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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 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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Elderly people who begin benzodiazepine therapy (recipients) are already sicker and more prone to fractures than nonrecipients. Figure is based on data extracted from Luijendijk et al (35).Patient CharacteristicPercentage Increase in Risk (Hazard Ratio), Benzodiazepine Recipients vs NonrecipientsFemale67Depression53Hypertension29Pain-related joint complaints45Health self-reported as worse than that of peers50Current smoker36
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Figure 9: Elderly people who begin benzodiazepine therapy (recipients) are already sicker and more prone to fractures than nonrecipients. Figure is based on data extracted from Luijendijk et al (35).Patient CharacteristicPercentage Increase in Risk (Hazard Ratio), Benzodiazepine Recipients vs NonrecipientsFemale67Depression53Hypertension29Pain-related joint complaints45Health self-reported as worse than that of peers50Current smoker36

Mentions: Confounding by indication may be especially problematic in studies of benzodiazepines because physicians prescribe them to elderly patients who are sick and frail. Because sickness and frailty are often unmeasured, their biasing effects are hidden. Compared with elderly people who do not use benzodiazepines, elderly people who start benzodiazepine therapy have a 29% increased risk for hypertension, a 45% increased risk for pain-related joint complaints (an obvious predictor of hip fractures that is rarely measured in research data), a 50% increased risk for self-reporting health as worse than that of peers, and a 36% increased risk for being a current smoker (Figure 9) (35). Moreover, elderly people prescribed benzodiazepines are more likely to have dementia, a powerful cause of falls and fractures (36). So benzodiazepine users are more likely to fracture their hip even without taking any medication.


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)

Elderly people who begin benzodiazepine therapy (recipients) are already sicker and more prone to fractures than nonrecipients. Figure is based on data extracted from Luijendijk et al (35).Patient CharacteristicPercentage Increase in Risk (Hazard Ratio), Benzodiazepine Recipients vs NonrecipientsFemale67Depression53Hypertension29Pain-related joint complaints45Health self-reported as worse than that of peers50Current smoker36
© Copyright Policy
Related In: Results  -  Collection

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

Figure 9: Elderly people who begin benzodiazepine therapy (recipients) are already sicker and more prone to fractures than nonrecipients. Figure is based on data extracted from Luijendijk et al (35).Patient CharacteristicPercentage Increase in Risk (Hazard Ratio), Benzodiazepine Recipients vs NonrecipientsFemale67Depression53Hypertension29Pain-related joint complaints45Health self-reported as worse than that of peers50Current smoker36
Mentions: Confounding by indication may be especially problematic in studies of benzodiazepines because physicians prescribe them to elderly patients who are sick and frail. Because sickness and frailty are often unmeasured, their biasing effects are hidden. Compared with elderly people who do not use benzodiazepines, elderly people who start benzodiazepine therapy have a 29% increased risk for hypertension, a 45% increased risk for pain-related joint complaints (an obvious predictor of hip fractures that is rarely measured in research data), a 50% increased risk for self-reporting health as worse than that of peers, and a 36% increased risk for being a current smoker (Figure 9) (35). Moreover, elderly people prescribed benzodiazepines are more likely to have dementia, a powerful cause of falls and fractures (36). So benzodiazepine users are more likely to fracture their hip even without taking any medication.

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 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