BACKGROUND: Prostate cancer is the second leading cause of death due to cancer in men, but substantial controversy surrounds the role of PSA in screening asymptomatic patients. Although the test can help detect prostate cancer earlier, we currently lack evidence that this early detection will increase length or quality of life. The issues involved in the controversy include frequent false-positive results, potential for complications from treatment, and the frequency of slow-growing tumors that may never become clinically significant. In recognition of this complexity, the American Cancer Society and the American Urological Association revised their recommendations for men older than 50 years, calling for shared decision making in which the patient and physician discuss options and together make a decision that agrees with the patient’s individual health preferences. Of note, most other major organizations do not advocate routine PSA tests for screening. Previous research has shown that the way information about PSA testing is presented can influence the outcome of shared decision making. This study compared the effect of either a scripted discussion or videotape on men’s opinions about taking the PSA test.

POPULATION STUDIED: The investigators approached all men older than 50 years who were presenting for an annual preventive care evaluation at a large health maintenance organization (HMO). The participants (n=176) were sequentially assigned to 1 of 4 interventions: usual care, a discussion about risks and benefits of PSA, a shared decision-making video, or the video plus discussion. Baseline characteristics including age, education, marital status, ethnicity (more than 70% white), history of friend or family member with prostate cancer, and previous PSA testing did not differ among groups. Approximately 40% of those contacted to participate in 1 of the 3 interventions refused, but recruitment rates did not differ among the intervention groups.

STUDY DESIGN AND VALIDITY: The investigators used a nonrandomized unblinded 2x2 factorial comparison of the discussion and video formats that yielded the 4 groups described above. A previous study evaluated and described the 25-minute video, and the lecture-format discussion closely followed the content of the video.

OUTCOMES MEASURED: Measured responses in all groups included whether they wanted PSA testing, their level of confidence in their decision, and levels of knowledge and concern about prostate cancer. Those in the intervention groups also rated the amount, clarity, and perceived balance and fairness of the presentations. The study did not measure the actual incidence of subsequent PSA testing.

RESULTS: Almost all (97%) in the usual care group opted for testing. Discussion decreased the testing rate to 82% (P <.05), and members of the video (63%) and video/discussion (50%) groups chose testing even less frequently (P <.05 for difference between the discussion-only and either video group). All of the interventions (other than usual care) significantly increased knowledge about prostate cancer (3.4-3.9 correct responses to 5 questions vs 1.6, P <.001) and decreased confidence in the decision regarding PSA. Subjects in the usual care group expressed more concern about prostate cancer than those in the intervention groups. Less than 1% of subjects felt negative about participating in the interventions. Eighty-two percent considered the presentation balanced; 8% felt it was slanted in favor of screening; and 11% felt it was slanted against having PSA testing.

BACKGROUND: Prostate cancer is the second leading cause of death due to cancer in men, but substantial controversy surrounds the role of PSA in screening asymptomatic patients. Although the test can help detect prostate cancer earlier, we currently lack evidence that this early detection will increase length or quality of life. The issues involved in the controversy include frequent false-positive results, potential for complications from treatment, and the frequency of slow-growing tumors that may never become clinically significant. In recognition of this complexity, the American Cancer Society and the American Urological Association revised their recommendations for men older than 50 years, calling for shared decision making in which the patient and physician discuss options and together make a decision that agrees with the patient’s individual health preferences. Of note, most other major organizations do not advocate routine PSA tests for screening. Previous research has shown that the way information about PSA testing is presented can influence the outcome of shared decision making. This study compared the effect of either a scripted discussion or videotape on men’s opinions about taking the PSA test.

POPULATION STUDIED: The investigators approached all men older than 50 years who were presenting for an annual preventive care evaluation at a large health maintenance organization (HMO). The participants (n=176) were sequentially assigned to 1 of 4 interventions: usual care, a discussion about risks and benefits of PSA, a shared decision-making video, or the video plus discussion. Baseline characteristics including age, education, marital status, ethnicity (more than 70% white), history of friend or family member with prostate cancer, and previous PSA testing did not differ among groups. Approximately 40% of those contacted to participate in 1 of the 3 interventions refused, but recruitment rates did not differ among the intervention groups.

STUDY DESIGN AND VALIDITY: The investigators used a nonrandomized unblinded 2x2 factorial comparison of the discussion and video formats that yielded the 4 groups described above. A previous study evaluated and described the 25-minute video, and the lecture-format discussion closely followed the content of the video.

OUTCOMES MEASURED: Measured responses in all groups included whether they wanted PSA testing, their level of confidence in their decision, and levels of knowledge and concern about prostate cancer. Those in the intervention groups also rated the amount, clarity, and perceived balance and fairness of the presentations. The study did not measure the actual incidence of subsequent PSA testing.

RESULTS: Almost all (97%) in the usual care group opted for testing. Discussion decreased the testing rate to 82% (P <.05), and members of the video (63%) and video/discussion (50%) groups chose testing even less frequently (P <.05 for difference between the discussion-only and either video group). All of the interventions (other than usual care) significantly increased knowledge about prostate cancer (3.4-3.9 correct responses to 5 questions vs 1.6, P <.001) and decreased confidence in the decision regarding PSA. Subjects in the usual care group expressed more concern about prostate cancer than those in the intervention groups. Less than 1% of subjects felt negative about participating in the interventions. Eighty-two percent considered the presentation balanced; 8% felt it was slanted in favor of screening; and 11% felt it was slanted against having PSA testing.

BACKGROUND: Prostate cancer is the second leading cause of death due to cancer in men, but substantial controversy surrounds the role of PSA in screening asymptomatic patients. Although the test can help detect prostate cancer earlier, we currently lack evidence that this early detection will increase length or quality of life. The issues involved in the controversy include frequent false-positive results, potential for complications from treatment, and the frequency of slow-growing tumors that may never become clinically significant. In recognition of this complexity, the American Cancer Society and the American Urological Association revised their recommendations for men older than 50 years, calling for shared decision making in which the patient and physician discuss options and together make a decision that agrees with the patient’s individual health preferences. Of note, most other major organizations do not advocate routine PSA tests for screening. Previous research has shown that the way information about PSA testing is presented can influence the outcome of shared decision making. This study compared the effect of either a scripted discussion or videotape on men’s opinions about taking the PSA test.

POPULATION STUDIED: The investigators approached all men older than 50 years who were presenting for an annual preventive care evaluation at a large health maintenance organization (HMO). The participants (n=176) were sequentially assigned to 1 of 4 interventions: usual care, a discussion about risks and benefits of PSA, a shared decision-making video, or the video plus discussion. Baseline characteristics including age, education, marital status, ethnicity (more than 70% white), history of friend or family member with prostate cancer, and previous PSA testing did not differ among groups. Approximately 40% of those contacted to participate in 1 of the 3 interventions refused, but recruitment rates did not differ among the intervention groups.

STUDY DESIGN AND VALIDITY: The investigators used a nonrandomized unblinded 2x2 factorial comparison of the discussion and video formats that yielded the 4 groups described above. A previous study evaluated and described the 25-minute video, and the lecture-format discussion closely followed the content of the video.

OUTCOMES MEASURED: Measured responses in all groups included whether they wanted PSA testing, their level of confidence in their decision, and levels of knowledge and concern about prostate cancer. Those in the intervention groups also rated the amount, clarity, and perceived balance and fairness of the presentations. The study did not measure the actual incidence of subsequent PSA testing.

RESULTS: Almost all (97%) in the usual care group opted for testing. Discussion decreased the testing rate to 82% (P <.05), and members of the video (63%) and video/discussion (50%) groups chose testing even less frequently (P <.05 for difference between the discussion-only and either video group). All of the interventions (other than usual care) significantly increased knowledge about prostate cancer (3.4-3.9 correct responses to 5 questions vs 1.6, P <.001) and decreased confidence in the decision regarding PSA. Subjects in the usual care group expressed more concern about prostate cancer than those in the intervention groups. Less than 1% of subjects felt negative about participating in the interventions. Eighty-two percent considered the presentation balanced; 8% felt it was slanted in favor of screening; and 11% felt it was slanted against having PSA testing.

BACKGROUND: Many asthmatics do not have adequate symptom control despite using inhaled corticosteroids. This study evaluates the effectiveness of salmeterol and montelukast as second-line agents added to inhaled corticosteroids.

POPULATION STUDIED: The authors enrolled 20 patients with moderate persistent asthma (forced expiratory volume in 1 second = 79.1; forced expiratory flow = 25-50, 51.5% predicted). All were suboptimally controlled despite monotherapy with at least 400 mg per day of inhaled corticosteroid (median dose = 800 mg/day). The subjects were required to have persistent asthma symptoms requiring 2 puffs per day of a short-acting b2-agonist as rescue therapy, to have at least 10% diurnal variation in their morning and evening peak expiratory flow (PEF) rates, and to be responsive to adenosine monophosphate (AMP) bronchial challenge testing. The study population is likely to be similar to that subset of primary care patients with suboptimally controlled asthma symptoms, although no information is given about those excluded from the study.

STUDY DESIGN AND VALIDITY: The study was a randomized placebo-controlled single-blind double-dummy crossover design. In addition to receiving their usual maintenance dose of inhaled corticosteroid throughout the study, the patients were randomized to receive either inhaled salmeterol 50 mg twice daily plus a placebo tablet once daily, or oral montelukast 10 mg once daily plus a placebo inhaler twice daily. There was a 1-week run-in period where all subjects received double placebo, followed by 2 weeks of active treatment. The patients then had another week of double placebo after which they were switched over to the opposite active drug and placebo combination for the final 2 weeks. Standardized instructions, as well as written instructions, were given by a third party. All laboratory measurements were performed at 8 AM. Data from patients with greater than 90% compliance were considered evaluable. The major strengths of this study were the randomization and crossover design that allowed patients to serve as their own control. This greatly increased the ability of the study to detect a difference if one existed, despite the small number of patients. Weaknesses included the strong emphasis placed on disease-oriented outcomes, being only single blinded, and the crudeness of the scale used to measure symptoms (a 4-point scale from no symptoms to severe symptoms).

OUTCOMES MEASURED: The primary endpoint was the effect on AMP bronchial challenge (PC20), which causes bronchoconstriction indirectly by release of inflammatory mediators. Secondary outcomes included exhaled nitric oxide, blood eosinophil count, daily symptom control, rescue bronchodilator requirements, PEF, and lung function.

RESULTS: Montelukast was found to produce a significant difference in PC20 after the first dose, as well as at the end of 2 weeks (last dose). Salmeterol produced a significant difference in PC20 after the first dose but not after the last dose. Montelukast was superior to salmeterol in lowering blood eosinophil counts. There was no difference in nitric oxide measurements. Compared with placebo, salmeterol significantly improved daytime and nighttime symptom scoring and need for rescue therapy, as well as morning PEF rate. Montelukast showed significant improvement in daytime and nocturnal need for rescue therapy and morning PEF rate but not in symptom control.

BACKGROUND: Many asthmatics do not have adequate symptom control despite using inhaled corticosteroids. This study evaluates the effectiveness of salmeterol and montelukast as second-line agents added to inhaled corticosteroids.

POPULATION STUDIED: The authors enrolled 20 patients with moderate persistent asthma (forced expiratory volume in 1 second = 79.1; forced expiratory flow = 25-50, 51.5% predicted). All were suboptimally controlled despite monotherapy with at least 400 mg per day of inhaled corticosteroid (median dose = 800 mg/day). The subjects were required to have persistent asthma symptoms requiring 2 puffs per day of a short-acting b2-agonist as rescue therapy, to have at least 10% diurnal variation in their morning and evening peak expiratory flow (PEF) rates, and to be responsive to adenosine monophosphate (AMP) bronchial challenge testing. The study population is likely to be similar to that subset of primary care patients with suboptimally controlled asthma symptoms, although no information is given about those excluded from the study.

STUDY DESIGN AND VALIDITY: The study was a randomized placebo-controlled single-blind double-dummy crossover design. In addition to receiving their usual maintenance dose of inhaled corticosteroid throughout the study, the patients were randomized to receive either inhaled salmeterol 50 mg twice daily plus a placebo tablet once daily, or oral montelukast 10 mg once daily plus a placebo inhaler twice daily. There was a 1-week run-in period where all subjects received double placebo, followed by 2 weeks of active treatment. The patients then had another week of double placebo after which they were switched over to the opposite active drug and placebo combination for the final 2 weeks. Standardized instructions, as well as written instructions, were given by a third party. All laboratory measurements were performed at 8 AM. Data from patients with greater than 90% compliance were considered evaluable. The major strengths of this study were the randomization and crossover design that allowed patients to serve as their own control. This greatly increased the ability of the study to detect a difference if one existed, despite the small number of patients. Weaknesses included the strong emphasis placed on disease-oriented outcomes, being only single blinded, and the crudeness of the scale used to measure symptoms (a 4-point scale from no symptoms to severe symptoms).

OUTCOMES MEASURED: The primary endpoint was the effect on AMP bronchial challenge (PC20), which causes bronchoconstriction indirectly by release of inflammatory mediators. Secondary outcomes included exhaled nitric oxide, blood eosinophil count, daily symptom control, rescue bronchodilator requirements, PEF, and lung function.

RESULTS: Montelukast was found to produce a significant difference in PC20 after the first dose, as well as at the end of 2 weeks (last dose). Salmeterol produced a significant difference in PC20 after the first dose but not after the last dose. Montelukast was superior to salmeterol in lowering blood eosinophil counts. There was no difference in nitric oxide measurements. Compared with placebo, salmeterol significantly improved daytime and nighttime symptom scoring and need for rescue therapy, as well as morning PEF rate. Montelukast showed significant improvement in daytime and nocturnal need for rescue therapy and morning PEF rate but not in symptom control.

BACKGROUND: Many asthmatics do not have adequate symptom control despite using inhaled corticosteroids. This study evaluates the effectiveness of salmeterol and montelukast as second-line agents added to inhaled corticosteroids.

POPULATION STUDIED: The authors enrolled 20 patients with moderate persistent asthma (forced expiratory volume in 1 second = 79.1; forced expiratory flow = 25-50, 51.5% predicted). All were suboptimally controlled despite monotherapy with at least 400 mg per day of inhaled corticosteroid (median dose = 800 mg/day). The subjects were required to have persistent asthma symptoms requiring 2 puffs per day of a short-acting b2-agonist as rescue therapy, to have at least 10% diurnal variation in their morning and evening peak expiratory flow (PEF) rates, and to be responsive to adenosine monophosphate (AMP) bronchial challenge testing. The study population is likely to be similar to that subset of primary care patients with suboptimally controlled asthma symptoms, although no information is given about those excluded from the study.

STUDY DESIGN AND VALIDITY: The study was a randomized placebo-controlled single-blind double-dummy crossover design. In addition to receiving their usual maintenance dose of inhaled corticosteroid throughout the study, the patients were randomized to receive either inhaled salmeterol 50 mg twice daily plus a placebo tablet once daily, or oral montelukast 10 mg once daily plus a placebo inhaler twice daily. There was a 1-week run-in period where all subjects received double placebo, followed by 2 weeks of active treatment. The patients then had another week of double placebo after which they were switched over to the opposite active drug and placebo combination for the final 2 weeks. Standardized instructions, as well as written instructions, were given by a third party. All laboratory measurements were performed at 8 AM. Data from patients with greater than 90% compliance were considered evaluable. The major strengths of this study were the randomization and crossover design that allowed patients to serve as their own control. This greatly increased the ability of the study to detect a difference if one existed, despite the small number of patients. Weaknesses included the strong emphasis placed on disease-oriented outcomes, being only single blinded, and the crudeness of the scale used to measure symptoms (a 4-point scale from no symptoms to severe symptoms).

OUTCOMES MEASURED: The primary endpoint was the effect on AMP bronchial challenge (PC20), which causes bronchoconstriction indirectly by release of inflammatory mediators. Secondary outcomes included exhaled nitric oxide, blood eosinophil count, daily symptom control, rescue bronchodilator requirements, PEF, and lung function.

RESULTS: Montelukast was found to produce a significant difference in PC20 after the first dose, as well as at the end of 2 weeks (last dose). Salmeterol produced a significant difference in PC20 after the first dose but not after the last dose. Montelukast was superior to salmeterol in lowering blood eosinophil counts. There was no difference in nitric oxide measurements. Compared with placebo, salmeterol significantly improved daytime and nighttime symptom scoring and need for rescue therapy, as well as morning PEF rate. Montelukast showed significant improvement in daytime and nocturnal need for rescue therapy and morning PEF rate but not in symptom control.