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How Do You Know Which Health Care Effectiveness Research You Can Trust? A Guide to Study Design for the Perplexed.

Soumerai SB, Starr D, Majumdar SR - Prev Chronic Dis (2015)

View Article: PubMed Central - PubMed

Affiliation: Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Ave, 6th Floor, Boston, MA 02215. Email: ssoumerai@hms.harvard.edu. Dr Soumerai is also co-chair of the Evaluative Sciences and Statistics Concentration of Harvard University's PhD Program in Health Policy.

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Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians... Medscape, LLC designates this Journal-based CME activity for a maximum of 1... Upon completion of this activity, participants will be able to: Define healthy user bias in health care research and means to reduce it Assess means to reduce selection bias in health care research Assess how to overcome confounding factors by indication in health care research Evaluate social desirability bias and history bias in health care research Ellen Taratus, Editor, Preventing Chronic Disease... Another pattern in the evolution of science is that early studies of new treatments tend to show the most dramatic, positive health effects, and these effects diminish or disappear as more rigorous and larger studies are conducted... As these positive effects decrease, harmful side effects emerge... Sometimes researchers may publish overly definitive conclusions using unreliable study designs, reasoning that it is better to have unreliable data than no data at all and that the natural progression of science will eventually sort things out... We do not agree... For example, one of many weak cohort studies purported to show that flu vaccines reduce mortality in the elderly (Figure 2)... This study, which was widely reported in the news media and influenced policy, found significant differences in the rate of flu-related deaths and hospitalizations among the vaccinated elderly compared with that of their unvaccinated peers... One of the oldest and most accepted “truths” in the history of medication safety research is that benzodiazepines (popular medications such as Valium and Xanax that are prescribed for sleep and anxiety) may cause hip fractures among the elderly... This intervention took place during an explosion of research and news media reporting on treatments for acute myocardial infarction that could have influenced the prescribing behavior of physicians... These data demonstrate that inpatient mortality in the United States was declining before, during, and after the 100,000 Lives Campaign... The program itself probably had no effect on the trend, yet the widespread policy and media reports led to several European countries adopting this “successful” model of patient safety at considerable costs... Subsequently, several large RCTs demonstrated that many components of the 100,000 Lives Campaign were not particularly effective, especially when compared with the benefits reported in the IHI’s press releases.

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Benzodiazepine (BZ) use and risk of hip fracture among women with Medicaid before and after regulatory surveillance restricting BZ use in New York State. A BZ user was defined as a person who had received at least 1 dispensed BZ in the year before the policy. Figure was adapted from Wagner et al (33). Reprinted with the permission of American College of Physicians, Inc.
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Figure 12: Benzodiazepine (BZ) use and risk of hip fracture among women with Medicaid before and after regulatory surveillance restricting BZ use in New York State. A BZ user was defined as a person who had received at least 1 dispensed BZ in the year before the policy. Figure was adapted from Wagner et al (33). Reprinted with the permission of American College of Physicians, Inc.

Mentions: In 1989 New York State began to require every prescription of benzodiazepine to be accompanied by a triplicate prescription form, a copy of which went to the New York State Department of Health. State policy makers thought this would limit benzodiazepine use, thereby reducing costs, the prevalence of benzodiazepine abuse, and the risk of hip fracture. (In formulating the policy, policy makers referred to the 1987 landmark study on benzodiazepines and hip fractures [32].) In 2007 researchers examined the effects of the policy with a longitudinal study. The investigators examined health data for tens of thousands of elderly women in New York State, before, during, and after the policy limiting benzodiazepine use had been put into effect. The policy had its intended effect: benzodiazepine use dropped by 60% (Figure 12). The researchers also collected similar data for a control group of elderly women in New Jersey, where no such policy had been put in place, and medication use did not change.


How Do You Know Which Health Care Effectiveness Research You Can Trust? A Guide to Study Design for the Perplexed.

Soumerai SB, Starr D, Majumdar SR - Prev Chronic Dis (2015)

Benzodiazepine (BZ) use and risk of hip fracture among women with Medicaid before and after regulatory surveillance restricting BZ use in New York State. A BZ user was defined as a person who had received at least 1 dispensed BZ in the year before the policy. Figure was adapted from Wagner et al (33). Reprinted with the permission of American College of Physicians, Inc.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4492215&req=5

Figure 12: Benzodiazepine (BZ) use and risk of hip fracture among women with Medicaid before and after regulatory surveillance restricting BZ use in New York State. A BZ user was defined as a person who had received at least 1 dispensed BZ in the year before the policy. Figure was adapted from Wagner et al (33). Reprinted with the permission of American College of Physicians, Inc.
Mentions: In 1989 New York State began to require every prescription of benzodiazepine to be accompanied by a triplicate prescription form, a copy of which went to the New York State Department of Health. State policy makers thought this would limit benzodiazepine use, thereby reducing costs, the prevalence of benzodiazepine abuse, and the risk of hip fracture. (In formulating the policy, policy makers referred to the 1987 landmark study on benzodiazepines and hip fractures [32].) In 2007 researchers examined the effects of the policy with a longitudinal study. The investigators examined health data for tens of thousands of elderly women in New York State, before, during, and after the policy limiting benzodiazepine use had been put into effect. The policy had its intended effect: benzodiazepine use dropped by 60% (Figure 12). The researchers also collected similar data for a control group of elderly women in New Jersey, where no such policy had been put in place, and medication use did not change.

View Article: PubMed Central - PubMed

Affiliation: Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Ave, 6th Floor, Boston, MA 02215. Email: ssoumerai@hms.harvard.edu. Dr Soumerai is also co-chair of the Evaluative Sciences and Statistics Concentration of Harvard University's PhD Program in Health Policy.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians... Medscape, LLC designates this Journal-based CME activity for a maximum of 1... Upon completion of this activity, participants will be able to: Define healthy user bias in health care research and means to reduce it Assess means to reduce selection bias in health care research Assess how to overcome confounding factors by indication in health care research Evaluate social desirability bias and history bias in health care research Ellen Taratus, Editor, Preventing Chronic Disease... Another pattern in the evolution of science is that early studies of new treatments tend to show the most dramatic, positive health effects, and these effects diminish or disappear as more rigorous and larger studies are conducted... As these positive effects decrease, harmful side effects emerge... Sometimes researchers may publish overly definitive conclusions using unreliable study designs, reasoning that it is better to have unreliable data than no data at all and that the natural progression of science will eventually sort things out... We do not agree... For example, one of many weak cohort studies purported to show that flu vaccines reduce mortality in the elderly (Figure 2)... This study, which was widely reported in the news media and influenced policy, found significant differences in the rate of flu-related deaths and hospitalizations among the vaccinated elderly compared with that of their unvaccinated peers... One of the oldest and most accepted “truths” in the history of medication safety research is that benzodiazepines (popular medications such as Valium and Xanax that are prescribed for sleep and anxiety) may cause hip fractures among the elderly... This intervention took place during an explosion of research and news media reporting on treatments for acute myocardial infarction that could have influenced the prescribing behavior of physicians... These data demonstrate that inpatient mortality in the United States was declining before, during, and after the 100,000 Lives Campaign... The program itself probably had no effect on the trend, yet the widespread policy and media reports led to several European countries adopting this “successful” model of patient safety at considerable costs... Subsequently, several large RCTs demonstrated that many components of the 100,000 Lives Campaign were not particularly effective, especially when compared with the benefits reported in the IHI’s press releases.

Show MeSH
Related in: MedlinePlus