Pediatrics

Leukemia patient

Photo by Bill Branson

VALENCIA, SPAIN—The adjunct T-cell therapy BPX-501 can make haploidentical hematopoietic stem cell transplant (haplo-HSCT) an “attractive option” for pediatric patients with acute leukemia, according to a presentation at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).

Acute leukemia patients who received BPX-501 after haplo-HSCT in a phase 1/2 trial tended to have favorable outcomes.

At a median follow-up of 7 months, 16 of the 17 patients were alive and disease-free.

There were several cases of graft-versus-host disease (GVHD), but nearly all of these resolved.

Franco Locatelli, MD, PhD, of Bambino Gesù Children’s Hospital in Rome, Italy, presented these results at the EBMT meeting as abstract WP16.*

The trial, known as BP-004, was sponsored by Bellicum Pharmaceuticals, the company developing BPX-501.

About BPX-501

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate cells in the event of toxicity.

The goal is to allow physicians to more safely perform haplo-HSCTs by giving patients BPX-501 to speed immune reconstitution and provide control over viral infections. But the technology is designed to provide a safety net to eliminate BPX-501 alloreactive T cells if severe GVHD occurs.

The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. The idea is that, if a patient develops severe GVHD, he can receive an infusion with the small molecule rimiducid. And this will trigger activation of the domain of caspase-9, which leads to selective apoptosis of the CaspaCIDe-containing cells.

About BP-004

In late 2014, Bellicum initiated BP-004, a phase 1/2 trial in children with leukemias, lymphomas, or orphan inherited blood disorders. The trial is being conducted in European and US pediatric transplant centers and is set to enroll up to 90 patients.

At the EBMT meeting, researchers reported results in 41 patients treated on this trial.

Dr Locatelli presented data on 17 patients with acute leukemias—13 with acute lymphoblastic leukemia and 4 with acute myeloid leukemia. Their median age at HSCT was 6.5 years (range, 0.9-16.1)

All of these patients received a T-cell-depleted haplo-HSCT without post-transplant GVHD prophylaxis. All were in complete remission at the time of transplant.

The patients received BPX-501 within 14 ± 4 days after haplo-HSCT. The phase 1 portion of the trial consisted of a classical 3+3 design, with 3 cohorts receiving escalating doses of BPX-501 cells—2.5 x 10⁵, 5 x 10⁵, and 1 x 10⁶ cells/kg.

In the phase 2 portion, patients received 1 X 10⁶ BPX-501 cells/kg. Rimiducid was only used in the event of uncontrollable GVHD.

Results

The median follow-up was 7 months (range, 1-15.6). The median time to platelet recovery was 11 days (range, 9-13), and the median time to neutrophil recovery was 17 days (range, 10-22).

Three patients developed skin-only acute GVHD, were treated with topical steroids, and the GVHD resolved. Two patients developed acute grade 3 GVHD, were treated with systemic steroids, and the GVHD resolved.

Two patients developed mild chronic GVHD, received systemic steroids, and the GVHD resolved. And 1 patient developed severe chronic GVHD, received systemic steroids and rimiducid, and the GVHD improved.

One patient relapsed. The estimated 1-year disease-free survival was 92.9%. Dr Locatelli noted that, although the follow-up is still limited, these results compare favorably to results in historical controls.

“These interim results continue to be very encouraging and indicate that a haploidentical transplant, with the addition of BPX-501-modified donor T cells, can be an attractive option for children in need of a transplant,” he said.

“Future studies will address the role of repeated infusions or higher numbers of BPX-501 cells in malignant patients with resistant disease.”

The BP-004 trial also included 24 patients with nonmalignant disorders. Results in these patients were presented at the EBMT meeting as abstract O007.

*Information in the abstract differs from that presented at the meeting.

Leukemia patient

Photo by Bill Branson

VALENCIA, SPAIN—The adjunct T-cell therapy BPX-501 can make haploidentical hematopoietic stem cell transplant (haplo-HSCT) an “attractive option” for pediatric patients with acute leukemia, according to a presentation at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).

Acute leukemia patients who received BPX-501 after haplo-HSCT in a phase 1/2 trial tended to have favorable outcomes.

At a median follow-up of 7 months, 16 of the 17 patients were alive and disease-free.

There were several cases of graft-versus-host disease (GVHD), but nearly all of these resolved.

Franco Locatelli, MD, PhD, of Bambino Gesù Children’s Hospital in Rome, Italy, presented these results at the EBMT meeting as abstract WP16.*

The trial, known as BP-004, was sponsored by Bellicum Pharmaceuticals, the company developing BPX-501.

About BPX-501

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate cells in the event of toxicity.

The goal is to allow physicians to more safely perform haplo-HSCTs by giving patients BPX-501 to speed immune reconstitution and provide control over viral infections. But the technology is designed to provide a safety net to eliminate BPX-501 alloreactive T cells if severe GVHD occurs.

The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. The idea is that, if a patient develops severe GVHD, he can receive an infusion with the small molecule rimiducid. And this will trigger activation of the domain of caspase-9, which leads to selective apoptosis of the CaspaCIDe-containing cells.

About BP-004

In late 2014, Bellicum initiated BP-004, a phase 1/2 trial in children with leukemias, lymphomas, or orphan inherited blood disorders. The trial is being conducted in European and US pediatric transplant centers and is set to enroll up to 90 patients.

At the EBMT meeting, researchers reported results in 41 patients treated on this trial.

Dr Locatelli presented data on 17 patients with acute leukemias—13 with acute lymphoblastic leukemia and 4 with acute myeloid leukemia. Their median age at HSCT was 6.5 years (range, 0.9-16.1)

All of these patients received a T-cell-depleted haplo-HSCT without post-transplant GVHD prophylaxis. All were in complete remission at the time of transplant.

The patients received BPX-501 within 14 ± 4 days after haplo-HSCT. The phase 1 portion of the trial consisted of a classical 3+3 design, with 3 cohorts receiving escalating doses of BPX-501 cells—2.5 x 10⁵, 5 x 10⁵, and 1 x 10⁶ cells/kg.

In the phase 2 portion, patients received 1 X 10⁶ BPX-501 cells/kg. Rimiducid was only used in the event of uncontrollable GVHD.

Results

The median follow-up was 7 months (range, 1-15.6). The median time to platelet recovery was 11 days (range, 9-13), and the median time to neutrophil recovery was 17 days (range, 10-22).

Three patients developed skin-only acute GVHD, were treated with topical steroids, and the GVHD resolved. Two patients developed acute grade 3 GVHD, were treated with systemic steroids, and the GVHD resolved.

Two patients developed mild chronic GVHD, received systemic steroids, and the GVHD resolved. And 1 patient developed severe chronic GVHD, received systemic steroids and rimiducid, and the GVHD improved.

One patient relapsed. The estimated 1-year disease-free survival was 92.9%. Dr Locatelli noted that, although the follow-up is still limited, these results compare favorably to results in historical controls.

“These interim results continue to be very encouraging and indicate that a haploidentical transplant, with the addition of BPX-501-modified donor T cells, can be an attractive option for children in need of a transplant,” he said.

“Future studies will address the role of repeated infusions or higher numbers of BPX-501 cells in malignant patients with resistant disease.”

The BP-004 trial also included 24 patients with nonmalignant disorders. Results in these patients were presented at the EBMT meeting as abstract O007.

*Information in the abstract differs from that presented at the meeting.

Leukemia patient

Photo by Bill Branson

VALENCIA, SPAIN—The adjunct T-cell therapy BPX-501 can make haploidentical hematopoietic stem cell transplant (haplo-HSCT) an “attractive option” for pediatric patients with acute leukemia, according to a presentation at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).

Acute leukemia patients who received BPX-501 after haplo-HSCT in a phase 1/2 trial tended to have favorable outcomes.

At a median follow-up of 7 months, 16 of the 17 patients were alive and disease-free.

There were several cases of graft-versus-host disease (GVHD), but nearly all of these resolved.

Franco Locatelli, MD, PhD, of Bambino Gesù Children’s Hospital in Rome, Italy, presented these results at the EBMT meeting as abstract WP16.*

The trial, known as BP-004, was sponsored by Bellicum Pharmaceuticals, the company developing BPX-501.

About BPX-501

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate cells in the event of toxicity.

The goal is to allow physicians to more safely perform haplo-HSCTs by giving patients BPX-501 to speed immune reconstitution and provide control over viral infections. But the technology is designed to provide a safety net to eliminate BPX-501 alloreactive T cells if severe GVHD occurs.

The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. The idea is that, if a patient develops severe GVHD, he can receive an infusion with the small molecule rimiducid. And this will trigger activation of the domain of caspase-9, which leads to selective apoptosis of the CaspaCIDe-containing cells.

About BP-004

In late 2014, Bellicum initiated BP-004, a phase 1/2 trial in children with leukemias, lymphomas, or orphan inherited blood disorders. The trial is being conducted in European and US pediatric transplant centers and is set to enroll up to 90 patients.

At the EBMT meeting, researchers reported results in 41 patients treated on this trial.

Dr Locatelli presented data on 17 patients with acute leukemias—13 with acute lymphoblastic leukemia and 4 with acute myeloid leukemia. Their median age at HSCT was 6.5 years (range, 0.9-16.1)

All of these patients received a T-cell-depleted haplo-HSCT without post-transplant GVHD prophylaxis. All were in complete remission at the time of transplant.

The patients received BPX-501 within 14 ± 4 days after haplo-HSCT. The phase 1 portion of the trial consisted of a classical 3+3 design, with 3 cohorts receiving escalating doses of BPX-501 cells—2.5 x 10⁵, 5 x 10⁵, and 1 x 10⁶ cells/kg.

In the phase 2 portion, patients received 1 X 10⁶ BPX-501 cells/kg. Rimiducid was only used in the event of uncontrollable GVHD.

Results

The median follow-up was 7 months (range, 1-15.6). The median time to platelet recovery was 11 days (range, 9-13), and the median time to neutrophil recovery was 17 days (range, 10-22).

Three patients developed skin-only acute GVHD, were treated with topical steroids, and the GVHD resolved. Two patients developed acute grade 3 GVHD, were treated with systemic steroids, and the GVHD resolved.

Two patients developed mild chronic GVHD, received systemic steroids, and the GVHD resolved. And 1 patient developed severe chronic GVHD, received systemic steroids and rimiducid, and the GVHD improved.

One patient relapsed. The estimated 1-year disease-free survival was 92.9%. Dr Locatelli noted that, although the follow-up is still limited, these results compare favorably to results in historical controls.

“These interim results continue to be very encouraging and indicate that a haploidentical transplant, with the addition of BPX-501-modified donor T cells, can be an attractive option for children in need of a transplant,” he said.

“Future studies will address the role of repeated infusions or higher numbers of BPX-501 cells in malignant patients with resistant disease.”

The BP-004 trial also included 24 patients with nonmalignant disorders. Results in these patients were presented at the EBMT meeting as abstract O007.

*Information in the abstract differs from that presented at the meeting.

A few weeks ago, a young man, a child psychiatrist, called saying that he had read the first Weighty Issues column and that he agreed that psychiatrists should be actively involved in the weight loss arena.

He shared that he had several children in his practice whose body-mass indices were over 40 and that he was frustrated that the pediatricians he had spoken with seemed to be only watching and waiting for the children to grow taller. I told him what he already knew: Pediatricians have in place a very specific protocol to follow regarding the treatment of overweight and obesity in children.

I had the impression from him that he was not exactly sure that the protocol was being followed and that he was absolutely sure that the pediatricians had no appreciation of the emotional aspects of these children’s weights. He said he was so fired up about this that he was going to pursue American Board of Obesity Medicine diplomate status himself. In addition to his background in child psychiatry, he also had studied public health, and his parents had worked in the area of disease prevention.

I was thrilled by his call because he got it! Overweight and obesity are a public health menace. Every day, psychiatrists see patients with these maladies, and we should be more knowledgeable about them or armed to get the treatment started ourselves. Although this child psychiatrist continues to intervene with his patients’ pediatricians and embarks on his own ABOM studies, he can, as he sees his patients and their families, write prescriptions for exercise and play time for the family, limited screen time (TV and computer) for the youngsters, no sweetened beverages, fewer simple carbohydrates, and more plain water. These interventions all are consistent with routine lifestyle recommendations for children (and adults), and they also can promote improved well-being for children and family members.

A recent report indicated that about a quarter of 2- to 5-year-olds and one-third of school-aged children (6-18 years) are overweight or obese in the United States (JAMA. 2014 Feb 26;311[8]:306-14). By convention, body-mass index, a measure of relative body fat, is used to indicate underweight, normal weight, overweight, and obesity. It is derived from a formula: weight in kilograms divided by height in meters squared. In adults, normal is 18.5-24.9, overweight is 25-29.9, and obese is greater than or equal to 30 (National Institutes of Health/World Health Organization guidelines for BMI). For children, one calculates the BMI and then plots this on a graph in comparison to other children of the same age and sex to derive a percentile scale number. Percentile scale numbers from 58-94 indicate overweight, and percentiles greater than or equal to 95 indicate obesity in children aged 2-18 years. For children aged 0-2, a weight for length above the 95th percentile indicates overweight.

Childhood obesity is a major risk factor for overweight and obesity in adulthood, and for depression and cardiovascular disease in childhood and adulthood. It also sets one up for potential trouble in the areas of self-esteem, body image, body protection, poor school performance, and relationship issues with peers. These are areas of importance for psychiatrists, child and adult, as we assess, plan for, and treat our patients day to day. Furthermore, childhood overweight puts children at risk for type 2 diabetes, metabolic syndrome, high cholesterol and high blood pressure, asthma, sleep disorders, early puberty or menstruation, Blount’s disease (progressive turning of the lower leg, resembling bowleg), and nonalcoholic fatty liver disease. Obesity in adulthood leads to high blood pressure, strokes, type 2 diabetes, dementia, osteoarthritis, sleep apnea, obesity hypoventilation syndrome, reproductive problems, gallstones, and some cancers (esophagus, pancreas, colon, rectum, breast-after menopause, endometrium, kidney, thyroid, and gallbladder).

The late Dr. Hilde Bruch, one of my mentors in the 1970s, was an early thought leader in childhood obesity. She did research in this area starting in 1937 while practicing pediatrics before she became a psychiatrist in 1943. She said that she was struck by the number of overweight and obese children she observed in the United States, compared with what she had observed in Germany and England. (She died in 1984 at the age of 80 and would be greatly saddened that childhood obesity is now a global issue.) In her 1973 book, “Eating Disorders: Obesity, Anorexia Nervosa, and the Person Within,” she grappled with the taking in of calories, and, speaking of hunger, said that “it is not innate, but something that contains important elements of learning.”

As an analyst, she thought of feeding learning as coming primarily from early mother-child interactions, but we now know that this learning can come through any repeated interaction and that genetic, social, cultural and environmental, and biological factors also apply.

The psychiatrist or anyone else working with children and families must endeavor to reduce self-blame, explore influences, and instill hope in the process toward normal weight and/or adequate management of weight. The psychiatrist and anyone else working with the child and family will appreciate that, if energy intake and physical activity output are manipulated consistently, the tendency for the child will be increasing height and decreasing BMI. The Prevention and Management of Obesity for Children and Adolescents Guideline is very clear about when to refer to a tertiary special weight management program for children. The guideline also speaks to use of weight-loss medication (orlistat for children 12 years and older, sibutramine for children 16 years and older). Bariatric surgery is recommended for children who have finished growing up (by growth plate evidence) and face imminent serious health issues if their weight cannot be brought under control. These children, after surgery, will need to radically restrain their eating, take supplements, and be followed for the rest of their lives to forestall complications and return to overweight and obesity. I believe that child and adult psychiatrists can be of tremendous use here in helping sort out both the physical and course-of-life issues that could threaten successful continued weight loss, whether the weight loss comes through lifestyle change, lifestyle change and medications, or bariatric surgery and subsequent lifestyle change.

I would like to thank that young child psychiatrist who called, because he spurred me to continue our “Weighty Issues” journey by looking at childhood and overweight and obesity and how it can affect our work as physicians and psychiatrists. Parental physical condition at conception and gestation, and genetics may set the stage, and then interaction with the family, the culture, the society, and the environment all interplay in the child’s development to produce an outcome of an overweight or obese child. We still are trying to discover why some but not all children in the same family, neighborhood, socioeconomic strata, culture, etc., are burdened by overweight. The reasons may be found through biological inquiry, but it may just as well in found in psychiatric/psychological inquiry.

Dr. Harris, a diplomate of the American Board of Obesity Medicine, is in private practice in adult and geriatric psychiatry in Hartford, Conn. She also works as a psychiatric consultant to continuing care retirement organizations and professional groups. Dr. Harris, a former president of the Black Psychiatrists of America, is a Distinguished Fellow of the American Psychiatric Association. Besides psychotherapy, her major clinical interests include geriatrics, and the interface between general medicine and psychiatry.

A few weeks ago, a young man, a child psychiatrist, called saying that he had read the first Weighty Issues column and that he agreed that psychiatrists should be actively involved in the weight loss arena.

He shared that he had several children in his practice whose body-mass indices were over 40 and that he was frustrated that the pediatricians he had spoken with seemed to be only watching and waiting for the children to grow taller. I told him what he already knew: Pediatricians have in place a very specific protocol to follow regarding the treatment of overweight and obesity in children.

I had the impression from him that he was not exactly sure that the protocol was being followed and that he was absolutely sure that the pediatricians had no appreciation of the emotional aspects of these children’s weights. He said he was so fired up about this that he was going to pursue American Board of Obesity Medicine diplomate status himself. In addition to his background in child psychiatry, he also had studied public health, and his parents had worked in the area of disease prevention.

I was thrilled by his call because he got it! Overweight and obesity are a public health menace. Every day, psychiatrists see patients with these maladies, and we should be more knowledgeable about them or armed to get the treatment started ourselves. Although this child psychiatrist continues to intervene with his patients’ pediatricians and embarks on his own ABOM studies, he can, as he sees his patients and their families, write prescriptions for exercise and play time for the family, limited screen time (TV and computer) for the youngsters, no sweetened beverages, fewer simple carbohydrates, and more plain water. These interventions all are consistent with routine lifestyle recommendations for children (and adults), and they also can promote improved well-being for children and family members.

A recent report indicated that about a quarter of 2- to 5-year-olds and one-third of school-aged children (6-18 years) are overweight or obese in the United States (JAMA. 2014 Feb 26;311[8]:306-14). By convention, body-mass index, a measure of relative body fat, is used to indicate underweight, normal weight, overweight, and obesity. It is derived from a formula: weight in kilograms divided by height in meters squared. In adults, normal is 18.5-24.9, overweight is 25-29.9, and obese is greater than or equal to 30 (National Institutes of Health/World Health Organization guidelines for BMI). For children, one calculates the BMI and then plots this on a graph in comparison to other children of the same age and sex to derive a percentile scale number. Percentile scale numbers from 58-94 indicate overweight, and percentiles greater than or equal to 95 indicate obesity in children aged 2-18 years. For children aged 0-2, a weight for length above the 95th percentile indicates overweight.

Childhood obesity is a major risk factor for overweight and obesity in adulthood, and for depression and cardiovascular disease in childhood and adulthood. It also sets one up for potential trouble in the areas of self-esteem, body image, body protection, poor school performance, and relationship issues with peers. These are areas of importance for psychiatrists, child and adult, as we assess, plan for, and treat our patients day to day. Furthermore, childhood overweight puts children at risk for type 2 diabetes, metabolic syndrome, high cholesterol and high blood pressure, asthma, sleep disorders, early puberty or menstruation, Blount’s disease (progressive turning of the lower leg, resembling bowleg), and nonalcoholic fatty liver disease. Obesity in adulthood leads to high blood pressure, strokes, type 2 diabetes, dementia, osteoarthritis, sleep apnea, obesity hypoventilation syndrome, reproductive problems, gallstones, and some cancers (esophagus, pancreas, colon, rectum, breast-after menopause, endometrium, kidney, thyroid, and gallbladder).

The late Dr. Hilde Bruch, one of my mentors in the 1970s, was an early thought leader in childhood obesity. She did research in this area starting in 1937 while practicing pediatrics before she became a psychiatrist in 1943. She said that she was struck by the number of overweight and obese children she observed in the United States, compared with what she had observed in Germany and England. (She died in 1984 at the age of 80 and would be greatly saddened that childhood obesity is now a global issue.) In her 1973 book, “Eating Disorders: Obesity, Anorexia Nervosa, and the Person Within,” she grappled with the taking in of calories, and, speaking of hunger, said that “it is not innate, but something that contains important elements of learning.”

As an analyst, she thought of feeding learning as coming primarily from early mother-child interactions, but we now know that this learning can come through any repeated interaction and that genetic, social, cultural and environmental, and biological factors also apply.

The psychiatrist or anyone else working with children and families must endeavor to reduce self-blame, explore influences, and instill hope in the process toward normal weight and/or adequate management of weight. The psychiatrist and anyone else working with the child and family will appreciate that, if energy intake and physical activity output are manipulated consistently, the tendency for the child will be increasing height and decreasing BMI. The Prevention and Management of Obesity for Children and Adolescents Guideline is very clear about when to refer to a tertiary special weight management program for children. The guideline also speaks to use of weight-loss medication (orlistat for children 12 years and older, sibutramine for children 16 years and older). Bariatric surgery is recommended for children who have finished growing up (by growth plate evidence) and face imminent serious health issues if their weight cannot be brought under control. These children, after surgery, will need to radically restrain their eating, take supplements, and be followed for the rest of their lives to forestall complications and return to overweight and obesity. I believe that child and adult psychiatrists can be of tremendous use here in helping sort out both the physical and course-of-life issues that could threaten successful continued weight loss, whether the weight loss comes through lifestyle change, lifestyle change and medications, or bariatric surgery and subsequent lifestyle change.

I would like to thank that young child psychiatrist who called, because he spurred me to continue our “Weighty Issues” journey by looking at childhood and overweight and obesity and how it can affect our work as physicians and psychiatrists. Parental physical condition at conception and gestation, and genetics may set the stage, and then interaction with the family, the culture, the society, and the environment all interplay in the child’s development to produce an outcome of an overweight or obese child. We still are trying to discover why some but not all children in the same family, neighborhood, socioeconomic strata, culture, etc., are burdened by overweight. The reasons may be found through biological inquiry, but it may just as well in found in psychiatric/psychological inquiry.

Dr. Harris, a diplomate of the American Board of Obesity Medicine, is in private practice in adult and geriatric psychiatry in Hartford, Conn. She also works as a psychiatric consultant to continuing care retirement organizations and professional groups. Dr. Harris, a former president of the Black Psychiatrists of America, is a Distinguished Fellow of the American Psychiatric Association. Besides psychotherapy, her major clinical interests include geriatrics, and the interface between general medicine and psychiatry.

A few weeks ago, a young man, a child psychiatrist, called saying that he had read the first Weighty Issues column and that he agreed that psychiatrists should be actively involved in the weight loss arena.

He shared that he had several children in his practice whose body-mass indices were over 40 and that he was frustrated that the pediatricians he had spoken with seemed to be only watching and waiting for the children to grow taller. I told him what he already knew: Pediatricians have in place a very specific protocol to follow regarding the treatment of overweight and obesity in children.

I had the impression from him that he was not exactly sure that the protocol was being followed and that he was absolutely sure that the pediatricians had no appreciation of the emotional aspects of these children’s weights. He said he was so fired up about this that he was going to pursue American Board of Obesity Medicine diplomate status himself. In addition to his background in child psychiatry, he also had studied public health, and his parents had worked in the area of disease prevention.

I was thrilled by his call because he got it! Overweight and obesity are a public health menace. Every day, psychiatrists see patients with these maladies, and we should be more knowledgeable about them or armed to get the treatment started ourselves. Although this child psychiatrist continues to intervene with his patients’ pediatricians and embarks on his own ABOM studies, he can, as he sees his patients and their families, write prescriptions for exercise and play time for the family, limited screen time (TV and computer) for the youngsters, no sweetened beverages, fewer simple carbohydrates, and more plain water. These interventions all are consistent with routine lifestyle recommendations for children (and adults), and they also can promote improved well-being for children and family members.

A recent report indicated that about a quarter of 2- to 5-year-olds and one-third of school-aged children (6-18 years) are overweight or obese in the United States (JAMA. 2014 Feb 26;311[8]:306-14). By convention, body-mass index, a measure of relative body fat, is used to indicate underweight, normal weight, overweight, and obesity. It is derived from a formula: weight in kilograms divided by height in meters squared. In adults, normal is 18.5-24.9, overweight is 25-29.9, and obese is greater than or equal to 30 (National Institutes of Health/World Health Organization guidelines for BMI). For children, one calculates the BMI and then plots this on a graph in comparison to other children of the same age and sex to derive a percentile scale number. Percentile scale numbers from 58-94 indicate overweight, and percentiles greater than or equal to 95 indicate obesity in children aged 2-18 years. For children aged 0-2, a weight for length above the 95th percentile indicates overweight.

Childhood obesity is a major risk factor for overweight and obesity in adulthood, and for depression and cardiovascular disease in childhood and adulthood. It also sets one up for potential trouble in the areas of self-esteem, body image, body protection, poor school performance, and relationship issues with peers. These are areas of importance for psychiatrists, child and adult, as we assess, plan for, and treat our patients day to day. Furthermore, childhood overweight puts children at risk for type 2 diabetes, metabolic syndrome, high cholesterol and high blood pressure, asthma, sleep disorders, early puberty or menstruation, Blount’s disease (progressive turning of the lower leg, resembling bowleg), and nonalcoholic fatty liver disease. Obesity in adulthood leads to high blood pressure, strokes, type 2 diabetes, dementia, osteoarthritis, sleep apnea, obesity hypoventilation syndrome, reproductive problems, gallstones, and some cancers (esophagus, pancreas, colon, rectum, breast-after menopause, endometrium, kidney, thyroid, and gallbladder).

The late Dr. Hilde Bruch, one of my mentors in the 1970s, was an early thought leader in childhood obesity. She did research in this area starting in 1937 while practicing pediatrics before she became a psychiatrist in 1943. She said that she was struck by the number of overweight and obese children she observed in the United States, compared with what she had observed in Germany and England. (She died in 1984 at the age of 80 and would be greatly saddened that childhood obesity is now a global issue.) In her 1973 book, “Eating Disorders: Obesity, Anorexia Nervosa, and the Person Within,” she grappled with the taking in of calories, and, speaking of hunger, said that “it is not innate, but something that contains important elements of learning.”

As an analyst, she thought of feeding learning as coming primarily from early mother-child interactions, but we now know that this learning can come through any repeated interaction and that genetic, social, cultural and environmental, and biological factors also apply.

The psychiatrist or anyone else working with children and families must endeavor to reduce self-blame, explore influences, and instill hope in the process toward normal weight and/or adequate management of weight. The psychiatrist and anyone else working with the child and family will appreciate that, if energy intake and physical activity output are manipulated consistently, the tendency for the child will be increasing height and decreasing BMI. The Prevention and Management of Obesity for Children and Adolescents Guideline is very clear about when to refer to a tertiary special weight management program for children. The guideline also speaks to use of weight-loss medication (orlistat for children 12 years and older, sibutramine for children 16 years and older). Bariatric surgery is recommended for children who have finished growing up (by growth plate evidence) and face imminent serious health issues if their weight cannot be brought under control. These children, after surgery, will need to radically restrain their eating, take supplements, and be followed for the rest of their lives to forestall complications and return to overweight and obesity. I believe that child and adult psychiatrists can be of tremendous use here in helping sort out both the physical and course-of-life issues that could threaten successful continued weight loss, whether the weight loss comes through lifestyle change, lifestyle change and medications, or bariatric surgery and subsequent lifestyle change.

I would like to thank that young child psychiatrist who called, because he spurred me to continue our “Weighty Issues” journey by looking at childhood and overweight and obesity and how it can affect our work as physicians and psychiatrists. Parental physical condition at conception and gestation, and genetics may set the stage, and then interaction with the family, the culture, the society, and the environment all interplay in the child’s development to produce an outcome of an overweight or obese child. We still are trying to discover why some but not all children in the same family, neighborhood, socioeconomic strata, culture, etc., are burdened by overweight. The reasons may be found through biological inquiry, but it may just as well in found in psychiatric/psychological inquiry.

Dr. Harris, a diplomate of the American Board of Obesity Medicine, is in private practice in adult and geriatric psychiatry in Hartford, Conn. She also works as a psychiatric consultant to continuing care retirement organizations and professional groups. Dr. Harris, a former president of the Black Psychiatrists of America, is a Distinguished Fellow of the American Psychiatric Association. Besides psychotherapy, her major clinical interests include geriatrics, and the interface between general medicine and psychiatry.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

BOSTON – The longer that estrogen therapy is delayed in girls with Turner syndrome, the lower their bone density will be in subsequent years, based on results of a retrospective, cross-sectional study from Monash University, in Melbourne, Australia.

For every year after age 11 that Turner patients went without estrogen – generally due to delayed initiation, but sometimes noncompliance – there was a significant reduction in bone mineral density in both the lumbar spine (Beta -0.582, P less than 0.001) and femoral neck (Beta -0.383, P = 0.008).

Estrogen deficiency and subsequent suboptimal bone mass accrual are known to contribute to the increased risk of osteoporosis in women with Turner syndrome, and about a doubling of the risk of fragility fractures, mostly of the forearm. About a third of the 76 women in the study had at least one fracture, explained investigator Dr. Amanda Vincent, head of the Midlife Health and Menopause Program at Monash.

“Avoiding estrogen deficiency is important to optimize bone health in Turner syndrome.” It “depends on early diagnosis, age-appropriate pubertal induction, and optimization of compliance,” Dr. Vincent said at the Endocrine Society annual meeting.

The median age of Turner syndrome diagnosis was 11 years, but estrogen treatments didn’t begin until a median age of 15. The women in the study were a median of about 30 years old, which means that they were adolescents at the time when estrogen treatment was often delayed in the mistaken belief that growth hormone therapy would be more effective before puberty was induced.

It’s now known that estrogen replacement works synergistically with, and even potentiates, the effects of growth hormone. Current guidelines recommend pubertal induction by age 13 (J Clin Endocrinol Metab. 2007 Jan;92(1):10-25).

The women had at least one dual-energy x-ray absorptiometry scan at Monash since 1998. Z-scores below - 2, indicating low bone density, were found in the lumbar spines of about a quarter the subjects, and in the femoral necks of about 8%. Primary amenorrhea and premature menopause, followed by vitamin D deficiency, were the most common risk factors for low bone mass. Almost 40% of the women reported non-continuous use of estrogen. About half had undergone growth hormone therapy.

At a median height of 149 cm, the subjects were about 15 cm shorter than age-matched, healthy controls, and also had a slightly higher median body mass index of 25.6 kg/m². Lumbar spine bone area, bone mineral content, areal bone mineral density, and bone mineral apparent density were significantly lower in Turner syndrome patients. In the femoral neck, areal bone mineral density was significantly lower.

There was no relationship between bone markers and growth hormone use or Turner syndrome karyotype; the predominant karyotype was 45XO, but the study also included mosaic karyotypes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

BOSTON – The longer that estrogen therapy is delayed in girls with Turner syndrome, the lower their bone density will be in subsequent years, based on results of a retrospective, cross-sectional study from Monash University, in Melbourne, Australia.

For every year after age 11 that Turner patients went without estrogen – generally due to delayed initiation, but sometimes noncompliance – there was a significant reduction in bone mineral density in both the lumbar spine (Beta -0.582, P less than 0.001) and femoral neck (Beta -0.383, P = 0.008).

Estrogen deficiency and subsequent suboptimal bone mass accrual are known to contribute to the increased risk of osteoporosis in women with Turner syndrome, and about a doubling of the risk of fragility fractures, mostly of the forearm. About a third of the 76 women in the study had at least one fracture, explained investigator Dr. Amanda Vincent, head of the Midlife Health and Menopause Program at Monash.

“Avoiding estrogen deficiency is important to optimize bone health in Turner syndrome.” It “depends on early diagnosis, age-appropriate pubertal induction, and optimization of compliance,” Dr. Vincent said at the Endocrine Society annual meeting.

The median age of Turner syndrome diagnosis was 11 years, but estrogen treatments didn’t begin until a median age of 15. The women in the study were a median of about 30 years old, which means that they were adolescents at the time when estrogen treatment was often delayed in the mistaken belief that growth hormone therapy would be more effective before puberty was induced.

It’s now known that estrogen replacement works synergistically with, and even potentiates, the effects of growth hormone. Current guidelines recommend pubertal induction by age 13 (J Clin Endocrinol Metab. 2007 Jan;92(1):10-25).

The women had at least one dual-energy x-ray absorptiometry scan at Monash since 1998. Z-scores below - 2, indicating low bone density, were found in the lumbar spines of about a quarter the subjects, and in the femoral necks of about 8%. Primary amenorrhea and premature menopause, followed by vitamin D deficiency, were the most common risk factors for low bone mass. Almost 40% of the women reported non-continuous use of estrogen. About half had undergone growth hormone therapy.

At a median height of 149 cm, the subjects were about 15 cm shorter than age-matched, healthy controls, and also had a slightly higher median body mass index of 25.6 kg/m². Lumbar spine bone area, bone mineral content, areal bone mineral density, and bone mineral apparent density were significantly lower in Turner syndrome patients. In the femoral neck, areal bone mineral density was significantly lower.

There was no relationship between bone markers and growth hormone use or Turner syndrome karyotype; the predominant karyotype was 45XO, but the study also included mosaic karyotypes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

BOSTON – The longer that estrogen therapy is delayed in girls with Turner syndrome, the lower their bone density will be in subsequent years, based on results of a retrospective, cross-sectional study from Monash University, in Melbourne, Australia.

For every year after age 11 that Turner patients went without estrogen – generally due to delayed initiation, but sometimes noncompliance – there was a significant reduction in bone mineral density in both the lumbar spine (Beta -0.582, P less than 0.001) and femoral neck (Beta -0.383, P = 0.008).

Estrogen deficiency and subsequent suboptimal bone mass accrual are known to contribute to the increased risk of osteoporosis in women with Turner syndrome, and about a doubling of the risk of fragility fractures, mostly of the forearm. About a third of the 76 women in the study had at least one fracture, explained investigator Dr. Amanda Vincent, head of the Midlife Health and Menopause Program at Monash.

“Avoiding estrogen deficiency is important to optimize bone health in Turner syndrome.” It “depends on early diagnosis, age-appropriate pubertal induction, and optimization of compliance,” Dr. Vincent said at the Endocrine Society annual meeting.

The median age of Turner syndrome diagnosis was 11 years, but estrogen treatments didn’t begin until a median age of 15. The women in the study were a median of about 30 years old, which means that they were adolescents at the time when estrogen treatment was often delayed in the mistaken belief that growth hormone therapy would be more effective before puberty was induced.

It’s now known that estrogen replacement works synergistically with, and even potentiates, the effects of growth hormone. Current guidelines recommend pubertal induction by age 13 (J Clin Endocrinol Metab. 2007 Jan;92(1):10-25).

The women had at least one dual-energy x-ray absorptiometry scan at Monash since 1998. Z-scores below - 2, indicating low bone density, were found in the lumbar spines of about a quarter the subjects, and in the femoral necks of about 8%. Primary amenorrhea and premature menopause, followed by vitamin D deficiency, were the most common risk factors for low bone mass. Almost 40% of the women reported non-continuous use of estrogen. About half had undergone growth hormone therapy.

At a median height of 149 cm, the subjects were about 15 cm shorter than age-matched, healthy controls, and also had a slightly higher median body mass index of 25.6 kg/m². Lumbar spine bone area, bone mineral content, areal bone mineral density, and bone mineral apparent density were significantly lower in Turner syndrome patients. In the femoral neck, areal bone mineral density was significantly lower.

There was no relationship between bone markers and growth hormone use or Turner syndrome karyotype; the predominant karyotype was 45XO, but the study also included mosaic karyotypes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

WASHINGTON – Practices and clinics should implement cultural humility training and gender protocols for dealing with transgender youth because many of these youth and their parents find health care experiences to be difficult when procedures for treating and interacting with transgender youth are confusing or nonexistent.

The study is part of an ongoing effort to “provide high-quality, respectful health care for transgender youth [because] these youth are at greatly increased risk of issues including substance abuse, depression, anxiety, homelessness, and suicide,” explained Julia M. Crouch of Seattle Children’s Research Institute.

“A growing body of evidence shows improved health outcomes for transgender youth who received support from family, schools, and providers, and there are now an increasing number of multidisciplinary gender clinics throughout the country [that] have been demonstrated to be a feasible and effective way to provide coordinated care to this population,” Ms. Crouch said at the annual meeting of the Society for Adolescent Health and Medicine.

Ms. Crouch and her coinvestigators recruited transgender youth between the ages of 14 and 22 years, along with parents of transgender youth, all of whom were evaluated and enrolled from the Seattle metropolitan area. Both parents and youth were given the option of participating in either a semistructured interview or a focus group discussion, during which investigators learned about the concerns and experiences of both youth and parents when visiting their health care clinics (J Adolesc Health. 2011 Apr;48[4]:351-7; J Adolesc Health. 2011 Apr;48(4):351-7)..

In total, 13 youth and 16 parents – the latter of whom were not made up of 8 pairs of parents, but rather 16 individual parents of transgender youth who were not necessarily the same 13 youth recruited for the study – were eventually selected for inclusion. The parents split evenly between opting for interviews and focus groups, while four of the youth chose interviews and the remaining nine chose focus groups. Seven youth identified themselves as male, three identified as female, and the remaining three identified as “genderqueer or gender fluid.”

Analysis of interview and focus group conversations identified six key “barriers to care” that Ms. Crouch and her coauthors call necessary to rectify in order to improve the quality of health care provided to transgender youth. These are:

• The dearth of health care providers with sufficient knowledge and interest in working with transgender youth.

• The lack of access to pubertal blockers and cross-sex hormones.

• Doctors and their staff who are unable or unwilling to use the names and pronouns that youths prefer to go by.

• Patients being made to feel uncomfortable or “not normal” by health care providers,

• The lack of a set protocol or treatment methodology for dealing with transgender youth.

• The lack of coordination between health care providers and specialties on treating transgender youth – specifically, a lack of cohesive care between mental and medical health care.

“ ‘It was hard enough to find providers who were accepting new patients, worked with adolescents and my insurance, [and] on top of it, finding someone who was transfriendly made it all but impossible,’ ” Ms. Crouch recalled one transgender youth saying during the study.

Ms. Crouch also recounted that providers’ inability to consistently use the correct pronoun when talking about or to a transgender patient was harmful, and despite most instances being dismissed as unintentional, several were said to be intentional and malicious.

“For example, one parent told us [their] doctor said, ‘her, her, her,’ and [her] son, who was 10 years old, said, ‘him, him, him,’ and the doctor got mad, became dismissive and irritated, and kept saying ‘her,’ ” said Ms. Crouch.

The average age of the youth was 18 years, and of the parents was 49 years. The parents were 88% white and 75% female, with 44% holding at least a college degree. Most of the youth were white (69%), and 77% had either completed high school or some college. Youth and parents were recruited in 2015 from local clinics in the Seattle area, as well as through local and national listservs. Thirty-three percent of the parents were from outside the state of Washington.

The study was funded by the Center for Diversity and Health Equity, and the Clinical and Translational Research Faculty Research Support Fund, at Seattle Children’s Research Institute. Ms. Crouch did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

WASHINGTON – Practices and clinics should implement cultural humility training and gender protocols for dealing with transgender youth because many of these youth and their parents find health care experiences to be difficult when procedures for treating and interacting with transgender youth are confusing or nonexistent.

The study is part of an ongoing effort to “provide high-quality, respectful health care for transgender youth [because] these youth are at greatly increased risk of issues including substance abuse, depression, anxiety, homelessness, and suicide,” explained Julia M. Crouch of Seattle Children’s Research Institute.

“A growing body of evidence shows improved health outcomes for transgender youth who received support from family, schools, and providers, and there are now an increasing number of multidisciplinary gender clinics throughout the country [that] have been demonstrated to be a feasible and effective way to provide coordinated care to this population,” Ms. Crouch said at the annual meeting of the Society for Adolescent Health and Medicine.

Ms. Crouch and her coinvestigators recruited transgender youth between the ages of 14 and 22 years, along with parents of transgender youth, all of whom were evaluated and enrolled from the Seattle metropolitan area. Both parents and youth were given the option of participating in either a semistructured interview or a focus group discussion, during which investigators learned about the concerns and experiences of both youth and parents when visiting their health care clinics (J Adolesc Health. 2011 Apr;48[4]:351-7; J Adolesc Health. 2011 Apr;48(4):351-7)..

In total, 13 youth and 16 parents – the latter of whom were not made up of 8 pairs of parents, but rather 16 individual parents of transgender youth who were not necessarily the same 13 youth recruited for the study – were eventually selected for inclusion. The parents split evenly between opting for interviews and focus groups, while four of the youth chose interviews and the remaining nine chose focus groups. Seven youth identified themselves as male, three identified as female, and the remaining three identified as “genderqueer or gender fluid.”

Analysis of interview and focus group conversations identified six key “barriers to care” that Ms. Crouch and her coauthors call necessary to rectify in order to improve the quality of health care provided to transgender youth. These are:

• The dearth of health care providers with sufficient knowledge and interest in working with transgender youth.

• The lack of access to pubertal blockers and cross-sex hormones.

• Doctors and their staff who are unable or unwilling to use the names and pronouns that youths prefer to go by.

• Patients being made to feel uncomfortable or “not normal” by health care providers,

• The lack of a set protocol or treatment methodology for dealing with transgender youth.

• The lack of coordination between health care providers and specialties on treating transgender youth – specifically, a lack of cohesive care between mental and medical health care.

“ ‘It was hard enough to find providers who were accepting new patients, worked with adolescents and my insurance, [and] on top of it, finding someone who was transfriendly made it all but impossible,’ ” Ms. Crouch recalled one transgender youth saying during the study.

Ms. Crouch also recounted that providers’ inability to consistently use the correct pronoun when talking about or to a transgender patient was harmful, and despite most instances being dismissed as unintentional, several were said to be intentional and malicious.

“For example, one parent told us [their] doctor said, ‘her, her, her,’ and [her] son, who was 10 years old, said, ‘him, him, him,’ and the doctor got mad, became dismissive and irritated, and kept saying ‘her,’ ” said Ms. Crouch.

The average age of the youth was 18 years, and of the parents was 49 years. The parents were 88% white and 75% female, with 44% holding at least a college degree. Most of the youth were white (69%), and 77% had either completed high school or some college. Youth and parents were recruited in 2015 from local clinics in the Seattle area, as well as through local and national listservs. Thirty-three percent of the parents were from outside the state of Washington.

The study was funded by the Center for Diversity and Health Equity, and the Clinical and Translational Research Faculty Research Support Fund, at Seattle Children’s Research Institute. Ms. Crouch did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

WASHINGTON – Practices and clinics should implement cultural humility training and gender protocols for dealing with transgender youth because many of these youth and their parents find health care experiences to be difficult when procedures for treating and interacting with transgender youth are confusing or nonexistent.

The study is part of an ongoing effort to “provide high-quality, respectful health care for transgender youth [because] these youth are at greatly increased risk of issues including substance abuse, depression, anxiety, homelessness, and suicide,” explained Julia M. Crouch of Seattle Children’s Research Institute.

“A growing body of evidence shows improved health outcomes for transgender youth who received support from family, schools, and providers, and there are now an increasing number of multidisciplinary gender clinics throughout the country [that] have been demonstrated to be a feasible and effective way to provide coordinated care to this population,” Ms. Crouch said at the annual meeting of the Society for Adolescent Health and Medicine.

Ms. Crouch and her coinvestigators recruited transgender youth between the ages of 14 and 22 years, along with parents of transgender youth, all of whom were evaluated and enrolled from the Seattle metropolitan area. Both parents and youth were given the option of participating in either a semistructured interview or a focus group discussion, during which investigators learned about the concerns and experiences of both youth and parents when visiting their health care clinics (J Adolesc Health. 2011 Apr;48[4]:351-7; J Adolesc Health. 2011 Apr;48(4):351-7)..

In total, 13 youth and 16 parents – the latter of whom were not made up of 8 pairs of parents, but rather 16 individual parents of transgender youth who were not necessarily the same 13 youth recruited for the study – were eventually selected for inclusion. The parents split evenly between opting for interviews and focus groups, while four of the youth chose interviews and the remaining nine chose focus groups. Seven youth identified themselves as male, three identified as female, and the remaining three identified as “genderqueer or gender fluid.”

Analysis of interview and focus group conversations identified six key “barriers to care” that Ms. Crouch and her coauthors call necessary to rectify in order to improve the quality of health care provided to transgender youth. These are:

• The dearth of health care providers with sufficient knowledge and interest in working with transgender youth.

• The lack of access to pubertal blockers and cross-sex hormones.

• Doctors and their staff who are unable or unwilling to use the names and pronouns that youths prefer to go by.

• Patients being made to feel uncomfortable or “not normal” by health care providers,

• The lack of a set protocol or treatment methodology for dealing with transgender youth.

• The lack of coordination between health care providers and specialties on treating transgender youth – specifically, a lack of cohesive care between mental and medical health care.

“ ‘It was hard enough to find providers who were accepting new patients, worked with adolescents and my insurance, [and] on top of it, finding someone who was transfriendly made it all but impossible,’ ” Ms. Crouch recalled one transgender youth saying during the study.

Ms. Crouch also recounted that providers’ inability to consistently use the correct pronoun when talking about or to a transgender patient was harmful, and despite most instances being dismissed as unintentional, several were said to be intentional and malicious.

“For example, one parent told us [their] doctor said, ‘her, her, her,’ and [her] son, who was 10 years old, said, ‘him, him, him,’ and the doctor got mad, became dismissive and irritated, and kept saying ‘her,’ ” said Ms. Crouch.

The average age of the youth was 18 years, and of the parents was 49 years. The parents were 88% white and 75% female, with 44% holding at least a college degree. Most of the youth were white (69%), and 77% had either completed high school or some college. Youth and parents were recruited in 2015 from local clinics in the Seattle area, as well as through local and national listservs. Thirty-three percent of the parents were from outside the state of Washington.

The study was funded by the Center for Diversity and Health Equity, and the Clinical and Translational Research Faculty Research Support Fund, at Seattle Children’s Research Institute. Ms. Crouch did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

A lack of psychiatrists only partially accounted for substantial variations in rates of mental illness diagnosis and prescriptions for psychotropic medications in practices nationwide, a study has shown.

Although a lack of available specialty care was associated with significantly higher odds of a diagnosis or prescription, the colocation of mental health professionals or percentage of children in foster care treated in a practice did not fully explain the differences.

Among 294,748 children aged 4-18 years, seen one or more times in 43 primary care practices nationwide, 15% received a mental health diagnosis between Jan. 1, 2009, and June 30, 2014. Psychotropic medications were prescribed to 14%, reported lead researcher Stephanie L. Mayne of the center for pediatric clinical effectiveness at the the Children’s Hospital of Philadelphia (Pediatrics. 2016 doi: 10.1542/peds.2015-2974).

The most common diagnosis was attention-deficit/hyperactivity disorder at a rate of between 1% and 16%. Differences in other diagnoses “were smaller, but still meaningful” at ranges of 1%-8% for anxiety, 0%-5% for depression, 0.2%-3% for autism, 0%-3% for conduct disorder, and 0%-2% for oppositional-defiant disorder. Bipolar disorder was “uncommon” at less than 1%, Ms. Mayne and her associates reported.

The rate of children receiving any psychotropic medication was between 4% and 26%, while the proportion of patients receiving two or more medication classes ranged between 1% and 12%. Prescription rates for specific medication classes also varied at between 4% and 18% for stimulants, 1% and 12% for antidepressants, 0.1% and 8% for alpha-agonists, and 0.1% and 5% for second-generation antipsychotics.

“Primary care providers’ level of agreement with current guidelines, perceived self-efficacy in diagnosing or treating particular conditions, training, relationships with schools, and reimbursement from insurers might affect prescribing practices,” Ms. Mayne and her associates wrote.

“Even with colocation, barriers such as financial differences in reimbursement for medical and mental health services, difficulties with information sharing, differing expertise, and limited hours may impede integration,” they commented.

Dr. Alexander G. Fiks is an investigator for Pfizer; the other researchers said they had no relevant financial disclosures. This study was funded by the National Institutes of Health and the National Institute of Child Health and Human Development under the Best Pharmaceuticals for Children Act.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

A lack of psychiatrists only partially accounted for substantial variations in rates of mental illness diagnosis and prescriptions for psychotropic medications in practices nationwide, a study has shown.

Although a lack of available specialty care was associated with significantly higher odds of a diagnosis or prescription, the colocation of mental health professionals or percentage of children in foster care treated in a practice did not fully explain the differences.

Among 294,748 children aged 4-18 years, seen one or more times in 43 primary care practices nationwide, 15% received a mental health diagnosis between Jan. 1, 2009, and June 30, 2014. Psychotropic medications were prescribed to 14%, reported lead researcher Stephanie L. Mayne of the center for pediatric clinical effectiveness at the the Children’s Hospital of Philadelphia (Pediatrics. 2016 doi: 10.1542/peds.2015-2974).

The most common diagnosis was attention-deficit/hyperactivity disorder at a rate of between 1% and 16%. Differences in other diagnoses “were smaller, but still meaningful” at ranges of 1%-8% for anxiety, 0%-5% for depression, 0.2%-3% for autism, 0%-3% for conduct disorder, and 0%-2% for oppositional-defiant disorder. Bipolar disorder was “uncommon” at less than 1%, Ms. Mayne and her associates reported.

The rate of children receiving any psychotropic medication was between 4% and 26%, while the proportion of patients receiving two or more medication classes ranged between 1% and 12%. Prescription rates for specific medication classes also varied at between 4% and 18% for stimulants, 1% and 12% for antidepressants, 0.1% and 8% for alpha-agonists, and 0.1% and 5% for second-generation antipsychotics.

“Primary care providers’ level of agreement with current guidelines, perceived self-efficacy in diagnosing or treating particular conditions, training, relationships with schools, and reimbursement from insurers might affect prescribing practices,” Ms. Mayne and her associates wrote.

“Even with colocation, barriers such as financial differences in reimbursement for medical and mental health services, difficulties with information sharing, differing expertise, and limited hours may impede integration,” they commented.

Dr. Alexander G. Fiks is an investigator for Pfizer; the other researchers said they had no relevant financial disclosures. This study was funded by the National Institutes of Health and the National Institute of Child Health and Human Development under the Best Pharmaceuticals for Children Act.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

A lack of psychiatrists only partially accounted for substantial variations in rates of mental illness diagnosis and prescriptions for psychotropic medications in practices nationwide, a study has shown.

Although a lack of available specialty care was associated with significantly higher odds of a diagnosis or prescription, the colocation of mental health professionals or percentage of children in foster care treated in a practice did not fully explain the differences.

Among 294,748 children aged 4-18 years, seen one or more times in 43 primary care practices nationwide, 15% received a mental health diagnosis between Jan. 1, 2009, and June 30, 2014. Psychotropic medications were prescribed to 14%, reported lead researcher Stephanie L. Mayne of the center for pediatric clinical effectiveness at the the Children’s Hospital of Philadelphia (Pediatrics. 2016 doi: 10.1542/peds.2015-2974).

The most common diagnosis was attention-deficit/hyperactivity disorder at a rate of between 1% and 16%. Differences in other diagnoses “were smaller, but still meaningful” at ranges of 1%-8% for anxiety, 0%-5% for depression, 0.2%-3% for autism, 0%-3% for conduct disorder, and 0%-2% for oppositional-defiant disorder. Bipolar disorder was “uncommon” at less than 1%, Ms. Mayne and her associates reported.

The rate of children receiving any psychotropic medication was between 4% and 26%, while the proportion of patients receiving two or more medication classes ranged between 1% and 12%. Prescription rates for specific medication classes also varied at between 4% and 18% for stimulants, 1% and 12% for antidepressants, 0.1% and 8% for alpha-agonists, and 0.1% and 5% for second-generation antipsychotics.

“Primary care providers’ level of agreement with current guidelines, perceived self-efficacy in diagnosing or treating particular conditions, training, relationships with schools, and reimbursement from insurers might affect prescribing practices,” Ms. Mayne and her associates wrote.

“Even with colocation, barriers such as financial differences in reimbursement for medical and mental health services, difficulties with information sharing, differing expertise, and limited hours may impede integration,” they commented.

Dr. Alexander G. Fiks is an investigator for Pfizer; the other researchers said they had no relevant financial disclosures. This study was funded by the National Institutes of Health and the National Institute of Child Health and Human Development under the Best Pharmaceuticals for Children Act.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight