Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial

Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Veroniki, Areti Angeliki [verfasserIn] Straus, Sharon E. Ashoor, Huda Stewart, Lesley A. Clarke, Mike Tricco, Andrea C.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2016

Schlagwörter:	Meta-analysis Patient-level data Individual patient data Individual participant data Incentive Data retrieval Data collection Response rate

Anmerkung:	© Veroniki et al. 2016

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 17(2016), 1 vom: 15. März
Übergeordnetes Werk:	volume:17 ; year:2016 ; number:1 ; day:15 ; month:03

Links:	Volltext

DOI / URN:	10.1186/s13063-016-1238-z

Katalog-ID:	SPR03008718X

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allfields	10.1186/s13063-016-1238-z doi (DE-627)SPR03008718X (SPR)s13063-016-1238-z-e DE-627 ger DE-627 rakwb eng Veroniki, Areti Angeliki verfasserin aut Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Veroniki et al. 2016 Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213 Straus, Sharon E. aut Ashoor, Huda aut Stewart, Lesley A. aut Clarke, Mike aut Tricco, Andrea C. aut Enthalten in Trials London : BioMed Central, 2000 17(2016), 1 vom: 15. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:17 year:2016 number:1 day:15 month:03 https://dx.doi.org/10.1186/s13063-016-1238-z 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_2011 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 17 2016 1 15 03
spelling	10.1186/s13063-016-1238-z doi (DE-627)SPR03008718X (SPR)s13063-016-1238-z-e DE-627 ger DE-627 rakwb eng Veroniki, Areti Angeliki verfasserin aut Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Veroniki et al. 2016 Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213 Straus, Sharon E. aut Ashoor, Huda aut Stewart, Lesley A. aut Clarke, Mike aut Tricco, Andrea C. aut Enthalten in Trials London : BioMed Central, 2000 17(2016), 1 vom: 15. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:17 year:2016 number:1 day:15 month:03 https://dx.doi.org/10.1186/s13063-016-1238-z 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_2011 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 17 2016 1 15 03
allfields_unstemmed	10.1186/s13063-016-1238-z doi (DE-627)SPR03008718X (SPR)s13063-016-1238-z-e DE-627 ger DE-627 rakwb eng Veroniki, Areti Angeliki verfasserin aut Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Veroniki et al. 2016 Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213 Straus, Sharon E. aut Ashoor, Huda aut Stewart, Lesley A. aut Clarke, Mike aut Tricco, Andrea C. aut Enthalten in Trials London : BioMed Central, 2000 17(2016), 1 vom: 15. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:17 year:2016 number:1 day:15 month:03 https://dx.doi.org/10.1186/s13063-016-1238-z 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_2011 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 17 2016 1 15 03
allfieldsGer	10.1186/s13063-016-1238-z doi (DE-627)SPR03008718X (SPR)s13063-016-1238-z-e DE-627 ger DE-627 rakwb eng Veroniki, Areti Angeliki verfasserin aut Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Veroniki et al. 2016 Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213 Straus, Sharon E. aut Ashoor, Huda aut Stewart, Lesley A. aut Clarke, Mike aut Tricco, Andrea C. aut Enthalten in Trials London : BioMed Central, 2000 17(2016), 1 vom: 15. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:17 year:2016 number:1 day:15 month:03 https://dx.doi.org/10.1186/s13063-016-1238-z 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_2011 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 17 2016 1 15 03
allfieldsSound	10.1186/s13063-016-1238-z doi (DE-627)SPR03008718X (SPR)s13063-016-1238-z-e DE-627 ger DE-627 rakwb eng Veroniki, Areti Angeliki verfasserin aut Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Veroniki et al. 2016 Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213 Straus, Sharon E. aut Ashoor, Huda aut Stewart, Lesley A. aut Clarke, Mike aut Tricco, Andrea C. aut Enthalten in Trials London : BioMed Central, 2000 17(2016), 1 vom: 15. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:17 year:2016 number:1 day:15 month:03 https://dx.doi.org/10.1186/s13063-016-1238-z 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_2011 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 17 2016 1 15 03
language	English
source	Enthalten in Trials 17(2016), 1 vom: 15. März volume:17 year:2016 number:1 day:15 month:03
sourceStr	Enthalten in Trials 17(2016), 1 vom: 15. März volume:17 year:2016 number:1 day:15 month:03
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institution	findex.gbv.de
topic_facet	Meta-analysis Patient-level data Individual patient data Individual participant data Incentive Data retrieval Data collection Response rate
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topic_title	Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial Meta-analysis (dpeaa)DE-He213 Patient-level data (dpeaa)DE-He213 Individual patient data (dpeaa)DE-He213 Individual participant data (dpeaa)DE-He213 Incentive (dpeaa)DE-He213 Data retrieval (dpeaa)DE-He213 Data collection (dpeaa)DE-He213 Response rate (dpeaa)DE-He213
topic	misc Meta-analysis misc Patient-level data misc Individual patient data misc Individual participant data misc Incentive misc Data retrieval misc Data collection misc Response rate
topic_unstemmed	misc Meta-analysis misc Patient-level data misc Individual patient data misc Individual participant data misc Incentive misc Data retrieval misc Data collection misc Response rate
topic_browse	misc Meta-analysis misc Patient-level data misc Individual patient data misc Individual participant data misc Incentive misc Data retrieval misc Data collection misc Response rate
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title	Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
ctrlnum	(DE-627)SPR03008718X (SPR)s13063-016-1238-z-e
title_full	Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
author_sort	Veroniki, Areti Angeliki
journal	Trials
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author_browse	Veroniki, Areti Angeliki Straus, Sharon E. Ashoor, Huda Stewart, Lesley A. Clarke, Mike Tricco, Andrea C.
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author-letter	Veroniki, Areti Angeliki
doi_str_mv	10.1186/s13063-016-1238-z
title_sort	contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
title_auth	Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
abstract	Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. © Veroniki et al. 2016
abstractGer	Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. © Veroniki et al. 2016
abstract_unstemmed	Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. Methods/Design We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer’s dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors’ response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. Discussion This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT02569411. Date of registration 5 October 2015. © Veroniki et al. 2016
collection_details	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_2011 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
container_issue	1
title_short	Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
url	https://dx.doi.org/10.1186/s13063-016-1238-z
remote_bool	true
author2	Straus, Sharon E. Ashoor, Huda Stewart, Lesley A. Clarke, Mike Tricco, Andrea C.
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up_date	2024-07-03T13:49:44.138Z
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