total of 68 RCTs regarding smoking cessation were included. As for the baseline measurements, the frequency from high to low were age, sex, daily cigarette, smoking duration, Fagerstrom Test For Nicotine Dependence (FTND), race and education, etc.; there were significant differences of race, education level, smoking duration, smoking, starting age of smoking, attempts of trying to stop smoking, the presence of other basic disease, FTND and quit date between English and Chinese RCTs (all P<0.05). As for efficacy measurements, the continuous abstinence rate (77.8%) was mainly adopted in Chinese RCTs, while point abstinence rate (95.1%) and continuous abstinence rate (82.9%) was selected in English RCTs. As for the follow-up measurements, 22.1% of the included RCTs did not report it, 70.6% of the RCTs reported abstinence rate, and the follow-up time in Chinese RCTs was shorter than that in the English RCTs (P<0.05). Conclusion The selection of outcome measurements is significantly different among RCTs regarding smoking cessation, the Chinese RCTs are inferior to English RCTs, and these are needed to be improved in the future clinical trials.

Citation： LIUZhao, WUYuan, YANGJin-sheng, QIShu-lan, WANGYing-ying. Literature Analysis of the Reporting of Outcome Measurements in Randomized Controlled Trials of Smoking Cessation. Chinese Journal of Evidence-Based Medicine, 2015, 15(6): 730-734. doi: 10.7507/1672-2531.20150121 Copy

1.	俞银娇.吸烟的危害与尼古丁替代疗法.药物不良反应杂志,2008,1(5):346-351.
2.	杨功焕.烟草对健康的危害及控烟策略.中国慢性病预防与控制,1999,7(3):97-99.
3.	中国疾病预防控制中心.卫生部2013年中国控制吸烟报告.2013.
4.	Herson J.The use of surrogate endpoints in clinical trials.Statistics in Medicine,1989,8(4):403-404.
5.	胡大一,项志敏.临床医学模式转变一从经验医学到循证医学.中国实用内科杂志,1998,18(11):688.
6.	David Moher,Sally Hopewell,Kenneth F Schulz,et al.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):701-738.
7.	Castaldelli-Maia JM,Carvalho CF,Armentano F,et al.Outcome predictors of smoking cessation treatment provided by an addiction care unit between 2007 and 2010.Rev Bras Psiquiatr,2013,35(4):338-46.
8.	Sargent JD,Mott LA,Stevens M.Predictors of smoking cessation in adolescents.Arch PediatrAdolesc Med,1998,152(4):388-393.
9.	David K,Randall H,Usha S,et al.A prospective study of persistence in the prediction of smoking cessation outcome:Results from a randomized clinical trial.Addictive Behaviors,2010,35(2):179-182.
10.	Harris KJ,Okuyemi KS,Catley D,et al.Predictors of smoking cessation among African-Americans enrolled in a randomized controlled trial of bupropion.Prev Med,2004,38(4):498-502.
11.	Robinson SM.,Sobell LC,Sobell MB.Alcohol and drug treatment outcome studies:new methodological review (2005-2010) and comparison with past reviews.Addictive Behaviors,2014,39(1):39-47.
12.	刘清海,方积乾.医学论文统计学报告水平评价量表的研制及其意义.编辑学报,2008,20(3):278-280.
13.	Weinberger AH,Reutenauer EL,Allen TM,et al.Reliability of the fagerström test for nicotine dependence,minnesota nicotine withdrawal scale,and tiffany questionnaire for smoking urges in smokers with and without schizophrenia.Drug Alcohol Depend,2007,86(2):278-282.
14.	康纪明,姜垣.被动吸烟暴露评价的常用方法.卫生研究,2006,36(6):781-784.
15.	Velicer WF,Prochaska JO,Rossi JS,et al.Assessing outcome in smoking cessation studies.Psychol Bull,1992,111(1):23-41.
16.	Hughes JR.,Keely JP,Niaura RS,et al.Measures of abstinence in clinical trials:issues and Recommendations.Nicotine&Tobacco Research,2003,5(1):13-25.
17.	Gutmann LB,Sobell LC,Prevo MH,et al.Outcome research methodology of smoking cessation trials (1994-1998).Addictive Behaviors,2004,29(3):441-463.
18.	Velicer WF,Prochaska JO.A comparison of four self-report smoking cessation outcome measures.Addictive Behaviors,2004,29(1):51-60.
19.	Kenford SL,Fiore MC,Jorenby DE,et al.Predicting smoking cessation:Who will quit with and without the nicotine patch.JAMA,1994,271(8):589-594.
20.	常艳鹏,魏戌,谢雁鸣.临床随访研究中存在的问题及对策.中医杂志,2012,53(22):1913-1916.
21.	王明航,李建生,余学庆,等.慢性阻塞性肺疾病稳定期随机对照临床试验的结局指标系统评价.中国老年学杂志,2011,31(6):1943-1947.
22.	22刘文贵.临床病例的远期随访方法.中国病案,2011,12(6):5-6.
23.	Berlin I,Singleton EG,Heishman SJ.Predicting smoking relapse with a multidimensional versus asingle-item tobacco craving measure.Drug Alcohol Depend,2013,132(3):513-20.
24.	孙晓东,黄育北,王波,等.中国人群吸烟与胃癌发病关系的Meta分析.中国慢性病预防与控制,2009,17(3):247-250.
25.	Heishman SJ,Kleykamp BA,Singleton EG.Meta-analysis of the acute effects of nicotine and smoking on human performance.Psychopharmacology (Berl),2010,210(4):453-469.
26.	Giles EL,Robalino S,McColl E,et al.The effectiveness of financial incentives for health behaviour change:systematic review and meta-analysis.PLoS One,2014,9(3):684-688.
27.	杨扬,董燕萍.生存分析在临床随访研究中的正确应用.中国医药指南,2012,10(23):447-448.
28.	Koehler KJ,McGovern PG.An application of the LFP survival model to smoking cessation data.Statistics in Medicine,1990,9(4):409-421.

1. 俞银娇.吸烟的危害与尼古丁替代疗法.药物不良反应杂志,2008,1(5):346-351.
2. 杨功焕.烟草对健康的危害及控烟策略.中国慢性病预防与控制,1999,7(3):97-99.
3. 中国疾病预防控制中心.卫生部2013年中国控制吸烟报告.2013.
4. Herson J.The use of surrogate endpoints in clinical trials.Statistics in Medicine,1989,8(4):403-404.
5. 胡大一,项志敏.临床医学模式转变一从经验医学到循证医学.中国实用内科杂志,1998,18(11):688.
6. David Moher,Sally Hopewell,Kenneth F Schulz,et al.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):701-738.
7. Castaldelli-Maia JM,Carvalho CF,Armentano F,et al.Outcome predictors of smoking cessation treatment provided by an addiction care unit between 2007 and 2010.Rev Bras Psiquiatr,2013,35(4):338-46.
8. Sargent JD,Mott LA,Stevens M.Predictors of smoking cessation in adolescents.Arch PediatrAdolesc Med,1998,152(4):388-393.
9. David K,Randall H,Usha S,et al.A prospective study of persistence in the prediction of smoking cessation outcome:Results from a randomized clinical trial.Addictive Behaviors,2010,35(2):179-182.
10. Harris KJ,Okuyemi KS,Catley D,et al.Predictors of smoking cessation among African-Americans enrolled in a randomized controlled trial of bupropion.Prev Med,2004,38(4):498-502.
11. Robinson SM.,Sobell LC,Sobell MB.Alcohol and drug treatment outcome studies:new methodological review (2005-2010) and comparison with past reviews.Addictive Behaviors,2014,39(1):39-47.
12. 刘清海,方积乾.医学论文统计学报告水平评价量表的研制及其意义.编辑学报,2008,20(3):278-280.
13. Weinberger AH,Reutenauer EL,Allen TM,et al.Reliability of the fagerström test for nicotine dependence,minnesota nicotine withdrawal scale,and tiffany questionnaire for smoking urges in smokers with and without schizophrenia.Drug Alcohol Depend,2007,86(2):278-282.
14. 康纪明,姜垣.被动吸烟暴露评价的常用方法.卫生研究,2006,36(6):781-784.
15. Velicer WF,Prochaska JO,Rossi JS,et al.Assessing outcome in smoking cessation studies.Psychol Bull,1992,111(1):23-41.
16. Hughes JR.,Keely JP,Niaura RS,et al.Measures of abstinence in clinical trials:issues and Recommendations.Nicotine&Tobacco Research,2003,5(1):13-25.
17. Gutmann LB,Sobell LC,Prevo MH,et al.Outcome research methodology of smoking cessation trials (1994-1998).Addictive Behaviors,2004,29(3):441-463.
18. Velicer WF,Prochaska JO.A comparison of four self-report smoking cessation outcome measures.Addictive Behaviors,2004,29(1):51-60.
19. Kenford SL,Fiore MC,Jorenby DE,et al.Predicting smoking cessation:Who will quit with and without the nicotine patch.JAMA,1994,271(8):589-594.
20. 常艳鹏,魏戌,谢雁鸣.临床随访研究中存在的问题及对策.中医杂志,2012,53(22):1913-1916.
21. 王明航,李建生,余学庆,等.慢性阻塞性肺疾病稳定期随机对照临床试验的结局指标系统评价.中国老年学杂志,2011,31(6):1943-1947.
22. 22刘文贵.临床病例的远期随访方法.中国病案,2011,12(6):5-6.
23. Berlin I,Singleton EG,Heishman SJ.Predicting smoking relapse with a multidimensional versus asingle-item tobacco craving measure.Drug Alcohol Depend,2013,132(3):513-20.
24. 孙晓东,黄育北,王波,等.中国人群吸烟与胃癌发病关系的Meta分析.中国慢性病预防与控制,2009,17(3):247-250.
25. Heishman SJ,Kleykamp BA,Singleton EG.Meta-analysis of the acute effects of nicotine and smoking on human performance.Psychopharmacology (Berl),2010,210(4):453-469.
26. Giles EL,Robalino S,McColl E,et al.The effectiveness of financial incentives for health behaviour change:systematic review and meta-analysis.PLoS One,2014,9(3):684-688.
27. 杨扬,董燕萍.生存分析在临床随访研究中的正确应用.中国医药指南,2012,10(23):447-448.
28. Koehler KJ,McGovern PG.An application of the LFP survival model to smoking cessation data.Statistics in Medicine,1990,9(4):409-421.

Chinese Journal of Evidence-Based Medicine

Literature Analysis of the Reporting of Outcome Measurements in Randomized Controlled Trials of Smoking Cessation

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