Outcomes Research in Review

Study Overview

Objective. To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma or COPD.

Design. Multi-center, placebo-controlled, randomized clinical trial.

Setting and participants. This study was conducted at 4 UK centers (the Universities of Bristol, Southampton, Nottingham, and Oxford) between July 2013 and October 2014. Patients with acute cough (≤ 28 days) and at least 1 of the following lower respiratory tract symptoms (phlegm, chest pain, wheezing, or shortness of breath) were recruited by family physicians and nurses. Patients with chronic pulmonary disease, who had received asthma medication in the past 5 years, required hospital admission, or required same-day antibiotics were excluded. Patients were randomized by variable block size into prednisolone or placebo groups in a 1:1 ratio, stratified by center.

Intervention. Participants were asked to take 2 tablets of either 20-mg oral prednisolone or placebo tablets once daily for 5 days. The medications, which looked and tasted identical, were packaged into numbered packs by an independent pharmacist and were delivered to the family practices to be distributed to the enrolled patients. Participants were invited to report daily, using web or paper version, the severity of symptoms using a scale 0 to 6, along with twice-daily peak flow, for 28 days or until symptom resolution. Participants received shopping vouchers. Medical notes were reviewed at 3 months for new diagnosis of asthma, chronic obstructive pulmonary disease, whooping cough, and lung cancer.

 Main outcome measures . The primary outcomes were the duration of moderately bad or worse cough (defined as the number of days from randomization to the last day with a score of at least 3 points prior to at least 2 consecutive days with a score of less than 3, up to a maximum of 28 days); and the mean severity score (range 0–6) of the 6 main symptoms (cough, phlegm, shortness of breath, sleep disturbance, feeling generally unwell, and activity disturbance) on days 2 to 4.

Main results. 401 patients were randomized; 25 patients were lost to follow-up, leaving 173 in prednisolone group and 161 in placebo group for analysis. The prednisolone group was slightly more likely to be male, older, and to have received an influenza vaccine. 96% were white. Symptom diaries were returned by 94% of patients. For primary outcome 1, duration of moderately bad or worse cough, the median time to recovery from moderately bad or worse cough was 5 days (interquartile range, 3–8 days) in both groups. There was no difference after sensitivity analysis (multiple imputation of missing data, per-protocol analysis, and adjusting for day of recruitment). Primary outcome 2, the mean symptom severity score, after adjustment for center and baseline measure, was lower (hazard ratio, –0.20) in the prednisolone group compared with the placebo group; however, after secondary additional adjustment for age, sex, influenza vaccine, and smoking, the difference was not statistically significant. Secondary outcomes included total duration and severity of each symptom up to 28 days, duration of abnormal peak flow up to 28 days, cough duration of any severity up to 56 days, antibiotic use, patient satisfaction, adverse events were not different between the two groups. There were no new urinary or visual symptoms and none of the patients reporting fatigue, thirst, or dry throat had diabetes.

Conclusion. Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity.

Commentary

This study by Hay et al prospectively recruited patients with acute respiratory illness presenting to an outpatient setting within multiple centers for a placebo-controlled randomized study to evaluate the effectiveness of oral corticosteroids for acute lower respiratory tract infection. Patients with pre-existing lung disease such as asthma or COPD were excluded. This study showed moderate-dose oral prednisolone (20 mg twice a day for 5 days) did not reduce the duration of cough, and there was no statistically significant differences in primary and secondary outcomes between the 2 groups.

The beneficial effect of corticosteroids is thought to be due to its anti-inflammatory effect and decreasing harmful cytokines, which can be elevated during acute respiratory illness. In patients with severe pneumonia, patients potentially benefitted from corticosteroids by achieving clinical stability faster, reducing risk for treatment failure or ARDS and reducing hospital length of stay. However, corticosteroids are associated with hyperglycemia, myopathy, superinfection, osteopenia, and increased risk for gastrointestinal bleeding [1]. Corticosteroids have shown benefit repeatedly in patients with pneumonia severe enough to require hospitalization or intensive care unit stay [2–7].

The use of oral corticosteroids in non-critical acute respiratory tract illness without underlying obstructive lung disease has been a somewhat common practice (15%) [8]. However, no study to date firmly supports the use of oral corticosteroids in this patient group. A recently published randomized study attempted to determine if there is a benefit of oral dexamethasone in patients with acute sore throat, and found none [9]. No randomized controlled data has been published on the outpatient use of oral corticosteroids for acute lower respiratory illness.

The current study offers further evidence against the use of oral corticosteroids for acute, non-critical inflammation of the respiratory tract in nonasthmatic patients. Strengths of the study include its blinded and randomized study design and large number of patients. However, there are some limitations. Acute lower respiratory infection is associated with a wide spectrum of causative organisms and severity. It is possible that the beneficial effects of corticosteroids are only measurable when disease severity is high and there will be a systemic inflammatory response. In addition, outcome measurement was limited to a few items, namely patient-reported symptom score and duration. Furthermore, they measured the peak flow adjunctively. Without underlying airway hyperreactivity, substantial differences in peak flow are unlikely to be evident, limiting the usefulness of this as an indicator of disease in patients without chronic pulmonary disease.

Other study limitations include low patient recruitment rate, a large number of patients who did not have moderately bad cough at presentation or during the first 2 days, absence of baseline biomarkers (such as inflammatory, microbiological, spirometric or radiographic) and patient-reported outcome measures, and a sample largely homogenous in ethnicity with a small number of smokers. It is unclear whether similar results could be achieved in a more diverse population and with a greater percentage of smokers. In addition, although overall both groups were well balanced, including the number of patients taking over-the-counter cough suppressants and delayed antibiotics, the tracking of other concurrent therapies such as NSAIDs or acetaminophen was not included in the study design and the type of antibiotic was not tabulated. Such concurrent drugs could have masked a true benefit of oral corticosteroids.

Applications for Clinical Practice

This study will help prevent excessive prescription of oral corticosteroids for acute minor lower respiratory infection that requires only outpatient treatment. However, the evidence is limited to patients in stable condition. Patients with more severe acute lower respiratory infection, such as patients requiring hospitalization, may still benefit from a short course of oral corticosteroids. Furthermore, patients with underlying obstructive airways disease such as asthma or COPD should still be considered for oral corticosteroid therapy depending on their clinical circumstances.

—Minkyung Kwon, MD,  Joel Roberson, MD, and Jack Leventhal, MD,
Pulmonary and Critical Care Medicine,Mayo Clini c Florida, Jacksonville, FL (Drs. Kwon andLeventhal), and Department of Radiology, Oakland University Beaumont Hospital, Royal Oak, MI (Dr. Roberson)

Study Overview

Objective. To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma or COPD.

Design. Multi-center, placebo-controlled, randomized clinical trial.

Setting and participants. This study was conducted at 4 UK centers (the Universities of Bristol, Southampton, Nottingham, and Oxford) between July 2013 and October 2014. Patients with acute cough (≤ 28 days) and at least 1 of the following lower respiratory tract symptoms (phlegm, chest pain, wheezing, or shortness of breath) were recruited by family physicians and nurses. Patients with chronic pulmonary disease, who had received asthma medication in the past 5 years, required hospital admission, or required same-day antibiotics were excluded. Patients were randomized by variable block size into prednisolone or placebo groups in a 1:1 ratio, stratified by center.

Intervention. Participants were asked to take 2 tablets of either 20-mg oral prednisolone or placebo tablets once daily for 5 days. The medications, which looked and tasted identical, were packaged into numbered packs by an independent pharmacist and were delivered to the family practices to be distributed to the enrolled patients. Participants were invited to report daily, using web or paper version, the severity of symptoms using a scale 0 to 6, along with twice-daily peak flow, for 28 days or until symptom resolution. Participants received shopping vouchers. Medical notes were reviewed at 3 months for new diagnosis of asthma, chronic obstructive pulmonary disease, whooping cough, and lung cancer.

 Main outcome measures . The primary outcomes were the duration of moderately bad or worse cough (defined as the number of days from randomization to the last day with a score of at least 3 points prior to at least 2 consecutive days with a score of less than 3, up to a maximum of 28 days); and the mean severity score (range 0–6) of the 6 main symptoms (cough, phlegm, shortness of breath, sleep disturbance, feeling generally unwell, and activity disturbance) on days 2 to 4.

Main results. 401 patients were randomized; 25 patients were lost to follow-up, leaving 173 in prednisolone group and 161 in placebo group for analysis. The prednisolone group was slightly more likely to be male, older, and to have received an influenza vaccine. 96% were white. Symptom diaries were returned by 94% of patients. For primary outcome 1, duration of moderately bad or worse cough, the median time to recovery from moderately bad or worse cough was 5 days (interquartile range, 3–8 days) in both groups. There was no difference after sensitivity analysis (multiple imputation of missing data, per-protocol analysis, and adjusting for day of recruitment). Primary outcome 2, the mean symptom severity score, after adjustment for center and baseline measure, was lower (hazard ratio, –0.20) in the prednisolone group compared with the placebo group; however, after secondary additional adjustment for age, sex, influenza vaccine, and smoking, the difference was not statistically significant. Secondary outcomes included total duration and severity of each symptom up to 28 days, duration of abnormal peak flow up to 28 days, cough duration of any severity up to 56 days, antibiotic use, patient satisfaction, adverse events were not different between the two groups. There were no new urinary or visual symptoms and none of the patients reporting fatigue, thirst, or dry throat had diabetes.

Conclusion. Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity.

Commentary

This study by Hay et al prospectively recruited patients with acute respiratory illness presenting to an outpatient setting within multiple centers for a placebo-controlled randomized study to evaluate the effectiveness of oral corticosteroids for acute lower respiratory tract infection. Patients with pre-existing lung disease such as asthma or COPD were excluded. This study showed moderate-dose oral prednisolone (20 mg twice a day for 5 days) did not reduce the duration of cough, and there was no statistically significant differences in primary and secondary outcomes between the 2 groups.

The beneficial effect of corticosteroids is thought to be due to its anti-inflammatory effect and decreasing harmful cytokines, which can be elevated during acute respiratory illness. In patients with severe pneumonia, patients potentially benefitted from corticosteroids by achieving clinical stability faster, reducing risk for treatment failure or ARDS and reducing hospital length of stay. However, corticosteroids are associated with hyperglycemia, myopathy, superinfection, osteopenia, and increased risk for gastrointestinal bleeding [1]. Corticosteroids have shown benefit repeatedly in patients with pneumonia severe enough to require hospitalization or intensive care unit stay [2–7].

The use of oral corticosteroids in non-critical acute respiratory tract illness without underlying obstructive lung disease has been a somewhat common practice (15%) [8]. However, no study to date firmly supports the use of oral corticosteroids in this patient group. A recently published randomized study attempted to determine if there is a benefit of oral dexamethasone in patients with acute sore throat, and found none [9]. No randomized controlled data has been published on the outpatient use of oral corticosteroids for acute lower respiratory illness.

The current study offers further evidence against the use of oral corticosteroids for acute, non-critical inflammation of the respiratory tract in nonasthmatic patients. Strengths of the study include its blinded and randomized study design and large number of patients. However, there are some limitations. Acute lower respiratory infection is associated with a wide spectrum of causative organisms and severity. It is possible that the beneficial effects of corticosteroids are only measurable when disease severity is high and there will be a systemic inflammatory response. In addition, outcome measurement was limited to a few items, namely patient-reported symptom score and duration. Furthermore, they measured the peak flow adjunctively. Without underlying airway hyperreactivity, substantial differences in peak flow are unlikely to be evident, limiting the usefulness of this as an indicator of disease in patients without chronic pulmonary disease.

Other study limitations include low patient recruitment rate, a large number of patients who did not have moderately bad cough at presentation or during the first 2 days, absence of baseline biomarkers (such as inflammatory, microbiological, spirometric or radiographic) and patient-reported outcome measures, and a sample largely homogenous in ethnicity with a small number of smokers. It is unclear whether similar results could be achieved in a more diverse population and with a greater percentage of smokers. In addition, although overall both groups were well balanced, including the number of patients taking over-the-counter cough suppressants and delayed antibiotics, the tracking of other concurrent therapies such as NSAIDs or acetaminophen was not included in the study design and the type of antibiotic was not tabulated. Such concurrent drugs could have masked a true benefit of oral corticosteroids.

Applications for Clinical Practice

This study will help prevent excessive prescription of oral corticosteroids for acute minor lower respiratory infection that requires only outpatient treatment. However, the evidence is limited to patients in stable condition. Patients with more severe acute lower respiratory infection, such as patients requiring hospitalization, may still benefit from a short course of oral corticosteroids. Furthermore, patients with underlying obstructive airways disease such as asthma or COPD should still be considered for oral corticosteroid therapy depending on their clinical circumstances.

—Minkyung Kwon, MD,  Joel Roberson, MD, and Jack Leventhal, MD,
Pulmonary and Critical Care Medicine,Mayo Clini c Florida, Jacksonville, FL (Drs. Kwon andLeventhal), and Department of Radiology, Oakland University Beaumont Hospital, Royal Oak, MI (Dr. Roberson)

Study Overview

Objective. To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma or COPD.

Design. Multi-center, placebo-controlled, randomized clinical trial.

Setting and participants. This study was conducted at 4 UK centers (the Universities of Bristol, Southampton, Nottingham, and Oxford) between July 2013 and October 2014. Patients with acute cough (≤ 28 days) and at least 1 of the following lower respiratory tract symptoms (phlegm, chest pain, wheezing, or shortness of breath) were recruited by family physicians and nurses. Patients with chronic pulmonary disease, who had received asthma medication in the past 5 years, required hospital admission, or required same-day antibiotics were excluded. Patients were randomized by variable block size into prednisolone or placebo groups in a 1:1 ratio, stratified by center.

Intervention. Participants were asked to take 2 tablets of either 20-mg oral prednisolone or placebo tablets once daily for 5 days. The medications, which looked and tasted identical, were packaged into numbered packs by an independent pharmacist and were delivered to the family practices to be distributed to the enrolled patients. Participants were invited to report daily, using web or paper version, the severity of symptoms using a scale 0 to 6, along with twice-daily peak flow, for 28 days or until symptom resolution. Participants received shopping vouchers. Medical notes were reviewed at 3 months for new diagnosis of asthma, chronic obstructive pulmonary disease, whooping cough, and lung cancer.

 Main outcome measures . The primary outcomes were the duration of moderately bad or worse cough (defined as the number of days from randomization to the last day with a score of at least 3 points prior to at least 2 consecutive days with a score of less than 3, up to a maximum of 28 days); and the mean severity score (range 0–6) of the 6 main symptoms (cough, phlegm, shortness of breath, sleep disturbance, feeling generally unwell, and activity disturbance) on days 2 to 4.

Main results. 401 patients were randomized; 25 patients were lost to follow-up, leaving 173 in prednisolone group and 161 in placebo group for analysis. The prednisolone group was slightly more likely to be male, older, and to have received an influenza vaccine. 96% were white. Symptom diaries were returned by 94% of patients. For primary outcome 1, duration of moderately bad or worse cough, the median time to recovery from moderately bad or worse cough was 5 days (interquartile range, 3–8 days) in both groups. There was no difference after sensitivity analysis (multiple imputation of missing data, per-protocol analysis, and adjusting for day of recruitment). Primary outcome 2, the mean symptom severity score, after adjustment for center and baseline measure, was lower (hazard ratio, –0.20) in the prednisolone group compared with the placebo group; however, after secondary additional adjustment for age, sex, influenza vaccine, and smoking, the difference was not statistically significant. Secondary outcomes included total duration and severity of each symptom up to 28 days, duration of abnormal peak flow up to 28 days, cough duration of any severity up to 56 days, antibiotic use, patient satisfaction, adverse events were not different between the two groups. There were no new urinary or visual symptoms and none of the patients reporting fatigue, thirst, or dry throat had diabetes.

Conclusion. Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity.

Commentary

This study by Hay et al prospectively recruited patients with acute respiratory illness presenting to an outpatient setting within multiple centers for a placebo-controlled randomized study to evaluate the effectiveness of oral corticosteroids for acute lower respiratory tract infection. Patients with pre-existing lung disease such as asthma or COPD were excluded. This study showed moderate-dose oral prednisolone (20 mg twice a day for 5 days) did not reduce the duration of cough, and there was no statistically significant differences in primary and secondary outcomes between the 2 groups.

The beneficial effect of corticosteroids is thought to be due to its anti-inflammatory effect and decreasing harmful cytokines, which can be elevated during acute respiratory illness. In patients with severe pneumonia, patients potentially benefitted from corticosteroids by achieving clinical stability faster, reducing risk for treatment failure or ARDS and reducing hospital length of stay. However, corticosteroids are associated with hyperglycemia, myopathy, superinfection, osteopenia, and increased risk for gastrointestinal bleeding [1]. Corticosteroids have shown benefit repeatedly in patients with pneumonia severe enough to require hospitalization or intensive care unit stay [2–7].

The use of oral corticosteroids in non-critical acute respiratory tract illness without underlying obstructive lung disease has been a somewhat common practice (15%) [8]. However, no study to date firmly supports the use of oral corticosteroids in this patient group. A recently published randomized study attempted to determine if there is a benefit of oral dexamethasone in patients with acute sore throat, and found none [9]. No randomized controlled data has been published on the outpatient use of oral corticosteroids for acute lower respiratory illness.

The current study offers further evidence against the use of oral corticosteroids for acute, non-critical inflammation of the respiratory tract in nonasthmatic patients. Strengths of the study include its blinded and randomized study design and large number of patients. However, there are some limitations. Acute lower respiratory infection is associated with a wide spectrum of causative organisms and severity. It is possible that the beneficial effects of corticosteroids are only measurable when disease severity is high and there will be a systemic inflammatory response. In addition, outcome measurement was limited to a few items, namely patient-reported symptom score and duration. Furthermore, they measured the peak flow adjunctively. Without underlying airway hyperreactivity, substantial differences in peak flow are unlikely to be evident, limiting the usefulness of this as an indicator of disease in patients without chronic pulmonary disease.

Other study limitations include low patient recruitment rate, a large number of patients who did not have moderately bad cough at presentation or during the first 2 days, absence of baseline biomarkers (such as inflammatory, microbiological, spirometric or radiographic) and patient-reported outcome measures, and a sample largely homogenous in ethnicity with a small number of smokers. It is unclear whether similar results could be achieved in a more diverse population and with a greater percentage of smokers. In addition, although overall both groups were well balanced, including the number of patients taking over-the-counter cough suppressants and delayed antibiotics, the tracking of other concurrent therapies such as NSAIDs or acetaminophen was not included in the study design and the type of antibiotic was not tabulated. Such concurrent drugs could have masked a true benefit of oral corticosteroids.

Applications for Clinical Practice

This study will help prevent excessive prescription of oral corticosteroids for acute minor lower respiratory infection that requires only outpatient treatment. However, the evidence is limited to patients in stable condition. Patients with more severe acute lower respiratory infection, such as patients requiring hospitalization, may still benefit from a short course of oral corticosteroids. Furthermore, patients with underlying obstructive airways disease such as asthma or COPD should still be considered for oral corticosteroid therapy depending on their clinical circumstances.

—Minkyung Kwon, MD,  Joel Roberson, MD, and Jack Leventhal, MD,
Pulmonary and Critical Care Medicine,Mayo Clini c Florida, Jacksonville, FL (Drs. Kwon andLeventhal), and Department of Radiology, Oakland University Beaumont Hospital, Royal Oak, MI (Dr. Roberson)

Study Overview

Objective. To develop and validate a risk stratification tool to categorize 12-month risk of hypoglycemia-related emergency department (ED) or hospital use among patients with type 2 diabetes (T2D).

Design. Prospective cohort study.

Setting and participants. Patients with T2D from Kaiser Permanente Northern California were identified using electronic medical records (EMR). Patients had to be 21 years of age or older as of the baseline date of 1 January 2014, with continuous health plan membership for 24 months prebaseline and pharmacy benefits for 12 months prebaseline. Of the 233,330 adults identified, 24,719 were excluded for unknown diabetes type, and 3614 were excluded for type 1 diabetes. The remaining 206,435 eligible patients with T2D were randomly split into an 80% derivation sample (n = 165,148) for tool development and 20% internal validation sample (n = 41,287). Using similar eligibility criteria, 2 external validation samples were derived from the Veterans Administration Diabetes Epidemiology Cohort (VA) (n = 1,335,966 adults) as well as from Group Health Cooperative (GH) (n = 14,972).

Main outcome measure. The primary outcome was the occurrence of any hypoglycemia-related ED visit or hospital use during the 12 months postbaseline. A primary diagnosis of hypoglycemia was ascertained using the following International Classification of Diseases, Ninth Revision (ICD-9) codes: 251.0, 251.1, 251.2, 962.3, or 250.8, without concurrent 259.3, 272.7, 681.xx, 686.9x, 707.a-707.9, 709.3, 730.0-730.2, or 731.8 codes [1]. Secondary discharge diagnoses for hypoglycemia were not used because they are often attributable to events that occurred during the ED or hospital encounter.

Main results. Beginning with 156 (122 categorical and 34 continuous) candidate clinical, demographic, and behavioral predictor variables for model development, the final classification tree was based on 6 patient-specific variables: total number of prior episodes of hypoglycemia-related ED or hospital utilization (0, 1–2, ≥ 3 times), number of ED encounters for any reason in the prior 12 months (< 2, ≥ 2 times), insulin use (yes/no), sulfonylurea use (yes/no), presence of severe or end-stage kidney disease (dialysis or chronic kidney disease stage 4 or 5 determined by estimated glomerular filtration rate of ≤ 29 mL/min/1.73 m² (yes/no), and age younger than 77 years (yes/no). This classification tree resulted in 10 mutually exclusive leaf nodes, each yielding an estimated annual risk of hypoglycemia-related utilization, which were categorized as high (> 5%), intermediate (1%–5%), or low (< 1%).

The above classification model was then transcribed into a checklist-style hypoglycemia risk stratification tool by mapping the combination of risk factors to high, intermediate, or low risk of having any hypoglycemia-related utilization in the following 12 months.

Regarding patient characteristics, there were no significant differences in the distribution of the 6 predictors between the Kaiser derivation vs. validation samples, but there were significant differences across external validation samples. For example, the VA sample was predominantly men, with a higher proportion of patients older than 77 years, and had the highest proportion of patients with severe or end-stage kidney disease. Regarding model validation, the tool performed well in both internal validation (C statistic = 0.83) and external validation samples (VA C statistic = 0.81; GH C statistic = 0.79).

Conclusion. This hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions to reduce hypoglycemia risk and improve patient safety.

Commentary

It is estimated that 25 million people in the United States have diabetes [2]. Hypoglycemia is a frequent adverse event in patients with T2D, being more common than acute hyperglycemic emergencies such as hyperosmolar hyperglycemic state [3]. Iatrogenic hypoglycemia due to glucose-lowering medication can result in hypoglycemic crisis that requires administration of carbohydrates, glucagon, or other resuscitative actions in the ED or in hospital [4,5]. The estimated total annual direct medical costs of hypoglycemia-related utilization were estimated at approximately $1.8 billion in the United States in 2009.

The risk of hypoglycemia varies widely in patients with T2D and there are no validated methods to target interventions to the at-risk population. In this article, Karter and colleagues developed and validated a pragmatic hypoglycemia risk stratification tool that uses 6 factors to categorize the 12-month risk of hypoglycemia-related ED or hospital utilization.

Identifying patients at high-risk for hypoglycemia-related utilization provides an opportunity to mobilize resources to target this minority of patients with T2D, including deintensifying or simplifying medication regimens, prescribing glucagon kits or continuous glucose monitors, making referrals to clinical pharmacists or nurse care managers, and regularly asking about hypoglycemia events occurring outside the medical setting. This is important, as more than 95% of severe hypoglycemia events may go clinically unrecognized because they did not result in ED or hospital use [6]. In addition, as the 6 inputs were identified by EMR, intervention can include automated clinical alert flags in the EMR and automated messaging to patients with elevated risk.

Several limitations exist. The study excluded secondary discharge diagnoses for hypoglycemia as these may occur due to sepsis, acute renal failure, trauma, or other causes. In addition, the external validation populations had different distributions of disease severity and case mix. The authors attribute some of the inconsistent findings to sparse data in the GH validation sample (n = 14,972). Finally, this tool was developed to stratify the population into 3 levels of risk, and it should not be used to estimate the probability of hypoglycemic-related utilization for an individual patient.

Applications for Clinical Practice

The EMR-based hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions, including integration into existing EMR as clinical decision aid, to reduce hypoglycemia risk and improve patient safety.

—Ka Ming Gordon Ngai, MD, MPH

Study Overview

Objective. To develop and validate a risk stratification tool to categorize 12-month risk of hypoglycemia-related emergency department (ED) or hospital use among patients with type 2 diabetes (T2D).

Design. Prospective cohort study.

Setting and participants. Patients with T2D from Kaiser Permanente Northern California were identified using electronic medical records (EMR). Patients had to be 21 years of age or older as of the baseline date of 1 January 2014, with continuous health plan membership for 24 months prebaseline and pharmacy benefits for 12 months prebaseline. Of the 233,330 adults identified, 24,719 were excluded for unknown diabetes type, and 3614 were excluded for type 1 diabetes. The remaining 206,435 eligible patients with T2D were randomly split into an 80% derivation sample (n = 165,148) for tool development and 20% internal validation sample (n = 41,287). Using similar eligibility criteria, 2 external validation samples were derived from the Veterans Administration Diabetes Epidemiology Cohort (VA) (n = 1,335,966 adults) as well as from Group Health Cooperative (GH) (n = 14,972).

Main outcome measure. The primary outcome was the occurrence of any hypoglycemia-related ED visit or hospital use during the 12 months postbaseline. A primary diagnosis of hypoglycemia was ascertained using the following International Classification of Diseases, Ninth Revision (ICD-9) codes: 251.0, 251.1, 251.2, 962.3, or 250.8, without concurrent 259.3, 272.7, 681.xx, 686.9x, 707.a-707.9, 709.3, 730.0-730.2, or 731.8 codes [1]. Secondary discharge diagnoses for hypoglycemia were not used because they are often attributable to events that occurred during the ED or hospital encounter.

Main results. Beginning with 156 (122 categorical and 34 continuous) candidate clinical, demographic, and behavioral predictor variables for model development, the final classification tree was based on 6 patient-specific variables: total number of prior episodes of hypoglycemia-related ED or hospital utilization (0, 1–2, ≥ 3 times), number of ED encounters for any reason in the prior 12 months (< 2, ≥ 2 times), insulin use (yes/no), sulfonylurea use (yes/no), presence of severe or end-stage kidney disease (dialysis or chronic kidney disease stage 4 or 5 determined by estimated glomerular filtration rate of ≤ 29 mL/min/1.73 m² (yes/no), and age younger than 77 years (yes/no). This classification tree resulted in 10 mutually exclusive leaf nodes, each yielding an estimated annual risk of hypoglycemia-related utilization, which were categorized as high (> 5%), intermediate (1%–5%), or low (< 1%).

The above classification model was then transcribed into a checklist-style hypoglycemia risk stratification tool by mapping the combination of risk factors to high, intermediate, or low risk of having any hypoglycemia-related utilization in the following 12 months.

Regarding patient characteristics, there were no significant differences in the distribution of the 6 predictors between the Kaiser derivation vs. validation samples, but there were significant differences across external validation samples. For example, the VA sample was predominantly men, with a higher proportion of patients older than 77 years, and had the highest proportion of patients with severe or end-stage kidney disease. Regarding model validation, the tool performed well in both internal validation (C statistic = 0.83) and external validation samples (VA C statistic = 0.81; GH C statistic = 0.79).

Conclusion. This hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions to reduce hypoglycemia risk and improve patient safety.

Commentary

It is estimated that 25 million people in the United States have diabetes [2]. Hypoglycemia is a frequent adverse event in patients with T2D, being more common than acute hyperglycemic emergencies such as hyperosmolar hyperglycemic state [3]. Iatrogenic hypoglycemia due to glucose-lowering medication can result in hypoglycemic crisis that requires administration of carbohydrates, glucagon, or other resuscitative actions in the ED or in hospital [4,5]. The estimated total annual direct medical costs of hypoglycemia-related utilization were estimated at approximately $1.8 billion in the United States in 2009.

The risk of hypoglycemia varies widely in patients with T2D and there are no validated methods to target interventions to the at-risk population. In this article, Karter and colleagues developed and validated a pragmatic hypoglycemia risk stratification tool that uses 6 factors to categorize the 12-month risk of hypoglycemia-related ED or hospital utilization.

Identifying patients at high-risk for hypoglycemia-related utilization provides an opportunity to mobilize resources to target this minority of patients with T2D, including deintensifying or simplifying medication regimens, prescribing glucagon kits or continuous glucose monitors, making referrals to clinical pharmacists or nurse care managers, and regularly asking about hypoglycemia events occurring outside the medical setting. This is important, as more than 95% of severe hypoglycemia events may go clinically unrecognized because they did not result in ED or hospital use [6]. In addition, as the 6 inputs were identified by EMR, intervention can include automated clinical alert flags in the EMR and automated messaging to patients with elevated risk.

Several limitations exist. The study excluded secondary discharge diagnoses for hypoglycemia as these may occur due to sepsis, acute renal failure, trauma, or other causes. In addition, the external validation populations had different distributions of disease severity and case mix. The authors attribute some of the inconsistent findings to sparse data in the GH validation sample (n = 14,972). Finally, this tool was developed to stratify the population into 3 levels of risk, and it should not be used to estimate the probability of hypoglycemic-related utilization for an individual patient.

Applications for Clinical Practice

The EMR-based hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions, including integration into existing EMR as clinical decision aid, to reduce hypoglycemia risk and improve patient safety.

—Ka Ming Gordon Ngai, MD, MPH

Study Overview

Objective. To develop and validate a risk stratification tool to categorize 12-month risk of hypoglycemia-related emergency department (ED) or hospital use among patients with type 2 diabetes (T2D).

Design. Prospective cohort study.

Setting and participants. Patients with T2D from Kaiser Permanente Northern California were identified using electronic medical records (EMR). Patients had to be 21 years of age or older as of the baseline date of 1 January 2014, with continuous health plan membership for 24 months prebaseline and pharmacy benefits for 12 months prebaseline. Of the 233,330 adults identified, 24,719 were excluded for unknown diabetes type, and 3614 were excluded for type 1 diabetes. The remaining 206,435 eligible patients with T2D were randomly split into an 80% derivation sample (n = 165,148) for tool development and 20% internal validation sample (n = 41,287). Using similar eligibility criteria, 2 external validation samples were derived from the Veterans Administration Diabetes Epidemiology Cohort (VA) (n = 1,335,966 adults) as well as from Group Health Cooperative (GH) (n = 14,972).

Main outcome measure. The primary outcome was the occurrence of any hypoglycemia-related ED visit or hospital use during the 12 months postbaseline. A primary diagnosis of hypoglycemia was ascertained using the following International Classification of Diseases, Ninth Revision (ICD-9) codes: 251.0, 251.1, 251.2, 962.3, or 250.8, without concurrent 259.3, 272.7, 681.xx, 686.9x, 707.a-707.9, 709.3, 730.0-730.2, or 731.8 codes [1]. Secondary discharge diagnoses for hypoglycemia were not used because they are often attributable to events that occurred during the ED or hospital encounter.

Main results. Beginning with 156 (122 categorical and 34 continuous) candidate clinical, demographic, and behavioral predictor variables for model development, the final classification tree was based on 6 patient-specific variables: total number of prior episodes of hypoglycemia-related ED or hospital utilization (0, 1–2, ≥ 3 times), number of ED encounters for any reason in the prior 12 months (< 2, ≥ 2 times), insulin use (yes/no), sulfonylurea use (yes/no), presence of severe or end-stage kidney disease (dialysis or chronic kidney disease stage 4 or 5 determined by estimated glomerular filtration rate of ≤ 29 mL/min/1.73 m² (yes/no), and age younger than 77 years (yes/no). This classification tree resulted in 10 mutually exclusive leaf nodes, each yielding an estimated annual risk of hypoglycemia-related utilization, which were categorized as high (> 5%), intermediate (1%–5%), or low (< 1%).

The above classification model was then transcribed into a checklist-style hypoglycemia risk stratification tool by mapping the combination of risk factors to high, intermediate, or low risk of having any hypoglycemia-related utilization in the following 12 months.

Regarding patient characteristics, there were no significant differences in the distribution of the 6 predictors between the Kaiser derivation vs. validation samples, but there were significant differences across external validation samples. For example, the VA sample was predominantly men, with a higher proportion of patients older than 77 years, and had the highest proportion of patients with severe or end-stage kidney disease. Regarding model validation, the tool performed well in both internal validation (C statistic = 0.83) and external validation samples (VA C statistic = 0.81; GH C statistic = 0.79).

Conclusion. This hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions to reduce hypoglycemia risk and improve patient safety.

Commentary

It is estimated that 25 million people in the United States have diabetes [2]. Hypoglycemia is a frequent adverse event in patients with T2D, being more common than acute hyperglycemic emergencies such as hyperosmolar hyperglycemic state [3]. Iatrogenic hypoglycemia due to glucose-lowering medication can result in hypoglycemic crisis that requires administration of carbohydrates, glucagon, or other resuscitative actions in the ED or in hospital [4,5]. The estimated total annual direct medical costs of hypoglycemia-related utilization were estimated at approximately $1.8 billion in the United States in 2009.

The risk of hypoglycemia varies widely in patients with T2D and there are no validated methods to target interventions to the at-risk population. In this article, Karter and colleagues developed and validated a pragmatic hypoglycemia risk stratification tool that uses 6 factors to categorize the 12-month risk of hypoglycemia-related ED or hospital utilization.

Identifying patients at high-risk for hypoglycemia-related utilization provides an opportunity to mobilize resources to target this minority of patients with T2D, including deintensifying or simplifying medication regimens, prescribing glucagon kits or continuous glucose monitors, making referrals to clinical pharmacists or nurse care managers, and regularly asking about hypoglycemia events occurring outside the medical setting. This is important, as more than 95% of severe hypoglycemia events may go clinically unrecognized because they did not result in ED or hospital use [6]. In addition, as the 6 inputs were identified by EMR, intervention can include automated clinical alert flags in the EMR and automated messaging to patients with elevated risk.

Several limitations exist. The study excluded secondary discharge diagnoses for hypoglycemia as these may occur due to sepsis, acute renal failure, trauma, or other causes. In addition, the external validation populations had different distributions of disease severity and case mix. The authors attribute some of the inconsistent findings to sparse data in the GH validation sample (n = 14,972). Finally, this tool was developed to stratify the population into 3 levels of risk, and it should not be used to estimate the probability of hypoglycemic-related utilization for an individual patient.

Applications for Clinical Practice

The EMR-based hypoglycemia risk stratification tool categorizes the 12-month risk of hypoglycemia-related utilization in patients with T2D using 6 easily obtained inputs. This tool can facilitate efficient targeting of population management interventions, including integration into existing EMR as clinical decision aid, to reduce hypoglycemia risk and improve patient safety.

—Ka Ming Gordon Ngai, MD, MPH

Study Overview

Objective. To determine the effect of implementing an intervention to reduce catheter-associated urinary tract infections (CAUTIs) in nursing homes.

Design. Prospective implementation project.

Setting and participants. The study was conducted between March 2014 and August 2016 in 12-month cohorts of community-based nursing homes participating in the Agency for Healthcare Research and Quality Safety Program for Long-Term Care. A total of 568 nursing homes located across 48 states, Washington DC, and Puerto Rico were recruited to participate.

Intervention. The intervention was developed with the goal of modifying the elements of the Comprehensive Unit-Based Safety Program utilized in hospitals for adoption in nursing homes. The intervention included a technical bundle, that is, catheter removal, aseptic insertion, using regular assessments, training for catheter care, and incontinence care planning [1], as well as socioadaptive interventions focused on empowering teams, addressing implementation challenges, offering solutions, promoting resident safety culture, team building, leadership, and resident and family engagement. The interventions were implemented over a 12-month period. To be included in the data analysis, nursing homes need to remain active through the end of the 12-month period and report 2 months or more of outcome data and device-days. Nursing homes that reported large fluctuations in reported data were excluded from the analysis. A total of 433 nursing homes remained active throughout the intervention period.

Main outcome measures. The main study outcome measure was the CAUTI incidence rate, defined as the number of CAUTIs divided by the number of catheter-days and multiplied by 1000. National Healthcare Safety Network definitions were used. The criteria for UTI
included objective systemic and localizing clinical findings along with laboratory-based criteria. A secondary outcome was the urinary catheter utilization ratio, defined as the number of catheter-days divided by the number of resident-days multiplied by 100 and reported as a percentage. Participating nursing homes collected data on the daily number of CAUTIs, catheter days, resident days, and urine cultures for each month of the project period and these metrics were reported using the Health Research and Educational Trust, a research affiliate of the American Hospital Association, Comprehensive Data System.

Conclusion. A multicomponent intervention implemented in community-based nursing homes across the country was associated with a reduction in CAUTI rates. The study shows that the intervention to reduce CAUTI can be implemented on a large scale and can be associated with improvement in patient safety.

Commentary

Catheter-associated urinary tract infection is a common condition that affects nursing home residents, as nursing home residents often have an indwelling urinary catheter on admission to the nursing home. These infections can be costly, lead to hospital admissions, and can contribute to the development of multidrug-resistant organisms, which pose a significant public health threat [2]. CAUTIs, however, are potentially preventable through the use of practices that promote judicious use of urinary catheters and attention to aseptic insertion and catheter care [3,4]. Although prior randomized controlled trials demonstrated the potential impact of interventions that reduce incidence of urinary tract infections [5], the interventions have not been adopted widely.

Recognizing the importance of improving safety through reducing CAUTIs, the Agency for Healthcare Research and Quality has established toolkits and implementation guides for health care facilities to adopt better practices for reducing catheter-associated infections. This study adds to the current literature by demonstrating the feasibility and beneficial impact of widespread implementation of AHRQ tools.

The study evaluated the impact of the intervention in a large cohort of nursing homes, comparing outcome measures pre and post intervention. One limitation of the study is that other factors that were present concurrently may have contributed to the observed changes in CAUTI outcomes. The study also did not have a control group, and the changes in outcome rates were not compared with rates in homes that did not participate in the project. Also, it is not possible to examine the effect of the individual components of the intervention as this intervention had multiple components delivered simultaneously. Despite these drawbacks, the study makes a strong case that project implementation is associated with a reduction in CAUTI rates of more than 50%.

A next step to better understand how best to disseminate the intervention is to identify factors associated with greater improvements in outcomes among the cohort of nursing homes and also to understand the variations in how nursing homes are implementing the intervention and what impact these differences might have. This in turn may guide further efforts to broaden the impact through more nuanced application of the intervention.

Applications for Clinical Practice

This study demonstrates that CAUTI can be prevented through a multicomponent intervention that focuses on appropriate use and discontinuation of urinary catheters and proper catheter care. Given that these tools and guides are available for use through AHRQ, nursing homes should examine the potential for adoption in their facilities. This can enhance the safety for their residents by reducing the risk of a potentially preventable complication.

—William W. Hung, MD, MPH

Study Overview

Objective. To determine the effect of implementing an intervention to reduce catheter-associated urinary tract infections (CAUTIs) in nursing homes.

Design. Prospective implementation project.

Setting and participants. The study was conducted between March 2014 and August 2016 in 12-month cohorts of community-based nursing homes participating in the Agency for Healthcare Research and Quality Safety Program for Long-Term Care. A total of 568 nursing homes located across 48 states, Washington DC, and Puerto Rico were recruited to participate.

Intervention. The intervention was developed with the goal of modifying the elements of the Comprehensive Unit-Based Safety Program utilized in hospitals for adoption in nursing homes. The intervention included a technical bundle, that is, catheter removal, aseptic insertion, using regular assessments, training for catheter care, and incontinence care planning [1], as well as socioadaptive interventions focused on empowering teams, addressing implementation challenges, offering solutions, promoting resident safety culture, team building, leadership, and resident and family engagement. The interventions were implemented over a 12-month period. To be included in the data analysis, nursing homes need to remain active through the end of the 12-month period and report 2 months or more of outcome data and device-days. Nursing homes that reported large fluctuations in reported data were excluded from the analysis. A total of 433 nursing homes remained active throughout the intervention period.

Main outcome measures. The main study outcome measure was the CAUTI incidence rate, defined as the number of CAUTIs divided by the number of catheter-days and multiplied by 1000. National Healthcare Safety Network definitions were used. The criteria for UTI
included objective systemic and localizing clinical findings along with laboratory-based criteria. A secondary outcome was the urinary catheter utilization ratio, defined as the number of catheter-days divided by the number of resident-days multiplied by 100 and reported as a percentage. Participating nursing homes collected data on the daily number of CAUTIs, catheter days, resident days, and urine cultures for each month of the project period and these metrics were reported using the Health Research and Educational Trust, a research affiliate of the American Hospital Association, Comprehensive Data System.

Conclusion. A multicomponent intervention implemented in community-based nursing homes across the country was associated with a reduction in CAUTI rates. The study shows that the intervention to reduce CAUTI can be implemented on a large scale and can be associated with improvement in patient safety.

Commentary

Catheter-associated urinary tract infection is a common condition that affects nursing home residents, as nursing home residents often have an indwelling urinary catheter on admission to the nursing home. These infections can be costly, lead to hospital admissions, and can contribute to the development of multidrug-resistant organisms, which pose a significant public health threat [2]. CAUTIs, however, are potentially preventable through the use of practices that promote judicious use of urinary catheters and attention to aseptic insertion and catheter care [3,4]. Although prior randomized controlled trials demonstrated the potential impact of interventions that reduce incidence of urinary tract infections [5], the interventions have not been adopted widely.

Recognizing the importance of improving safety through reducing CAUTIs, the Agency for Healthcare Research and Quality has established toolkits and implementation guides for health care facilities to adopt better practices for reducing catheter-associated infections. This study adds to the current literature by demonstrating the feasibility and beneficial impact of widespread implementation of AHRQ tools.

The study evaluated the impact of the intervention in a large cohort of nursing homes, comparing outcome measures pre and post intervention. One limitation of the study is that other factors that were present concurrently may have contributed to the observed changes in CAUTI outcomes. The study also did not have a control group, and the changes in outcome rates were not compared with rates in homes that did not participate in the project. Also, it is not possible to examine the effect of the individual components of the intervention as this intervention had multiple components delivered simultaneously. Despite these drawbacks, the study makes a strong case that project implementation is associated with a reduction in CAUTI rates of more than 50%.

A next step to better understand how best to disseminate the intervention is to identify factors associated with greater improvements in outcomes among the cohort of nursing homes and also to understand the variations in how nursing homes are implementing the intervention and what impact these differences might have. This in turn may guide further efforts to broaden the impact through more nuanced application of the intervention.

Applications for Clinical Practice

This study demonstrates that CAUTI can be prevented through a multicomponent intervention that focuses on appropriate use and discontinuation of urinary catheters and proper catheter care. Given that these tools and guides are available for use through AHRQ, nursing homes should examine the potential for adoption in their facilities. This can enhance the safety for their residents by reducing the risk of a potentially preventable complication.

—William W. Hung, MD, MPH

Study Overview

Objective. To determine the effect of implementing an intervention to reduce catheter-associated urinary tract infections (CAUTIs) in nursing homes.

Design. Prospective implementation project.

Setting and participants. The study was conducted between March 2014 and August 2016 in 12-month cohorts of community-based nursing homes participating in the Agency for Healthcare Research and Quality Safety Program for Long-Term Care. A total of 568 nursing homes located across 48 states, Washington DC, and Puerto Rico were recruited to participate.

Intervention. The intervention was developed with the goal of modifying the elements of the Comprehensive Unit-Based Safety Program utilized in hospitals for adoption in nursing homes. The intervention included a technical bundle, that is, catheter removal, aseptic insertion, using regular assessments, training for catheter care, and incontinence care planning [1], as well as socioadaptive interventions focused on empowering teams, addressing implementation challenges, offering solutions, promoting resident safety culture, team building, leadership, and resident and family engagement. The interventions were implemented over a 12-month period. To be included in the data analysis, nursing homes need to remain active through the end of the 12-month period and report 2 months or more of outcome data and device-days. Nursing homes that reported large fluctuations in reported data were excluded from the analysis. A total of 433 nursing homes remained active throughout the intervention period.

Main outcome measures. The main study outcome measure was the CAUTI incidence rate, defined as the number of CAUTIs divided by the number of catheter-days and multiplied by 1000. National Healthcare Safety Network definitions were used. The criteria for UTI
included objective systemic and localizing clinical findings along with laboratory-based criteria. A secondary outcome was the urinary catheter utilization ratio, defined as the number of catheter-days divided by the number of resident-days multiplied by 100 and reported as a percentage. Participating nursing homes collected data on the daily number of CAUTIs, catheter days, resident days, and urine cultures for each month of the project period and these metrics were reported using the Health Research and Educational Trust, a research affiliate of the American Hospital Association, Comprehensive Data System.

Conclusion. A multicomponent intervention implemented in community-based nursing homes across the country was associated with a reduction in CAUTI rates. The study shows that the intervention to reduce CAUTI can be implemented on a large scale and can be associated with improvement in patient safety.

Commentary

Catheter-associated urinary tract infection is a common condition that affects nursing home residents, as nursing home residents often have an indwelling urinary catheter on admission to the nursing home. These infections can be costly, lead to hospital admissions, and can contribute to the development of multidrug-resistant organisms, which pose a significant public health threat [2]. CAUTIs, however, are potentially preventable through the use of practices that promote judicious use of urinary catheters and attention to aseptic insertion and catheter care [3,4]. Although prior randomized controlled trials demonstrated the potential impact of interventions that reduce incidence of urinary tract infections [5], the interventions have not been adopted widely.

Recognizing the importance of improving safety through reducing CAUTIs, the Agency for Healthcare Research and Quality has established toolkits and implementation guides for health care facilities to adopt better practices for reducing catheter-associated infections. This study adds to the current literature by demonstrating the feasibility and beneficial impact of widespread implementation of AHRQ tools.

The study evaluated the impact of the intervention in a large cohort of nursing homes, comparing outcome measures pre and post intervention. One limitation of the study is that other factors that were present concurrently may have contributed to the observed changes in CAUTI outcomes. The study also did not have a control group, and the changes in outcome rates were not compared with rates in homes that did not participate in the project. Also, it is not possible to examine the effect of the individual components of the intervention as this intervention had multiple components delivered simultaneously. Despite these drawbacks, the study makes a strong case that project implementation is associated with a reduction in CAUTI rates of more than 50%.

A next step to better understand how best to disseminate the intervention is to identify factors associated with greater improvements in outcomes among the cohort of nursing homes and also to understand the variations in how nursing homes are implementing the intervention and what impact these differences might have. This in turn may guide further efforts to broaden the impact through more nuanced application of the intervention.

Applications for Clinical Practice

This study demonstrates that CAUTI can be prevented through a multicomponent intervention that focuses on appropriate use and discontinuation of urinary catheters and proper catheter care. Given that these tools and guides are available for use through AHRQ, nursing homes should examine the potential for adoption in their facilities. This can enhance the safety for their residents by reducing the risk of a potentially preventable complication.

—William W. Hung, MD, MPH

Study Overview

Objective. To develop and test a photoaging app designed for melanoma prevention through enhancing sun protective behaviors.

Design. Cross-sectional pilot study.

Setting and participants. 25 students (56% male) with a median age of 22 years (range 19–25) attending the University of Essen in Germany.

Intervention. The researchers tested a free mobile app called Sunface. The app has the user take a self-portrait (selfie) and then photoages the image based on self-reported Fitzpatrick skin type and individual UV protection behavior. The 6 categories of skin on the Fitzpatrick Scale are Type I – always burns, never tans; Type II – usually burns, tans minimally; Type III – sometimes mild burn, gradually tans; Type IV – rarely burns, tans with ease; Type V – very rarely burns, tans very easily; Type VI – never burns, tans very easily. Afterward, the app explains the results and provides recommendations on sun protection as well as the ABCDE rule for skin cancer detection (asymmetrical shape, border, color, diameter, evolution). An interviewer walked up to each student, asked for oral consent, handed them an iPod Touch with the app pre-installed, and let them use the app.

Main outcome measures. Student attitudes about the app as collected on an anonymous paper and pencil questionnaire. Items were statements (see Results below), and responses were on a Likert scale ranging from fully agree to fully disagree.

Results. The majority of students (82%) stated that they would download the app, that the intervention had the potential to motivate them to use sun protection (92%) and that they thought such an app could change their perceptions that tanning makes you attractive (76%). Only a minority of students disagreed or fully disagreed that they would download such an app (2/25, 8%) or that such an app could change their perceptions on tanning and attractiveness (4/25, 16%).

Conclusion. Based on previous studies and the initial study results presented here, it is reasonable to speculate that the app may induce behavioral change in the target population. Further work is required to implement and examine the effectiveness of app-based photoaging interventions within risk groups from various cultural backgrounds.

Commentary

The relationship between skin cancer and ultraviolet radiation is well established [1]. Despite the known risks, tanning behavior, including use of tanning beds, is common. Indoor tanning is prevalent, particularly among female adolescents, and aligns with other risk behaviors, appearance-related factors, and intentional sunbathing [2]. Behaviors such as seeking shade, avoiding sun exposure during peak hours of radiation, wearing protective clothing, or some combination of these behaviors can provide protection against ultraviolet radiation [1].Significantly lower frequencies of almost all recommended sun-protective measures are found in younger patient subgroups (age 14 to 25 years) [3]. Thus, it makes sense to target interventions at the adolescent age-group.

Counseling adolescents regarding the dangers of tanning can be difficult due to the pressure the media places on young women and men to enhance their appearance. As a result, appeals to the negative cosmetic impact of sun and indoor tanning may be more effective than health-based appeals [4].

In this pilot study, the authors tested a creative sun protection app that photoages the user’s image based on skin type and aging algorithms. The underlying aging algorithms are based on publications showing UV-induced skin damage by outdoor as well as indoor tanning. Afterward, the app explains the visual results and aims at increasing self-competence on skin cancer prevention by providing guideline recommendations on sun protection and the ABCDE rule for melanoma self-detection. The app was very well received by the partipating college students, and the researchers concluded that the app may aid in the prevention of melanoma by enhancing the adoption of sun protective behaviors. However, this study was very small.

Mobile phone apps are proliferating and they are recognized as a potential low cost way to deliver health interventions [5]. A previous trial by Buller [6] used a randomized controlled design to evaluate a smartphone app that delivered real-time advice about sun protection, such as alerts to apply or reapply sunscreen or wear a hat. Only 1 out of 7 sun-safety practices was used more frequently by intervention versus control participants. The authors of an evidence review of the effectiveness of mobile phone apps in achieving health-related behavior change note that adequately powered and relatively longer RCTs are needed to better determine the effectiveness of app-based interventions [5].

Applications for Clinical Practice

Warnings on the dangers of sunburn and indoor tanning at any age should be emphasized, and there is an important role for primary care physician and other clinician counseling as well as public health outreach. Phone apps have the benefit of being able to reach large numbers at low cost and can offer an interactive and personalized health education experience. Such nontraditional strategies offer promise. Further studies should shed light on what app features are most important to users and whether their deployment can have a measurable impact on cancer prevention.

Study Overview

Objective. To develop and test a photoaging app designed for melanoma prevention through enhancing sun protective behaviors.

Design. Cross-sectional pilot study.

Setting and participants. 25 students (56% male) with a median age of 22 years (range 19–25) attending the University of Essen in Germany.

Intervention. The researchers tested a free mobile app called Sunface. The app has the user take a self-portrait (selfie) and then photoages the image based on self-reported Fitzpatrick skin type and individual UV protection behavior. The 6 categories of skin on the Fitzpatrick Scale are Type I – always burns, never tans; Type II – usually burns, tans minimally; Type III – sometimes mild burn, gradually tans; Type IV – rarely burns, tans with ease; Type V – very rarely burns, tans very easily; Type VI – never burns, tans very easily. Afterward, the app explains the results and provides recommendations on sun protection as well as the ABCDE rule for skin cancer detection (asymmetrical shape, border, color, diameter, evolution). An interviewer walked up to each student, asked for oral consent, handed them an iPod Touch with the app pre-installed, and let them use the app.

Main outcome measures. Student attitudes about the app as collected on an anonymous paper and pencil questionnaire. Items were statements (see Results below), and responses were on a Likert scale ranging from fully agree to fully disagree.

Results. The majority of students (82%) stated that they would download the app, that the intervention had the potential to motivate them to use sun protection (92%) and that they thought such an app could change their perceptions that tanning makes you attractive (76%). Only a minority of students disagreed or fully disagreed that they would download such an app (2/25, 8%) or that such an app could change their perceptions on tanning and attractiveness (4/25, 16%).

Conclusion. Based on previous studies and the initial study results presented here, it is reasonable to speculate that the app may induce behavioral change in the target population. Further work is required to implement and examine the effectiveness of app-based photoaging interventions within risk groups from various cultural backgrounds.

Commentary

The relationship between skin cancer and ultraviolet radiation is well established [1]. Despite the known risks, tanning behavior, including use of tanning beds, is common. Indoor tanning is prevalent, particularly among female adolescents, and aligns with other risk behaviors, appearance-related factors, and intentional sunbathing [2]. Behaviors such as seeking shade, avoiding sun exposure during peak hours of radiation, wearing protective clothing, or some combination of these behaviors can provide protection against ultraviolet radiation [1].Significantly lower frequencies of almost all recommended sun-protective measures are found in younger patient subgroups (age 14 to 25 years) [3]. Thus, it makes sense to target interventions at the adolescent age-group.

Counseling adolescents regarding the dangers of tanning can be difficult due to the pressure the media places on young women and men to enhance their appearance. As a result, appeals to the negative cosmetic impact of sun and indoor tanning may be more effective than health-based appeals [4].

In this pilot study, the authors tested a creative sun protection app that photoages the user’s image based on skin type and aging algorithms. The underlying aging algorithms are based on publications showing UV-induced skin damage by outdoor as well as indoor tanning. Afterward, the app explains the visual results and aims at increasing self-competence on skin cancer prevention by providing guideline recommendations on sun protection and the ABCDE rule for melanoma self-detection. The app was very well received by the partipating college students, and the researchers concluded that the app may aid in the prevention of melanoma by enhancing the adoption of sun protective behaviors. However, this study was very small.

Mobile phone apps are proliferating and they are recognized as a potential low cost way to deliver health interventions [5]. A previous trial by Buller [6] used a randomized controlled design to evaluate a smartphone app that delivered real-time advice about sun protection, such as alerts to apply or reapply sunscreen or wear a hat. Only 1 out of 7 sun-safety practices was used more frequently by intervention versus control participants. The authors of an evidence review of the effectiveness of mobile phone apps in achieving health-related behavior change note that adequately powered and relatively longer RCTs are needed to better determine the effectiveness of app-based interventions [5].

Applications for Clinical Practice

Warnings on the dangers of sunburn and indoor tanning at any age should be emphasized, and there is an important role for primary care physician and other clinician counseling as well as public health outreach. Phone apps have the benefit of being able to reach large numbers at low cost and can offer an interactive and personalized health education experience. Such nontraditional strategies offer promise. Further studies should shed light on what app features are most important to users and whether their deployment can have a measurable impact on cancer prevention.

Study Overview

Objective. To develop and test a photoaging app designed for melanoma prevention through enhancing sun protective behaviors.

Design. Cross-sectional pilot study.

Setting and participants. 25 students (56% male) with a median age of 22 years (range 19–25) attending the University of Essen in Germany.

Intervention. The researchers tested a free mobile app called Sunface. The app has the user take a self-portrait (selfie) and then photoages the image based on self-reported Fitzpatrick skin type and individual UV protection behavior. The 6 categories of skin on the Fitzpatrick Scale are Type I – always burns, never tans; Type II – usually burns, tans minimally; Type III – sometimes mild burn, gradually tans; Type IV – rarely burns, tans with ease; Type V – very rarely burns, tans very easily; Type VI – never burns, tans very easily. Afterward, the app explains the results and provides recommendations on sun protection as well as the ABCDE rule for skin cancer detection (asymmetrical shape, border, color, diameter, evolution). An interviewer walked up to each student, asked for oral consent, handed them an iPod Touch with the app pre-installed, and let them use the app.

Main outcome measures. Student attitudes about the app as collected on an anonymous paper and pencil questionnaire. Items were statements (see Results below), and responses were on a Likert scale ranging from fully agree to fully disagree.

Results. The majority of students (82%) stated that they would download the app, that the intervention had the potential to motivate them to use sun protection (92%) and that they thought such an app could change their perceptions that tanning makes you attractive (76%). Only a minority of students disagreed or fully disagreed that they would download such an app (2/25, 8%) or that such an app could change their perceptions on tanning and attractiveness (4/25, 16%).

Conclusion. Based on previous studies and the initial study results presented here, it is reasonable to speculate that the app may induce behavioral change in the target population. Further work is required to implement and examine the effectiveness of app-based photoaging interventions within risk groups from various cultural backgrounds.

Commentary

The relationship between skin cancer and ultraviolet radiation is well established [1]. Despite the known risks, tanning behavior, including use of tanning beds, is common. Indoor tanning is prevalent, particularly among female adolescents, and aligns with other risk behaviors, appearance-related factors, and intentional sunbathing [2]. Behaviors such as seeking shade, avoiding sun exposure during peak hours of radiation, wearing protective clothing, or some combination of these behaviors can provide protection against ultraviolet radiation [1].Significantly lower frequencies of almost all recommended sun-protective measures are found in younger patient subgroups (age 14 to 25 years) [3]. Thus, it makes sense to target interventions at the adolescent age-group.

Counseling adolescents regarding the dangers of tanning can be difficult due to the pressure the media places on young women and men to enhance their appearance. As a result, appeals to the negative cosmetic impact of sun and indoor tanning may be more effective than health-based appeals [4].

In this pilot study, the authors tested a creative sun protection app that photoages the user’s image based on skin type and aging algorithms. The underlying aging algorithms are based on publications showing UV-induced skin damage by outdoor as well as indoor tanning. Afterward, the app explains the visual results and aims at increasing self-competence on skin cancer prevention by providing guideline recommendations on sun protection and the ABCDE rule for melanoma self-detection. The app was very well received by the partipating college students, and the researchers concluded that the app may aid in the prevention of melanoma by enhancing the adoption of sun protective behaviors. However, this study was very small.

Mobile phone apps are proliferating and they are recognized as a potential low cost way to deliver health interventions [5]. A previous trial by Buller [6] used a randomized controlled design to evaluate a smartphone app that delivered real-time advice about sun protection, such as alerts to apply or reapply sunscreen or wear a hat. Only 1 out of 7 sun-safety practices was used more frequently by intervention versus control participants. The authors of an evidence review of the effectiveness of mobile phone apps in achieving health-related behavior change note that adequately powered and relatively longer RCTs are needed to better determine the effectiveness of app-based interventions [5].

Applications for Clinical Practice

Warnings on the dangers of sunburn and indoor tanning at any age should be emphasized, and there is an important role for primary care physician and other clinician counseling as well as public health outreach. Phone apps have the benefit of being able to reach large numbers at low cost and can offer an interactive and personalized health education experience. Such nontraditional strategies offer promise. Further studies should shed light on what app features are most important to users and whether their deployment can have a measurable impact on cancer prevention.

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To explore the views of general practice staff on managing childhood obesity in primary care.

Design. Qualitative study.

Setting and participants. General practices across England (n = 7303) of varying practice list size (low/medium/high) and “deprivation” level (low/medium/high, based on Index of Multiple Deprivation (IMD) score, which measures deprivation based on income, employment, health, education, barriers to services, living environment and crime) were stratified into a 3 x 3 matrix, resulting in recruitment targets of 3 to 5 practices per each of 9 recruitment strata. Practices in each strata were grouped into batches and approached in a random list order to take part in the study. Recruitment continued until the strata target was reached. Interviews were conducted by 2 researchers, either in the interviewee’s workplace or by telephone.

Main outcomes measures. The interview topic guide included 2 questions related to childhood obesity: (1) theirperceptions of the barriers and enablers to general practitioners taking a more active role in childhood obesity; and (2) their views on what was needed to improve integrated local pathways to manage childhood obesity. Follow-up questions were used in response to issues raised by interviewees. All interviews were audiotaped, professionally transcribed verbatim, and checked for accuracy. Copies of transcripts were available to interviewees, although none requested to see them. Key themes were identified through thematic analysis of transcripts using an inductive approach. Initial codes were discussed and combined to form themes which were discussed until agreement was reached that these reflected the data. Results are based upon a synthesis of all the interviews.

Main results. A total of 32 practices were recruited, of which 30 identified 52 staff (56% female) to participate in semi-structured interviews: 29 general practitioners (28% female), 14 practice managers (86% female), 7 nursing staff (100% female), 1 health care assistant (female), and 1 administrative staff (female). Almost all interviewees identified childhood obesity as an increasingly important issue with potential long-term health implications. However, most did not frame it as a medical problem in itself or view its management as a general practice responsibility.

Three themes were identified: lack of contact with well children, sensitivity of the issue, and the potential impact of general practice. Identifying overweight children was challenging because well children rarely attended the practice. Interviewees felt that consultation time was limited and focused on addressing acute illness. Generally, raising the issue was described as sensitive. Interviewees also felt ill equipped to solve the issue because they lacked influence over the environmental, economic, and lifestyle factors underpinning obesity. They described little evidence to support general practice intervention and seemed unaware of other services. Interviewees felt their efforts should be directed towards health problems they identified as medical issues where evidence suggests they can make a difference.

Conclusions. Although general practice staff viewed childhood obesity as an important issue with the poten-tial to impact on health outcomes, they were unconvinced that they could have a significant role in managing childhood obesity on a large scale. Participants believed schools have more contact with children and should coordinate the identification and management of overweight children. Future policy could recommend a minor role for general practice involving opportunistic identification of overweight children and referral to specialist/obesity services

Commentary

The prevalence of childhood overweight and obesity continues to rise in the United States and worldwide with extensive economic, physical, and psychosocial consequences [1–6]. Lifestyle interventions that target obesity-related behaviors including physical activity, sedentary behavior, and diet, are considered the therapy of choice [7–10]. Indeed, the US Preventive Services Task Force recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight status [11]. Similar recommendations can be seen in other national guidelines regarding the management of childhood obesity [12].

Beyond screening and referral, some have outlined more specific opportunities for health professionals to play a more significant role in confronting child obesity, particularly among general practitioners and primary care providers [13–15]. In addition, several reviews have looked at the expanding role of primary care in the prevention and treatment of childhood obesity [16,17]. However, it remains unclear whether provider perspectives about their role in addressing childhood obesity align with such guidelines and suggestions. In fact, several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [18–20]. This study adds to the literature by qualitatively assessing perspectives of general practice staff from a variety of practices regarding their role in addressing childhood obesity.

In qualitative research, typically small samples require careful consideration of the representativeness of participants in terms of characteristics and relevance to the wider population. As the authors highlight, a key strength of this study is that staff from a large number of practices in different geographical areas across England were recruited and broadly represented general practices in terms of practice list size and deprivation. This may contribute to greater likelihood of generalizability compared to similar studies that are limited to specific states in a country or small geographic areas. Additional strengths of this study include the use of a specific framework to guide analysis, 2 independent coders to analyze transcripts, and a brief discussion of how the researcher, through the structure of the interview, may have introduced bias to the results. However, the authors did not include whether any outlying or negative/deviant cases were presented that did not fit with discussed themes or if there were any differences in findings by gender or by years since qualified to practice. Additionally, the authors did not specify if results were confirmed or validated by their study participants to increase reliability and trustworthiness of analysis and interpretation.

Applications for Clinical Practice

Although the authors highlight that their findings suggest that policies expanding the role for general practitioners in prevention, identification, and management of childhood obesity at a population-level are unlikely to be successful, findings may instead highlight specific barriers to target and overcome in order to expand the role for general practitioners. Even though contact with well children may be limited, standard practices to incorporate brief counseling could contribute to a shift in practice and patient expectations of what is discussed during visits. Increased training and awareness of resources and innovative technologies that can assist patients with addressing obesity-related environmental, economic, and lifestyle factors can also be incorporated into medical education and professional development. In addition, practices can partner with community-based programs and organizations implementing childhood obesity interventions to expand referral options. General practitioners and primary care providers remain an important source of health information and expertise, and thus should play a key role in supporting broader initiatives to address childhood obesity.

—Katrina F. Mateo, MPH

Study Overview

Objective. To explore the views of general practice staff on managing childhood obesity in primary care.

Design. Qualitative study.

Setting and participants. General practices across England (n = 7303) of varying practice list size (low/medium/high) and “deprivation” level (low/medium/high, based on Index of Multiple Deprivation (IMD) score, which measures deprivation based on income, employment, health, education, barriers to services, living environment and crime) were stratified into a 3 x 3 matrix, resulting in recruitment targets of 3 to 5 practices per each of 9 recruitment strata. Practices in each strata were grouped into batches and approached in a random list order to take part in the study. Recruitment continued until the strata target was reached. Interviews were conducted by 2 researchers, either in the interviewee’s workplace or by telephone.

Main outcomes measures. The interview topic guide included 2 questions related to childhood obesity: (1) theirperceptions of the barriers and enablers to general practitioners taking a more active role in childhood obesity; and (2) their views on what was needed to improve integrated local pathways to manage childhood obesity. Follow-up questions were used in response to issues raised by interviewees. All interviews were audiotaped, professionally transcribed verbatim, and checked for accuracy. Copies of transcripts were available to interviewees, although none requested to see them. Key themes were identified through thematic analysis of transcripts using an inductive approach. Initial codes were discussed and combined to form themes which were discussed until agreement was reached that these reflected the data. Results are based upon a synthesis of all the interviews.

Main results. A total of 32 practices were recruited, of which 30 identified 52 staff (56% female) to participate in semi-structured interviews: 29 general practitioners (28% female), 14 practice managers (86% female), 7 nursing staff (100% female), 1 health care assistant (female), and 1 administrative staff (female). Almost all interviewees identified childhood obesity as an increasingly important issue with potential long-term health implications. However, most did not frame it as a medical problem in itself or view its management as a general practice responsibility.

Three themes were identified: lack of contact with well children, sensitivity of the issue, and the potential impact of general practice. Identifying overweight children was challenging because well children rarely attended the practice. Interviewees felt that consultation time was limited and focused on addressing acute illness. Generally, raising the issue was described as sensitive. Interviewees also felt ill equipped to solve the issue because they lacked influence over the environmental, economic, and lifestyle factors underpinning obesity. They described little evidence to support general practice intervention and seemed unaware of other services. Interviewees felt their efforts should be directed towards health problems they identified as medical issues where evidence suggests they can make a difference.

Conclusions. Although general practice staff viewed childhood obesity as an important issue with the poten-tial to impact on health outcomes, they were unconvinced that they could have a significant role in managing childhood obesity on a large scale. Participants believed schools have more contact with children and should coordinate the identification and management of overweight children. Future policy could recommend a minor role for general practice involving opportunistic identification of overweight children and referral to specialist/obesity services

Commentary

The prevalence of childhood overweight and obesity continues to rise in the United States and worldwide with extensive economic, physical, and psychosocial consequences [1–6]. Lifestyle interventions that target obesity-related behaviors including physical activity, sedentary behavior, and diet, are considered the therapy of choice [7–10]. Indeed, the US Preventive Services Task Force recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight status [11]. Similar recommendations can be seen in other national guidelines regarding the management of childhood obesity [12].

Beyond screening and referral, some have outlined more specific opportunities for health professionals to play a more significant role in confronting child obesity, particularly among general practitioners and primary care providers [13–15]. In addition, several reviews have looked at the expanding role of primary care in the prevention and treatment of childhood obesity [16,17]. However, it remains unclear whether provider perspectives about their role in addressing childhood obesity align with such guidelines and suggestions. In fact, several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [18–20]. This study adds to the literature by qualitatively assessing perspectives of general practice staff from a variety of practices regarding their role in addressing childhood obesity.

In qualitative research, typically small samples require careful consideration of the representativeness of participants in terms of characteristics and relevance to the wider population. As the authors highlight, a key strength of this study is that staff from a large number of practices in different geographical areas across England were recruited and broadly represented general practices in terms of practice list size and deprivation. This may contribute to greater likelihood of generalizability compared to similar studies that are limited to specific states in a country or small geographic areas. Additional strengths of this study include the use of a specific framework to guide analysis, 2 independent coders to analyze transcripts, and a brief discussion of how the researcher, through the structure of the interview, may have introduced bias to the results. However, the authors did not include whether any outlying or negative/deviant cases were presented that did not fit with discussed themes or if there were any differences in findings by gender or by years since qualified to practice. Additionally, the authors did not specify if results were confirmed or validated by their study participants to increase reliability and trustworthiness of analysis and interpretation.

Applications for Clinical Practice

Although the authors highlight that their findings suggest that policies expanding the role for general practitioners in prevention, identification, and management of childhood obesity at a population-level are unlikely to be successful, findings may instead highlight specific barriers to target and overcome in order to expand the role for general practitioners. Even though contact with well children may be limited, standard practices to incorporate brief counseling could contribute to a shift in practice and patient expectations of what is discussed during visits. Increased training and awareness of resources and innovative technologies that can assist patients with addressing obesity-related environmental, economic, and lifestyle factors can also be incorporated into medical education and professional development. In addition, practices can partner with community-based programs and organizations implementing childhood obesity interventions to expand referral options. General practitioners and primary care providers remain an important source of health information and expertise, and thus should play a key role in supporting broader initiatives to address childhood obesity.

—Katrina F. Mateo, MPH

Study Overview

Objective. To explore the views of general practice staff on managing childhood obesity in primary care.

Design. Qualitative study.

Setting and participants. General practices across England (n = 7303) of varying practice list size (low/medium/high) and “deprivation” level (low/medium/high, based on Index of Multiple Deprivation (IMD) score, which measures deprivation based on income, employment, health, education, barriers to services, living environment and crime) were stratified into a 3 x 3 matrix, resulting in recruitment targets of 3 to 5 practices per each of 9 recruitment strata. Practices in each strata were grouped into batches and approached in a random list order to take part in the study. Recruitment continued until the strata target was reached. Interviews were conducted by 2 researchers, either in the interviewee’s workplace or by telephone.

Main outcomes measures. The interview topic guide included 2 questions related to childhood obesity: (1) theirperceptions of the barriers and enablers to general practitioners taking a more active role in childhood obesity; and (2) their views on what was needed to improve integrated local pathways to manage childhood obesity. Follow-up questions were used in response to issues raised by interviewees. All interviews were audiotaped, professionally transcribed verbatim, and checked for accuracy. Copies of transcripts were available to interviewees, although none requested to see them. Key themes were identified through thematic analysis of transcripts using an inductive approach. Initial codes were discussed and combined to form themes which were discussed until agreement was reached that these reflected the data. Results are based upon a synthesis of all the interviews.

Main results. A total of 32 practices were recruited, of which 30 identified 52 staff (56% female) to participate in semi-structured interviews: 29 general practitioners (28% female), 14 practice managers (86% female), 7 nursing staff (100% female), 1 health care assistant (female), and 1 administrative staff (female). Almost all interviewees identified childhood obesity as an increasingly important issue with potential long-term health implications. However, most did not frame it as a medical problem in itself or view its management as a general practice responsibility.

Three themes were identified: lack of contact with well children, sensitivity of the issue, and the potential impact of general practice. Identifying overweight children was challenging because well children rarely attended the practice. Interviewees felt that consultation time was limited and focused on addressing acute illness. Generally, raising the issue was described as sensitive. Interviewees also felt ill equipped to solve the issue because they lacked influence over the environmental, economic, and lifestyle factors underpinning obesity. They described little evidence to support general practice intervention and seemed unaware of other services. Interviewees felt their efforts should be directed towards health problems they identified as medical issues where evidence suggests they can make a difference.

Conclusions. Although general practice staff viewed childhood obesity as an important issue with the poten-tial to impact on health outcomes, they were unconvinced that they could have a significant role in managing childhood obesity on a large scale. Participants believed schools have more contact with children and should coordinate the identification and management of overweight children. Future policy could recommend a minor role for general practice involving opportunistic identification of overweight children and referral to specialist/obesity services

Commentary

The prevalence of childhood overweight and obesity continues to rise in the United States and worldwide with extensive economic, physical, and psychosocial consequences [1–6]. Lifestyle interventions that target obesity-related behaviors including physical activity, sedentary behavior, and diet, are considered the therapy of choice [7–10]. Indeed, the US Preventive Services Task Force recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight status [11]. Similar recommendations can be seen in other national guidelines regarding the management of childhood obesity [12].

Beyond screening and referral, some have outlined more specific opportunities for health professionals to play a more significant role in confronting child obesity, particularly among general practitioners and primary care providers [13–15]. In addition, several reviews have looked at the expanding role of primary care in the prevention and treatment of childhood obesity [16,17]. However, it remains unclear whether provider perspectives about their role in addressing childhood obesity align with such guidelines and suggestions. In fact, several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [18–20]. This study adds to the literature by qualitatively assessing perspectives of general practice staff from a variety of practices regarding their role in addressing childhood obesity.

In qualitative research, typically small samples require careful consideration of the representativeness of participants in terms of characteristics and relevance to the wider population. As the authors highlight, a key strength of this study is that staff from a large number of practices in different geographical areas across England were recruited and broadly represented general practices in terms of practice list size and deprivation. This may contribute to greater likelihood of generalizability compared to similar studies that are limited to specific states in a country or small geographic areas. Additional strengths of this study include the use of a specific framework to guide analysis, 2 independent coders to analyze transcripts, and a brief discussion of how the researcher, through the structure of the interview, may have introduced bias to the results. However, the authors did not include whether any outlying or negative/deviant cases were presented that did not fit with discussed themes or if there were any differences in findings by gender or by years since qualified to practice. Additionally, the authors did not specify if results were confirmed or validated by their study participants to increase reliability and trustworthiness of analysis and interpretation.

Applications for Clinical Practice

Although the authors highlight that their findings suggest that policies expanding the role for general practitioners in prevention, identification, and management of childhood obesity at a population-level are unlikely to be successful, findings may instead highlight specific barriers to target and overcome in order to expand the role for general practitioners. Even though contact with well children may be limited, standard practices to incorporate brief counseling could contribute to a shift in practice and patient expectations of what is discussed during visits. Increased training and awareness of resources and innovative technologies that can assist patients with addressing obesity-related environmental, economic, and lifestyle factors can also be incorporated into medical education and professional development. In addition, practices can partner with community-based programs and organizations implementing childhood obesity interventions to expand referral options. General practitioners and primary care providers remain an important source of health information and expertise, and thus should play a key role in supporting broader initiatives to address childhood obesity.

—Katrina F. Mateo, MPH

Study Overview

Objective. To examine the heterogeneity in colorectal cancer (CRC) incidence in intermediate-risk patients and the effect of surveillance on CRC incidence.

Design. Retrospective, multicenter cohort study.

Setting and participants. Study patients underwent colonoscopy between 1 January 1990 and 21 December 2010 at 17 hospitals in the United Kingdom. Patients  were eligible for the study if they had a baseline colonoscopy with a newly diagnosed intermediate-risk adenoma. Intermediate-risk adenomas (as defined by the UK guidelines) included 1 to 2 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size. Patients with a history of prior resections, colorectal cancer, inflammatory bowel disease or a family history of CRC were excluded from the study. Patient, procedural, and polyp characteristics were assessed at baseline.

Main outcome measures. The primary outcome was inci-dence of CRC. Additional factors assessed included age at first polyp detection, sex, completeness of colonoscopy, preparation quality, number of adenomas, size of largest adenoma, histology, and location. Proximal polyps were defined as those proximal to the descending colon. Information regarding social history (eg, smoking status) was not available.

Results. The authors identified 253,798 patients who underwent colonoscopy between 1 January 1990 and 21 December 2010. Of those, 223,539 were excluded based on not meeting the pre-specified inclusion criteria, resulting in 30,259 eligible patients for analysis. Review of histological data confirmed intermediate-risk adenomas in 11,995 (40%) of the patients. The median age in this study was 66 years and 55% were men. Fifty-eight percent attended 1 or more follow-up surveillance visits while 42% had no follow-up surveillance colonoscopy. Those who attended more than 1 follow-up surveillance visits were younger, had a greater proportion of large adenomas (> 20 mm), or had an adenoma with high-grade dysplasia. Both groups had similar rates of villous histology (9% vs. 10%).

After a median follow-up of 7.9 years, 210 CRCs were diagnosed and 32% of patients died. In the group with no follow-up surveillance, 46% died and 2% were diagnosed with cancer. In the group who had 1 or more follow-up colonoscopies, 21% died and 1% were diagnosed with cancer. One or 2 surveillance visits were associated with a significant reduction in CRC incidence (HR 0.57 [95% confidence interval {CI} 0.4–0.8) and 0.51 [95% CI 0.31–0.84], respectively). Three or more surveillance exams were also associated with a similar reduction in CRC incidence (HR 0.54; CI 0.29–0.99). Characteristics associated with increased CRC incidence were older age, adenomas > 20 mm, high-grade dysplasia, proximal polyps, and colonoscopies that were either incomplete or with poor preparation. The number of adenomas was not independently associated with CRC incidence.

The authors divided the cohort into higher-risk (74%) and lower-risk (26%)  subgroups based on polyp and procedural characteristics. The higher-risk group included patients with baseline adenomas ≥ 20 mm, high-grade dysplasia, proximal polyps, or suboptimal evaluation. The lower-risk group included all others. CRC incidence was higher in the “higher-risk” subgroup (247 CRC per 100,000 vs. 93 CRC per 100,000). In the higher-risk group, risk of CRC decreased with more surveillance visits, a finding that was not observed in the lower-risk group. The 10-year incidence of CRC in the cohort overall was 2.7%, in the higher-risk group was 3.3% and in the lower risk group was 1.1%. CRC incidence was significantly higher in the higher-risk subgroup compared with the general population.

Conclusion. Colonoscopy surveillance significantly reducedthe incidence of CRC in intermediate-risk patients (1 to 3 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size) who were offered surveillance at 3-year intervals. Moreover, the benefit of surveillance was particularly noted in a sub-group of patients who had large adenomas (≥ 20 mm), high-grade dysplasia, proximal polyps or poor endoscopic evaluation at the time of initial screening.

Commentary

Screening colonoscopy with removal of adenomatous polyps prevents many CRCs and has been shown to reduce mortality [1]. The results of this retrospective study suggest that patients with intermediate-risk adenomas who underwent at least 1 surveillance colonoscopy at 3-year intervals had a significant reduction in the incidence of CRC. The authors have identified a subgroup of patients at higher risk for CRC, which included those who had a suboptimal initial colonoscopy including poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia, or proximal adenomas. In particular, ongoing surveillance in this high-risk cohort was associated with significant reductions in CRC incidence. Conversely, those in the lower-risk group had a CRC incidence lower than that of the general population,  raising some questions as to whether this group benefits from ongoing surveillance. However, definitive conclusions are difficult to make given the relatively low incidence of CRC in this group.

The risk of neoplasia in patients with colorectal ade-nomas has been evaluated in multiple studies. A pooled analysis by Martinez and colleagues examined over 9000 patients and noted advanced adenomas were found during follow up in 11.2% of the population, with 0.6% of the population developing invasive CRC [2]. Compared with adenomas < 5 mm, those with baseline adenomas 10–19 mm had a higher risk of advanced neoplasia (15.9% vs 7.7%; OR 2.2). Moreover, those with a baseline polyp ≥ 20 mm had a risk of advanced neoplasia at follow-up of 19.3% (OR 2.99). The results of the current investigation also suggest an increased risk of neoplasia with increased polyp size. Interestingly, the polyp size that conferred a higher risk in this study was ≥ 20 mm. The authors of this study suggest that polyps ≥ 20 mm along with the previously mentioned high-risk features may identify a subgroup within the intermediate-risk population who may benefit from close surveillance. One particularly interesting finding in this study was the identification of proximal colon polyps as a risk factor. While less well defined, previous investigations have noted a similar finding suggesting a risk of advanced neoplasia of up to 80% in patients with proximal polyps [3]. Given such, intensive surveillance may not be appropriate for all intermediate-risk patients and a more refined risk-adapted approach may be preferred.

There are some important limitations of the current study that warrant discussion. First, it should be emphasized that this study is observational in nature and therefore, definitive conclusions cannot be made despite the significant effect of surveillance colonoscopy in patients with high-risk features. In addition, the median follow-up in this study was 7.9 years and one could argue that longer-follow up is needed in order to validate the findings of this study, particularly in patients in the lower-risk cohort. Nevertheless, this study does suggest that there may be a population of patients that harbor higher-risk features and close surveillance limited to this group may be more appropriate. Furthermore, the duration of surveillance remains an important clinical question that requires further research.

Applications for Clinical Practice

In 2012, the United States Multi-Society Task Force (MSTF) on CRC issued updated guidelines defining adenoma risk and postpolypectomy surveillance. Low-risk adenomas (1 to 2 tubular adenomas ≤ 10 mm at baseline) should have repeat surveillance colonoscopy in 5 to 10 years. Advanced adenomas (≥ 10 mm, villous histology, or high-grade dysplasia) or those with 3 to 10 adenomas at baseline should undergo first surveillance in 3 years [4]. The authors of the current study suggest that surveillance colonoscopy at 3-year intervals for patients with particularly high-risk features including those with poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia or proximal adenomas benefit the greatest from at least 1 surveillance colonoscopy. Those with lower- risk features may not require such rigorous follow-up; however, further work to define which high-risk cohorts should undergo close surveillance is warranted. It is vital that the primary care provider understand such guidelines in order to facilitate the appropriate follow-up.

—Daniel Isaac, DO, MS, Michigan State University, East Lansing, MI

Study Overview

Objective. To examine the heterogeneity in colorectal cancer (CRC) incidence in intermediate-risk patients and the effect of surveillance on CRC incidence.

Design. Retrospective, multicenter cohort study.

Setting and participants. Study patients underwent colonoscopy between 1 January 1990 and 21 December 2010 at 17 hospitals in the United Kingdom. Patients  were eligible for the study if they had a baseline colonoscopy with a newly diagnosed intermediate-risk adenoma. Intermediate-risk adenomas (as defined by the UK guidelines) included 1 to 2 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size. Patients with a history of prior resections, colorectal cancer, inflammatory bowel disease or a family history of CRC were excluded from the study. Patient, procedural, and polyp characteristics were assessed at baseline.

Main outcome measures. The primary outcome was inci-dence of CRC. Additional factors assessed included age at first polyp detection, sex, completeness of colonoscopy, preparation quality, number of adenomas, size of largest adenoma, histology, and location. Proximal polyps were defined as those proximal to the descending colon. Information regarding social history (eg, smoking status) was not available.

Results. The authors identified 253,798 patients who underwent colonoscopy between 1 January 1990 and 21 December 2010. Of those, 223,539 were excluded based on not meeting the pre-specified inclusion criteria, resulting in 30,259 eligible patients for analysis. Review of histological data confirmed intermediate-risk adenomas in 11,995 (40%) of the patients. The median age in this study was 66 years and 55% were men. Fifty-eight percent attended 1 or more follow-up surveillance visits while 42% had no follow-up surveillance colonoscopy. Those who attended more than 1 follow-up surveillance visits were younger, had a greater proportion of large adenomas (> 20 mm), or had an adenoma with high-grade dysplasia. Both groups had similar rates of villous histology (9% vs. 10%).

After a median follow-up of 7.9 years, 210 CRCs were diagnosed and 32% of patients died. In the group with no follow-up surveillance, 46% died and 2% were diagnosed with cancer. In the group who had 1 or more follow-up colonoscopies, 21% died and 1% were diagnosed with cancer. One or 2 surveillance visits were associated with a significant reduction in CRC incidence (HR 0.57 [95% confidence interval {CI} 0.4–0.8) and 0.51 [95% CI 0.31–0.84], respectively). Three or more surveillance exams were also associated with a similar reduction in CRC incidence (HR 0.54; CI 0.29–0.99). Characteristics associated with increased CRC incidence were older age, adenomas > 20 mm, high-grade dysplasia, proximal polyps, and colonoscopies that were either incomplete or with poor preparation. The number of adenomas was not independently associated with CRC incidence.

The authors divided the cohort into higher-risk (74%) and lower-risk (26%)  subgroups based on polyp and procedural characteristics. The higher-risk group included patients with baseline adenomas ≥ 20 mm, high-grade dysplasia, proximal polyps, or suboptimal evaluation. The lower-risk group included all others. CRC incidence was higher in the “higher-risk” subgroup (247 CRC per 100,000 vs. 93 CRC per 100,000). In the higher-risk group, risk of CRC decreased with more surveillance visits, a finding that was not observed in the lower-risk group. The 10-year incidence of CRC in the cohort overall was 2.7%, in the higher-risk group was 3.3% and in the lower risk group was 1.1%. CRC incidence was significantly higher in the higher-risk subgroup compared with the general population.

Conclusion. Colonoscopy surveillance significantly reducedthe incidence of CRC in intermediate-risk patients (1 to 3 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size) who were offered surveillance at 3-year intervals. Moreover, the benefit of surveillance was particularly noted in a sub-group of patients who had large adenomas (≥ 20 mm), high-grade dysplasia, proximal polyps or poor endoscopic evaluation at the time of initial screening.

Commentary

Screening colonoscopy with removal of adenomatous polyps prevents many CRCs and has been shown to reduce mortality [1]. The results of this retrospective study suggest that patients with intermediate-risk adenomas who underwent at least 1 surveillance colonoscopy at 3-year intervals had a significant reduction in the incidence of CRC. The authors have identified a subgroup of patients at higher risk for CRC, which included those who had a suboptimal initial colonoscopy including poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia, or proximal adenomas. In particular, ongoing surveillance in this high-risk cohort was associated with significant reductions in CRC incidence. Conversely, those in the lower-risk group had a CRC incidence lower than that of the general population,  raising some questions as to whether this group benefits from ongoing surveillance. However, definitive conclusions are difficult to make given the relatively low incidence of CRC in this group.

The risk of neoplasia in patients with colorectal ade-nomas has been evaluated in multiple studies. A pooled analysis by Martinez and colleagues examined over 9000 patients and noted advanced adenomas were found during follow up in 11.2% of the population, with 0.6% of the population developing invasive CRC [2]. Compared with adenomas < 5 mm, those with baseline adenomas 10–19 mm had a higher risk of advanced neoplasia (15.9% vs 7.7%; OR 2.2). Moreover, those with a baseline polyp ≥ 20 mm had a risk of advanced neoplasia at follow-up of 19.3% (OR 2.99). The results of the current investigation also suggest an increased risk of neoplasia with increased polyp size. Interestingly, the polyp size that conferred a higher risk in this study was ≥ 20 mm. The authors of this study suggest that polyps ≥ 20 mm along with the previously mentioned high-risk features may identify a subgroup within the intermediate-risk population who may benefit from close surveillance. One particularly interesting finding in this study was the identification of proximal colon polyps as a risk factor. While less well defined, previous investigations have noted a similar finding suggesting a risk of advanced neoplasia of up to 80% in patients with proximal polyps [3]. Given such, intensive surveillance may not be appropriate for all intermediate-risk patients and a more refined risk-adapted approach may be preferred.

There are some important limitations of the current study that warrant discussion. First, it should be emphasized that this study is observational in nature and therefore, definitive conclusions cannot be made despite the significant effect of surveillance colonoscopy in patients with high-risk features. In addition, the median follow-up in this study was 7.9 years and one could argue that longer-follow up is needed in order to validate the findings of this study, particularly in patients in the lower-risk cohort. Nevertheless, this study does suggest that there may be a population of patients that harbor higher-risk features and close surveillance limited to this group may be more appropriate. Furthermore, the duration of surveillance remains an important clinical question that requires further research.

Applications for Clinical Practice

In 2012, the United States Multi-Society Task Force (MSTF) on CRC issued updated guidelines defining adenoma risk and postpolypectomy surveillance. Low-risk adenomas (1 to 2 tubular adenomas ≤ 10 mm at baseline) should have repeat surveillance colonoscopy in 5 to 10 years. Advanced adenomas (≥ 10 mm, villous histology, or high-grade dysplasia) or those with 3 to 10 adenomas at baseline should undergo first surveillance in 3 years [4]. The authors of the current study suggest that surveillance colonoscopy at 3-year intervals for patients with particularly high-risk features including those with poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia or proximal adenomas benefit the greatest from at least 1 surveillance colonoscopy. Those with lower- risk features may not require such rigorous follow-up; however, further work to define which high-risk cohorts should undergo close surveillance is warranted. It is vital that the primary care provider understand such guidelines in order to facilitate the appropriate follow-up.

—Daniel Isaac, DO, MS, Michigan State University, East Lansing, MI

Study Overview

Objective. To examine the heterogeneity in colorectal cancer (CRC) incidence in intermediate-risk patients and the effect of surveillance on CRC incidence.

Design. Retrospective, multicenter cohort study.

Setting and participants. Study patients underwent colonoscopy between 1 January 1990 and 21 December 2010 at 17 hospitals in the United Kingdom. Patients  were eligible for the study if they had a baseline colonoscopy with a newly diagnosed intermediate-risk adenoma. Intermediate-risk adenomas (as defined by the UK guidelines) included 1 to 2 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size. Patients with a history of prior resections, colorectal cancer, inflammatory bowel disease or a family history of CRC were excluded from the study. Patient, procedural, and polyp characteristics were assessed at baseline.

Main outcome measures. The primary outcome was inci-dence of CRC. Additional factors assessed included age at first polyp detection, sex, completeness of colonoscopy, preparation quality, number of adenomas, size of largest adenoma, histology, and location. Proximal polyps were defined as those proximal to the descending colon. Information regarding social history (eg, smoking status) was not available.

Results. The authors identified 253,798 patients who underwent colonoscopy between 1 January 1990 and 21 December 2010. Of those, 223,539 were excluded based on not meeting the pre-specified inclusion criteria, resulting in 30,259 eligible patients for analysis. Review of histological data confirmed intermediate-risk adenomas in 11,995 (40%) of the patients. The median age in this study was 66 years and 55% were men. Fifty-eight percent attended 1 or more follow-up surveillance visits while 42% had no follow-up surveillance colonoscopy. Those who attended more than 1 follow-up surveillance visits were younger, had a greater proportion of large adenomas (> 20 mm), or had an adenoma with high-grade dysplasia. Both groups had similar rates of villous histology (9% vs. 10%).

After a median follow-up of 7.9 years, 210 CRCs were diagnosed and 32% of patients died. In the group with no follow-up surveillance, 46% died and 2% were diagnosed with cancer. In the group who had 1 or more follow-up colonoscopies, 21% died and 1% were diagnosed with cancer. One or 2 surveillance visits were associated with a significant reduction in CRC incidence (HR 0.57 [95% confidence interval {CI} 0.4–0.8) and 0.51 [95% CI 0.31–0.84], respectively). Three or more surveillance exams were also associated with a similar reduction in CRC incidence (HR 0.54; CI 0.29–0.99). Characteristics associated with increased CRC incidence were older age, adenomas > 20 mm, high-grade dysplasia, proximal polyps, and colonoscopies that were either incomplete or with poor preparation. The number of adenomas was not independently associated with CRC incidence.

The authors divided the cohort into higher-risk (74%) and lower-risk (26%)  subgroups based on polyp and procedural characteristics. The higher-risk group included patients with baseline adenomas ≥ 20 mm, high-grade dysplasia, proximal polyps, or suboptimal evaluation. The lower-risk group included all others. CRC incidence was higher in the “higher-risk” subgroup (247 CRC per 100,000 vs. 93 CRC per 100,000). In the higher-risk group, risk of CRC decreased with more surveillance visits, a finding that was not observed in the lower-risk group. The 10-year incidence of CRC in the cohort overall was 2.7%, in the higher-risk group was 3.3% and in the lower risk group was 1.1%. CRC incidence was significantly higher in the higher-risk subgroup compared with the general population.

Conclusion. Colonoscopy surveillance significantly reducedthe incidence of CRC in intermediate-risk patients (1 to 3 large adenomas ≥ 10 mm or 3 to 4 small adenomas < 10 mm in size) who were offered surveillance at 3-year intervals. Moreover, the benefit of surveillance was particularly noted in a sub-group of patients who had large adenomas (≥ 20 mm), high-grade dysplasia, proximal polyps or poor endoscopic evaluation at the time of initial screening.

Commentary

Screening colonoscopy with removal of adenomatous polyps prevents many CRCs and has been shown to reduce mortality [1]. The results of this retrospective study suggest that patients with intermediate-risk adenomas who underwent at least 1 surveillance colonoscopy at 3-year intervals had a significant reduction in the incidence of CRC. The authors have identified a subgroup of patients at higher risk for CRC, which included those who had a suboptimal initial colonoscopy including poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia, or proximal adenomas. In particular, ongoing surveillance in this high-risk cohort was associated with significant reductions in CRC incidence. Conversely, those in the lower-risk group had a CRC incidence lower than that of the general population,  raising some questions as to whether this group benefits from ongoing surveillance. However, definitive conclusions are difficult to make given the relatively low incidence of CRC in this group.

The risk of neoplasia in patients with colorectal ade-nomas has been evaluated in multiple studies. A pooled analysis by Martinez and colleagues examined over 9000 patients and noted advanced adenomas were found during follow up in 11.2% of the population, with 0.6% of the population developing invasive CRC [2]. Compared with adenomas < 5 mm, those with baseline adenomas 10–19 mm had a higher risk of advanced neoplasia (15.9% vs 7.7%; OR 2.2). Moreover, those with a baseline polyp ≥ 20 mm had a risk of advanced neoplasia at follow-up of 19.3% (OR 2.99). The results of the current investigation also suggest an increased risk of neoplasia with increased polyp size. Interestingly, the polyp size that conferred a higher risk in this study was ≥ 20 mm. The authors of this study suggest that polyps ≥ 20 mm along with the previously mentioned high-risk features may identify a subgroup within the intermediate-risk population who may benefit from close surveillance. One particularly interesting finding in this study was the identification of proximal colon polyps as a risk factor. While less well defined, previous investigations have noted a similar finding suggesting a risk of advanced neoplasia of up to 80% in patients with proximal polyps [3]. Given such, intensive surveillance may not be appropriate for all intermediate-risk patients and a more refined risk-adapted approach may be preferred.

There are some important limitations of the current study that warrant discussion. First, it should be emphasized that this study is observational in nature and therefore, definitive conclusions cannot be made despite the significant effect of surveillance colonoscopy in patients with high-risk features. In addition, the median follow-up in this study was 7.9 years and one could argue that longer-follow up is needed in order to validate the findings of this study, particularly in patients in the lower-risk cohort. Nevertheless, this study does suggest that there may be a population of patients that harbor higher-risk features and close surveillance limited to this group may be more appropriate. Furthermore, the duration of surveillance remains an important clinical question that requires further research.

Applications for Clinical Practice

In 2012, the United States Multi-Society Task Force (MSTF) on CRC issued updated guidelines defining adenoma risk and postpolypectomy surveillance. Low-risk adenomas (1 to 2 tubular adenomas ≤ 10 mm at baseline) should have repeat surveillance colonoscopy in 5 to 10 years. Advanced adenomas (≥ 10 mm, villous histology, or high-grade dysplasia) or those with 3 to 10 adenomas at baseline should undergo first surveillance in 3 years [4]. The authors of the current study suggest that surveillance colonoscopy at 3-year intervals for patients with particularly high-risk features including those with poor bowel preparation, adenomas ≥ 20 mm, adenomas with high-grade dysplasia or proximal adenomas benefit the greatest from at least 1 surveillance colonoscopy. Those with lower- risk features may not require such rigorous follow-up; however, further work to define which high-risk cohorts should undergo close surveillance is warranted. It is vital that the primary care provider understand such guidelines in order to facilitate the appropriate follow-up.

—Daniel Isaac, DO, MS, Michigan State University, East Lansing, MI

Study Overview

Objective. To evaluate the effectiveness of OASIS, a large-scale, statewide communication training program, on the reduction of antipsychotic use in nursing homes (NHs).

Design. Quasi-experimental longitudinal study with external controls.

Setting and participants. The participants were residents living in NHs between 1 March 2011 and 31 August 2013. The intervention group consisted of NHs in Massachusetts that were enrolled in the OASIS intervention and the control group consisted of NHs in Massachusetts and New York. The Centers for Medicare & Medicaid Services Minimum Data Set (MDS) 3.0 data was analyzed to determine medication use and behavior of residents of NHs. Residents of these NHs were excluded if they had a US Food and Drug Administration (FDA)-approved indication for antipsychotic use (eg, schizophrenia); were short-term residents (length of stay < 90 days); or had missing data on psychopharmacological medication use or behavior.

Intervention. The OASIS is an educational program that targeted both direct care and non-direct care staff in NHs to assist them in meeting the needs and challenges of caring for long-term care residents. Utilizing a train-the-trainer model, OASIS program coordinators and champions from each intervention NH participated in an 8-hour in-person training session that focused on enhancing communication skills between NH staff and residents with cognitive impairment. These trainers subsequently instructed the OASIS program to staff at their respective NHs using a team-based care approach. Addi-tional support of the OASIS educational program, such as telephone support, 12 webinars, 2 regional seminars, and 2 booster sessions, were provided to participating NHs.

Main outcome measures. The main outcome measure was facility-level prevalence of antipsychotic use in long-term NH residents captured by MDS in the 7 days preceding the MDS assessment. The secondary outcome measures were facility-level quarterly prevalence of psychotropic medications that may have been substituted for antipsychotic medications (ie, anxiolytics, antidepressants, and hypnotics) and behavioral disturbances (ie, physically abusive behavior, verbally abusive behavior, and rejecting care). All secondary outcomes were dichotomized in the 7 days preceding the MDS assessment and aggregated at the facility level for each quarter.

The analysis utilized an interrupted time series model of facility-level prevalence of antipsychotic medication use, other psychotropic medication use, and behavioral disturbances to evaluate the OASIS intervention’s effectiveness in participating facilities compared with control NHs. This methodology allowed the assessment of changes in the trend of antipsychotic use after the OASIS intervention controlling for historical trends. Data from the 18-month pre-intervention (baseline) period was compared with that of a 3-month training phase, a 6-month implementation phase, and a 3-month maintenance phase.

Main results. 93 NHs received OASIS intervention (27 with high prevalence of antipsychotic use) while 831 NHs did not (non-intervention control). The intervention NHs had a higher prevalence of antipsychotic use before OASIS training (baseline period) than the control NHs (34.1% vs. 22.7%, P < 0.001). The intervention NHs compared to controls were smaller in size (122 beds [interquartile range {IQR}, 88–152 beds] vs. 140 beds; [IQR, 104–200 beds]; P < 0.001), more likely to be for profit (77.4% vs. 62.0%, P = 0.009), had corporate ownership (93.5% vs. 74.6%, P < 0.001), and provided resident-only councils (78.5% vs. 52.9%, P < 0.001). The intervention NHs had higher registered nurse (RN) staffing hours per resident (0.8 vs. 0.7; P = 0.01) but lower certified nursing assistant (CNA) hours per resident (2.3 vs. 2.4; P = 0.04) than control NHs. There was no difference in licensed practical nurse hours per resident between groups.

All 93 intervention NHs completed the 8-hour in-person training session and attended an average of 6.5 (range, 0–12) subsequent support webinars. Thirteen NHs (14.0%) attended no regional seminars, 32 (34.4%) attended one, and 48 (51.6%) attended both. Four NHs (4.3%) attended one booster session, and 13 (14.0%) attended both. The NH staff most often trained in the OASIS training program were the directors of nursing, RNs, CNAs, and activities personnel. Support staff including housekeeping and dietary were trained in about half of the reporting intervention NHs, while physicians and nurse practitioners participated infrequently. Concurrent training programs in dementia care (Hand-in-Hand, Alzheimer Association training, MassPRO dementia care training) were implemented in 67.2% of intervention NHs.

In the intervention NHs, the prevalence of antipsych-otic prescribing decreased from 34.1% at baseline to 26.5% at the study end (7.6% absolute reduction, 22.3% relative reduction). In comparison, the prevalence of antipsychotic prescribing in control NHs decreased from 22.7% to 18.8% over the same period (3.9% absolute reduction, 17.2% relative reduction). During the OASIS implementation phase, the intervention NHs had a reduc-tion in prevalence of antipsychotic use (–1.20% [95% confidence interval {CI}, –1.85% to –0.09% per quarter]) greater than that of the control NHs (–0.23% [95% CI, –0.47% to 0.01% per quarter]), resulting in a net OASIS influence of –0.97% (95% CI, –1.85% to –0.09% per quarter; P = 0.03). The antipsychotic use reduction observed in the implementation phase was not sustained in the maintenance phase (difference of 0.93%; 95% CI, –0.66% to 2.54%; P = 0.48). No increases in other psychotropic medication use (anxiolytics, antidepressants, hypnotics) or behavioral disturbances (physically abusive behavior, verbally abusive behavior, and rejecting care) were observed during the OASIS training and implementation phases.

Conclusion. The OASIS communication training program reduced the prevalence of antipsychotic use in NHs during its implementation phase, but its effect was not sustained in the subsequent maintenance phase. The use of other psychotropic medications and behavior disturbances did not increase during the implementation of OASIS program. The findings from this study provided further support for utilizing nonpharmacologic programs to treat behavioral and psychological symptoms of dementia in older adults who reside in NHs.

Commentary

The use of both conventional and atypical antipsychotic medications is associated with a dose-related, approximately 2-fold increased risk of sudden cardiac death in older adults [1,2]. In 2006, the FDA issued a public health advisory stating that both conventional and atypical anti-psychotic medications are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. Despite this black box warning and growing recognition that antipsychotic medications are not indicated for the treatment of dementia-related psychosis, the off-label use of antipsychotic medications to treat behavioral and psychological symptoms of dementia in older adults remains a common practice in nursing homes [3]. Thus, there is an urgent need to assess and develop effective interventions that reduce the practice of antipsychotic medication prescribing in long-term care. To that effect, the study reported by Tjia et al appropriately investigated the impact of the OASIS communication training program, a nonpharmacologic intervention, on the reduction of antipsychotic use in NHs.

This study was well designed and had a number of strengths. It utilized an interrupted time series model, one of the strongest quasi-experimental approaches due to its robustness to threats of internal validity, for evaluating longitudinal effects of an intervention intended to improve the quality of medication use. Moreover, this study included a large sample size and comparison facilities from the same geographical areas (NHs in Massachusetts and New York State) that served as external controls. Several potential weaknesses of the study were identified. Because facility-level aggregate data from NHs were used for analysis, individual level (long-term care resident) characteristics were not accounted for in the analysis. In addition, while the post-OASIS intervention questionnaire response rate was 65.6% (61 of 93 intervention NHs), a higher response rate would provide better characterization of NH staff that participated in OASIS program training, program completion rate, and a more complete representation of competing dementia care training programs concurrently implemented in these NHs.

Several studies, most utilizing various provider education methods, had explored whether these interventions could curb antipsychotic use in NHs with limited success. The largest successful intervention was reported by Meador et al [4], where a focused provider education program facilitated a relative reduction in antipsychotic medication use of 23% compared to control NHs. However, the implementation of this specific program was time- and resource-intensive, requiring geropsychiatry evaluation to all physicians (45 to 60 min), nurse-educator in-service programs for NH staff (5 to 6 one-hr sessions), management specialist consultation to NH administrators (4 hr), and evening meeting for the families of NH residents. The current study by Tjia et al, the largest study to date conducted in the context of competing dementia care training programs and increased awareness of the danger of antipsychotic use in the elderly, similarly showed a meaningful reduction in antipsychotic medication use in NHs that received the OASIS communication training program. The OASIS program appears to be less resource-intensive than the provider education program modeled by Meador et al, and its train-the-trainer model is likely more adaptable to meet the limitations (eg, low staffing and staff turnover) inherent in NHs. The beneficial effect of the OASIS program on reduction of antipsychotic medication prescribing was observed despite low participation by prescribers (11.5% of physicians and 11.5% of nurse practitioners). Although it is unclear why this was observed, this finding is intriguing in that a communication training program that reframes challenging behavior of NH residents with cognitive impairment as (1) communication of unmet needs, (2) train staff to anticipate resident needs, and (3) integrate resident strengths into daily care plans can alter provider prescription behavior. The implication of this is that provider practice in managing behavioral and psychological symptoms of dementia can be improved by optimizing communication training in NH staff. Taken together, this study adds to evidence in favor of utilizing nonpharmacologic interventions to reduce antipsychotic use in long-term care.

Applications for Clinical Practice

OASIS, a communication training program for NH staff, reduces antipsychotic medication use in NHs during its implementation phase. Future studies need to investigate pragmatic methods to sustain the beneficial effect of OASIS after its implementation phase.

—Fred Ko, MD, MS, Icahn School of Medicine at Mount Sinai, New York, NY

Study Overview

Objective. To evaluate the effectiveness of OASIS, a large-scale, statewide communication training program, on the reduction of antipsychotic use in nursing homes (NHs).

Design. Quasi-experimental longitudinal study with external controls.

Setting and participants. The participants were residents living in NHs between 1 March 2011 and 31 August 2013. The intervention group consisted of NHs in Massachusetts that were enrolled in the OASIS intervention and the control group consisted of NHs in Massachusetts and New York. The Centers for Medicare & Medicaid Services Minimum Data Set (MDS) 3.0 data was analyzed to determine medication use and behavior of residents of NHs. Residents of these NHs were excluded if they had a US Food and Drug Administration (FDA)-approved indication for antipsychotic use (eg, schizophrenia); were short-term residents (length of stay < 90 days); or had missing data on psychopharmacological medication use or behavior.

Intervention. The OASIS is an educational program that targeted both direct care and non-direct care staff in NHs to assist them in meeting the needs and challenges of caring for long-term care residents. Utilizing a train-the-trainer model, OASIS program coordinators and champions from each intervention NH participated in an 8-hour in-person training session that focused on enhancing communication skills between NH staff and residents with cognitive impairment. These trainers subsequently instructed the OASIS program to staff at their respective NHs using a team-based care approach. Addi-tional support of the OASIS educational program, such as telephone support, 12 webinars, 2 regional seminars, and 2 booster sessions, were provided to participating NHs.

Main outcome measures. The main outcome measure was facility-level prevalence of antipsychotic use in long-term NH residents captured by MDS in the 7 days preceding the MDS assessment. The secondary outcome measures were facility-level quarterly prevalence of psychotropic medications that may have been substituted for antipsychotic medications (ie, anxiolytics, antidepressants, and hypnotics) and behavioral disturbances (ie, physically abusive behavior, verbally abusive behavior, and rejecting care). All secondary outcomes were dichotomized in the 7 days preceding the MDS assessment and aggregated at the facility level for each quarter.

The analysis utilized an interrupted time series model of facility-level prevalence of antipsychotic medication use, other psychotropic medication use, and behavioral disturbances to evaluate the OASIS intervention’s effectiveness in participating facilities compared with control NHs. This methodology allowed the assessment of changes in the trend of antipsychotic use after the OASIS intervention controlling for historical trends. Data from the 18-month pre-intervention (baseline) period was compared with that of a 3-month training phase, a 6-month implementation phase, and a 3-month maintenance phase.

Main results. 93 NHs received OASIS intervention (27 with high prevalence of antipsychotic use) while 831 NHs did not (non-intervention control). The intervention NHs had a higher prevalence of antipsychotic use before OASIS training (baseline period) than the control NHs (34.1% vs. 22.7%, P < 0.001). The intervention NHs compared to controls were smaller in size (122 beds [interquartile range {IQR}, 88–152 beds] vs. 140 beds; [IQR, 104–200 beds]; P < 0.001), more likely to be for profit (77.4% vs. 62.0%, P = 0.009), had corporate ownership (93.5% vs. 74.6%, P < 0.001), and provided resident-only councils (78.5% vs. 52.9%, P < 0.001). The intervention NHs had higher registered nurse (RN) staffing hours per resident (0.8 vs. 0.7; P = 0.01) but lower certified nursing assistant (CNA) hours per resident (2.3 vs. 2.4; P = 0.04) than control NHs. There was no difference in licensed practical nurse hours per resident between groups.

All 93 intervention NHs completed the 8-hour in-person training session and attended an average of 6.5 (range, 0–12) subsequent support webinars. Thirteen NHs (14.0%) attended no regional seminars, 32 (34.4%) attended one, and 48 (51.6%) attended both. Four NHs (4.3%) attended one booster session, and 13 (14.0%) attended both. The NH staff most often trained in the OASIS training program were the directors of nursing, RNs, CNAs, and activities personnel. Support staff including housekeeping and dietary were trained in about half of the reporting intervention NHs, while physicians and nurse practitioners participated infrequently. Concurrent training programs in dementia care (Hand-in-Hand, Alzheimer Association training, MassPRO dementia care training) were implemented in 67.2% of intervention NHs.

In the intervention NHs, the prevalence of antipsych-otic prescribing decreased from 34.1% at baseline to 26.5% at the study end (7.6% absolute reduction, 22.3% relative reduction). In comparison, the prevalence of antipsychotic prescribing in control NHs decreased from 22.7% to 18.8% over the same period (3.9% absolute reduction, 17.2% relative reduction). During the OASIS implementation phase, the intervention NHs had a reduc-tion in prevalence of antipsychotic use (–1.20% [95% confidence interval {CI}, –1.85% to –0.09% per quarter]) greater than that of the control NHs (–0.23% [95% CI, –0.47% to 0.01% per quarter]), resulting in a net OASIS influence of –0.97% (95% CI, –1.85% to –0.09% per quarter; P = 0.03). The antipsychotic use reduction observed in the implementation phase was not sustained in the maintenance phase (difference of 0.93%; 95% CI, –0.66% to 2.54%; P = 0.48). No increases in other psychotropic medication use (anxiolytics, antidepressants, hypnotics) or behavioral disturbances (physically abusive behavior, verbally abusive behavior, and rejecting care) were observed during the OASIS training and implementation phases.

Conclusion. The OASIS communication training program reduced the prevalence of antipsychotic use in NHs during its implementation phase, but its effect was not sustained in the subsequent maintenance phase. The use of other psychotropic medications and behavior disturbances did not increase during the implementation of OASIS program. The findings from this study provided further support for utilizing nonpharmacologic programs to treat behavioral and psychological symptoms of dementia in older adults who reside in NHs.

Commentary

The use of both conventional and atypical antipsychotic medications is associated with a dose-related, approximately 2-fold increased risk of sudden cardiac death in older adults [1,2]. In 2006, the FDA issued a public health advisory stating that both conventional and atypical anti-psychotic medications are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. Despite this black box warning and growing recognition that antipsychotic medications are not indicated for the treatment of dementia-related psychosis, the off-label use of antipsychotic medications to treat behavioral and psychological symptoms of dementia in older adults remains a common practice in nursing homes [3]. Thus, there is an urgent need to assess and develop effective interventions that reduce the practice of antipsychotic medication prescribing in long-term care. To that effect, the study reported by Tjia et al appropriately investigated the impact of the OASIS communication training program, a nonpharmacologic intervention, on the reduction of antipsychotic use in NHs.

This study was well designed and had a number of strengths. It utilized an interrupted time series model, one of the strongest quasi-experimental approaches due to its robustness to threats of internal validity, for evaluating longitudinal effects of an intervention intended to improve the quality of medication use. Moreover, this study included a large sample size and comparison facilities from the same geographical areas (NHs in Massachusetts and New York State) that served as external controls. Several potential weaknesses of the study were identified. Because facility-level aggregate data from NHs were used for analysis, individual level (long-term care resident) characteristics were not accounted for in the analysis. In addition, while the post-OASIS intervention questionnaire response rate was 65.6% (61 of 93 intervention NHs), a higher response rate would provide better characterization of NH staff that participated in OASIS program training, program completion rate, and a more complete representation of competing dementia care training programs concurrently implemented in these NHs.

Several studies, most utilizing various provider education methods, had explored whether these interventions could curb antipsychotic use in NHs with limited success. The largest successful intervention was reported by Meador et al [4], where a focused provider education program facilitated a relative reduction in antipsychotic medication use of 23% compared to control NHs. However, the implementation of this specific program was time- and resource-intensive, requiring geropsychiatry evaluation to all physicians (45 to 60 min), nurse-educator in-service programs for NH staff (5 to 6 one-hr sessions), management specialist consultation to NH administrators (4 hr), and evening meeting for the families of NH residents. The current study by Tjia et al, the largest study to date conducted in the context of competing dementia care training programs and increased awareness of the danger of antipsychotic use in the elderly, similarly showed a meaningful reduction in antipsychotic medication use in NHs that received the OASIS communication training program. The OASIS program appears to be less resource-intensive than the provider education program modeled by Meador et al, and its train-the-trainer model is likely more adaptable to meet the limitations (eg, low staffing and staff turnover) inherent in NHs. The beneficial effect of the OASIS program on reduction of antipsychotic medication prescribing was observed despite low participation by prescribers (11.5% of physicians and 11.5% of nurse practitioners). Although it is unclear why this was observed, this finding is intriguing in that a communication training program that reframes challenging behavior of NH residents with cognitive impairment as (1) communication of unmet needs, (2) train staff to anticipate resident needs, and (3) integrate resident strengths into daily care plans can alter provider prescription behavior. The implication of this is that provider practice in managing behavioral and psychological symptoms of dementia can be improved by optimizing communication training in NH staff. Taken together, this study adds to evidence in favor of utilizing nonpharmacologic interventions to reduce antipsychotic use in long-term care.

Applications for Clinical Practice

OASIS, a communication training program for NH staff, reduces antipsychotic medication use in NHs during its implementation phase. Future studies need to investigate pragmatic methods to sustain the beneficial effect of OASIS after its implementation phase.

—Fred Ko, MD, MS, Icahn School of Medicine at Mount Sinai, New York, NY

Study Overview

Objective. To evaluate the effectiveness of OASIS, a large-scale, statewide communication training program, on the reduction of antipsychotic use in nursing homes (NHs).

Design. Quasi-experimental longitudinal study with external controls.

Setting and participants. The participants were residents living in NHs between 1 March 2011 and 31 August 2013. The intervention group consisted of NHs in Massachusetts that were enrolled in the OASIS intervention and the control group consisted of NHs in Massachusetts and New York. The Centers for Medicare & Medicaid Services Minimum Data Set (MDS) 3.0 data was analyzed to determine medication use and behavior of residents of NHs. Residents of these NHs were excluded if they had a US Food and Drug Administration (FDA)-approved indication for antipsychotic use (eg, schizophrenia); were short-term residents (length of stay < 90 days); or had missing data on psychopharmacological medication use or behavior.

Intervention. The OASIS is an educational program that targeted both direct care and non-direct care staff in NHs to assist them in meeting the needs and challenges of caring for long-term care residents. Utilizing a train-the-trainer model, OASIS program coordinators and champions from each intervention NH participated in an 8-hour in-person training session that focused on enhancing communication skills between NH staff and residents with cognitive impairment. These trainers subsequently instructed the OASIS program to staff at their respective NHs using a team-based care approach. Addi-tional support of the OASIS educational program, such as telephone support, 12 webinars, 2 regional seminars, and 2 booster sessions, were provided to participating NHs.

Main outcome measures. The main outcome measure was facility-level prevalence of antipsychotic use in long-term NH residents captured by MDS in the 7 days preceding the MDS assessment. The secondary outcome measures were facility-level quarterly prevalence of psychotropic medications that may have been substituted for antipsychotic medications (ie, anxiolytics, antidepressants, and hypnotics) and behavioral disturbances (ie, physically abusive behavior, verbally abusive behavior, and rejecting care). All secondary outcomes were dichotomized in the 7 days preceding the MDS assessment and aggregated at the facility level for each quarter.

The analysis utilized an interrupted time series model of facility-level prevalence of antipsychotic medication use, other psychotropic medication use, and behavioral disturbances to evaluate the OASIS intervention’s effectiveness in participating facilities compared with control NHs. This methodology allowed the assessment of changes in the trend of antipsychotic use after the OASIS intervention controlling for historical trends. Data from the 18-month pre-intervention (baseline) period was compared with that of a 3-month training phase, a 6-month implementation phase, and a 3-month maintenance phase.

Main results. 93 NHs received OASIS intervention (27 with high prevalence of antipsychotic use) while 831 NHs did not (non-intervention control). The intervention NHs had a higher prevalence of antipsychotic use before OASIS training (baseline period) than the control NHs (34.1% vs. 22.7%, P < 0.001). The intervention NHs compared to controls were smaller in size (122 beds [interquartile range {IQR}, 88–152 beds] vs. 140 beds; [IQR, 104–200 beds]; P < 0.001), more likely to be for profit (77.4% vs. 62.0%, P = 0.009), had corporate ownership (93.5% vs. 74.6%, P < 0.001), and provided resident-only councils (78.5% vs. 52.9%, P < 0.001). The intervention NHs had higher registered nurse (RN) staffing hours per resident (0.8 vs. 0.7; P = 0.01) but lower certified nursing assistant (CNA) hours per resident (2.3 vs. 2.4; P = 0.04) than control NHs. There was no difference in licensed practical nurse hours per resident between groups.

All 93 intervention NHs completed the 8-hour in-person training session and attended an average of 6.5 (range, 0–12) subsequent support webinars. Thirteen NHs (14.0%) attended no regional seminars, 32 (34.4%) attended one, and 48 (51.6%) attended both. Four NHs (4.3%) attended one booster session, and 13 (14.0%) attended both. The NH staff most often trained in the OASIS training program were the directors of nursing, RNs, CNAs, and activities personnel. Support staff including housekeeping and dietary were trained in about half of the reporting intervention NHs, while physicians and nurse practitioners participated infrequently. Concurrent training programs in dementia care (Hand-in-Hand, Alzheimer Association training, MassPRO dementia care training) were implemented in 67.2% of intervention NHs.

In the intervention NHs, the prevalence of antipsych-otic prescribing decreased from 34.1% at baseline to 26.5% at the study end (7.6% absolute reduction, 22.3% relative reduction). In comparison, the prevalence of antipsychotic prescribing in control NHs decreased from 22.7% to 18.8% over the same period (3.9% absolute reduction, 17.2% relative reduction). During the OASIS implementation phase, the intervention NHs had a reduc-tion in prevalence of antipsychotic use (–1.20% [95% confidence interval {CI}, –1.85% to –0.09% per quarter]) greater than that of the control NHs (–0.23% [95% CI, –0.47% to 0.01% per quarter]), resulting in a net OASIS influence of –0.97% (95% CI, –1.85% to –0.09% per quarter; P = 0.03). The antipsychotic use reduction observed in the implementation phase was not sustained in the maintenance phase (difference of 0.93%; 95% CI, –0.66% to 2.54%; P = 0.48). No increases in other psychotropic medication use (anxiolytics, antidepressants, hypnotics) or behavioral disturbances (physically abusive behavior, verbally abusive behavior, and rejecting care) were observed during the OASIS training and implementation phases.

Conclusion. The OASIS communication training program reduced the prevalence of antipsychotic use in NHs during its implementation phase, but its effect was not sustained in the subsequent maintenance phase. The use of other psychotropic medications and behavior disturbances did not increase during the implementation of OASIS program. The findings from this study provided further support for utilizing nonpharmacologic programs to treat behavioral and psychological symptoms of dementia in older adults who reside in NHs.

Commentary

The use of both conventional and atypical antipsychotic medications is associated with a dose-related, approximately 2-fold increased risk of sudden cardiac death in older adults [1,2]. In 2006, the FDA issued a public health advisory stating that both conventional and atypical anti-psychotic medications are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. Despite this black box warning and growing recognition that antipsychotic medications are not indicated for the treatment of dementia-related psychosis, the off-label use of antipsychotic medications to treat behavioral and psychological symptoms of dementia in older adults remains a common practice in nursing homes [3]. Thus, there is an urgent need to assess and develop effective interventions that reduce the practice of antipsychotic medication prescribing in long-term care. To that effect, the study reported by Tjia et al appropriately investigated the impact of the OASIS communication training program, a nonpharmacologic intervention, on the reduction of antipsychotic use in NHs.

This study was well designed and had a number of strengths. It utilized an interrupted time series model, one of the strongest quasi-experimental approaches due to its robustness to threats of internal validity, for evaluating longitudinal effects of an intervention intended to improve the quality of medication use. Moreover, this study included a large sample size and comparison facilities from the same geographical areas (NHs in Massachusetts and New York State) that served as external controls. Several potential weaknesses of the study were identified. Because facility-level aggregate data from NHs were used for analysis, individual level (long-term care resident) characteristics were not accounted for in the analysis. In addition, while the post-OASIS intervention questionnaire response rate was 65.6% (61 of 93 intervention NHs), a higher response rate would provide better characterization of NH staff that participated in OASIS program training, program completion rate, and a more complete representation of competing dementia care training programs concurrently implemented in these NHs.

Several studies, most utilizing various provider education methods, had explored whether these interventions could curb antipsychotic use in NHs with limited success. The largest successful intervention was reported by Meador et al [4], where a focused provider education program facilitated a relative reduction in antipsychotic medication use of 23% compared to control NHs. However, the implementation of this specific program was time- and resource-intensive, requiring geropsychiatry evaluation to all physicians (45 to 60 min), nurse-educator in-service programs for NH staff (5 to 6 one-hr sessions), management specialist consultation to NH administrators (4 hr), and evening meeting for the families of NH residents. The current study by Tjia et al, the largest study to date conducted in the context of competing dementia care training programs and increased awareness of the danger of antipsychotic use in the elderly, similarly showed a meaningful reduction in antipsychotic medication use in NHs that received the OASIS communication training program. The OASIS program appears to be less resource-intensive than the provider education program modeled by Meador et al, and its train-the-trainer model is likely more adaptable to meet the limitations (eg, low staffing and staff turnover) inherent in NHs. The beneficial effect of the OASIS program on reduction of antipsychotic medication prescribing was observed despite low participation by prescribers (11.5% of physicians and 11.5% of nurse practitioners). Although it is unclear why this was observed, this finding is intriguing in that a communication training program that reframes challenging behavior of NH residents with cognitive impairment as (1) communication of unmet needs, (2) train staff to anticipate resident needs, and (3) integrate resident strengths into daily care plans can alter provider prescription behavior. The implication of this is that provider practice in managing behavioral and psychological symptoms of dementia can be improved by optimizing communication training in NH staff. Taken together, this study adds to evidence in favor of utilizing nonpharmacologic interventions to reduce antipsychotic use in long-term care.

Applications for Clinical Practice

OASIS, a communication training program for NH staff, reduces antipsychotic medication use in NHs during its implementation phase. Future studies need to investigate pragmatic methods to sustain the beneficial effect of OASIS after its implementation phase.

—Fred Ko, MD, MS, Icahn School of Medicine at Mount Sinai, New York, NY

Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate long-term adherence to antihypertensive therapy among patients on fixed-dose combination medication as well as antihypertensive monotherapy; and to identify demographic and clinical risk factors associated with selection of and adherence and persistence to antihypertensive medication therapy.

Design. Retrospective cohort study using claims data from a large nationwide insurer.

Setting and participants. The study population included patients older than age 18 who initiated antihypertensive medication between 1 January 2009 and 31 December 2012 and who were continually enrolled at least 180 days before and 365 days after the index date, defined as the date of initiation of antihypertensive therapy. Patients were excluded from the study if they had previously filled any antihypertensive medication at any time prior to the index date. Patients were categorized based on the number and type of antihypertensive medications (fixed-dose combination, defined as a single pill containing multiple medications; multi-pill combination, defined as 2 or more distinct antihypertensive tablets or capsules; or single therapy, defined as only 1 medication) using National Drug Codes (NDC). Study authors also measured patient baseline characteristics, such as age, region, gender, diagnoses as defined by ICD-9 codes, patient utilization characteristics (both outpatient visits and hospitalizations) and characteristics of the initiated medication, including patient copayment and number of days of medication supplied.

Main outcome measures. The primary outcome of inte-rest was persistence, defined as having supply for any antihypertensive medication that overlapped with the 365th day after initiation (index date), whether the initiated medication or other antihypertensive. Additional outcomes included adherence to at least 1 antihypertensive in the 12 months after initiation and refilling at least 1 antihypertensive medication. To determine adherence, the study authors calculated the proportion of days the patient had any antihypertensive available to them (proportion of days covered; PDC). PDC > 80% to at least 1 antihypertensive in the 12 months after initiation was defined as “fully adherent.”

Statistical analysis utilized modified multivariable Poisson regression models and sensitivity analyses were performed. The main study comparisons focused on patients initiating fixed-dose combination therapy and monotherapy because these groups were more comparable in terms of baseline characteristics and medications initiated than the multi-pill combination group.

Main results. The study sample consisted of 484,493 patients who initiated an oral antihypertensive, including 78,958 patient initiating fixed-dose combinations, 380,269 filled a single therapy, and 22,266 who initiated multi-pill combinations. The most frequently initiated fixed-dose combination was lisinopril-hydrochlorothiazide. Lisinopril, hydrochlorothiazide, and amlodipine with the most frequently initiated monotherapy. The mean age of the study population was 47.2 years and 51.8% were women. Patients initiating multiple pill combinations were older (mean age 52.5) and tended to be sicker with more comorbidities than fixed-dose combinations or monotherapy. Patients initiating fixed-dose combination had higher prescription copayments than patients using single medication (prescription copay $14.4 versus $9.6). Patients initiating fixed-dose combinations were 9% more likely to be persistent (relative risk [RR] 1.09, 95% CI 1.08–1.10) and 13% more likely to be adherent (RR 1.13, 95% CI 1.11–1.14) than those who started on a monotherapy. Refill rates were also slightly higher among fixed-dose combination initiators (RR 1.06, 95% CI 1.05-1.07).

Conclusion. Compared with monotherapy, fixed-dose combination therapy appears to improve adherence and persistence to antihypertensive medications.

Commentary

Approximately half of US of individuals with diagnosed hypertension obtain control of their condition based on currently defined targets [1]. The most effective approach to blood pressure management has been controversial. The JNC8 [2] guidelines liberalized blood pressure targets, while recent results from the SPRINT (systolic blood pressure intervention trial) [3] indicates that lower blood pressure targets are able to prevent hypertension-related complications without significant additional risk. Given these conflicts, there is clearly ambiguity in the most effective approach to initiating antihypertensive treatment. Prior studies have shown that fewer than 50% of patients continue to take their medications just 12 months after initiation [4,5].

Fixed-dose combination therapy for blood pressure management has been cited as better for adherence and is now making its way into clinical guidelines [6–8]. However, it should be noted that fixed-dose combination therapy for blood pressure management limits dosing flexibility. Dose titration may be needed, potentially leading to additional prescriptions, thus potentially complicating the drug regimen and adding additional cost. Complicating matters further, quality metrics and reporting requirements for hypertension require primary care providers to achieve blood pressure control while also ensuring patient adherence and concomitantly avoiding side effects related to medication therapy.

This study was conducted using claims data for commercially insured patients or those with Medicare Advan-tage and is unlikely to be representative of the entire population. Additionally, the study authors did not have detailed clinical information about patients, limiting the ability to understand the true clinical implications. Further, patients may have initiated medications for indications other than hypertension. In addition, causality cannot be established given the retrospective observational cohort nature of this study.

Applications for Clinical Practice

Primary care physicians face substantial challenges in the treatment of hypertension, including with respect to selection of initial medication therapy. Results from this study add to the evidence base that fixed-dose combination therapy is more effective in obtaining blood pressure control than monotherapy or multiple-pill therapy. Medication adherence in primary care practice is challenging. Strategies such as fixed-dose combination therapy are reasonable to employ to improve medication adherence; however, costs must be considered.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC