New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

Gallbladder surgery uncovers something more

ABDOMINAL PAIN prompted a 46-year-old woman to seek treatment at a local medical center, where she had minor therapy. She returned to the hospital repeatedly over the next 3 years and received various treatments for abdominal pain, culminating in the removal of her gallbladder.

During the procedure, the surgeon found an ovarian tumor that turned out to be stage III cancer. The patient underwent oophorectomy and several courses of chemotherapy.

PLAINTIFF’S CLAIM The cancer should have been diagnosed at any of the patient’s previous examinations.

THE DEFENSE The patient’s symptoms were vague; ovarian cancer is often diagnosed at a late stage.

VERDICT $160,000 New York settlement.

COMMENT It never ceases to amaze that we’re held to such high (irrational?) standards whenever cancer is diagnosed. Although pertinent details of this case—such as the size of the tumor and frequency of pelvic exams—aren’t provided, it goes to show you that lawyers will do what lawyers do.

Diagnosis minus treatment equals catastrophe

A SWOLLEN, PAINFUL LEFT KNEE led a 65-year-old man to go to the emergency department (ED). The physician who examined his knee prescribed acetaminophen and hydrocodone and naproxen and sent the patient home with instructions to apply ice and heat.

The patient went back to the ED 2 days later because the knee was still swollen and painful. He was told to keep taking the prescribed medications and to follow up with a doctor at a local practice, who examined the patient later that day. The doctor aspirated brown, pus-filled material from the knee and diagnosed sepsis in the knee joint. He told the patient to drive to his family physician’s office, about 70 miles away, for treatment. The patient was carried back to his car and made the drive slowly.

By the time he arrived at his doctor’s office, the patient was in shock and kidney failure and breathing with difficulty. He was put on a ventilator and given antibiotics. He died several days later from septic shock and multiple organ failure.

PLAINTIFF’S CLAIM If the patient had been given antibiotics during his first or second examination, he would have lived.

THE DEFENSE No information about the defense is available.

VERDICT $10.9 million South Carolina verdict.

COMMENT It’s horrible enough that this patient wasn’t diagnosed promptly, but unfathomable that he was sent on his way without treatment!

Circumcision proceeds without consent

AFTER THE BIRTH OF A HEALTHY BABY BOY, a nurse presented the baby’s mother with a consent form for circumcision, which she didn’t sign. Before the birth, the parents had told the child’s pediatrician—who had also been the pediatrician for the mother’s 2 brothers and her oldest son—that they didn’t want their baby circumcised if it was a boy. Despite a lack of consent, the pediatrician circumcised the infant, without incident, the day after his birth. The parents were outraged.

PLAINTIFF’S CLAIM Because the pediatrician had cared for other male members of the family, he should have been aware of the family’s wishes regarding circumcision. The Gomco clamp method used to circumcise the baby caused pain throughout the 25-minute procedure, and the child suffered pain for 2 weeks while his penis healed. The baby, who had been calm before the surgery, became fussy afterwards and remained so for a year. He has a greater risk of developing some health problems because of the circumcision.

THE DEFENSE The circumcision was performed because the hospital staff erred in not following the hospital’s protocol. The procedure was done properly and without complications; the baby suffered no injuries from it. Remaining uncircumcised has no benefit; because circumcision lowers the risk of urinary tract and foreskin infections, as well as other illnesses, the child would be healthier than uncircumcised boys.

VERDICT Indiana defense verdict for the pediatrician. (The hospital reached a confidential settlement with the parents before trial.)

COMMENT It still astounds when wrong side surgeries occur—and how about this example of a circumcision without consent?! This is why checklists are so important. Obviously, appropriate informed consent should precede any procedure.

A drug adverse effect—that wasn’t

A 68-YEAR-OLD WOMAN went to her physician complaining of gastrointestinal discomfort. The doctor surmised that medication prescribed for hypertension was causing the discomfort and changed the medication. He recommended a follow-up visit in 2 weeks.

Three days later, the patient returned to the clinic complaining of abdominal pain. A physician assistant made the same diagnosis as the physician.

The patient went to the hospital 4 days later because the pain had increased. She was found to have a ruptured appendix and underwent an appendectomy. After surgery, the patient experienced residual pain.

PLAINTIFF’S CLAIM The physician and physician assistant were negligent in failing to diagnose appendicitis promptly. The case proceeded to trial against the physician assistant and the clinic.

THE DEFENSE The patient was properly evaluated and didn’t have symptoms suggesting appendicitis. Diagnostic tests weren’t necessary because the second visit was a follow-up examination.

VERDICT $150,000 New York verdict.

COMMENT Thoroughly documenting the history and physical examination is key to avoiding malpractice claims.

Antibiotics prescribed by phone can’t substitute for office visit

THREE DAYS OF FATIGUE AND A 103°F FEVER in a 42-year-old man prompted his wife to call his primary care physician. She discussed the symptoms with a nurse, who told her the doctor didn’t have an opening to see her husband. Instead, the physician called in a prescription for antibiotics because the symptoms resembled ones the patient had had about 8 months earlier that cleared up with antibiotics.

The patient felt well enough to pick up the antibiotics and the couple’s 2 children from preschool. When he got home, he took the antibiotics and went to bed. His wife found him dead that evening. The cause was determined to be cardiac arrest from myocarditis.

PLAINTIFF’S CLAIM Based on the reported symptoms, the doctor should have seen the patient immediately and referred him to an emergency department, where myocarditis would have been diagnosed and lifesaving treatment could have been started.

THE DEFENSE The patient’s wife didn’t properly describe all the symptoms to the nurse when she called. If she had, the doctor’s office would have scheduled an immediate appointment. In any case, myocarditis is difficult to diagnose; a pathologist’s findings indicated that the patient had focal myocarditis only in the right ventricle, which would have caused no symptoms detectable by a physical examination or electrocardiogram.

VERDICT $220,255 New Jersey judgment. The jury returned a $1 million verdict on a finding that the doctor was 20% responsible for the damages and the patient’s pre-existing condition was 80% responsible.

COMMENT I’m increasingly alarmed by the trend to find clinicians partially responsible for damages. A 20% share of liability added up to more than $200,000 in this case.

Gallbladder surgery uncovers something more

ABDOMINAL PAIN prompted a 46-year-old woman to seek treatment at a local medical center, where she had minor therapy. She returned to the hospital repeatedly over the next 3 years and received various treatments for abdominal pain, culminating in the removal of her gallbladder.

During the procedure, the surgeon found an ovarian tumor that turned out to be stage III cancer. The patient underwent oophorectomy and several courses of chemotherapy.

PLAINTIFF’S CLAIM The cancer should have been diagnosed at any of the patient’s previous examinations.

THE DEFENSE The patient’s symptoms were vague; ovarian cancer is often diagnosed at a late stage.

VERDICT $160,000 New York settlement.

COMMENT It never ceases to amaze that we’re held to such high (irrational?) standards whenever cancer is diagnosed. Although pertinent details of this case—such as the size of the tumor and frequency of pelvic exams—aren’t provided, it goes to show you that lawyers will do what lawyers do.

Diagnosis minus treatment equals catastrophe

A SWOLLEN, PAINFUL LEFT KNEE led a 65-year-old man to go to the emergency department (ED). The physician who examined his knee prescribed acetaminophen and hydrocodone and naproxen and sent the patient home with instructions to apply ice and heat.

The patient went back to the ED 2 days later because the knee was still swollen and painful. He was told to keep taking the prescribed medications and to follow up with a doctor at a local practice, who examined the patient later that day. The doctor aspirated brown, pus-filled material from the knee and diagnosed sepsis in the knee joint. He told the patient to drive to his family physician’s office, about 70 miles away, for treatment. The patient was carried back to his car and made the drive slowly.

By the time he arrived at his doctor’s office, the patient was in shock and kidney failure and breathing with difficulty. He was put on a ventilator and given antibiotics. He died several days later from septic shock and multiple organ failure.

PLAINTIFF’S CLAIM If the patient had been given antibiotics during his first or second examination, he would have lived.

THE DEFENSE No information about the defense is available.

VERDICT $10.9 million South Carolina verdict.

COMMENT It’s horrible enough that this patient wasn’t diagnosed promptly, but unfathomable that he was sent on his way without treatment!

Circumcision proceeds without consent

AFTER THE BIRTH OF A HEALTHY BABY BOY, a nurse presented the baby’s mother with a consent form for circumcision, which she didn’t sign. Before the birth, the parents had told the child’s pediatrician—who had also been the pediatrician for the mother’s 2 brothers and her oldest son—that they didn’t want their baby circumcised if it was a boy. Despite a lack of consent, the pediatrician circumcised the infant, without incident, the day after his birth. The parents were outraged.

PLAINTIFF’S CLAIM Because the pediatrician had cared for other male members of the family, he should have been aware of the family’s wishes regarding circumcision. The Gomco clamp method used to circumcise the baby caused pain throughout the 25-minute procedure, and the child suffered pain for 2 weeks while his penis healed. The baby, who had been calm before the surgery, became fussy afterwards and remained so for a year. He has a greater risk of developing some health problems because of the circumcision.

THE DEFENSE The circumcision was performed because the hospital staff erred in not following the hospital’s protocol. The procedure was done properly and without complications; the baby suffered no injuries from it. Remaining uncircumcised has no benefit; because circumcision lowers the risk of urinary tract and foreskin infections, as well as other illnesses, the child would be healthier than uncircumcised boys.

VERDICT Indiana defense verdict for the pediatrician. (The hospital reached a confidential settlement with the parents before trial.)

COMMENT It still astounds when wrong side surgeries occur—and how about this example of a circumcision without consent?! This is why checklists are so important. Obviously, appropriate informed consent should precede any procedure.

A drug adverse effect—that wasn’t

A 68-YEAR-OLD WOMAN went to her physician complaining of gastrointestinal discomfort. The doctor surmised that medication prescribed for hypertension was causing the discomfort and changed the medication. He recommended a follow-up visit in 2 weeks.

Three days later, the patient returned to the clinic complaining of abdominal pain. A physician assistant made the same diagnosis as the physician.

The patient went to the hospital 4 days later because the pain had increased. She was found to have a ruptured appendix and underwent an appendectomy. After surgery, the patient experienced residual pain.

PLAINTIFF’S CLAIM The physician and physician assistant were negligent in failing to diagnose appendicitis promptly. The case proceeded to trial against the physician assistant and the clinic.

THE DEFENSE The patient was properly evaluated and didn’t have symptoms suggesting appendicitis. Diagnostic tests weren’t necessary because the second visit was a follow-up examination.

VERDICT $150,000 New York verdict.

COMMENT Thoroughly documenting the history and physical examination is key to avoiding malpractice claims.

Antibiotics prescribed by phone can’t substitute for office visit

THREE DAYS OF FATIGUE AND A 103°F FEVER in a 42-year-old man prompted his wife to call his primary care physician. She discussed the symptoms with a nurse, who told her the doctor didn’t have an opening to see her husband. Instead, the physician called in a prescription for antibiotics because the symptoms resembled ones the patient had had about 8 months earlier that cleared up with antibiotics.

The patient felt well enough to pick up the antibiotics and the couple’s 2 children from preschool. When he got home, he took the antibiotics and went to bed. His wife found him dead that evening. The cause was determined to be cardiac arrest from myocarditis.

PLAINTIFF’S CLAIM Based on the reported symptoms, the doctor should have seen the patient immediately and referred him to an emergency department, where myocarditis would have been diagnosed and lifesaving treatment could have been started.

THE DEFENSE The patient’s wife didn’t properly describe all the symptoms to the nurse when she called. If she had, the doctor’s office would have scheduled an immediate appointment. In any case, myocarditis is difficult to diagnose; a pathologist’s findings indicated that the patient had focal myocarditis only in the right ventricle, which would have caused no symptoms detectable by a physical examination or electrocardiogram.

VERDICT $220,255 New Jersey judgment. The jury returned a $1 million verdict on a finding that the doctor was 20% responsible for the damages and the patient’s pre-existing condition was 80% responsible.

COMMENT I’m increasingly alarmed by the trend to find clinicians partially responsible for damages. A 20% share of liability added up to more than $200,000 in this case.

Gallbladder surgery uncovers something more

ABDOMINAL PAIN prompted a 46-year-old woman to seek treatment at a local medical center, where she had minor therapy. She returned to the hospital repeatedly over the next 3 years and received various treatments for abdominal pain, culminating in the removal of her gallbladder.

During the procedure, the surgeon found an ovarian tumor that turned out to be stage III cancer. The patient underwent oophorectomy and several courses of chemotherapy.

PLAINTIFF’S CLAIM The cancer should have been diagnosed at any of the patient’s previous examinations.

THE DEFENSE The patient’s symptoms were vague; ovarian cancer is often diagnosed at a late stage.

VERDICT $160,000 New York settlement.

COMMENT It never ceases to amaze that we’re held to such high (irrational?) standards whenever cancer is diagnosed. Although pertinent details of this case—such as the size of the tumor and frequency of pelvic exams—aren’t provided, it goes to show you that lawyers will do what lawyers do.

Diagnosis minus treatment equals catastrophe

A SWOLLEN, PAINFUL LEFT KNEE led a 65-year-old man to go to the emergency department (ED). The physician who examined his knee prescribed acetaminophen and hydrocodone and naproxen and sent the patient home with instructions to apply ice and heat.

The patient went back to the ED 2 days later because the knee was still swollen and painful. He was told to keep taking the prescribed medications and to follow up with a doctor at a local practice, who examined the patient later that day. The doctor aspirated brown, pus-filled material from the knee and diagnosed sepsis in the knee joint. He told the patient to drive to his family physician’s office, about 70 miles away, for treatment. The patient was carried back to his car and made the drive slowly.

By the time he arrived at his doctor’s office, the patient was in shock and kidney failure and breathing with difficulty. He was put on a ventilator and given antibiotics. He died several days later from septic shock and multiple organ failure.

PLAINTIFF’S CLAIM If the patient had been given antibiotics during his first or second examination, he would have lived.

THE DEFENSE No information about the defense is available.

VERDICT $10.9 million South Carolina verdict.

COMMENT It’s horrible enough that this patient wasn’t diagnosed promptly, but unfathomable that he was sent on his way without treatment!

Circumcision proceeds without consent

AFTER THE BIRTH OF A HEALTHY BABY BOY, a nurse presented the baby’s mother with a consent form for circumcision, which she didn’t sign. Before the birth, the parents had told the child’s pediatrician—who had also been the pediatrician for the mother’s 2 brothers and her oldest son—that they didn’t want their baby circumcised if it was a boy. Despite a lack of consent, the pediatrician circumcised the infant, without incident, the day after his birth. The parents were outraged.

PLAINTIFF’S CLAIM Because the pediatrician had cared for other male members of the family, he should have been aware of the family’s wishes regarding circumcision. The Gomco clamp method used to circumcise the baby caused pain throughout the 25-minute procedure, and the child suffered pain for 2 weeks while his penis healed. The baby, who had been calm before the surgery, became fussy afterwards and remained so for a year. He has a greater risk of developing some health problems because of the circumcision.

THE DEFENSE The circumcision was performed because the hospital staff erred in not following the hospital’s protocol. The procedure was done properly and without complications; the baby suffered no injuries from it. Remaining uncircumcised has no benefit; because circumcision lowers the risk of urinary tract and foreskin infections, as well as other illnesses, the child would be healthier than uncircumcised boys.

VERDICT Indiana defense verdict for the pediatrician. (The hospital reached a confidential settlement with the parents before trial.)

COMMENT It still astounds when wrong side surgeries occur—and how about this example of a circumcision without consent?! This is why checklists are so important. Obviously, appropriate informed consent should precede any procedure.

A drug adverse effect—that wasn’t

A 68-YEAR-OLD WOMAN went to her physician complaining of gastrointestinal discomfort. The doctor surmised that medication prescribed for hypertension was causing the discomfort and changed the medication. He recommended a follow-up visit in 2 weeks.

Three days later, the patient returned to the clinic complaining of abdominal pain. A physician assistant made the same diagnosis as the physician.

The patient went to the hospital 4 days later because the pain had increased. She was found to have a ruptured appendix and underwent an appendectomy. After surgery, the patient experienced residual pain.

PLAINTIFF’S CLAIM The physician and physician assistant were negligent in failing to diagnose appendicitis promptly. The case proceeded to trial against the physician assistant and the clinic.

THE DEFENSE The patient was properly evaluated and didn’t have symptoms suggesting appendicitis. Diagnostic tests weren’t necessary because the second visit was a follow-up examination.

VERDICT $150,000 New York verdict.

COMMENT Thoroughly documenting the history and physical examination is key to avoiding malpractice claims.

Antibiotics prescribed by phone can’t substitute for office visit

THREE DAYS OF FATIGUE AND A 103°F FEVER in a 42-year-old man prompted his wife to call his primary care physician. She discussed the symptoms with a nurse, who told her the doctor didn’t have an opening to see her husband. Instead, the physician called in a prescription for antibiotics because the symptoms resembled ones the patient had had about 8 months earlier that cleared up with antibiotics.

The patient felt well enough to pick up the antibiotics and the couple’s 2 children from preschool. When he got home, he took the antibiotics and went to bed. His wife found him dead that evening. The cause was determined to be cardiac arrest from myocarditis.

PLAINTIFF’S CLAIM Based on the reported symptoms, the doctor should have seen the patient immediately and referred him to an emergency department, where myocarditis would have been diagnosed and lifesaving treatment could have been started.

THE DEFENSE The patient’s wife didn’t properly describe all the symptoms to the nurse when she called. If she had, the doctor’s office would have scheduled an immediate appointment. In any case, myocarditis is difficult to diagnose; a pathologist’s findings indicated that the patient had focal myocarditis only in the right ventricle, which would have caused no symptoms detectable by a physical examination or electrocardiogram.

VERDICT $220,255 New Jersey judgment. The jury returned a $1 million verdict on a finding that the doctor was 20% responsible for the damages and the patient’s pre-existing condition was 80% responsible.

COMMENT I’m increasingly alarmed by the trend to find clinicians partially responsible for damages. A 20% share of liability added up to more than $200,000 in this case.

ILLUSTRATIVE CASE

A 66-year-old man comes to your office complaining of urinary frequency and straining to begin urination. He was recently diagnosed with BPh by a urologist, but is hesitant to begin taking a prescription drug. The patient, who is on a fixed income, asks you if saw palmetto extract might relieve his urinary symptoms. What should you tell him?

Roughly 40% of American men older than 60 years and nearly 90% of men older than 80 suffer from BPH and the troublesome lower urinary tract symptoms (LUTS) that it causes.³ Established medical and surgical options, as well as over-the-counter (OTC) plant-based products, are used for symptom relief. The OTC remedy most commonly used for BPH is Serenoa repens, derived from the saw palmetto dwarf palm tree. In a 2007 survey, 1.6 million US adults reported using saw palmetto extract, often as a treatment for BPH, in the 30 days prior to the survey.⁴

Until now, more questions than answers
As a family physician, you undoubtedly have many patients who are taking or considering taking saw palmetto for relief of BPH symptoms. The significant adverse effects of alpha-blockers and 5-alpha-reductase inhibitors, which are typically prescribed for LUTS—including decreased libido and dizziness—may help account for their interest in this alternative treatment.^5,6

Until recently, evidence of saw palmetto’s efficacy has been limited and conflicting, despite widespread use of the extract. That has left many of us wondering whether we should recommend that men with BPH try saw palmetto despite the limited evidence; whether it is effective for some, but not all, BPH symptoms; and whether an increase in dose would increase its efficacy.

A 2002 Cochrane meta-analysis of 21 trials of saw palmetto extract for LUTS reported reduced nocturia, improved self-reported symptoms, and increased peak uroflow compared with placebo, without significant adverse effects.⁷ An updated Cochrane review published in 2009 included several more rigorous trials—and had very different results: This meta-analysis, which was based on 30 trials, found a reduction in nocturia, but failed to show improvement in other self-reported symptoms or peak uroflow.²

The largest trial included in the 2009 review was the Saw Palmetto Treatment for Enlarged Prostates (STEP) study,⁸ a one-year study with 225 participants. Its findings: no improvement in the treatment group compared with the placebo group in symptom scores or any secondary endpoints, and no important toxicity.⁸ Of note, the STEP study and most trials included in the 2009 Cochrane review used the standard saw palmetto extract dose of 160 mg twice daily.^1,2

STUDY SUMMARY: Saw palmetto is ineffective, even at triple the dose

Barry et al conducted a 72-week double-blind, multicenter placebo-controlled trial to assess the effect of double (640 mg/d) and triple (960 mg/d) the standard dose of saw palmetto extract on BPH symptoms.¹ The study included 369 men with moderate LUTS who had not recently received treatment for BPH. Exclusion criteria included a history of invasive BPH treatment, recent treatment with either an alpha-blocker or a 5-alpha-reductase inhibitor; recent phytotherapy, including saw palmetto; and a history of prostate or bladder cancer. Participants were randomized to receive either saw palmetto extract or an identical-looking placebo gel cap. Doses started at 320 mg/d and were increased to 640 mg/d at 24 weeks and 960 mg/d at 48 weeks.

The primary outcome was the change in the American Urological Association Symptom Index (AUASI) score from baseline to 72 weeks. AUASI, a scale of 0 to 35 in which higher numbers represent increased symptoms, is the same scoring tool used in both the Cochrane review and the STEP trial. Secondary measures included other symptom scales, peak uroflow, and poststudy satisfaction. The treatment and placebo groups had statistically identical baseline characteristics, and the sample size was large enough to detect clinically significant differences.

The AUASI score decreased by a mean of 2.20 points (95% confidence interval [CI], -3.04 to -0.36) in the group that received saw palmetto and by 2.99 points (95% CI, -3.81 to -2.17) in the placebo group—a mean difference of 0.79 in favor of the placebo group (P=.91). The proportion of participants achieving a 3-point reduction in AUASI score was statistically similar between the 2 groups (P=0.66). There was no significant dose response difference between the 2 groups, and saw palmetto proved to be no better than placebo for any of the secondary outcomes.

Subgroup analysis did not reveal any results that differed from the main outcomes. The only adverse events that were significantly different between the 2 groups related to physical injury or trauma, which were unlikely to be due to the intervention.¹

By using the same symptom scoring system (AUASI) as many studies in the previous Cochrane reviews, Barry et al were able to compare their findings with those of other high-quality studies with similar methodologies and outcome measures. Despite using an even higher dose of the extract, the results of this trial are remarkably consistent with previous conclusions: Saw palmetto is not an effective treatment for symptoms associated with BPH. Moreover, this trial had a broad base of participants similar to the population in a primary care practice, including patients who would typically choose a natural remedy for LUTS.¹

WHAT’S NEW: We now have answers to queries about saw palmetto

This trial is the first to compare higher doses of saw palmetto with placebo to assess a dosage threshold for effectiveness. While the study found no evidence of saw palmetto toxicity even at these higher doses, the extract did not outperform placebo for any measured outcome.¹

This high-quality study confirmed the recent series of rigorous studies with negative outcomes by showing that the use of a standard dosage was not a study limitation and that saw palmetto extract is not effective for treating LUTS at any dosage. This trial should substantially affect future guideline recommendations that were limited by methodological concerns in the past.^9-11

CAVEATS: In theory, individual preparations could work differently

It is not possible to be absolutely certain that these findings apply to all saw palmetto extract preparations, given the unknown active ingredients and unknown mechanism of action. However, the researchers used a high-quality preparation (a proprietary lipidic ethanolic extract) of saw palmetto at higher doses than the STEP trial and came to a similar conclusion, making it highly unlikely that another preparation would perform differently.

CHALLENGES TO IMPLEMENTATION: There are none

We see no challenges to implementation of this recommendation.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 66-year-old man comes to your office complaining of urinary frequency and straining to begin urination. He was recently diagnosed with BPh by a urologist, but is hesitant to begin taking a prescription drug. The patient, who is on a fixed income, asks you if saw palmetto extract might relieve his urinary symptoms. What should you tell him?

Roughly 40% of American men older than 60 years and nearly 90% of men older than 80 suffer from BPH and the troublesome lower urinary tract symptoms (LUTS) that it causes.³ Established medical and surgical options, as well as over-the-counter (OTC) plant-based products, are used for symptom relief. The OTC remedy most commonly used for BPH is Serenoa repens, derived from the saw palmetto dwarf palm tree. In a 2007 survey, 1.6 million US adults reported using saw palmetto extract, often as a treatment for BPH, in the 30 days prior to the survey.⁴

Until now, more questions than answers
As a family physician, you undoubtedly have many patients who are taking or considering taking saw palmetto for relief of BPH symptoms. The significant adverse effects of alpha-blockers and 5-alpha-reductase inhibitors, which are typically prescribed for LUTS—including decreased libido and dizziness—may help account for their interest in this alternative treatment.^5,6

Until recently, evidence of saw palmetto’s efficacy has been limited and conflicting, despite widespread use of the extract. That has left many of us wondering whether we should recommend that men with BPH try saw palmetto despite the limited evidence; whether it is effective for some, but not all, BPH symptoms; and whether an increase in dose would increase its efficacy.

A 2002 Cochrane meta-analysis of 21 trials of saw palmetto extract for LUTS reported reduced nocturia, improved self-reported symptoms, and increased peak uroflow compared with placebo, without significant adverse effects.⁷ An updated Cochrane review published in 2009 included several more rigorous trials—and had very different results: This meta-analysis, which was based on 30 trials, found a reduction in nocturia, but failed to show improvement in other self-reported symptoms or peak uroflow.²

The largest trial included in the 2009 review was the Saw Palmetto Treatment for Enlarged Prostates (STEP) study,⁸ a one-year study with 225 participants. Its findings: no improvement in the treatment group compared with the placebo group in symptom scores or any secondary endpoints, and no important toxicity.⁸ Of note, the STEP study and most trials included in the 2009 Cochrane review used the standard saw palmetto extract dose of 160 mg twice daily.^1,2

STUDY SUMMARY: Saw palmetto is ineffective, even at triple the dose

Barry et al conducted a 72-week double-blind, multicenter placebo-controlled trial to assess the effect of double (640 mg/d) and triple (960 mg/d) the standard dose of saw palmetto extract on BPH symptoms.¹ The study included 369 men with moderate LUTS who had not recently received treatment for BPH. Exclusion criteria included a history of invasive BPH treatment, recent treatment with either an alpha-blocker or a 5-alpha-reductase inhibitor; recent phytotherapy, including saw palmetto; and a history of prostate or bladder cancer. Participants were randomized to receive either saw palmetto extract or an identical-looking placebo gel cap. Doses started at 320 mg/d and were increased to 640 mg/d at 24 weeks and 960 mg/d at 48 weeks.

The primary outcome was the change in the American Urological Association Symptom Index (AUASI) score from baseline to 72 weeks. AUASI, a scale of 0 to 35 in which higher numbers represent increased symptoms, is the same scoring tool used in both the Cochrane review and the STEP trial. Secondary measures included other symptom scales, peak uroflow, and poststudy satisfaction. The treatment and placebo groups had statistically identical baseline characteristics, and the sample size was large enough to detect clinically significant differences.

The AUASI score decreased by a mean of 2.20 points (95% confidence interval [CI], -3.04 to -0.36) in the group that received saw palmetto and by 2.99 points (95% CI, -3.81 to -2.17) in the placebo group—a mean difference of 0.79 in favor of the placebo group (P=.91). The proportion of participants achieving a 3-point reduction in AUASI score was statistically similar between the 2 groups (P=0.66). There was no significant dose response difference between the 2 groups, and saw palmetto proved to be no better than placebo for any of the secondary outcomes.

Subgroup analysis did not reveal any results that differed from the main outcomes. The only adverse events that were significantly different between the 2 groups related to physical injury or trauma, which were unlikely to be due to the intervention.¹

By using the same symptom scoring system (AUASI) as many studies in the previous Cochrane reviews, Barry et al were able to compare their findings with those of other high-quality studies with similar methodologies and outcome measures. Despite using an even higher dose of the extract, the results of this trial are remarkably consistent with previous conclusions: Saw palmetto is not an effective treatment for symptoms associated with BPH. Moreover, this trial had a broad base of participants similar to the population in a primary care practice, including patients who would typically choose a natural remedy for LUTS.¹

WHAT’S NEW: We now have answers to queries about saw palmetto

This trial is the first to compare higher doses of saw palmetto with placebo to assess a dosage threshold for effectiveness. While the study found no evidence of saw palmetto toxicity even at these higher doses, the extract did not outperform placebo for any measured outcome.¹

This high-quality study confirmed the recent series of rigorous studies with negative outcomes by showing that the use of a standard dosage was not a study limitation and that saw palmetto extract is not effective for treating LUTS at any dosage. This trial should substantially affect future guideline recommendations that were limited by methodological concerns in the past.^9-11

CAVEATS: In theory, individual preparations could work differently

It is not possible to be absolutely certain that these findings apply to all saw palmetto extract preparations, given the unknown active ingredients and unknown mechanism of action. However, the researchers used a high-quality preparation (a proprietary lipidic ethanolic extract) of saw palmetto at higher doses than the STEP trial and came to a similar conclusion, making it highly unlikely that another preparation would perform differently.

CHALLENGES TO IMPLEMENTATION: There are none

We see no challenges to implementation of this recommendation.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 66-year-old man comes to your office complaining of urinary frequency and straining to begin urination. He was recently diagnosed with BPh by a urologist, but is hesitant to begin taking a prescription drug. The patient, who is on a fixed income, asks you if saw palmetto extract might relieve his urinary symptoms. What should you tell him?

Roughly 40% of American men older than 60 years and nearly 90% of men older than 80 suffer from BPH and the troublesome lower urinary tract symptoms (LUTS) that it causes.³ Established medical and surgical options, as well as over-the-counter (OTC) plant-based products, are used for symptom relief. The OTC remedy most commonly used for BPH is Serenoa repens, derived from the saw palmetto dwarf palm tree. In a 2007 survey, 1.6 million US adults reported using saw palmetto extract, often as a treatment for BPH, in the 30 days prior to the survey.⁴

Until now, more questions than answers
As a family physician, you undoubtedly have many patients who are taking or considering taking saw palmetto for relief of BPH symptoms. The significant adverse effects of alpha-blockers and 5-alpha-reductase inhibitors, which are typically prescribed for LUTS—including decreased libido and dizziness—may help account for their interest in this alternative treatment.^5,6

Until recently, evidence of saw palmetto’s efficacy has been limited and conflicting, despite widespread use of the extract. That has left many of us wondering whether we should recommend that men with BPH try saw palmetto despite the limited evidence; whether it is effective for some, but not all, BPH symptoms; and whether an increase in dose would increase its efficacy.

A 2002 Cochrane meta-analysis of 21 trials of saw palmetto extract for LUTS reported reduced nocturia, improved self-reported symptoms, and increased peak uroflow compared with placebo, without significant adverse effects.⁷ An updated Cochrane review published in 2009 included several more rigorous trials—and had very different results: This meta-analysis, which was based on 30 trials, found a reduction in nocturia, but failed to show improvement in other self-reported symptoms or peak uroflow.²

The largest trial included in the 2009 review was the Saw Palmetto Treatment for Enlarged Prostates (STEP) study,⁸ a one-year study with 225 participants. Its findings: no improvement in the treatment group compared with the placebo group in symptom scores or any secondary endpoints, and no important toxicity.⁸ Of note, the STEP study and most trials included in the 2009 Cochrane review used the standard saw palmetto extract dose of 160 mg twice daily.^1,2

STUDY SUMMARY: Saw palmetto is ineffective, even at triple the dose

Barry et al conducted a 72-week double-blind, multicenter placebo-controlled trial to assess the effect of double (640 mg/d) and triple (960 mg/d) the standard dose of saw palmetto extract on BPH symptoms.¹ The study included 369 men with moderate LUTS who had not recently received treatment for BPH. Exclusion criteria included a history of invasive BPH treatment, recent treatment with either an alpha-blocker or a 5-alpha-reductase inhibitor; recent phytotherapy, including saw palmetto; and a history of prostate or bladder cancer. Participants were randomized to receive either saw palmetto extract or an identical-looking placebo gel cap. Doses started at 320 mg/d and were increased to 640 mg/d at 24 weeks and 960 mg/d at 48 weeks.

The primary outcome was the change in the American Urological Association Symptom Index (AUASI) score from baseline to 72 weeks. AUASI, a scale of 0 to 35 in which higher numbers represent increased symptoms, is the same scoring tool used in both the Cochrane review and the STEP trial. Secondary measures included other symptom scales, peak uroflow, and poststudy satisfaction. The treatment and placebo groups had statistically identical baseline characteristics, and the sample size was large enough to detect clinically significant differences.

The AUASI score decreased by a mean of 2.20 points (95% confidence interval [CI], -3.04 to -0.36) in the group that received saw palmetto and by 2.99 points (95% CI, -3.81 to -2.17) in the placebo group—a mean difference of 0.79 in favor of the placebo group (P=.91). The proportion of participants achieving a 3-point reduction in AUASI score was statistically similar between the 2 groups (P=0.66). There was no significant dose response difference between the 2 groups, and saw palmetto proved to be no better than placebo for any of the secondary outcomes.

Subgroup analysis did not reveal any results that differed from the main outcomes. The only adverse events that were significantly different between the 2 groups related to physical injury or trauma, which were unlikely to be due to the intervention.¹

By using the same symptom scoring system (AUASI) as many studies in the previous Cochrane reviews, Barry et al were able to compare their findings with those of other high-quality studies with similar methodologies and outcome measures. Despite using an even higher dose of the extract, the results of this trial are remarkably consistent with previous conclusions: Saw palmetto is not an effective treatment for symptoms associated with BPH. Moreover, this trial had a broad base of participants similar to the population in a primary care practice, including patients who would typically choose a natural remedy for LUTS.¹

WHAT’S NEW: We now have answers to queries about saw palmetto

This trial is the first to compare higher doses of saw palmetto with placebo to assess a dosage threshold for effectiveness. While the study found no evidence of saw palmetto toxicity even at these higher doses, the extract did not outperform placebo for any measured outcome.¹

This high-quality study confirmed the recent series of rigorous studies with negative outcomes by showing that the use of a standard dosage was not a study limitation and that saw palmetto extract is not effective for treating LUTS at any dosage. This trial should substantially affect future guideline recommendations that were limited by methodological concerns in the past.^9-11

CAVEATS: In theory, individual preparations could work differently

It is not possible to be absolutely certain that these findings apply to all saw palmetto extract preparations, given the unknown active ingredients and unknown mechanism of action. However, the researchers used a high-quality preparation (a proprietary lipidic ethanolic extract) of saw palmetto at higher doses than the STEP trial and came to a similar conclusion, making it highly unlikely that another preparation would perform differently.

CHALLENGES TO IMPLEMENTATION: There are none

We see no challenges to implementation of this recommendation.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Evidence summary

The National Cancer Institute reports an annual anal cancer incidence of 1.6 per 100,000 and as of November of last year, expected that 5820 men and women would receive the diagnosis in 2011.¹ The 5-year survival rate is 64.9%. For men who have sex with men, the incidence ranges from 35 to 100 per 100,000, with a higher incidence in HIV-positive men.²

Men who have sex with men also have a higher prevalence of human papillomavirus (HPV) than the general population.^3,4 HPV is the most common cause of anal squamous intraepithelial lesions. In theory, screening for anal cancer may reduce morbidity and mortality by identifying and treating anal cancer precursors, much as screening has done for cervical cancer.

Small studies suggest that screening may be effective
One study has demonstrated that anal pap smears are potentially effective as a screening tool for detecting anal intraepithelial neoplasia.⁵ The study was limited by small sample size and failure to address patient-centered outcomes, however. It included only 395 subjects, most of whom (54%) were HIV positive. Additional studies evaluated 265 HIV-positive men and 658 men, of whom 407 were HIV positive, with similar findings.^6,7

But a larger study shows no impact
The largest study to date, which included 5083 HIV-positive patients (contributing 13,411 patient-years), didn’t demonstrate a decrease in invasive anal carcinoma during the screening period.⁸ The difference in HPV prevalence between HIV-positive and HIV-negative men who have sex with men (96% vs 58.9%; P<.001) limits the ability to generalize the conclusions of this study to all men who have sex with men.⁹

Recommendations

No consensus guidelines exist on screening for anal cancer in men who have sex with men, regardless of HIV status.

The New York State Department of Health recommends baseline cytology and annual anal cancer screening for all HIV-positive men who have sex with men.

Based on the high prevalence of HPV in the HIV-positive population, some experts suggest anal cancer screening for HIV-positive men who have sex with men.¹⁰

Evidence summary

The National Cancer Institute reports an annual anal cancer incidence of 1.6 per 100,000 and as of November of last year, expected that 5820 men and women would receive the diagnosis in 2011.¹ The 5-year survival rate is 64.9%. For men who have sex with men, the incidence ranges from 35 to 100 per 100,000, with a higher incidence in HIV-positive men.²

Men who have sex with men also have a higher prevalence of human papillomavirus (HPV) than the general population.^3,4 HPV is the most common cause of anal squamous intraepithelial lesions. In theory, screening for anal cancer may reduce morbidity and mortality by identifying and treating anal cancer precursors, much as screening has done for cervical cancer.

Small studies suggest that screening may be effective
One study has demonstrated that anal pap smears are potentially effective as a screening tool for detecting anal intraepithelial neoplasia.⁵ The study was limited by small sample size and failure to address patient-centered outcomes, however. It included only 395 subjects, most of whom (54%) were HIV positive. Additional studies evaluated 265 HIV-positive men and 658 men, of whom 407 were HIV positive, with similar findings.^6,7

But a larger study shows no impact
The largest study to date, which included 5083 HIV-positive patients (contributing 13,411 patient-years), didn’t demonstrate a decrease in invasive anal carcinoma during the screening period.⁸ The difference in HPV prevalence between HIV-positive and HIV-negative men who have sex with men (96% vs 58.9%; P<.001) limits the ability to generalize the conclusions of this study to all men who have sex with men.⁹

Recommendations

No consensus guidelines exist on screening for anal cancer in men who have sex with men, regardless of HIV status.

The New York State Department of Health recommends baseline cytology and annual anal cancer screening for all HIV-positive men who have sex with men.

Based on the high prevalence of HPV in the HIV-positive population, some experts suggest anal cancer screening for HIV-positive men who have sex with men.¹⁰

Evidence summary

The National Cancer Institute reports an annual anal cancer incidence of 1.6 per 100,000 and as of November of last year, expected that 5820 men and women would receive the diagnosis in 2011.¹ The 5-year survival rate is 64.9%. For men who have sex with men, the incidence ranges from 35 to 100 per 100,000, with a higher incidence in HIV-positive men.²

Men who have sex with men also have a higher prevalence of human papillomavirus (HPV) than the general population.^3,4 HPV is the most common cause of anal squamous intraepithelial lesions. In theory, screening for anal cancer may reduce morbidity and mortality by identifying and treating anal cancer precursors, much as screening has done for cervical cancer.

Small studies suggest that screening may be effective
One study has demonstrated that anal pap smears are potentially effective as a screening tool for detecting anal intraepithelial neoplasia.⁵ The study was limited by small sample size and failure to address patient-centered outcomes, however. It included only 395 subjects, most of whom (54%) were HIV positive. Additional studies evaluated 265 HIV-positive men and 658 men, of whom 407 were HIV positive, with similar findings.^6,7

But a larger study shows no impact
The largest study to date, which included 5083 HIV-positive patients (contributing 13,411 patient-years), didn’t demonstrate a decrease in invasive anal carcinoma during the screening period.⁸ The difference in HPV prevalence between HIV-positive and HIV-negative men who have sex with men (96% vs 58.9%; P<.001) limits the ability to generalize the conclusions of this study to all men who have sex with men.⁹

Recommendations

No consensus guidelines exist on screening for anal cancer in men who have sex with men, regardless of HIV status.

The New York State Department of Health recommends baseline cytology and annual anal cancer screening for all HIV-positive men who have sex with men.

Based on the high prevalence of HPV in the HIV-positive population, some experts suggest anal cancer screening for HIV-positive men who have sex with men.¹⁰

To maintain the cost-effectiveness of health insurance, many organizations, including government agencies, routinely evaluate and choose to adopt alternative treatment modalities. But how do such changes affect patient outcomes? And do near-term cost savings from formulary changes lead to long-term cost benefits?

Chronic disease management and associated complex medication regimens account for most health insurance expenditures.^1,2 Changes to prescription formularies are common,³ with medications being added or removed to reduce costs or to respond to revised practice guidelines.^4,5

Researchers have examined the clinical risks and merits of changing from one drug to another, as well as the impact of implementing formulary changes on administrative and other costs, overall effectiveness of disease management, and the operational adeptness of health systems.^6-10 Routine formulary changes may yield immediate cost savings, but net costs may increase downstream due to disruptions in patient care.^11,12 Insurance-driven medication changes have also been shown to negatively affect patient adherence to medical treatment and also disease outcomes.^13,14

Patient-level data related to formulary restrictions are limited,¹⁵ and analyses of patients’ experiences of medication changes are rare. A better understanding of patients’ experiences in this context could guide interventions to minimize treatment delays and improve outcomes. Our study assessed the effect of insurance-driven medication changes on primary care patients; specifically, the prevalence of difficulty in filling a prescription, resultant problems, and patient characteristics associated with reporting a problem.

Methods

Data collection

We mailed questionnaires to a random sample of 1200 adult patients (≥40 years) who had been seen within the previous 6 months at one of 3 family practices in northeastern Ohio. We asked respondents to quantify and describe any insurance-driven problems they encountered while attempting to fill or refill a prescription over the past year. We recorded each respondent’s insurance status, the name of the medication at issue and other medications they were taking, and demographic data. Comparative data for age and sex were collected for nonrespondents. The University Hospitals Case Medical Center Institutional Review Board approved all data collection procedures and methods for this cross-sectional study.

Data analysis

We tabulated and analyzed data from the surveys using Statistical Package for the Social Sciences (SPSS). We compared age and sex data (using t-test and chi-square test, respectively) between respondents and nonrespondents. We calculated descriptive statistics for all demographic, control, and outcome variables, and computed measures of association between demographic and health-related variables and insurance-driven problems encountered while filling a prescription. Using logistic regression analysis, we identified demographic and health-related variables independently associated with a problematic prescription.

We calculated the frequencies of problems encountered while trying to fill a prescription, and grouped the problems into 3 mutually exclusive categories: adverse medical outcomes, decreased patient satisfaction, and burden on physician practice. Adverse medical outcomes included missed doses of medication, inability to obtain medication, worsened medical condition, new medication adverse effects, and having to go to the emergency department (ED) because of a medication issue. We sorted medications into categories, and calculated the frequency of problems associated with each category.

We based our decision to mail 1200 surveys on a power calculation assuming a 40% response rate and approximately 25% of patients reporting a problem. A sample size of 480 or more provides 80% power to detect moderate differences in characteristics between those reporting a problem and those not reporting a problem.

Results

Four-hundred thirty-four patients returned the survey (36% response rate). We excluded 6 participants from analysis due to incomplete data for the primary outcome variable (problem with a prescription). Respondents and nonrespondents were similar in sex ratio, but respondents on average were 3 years older (P<.001). The average number of prescriptions taken was 3.4, and most patients (85%) had some form of private insurance ( TABLE 1 ). Most patients were female, in good health, and well educated.

Of the 428 study participants, 100 (23%) reported at least one problem obtaining a prescribed medication due to insurance. Generally, those who experienced a problem were younger, more likely to be female, and reported poorer health status than those reporting no problem ( TABLE 1 ). Additionally, those who encountered a problem were more than twice as likely to rely solely on Medicaid or Medicare, and were also taking more prescription medications. Problems filling a prescription were also reported more often in an urban setting than in suburban or semirural areas.

TABLE 1
Demographic variables for patients who did and didn’t report problems filling prescriptions

Using logistic regression, we analyzed a model that included all significant variables (age, total number of prescription drugs taken, sex, health status, insurance type, and practice location). The final logistic regression model showed statistical significance for only 3 variables: type of insurance, total number of prescription drugs taken, and age. (When we included type of insurance in the analysis, practice location was not associated with a problem filling a prescription.)

Specifically, the independent predictors of an insurance-related problem in filling a prescription were reliance solely on government-provided insurance, as opposed to private insurance or government insurance supplemented with private insurance (odds ratio [OR]=1.90; 95% confidence interval [CI], 1.02-3.61); taking more prescription medications (OR=1.19; 95% CI, 1.10-1.29); and being younger (OR=0.96; 95% CI, 0.94-0.99).

Respondents reporting at least one insurance-driven impediment to filling a prescription encountered an average of 2.9 different types of resultant problems ( TABLE 2 ). Insurance-related problems with medications were not limited to new prescriptions. Of the 100 patients reporting a problem with a medication, 21% had a problem with a new prescription, 42% with a medication they were already taking, and 37% with both a new and a previously prescribed medication.

TABLE 2
Resultant problems when patients had at least one insurance-related issue filling a prescription in the previous year

Forty-one percent of patients reporting a problem experienced adverse medical outcomes. The most serious adverse medical outcomes were reported least often, but occurred nonetheless: worsening of medical condition (8%), new medication adverse effects (6%), and requiring a visit to the ED (5%). More commonly reported was decreased satisfaction with the health care system (68%). Patients were less likely to report being upset with their physician than their insurance company or pharmacist. Problems that burdened the physician practice were reported most frequently (83%).

TABLE 3 shows the medication categories that were affected when respondents reported at least one problem. Formulary changes or restrictions involving cardiac/hypertension/lipid and neurologic/psychiatric medications were linked to the most problems.

TABLE 3
Which medication categories were most affected when patients had a problem filling a prescription?

Discussion

Nearly one quarter of patients in our sample (23%) experienced problems caused by insurance constraints while they attempted to follow the treatment regimens prescribed by their physicians. Although the most commonly reported insurance-related problems (waiting for pharmacist authorization, making extra phone calls to the physician’s office) could be perceived as minor inconveniences, serious consequences were also common. Our study showed that patients who rely solely on Medicaid or Medicare bore the greatest burden of insurance-related obstacles when filling prescriptions, although others were also affected.

Consistent with prior research in Medicare and Medicaid populations, our study found that medication access restrictions can negatively affect patient adherence.^13,16,17 Our study showed that 41% of patients who encountered a problem experienced a medically meaningful adverse outcome; 19% reported they received no medication for their condition. Similarly, a study of Medicare beneficiaries who had failed to fill or refill a prescription found that 20% cited lack of insurance coverage for the medication as a reason for not filling the prescription.¹⁷

In our study, 23% of patients reported missing doses of their medication due to insurance-related difficulties, and 8% reported a worsening of their medical condition. The increased costs associated with poor chronic care management are well documented.¹⁸ Less well described is the potential net savings produced when insurance formularies are adjusted to expand coverage and lower patient costs for prescription treatments for chronic conditions. In an analysis of cost data from the Pitney-Bowes Corporation, Mahoney¹² revealed a significant net savings in health care costs and lost productivity when treatments for chronic conditions were moved to the lowest tier of the formulary, thereby making them available to health plan participants at the lowest cost.

We could not link patient reports of treatment disruptions empirically to medical outcomes or increased costs, due to the constraints of our research question and study design. However, it is reasonable to suggest that longer-term insurance costs for these patients could, in fact, negate any short-term cost savings generated from formulary restrictions. In particular, the 5% of our patient sample who reported using the ED as a consequence of an insurance-related disruption of their prescribed treatment likely added significant unnecessary cost to their treatment. This effect has been seen in other studies.^19,20 In our study, cardiac/hypertension/lipid medications and medications for neurologic or psychiatric conditions were the most likely to be problematic. In these categories, competition of branded products may contribute to more frequent formulary changes. Furthermore, increases in morbidity and mortality associated with inadequate treatment of the conditions represented in these 2 categories of medications represent a significant burden to the US health system, including insurers, employers, and individuals.^21-23

Although patients were less likely to report being upset with their physician than their insurance company or pharmacist, physicians bore a considerable burden for resolving a number of prevalent patient issues. Most of these problems required extra phone calls to the practice, additional medication authorization, or extra office visits. Physicians and their support staff may serve as buffers between patients and the insurance formulary rules, but at significant cost in their time and effort.

Electronic prescribing systems with real-time pharmacy benefit verification may provide additional efficiencies and help physicians and patients avoid some of the problems cited by our respondents. Providers with such systems receive immediate notification of formulary status, including tier and co-pay levels, which can aid in shared decision-making at the point of prescribing. Physicians without access to e-prescribing may want to use newer formulary search engines that can check formulary status of medications across multiple insurance plans. However, these electronic tools often fail to account for variations in formularies within the same insurance plan for different employers based on their benefit structure. Still, when a medication is not on formulary or a co-payment is required, the physician may be forced to play the role of apologist for the constraints imposed by the insurance formulary.

In cases where formularies restrict the patient’s potential access to a preferred treatment plan, the burden of prior authorizations continues to be borne by physicians. Coverage limitations lead to financial and medical consequences that must be managed in partnership with the patient. A system should be put in place by insurance companies that facilitates out-of-formulary authorizations to prevent lapses in patient care or deleterious changes in medical management.

Study limitations

The findings reported here should be interpreted in light of some limitations of this study. The response rate to our mailed patient survey was modest (36%), although typical for this method. The sex mix of respondents was similar to that of nonrespondents, but nonrespondents were slightly younger. Given that younger age is associated with a greater likelihood of experiencing a problem filling a medication, our findings may underestimate the frequency of this dilemma. In addition, our survey asked patients to recall events that occurred over the past year, introducing a potential for recall bias.

While the overall sample size was relatively small (n=428), it is close to the number calculated for sufficient power to conduct the analyses (n=480). Furthermore, data were collected from 3 distinct patient populations: urban, suburban and semirural. Although the scope of our study included only one geographic region, variability in practice setting lends some tentative support to the generalizability of the findings.

Looking forward

As a standard method to control costs and update treatment guidelines, insurance-mediated medication changes will continue to present unique challenges for patients and health care providers. Formulary changes burden the downstream delivery of medical care with expensive administrative responsibilities and disrupt effective disease management and prevention. Until insurance companies and pharmacy benefit managers start paying heed to total costs of care when contemplating formulary changes, physicians should try to identify formulary conflicts as early as possible in the prescribing process so as to save time for all parties later and improve compliance.

As practices proceed toward adoption of electronic health records, e-prescribing, and the Centers for Medicare & Medicaid Services’ “meaningful use” criteria, physicians may use systems that provide real-time formulary information, which can flag issues before the patient leaves the exam room. Future research should explore the ways formulary changes might be implemented to provide the strongest continuity of patient care with the least amount of cost shifting.

CORRESPONDENCE
Susan A. Flocke, PhD, CWRU Department of Family Medicine & Community Health, 11000 Cedar Avenue, Suite 402, Cleveland, OH 44106; [email protected]

To maintain the cost-effectiveness of health insurance, many organizations, including government agencies, routinely evaluate and choose to adopt alternative treatment modalities. But how do such changes affect patient outcomes? And do near-term cost savings from formulary changes lead to long-term cost benefits?

Chronic disease management and associated complex medication regimens account for most health insurance expenditures.^1,2 Changes to prescription formularies are common,³ with medications being added or removed to reduce costs or to respond to revised practice guidelines.^4,5

Researchers have examined the clinical risks and merits of changing from one drug to another, as well as the impact of implementing formulary changes on administrative and other costs, overall effectiveness of disease management, and the operational adeptness of health systems.^6-10 Routine formulary changes may yield immediate cost savings, but net costs may increase downstream due to disruptions in patient care.^11,12 Insurance-driven medication changes have also been shown to negatively affect patient adherence to medical treatment and also disease outcomes.^13,14

Patient-level data related to formulary restrictions are limited,¹⁵ and analyses of patients’ experiences of medication changes are rare. A better understanding of patients’ experiences in this context could guide interventions to minimize treatment delays and improve outcomes. Our study assessed the effect of insurance-driven medication changes on primary care patients; specifically, the prevalence of difficulty in filling a prescription, resultant problems, and patient characteristics associated with reporting a problem.

Methods

Data collection

We mailed questionnaires to a random sample of 1200 adult patients (≥40 years) who had been seen within the previous 6 months at one of 3 family practices in northeastern Ohio. We asked respondents to quantify and describe any insurance-driven problems they encountered while attempting to fill or refill a prescription over the past year. We recorded each respondent’s insurance status, the name of the medication at issue and other medications they were taking, and demographic data. Comparative data for age and sex were collected for nonrespondents. The University Hospitals Case Medical Center Institutional Review Board approved all data collection procedures and methods for this cross-sectional study.

Data analysis

We tabulated and analyzed data from the surveys using Statistical Package for the Social Sciences (SPSS). We compared age and sex data (using t-test and chi-square test, respectively) between respondents and nonrespondents. We calculated descriptive statistics for all demographic, control, and outcome variables, and computed measures of association between demographic and health-related variables and insurance-driven problems encountered while filling a prescription. Using logistic regression analysis, we identified demographic and health-related variables independently associated with a problematic prescription.

We calculated the frequencies of problems encountered while trying to fill a prescription, and grouped the problems into 3 mutually exclusive categories: adverse medical outcomes, decreased patient satisfaction, and burden on physician practice. Adverse medical outcomes included missed doses of medication, inability to obtain medication, worsened medical condition, new medication adverse effects, and having to go to the emergency department (ED) because of a medication issue. We sorted medications into categories, and calculated the frequency of problems associated with each category.

We based our decision to mail 1200 surveys on a power calculation assuming a 40% response rate and approximately 25% of patients reporting a problem. A sample size of 480 or more provides 80% power to detect moderate differences in characteristics between those reporting a problem and those not reporting a problem.

Results

Four-hundred thirty-four patients returned the survey (36% response rate). We excluded 6 participants from analysis due to incomplete data for the primary outcome variable (problem with a prescription). Respondents and nonrespondents were similar in sex ratio, but respondents on average were 3 years older (P<.001). The average number of prescriptions taken was 3.4, and most patients (85%) had some form of private insurance ( TABLE 1 ). Most patients were female, in good health, and well educated.

Of the 428 study participants, 100 (23%) reported at least one problem obtaining a prescribed medication due to insurance. Generally, those who experienced a problem were younger, more likely to be female, and reported poorer health status than those reporting no problem ( TABLE 1 ). Additionally, those who encountered a problem were more than twice as likely to rely solely on Medicaid or Medicare, and were also taking more prescription medications. Problems filling a prescription were also reported more often in an urban setting than in suburban or semirural areas.

TABLE 1
Demographic variables for patients who did and didn’t report problems filling prescriptions

Using logistic regression, we analyzed a model that included all significant variables (age, total number of prescription drugs taken, sex, health status, insurance type, and practice location). The final logistic regression model showed statistical significance for only 3 variables: type of insurance, total number of prescription drugs taken, and age. (When we included type of insurance in the analysis, practice location was not associated with a problem filling a prescription.)

Specifically, the independent predictors of an insurance-related problem in filling a prescription were reliance solely on government-provided insurance, as opposed to private insurance or government insurance supplemented with private insurance (odds ratio [OR]=1.90; 95% confidence interval [CI], 1.02-3.61); taking more prescription medications (OR=1.19; 95% CI, 1.10-1.29); and being younger (OR=0.96; 95% CI, 0.94-0.99).

Respondents reporting at least one insurance-driven impediment to filling a prescription encountered an average of 2.9 different types of resultant problems ( TABLE 2 ). Insurance-related problems with medications were not limited to new prescriptions. Of the 100 patients reporting a problem with a medication, 21% had a problem with a new prescription, 42% with a medication they were already taking, and 37% with both a new and a previously prescribed medication.

TABLE 2
Resultant problems when patients had at least one insurance-related issue filling a prescription in the previous year

Forty-one percent of patients reporting a problem experienced adverse medical outcomes. The most serious adverse medical outcomes were reported least often, but occurred nonetheless: worsening of medical condition (8%), new medication adverse effects (6%), and requiring a visit to the ED (5%). More commonly reported was decreased satisfaction with the health care system (68%). Patients were less likely to report being upset with their physician than their insurance company or pharmacist. Problems that burdened the physician practice were reported most frequently (83%).

TABLE 3 shows the medication categories that were affected when respondents reported at least one problem. Formulary changes or restrictions involving cardiac/hypertension/lipid and neurologic/psychiatric medications were linked to the most problems.

TABLE 3
Which medication categories were most affected when patients had a problem filling a prescription?

Discussion

Nearly one quarter of patients in our sample (23%) experienced problems caused by insurance constraints while they attempted to follow the treatment regimens prescribed by their physicians. Although the most commonly reported insurance-related problems (waiting for pharmacist authorization, making extra phone calls to the physician’s office) could be perceived as minor inconveniences, serious consequences were also common. Our study showed that patients who rely solely on Medicaid or Medicare bore the greatest burden of insurance-related obstacles when filling prescriptions, although others were also affected.

Consistent with prior research in Medicare and Medicaid populations, our study found that medication access restrictions can negatively affect patient adherence.^13,16,17 Our study showed that 41% of patients who encountered a problem experienced a medically meaningful adverse outcome; 19% reported they received no medication for their condition. Similarly, a study of Medicare beneficiaries who had failed to fill or refill a prescription found that 20% cited lack of insurance coverage for the medication as a reason for not filling the prescription.¹⁷

In our study, 23% of patients reported missing doses of their medication due to insurance-related difficulties, and 8% reported a worsening of their medical condition. The increased costs associated with poor chronic care management are well documented.¹⁸ Less well described is the potential net savings produced when insurance formularies are adjusted to expand coverage and lower patient costs for prescription treatments for chronic conditions. In an analysis of cost data from the Pitney-Bowes Corporation, Mahoney¹² revealed a significant net savings in health care costs and lost productivity when treatments for chronic conditions were moved to the lowest tier of the formulary, thereby making them available to health plan participants at the lowest cost.

We could not link patient reports of treatment disruptions empirically to medical outcomes or increased costs, due to the constraints of our research question and study design. However, it is reasonable to suggest that longer-term insurance costs for these patients could, in fact, negate any short-term cost savings generated from formulary restrictions. In particular, the 5% of our patient sample who reported using the ED as a consequence of an insurance-related disruption of their prescribed treatment likely added significant unnecessary cost to their treatment. This effect has been seen in other studies.^19,20 In our study, cardiac/hypertension/lipid medications and medications for neurologic or psychiatric conditions were the most likely to be problematic. In these categories, competition of branded products may contribute to more frequent formulary changes. Furthermore, increases in morbidity and mortality associated with inadequate treatment of the conditions represented in these 2 categories of medications represent a significant burden to the US health system, including insurers, employers, and individuals.^21-23

Although patients were less likely to report being upset with their physician than their insurance company or pharmacist, physicians bore a considerable burden for resolving a number of prevalent patient issues. Most of these problems required extra phone calls to the practice, additional medication authorization, or extra office visits. Physicians and their support staff may serve as buffers between patients and the insurance formulary rules, but at significant cost in their time and effort.

Electronic prescribing systems with real-time pharmacy benefit verification may provide additional efficiencies and help physicians and patients avoid some of the problems cited by our respondents. Providers with such systems receive immediate notification of formulary status, including tier and co-pay levels, which can aid in shared decision-making at the point of prescribing. Physicians without access to e-prescribing may want to use newer formulary search engines that can check formulary status of medications across multiple insurance plans. However, these electronic tools often fail to account for variations in formularies within the same insurance plan for different employers based on their benefit structure. Still, when a medication is not on formulary or a co-payment is required, the physician may be forced to play the role of apologist for the constraints imposed by the insurance formulary.

In cases where formularies restrict the patient’s potential access to a preferred treatment plan, the burden of prior authorizations continues to be borne by physicians. Coverage limitations lead to financial and medical consequences that must be managed in partnership with the patient. A system should be put in place by insurance companies that facilitates out-of-formulary authorizations to prevent lapses in patient care or deleterious changes in medical management.

Study limitations

The findings reported here should be interpreted in light of some limitations of this study. The response rate to our mailed patient survey was modest (36%), although typical for this method. The sex mix of respondents was similar to that of nonrespondents, but nonrespondents were slightly younger. Given that younger age is associated with a greater likelihood of experiencing a problem filling a medication, our findings may underestimate the frequency of this dilemma. In addition, our survey asked patients to recall events that occurred over the past year, introducing a potential for recall bias.

While the overall sample size was relatively small (n=428), it is close to the number calculated for sufficient power to conduct the analyses (n=480). Furthermore, data were collected from 3 distinct patient populations: urban, suburban and semirural. Although the scope of our study included only one geographic region, variability in practice setting lends some tentative support to the generalizability of the findings.

Looking forward

As a standard method to control costs and update treatment guidelines, insurance-mediated medication changes will continue to present unique challenges for patients and health care providers. Formulary changes burden the downstream delivery of medical care with expensive administrative responsibilities and disrupt effective disease management and prevention. Until insurance companies and pharmacy benefit managers start paying heed to total costs of care when contemplating formulary changes, physicians should try to identify formulary conflicts as early as possible in the prescribing process so as to save time for all parties later and improve compliance.

As practices proceed toward adoption of electronic health records, e-prescribing, and the Centers for Medicare & Medicaid Services’ “meaningful use” criteria, physicians may use systems that provide real-time formulary information, which can flag issues before the patient leaves the exam room. Future research should explore the ways formulary changes might be implemented to provide the strongest continuity of patient care with the least amount of cost shifting.

CORRESPONDENCE
Susan A. Flocke, PhD, CWRU Department of Family Medicine & Community Health, 11000 Cedar Avenue, Suite 402, Cleveland, OH 44106; [email protected]

To maintain the cost-effectiveness of health insurance, many organizations, including government agencies, routinely evaluate and choose to adopt alternative treatment modalities. But how do such changes affect patient outcomes? And do near-term cost savings from formulary changes lead to long-term cost benefits?

Chronic disease management and associated complex medication regimens account for most health insurance expenditures.^1,2 Changes to prescription formularies are common,³ with medications being added or removed to reduce costs or to respond to revised practice guidelines.^4,5

Researchers have examined the clinical risks and merits of changing from one drug to another, as well as the impact of implementing formulary changes on administrative and other costs, overall effectiveness of disease management, and the operational adeptness of health systems.^6-10 Routine formulary changes may yield immediate cost savings, but net costs may increase downstream due to disruptions in patient care.^11,12 Insurance-driven medication changes have also been shown to negatively affect patient adherence to medical treatment and also disease outcomes.^13,14

Patient-level data related to formulary restrictions are limited,¹⁵ and analyses of patients’ experiences of medication changes are rare. A better understanding of patients’ experiences in this context could guide interventions to minimize treatment delays and improve outcomes. Our study assessed the effect of insurance-driven medication changes on primary care patients; specifically, the prevalence of difficulty in filling a prescription, resultant problems, and patient characteristics associated with reporting a problem.

Methods

Data collection

We mailed questionnaires to a random sample of 1200 adult patients (≥40 years) who had been seen within the previous 6 months at one of 3 family practices in northeastern Ohio. We asked respondents to quantify and describe any insurance-driven problems they encountered while attempting to fill or refill a prescription over the past year. We recorded each respondent’s insurance status, the name of the medication at issue and other medications they were taking, and demographic data. Comparative data for age and sex were collected for nonrespondents. The University Hospitals Case Medical Center Institutional Review Board approved all data collection procedures and methods for this cross-sectional study.

Data analysis

We tabulated and analyzed data from the surveys using Statistical Package for the Social Sciences (SPSS). We compared age and sex data (using t-test and chi-square test, respectively) between respondents and nonrespondents. We calculated descriptive statistics for all demographic, control, and outcome variables, and computed measures of association between demographic and health-related variables and insurance-driven problems encountered while filling a prescription. Using logistic regression analysis, we identified demographic and health-related variables independently associated with a problematic prescription.

We calculated the frequencies of problems encountered while trying to fill a prescription, and grouped the problems into 3 mutually exclusive categories: adverse medical outcomes, decreased patient satisfaction, and burden on physician practice. Adverse medical outcomes included missed doses of medication, inability to obtain medication, worsened medical condition, new medication adverse effects, and having to go to the emergency department (ED) because of a medication issue. We sorted medications into categories, and calculated the frequency of problems associated with each category.

We based our decision to mail 1200 surveys on a power calculation assuming a 40% response rate and approximately 25% of patients reporting a problem. A sample size of 480 or more provides 80% power to detect moderate differences in characteristics between those reporting a problem and those not reporting a problem.

Results

Four-hundred thirty-four patients returned the survey (36% response rate). We excluded 6 participants from analysis due to incomplete data for the primary outcome variable (problem with a prescription). Respondents and nonrespondents were similar in sex ratio, but respondents on average were 3 years older (P<.001). The average number of prescriptions taken was 3.4, and most patients (85%) had some form of private insurance ( TABLE 1 ). Most patients were female, in good health, and well educated.

Of the 428 study participants, 100 (23%) reported at least one problem obtaining a prescribed medication due to insurance. Generally, those who experienced a problem were younger, more likely to be female, and reported poorer health status than those reporting no problem ( TABLE 1 ). Additionally, those who encountered a problem were more than twice as likely to rely solely on Medicaid or Medicare, and were also taking more prescription medications. Problems filling a prescription were also reported more often in an urban setting than in suburban or semirural areas.

TABLE 1
Demographic variables for patients who did and didn’t report problems filling prescriptions

Using logistic regression, we analyzed a model that included all significant variables (age, total number of prescription drugs taken, sex, health status, insurance type, and practice location). The final logistic regression model showed statistical significance for only 3 variables: type of insurance, total number of prescription drugs taken, and age. (When we included type of insurance in the analysis, practice location was not associated with a problem filling a prescription.)

Specifically, the independent predictors of an insurance-related problem in filling a prescription were reliance solely on government-provided insurance, as opposed to private insurance or government insurance supplemented with private insurance (odds ratio [OR]=1.90; 95% confidence interval [CI], 1.02-3.61); taking more prescription medications (OR=1.19; 95% CI, 1.10-1.29); and being younger (OR=0.96; 95% CI, 0.94-0.99).

Respondents reporting at least one insurance-driven impediment to filling a prescription encountered an average of 2.9 different types of resultant problems ( TABLE 2 ). Insurance-related problems with medications were not limited to new prescriptions. Of the 100 patients reporting a problem with a medication, 21% had a problem with a new prescription, 42% with a medication they were already taking, and 37% with both a new and a previously prescribed medication.

TABLE 2
Resultant problems when patients had at least one insurance-related issue filling a prescription in the previous year

Forty-one percent of patients reporting a problem experienced adverse medical outcomes. The most serious adverse medical outcomes were reported least often, but occurred nonetheless: worsening of medical condition (8%), new medication adverse effects (6%), and requiring a visit to the ED (5%). More commonly reported was decreased satisfaction with the health care system (68%). Patients were less likely to report being upset with their physician than their insurance company or pharmacist. Problems that burdened the physician practice were reported most frequently (83%).

TABLE 3 shows the medication categories that were affected when respondents reported at least one problem. Formulary changes or restrictions involving cardiac/hypertension/lipid and neurologic/psychiatric medications were linked to the most problems.

TABLE 3
Which medication categories were most affected when patients had a problem filling a prescription?

Discussion

Nearly one quarter of patients in our sample (23%) experienced problems caused by insurance constraints while they attempted to follow the treatment regimens prescribed by their physicians. Although the most commonly reported insurance-related problems (waiting for pharmacist authorization, making extra phone calls to the physician’s office) could be perceived as minor inconveniences, serious consequences were also common. Our study showed that patients who rely solely on Medicaid or Medicare bore the greatest burden of insurance-related obstacles when filling prescriptions, although others were also affected.

Consistent with prior research in Medicare and Medicaid populations, our study found that medication access restrictions can negatively affect patient adherence.^13,16,17 Our study showed that 41% of patients who encountered a problem experienced a medically meaningful adverse outcome; 19% reported they received no medication for their condition. Similarly, a study of Medicare beneficiaries who had failed to fill or refill a prescription found that 20% cited lack of insurance coverage for the medication as a reason for not filling the prescription.¹⁷

In our study, 23% of patients reported missing doses of their medication due to insurance-related difficulties, and 8% reported a worsening of their medical condition. The increased costs associated with poor chronic care management are well documented.¹⁸ Less well described is the potential net savings produced when insurance formularies are adjusted to expand coverage and lower patient costs for prescription treatments for chronic conditions. In an analysis of cost data from the Pitney-Bowes Corporation, Mahoney¹² revealed a significant net savings in health care costs and lost productivity when treatments for chronic conditions were moved to the lowest tier of the formulary, thereby making them available to health plan participants at the lowest cost.

We could not link patient reports of treatment disruptions empirically to medical outcomes or increased costs, due to the constraints of our research question and study design. However, it is reasonable to suggest that longer-term insurance costs for these patients could, in fact, negate any short-term cost savings generated from formulary restrictions. In particular, the 5% of our patient sample who reported using the ED as a consequence of an insurance-related disruption of their prescribed treatment likely added significant unnecessary cost to their treatment. This effect has been seen in other studies.^19,20 In our study, cardiac/hypertension/lipid medications and medications for neurologic or psychiatric conditions were the most likely to be problematic. In these categories, competition of branded products may contribute to more frequent formulary changes. Furthermore, increases in morbidity and mortality associated with inadequate treatment of the conditions represented in these 2 categories of medications represent a significant burden to the US health system, including insurers, employers, and individuals.^21-23

Although patients were less likely to report being upset with their physician than their insurance company or pharmacist, physicians bore a considerable burden for resolving a number of prevalent patient issues. Most of these problems required extra phone calls to the practice, additional medication authorization, or extra office visits. Physicians and their support staff may serve as buffers between patients and the insurance formulary rules, but at significant cost in their time and effort.

Electronic prescribing systems with real-time pharmacy benefit verification may provide additional efficiencies and help physicians and patients avoid some of the problems cited by our respondents. Providers with such systems receive immediate notification of formulary status, including tier and co-pay levels, which can aid in shared decision-making at the point of prescribing. Physicians without access to e-prescribing may want to use newer formulary search engines that can check formulary status of medications across multiple insurance plans. However, these electronic tools often fail to account for variations in formularies within the same insurance plan for different employers based on their benefit structure. Still, when a medication is not on formulary or a co-payment is required, the physician may be forced to play the role of apologist for the constraints imposed by the insurance formulary.

In cases where formularies restrict the patient’s potential access to a preferred treatment plan, the burden of prior authorizations continues to be borne by physicians. Coverage limitations lead to financial and medical consequences that must be managed in partnership with the patient. A system should be put in place by insurance companies that facilitates out-of-formulary authorizations to prevent lapses in patient care or deleterious changes in medical management.

Study limitations

The findings reported here should be interpreted in light of some limitations of this study. The response rate to our mailed patient survey was modest (36%), although typical for this method. The sex mix of respondents was similar to that of nonrespondents, but nonrespondents were slightly younger. Given that younger age is associated with a greater likelihood of experiencing a problem filling a medication, our findings may underestimate the frequency of this dilemma. In addition, our survey asked patients to recall events that occurred over the past year, introducing a potential for recall bias.

While the overall sample size was relatively small (n=428), it is close to the number calculated for sufficient power to conduct the analyses (n=480). Furthermore, data were collected from 3 distinct patient populations: urban, suburban and semirural. Although the scope of our study included only one geographic region, variability in practice setting lends some tentative support to the generalizability of the findings.

Looking forward

As a standard method to control costs and update treatment guidelines, insurance-mediated medication changes will continue to present unique challenges for patients and health care providers. Formulary changes burden the downstream delivery of medical care with expensive administrative responsibilities and disrupt effective disease management and prevention. Until insurance companies and pharmacy benefit managers start paying heed to total costs of care when contemplating formulary changes, physicians should try to identify formulary conflicts as early as possible in the prescribing process so as to save time for all parties later and improve compliance.

As practices proceed toward adoption of electronic health records, e-prescribing, and the Centers for Medicare & Medicaid Services’ “meaningful use” criteria, physicians may use systems that provide real-time formulary information, which can flag issues before the patient leaves the exam room. Future research should explore the ways formulary changes might be implemented to provide the strongest continuity of patient care with the least amount of cost shifting.

CORRESPONDENCE
Susan A. Flocke, PhD, CWRU Department of Family Medicine & Community Health, 11000 Cedar Avenue, Suite 402, Cleveland, OH 44106; [email protected]

A suicide rehearsal is a behavioral enactment of a suicide method, usually as part of a suicide plan. A mental suicide rehearsal is a process that evolves over time into a plan. Patients who are intent on attempting suicide usually do not reveal their plans. However, behavioral rehearsals display specific clinical characteristics that speak louder than the guarded patient’s denials, revealing the patient’s suicide plan (Table).

Suicide rehearsals may precede suicide attempts or suicide completions. The percentage of patients who stage suicide rehearsals before attempting or completing suicide is unknown; however, in my experience, suicide rehearsals are relatively common. This article describes suicide rehearsals, and offers 4 cases that illustrate what clinicians can learn from rehearsals to improve their patients’ safety.

Table

Clinical characteristics of suicide rehearsals

The psychology behind suicide rehearsals

Rehearsing suicidal behavior can lower the barrier to a suicide plan, thereby increasing a patient’s resolve and risk. Joiner¹ notes that engaging in behavioral or mental suicide rehearsals increases the risk of suicide. Moreover, rehearsals diminish the prohibition against suicidal behavior and the fear of pain and dying. Examples of rehearsal psychology include:

• overcoming ambivalence about dying
• desensitizing anxiety about performing the suicide act
• testing or “perfecting” the method of a planned suicide
• firming one’s resolve to complete suicide.

Other non-lethal motivations include “a cry for help” and self-injurious behaviors motivated by external gains. Patients who do not intend to attempt suicide may openly rehearse low-risk methods, such as superficial cutting.

Rehearsal characteristics

Suicide rehearsals can be confused with aborted, interrupted, or failed suicide attempts. Suicide rehearsals usually are associated with severe psychiatric illness and high-risk lethal methods of attempting suicide. My experience is that suicide attempts or suicide completions often follow a rehearsal within a few hours or days. However, no short-term suicide risk factors—within hours, days, or weeks—can predict when or if a rehearsed suicide will proceed to a suicide attempt.²

A suicide rehearsal is presumptive evidence that the patient is at acute, high risk for suicide and immediate clinical intervention is necessary. A rehearsal allows the clinician to explore the various methods of suicide that the patient has considered, including prior rehearsals. Knowledge of prior rehearsals can inform the clinician’s management of the current suicide rehearsal.

Suicide rehearsals often are conducted covertly. On inpatient psychiatric units, the rehearsal usually is discovered by staff members or reported by other patients. In outpatient settings, the patient or a significant other may report a rehearsal.

The suicide method displayed in a rehearsal may change. A patient who is rehearsing a hanging may attempt suicide by overdose or a firearm. In a systematic review of prior suicide attempts (N = 1,397), Isometsä et al³ found that 82% of patients used 2 or more different methods in suicide attempts, including the completed suicide. However, in a cohort study of 48,649 individuals admitted to a hospital after an attempted suicide, Runeson et al⁴ found that patients who attempt suicide often used the same method in completed suicide (ie, >90% by hanging for both men and women). Therefore, when taking measures to restrict the patient’s access to lethal means, safety efforts should not be limited to the method used in the suicide rehearsal. Patients can always substitute methods.

Making overall preparations for suicide—for example, making a will, giving away valuable possessions, or putting financial affairs in order—could be confused with a suicide rehearsal, which displays the lethal method to be used in a suicide attempt, often after preparations are made. Suicide rehearsals tend to occur much closer in time to the suicide attempt than preparations for suicide. Similarly, a patient’s plan to hoard drugs for a suicide attempt is not the same as ingesting a sub-lethal dose of a drug to test his or her resolve to die.

By definition, impulsive suicide attempts are not rehearsed. However, an individual’s suicide rehearsal can impulsively segue into a suicide attempt. In a case control study (N = 153) Simon et al⁵ found that 24% of patients spent 6 found that 26% of individuals with lifetime suicide ideation transitioned from suicide ideation to an unplanned suicide attempt. In my experience, a suicide rehearsal before a suicide completion is presumptive evidence against an impulsive suicide.

Patients contemplating suicide may visit Web sites with instructions on “how to suicide,” providing “virtual” opportunities to rehearse suicide.⁷ Patients who are at risk for suicide should be asked if they have searched the Internet for suicide methodology.

What we can learn from rehearsals

Although the following case examples are fictional, they illustrate suicide rehearsals encountered in my clinical and forensic practice.

CASE 1: Looking for a location

Ms. B, a 28-year-old divorced mother of 2, is observed tarrying at the high point of a bridge on successive days. When police arrive and question her, she becomes agitated and distraught. Ms. B admits to “scoping out” the bridge and is taken to a hospital emergency room (ER). In the ER, Ms. B discloses, “I was looking for a good spot to jump.” She tells the triage nurse that she is very depressed but, “I couldn’t do it to my children.” Ms. B is placed in an unlocked room while she waits to be assessed by a psychiatrist. She leaves the ER, runs to a nearby parking garage, and jumps from the top level to her death.

Comment: A patient’s denial of suicide intent following a suicide rehearsal cannot be relied upon. Ms. B’s rehearsal revealed a plan with high-risk suicide intent and a lethal suicide method. Systematic suicide assessment that informs immediate clinical intervention is required.

CASE 2: Changing lethal means

Mr. N, a 43-year-old chief executive officer of a large company, is observed by an assistant loading and unloading a revolver at his desk. Alarmed, the assistant calls the company physician. Mr. N refuses psychiatric treatment, saying, “I’ll be all right; this is just a passing thing.” His wife tells the physician that her husband has a history of bipolar disorder but no prior suicide attempts. Guns and ammunition are removed from the home. One week later, Mr. N is found hanging in his garage. A loaded pistol is discovered in the glove compartment of his car.

Comment: There is no certainty that a subsequent suicide attempt will replicate the rehearsed method. A psychological autopsy was conducted, but no explanation was found for why Mr. N chose hanging after having rehearsed suicide with a loaded handgun. His wife thought that her husband, a very tidy person, did not want to leave a mess.

CASE 3: Grieving and depressed

Mr. O, age 67, is depressed after recently losing his wife. He considers a number of suicide methods. Mr. O decides to use a plastic bag to suffocate himself because he believes that this method will allow him to change his mind. Mr. O practices tying the bag tight around his neck. During this rehearsal, he realizes that he does not want to die. Instead, he pursues grief counseling.

Comment: For some patients, the act of rehearsing suicide can help them resolve ambivalent feelings about wanting to die in favor of wanting to live.

CASE 4: Suicide method and the Internet

Ms. S, a 22-year-old college student, is undergoing outpatient treatment for depression. She is accumulating prescription drugs to take as an overdose. Ms. S also searches the Internet for information about other suicide methods. Because she wants a “sure” method of suicide, she persuades an acquaintance to purchase a handgun. In private, Ms. S places the unloaded gun to her head and plays “Russian roulette,” pulling the trigger several times. Her mother discovers the gun and confronts her daughter. Ms. S is hospitalized on a closed psychiatric unit and tells a staff member, “I was practicing suicide with the gun.” Before Ms. S is discharged from the hospital, her parents are advised to watch for suicidal behaviors, especially the recurrence of rehearsals that indicate an acute, high suicide risk. Ms. S’s Internet use is restricted and monitored.

Comment: Suicide rehearsal with a gun reinforces the belief that a firearm death is quick and easy.⁸ Reaching for a loaded gun takes less time than most other methods of suicide. Patients who rehearse suicide with a gun should be prevented from having access to any firearms, weapons, or other highly lethal means of suicide.

Recognition and intervention

A guarded psychiatric inpatient who is intent on attempting suicide is unmasked when the discovery of a suicidal rehearsal reveals a suicide plan. This creates an opportunity for clinicians to intervene. The patient may attempt to cover up suicidal intent by stating, “I was just playing around” or “I just wanted to get attention.” Recognizing the emergency posed by a suicide rehearsal informs treatment. Safety measures—including 1-to-1 supervision—may be necessary during a period of acute, high suicide risk. The patient’s diagnosis, severity of illness, and treatment require reevaluation.

An outpatient who performs a suicide rehearsal should be considered at acute, high risk for suicide, and immediate psychiatric hospitalization may be necessary. Whether as an inpatient or outpatient, the patient’s suicide intent and plan require careful exploration. The information gained will guide treatment and management decisions. Continuing systematic suicide risk assessment is essential.

Related Resources

• American Association of Suicidology. www.suicidology.org.
• Joiner T. Why people die by suicide. Cambridge, MA: Harvard University Press; 2007.
• American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Washington, DC: American Psychiatric Publishing, Inc. 2003.
• Simon RI. Preventing patient suicide: clinical assessment and management. Arlington, VA: American Psychiatric Publishing, Inc.; 2011.

Disclosure

Dr. Simon reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

A suicide rehearsal is a behavioral enactment of a suicide method, usually as part of a suicide plan. A mental suicide rehearsal is a process that evolves over time into a plan. Patients who are intent on attempting suicide usually do not reveal their plans. However, behavioral rehearsals display specific clinical characteristics that speak louder than the guarded patient’s denials, revealing the patient’s suicide plan (Table).

Suicide rehearsals may precede suicide attempts or suicide completions. The percentage of patients who stage suicide rehearsals before attempting or completing suicide is unknown; however, in my experience, suicide rehearsals are relatively common. This article describes suicide rehearsals, and offers 4 cases that illustrate what clinicians can learn from rehearsals to improve their patients’ safety.

Table

Clinical characteristics of suicide rehearsals

The psychology behind suicide rehearsals

Rehearsing suicidal behavior can lower the barrier to a suicide plan, thereby increasing a patient’s resolve and risk. Joiner¹ notes that engaging in behavioral or mental suicide rehearsals increases the risk of suicide. Moreover, rehearsals diminish the prohibition against suicidal behavior and the fear of pain and dying. Examples of rehearsal psychology include:

• overcoming ambivalence about dying
• desensitizing anxiety about performing the suicide act
• testing or “perfecting” the method of a planned suicide
• firming one’s resolve to complete suicide.

Other non-lethal motivations include “a cry for help” and self-injurious behaviors motivated by external gains. Patients who do not intend to attempt suicide may openly rehearse low-risk methods, such as superficial cutting.

Rehearsal characteristics

Suicide rehearsals can be confused with aborted, interrupted, or failed suicide attempts. Suicide rehearsals usually are associated with severe psychiatric illness and high-risk lethal methods of attempting suicide. My experience is that suicide attempts or suicide completions often follow a rehearsal within a few hours or days. However, no short-term suicide risk factors—within hours, days, or weeks—can predict when or if a rehearsed suicide will proceed to a suicide attempt.²

A suicide rehearsal is presumptive evidence that the patient is at acute, high risk for suicide and immediate clinical intervention is necessary. A rehearsal allows the clinician to explore the various methods of suicide that the patient has considered, including prior rehearsals. Knowledge of prior rehearsals can inform the clinician’s management of the current suicide rehearsal.

Suicide rehearsals often are conducted covertly. On inpatient psychiatric units, the rehearsal usually is discovered by staff members or reported by other patients. In outpatient settings, the patient or a significant other may report a rehearsal.

The suicide method displayed in a rehearsal may change. A patient who is rehearsing a hanging may attempt suicide by overdose or a firearm. In a systematic review of prior suicide attempts (N = 1,397), Isometsä et al³ found that 82% of patients used 2 or more different methods in suicide attempts, including the completed suicide. However, in a cohort study of 48,649 individuals admitted to a hospital after an attempted suicide, Runeson et al⁴ found that patients who attempt suicide often used the same method in completed suicide (ie, >90% by hanging for both men and women). Therefore, when taking measures to restrict the patient’s access to lethal means, safety efforts should not be limited to the method used in the suicide rehearsal. Patients can always substitute methods.

Making overall preparations for suicide—for example, making a will, giving away valuable possessions, or putting financial affairs in order—could be confused with a suicide rehearsal, which displays the lethal method to be used in a suicide attempt, often after preparations are made. Suicide rehearsals tend to occur much closer in time to the suicide attempt than preparations for suicide. Similarly, a patient’s plan to hoard drugs for a suicide attempt is not the same as ingesting a sub-lethal dose of a drug to test his or her resolve to die.

By definition, impulsive suicide attempts are not rehearsed. However, an individual’s suicide rehearsal can impulsively segue into a suicide attempt. In a case control study (N = 153) Simon et al⁵ found that 24% of patients spent 6 found that 26% of individuals with lifetime suicide ideation transitioned from suicide ideation to an unplanned suicide attempt. In my experience, a suicide rehearsal before a suicide completion is presumptive evidence against an impulsive suicide.

Patients contemplating suicide may visit Web sites with instructions on “how to suicide,” providing “virtual” opportunities to rehearse suicide.⁷ Patients who are at risk for suicide should be asked if they have searched the Internet for suicide methodology.

What we can learn from rehearsals

Although the following case examples are fictional, they illustrate suicide rehearsals encountered in my clinical and forensic practice.

CASE 1: Looking for a location

Ms. B, a 28-year-old divorced mother of 2, is observed tarrying at the high point of a bridge on successive days. When police arrive and question her, she becomes agitated and distraught. Ms. B admits to “scoping out” the bridge and is taken to a hospital emergency room (ER). In the ER, Ms. B discloses, “I was looking for a good spot to jump.” She tells the triage nurse that she is very depressed but, “I couldn’t do it to my children.” Ms. B is placed in an unlocked room while she waits to be assessed by a psychiatrist. She leaves the ER, runs to a nearby parking garage, and jumps from the top level to her death.

Comment: A patient’s denial of suicide intent following a suicide rehearsal cannot be relied upon. Ms. B’s rehearsal revealed a plan with high-risk suicide intent and a lethal suicide method. Systematic suicide assessment that informs immediate clinical intervention is required.

CASE 2: Changing lethal means

Mr. N, a 43-year-old chief executive officer of a large company, is observed by an assistant loading and unloading a revolver at his desk. Alarmed, the assistant calls the company physician. Mr. N refuses psychiatric treatment, saying, “I’ll be all right; this is just a passing thing.” His wife tells the physician that her husband has a history of bipolar disorder but no prior suicide attempts. Guns and ammunition are removed from the home. One week later, Mr. N is found hanging in his garage. A loaded pistol is discovered in the glove compartment of his car.

Comment: There is no certainty that a subsequent suicide attempt will replicate the rehearsed method. A psychological autopsy was conducted, but no explanation was found for why Mr. N chose hanging after having rehearsed suicide with a loaded handgun. His wife thought that her husband, a very tidy person, did not want to leave a mess.

CASE 3: Grieving and depressed

Mr. O, age 67, is depressed after recently losing his wife. He considers a number of suicide methods. Mr. O decides to use a plastic bag to suffocate himself because he believes that this method will allow him to change his mind. Mr. O practices tying the bag tight around his neck. During this rehearsal, he realizes that he does not want to die. Instead, he pursues grief counseling.

Comment: For some patients, the act of rehearsing suicide can help them resolve ambivalent feelings about wanting to die in favor of wanting to live.

CASE 4: Suicide method and the Internet

Ms. S, a 22-year-old college student, is undergoing outpatient treatment for depression. She is accumulating prescription drugs to take as an overdose. Ms. S also searches the Internet for information about other suicide methods. Because she wants a “sure” method of suicide, she persuades an acquaintance to purchase a handgun. In private, Ms. S places the unloaded gun to her head and plays “Russian roulette,” pulling the trigger several times. Her mother discovers the gun and confronts her daughter. Ms. S is hospitalized on a closed psychiatric unit and tells a staff member, “I was practicing suicide with the gun.” Before Ms. S is discharged from the hospital, her parents are advised to watch for suicidal behaviors, especially the recurrence of rehearsals that indicate an acute, high suicide risk. Ms. S’s Internet use is restricted and monitored.

Comment: Suicide rehearsal with a gun reinforces the belief that a firearm death is quick and easy.⁸ Reaching for a loaded gun takes less time than most other methods of suicide. Patients who rehearse suicide with a gun should be prevented from having access to any firearms, weapons, or other highly lethal means of suicide.

Recognition and intervention

A guarded psychiatric inpatient who is intent on attempting suicide is unmasked when the discovery of a suicidal rehearsal reveals a suicide plan. This creates an opportunity for clinicians to intervene. The patient may attempt to cover up suicidal intent by stating, “I was just playing around” or “I just wanted to get attention.” Recognizing the emergency posed by a suicide rehearsal informs treatment. Safety measures—including 1-to-1 supervision—may be necessary during a period of acute, high suicide risk. The patient’s diagnosis, severity of illness, and treatment require reevaluation.

An outpatient who performs a suicide rehearsal should be considered at acute, high risk for suicide, and immediate psychiatric hospitalization may be necessary. Whether as an inpatient or outpatient, the patient’s suicide intent and plan require careful exploration. The information gained will guide treatment and management decisions. Continuing systematic suicide risk assessment is essential.

Related Resources

• American Association of Suicidology. www.suicidology.org.
• Joiner T. Why people die by suicide. Cambridge, MA: Harvard University Press; 2007.
• American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Washington, DC: American Psychiatric Publishing, Inc. 2003.
• Simon RI. Preventing patient suicide: clinical assessment and management. Arlington, VA: American Psychiatric Publishing, Inc.; 2011.

Disclosure

Dr. Simon reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

A suicide rehearsal is a behavioral enactment of a suicide method, usually as part of a suicide plan. A mental suicide rehearsal is a process that evolves over time into a plan. Patients who are intent on attempting suicide usually do not reveal their plans. However, behavioral rehearsals display specific clinical characteristics that speak louder than the guarded patient’s denials, revealing the patient’s suicide plan (Table).

Suicide rehearsals may precede suicide attempts or suicide completions. The percentage of patients who stage suicide rehearsals before attempting or completing suicide is unknown; however, in my experience, suicide rehearsals are relatively common. This article describes suicide rehearsals, and offers 4 cases that illustrate what clinicians can learn from rehearsals to improve their patients’ safety.

Table

Clinical characteristics of suicide rehearsals

The psychology behind suicide rehearsals

Rehearsing suicidal behavior can lower the barrier to a suicide plan, thereby increasing a patient’s resolve and risk. Joiner¹ notes that engaging in behavioral or mental suicide rehearsals increases the risk of suicide. Moreover, rehearsals diminish the prohibition against suicidal behavior and the fear of pain and dying. Examples of rehearsal psychology include:

• overcoming ambivalence about dying
• desensitizing anxiety about performing the suicide act
• testing or “perfecting” the method of a planned suicide
• firming one’s resolve to complete suicide.

Other non-lethal motivations include “a cry for help” and self-injurious behaviors motivated by external gains. Patients who do not intend to attempt suicide may openly rehearse low-risk methods, such as superficial cutting.

Rehearsal characteristics

Suicide rehearsals can be confused with aborted, interrupted, or failed suicide attempts. Suicide rehearsals usually are associated with severe psychiatric illness and high-risk lethal methods of attempting suicide. My experience is that suicide attempts or suicide completions often follow a rehearsal within a few hours or days. However, no short-term suicide risk factors—within hours, days, or weeks—can predict when or if a rehearsed suicide will proceed to a suicide attempt.²

A suicide rehearsal is presumptive evidence that the patient is at acute, high risk for suicide and immediate clinical intervention is necessary. A rehearsal allows the clinician to explore the various methods of suicide that the patient has considered, including prior rehearsals. Knowledge of prior rehearsals can inform the clinician’s management of the current suicide rehearsal.

Suicide rehearsals often are conducted covertly. On inpatient psychiatric units, the rehearsal usually is discovered by staff members or reported by other patients. In outpatient settings, the patient or a significant other may report a rehearsal.

The suicide method displayed in a rehearsal may change. A patient who is rehearsing a hanging may attempt suicide by overdose or a firearm. In a systematic review of prior suicide attempts (N = 1,397), Isometsä et al³ found that 82% of patients used 2 or more different methods in suicide attempts, including the completed suicide. However, in a cohort study of 48,649 individuals admitted to a hospital after an attempted suicide, Runeson et al⁴ found that patients who attempt suicide often used the same method in completed suicide (ie, >90% by hanging for both men and women). Therefore, when taking measures to restrict the patient’s access to lethal means, safety efforts should not be limited to the method used in the suicide rehearsal. Patients can always substitute methods.

Making overall preparations for suicide—for example, making a will, giving away valuable possessions, or putting financial affairs in order—could be confused with a suicide rehearsal, which displays the lethal method to be used in a suicide attempt, often after preparations are made. Suicide rehearsals tend to occur much closer in time to the suicide attempt than preparations for suicide. Similarly, a patient’s plan to hoard drugs for a suicide attempt is not the same as ingesting a sub-lethal dose of a drug to test his or her resolve to die.

By definition, impulsive suicide attempts are not rehearsed. However, an individual’s suicide rehearsal can impulsively segue into a suicide attempt. In a case control study (N = 153) Simon et al⁵ found that 24% of patients spent 6 found that 26% of individuals with lifetime suicide ideation transitioned from suicide ideation to an unplanned suicide attempt. In my experience, a suicide rehearsal before a suicide completion is presumptive evidence against an impulsive suicide.

Patients contemplating suicide may visit Web sites with instructions on “how to suicide,” providing “virtual” opportunities to rehearse suicide.⁷ Patients who are at risk for suicide should be asked if they have searched the Internet for suicide methodology.

What we can learn from rehearsals

Although the following case examples are fictional, they illustrate suicide rehearsals encountered in my clinical and forensic practice.

CASE 1: Looking for a location

Ms. B, a 28-year-old divorced mother of 2, is observed tarrying at the high point of a bridge on successive days. When police arrive and question her, she becomes agitated and distraught. Ms. B admits to “scoping out” the bridge and is taken to a hospital emergency room (ER). In the ER, Ms. B discloses, “I was looking for a good spot to jump.” She tells the triage nurse that she is very depressed but, “I couldn’t do it to my children.” Ms. B is placed in an unlocked room while she waits to be assessed by a psychiatrist. She leaves the ER, runs to a nearby parking garage, and jumps from the top level to her death.

Comment: A patient’s denial of suicide intent following a suicide rehearsal cannot be relied upon. Ms. B’s rehearsal revealed a plan with high-risk suicide intent and a lethal suicide method. Systematic suicide assessment that informs immediate clinical intervention is required.

CASE 2: Changing lethal means

Mr. N, a 43-year-old chief executive officer of a large company, is observed by an assistant loading and unloading a revolver at his desk. Alarmed, the assistant calls the company physician. Mr. N refuses psychiatric treatment, saying, “I’ll be all right; this is just a passing thing.” His wife tells the physician that her husband has a history of bipolar disorder but no prior suicide attempts. Guns and ammunition are removed from the home. One week later, Mr. N is found hanging in his garage. A loaded pistol is discovered in the glove compartment of his car.

Comment: There is no certainty that a subsequent suicide attempt will replicate the rehearsed method. A psychological autopsy was conducted, but no explanation was found for why Mr. N chose hanging after having rehearsed suicide with a loaded handgun. His wife thought that her husband, a very tidy person, did not want to leave a mess.

CASE 3: Grieving and depressed

Mr. O, age 67, is depressed after recently losing his wife. He considers a number of suicide methods. Mr. O decides to use a plastic bag to suffocate himself because he believes that this method will allow him to change his mind. Mr. O practices tying the bag tight around his neck. During this rehearsal, he realizes that he does not want to die. Instead, he pursues grief counseling.

Comment: For some patients, the act of rehearsing suicide can help them resolve ambivalent feelings about wanting to die in favor of wanting to live.

CASE 4: Suicide method and the Internet

Ms. S, a 22-year-old college student, is undergoing outpatient treatment for depression. She is accumulating prescription drugs to take as an overdose. Ms. S also searches the Internet for information about other suicide methods. Because she wants a “sure” method of suicide, she persuades an acquaintance to purchase a handgun. In private, Ms. S places the unloaded gun to her head and plays “Russian roulette,” pulling the trigger several times. Her mother discovers the gun and confronts her daughter. Ms. S is hospitalized on a closed psychiatric unit and tells a staff member, “I was practicing suicide with the gun.” Before Ms. S is discharged from the hospital, her parents are advised to watch for suicidal behaviors, especially the recurrence of rehearsals that indicate an acute, high suicide risk. Ms. S’s Internet use is restricted and monitored.

Comment: Suicide rehearsal with a gun reinforces the belief that a firearm death is quick and easy.⁸ Reaching for a loaded gun takes less time than most other methods of suicide. Patients who rehearse suicide with a gun should be prevented from having access to any firearms, weapons, or other highly lethal means of suicide.

Recognition and intervention

A guarded psychiatric inpatient who is intent on attempting suicide is unmasked when the discovery of a suicidal rehearsal reveals a suicide plan. This creates an opportunity for clinicians to intervene. The patient may attempt to cover up suicidal intent by stating, “I was just playing around” or “I just wanted to get attention.” Recognizing the emergency posed by a suicide rehearsal informs treatment. Safety measures—including 1-to-1 supervision—may be necessary during a period of acute, high suicide risk. The patient’s diagnosis, severity of illness, and treatment require reevaluation.

An outpatient who performs a suicide rehearsal should be considered at acute, high risk for suicide, and immediate psychiatric hospitalization may be necessary. Whether as an inpatient or outpatient, the patient’s suicide intent and plan require careful exploration. The information gained will guide treatment and management decisions. Continuing systematic suicide risk assessment is essential.

Related Resources

• American Association of Suicidology. www.suicidology.org.
• Joiner T. Why people die by suicide. Cambridge, MA: Harvard University Press; 2007.
• American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Washington, DC: American Psychiatric Publishing, Inc. 2003.
• Simon RI. Preventing patient suicide: clinical assessment and management. Arlington, VA: American Psychiatric Publishing, Inc.; 2011.

Disclosure

Dr. Simon reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Patients with delusional infestation (DI) falsely believe that they are infested with tiny infectious agents—typically vermin, insects, or small animals—that crawl on, in, or under their skin, leaving marks and building nests.¹ Patients often describe the pathogens on the skin of hands, arms, feet, lower legs, scalp, or genital areas. They state the pathogen is difficult to diagnose and usually is contracted by human contact. Most patients with DI engage in intensive, repetitive, and often dangerous self-cleansing to get rid of the pathogens, which results in skin lesions.¹ Less often, patients believe they are infested with bacteria or viruses.¹

The typical DI patient is a middle age or older female with few social contacts, no psychiatric history, and normal cognitive and social function.¹ Geriatric patients with dementia and vision or hearing impairment who live in a nursing home may develop DI; it also may be seen in geriatric patients with vascular encephalopathy.

What to consider

First rule out a genuine infestation by referring your patient for dermatologic and microbiologic testing. Order basic laboratory tests to assess inflammation markers—complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, electrolytes, liver function, thyroid-stimulating hormone, and fasting glucose.¹ Suggest a cranial MRI to rule out a brain disorder. Also, perform a urinalysis for cocaine, amphetamines, or cannabinoids, which can cause DI.¹ Rule out medical conditions that are associated with pruritus and psychiatric symptoms, including endocrine, renal, hepatic, rheumatoid, and nutritional conditions.

Treating DI patients

Collaborate with a dermatologist, microbiologist, and primary care physician because these clinicians can deliver medical interventions, such as treating skin lesions and prescribing non-sedating antihistamines to alleviate pruritus. The Table¹ offers other suggestions for managing DI patients.

Pharmacotherapy. Although high-quality evidence supporting antipsychotics for treating DI is lacking, olanzapine and risperidone are considered first-line agents; haloperidol and perphenazine also are recommended.¹ Response and remission rates are similar with typical and atypical antipsychotics and the median onset of efficacy with antipsychotics is approximately 1.5 weeks.^1,2 Antidepressants—including escitalopram, sertraline, mirtazapine, and venlafaxine—have been shown to effectively treat DI.³ In treatment-resistant cases, pimozide and electroconvulsive therapy have been used.¹

Psychotherapy is effective for only 10% of DI patients.⁴

Table

Treating patients with DI: What to do and what to avoid

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Patients with delusional infestation (DI) falsely believe that they are infested with tiny infectious agents—typically vermin, insects, or small animals—that crawl on, in, or under their skin, leaving marks and building nests.¹ Patients often describe the pathogens on the skin of hands, arms, feet, lower legs, scalp, or genital areas. They state the pathogen is difficult to diagnose and usually is contracted by human contact. Most patients with DI engage in intensive, repetitive, and often dangerous self-cleansing to get rid of the pathogens, which results in skin lesions.¹ Less often, patients believe they are infested with bacteria or viruses.¹

The typical DI patient is a middle age or older female with few social contacts, no psychiatric history, and normal cognitive and social function.¹ Geriatric patients with dementia and vision or hearing impairment who live in a nursing home may develop DI; it also may be seen in geriatric patients with vascular encephalopathy.

What to consider

First rule out a genuine infestation by referring your patient for dermatologic and microbiologic testing. Order basic laboratory tests to assess inflammation markers—complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, electrolytes, liver function, thyroid-stimulating hormone, and fasting glucose.¹ Suggest a cranial MRI to rule out a brain disorder. Also, perform a urinalysis for cocaine, amphetamines, or cannabinoids, which can cause DI.¹ Rule out medical conditions that are associated with pruritus and psychiatric symptoms, including endocrine, renal, hepatic, rheumatoid, and nutritional conditions.

Treating DI patients

Collaborate with a dermatologist, microbiologist, and primary care physician because these clinicians can deliver medical interventions, such as treating skin lesions and prescribing non-sedating antihistamines to alleviate pruritus. The Table¹ offers other suggestions for managing DI patients.

Pharmacotherapy. Although high-quality evidence supporting antipsychotics for treating DI is lacking, olanzapine and risperidone are considered first-line agents; haloperidol and perphenazine also are recommended.¹ Response and remission rates are similar with typical and atypical antipsychotics and the median onset of efficacy with antipsychotics is approximately 1.5 weeks.^1,2 Antidepressants—including escitalopram, sertraline, mirtazapine, and venlafaxine—have been shown to effectively treat DI.³ In treatment-resistant cases, pimozide and electroconvulsive therapy have been used.¹

Psychotherapy is effective for only 10% of DI patients.⁴

Table

Treating patients with DI: What to do and what to avoid

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Patients with delusional infestation (DI) falsely believe that they are infested with tiny infectious agents—typically vermin, insects, or small animals—that crawl on, in, or under their skin, leaving marks and building nests.¹ Patients often describe the pathogens on the skin of hands, arms, feet, lower legs, scalp, or genital areas. They state the pathogen is difficult to diagnose and usually is contracted by human contact. Most patients with DI engage in intensive, repetitive, and often dangerous self-cleansing to get rid of the pathogens, which results in skin lesions.¹ Less often, patients believe they are infested with bacteria or viruses.¹

The typical DI patient is a middle age or older female with few social contacts, no psychiatric history, and normal cognitive and social function.¹ Geriatric patients with dementia and vision or hearing impairment who live in a nursing home may develop DI; it also may be seen in geriatric patients with vascular encephalopathy.

What to consider

First rule out a genuine infestation by referring your patient for dermatologic and microbiologic testing. Order basic laboratory tests to assess inflammation markers—complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, electrolytes, liver function, thyroid-stimulating hormone, and fasting glucose.¹ Suggest a cranial MRI to rule out a brain disorder. Also, perform a urinalysis for cocaine, amphetamines, or cannabinoids, which can cause DI.¹ Rule out medical conditions that are associated with pruritus and psychiatric symptoms, including endocrine, renal, hepatic, rheumatoid, and nutritional conditions.

Treating DI patients

Collaborate with a dermatologist, microbiologist, and primary care physician because these clinicians can deliver medical interventions, such as treating skin lesions and prescribing non-sedating antihistamines to alleviate pruritus. The Table¹ offers other suggestions for managing DI patients.

Pharmacotherapy. Although high-quality evidence supporting antipsychotics for treating DI is lacking, olanzapine and risperidone are considered first-line agents; haloperidol and perphenazine also are recommended.¹ Response and remission rates are similar with typical and atypical antipsychotics and the median onset of efficacy with antipsychotics is approximately 1.5 weeks.^1,2 Antidepressants—including escitalopram, sertraline, mirtazapine, and venlafaxine—have been shown to effectively treat DI.³ In treatment-resistant cases, pimozide and electroconvulsive therapy have been used.¹

Psychotherapy is effective for only 10% of DI patients.⁴

Table

Treating patients with DI: What to do and what to avoid

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Suck it up. Tough it out. There is no “I” in team. These are a few of the messages athletes receive from coaches, teammates, and fans. There are norms, values, and expectations in every culture, including sports, that affect behavior and emotional expression. When taking a patient’s history, clinicians may ask about participation in sports because it provides health and lifestyle information. However, many clinicians fail to consider the extent to which sport participation can influence a person’s explanatory style, experience of injury, and attitude toward medications. Whether your patient is an elite athlete or someone who participates in sports solely for exercise, the extent to which he or she identifies as an athlete is worth exploring.

Research on athletes has focused on physical aspects of injury, but this may be just a small component of an athlete’s devastation after serious injury. In this article, we discuss athletes’:

• psychiatric risks after injury
• expression of pain
• risks of having an identity driven solely by sports
• distress tolerance.

We also provide tips for making a differential diagnosis and providing treatment. This information is based on our experience treating athletes, supplemented by relevant literature.

Psychiatric risks after injury

Research has explored eating disorders and substance use among athletes, but clinicians generally are less aware of the prevalence of mood and anxiety disorders in this population. Although participating in sports can protect against emotional distress, athletes who sustain an injury are at risk for major depressive disorder, posttraumatic stress disorder (PTSD), or an adjustment disorder.¹ Only about 10% of injured athletes have severe, long-term psychological consequences,² but the prevalence of anger and depression after an injury is well documented.^3,4 Researchers have found that injured athletes experience clinically significant depression 6 times as often as non-injured athletes.⁵ Injured athletes also exhibit significantly greater anxiety and lower self-esteem than non-injured controls immediately after injury and at 2-month follow-up; those with more severe injuries are more likely to become depressed.⁶ Non-injured athletes seem to experience depression at the same rate as the general population.⁷

Injury and expression of pain

Psychiatric illnesses often are underreported and undertreated in athletes.⁸ This may be because athletes feel that admitting they have a psychiatric illness or symptoms could threaten their status with their team. One professional figure skater we treated failed to seek recommended treatment for a psychiatric disorder because she feared she would be asked to leave her skating company. Her symptoms dangerously escalated before she was hospitalized.

Based on our clinical experience, many athletes feel acute pressure to play through psychological and physical pain. Some athletes continue to play with an injury to hold on to a paycheck or scholarship. Some continue to play even though they no longer enjoy the sport to prevent letting down parents or coaches; others know no other way but to “tough it out.” Supporters such as coaches, parents, or teammates may encourage athletes to play with injury, and sometimes provide medication to do so.

Mostly, however, the pressure to continue to play despite injury comes from athletes themselves. The culture of sport may lead athletes to minimize pain, fear, and self doubt.⁹ Athletes who fuse the culture of sport with their own being may underreport physical and psychiatric symptoms. In a survey of National Collegiate Athletic Association Division I athletes, Nixon⁹ found that 70% of respondents reported having been injured at least once, and more than one-half felt pressure to play while injured. Feeling pressure to perform with injury was affected by “starter” status, and whites and men scored highest on pressure scales, although women showed a roughly equal probability of playing through injury. Students who received an athletic scholarship experienced more injuries that required surgery. There was no difference in pain expression between players of contact and non-contact sports. Finally, athletes may be less likely to seek pharmacologic treatments because of cultural messages that emphasize ideas such as “the body is a temple.”

Loss of identity

An athlete’s injury should be analyzed for meaning; what may seem insignificant to one person may be quite different for another. When injury makes athletic activity impossible, an athlete may suffer more distress than someone who does not exercise regularly. Understanding the significance of the experience for an athlete is crucial to achieving recovery.¹⁰ For example, to a non-athlete a fractured wrist may be an annoyance, but it may be disastrous to a collegiate pitcher who is forced to be inactive when scouts for Major League Baseball teams search for prospects.

To an athlete, injury can mean loss of identity. Whereas most people become competent in many aspects of life, and develop support systems across multiple contexts, an athlete—particularly an extraordinarily talented one—may have focused only on his or her sport. Although athletics can help young people develop confidence, participation also can be a trap. Individuals with strong athletic identities are less likely to explore other career, educational, and lifestyle options.¹¹ In the context of team sports, an athlete may feel less emotionally supported if an injury results in the loss of his or her central role with the team. Helping athletes form an identity that is not based solely on sports is ideal because subsequent injuries could lead to recurrent struggles with loss of identity.

Athletes who achieve higher levels of success have higher levels of depression and higher suicidal ideation after injury.¹² An athlete may attempt or complete suicide, particularly those who are injured (Box).^13-16

Student athletes. When working with student athletes, it is crucial to understand the lifestyle that promotes forming a single-factor identity. Student athletes may be required to train 2 or 3 times a day, rarely spend their school breaks in tropical locations, often miss social events, and may forgo commencement ceremonies. When an injury suddenly makes these perpetual sacrifices seem to be in vain, the risk of psychiatric illness may increase.

Box

Tolerating distress

Athletes often use their sport as an outlet for emotional expression. When an injury removes that outlet, an athlete may develop anxiety and disappointment. Left alone to manage these emotions, an athlete may become irritable, passive, socially isolated, depressed, or suicidal.¹⁷ Trying but failing to find socially acceptable ways to express these feelings may intensify depression or anger. Difficult life issues, such as avoided losses, relationship issues, or various insecurities, may come to the surface when an athlete’s primary coping skill is lost. In addition, without the support of the athletic “family” (eg, teammates, coaches, staff) many athletes turn to alcohol or drugs unless they have alternate coping strategies and social supports.¹⁸

Overtraining and stress

The differential diagnosis for athletes who present with psychiatric symptoms includes several mood and anxiety disorders and other conditions (Table). When evaluating athletes who have depressive symptoms, it is essential to rule out overtraining syndrome (OTS). A common phenomenon among athletes, OTS is characterized by athletic “staleness” and chronic fatigue.¹⁹ Although there are no official OTS diagnostic criteria, characteristic symptoms include decreased physical performance or stamina, fatigue, insomnia, change in appetite, irritability, restlessness, excitability, anxiety, weight loss, loss of motivation, and poor concentration.¹⁹ The primary distinction between OTS and depression is that OTS results from athletic endeavors and can be reversed by reducing activity.

Experiencing an injury—or even a near-miss—can be terrifying to a person who derives his or her identity from a fully functioning body and feels that a perfectly working body is essential to an acceptable life. Such athletes may develop acute stress disorder or PTSD.^20,21 We treated a hockey player who just missed being involved in a serious incident on the ice. “I watched my whole athletic career up to that point flash before my eyes.… I keep getting flashes of that,” he said. After the incident, he experienced hypervigilance, avoidance, and anxiety—both on and off the ice—and was diagnosed with acute stress disorder. Similarly, we cared for a young running back whose physical symptoms had abated after experiencing a concussion. He developed an irrational fear that he would become injured again. Neither athlete had a history of psychiatric illness or serious injury, and both were paralyzed by the idea of returning to play. One of these athletes successfully engaged in exposure therapy, and the other experienced severe avoidance, hopelessness, depression, nightmares, and flashbacks before seeking treatment.

Table

Differential diagnosis of conditions associated with athletic injury

Substance use: Common and risky

Anecdotal and clinical evidence suggests that athletes in different sports engage in different substance abuse patterns. Studies show that college athletes use alcohol at higher rates than non-athletes.^22,23 In 2000, the American College of Sports Medicine reported that athletes’ abuse of recreational drugs far surpasses their abuse of performance-enhancing drugs.²⁴ Some athletes may use prescription pain medications recreationally or to self-medicate emotional pain as a result of injury. Athletes may not understand the risks of recreational use of prescription medications or illicit substances—such as cocaine’s deleterious cardiovascular effects—and may hesitate to discuss their self-medicating with physicians.

Some athletes abuse performance-enhancing drugs, such as anabolic steroids, androstenedione, stimulants, diuretics, and creatine.²⁵ Side effects of these substances include liver disease, brain hemorrhage, weight loss, and depression.²⁵

Our recommendations

Working with athletes—particularly injured athletes who have internalized sports culture—requires informed clinical effort, whether your patient is a student athlete, elite athlete, leisure athlete, or former athlete. Successful diagnosis and treatment requires understanding the meaning of athletics in your patient’s life and the extent to which he or she has “back-up” stress relievers and support systems, and assessing for cognitive dysfunction that may contribute to mood or anxiety symptoms. During evaluation, take a careful history to distinguish major depression or adjustment disorders from OTS, and assess for PTSD symptoms. When treating an injured athlete, help the patient determine whether he or she can find another outlet—preferably more than one—to replace athletics.

For an athlete who has depressive symptoms, we recommend determining whether the patient’s symptoms remit after a brief period of rest before initiating pharmacotherapy. For patients who exhibit minimal neurovegetative features, we recommend psychotherapy as a first-line treatment. Many athletes are reluctant to take medication and would be more likely to follow through with cognitive-behavioral and biofeedback interventions.

If a patient requires pharmacotherapy, ask about his or her feelings toward medications that may impact adherence. For example, is a gymnast worried about weight gain? Is a sprinter concerned with lethargy? When prescribing, be aware of the prevalence of drug and alcohol problems among athletes, understand how habits and temptations differ among sports cultures, and provide patients with psychoeducation about substance abuse when appropriate.

Related Resources

• International Society for Sports Psychiatry. http://sportspsychiatry.org.
• Sabo D, Miller KE, Melnick MJ, et al. High school athletic participation and adolescent suicide: a nationwide U.S. study. Int Rev Sociol Sport. 2005;40(1):5-23. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2563797. Accessed June 7, 2012.

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Suck it up. Tough it out. There is no “I” in team. These are a few of the messages athletes receive from coaches, teammates, and fans. There are norms, values, and expectations in every culture, including sports, that affect behavior and emotional expression. When taking a patient’s history, clinicians may ask about participation in sports because it provides health and lifestyle information. However, many clinicians fail to consider the extent to which sport participation can influence a person’s explanatory style, experience of injury, and attitude toward medications. Whether your patient is an elite athlete or someone who participates in sports solely for exercise, the extent to which he or she identifies as an athlete is worth exploring.

Research on athletes has focused on physical aspects of injury, but this may be just a small component of an athlete’s devastation after serious injury. In this article, we discuss athletes’:

• psychiatric risks after injury
• expression of pain
• risks of having an identity driven solely by sports
• distress tolerance.

We also provide tips for making a differential diagnosis and providing treatment. This information is based on our experience treating athletes, supplemented by relevant literature.

Psychiatric risks after injury

Research has explored eating disorders and substance use among athletes, but clinicians generally are less aware of the prevalence of mood and anxiety disorders in this population. Although participating in sports can protect against emotional distress, athletes who sustain an injury are at risk for major depressive disorder, posttraumatic stress disorder (PTSD), or an adjustment disorder.¹ Only about 10% of injured athletes have severe, long-term psychological consequences,² but the prevalence of anger and depression after an injury is well documented.^3,4 Researchers have found that injured athletes experience clinically significant depression 6 times as often as non-injured athletes.⁵ Injured athletes also exhibit significantly greater anxiety and lower self-esteem than non-injured controls immediately after injury and at 2-month follow-up; those with more severe injuries are more likely to become depressed.⁶ Non-injured athletes seem to experience depression at the same rate as the general population.⁷

Injury and expression of pain

Psychiatric illnesses often are underreported and undertreated in athletes.⁸ This may be because athletes feel that admitting they have a psychiatric illness or symptoms could threaten their status with their team. One professional figure skater we treated failed to seek recommended treatment for a psychiatric disorder because she feared she would be asked to leave her skating company. Her symptoms dangerously escalated before she was hospitalized.

Based on our clinical experience, many athletes feel acute pressure to play through psychological and physical pain. Some athletes continue to play with an injury to hold on to a paycheck or scholarship. Some continue to play even though they no longer enjoy the sport to prevent letting down parents or coaches; others know no other way but to “tough it out.” Supporters such as coaches, parents, or teammates may encourage athletes to play with injury, and sometimes provide medication to do so.

Mostly, however, the pressure to continue to play despite injury comes from athletes themselves. The culture of sport may lead athletes to minimize pain, fear, and self doubt.⁹ Athletes who fuse the culture of sport with their own being may underreport physical and psychiatric symptoms. In a survey of National Collegiate Athletic Association Division I athletes, Nixon⁹ found that 70% of respondents reported having been injured at least once, and more than one-half felt pressure to play while injured. Feeling pressure to perform with injury was affected by “starter” status, and whites and men scored highest on pressure scales, although women showed a roughly equal probability of playing through injury. Students who received an athletic scholarship experienced more injuries that required surgery. There was no difference in pain expression between players of contact and non-contact sports. Finally, athletes may be less likely to seek pharmacologic treatments because of cultural messages that emphasize ideas such as “the body is a temple.”

Loss of identity

An athlete’s injury should be analyzed for meaning; what may seem insignificant to one person may be quite different for another. When injury makes athletic activity impossible, an athlete may suffer more distress than someone who does not exercise regularly. Understanding the significance of the experience for an athlete is crucial to achieving recovery.¹⁰ For example, to a non-athlete a fractured wrist may be an annoyance, but it may be disastrous to a collegiate pitcher who is forced to be inactive when scouts for Major League Baseball teams search for prospects.

To an athlete, injury can mean loss of identity. Whereas most people become competent in many aspects of life, and develop support systems across multiple contexts, an athlete—particularly an extraordinarily talented one—may have focused only on his or her sport. Although athletics can help young people develop confidence, participation also can be a trap. Individuals with strong athletic identities are less likely to explore other career, educational, and lifestyle options.¹¹ In the context of team sports, an athlete may feel less emotionally supported if an injury results in the loss of his or her central role with the team. Helping athletes form an identity that is not based solely on sports is ideal because subsequent injuries could lead to recurrent struggles with loss of identity.

Athletes who achieve higher levels of success have higher levels of depression and higher suicidal ideation after injury.¹² An athlete may attempt or complete suicide, particularly those who are injured (Box).^13-16

Student athletes. When working with student athletes, it is crucial to understand the lifestyle that promotes forming a single-factor identity. Student athletes may be required to train 2 or 3 times a day, rarely spend their school breaks in tropical locations, often miss social events, and may forgo commencement ceremonies. When an injury suddenly makes these perpetual sacrifices seem to be in vain, the risk of psychiatric illness may increase.

Box

Tolerating distress

Athletes often use their sport as an outlet for emotional expression. When an injury removes that outlet, an athlete may develop anxiety and disappointment. Left alone to manage these emotions, an athlete may become irritable, passive, socially isolated, depressed, or suicidal.¹⁷ Trying but failing to find socially acceptable ways to express these feelings may intensify depression or anger. Difficult life issues, such as avoided losses, relationship issues, or various insecurities, may come to the surface when an athlete’s primary coping skill is lost. In addition, without the support of the athletic “family” (eg, teammates, coaches, staff) many athletes turn to alcohol or drugs unless they have alternate coping strategies and social supports.¹⁸

Overtraining and stress

The differential diagnosis for athletes who present with psychiatric symptoms includes several mood and anxiety disorders and other conditions (Table). When evaluating athletes who have depressive symptoms, it is essential to rule out overtraining syndrome (OTS). A common phenomenon among athletes, OTS is characterized by athletic “staleness” and chronic fatigue.¹⁹ Although there are no official OTS diagnostic criteria, characteristic symptoms include decreased physical performance or stamina, fatigue, insomnia, change in appetite, irritability, restlessness, excitability, anxiety, weight loss, loss of motivation, and poor concentration.¹⁹ The primary distinction between OTS and depression is that OTS results from athletic endeavors and can be reversed by reducing activity.

Experiencing an injury—or even a near-miss—can be terrifying to a person who derives his or her identity from a fully functioning body and feels that a perfectly working body is essential to an acceptable life. Such athletes may develop acute stress disorder or PTSD.^20,21 We treated a hockey player who just missed being involved in a serious incident on the ice. “I watched my whole athletic career up to that point flash before my eyes.… I keep getting flashes of that,” he said. After the incident, he experienced hypervigilance, avoidance, and anxiety—both on and off the ice—and was diagnosed with acute stress disorder. Similarly, we cared for a young running back whose physical symptoms had abated after experiencing a concussion. He developed an irrational fear that he would become injured again. Neither athlete had a history of psychiatric illness or serious injury, and both were paralyzed by the idea of returning to play. One of these athletes successfully engaged in exposure therapy, and the other experienced severe avoidance, hopelessness, depression, nightmares, and flashbacks before seeking treatment.

Table

Differential diagnosis of conditions associated with athletic injury

Substance use: Common and risky

Anecdotal and clinical evidence suggests that athletes in different sports engage in different substance abuse patterns. Studies show that college athletes use alcohol at higher rates than non-athletes.^22,23 In 2000, the American College of Sports Medicine reported that athletes’ abuse of recreational drugs far surpasses their abuse of performance-enhancing drugs.²⁴ Some athletes may use prescription pain medications recreationally or to self-medicate emotional pain as a result of injury. Athletes may not understand the risks of recreational use of prescription medications or illicit substances—such as cocaine’s deleterious cardiovascular effects—and may hesitate to discuss their self-medicating with physicians.

Some athletes abuse performance-enhancing drugs, such as anabolic steroids, androstenedione, stimulants, diuretics, and creatine.²⁵ Side effects of these substances include liver disease, brain hemorrhage, weight loss, and depression.²⁵

Our recommendations

Working with athletes—particularly injured athletes who have internalized sports culture—requires informed clinical effort, whether your patient is a student athlete, elite athlete, leisure athlete, or former athlete. Successful diagnosis and treatment requires understanding the meaning of athletics in your patient’s life and the extent to which he or she has “back-up” stress relievers and support systems, and assessing for cognitive dysfunction that may contribute to mood or anxiety symptoms. During evaluation, take a careful history to distinguish major depression or adjustment disorders from OTS, and assess for PTSD symptoms. When treating an injured athlete, help the patient determine whether he or she can find another outlet—preferably more than one—to replace athletics.

For an athlete who has depressive symptoms, we recommend determining whether the patient’s symptoms remit after a brief period of rest before initiating pharmacotherapy. For patients who exhibit minimal neurovegetative features, we recommend psychotherapy as a first-line treatment. Many athletes are reluctant to take medication and would be more likely to follow through with cognitive-behavioral and biofeedback interventions.

If a patient requires pharmacotherapy, ask about his or her feelings toward medications that may impact adherence. For example, is a gymnast worried about weight gain? Is a sprinter concerned with lethargy? When prescribing, be aware of the prevalence of drug and alcohol problems among athletes, understand how habits and temptations differ among sports cultures, and provide patients with psychoeducation about substance abuse when appropriate.

Related Resources

• International Society for Sports Psychiatry. http://sportspsychiatry.org.
• Sabo D, Miller KE, Melnick MJ, et al. High school athletic participation and adolescent suicide: a nationwide U.S. study. Int Rev Sociol Sport. 2005;40(1):5-23. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2563797. Accessed June 7, 2012.

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Suck it up. Tough it out. There is no “I” in team. These are a few of the messages athletes receive from coaches, teammates, and fans. There are norms, values, and expectations in every culture, including sports, that affect behavior and emotional expression. When taking a patient’s history, clinicians may ask about participation in sports because it provides health and lifestyle information. However, many clinicians fail to consider the extent to which sport participation can influence a person’s explanatory style, experience of injury, and attitude toward medications. Whether your patient is an elite athlete or someone who participates in sports solely for exercise, the extent to which he or she identifies as an athlete is worth exploring.

Research on athletes has focused on physical aspects of injury, but this may be just a small component of an athlete’s devastation after serious injury. In this article, we discuss athletes’:

• psychiatric risks after injury
• expression of pain
• risks of having an identity driven solely by sports
• distress tolerance.

We also provide tips for making a differential diagnosis and providing treatment. This information is based on our experience treating athletes, supplemented by relevant literature.

Psychiatric risks after injury

Research has explored eating disorders and substance use among athletes, but clinicians generally are less aware of the prevalence of mood and anxiety disorders in this population. Although participating in sports can protect against emotional distress, athletes who sustain an injury are at risk for major depressive disorder, posttraumatic stress disorder (PTSD), or an adjustment disorder.¹ Only about 10% of injured athletes have severe, long-term psychological consequences,² but the prevalence of anger and depression after an injury is well documented.^3,4 Researchers have found that injured athletes experience clinically significant depression 6 times as often as non-injured athletes.⁵ Injured athletes also exhibit significantly greater anxiety and lower self-esteem than non-injured controls immediately after injury and at 2-month follow-up; those with more severe injuries are more likely to become depressed.⁶ Non-injured athletes seem to experience depression at the same rate as the general population.⁷

Injury and expression of pain

Psychiatric illnesses often are underreported and undertreated in athletes.⁸ This may be because athletes feel that admitting they have a psychiatric illness or symptoms could threaten their status with their team. One professional figure skater we treated failed to seek recommended treatment for a psychiatric disorder because she feared she would be asked to leave her skating company. Her symptoms dangerously escalated before she was hospitalized.

Based on our clinical experience, many athletes feel acute pressure to play through psychological and physical pain. Some athletes continue to play with an injury to hold on to a paycheck or scholarship. Some continue to play even though they no longer enjoy the sport to prevent letting down parents or coaches; others know no other way but to “tough it out.” Supporters such as coaches, parents, or teammates may encourage athletes to play with injury, and sometimes provide medication to do so.

Mostly, however, the pressure to continue to play despite injury comes from athletes themselves. The culture of sport may lead athletes to minimize pain, fear, and self doubt.⁹ Athletes who fuse the culture of sport with their own being may underreport physical and psychiatric symptoms. In a survey of National Collegiate Athletic Association Division I athletes, Nixon⁹ found that 70% of respondents reported having been injured at least once, and more than one-half felt pressure to play while injured. Feeling pressure to perform with injury was affected by “starter” status, and whites and men scored highest on pressure scales, although women showed a roughly equal probability of playing through injury. Students who received an athletic scholarship experienced more injuries that required surgery. There was no difference in pain expression between players of contact and non-contact sports. Finally, athletes may be less likely to seek pharmacologic treatments because of cultural messages that emphasize ideas such as “the body is a temple.”

Loss of identity

An athlete’s injury should be analyzed for meaning; what may seem insignificant to one person may be quite different for another. When injury makes athletic activity impossible, an athlete may suffer more distress than someone who does not exercise regularly. Understanding the significance of the experience for an athlete is crucial to achieving recovery.¹⁰ For example, to a non-athlete a fractured wrist may be an annoyance, but it may be disastrous to a collegiate pitcher who is forced to be inactive when scouts for Major League Baseball teams search for prospects.

To an athlete, injury can mean loss of identity. Whereas most people become competent in many aspects of life, and develop support systems across multiple contexts, an athlete—particularly an extraordinarily talented one—may have focused only on his or her sport. Although athletics can help young people develop confidence, participation also can be a trap. Individuals with strong athletic identities are less likely to explore other career, educational, and lifestyle options.¹¹ In the context of team sports, an athlete may feel less emotionally supported if an injury results in the loss of his or her central role with the team. Helping athletes form an identity that is not based solely on sports is ideal because subsequent injuries could lead to recurrent struggles with loss of identity.

Athletes who achieve higher levels of success have higher levels of depression and higher suicidal ideation after injury.¹² An athlete may attempt or complete suicide, particularly those who are injured (Box).^13-16

Student athletes. When working with student athletes, it is crucial to understand the lifestyle that promotes forming a single-factor identity. Student athletes may be required to train 2 or 3 times a day, rarely spend their school breaks in tropical locations, often miss social events, and may forgo commencement ceremonies. When an injury suddenly makes these perpetual sacrifices seem to be in vain, the risk of psychiatric illness may increase.

Box

Tolerating distress

Athletes often use their sport as an outlet for emotional expression. When an injury removes that outlet, an athlete may develop anxiety and disappointment. Left alone to manage these emotions, an athlete may become irritable, passive, socially isolated, depressed, or suicidal.¹⁷ Trying but failing to find socially acceptable ways to express these feelings may intensify depression or anger. Difficult life issues, such as avoided losses, relationship issues, or various insecurities, may come to the surface when an athlete’s primary coping skill is lost. In addition, without the support of the athletic “family” (eg, teammates, coaches, staff) many athletes turn to alcohol or drugs unless they have alternate coping strategies and social supports.¹⁸

Overtraining and stress

The differential diagnosis for athletes who present with psychiatric symptoms includes several mood and anxiety disorders and other conditions (Table). When evaluating athletes who have depressive symptoms, it is essential to rule out overtraining syndrome (OTS). A common phenomenon among athletes, OTS is characterized by athletic “staleness” and chronic fatigue.¹⁹ Although there are no official OTS diagnostic criteria, characteristic symptoms include decreased physical performance or stamina, fatigue, insomnia, change in appetite, irritability, restlessness, excitability, anxiety, weight loss, loss of motivation, and poor concentration.¹⁹ The primary distinction between OTS and depression is that OTS results from athletic endeavors and can be reversed by reducing activity.

Experiencing an injury—or even a near-miss—can be terrifying to a person who derives his or her identity from a fully functioning body and feels that a perfectly working body is essential to an acceptable life. Such athletes may develop acute stress disorder or PTSD.^20,21 We treated a hockey player who just missed being involved in a serious incident on the ice. “I watched my whole athletic career up to that point flash before my eyes.… I keep getting flashes of that,” he said. After the incident, he experienced hypervigilance, avoidance, and anxiety—both on and off the ice—and was diagnosed with acute stress disorder. Similarly, we cared for a young running back whose physical symptoms had abated after experiencing a concussion. He developed an irrational fear that he would become injured again. Neither athlete had a history of psychiatric illness or serious injury, and both were paralyzed by the idea of returning to play. One of these athletes successfully engaged in exposure therapy, and the other experienced severe avoidance, hopelessness, depression, nightmares, and flashbacks before seeking treatment.

Table

Differential diagnosis of conditions associated with athletic injury

Substance use: Common and risky

Anecdotal and clinical evidence suggests that athletes in different sports engage in different substance abuse patterns. Studies show that college athletes use alcohol at higher rates than non-athletes.^22,23 In 2000, the American College of Sports Medicine reported that athletes’ abuse of recreational drugs far surpasses their abuse of performance-enhancing drugs.²⁴ Some athletes may use prescription pain medications recreationally or to self-medicate emotional pain as a result of injury. Athletes may not understand the risks of recreational use of prescription medications or illicit substances—such as cocaine’s deleterious cardiovascular effects—and may hesitate to discuss their self-medicating with physicians.

Some athletes abuse performance-enhancing drugs, such as anabolic steroids, androstenedione, stimulants, diuretics, and creatine.²⁵ Side effects of these substances include liver disease, brain hemorrhage, weight loss, and depression.²⁵

Our recommendations

Working with athletes—particularly injured athletes who have internalized sports culture—requires informed clinical effort, whether your patient is a student athlete, elite athlete, leisure athlete, or former athlete. Successful diagnosis and treatment requires understanding the meaning of athletics in your patient’s life and the extent to which he or she has “back-up” stress relievers and support systems, and assessing for cognitive dysfunction that may contribute to mood or anxiety symptoms. During evaluation, take a careful history to distinguish major depression or adjustment disorders from OTS, and assess for PTSD symptoms. When treating an injured athlete, help the patient determine whether he or she can find another outlet—preferably more than one—to replace athletics.

For an athlete who has depressive symptoms, we recommend determining whether the patient’s symptoms remit after a brief period of rest before initiating pharmacotherapy. For patients who exhibit minimal neurovegetative features, we recommend psychotherapy as a first-line treatment. Many athletes are reluctant to take medication and would be more likely to follow through with cognitive-behavioral and biofeedback interventions.

If a patient requires pharmacotherapy, ask about his or her feelings toward medications that may impact adherence. For example, is a gymnast worried about weight gain? Is a sprinter concerned with lethargy? When prescribing, be aware of the prevalence of drug and alcohol problems among athletes, understand how habits and temptations differ among sports cultures, and provide patients with psychoeducation about substance abuse when appropriate.

Related Resources

• International Society for Sports Psychiatry. http://sportspsychiatry.org.
• Sabo D, Miller KE, Melnick MJ, et al. High school athletic participation and adolescent suicide: a nationwide U.S. study. Int Rev Sociol Sport. 2005;40(1):5-23. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2563797. Accessed June 7, 2012.

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

AMSTERDAM – Although it is rare and the prognosis for patients is often poor, the presence of central nervous system involvement at the time of diagnosis of mantle cell lymphoma is not always immediately fatal, according to findings from an international study.

According to the European Mantle Cell Lymphoma Network (EMCLN) findings, the crude prevalence of CNS events was 0.9% at the time of diagnosis and 4.1% at any time. The multicenter, retrospective study found that the median time to a CNS event’s occurring was 15.2 months, with an overall survival of 3.9 months after the event was identified, but some patients were still alive 2 years later.

"We now have some better descriptors about what the expectations and outcome of patients with central nervous system involvement are," Dr. John Seymour said in an interview at the annual congress of the European Hematology Association.

Dr. Seymour, professor and chair of the hematology service at Australia’s Peter MacCallum Cancer Centre in East Melbourne, Victoria, added that even though the overall prognosis of patients who develop CNS involvement is very poor, there are some patients who do better than others.

There is "a subgroup [of patients] who are able to receive high-dose ara-c [cytarabine] or high-dose methotrexate treatment, who are young and fit enough, who do somewhat better," Dr. Seymour said. "A proportion will be alive at 2 years, so it’s not an inevitably, rapidly fatal, and ... futile situation."

Mantle cell lymphomas are a rare type of non-Hodgkin’s lymphoma (NHL), accounting for just less than 3% of all NHL cases in the United States and affecting primarily more elderly patients (Cancer 2008;113:791-8).CNS involvement is also a rare and often devastating event, but it has not previously been very well characterized. As a result, it’s not known whether CNS prophylaxis is of benefit to patients.

The aim of the EMCLN study, therefore, was to look at the problem in more detail, to determine the prevalence of CNS involvement, and to look for any clinically defining features, effect of treatment, and patient outcomes.

A retrospective database review by EMCLN members in 12 centers identified 1,396 patients with mantle cell lymphoma, of whom 1,339 had no CNS involvement. Of the 57 patients with CNS involvement, most (44) developed it at some point during the course of their follow-up.

At diagnosis of mantle cell lymphoma, the patients who developed CNS involvement had a median age of 61 years, but this ranged from 38 years to 82 years; patients were predominantly men (70%), with stage IV (91%) disease, and 28% had blastoid histology. Isolated CNS involvement occurred in 15 cases.

Prominent features were a high MIPI (Mantle Cell Lymphoma International Prognostic Index) score (61% of cases), a Ki-67 greater than 30% in 69% of patients, and increased beta₂-microglobulin and lactate dehydrogenase in 77% and 75% of cases, respectively. The bone marrow and the peripheral blood were the most common extranodal sites involved, affecting two or more sites in 61% of patients.

At diagnosis of CNS involvement, patients’ neurologic symptoms included weakness, altered mental state, headache, and ocular problems such as double vision. Other symptoms – such as sensory disturbances, pain, sciatica, dizziness, vertigo, ataxia, seizure, and dysphagia – occurred but were less frequent.

CSF cytology and flow cytometry showed a high sensitivity for identifying CNS involvement, with 85% having positive cytology and 91% a positive flow cytometry result.

"Patients had a range of chemotherapies prior to developing central nervous system involvement, but receipt of these regimens was not totally protective," Dr. Seymour said. Data were not collected to enable the relative risk of CNS development with the regimens received.

Chemotherapy was the most frequent treatment strategy to allay CNS disease (67%), and some patients did appear to achieve a complete remission of the CNS disease as a result. In an exploratory analysis, these patients also tended to have improved overall survival, as did those with lower white cell counts (less than 10.9 x 10⁹/L), and who received treatment with high-dose antimetabolites.

"In the longer term, these data will provide a foundation for us to identify predictive factors, to identify – ahead of the event – those people at increased risk," Dr. Seymour said, adding his hope that this will allow preventive steps to be taken.

Dr. Seymour had no conflicts of interest.

AMSTERDAM – Although it is rare and the prognosis for patients is often poor, the presence of central nervous system involvement at the time of diagnosis of mantle cell lymphoma is not always immediately fatal, according to findings from an international study.

According to the European Mantle Cell Lymphoma Network (EMCLN) findings, the crude prevalence of CNS events was 0.9% at the time of diagnosis and 4.1% at any time. The multicenter, retrospective study found that the median time to a CNS event’s occurring was 15.2 months, with an overall survival of 3.9 months after the event was identified, but some patients were still alive 2 years later.

"We now have some better descriptors about what the expectations and outcome of patients with central nervous system involvement are," Dr. John Seymour said in an interview at the annual congress of the European Hematology Association.

Dr. Seymour, professor and chair of the hematology service at Australia’s Peter MacCallum Cancer Centre in East Melbourne, Victoria, added that even though the overall prognosis of patients who develop CNS involvement is very poor, there are some patients who do better than others.

There is "a subgroup [of patients] who are able to receive high-dose ara-c [cytarabine] or high-dose methotrexate treatment, who are young and fit enough, who do somewhat better," Dr. Seymour said. "A proportion will be alive at 2 years, so it’s not an inevitably, rapidly fatal, and ... futile situation."

Mantle cell lymphomas are a rare type of non-Hodgkin’s lymphoma (NHL), accounting for just less than 3% of all NHL cases in the United States and affecting primarily more elderly patients (Cancer 2008;113:791-8).CNS involvement is also a rare and often devastating event, but it has not previously been very well characterized. As a result, it’s not known whether CNS prophylaxis is of benefit to patients.

The aim of the EMCLN study, therefore, was to look at the problem in more detail, to determine the prevalence of CNS involvement, and to look for any clinically defining features, effect of treatment, and patient outcomes.

A retrospective database review by EMCLN members in 12 centers identified 1,396 patients with mantle cell lymphoma, of whom 1,339 had no CNS involvement. Of the 57 patients with CNS involvement, most (44) developed it at some point during the course of their follow-up.

At diagnosis of mantle cell lymphoma, the patients who developed CNS involvement had a median age of 61 years, but this ranged from 38 years to 82 years; patients were predominantly men (70%), with stage IV (91%) disease, and 28% had blastoid histology. Isolated CNS involvement occurred in 15 cases.

Prominent features were a high MIPI (Mantle Cell Lymphoma International Prognostic Index) score (61% of cases), a Ki-67 greater than 30% in 69% of patients, and increased beta₂-microglobulin and lactate dehydrogenase in 77% and 75% of cases, respectively. The bone marrow and the peripheral blood were the most common extranodal sites involved, affecting two or more sites in 61% of patients.

At diagnosis of CNS involvement, patients’ neurologic symptoms included weakness, altered mental state, headache, and ocular problems such as double vision. Other symptoms – such as sensory disturbances, pain, sciatica, dizziness, vertigo, ataxia, seizure, and dysphagia – occurred but were less frequent.

CSF cytology and flow cytometry showed a high sensitivity for identifying CNS involvement, with 85% having positive cytology and 91% a positive flow cytometry result.

"Patients had a range of chemotherapies prior to developing central nervous system involvement, but receipt of these regimens was not totally protective," Dr. Seymour said. Data were not collected to enable the relative risk of CNS development with the regimens received.

Chemotherapy was the most frequent treatment strategy to allay CNS disease (67%), and some patients did appear to achieve a complete remission of the CNS disease as a result. In an exploratory analysis, these patients also tended to have improved overall survival, as did those with lower white cell counts (less than 10.9 x 10⁹/L), and who received treatment with high-dose antimetabolites.

"In the longer term, these data will provide a foundation for us to identify predictive factors, to identify – ahead of the event – those people at increased risk," Dr. Seymour said, adding his hope that this will allow preventive steps to be taken.

Dr. Seymour had no conflicts of interest.

AMSTERDAM – Although it is rare and the prognosis for patients is often poor, the presence of central nervous system involvement at the time of diagnosis of mantle cell lymphoma is not always immediately fatal, according to findings from an international study.

According to the European Mantle Cell Lymphoma Network (EMCLN) findings, the crude prevalence of CNS events was 0.9% at the time of diagnosis and 4.1% at any time. The multicenter, retrospective study found that the median time to a CNS event’s occurring was 15.2 months, with an overall survival of 3.9 months after the event was identified, but some patients were still alive 2 years later.

"We now have some better descriptors about what the expectations and outcome of patients with central nervous system involvement are," Dr. John Seymour said in an interview at the annual congress of the European Hematology Association.

Dr. Seymour, professor and chair of the hematology service at Australia’s Peter MacCallum Cancer Centre in East Melbourne, Victoria, added that even though the overall prognosis of patients who develop CNS involvement is very poor, there are some patients who do better than others.

There is "a subgroup [of patients] who are able to receive high-dose ara-c [cytarabine] or high-dose methotrexate treatment, who are young and fit enough, who do somewhat better," Dr. Seymour said. "A proportion will be alive at 2 years, so it’s not an inevitably, rapidly fatal, and ... futile situation."

Mantle cell lymphomas are a rare type of non-Hodgkin’s lymphoma (NHL), accounting for just less than 3% of all NHL cases in the United States and affecting primarily more elderly patients (Cancer 2008;113:791-8).CNS involvement is also a rare and often devastating event, but it has not previously been very well characterized. As a result, it’s not known whether CNS prophylaxis is of benefit to patients.

The aim of the EMCLN study, therefore, was to look at the problem in more detail, to determine the prevalence of CNS involvement, and to look for any clinically defining features, effect of treatment, and patient outcomes.

A retrospective database review by EMCLN members in 12 centers identified 1,396 patients with mantle cell lymphoma, of whom 1,339 had no CNS involvement. Of the 57 patients with CNS involvement, most (44) developed it at some point during the course of their follow-up.

At diagnosis of mantle cell lymphoma, the patients who developed CNS involvement had a median age of 61 years, but this ranged from 38 years to 82 years; patients were predominantly men (70%), with stage IV (91%) disease, and 28% had blastoid histology. Isolated CNS involvement occurred in 15 cases.

Prominent features were a high MIPI (Mantle Cell Lymphoma International Prognostic Index) score (61% of cases), a Ki-67 greater than 30% in 69% of patients, and increased beta₂-microglobulin and lactate dehydrogenase in 77% and 75% of cases, respectively. The bone marrow and the peripheral blood were the most common extranodal sites involved, affecting two or more sites in 61% of patients.

At diagnosis of CNS involvement, patients’ neurologic symptoms included weakness, altered mental state, headache, and ocular problems such as double vision. Other symptoms – such as sensory disturbances, pain, sciatica, dizziness, vertigo, ataxia, seizure, and dysphagia – occurred but were less frequent.

CSF cytology and flow cytometry showed a high sensitivity for identifying CNS involvement, with 85% having positive cytology and 91% a positive flow cytometry result.

"Patients had a range of chemotherapies prior to developing central nervous system involvement, but receipt of these regimens was not totally protective," Dr. Seymour said. Data were not collected to enable the relative risk of CNS development with the regimens received.

Chemotherapy was the most frequent treatment strategy to allay CNS disease (67%), and some patients did appear to achieve a complete remission of the CNS disease as a result. In an exploratory analysis, these patients also tended to have improved overall survival, as did those with lower white cell counts (less than 10.9 x 10⁹/L), and who received treatment with high-dose antimetabolites.

"In the longer term, these data will provide a foundation for us to identify predictive factors, to identify – ahead of the event – those people at increased risk," Dr. Seymour said, adding his hope that this will allow preventive steps to be taken.

Dr. Seymour had no conflicts of interest.

The U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28. Democrats claimed victory while Republicans resolved to repeal the law in Congress and use the justice's comments as ammunition against President Obama in the coming election. See our video for more details.

The U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28. Democrats claimed victory while Republicans resolved to repeal the law in Congress and use the justice's comments as ammunition against President Obama in the coming election. See our video for more details.

The U.S. Supreme Court, in a 5-4 ruling, upheld the constitutionality of most provisions of the Affordable Care Act on June 28. Democrats claimed victory while Republicans resolved to repeal the law in Congress and use the justice's comments as ammunition against President Obama in the coming election. See our video for more details.