How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial

<p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being t...
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Autor*in:	Selby Peter [verfasserIn] Brosky Gerald [verfasserIn] Oh Paul I [verfasserIn] Raymond Vincent [verfasserIn] Ranger Suzanne [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2012

Schlagwörter:	Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy

Übergeordnetes Werk:	In: BMC Medical Research Methodology - BMC, 2003, 12(2012), 1, p 101
Übergeordnetes Werk:	volume:12 ; year:2012 ; number:1, p 101

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/1471-2288-12-101

Katalog-ID:	DOAJ065884272

Internformat


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spelling	10.1186/1471-2288-12-101 doi (DE-627)DOAJ065884272 (DE-599)DOAJcbf2f96e714d49209e8bce774a1a4f42 DE-627 ger DE-627 rakwb eng R5-920 Selby Peter verfasserin aut How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p< Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy Medicine (General) Brosky Gerald verfasserin aut Oh Paul I verfasserin aut Raymond Vincent verfasserin aut Ranger Suzanne verfasserin aut In BMC Medical Research Methodology BMC, 2003 12(2012), 1, p 101 (DE-627)326643818 (DE-600)2041362-2 14712288 nnns volume:12 year:2012 number:1, p 101 https://doi.org/10.1186/1471-2288-12-101 kostenfrei https://doaj.org/article/cbf2f96e714d49209e8bce774a1a4f42 kostenfrei http://www.biomedcentral.com/1471-2288/12/101 kostenfrei https://doaj.org/toc/1471-2288 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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_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 12 2012 1, p 101
allfields_unstemmed	10.1186/1471-2288-12-101 doi (DE-627)DOAJ065884272 (DE-599)DOAJcbf2f96e714d49209e8bce774a1a4f42 DE-627 ger DE-627 rakwb eng R5-920 Selby Peter verfasserin aut How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p< Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy Medicine (General) Brosky Gerald verfasserin aut Oh Paul I verfasserin aut Raymond Vincent verfasserin aut Ranger Suzanne verfasserin aut In BMC Medical Research Methodology BMC, 2003 12(2012), 1, p 101 (DE-627)326643818 (DE-600)2041362-2 14712288 nnns volume:12 year:2012 number:1, p 101 https://doi.org/10.1186/1471-2288-12-101 kostenfrei https://doaj.org/article/cbf2f96e714d49209e8bce774a1a4f42 kostenfrei http://www.biomedcentral.com/1471-2288/12/101 kostenfrei https://doaj.org/toc/1471-2288 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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_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 12 2012 1, p 101
allfieldsGer	10.1186/1471-2288-12-101 doi (DE-627)DOAJ065884272 (DE-599)DOAJcbf2f96e714d49209e8bce774a1a4f42 DE-627 ger DE-627 rakwb eng R5-920 Selby Peter verfasserin aut How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p< Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy Medicine (General) Brosky Gerald verfasserin aut Oh Paul I verfasserin aut Raymond Vincent verfasserin aut Ranger Suzanne verfasserin aut In BMC Medical Research Methodology BMC, 2003 12(2012), 1, p 101 (DE-627)326643818 (DE-600)2041362-2 14712288 nnns volume:12 year:2012 number:1, p 101 https://doi.org/10.1186/1471-2288-12-101 kostenfrei https://doaj.org/article/cbf2f96e714d49209e8bce774a1a4f42 kostenfrei http://www.biomedcentral.com/1471-2288/12/101 kostenfrei https://doaj.org/toc/1471-2288 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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_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 12 2012 1, p 101
allfieldsSound	10.1186/1471-2288-12-101 doi (DE-627)DOAJ065884272 (DE-599)DOAJcbf2f96e714d49209e8bce774a1a4f42 DE-627 ger DE-627 rakwb eng R5-920 Selby Peter verfasserin aut How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p< Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy Medicine (General) Brosky Gerald verfasserin aut Oh Paul I verfasserin aut Raymond Vincent verfasserin aut Ranger Suzanne verfasserin aut In BMC Medical Research Methodology BMC, 2003 12(2012), 1, p 101 (DE-627)326643818 (DE-600)2041362-2 14712288 nnns volume:12 year:2012 number:1, p 101 https://doi.org/10.1186/1471-2288-12-101 kostenfrei https://doaj.org/article/cbf2f96e714d49209e8bce774a1a4f42 kostenfrei http://www.biomedcentral.com/1471-2288/12/101 kostenfrei https://doaj.org/toc/1471-2288 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_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_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 12 2012 1, p 101
language	English
source	In BMC Medical Research Methodology 12(2012), 1, p 101 volume:12 year:2012 number:1, p 101
sourceStr	In BMC Medical Research Methodology 12(2012), 1, p 101 volume:12 year:2012 number:1, p 101
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy Medicine (General)
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container_title	BMC Medical Research Methodology
authorswithroles_txt_mv	Selby Peter @@aut@@ Brosky Gerald @@aut@@ Oh Paul I @@aut@@ Raymond Vincent @@aut@@ Ranger Suzanne @@aut@@
publishDateDaySort_date	2012-01-01T00:00:00Z
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callnumber-first	R - Medicine
author	Selby Peter
spellingShingle	Selby Peter misc R5-920 misc Clinical trial misc Explanatory misc Pragmatic misc Smoking cessation misc PRECIS misc Varenicline misc Bupropion misc Nicotine replacement therapy misc Medicine (General) How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial
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topic_title	R5-920 How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial Clinical trial Explanatory Pragmatic Smoking cessation PRECIS Varenicline Bupropion Nicotine replacement therapy
topic	misc R5-920 misc Clinical trial misc Explanatory misc Pragmatic misc Smoking cessation misc PRECIS misc Varenicline misc Bupropion misc Nicotine replacement therapy misc Medicine (General)
topic_unstemmed	misc R5-920 misc Clinical trial misc Explanatory misc Pragmatic misc Smoking cessation misc PRECIS misc Varenicline misc Bupropion misc Nicotine replacement therapy misc Medicine (General)
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title	How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial
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title_full	How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial
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title_sort	how pragmatic or explanatory is the randomized, controlled trial? the application and enhancement of the precis tool to the evaluation of a smoking cessation trial
callnumber	R5-920
title_auth	How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial
abstract	<p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p<
abstractGer	<p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p<
abstract_unstemmed	<p<Abstract</p< <p<Background</p< <p<Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.</p< <p<Methods</p< <p<We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS)’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.</p< <p<Results</p< <p<After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.</p< <p<Conclusions</p< <p<This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.</p<
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title_short	How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial
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How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial

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