Nucryst Pharmaceuticals, Inc., announced the results of its first human trial of NPI 32101, a topical form of its skin ointment. A total of 225 patients diagnosed with skin irritations were randomly divided into three groups as part of a double-blind, placebo-controlled study to test the effectiveness of the new topical cream. The first group received a 0.5% cream, the second group received a 1.0% cream, and the third group received a placebo. Groups were treated twice daily for a 6-week period.


c. What does it mean for this study to be double-blind?

Each of the following surveys has bias. Identify the type of bias.

A researcher conducting a poll about national politics sends a survey to a random sample of subscribers to Time magazine.

Shapely Glasses Does the shape of a glass play a role in determining the amount of time it takes to finish the drink? Researchers identified 159 male and female self-professed social drinkers. One week the subjects were given a 12 ounce beer with either a straight glass or a curved glass. A week later the subjects were given a 12 ounce beer in the other glass. The first week, subjects were given a glass and asked to consume the drink at their own pace while watching television. The time to complete the drink was measured. During the second week, the subjects were given the other shaped glass and asked to complete a computer task. Again, the time to complete the drink was measured. The type of glass given in the first week was determined randomly. The researchers found that the time to complete the drink was significantly faster for the curved glass.

Who are the subjects?

Shapely Glasses Does the shape of a glass play a role in determining the amount of time it takes to finish the drink? Researchers identified 159 male and female self-professed social drinkers. One week the subjects were given a 12 ounce beer with either a straight glass or a curved glass. A week later the subjects were given a 12 ounce beer in the other glass. The first week, subjects were given a glass and asked to consume the drink at their own pace while watching television. The time to complete the drink was measured. During the second week, the subjects were given the other shaped glass and asked to complete a computer task. Again, the time to complete the drink was measured. The type of glass given in the first week was determined randomly. The researchers found that the time to complete the drink was significantly faster for the curved glass.

What is the response variable? Is it qualitative or quantitative?

Shapely Glasses Does the shape of a glass play a role in determining the amount of time it takes to finish the drink? Researchers identified 159 male and female self-professed social drinkers. One week the subjects were given a 12 ounce beer with either a straight glass or a curved glass. A week later the subjects were given a 12 ounce beer in the other glass. The first week, subjects were given a glass and asked to consume the drink at their own pace while watching television. The time to complete the drink was measured. During the second week, the subjects were given the other shaped glass and asked to complete a computer task. Again, the time to complete the drink was measured. The type of glass given in the first week was determined randomly. The researchers found that the time to complete the drink was significantly faster for the curved glass.

e. Explain the role randomization plays in this experiment.

Insomnia Researchers wanted to test the effectiveness of a new cognitive behavioral therapy (CBT) compared with both an older behavioral treatment and a placebo therapy for treating insomnia. They identified 75 adults with insomnia. Patients were randomly assigned to one of three treatment groups. Twenty-five patients were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions), another 25 received muscle relaxation training (RT), and the final 25 received a placebo treatment. Treatment lasted 6 weeks, with follow-up conducted at 6 months. To measure the effectiveness of the treatment, researchers used wake time after sleep onset (WASO). CBT produced larger improvements than did RT or placebo treatment. For example, the CBT-treated patients achieved an average 54% reduction in their WASO, whereas RT-treated and placebo-treated patients, respectively, achieved only 16% and 12% reductions in this measure. Results suggest that CBT treatment leads to significant sleep improvements within 6 weeks, and these improvements appear to endure through 6 months of follow-up. 53 Source: Jack D. Edinger, PhD; William K. Wohlgemuth, PhD; Rodney A. Radtke, MD; Gail R. Marsh, PhD; Ruth E. Quillian, PhD. “Cognitive Behavioral Therapy for Treatment of Chronic Primary Insomnia,” Journal of the American Medical Association 285: 1856–1864, 2001

What is the population being studied?

Insomnia Researchers wanted to test the effectiveness of a new cognitive behavioral therapy (CBT) compared with both an older behavioral treatment and a placebo therapy for treating insomnia. They identified 75 adults with insomnia. Patients were randomly assigned to one of three treatment groups. Twenty-five patients were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions), another 25 received muscle relaxation training (RT), and the final 25 received a placebo treatment. Treatment lasted 6 weeks, with follow-up conducted at 6 months. To measure the effectiveness of the treatment, researchers used wake time after sleep onset (WASO). CBT produced larger improvements than did RT or placebo treatment. For example, the CBT-treated patients achieved an average 54% reduction in their WASO, whereas RT-treated and placebo-treated patients, respectively, achieved only 16% and 12% reductions in this measure. Results suggest that CBT treatment leads to significant sleep improvements within 6 weeks, and these improvements appear to endure through 6 months of follow-up. 53 Source: Jack D. Edinger, PhD; William K. Wohlgemuth, PhD; Rodney A. Radtke, MD; Gail R. Marsh, PhD; Ruth E. Quillian, PhD. “Cognitive Behavioral Therapy for Treatment of Chronic Primary Insomnia,” Journal of the American Medical Association 285: 1856–1864, 2001

What is the response variable in this study?

The Memory Drug? Researchers wanted to evaluate whether ginkgo, an over-the-counter herb marketed as enhancing memory, improves memory in elderly adults as measured by objective tests. To do this, they recruited 98 men and 132 women older than 60 years and in good health. Participants were randomly assigned to receive ginkgo, 40 milligrams (mg) 3 times per day, or a matching placebo. The measure of memory improvement was determined by a standardized test of learning and memory. After 6 weeks of treatment, the data indicated that ginkgo did not increase performance on standard tests of learning, memory, attention, and concentration. These data suggest that, when taken following the manufacturer’s instructions, ginkgo provides no measurable increase in memory or related cognitive function to adults with healthy cognitive function.

What is the factor that is set to predetermined levels? What are the treatments?

Platelet-Rich Plasma Does a platelet-rich plasma (PRP) injection into the scalp promote hair growth? Researchers identified 30 female patients with female pattern hair loss. The patients ranged in age from 20 to 45 years. For each patient, two areas with hair loss were identified. A coin toss was used to decide which area received the PRP injection and which received a saline injection. Injections were given to each patient at one-week intervals. After 6 months the change in the patients’ hair density (number of hairs per square centimeter) and hair diameter (millimeters) was measured. The mean difference in hair density (PCP minus saline) was 59.47 hairs/cm2 and the mean difference in hair thickness was 0.08 mm.

What type of experimental design is this?