Public Release: 

Placebo delivery method affects patient response

American College of Physicians

1. Placebo delivery method affects patient response to "therapy"

Free abstract: http://www.annals.org/article.aspx?doi=10.7326/M15-0623

URLs go live when embargo lifts

A systematic evidence review published in Annals of Internal Medicine finds that the way in which a placebo is delivered makes a difference in how patients respond to "therapy." Having a clinically significant response to the sham treatment could substantially affect outcomes in placebo-controlled trials. The data suggests that some placebos have a stronger effect than others.

Placebo controls, or supposedly ineffectual treatments, help to maintain blinding in evaluations of the effectiveness of medical treatments in clinical trials. It is unclear whether different placebo delivery methods yield different effects. Using knee osteoarthritis as an example, researchers reviewed 149 randomized trials comparing widely used pharmaceuticals against the following four placebos: oral, intra-articular, topical, and oral plus topical to quantify the effect of differential placebo effects on active-treatment effect estimates. The researchers concluded intra-articular and topical placebo interventions were associated with greater responses than oral placebo. This finding supports the notion that placebo treatments can exert clinically relevant effects and that the possibility of differential placebo effects need to be considered in assessment of the relative efficacies and rankings of active treatments versus different placebos.

Notes: For an embargoed PDF, please contact Cara Graeff or Steve Majewski. To speak with the lead author, Dr. Raveendhara Bannuru, please contact Jeremy Lechan at JLechan@tuftsmedicalcenter.org or 617-636-0104.


2. Wide variations in blood pressure linked to heart disease and death

Free abstract: http://www.annals.org/article.aspx?doi=10.7326/M14-2803

URLs go live when the embargo lifts

Higher variability of blood pressure readings between outpatient visits is associated with an increased risk for heart disease and death, according to a study published in Annals of Internal Medicine.

Previously, variations in blood pressure readings across outpatient visits were dismissed as a random fluctuation around a patient's true underlying blood pressure. Recent research has found an association between blood pressure variances and increased risk for stroke and heart disease, but other studies failed to reach the same conclusion.

Researchers studied data for 25,814 patients participating in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) to examine the association of visit-to-visit variability of systolic blood pressure and diastolic blood pressure with cardiovascular disease and mortality outcomes. The data showed a strong association between wide fluctuations in systolic blood pressure and fatal coronary heart disease or nonfatal myocardial infarction, all-cause mortality, stroke, and heart failure. Variations in diastolic blood pressure was also associated with these outcomes. The authors stress that their secondary analysis of ALLHAT data is presented using an observational study design and, therefore, causality cannot be determined.

Notes: For an embargoed PDF, please contact Cara Graeff or Steve Majewski. To reach the lead author, Dr. Paul Muntner, please contact Nicole Wyatt, 205-934-8938, nwyatt@uab.edu.


3. Study quantifies the cost of top medical board's physician certification program

Free abstract: http://www.annals.org/article.aspx?doi=10.7326/M15-1011

URLs go live when the embargo lifts

The American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) MOC requirements will cost internal medicine physicians an average of $23,607 over 10 years, ranging from $16,725 for general internists to $40,495 for hematologists-oncologists, according to a cost analysis published in Annals of Internal Medicine. The expenses include $2,349 in fees to ABIM and $21,259 in time costs. Cumulatively, the 10-year MOC cycle will cost $5.7 billion between 2015 and 2024, $1.2 billion more than the previous ABIM recertification process.

Testing costs include annual fees paid to ABIM to access online modules and retesting fees for physicians who failed their first recertification examination. Time costs capture the market value of the time physicians spend completing MOC and related documentation. Time accounts for $9 of every $10 spent on MOC.

The authors conclude that MOC reform should focus on decreasing the time required to fulfill MOC requirements and increasing integration with existing CME activities. A rigorous evaluation of MOC's effect on clinical and economic outcomes is warranted to better balance potential gains in the quality and efficiency of clinical care against the costs.

Notes: For an embargoed PDF, please contact Cara Graeff or Steve Majewski. To reach the lead author, Dr. Dhruv S. Kazi, please contact Scott Maier at Scott.Maier@ucsf.edu or 415-476-3595.

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Also in this issue:

Using Agent-Based Models to Address "Wicked Problems" Like Tobacco Use: A Report from the Institute of Medicine
Nancy A. Rigotti, MD, and Robert B. Wallace, MD, MSc
Ideas and Opinions
M15-1567
http://www.annals.org/article.aspx?doi=10.7326/M15-1567

Pragmatic Randomized Trials Without Standard Informed Consent? A National Survey
Rahul K. Nayak, BSE; David Wendler, PhD; Franklin G. Miller, PhD; and Scott Y.H. Kim, MD, PhD
Original Research
M15-0817
http://www.annals.org/article.aspx?doi=10.7326/M15-0817

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