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.	俞銀嬌.吸煙的危害與尼古丁替代療法.藥物不良反應雜志,2008,1(5):346-351.
2.	楊功煥.煙草對健康的危害及控煙策略.中國慢性病預防與控制,1999,7(3):97-99.
3.	中國疾病預防控制中心.衛生部2013年中國控制吸煙報告.2013.
4.	Herson J.The use of surrogate endpoints in clinical trials.Statistics in Medicine,1989,8(4):403-404.
5.	胡大一,項志敏.臨床醫學模式轉變一從經驗醫學到循證醫學.中國實用內科雜志,1998,18(11):688.
6.	David Moher,Sally Hopewell,Kenneth F Schulz,et al.CONSORT 2010說明與詳述:報告平行對照隨機臨床試驗指南的更新.中西醫結合學報,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.	劉清海,方積乾.醫學論文統計學報告水平評價量表的研制及其意義.編輯學報,2008,20(3):278-280.
13.	Weinberger AH,Reutenauer EL,Allen TM,et al.Reliability of the fagerstr?m 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.	康紀明,姜垣.被動吸煙暴露評價的常用方法.衛生研究,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.	常艷鵬,魏戌,謝雁鳴.臨床隨訪研究中存在的問題及對策.中醫雜志,2012,53(22):1913-1916.
21.	王明航,李建生,余學慶,等.慢性阻塞性肺疾病穩定期隨機對照臨床試驗的結局指標系統評價.中國老年學雜志,2011,31(6):1943-1947.
22.	22劉文貴.臨床病例的遠期隨訪方法.中國病案,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.	孫曉東,黃育北,王波,等.中國人群吸煙與胃癌發病關系的Meta分析.中國慢性病預防與控制,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.	楊揚,董燕萍.生存分析在臨床隨訪研究中的正確應用.中國醫藥指南,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. 俞銀嬌.吸煙的危害與尼古丁替代療法.藥物不良反應雜志,2008,1(5):346-351.
2. 楊功煥.煙草對健康的危害及控煙策略.中國慢性病預防與控制,1999,7(3):97-99.
3. 中國疾病預防控制中心.衛生部2013年中國控制吸煙報告.2013.
4. Herson J.The use of surrogate endpoints in clinical trials.Statistics in Medicine,1989,8(4):403-404.
5. 胡大一,項志敏.臨床醫學模式轉變一從經驗醫學到循證醫學.中國實用內科雜志,1998,18(11):688.
6. David Moher,Sally Hopewell,Kenneth F Schulz,et al.CONSORT 2010說明與詳述:報告平行對照隨機臨床試驗指南的更新.中西醫結合學報,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. 劉清海,方積乾.醫學論文統計學報告水平評價量表的研制及其意義.編輯學報,2008,20(3):278-280.
13. Weinberger AH,Reutenauer EL,Allen TM,et al.Reliability of the fagerstr?m 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. 康紀明,姜垣.被動吸煙暴露評價的常用方法.衛生研究,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. 常艷鵬,魏戌,謝雁鳴.臨床隨訪研究中存在的問題及對策.中醫雜志,2012,53(22):1913-1916.
21. 王明航,李建生,余學慶,等.慢性阻塞性肺疾病穩定期隨機對照臨床試驗的結局指標系統評價.中國老年學雜志,2011,31(6):1943-1947.
22. 22劉文貴.臨床病例的遠期隨訪方法.中國病案,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. 孫曉東,黃育北,王波,等.中國人群吸煙與胃癌發病關系的Meta分析.中國慢性病預防與控制,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. 楊揚,董燕萍.生存分析在臨床隨訪研究中的正確應用.中國醫藥指南,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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