Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence
<p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimat...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Prevost A Toby [verfasserIn] Wright Alison J [verfasserIn] Johnstone Elaine C [verfasserIn] Hollands Gareth J [verfasserIn] Crockett Rachel A [verfasserIn] Willis Thomas A [verfasserIn] Whitwell Sophia [verfasserIn] Hill Chloe [verfasserIn] Aveyard Paul [verfasserIn] Munafò Marcus R [verfasserIn] Marteau Theresa M [verfasserIn] Armstrong David [verfasserIn] Sutton Stephen [verfasserIn] Kinmonth Ann [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2010 |
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| Übergeordnetes Werk: |
In: BMC Public Health - BMC, 2003, 10(2010), 1, p 680 |
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| Übergeordnetes Werk: |
volume:10 ; year:2010 ; number:1, p 680 |
| Links: |
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| DOI / URN: |
10.1186/1471-2458-10-680 |
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| Katalog-ID: |
DOAJ025171054 |
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| 520 | |a <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< | ||
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10.1186/1471-2458-10-680 doi (DE-627)DOAJ025171054 (DE-599)DOAJ23a2c27996ac49399bda445febeffddd DE-627 ger DE-627 rakwb eng RA1-1270 Prevost A Toby verfasserin aut Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< Public aspects of medicine Wright Alison J verfasserin aut Johnstone Elaine C verfasserin aut Hollands Gareth J verfasserin aut Crockett Rachel A verfasserin aut Willis Thomas A verfasserin aut Whitwell Sophia verfasserin aut Hill Chloe verfasserin aut Aveyard Paul verfasserin aut Munafò Marcus R verfasserin aut Marteau Theresa M verfasserin aut Armstrong David verfasserin aut Sutton Stephen verfasserin aut Kinmonth Ann verfasserin aut In BMC Public Health BMC, 2003 10(2010), 1, p 680 (DE-627)326643583 (DE-600)2041338-5 14712458 nnns volume:10 year:2010 number:1, p 680 https://doi.org/10.1186/1471-2458-10-680 kostenfrei https://doaj.org/article/23a2c27996ac49399bda445febeffddd kostenfrei http://www.biomedcentral.com/1471-2458/10/680 kostenfrei https://doaj.org/toc/1471-2458 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1, p 680 |
| spelling |
10.1186/1471-2458-10-680 doi (DE-627)DOAJ025171054 (DE-599)DOAJ23a2c27996ac49399bda445febeffddd DE-627 ger DE-627 rakwb eng RA1-1270 Prevost A Toby verfasserin aut Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< Public aspects of medicine Wright Alison J verfasserin aut Johnstone Elaine C verfasserin aut Hollands Gareth J verfasserin aut Crockett Rachel A verfasserin aut Willis Thomas A verfasserin aut Whitwell Sophia verfasserin aut Hill Chloe verfasserin aut Aveyard Paul verfasserin aut Munafò Marcus R verfasserin aut Marteau Theresa M verfasserin aut Armstrong David verfasserin aut Sutton Stephen verfasserin aut Kinmonth Ann verfasserin aut In BMC Public Health BMC, 2003 10(2010), 1, p 680 (DE-627)326643583 (DE-600)2041338-5 14712458 nnns volume:10 year:2010 number:1, p 680 https://doi.org/10.1186/1471-2458-10-680 kostenfrei https://doaj.org/article/23a2c27996ac49399bda445febeffddd kostenfrei http://www.biomedcentral.com/1471-2458/10/680 kostenfrei https://doaj.org/toc/1471-2458 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1, p 680 |
| allfields_unstemmed |
10.1186/1471-2458-10-680 doi (DE-627)DOAJ025171054 (DE-599)DOAJ23a2c27996ac49399bda445febeffddd DE-627 ger DE-627 rakwb eng RA1-1270 Prevost A Toby verfasserin aut Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< Public aspects of medicine Wright Alison J verfasserin aut Johnstone Elaine C verfasserin aut Hollands Gareth J verfasserin aut Crockett Rachel A verfasserin aut Willis Thomas A verfasserin aut Whitwell Sophia verfasserin aut Hill Chloe verfasserin aut Aveyard Paul verfasserin aut Munafò Marcus R verfasserin aut Marteau Theresa M verfasserin aut Armstrong David verfasserin aut Sutton Stephen verfasserin aut Kinmonth Ann verfasserin aut In BMC Public Health BMC, 2003 10(2010), 1, p 680 (DE-627)326643583 (DE-600)2041338-5 14712458 nnns volume:10 year:2010 number:1, p 680 https://doi.org/10.1186/1471-2458-10-680 kostenfrei https://doaj.org/article/23a2c27996ac49399bda445febeffddd kostenfrei http://www.biomedcentral.com/1471-2458/10/680 kostenfrei https://doaj.org/toc/1471-2458 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1, p 680 |
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10.1186/1471-2458-10-680 doi (DE-627)DOAJ025171054 (DE-599)DOAJ23a2c27996ac49399bda445febeffddd DE-627 ger DE-627 rakwb eng RA1-1270 Prevost A Toby verfasserin aut Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< Public aspects of medicine Wright Alison J verfasserin aut Johnstone Elaine C verfasserin aut Hollands Gareth J verfasserin aut Crockett Rachel A verfasserin aut Willis Thomas A verfasserin aut Whitwell Sophia verfasserin aut Hill Chloe verfasserin aut Aveyard Paul verfasserin aut Munafò Marcus R verfasserin aut Marteau Theresa M verfasserin aut Armstrong David verfasserin aut Sutton Stephen verfasserin aut Kinmonth Ann verfasserin aut In BMC Public Health BMC, 2003 10(2010), 1, p 680 (DE-627)326643583 (DE-600)2041338-5 14712458 nnns volume:10 year:2010 number:1, p 680 https://doi.org/10.1186/1471-2458-10-680 kostenfrei https://doaj.org/article/23a2c27996ac49399bda445febeffddd kostenfrei http://www.biomedcentral.com/1471-2458/10/680 kostenfrei https://doaj.org/toc/1471-2458 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1, p 680 |
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10.1186/1471-2458-10-680 doi (DE-627)DOAJ025171054 (DE-599)DOAJ23a2c27996ac49399bda445febeffddd DE-627 ger DE-627 rakwb eng RA1-1270 Prevost A Toby verfasserin aut Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< Public aspects of medicine Wright Alison J verfasserin aut Johnstone Elaine C verfasserin aut Hollands Gareth J verfasserin aut Crockett Rachel A verfasserin aut Willis Thomas A verfasserin aut Whitwell Sophia verfasserin aut Hill Chloe verfasserin aut Aveyard Paul verfasserin aut Munafò Marcus R verfasserin aut Marteau Theresa M verfasserin aut Armstrong David verfasserin aut Sutton Stephen verfasserin aut Kinmonth Ann verfasserin aut In BMC Public Health BMC, 2003 10(2010), 1, p 680 (DE-627)326643583 (DE-600)2041338-5 14712458 nnns volume:10 year:2010 number:1, p 680 https://doi.org/10.1186/1471-2458-10-680 kostenfrei https://doaj.org/article/23a2c27996ac49399bda445febeffddd kostenfrei http://www.biomedcentral.com/1471-2458/10/680 kostenfrei https://doaj.org/toc/1471-2458 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1, p 680 |
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The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. 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<p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< |
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<p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< |
| abstract_unstemmed |
<p<Abstract</p< <p<Background</p< <p<The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:</p< <p indent="1"<IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).</p< <p indent="1"<II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.</p< <p<Methods/Design</p< <p<An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:</p< <p indent="1"<i. NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.</p< <p<Trial details</p< <p<Funder: Medical Research Council (MRC)</p< <p<Grant number: G0500274</p< <p<ISRCTN: 14352545</p< <p<Date trial stated: June 2007</p< <p<Expected end date: December 2009</p< <p<Expected reporting date: December 2010</p< |
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NRT oral dose tailored by DNA analysis (<it<OPRM1 </it<gene) (genotype), or</p< <p indent="1"<ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)</p< <p<The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples <it<t</it<-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).</p< <p<Discussion</p< <p<This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. 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