Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Article Type
Changed
Wed, 03/27/2019 - 13:03
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Author and Disclosure Information

Author and Disclosure Information

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Article Source

FROM JAMA

PURLs Copyright

Inside the Article

Vitals

Major Finding: A study that included 29 meta-analyses of pharmaceutical treatment trials found that only 7% reported funding sources for the trials, and none of them reported ties between trial authors and the pharmaceutical industry.

Data Source: Analysis of meta-analyses reported in ‘high impact’ medical journals.

Disclosures: Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Article Type
Changed
Wed, 03/27/2019 - 13:03
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Author and Disclosure Information

Author and Disclosure Information

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Article Source

FROM JAMA

PURLs Copyright

Inside the Article

Vitals

Major Finding: A study that included 29 meta-analyses of pharmaceutical treatment trials found that only 7% reported funding sources for the trials, and none of them reported ties between trial authors and the pharmaceutical industry.

Data Source: Analysis of meta-analyses reported in ‘high impact’ medical journals.

Disclosures: Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Article Type
Changed
Wed, 03/27/2019 - 13:03
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Author and Disclosure Information

Author and Disclosure Information

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Article Source

FROM JAMA

PURLs Copyright

Inside the Article

Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Article Type
Changed
Wed, 03/27/2019 - 15:01
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials' funding sources and authors' financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial's funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study's authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers' financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Author and Disclosure Information

Author and Disclosure Information

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials' funding sources and authors' financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial's funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study's authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers' financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials' funding sources and authors' financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial's funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study's authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers' financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Article Source

FROM JAMA

PURLs Copyright

Inside the Article

Vitals

Major Finding: A study that included 29 meta-analyses of pharmaceutical treatment trials found that only 7% reported funding sources for the trials, and none of them reported ties between trial authors and the pharmaceutical industry.

Data Source: Analysis of meta-analyses reported in 'high impact' medical journals.

Disclosures: Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Article Type
Changed
Wed, 03/27/2019 - 13:03
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Author and Disclosure Information

Author and Disclosure Information

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Most meta-analyses of pharmaceutical treatments published in major medical journals fail to include information on financial conflicts of interest in the original trials, even when the trials were funded by the pharmaceutical industry or include authors employed by drug manufacturers, a study published March 9 in JAMA showed.

The omission of those data from meta-analyses represents "a major gap in the reporting of conflicts of interest, and suggest[s] that, without a formal reporting policy, [conflicts of interest] from [randomized, controlled trials] are unlikely to be reported when results are synthesized in meta-analyses," reported Michelle Roseman of the department of psychiatry at McGill University, Montreal, and her colleagues.

The authors recommended that the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines, which most researchers follow when reporting data for meta-analyses, be updated to require authors of meta-analyses to report funding sources of included randomized controlled trials.

Authors of meta-analyses also should include information on trials’ funding sources and authors’ financial ties to industry when evaluating the risk of trial bias, the study authors recommended.

The researchers investigated whether meta-analyses of pharmacological treatments published in "high-impact" biomedical journals included information on the conflicts of interest reported in the original studies. They selected 29 meta-analyses of patented pharmacological treatments, all of which were published in major medical journals in 2009. The journals included JAMA, the Lancet, Annals of Internal Medicine, and BMJ.

The 29 meta-analyses reviewed included 509 randomized clinical trials. Of those, only two meta-analyses, or 7%, reported randomized, controlled trial funding sources, and none reported author-industry ties or employment by the pharmaceutical industry, the investigators found (JAMA 2011;305:1008-17).

However, when the study authors evaluated the individual randomized controlled trials included in the meta-analyses, they found that more than 62% included information on the trial’s funding source. Of those, nearly 69% were funded in part or entirely by the pharmaceutical industry, about 30% were funded by nonindustry sources, and fewer than 1% reported that the trial received no funding.

Only about 26% of the randomized, controlled trials included in the 29 meta-analyses reported author financial disclosures, according to the study. Of those, nearly 69% reported one or more authors having financial ties to the pharmaceutical industry. Almost all of the randomized, controlled trials included in the 29 meta-analyses examined in the JAMA study – 95% – reported author affiliations, and more than 26% of the trials included at least one author employed by the pharmaceutical industry.

Of the two meta-analyses that reported funding sources of the included randomized, controlled trials, one listed funding sources in a table footnote, and the other in the "Characteristics of Studies" table that followed the main document and references, according to the researchers. "Neither mentioned [randomized, controlled trial] funding sources in the column of a core table, in the text, or in an assessment of potential bias," they noted.

None of the 29 meta-analyses analyzed reported author-industry financial ties or employment associated with the included clinical trials.

The study’s authors said that "consumers of research, including patients and physicians," want to see disclosures of researchers’ financial ties to industry.

"Authors of meta-analyses are expected to transparently assess and interpret potential sources of bias from included studies that could influence outcomes," the authors wrote. "Meta-analysis authors should document that they have evaluated all potentially relevant sources of bias, whether or not a particular source of possible bias is present in the studies reviewed and whether or not the magnitude of bias is expected to be large in comparison with other likely sources of bias."

Author Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Display Headline
Financial Conflicts Often Unreported in Pharma Trial Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Legacy Keywords
financial conflicts of interest, clinical trials, pharmaceutical industry, drug manufacturers, JAMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Article Source

FROM JAMA

PURLs Copyright

Inside the Article

Vitals

Major Finding: A study that included 29 meta-analyses of pharmaceutical treatment trials found that only 7% reported funding sources for the trials, and none of them reported ties between trial authors and the pharmaceutical industry.

Data Source: Analysis of meta-analyses reported in ‘high impact’ medical journals.

Disclosures: Dr. Joel Lexchin reported being a consultant to a law firm representing Apotex in 2007, the Canadian federal government in a lawsuit challenging the Canadian ban on direct-to-consumer advertising of prescription drugs in 2007-2008, and a law firm representing a plaintiff in a case against Allergan in 2010. The other authors reported no disclosures.

Incentives Play Larger Role in Hospitalist Compensation

Article Type
Changed
Wed, 03/27/2019 - 13:04
Display Headline
Incentives Play Larger Role in Hospitalist Compensation

Although base salary plus added bonuses based on quality and productivity measures represent the predominant compensation structure for hospitalists, methodologies for paying hospitalists vary widely and appear to be evolving toward paying a higher percentage of compensation as incentives, experts said.

The bulk of hospitalist reimbursement is centered on salary, but productivity and quality incentives can provide as much as 30%, 40%, or even 50% of compensation, according to Jeffery Milburn, a consultant with MGMA Healthcare Consulting Group. “Employers – especially hospitals – are paying more at the moment to try and align hospital and physician goals,” he said.

Dr. Steven Deitelzweig, chairman of hospital medicine at Ochsner Medical Center, New Orleans, agreed. “Base plus incentives are becoming the rule, with the incentives focusing on the hospital's goals and objectives for the calendar year.”

Dr. Deitelzweig added that incentives can be tied to the gamut of hospital goals, from increasing relative value units (RVUs) and diagnosis-related group payment to quality and outcomes measures such as mortality and complication rates. Under health care reform, greater emphasis is likely to be placed on utilization measures, such as readmission rates and discharge times. Patient satisfaction, academic productivity, and “general citizenship,” which can include working on committees or spearheading new programs, may also play a role.

A small number of hospitalists are reimbursed solely on the basis of their productivity, Mr. Milburn said. In those cases, the hospital or physician group measures work RVUs or patient encounters and pays a flat rate based on how much work the physician performs, “regardless of how many days or hours you work.”

It can be difficult to craft these types of productivity incentives for hospitalists because they have limited control over the patient population at any given time, he said. “Hospitals don't want them churning patients or overcoding, and hospitals don't want them fraudulently billing to make up their productivity,” he said.

Quality incentive payments based on patient satisfaction can be tricky as well, Mr. Milburn said, adding, “half the time the patient doesn't even remember who called on them. Also, a lot of patients are going to see two or three different hospitalists during their stays.”

In most cases, the physicians and the facility determine what to measure together – that way, the hospitalists buy into the measures.

Hospitalists seem comfortable with most payment methodologies, as long as they're communicated fairly, Dr. Deitelzweig agreed.

In most practice environments, new physicians tend to prefer guaranteed compensation in the form of straight salary. As physicians become more experienced, they're more willing to accept productivity-based compensation plans, Mr. Milburn said.

Dr. Alpesh Amin, professor and chairman of medicine at the University of California, Irvine, and executive director of its hospitalist program, said he thinks incentive payments that provide about 20%-30% in compensation above a base salary work well. “If you just give someone a $5,000 bonus, how meaningful is that for someone who makes $200,000?” he asks. “A $50,000-$60,000 bonus is a lot more meaningful.” The bonus also should be above a fair salary, not “something that gets them back to a reasonable market value salary.”

Incentive plans based on individual RVUs have limitations because hospitalists don't have complete control over their work RVUs, he said. Metrics that measure whether hospitalists are documenting and coding to an appropriate maximum level potentially can work better, he said. Another component to an incentive program could involve chart reviews.

Incentive payments that provide about 20%-30% in compensation above a base salary work well.

Source DR. AMIN

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

Although base salary plus added bonuses based on quality and productivity measures represent the predominant compensation structure for hospitalists, methodologies for paying hospitalists vary widely and appear to be evolving toward paying a higher percentage of compensation as incentives, experts said.

The bulk of hospitalist reimbursement is centered on salary, but productivity and quality incentives can provide as much as 30%, 40%, or even 50% of compensation, according to Jeffery Milburn, a consultant with MGMA Healthcare Consulting Group. “Employers – especially hospitals – are paying more at the moment to try and align hospital and physician goals,” he said.

Dr. Steven Deitelzweig, chairman of hospital medicine at Ochsner Medical Center, New Orleans, agreed. “Base plus incentives are becoming the rule, with the incentives focusing on the hospital's goals and objectives for the calendar year.”

Dr. Deitelzweig added that incentives can be tied to the gamut of hospital goals, from increasing relative value units (RVUs) and diagnosis-related group payment to quality and outcomes measures such as mortality and complication rates. Under health care reform, greater emphasis is likely to be placed on utilization measures, such as readmission rates and discharge times. Patient satisfaction, academic productivity, and “general citizenship,” which can include working on committees or spearheading new programs, may also play a role.

A small number of hospitalists are reimbursed solely on the basis of their productivity, Mr. Milburn said. In those cases, the hospital or physician group measures work RVUs or patient encounters and pays a flat rate based on how much work the physician performs, “regardless of how many days or hours you work.”

It can be difficult to craft these types of productivity incentives for hospitalists because they have limited control over the patient population at any given time, he said. “Hospitals don't want them churning patients or overcoding, and hospitals don't want them fraudulently billing to make up their productivity,” he said.

Quality incentive payments based on patient satisfaction can be tricky as well, Mr. Milburn said, adding, “half the time the patient doesn't even remember who called on them. Also, a lot of patients are going to see two or three different hospitalists during their stays.”

In most cases, the physicians and the facility determine what to measure together – that way, the hospitalists buy into the measures.

Hospitalists seem comfortable with most payment methodologies, as long as they're communicated fairly, Dr. Deitelzweig agreed.

In most practice environments, new physicians tend to prefer guaranteed compensation in the form of straight salary. As physicians become more experienced, they're more willing to accept productivity-based compensation plans, Mr. Milburn said.

Dr. Alpesh Amin, professor and chairman of medicine at the University of California, Irvine, and executive director of its hospitalist program, said he thinks incentive payments that provide about 20%-30% in compensation above a base salary work well. “If you just give someone a $5,000 bonus, how meaningful is that for someone who makes $200,000?” he asks. “A $50,000-$60,000 bonus is a lot more meaningful.” The bonus also should be above a fair salary, not “something that gets them back to a reasonable market value salary.”

Incentive plans based on individual RVUs have limitations because hospitalists don't have complete control over their work RVUs, he said. Metrics that measure whether hospitalists are documenting and coding to an appropriate maximum level potentially can work better, he said. Another component to an incentive program could involve chart reviews.

Incentive payments that provide about 20%-30% in compensation above a base salary work well.

Source DR. AMIN

Although base salary plus added bonuses based on quality and productivity measures represent the predominant compensation structure for hospitalists, methodologies for paying hospitalists vary widely and appear to be evolving toward paying a higher percentage of compensation as incentives, experts said.

The bulk of hospitalist reimbursement is centered on salary, but productivity and quality incentives can provide as much as 30%, 40%, or even 50% of compensation, according to Jeffery Milburn, a consultant with MGMA Healthcare Consulting Group. “Employers – especially hospitals – are paying more at the moment to try and align hospital and physician goals,” he said.

Dr. Steven Deitelzweig, chairman of hospital medicine at Ochsner Medical Center, New Orleans, agreed. “Base plus incentives are becoming the rule, with the incentives focusing on the hospital's goals and objectives for the calendar year.”

Dr. Deitelzweig added that incentives can be tied to the gamut of hospital goals, from increasing relative value units (RVUs) and diagnosis-related group payment to quality and outcomes measures such as mortality and complication rates. Under health care reform, greater emphasis is likely to be placed on utilization measures, such as readmission rates and discharge times. Patient satisfaction, academic productivity, and “general citizenship,” which can include working on committees or spearheading new programs, may also play a role.

A small number of hospitalists are reimbursed solely on the basis of their productivity, Mr. Milburn said. In those cases, the hospital or physician group measures work RVUs or patient encounters and pays a flat rate based on how much work the physician performs, “regardless of how many days or hours you work.”

It can be difficult to craft these types of productivity incentives for hospitalists because they have limited control over the patient population at any given time, he said. “Hospitals don't want them churning patients or overcoding, and hospitals don't want them fraudulently billing to make up their productivity,” he said.

Quality incentive payments based on patient satisfaction can be tricky as well, Mr. Milburn said, adding, “half the time the patient doesn't even remember who called on them. Also, a lot of patients are going to see two or three different hospitalists during their stays.”

In most cases, the physicians and the facility determine what to measure together – that way, the hospitalists buy into the measures.

Hospitalists seem comfortable with most payment methodologies, as long as they're communicated fairly, Dr. Deitelzweig agreed.

In most practice environments, new physicians tend to prefer guaranteed compensation in the form of straight salary. As physicians become more experienced, they're more willing to accept productivity-based compensation plans, Mr. Milburn said.

Dr. Alpesh Amin, professor and chairman of medicine at the University of California, Irvine, and executive director of its hospitalist program, said he thinks incentive payments that provide about 20%-30% in compensation above a base salary work well. “If you just give someone a $5,000 bonus, how meaningful is that for someone who makes $200,000?” he asks. “A $50,000-$60,000 bonus is a lot more meaningful.” The bonus also should be above a fair salary, not “something that gets them back to a reasonable market value salary.”

Incentive plans based on individual RVUs have limitations because hospitalists don't have complete control over their work RVUs, he said. Metrics that measure whether hospitalists are documenting and coding to an appropriate maximum level potentially can work better, he said. Another component to an incentive program could involve chart reviews.

Incentive payments that provide about 20%-30% in compensation above a base salary work well.

Source DR. AMIN

Publications
Publications
Topics
Article Type
Display Headline
Incentives Play Larger Role in Hospitalist Compensation
Display Headline
Incentives Play Larger Role in Hospitalist Compensation
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Tool Refines Risk Assessment of Hospitals

Article Type
Changed
Wed, 03/27/2019 - 13:04
Display Headline
Tool Refines Risk Assessment of Hospitals

A research team based at the Cleveland Clinic has released a new risk assessment tool to allow fair comparison of hospital outcomes across institutions. The tool provides a reliable way for hospitals to predict length of stay and mortality for surgical patients using only administrative data, researchers said.

The tool – the Risk Stratification Index – is in the public domain. The Cleveland Clinic uses it to stratify risk in its internal outcomes analyses, according to Dr. Daniel Sessler, the article's lead author, who chairs the department of outcomes research at the clinic (Anesthesiology 2010;113:1026-37).

“Hospitals are already being compared,” Dr. Sessler said in an interview. “But comparisons only make sense after adjusting for baseline and the risk associated with different operations. Our Risk Stratification Index allows for an accurate and fair comparison among hospitals using only publicly available data.” He said a new risk assessment tool was needed because institutions use various systems to evaluate outcomes, and many of these systems are proprietary and nontransparent.

“Available systems are either inaccurate or require special clinical data that are not generally or publicly available,” he said, adding that the Risk Stratification Index (RSI) is more accurate than other generally available nonproprietary systems, and uses only publicly available billing information.

To develop the index, Dr. Sessler and his colleagues used more than 35 million patient stay records from 2001-2006 Medicare Provider Analysis and Review files, randomly dividing them into development and validation sets. RSIs for length of stay and mortality end points were derived from aggregate risk associated with individual diagnostic and procedure codes.

Next, the researchers tested performance of the RSIs prospectively on the validation database, as well as on a single institution registry of 103,324 adult surgical patients, and compared the results with an index designed to predict 1-year mortality.

They found that the risk stratification model accurately predicted 30-day and 1-year postdischarge mortality, while separate risk stratification models predicted length of stay and in-hospital mortality. The risk predictions are accurate for as few as 2,000 patients, meaning the system can be used effectively by small hospitals.

“RSI is a broadly applicable and robust system for assessing hospital length of stay and mortality for groups of surgical patients based solely on administrative data,” Dr. Sessler and his colleagues concluded in their paper.

They wanted to make the RSI available to any hospital, so they put it in the public domain, Dr. Sessler explained. He anticipates that it will be adopted rapidly because it's objective, transparent, requires only billing codes, and is free to use. Details of how to use the system and sample files are available at www.clevelandclinic.org/RSI

The tool shows promise but has some drawbacks, Dr. Charles Mabry of the University of Arkansas in Pine Bluff noted in an interview. “Like many risk adjustment methods, this relies upon the administrative data set, which is submitted with hospital bills to insurers. As such, many clinical factors, such as weight, blood pressure, drugs used, socioeconomic status, etc., aren't reported, and thus [are] unavailable to help with risk stratification.”

For large numbers of patients, the administrative data set can help reveal major differences in such factors as treatment and medications, Dr. Mabry said. However, for smaller numbers of patients – for example, the number in a group that had one particular surgical procedure – it becomes weaker, he said.

Other large organizations, along with the Centers for Medicare and Medicaid Services, are using the administrative data set for their own risk adjustment algorithms, Dr. Mabry noted.

The American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) does measure the clinical factors omitted from the administrative data set, along with some complications that might also be missed, said Dr. Mabry. “Thus, compared with the Sessler index, it can more reliably detect differences in outcomes for smaller numbers of patients, such as comparing the outcomes of gallbladder surgery between various hospitals,” he said.

However, the Physician Quality Reporting Initiative (PQRI) primarily measures process as opposed to outcomes, Dr. Mabry said. “I think PQRI is a waste of time and effort,” he said. “Many feel that outcomes measurement is really what we need to be aiming for, rather than process compliance.”

Dr. Chad Rubin, a surgeon in Columbia, S.C., agreed that the RSI is limited through its use of the administrative data set. “While it appears a useful tool, I am always reticent to give credence to something so important as hospital (and maybe doctor) outcomes when the original data may be flawed,” he said in an interview.

 

 

The NSQIP, meanwhile, “may be more relevant to quality. For instance, the definition of skin and soft tissue infection, while a very common diagnosis/complication, varies widely in the claims data but has a strict definition by NSQIP,” Dr. Rubin said. “While NSQIP is expensive (both the enrollment and FTE required), it depends on the quality of the data as to whether it is too resource-intensive. I'm sure hospitals have spent a lot more on SCIP [Surgical Care Improvement Project] than on NSQIP for a lot less improvement in quality.”

NSQIP remains the gold standard, Dr. Rubin said. “The use of good clinical data carefully collected and carefully risk adjusted is, in my opinion, the way to go,” he said. “I'm worried that lesser claims data will not be accurate but will be acted upon as if it were.”

Dr. Sessler said he agrees that the NSQIP registry is valuable, but it applies to a limited number of hospitals, and fewer than 1% of U.S. surgical patients. “Specially trained nurses must abstract clinical details from the records of each NSQIP patient,” he said. “Because NSQIP applies to so few patients in so few hospitals, it cannot be used to compare hospital performance.”

The RSI provides 'an accurate and fair comparison among hospitals using only publicly available data.'

Source DR. SESSLER

Article PDF
Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Article PDF
Article PDF

A research team based at the Cleveland Clinic has released a new risk assessment tool to allow fair comparison of hospital outcomes across institutions. The tool provides a reliable way for hospitals to predict length of stay and mortality for surgical patients using only administrative data, researchers said.

The tool – the Risk Stratification Index – is in the public domain. The Cleveland Clinic uses it to stratify risk in its internal outcomes analyses, according to Dr. Daniel Sessler, the article's lead author, who chairs the department of outcomes research at the clinic (Anesthesiology 2010;113:1026-37).

“Hospitals are already being compared,” Dr. Sessler said in an interview. “But comparisons only make sense after adjusting for baseline and the risk associated with different operations. Our Risk Stratification Index allows for an accurate and fair comparison among hospitals using only publicly available data.” He said a new risk assessment tool was needed because institutions use various systems to evaluate outcomes, and many of these systems are proprietary and nontransparent.

“Available systems are either inaccurate or require special clinical data that are not generally or publicly available,” he said, adding that the Risk Stratification Index (RSI) is more accurate than other generally available nonproprietary systems, and uses only publicly available billing information.

To develop the index, Dr. Sessler and his colleagues used more than 35 million patient stay records from 2001-2006 Medicare Provider Analysis and Review files, randomly dividing them into development and validation sets. RSIs for length of stay and mortality end points were derived from aggregate risk associated with individual diagnostic and procedure codes.

Next, the researchers tested performance of the RSIs prospectively on the validation database, as well as on a single institution registry of 103,324 adult surgical patients, and compared the results with an index designed to predict 1-year mortality.

They found that the risk stratification model accurately predicted 30-day and 1-year postdischarge mortality, while separate risk stratification models predicted length of stay and in-hospital mortality. The risk predictions are accurate for as few as 2,000 patients, meaning the system can be used effectively by small hospitals.

“RSI is a broadly applicable and robust system for assessing hospital length of stay and mortality for groups of surgical patients based solely on administrative data,” Dr. Sessler and his colleagues concluded in their paper.

They wanted to make the RSI available to any hospital, so they put it in the public domain, Dr. Sessler explained. He anticipates that it will be adopted rapidly because it's objective, transparent, requires only billing codes, and is free to use. Details of how to use the system and sample files are available at www.clevelandclinic.org/RSI

The tool shows promise but has some drawbacks, Dr. Charles Mabry of the University of Arkansas in Pine Bluff noted in an interview. “Like many risk adjustment methods, this relies upon the administrative data set, which is submitted with hospital bills to insurers. As such, many clinical factors, such as weight, blood pressure, drugs used, socioeconomic status, etc., aren't reported, and thus [are] unavailable to help with risk stratification.”

For large numbers of patients, the administrative data set can help reveal major differences in such factors as treatment and medications, Dr. Mabry said. However, for smaller numbers of patients – for example, the number in a group that had one particular surgical procedure – it becomes weaker, he said.

Other large organizations, along with the Centers for Medicare and Medicaid Services, are using the administrative data set for their own risk adjustment algorithms, Dr. Mabry noted.

The American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) does measure the clinical factors omitted from the administrative data set, along with some complications that might also be missed, said Dr. Mabry. “Thus, compared with the Sessler index, it can more reliably detect differences in outcomes for smaller numbers of patients, such as comparing the outcomes of gallbladder surgery between various hospitals,” he said.

However, the Physician Quality Reporting Initiative (PQRI) primarily measures process as opposed to outcomes, Dr. Mabry said. “I think PQRI is a waste of time and effort,” he said. “Many feel that outcomes measurement is really what we need to be aiming for, rather than process compliance.”

Dr. Chad Rubin, a surgeon in Columbia, S.C., agreed that the RSI is limited through its use of the administrative data set. “While it appears a useful tool, I am always reticent to give credence to something so important as hospital (and maybe doctor) outcomes when the original data may be flawed,” he said in an interview.

 

 

The NSQIP, meanwhile, “may be more relevant to quality. For instance, the definition of skin and soft tissue infection, while a very common diagnosis/complication, varies widely in the claims data but has a strict definition by NSQIP,” Dr. Rubin said. “While NSQIP is expensive (both the enrollment and FTE required), it depends on the quality of the data as to whether it is too resource-intensive. I'm sure hospitals have spent a lot more on SCIP [Surgical Care Improvement Project] than on NSQIP for a lot less improvement in quality.”

NSQIP remains the gold standard, Dr. Rubin said. “The use of good clinical data carefully collected and carefully risk adjusted is, in my opinion, the way to go,” he said. “I'm worried that lesser claims data will not be accurate but will be acted upon as if it were.”

Dr. Sessler said he agrees that the NSQIP registry is valuable, but it applies to a limited number of hospitals, and fewer than 1% of U.S. surgical patients. “Specially trained nurses must abstract clinical details from the records of each NSQIP patient,” he said. “Because NSQIP applies to so few patients in so few hospitals, it cannot be used to compare hospital performance.”

The RSI provides 'an accurate and fair comparison among hospitals using only publicly available data.'

Source DR. SESSLER

A research team based at the Cleveland Clinic has released a new risk assessment tool to allow fair comparison of hospital outcomes across institutions. The tool provides a reliable way for hospitals to predict length of stay and mortality for surgical patients using only administrative data, researchers said.

The tool – the Risk Stratification Index – is in the public domain. The Cleveland Clinic uses it to stratify risk in its internal outcomes analyses, according to Dr. Daniel Sessler, the article's lead author, who chairs the department of outcomes research at the clinic (Anesthesiology 2010;113:1026-37).

“Hospitals are already being compared,” Dr. Sessler said in an interview. “But comparisons only make sense after adjusting for baseline and the risk associated with different operations. Our Risk Stratification Index allows for an accurate and fair comparison among hospitals using only publicly available data.” He said a new risk assessment tool was needed because institutions use various systems to evaluate outcomes, and many of these systems are proprietary and nontransparent.

“Available systems are either inaccurate or require special clinical data that are not generally or publicly available,” he said, adding that the Risk Stratification Index (RSI) is more accurate than other generally available nonproprietary systems, and uses only publicly available billing information.

To develop the index, Dr. Sessler and his colleagues used more than 35 million patient stay records from 2001-2006 Medicare Provider Analysis and Review files, randomly dividing them into development and validation sets. RSIs for length of stay and mortality end points were derived from aggregate risk associated with individual diagnostic and procedure codes.

Next, the researchers tested performance of the RSIs prospectively on the validation database, as well as on a single institution registry of 103,324 adult surgical patients, and compared the results with an index designed to predict 1-year mortality.

They found that the risk stratification model accurately predicted 30-day and 1-year postdischarge mortality, while separate risk stratification models predicted length of stay and in-hospital mortality. The risk predictions are accurate for as few as 2,000 patients, meaning the system can be used effectively by small hospitals.

“RSI is a broadly applicable and robust system for assessing hospital length of stay and mortality for groups of surgical patients based solely on administrative data,” Dr. Sessler and his colleagues concluded in their paper.

They wanted to make the RSI available to any hospital, so they put it in the public domain, Dr. Sessler explained. He anticipates that it will be adopted rapidly because it's objective, transparent, requires only billing codes, and is free to use. Details of how to use the system and sample files are available at www.clevelandclinic.org/RSI

The tool shows promise but has some drawbacks, Dr. Charles Mabry of the University of Arkansas in Pine Bluff noted in an interview. “Like many risk adjustment methods, this relies upon the administrative data set, which is submitted with hospital bills to insurers. As such, many clinical factors, such as weight, blood pressure, drugs used, socioeconomic status, etc., aren't reported, and thus [are] unavailable to help with risk stratification.”

For large numbers of patients, the administrative data set can help reveal major differences in such factors as treatment and medications, Dr. Mabry said. However, for smaller numbers of patients – for example, the number in a group that had one particular surgical procedure – it becomes weaker, he said.

Other large organizations, along with the Centers for Medicare and Medicaid Services, are using the administrative data set for their own risk adjustment algorithms, Dr. Mabry noted.

The American College of Surgeons' National Surgical Quality Improvement Program (NSQIP) does measure the clinical factors omitted from the administrative data set, along with some complications that might also be missed, said Dr. Mabry. “Thus, compared with the Sessler index, it can more reliably detect differences in outcomes for smaller numbers of patients, such as comparing the outcomes of gallbladder surgery between various hospitals,” he said.

However, the Physician Quality Reporting Initiative (PQRI) primarily measures process as opposed to outcomes, Dr. Mabry said. “I think PQRI is a waste of time and effort,” he said. “Many feel that outcomes measurement is really what we need to be aiming for, rather than process compliance.”

Dr. Chad Rubin, a surgeon in Columbia, S.C., agreed that the RSI is limited through its use of the administrative data set. “While it appears a useful tool, I am always reticent to give credence to something so important as hospital (and maybe doctor) outcomes when the original data may be flawed,” he said in an interview.

 

 

The NSQIP, meanwhile, “may be more relevant to quality. For instance, the definition of skin and soft tissue infection, while a very common diagnosis/complication, varies widely in the claims data but has a strict definition by NSQIP,” Dr. Rubin said. “While NSQIP is expensive (both the enrollment and FTE required), it depends on the quality of the data as to whether it is too resource-intensive. I'm sure hospitals have spent a lot more on SCIP [Surgical Care Improvement Project] than on NSQIP for a lot less improvement in quality.”

NSQIP remains the gold standard, Dr. Rubin said. “The use of good clinical data carefully collected and carefully risk adjusted is, in my opinion, the way to go,” he said. “I'm worried that lesser claims data will not be accurate but will be acted upon as if it were.”

Dr. Sessler said he agrees that the NSQIP registry is valuable, but it applies to a limited number of hospitals, and fewer than 1% of U.S. surgical patients. “Specially trained nurses must abstract clinical details from the records of each NSQIP patient,” he said. “Because NSQIP applies to so few patients in so few hospitals, it cannot be used to compare hospital performance.”

The RSI provides 'an accurate and fair comparison among hospitals using only publicly available data.'

Source DR. SESSLER

Publications
Publications
Topics
Article Type
Display Headline
Tool Refines Risk Assessment of Hospitals
Display Headline
Tool Refines Risk Assessment of Hospitals
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Patients Face Problems Organizing Multiple Prescriptions

Article Type
Changed
Wed, 03/27/2019 - 13:05
Display Headline
Patients Face Problems Organizing Multiple Prescriptions

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
pharmacology
Author and Disclosure Information

Author and Disclosure Information

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Legacy Keywords
pharmacology
Legacy Keywords
pharmacology
Article Source

FROM THE ARCHIVES OF INTERNAL MEDICINE

PURLs Copyright

Inside the Article

Vitals

Major Finding: Given a hypothetical seven-drug regimen that ideally would be taken in four dosing sessions per day, patients on average identified six times when they would take the drugs over 24 hours. Only 15% organized the medication regimen into four or fewer dosing sessions, and 29% said they would take doses seven or more times per day. Lower patient literacy correlated with less-efficient dosing regimens from the patients.

Data Source: Interviews with 464 adults receiving care at either an academic general medicine practice or at a federally qualified health center in Chicago.

Disclosures: None reported.

Patients Face Problems Organizing Multiple Prescriptions

Article Type
Changed
Wed, 03/27/2019 - 13:05
Display Headline
Patients Face Problems Organizing Multiple Prescriptions

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
pharmacology
Author and Disclosure Information

Author and Disclosure Information

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Legacy Keywords
pharmacology
Legacy Keywords
pharmacology
Article Source

FROM THE ARCHIVES OF INTERNAL MEDICINE

PURLs Copyright

Inside the Article

Vitals

Major Finding: Given a hypothetical seven-drug regimen that ideally would be taken in four dosing sessions per day, patients on average identified six times when they would take the drugs over 24 hours. Only 15% organized the medication regimen into four or fewer dosing sessions, and 29% said they would take doses seven or more times per day. Lower patient literacy correlated with less-efficient dosing regimens from the patients.

Data Source: Interviews with 464 adults receiving care at either an academic general medicine practice or at a federally qualified health center in Chicago.

Disclosures: None reported.

Patients Face Problems Organizing Multiple Prescriptions

Article Type
Changed
Wed, 03/27/2019 - 13:05
Display Headline
Patients Face Problems Organizing Multiple Prescriptions

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
pharmacology
Author and Disclosure Information

Author and Disclosure Information

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Many patients getting multiple prescription medications take their drugs inefficiently through the day, potentially leading to missed doses and incorrectly administered drugs, researchers reported in the Feb. 28 issue of the Archives of Internal Medicine.

Photo credit: Tim Gillin (Creative Commons)
Many patients have trouble determining the most efficient way to take a complex drug regimen, according to a new study.    

The study’s authors said that especially patients of low literacy need more education on how to take multiple prescriptions, given heightened concerns over medication safety and adherence. "In particular, strategies are needed to help patients not only to understand how to take a particular medicine but also to consolidate and simplify how to take an entire drug regimen," the authors wrote (Arch. Intern. Med. 2011 Feb. 28;171:300-5).

Led by a team from Northwestern University, Chicago, the researchers conducted interviews with 464 adults aged 55-74 years who were receiving care either at an academic general medicine practice or at a health center in Chicago.

Participants were given a hypothetical seven-drug regimen and asked to describe how and when they would take the oral medications over a 24-hour period. Ideally, the medications would be taken in just four sessions during the 24-hour period, said the researchers. Just 15% of the patients organized the medication regimen into four or fewer dosing sessions per day, the researchers found.

On average, participants identified six times when they would take the seven drugs over 24 hours, and nearly one-third of the patients (29%) said they would take doses seven or more times per day. People who said they would dose most frequently tended to have lower literacy rates than did other study participants.

Instructions for two of the seven drugs were identical, but 31% of the participants would not have taken these medications at the same time, the researchers found. Another set of drugs had similar instructions, although only one of these medications said to take it "with food and water." Half of the study participants said they would take the three medications at different times.

In addition, when the medications used different words to describe the same dose frequency – for example, "every 12 hours" vs. "twice daily" – four out of five participants failed to consolidate the medication schedules.

The study shows that most patients probably self-administer multiple-drug regimens more times a day than necessary, the authors said. "This increased complexity, at the very least, translates to taking medication too often each day, leading to substantial interference with patients’ lives," they wrote. "As a result, doses may be frequently missed or incorrectly administered."

Variations in how instructions are written, both in describing the timing of doses and including instructions such as "take with food," also can confuse individuals and prevent them from consolidating regimens, the authors said. Patients "might not understand that they can take different medications at the same time," the researchers speculated.

Because many elderly and chronically ill patients take far more medications than in the study’s seven-drug regimen, the findings could underestimate the potential for confusion among older adults when trying to streamline and manage their daily prescriptions, the authors said.

Physicians can help their patients by providing standard, explicit written instructions, but patients probably need spoken communication with their physicians and pharmacists about organizing their prescriptions, the authors concluded. They added that public health initiatives can help patients learn how to take prescription medicines and when it’s safe to take them together.

The authors reported no financial disclosures.

Publications
Publications
Topics
Article Type
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Display Headline
Patients Face Problems Organizing Multiple Prescriptions
Legacy Keywords
pharmacology
Legacy Keywords
pharmacology
Article Source

FROM THE ARCHIVES OF INTERNAL MEDICINE

PURLs Copyright

Inside the Article

Vitals

Major Finding: Given a hypothetical seven-drug regimen that ideally would be taken in four dosing sessions per day, patients on average identified six times when they would take the drugs over 24 hours. Only 15% organized the medication regimen into four or fewer dosing sessions, and 29% said they would take doses seven or more times per day. Lower patient literacy correlated with less-efficient dosing regimens from the patients.

Data Source: Interviews with 464 adults receiving care at either an academic general medicine practice or at a federally qualified health center in Chicago.

Disclosures: None reported.