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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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Example of a strong time-series design that controlled for history bias in the Institute for Healthcare Improvement’s 100,000 Lives Campaign. Figure is based on data from the Agency for Healthcare Research and Quality (48).YearDeaths per 100 Discharges19932.7219942.6319952.5819962.5419972.4619982.5019992.4620002.3720012.3220022.2420032.2220042.132005 (Quality of care program began in January 2005)2.0920062.0420071.9420082.0320091.9220101.9020111.91
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Figure 18: Example of a strong time-series design that controlled for history bias in the Institute for Healthcare Improvement’s 100,000 Lives Campaign. Figure is based on data from the Agency for Healthcare Research and Quality (48).YearDeaths per 100 Discharges19932.7219942.6319952.5819962.5419972.4619982.5019992.4620002.3720012.3220022.2420032.2220042.132005 (Quality of care program began in January 2005)2.0920062.0420071.9420082.0320091.9220101.9020111.91

Mentions: Does more rigorous evidence support the notion that the 100,000 Lives Campaign actually reduced mortality rates? To investigate that question, we obtained 12 years of national statistics on hospital mortality, longitudinal data from before the program went into effect (48). We found that mortality was already declining long before the program began (Figure 18) and that during the program the decline continued at roughly the same rate. 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.


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)

Example of a strong time-series design that controlled for history bias in the Institute for Healthcare Improvement’s 100,000 Lives Campaign. Figure is based on data from the Agency for Healthcare Research and Quality (48).YearDeaths per 100 Discharges19932.7219942.6319952.5819962.5419972.4619982.5019992.4620002.3720012.3220022.2420032.2220042.132005 (Quality of care program began in January 2005)2.0920062.0420071.9420082.0320091.9220101.9020111.91
© Copyright Policy
Related In: Results  -  Collection

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

Figure 18: Example of a strong time-series design that controlled for history bias in the Institute for Healthcare Improvement’s 100,000 Lives Campaign. Figure is based on data from the Agency for Healthcare Research and Quality (48).YearDeaths per 100 Discharges19932.7219942.6319952.5819962.5419972.4619982.5019992.4620002.3720012.3220022.2420032.2220042.132005 (Quality of care program began in January 2005)2.0920062.0420071.9420082.0320091.9220101.9020111.91
Mentions: Does more rigorous evidence support the notion that the 100,000 Lives Campaign actually reduced mortality rates? To investigate that question, we obtained 12 years of national statistics on hospital mortality, longitudinal data from before the program went into effect (48). We found that mortality was already declining long before the program began (Figure 18) and that during the program the decline continued at roughly the same rate. 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.

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