Photo by Rhoda Baer

Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.

The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.

However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.

Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.

The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.

So the researchers developed a concise alternative to consent documents used in the multinational START trial.

The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.

Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.

The sites were randomly allocated to either the concise or the standard consent documents for participants to review.

There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).

However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).

The researchers did find several factors that were associated with significantly better comprehension.

Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.

Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).

Photo by Rhoda Baer

Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.

The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.

However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.

Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.

The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.

So the researchers developed a concise alternative to consent documents used in the multinational START trial.

The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.

Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.

The sites were randomly allocated to either the concise or the standard consent documents for participants to review.

There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).

However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).

The researchers did find several factors that were associated with significantly better comprehension.

Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.

Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).

Photo by Rhoda Baer

Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.

The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.

However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.

Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.

The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.

So the researchers developed a concise alternative to consent documents used in the multinational START trial.

The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.

Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.

The sites were randomly allocated to either the concise or the standard consent documents for participants to review.

There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).

However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).

The researchers did find several factors that were associated with significantly better comprehension.

Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.

Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).

Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.

A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.¹ The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.²

Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).³

This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.

MEDITERRANEAN

The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.⁴

In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.⁵

LOW-CARBOHYDRATE

Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.⁶

In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.⁵

A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.⁶ Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.⁷

A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.⁸

PALEOLITHIC

The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.

In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.⁹

GLYCEMIC INDEX

The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.

A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.¹⁰

Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.⁵

HIGH-FIBER

A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.¹¹

VEGAN

Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.⁵

In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.¹²

Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.¹³ Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.¹²

CONCLUSION

Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.

The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.

Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.

A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.¹ The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.²

Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).³

This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.

MEDITERRANEAN

The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.⁴

In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.⁵

LOW-CARBOHYDRATE

Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.⁶

In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.⁵

A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.⁶ Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.⁷

A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.⁸

PALEOLITHIC

The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.

In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.⁹

GLYCEMIC INDEX

The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.

A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.¹⁰

Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.⁵

HIGH-FIBER

A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.¹¹

VEGAN

Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.⁵

In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.¹²

Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.¹³ Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.¹²

CONCLUSION

Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.

The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.

Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.

A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.¹ The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.²

Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).³

This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.

MEDITERRANEAN

The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.⁴

In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.⁵

LOW-CARBOHYDRATE

Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.⁶

In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.⁵

A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.⁶ Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.⁷

A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.⁸

PALEOLITHIC

The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.

In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.⁹

GLYCEMIC INDEX

The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.

A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.¹⁰

Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.⁵

HIGH-FIBER

A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.¹¹

VEGAN

Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.⁵

In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.¹²

Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.¹³ Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.¹²

CONCLUSION

Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.

The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.

Hospitalists packed the room on Monday for a pre-course brimming with information on how to better care for patients undergoing surgery – a category of care that can involve high-stakes and complex decisions before and after a procedure.

Topics covered in the wide-ranging talks included how to assess risk in those with ischemic heart disease, ways to manage anticoagulants in a variety of patients, the basics of anesthesia, and issues particular to patients with neurologic diseases.

Darnell Scott

Darnell Scott

Hospitalists packed the room on Monday for a pre-course brimming with information on how to better care for patients undergoing surgery – a category of care that can involve high-stakes and complex decisions before and after a procedure.

Topics covered in the wide-ranging talks included how to assess risk in those with ischemic heart disease, ways to manage anticoagulants in a variety of patients, the basics of anesthesia, and issues particular to patients with neurologic diseases.

Darnell Scott

Darnell Scott

Hospitalists packed the room on Monday for a pre-course brimming with information on how to better care for patients undergoing surgery – a category of care that can involve high-stakes and complex decisions before and after a procedure.

Topics covered in the wide-ranging talks included how to assess risk in those with ischemic heart disease, ways to manage anticoagulants in a variety of patients, the basics of anesthesia, and issues particular to patients with neurologic diseases.

Darnell Scott

Darnell Scott

We get paid to see patients. So what happens when patients aren’t in the room?

This is a big, and growing, issue in medicine.

I do hospital call on weekends, and occasionally, I have a long meeting with families. In some cases, this involves a large group in a conference room. These meetings can take quite a bit of time, but since, technically, the patient isn’t present, it requires different charges than if he or she were, even if the whole meeting is about him or her.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

We get paid to see patients. So what happens when patients aren’t in the room?

This is a big, and growing, issue in medicine.

I do hospital call on weekends, and occasionally, I have a long meeting with families. In some cases, this involves a large group in a conference room. These meetings can take quite a bit of time, but since, technically, the patient isn’t present, it requires different charges than if he or she were, even if the whole meeting is about him or her.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

We get paid to see patients. So what happens when patients aren’t in the room?

This is a big, and growing, issue in medicine.

I do hospital call on weekends, and occasionally, I have a long meeting with families. In some cases, this involves a large group in a conference room. These meetings can take quite a bit of time, but since, technically, the patient isn’t present, it requires different charges than if he or she were, even if the whole meeting is about him or her.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The hospital medicine field has struggled with the issue of burnout for years. The supply of hospitalists has had trouble keeping up with the demand. Hospitalists, often viewed as agents of change, are also encouraged to take on projects, such as quality improvement initiatives, beyond their clinical duties.

A talk at this year’s meeting will take on the issue of work-life balance, which is often an ideal that hospitalists find difficult to attain.

Dawna Ballard, PhD, will lead the session “Why We Fail at Work-Life Balance,” scheduled for Tuesday, May 2, 3:05–3:45 p.m., as part of the Rapid Fire track.

Dr. Ballard is an associate professor in communication studies at the University of Texas at Austin and is an expert on chronemics, which, as her professional website puts it, is the “study of time as it is bound to human communication.” She does research on why we lead our lives at a certain pace and the effect this pace has on our communication and, ultimately, on the long-term health of organizations.

Recently, she has studied the historical and contemporary problems with the discourse on “work-life balance.” She is also a coauthor of the 2016 book Work Pressures, which explores the ways pressure at work can erode the performance and vitality of people and their organizations.

Dr. Ballard said she has found in her research that the very idea of a “work-life balance” can bring about confusion and frustration.

“Just this morning, someone tweeted me that they don’t really like the notion of balance, and they always feel like they’re being punished,” she said recently. “A big part of the problem is our expectations about ourselves around time.”

[[{"fid":"195467","view_mode":"medstat_image_flush_right","attributes":{"height":"220","width":"147","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":""}},"link_text":false}]]Dr. Ballard said she will focus on promoting a better understanding of the relationship between time and work.

“I will identify a few common themes (in everyday talk and popular culture) about the role of time in being effective at work,” she said. “I will then discuss what the research and data suggest is actually true about these relationships between time and work.”

Struggles with balancing personal time and time in the workplace seem to be linked with job satisfaction in hospital medicine, the literature suggests. In survey results published in 2012, 63% of hospitalists reported high job satisfaction, but personal time was one area in which they reported being least satisfied. Satisfaction or dissatisfaction with personal time was also one of the areas that predicted satisfaction or dissatisfaction with their specialty.¹

Dr. Ballard said that she hopes to debunk some misconceptions. “The goal of this talk is to identify problems with commonly held assumptions that actually lead to reduced effectiveness at work and increased stress,” she said. “Given the centrality of time to our experience as professional and personal selves, working with a clear (evidence-based) understanding of the sociocultural and historical underpinnings of common assumptions is critical.”

One problem, she said, is that there is “a mythology that this is something that has ever existed or ever could exist, and so it disciplines people and it makes people feel like they’re failing.”

“Work is uneven – especially for doctors, it’s really uneven,” she said. “It can be really intense sometimes and then there can be times where we can pull back. ... Intensity doesn’t have to be bad and not good. It just is descriptive.”

She added, “We love work that can be intense at times.”
 

Reference
1. Hinami K, Whelan CT, Wolosin RJ, et al. “Worklife and satisfaction of hospitalists: Toward flourishing careers.” J Gen Intern Med. 2012;27(1):28-36.

“Why We Fail at Work-Life Balance”
Tuesday, May 2, 3:05–3:45 p.m.

The hospital medicine field has struggled with the issue of burnout for years. The supply of hospitalists has had trouble keeping up with the demand. Hospitalists, often viewed as agents of change, are also encouraged to take on projects, such as quality improvement initiatives, beyond their clinical duties.

A talk at this year’s meeting will take on the issue of work-life balance, which is often an ideal that hospitalists find difficult to attain.

Dawna Ballard, PhD, will lead the session “Why We Fail at Work-Life Balance,” scheduled for Tuesday, May 2, 3:05–3:45 p.m., as part of the Rapid Fire track.

Dr. Ballard is an associate professor in communication studies at the University of Texas at Austin and is an expert on chronemics, which, as her professional website puts it, is the “study of time as it is bound to human communication.” She does research on why we lead our lives at a certain pace and the effect this pace has on our communication and, ultimately, on the long-term health of organizations.

Recently, she has studied the historical and contemporary problems with the discourse on “work-life balance.” She is also a coauthor of the 2016 book Work Pressures, which explores the ways pressure at work can erode the performance and vitality of people and their organizations.

Dr. Ballard said she has found in her research that the very idea of a “work-life balance” can bring about confusion and frustration.

“Just this morning, someone tweeted me that they don’t really like the notion of balance, and they always feel like they’re being punished,” she said recently. “A big part of the problem is our expectations about ourselves around time.”

[[{"fid":"195467","view_mode":"medstat_image_flush_right","attributes":{"height":"220","width":"147","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":""}},"link_text":false}]]Dr. Ballard said she will focus on promoting a better understanding of the relationship between time and work.

“I will identify a few common themes (in everyday talk and popular culture) about the role of time in being effective at work,” she said. “I will then discuss what the research and data suggest is actually true about these relationships between time and work.”

Struggles with balancing personal time and time in the workplace seem to be linked with job satisfaction in hospital medicine, the literature suggests. In survey results published in 2012, 63% of hospitalists reported high job satisfaction, but personal time was one area in which they reported being least satisfied. Satisfaction or dissatisfaction with personal time was also one of the areas that predicted satisfaction or dissatisfaction with their specialty.¹

Dr. Ballard said that she hopes to debunk some misconceptions. “The goal of this talk is to identify problems with commonly held assumptions that actually lead to reduced effectiveness at work and increased stress,” she said. “Given the centrality of time to our experience as professional and personal selves, working with a clear (evidence-based) understanding of the sociocultural and historical underpinnings of common assumptions is critical.”

One problem, she said, is that there is “a mythology that this is something that has ever existed or ever could exist, and so it disciplines people and it makes people feel like they’re failing.”

“Work is uneven – especially for doctors, it’s really uneven,” she said. “It can be really intense sometimes and then there can be times where we can pull back. ... Intensity doesn’t have to be bad and not good. It just is descriptive.”

She added, “We love work that can be intense at times.”
 

Reference
1. Hinami K, Whelan CT, Wolosin RJ, et al. “Worklife and satisfaction of hospitalists: Toward flourishing careers.” J Gen Intern Med. 2012;27(1):28-36.

“Why We Fail at Work-Life Balance”
Tuesday, May 2, 3:05–3:45 p.m.

The hospital medicine field has struggled with the issue of burnout for years. The supply of hospitalists has had trouble keeping up with the demand. Hospitalists, often viewed as agents of change, are also encouraged to take on projects, such as quality improvement initiatives, beyond their clinical duties.

A talk at this year’s meeting will take on the issue of work-life balance, which is often an ideal that hospitalists find difficult to attain.

Dawna Ballard, PhD, will lead the session “Why We Fail at Work-Life Balance,” scheduled for Tuesday, May 2, 3:05–3:45 p.m., as part of the Rapid Fire track.

Dr. Ballard is an associate professor in communication studies at the University of Texas at Austin and is an expert on chronemics, which, as her professional website puts it, is the “study of time as it is bound to human communication.” She does research on why we lead our lives at a certain pace and the effect this pace has on our communication and, ultimately, on the long-term health of organizations.

Recently, she has studied the historical and contemporary problems with the discourse on “work-life balance.” She is also a coauthor of the 2016 book Work Pressures, which explores the ways pressure at work can erode the performance and vitality of people and their organizations.

Dr. Ballard said she has found in her research that the very idea of a “work-life balance” can bring about confusion and frustration.

“Just this morning, someone tweeted me that they don’t really like the notion of balance, and they always feel like they’re being punished,” she said recently. “A big part of the problem is our expectations about ourselves around time.”

[[{"fid":"195467","view_mode":"medstat_image_flush_right","attributes":{"height":"220","width":"147","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Dawna Ballard","field_file_image_credit[und][0][value]":""}},"link_text":false}]]Dr. Ballard said she will focus on promoting a better understanding of the relationship between time and work.

“I will identify a few common themes (in everyday talk and popular culture) about the role of time in being effective at work,” she said. “I will then discuss what the research and data suggest is actually true about these relationships between time and work.”

Struggles with balancing personal time and time in the workplace seem to be linked with job satisfaction in hospital medicine, the literature suggests. In survey results published in 2012, 63% of hospitalists reported high job satisfaction, but personal time was one area in which they reported being least satisfied. Satisfaction or dissatisfaction with personal time was also one of the areas that predicted satisfaction or dissatisfaction with their specialty.¹

Dr. Ballard said that she hopes to debunk some misconceptions. “The goal of this talk is to identify problems with commonly held assumptions that actually lead to reduced effectiveness at work and increased stress,” she said. “Given the centrality of time to our experience as professional and personal selves, working with a clear (evidence-based) understanding of the sociocultural and historical underpinnings of common assumptions is critical.”

One problem, she said, is that there is “a mythology that this is something that has ever existed or ever could exist, and so it disciplines people and it makes people feel like they’re failing.”

“Work is uneven – especially for doctors, it’s really uneven,” she said. “It can be really intense sometimes and then there can be times where we can pull back. ... Intensity doesn’t have to be bad and not good. It just is descriptive.”

She added, “We love work that can be intense at times.”
 

Reference
1. Hinami K, Whelan CT, Wolosin RJ, et al. “Worklife and satisfaction of hospitalists: Toward flourishing careers.” J Gen Intern Med. 2012;27(1):28-36.

“Why We Fail at Work-Life Balance”
Tuesday, May 2, 3:05–3:45 p.m.

To improve patient care and outcomes, leading dermatologists offered their recommendations on products for sensitive skin. Consideration must be given to:

• Avène Cicalfate Restorative Skin Cream
  Pierre Fabre Dermo-Cosmetique USA
  “Sucralfate for speeding up skin repair and the soothing thermal spring waters found in this product make it perfect postprocedure for immediately cooling and calming the skin.”—Jeannette Graf, MD, New York, New York

• Cetaphil RestoraDerm Eczema Calming Body Moisturizer
  Galderma Laboratories, LP
  “This product is formulated for atopic skin. I personally use it on my face as a moisturizer during the cold New York City winter.”—Anthony M. Rossi, MD, New York, New York

• Vanicream
  Pharmaceutical Specialties, Inc
  “I recommend Vanicream brand products to patients with sensitive skin or eczema. These products are fragrance free and have minimal ingredients.”— Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Athlete's foot treatments, cleansing devices, redness-reducing products, and face scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on products for sensitive skin. Consideration must be given to:

• Avène Cicalfate Restorative Skin Cream
  Pierre Fabre Dermo-Cosmetique USA
  “Sucralfate for speeding up skin repair and the soothing thermal spring waters found in this product make it perfect postprocedure for immediately cooling and calming the skin.”—Jeannette Graf, MD, New York, New York

• Cetaphil RestoraDerm Eczema Calming Body Moisturizer
  Galderma Laboratories, LP
  “This product is formulated for atopic skin. I personally use it on my face as a moisturizer during the cold New York City winter.”—Anthony M. Rossi, MD, New York, New York

• Vanicream
  Pharmaceutical Specialties, Inc
  “I recommend Vanicream brand products to patients with sensitive skin or eczema. These products are fragrance free and have minimal ingredients.”— Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Athlete's foot treatments, cleansing devices, redness-reducing products, and face scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on products for sensitive skin. Consideration must be given to:

• Avène Cicalfate Restorative Skin Cream
  Pierre Fabre Dermo-Cosmetique USA
  “Sucralfate for speeding up skin repair and the soothing thermal spring waters found in this product make it perfect postprocedure for immediately cooling and calming the skin.”—Jeannette Graf, MD, New York, New York

• Cetaphil RestoraDerm Eczema Calming Body Moisturizer
  Galderma Laboratories, LP
  “This product is formulated for atopic skin. I personally use it on my face as a moisturizer during the cold New York City winter.”—Anthony M. Rossi, MD, New York, New York

• Vanicream
  Pharmaceutical Specialties, Inc
  “I recommend Vanicream brand products to patients with sensitive skin or eczema. These products are fragrance free and have minimal ingredients.”— Gary Goldenberg, MD, New York, New York

Cutis invites readers to send us their recommendations. Athlete's foot treatments, cleansing devices, redness-reducing products, and face scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

PARIS – Two regimens of bromocriptine treatment administered with anticoagulation and standard heart failure management were safe, and often effective, for normalizing ejection fraction levels in women diagnosed with peripartum cardiomyopathy in a study with 63 women and designed to be the pivotal trial for this management strategy.

“Bromocriptine therapy applied for 1 week seems sufficient to promote healing from PPCM [peripartum cardiomyopathy] in most patients, although critically ill patients may profit from prolonged [8 week] treatment,” Denise Hilfiker-Kleiner, PhD, said at a meeting of the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

PARIS – Two regimens of bromocriptine treatment administered with anticoagulation and standard heart failure management were safe, and often effective, for normalizing ejection fraction levels in women diagnosed with peripartum cardiomyopathy in a study with 63 women and designed to be the pivotal trial for this management strategy.

“Bromocriptine therapy applied for 1 week seems sufficient to promote healing from PPCM [peripartum cardiomyopathy] in most patients, although critically ill patients may profit from prolonged [8 week] treatment,” Denise Hilfiker-Kleiner, PhD, said at a meeting of the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

PARIS – Two regimens of bromocriptine treatment administered with anticoagulation and standard heart failure management were safe, and often effective, for normalizing ejection fraction levels in women diagnosed with peripartum cardiomyopathy in a study with 63 women and designed to be the pivotal trial for this management strategy.

“Bromocriptine therapy applied for 1 week seems sufficient to promote healing from PPCM [peripartum cardiomyopathy] in most patients, although critically ill patients may profit from prolonged [8 week] treatment,” Denise Hilfiker-Kleiner, PhD, said at a meeting of the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

Hospitalists participated in a double-header of hands-on point-of-care ultrasound training here on Monday, looking to gain an edge in expertise in a role that’s becoming more and more common.

Nearly 100 hospitalists and other health care professionals heard talks on the fundamental principles of ultrasound and cardiac, lung and vascular, and abdominal ultrasound. The highlights of the sessions were two 80-minute hands-on segments using the probes.

“This course has grown and grown – this is the largest we’ve ever done,” said pre-course director Nilam Soni, MD, MS, FHM, associate professor of medicine at the University of Texas Health Science Center San Antonio.

Darnell Scott/Frontline Medical News

Darnell Scott/Frontline Medical News

Hospitalists participated in a double-header of hands-on point-of-care ultrasound training here on Monday, looking to gain an edge in expertise in a role that’s becoming more and more common.

Nearly 100 hospitalists and other health care professionals heard talks on the fundamental principles of ultrasound and cardiac, lung and vascular, and abdominal ultrasound. The highlights of the sessions were two 80-minute hands-on segments using the probes.

“This course has grown and grown – this is the largest we’ve ever done,” said pre-course director Nilam Soni, MD, MS, FHM, associate professor of medicine at the University of Texas Health Science Center San Antonio.

Darnell Scott/Frontline Medical News

Darnell Scott/Frontline Medical News

Hospitalists participated in a double-header of hands-on point-of-care ultrasound training here on Monday, looking to gain an edge in expertise in a role that’s becoming more and more common.

Nearly 100 hospitalists and other health care professionals heard talks on the fundamental principles of ultrasound and cardiac, lung and vascular, and abdominal ultrasound. The highlights of the sessions were two 80-minute hands-on segments using the probes.

“This course has grown and grown – this is the largest we’ve ever done,” said pre-course director Nilam Soni, MD, MS, FHM, associate professor of medicine at the University of Texas Health Science Center San Antonio.

Darnell Scott/Frontline Medical News

Darnell Scott/Frontline Medical News

Identifying Characteristics and Disease Transmission

Cheyletiella are nonburrowing mites characterized by hooklike anterior palps (Figure 1) that have a worldwide distribution. Human dermatitis is the result of contact with an affected animal and may present as papular or bullous lesions. Cheyletiella blakei affects cats, Cheyletiella parasitovorax is found on rabbits, and Cheyletiella yasguri is found on dogs. The mites live in the outer layer of the epidermis of the host animal and feed on surface debris and tissue fluids.¹ They complete an entire 35-day life cycle on a single animal host. The larval, nymph, and adult male mites die within 48 hours of separation from a host. The female mite and possibly the eggs can live up to 10 days off the host, which makes environmental decontamination a critical part of pest control.² In animals, the mite often produces a subtle dermatitis sometimes called walking dandruff (Figure 2).³ Affected animals also can be asymptomatic, and up to 50% of rabbits in commercial colonies may harbor Cheyletiella or other mites.⁴

The typical human patient with Cheyletiella-associated dermatitis is a female 40 years or younger who presents with grouped pruritic papules.⁵ Although papules usually are grouped on exposed areas, they also may be widespread.^6,7 Bullous eruptions caused by Cheyletiella mites may mimic those found in immunobullous diseases (Figure 3).⁸ Children may experience widespread dermatitis after taking a nap where a dog has slept.⁹ Pet owners, farmers, and veterinarians frequently present with zoonotic mite-induced dermatitis.¹⁰ Arthralgia and peripheral eosinophilia caused by Cheyletiella infestation also has been reported.¹¹

Management of Affected Pets

In a case of human infestation resulting from an affected pet, the implicated pet should be evaluated by a qualified veterinarian. Various diagnostic techniques for animals have been used, including adhesive tape preparations.¹² A rapid knockdown insecticidal spray marketed for use on animals has been used to facilitate collection of mites, but some pets may be susceptible to toxicity from insecticides. The scaly area should be carefully brushed with a toothbrush or fine-tooth comb, and all scales, crust, and hair collected should be placed in a resealable plastic storage bag. When alcohol is added to the bag, most contents will sink, but the mites tend to float. Vacuum cleaners fitted with in-line filters also have been used to collect mites. The filter samples can be treated with hot potassium hydroxide, then floated in a concentrated sugar solution to collect the ectoparasites.¹³ Often, a straightforward approach using a #10 blade to provide a skin scraping from the animal in question is effective.¹⁴

Various treatment modalities may be employed by the veterinarian, including dips or shampoos, as well as fipronil.^15,16 A single application of fipronil 10% has been shown to be highly effective in the elimination of mites after a single application in cats.¹⁷ Oral ivermectin and topical amitraz also have been used.^18,19 A veterinarian should treat the animals, as some are more susceptible to toxicity from topical or systemic agents.

Treatment in Humans

Cheyletiella infestations in humans usually are self-limited and resolve within a few weeks after treatment of the source animal. Symptomatic treatment with antipruritic medications and topical steroids may be of use while awaiting resolution. Identification and treatment of the vector is key to eliminating the infestation and preventing recurrence.

Identifying Characteristics and Disease Transmission

Cheyletiella are nonburrowing mites characterized by hooklike anterior palps (Figure 1) that have a worldwide distribution. Human dermatitis is the result of contact with an affected animal and may present as papular or bullous lesions. Cheyletiella blakei affects cats, Cheyletiella parasitovorax is found on rabbits, and Cheyletiella yasguri is found on dogs. The mites live in the outer layer of the epidermis of the host animal and feed on surface debris and tissue fluids.¹ They complete an entire 35-day life cycle on a single animal host. The larval, nymph, and adult male mites die within 48 hours of separation from a host. The female mite and possibly the eggs can live up to 10 days off the host, which makes environmental decontamination a critical part of pest control.² In animals, the mite often produces a subtle dermatitis sometimes called walking dandruff (Figure 2).³ Affected animals also can be asymptomatic, and up to 50% of rabbits in commercial colonies may harbor Cheyletiella or other mites.⁴

The typical human patient with Cheyletiella-associated dermatitis is a female 40 years or younger who presents with grouped pruritic papules.⁵ Although papules usually are grouped on exposed areas, they also may be widespread.^6,7 Bullous eruptions caused by Cheyletiella mites may mimic those found in immunobullous diseases (Figure 3).⁸ Children may experience widespread dermatitis after taking a nap where a dog has slept.⁹ Pet owners, farmers, and veterinarians frequently present with zoonotic mite-induced dermatitis.¹⁰ Arthralgia and peripheral eosinophilia caused by Cheyletiella infestation also has been reported.¹¹

Management of Affected Pets

In a case of human infestation resulting from an affected pet, the implicated pet should be evaluated by a qualified veterinarian. Various diagnostic techniques for animals have been used, including adhesive tape preparations.¹² A rapid knockdown insecticidal spray marketed for use on animals has been used to facilitate collection of mites, but some pets may be susceptible to toxicity from insecticides. The scaly area should be carefully brushed with a toothbrush or fine-tooth comb, and all scales, crust, and hair collected should be placed in a resealable plastic storage bag. When alcohol is added to the bag, most contents will sink, but the mites tend to float. Vacuum cleaners fitted with in-line filters also have been used to collect mites. The filter samples can be treated with hot potassium hydroxide, then floated in a concentrated sugar solution to collect the ectoparasites.¹³ Often, a straightforward approach using a #10 blade to provide a skin scraping from the animal in question is effective.¹⁴

Various treatment modalities may be employed by the veterinarian, including dips or shampoos, as well as fipronil.^15,16 A single application of fipronil 10% has been shown to be highly effective in the elimination of mites after a single application in cats.¹⁷ Oral ivermectin and topical amitraz also have been used.^18,19 A veterinarian should treat the animals, as some are more susceptible to toxicity from topical or systemic agents.

Treatment in Humans

Cheyletiella infestations in humans usually are self-limited and resolve within a few weeks after treatment of the source animal. Symptomatic treatment with antipruritic medications and topical steroids may be of use while awaiting resolution. Identification and treatment of the vector is key to eliminating the infestation and preventing recurrence.

Identifying Characteristics and Disease Transmission

Cheyletiella are nonburrowing mites characterized by hooklike anterior palps (Figure 1) that have a worldwide distribution. Human dermatitis is the result of contact with an affected animal and may present as papular or bullous lesions. Cheyletiella blakei affects cats, Cheyletiella parasitovorax is found on rabbits, and Cheyletiella yasguri is found on dogs. The mites live in the outer layer of the epidermis of the host animal and feed on surface debris and tissue fluids.¹ They complete an entire 35-day life cycle on a single animal host. The larval, nymph, and adult male mites die within 48 hours of separation from a host. The female mite and possibly the eggs can live up to 10 days off the host, which makes environmental decontamination a critical part of pest control.² In animals, the mite often produces a subtle dermatitis sometimes called walking dandruff (Figure 2).³ Affected animals also can be asymptomatic, and up to 50% of rabbits in commercial colonies may harbor Cheyletiella or other mites.⁴

The typical human patient with Cheyletiella-associated dermatitis is a female 40 years or younger who presents with grouped pruritic papules.⁵ Although papules usually are grouped on exposed areas, they also may be widespread.^6,7 Bullous eruptions caused by Cheyletiella mites may mimic those found in immunobullous diseases (Figure 3).⁸ Children may experience widespread dermatitis after taking a nap where a dog has slept.⁹ Pet owners, farmers, and veterinarians frequently present with zoonotic mite-induced dermatitis.¹⁰ Arthralgia and peripheral eosinophilia caused by Cheyletiella infestation also has been reported.¹¹

Management of Affected Pets

In a case of human infestation resulting from an affected pet, the implicated pet should be evaluated by a qualified veterinarian. Various diagnostic techniques for animals have been used, including adhesive tape preparations.¹² A rapid knockdown insecticidal spray marketed for use on animals has been used to facilitate collection of mites, but some pets may be susceptible to toxicity from insecticides. The scaly area should be carefully brushed with a toothbrush or fine-tooth comb, and all scales, crust, and hair collected should be placed in a resealable plastic storage bag. When alcohol is added to the bag, most contents will sink, but the mites tend to float. Vacuum cleaners fitted with in-line filters also have been used to collect mites. The filter samples can be treated with hot potassium hydroxide, then floated in a concentrated sugar solution to collect the ectoparasites.¹³ Often, a straightforward approach using a #10 blade to provide a skin scraping from the animal in question is effective.¹⁴

Various treatment modalities may be employed by the veterinarian, including dips or shampoos, as well as fipronil.^15,16 A single application of fipronil 10% has been shown to be highly effective in the elimination of mites after a single application in cats.¹⁷ Oral ivermectin and topical amitraz also have been used.^18,19 A veterinarian should treat the animals, as some are more susceptible to toxicity from topical or systemic agents.

Treatment in Humans

Cheyletiella infestations in humans usually are self-limited and resolve within a few weeks after treatment of the source animal. Symptomatic treatment with antipruritic medications and topical steroids may be of use while awaiting resolution. Identification and treatment of the vector is key to eliminating the infestation and preventing recurrence.

Psoriasis impacts the ability to perform activities, causes embarrassment and social discrimination, and leads to a severe emotional impact in both adult and pediatric patients, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives. A common source of distress in daily life among psoriasis patients was the lack of understanding of the disease in the general population with wrongful concerns that psoriasis is infectious or contagious.

Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast. The impact of psoriasis on daily life was underscored throughout the meeting. Daily activities impacted by psoriasis included physical limitations such as an inability to participate in sports among children due to cracking of the hands and feet, or the impracticability of managing a household or going to work among adults. The inconsistency and unpredictability of the condition led patients to be viewed as unreliable. One participant explained, “If you join a team you can play this week but you can’t play next week.”

Patients and their loved ones often experienced embarrassment and social discrimination. A caregiver stated, “Specifically to a child, psoriasis means something different. It means hiding. It means feeling ashamed and it means being ashamed, and it means thinking twice before being yourself. No child should have to think twice before learning to express themselves.” Social isolation and bullying also were prominent in children, mostly because an uniformed parent or classmate did not understand the disease process.

These effects on the daily life of psoriasis patients often led to a severe emotional impact and social isolation. At a young age, psoriasis can have a devastating social and emotional toll. One caregiver shared that his/her child admitted to having thoughts of suicide. The FDA asked how many participants missed days from work and school because of the emotional toll of their psoriasis symptoms and the majority of participants raised their hands. Several participants also indicated that they had sought treatment for depression and anxiety. Many adult patients also noted that they reconsidered having children because of the destructive effects psoriasis has had on multiple generations of family members.

Dermatologists may use these patient insights to monitor the psychological impact of psoriasis on patients and refer them to a psychiatrist or psychologist when needed.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Psoriasis impacts the ability to perform activities, causes embarrassment and social discrimination, and leads to a severe emotional impact in both adult and pediatric patients, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives. A common source of distress in daily life among psoriasis patients was the lack of understanding of the disease in the general population with wrongful concerns that psoriasis is infectious or contagious.

Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast. The impact of psoriasis on daily life was underscored throughout the meeting. Daily activities impacted by psoriasis included physical limitations such as an inability to participate in sports among children due to cracking of the hands and feet, or the impracticability of managing a household or going to work among adults. The inconsistency and unpredictability of the condition led patients to be viewed as unreliable. One participant explained, “If you join a team you can play this week but you can’t play next week.”

Patients and their loved ones often experienced embarrassment and social discrimination. A caregiver stated, “Specifically to a child, psoriasis means something different. It means hiding. It means feeling ashamed and it means being ashamed, and it means thinking twice before being yourself. No child should have to think twice before learning to express themselves.” Social isolation and bullying also were prominent in children, mostly because an uniformed parent or classmate did not understand the disease process.

These effects on the daily life of psoriasis patients often led to a severe emotional impact and social isolation. At a young age, psoriasis can have a devastating social and emotional toll. One caregiver shared that his/her child admitted to having thoughts of suicide. The FDA asked how many participants missed days from work and school because of the emotional toll of their psoriasis symptoms and the majority of participants raised their hands. Several participants also indicated that they had sought treatment for depression and anxiety. Many adult patients also noted that they reconsidered having children because of the destructive effects psoriasis has had on multiple generations of family members.

Dermatologists may use these patient insights to monitor the psychological impact of psoriasis on patients and refer them to a psychiatrist or psychologist when needed.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.

Psoriasis impacts the ability to perform activities, causes embarrassment and social discrimination, and leads to a severe emotional impact in both adult and pediatric patients, according to a public meeting hosted by the US Food and Drug Administration (FDA) to hear patient perspectives. A common source of distress in daily life among psoriasis patients was the lack of understanding of the disease in the general population with wrongful concerns that psoriasis is infectious or contagious.

Approximately 70 psoriasis patients or patient representatives attended the meeting in person and others attended through a live webcast. The impact of psoriasis on daily life was underscored throughout the meeting. Daily activities impacted by psoriasis included physical limitations such as an inability to participate in sports among children due to cracking of the hands and feet, or the impracticability of managing a household or going to work among adults. The inconsistency and unpredictability of the condition led patients to be viewed as unreliable. One participant explained, “If you join a team you can play this week but you can’t play next week.”

Patients and their loved ones often experienced embarrassment and social discrimination. A caregiver stated, “Specifically to a child, psoriasis means something different. It means hiding. It means feeling ashamed and it means being ashamed, and it means thinking twice before being yourself. No child should have to think twice before learning to express themselves.” Social isolation and bullying also were prominent in children, mostly because an uniformed parent or classmate did not understand the disease process.

These effects on the daily life of psoriasis patients often led to a severe emotional impact and social isolation. At a young age, psoriasis can have a devastating social and emotional toll. One caregiver shared that his/her child admitted to having thoughts of suicide. The FDA asked how many participants missed days from work and school because of the emotional toll of their psoriasis symptoms and the majority of participants raised their hands. Several participants also indicated that they had sought treatment for depression and anxiety. Many adult patients also noted that they reconsidered having children because of the destructive effects psoriasis has had on multiple generations of family members.

Dermatologists may use these patient insights to monitor the psychological impact of psoriasis on patients and refer them to a psychiatrist or psychologist when needed.

The psoriasis public meeting in March 2016 was the FDA’s 18th patient-focused drug development meeting. The FDA sought this information to have a greater understanding of the burden of psoriasis on patients and the treatments currently used to treat psoriasis and its symptoms. This information will help guide the FDA as they consider future drug approvals.