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Did PSA finding get lost in the shuffle?...Woman sent home from ER dies of aneurysm...more
Did PSA finding get lost in the shuffle?
A SCREENING PROSTATE-SPECIFIC ANTIGEN (PSA) TEST ordered for a 76-year-old man by his primary care physician was within normal limits at 3.1. Two years later, the patient saw a urologist, who diagnosed renal cysts and bladder trabeculation based on a CT scan. Five months after that, the primary care physician ordered a second screening PSA, which was elevated at 12.
About a week later, the primary care physician noted that the patient was scheduled to see the urologist the next day, but didn’t indicate that the urologist had been informed of the elevated PSA or that the patient had been told of its significance. A letter from the primary care physician to the urologist after the patient’s visit stated that the patient was being treated for microscopic hematuria but didn’t mention elevated PSA. A letter several weeks later from the urologist to the primary care physician discussed the patient’s elevated PSA. The primary care physician didn’t contact the urologist to follow up on the finding, however.
After a year of testing, the urologist concluded that the hematuria was probably related to the kidney, or perhaps the prostate, and started the patient on dutasteride, which helped the bleeding. Two months after the start of treatment, the urologist ordered a PSA test, which was extremely elevated. A subsequent biopsy revealed adenocarcinoma, and a bone scan showed metastatic bony disease, which hadn’t shown up on a bone scan done 6 months before. The patient died 2 years later. The cause of death was listed as cardiopulmonary arrest, cardiogenic shock, and myocardial infarction.
PLAINTIFF’S CLAIM The plaintiff’s claim focused on the handling of the PSA test, though the specifics of the claim were not detailed in the case summary.
DOCTOR’S DEFENSE The primary care physician claimed that his nurse told the patient after the second PSA test that the PSA was 12 and encouraged the patient to see the urologist to discuss the elevated level. The physician also claimed that he had faxed the elevated PSA test result to the urologist and that the patient was reminded of the elevated PSA during his visit to the urologist. No information about the urologist’s defense was available.
VERDICT $325,000 Massachusetts settlement.
COMMENT Coordination of care and documentation of communication are keys to good patient care—and avoiding lawsuits.
Woman sent home from ER dies of aneurysm
SEVERE HEADACHES prompted a 38-year-old woman to visit her family physician, who referred her to a neurologist; an appointment was scheduled for more than a month later. A month after seeing the family physician, the patient went to the emergency room complaining of a severe headache.
A CT scan ordered by the ER physician showed a large mass in the patient’s brain. The ER physician gave the patient the scan report, told her to see her family doctor, and sent her home without consulting a neurosurgeon. Later that day, the aneurysm ruptured; the patient’s family took her to the hospital, where she died the next morning.
PLAINTIFF’S CLAIM The family physician should have ordered a CT scan, which would have revealed the aneurysm. The ER physician should have ordered an immediate neurologic consult, which would have led to surgical repair of the leaking aneurysm. Either measure would have saved the patient’s life.
DOCTOR’S DEFENSE The family physician claimed that the patient’s complaints weren’t urgent and he made a proper referral. The ER physician claimed that the patient wouldn’t have lived even if he’d arranged an immediate consult.
VERDICT $1.5 million Michigan verdict against the ER physician.
COMMENT This case illustrates the value of clearly documenting referrals and suggesting follow-up if a change in symptoms occurs.
Jaundiced newborn dies after slip-ups
AN INFANT BORN AT 36 WEEKS and the baby’s 20-year-old mother were discharged from the hospital fewer than 48 hours after delivery, with an appointment with a visiting nurse for the following day and a pediatrician 3 days later. Hospital medical records reported infrequent breast feeding, significant decrease in weight, and a bruise on the back of the infant’s head.
The visiting nurse who examined the baby noted moderate facial jaundice, mild jaundice in the groin, and slight jaundice in the sclera of the eyes, as well as the bruise on the back of the head. The nurse didn’t notify the pediatrician of the jaundice. The mother said that when she voiced concern about the jaundice, the nurse told her to feed the infant more often and expose her to sunlight.
The day after the nurse’s visit, the parents noticed that the baby was more jaundiced and had started to arch her back, grunt, and whine. The mother called the pediatrician’s office that day and reported the symptoms; the nurse told her that the pediatrician felt that he didn’t need to see the baby before her appointment the following day. As the symptoms worsened, the mother called the pediatrician’s office 3 more times before 6 PM, speaking with 2 nurses, neither of whom took a medical history.
The mother called again after the office had closed. A nurse arranged for the infant to be seen at the hospital, where the baby was admitted with a critically low temperature, decreased muscle tone, arching of the back, and an elevated bilirubin level of 35.4 mg/dL. Despite phototherapy and intubation, the infant’s condition deteriorated, and she was airlifted to another medical facility for more advanced care. The baby was given cardiopulmonary resuscitation on arrival, but died 4 hours later of acute bilirubin encephalopathy.
PLAINTIFF’S CLAIM In light of her symptoms, the baby shouldn’t have been discharged from the hospital. The visiting nurse should have reported the baby’s symptoms to the pediatrician or recommended that the parents take the baby to the doctor right away. The nurses in the pediatrician’s office were negligent in not taking a full medical history. The pediatrician should have seen the baby immediately. He failed to recognize the symptoms of possible hyperbilirubinemia, a medical emergency.
DOCTOR’S DEFENSE No information about the doctor’s or nurses’ defense is available.
VERDICT $460,000 Massachusetts settlement.
COMMENT This case illustrates, once again, the importance of care coordination and sharing information on a timely basis.
Did PSA finding get lost in the shuffle?
A SCREENING PROSTATE-SPECIFIC ANTIGEN (PSA) TEST ordered for a 76-year-old man by his primary care physician was within normal limits at 3.1. Two years later, the patient saw a urologist, who diagnosed renal cysts and bladder trabeculation based on a CT scan. Five months after that, the primary care physician ordered a second screening PSA, which was elevated at 12.
About a week later, the primary care physician noted that the patient was scheduled to see the urologist the next day, but didn’t indicate that the urologist had been informed of the elevated PSA or that the patient had been told of its significance. A letter from the primary care physician to the urologist after the patient’s visit stated that the patient was being treated for microscopic hematuria but didn’t mention elevated PSA. A letter several weeks later from the urologist to the primary care physician discussed the patient’s elevated PSA. The primary care physician didn’t contact the urologist to follow up on the finding, however.
After a year of testing, the urologist concluded that the hematuria was probably related to the kidney, or perhaps the prostate, and started the patient on dutasteride, which helped the bleeding. Two months after the start of treatment, the urologist ordered a PSA test, which was extremely elevated. A subsequent biopsy revealed adenocarcinoma, and a bone scan showed metastatic bony disease, which hadn’t shown up on a bone scan done 6 months before. The patient died 2 years later. The cause of death was listed as cardiopulmonary arrest, cardiogenic shock, and myocardial infarction.
PLAINTIFF’S CLAIM The plaintiff’s claim focused on the handling of the PSA test, though the specifics of the claim were not detailed in the case summary.
DOCTOR’S DEFENSE The primary care physician claimed that his nurse told the patient after the second PSA test that the PSA was 12 and encouraged the patient to see the urologist to discuss the elevated level. The physician also claimed that he had faxed the elevated PSA test result to the urologist and that the patient was reminded of the elevated PSA during his visit to the urologist. No information about the urologist’s defense was available.
VERDICT $325,000 Massachusetts settlement.
COMMENT Coordination of care and documentation of communication are keys to good patient care—and avoiding lawsuits.
Woman sent home from ER dies of aneurysm
SEVERE HEADACHES prompted a 38-year-old woman to visit her family physician, who referred her to a neurologist; an appointment was scheduled for more than a month later. A month after seeing the family physician, the patient went to the emergency room complaining of a severe headache.
A CT scan ordered by the ER physician showed a large mass in the patient’s brain. The ER physician gave the patient the scan report, told her to see her family doctor, and sent her home without consulting a neurosurgeon. Later that day, the aneurysm ruptured; the patient’s family took her to the hospital, where she died the next morning.
PLAINTIFF’S CLAIM The family physician should have ordered a CT scan, which would have revealed the aneurysm. The ER physician should have ordered an immediate neurologic consult, which would have led to surgical repair of the leaking aneurysm. Either measure would have saved the patient’s life.
DOCTOR’S DEFENSE The family physician claimed that the patient’s complaints weren’t urgent and he made a proper referral. The ER physician claimed that the patient wouldn’t have lived even if he’d arranged an immediate consult.
VERDICT $1.5 million Michigan verdict against the ER physician.
COMMENT This case illustrates the value of clearly documenting referrals and suggesting follow-up if a change in symptoms occurs.
Jaundiced newborn dies after slip-ups
AN INFANT BORN AT 36 WEEKS and the baby’s 20-year-old mother were discharged from the hospital fewer than 48 hours after delivery, with an appointment with a visiting nurse for the following day and a pediatrician 3 days later. Hospital medical records reported infrequent breast feeding, significant decrease in weight, and a bruise on the back of the infant’s head.
The visiting nurse who examined the baby noted moderate facial jaundice, mild jaundice in the groin, and slight jaundice in the sclera of the eyes, as well as the bruise on the back of the head. The nurse didn’t notify the pediatrician of the jaundice. The mother said that when she voiced concern about the jaundice, the nurse told her to feed the infant more often and expose her to sunlight.
The day after the nurse’s visit, the parents noticed that the baby was more jaundiced and had started to arch her back, grunt, and whine. The mother called the pediatrician’s office that day and reported the symptoms; the nurse told her that the pediatrician felt that he didn’t need to see the baby before her appointment the following day. As the symptoms worsened, the mother called the pediatrician’s office 3 more times before 6 PM, speaking with 2 nurses, neither of whom took a medical history.
The mother called again after the office had closed. A nurse arranged for the infant to be seen at the hospital, where the baby was admitted with a critically low temperature, decreased muscle tone, arching of the back, and an elevated bilirubin level of 35.4 mg/dL. Despite phototherapy and intubation, the infant’s condition deteriorated, and she was airlifted to another medical facility for more advanced care. The baby was given cardiopulmonary resuscitation on arrival, but died 4 hours later of acute bilirubin encephalopathy.
PLAINTIFF’S CLAIM In light of her symptoms, the baby shouldn’t have been discharged from the hospital. The visiting nurse should have reported the baby’s symptoms to the pediatrician or recommended that the parents take the baby to the doctor right away. The nurses in the pediatrician’s office were negligent in not taking a full medical history. The pediatrician should have seen the baby immediately. He failed to recognize the symptoms of possible hyperbilirubinemia, a medical emergency.
DOCTOR’S DEFENSE No information about the doctor’s or nurses’ defense is available.
VERDICT $460,000 Massachusetts settlement.
COMMENT This case illustrates, once again, the importance of care coordination and sharing information on a timely basis.
Did PSA finding get lost in the shuffle?
A SCREENING PROSTATE-SPECIFIC ANTIGEN (PSA) TEST ordered for a 76-year-old man by his primary care physician was within normal limits at 3.1. Two years later, the patient saw a urologist, who diagnosed renal cysts and bladder trabeculation based on a CT scan. Five months after that, the primary care physician ordered a second screening PSA, which was elevated at 12.
About a week later, the primary care physician noted that the patient was scheduled to see the urologist the next day, but didn’t indicate that the urologist had been informed of the elevated PSA or that the patient had been told of its significance. A letter from the primary care physician to the urologist after the patient’s visit stated that the patient was being treated for microscopic hematuria but didn’t mention elevated PSA. A letter several weeks later from the urologist to the primary care physician discussed the patient’s elevated PSA. The primary care physician didn’t contact the urologist to follow up on the finding, however.
After a year of testing, the urologist concluded that the hematuria was probably related to the kidney, or perhaps the prostate, and started the patient on dutasteride, which helped the bleeding. Two months after the start of treatment, the urologist ordered a PSA test, which was extremely elevated. A subsequent biopsy revealed adenocarcinoma, and a bone scan showed metastatic bony disease, which hadn’t shown up on a bone scan done 6 months before. The patient died 2 years later. The cause of death was listed as cardiopulmonary arrest, cardiogenic shock, and myocardial infarction.
PLAINTIFF’S CLAIM The plaintiff’s claim focused on the handling of the PSA test, though the specifics of the claim were not detailed in the case summary.
DOCTOR’S DEFENSE The primary care physician claimed that his nurse told the patient after the second PSA test that the PSA was 12 and encouraged the patient to see the urologist to discuss the elevated level. The physician also claimed that he had faxed the elevated PSA test result to the urologist and that the patient was reminded of the elevated PSA during his visit to the urologist. No information about the urologist’s defense was available.
VERDICT $325,000 Massachusetts settlement.
COMMENT Coordination of care and documentation of communication are keys to good patient care—and avoiding lawsuits.
Woman sent home from ER dies of aneurysm
SEVERE HEADACHES prompted a 38-year-old woman to visit her family physician, who referred her to a neurologist; an appointment was scheduled for more than a month later. A month after seeing the family physician, the patient went to the emergency room complaining of a severe headache.
A CT scan ordered by the ER physician showed a large mass in the patient’s brain. The ER physician gave the patient the scan report, told her to see her family doctor, and sent her home without consulting a neurosurgeon. Later that day, the aneurysm ruptured; the patient’s family took her to the hospital, where she died the next morning.
PLAINTIFF’S CLAIM The family physician should have ordered a CT scan, which would have revealed the aneurysm. The ER physician should have ordered an immediate neurologic consult, which would have led to surgical repair of the leaking aneurysm. Either measure would have saved the patient’s life.
DOCTOR’S DEFENSE The family physician claimed that the patient’s complaints weren’t urgent and he made a proper referral. The ER physician claimed that the patient wouldn’t have lived even if he’d arranged an immediate consult.
VERDICT $1.5 million Michigan verdict against the ER physician.
COMMENT This case illustrates the value of clearly documenting referrals and suggesting follow-up if a change in symptoms occurs.
Jaundiced newborn dies after slip-ups
AN INFANT BORN AT 36 WEEKS and the baby’s 20-year-old mother were discharged from the hospital fewer than 48 hours after delivery, with an appointment with a visiting nurse for the following day and a pediatrician 3 days later. Hospital medical records reported infrequent breast feeding, significant decrease in weight, and a bruise on the back of the infant’s head.
The visiting nurse who examined the baby noted moderate facial jaundice, mild jaundice in the groin, and slight jaundice in the sclera of the eyes, as well as the bruise on the back of the head. The nurse didn’t notify the pediatrician of the jaundice. The mother said that when she voiced concern about the jaundice, the nurse told her to feed the infant more often and expose her to sunlight.
The day after the nurse’s visit, the parents noticed that the baby was more jaundiced and had started to arch her back, grunt, and whine. The mother called the pediatrician’s office that day and reported the symptoms; the nurse told her that the pediatrician felt that he didn’t need to see the baby before her appointment the following day. As the symptoms worsened, the mother called the pediatrician’s office 3 more times before 6 PM, speaking with 2 nurses, neither of whom took a medical history.
The mother called again after the office had closed. A nurse arranged for the infant to be seen at the hospital, where the baby was admitted with a critically low temperature, decreased muscle tone, arching of the back, and an elevated bilirubin level of 35.4 mg/dL. Despite phototherapy and intubation, the infant’s condition deteriorated, and she was airlifted to another medical facility for more advanced care. The baby was given cardiopulmonary resuscitation on arrival, but died 4 hours later of acute bilirubin encephalopathy.
PLAINTIFF’S CLAIM In light of her symptoms, the baby shouldn’t have been discharged from the hospital. The visiting nurse should have reported the baby’s symptoms to the pediatrician or recommended that the parents take the baby to the doctor right away. The nurses in the pediatrician’s office were negligent in not taking a full medical history. The pediatrician should have seen the baby immediately. He failed to recognize the symptoms of possible hyperbilirubinemia, a medical emergency.
DOCTOR’S DEFENSE No information about the doctor’s or nurses’ defense is available.
VERDICT $460,000 Massachusetts settlement.
COMMENT This case illustrates, once again, the importance of care coordination and sharing information on a timely basis.
Delayed testing leads to death from embolism...Heart attack blamed on lack of workup, referral...more...
Delayed testing leads to death from embolism
SWELLING OF HIS RIGHT FOOT prompted a 75-year-old man to seek medical attention. He had a history of blood clots and wore compression stockings. The physician spent 10 minutes with the patient; he did not remove the compression stockings during the examination. The physician scheduled a sonogram for the next day.
After the sonogram, the patient returned to the physician complaining of a back problem. While in the waiting room, the patient collapsed and died of a massive pulmonary embolism.
PLAINTIFF’S CLAIM: The patient had classic symptoms of a blood clot and should have been tested immediately.
DOCTOR’S DEFENSE: The patient didn’t wear compression stockings to prevent blood clots but because of swelling from a long history of postphlebitic syndrome. The foot and back complaints were similar to previous complaints related to the patient’s postphlebitic syndrome and degenerative disc disease. Moreover, the sonogram was negative for acute clots.
VERDICT: $5.2 million Texas verdict.
COMMENT: Although the facts of this case aren’t altogether clear, timely evaluation might have prevented the unfortunate outcome. As with many malpractice allegations, documentation remains key to a physician’s defense. If it’s not documented, it didn’t happen. JLS
Heart attack blamed on lack of workup, referral
A 57-YEAR-OLD MAN, who had been under the regular care of an internist for 5 years, died suddenly of an acute myocardial infarction. He had a history of high cholesterol and high blood pressure, as well as a family history of heart disease, and he was a heavy smoker. The internist had ordered resting electrocardiograms over the years but hadn’t done a workup for heart disease or referred the patient to a cardiologist.
PLAINTIFF’S CLAIM: The internist should have performed appropriate testing or referred the patient to a cardiologist because the patient had all the risk factors for heart disease. If the doctor had done any of these things, the patient’s heart disease would have been diagnosed and cardiac bypass surgery would have saved his life.
DOCTOR’S DEFENSE: The patient’s continued heavy smoking caused or contributed to his fatal heart attack. The attack was unpredictable and untreatable because it was caused by new and unstable plaque rupture and thrombosis. (The plaintiff countered that the patient didn’t suffer from ruptured plaque or thrombosis.)
VERDICT: $377,500 Michigan settlement.
COMMENT: How aggressively should we evaluate the patient with multiple cardiac risk factors? This case suggests that we need to strongly consider definitive evaluation of the patient at high risk of coronary artery disease. JLS
Death after repeated calls to doctors
AFTER SUFFERING SEVERE BURNS to his leg and foot while cooking French fries, a 48-year-old man was treated by his family physician as well as a surgeon specializing in skin grafts. During rehabilitation, the patient became disoriented and short of breath; he hyperventilated and reported that he was seeing aliens. He was also depressed.
His wife called the offices of both the family physician and the surgeon 4 times over 2 days. She never spoke to a doctor. Two days later, a nurse practitioner returned her call and prescribed fluoxetine for depression. Very shortly thereafter, the patient suffered a massive pulmonary embolism. He was taken to an emergency room, where he was pronounced dead.
PLAINTIFF’S CLAIM: The physician and surgeon were negligent in their failure to respond properly to the wife’s phone calls. Prompt intervention would have prevented the pulmonary embolism.
DOCTORS’ DEFENSE: The only information that was relayed to the doctors’ offices was that the patient was depressed and “talking funny.”
VERDICT: Indiana defense verdict.
COMMENT: We’re only as good as our staff and systems of care. Here’s another patient with pulmonary embolus who might have survived if appropriate evaluation had occurred promptly. JLS
2 cases, 1 theme: A purported lack of follow-up
A 62-YEAR-OLD MAN with an abdominal aortic aneurysm was seen by an internist at a Veterans Administration hospital. The aneurysm subsequently ruptured, necessitating emergency surgery. The surgery was successful, but the patient required attendant living assistance and neuropsychological retraining.
PLAINTIFF’S CLAIM: The internist was told that the patient’s father had been diagnosed with an abdominal aortic aneurysm, and that the patient himself had been diagnosed with a 2- to 3-cm aortic aneurysm and advised to have it rescanned periodically. The patient further informed the internist that he had been told that the aneurysm would require surgery if it reached 5 or 6 cm.
The patient saw the doctor many times after the first visit, but no history of abdominal aortic aneurysm was ever recorded and no scanning was performed. Serial monitoring would have revealed a slowly enlarging aneurysm, and elective surgery could have treated it.
DOCTOR’S DEFENSE: The patient failed to inform the internist of the history of abdominal aortic aneurysm. An aneurysm of 2 to 3 cm does not require follow-up.
VERDICT: $200,000 California settlement.
A CHEST RADIOGRAPH of a 74-year-old woman showed lung densities and artifacts. No follow-up radiography was performed. Two years later, the patient was diagnosed with lung cancer, which had metastasized to her liver. The patient died 5 months after the diagnosis.
PLAINTIFF’S CLAIM: The internist should have ordered a CT scan to further investigate the abnormalities.
DOCTOR’S DEFENSE: A follow-up radiograph was ordered, which the patient refused. (The plaintiff denied that follow-up radiographs were ordered and argued that even if they had been performed, the outcome would have been the same.)
VERDICT: Illinois defense verdict.
COMMENT: Tracking and following up test results is often a challenge in primary care offices. Although the advice given to the first patient concerning follow-up of his abdominal aortic aneurysm appears to be sound, the lack of follow-through resulted in serious consequences. It’s important to assure timely reevaluation of abnormalities, such as repeat CT or workup of a chest mass, repeat mammography, or tracking of an abdominal aortic aneurysm. JLS
Delayed testing leads to death from embolism
SWELLING OF HIS RIGHT FOOT prompted a 75-year-old man to seek medical attention. He had a history of blood clots and wore compression stockings. The physician spent 10 minutes with the patient; he did not remove the compression stockings during the examination. The physician scheduled a sonogram for the next day.
After the sonogram, the patient returned to the physician complaining of a back problem. While in the waiting room, the patient collapsed and died of a massive pulmonary embolism.
PLAINTIFF’S CLAIM: The patient had classic symptoms of a blood clot and should have been tested immediately.
DOCTOR’S DEFENSE: The patient didn’t wear compression stockings to prevent blood clots but because of swelling from a long history of postphlebitic syndrome. The foot and back complaints were similar to previous complaints related to the patient’s postphlebitic syndrome and degenerative disc disease. Moreover, the sonogram was negative for acute clots.
VERDICT: $5.2 million Texas verdict.
COMMENT: Although the facts of this case aren’t altogether clear, timely evaluation might have prevented the unfortunate outcome. As with many malpractice allegations, documentation remains key to a physician’s defense. If it’s not documented, it didn’t happen. JLS
Heart attack blamed on lack of workup, referral
A 57-YEAR-OLD MAN, who had been under the regular care of an internist for 5 years, died suddenly of an acute myocardial infarction. He had a history of high cholesterol and high blood pressure, as well as a family history of heart disease, and he was a heavy smoker. The internist had ordered resting electrocardiograms over the years but hadn’t done a workup for heart disease or referred the patient to a cardiologist.
PLAINTIFF’S CLAIM: The internist should have performed appropriate testing or referred the patient to a cardiologist because the patient had all the risk factors for heart disease. If the doctor had done any of these things, the patient’s heart disease would have been diagnosed and cardiac bypass surgery would have saved his life.
DOCTOR’S DEFENSE: The patient’s continued heavy smoking caused or contributed to his fatal heart attack. The attack was unpredictable and untreatable because it was caused by new and unstable plaque rupture and thrombosis. (The plaintiff countered that the patient didn’t suffer from ruptured plaque or thrombosis.)
VERDICT: $377,500 Michigan settlement.
COMMENT: How aggressively should we evaluate the patient with multiple cardiac risk factors? This case suggests that we need to strongly consider definitive evaluation of the patient at high risk of coronary artery disease. JLS
Death after repeated calls to doctors
AFTER SUFFERING SEVERE BURNS to his leg and foot while cooking French fries, a 48-year-old man was treated by his family physician as well as a surgeon specializing in skin grafts. During rehabilitation, the patient became disoriented and short of breath; he hyperventilated and reported that he was seeing aliens. He was also depressed.
His wife called the offices of both the family physician and the surgeon 4 times over 2 days. She never spoke to a doctor. Two days later, a nurse practitioner returned her call and prescribed fluoxetine for depression. Very shortly thereafter, the patient suffered a massive pulmonary embolism. He was taken to an emergency room, where he was pronounced dead.
PLAINTIFF’S CLAIM: The physician and surgeon were negligent in their failure to respond properly to the wife’s phone calls. Prompt intervention would have prevented the pulmonary embolism.
DOCTORS’ DEFENSE: The only information that was relayed to the doctors’ offices was that the patient was depressed and “talking funny.”
VERDICT: Indiana defense verdict.
COMMENT: We’re only as good as our staff and systems of care. Here’s another patient with pulmonary embolus who might have survived if appropriate evaluation had occurred promptly. JLS
2 cases, 1 theme: A purported lack of follow-up
A 62-YEAR-OLD MAN with an abdominal aortic aneurysm was seen by an internist at a Veterans Administration hospital. The aneurysm subsequently ruptured, necessitating emergency surgery. The surgery was successful, but the patient required attendant living assistance and neuropsychological retraining.
PLAINTIFF’S CLAIM: The internist was told that the patient’s father had been diagnosed with an abdominal aortic aneurysm, and that the patient himself had been diagnosed with a 2- to 3-cm aortic aneurysm and advised to have it rescanned periodically. The patient further informed the internist that he had been told that the aneurysm would require surgery if it reached 5 or 6 cm.
The patient saw the doctor many times after the first visit, but no history of abdominal aortic aneurysm was ever recorded and no scanning was performed. Serial monitoring would have revealed a slowly enlarging aneurysm, and elective surgery could have treated it.
DOCTOR’S DEFENSE: The patient failed to inform the internist of the history of abdominal aortic aneurysm. An aneurysm of 2 to 3 cm does not require follow-up.
VERDICT: $200,000 California settlement.
A CHEST RADIOGRAPH of a 74-year-old woman showed lung densities and artifacts. No follow-up radiography was performed. Two years later, the patient was diagnosed with lung cancer, which had metastasized to her liver. The patient died 5 months after the diagnosis.
PLAINTIFF’S CLAIM: The internist should have ordered a CT scan to further investigate the abnormalities.
DOCTOR’S DEFENSE: A follow-up radiograph was ordered, which the patient refused. (The plaintiff denied that follow-up radiographs were ordered and argued that even if they had been performed, the outcome would have been the same.)
VERDICT: Illinois defense verdict.
COMMENT: Tracking and following up test results is often a challenge in primary care offices. Although the advice given to the first patient concerning follow-up of his abdominal aortic aneurysm appears to be sound, the lack of follow-through resulted in serious consequences. It’s important to assure timely reevaluation of abnormalities, such as repeat CT or workup of a chest mass, repeat mammography, or tracking of an abdominal aortic aneurysm. JLS
Delayed testing leads to death from embolism
SWELLING OF HIS RIGHT FOOT prompted a 75-year-old man to seek medical attention. He had a history of blood clots and wore compression stockings. The physician spent 10 minutes with the patient; he did not remove the compression stockings during the examination. The physician scheduled a sonogram for the next day.
After the sonogram, the patient returned to the physician complaining of a back problem. While in the waiting room, the patient collapsed and died of a massive pulmonary embolism.
PLAINTIFF’S CLAIM: The patient had classic symptoms of a blood clot and should have been tested immediately.
DOCTOR’S DEFENSE: The patient didn’t wear compression stockings to prevent blood clots but because of swelling from a long history of postphlebitic syndrome. The foot and back complaints were similar to previous complaints related to the patient’s postphlebitic syndrome and degenerative disc disease. Moreover, the sonogram was negative for acute clots.
VERDICT: $5.2 million Texas verdict.
COMMENT: Although the facts of this case aren’t altogether clear, timely evaluation might have prevented the unfortunate outcome. As with many malpractice allegations, documentation remains key to a physician’s defense. If it’s not documented, it didn’t happen. JLS
Heart attack blamed on lack of workup, referral
A 57-YEAR-OLD MAN, who had been under the regular care of an internist for 5 years, died suddenly of an acute myocardial infarction. He had a history of high cholesterol and high blood pressure, as well as a family history of heart disease, and he was a heavy smoker. The internist had ordered resting electrocardiograms over the years but hadn’t done a workup for heart disease or referred the patient to a cardiologist.
PLAINTIFF’S CLAIM: The internist should have performed appropriate testing or referred the patient to a cardiologist because the patient had all the risk factors for heart disease. If the doctor had done any of these things, the patient’s heart disease would have been diagnosed and cardiac bypass surgery would have saved his life.
DOCTOR’S DEFENSE: The patient’s continued heavy smoking caused or contributed to his fatal heart attack. The attack was unpredictable and untreatable because it was caused by new and unstable plaque rupture and thrombosis. (The plaintiff countered that the patient didn’t suffer from ruptured plaque or thrombosis.)
VERDICT: $377,500 Michigan settlement.
COMMENT: How aggressively should we evaluate the patient with multiple cardiac risk factors? This case suggests that we need to strongly consider definitive evaluation of the patient at high risk of coronary artery disease. JLS
Death after repeated calls to doctors
AFTER SUFFERING SEVERE BURNS to his leg and foot while cooking French fries, a 48-year-old man was treated by his family physician as well as a surgeon specializing in skin grafts. During rehabilitation, the patient became disoriented and short of breath; he hyperventilated and reported that he was seeing aliens. He was also depressed.
His wife called the offices of both the family physician and the surgeon 4 times over 2 days. She never spoke to a doctor. Two days later, a nurse practitioner returned her call and prescribed fluoxetine for depression. Very shortly thereafter, the patient suffered a massive pulmonary embolism. He was taken to an emergency room, where he was pronounced dead.
PLAINTIFF’S CLAIM: The physician and surgeon were negligent in their failure to respond properly to the wife’s phone calls. Prompt intervention would have prevented the pulmonary embolism.
DOCTORS’ DEFENSE: The only information that was relayed to the doctors’ offices was that the patient was depressed and “talking funny.”
VERDICT: Indiana defense verdict.
COMMENT: We’re only as good as our staff and systems of care. Here’s another patient with pulmonary embolus who might have survived if appropriate evaluation had occurred promptly. JLS
2 cases, 1 theme: A purported lack of follow-up
A 62-YEAR-OLD MAN with an abdominal aortic aneurysm was seen by an internist at a Veterans Administration hospital. The aneurysm subsequently ruptured, necessitating emergency surgery. The surgery was successful, but the patient required attendant living assistance and neuropsychological retraining.
PLAINTIFF’S CLAIM: The internist was told that the patient’s father had been diagnosed with an abdominal aortic aneurysm, and that the patient himself had been diagnosed with a 2- to 3-cm aortic aneurysm and advised to have it rescanned periodically. The patient further informed the internist that he had been told that the aneurysm would require surgery if it reached 5 or 6 cm.
The patient saw the doctor many times after the first visit, but no history of abdominal aortic aneurysm was ever recorded and no scanning was performed. Serial monitoring would have revealed a slowly enlarging aneurysm, and elective surgery could have treated it.
DOCTOR’S DEFENSE: The patient failed to inform the internist of the history of abdominal aortic aneurysm. An aneurysm of 2 to 3 cm does not require follow-up.
VERDICT: $200,000 California settlement.
A CHEST RADIOGRAPH of a 74-year-old woman showed lung densities and artifacts. No follow-up radiography was performed. Two years later, the patient was diagnosed with lung cancer, which had metastasized to her liver. The patient died 5 months after the diagnosis.
PLAINTIFF’S CLAIM: The internist should have ordered a CT scan to further investigate the abnormalities.
DOCTOR’S DEFENSE: A follow-up radiograph was ordered, which the patient refused. (The plaintiff denied that follow-up radiographs were ordered and argued that even if they had been performed, the outcome would have been the same.)
VERDICT: Illinois defense verdict.
COMMENT: Tracking and following up test results is often a challenge in primary care offices. Although the advice given to the first patient concerning follow-up of his abdominal aortic aneurysm appears to be sound, the lack of follow-through resulted in serious consequences. It’s important to assure timely reevaluation of abnormalities, such as repeat CT or workup of a chest mass, repeat mammography, or tracking of an abdominal aortic aneurysm. JLS
Hospitalists: Scourge or salvation?
It is hard to believe that hospitalists were only first well-described in 1996, given the prominent role these physicians currently play. Of course, many groups had physicians take turns doing hospital care, at least on the weekends and holidays. And training programs often employed individuals who served as inpatient attend-ings on a regular basis.
Initially associated with the managed care movement, particularly on the West coast, proponents claimed hospitalists cut costs and ensured quality. Detractors countered that important aspects of continuity and communication were lost. Unlike some of the trappings of the managed care movement (how many of you still serve as gatekeepers?), hospitalists appear to be here to stay.
As Family Medicine looks toward the future, will we remain a linchpin in care of hospitalized patients? How do we maintain continuity and enhance communication with our hospitalized patients? What cost shifts occur between hospital and outpatient care? Are the promises of the hospitalist movement being kept?
Many of you undoubtedly have strong opinions about this issue, and Dr Ann Scheck McAlearney’s interesting review (“Hospitalists and family physicians: Understanding opportunities and risks,” pages 473–481) in this issue of JFP will likely spur further debate.
What have been your experiences as clinicians in practice? Do you have stories to share? How have some of you successfully maintained a hospital practice? What efficiencies have you found in referring to a hospitalist? Are you comfortable with hospitalists now that this arrangement is more common? Whether you view hospitalists as a scourge or salvation, let me know how the hospitalist movement has touched you and your patients.
It is hard to believe that hospitalists were only first well-described in 1996, given the prominent role these physicians currently play. Of course, many groups had physicians take turns doing hospital care, at least on the weekends and holidays. And training programs often employed individuals who served as inpatient attend-ings on a regular basis.
Initially associated with the managed care movement, particularly on the West coast, proponents claimed hospitalists cut costs and ensured quality. Detractors countered that important aspects of continuity and communication were lost. Unlike some of the trappings of the managed care movement (how many of you still serve as gatekeepers?), hospitalists appear to be here to stay.
As Family Medicine looks toward the future, will we remain a linchpin in care of hospitalized patients? How do we maintain continuity and enhance communication with our hospitalized patients? What cost shifts occur between hospital and outpatient care? Are the promises of the hospitalist movement being kept?
Many of you undoubtedly have strong opinions about this issue, and Dr Ann Scheck McAlearney’s interesting review (“Hospitalists and family physicians: Understanding opportunities and risks,” pages 473–481) in this issue of JFP will likely spur further debate.
What have been your experiences as clinicians in practice? Do you have stories to share? How have some of you successfully maintained a hospital practice? What efficiencies have you found in referring to a hospitalist? Are you comfortable with hospitalists now that this arrangement is more common? Whether you view hospitalists as a scourge or salvation, let me know how the hospitalist movement has touched you and your patients.
It is hard to believe that hospitalists were only first well-described in 1996, given the prominent role these physicians currently play. Of course, many groups had physicians take turns doing hospital care, at least on the weekends and holidays. And training programs often employed individuals who served as inpatient attend-ings on a regular basis.
Initially associated with the managed care movement, particularly on the West coast, proponents claimed hospitalists cut costs and ensured quality. Detractors countered that important aspects of continuity and communication were lost. Unlike some of the trappings of the managed care movement (how many of you still serve as gatekeepers?), hospitalists appear to be here to stay.
As Family Medicine looks toward the future, will we remain a linchpin in care of hospitalized patients? How do we maintain continuity and enhance communication with our hospitalized patients? What cost shifts occur between hospital and outpatient care? Are the promises of the hospitalist movement being kept?
Many of you undoubtedly have strong opinions about this issue, and Dr Ann Scheck McAlearney’s interesting review (“Hospitalists and family physicians: Understanding opportunities and risks,” pages 473–481) in this issue of JFP will likely spur further debate.
What have been your experiences as clinicians in practice? Do you have stories to share? How have some of you successfully maintained a hospital practice? What efficiencies have you found in referring to a hospitalist? Are you comfortable with hospitalists now that this arrangement is more common? Whether you view hospitalists as a scourge or salvation, let me know how the hospitalist movement has touched you and your patients.
Improving diabetics care
For most of us, diabetes is the bread and butter of our practices (no pun intended)—but can you honestly say you are caring optimally for your patients with diabetes? I know I’m not.
This issue of JFP offers 3 articles on diabetes care (pages 366–374, 376–388, and 393–399)—reviewing the latest evidence on primary prevention, screening, and treatment—but I suspect that if you are like me, it’s not that you don’t know what to do for your patients with diabetes, but how to do it.
Soon the American Board of Family Practice, as part of its move to maintenance of certification, will be requiring all family physicians to engage in performance improvement efforts, and diabetes will be one of the initial areas of focus (www.abfp.org/MOC/index.aspx). So it’s apropos to begin thinking about enhancing our care now.
Perhaps you would like to focus on primary prevention by encouraging lifestyle changes in patients at risk, including those with obesity and metabolic syndrome. Or maybe you want to concentrate on screening populations at high risk, as encouraged by the American Diabetes Association and the US Preventive Services Task Force.
For me, it would be helpful to identify individuals with diabetes and be more aggressive about setting and tracking progress toward goals. Have my patients really achieved hemoglobin A1c, lipid, and blood pressure targets? It would also be nice to implement a recall system when my patient with poorly controlled hypertension and diabetes fails to make a return visit. And I wonder if I really have negotiated behavioral changes to which my patients can commit, given the substantial time and resources required to care for this chronic disease.
If you are like me, diabetes should be moved from an afterthought to the main course. What innovative performance improvement efforts have you implemented in your own practice?
For most of us, diabetes is the bread and butter of our practices (no pun intended)—but can you honestly say you are caring optimally for your patients with diabetes? I know I’m not.
This issue of JFP offers 3 articles on diabetes care (pages 366–374, 376–388, and 393–399)—reviewing the latest evidence on primary prevention, screening, and treatment—but I suspect that if you are like me, it’s not that you don’t know what to do for your patients with diabetes, but how to do it.
Soon the American Board of Family Practice, as part of its move to maintenance of certification, will be requiring all family physicians to engage in performance improvement efforts, and diabetes will be one of the initial areas of focus (www.abfp.org/MOC/index.aspx). So it’s apropos to begin thinking about enhancing our care now.
Perhaps you would like to focus on primary prevention by encouraging lifestyle changes in patients at risk, including those with obesity and metabolic syndrome. Or maybe you want to concentrate on screening populations at high risk, as encouraged by the American Diabetes Association and the US Preventive Services Task Force.
For me, it would be helpful to identify individuals with diabetes and be more aggressive about setting and tracking progress toward goals. Have my patients really achieved hemoglobin A1c, lipid, and blood pressure targets? It would also be nice to implement a recall system when my patient with poorly controlled hypertension and diabetes fails to make a return visit. And I wonder if I really have negotiated behavioral changes to which my patients can commit, given the substantial time and resources required to care for this chronic disease.
If you are like me, diabetes should be moved from an afterthought to the main course. What innovative performance improvement efforts have you implemented in your own practice?
For most of us, diabetes is the bread and butter of our practices (no pun intended)—but can you honestly say you are caring optimally for your patients with diabetes? I know I’m not.
This issue of JFP offers 3 articles on diabetes care (pages 366–374, 376–388, and 393–399)—reviewing the latest evidence on primary prevention, screening, and treatment—but I suspect that if you are like me, it’s not that you don’t know what to do for your patients with diabetes, but how to do it.
Soon the American Board of Family Practice, as part of its move to maintenance of certification, will be requiring all family physicians to engage in performance improvement efforts, and diabetes will be one of the initial areas of focus (www.abfp.org/MOC/index.aspx). So it’s apropos to begin thinking about enhancing our care now.
Perhaps you would like to focus on primary prevention by encouraging lifestyle changes in patients at risk, including those with obesity and metabolic syndrome. Or maybe you want to concentrate on screening populations at high risk, as encouraged by the American Diabetes Association and the US Preventive Services Task Force.
For me, it would be helpful to identify individuals with diabetes and be more aggressive about setting and tracking progress toward goals. Have my patients really achieved hemoglobin A1c, lipid, and blood pressure targets? It would also be nice to implement a recall system when my patient with poorly controlled hypertension and diabetes fails to make a return visit. And I wonder if I really have negotiated behavioral changes to which my patients can commit, given the substantial time and resources required to care for this chronic disease.
If you are like me, diabetes should be moved from an afterthought to the main course. What innovative performance improvement efforts have you implemented in your own practice?
Old and new features: Original Research, Grand Rounds
I am often asked if the JOURNAL OF FAMILY PRACTICE still publishes research, and if so, what type of studies we seek? In a word, “YES”, JFP remains committed to publishing original research (typically one article per issue).
Of course, we begin by assessing a study’s validity. But good research design is not enough. We seek studies that are immediately clinically relevant or intensely thought provoking—preferably both. We are fortunate to have a steady stream of submissions ranging from focused systematic reviews and meta-analyses, to clinical trials in real world practice, to provocative qualitative studies.
There is no set formula for our research articles. Initially, I review every article and deem about half as obviously flawed or inappropriate for our audience. The remainder is reviewed by Cheryl Flynn and John Hickner, our Associate Editors. Typically, half of these articles pass muster. My goal is to send to review only articles that have a significant chance, with revision, to be acceptable.
So while research has become a less prominent part of JFP, I delight in bringing you work that I have found exciting, stimulating and useful. Enjoy this issue’s article on physician self-doctoring—a study I found creative and thought-provoking. And let us know how we can continue to make this aspect of the Journal an important part of your “required reading.”
Family Medicine Grand Rounds
One of my fondest memories of medical school is attending medical grand rounds, where invariably the most obscure diseases would be diagnosed by astoundingly astute clinicians. As I have gained more experience as a family physician, my focus on “fascinomas” has decreased, while my interest in grand rounds has endured. I hope this new JFPfeature, Family Medicine Grand Rounds, edited by Audrey Paulman, MD (Assistant Professor in the Department of Family Medicine at the University of Nebraska Medical Center) will recall the lively give and take of those days past, while offering much more practical, useful information.
If you have a particularly instructive case that combines the art and scholarship of family medicine, or have suggestions on how to make this feature of more value to your practice, please let us know.
I am often asked if the JOURNAL OF FAMILY PRACTICE still publishes research, and if so, what type of studies we seek? In a word, “YES”, JFP remains committed to publishing original research (typically one article per issue).
Of course, we begin by assessing a study’s validity. But good research design is not enough. We seek studies that are immediately clinically relevant or intensely thought provoking—preferably both. We are fortunate to have a steady stream of submissions ranging from focused systematic reviews and meta-analyses, to clinical trials in real world practice, to provocative qualitative studies.
There is no set formula for our research articles. Initially, I review every article and deem about half as obviously flawed or inappropriate for our audience. The remainder is reviewed by Cheryl Flynn and John Hickner, our Associate Editors. Typically, half of these articles pass muster. My goal is to send to review only articles that have a significant chance, with revision, to be acceptable.
So while research has become a less prominent part of JFP, I delight in bringing you work that I have found exciting, stimulating and useful. Enjoy this issue’s article on physician self-doctoring—a study I found creative and thought-provoking. And let us know how we can continue to make this aspect of the Journal an important part of your “required reading.”
Family Medicine Grand Rounds
One of my fondest memories of medical school is attending medical grand rounds, where invariably the most obscure diseases would be diagnosed by astoundingly astute clinicians. As I have gained more experience as a family physician, my focus on “fascinomas” has decreased, while my interest in grand rounds has endured. I hope this new JFPfeature, Family Medicine Grand Rounds, edited by Audrey Paulman, MD (Assistant Professor in the Department of Family Medicine at the University of Nebraska Medical Center) will recall the lively give and take of those days past, while offering much more practical, useful information.
If you have a particularly instructive case that combines the art and scholarship of family medicine, or have suggestions on how to make this feature of more value to your practice, please let us know.
I am often asked if the JOURNAL OF FAMILY PRACTICE still publishes research, and if so, what type of studies we seek? In a word, “YES”, JFP remains committed to publishing original research (typically one article per issue).
Of course, we begin by assessing a study’s validity. But good research design is not enough. We seek studies that are immediately clinically relevant or intensely thought provoking—preferably both. We are fortunate to have a steady stream of submissions ranging from focused systematic reviews and meta-analyses, to clinical trials in real world practice, to provocative qualitative studies.
There is no set formula for our research articles. Initially, I review every article and deem about half as obviously flawed or inappropriate for our audience. The remainder is reviewed by Cheryl Flynn and John Hickner, our Associate Editors. Typically, half of these articles pass muster. My goal is to send to review only articles that have a significant chance, with revision, to be acceptable.
So while research has become a less prominent part of JFP, I delight in bringing you work that I have found exciting, stimulating and useful. Enjoy this issue’s article on physician self-doctoring—a study I found creative and thought-provoking. And let us know how we can continue to make this aspect of the Journal an important part of your “required reading.”
Family Medicine Grand Rounds
One of my fondest memories of medical school is attending medical grand rounds, where invariably the most obscure diseases would be diagnosed by astoundingly astute clinicians. As I have gained more experience as a family physician, my focus on “fascinomas” has decreased, while my interest in grand rounds has endured. I hope this new JFPfeature, Family Medicine Grand Rounds, edited by Audrey Paulman, MD (Assistant Professor in the Department of Family Medicine at the University of Nebraska Medical Center) will recall the lively give and take of those days past, while offering much more practical, useful information.
If you have a particularly instructive case that combines the art and scholarship of family medicine, or have suggestions on how to make this feature of more value to your practice, please let us know.
Supplements, “ride-alongs,” and maintaining your trust
With this issue of the journal, you will receive a supplemental Clinical Update on basal insulin therapy. Many of you probably wonder what our policy is for supplements (and other materials) bundled with the journal.
As Editor, I have final approval for all parts of the journal, including supplements. In JFP we focus on highly practical, evidence-based articles emphasizing quantitative, patient-oriented outcomes. We also have uniform standards for style, length, and content. Every piece is sent for peer review and must be scientifically accurate and reflect fair balance. Information that you can trust is our stock in trade.
Supplements reflect more diversity of presentation style, relevancy, the use of cases, and the discussion of patient-oriented evidence. All such manuscripts—whether accredited for continuing medical education (CME) or not—are peer-reviewed, assessed by content experts, and must be scientifically accurate and balanced. Some supplements are quite narrow and discuss a single drug or device. When this is the case, a comparison with competing alternatives is required, and we make a concerted effort to achieve an even-handed presentation. Conflicts of interest and author disclosure of pharmaceutical company ties must be clearly noted. In one notable example, a supplement went through almost a dozen revisions before being suitable for publication. In my mind, every piece accompanying the journal reflects the confidence you put in us—and I am fortunate to have a publisher that supports this editorial control.
Finally, let me address the how and why of supplements. All such pieces are sponsored—this typically is provided by a drug or device manufacturer. The rules for such pieces have become quite stringent, and have served to eliminate some of the more biased practices of the past. Often, as Editor, I will be involved in the suggestion of authors, development of the supplement’s goals, and comments on interim drafts. Even when “finished” pieces come to the journal, multiple revisions are the norm, not the exception.
In the end, I view supplements and “ride-alongs” as value-added editorial units, which our readers may choose to read or not because of their commercial sponsorship. Let me know your thoughts about supplements and the related ethical issues they raise, at jfp@fammed.uc.edu.
With this issue of the journal, you will receive a supplemental Clinical Update on basal insulin therapy. Many of you probably wonder what our policy is for supplements (and other materials) bundled with the journal.
As Editor, I have final approval for all parts of the journal, including supplements. In JFP we focus on highly practical, evidence-based articles emphasizing quantitative, patient-oriented outcomes. We also have uniform standards for style, length, and content. Every piece is sent for peer review and must be scientifically accurate and reflect fair balance. Information that you can trust is our stock in trade.
Supplements reflect more diversity of presentation style, relevancy, the use of cases, and the discussion of patient-oriented evidence. All such manuscripts—whether accredited for continuing medical education (CME) or not—are peer-reviewed, assessed by content experts, and must be scientifically accurate and balanced. Some supplements are quite narrow and discuss a single drug or device. When this is the case, a comparison with competing alternatives is required, and we make a concerted effort to achieve an even-handed presentation. Conflicts of interest and author disclosure of pharmaceutical company ties must be clearly noted. In one notable example, a supplement went through almost a dozen revisions before being suitable for publication. In my mind, every piece accompanying the journal reflects the confidence you put in us—and I am fortunate to have a publisher that supports this editorial control.
Finally, let me address the how and why of supplements. All such pieces are sponsored—this typically is provided by a drug or device manufacturer. The rules for such pieces have become quite stringent, and have served to eliminate some of the more biased practices of the past. Often, as Editor, I will be involved in the suggestion of authors, development of the supplement’s goals, and comments on interim drafts. Even when “finished” pieces come to the journal, multiple revisions are the norm, not the exception.
In the end, I view supplements and “ride-alongs” as value-added editorial units, which our readers may choose to read or not because of their commercial sponsorship. Let me know your thoughts about supplements and the related ethical issues they raise, at jfp@fammed.uc.edu.
With this issue of the journal, you will receive a supplemental Clinical Update on basal insulin therapy. Many of you probably wonder what our policy is for supplements (and other materials) bundled with the journal.
As Editor, I have final approval for all parts of the journal, including supplements. In JFP we focus on highly practical, evidence-based articles emphasizing quantitative, patient-oriented outcomes. We also have uniform standards for style, length, and content. Every piece is sent for peer review and must be scientifically accurate and reflect fair balance. Information that you can trust is our stock in trade.
Supplements reflect more diversity of presentation style, relevancy, the use of cases, and the discussion of patient-oriented evidence. All such manuscripts—whether accredited for continuing medical education (CME) or not—are peer-reviewed, assessed by content experts, and must be scientifically accurate and balanced. Some supplements are quite narrow and discuss a single drug or device. When this is the case, a comparison with competing alternatives is required, and we make a concerted effort to achieve an even-handed presentation. Conflicts of interest and author disclosure of pharmaceutical company ties must be clearly noted. In one notable example, a supplement went through almost a dozen revisions before being suitable for publication. In my mind, every piece accompanying the journal reflects the confidence you put in us—and I am fortunate to have a publisher that supports this editorial control.
Finally, let me address the how and why of supplements. All such pieces are sponsored—this typically is provided by a drug or device manufacturer. The rules for such pieces have become quite stringent, and have served to eliminate some of the more biased practices of the past. Often, as Editor, I will be involved in the suggestion of authors, development of the supplement’s goals, and comments on interim drafts. Even when “finished” pieces come to the journal, multiple revisions are the norm, not the exception.
In the end, I view supplements and “ride-alongs” as value-added editorial units, which our readers may choose to read or not because of their commercial sponsorship. Let me know your thoughts about supplements and the related ethical issues they raise, at jfp@fammed.uc.edu.
Making evidence user-friendly
In this issue of The Journal of Family Practice, you will find the result of an extraordinary collaboration among the editors of the major family medicine journals: SORT, which stands for the Strength of Recommendation Taxonomy. This evidence rating system provides a unified and comprehensive approach to “grading” levels of evidence and strengths of recommendation. Why another evidence rating scheme? After all, don’t we have adequate systems from the Oxford Centre for Evidence Based Medicine (JFP’s current schema), the United States Preventive Services Task Force (USPSTF), and others?
Equipping our specialty
My primary reason for supporting this effort is the goal of giving our specialty a consistent and immediately familiar code for evidence recommendations. Given the variability and multitude of current evidence systems, family physicians either must remember their nuances, search their meaning, or—more likely, I suspect—give up on trying to understand the evidence behind the recommendations all together. With adoption of this proposal, our readers will be able to understand the results of a study presented in our major family medicine journals much more intuitively.
Is it meant for everyone?
You might wonder if we are swimming upstream. After all, will the evidence-based “gurus” rush to adopt our system? And won’t this effort merely add to the confusion? Undeniably, there will remain a multiplicity of evidence-based rating systems. But my desire is not to see our family medicine system used universally. Rather, I trust SORT will be a reliable resource for all of us within the specialty and enhance our identity as family physicians.
As the Future of Family Medicine Project advances, this small step should enhance our discipline’s ability to attain a single, immediately identifiable yardstick for scholarship. I invite your comments and support as we make the transition to this new system.
In this issue of The Journal of Family Practice, you will find the result of an extraordinary collaboration among the editors of the major family medicine journals: SORT, which stands for the Strength of Recommendation Taxonomy. This evidence rating system provides a unified and comprehensive approach to “grading” levels of evidence and strengths of recommendation. Why another evidence rating scheme? After all, don’t we have adequate systems from the Oxford Centre for Evidence Based Medicine (JFP’s current schema), the United States Preventive Services Task Force (USPSTF), and others?
Equipping our specialty
My primary reason for supporting this effort is the goal of giving our specialty a consistent and immediately familiar code for evidence recommendations. Given the variability and multitude of current evidence systems, family physicians either must remember their nuances, search their meaning, or—more likely, I suspect—give up on trying to understand the evidence behind the recommendations all together. With adoption of this proposal, our readers will be able to understand the results of a study presented in our major family medicine journals much more intuitively.
Is it meant for everyone?
You might wonder if we are swimming upstream. After all, will the evidence-based “gurus” rush to adopt our system? And won’t this effort merely add to the confusion? Undeniably, there will remain a multiplicity of evidence-based rating systems. But my desire is not to see our family medicine system used universally. Rather, I trust SORT will be a reliable resource for all of us within the specialty and enhance our identity as family physicians.
As the Future of Family Medicine Project advances, this small step should enhance our discipline’s ability to attain a single, immediately identifiable yardstick for scholarship. I invite your comments and support as we make the transition to this new system.
In this issue of The Journal of Family Practice, you will find the result of an extraordinary collaboration among the editors of the major family medicine journals: SORT, which stands for the Strength of Recommendation Taxonomy. This evidence rating system provides a unified and comprehensive approach to “grading” levels of evidence and strengths of recommendation. Why another evidence rating scheme? After all, don’t we have adequate systems from the Oxford Centre for Evidence Based Medicine (JFP’s current schema), the United States Preventive Services Task Force (USPSTF), and others?
Equipping our specialty
My primary reason for supporting this effort is the goal of giving our specialty a consistent and immediately familiar code for evidence recommendations. Given the variability and multitude of current evidence systems, family physicians either must remember their nuances, search their meaning, or—more likely, I suspect—give up on trying to understand the evidence behind the recommendations all together. With adoption of this proposal, our readers will be able to understand the results of a study presented in our major family medicine journals much more intuitively.
Is it meant for everyone?
You might wonder if we are swimming upstream. After all, will the evidence-based “gurus” rush to adopt our system? And won’t this effort merely add to the confusion? Undeniably, there will remain a multiplicity of evidence-based rating systems. But my desire is not to see our family medicine system used universally. Rather, I trust SORT will be a reliable resource for all of us within the specialty and enhance our identity as family physicians.
As the Future of Family Medicine Project advances, this small step should enhance our discipline’s ability to attain a single, immediately identifiable yardstick for scholarship. I invite your comments and support as we make the transition to this new system.
JFP: A new year full of opportunities
The Chinese characters for “crisis” embody 2 concepts: the top represents danger and the bottom, opportunity.
January 1 marks the end of my first official year as Editor of The Journal of Family Practice. And I feel as if I have been traversing this fine line between danger and opportunity—wanting to proactively change JFP to better meet your needs for immediate relevancy, while wishing to preserve its scholarly, evidence-based approach. Let me share a few observations about this experience.
First, I’m impressed with our readers! I am delighted how closely you scrutinize the journal, passionately highlight the shortcomings of the studies we review, and enthusiastically endorse most of the changes we’ve made. You are a practical lot: you want articles that are going to change your practice tomorrow. You want information to guide decisions, even when evidence is scant. To this end, we’ve expanded our coverage of Applied Evidence (from narrower systematic reviews, such as “Incontinence” in this issue of the Journal, to broader analyses of important topics).
Many of you voice reservations about evidence-based medicine. Some of you have been around long enough to know that today’s evidence (dogma?) is often viewed as tomorrow’s quackery (witness hormone replacement therapy) and question the reductionistic approach to evidence. You fear the EBM movement will limit appropriate variation in practice. You wonder who is paying attention to the art of medicine. You remain suspicious of attempts to standardize diagnosis and management. Our ongoing critical review of guidelines, discussions of controversies in EBM, and original research articles continue to challenge our assumptions.
Finally, some of you express worry about the pace of change and direction in which medicine is moving: concierge medicine, maintenance of certification, Medicare HMOs. You worry that our commitment to healthcare for all is vanishing, that stewardship of our communities is eroding, and that personal satisfaction is slipping. You see crises at every turn. Essays on the art of medicine and future articles on hot topics, such as hospitalists, will continue to address these controversies.
As we face the New Year, I trust we all will find the opportunities in the crises we face.
The Chinese characters for “crisis” embody 2 concepts: the top represents danger and the bottom, opportunity.
January 1 marks the end of my first official year as Editor of The Journal of Family Practice. And I feel as if I have been traversing this fine line between danger and opportunity—wanting to proactively change JFP to better meet your needs for immediate relevancy, while wishing to preserve its scholarly, evidence-based approach. Let me share a few observations about this experience.
First, I’m impressed with our readers! I am delighted how closely you scrutinize the journal, passionately highlight the shortcomings of the studies we review, and enthusiastically endorse most of the changes we’ve made. You are a practical lot: you want articles that are going to change your practice tomorrow. You want information to guide decisions, even when evidence is scant. To this end, we’ve expanded our coverage of Applied Evidence (from narrower systematic reviews, such as “Incontinence” in this issue of the Journal, to broader analyses of important topics).
Many of you voice reservations about evidence-based medicine. Some of you have been around long enough to know that today’s evidence (dogma?) is often viewed as tomorrow’s quackery (witness hormone replacement therapy) and question the reductionistic approach to evidence. You fear the EBM movement will limit appropriate variation in practice. You wonder who is paying attention to the art of medicine. You remain suspicious of attempts to standardize diagnosis and management. Our ongoing critical review of guidelines, discussions of controversies in EBM, and original research articles continue to challenge our assumptions.
Finally, some of you express worry about the pace of change and direction in which medicine is moving: concierge medicine, maintenance of certification, Medicare HMOs. You worry that our commitment to healthcare for all is vanishing, that stewardship of our communities is eroding, and that personal satisfaction is slipping. You see crises at every turn. Essays on the art of medicine and future articles on hot topics, such as hospitalists, will continue to address these controversies.
As we face the New Year, I trust we all will find the opportunities in the crises we face.
The Chinese characters for “crisis” embody 2 concepts: the top represents danger and the bottom, opportunity.
January 1 marks the end of my first official year as Editor of The Journal of Family Practice. And I feel as if I have been traversing this fine line between danger and opportunity—wanting to proactively change JFP to better meet your needs for immediate relevancy, while wishing to preserve its scholarly, evidence-based approach. Let me share a few observations about this experience.
First, I’m impressed with our readers! I am delighted how closely you scrutinize the journal, passionately highlight the shortcomings of the studies we review, and enthusiastically endorse most of the changes we’ve made. You are a practical lot: you want articles that are going to change your practice tomorrow. You want information to guide decisions, even when evidence is scant. To this end, we’ve expanded our coverage of Applied Evidence (from narrower systematic reviews, such as “Incontinence” in this issue of the Journal, to broader analyses of important topics).
Many of you voice reservations about evidence-based medicine. Some of you have been around long enough to know that today’s evidence (dogma?) is often viewed as tomorrow’s quackery (witness hormone replacement therapy) and question the reductionistic approach to evidence. You fear the EBM movement will limit appropriate variation in practice. You wonder who is paying attention to the art of medicine. You remain suspicious of attempts to standardize diagnosis and management. Our ongoing critical review of guidelines, discussions of controversies in EBM, and original research articles continue to challenge our assumptions.
Finally, some of you express worry about the pace of change and direction in which medicine is moving: concierge medicine, maintenance of certification, Medicare HMOs. You worry that our commitment to healthcare for all is vanishing, that stewardship of our communities is eroding, and that personal satisfaction is slipping. You see crises at every turn. Essays on the art of medicine and future articles on hot topics, such as hospitalists, will continue to address these controversies.
As we face the New Year, I trust we all will find the opportunities in the crises we face.
Managing musculoskeletal complaints with rehabilitation therapy: Summary of the Philadelphia Panel evidence-based clinical practice guidelines on musculoskeletal rehabilitation interventions
OBJECTIVE: The Philadelphia Panel recently formulated evidence-based guidelines for selected rehabilitation interventions in the management of low back, knee, neck, and shoulder pain.
STUDY DESIGN: The guidelines were developed with the use of a 5-step process: define the intervention, collect evidence, synthesize results, make recommendations based on the research, and grade the strength of the recommendations.
POPULATION: Outpatient adults with low back, knee, neck, or shoulder pain without vertebral disk involvement, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were included in the review.
OUTCOMES MEASURED: To prepare the data, systematic reviews were performed for low back, knee, neck, and shoulder pain. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation, thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Studies were identified and analyzed based on study type, clinical significance, and statistical significance.
CONCLUSIONS: The Philadelphia Panel guidelines recommend continued normal activity for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain; transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis; proprioceptive and therapeutic exercise for chronic neck pain; and the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The Philadelphia Panel recommends continued normal activities for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain.
- The Philadelphia Panel also recommends transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis.
- For chronic neck pain, the Philadelphia Panel recommends proprioceptive and therapeutic exercise.
- The Philadelphia Panel found evidence to support the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed, prospective, randomized, controlled trials.
The Philadelphia Panel evidence-based clinical guidelines on musculoskeletal rehabilitation interventions were published as 5 separate articles in the October 2001 issue of Physical Therapy, the journal of the American Physical Therapy Association.1-5 Originally convened on December 17, 1999, the panel included member representatives from the American Physical Therapy Association (Andrew A. Guccione, PT, PhD), the American College of Rheumatology (Scott M. Hasson, PT, PhD), the American Academy of Orthopedic Surgeons (John Albright, MD), the American Academy of Neurology (Bruce Dobkin, MD), the American College of Physicians (Richard Allman, MD, and Alicia Conill, MD), the Cochrane Back Group (Paul Shekelle, PhD), the American Society of Physical Medicine and Rehabilitation (Randolph Russo, MD, and Richard Paul Bonfiglio, MD), and the American Academy of Family Physicians (Jeffrey L. Susman, MD). The purpose of the group was to create evidence-based practice guidelines that identify the clinical benefit of rehabilitation interventions for low back, knee, neck, and shoulder problems. The guidelines did not address medical or pharmacologic management of these conditions. Although the guidelines primarily benefit the rehabilitation specialist (physical therapists, occupational therapists, and sports therapists), family practitioners and other primary care physicians are responsible for managing these conditions and their treatments. By knowing which rehabilitation interventions have proven clinical benefit, physicians can better coordinate a patient’s care and make evidence-based decisions when ordering physical therapy. In this report, we summarize and disseminate these guidelines for specific rehabilitation modalities in the management of common conditions that cause back pain, knee pain, neck pain, or shoulder pain.
Background
The Philadelphia Panel is not a novel evaluation of evidence-based rehabilitation interventions. Previous assessments of therapies have been published by Disorders; the Agency for Health Care Policy and Research (guidelines for low back problems); the British Medical Journal; Clinical Evidence; and the American College of Rheumatology (guidelines for knee osteoarthritis). However, those guidelines had significant limitations or have become outdated. The Philadelphia Panel set out to provide a structured and rigorous set of evidence-based clinical guidelines for the conservative (nonsurgical) management of conditions associated with low back, knee, neck, or shoulder pain.
Professional organizations of clinicians who routinely care for patients with back, knee, neck, and shoulder pain nominated members to create the Philadelphia Panel. Panelists were nominated based on their clinical expertise and previous experience developing evidence-based guidelines. Members of the panel included an orthopedic surgeon, a rheumatologist, an internist, a physiatrist, a neurologist, a family physician, a doctorate-level researcher from the Cochrane Back Group, and 2 physical therapists. The panel chair formed a research staff to identify and screen articles and construct evidence tables for pertinent references.
Development of guidelines
To provide evidence-based practice guidelines for each condition, a 5-step process was established: defining the intervention, collecting the evidence, synthesizing the results, making recommendations based on the research, and grading the strength of the recommendations. To prepare the data, systematic reviews were performed for the conditions of interest and specific interventions. Rehabilitation interventions frequently used in the care of low back, knee, neck, and shoulder pain were identified, and the patient population was defined. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation (TENS), thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Evidence from randomized controlled trials and observational studies such as controlled clinical trials, cohort studies, and case-control studies was identified and analyzed. Studies were included if they had evaluated outcome measures such as pain, function, strength, range of motion, return to work, patient satisfaction, activities of daily living, or quality of life. Data from studies that included outpatient adults with vertebral disk disease, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were excluded.
The data from pertinent articles were synthesized, and the relative clinical benefit between treatment and control groups was calculated for each condition for each intervention. The panel deemed a 15% or greater improvement between treatment and control groups to be clinically important. Relevant studies were then graded according to the type and clinical importance of the presented data. The grading scheme is summarized in Table 1. Once the panel compiled the intervention recommendations for each condition, external review by practitioners ensured the relevance of the recommendations. Interventions with a grade of A or B were to be included in the guidelines. No grade B recommendations were made. Grade C interventions could be neither included nor excluded in the final guidelines due to lack of demonstrated clinical benefit.
TABLE 1
Details of the Philadelphia Panel Classification System*
Grade | Clinical importance | Study design type |
---|---|---|
A | 15% | RCT (single or meta-analysis) |
B | 15% | CCT or observational study (single or meta-analysis) |
C | 15% | RCT or CCT or observational (single or meta-analysis) |
ID | NA | Insufficient or no data |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.5 | ||
CCT, controlled clinical trial; NA, not applicable; RCT, randomized, controlled trial. |
Recommendations for low back pain
Low back pain results in significant socioeconomic repercussions due to the restriction of occupational activities and functional ability in the activities of daily living. Treatment goals in the care of patients with low back pain include relief from pain, reduction of muscle spasm, improvement in range of motion and strength, correction of postural problems, and improvement of functional status at work and in daily life. The care of patients with low back pain can be a very frustrating process for physicians or therapists. Use of treatment modalities with proven effectiveness can provide structure and credibility to the recovery process. The Philadelphia Panel’s recommendations are summarized in Table 2.
The panel found grade A evidence for improvement in the ability to return to work with continuation of normal activity vs enforced bedrest for acute low back pain (<4 weeks). Interestingly, no clinically important benefit was shown for the continuation of normal activity for the improvement, of pain (5% decrease) or function (10% improvement). It is important to note that the recommendations for low back pain are based on studies that excluded patients with disk involvement; therefore, the effects of continuing normal activity in patients with acute back pain and disk involvement were not assessed. The Philadelphia Panel chose not to evaluate data from studies with vertebral disk involvement in their patient population.
With regard to acute low back pain, data from randomized controlled trials demonstrated no clinically important benefit (<15% from control) of stretching or strengthening exercises, mechanical traction, or TENS. Likewise, a study of therapeutic ultrasound showed no demonstrable clinical benefit. There was poor evidence to include or exclude these modalities alone as an intervention for acute low back pain. No study with an acceptable research design was identified for thermotherapy, electrical stimulation, therapeutic massage, or electromyographic biofeedback as interventions for low back pain.
For subacute low back pain (4–12 weeks), data from randomized controlled trials showed a clinically significant improvement in pain, function, and global assessment from therapeutic exercise. Mechanical traction for subacute low back pain was given a grade C rating for patient global improvement and return to work. Consequently, there is poor evidence to include or exclude mechanical traction alone for low back pain.
The assessment of chronic low back pain (>12 weeks) identified 1 grade A guideline. Therapeutic exercise, including stretching, strengthening, and mobility exercises, resulted in clinically significant improvement in pain and function but had no clinical benefit in facilitating return to work. Mechanical traction, TENS, electromyographic biofeedback, and therapeutic ultrasound showed no clinical benefit. No studies assessed efficacy of thermotherapy, massage, or electrical stimulation.
Back pain due to prior back surgery was considered separately from other conditions. A grade A guideline was given to therapeutic exercise for pain due to prior back surgery.
Combinations of rehabilitation interventions for acute and chronic low back pain produced insufficient data to make a recommendation. Although most patients who are referred to physical therapy undergo combination therapy, the panel could not formalize a guideline for combination therapy.
TABLE 2
Summary grid of low back pain guidelines*
Therapy | Acute | Subacute | Chronic | Postsurgery |
---|---|---|---|---|
Exercise | C | A | A | A |
Continue normal activities | A | ID | ID | ID |
Traction | C | C | C | ID |
Ultrasound | C | ID | C | ID |
TENS | C | ID | C | ID |
EMG biofeedback | ID | ID | C | ID |
Massage | ID | ID | ID | ID |
Thermotherapy | ID | ID | ID | ID |
Electrical stimulation | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.4 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for knee pain
Chronic knee pain is one of the more common complaints presented to primary care physicians. Acute and chronic pain can be related to acute injury, osteoarthritis, overuse injuries, or knee surgery. Due to the frequency of knee pain and its tendency to improve with time, there is a need to provide clinicians with the ability to make informed decisions regarding treatment options. The panel’s recommendations are summarized in Table 3.
The Philadelphia Panel identified two interventions that demonstrated grade A data for the treatment of osteoarthritis. Therapeutic exercise and TENS showed clinically important benefit for pain and patient global assessment in osteoarthritis. Thermotherapy, ultrasound, and electrical stimulation demonstrated no clinically important benefit for knee osteoarthritis. In summary, there is poor evidence to include or exclude thermotherapy, ultrasound, or electrical stimulation in the treatment of knee osteoarthritis.
With regard to knee tendonitis, the only intervention with significant data was deep transverse friction massage, which showed no clinical benefit. Patellofemoral pain also had 1 grade C intervention recommendation for the use of ultrasound. Further, preoperative exercise, thermotherapy, and TENS showed no clinical benefit for the management of postsurgical knee pain.
The remaining interventions for osteoarthritis of the knee, patellofemoral pain, tendonitis of the knee, and postsurgical pain showed insufficient evidence for the Philadelphia Panel to make guideline recommendations. The major implication of this analysis is that there is poor evidence to support the use of several widely accepted interventions in the treatment of knee pain.
TABLE 3
Summary grid of knee pain guidelines*
Therapy | Patellofemoral | Postsurgery | Osteoarthritis | Kneetendinitis |
---|---|---|---|---|
Exercise | ID | C | A | ID |
TENS | ID | C | A | ID |
Massage | ID | ID | ID | C |
Thermotherapy | ID | C | C | ID |
Ultrasound | C | ID | C | ID |
Electrical stimulation | ID | ID | C | ID |
EMG biofeedback | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.3 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for neck pain
Acute neck pain is often associated with injury or accident, whereas chronic neck pain is related to repetitive injury. Neck pain is commonly managed with analgesics and rest, but referrals to rehabilitation are increasing. The Philadelphia Panel sought to improve the appropriate use of rehabilitation interventions for neck pain by providing evidence-based guidelines. A summary of the Panel’s recommendations can be found in Table 4.
Only 8 trials met all selection criteria for the management of neck pain. Of these trials, only proprioceptive and therapeutic exercise for chronic neck pain showed clinical benefit for pain and function. The remaining studies showed no clinical benefit or insufficient data. Mechanical traction showed no clinically important benefit in the treatment of acute or chronic neck pain. No further studies that met selection criteria were found with regard to rehabilitation interventions for neck pain. Clearly there are insufficient data in the medical literature with regard to neck pain.
TABLE 4
Summary grid of neck pain guidelines*
Therapy | Acute | Chronic |
---|---|---|
Exercise/neuro-muscular reeducation | ID | A |
Traction | C | C |
Ultrasound | ID | C |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
Electrical stimulation | ID | ID |
EMG biofeedback | ID | ID |
Combined rehabilitation interventions | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.2 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for shoulder pain
Rehabilitation specialists offer several conservative interventions for the management of shoulder pain. There are few published guidelines for the management of shoulder pain. Results of the analysis are shown in Table 5. As in the analysis of neck pain, the Philadelphia Panel was able to develop a single recommendation with clinical benefit. Clinically important benefit was shown for ultrasound for calcific tendonitis. There was no evidence of clinically important benefit for the use of ultrasound for capsulitis, bursitis, or tendonitis.
TABLE 5
Summary grid of shoulder pain guidelines*
Therapy | Calcific tendinitis, | Capsulitis, bursitis, tendinitis nonspecific pain |
---|---|---|
Ultrasound | A | C |
Exercise | ID | ID |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
EMG biofeedback | ID | ID |
Electrical stimulation | ID | ID |
Combined rehabilitation modalities | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.1 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Discussion
By using a rigorous methodology, the Philadelphia Panel has created evidence-based clinical practice guidelines for low back, knee, neck, and shoulder pain rehabilitation based on the current medical literature. Despite the thorough techniques used to create the guidelines, there are methodologic limitations, as with all such reviews. The panel identified many problems with the current body of evidence in the medical literature. The main difficulty with the current literature is the lack of standardization of outcome measurements used in different studies. Future studies need to develop standards of measurement that are valid, reliable, and sensitive to changes in outcome. Further, current studies have used broad inclusion criteria and enrolled patients with diverse etiologies for their pain. Problems with selection and description of patients, definitions of conditions, and standardizations of treatments and outcome measures need to be solved to properly demonstrate benefit from a rehabilitation intervention and remove misclassification bias.
Another limitation is the inherent difficulty of studying rehabilitation interventions. The effectiveness of physical rehabilitation interventions is affected by psychosocial, physical, and occupational factors. These factors can be minimized by fully randomizing large patient groups, thus minimizing selection bias. Another difficulty with developing high-quality randomized controlled trials in the area of rehabilitation is the blinding of patients or caregivers to interventions.
In future studies, it will be necessary to specifically clarify the type and manner of an intervention, intervention intensity and duration, and progression of the intervention according to patient-specific outcomes. Further, a patient typically receives several rehabilitation interventions during a therapy session. These modalities change depending on the phase of recovery (ie, ice, rest, and compression initially, evolving to strengthening, stretching, and electrotherapy with progress). A more thorough means of standardizing this progression in a patient’s care is needed.
In addition, the guidelines did not address cost, patient preferences, or potential harm associated with each intervention for the specific conditions.
Overall, there is a pressing need for further work in the study of rehabilitation interventions, due especially to the increased use of physical therapy for the management of low back pain, knee pain, neck pain, and shoulder pain.
1. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for shoulder pain. Phys Ther 2001;81:1719-30.
2. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther 2001;81:1701-17.
3. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for knee pain. Phys Ther 2001;81:1675-700.
4. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. Phys Ther 2001;81:1641-74.
5. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions: overview and methodology. Phys Ther 2001;81:1629-40.
OBJECTIVE: The Philadelphia Panel recently formulated evidence-based guidelines for selected rehabilitation interventions in the management of low back, knee, neck, and shoulder pain.
STUDY DESIGN: The guidelines were developed with the use of a 5-step process: define the intervention, collect evidence, synthesize results, make recommendations based on the research, and grade the strength of the recommendations.
POPULATION: Outpatient adults with low back, knee, neck, or shoulder pain without vertebral disk involvement, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were included in the review.
OUTCOMES MEASURED: To prepare the data, systematic reviews were performed for low back, knee, neck, and shoulder pain. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation, thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Studies were identified and analyzed based on study type, clinical significance, and statistical significance.
CONCLUSIONS: The Philadelphia Panel guidelines recommend continued normal activity for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain; transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis; proprioceptive and therapeutic exercise for chronic neck pain; and the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The Philadelphia Panel recommends continued normal activities for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain.
- The Philadelphia Panel also recommends transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis.
- For chronic neck pain, the Philadelphia Panel recommends proprioceptive and therapeutic exercise.
- The Philadelphia Panel found evidence to support the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed, prospective, randomized, controlled trials.
The Philadelphia Panel evidence-based clinical guidelines on musculoskeletal rehabilitation interventions were published as 5 separate articles in the October 2001 issue of Physical Therapy, the journal of the American Physical Therapy Association.1-5 Originally convened on December 17, 1999, the panel included member representatives from the American Physical Therapy Association (Andrew A. Guccione, PT, PhD), the American College of Rheumatology (Scott M. Hasson, PT, PhD), the American Academy of Orthopedic Surgeons (John Albright, MD), the American Academy of Neurology (Bruce Dobkin, MD), the American College of Physicians (Richard Allman, MD, and Alicia Conill, MD), the Cochrane Back Group (Paul Shekelle, PhD), the American Society of Physical Medicine and Rehabilitation (Randolph Russo, MD, and Richard Paul Bonfiglio, MD), and the American Academy of Family Physicians (Jeffrey L. Susman, MD). The purpose of the group was to create evidence-based practice guidelines that identify the clinical benefit of rehabilitation interventions for low back, knee, neck, and shoulder problems. The guidelines did not address medical or pharmacologic management of these conditions. Although the guidelines primarily benefit the rehabilitation specialist (physical therapists, occupational therapists, and sports therapists), family practitioners and other primary care physicians are responsible for managing these conditions and their treatments. By knowing which rehabilitation interventions have proven clinical benefit, physicians can better coordinate a patient’s care and make evidence-based decisions when ordering physical therapy. In this report, we summarize and disseminate these guidelines for specific rehabilitation modalities in the management of common conditions that cause back pain, knee pain, neck pain, or shoulder pain.
Background
The Philadelphia Panel is not a novel evaluation of evidence-based rehabilitation interventions. Previous assessments of therapies have been published by Disorders; the Agency for Health Care Policy and Research (guidelines for low back problems); the British Medical Journal; Clinical Evidence; and the American College of Rheumatology (guidelines for knee osteoarthritis). However, those guidelines had significant limitations or have become outdated. The Philadelphia Panel set out to provide a structured and rigorous set of evidence-based clinical guidelines for the conservative (nonsurgical) management of conditions associated with low back, knee, neck, or shoulder pain.
Professional organizations of clinicians who routinely care for patients with back, knee, neck, and shoulder pain nominated members to create the Philadelphia Panel. Panelists were nominated based on their clinical expertise and previous experience developing evidence-based guidelines. Members of the panel included an orthopedic surgeon, a rheumatologist, an internist, a physiatrist, a neurologist, a family physician, a doctorate-level researcher from the Cochrane Back Group, and 2 physical therapists. The panel chair formed a research staff to identify and screen articles and construct evidence tables for pertinent references.
Development of guidelines
To provide evidence-based practice guidelines for each condition, a 5-step process was established: defining the intervention, collecting the evidence, synthesizing the results, making recommendations based on the research, and grading the strength of the recommendations. To prepare the data, systematic reviews were performed for the conditions of interest and specific interventions. Rehabilitation interventions frequently used in the care of low back, knee, neck, and shoulder pain were identified, and the patient population was defined. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation (TENS), thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Evidence from randomized controlled trials and observational studies such as controlled clinical trials, cohort studies, and case-control studies was identified and analyzed. Studies were included if they had evaluated outcome measures such as pain, function, strength, range of motion, return to work, patient satisfaction, activities of daily living, or quality of life. Data from studies that included outpatient adults with vertebral disk disease, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were excluded.
The data from pertinent articles were synthesized, and the relative clinical benefit between treatment and control groups was calculated for each condition for each intervention. The panel deemed a 15% or greater improvement between treatment and control groups to be clinically important. Relevant studies were then graded according to the type and clinical importance of the presented data. The grading scheme is summarized in Table 1. Once the panel compiled the intervention recommendations for each condition, external review by practitioners ensured the relevance of the recommendations. Interventions with a grade of A or B were to be included in the guidelines. No grade B recommendations were made. Grade C interventions could be neither included nor excluded in the final guidelines due to lack of demonstrated clinical benefit.
TABLE 1
Details of the Philadelphia Panel Classification System*
Grade | Clinical importance | Study design type |
---|---|---|
A | 15% | RCT (single or meta-analysis) |
B | 15% | CCT or observational study (single or meta-analysis) |
C | 15% | RCT or CCT or observational (single or meta-analysis) |
ID | NA | Insufficient or no data |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.5 | ||
CCT, controlled clinical trial; NA, not applicable; RCT, randomized, controlled trial. |
Recommendations for low back pain
Low back pain results in significant socioeconomic repercussions due to the restriction of occupational activities and functional ability in the activities of daily living. Treatment goals in the care of patients with low back pain include relief from pain, reduction of muscle spasm, improvement in range of motion and strength, correction of postural problems, and improvement of functional status at work and in daily life. The care of patients with low back pain can be a very frustrating process for physicians or therapists. Use of treatment modalities with proven effectiveness can provide structure and credibility to the recovery process. The Philadelphia Panel’s recommendations are summarized in Table 2.
The panel found grade A evidence for improvement in the ability to return to work with continuation of normal activity vs enforced bedrest for acute low back pain (<4 weeks). Interestingly, no clinically important benefit was shown for the continuation of normal activity for the improvement, of pain (5% decrease) or function (10% improvement). It is important to note that the recommendations for low back pain are based on studies that excluded patients with disk involvement; therefore, the effects of continuing normal activity in patients with acute back pain and disk involvement were not assessed. The Philadelphia Panel chose not to evaluate data from studies with vertebral disk involvement in their patient population.
With regard to acute low back pain, data from randomized controlled trials demonstrated no clinically important benefit (<15% from control) of stretching or strengthening exercises, mechanical traction, or TENS. Likewise, a study of therapeutic ultrasound showed no demonstrable clinical benefit. There was poor evidence to include or exclude these modalities alone as an intervention for acute low back pain. No study with an acceptable research design was identified for thermotherapy, electrical stimulation, therapeutic massage, or electromyographic biofeedback as interventions for low back pain.
For subacute low back pain (4–12 weeks), data from randomized controlled trials showed a clinically significant improvement in pain, function, and global assessment from therapeutic exercise. Mechanical traction for subacute low back pain was given a grade C rating for patient global improvement and return to work. Consequently, there is poor evidence to include or exclude mechanical traction alone for low back pain.
The assessment of chronic low back pain (>12 weeks) identified 1 grade A guideline. Therapeutic exercise, including stretching, strengthening, and mobility exercises, resulted in clinically significant improvement in pain and function but had no clinical benefit in facilitating return to work. Mechanical traction, TENS, electromyographic biofeedback, and therapeutic ultrasound showed no clinical benefit. No studies assessed efficacy of thermotherapy, massage, or electrical stimulation.
Back pain due to prior back surgery was considered separately from other conditions. A grade A guideline was given to therapeutic exercise for pain due to prior back surgery.
Combinations of rehabilitation interventions for acute and chronic low back pain produced insufficient data to make a recommendation. Although most patients who are referred to physical therapy undergo combination therapy, the panel could not formalize a guideline for combination therapy.
TABLE 2
Summary grid of low back pain guidelines*
Therapy | Acute | Subacute | Chronic | Postsurgery |
---|---|---|---|---|
Exercise | C | A | A | A |
Continue normal activities | A | ID | ID | ID |
Traction | C | C | C | ID |
Ultrasound | C | ID | C | ID |
TENS | C | ID | C | ID |
EMG biofeedback | ID | ID | C | ID |
Massage | ID | ID | ID | ID |
Thermotherapy | ID | ID | ID | ID |
Electrical stimulation | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.4 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for knee pain
Chronic knee pain is one of the more common complaints presented to primary care physicians. Acute and chronic pain can be related to acute injury, osteoarthritis, overuse injuries, or knee surgery. Due to the frequency of knee pain and its tendency to improve with time, there is a need to provide clinicians with the ability to make informed decisions regarding treatment options. The panel’s recommendations are summarized in Table 3.
The Philadelphia Panel identified two interventions that demonstrated grade A data for the treatment of osteoarthritis. Therapeutic exercise and TENS showed clinically important benefit for pain and patient global assessment in osteoarthritis. Thermotherapy, ultrasound, and electrical stimulation demonstrated no clinically important benefit for knee osteoarthritis. In summary, there is poor evidence to include or exclude thermotherapy, ultrasound, or electrical stimulation in the treatment of knee osteoarthritis.
With regard to knee tendonitis, the only intervention with significant data was deep transverse friction massage, which showed no clinical benefit. Patellofemoral pain also had 1 grade C intervention recommendation for the use of ultrasound. Further, preoperative exercise, thermotherapy, and TENS showed no clinical benefit for the management of postsurgical knee pain.
The remaining interventions for osteoarthritis of the knee, patellofemoral pain, tendonitis of the knee, and postsurgical pain showed insufficient evidence for the Philadelphia Panel to make guideline recommendations. The major implication of this analysis is that there is poor evidence to support the use of several widely accepted interventions in the treatment of knee pain.
TABLE 3
Summary grid of knee pain guidelines*
Therapy | Patellofemoral | Postsurgery | Osteoarthritis | Kneetendinitis |
---|---|---|---|---|
Exercise | ID | C | A | ID |
TENS | ID | C | A | ID |
Massage | ID | ID | ID | C |
Thermotherapy | ID | C | C | ID |
Ultrasound | C | ID | C | ID |
Electrical stimulation | ID | ID | C | ID |
EMG biofeedback | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.3 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for neck pain
Acute neck pain is often associated with injury or accident, whereas chronic neck pain is related to repetitive injury. Neck pain is commonly managed with analgesics and rest, but referrals to rehabilitation are increasing. The Philadelphia Panel sought to improve the appropriate use of rehabilitation interventions for neck pain by providing evidence-based guidelines. A summary of the Panel’s recommendations can be found in Table 4.
Only 8 trials met all selection criteria for the management of neck pain. Of these trials, only proprioceptive and therapeutic exercise for chronic neck pain showed clinical benefit for pain and function. The remaining studies showed no clinical benefit or insufficient data. Mechanical traction showed no clinically important benefit in the treatment of acute or chronic neck pain. No further studies that met selection criteria were found with regard to rehabilitation interventions for neck pain. Clearly there are insufficient data in the medical literature with regard to neck pain.
TABLE 4
Summary grid of neck pain guidelines*
Therapy | Acute | Chronic |
---|---|---|
Exercise/neuro-muscular reeducation | ID | A |
Traction | C | C |
Ultrasound | ID | C |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
Electrical stimulation | ID | ID |
EMG biofeedback | ID | ID |
Combined rehabilitation interventions | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.2 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for shoulder pain
Rehabilitation specialists offer several conservative interventions for the management of shoulder pain. There are few published guidelines for the management of shoulder pain. Results of the analysis are shown in Table 5. As in the analysis of neck pain, the Philadelphia Panel was able to develop a single recommendation with clinical benefit. Clinically important benefit was shown for ultrasound for calcific tendonitis. There was no evidence of clinically important benefit for the use of ultrasound for capsulitis, bursitis, or tendonitis.
TABLE 5
Summary grid of shoulder pain guidelines*
Therapy | Calcific tendinitis, | Capsulitis, bursitis, tendinitis nonspecific pain |
---|---|---|
Ultrasound | A | C |
Exercise | ID | ID |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
EMG biofeedback | ID | ID |
Electrical stimulation | ID | ID |
Combined rehabilitation modalities | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.1 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Discussion
By using a rigorous methodology, the Philadelphia Panel has created evidence-based clinical practice guidelines for low back, knee, neck, and shoulder pain rehabilitation based on the current medical literature. Despite the thorough techniques used to create the guidelines, there are methodologic limitations, as with all such reviews. The panel identified many problems with the current body of evidence in the medical literature. The main difficulty with the current literature is the lack of standardization of outcome measurements used in different studies. Future studies need to develop standards of measurement that are valid, reliable, and sensitive to changes in outcome. Further, current studies have used broad inclusion criteria and enrolled patients with diverse etiologies for their pain. Problems with selection and description of patients, definitions of conditions, and standardizations of treatments and outcome measures need to be solved to properly demonstrate benefit from a rehabilitation intervention and remove misclassification bias.
Another limitation is the inherent difficulty of studying rehabilitation interventions. The effectiveness of physical rehabilitation interventions is affected by psychosocial, physical, and occupational factors. These factors can be minimized by fully randomizing large patient groups, thus minimizing selection bias. Another difficulty with developing high-quality randomized controlled trials in the area of rehabilitation is the blinding of patients or caregivers to interventions.
In future studies, it will be necessary to specifically clarify the type and manner of an intervention, intervention intensity and duration, and progression of the intervention according to patient-specific outcomes. Further, a patient typically receives several rehabilitation interventions during a therapy session. These modalities change depending on the phase of recovery (ie, ice, rest, and compression initially, evolving to strengthening, stretching, and electrotherapy with progress). A more thorough means of standardizing this progression in a patient’s care is needed.
In addition, the guidelines did not address cost, patient preferences, or potential harm associated with each intervention for the specific conditions.
Overall, there is a pressing need for further work in the study of rehabilitation interventions, due especially to the increased use of physical therapy for the management of low back pain, knee pain, neck pain, and shoulder pain.
OBJECTIVE: The Philadelphia Panel recently formulated evidence-based guidelines for selected rehabilitation interventions in the management of low back, knee, neck, and shoulder pain.
STUDY DESIGN: The guidelines were developed with the use of a 5-step process: define the intervention, collect evidence, synthesize results, make recommendations based on the research, and grade the strength of the recommendations.
POPULATION: Outpatient adults with low back, knee, neck, or shoulder pain without vertebral disk involvement, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were included in the review.
OUTCOMES MEASURED: To prepare the data, systematic reviews were performed for low back, knee, neck, and shoulder pain. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation, thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Studies were identified and analyzed based on study type, clinical significance, and statistical significance.
CONCLUSIONS: The Philadelphia Panel guidelines recommend continued normal activity for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain; transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis; proprioceptive and therapeutic exercise for chronic neck pain; and the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The Philadelphia Panel recommends continued normal activities for acute, uncomplicated low back pain and therapeutic exercise for chronic, subacute, and postsurgical low back pain.
- The Philadelphia Panel also recommends transcutaneous electrical nerve stimulation and exercise for knee osteoarthritis.
- For chronic neck pain, the Philadelphia Panel recommends proprioceptive and therapeutic exercise.
- The Philadelphia Panel found evidence to support the use of therapeutic ultrasound in the treatment of calcific tendonitis of the shoulder.
- The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed, prospective, randomized, controlled trials.
The Philadelphia Panel evidence-based clinical guidelines on musculoskeletal rehabilitation interventions were published as 5 separate articles in the October 2001 issue of Physical Therapy, the journal of the American Physical Therapy Association.1-5 Originally convened on December 17, 1999, the panel included member representatives from the American Physical Therapy Association (Andrew A. Guccione, PT, PhD), the American College of Rheumatology (Scott M. Hasson, PT, PhD), the American Academy of Orthopedic Surgeons (John Albright, MD), the American Academy of Neurology (Bruce Dobkin, MD), the American College of Physicians (Richard Allman, MD, and Alicia Conill, MD), the Cochrane Back Group (Paul Shekelle, PhD), the American Society of Physical Medicine and Rehabilitation (Randolph Russo, MD, and Richard Paul Bonfiglio, MD), and the American Academy of Family Physicians (Jeffrey L. Susman, MD). The purpose of the group was to create evidence-based practice guidelines that identify the clinical benefit of rehabilitation interventions for low back, knee, neck, and shoulder problems. The guidelines did not address medical or pharmacologic management of these conditions. Although the guidelines primarily benefit the rehabilitation specialist (physical therapists, occupational therapists, and sports therapists), family practitioners and other primary care physicians are responsible for managing these conditions and their treatments. By knowing which rehabilitation interventions have proven clinical benefit, physicians can better coordinate a patient’s care and make evidence-based decisions when ordering physical therapy. In this report, we summarize and disseminate these guidelines for specific rehabilitation modalities in the management of common conditions that cause back pain, knee pain, neck pain, or shoulder pain.
Background
The Philadelphia Panel is not a novel evaluation of evidence-based rehabilitation interventions. Previous assessments of therapies have been published by Disorders; the Agency for Health Care Policy and Research (guidelines for low back problems); the British Medical Journal; Clinical Evidence; and the American College of Rheumatology (guidelines for knee osteoarthritis). However, those guidelines had significant limitations or have become outdated. The Philadelphia Panel set out to provide a structured and rigorous set of evidence-based clinical guidelines for the conservative (nonsurgical) management of conditions associated with low back, knee, neck, or shoulder pain.
Professional organizations of clinicians who routinely care for patients with back, knee, neck, and shoulder pain nominated members to create the Philadelphia Panel. Panelists were nominated based on their clinical expertise and previous experience developing evidence-based guidelines. Members of the panel included an orthopedic surgeon, a rheumatologist, an internist, a physiatrist, a neurologist, a family physician, a doctorate-level researcher from the Cochrane Back Group, and 2 physical therapists. The panel chair formed a research staff to identify and screen articles and construct evidence tables for pertinent references.
Development of guidelines
To provide evidence-based practice guidelines for each condition, a 5-step process was established: defining the intervention, collecting the evidence, synthesizing the results, making recommendations based on the research, and grading the strength of the recommendations. To prepare the data, systematic reviews were performed for the conditions of interest and specific interventions. Rehabilitation interventions frequently used in the care of low back, knee, neck, and shoulder pain were identified, and the patient population was defined. Therapeutic exercise, massage, transcutaneous electrical nerve stimulation (TENS), thermotherapy, ultrasound, electrical stimulation, and combinations of these therapies were included in the literature search. Evidence from randomized controlled trials and observational studies such as controlled clinical trials, cohort studies, and case-control studies was identified and analyzed. Studies were included if they had evaluated outcome measures such as pain, function, strength, range of motion, return to work, patient satisfaction, activities of daily living, or quality of life. Data from studies that included outpatient adults with vertebral disk disease, scoliosis, cancer, or pulmonary, neurologic, cardiac, dermatologic, or psychiatric conditions were excluded.
The data from pertinent articles were synthesized, and the relative clinical benefit between treatment and control groups was calculated for each condition for each intervention. The panel deemed a 15% or greater improvement between treatment and control groups to be clinically important. Relevant studies were then graded according to the type and clinical importance of the presented data. The grading scheme is summarized in Table 1. Once the panel compiled the intervention recommendations for each condition, external review by practitioners ensured the relevance of the recommendations. Interventions with a grade of A or B were to be included in the guidelines. No grade B recommendations were made. Grade C interventions could be neither included nor excluded in the final guidelines due to lack of demonstrated clinical benefit.
TABLE 1
Details of the Philadelphia Panel Classification System*
Grade | Clinical importance | Study design type |
---|---|---|
A | 15% | RCT (single or meta-analysis) |
B | 15% | CCT or observational study (single or meta-analysis) |
C | 15% | RCT or CCT or observational (single or meta-analysis) |
ID | NA | Insufficient or no data |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.5 | ||
CCT, controlled clinical trial; NA, not applicable; RCT, randomized, controlled trial. |
Recommendations for low back pain
Low back pain results in significant socioeconomic repercussions due to the restriction of occupational activities and functional ability in the activities of daily living. Treatment goals in the care of patients with low back pain include relief from pain, reduction of muscle spasm, improvement in range of motion and strength, correction of postural problems, and improvement of functional status at work and in daily life. The care of patients with low back pain can be a very frustrating process for physicians or therapists. Use of treatment modalities with proven effectiveness can provide structure and credibility to the recovery process. The Philadelphia Panel’s recommendations are summarized in Table 2.
The panel found grade A evidence for improvement in the ability to return to work with continuation of normal activity vs enforced bedrest for acute low back pain (<4 weeks). Interestingly, no clinically important benefit was shown for the continuation of normal activity for the improvement, of pain (5% decrease) or function (10% improvement). It is important to note that the recommendations for low back pain are based on studies that excluded patients with disk involvement; therefore, the effects of continuing normal activity in patients with acute back pain and disk involvement were not assessed. The Philadelphia Panel chose not to evaluate data from studies with vertebral disk involvement in their patient population.
With regard to acute low back pain, data from randomized controlled trials demonstrated no clinically important benefit (<15% from control) of stretching or strengthening exercises, mechanical traction, or TENS. Likewise, a study of therapeutic ultrasound showed no demonstrable clinical benefit. There was poor evidence to include or exclude these modalities alone as an intervention for acute low back pain. No study with an acceptable research design was identified for thermotherapy, electrical stimulation, therapeutic massage, or electromyographic biofeedback as interventions for low back pain.
For subacute low back pain (4–12 weeks), data from randomized controlled trials showed a clinically significant improvement in pain, function, and global assessment from therapeutic exercise. Mechanical traction for subacute low back pain was given a grade C rating for patient global improvement and return to work. Consequently, there is poor evidence to include or exclude mechanical traction alone for low back pain.
The assessment of chronic low back pain (>12 weeks) identified 1 grade A guideline. Therapeutic exercise, including stretching, strengthening, and mobility exercises, resulted in clinically significant improvement in pain and function but had no clinical benefit in facilitating return to work. Mechanical traction, TENS, electromyographic biofeedback, and therapeutic ultrasound showed no clinical benefit. No studies assessed efficacy of thermotherapy, massage, or electrical stimulation.
Back pain due to prior back surgery was considered separately from other conditions. A grade A guideline was given to therapeutic exercise for pain due to prior back surgery.
Combinations of rehabilitation interventions for acute and chronic low back pain produced insufficient data to make a recommendation. Although most patients who are referred to physical therapy undergo combination therapy, the panel could not formalize a guideline for combination therapy.
TABLE 2
Summary grid of low back pain guidelines*
Therapy | Acute | Subacute | Chronic | Postsurgery |
---|---|---|---|---|
Exercise | C | A | A | A |
Continue normal activities | A | ID | ID | ID |
Traction | C | C | C | ID |
Ultrasound | C | ID | C | ID |
TENS | C | ID | C | ID |
EMG biofeedback | ID | ID | C | ID |
Massage | ID | ID | ID | ID |
Thermotherapy | ID | ID | ID | ID |
Electrical stimulation | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.4 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for knee pain
Chronic knee pain is one of the more common complaints presented to primary care physicians. Acute and chronic pain can be related to acute injury, osteoarthritis, overuse injuries, or knee surgery. Due to the frequency of knee pain and its tendency to improve with time, there is a need to provide clinicians with the ability to make informed decisions regarding treatment options. The panel’s recommendations are summarized in Table 3.
The Philadelphia Panel identified two interventions that demonstrated grade A data for the treatment of osteoarthritis. Therapeutic exercise and TENS showed clinically important benefit for pain and patient global assessment in osteoarthritis. Thermotherapy, ultrasound, and electrical stimulation demonstrated no clinically important benefit for knee osteoarthritis. In summary, there is poor evidence to include or exclude thermotherapy, ultrasound, or electrical stimulation in the treatment of knee osteoarthritis.
With regard to knee tendonitis, the only intervention with significant data was deep transverse friction massage, which showed no clinical benefit. Patellofemoral pain also had 1 grade C intervention recommendation for the use of ultrasound. Further, preoperative exercise, thermotherapy, and TENS showed no clinical benefit for the management of postsurgical knee pain.
The remaining interventions for osteoarthritis of the knee, patellofemoral pain, tendonitis of the knee, and postsurgical pain showed insufficient evidence for the Philadelphia Panel to make guideline recommendations. The major implication of this analysis is that there is poor evidence to support the use of several widely accepted interventions in the treatment of knee pain.
TABLE 3
Summary grid of knee pain guidelines*
Therapy | Patellofemoral | Postsurgery | Osteoarthritis | Kneetendinitis |
---|---|---|---|---|
Exercise | ID | C | A | ID |
TENS | ID | C | A | ID |
Massage | ID | ID | ID | C |
Thermotherapy | ID | C | C | ID |
Ultrasound | C | ID | C | ID |
Electrical stimulation | ID | ID | C | ID |
EMG biofeedback | ID | ID | ID | ID |
Combined rehabilitation modalities | ID | ID | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.3 | ||||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for neck pain
Acute neck pain is often associated with injury or accident, whereas chronic neck pain is related to repetitive injury. Neck pain is commonly managed with analgesics and rest, but referrals to rehabilitation are increasing. The Philadelphia Panel sought to improve the appropriate use of rehabilitation interventions for neck pain by providing evidence-based guidelines. A summary of the Panel’s recommendations can be found in Table 4.
Only 8 trials met all selection criteria for the management of neck pain. Of these trials, only proprioceptive and therapeutic exercise for chronic neck pain showed clinical benefit for pain and function. The remaining studies showed no clinical benefit or insufficient data. Mechanical traction showed no clinically important benefit in the treatment of acute or chronic neck pain. No further studies that met selection criteria were found with regard to rehabilitation interventions for neck pain. Clearly there are insufficient data in the medical literature with regard to neck pain.
TABLE 4
Summary grid of neck pain guidelines*
Therapy | Acute | Chronic |
---|---|---|
Exercise/neuro-muscular reeducation | ID | A |
Traction | C | C |
Ultrasound | ID | C |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
Electrical stimulation | ID | ID |
EMG biofeedback | ID | ID |
Combined rehabilitation interventions | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.2 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Recommendations for shoulder pain
Rehabilitation specialists offer several conservative interventions for the management of shoulder pain. There are few published guidelines for the management of shoulder pain. Results of the analysis are shown in Table 5. As in the analysis of neck pain, the Philadelphia Panel was able to develop a single recommendation with clinical benefit. Clinically important benefit was shown for ultrasound for calcific tendonitis. There was no evidence of clinically important benefit for the use of ultrasound for capsulitis, bursitis, or tendonitis.
TABLE 5
Summary grid of shoulder pain guidelines*
Therapy | Calcific tendinitis, | Capsulitis, bursitis, tendinitis nonspecific pain |
---|---|---|
Ultrasound | A | C |
Exercise | ID | ID |
TENS | ID | ID |
Massage | ID | ID |
Thermotherapy | ID | ID |
EMG biofeedback | ID | ID |
Electrical stimulation | ID | ID |
Combined rehabilitation modalities | ID | ID |
*Adapted from the Philadelphia Panel Members and Ottawa Methods Group.1 | ||
A, benefit demonstrated; C, no benefit demonstrated; EMG, electromyographic; ID, insufficient or no data; TENS, transcutaneous electrical nerve stimulation. |
Discussion
By using a rigorous methodology, the Philadelphia Panel has created evidence-based clinical practice guidelines for low back, knee, neck, and shoulder pain rehabilitation based on the current medical literature. Despite the thorough techniques used to create the guidelines, there are methodologic limitations, as with all such reviews. The panel identified many problems with the current body of evidence in the medical literature. The main difficulty with the current literature is the lack of standardization of outcome measurements used in different studies. Future studies need to develop standards of measurement that are valid, reliable, and sensitive to changes in outcome. Further, current studies have used broad inclusion criteria and enrolled patients with diverse etiologies for their pain. Problems with selection and description of patients, definitions of conditions, and standardizations of treatments and outcome measures need to be solved to properly demonstrate benefit from a rehabilitation intervention and remove misclassification bias.
Another limitation is the inherent difficulty of studying rehabilitation interventions. The effectiveness of physical rehabilitation interventions is affected by psychosocial, physical, and occupational factors. These factors can be minimized by fully randomizing large patient groups, thus minimizing selection bias. Another difficulty with developing high-quality randomized controlled trials in the area of rehabilitation is the blinding of patients or caregivers to interventions.
In future studies, it will be necessary to specifically clarify the type and manner of an intervention, intervention intensity and duration, and progression of the intervention according to patient-specific outcomes. Further, a patient typically receives several rehabilitation interventions during a therapy session. These modalities change depending on the phase of recovery (ie, ice, rest, and compression initially, evolving to strengthening, stretching, and electrotherapy with progress). A more thorough means of standardizing this progression in a patient’s care is needed.
In addition, the guidelines did not address cost, patient preferences, or potential harm associated with each intervention for the specific conditions.
Overall, there is a pressing need for further work in the study of rehabilitation interventions, due especially to the increased use of physical therapy for the management of low back pain, knee pain, neck pain, and shoulder pain.
1. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for shoulder pain. Phys Ther 2001;81:1719-30.
2. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther 2001;81:1701-17.
3. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for knee pain. Phys Ther 2001;81:1675-700.
4. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. Phys Ther 2001;81:1641-74.
5. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions: overview and methodology. Phys Ther 2001;81:1629-40.
1. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for shoulder pain. Phys Ther 2001;81:1719-30.
2. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther 2001;81:1701-17.
3. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for knee pain. Phys Ther 2001;81:1675-700.
4. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. Phys Ther 2001;81:1641-74.
5. The Philadelphia Panel Members and Ottawa Methods Group. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions: overview and methodology. Phys Ther 2001;81:1629-40.