The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial

Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative an...
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Autor*in:	Piaggio, Gilda [verfasserIn] Elbourne, Diana Schulz, Kenneth F Villar, José Pinol, Alain PY Gülmezoglu, A Metin

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2003

Schlagwörter:	clinical trials reporting randomisation allocation concealment blinding misoprostol selection bias ascertainment bias equivalence trial developing countries

Anmerkung:	© Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.

Übergeordnetes Werk:	Enthalten in: BMC medical research methodology - London : BioMed Central, 2001, 3(2003), 1 vom: 03. Okt.
Übergeordnetes Werk:	volume:3 ; year:2003 ; number:1 ; day:03 ; month:10

Links:	Volltext

DOI / URN:	10.1186/1471-2288-3-19

Katalog-ID:	SPR027357929

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520			\|a Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future.
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allfields	10.1186/1471-2288-3-19 doi (DE-627)SPR027357929 (SPR)1471-2288-3-19-e DE-627 ger DE-627 rakwb eng Piaggio, Gilda verfasserin aut The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL. Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213 Elbourne, Diana aut Schulz, Kenneth F aut Villar, José aut Pinol, Alain PY aut Gülmezoglu, A Metin aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 3(2003), 1 vom: 03. Okt. (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:3 year:2003 number:1 day:03 month:10 https://dx.doi.org/10.1186/1471-2288-3-19 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_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 3 2003 1 03 10
spelling	10.1186/1471-2288-3-19 doi (DE-627)SPR027357929 (SPR)1471-2288-3-19-e DE-627 ger DE-627 rakwb eng Piaggio, Gilda verfasserin aut The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL. Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213 Elbourne, Diana aut Schulz, Kenneth F aut Villar, José aut Pinol, Alain PY aut Gülmezoglu, A Metin aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 3(2003), 1 vom: 03. Okt. (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:3 year:2003 number:1 day:03 month:10 https://dx.doi.org/10.1186/1471-2288-3-19 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_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 3 2003 1 03 10
allfields_unstemmed	10.1186/1471-2288-3-19 doi (DE-627)SPR027357929 (SPR)1471-2288-3-19-e DE-627 ger DE-627 rakwb eng Piaggio, Gilda verfasserin aut The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL. Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213 Elbourne, Diana aut Schulz, Kenneth F aut Villar, José aut Pinol, Alain PY aut Gülmezoglu, A Metin aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 3(2003), 1 vom: 03. Okt. (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:3 year:2003 number:1 day:03 month:10 https://dx.doi.org/10.1186/1471-2288-3-19 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_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 3 2003 1 03 10
allfieldsGer	10.1186/1471-2288-3-19 doi (DE-627)SPR027357929 (SPR)1471-2288-3-19-e DE-627 ger DE-627 rakwb eng Piaggio, Gilda verfasserin aut The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL. Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213 Elbourne, Diana aut Schulz, Kenneth F aut Villar, José aut Pinol, Alain PY aut Gülmezoglu, A Metin aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 3(2003), 1 vom: 03. Okt. (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:3 year:2003 number:1 day:03 month:10 https://dx.doi.org/10.1186/1471-2288-3-19 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_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 3 2003 1 03 10
allfieldsSound	10.1186/1471-2288-3-19 doi (DE-627)SPR027357929 (SPR)1471-2288-3-19-e DE-627 ger DE-627 rakwb eng Piaggio, Gilda verfasserin aut The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL. Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213 Elbourne, Diana aut Schulz, Kenneth F aut Villar, José aut Pinol, Alain PY aut Gülmezoglu, A Metin aut Enthalten in BMC medical research methodology London : BioMed Central, 2001 3(2003), 1 vom: 03. Okt. (DE-627)326643818 (DE-600)2041362-2 1471-2288 nnns volume:3 year:2003 number:1 day:03 month:10 https://dx.doi.org/10.1186/1471-2288-3-19 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_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 3 2003 1 03 10
language	English
source	Enthalten in BMC medical research methodology 3(2003), 1 vom: 03. Okt. volume:3 year:2003 number:1 day:03 month:10
sourceStr	Enthalten in BMC medical research methodology 3(2003), 1 vom: 03. Okt. volume:3 year:2003 number:1 day:03 month:10
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	clinical trials reporting randomisation allocation concealment blinding misoprostol selection bias ascertainment bias equivalence trial developing countries
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container_title	BMC medical research methodology
authorswithroles_txt_mv	Piaggio, Gilda @@aut@@ Elbourne, Diana @@aut@@ Schulz, Kenneth F @@aut@@ Villar, José @@aut@@ Pinol, Alain PY @@aut@@ Gülmezoglu, A Metin @@aut@@
publishDateDaySort_date	2003-10-03T00:00:00Z
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author	Piaggio, Gilda
spellingShingle	Piaggio, Gilda misc clinical trials misc reporting misc randomisation misc allocation concealment misc blinding misc misoprostol misc selection bias misc ascertainment bias misc equivalence trial misc developing countries The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial
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topic_title	The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial clinical trials (dpeaa)DE-He213 reporting (dpeaa)DE-He213 randomisation (dpeaa)DE-He213 allocation concealment (dpeaa)DE-He213 blinding (dpeaa)DE-He213 misoprostol (dpeaa)DE-He213 selection bias (dpeaa)DE-He213 ascertainment bias (dpeaa)DE-He213 equivalence trial (dpeaa)DE-He213 developing countries (dpeaa)DE-He213
topic	misc clinical trials misc reporting misc randomisation misc allocation concealment misc blinding misc misoprostol misc selection bias misc ascertainment bias misc equivalence trial misc developing countries
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title	The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial
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title_sort	reporting of methods for reducing and detecting bias: an example from the who misoprostol third stage of labour equivalence randomised controlled trial
title_auth	The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial
abstract	Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
abstractGer	Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
abstract_unstemmed	Background The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. Methods We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. Results The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. Conclusions Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future. © Piaggio et al; licensee BioMed Central Ltd. 2003. This article is published under license to BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
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title_short	The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial
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The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial

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