Inhaled Corticosteroids Decrease Inflammation in Moderate to Severe COPD

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Inhaled Corticosteroids Decrease Inflammation in Moderate to Severe COPD

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

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Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

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Resident Fatigue and Distress Contribute to Perceived Medical Errors

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Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

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Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

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Dabigatran Is Not Inferior to Warfarin in Atrial Fibrillation

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Dabigatran Is Not Inferior to Warfarin in Atrial Fibrillation

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

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Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

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Cardiac Resynchronization Therapy with Implantable Cardioverter Defibrillator Placement Decreases Heart Failure

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Cardiac Resynchronization Therapy with Implantable Cardioverter Defibrillator Placement Decreases Heart Failure

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

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Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

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Fluvastatin Improves Postoperative Cardiac Outcomes in Patients Undergoing Vascular Surgery

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Fluvastatin Improves Postoperative Cardiac Outcomes in Patients Undergoing Vascular Surgery

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

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Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

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New criteria for diagnosing MM could prevent organ damage

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New criteria for diagnosing MM could prevent organ damage

Bone marrow biopsy

Credit: Chad McNeeley

The International Myeloma Working Group (IMWG) has published new criteria for diagnosing multiple myeloma (MM) in The Lancet Oncology.

The group has added validated biomarkers to the current clinical symptoms used for MM diagnosis—hypercalcemia, renal failure, anemia, and bone lesions.

This addition will allow physicians to diagnose MM before patients become symptomatic and, therefore, before organ damage occurs, according to the IMWG.

Lead author S. Vincent Rajkumar, MD, of the Mayo Clinic in Rochester, Minnesota, noted that MM is always preceded sequentially by two conditions—monoclonal gammopathy of undetermined significance and smoldering MM. Since both are asymptomatic, most MM patients are not diagnosed until organ damage occurs.

“The new IMWG criteria allow for the diagnosis of myeloma to be made in patients without symptoms and before organ damage occurs, using validated biomarkers that identify patients with [smoldering] MM who have an ‘ultra-high’ risk of progression to multiple myeloma,” Dr Rajkumar said.

“These biomarkers are associated with the near-inevitable development of clinical symptoms and are important for early diagnosis and treatment, which is very important for patients.”

Other updates to the criteria used to diagnose MM include the use of CT and PET-CT scans to identify bone lesions. According to the authors, this will enable more accurate diagnosis and intervention before fractures or other serious problems arise.

“We believe that the new criteria will rectify the situation where we were unable to use the considerable advances in multiple myeloma therapy prior to organ damage,” Dr Rajkumar said. “We can now initiate therapy in some patients early on in the course of their disease.”

The IMWG’s revised diagnostic criteria for MM and smoldering MM are as follows.

Definition of MM

Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma* and one or more of the following myeloma defining events:

  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:

    • Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL).
    • Renal insufficiency: creatinine clearance <40 mL per min (measured or estimated by validated equations) or serum creatinine >177 μmol/L (>2 mg/dL).
    • Anemia: hemoglobin value of >20 g/L below the lower limit of normal or a hemoglobin value <100 g/L.
    • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT. If the bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.

  • One or more of the following biomarkers:

    • Clonal bone marrow plasma cell percentage ≥60%.
    • Involved:uninvolved serum free light chain ratio ≥100. These values are based on the serum Freelite assay (The Binding Site Group, Birmingham, UK). The involved free light chain must be ≥100 mg/L.
    • >1 focal lesions on MRI studies. Each focal lesion must be 5 mm or more in size.

*The IMWG said clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone

marrow plasma cell percentage should preferably be estimated from a core biopsy specimen. In case of a disparity between the aspirate and core biopsy, the highest value should be used.

Definition of smoldering MM

Both of the following criteria must be met:

  • Serum monoclonal protein (IgG or IgA) ≥30 g/L or urinary monoclonal protein ≥500 mg per 24 hours and/or clonal bone marrow plasma cells 10%–60%.
  • Absence of myeloma defining events or amyloidosis.
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Bone marrow biopsy

Credit: Chad McNeeley

The International Myeloma Working Group (IMWG) has published new criteria for diagnosing multiple myeloma (MM) in The Lancet Oncology.

The group has added validated biomarkers to the current clinical symptoms used for MM diagnosis—hypercalcemia, renal failure, anemia, and bone lesions.

This addition will allow physicians to diagnose MM before patients become symptomatic and, therefore, before organ damage occurs, according to the IMWG.

Lead author S. Vincent Rajkumar, MD, of the Mayo Clinic in Rochester, Minnesota, noted that MM is always preceded sequentially by two conditions—monoclonal gammopathy of undetermined significance and smoldering MM. Since both are asymptomatic, most MM patients are not diagnosed until organ damage occurs.

“The new IMWG criteria allow for the diagnosis of myeloma to be made in patients without symptoms and before organ damage occurs, using validated biomarkers that identify patients with [smoldering] MM who have an ‘ultra-high’ risk of progression to multiple myeloma,” Dr Rajkumar said.

“These biomarkers are associated with the near-inevitable development of clinical symptoms and are important for early diagnosis and treatment, which is very important for patients.”

Other updates to the criteria used to diagnose MM include the use of CT and PET-CT scans to identify bone lesions. According to the authors, this will enable more accurate diagnosis and intervention before fractures or other serious problems arise.

“We believe that the new criteria will rectify the situation where we were unable to use the considerable advances in multiple myeloma therapy prior to organ damage,” Dr Rajkumar said. “We can now initiate therapy in some patients early on in the course of their disease.”

The IMWG’s revised diagnostic criteria for MM and smoldering MM are as follows.

Definition of MM

Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma* and one or more of the following myeloma defining events:

  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:

    • Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL).
    • Renal insufficiency: creatinine clearance <40 mL per min (measured or estimated by validated equations) or serum creatinine >177 μmol/L (>2 mg/dL).
    • Anemia: hemoglobin value of >20 g/L below the lower limit of normal or a hemoglobin value <100 g/L.
    • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT. If the bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.

  • One or more of the following biomarkers:

    • Clonal bone marrow plasma cell percentage ≥60%.
    • Involved:uninvolved serum free light chain ratio ≥100. These values are based on the serum Freelite assay (The Binding Site Group, Birmingham, UK). The involved free light chain must be ≥100 mg/L.
    • >1 focal lesions on MRI studies. Each focal lesion must be 5 mm or more in size.

*The IMWG said clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone

marrow plasma cell percentage should preferably be estimated from a core biopsy specimen. In case of a disparity between the aspirate and core biopsy, the highest value should be used.

Definition of smoldering MM

Both of the following criteria must be met:

  • Serum monoclonal protein (IgG or IgA) ≥30 g/L or urinary monoclonal protein ≥500 mg per 24 hours and/or clonal bone marrow plasma cells 10%–60%.
  • Absence of myeloma defining events or amyloidosis.

Bone marrow biopsy

Credit: Chad McNeeley

The International Myeloma Working Group (IMWG) has published new criteria for diagnosing multiple myeloma (MM) in The Lancet Oncology.

The group has added validated biomarkers to the current clinical symptoms used for MM diagnosis—hypercalcemia, renal failure, anemia, and bone lesions.

This addition will allow physicians to diagnose MM before patients become symptomatic and, therefore, before organ damage occurs, according to the IMWG.

Lead author S. Vincent Rajkumar, MD, of the Mayo Clinic in Rochester, Minnesota, noted that MM is always preceded sequentially by two conditions—monoclonal gammopathy of undetermined significance and smoldering MM. Since both are asymptomatic, most MM patients are not diagnosed until organ damage occurs.

“The new IMWG criteria allow for the diagnosis of myeloma to be made in patients without symptoms and before organ damage occurs, using validated biomarkers that identify patients with [smoldering] MM who have an ‘ultra-high’ risk of progression to multiple myeloma,” Dr Rajkumar said.

“These biomarkers are associated with the near-inevitable development of clinical symptoms and are important for early diagnosis and treatment, which is very important for patients.”

Other updates to the criteria used to diagnose MM include the use of CT and PET-CT scans to identify bone lesions. According to the authors, this will enable more accurate diagnosis and intervention before fractures or other serious problems arise.

“We believe that the new criteria will rectify the situation where we were unable to use the considerable advances in multiple myeloma therapy prior to organ damage,” Dr Rajkumar said. “We can now initiate therapy in some patients early on in the course of their disease.”

The IMWG’s revised diagnostic criteria for MM and smoldering MM are as follows.

Definition of MM

Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma* and one or more of the following myeloma defining events:

  • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:

    • Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL).
    • Renal insufficiency: creatinine clearance <40 mL per min (measured or estimated by validated equations) or serum creatinine >177 μmol/L (>2 mg/dL).
    • Anemia: hemoglobin value of >20 g/L below the lower limit of normal or a hemoglobin value <100 g/L.
    • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT. If the bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.

  • One or more of the following biomarkers:

    • Clonal bone marrow plasma cell percentage ≥60%.
    • Involved:uninvolved serum free light chain ratio ≥100. These values are based on the serum Freelite assay (The Binding Site Group, Birmingham, UK). The involved free light chain must be ≥100 mg/L.
    • >1 focal lesions on MRI studies. Each focal lesion must be 5 mm or more in size.

*The IMWG said clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone

marrow plasma cell percentage should preferably be estimated from a core biopsy specimen. In case of a disparity between the aspirate and core biopsy, the highest value should be used.

Definition of smoldering MM

Both of the following criteria must be met:

  • Serum monoclonal protein (IgG or IgA) ≥30 g/L or urinary monoclonal protein ≥500 mg per 24 hours and/or clonal bone marrow plasma cells 10%–60%.
  • Absence of myeloma defining events or amyloidosis.
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Device monitors methotrexate levels faster

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Device monitors methotrexate levels faster

Blood sample collection

Credit: Juan D. Alfonso

A new device can measure methotrexate levels in a patient’s blood in less than a minute, according to research published in Biosensors and Bioelectronics.

Researchers say this nanoscale device is just as accurate and 10 times less expensive than equipment currently used in hospitals.

It has an optical system that can rapidly gauge the optimal dose of methotrexate a patient needs, thereby reducing the risk of adverse effects.

“While effective, methotrexate is also highly toxic and can damage the healthy cells of patients, hence the importance of closely monitoring the drug’s concentration in the serum of treated individuals to adjust the dosage,” said study author Jean François Masson, PhD, of the University of Montreal in Quebec, Canada.

“The operation of the current [methotrexate monitoring] device is based on a cumbersome, expensive platform that requires experienced personnel because of the many samples that need to be manipulated.”

With this in mind, Dr Masson and his colleagues set out to simplify methotrexate monitoring.

In the course of their research, the team developed and manufactured a miniaturized device that works by surface plasmon resonance. It measures the concentration of serum methotrexate through gold nanoparticles on the surface of a receptacle.

In “competing” with methotrexate to block the enzyme dihydrofolate reductase, the gold nanoparticles change the color of the light detected by the instrument. And the color of the light detected reflects the exact concentration of the drug in the blood sample.

The researchers compared the accuracy of measurements taken with the new device to those taken with equipment used at the Maisonneuve-Rosemont Hospital in Montreal.

“Testing was conclusive,” Dr Masson said. “Not only were the measurements as accurate, but our device took less than 60 seconds to produce results, compared to 30 minutes for current devices.”

Moreover, the comparative tests were performed by lab technicians who were not experienced with surface plasmon resonance and did not encounter major difficulties in operating the new equipment or obtaining the same conclusive results as Dr Masson and his research team.

“In the near future, we can foresee the device in doctors’ offices or even at the bedside, where patients would receive individualized and optimal doses while minimizing the risk of complications,” Dr Masson said.

“While traditional equipment requires an investment of around $100,000, the new mobile device would likely cost 10 times less, around $10,000.”

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Blood sample collection

Credit: Juan D. Alfonso

A new device can measure methotrexate levels in a patient’s blood in less than a minute, according to research published in Biosensors and Bioelectronics.

Researchers say this nanoscale device is just as accurate and 10 times less expensive than equipment currently used in hospitals.

It has an optical system that can rapidly gauge the optimal dose of methotrexate a patient needs, thereby reducing the risk of adverse effects.

“While effective, methotrexate is also highly toxic and can damage the healthy cells of patients, hence the importance of closely monitoring the drug’s concentration in the serum of treated individuals to adjust the dosage,” said study author Jean François Masson, PhD, of the University of Montreal in Quebec, Canada.

“The operation of the current [methotrexate monitoring] device is based on a cumbersome, expensive platform that requires experienced personnel because of the many samples that need to be manipulated.”

With this in mind, Dr Masson and his colleagues set out to simplify methotrexate monitoring.

In the course of their research, the team developed and manufactured a miniaturized device that works by surface plasmon resonance. It measures the concentration of serum methotrexate through gold nanoparticles on the surface of a receptacle.

In “competing” with methotrexate to block the enzyme dihydrofolate reductase, the gold nanoparticles change the color of the light detected by the instrument. And the color of the light detected reflects the exact concentration of the drug in the blood sample.

The researchers compared the accuracy of measurements taken with the new device to those taken with equipment used at the Maisonneuve-Rosemont Hospital in Montreal.

“Testing was conclusive,” Dr Masson said. “Not only were the measurements as accurate, but our device took less than 60 seconds to produce results, compared to 30 minutes for current devices.”

Moreover, the comparative tests were performed by lab technicians who were not experienced with surface plasmon resonance and did not encounter major difficulties in operating the new equipment or obtaining the same conclusive results as Dr Masson and his research team.

“In the near future, we can foresee the device in doctors’ offices or even at the bedside, where patients would receive individualized and optimal doses while minimizing the risk of complications,” Dr Masson said.

“While traditional equipment requires an investment of around $100,000, the new mobile device would likely cost 10 times less, around $10,000.”

Blood sample collection

Credit: Juan D. Alfonso

A new device can measure methotrexate levels in a patient’s blood in less than a minute, according to research published in Biosensors and Bioelectronics.

Researchers say this nanoscale device is just as accurate and 10 times less expensive than equipment currently used in hospitals.

It has an optical system that can rapidly gauge the optimal dose of methotrexate a patient needs, thereby reducing the risk of adverse effects.

“While effective, methotrexate is also highly toxic and can damage the healthy cells of patients, hence the importance of closely monitoring the drug’s concentration in the serum of treated individuals to adjust the dosage,” said study author Jean François Masson, PhD, of the University of Montreal in Quebec, Canada.

“The operation of the current [methotrexate monitoring] device is based on a cumbersome, expensive platform that requires experienced personnel because of the many samples that need to be manipulated.”

With this in mind, Dr Masson and his colleagues set out to simplify methotrexate monitoring.

In the course of their research, the team developed and manufactured a miniaturized device that works by surface plasmon resonance. It measures the concentration of serum methotrexate through gold nanoparticles on the surface of a receptacle.

In “competing” with methotrexate to block the enzyme dihydrofolate reductase, the gold nanoparticles change the color of the light detected by the instrument. And the color of the light detected reflects the exact concentration of the drug in the blood sample.

The researchers compared the accuracy of measurements taken with the new device to those taken with equipment used at the Maisonneuve-Rosemont Hospital in Montreal.

“Testing was conclusive,” Dr Masson said. “Not only were the measurements as accurate, but our device took less than 60 seconds to produce results, compared to 30 minutes for current devices.”

Moreover, the comparative tests were performed by lab technicians who were not experienced with surface plasmon resonance and did not encounter major difficulties in operating the new equipment or obtaining the same conclusive results as Dr Masson and his research team.

“In the near future, we can foresee the device in doctors’ offices or even at the bedside, where patients would receive individualized and optimal doses while minimizing the risk of complications,” Dr Masson said.

“While traditional equipment requires an investment of around $100,000, the new mobile device would likely cost 10 times less, around $10,000.”

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Drug gets orphan status for PNH in US

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red blood cells

Red blood cells

The US Food and Drug Administration (FDA) has granted the complement inhibitor AMY-101 orphan status as a treatment for paroxysmal nocturnal

hemoglobinuria (PNH).

Roughly 2 months ago, the European Medicines Agency (EMA) did the same.

Orphan designation will allow Amyndas Pharmaceuticals, the company developing AMY-101, to proceed with expedited clinical development. The company is

planning to move the drug into clinical trials in 2015.

If AMY-101 is approved by the FDA, orphan status will allow for a 7-year period of market exclusivity from product launch in the US. It will also allow Amyndas to apply for research funding, tax credits for certain research expenses, and assistance for clinical research study design. It provides a waiver from the FDA’s Prescription Drug User Fee as well.

“Receiving the orphan drug designation from both the FDA and the EMA is an important achievement and a key milestone in the development pathway of AMY-101, and we are optimistic regarding the long-term potential of this potent complement inhibitor,” said John Lambris, PhD, of the University of Pennsylvania.

Dr Lambris developed AMY-101 at the University of Pennsylvania, and the university licensed the drug to Amyndas Pharmaceuticals. Dr Lambris is a founder and equity holder of Amyndas Pharmaceuticals.

About AMY-101 and PNH

PNH is caused by the defective expression of regulatory proteins on the surface of blood cells, which leaves them vulnerable to complement attack. This can lead to hemolysis, which results in severe anemia and contributes to a high risk of thrombosis.

The monoclonal antibody eculizumab is often successful in treating PNH, but roughly a third of patients do not respond well to the drug and still require blood transfusions to manage their anemia.

Research has suggested this lack of response is due to fragments of complement C3 proteins on the surface of the patients’ red blood cells, which are eventually attacked by immune cells.

In an attempt to overcome this problem, Dr Lambris and his colleagues developed AMY-101. The drug is designed to inhibit C3, thereby preventing hemolysis and immune cell recognition.

The researchers have investigated the effects of AMY-101 on self-attack and the resulting hemolysis in human PNH cells and found the drug to be active.

These results have not been published, but the group has published results with a C3 inhibitor known as Cp40, and AMY-101 is based on Cp40.

The researchers reported in Blood that Cp40 and its long-acting form, PEG-Cp40, effectively inhibited hemolysis and efficiently prevented the deposition of C3 fragments on red blood cells from patients with PNH.

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red blood cells

Red blood cells

The US Food and Drug Administration (FDA) has granted the complement inhibitor AMY-101 orphan status as a treatment for paroxysmal nocturnal

hemoglobinuria (PNH).

Roughly 2 months ago, the European Medicines Agency (EMA) did the same.

Orphan designation will allow Amyndas Pharmaceuticals, the company developing AMY-101, to proceed with expedited clinical development. The company is

planning to move the drug into clinical trials in 2015.

If AMY-101 is approved by the FDA, orphan status will allow for a 7-year period of market exclusivity from product launch in the US. It will also allow Amyndas to apply for research funding, tax credits for certain research expenses, and assistance for clinical research study design. It provides a waiver from the FDA’s Prescription Drug User Fee as well.

“Receiving the orphan drug designation from both the FDA and the EMA is an important achievement and a key milestone in the development pathway of AMY-101, and we are optimistic regarding the long-term potential of this potent complement inhibitor,” said John Lambris, PhD, of the University of Pennsylvania.

Dr Lambris developed AMY-101 at the University of Pennsylvania, and the university licensed the drug to Amyndas Pharmaceuticals. Dr Lambris is a founder and equity holder of Amyndas Pharmaceuticals.

About AMY-101 and PNH

PNH is caused by the defective expression of regulatory proteins on the surface of blood cells, which leaves them vulnerable to complement attack. This can lead to hemolysis, which results in severe anemia and contributes to a high risk of thrombosis.

The monoclonal antibody eculizumab is often successful in treating PNH, but roughly a third of patients do not respond well to the drug and still require blood transfusions to manage their anemia.

Research has suggested this lack of response is due to fragments of complement C3 proteins on the surface of the patients’ red blood cells, which are eventually attacked by immune cells.

In an attempt to overcome this problem, Dr Lambris and his colleagues developed AMY-101. The drug is designed to inhibit C3, thereby preventing hemolysis and immune cell recognition.

The researchers have investigated the effects of AMY-101 on self-attack and the resulting hemolysis in human PNH cells and found the drug to be active.

These results have not been published, but the group has published results with a C3 inhibitor known as Cp40, and AMY-101 is based on Cp40.

The researchers reported in Blood that Cp40 and its long-acting form, PEG-Cp40, effectively inhibited hemolysis and efficiently prevented the deposition of C3 fragments on red blood cells from patients with PNH.

red blood cells

Red blood cells

The US Food and Drug Administration (FDA) has granted the complement inhibitor AMY-101 orphan status as a treatment for paroxysmal nocturnal

hemoglobinuria (PNH).

Roughly 2 months ago, the European Medicines Agency (EMA) did the same.

Orphan designation will allow Amyndas Pharmaceuticals, the company developing AMY-101, to proceed with expedited clinical development. The company is

planning to move the drug into clinical trials in 2015.

If AMY-101 is approved by the FDA, orphan status will allow for a 7-year period of market exclusivity from product launch in the US. It will also allow Amyndas to apply for research funding, tax credits for certain research expenses, and assistance for clinical research study design. It provides a waiver from the FDA’s Prescription Drug User Fee as well.

“Receiving the orphan drug designation from both the FDA and the EMA is an important achievement and a key milestone in the development pathway of AMY-101, and we are optimistic regarding the long-term potential of this potent complement inhibitor,” said John Lambris, PhD, of the University of Pennsylvania.

Dr Lambris developed AMY-101 at the University of Pennsylvania, and the university licensed the drug to Amyndas Pharmaceuticals. Dr Lambris is a founder and equity holder of Amyndas Pharmaceuticals.

About AMY-101 and PNH

PNH is caused by the defective expression of regulatory proteins on the surface of blood cells, which leaves them vulnerable to complement attack. This can lead to hemolysis, which results in severe anemia and contributes to a high risk of thrombosis.

The monoclonal antibody eculizumab is often successful in treating PNH, but roughly a third of patients do not respond well to the drug and still require blood transfusions to manage their anemia.

Research has suggested this lack of response is due to fragments of complement C3 proteins on the surface of the patients’ red blood cells, which are eventually attacked by immune cells.

In an attempt to overcome this problem, Dr Lambris and his colleagues developed AMY-101. The drug is designed to inhibit C3, thereby preventing hemolysis and immune cell recognition.

The researchers have investigated the effects of AMY-101 on self-attack and the resulting hemolysis in human PNH cells and found the drug to be active.

These results have not been published, but the group has published results with a C3 inhibitor known as Cp40, and AMY-101 is based on Cp40.

The researchers reported in Blood that Cp40 and its long-acting form, PEG-Cp40, effectively inhibited hemolysis and efficiently prevented the deposition of C3 fragments on red blood cells from patients with PNH.

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Texts improve malaria treatment adherence

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Texts improve malaria treatment adherence

Woman texting

Credit: Ed Yourdon

Text messages reminding patients to take malaria medication can improve treatment adherence, according to a study published in PLOS ONE.

“When patients don’t complete their full medication regimen, diseases can develop resistance to treatment,” said study author Julia Raifman, a PhD candidate at the Harvard School of Public Health in Boston.

“And with infectious diseases like malaria, drug-resistant diseases can spread to others. We’ve already begun to see resistance to artemisinin in Southeast Asia. It would be catastrophic if that became widespread and there was no effective treatment for the most deadly form of malaria.”

Working with researchers at the non-profit Innovations for Poverty Action in Ghana, Raifman and her colleagues drew on previous research using SMS reminders in situations where people fail to follow through on intentions, such as saving money, paying back loans, or completing college financial aid forms.

The researchers recruited 1140 people in Ghana who were taking artemisinin-based combination therapy to treat malaria.

Participants used their mobile phones to enroll in an automated system, and the system randomly assigned half of them to receive the text message reminders to take their medication.

Local researchers followed up with the participants several days later at their homes to see how many pills they had taken. Subjects who received the texts were significantly more likely to finish the full regimen.

The researchers also tested whether a short or longer, more informative message would be more effective. They were surprised to find the shorter messages had a significant impact, but the longer ones did not.

“SMS reminders are a ‘nudge,’ not a ‘shove,’” said Aaron Dibner-Dunlap, of Innovations for Poverty Action. “They can help people follow through on something they originally intended to do, but human nature is tricky, and the science is still young.”

“We’re optimistic because the technology has become so widespread and inexpensive to administer, that for programs like this one that work, there’s huge potential for helping people at very low cost.”

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Woman texting

Credit: Ed Yourdon

Text messages reminding patients to take malaria medication can improve treatment adherence, according to a study published in PLOS ONE.

“When patients don’t complete their full medication regimen, diseases can develop resistance to treatment,” said study author Julia Raifman, a PhD candidate at the Harvard School of Public Health in Boston.

“And with infectious diseases like malaria, drug-resistant diseases can spread to others. We’ve already begun to see resistance to artemisinin in Southeast Asia. It would be catastrophic if that became widespread and there was no effective treatment for the most deadly form of malaria.”

Working with researchers at the non-profit Innovations for Poverty Action in Ghana, Raifman and her colleagues drew on previous research using SMS reminders in situations where people fail to follow through on intentions, such as saving money, paying back loans, or completing college financial aid forms.

The researchers recruited 1140 people in Ghana who were taking artemisinin-based combination therapy to treat malaria.

Participants used their mobile phones to enroll in an automated system, and the system randomly assigned half of them to receive the text message reminders to take their medication.

Local researchers followed up with the participants several days later at their homes to see how many pills they had taken. Subjects who received the texts were significantly more likely to finish the full regimen.

The researchers also tested whether a short or longer, more informative message would be more effective. They were surprised to find the shorter messages had a significant impact, but the longer ones did not.

“SMS reminders are a ‘nudge,’ not a ‘shove,’” said Aaron Dibner-Dunlap, of Innovations for Poverty Action. “They can help people follow through on something they originally intended to do, but human nature is tricky, and the science is still young.”

“We’re optimistic because the technology has become so widespread and inexpensive to administer, that for programs like this one that work, there’s huge potential for helping people at very low cost.”

Woman texting

Credit: Ed Yourdon

Text messages reminding patients to take malaria medication can improve treatment adherence, according to a study published in PLOS ONE.

“When patients don’t complete their full medication regimen, diseases can develop resistance to treatment,” said study author Julia Raifman, a PhD candidate at the Harvard School of Public Health in Boston.

“And with infectious diseases like malaria, drug-resistant diseases can spread to others. We’ve already begun to see resistance to artemisinin in Southeast Asia. It would be catastrophic if that became widespread and there was no effective treatment for the most deadly form of malaria.”

Working with researchers at the non-profit Innovations for Poverty Action in Ghana, Raifman and her colleagues drew on previous research using SMS reminders in situations where people fail to follow through on intentions, such as saving money, paying back loans, or completing college financial aid forms.

The researchers recruited 1140 people in Ghana who were taking artemisinin-based combination therapy to treat malaria.

Participants used their mobile phones to enroll in an automated system, and the system randomly assigned half of them to receive the text message reminders to take their medication.

Local researchers followed up with the participants several days later at their homes to see how many pills they had taken. Subjects who received the texts were significantly more likely to finish the full regimen.

The researchers also tested whether a short or longer, more informative message would be more effective. They were surprised to find the shorter messages had a significant impact, but the longer ones did not.

“SMS reminders are a ‘nudge,’ not a ‘shove,’” said Aaron Dibner-Dunlap, of Innovations for Poverty Action. “They can help people follow through on something they originally intended to do, but human nature is tricky, and the science is still young.”

“We’re optimistic because the technology has become so widespread and inexpensive to administer, that for programs like this one that work, there’s huge potential for helping people at very low cost.”

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Smartphone‐Enabled Communication System

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A smartphone‐enabled communication system to improve hospital communication: Usage and perceptions of medical trainees and nurses on general internal medicine wards

Previous studies have advocated the importance of effective communication between clinicians as a critical component in the provision of high‐quality patient care.[1, 2, 3, 4] There is increasing interest in the use of information and communication technologies to improve how clinicians communicate in hospital settings. A number of hospitals have implemented different solutions to improve communication. These solutions include alphanumeric pagers,[5] smartphones,[6] e‐mail,[7] secure text messaging,[8] and a Web‐based interdisciplinary communication tool.[9]

These systems have different limitations that render them inefficient and likely inhibit collaborative care. Current systems, such as pagers, rely on the sender to ensure the message was received and are successful in delivering messages approximately 67% of the time.[5, 9, 10] Although alphanumeric pagers and secure text messaging can increase the likelihood of delivery, these messages are often isolated and not easily viewable by the whole care team.[11] Improved systems should also reduce unnecessary interruptions by providing support for both urgent and delayed messages. Finally, messages should be stored and retrievable to enable increased accountability and allow for review for quality improvement initiatives.

It is also important to consider the unintended consequences of technology implementations.[12] Moving communication to text messages and smartphones has the potential to reduce interprofessional relations and can increase confusion if used for complex issues.[10, 13] In this article, we present a system designed to improve interprofessional communication on general internal medicine wards by incorporating these desired features and describe the usage and attitudes toward the system, specifically assessing for effects on multiple domains including efficiency, interprofessional collaboration, and relationships.

METHODS

Research Question

Will nurses and physicians use a system designed to improve interprofessional communication and will they perceive it to be effective and improve workflow?

Setting

The study took place on the general internal medicine wards at Toronto General Hospital and Toronto Western Hospital, 2 large academic teaching hospitals. There are several general internal medicine wards at each site with approximately 80 beds at each site. At each site there are 4 clinical teaching units and 1 hospitalist team. The study was approved by the research ethics board at the University Health Network.

Intervention

To address issues with communication, we developed a systemClinical Message (CM)that included 2 main components: a physician handover tool and secure messaging module. The focus of CM was to improve communication and information flow among different healthcare providers (physicians, nurses, pharmacists, social workers and therapists) through a secure, shared platform.

Physician Handover

The physician handover tool was designed to facilitate the physician handover process at shift change and is used as a patient rounding tool for day‐to‐day management of patients. It is also accessed by nurses and other clinicians to view the physicians' notes and to stay informed on the overall care plan. The tool contains standard elements including a list of patients with the following information on each patient: demographics, diagnosis, code status, medical history, active issues, and discharge plans (Figure 1).

Figure 1
Physician handover tool: patient list showing patient information and physician notes for a selected patient. (Note: not real patients.)

Secure Messaging

Secure messaging was designed around our dominant communication: nurses sending messages to physicians who would then respond. Nurses and other health professionals sent messages to the medical teams by accessing CM, selecting the appropriate patient, and filling out a message template. The system automatically populated the To field with the team assigned to the selected patient. Messaging for each team was centralized around a single team smartphone that was carried 24 hours a day, 7 days a week by a physician on that team. This removed the guesswork of trying to identify the individual physician responsible for that patient. For each message, a subject or issue and content were entered (Figure 2). Logic was also incorporated to reduce the amount of unnecessary interruptions. Senders would choose to send the message immediately as an interrupt message (urgent) for urgent/time sensitive issues or as an allow time to respond message (delayed). For the latter, the message was posted to the system where physicians could check and answer them. Interrupt messages were sent to the team smartphone using the Short Message Service (SMS) protocol. To try and ensure the communication loop on any issues was closed, when a message requested a response and did not receive it, the system sent another message. For urgent messages, a repeat message was initiated after 15 minutes. For delayed messages, the sender defined when they needed a response, typically within 2 to 8 hours. Senders were also able to select the mode of response that would best meet their needs from a workflow perspective: call back, text reply, or to specify that a reply was not required. Senders were also able to verify if the messages were received by the physician's smartphone. Physicians could view the messages within CM and reply. For messages that went to their team smartphone, physicians could respond from the smartphone through a secure Web link.

Figure 2
Patient list with a selected patient: sending a message on the Clinical Message system. (Note: not real patients.)

Because the messages were linked to the patients, they were visible to the entire care team, not just the message sender and recipient. If the care of the patient was transferred from 1 clinician to the next, the new clinician could easily review prior messages to understand recent patient events. The system was accessible through a browser on the intranet. The system regularly pulled patient demographic details such as name, age, medical record number, and location from our electronic medical record through a 1‐way interface. Information from this communication system was not considered part of the medical record but was retrievable.

The system was introduced as the new standard method of communication for nurses to reach physicians for all of the general internal medicine wards and for all medical teams at site 1 on May 2, 2011 and site 2 on June 6, 2011. The system replaced a text‐based Web‐paging system and supplemented the numeric pager carried by residents. Initial training of a half hour was provided to all nurses and residents.

Message Analysis for Usage Statistics

We analyzed messages created and sent via the CM system from May 2011 until August 2012. The extracted message information included date and time sent, issue, level of urgency, response type requested, roles of clinicians involved from the associated team, hospital site (senders and receivers), and message details. The following inclusion criteria were used for the analyses: (1) the senders and receivers of the messages could not be CM support staff, and (2) the messages sent were intended for the team smartphones used by the respective medical teams, not individual clinicians. Descriptive statistics and frequency analysis were performed using Microsoft Excel (Microsoft Corp., Redmond, WA) and IBM SPSS (IBM, Armonk, NY).

Survey

Development of the Survey

We used standard methods to develop a survey to assess staff perceptions on the impact of the new communication system. Relevant questionnaire items were compiled from a systematic review of the literature for communication surveys and communication issues that included the following domains: efficiency, accountability, accuracy, collaboration, timeliness, richness of the communication medium, and impact on interprofessional relationships and verbal communication.[10, 14, 15] We carried out pilot testing with 5 nurses and physicians, and modified the questionnaires based on their feedback.

Sampling and Data Collection of the Survey

Survey participants consisted of 2 groups of clinicians: (1) medical trainees that included medical residents, medical interns, and clinical fellows, and (2) nursing staff that included part‐time and full‐time nurses. To qualify for inclusion, participants had to have used the CM system for at least a month prior to administration of the questionnaire.

Data Analysis

Responses were recorded into an Excel spreadsheet that was imported into SPSS for analysis. Categorical variables were described using proportions. Survey comments were grouped into common themes, and themes mentioned by more than 1 respondent were reported.

RESULTS

Usage Analysis

A total of 60,969 messages were sent using CM between May 2, 2011 and August 19, 2012. On average, a team would receive 14.8 messages per day. Of all messages, 76.5% requested a text reply, 7.7% requested a call‐back, and 15.7% did not request a response. More than two‐thirds of messages at both hospitals were sent as immediate. Of the nonurgent messages, 86% were not replied to within the desired time, requiring a repeat message to be sent. Examples of different types of messages are shown in Table 1.

Examples of Types of Messages Sent Through the System and the Replies
SenderIssueDetailsPriorityDesired Response TypeTime CreatedTime SentReplyTime Replied
  • NOTE: Abbreviations: BP, blood pressure; HR, heart rate; PT, patient; NG, nasogastric; creat, creatinine; NS, normal saline; RA, room air; IV, intravenous.

NurseVital signPt's BP is 182/95, HR is 108 now. Previous at 0800 was 165/78; HR was 99. PT is not on antihypertensive meds.Allow time to respond (23:00)Text reply21:4323:02OK. Will assess.23:03
NurseNG tubeNG tube is in place. Can you please enter portable chest x‐ray to check placement ASAP?ImmediateText reply16:5816:58Will do.17:00
NurseBloodworkPt creat=216. Pt has NS @ 75 cc/hr. Pt has noted crackles throughout lung fields and has productive cough; eating and drinking well. Would you like it continued as well? Pt O2Sat 93% RA; would you like 4 L of O2 continued? Pls call for telephone order.ImmediateCall back12:5313:04Dealt with it on phone.13:05
NursePain controlHello! Pt has been getting 1 mg hydromorphone IV q 1 hr and pain is still not controlled. Pt remains awake and alert. Thanks!ImmediateInfo only15:4115:41Thank you.15:42

For messages requesting a text reply, 8.6% did not receive a reply. The median response time was 2.3 minutes (interquartile range of 5.8 minutes), but some messages did not receive a response even after a week, which skewed the distribution of response times. For those messages that did receive a reply, 68.9% of them were responded to within 5 minutes, and 84.5% were responded to within 15 minutes. Messages were predominantly received between 9 am and midnight (see Supporting Figure 1 in the online version of this article). Because the sending of some messages was delayed, there appeared to be fewer messages received during protected educational times (89 am and 121 pm) as well as between midnight and 7 am compared to other times.

Survey Results

Between April 2013 and June 2013, 82 of 86 medical trainees (95.3%) and 83 of 116 nurses (71.6%) completed the survey, for an overall response rate of 81.7%. Clinicians perceived that CM appeared to have a positive impact on efficiency. In particular, 82.8% of physicians and 78.3% of nurses agreed or strongly agreed that CM helped speed up daily work tasks (Table 2). The majority of physicians and nurses agreed that the system increased accountability, increased timeliness of communication, and improved interprofessional relationships. It was not seen to be effective for communicating complex patient issues.

Summary of Survey Responses
 No. of Subitems in SurveyPhysician (% Agree, Strongly Agree), n=82Nurse (% Agree, Strongly Agree), n=83
  • NOTE: Major groupings are listed. For those with multiple (>3) items in the survey, important items are listed. Abbreviations: CM, Clinical Message.

Positive impact on efficiency.758.9%66.6%
The CM system helps speed up my daily work tasks. 82.8%78.3%
Positive impact on physician‐nurse collaboration.655.3%58.5%
The CM system increases the amount of communication between nurses and physicians. 50.6%67.1%
Improved timeliness of communication.554.2%50.5%
Communication through the CM system helps me resolve patient issues within the appropriate time frames. 66.7%55.6%
Increased accountability.267.1%73.2%
Improved accuracy of communications.341.6%50.7%
Improved interprofessional relationships.262.2%53.6%
Increased verbal communications.235.1%25.3%
Richness of the communication medium.640.7%48.3%
I find the CM system useful for communicating complex patient issues. 35.8%26.3%
I would prefer CM over standard hospital communication methods such as numeric paging.168.3%76.5%
I enjoy using the CM system for clinical communication on the wards.163.0%79.0%
Communication through the CM system helps to reduce interruptions for physicians.145.7% 

Survey comments revealed that nurses perceived a lack of desired response, whereas physicians noted being interrupted with low‐value information through the system (Table 3). Both commented that further functionality, such as an active message stream, would be of benefit. Difficulty in communicating complex issues was also noted.

Issues Mentioned in Survey Comments by Occurrences
IssueOccurrencesExample
MDRNTotal
  • NOTE: Abbreviations: CM, Clinical Message; MD, medical doctor; RN, registered nurse.

Lack of response11011It depends if they respond quickly or not. A few times I send the 2nd message to remind them of the issue. I also spend more time to check if they answer it or not. I even call their Blackberries at last to get a response.
Message stream347I wish that I could see follow‐up messages after my initial reply (ie, it would be nice to have an open message stream).
Difficult to communicate complex issues156Difficult to communicate complex issues. Takes a lot of time to respond, and it becomes inefficient when responding to nonurgent CM because it interrupts workflow.
Many messages are low‐value interrupts303CM is useful for handover between clinicians, but often it slows down the clinician when they are used for information‐related low‐value/noncritical messages between nurses and clinicians
Lack of detailed response033Specific messages regarding response to care is required most times. For example, acknowledged is not a favorable response.
Technical issues202I find CM very useful. We have had multiple issues with our Blackberry this month, and CM was not working. When it is up and running, however, it is a wonderful tool.
Discrepancy in perceived urgency202Discrepancy between what nurses find urgent and what we find urgent.

DISCUSSION

We describe an implementation of a system to improve clinical communication in hospitals. The system was highly used and was perceived to improve communication by both nurses and physicians. Specifically, users found that the system increased efficiency, accountability, timeliness, and collaboration, but that there were issues with message clarity for complex medical issues.

Other systems and approaches have been implemented to improve communication. These included the use of alphanumeric pagers, e‐mail, secure texting, and smartphones. There is evidence that more advanced systems can improve efficiency for senders.[16] A recent randomized trial of secure text messaging found that it was perceived to be more efficient than paging, but overall usage was low and inconsistent.[8] There is also evidence that smartphones may increase interruptions, worsen interprofessional relationships, and cause issues with professional behavior.[10] Unfortunately, there are a limited number of interventions that improve communication, with some improving efficiency but none demonstrating improved patient‐oriented outcomes.[16, 17] This study evaluated a novel system, with functionality to link communication to patients, and created a system that aligned with the workflow of the clinicians. Messages were linked to the patient, not the sender or receiver, so other clinicians in the patient's circle of care could easily view the communication. Moreover, the system was designed to improve message response rates and allow for nonurgent messages.

Our communication system uses standard, commercially available components (smartphones, SMS), and relatively basic functionality (handover, secure messaging). Important findings are that the current system of paging can be transformed to a more efficient system that users will readily adopt. We found positive effects with components of the system. It appeared to improve efficiency and increase accountability. Accountability is crucial and moves from undocumented conversation to fully documented details of interactions. This can be used for both incident review and to review for quality improvement.

Using the system, physicians perceived that they were bothered by low‐value information, whereas nurses perceived a lack of response, and both found that the system was not ideal for complex messages. The mismatch between what physicians and nurses perceive as important has been attributed to their different timeframes and context.[18] For nurses with an upcoming change of shift, they wanted resolution of issues before handover. A physician on a different ward may not appreciate the context of a nurse having to directly interact with an irate family member. These different perceptions likely contributed to the lack of response to 8.6% of text messages. This is still better than other systems, such as paging, which can be as high as 33%.[10] For nonurgent items, clinicians would ideally check and clear items regularly from the system using a desktop computer, responding within the allotted timeframe. Unfortunately, this never became part of routine physician workflow, likely due to their busy workload, so many physicians would only respond when items became overdue. However, having a method to deal with nonurgent messages may have prevented some interruptions during protected educational times of trainees. The system was also not ideal for urgent or complex items. Complex items can be difficult to convey using the rarified communication medium of text messages.[19, 20] Urgent or complex issues are likely best resolved with a face‐to‐face or telephone conversation.

There are several limitations in our study that should be considered when interpreting the results. It is a study of usage and perceptions after implementation. Although more rigorous study is required to evaluate the effects, we see this as a first step in process improvement. Future research should measure the impact on improving patient care of this system and on patient outcomes such as adverse events. The study and intervention was limited to general internal medicine wards in 2 academic hospital settings where there are frequent rotations of medical personnel. The findings may not be generalizable to other hospital settings.

Future directions should be to further improve on the communication system and to educate and train staff on how to effectively communicate. Survey results showed that although users perceived increased efficiency, there was still significant opportunity to improve. One way to improve would be to have a mobile application in which physicians can easily review nonurgent items. Improvements could also be realized by educating clinicians on the use of the system and providing immediate feedback. Providing feedback to physicians on how well they respond could address nurses' issues around lack of timely response. By creating consensus between nurses and physicians on what is of high and low value to communicate could increase satisfaction for all users.

In summary, we present the usage and perceptions of a system designed to improve hospital communication. We found that there was high uptake, and that users perceived it to improve efficiency, collaboration, and accountability, but it may not be useful for communicating complex issues.

ACKNOWLEDGEMENTS

The authors acknowledge the nurses, physicians, residents, and other health professions on the general internal medicine ward for their patience and support as we continue to try to innovate. The authors also acknowledge the members of the information systems department (Shared Information Management Systems, University Health Network) who helped to support the Communication System, and the software developer, QRS, that helped to codevelop the software system.

Disclosures: The hospital was in a codevelopment agreement that has since terminated. No researcher or hospital received any funds from private industry for any purpose including personal or research. The authors report no conflicts of interest.

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References
  1. Coiera E. When conversation is better than computation. J Am Med Inform Assoc. 2000;7(3):277286.
  2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370376.
  3. Woods DM, Holl JL, Angst DB, et al. Gaps in pediatric clinician communication and opportunities for improvement. J Healthc Qual. 2008;30(5):4354.
  4. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Hamilton JD. Quality in Australian health care study. Med J Aust. 1996;164(12):754.
  5. Wong BM, Quan S, Shadowitz S, Etchells E. Implementation and evaluation of an alphanumeric paging system on a resident inpatient teaching service. J Hosp Med. 2009;4(8):E34E40.
  6. Quan S, Wu R, Morra D, et al. Demonstrating the BlackBerry as a clinical communication tool: a pilot study conducted through the Centre for Innovation in Complex Care. Healthc Q. 2008;11(4):9498.
  7. O'Connor C, Friedrich JO, Scales DC, Adhikari NK. The use of wireless email to improve healthcare team communication. J Am Med Inform Assoc. 2009;16(5):705713.
  8. Przybylo JA, Wang A, Loftus P, Evans KH, Chu I, Shieh L. Smarter hospital communication: secure smartphone text messaging improves provider satisfaction and perception of efficacy, workflow. J Hosp Med. 2014;9(9):573578.
  9. Locke KA, Duffey‐Rosenstein B, De Lio G, Morra D, Hariton N. Beyond paging: building a web‐based communication tool for nurses and physicians. J Gen Intern Med. 2009;24(1):105110.
  10. Wu RC, Lo V, Morra D, et al. The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals. J Am Med Inform Assoc. 2013;20(4):766777.
  11. Wu RC, Lo V, Rossos P, et al. Improving hospital care and collaborative communications for the 21st century: key recommendations for general internal medicine. Interact J Med Res. 2012;1(2):e9.
  12. Bloomrosen M, Starren J, Lorenzi NM, Ash JS, Patel VL, Shortliffe EH. Anticipating and addressing the unintended consequences of health IT and policy: a report from the AMIA 2009 Health Policy Meeting. J Am Med Inform Assoc. 2011;18(1):8290.
  13. Wu R, Rossos P, Quan S, et al. An evaluation of the use of smartphones to communicate between clinicians: a mixed‐methods study. J Med Internet Res. 2011;13(3):e59.
  14. Shortell SM, Rousseau DM, Gillies RR, Devers KJ, Simons TL. Organizational assessment in intensive care units (ICUs): construct development, reliability, and validity of the ICU nurse‐physician questionnaire. Med Care. 1991;29(8):709726.
  15. Suh KS. Impact of communication medium on task performance and satisfaction: an examination of media‐richness theory. Inform Manag. 1999;35:295312.
  16. Wu RC, Tran K, Lo V, et al. Effects of clinical communication interventions in hospitals: a systematic review of information and communication technology adoptions for improved communication between clinicians. Int J Med Inform. 2012;81(11):723732.
  17. Walsh C, Siegler EL, Cheston E, et al. Provider‐to‐provider electronic communication in the era of meaningful use: a review of the evidence. J Hosp Med. 2013;8(10):589597.
  18. Quan SD, Morra D, Lau FY, et al. Perceptions of urgency: defining the gap between what physicians and nurses perceive to be an urgent issue. Int J Med Inform. 2013;82(5):378386.
  19. Wu R, Appel L, Morra D, Lo V, Kitto S, Quan S. Short message service or disService: issues with text messaging in a complex medical environment. Int J Med Inform. 2014;83(4):278284.
  20. Iversen TB, Melby L, Toussaint P. Instant messaging at the hospital: supporting articulation work? Int J Med Inform. 2013;82(9):753761.
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Previous studies have advocated the importance of effective communication between clinicians as a critical component in the provision of high‐quality patient care.[1, 2, 3, 4] There is increasing interest in the use of information and communication technologies to improve how clinicians communicate in hospital settings. A number of hospitals have implemented different solutions to improve communication. These solutions include alphanumeric pagers,[5] smartphones,[6] e‐mail,[7] secure text messaging,[8] and a Web‐based interdisciplinary communication tool.[9]

These systems have different limitations that render them inefficient and likely inhibit collaborative care. Current systems, such as pagers, rely on the sender to ensure the message was received and are successful in delivering messages approximately 67% of the time.[5, 9, 10] Although alphanumeric pagers and secure text messaging can increase the likelihood of delivery, these messages are often isolated and not easily viewable by the whole care team.[11] Improved systems should also reduce unnecessary interruptions by providing support for both urgent and delayed messages. Finally, messages should be stored and retrievable to enable increased accountability and allow for review for quality improvement initiatives.

It is also important to consider the unintended consequences of technology implementations.[12] Moving communication to text messages and smartphones has the potential to reduce interprofessional relations and can increase confusion if used for complex issues.[10, 13] In this article, we present a system designed to improve interprofessional communication on general internal medicine wards by incorporating these desired features and describe the usage and attitudes toward the system, specifically assessing for effects on multiple domains including efficiency, interprofessional collaboration, and relationships.

METHODS

Research Question

Will nurses and physicians use a system designed to improve interprofessional communication and will they perceive it to be effective and improve workflow?

Setting

The study took place on the general internal medicine wards at Toronto General Hospital and Toronto Western Hospital, 2 large academic teaching hospitals. There are several general internal medicine wards at each site with approximately 80 beds at each site. At each site there are 4 clinical teaching units and 1 hospitalist team. The study was approved by the research ethics board at the University Health Network.

Intervention

To address issues with communication, we developed a systemClinical Message (CM)that included 2 main components: a physician handover tool and secure messaging module. The focus of CM was to improve communication and information flow among different healthcare providers (physicians, nurses, pharmacists, social workers and therapists) through a secure, shared platform.

Physician Handover

The physician handover tool was designed to facilitate the physician handover process at shift change and is used as a patient rounding tool for day‐to‐day management of patients. It is also accessed by nurses and other clinicians to view the physicians' notes and to stay informed on the overall care plan. The tool contains standard elements including a list of patients with the following information on each patient: demographics, diagnosis, code status, medical history, active issues, and discharge plans (Figure 1).

Figure 1
Physician handover tool: patient list showing patient information and physician notes for a selected patient. (Note: not real patients.)

Secure Messaging

Secure messaging was designed around our dominant communication: nurses sending messages to physicians who would then respond. Nurses and other health professionals sent messages to the medical teams by accessing CM, selecting the appropriate patient, and filling out a message template. The system automatically populated the To field with the team assigned to the selected patient. Messaging for each team was centralized around a single team smartphone that was carried 24 hours a day, 7 days a week by a physician on that team. This removed the guesswork of trying to identify the individual physician responsible for that patient. For each message, a subject or issue and content were entered (Figure 2). Logic was also incorporated to reduce the amount of unnecessary interruptions. Senders would choose to send the message immediately as an interrupt message (urgent) for urgent/time sensitive issues or as an allow time to respond message (delayed). For the latter, the message was posted to the system where physicians could check and answer them. Interrupt messages were sent to the team smartphone using the Short Message Service (SMS) protocol. To try and ensure the communication loop on any issues was closed, when a message requested a response and did not receive it, the system sent another message. For urgent messages, a repeat message was initiated after 15 minutes. For delayed messages, the sender defined when they needed a response, typically within 2 to 8 hours. Senders were also able to select the mode of response that would best meet their needs from a workflow perspective: call back, text reply, or to specify that a reply was not required. Senders were also able to verify if the messages were received by the physician's smartphone. Physicians could view the messages within CM and reply. For messages that went to their team smartphone, physicians could respond from the smartphone through a secure Web link.

Figure 2
Patient list with a selected patient: sending a message on the Clinical Message system. (Note: not real patients.)

Because the messages were linked to the patients, they were visible to the entire care team, not just the message sender and recipient. If the care of the patient was transferred from 1 clinician to the next, the new clinician could easily review prior messages to understand recent patient events. The system was accessible through a browser on the intranet. The system regularly pulled patient demographic details such as name, age, medical record number, and location from our electronic medical record through a 1‐way interface. Information from this communication system was not considered part of the medical record but was retrievable.

The system was introduced as the new standard method of communication for nurses to reach physicians for all of the general internal medicine wards and for all medical teams at site 1 on May 2, 2011 and site 2 on June 6, 2011. The system replaced a text‐based Web‐paging system and supplemented the numeric pager carried by residents. Initial training of a half hour was provided to all nurses and residents.

Message Analysis for Usage Statistics

We analyzed messages created and sent via the CM system from May 2011 until August 2012. The extracted message information included date and time sent, issue, level of urgency, response type requested, roles of clinicians involved from the associated team, hospital site (senders and receivers), and message details. The following inclusion criteria were used for the analyses: (1) the senders and receivers of the messages could not be CM support staff, and (2) the messages sent were intended for the team smartphones used by the respective medical teams, not individual clinicians. Descriptive statistics and frequency analysis were performed using Microsoft Excel (Microsoft Corp., Redmond, WA) and IBM SPSS (IBM, Armonk, NY).

Survey

Development of the Survey

We used standard methods to develop a survey to assess staff perceptions on the impact of the new communication system. Relevant questionnaire items were compiled from a systematic review of the literature for communication surveys and communication issues that included the following domains: efficiency, accountability, accuracy, collaboration, timeliness, richness of the communication medium, and impact on interprofessional relationships and verbal communication.[10, 14, 15] We carried out pilot testing with 5 nurses and physicians, and modified the questionnaires based on their feedback.

Sampling and Data Collection of the Survey

Survey participants consisted of 2 groups of clinicians: (1) medical trainees that included medical residents, medical interns, and clinical fellows, and (2) nursing staff that included part‐time and full‐time nurses. To qualify for inclusion, participants had to have used the CM system for at least a month prior to administration of the questionnaire.

Data Analysis

Responses were recorded into an Excel spreadsheet that was imported into SPSS for analysis. Categorical variables were described using proportions. Survey comments were grouped into common themes, and themes mentioned by more than 1 respondent were reported.

RESULTS

Usage Analysis

A total of 60,969 messages were sent using CM between May 2, 2011 and August 19, 2012. On average, a team would receive 14.8 messages per day. Of all messages, 76.5% requested a text reply, 7.7% requested a call‐back, and 15.7% did not request a response. More than two‐thirds of messages at both hospitals were sent as immediate. Of the nonurgent messages, 86% were not replied to within the desired time, requiring a repeat message to be sent. Examples of different types of messages are shown in Table 1.

Examples of Types of Messages Sent Through the System and the Replies
SenderIssueDetailsPriorityDesired Response TypeTime CreatedTime SentReplyTime Replied
  • NOTE: Abbreviations: BP, blood pressure; HR, heart rate; PT, patient; NG, nasogastric; creat, creatinine; NS, normal saline; RA, room air; IV, intravenous.

NurseVital signPt's BP is 182/95, HR is 108 now. Previous at 0800 was 165/78; HR was 99. PT is not on antihypertensive meds.Allow time to respond (23:00)Text reply21:4323:02OK. Will assess.23:03
NurseNG tubeNG tube is in place. Can you please enter portable chest x‐ray to check placement ASAP?ImmediateText reply16:5816:58Will do.17:00
NurseBloodworkPt creat=216. Pt has NS @ 75 cc/hr. Pt has noted crackles throughout lung fields and has productive cough; eating and drinking well. Would you like it continued as well? Pt O2Sat 93% RA; would you like 4 L of O2 continued? Pls call for telephone order.ImmediateCall back12:5313:04Dealt with it on phone.13:05
NursePain controlHello! Pt has been getting 1 mg hydromorphone IV q 1 hr and pain is still not controlled. Pt remains awake and alert. Thanks!ImmediateInfo only15:4115:41Thank you.15:42

For messages requesting a text reply, 8.6% did not receive a reply. The median response time was 2.3 minutes (interquartile range of 5.8 minutes), but some messages did not receive a response even after a week, which skewed the distribution of response times. For those messages that did receive a reply, 68.9% of them were responded to within 5 minutes, and 84.5% were responded to within 15 minutes. Messages were predominantly received between 9 am and midnight (see Supporting Figure 1 in the online version of this article). Because the sending of some messages was delayed, there appeared to be fewer messages received during protected educational times (89 am and 121 pm) as well as between midnight and 7 am compared to other times.

Survey Results

Between April 2013 and June 2013, 82 of 86 medical trainees (95.3%) and 83 of 116 nurses (71.6%) completed the survey, for an overall response rate of 81.7%. Clinicians perceived that CM appeared to have a positive impact on efficiency. In particular, 82.8% of physicians and 78.3% of nurses agreed or strongly agreed that CM helped speed up daily work tasks (Table 2). The majority of physicians and nurses agreed that the system increased accountability, increased timeliness of communication, and improved interprofessional relationships. It was not seen to be effective for communicating complex patient issues.

Summary of Survey Responses
 No. of Subitems in SurveyPhysician (% Agree, Strongly Agree), n=82Nurse (% Agree, Strongly Agree), n=83
  • NOTE: Major groupings are listed. For those with multiple (>3) items in the survey, important items are listed. Abbreviations: CM, Clinical Message.

Positive impact on efficiency.758.9%66.6%
The CM system helps speed up my daily work tasks. 82.8%78.3%
Positive impact on physician‐nurse collaboration.655.3%58.5%
The CM system increases the amount of communication between nurses and physicians. 50.6%67.1%
Improved timeliness of communication.554.2%50.5%
Communication through the CM system helps me resolve patient issues within the appropriate time frames. 66.7%55.6%
Increased accountability.267.1%73.2%
Improved accuracy of communications.341.6%50.7%
Improved interprofessional relationships.262.2%53.6%
Increased verbal communications.235.1%25.3%
Richness of the communication medium.640.7%48.3%
I find the CM system useful for communicating complex patient issues. 35.8%26.3%
I would prefer CM over standard hospital communication methods such as numeric paging.168.3%76.5%
I enjoy using the CM system for clinical communication on the wards.163.0%79.0%
Communication through the CM system helps to reduce interruptions for physicians.145.7% 

Survey comments revealed that nurses perceived a lack of desired response, whereas physicians noted being interrupted with low‐value information through the system (Table 3). Both commented that further functionality, such as an active message stream, would be of benefit. Difficulty in communicating complex issues was also noted.

Issues Mentioned in Survey Comments by Occurrences
IssueOccurrencesExample
MDRNTotal
  • NOTE: Abbreviations: CM, Clinical Message; MD, medical doctor; RN, registered nurse.

Lack of response11011It depends if they respond quickly or not. A few times I send the 2nd message to remind them of the issue. I also spend more time to check if they answer it or not. I even call their Blackberries at last to get a response.
Message stream347I wish that I could see follow‐up messages after my initial reply (ie, it would be nice to have an open message stream).
Difficult to communicate complex issues156Difficult to communicate complex issues. Takes a lot of time to respond, and it becomes inefficient when responding to nonurgent CM because it interrupts workflow.
Many messages are low‐value interrupts303CM is useful for handover between clinicians, but often it slows down the clinician when they are used for information‐related low‐value/noncritical messages between nurses and clinicians
Lack of detailed response033Specific messages regarding response to care is required most times. For example, acknowledged is not a favorable response.
Technical issues202I find CM very useful. We have had multiple issues with our Blackberry this month, and CM was not working. When it is up and running, however, it is a wonderful tool.
Discrepancy in perceived urgency202Discrepancy between what nurses find urgent and what we find urgent.

DISCUSSION

We describe an implementation of a system to improve clinical communication in hospitals. The system was highly used and was perceived to improve communication by both nurses and physicians. Specifically, users found that the system increased efficiency, accountability, timeliness, and collaboration, but that there were issues with message clarity for complex medical issues.

Other systems and approaches have been implemented to improve communication. These included the use of alphanumeric pagers, e‐mail, secure texting, and smartphones. There is evidence that more advanced systems can improve efficiency for senders.[16] A recent randomized trial of secure text messaging found that it was perceived to be more efficient than paging, but overall usage was low and inconsistent.[8] There is also evidence that smartphones may increase interruptions, worsen interprofessional relationships, and cause issues with professional behavior.[10] Unfortunately, there are a limited number of interventions that improve communication, with some improving efficiency but none demonstrating improved patient‐oriented outcomes.[16, 17] This study evaluated a novel system, with functionality to link communication to patients, and created a system that aligned with the workflow of the clinicians. Messages were linked to the patient, not the sender or receiver, so other clinicians in the patient's circle of care could easily view the communication. Moreover, the system was designed to improve message response rates and allow for nonurgent messages.

Our communication system uses standard, commercially available components (smartphones, SMS), and relatively basic functionality (handover, secure messaging). Important findings are that the current system of paging can be transformed to a more efficient system that users will readily adopt. We found positive effects with components of the system. It appeared to improve efficiency and increase accountability. Accountability is crucial and moves from undocumented conversation to fully documented details of interactions. This can be used for both incident review and to review for quality improvement.

Using the system, physicians perceived that they were bothered by low‐value information, whereas nurses perceived a lack of response, and both found that the system was not ideal for complex messages. The mismatch between what physicians and nurses perceive as important has been attributed to their different timeframes and context.[18] For nurses with an upcoming change of shift, they wanted resolution of issues before handover. A physician on a different ward may not appreciate the context of a nurse having to directly interact with an irate family member. These different perceptions likely contributed to the lack of response to 8.6% of text messages. This is still better than other systems, such as paging, which can be as high as 33%.[10] For nonurgent items, clinicians would ideally check and clear items regularly from the system using a desktop computer, responding within the allotted timeframe. Unfortunately, this never became part of routine physician workflow, likely due to their busy workload, so many physicians would only respond when items became overdue. However, having a method to deal with nonurgent messages may have prevented some interruptions during protected educational times of trainees. The system was also not ideal for urgent or complex items. Complex items can be difficult to convey using the rarified communication medium of text messages.[19, 20] Urgent or complex issues are likely best resolved with a face‐to‐face or telephone conversation.

There are several limitations in our study that should be considered when interpreting the results. It is a study of usage and perceptions after implementation. Although more rigorous study is required to evaluate the effects, we see this as a first step in process improvement. Future research should measure the impact on improving patient care of this system and on patient outcomes such as adverse events. The study and intervention was limited to general internal medicine wards in 2 academic hospital settings where there are frequent rotations of medical personnel. The findings may not be generalizable to other hospital settings.

Future directions should be to further improve on the communication system and to educate and train staff on how to effectively communicate. Survey results showed that although users perceived increased efficiency, there was still significant opportunity to improve. One way to improve would be to have a mobile application in which physicians can easily review nonurgent items. Improvements could also be realized by educating clinicians on the use of the system and providing immediate feedback. Providing feedback to physicians on how well they respond could address nurses' issues around lack of timely response. By creating consensus between nurses and physicians on what is of high and low value to communicate could increase satisfaction for all users.

In summary, we present the usage and perceptions of a system designed to improve hospital communication. We found that there was high uptake, and that users perceived it to improve efficiency, collaboration, and accountability, but it may not be useful for communicating complex issues.

ACKNOWLEDGEMENTS

The authors acknowledge the nurses, physicians, residents, and other health professions on the general internal medicine ward for their patience and support as we continue to try to innovate. The authors also acknowledge the members of the information systems department (Shared Information Management Systems, University Health Network) who helped to support the Communication System, and the software developer, QRS, that helped to codevelop the software system.

Disclosures: The hospital was in a codevelopment agreement that has since terminated. No researcher or hospital received any funds from private industry for any purpose including personal or research. The authors report no conflicts of interest.

Previous studies have advocated the importance of effective communication between clinicians as a critical component in the provision of high‐quality patient care.[1, 2, 3, 4] There is increasing interest in the use of information and communication technologies to improve how clinicians communicate in hospital settings. A number of hospitals have implemented different solutions to improve communication. These solutions include alphanumeric pagers,[5] smartphones,[6] e‐mail,[7] secure text messaging,[8] and a Web‐based interdisciplinary communication tool.[9]

These systems have different limitations that render them inefficient and likely inhibit collaborative care. Current systems, such as pagers, rely on the sender to ensure the message was received and are successful in delivering messages approximately 67% of the time.[5, 9, 10] Although alphanumeric pagers and secure text messaging can increase the likelihood of delivery, these messages are often isolated and not easily viewable by the whole care team.[11] Improved systems should also reduce unnecessary interruptions by providing support for both urgent and delayed messages. Finally, messages should be stored and retrievable to enable increased accountability and allow for review for quality improvement initiatives.

It is also important to consider the unintended consequences of technology implementations.[12] Moving communication to text messages and smartphones has the potential to reduce interprofessional relations and can increase confusion if used for complex issues.[10, 13] In this article, we present a system designed to improve interprofessional communication on general internal medicine wards by incorporating these desired features and describe the usage and attitudes toward the system, specifically assessing for effects on multiple domains including efficiency, interprofessional collaboration, and relationships.

METHODS

Research Question

Will nurses and physicians use a system designed to improve interprofessional communication and will they perceive it to be effective and improve workflow?

Setting

The study took place on the general internal medicine wards at Toronto General Hospital and Toronto Western Hospital, 2 large academic teaching hospitals. There are several general internal medicine wards at each site with approximately 80 beds at each site. At each site there are 4 clinical teaching units and 1 hospitalist team. The study was approved by the research ethics board at the University Health Network.

Intervention

To address issues with communication, we developed a systemClinical Message (CM)that included 2 main components: a physician handover tool and secure messaging module. The focus of CM was to improve communication and information flow among different healthcare providers (physicians, nurses, pharmacists, social workers and therapists) through a secure, shared platform.

Physician Handover

The physician handover tool was designed to facilitate the physician handover process at shift change and is used as a patient rounding tool for day‐to‐day management of patients. It is also accessed by nurses and other clinicians to view the physicians' notes and to stay informed on the overall care plan. The tool contains standard elements including a list of patients with the following information on each patient: demographics, diagnosis, code status, medical history, active issues, and discharge plans (Figure 1).

Figure 1
Physician handover tool: patient list showing patient information and physician notes for a selected patient. (Note: not real patients.)

Secure Messaging

Secure messaging was designed around our dominant communication: nurses sending messages to physicians who would then respond. Nurses and other health professionals sent messages to the medical teams by accessing CM, selecting the appropriate patient, and filling out a message template. The system automatically populated the To field with the team assigned to the selected patient. Messaging for each team was centralized around a single team smartphone that was carried 24 hours a day, 7 days a week by a physician on that team. This removed the guesswork of trying to identify the individual physician responsible for that patient. For each message, a subject or issue and content were entered (Figure 2). Logic was also incorporated to reduce the amount of unnecessary interruptions. Senders would choose to send the message immediately as an interrupt message (urgent) for urgent/time sensitive issues or as an allow time to respond message (delayed). For the latter, the message was posted to the system where physicians could check and answer them. Interrupt messages were sent to the team smartphone using the Short Message Service (SMS) protocol. To try and ensure the communication loop on any issues was closed, when a message requested a response and did not receive it, the system sent another message. For urgent messages, a repeat message was initiated after 15 minutes. For delayed messages, the sender defined when they needed a response, typically within 2 to 8 hours. Senders were also able to select the mode of response that would best meet their needs from a workflow perspective: call back, text reply, or to specify that a reply was not required. Senders were also able to verify if the messages were received by the physician's smartphone. Physicians could view the messages within CM and reply. For messages that went to their team smartphone, physicians could respond from the smartphone through a secure Web link.

Figure 2
Patient list with a selected patient: sending a message on the Clinical Message system. (Note: not real patients.)

Because the messages were linked to the patients, they were visible to the entire care team, not just the message sender and recipient. If the care of the patient was transferred from 1 clinician to the next, the new clinician could easily review prior messages to understand recent patient events. The system was accessible through a browser on the intranet. The system regularly pulled patient demographic details such as name, age, medical record number, and location from our electronic medical record through a 1‐way interface. Information from this communication system was not considered part of the medical record but was retrievable.

The system was introduced as the new standard method of communication for nurses to reach physicians for all of the general internal medicine wards and for all medical teams at site 1 on May 2, 2011 and site 2 on June 6, 2011. The system replaced a text‐based Web‐paging system and supplemented the numeric pager carried by residents. Initial training of a half hour was provided to all nurses and residents.

Message Analysis for Usage Statistics

We analyzed messages created and sent via the CM system from May 2011 until August 2012. The extracted message information included date and time sent, issue, level of urgency, response type requested, roles of clinicians involved from the associated team, hospital site (senders and receivers), and message details. The following inclusion criteria were used for the analyses: (1) the senders and receivers of the messages could not be CM support staff, and (2) the messages sent were intended for the team smartphones used by the respective medical teams, not individual clinicians. Descriptive statistics and frequency analysis were performed using Microsoft Excel (Microsoft Corp., Redmond, WA) and IBM SPSS (IBM, Armonk, NY).

Survey

Development of the Survey

We used standard methods to develop a survey to assess staff perceptions on the impact of the new communication system. Relevant questionnaire items were compiled from a systematic review of the literature for communication surveys and communication issues that included the following domains: efficiency, accountability, accuracy, collaboration, timeliness, richness of the communication medium, and impact on interprofessional relationships and verbal communication.[10, 14, 15] We carried out pilot testing with 5 nurses and physicians, and modified the questionnaires based on their feedback.

Sampling and Data Collection of the Survey

Survey participants consisted of 2 groups of clinicians: (1) medical trainees that included medical residents, medical interns, and clinical fellows, and (2) nursing staff that included part‐time and full‐time nurses. To qualify for inclusion, participants had to have used the CM system for at least a month prior to administration of the questionnaire.

Data Analysis

Responses were recorded into an Excel spreadsheet that was imported into SPSS for analysis. Categorical variables were described using proportions. Survey comments were grouped into common themes, and themes mentioned by more than 1 respondent were reported.

RESULTS

Usage Analysis

A total of 60,969 messages were sent using CM between May 2, 2011 and August 19, 2012. On average, a team would receive 14.8 messages per day. Of all messages, 76.5% requested a text reply, 7.7% requested a call‐back, and 15.7% did not request a response. More than two‐thirds of messages at both hospitals were sent as immediate. Of the nonurgent messages, 86% were not replied to within the desired time, requiring a repeat message to be sent. Examples of different types of messages are shown in Table 1.

Examples of Types of Messages Sent Through the System and the Replies
SenderIssueDetailsPriorityDesired Response TypeTime CreatedTime SentReplyTime Replied
  • NOTE: Abbreviations: BP, blood pressure; HR, heart rate; PT, patient; NG, nasogastric; creat, creatinine; NS, normal saline; RA, room air; IV, intravenous.

NurseVital signPt's BP is 182/95, HR is 108 now. Previous at 0800 was 165/78; HR was 99. PT is not on antihypertensive meds.Allow time to respond (23:00)Text reply21:4323:02OK. Will assess.23:03
NurseNG tubeNG tube is in place. Can you please enter portable chest x‐ray to check placement ASAP?ImmediateText reply16:5816:58Will do.17:00
NurseBloodworkPt creat=216. Pt has NS @ 75 cc/hr. Pt has noted crackles throughout lung fields and has productive cough; eating and drinking well. Would you like it continued as well? Pt O2Sat 93% RA; would you like 4 L of O2 continued? Pls call for telephone order.ImmediateCall back12:5313:04Dealt with it on phone.13:05
NursePain controlHello! Pt has been getting 1 mg hydromorphone IV q 1 hr and pain is still not controlled. Pt remains awake and alert. Thanks!ImmediateInfo only15:4115:41Thank you.15:42

For messages requesting a text reply, 8.6% did not receive a reply. The median response time was 2.3 minutes (interquartile range of 5.8 minutes), but some messages did not receive a response even after a week, which skewed the distribution of response times. For those messages that did receive a reply, 68.9% of them were responded to within 5 minutes, and 84.5% were responded to within 15 minutes. Messages were predominantly received between 9 am and midnight (see Supporting Figure 1 in the online version of this article). Because the sending of some messages was delayed, there appeared to be fewer messages received during protected educational times (89 am and 121 pm) as well as between midnight and 7 am compared to other times.

Survey Results

Between April 2013 and June 2013, 82 of 86 medical trainees (95.3%) and 83 of 116 nurses (71.6%) completed the survey, for an overall response rate of 81.7%. Clinicians perceived that CM appeared to have a positive impact on efficiency. In particular, 82.8% of physicians and 78.3% of nurses agreed or strongly agreed that CM helped speed up daily work tasks (Table 2). The majority of physicians and nurses agreed that the system increased accountability, increased timeliness of communication, and improved interprofessional relationships. It was not seen to be effective for communicating complex patient issues.

Summary of Survey Responses
 No. of Subitems in SurveyPhysician (% Agree, Strongly Agree), n=82Nurse (% Agree, Strongly Agree), n=83
  • NOTE: Major groupings are listed. For those with multiple (>3) items in the survey, important items are listed. Abbreviations: CM, Clinical Message.

Positive impact on efficiency.758.9%66.6%
The CM system helps speed up my daily work tasks. 82.8%78.3%
Positive impact on physician‐nurse collaboration.655.3%58.5%
The CM system increases the amount of communication between nurses and physicians. 50.6%67.1%
Improved timeliness of communication.554.2%50.5%
Communication through the CM system helps me resolve patient issues within the appropriate time frames. 66.7%55.6%
Increased accountability.267.1%73.2%
Improved accuracy of communications.341.6%50.7%
Improved interprofessional relationships.262.2%53.6%
Increased verbal communications.235.1%25.3%
Richness of the communication medium.640.7%48.3%
I find the CM system useful for communicating complex patient issues. 35.8%26.3%
I would prefer CM over standard hospital communication methods such as numeric paging.168.3%76.5%
I enjoy using the CM system for clinical communication on the wards.163.0%79.0%
Communication through the CM system helps to reduce interruptions for physicians.145.7% 

Survey comments revealed that nurses perceived a lack of desired response, whereas physicians noted being interrupted with low‐value information through the system (Table 3). Both commented that further functionality, such as an active message stream, would be of benefit. Difficulty in communicating complex issues was also noted.

Issues Mentioned in Survey Comments by Occurrences
IssueOccurrencesExample
MDRNTotal
  • NOTE: Abbreviations: CM, Clinical Message; MD, medical doctor; RN, registered nurse.

Lack of response11011It depends if they respond quickly or not. A few times I send the 2nd message to remind them of the issue. I also spend more time to check if they answer it or not. I even call their Blackberries at last to get a response.
Message stream347I wish that I could see follow‐up messages after my initial reply (ie, it would be nice to have an open message stream).
Difficult to communicate complex issues156Difficult to communicate complex issues. Takes a lot of time to respond, and it becomes inefficient when responding to nonurgent CM because it interrupts workflow.
Many messages are low‐value interrupts303CM is useful for handover between clinicians, but often it slows down the clinician when they are used for information‐related low‐value/noncritical messages between nurses and clinicians
Lack of detailed response033Specific messages regarding response to care is required most times. For example, acknowledged is not a favorable response.
Technical issues202I find CM very useful. We have had multiple issues with our Blackberry this month, and CM was not working. When it is up and running, however, it is a wonderful tool.
Discrepancy in perceived urgency202Discrepancy between what nurses find urgent and what we find urgent.

DISCUSSION

We describe an implementation of a system to improve clinical communication in hospitals. The system was highly used and was perceived to improve communication by both nurses and physicians. Specifically, users found that the system increased efficiency, accountability, timeliness, and collaboration, but that there were issues with message clarity for complex medical issues.

Other systems and approaches have been implemented to improve communication. These included the use of alphanumeric pagers, e‐mail, secure texting, and smartphones. There is evidence that more advanced systems can improve efficiency for senders.[16] A recent randomized trial of secure text messaging found that it was perceived to be more efficient than paging, but overall usage was low and inconsistent.[8] There is also evidence that smartphones may increase interruptions, worsen interprofessional relationships, and cause issues with professional behavior.[10] Unfortunately, there are a limited number of interventions that improve communication, with some improving efficiency but none demonstrating improved patient‐oriented outcomes.[16, 17] This study evaluated a novel system, with functionality to link communication to patients, and created a system that aligned with the workflow of the clinicians. Messages were linked to the patient, not the sender or receiver, so other clinicians in the patient's circle of care could easily view the communication. Moreover, the system was designed to improve message response rates and allow for nonurgent messages.

Our communication system uses standard, commercially available components (smartphones, SMS), and relatively basic functionality (handover, secure messaging). Important findings are that the current system of paging can be transformed to a more efficient system that users will readily adopt. We found positive effects with components of the system. It appeared to improve efficiency and increase accountability. Accountability is crucial and moves from undocumented conversation to fully documented details of interactions. This can be used for both incident review and to review for quality improvement.

Using the system, physicians perceived that they were bothered by low‐value information, whereas nurses perceived a lack of response, and both found that the system was not ideal for complex messages. The mismatch between what physicians and nurses perceive as important has been attributed to their different timeframes and context.[18] For nurses with an upcoming change of shift, they wanted resolution of issues before handover. A physician on a different ward may not appreciate the context of a nurse having to directly interact with an irate family member. These different perceptions likely contributed to the lack of response to 8.6% of text messages. This is still better than other systems, such as paging, which can be as high as 33%.[10] For nonurgent items, clinicians would ideally check and clear items regularly from the system using a desktop computer, responding within the allotted timeframe. Unfortunately, this never became part of routine physician workflow, likely due to their busy workload, so many physicians would only respond when items became overdue. However, having a method to deal with nonurgent messages may have prevented some interruptions during protected educational times of trainees. The system was also not ideal for urgent or complex items. Complex items can be difficult to convey using the rarified communication medium of text messages.[19, 20] Urgent or complex issues are likely best resolved with a face‐to‐face or telephone conversation.

There are several limitations in our study that should be considered when interpreting the results. It is a study of usage and perceptions after implementation. Although more rigorous study is required to evaluate the effects, we see this as a first step in process improvement. Future research should measure the impact on improving patient care of this system and on patient outcomes such as adverse events. The study and intervention was limited to general internal medicine wards in 2 academic hospital settings where there are frequent rotations of medical personnel. The findings may not be generalizable to other hospital settings.

Future directions should be to further improve on the communication system and to educate and train staff on how to effectively communicate. Survey results showed that although users perceived increased efficiency, there was still significant opportunity to improve. One way to improve would be to have a mobile application in which physicians can easily review nonurgent items. Improvements could also be realized by educating clinicians on the use of the system and providing immediate feedback. Providing feedback to physicians on how well they respond could address nurses' issues around lack of timely response. By creating consensus between nurses and physicians on what is of high and low value to communicate could increase satisfaction for all users.

In summary, we present the usage and perceptions of a system designed to improve hospital communication. We found that there was high uptake, and that users perceived it to improve efficiency, collaboration, and accountability, but it may not be useful for communicating complex issues.

ACKNOWLEDGEMENTS

The authors acknowledge the nurses, physicians, residents, and other health professions on the general internal medicine ward for their patience and support as we continue to try to innovate. The authors also acknowledge the members of the information systems department (Shared Information Management Systems, University Health Network) who helped to support the Communication System, and the software developer, QRS, that helped to codevelop the software system.

Disclosures: The hospital was in a codevelopment agreement that has since terminated. No researcher or hospital received any funds from private industry for any purpose including personal or research. The authors report no conflicts of interest.

References
  1. Coiera E. When conversation is better than computation. J Am Med Inform Assoc. 2000;7(3):277286.
  2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370376.
  3. Woods DM, Holl JL, Angst DB, et al. Gaps in pediatric clinician communication and opportunities for improvement. J Healthc Qual. 2008;30(5):4354.
  4. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Hamilton JD. Quality in Australian health care study. Med J Aust. 1996;164(12):754.
  5. Wong BM, Quan S, Shadowitz S, Etchells E. Implementation and evaluation of an alphanumeric paging system on a resident inpatient teaching service. J Hosp Med. 2009;4(8):E34E40.
  6. Quan S, Wu R, Morra D, et al. Demonstrating the BlackBerry as a clinical communication tool: a pilot study conducted through the Centre for Innovation in Complex Care. Healthc Q. 2008;11(4):9498.
  7. O'Connor C, Friedrich JO, Scales DC, Adhikari NK. The use of wireless email to improve healthcare team communication. J Am Med Inform Assoc. 2009;16(5):705713.
  8. Przybylo JA, Wang A, Loftus P, Evans KH, Chu I, Shieh L. Smarter hospital communication: secure smartphone text messaging improves provider satisfaction and perception of efficacy, workflow. J Hosp Med. 2014;9(9):573578.
  9. Locke KA, Duffey‐Rosenstein B, De Lio G, Morra D, Hariton N. Beyond paging: building a web‐based communication tool for nurses and physicians. J Gen Intern Med. 2009;24(1):105110.
  10. Wu RC, Lo V, Morra D, et al. The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals. J Am Med Inform Assoc. 2013;20(4):766777.
  11. Wu RC, Lo V, Rossos P, et al. Improving hospital care and collaborative communications for the 21st century: key recommendations for general internal medicine. Interact J Med Res. 2012;1(2):e9.
  12. Bloomrosen M, Starren J, Lorenzi NM, Ash JS, Patel VL, Shortliffe EH. Anticipating and addressing the unintended consequences of health IT and policy: a report from the AMIA 2009 Health Policy Meeting. J Am Med Inform Assoc. 2011;18(1):8290.
  13. Wu R, Rossos P, Quan S, et al. An evaluation of the use of smartphones to communicate between clinicians: a mixed‐methods study. J Med Internet Res. 2011;13(3):e59.
  14. Shortell SM, Rousseau DM, Gillies RR, Devers KJ, Simons TL. Organizational assessment in intensive care units (ICUs): construct development, reliability, and validity of the ICU nurse‐physician questionnaire. Med Care. 1991;29(8):709726.
  15. Suh KS. Impact of communication medium on task performance and satisfaction: an examination of media‐richness theory. Inform Manag. 1999;35:295312.
  16. Wu RC, Tran K, Lo V, et al. Effects of clinical communication interventions in hospitals: a systematic review of information and communication technology adoptions for improved communication between clinicians. Int J Med Inform. 2012;81(11):723732.
  17. Walsh C, Siegler EL, Cheston E, et al. Provider‐to‐provider electronic communication in the era of meaningful use: a review of the evidence. J Hosp Med. 2013;8(10):589597.
  18. Quan SD, Morra D, Lau FY, et al. Perceptions of urgency: defining the gap between what physicians and nurses perceive to be an urgent issue. Int J Med Inform. 2013;82(5):378386.
  19. Wu R, Appel L, Morra D, Lo V, Kitto S, Quan S. Short message service or disService: issues with text messaging in a complex medical environment. Int J Med Inform. 2014;83(4):278284.
  20. Iversen TB, Melby L, Toussaint P. Instant messaging at the hospital: supporting articulation work? Int J Med Inform. 2013;82(9):753761.
References
  1. Coiera E. When conversation is better than computation. J Am Med Inform Assoc. 2000;7(3):277286.
  2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370376.
  3. Woods DM, Holl JL, Angst DB, et al. Gaps in pediatric clinician communication and opportunities for improvement. J Healthc Qual. 2008;30(5):4354.
  4. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Hamilton JD. Quality in Australian health care study. Med J Aust. 1996;164(12):754.
  5. Wong BM, Quan S, Shadowitz S, Etchells E. Implementation and evaluation of an alphanumeric paging system on a resident inpatient teaching service. J Hosp Med. 2009;4(8):E34E40.
  6. Quan S, Wu R, Morra D, et al. Demonstrating the BlackBerry as a clinical communication tool: a pilot study conducted through the Centre for Innovation in Complex Care. Healthc Q. 2008;11(4):9498.
  7. O'Connor C, Friedrich JO, Scales DC, Adhikari NK. The use of wireless email to improve healthcare team communication. J Am Med Inform Assoc. 2009;16(5):705713.
  8. Przybylo JA, Wang A, Loftus P, Evans KH, Chu I, Shieh L. Smarter hospital communication: secure smartphone text messaging improves provider satisfaction and perception of efficacy, workflow. J Hosp Med. 2014;9(9):573578.
  9. Locke KA, Duffey‐Rosenstein B, De Lio G, Morra D, Hariton N. Beyond paging: building a web‐based communication tool for nurses and physicians. J Gen Intern Med. 2009;24(1):105110.
  10. Wu RC, Lo V, Morra D, et al. The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals. J Am Med Inform Assoc. 2013;20(4):766777.
  11. Wu RC, Lo V, Rossos P, et al. Improving hospital care and collaborative communications for the 21st century: key recommendations for general internal medicine. Interact J Med Res. 2012;1(2):e9.
  12. Bloomrosen M, Starren J, Lorenzi NM, Ash JS, Patel VL, Shortliffe EH. Anticipating and addressing the unintended consequences of health IT and policy: a report from the AMIA 2009 Health Policy Meeting. J Am Med Inform Assoc. 2011;18(1):8290.
  13. Wu R, Rossos P, Quan S, et al. An evaluation of the use of smartphones to communicate between clinicians: a mixed‐methods study. J Med Internet Res. 2011;13(3):e59.
  14. Shortell SM, Rousseau DM, Gillies RR, Devers KJ, Simons TL. Organizational assessment in intensive care units (ICUs): construct development, reliability, and validity of the ICU nurse‐physician questionnaire. Med Care. 1991;29(8):709726.
  15. Suh KS. Impact of communication medium on task performance and satisfaction: an examination of media‐richness theory. Inform Manag. 1999;35:295312.
  16. Wu RC, Tran K, Lo V, et al. Effects of clinical communication interventions in hospitals: a systematic review of information and communication technology adoptions for improved communication between clinicians. Int J Med Inform. 2012;81(11):723732.
  17. Walsh C, Siegler EL, Cheston E, et al. Provider‐to‐provider electronic communication in the era of meaningful use: a review of the evidence. J Hosp Med. 2013;8(10):589597.
  18. Quan SD, Morra D, Lau FY, et al. Perceptions of urgency: defining the gap between what physicians and nurses perceive to be an urgent issue. Int J Med Inform. 2013;82(5):378386.
  19. Wu R, Appel L, Morra D, Lo V, Kitto S, Quan S. Short message service or disService: issues with text messaging in a complex medical environment. Int J Med Inform. 2014;83(4):278284.
  20. Iversen TB, Melby L, Toussaint P. Instant messaging at the hospital: supporting articulation work? Int J Med Inform. 2013;82(9):753761.
Issue
Journal of Hospital Medicine - 10(2)
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Journal of Hospital Medicine - 10(2)
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A smartphone‐enabled communication system to improve hospital communication: Usage and perceptions of medical trainees and nurses on general internal medicine wards
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A smartphone‐enabled communication system to improve hospital communication: Usage and perceptions of medical trainees and nurses on general internal medicine wards
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Address for correspondence and reprint requests: Robert Wu, MD, 200 Elizabeth St., 14EN‐222, Toronto, ON, M5G 2C4 Canada; Telephone: 416‐340‐4567; Fax: 416‐595‐5826; E‐mail: [email protected]
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