Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis
Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and...
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| Autor*in: |
Fu, Yu [verfasserIn] Persson, Monica S. M. [verfasserIn] Bhattacharya, Archan [verfasserIn] Goh, Siew-Li [verfasserIn] Stocks, Joanne [verfasserIn] van Middelkoop, Marienke [verfasserIn] Bierma-Zeinstra, Sita M. A. [verfasserIn] Walsh, David [verfasserIn] Doherty, Michael [verfasserIn] Zhang, Weiya [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2016 |
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| Übergeordnetes Werk: |
Enthalten in: Systematic Reviews - London : Biomed Central, 2012, 5(2016), 1 vom: 28. Okt. |
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| Übergeordnetes Werk: |
volume:5 ; year:2016 ; number:1 ; day:28 ; month:10 |
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| DOI / URN: |
10.1186/s13643-016-0362-x |
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| Katalog-ID: |
SPR032638752 |
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| 520 | |a Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 | ||
| 650 | 4 | |a Osteoarthritis |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Placebo response |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Individual patient data meta-analysis |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Persson, Monica S. M. |e verfasserin |4 aut | |
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| 700 | 1 | |a Doherty, Michael |e verfasserin |4 aut | |
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10.1186/s13643-016-0362-x doi (DE-627)SPR032638752 (SPR)s13643-016-0362-x-e DE-627 ger DE-627 rakwb eng 610 ASE Fu, Yu verfasserin aut Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 Osteoarthritis (dpeaa)DE-He213 Placebo response (dpeaa)DE-He213 Individual patient data meta-analysis (dpeaa)DE-He213 Persson, Monica S. M. verfasserin aut Bhattacharya, Archan verfasserin aut Goh, Siew-Li verfasserin aut Stocks, Joanne verfasserin aut van Middelkoop, Marienke verfasserin aut Bierma-Zeinstra, Sita M. A. verfasserin aut Walsh, David verfasserin aut Doherty, Michael verfasserin aut Zhang, Weiya verfasserin aut Enthalten in Systematic Reviews London : Biomed Central, 2012 5(2016), 1 vom: 28. Okt. (DE-627)718627210 (DE-600)2662257-9 2046-4053 nnns volume:5 year:2016 number:1 day:28 month:10 https://dx.doi.org/10.1186/s13643-016-0362-x 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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 5 2016 1 28 10 |
| spelling |
10.1186/s13643-016-0362-x doi (DE-627)SPR032638752 (SPR)s13643-016-0362-x-e DE-627 ger DE-627 rakwb eng 610 ASE Fu, Yu verfasserin aut Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 Osteoarthritis (dpeaa)DE-He213 Placebo response (dpeaa)DE-He213 Individual patient data meta-analysis (dpeaa)DE-He213 Persson, Monica S. M. verfasserin aut Bhattacharya, Archan verfasserin aut Goh, Siew-Li verfasserin aut Stocks, Joanne verfasserin aut van Middelkoop, Marienke verfasserin aut Bierma-Zeinstra, Sita M. A. verfasserin aut Walsh, David verfasserin aut Doherty, Michael verfasserin aut Zhang, Weiya verfasserin aut Enthalten in Systematic Reviews London : Biomed Central, 2012 5(2016), 1 vom: 28. Okt. (DE-627)718627210 (DE-600)2662257-9 2046-4053 nnns volume:5 year:2016 number:1 day:28 month:10 https://dx.doi.org/10.1186/s13643-016-0362-x 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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 5 2016 1 28 10 |
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10.1186/s13643-016-0362-x doi (DE-627)SPR032638752 (SPR)s13643-016-0362-x-e DE-627 ger DE-627 rakwb eng 610 ASE Fu, Yu verfasserin aut Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 Osteoarthritis (dpeaa)DE-He213 Placebo response (dpeaa)DE-He213 Individual patient data meta-analysis (dpeaa)DE-He213 Persson, Monica S. M. verfasserin aut Bhattacharya, Archan verfasserin aut Goh, Siew-Li verfasserin aut Stocks, Joanne verfasserin aut van Middelkoop, Marienke verfasserin aut Bierma-Zeinstra, Sita M. A. verfasserin aut Walsh, David verfasserin aut Doherty, Michael verfasserin aut Zhang, Weiya verfasserin aut Enthalten in Systematic Reviews London : Biomed Central, 2012 5(2016), 1 vom: 28. Okt. (DE-627)718627210 (DE-600)2662257-9 2046-4053 nnns volume:5 year:2016 number:1 day:28 month:10 https://dx.doi.org/10.1186/s13643-016-0362-x 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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 5 2016 1 28 10 |
| allfieldsGer |
10.1186/s13643-016-0362-x doi (DE-627)SPR032638752 (SPR)s13643-016-0362-x-e DE-627 ger DE-627 rakwb eng 610 ASE Fu, Yu verfasserin aut Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 Osteoarthritis (dpeaa)DE-He213 Placebo response (dpeaa)DE-He213 Individual patient data meta-analysis (dpeaa)DE-He213 Persson, Monica S. M. verfasserin aut Bhattacharya, Archan verfasserin aut Goh, Siew-Li verfasserin aut Stocks, Joanne verfasserin aut van Middelkoop, Marienke verfasserin aut Bierma-Zeinstra, Sita M. A. verfasserin aut Walsh, David verfasserin aut Doherty, Michael verfasserin aut Zhang, Weiya verfasserin aut Enthalten in Systematic Reviews London : Biomed Central, 2012 5(2016), 1 vom: 28. Okt. (DE-627)718627210 (DE-600)2662257-9 2046-4053 nnns volume:5 year:2016 number:1 day:28 month:10 https://dx.doi.org/10.1186/s13643-016-0362-x 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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 5 2016 1 28 10 |
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10.1186/s13643-016-0362-x doi (DE-627)SPR032638752 (SPR)s13643-016-0362-x-e DE-627 ger DE-627 rakwb eng 610 ASE Fu, Yu verfasserin aut Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 Osteoarthritis (dpeaa)DE-He213 Placebo response (dpeaa)DE-He213 Individual patient data meta-analysis (dpeaa)DE-He213 Persson, Monica S. M. verfasserin aut Bhattacharya, Archan verfasserin aut Goh, Siew-Li verfasserin aut Stocks, Joanne verfasserin aut van Middelkoop, Marienke verfasserin aut Bierma-Zeinstra, Sita M. A. verfasserin aut Walsh, David verfasserin aut Doherty, Michael verfasserin aut Zhang, Weiya verfasserin aut Enthalten in Systematic Reviews London : Biomed Central, 2012 5(2016), 1 vom: 28. Okt. (DE-627)718627210 (DE-600)2662257-9 2046-4053 nnns volume:5 year:2016 number:1 day:28 month:10 https://dx.doi.org/10.1186/s13643-016-0362-x 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_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 5 2016 1 28 10 |
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identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis |
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Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis |
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Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 |
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Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 |
| abstract_unstemmed |
Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 |
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Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis |
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Persson, Monica S. M. Bhattacharya, Archan Goh, Siew-Li Stocks, Joanne van Middelkoop, Marienke Bierma-Zeinstra, Sita M. A. Walsh, David Doherty, Michael Zhang, Weiya |
| author2Str |
Persson, Monica S. M. Bhattacharya, Archan Goh, Siew-Li Stocks, Joanne van Middelkoop, Marienke Bierma-Zeinstra, Sita M. A. Walsh, David Doherty, Michael Zhang, Weiya |
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