To the Editor:

Sports purpura can be broken down into different types including traumatic purpura,¹ exercise-induced cutaneous vasculitis,² occurrence of coincidental systemic purpura,³ and other conditions.^4-6 Traumatic purpura results from brutal contact with an opponent, the court, the equipment, or the ball. Three cases of sports purpura related to equipment and balls are reported.

An otherwise healthy 27-year-old woman presented with multiple ecchymotic round patches on her legs. The largest patch was 70 mm and displayed a heterogeneous Swiss cheese–like pattern with discrete whiter round areas within the patch (Figure 1). She reported that she played as a defender in a second division floorball team weekly, acknowledging frequent body contacts and being hit on the legs with the sticks and balls. Purpura was diagnosed due to hits from the floorball.

A 32-year-old healthy man presented with purpuric petechiae of the left palm after indoor climbing. He had been regularly climbing indoors for 3 years and denied a history of similar eruptions. The lesions were painless, noninfiltrated, and did not disappear after pressure (Figure 2). Lesions presumably were due to repeated friction on the climbing hold. Petechiae took a transiently golden hue before resolving within a week.

Figure 1. Multiple ecchymotic patches including the largest patch, which displayed a heterogeneous Swiss cheese–like pattern from the ball design.

Figure 2. Palmar petechiae after an indoor climbing session.

A 26-year-old right-handed woman injured the left forearm while practicing target archery. She was not wearing an arm guard at the time of the injury. Once released, the bowstring scraped the volar aspect of the forearm, causing a painful warm ecchymotic and swollen plaque. She denied neurologic or vascular symptoms. The hematoma rapidly evolved from red to blue (Figure 3) and spontaneously resolved within weeks.

Figure 3. An ecchymotic plaque on the forearm from an archery bowstring immediately after the trauma occurred (A) and after 24-hour evolution (B).

Purpura related to the high-velocity impact of sport balls has been previously reported with ping-pong,⁷ paintball,^8,9 racquetball, squash,¹⁰ and baseball. Floorball, one of the most popular team sports in Finland, is played indoors and resembles ice hockey. The players use graphite compound sticks and a light hollow plastic ball. Except for the goalkeeper, players do not wear specific protective gear. Accidental body contact, including a direct hit from the floorball stick or ball, are frequent.¹¹ The ball weighs 23 g, measures 72 mm in diameter, and has 26 holes that are 11 mm in diameter. The fastest shot was recorded at 127 miles per hour.¹² The cutaneous imprint from the ball impact on bare skin, as shown with patient 1, initially is annular,^8-10 but the bruise later takes an unusual design due to the peculiar shape of the ball. This complication is no stranger to floorball players but has been rarely reported. The diagnosis is easy, the condition is benign and asymptomatic, and it resolves when the season is over; therefore, players commonly will not seek medical attention. Of note, lower limb injuries, including joint sprains, muscle strains, and soft-tissue contusions, are frequent in female athletes.¹¹ Additional causes of purpura include collision with another player or with boards and stick hits.

Palmar petechiae from indoor climbing is similar to black palm from weight lifting.¹³ Although the typical black discoloration is absent, the mechanisms of friction and brutal trauma, clinical presentation, and evolution are similar.

Lastly, archery-induced hematomas are caused by the absence of an arm guard, which protects the wrist and forearm when the string snaps back.¹⁴ This complication is not often reported but is known by archers. Because archers usually wear protective gear, these injuries are expected to occur in novices or when safety measures are not respected.

To the Editor:

Sports purpura can be broken down into different types including traumatic purpura,¹ exercise-induced cutaneous vasculitis,² occurrence of coincidental systemic purpura,³ and other conditions.^4-6 Traumatic purpura results from brutal contact with an opponent, the court, the equipment, or the ball. Three cases of sports purpura related to equipment and balls are reported.

An otherwise healthy 27-year-old woman presented with multiple ecchymotic round patches on her legs. The largest patch was 70 mm and displayed a heterogeneous Swiss cheese–like pattern with discrete whiter round areas within the patch (Figure 1). She reported that she played as a defender in a second division floorball team weekly, acknowledging frequent body contacts and being hit on the legs with the sticks and balls. Purpura was diagnosed due to hits from the floorball.

A 32-year-old healthy man presented with purpuric petechiae of the left palm after indoor climbing. He had been regularly climbing indoors for 3 years and denied a history of similar eruptions. The lesions were painless, noninfiltrated, and did not disappear after pressure (Figure 2). Lesions presumably were due to repeated friction on the climbing hold. Petechiae took a transiently golden hue before resolving within a week.

Figure 1. Multiple ecchymotic patches including the largest patch, which displayed a heterogeneous Swiss cheese–like pattern from the ball design.

Figure 2. Palmar petechiae after an indoor climbing session.

A 26-year-old right-handed woman injured the left forearm while practicing target archery. She was not wearing an arm guard at the time of the injury. Once released, the bowstring scraped the volar aspect of the forearm, causing a painful warm ecchymotic and swollen plaque. She denied neurologic or vascular symptoms. The hematoma rapidly evolved from red to blue (Figure 3) and spontaneously resolved within weeks.

Figure 3. An ecchymotic plaque on the forearm from an archery bowstring immediately after the trauma occurred (A) and after 24-hour evolution (B).

Purpura related to the high-velocity impact of sport balls has been previously reported with ping-pong,⁷ paintball,^8,9 racquetball, squash,¹⁰ and baseball. Floorball, one of the most popular team sports in Finland, is played indoors and resembles ice hockey. The players use graphite compound sticks and a light hollow plastic ball. Except for the goalkeeper, players do not wear specific protective gear. Accidental body contact, including a direct hit from the floorball stick or ball, are frequent.¹¹ The ball weighs 23 g, measures 72 mm in diameter, and has 26 holes that are 11 mm in diameter. The fastest shot was recorded at 127 miles per hour.¹² The cutaneous imprint from the ball impact on bare skin, as shown with patient 1, initially is annular,^8-10 but the bruise later takes an unusual design due to the peculiar shape of the ball. This complication is no stranger to floorball players but has been rarely reported. The diagnosis is easy, the condition is benign and asymptomatic, and it resolves when the season is over; therefore, players commonly will not seek medical attention. Of note, lower limb injuries, including joint sprains, muscle strains, and soft-tissue contusions, are frequent in female athletes.¹¹ Additional causes of purpura include collision with another player or with boards and stick hits.

Palmar petechiae from indoor climbing is similar to black palm from weight lifting.¹³ Although the typical black discoloration is absent, the mechanisms of friction and brutal trauma, clinical presentation, and evolution are similar.

Lastly, archery-induced hematomas are caused by the absence of an arm guard, which protects the wrist and forearm when the string snaps back.¹⁴ This complication is not often reported but is known by archers. Because archers usually wear protective gear, these injuries are expected to occur in novices or when safety measures are not respected.

To the Editor:

Sports purpura can be broken down into different types including traumatic purpura,¹ exercise-induced cutaneous vasculitis,² occurrence of coincidental systemic purpura,³ and other conditions.^4-6 Traumatic purpura results from brutal contact with an opponent, the court, the equipment, or the ball. Three cases of sports purpura related to equipment and balls are reported.

An otherwise healthy 27-year-old woman presented with multiple ecchymotic round patches on her legs. The largest patch was 70 mm and displayed a heterogeneous Swiss cheese–like pattern with discrete whiter round areas within the patch (Figure 1). She reported that she played as a defender in a second division floorball team weekly, acknowledging frequent body contacts and being hit on the legs with the sticks and balls. Purpura was diagnosed due to hits from the floorball.

A 32-year-old healthy man presented with purpuric petechiae of the left palm after indoor climbing. He had been regularly climbing indoors for 3 years and denied a history of similar eruptions. The lesions were painless, noninfiltrated, and did not disappear after pressure (Figure 2). Lesions presumably were due to repeated friction on the climbing hold. Petechiae took a transiently golden hue before resolving within a week.

Figure 1. Multiple ecchymotic patches including the largest patch, which displayed a heterogeneous Swiss cheese–like pattern from the ball design.

Figure 2. Palmar petechiae after an indoor climbing session.

A 26-year-old right-handed woman injured the left forearm while practicing target archery. She was not wearing an arm guard at the time of the injury. Once released, the bowstring scraped the volar aspect of the forearm, causing a painful warm ecchymotic and swollen plaque. She denied neurologic or vascular symptoms. The hematoma rapidly evolved from red to blue (Figure 3) and spontaneously resolved within weeks.

Figure 3. An ecchymotic plaque on the forearm from an archery bowstring immediately after the trauma occurred (A) and after 24-hour evolution (B).

Purpura related to the high-velocity impact of sport balls has been previously reported with ping-pong,⁷ paintball,^8,9 racquetball, squash,¹⁰ and baseball. Floorball, one of the most popular team sports in Finland, is played indoors and resembles ice hockey. The players use graphite compound sticks and a light hollow plastic ball. Except for the goalkeeper, players do not wear specific protective gear. Accidental body contact, including a direct hit from the floorball stick or ball, are frequent.¹¹ The ball weighs 23 g, measures 72 mm in diameter, and has 26 holes that are 11 mm in diameter. The fastest shot was recorded at 127 miles per hour.¹² The cutaneous imprint from the ball impact on bare skin, as shown with patient 1, initially is annular,^8-10 but the bruise later takes an unusual design due to the peculiar shape of the ball. This complication is no stranger to floorball players but has been rarely reported. The diagnosis is easy, the condition is benign and asymptomatic, and it resolves when the season is over; therefore, players commonly will not seek medical attention. Of note, lower limb injuries, including joint sprains, muscle strains, and soft-tissue contusions, are frequent in female athletes.¹¹ Additional causes of purpura include collision with another player or with boards and stick hits.

Palmar petechiae from indoor climbing is similar to black palm from weight lifting.¹³ Although the typical black discoloration is absent, the mechanisms of friction and brutal trauma, clinical presentation, and evolution are similar.

Lastly, archery-induced hematomas are caused by the absence of an arm guard, which protects the wrist and forearm when the string snaps back.¹⁴ This complication is not often reported but is known by archers. Because archers usually wear protective gear, these injuries are expected to occur in novices or when safety measures are not respected.

ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

At least half of all cases of maternal morbidity and mortality could be prevented, or so studies suggest.^1,2

The main stumbling block?

Faulty communication.

That’s the word from the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the American College of Nurse-Midwives, and the Association of Women’s Health, Obstetric and Neonatal Nurses.³

In a joint “blueprint” to transform communication and enhance the safety culture in intrapartum care, these organizations, led by Audrey Lyndon, PhD, RN, FAAN, from the University of California, San Francisco, School of Nursing, describe the extent of the problem, steps that various team members can take to improve safety, notable success stories, and communication strategies.³ In this article, the joint blueprint is summarized, with a focus on steps obstetricians can take to improve the intrapartum safety culture.

Scope of the problem
A study of more than 3,282 physicians, midwives, and registered nurses produced a troubling statistic: More than 90% of respondents said that they had “witnessed shortcuts, missing competencies, disrespect, or performance problems” during the preceding year of practice.⁴ Few of these clinicians reported that they had discussed their concerns with the parties involved.

A second study of 1,932 clinicians found that 34% of physicians, 40% of midwives, and 56% of registered nurses had witnessed patients being put at risk within the preceding 2 years by other team members’ inattentiveness or lack of responsiveness.⁵

These findings suggest that health care providers often witness weak links in intrapartum safety but do not always address or report them. Among the reasons team members may be hesitant to speak up when they perceive a potential problem:

Although Lyndon and colleagues acknowledge that it is impossible to eliminate adverse outcomes entirely or completely eradicate human error, they argue that significant improvements can be made by adopting a number of manageable strategies.

Recommended strategies
Lyndon and colleagues describe some of the challenges of effective communication in a health care setting:

Lyndon and colleagues go on to mention a number of strategies to improve communication, boost safety, and reduce medical errors.

1. Remember that the patient is part of the team
The patient and her family play a key role in identifying the potential for harm during labor and delivery, Lyndon and colleagues assert. They should be considered members of the intrapartum team, care should be patient-focused, and any communications from the patient should not only be heard but fully considered. In fact, explicit elicitation of her experience and concerns is recommended.

2. Consider that you might be part of the problem
It is human nature to attribute a communication problem to the other people involved, rather than take responsibility for it oneself. One potential solution to this mindset is team training, where all members are encouraged to communicate clearly and listen attentively. Organizations that have been successful at improving their culture of safety have implemented such training, as well as the use of checklists, training in fetal heart-rate monitoring, formation of a patient safety committee, external review of safety practices, and designation of a key clinician to lead the safety program and oversee team training.

3. Structure handoffs 
The team should standardize handoffs so that they occur smoothly and all channels of communication remain open and clear.

“Having structured formats for debriefing and handoffs are steps in the right direction, but solving the problem of communication breakdowns is more complicated than standardizing the flow and format of information transfer,” Lyndon and colleagues assert. “Indeed, solving communication breakdowns is a matter of individual, group, organizational, and professional responsibility for creating and sustaining an environment of mutual respect, curiosity, and accountability for behavior and performance.”³

4. Learn to communicate responsibly
“Differences of opinion about clinical assessments, goals of care, and the pathway to optimal outcomes are bound to occur with some regularity in the dynamic environment of labor and delivery,” note Lyndon and colleagues. “Every person has the responsibility to contribute to improving how we relate to and communicate with each other. Collectively, we must create environments in which every team member (woman, family member, physician, midwife, nurse, unit clerk, patient care assistant, or scrub tech) is comfortable expressing and discussing concerns about safety or performance, is encouraged to do so, and has the support of the team to articulate the rationale for and urgency of the concern without fear of put-downs, retribution, or receiving poor-quality care.”³

5. Be persistent and proactive
When team members have differing expectations and communication styles, useful approaches include structured communication tools such as situation, background, assessment, recommendation (SBAR); structured handoffs; board rounds; huddles; attentive listening; and explicit elicitation of the patient’s concerns and desires.³

If someone fails to pay attention to a concern you raise, be persistent about restating that concern until you elicit a response.

If someone exhibits disruptive behavior, point to or establish a code of conduct that clearly describes professional behavior.

If there is a difference of opinion on patient management, such as fetal monitoring and interpretation, conduct regular case reviews and standardize a plan for notification of complications.

6. If you’re a team leader, set clear goals
Then ask team members what will be needed to achieve the outcomes desired.

“Team leaders need to develop outstanding skills for listening and eliciting feedback and cross-monitoring (being aware of each other’s actions and performance) from other team members,” note Lyndon and colleagues.

7. Increase public awareness of safety concepts
When these concepts and best practices are made known to the public, women and families become “empowered” to speak up when they have concerns about care.

And when they do speak up, it pays to listen.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

At least half of all cases of maternal morbidity and mortality could be prevented, or so studies suggest.^1,2

The main stumbling block?

Faulty communication.

That’s the word from the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the American College of Nurse-Midwives, and the Association of Women’s Health, Obstetric and Neonatal Nurses.³

In a joint “blueprint” to transform communication and enhance the safety culture in intrapartum care, these organizations, led by Audrey Lyndon, PhD, RN, FAAN, from the University of California, San Francisco, School of Nursing, describe the extent of the problem, steps that various team members can take to improve safety, notable success stories, and communication strategies.³ In this article, the joint blueprint is summarized, with a focus on steps obstetricians can take to improve the intrapartum safety culture.

Scope of the problem
A study of more than 3,282 physicians, midwives, and registered nurses produced a troubling statistic: More than 90% of respondents said that they had “witnessed shortcuts, missing competencies, disrespect, or performance problems” during the preceding year of practice.⁴ Few of these clinicians reported that they had discussed their concerns with the parties involved.

A second study of 1,932 clinicians found that 34% of physicians, 40% of midwives, and 56% of registered nurses had witnessed patients being put at risk within the preceding 2 years by other team members’ inattentiveness or lack of responsiveness.⁵

These findings suggest that health care providers often witness weak links in intrapartum safety but do not always address or report them. Among the reasons team members may be hesitant to speak up when they perceive a potential problem:

Although Lyndon and colleagues acknowledge that it is impossible to eliminate adverse outcomes entirely or completely eradicate human error, they argue that significant improvements can be made by adopting a number of manageable strategies.

Recommended strategies
Lyndon and colleagues describe some of the challenges of effective communication in a health care setting:

Lyndon and colleagues go on to mention a number of strategies to improve communication, boost safety, and reduce medical errors.

1. Remember that the patient is part of the team
The patient and her family play a key role in identifying the potential for harm during labor and delivery, Lyndon and colleagues assert. They should be considered members of the intrapartum team, care should be patient-focused, and any communications from the patient should not only be heard but fully considered. In fact, explicit elicitation of her experience and concerns is recommended.

2. Consider that you might be part of the problem
It is human nature to attribute a communication problem to the other people involved, rather than take responsibility for it oneself. One potential solution to this mindset is team training, where all members are encouraged to communicate clearly and listen attentively. Organizations that have been successful at improving their culture of safety have implemented such training, as well as the use of checklists, training in fetal heart-rate monitoring, formation of a patient safety committee, external review of safety practices, and designation of a key clinician to lead the safety program and oversee team training.

3. Structure handoffs 
The team should standardize handoffs so that they occur smoothly and all channels of communication remain open and clear.

“Having structured formats for debriefing and handoffs are steps in the right direction, but solving the problem of communication breakdowns is more complicated than standardizing the flow and format of information transfer,” Lyndon and colleagues assert. “Indeed, solving communication breakdowns is a matter of individual, group, organizational, and professional responsibility for creating and sustaining an environment of mutual respect, curiosity, and accountability for behavior and performance.”³

4. Learn to communicate responsibly
“Differences of opinion about clinical assessments, goals of care, and the pathway to optimal outcomes are bound to occur with some regularity in the dynamic environment of labor and delivery,” note Lyndon and colleagues. “Every person has the responsibility to contribute to improving how we relate to and communicate with each other. Collectively, we must create environments in which every team member (woman, family member, physician, midwife, nurse, unit clerk, patient care assistant, or scrub tech) is comfortable expressing and discussing concerns about safety or performance, is encouraged to do so, and has the support of the team to articulate the rationale for and urgency of the concern without fear of put-downs, retribution, or receiving poor-quality care.”³

5. Be persistent and proactive
When team members have differing expectations and communication styles, useful approaches include structured communication tools such as situation, background, assessment, recommendation (SBAR); structured handoffs; board rounds; huddles; attentive listening; and explicit elicitation of the patient’s concerns and desires.³

If someone fails to pay attention to a concern you raise, be persistent about restating that concern until you elicit a response.

If someone exhibits disruptive behavior, point to or establish a code of conduct that clearly describes professional behavior.

If there is a difference of opinion on patient management, such as fetal monitoring and interpretation, conduct regular case reviews and standardize a plan for notification of complications.

6. If you’re a team leader, set clear goals
Then ask team members what will be needed to achieve the outcomes desired.

“Team leaders need to develop outstanding skills for listening and eliciting feedback and cross-monitoring (being aware of each other’s actions and performance) from other team members,” note Lyndon and colleagues.

7. Increase public awareness of safety concepts
When these concepts and best practices are made known to the public, women and families become “empowered” to speak up when they have concerns about care.

And when they do speak up, it pays to listen.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

At least half of all cases of maternal morbidity and mortality could be prevented, or so studies suggest.^1,2

The main stumbling block?

Faulty communication.

That’s the word from the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the American College of Nurse-Midwives, and the Association of Women’s Health, Obstetric and Neonatal Nurses.³

In a joint “blueprint” to transform communication and enhance the safety culture in intrapartum care, these organizations, led by Audrey Lyndon, PhD, RN, FAAN, from the University of California, San Francisco, School of Nursing, describe the extent of the problem, steps that various team members can take to improve safety, notable success stories, and communication strategies.³ In this article, the joint blueprint is summarized, with a focus on steps obstetricians can take to improve the intrapartum safety culture.

Scope of the problem
A study of more than 3,282 physicians, midwives, and registered nurses produced a troubling statistic: More than 90% of respondents said that they had “witnessed shortcuts, missing competencies, disrespect, or performance problems” during the preceding year of practice.⁴ Few of these clinicians reported that they had discussed their concerns with the parties involved.

A second study of 1,932 clinicians found that 34% of physicians, 40% of midwives, and 56% of registered nurses had witnessed patients being put at risk within the preceding 2 years by other team members’ inattentiveness or lack of responsiveness.⁵

These findings suggest that health care providers often witness weak links in intrapartum safety but do not always address or report them. Among the reasons team members may be hesitant to speak up when they perceive a potential problem:

Although Lyndon and colleagues acknowledge that it is impossible to eliminate adverse outcomes entirely or completely eradicate human error, they argue that significant improvements can be made by adopting a number of manageable strategies.

Recommended strategies
Lyndon and colleagues describe some of the challenges of effective communication in a health care setting:

Lyndon and colleagues go on to mention a number of strategies to improve communication, boost safety, and reduce medical errors.

1. Remember that the patient is part of the team
The patient and her family play a key role in identifying the potential for harm during labor and delivery, Lyndon and colleagues assert. They should be considered members of the intrapartum team, care should be patient-focused, and any communications from the patient should not only be heard but fully considered. In fact, explicit elicitation of her experience and concerns is recommended.

2. Consider that you might be part of the problem
It is human nature to attribute a communication problem to the other people involved, rather than take responsibility for it oneself. One potential solution to this mindset is team training, where all members are encouraged to communicate clearly and listen attentively. Organizations that have been successful at improving their culture of safety have implemented such training, as well as the use of checklists, training in fetal heart-rate monitoring, formation of a patient safety committee, external review of safety practices, and designation of a key clinician to lead the safety program and oversee team training.

3. Structure handoffs 
The team should standardize handoffs so that they occur smoothly and all channels of communication remain open and clear.

“Having structured formats for debriefing and handoffs are steps in the right direction, but solving the problem of communication breakdowns is more complicated than standardizing the flow and format of information transfer,” Lyndon and colleagues assert. “Indeed, solving communication breakdowns is a matter of individual, group, organizational, and professional responsibility for creating and sustaining an environment of mutual respect, curiosity, and accountability for behavior and performance.”³

4. Learn to communicate responsibly
“Differences of opinion about clinical assessments, goals of care, and the pathway to optimal outcomes are bound to occur with some regularity in the dynamic environment of labor and delivery,” note Lyndon and colleagues. “Every person has the responsibility to contribute to improving how we relate to and communicate with each other. Collectively, we must create environments in which every team member (woman, family member, physician, midwife, nurse, unit clerk, patient care assistant, or scrub tech) is comfortable expressing and discussing concerns about safety or performance, is encouraged to do so, and has the support of the team to articulate the rationale for and urgency of the concern without fear of put-downs, retribution, or receiving poor-quality care.”³

5. Be persistent and proactive
When team members have differing expectations and communication styles, useful approaches include structured communication tools such as situation, background, assessment, recommendation (SBAR); structured handoffs; board rounds; huddles; attentive listening; and explicit elicitation of the patient’s concerns and desires.³

If someone fails to pay attention to a concern you raise, be persistent about restating that concern until you elicit a response.

If someone exhibits disruptive behavior, point to or establish a code of conduct that clearly describes professional behavior.

If there is a difference of opinion on patient management, such as fetal monitoring and interpretation, conduct regular case reviews and standardize a plan for notification of complications.

6. If you’re a team leader, set clear goals
Then ask team members what will be needed to achieve the outcomes desired.

“Team leaders need to develop outstanding skills for listening and eliciting feedback and cross-monitoring (being aware of each other’s actions and performance) from other team members,” note Lyndon and colleagues.

7. Increase public awareness of safety concepts
When these concepts and best practices are made known to the public, women and families become “empowered” to speak up when they have concerns about care.

And when they do speak up, it pays to listen.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In a poster presented at the 2015 ACOG Annual Clinical Meeting in San Francisco, Neal Marc Lonky, MD, and colleagues from the Southern California Permanente Group assessed the clinical acumen of physicians in estimating uterine size prior to elective hysterectomy for benign indications. They found that the correlation between estimates and actual uterine weight was 0.79 (P<.001), with a very low conversion rate for the surgery.¹

Lonky and colleagues collected preoperative uterine estimates and actual specimen weights prospectively for 1,079 cases of benign hysterectomy. The surgeries were performed by 186 primary surgeons and assistant surgeons at 10 Kaiser Permanente Southern California medical centers. Surgeons based the route of hysterectomy on estimates of uterine size, which were calculated using bimanual examination, ultrasonography, or both. Linear regression was used to measure and compare the relationship between estimated uterine size and the pelvic specimen weight.

Uterine size estimates ranged from 4 cm to 40 cm, and specimen weights ranged from 2 g to 4,607 g. The mean (SD) estimate of uterine size was 11.7 (4.43) cm, and the mean actual specimen weight was 334.6 (401.42) g.

The mean age of women in the sample was 47.2 (8.35) years. Overall, 379 women (35.1%) were Hispanic, 325 (30.1%) were non-Hispanic white, 281 (26.0%) were non-Hispanic black, and 81 (7.5%) were Asian/Pacific Islander. The mean body mass index (BMI) was 30.0 (6.37) kg/m², with a range of 16.8 to 67.9 kg/m².

“This is real world research,” said Dr. Lonky. “It’s called comparative effectiveness research. Basically, all patients who are undergoing the procedure are entered in the registry, and the clinical acumen of the physician—either using or not using ultrasound—is assessed.”  

“We looked at whether or not we had a bias toward one patient age group, race/ethnicity, BMI, or estimated uterine size. But there were no clusters, so this was truly a random distribution,” said Dr. Lonky.

“These findings may be population-specific to my group of doctors,” he added. “They should be replicated in other settings. It may be that residents are not going to be as linear.”

In a poster presented at the 2015 ACOG Annual Clinical Meeting in San Francisco, Neal Marc Lonky, MD, and colleagues from the Southern California Permanente Group assessed the clinical acumen of physicians in estimating uterine size prior to elective hysterectomy for benign indications. They found that the correlation between estimates and actual uterine weight was 0.79 (P<.001), with a very low conversion rate for the surgery.¹

Lonky and colleagues collected preoperative uterine estimates and actual specimen weights prospectively for 1,079 cases of benign hysterectomy. The surgeries were performed by 186 primary surgeons and assistant surgeons at 10 Kaiser Permanente Southern California medical centers. Surgeons based the route of hysterectomy on estimates of uterine size, which were calculated using bimanual examination, ultrasonography, or both. Linear regression was used to measure and compare the relationship between estimated uterine size and the pelvic specimen weight.

Uterine size estimates ranged from 4 cm to 40 cm, and specimen weights ranged from 2 g to 4,607 g. The mean (SD) estimate of uterine size was 11.7 (4.43) cm, and the mean actual specimen weight was 334.6 (401.42) g.

The mean age of women in the sample was 47.2 (8.35) years. Overall, 379 women (35.1%) were Hispanic, 325 (30.1%) were non-Hispanic white, 281 (26.0%) were non-Hispanic black, and 81 (7.5%) were Asian/Pacific Islander. The mean body mass index (BMI) was 30.0 (6.37) kg/m², with a range of 16.8 to 67.9 kg/m².

“This is real world research,” said Dr. Lonky. “It’s called comparative effectiveness research. Basically, all patients who are undergoing the procedure are entered in the registry, and the clinical acumen of the physician—either using or not using ultrasound—is assessed.”  

“We looked at whether or not we had a bias toward one patient age group, race/ethnicity, BMI, or estimated uterine size. But there were no clusters, so this was truly a random distribution,” said Dr. Lonky.

“These findings may be population-specific to my group of doctors,” he added. “They should be replicated in other settings. It may be that residents are not going to be as linear.”

In a poster presented at the 2015 ACOG Annual Clinical Meeting in San Francisco, Neal Marc Lonky, MD, and colleagues from the Southern California Permanente Group assessed the clinical acumen of physicians in estimating uterine size prior to elective hysterectomy for benign indications. They found that the correlation between estimates and actual uterine weight was 0.79 (P<.001), with a very low conversion rate for the surgery.¹

Lonky and colleagues collected preoperative uterine estimates and actual specimen weights prospectively for 1,079 cases of benign hysterectomy. The surgeries were performed by 186 primary surgeons and assistant surgeons at 10 Kaiser Permanente Southern California medical centers. Surgeons based the route of hysterectomy on estimates of uterine size, which were calculated using bimanual examination, ultrasonography, or both. Linear regression was used to measure and compare the relationship between estimated uterine size and the pelvic specimen weight.

Uterine size estimates ranged from 4 cm to 40 cm, and specimen weights ranged from 2 g to 4,607 g. The mean (SD) estimate of uterine size was 11.7 (4.43) cm, and the mean actual specimen weight was 334.6 (401.42) g.

The mean age of women in the sample was 47.2 (8.35) years. Overall, 379 women (35.1%) were Hispanic, 325 (30.1%) were non-Hispanic white, 281 (26.0%) were non-Hispanic black, and 81 (7.5%) were Asian/Pacific Islander. The mean body mass index (BMI) was 30.0 (6.37) kg/m², with a range of 16.8 to 67.9 kg/m².

“This is real world research,” said Dr. Lonky. “It’s called comparative effectiveness research. Basically, all patients who are undergoing the procedure are entered in the registry, and the clinical acumen of the physician—either using or not using ultrasound—is assessed.”  

“We looked at whether or not we had a bias toward one patient age group, race/ethnicity, BMI, or estimated uterine size. But there were no clusters, so this was truly a random distribution,” said Dr. Lonky.

“These findings may be population-specific to my group of doctors,” he added. “They should be replicated in other settings. It may be that residents are not going to be as linear.”

Photographs from the first day of Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

[gallery ids="9553,9555,9556,9557,9558,9559,9560,9561,9562,9563,9564,9565,9566,9567,9568,9569,9570,9571,9572,9573,9574,9575,9576,9577,9578,9579,9580,9581,9582,9583,9584"]

Photographs from the first day of Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

[gallery ids="9553,9555,9556,9557,9558,9559,9560,9561,9562,9563,9564,9565,9566,9567,9568,9569,9570,9571,9572,9573,9574,9575,9576,9577,9578,9579,9580,9581,9582,9583,9584"]

Photographs from the first day of Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

[gallery ids="9553,9555,9556,9557,9558,9559,9560,9561,9562,9563,9564,9565,9566,9567,9568,9569,9570,9571,9572,9573,9574,9575,9576,9577,9578,9579,9580,9581,9582,9583,9584"]

Tissue extraction during laparoscopic or robot-assisted laparoscopic gynecologic surgery raises safety concerns for dissemination of tissue during the open, or uncontained, electromechanical morcellation process. Researchers from Brigham & Women’s Hospital in Boston, Massachusetts, investigated whether contained tissue extraction using power morcellators entirely within a bag is safe and practical for preventing tissue spillage. Goggins and colleagues presented their findings in a poster at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, California.

A total of 76 women at 4 institutions underwent laparoscopic or robotic multiport surgery (42 hysterectomy; 34 myomectomy). The average (SD) age and body mass index of the women were 43.16 (8.53) years and 26.47 kg/m² (5.93), respectively. After surgical dissection, each specimen was placed into a containment bag that also included blue dye. The bag was insufflated intracorporeally and electromechanical morcellation and extraction of tissue were performed. The bag was evaluated visually for dye leakage or tears before and after the procedure.

Results
In one case, there was a tear in the bag before morcellation; no bag tears occurred during the morcellation process. Spillage of dye or tissue was noted in 7 cases, although containment bags were intact in each instance. One patient experienced intraoperative blood loss (3600 mL), and that procedure was converted to open radical hysterectomy. The most common pathologic finding was benign leiomyoma.

Conclusion
Goggins and colleagues concluded, “Contained tissue extraction using electromechanical morcellation and intracorporeally insufflated bags may provide a safe alternative to uncontained morcellation by decreasing the spread of tissue in the peritoneal cavity while allowing for the traditional benefits of laparoscopy.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Tissue extraction during laparoscopic or robot-assisted laparoscopic gynecologic surgery raises safety concerns for dissemination of tissue during the open, or uncontained, electromechanical morcellation process. Researchers from Brigham & Women’s Hospital in Boston, Massachusetts, investigated whether contained tissue extraction using power morcellators entirely within a bag is safe and practical for preventing tissue spillage. Goggins and colleagues presented their findings in a poster at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, California.

A total of 76 women at 4 institutions underwent laparoscopic or robotic multiport surgery (42 hysterectomy; 34 myomectomy). The average (SD) age and body mass index of the women were 43.16 (8.53) years and 26.47 kg/m² (5.93), respectively. After surgical dissection, each specimen was placed into a containment bag that also included blue dye. The bag was insufflated intracorporeally and electromechanical morcellation and extraction of tissue were performed. The bag was evaluated visually for dye leakage or tears before and after the procedure.

Results
In one case, there was a tear in the bag before morcellation; no bag tears occurred during the morcellation process. Spillage of dye or tissue was noted in 7 cases, although containment bags were intact in each instance. One patient experienced intraoperative blood loss (3600 mL), and that procedure was converted to open radical hysterectomy. The most common pathologic finding was benign leiomyoma.

Conclusion
Goggins and colleagues concluded, “Contained tissue extraction using electromechanical morcellation and intracorporeally insufflated bags may provide a safe alternative to uncontained morcellation by decreasing the spread of tissue in the peritoneal cavity while allowing for the traditional benefits of laparoscopy.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Tissue extraction during laparoscopic or robot-assisted laparoscopic gynecologic surgery raises safety concerns for dissemination of tissue during the open, or uncontained, electromechanical morcellation process. Researchers from Brigham & Women’s Hospital in Boston, Massachusetts, investigated whether contained tissue extraction using power morcellators entirely within a bag is safe and practical for preventing tissue spillage. Goggins and colleagues presented their findings in a poster at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, California.

A total of 76 women at 4 institutions underwent laparoscopic or robotic multiport surgery (42 hysterectomy; 34 myomectomy). The average (SD) age and body mass index of the women were 43.16 (8.53) years and 26.47 kg/m² (5.93), respectively. After surgical dissection, each specimen was placed into a containment bag that also included blue dye. The bag was insufflated intracorporeally and electromechanical morcellation and extraction of tissue were performed. The bag was evaluated visually for dye leakage or tears before and after the procedure.

Results
In one case, there was a tear in the bag before morcellation; no bag tears occurred during the morcellation process. Spillage of dye or tissue was noted in 7 cases, although containment bags were intact in each instance. One patient experienced intraoperative blood loss (3600 mL), and that procedure was converted to open radical hysterectomy. The most common pathologic finding was benign leiomyoma.

Conclusion
Goggins and colleagues concluded, “Contained tissue extraction using electromechanical morcellation and intracorporeally insufflated bags may provide a safe alternative to uncontained morcellation by decreasing the spread of tissue in the peritoneal cavity while allowing for the traditional benefits of laparoscopy.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Thrombus

Photo by Andre E.X. Brown

SEATTLE—Patients who undergo surgery for lung cancer may have a higher risk of developing venous thromboembolism (VTE) than we thought, according to a

new study.

About 12% of the patients studied developed deep vein thrombosis (DVT), pulmonary embolism (PE), or both, although they had received VTE prophylaxis until hospital discharge.

Only about 21% of these patients showed symptoms of VTE, and the clots conferred a higher risk of mortality at 30 days.

“This study shows that a significant proportion of lung cancer surgery patients are at risk of VTE and indicates a need for future research into minimizing the occurrence of DVT and PE,” said investigator Yaron Shargall, MD, of McMaster University in Hamilton, Ontario, Canada.

“It is possible that extended use of blood thinners beyond hospital discharge may reduce the number of patients who experience these life-threatening events and may help to reduce the rates of death after lung surgery.”

Dr Shargall presented this viewpoint at the 95th Annual Meeting of the American Association for Thoracic Surgery.

For their study, he and his colleagues evaluated 157 patients who underwent thoracic surgery for primary lung cancer (89.9%) or metastatic cancer (6.3%).

All patients received unfractionated heparin or low-molecular-weight heparin and graduated compression stockings as VTE prophylaxis from the time of surgery until leaving the hospital.

Two weeks later, these patients were evaluated for signs and symptoms of VTE. The investigators evaluated clinical outcomes at 30 ± 5 days post-operatively using CT pulmonary angiography and bilateral Doppler venous ultrasonography.

Patients who had developed symptoms suggestive of VTE within the 30 days after surgery underwent urgent CT-PE examination and had a repeat scan 30 days after surgery if the first scan was negative. Patients with VTE were monitored and treated.

In all, there were 19 VTEs, a 12.1% incidence rate. These included 14 PEs (8.9%), 3 DVTs (1.9%), and 1 combined PE/DVT. One patient developed a massive left atrial thrombus originating from a surgical stump and died.

For all 157 patients, the 30-day mortality rate was 0.64%. For those with VTE, it was 5.2%.

“This demonstrates the clinical importance and relative fatality of VTE following lung cancer surgery,” Dr Shargall said.

All of the patients who were diagnosed with a VTE had undergone anatomic resections (lobectomy or segmentectomy), and most had primary lung cancer. The clots tended to form on the same side as the lung surgery. The majority of patients developed lung clots without forming DVTs beforehand.

The investigators examined factors that might distinguish patients who developed VTEs from those who did not and could not find differences in patient age, lung function, hospital length of stay, comorbidities, lung cancer stage, smoking status, or Caprini Score.

Among patients diagnosed with a VTE, only 4 (21.1%) showed symptoms. All the events were diagnosed after the patient left the hospital and only because these patients were screened for VTEs as part of the study.

Thrombus

Photo by Andre E.X. Brown

SEATTLE—Patients who undergo surgery for lung cancer may have a higher risk of developing venous thromboembolism (VTE) than we thought, according to a

new study.

About 12% of the patients studied developed deep vein thrombosis (DVT), pulmonary embolism (PE), or both, although they had received VTE prophylaxis until hospital discharge.

Only about 21% of these patients showed symptoms of VTE, and the clots conferred a higher risk of mortality at 30 days.

“This study shows that a significant proportion of lung cancer surgery patients are at risk of VTE and indicates a need for future research into minimizing the occurrence of DVT and PE,” said investigator Yaron Shargall, MD, of McMaster University in Hamilton, Ontario, Canada.

“It is possible that extended use of blood thinners beyond hospital discharge may reduce the number of patients who experience these life-threatening events and may help to reduce the rates of death after lung surgery.”

Dr Shargall presented this viewpoint at the 95th Annual Meeting of the American Association for Thoracic Surgery.

For their study, he and his colleagues evaluated 157 patients who underwent thoracic surgery for primary lung cancer (89.9%) or metastatic cancer (6.3%).

All patients received unfractionated heparin or low-molecular-weight heparin and graduated compression stockings as VTE prophylaxis from the time of surgery until leaving the hospital.

Two weeks later, these patients were evaluated for signs and symptoms of VTE. The investigators evaluated clinical outcomes at 30 ± 5 days post-operatively using CT pulmonary angiography and bilateral Doppler venous ultrasonography.

Patients who had developed symptoms suggestive of VTE within the 30 days after surgery underwent urgent CT-PE examination and had a repeat scan 30 days after surgery if the first scan was negative. Patients with VTE were monitored and treated.

In all, there were 19 VTEs, a 12.1% incidence rate. These included 14 PEs (8.9%), 3 DVTs (1.9%), and 1 combined PE/DVT. One patient developed a massive left atrial thrombus originating from a surgical stump and died.

For all 157 patients, the 30-day mortality rate was 0.64%. For those with VTE, it was 5.2%.

“This demonstrates the clinical importance and relative fatality of VTE following lung cancer surgery,” Dr Shargall said.

All of the patients who were diagnosed with a VTE had undergone anatomic resections (lobectomy or segmentectomy), and most had primary lung cancer. The clots tended to form on the same side as the lung surgery. The majority of patients developed lung clots without forming DVTs beforehand.

The investigators examined factors that might distinguish patients who developed VTEs from those who did not and could not find differences in patient age, lung function, hospital length of stay, comorbidities, lung cancer stage, smoking status, or Caprini Score.

Among patients diagnosed with a VTE, only 4 (21.1%) showed symptoms. All the events were diagnosed after the patient left the hospital and only because these patients were screened for VTEs as part of the study.

Thrombus

Photo by Andre E.X. Brown

SEATTLE—Patients who undergo surgery for lung cancer may have a higher risk of developing venous thromboembolism (VTE) than we thought, according to a

new study.

About 12% of the patients studied developed deep vein thrombosis (DVT), pulmonary embolism (PE), or both, although they had received VTE prophylaxis until hospital discharge.

Only about 21% of these patients showed symptoms of VTE, and the clots conferred a higher risk of mortality at 30 days.

“This study shows that a significant proportion of lung cancer surgery patients are at risk of VTE and indicates a need for future research into minimizing the occurrence of DVT and PE,” said investigator Yaron Shargall, MD, of McMaster University in Hamilton, Ontario, Canada.

“It is possible that extended use of blood thinners beyond hospital discharge may reduce the number of patients who experience these life-threatening events and may help to reduce the rates of death after lung surgery.”

Dr Shargall presented this viewpoint at the 95th Annual Meeting of the American Association for Thoracic Surgery.

For their study, he and his colleagues evaluated 157 patients who underwent thoracic surgery for primary lung cancer (89.9%) or metastatic cancer (6.3%).

All patients received unfractionated heparin or low-molecular-weight heparin and graduated compression stockings as VTE prophylaxis from the time of surgery until leaving the hospital.

Two weeks later, these patients were evaluated for signs and symptoms of VTE. The investigators evaluated clinical outcomes at 30 ± 5 days post-operatively using CT pulmonary angiography and bilateral Doppler venous ultrasonography.

Patients who had developed symptoms suggestive of VTE within the 30 days after surgery underwent urgent CT-PE examination and had a repeat scan 30 days after surgery if the first scan was negative. Patients with VTE were monitored and treated.

In all, there were 19 VTEs, a 12.1% incidence rate. These included 14 PEs (8.9%), 3 DVTs (1.9%), and 1 combined PE/DVT. One patient developed a massive left atrial thrombus originating from a surgical stump and died.

For all 157 patients, the 30-day mortality rate was 0.64%. For those with VTE, it was 5.2%.

“This demonstrates the clinical importance and relative fatality of VTE following lung cancer surgery,” Dr Shargall said.

All of the patients who were diagnosed with a VTE had undergone anatomic resections (lobectomy or segmentectomy), and most had primary lung cancer. The clots tended to form on the same side as the lung surgery. The majority of patients developed lung clots without forming DVTs beforehand.

The investigators examined factors that might distinguish patients who developed VTEs from those who did not and could not find differences in patient age, lung function, hospital length of stay, comorbidities, lung cancer stage, smoking status, or Caprini Score.

Among patients diagnosed with a VTE, only 4 (21.1%) showed symptoms. All the events were diagnosed after the patient left the hospital and only because these patients were screened for VTEs as part of the study.

Binata Joddar, PhD

Photo courtesy of University

of Texas at El Paso

Researchers say they have developed a protocol to prepare human induced pluripotent stem (hiPS) cells using chemically fixed feeder cells.

This method saves time and money by avoiding the need for colony formation of live feeder cells, which is required by current conventional methods.

The new protocol challenges the theory that live feeder cells are required to provide nutrients to growing stem cells.

“We’ve proved an important phenomenon,” said Binata Joddar, PhD, of the University of Texas at El Paso. “And it suggests that these feeder cells, which are difficult to grow, may not be important at all for stem cell growth.”

Dr Joddar and her colleagues described the phenomenon in Journal of Materials Chemistry B.

Using 2.5% glutaraldehyde (GA) or formaldehyde (FA) for 10 minutes, the researchers prepared a niche matrix from autologus human dermal fibroblast (HDF) feeder cells.

They then introduced hiPS cells to the niche matrix, which adhered to and were maintained as colonies on the fixed feeder cells.

The colony doubling times of the cells grown this way were similar to those of hiPS cells grown on mitomycin-C-treated HDF or SNL feeders. (SNL cells are derived from mouse fibroblast STO cells transformed with a neomycin resistance gene.)

But the colony doubling time for the hiPS cells was shorter with the fixed feeder than for cells cultured on laminin-5.

The researchers also discovered that the average number of colonies per passage was signficiantly higher for hiPS cells cultured on fixed feeder cells compared to those cultured without feeders.

They noted hiPS cells cultured on gelatin did not grow beyond the first passage.

The team concluded that the two types of chemically fixed HDF feeder cells (HDF-glutaraldehyde and HDF-formaldehyde) can be used as substitutes for mitomycin-C-treated HDF feeders to culture hiPS cells.

This new method would not extend the doubling time, would save preparation time, and would avoid labor-intensive protocols to prepare.

In addition, after chemical fixation, the feeder cells are non-viable and cannot release active growth factors or chemokines into the cell culture. Therefore, fixed feeder cells can be refrigerated for long-term storage prior to use.

“Because feeder cells don’t need to stay alive in the process, we can store them at room temperature and spend less time cultivating them,” Dr Joddar said.

“This makes me think that we [could] use a nanomanufacturing approach to grow stem cells. We could mimic feeder cells’ nanotopology with 3-D printing techniques and skip using feeder cells altogether in the future.”

Binata Joddar, PhD

Photo courtesy of University

of Texas at El Paso

Researchers say they have developed a protocol to prepare human induced pluripotent stem (hiPS) cells using chemically fixed feeder cells.

This method saves time and money by avoiding the need for colony formation of live feeder cells, which is required by current conventional methods.

The new protocol challenges the theory that live feeder cells are required to provide nutrients to growing stem cells.

“We’ve proved an important phenomenon,” said Binata Joddar, PhD, of the University of Texas at El Paso. “And it suggests that these feeder cells, which are difficult to grow, may not be important at all for stem cell growth.”

Dr Joddar and her colleagues described the phenomenon in Journal of Materials Chemistry B.

Using 2.5% glutaraldehyde (GA) or formaldehyde (FA) for 10 minutes, the researchers prepared a niche matrix from autologus human dermal fibroblast (HDF) feeder cells.

They then introduced hiPS cells to the niche matrix, which adhered to and were maintained as colonies on the fixed feeder cells.

The colony doubling times of the cells grown this way were similar to those of hiPS cells grown on mitomycin-C-treated HDF or SNL feeders. (SNL cells are derived from mouse fibroblast STO cells transformed with a neomycin resistance gene.)

But the colony doubling time for the hiPS cells was shorter with the fixed feeder than for cells cultured on laminin-5.

The researchers also discovered that the average number of colonies per passage was signficiantly higher for hiPS cells cultured on fixed feeder cells compared to those cultured without feeders.

They noted hiPS cells cultured on gelatin did not grow beyond the first passage.

The team concluded that the two types of chemically fixed HDF feeder cells (HDF-glutaraldehyde and HDF-formaldehyde) can be used as substitutes for mitomycin-C-treated HDF feeders to culture hiPS cells.

This new method would not extend the doubling time, would save preparation time, and would avoid labor-intensive protocols to prepare.

In addition, after chemical fixation, the feeder cells are non-viable and cannot release active growth factors or chemokines into the cell culture. Therefore, fixed feeder cells can be refrigerated for long-term storage prior to use.

“Because feeder cells don’t need to stay alive in the process, we can store them at room temperature and spend less time cultivating them,” Dr Joddar said.

“This makes me think that we [could] use a nanomanufacturing approach to grow stem cells. We could mimic feeder cells’ nanotopology with 3-D printing techniques and skip using feeder cells altogether in the future.”

Binata Joddar, PhD

Photo courtesy of University

of Texas at El Paso

Researchers say they have developed a protocol to prepare human induced pluripotent stem (hiPS) cells using chemically fixed feeder cells.

This method saves time and money by avoiding the need for colony formation of live feeder cells, which is required by current conventional methods.

The new protocol challenges the theory that live feeder cells are required to provide nutrients to growing stem cells.

“We’ve proved an important phenomenon,” said Binata Joddar, PhD, of the University of Texas at El Paso. “And it suggests that these feeder cells, which are difficult to grow, may not be important at all for stem cell growth.”

Dr Joddar and her colleagues described the phenomenon in Journal of Materials Chemistry B.

Using 2.5% glutaraldehyde (GA) or formaldehyde (FA) for 10 minutes, the researchers prepared a niche matrix from autologus human dermal fibroblast (HDF) feeder cells.

They then introduced hiPS cells to the niche matrix, which adhered to and were maintained as colonies on the fixed feeder cells.

The colony doubling times of the cells grown this way were similar to those of hiPS cells grown on mitomycin-C-treated HDF or SNL feeders. (SNL cells are derived from mouse fibroblast STO cells transformed with a neomycin resistance gene.)

But the colony doubling time for the hiPS cells was shorter with the fixed feeder than for cells cultured on laminin-5.

The researchers also discovered that the average number of colonies per passage was signficiantly higher for hiPS cells cultured on fixed feeder cells compared to those cultured without feeders.

They noted hiPS cells cultured on gelatin did not grow beyond the first passage.

The team concluded that the two types of chemically fixed HDF feeder cells (HDF-glutaraldehyde and HDF-formaldehyde) can be used as substitutes for mitomycin-C-treated HDF feeders to culture hiPS cells.

This new method would not extend the doubling time, would save preparation time, and would avoid labor-intensive protocols to prepare.

In addition, after chemical fixation, the feeder cells are non-viable and cannot release active growth factors or chemokines into the cell culture. Therefore, fixed feeder cells can be refrigerated for long-term storage prior to use.

“Because feeder cells don’t need to stay alive in the process, we can store them at room temperature and spend less time cultivating them,” Dr Joddar said.

“This makes me think that we [could] use a nanomanufacturing approach to grow stem cells. We could mimic feeder cells’ nanotopology with 3-D printing techniques and skip using feeder cells altogether in the future.”

Study Overview

Objective. To determine the effectiveness of a nurse-led, telephone-delivered behavioral intervention for diabetes (DM) and hypertension (HTN) versus an attention control within primary care community practices.

Study design. A 9-site, 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited from 9 community practices within the Duke Primary Care Research Consortium. The practices were chosen because they traditionally operate outside of the academic context. Subjects were required to have both type 2 DM and HTN, as indicated by their medications and confirmed by administrative data as well as patient self-reporting. Participants had to have been seen at participating practices for at least 1 year and have poorly controlled DM (indicated by most recent A1c ≥ 7.5%), but they were not required to have poorly controlled HTN. Exclusion criteria included fewer than 1 primary care clinic visit during the previous year, serious comorbid illness, type 1 diabetes, inability to receive a telephone intervention in English, residence in a nursing home, and participation in another hypertension or diabetes study [1]. Participants were randomly assigned using a computer-generated randomization sequence [1] to either the intervention or control groups at a 1:1 ratio, stratified by clinic and baseline blood pressure (BP) control.

Intervention. A single nurse with extensive experience in case management delivered both the behavioral intervention and attention control by telephone. In both arms, calls were conducted once every 2 months over a 24-month period.

The calls in the intervention arm consisted of tailored behavior-modifying techniques according to patient barriers. This content was divided into a series of modules relevant to behaviors associated with improving control of BP or blood sugar, including physical activity, weight reduction, sodium intake, smoking cessation, medication adherence, and others. These modules were scheduled according to patient needs (based on certain parameters such as high body mass index or use of insulin) and preferences [1].

The calls in the attention control were not tailored but rather consisted of didactic health-related information unrelated to HTN or DM (eg, flu shots, skin cancer prevention). This content was also highly scripted and designed to limit the potential for interaction between the nurse and patient.

Main outcome measures. A1c and systolic blood pressure (SBP) were primary outcomes. Key secondary outcomes were diastolic blood pressure (DBP), overall BP control, weight, physical activity, self-efficacy, and medication adherence. Study staff obtained measurements at baseline and 6, 12, and 24 months [1].

Results. The researchers assessed 2601 patients for eligibility and excluded 2224. Most patients were excluded for not meeting inclusion criteria (n = 1156), in particular because of improved HbA1c control (n = 983), and 1064 declined to participate. They randomized 377 patients—193 to the intervention arm and 184 to the attention control arm. Participants had an average age of 58.7, 49.1% had an education level of high school or less, 50.1% were non-white, and 54.9% were unemployed/retired. Patient characteristics in the intervention and control arms were similar at baseline. Seventy-eight percent of patients completed the 12-month follow-up and 70% (263) reached the 24-month endpoint. Patients in the intervention arm completed 78% of scheduled calls while patients in the control group completed 81%.

After adjusting for stratification variables, the estimated mean A1c and SBP were similar between arms at 24 months (intervention 0.1% higher than control, 95% CI −0.3 % to 0.5 %, P = 0.50 for A1c; intervention 0.9 mm Hg lower than control, 95% CI −5.4 to 3.5, P = 0.69 for SBP). There were also no significant differences between arms in mean A1c or SBP at 6 or 12 months. However, A1c levels did improve within each arm at the end of the study, with the intervention group improving by approx-imately 0.5% and the control group improving by approximately 0.6%. In terms of secondary outcomes, there were no significant differences between arms in DBP, weight, physical activity, or BP control rates throughout the 2-year study period.

Conclusion. Overall, the intervention and control groups did not differ significantly in terms of A1c, SBP, or any of the secondary outcomes at any point during the 2-year study.

Commentary

The prevalence of type 2 diabetes and its comorbidities (such as hypertension and obesity) have increased due to a variety of factors including an aging population and an increasingly sedentary lifestyle. Several nurse management programs for DM and HTN have been shown to be efficacious in reducing blood sugar levels [2–4] and promoting BP control [5,6]. However, these interventions were conducted in tightly controlled academic settings, and it is unclear how well these programs may translate into community settings. The aim of this study was to test the effectiveness of a nurse-led behavioral telephone intervention for the comanagement of DM and HTN within non–academically affiliated community practices. Results indicated no significant differences between the intervention and control groups for A1c levels or SBP at any point during the 2-year study, but A1c levels did improve for both arms.

Despite this being a negative study, it is a unique and important contribution to the literature. It is the only trial as of yet that has tested the effectiveness of a nurse management intervention targeting both DM and HTN in a real-world, community setting. This novel approach is supported by data that suggests BP control is actually more cost-effective than intensive glycemic control in treating patients with type 2 diabetes [7]. There were several strengths to the study design, including the use of intention-to-treat analysis, stratified randomization, a diverse patient population, and blinding of the study staff who took BP and A1c measurements. Furthermore, a single nurse conducted all telephone calls, ensuring that differences in counseling skill levels would not affect the results of the study. The few weaknesses of the study included the fact that the nurse who delivered the intervention (as well as the patients) could not be blinded to treatment allocation, and the income of study participants was not reported.

The reasons for the negative outcomes of this study are unclear. The authors claim that similar interventions within academic settings have been shown to be effective and speculate that time and financial pressures of community practices may be reasons that the intervention was not successful. However, the “successful” interventions that they cite were quite different from and more intensive than this intervention. For instance, many of these studies used at least 1 call per month [3,4,8], and one even conducted several calls each week [3]. Furthermore, a DM study conducted by Blackberry et al in a community setting with less than 1 call per month (8 calls over 18 months) similarly failed to produce significant results [9], and therefore more frequent calls may be necessary in DM and HTN interventions. In a systematic review, Eakin et al demonstrated that 12 or more calls in a 6- to 12-month period were associated with better outcomes in physical activity and diet interventions [10], and this may also translate to closely related DM and HTN interventions.

In addition to the infrequent calls, this intervention also lacked communication and integration with patients’ primary care teams. Several studies have demonstrated that integration with primary care teams can improve outcomes in DM and HTN interventions [11,12], and nearly all of the successful studies cited by the authors also included at least some form of communication with patients’ primary care providers (PCPs) [2–4,5,8]. In many of these studies the nurse also had prescribing rights to alter medications [2,3,5]. The nurse in this study met monthly with an expert team of clinicians to discuss patient issues but did not communicate directly with any of the patients’ PCPs [1]. The authors acknowledge that this lack of integration may have contributed to their negative results and point to the fact that it is harder to integrate interventions within community practices that often lack internal integration. However, Walsh, Harris, and Roberts demonstrated that integration between primary and secondary care teams was both feasible and effective for a diabetes initiative within community practices [13].

An additional important feature not present in this intervention was self-monitoring of BP levels. Home self-monitoring of BP has been demonstrated to significantly improve BP levels [14], and 2 of the successful studies in academic settings cited by the authors also included a BP self-monitoring component [5,6]. In one of these studies [6], Bosworth et al conducted a 2 × 2 randomized trial to improve HTN control in which the arms consisted of (a) usual care, (b) bimonthly nurse administered telephone intervention only (this arm was highly similar to the intervention arm in this study), (c) BP monitoring 3 times a week only, and (d) a combination of the telephone intervention with the BP monitoring. Interestingly, the only arm that was successful relative to usual care was the combination of the telephone intervention and BP self-monitoring; the arm consisting only of bi-monthly telephone calls (very similar to this intervention) failed despite the study taking place in an academic setting (it was also less effective than BP monitoring only). Thus, the addition of self-monitoring to a nurse case management telephone intervention can achieve better results.

Applications for Clinical Practice

A telephone-based intervention delivered by a trained nurse for co-management of DM and HTN was not more effective than an attention control delivered by the same nurse in a community setting. This may have been due to several factors, including low intensity marked by less than 1 call per month, a lack of integration with other members of the primary care team, and lack of a BP self-monitoring component. Future studies are needed to determine the optimal type and duration of nurse case management interventions targeting glucose and BP control for diabetic patients in community settings.

—Sandeep Sikerwar, BA, and Melanie Jay, MD, MS

Study Overview

Objective. To determine the effectiveness of a nurse-led, telephone-delivered behavioral intervention for diabetes (DM) and hypertension (HTN) versus an attention control within primary care community practices.

Study design. A 9-site, 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited from 9 community practices within the Duke Primary Care Research Consortium. The practices were chosen because they traditionally operate outside of the academic context. Subjects were required to have both type 2 DM and HTN, as indicated by their medications and confirmed by administrative data as well as patient self-reporting. Participants had to have been seen at participating practices for at least 1 year and have poorly controlled DM (indicated by most recent A1c ≥ 7.5%), but they were not required to have poorly controlled HTN. Exclusion criteria included fewer than 1 primary care clinic visit during the previous year, serious comorbid illness, type 1 diabetes, inability to receive a telephone intervention in English, residence in a nursing home, and participation in another hypertension or diabetes study [1]. Participants were randomly assigned using a computer-generated randomization sequence [1] to either the intervention or control groups at a 1:1 ratio, stratified by clinic and baseline blood pressure (BP) control.

Intervention. A single nurse with extensive experience in case management delivered both the behavioral intervention and attention control by telephone. In both arms, calls were conducted once every 2 months over a 24-month period.

The calls in the intervention arm consisted of tailored behavior-modifying techniques according to patient barriers. This content was divided into a series of modules relevant to behaviors associated with improving control of BP or blood sugar, including physical activity, weight reduction, sodium intake, smoking cessation, medication adherence, and others. These modules were scheduled according to patient needs (based on certain parameters such as high body mass index or use of insulin) and preferences [1].

The calls in the attention control were not tailored but rather consisted of didactic health-related information unrelated to HTN or DM (eg, flu shots, skin cancer prevention). This content was also highly scripted and designed to limit the potential for interaction between the nurse and patient.

Main outcome measures. A1c and systolic blood pressure (SBP) were primary outcomes. Key secondary outcomes were diastolic blood pressure (DBP), overall BP control, weight, physical activity, self-efficacy, and medication adherence. Study staff obtained measurements at baseline and 6, 12, and 24 months [1].

Results. The researchers assessed 2601 patients for eligibility and excluded 2224. Most patients were excluded for not meeting inclusion criteria (n = 1156), in particular because of improved HbA1c control (n = 983), and 1064 declined to participate. They randomized 377 patients—193 to the intervention arm and 184 to the attention control arm. Participants had an average age of 58.7, 49.1% had an education level of high school or less, 50.1% were non-white, and 54.9% were unemployed/retired. Patient characteristics in the intervention and control arms were similar at baseline. Seventy-eight percent of patients completed the 12-month follow-up and 70% (263) reached the 24-month endpoint. Patients in the intervention arm completed 78% of scheduled calls while patients in the control group completed 81%.

After adjusting for stratification variables, the estimated mean A1c and SBP were similar between arms at 24 months (intervention 0.1% higher than control, 95% CI −0.3 % to 0.5 %, P = 0.50 for A1c; intervention 0.9 mm Hg lower than control, 95% CI −5.4 to 3.5, P = 0.69 for SBP). There were also no significant differences between arms in mean A1c or SBP at 6 or 12 months. However, A1c levels did improve within each arm at the end of the study, with the intervention group improving by approx-imately 0.5% and the control group improving by approximately 0.6%. In terms of secondary outcomes, there were no significant differences between arms in DBP, weight, physical activity, or BP control rates throughout the 2-year study period.

Conclusion. Overall, the intervention and control groups did not differ significantly in terms of A1c, SBP, or any of the secondary outcomes at any point during the 2-year study.

Commentary

The prevalence of type 2 diabetes and its comorbidities (such as hypertension and obesity) have increased due to a variety of factors including an aging population and an increasingly sedentary lifestyle. Several nurse management programs for DM and HTN have been shown to be efficacious in reducing blood sugar levels [2–4] and promoting BP control [5,6]. However, these interventions were conducted in tightly controlled academic settings, and it is unclear how well these programs may translate into community settings. The aim of this study was to test the effectiveness of a nurse-led behavioral telephone intervention for the comanagement of DM and HTN within non–academically affiliated community practices. Results indicated no significant differences between the intervention and control groups for A1c levels or SBP at any point during the 2-year study, but A1c levels did improve for both arms.

Despite this being a negative study, it is a unique and important contribution to the literature. It is the only trial as of yet that has tested the effectiveness of a nurse management intervention targeting both DM and HTN in a real-world, community setting. This novel approach is supported by data that suggests BP control is actually more cost-effective than intensive glycemic control in treating patients with type 2 diabetes [7]. There were several strengths to the study design, including the use of intention-to-treat analysis, stratified randomization, a diverse patient population, and blinding of the study staff who took BP and A1c measurements. Furthermore, a single nurse conducted all telephone calls, ensuring that differences in counseling skill levels would not affect the results of the study. The few weaknesses of the study included the fact that the nurse who delivered the intervention (as well as the patients) could not be blinded to treatment allocation, and the income of study participants was not reported.

The reasons for the negative outcomes of this study are unclear. The authors claim that similar interventions within academic settings have been shown to be effective and speculate that time and financial pressures of community practices may be reasons that the intervention was not successful. However, the “successful” interventions that they cite were quite different from and more intensive than this intervention. For instance, many of these studies used at least 1 call per month [3,4,8], and one even conducted several calls each week [3]. Furthermore, a DM study conducted by Blackberry et al in a community setting with less than 1 call per month (8 calls over 18 months) similarly failed to produce significant results [9], and therefore more frequent calls may be necessary in DM and HTN interventions. In a systematic review, Eakin et al demonstrated that 12 or more calls in a 6- to 12-month period were associated with better outcomes in physical activity and diet interventions [10], and this may also translate to closely related DM and HTN interventions.

In addition to the infrequent calls, this intervention also lacked communication and integration with patients’ primary care teams. Several studies have demonstrated that integration with primary care teams can improve outcomes in DM and HTN interventions [11,12], and nearly all of the successful studies cited by the authors also included at least some form of communication with patients’ primary care providers (PCPs) [2–4,5,8]. In many of these studies the nurse also had prescribing rights to alter medications [2,3,5]. The nurse in this study met monthly with an expert team of clinicians to discuss patient issues but did not communicate directly with any of the patients’ PCPs [1]. The authors acknowledge that this lack of integration may have contributed to their negative results and point to the fact that it is harder to integrate interventions within community practices that often lack internal integration. However, Walsh, Harris, and Roberts demonstrated that integration between primary and secondary care teams was both feasible and effective for a diabetes initiative within community practices [13].

An additional important feature not present in this intervention was self-monitoring of BP levels. Home self-monitoring of BP has been demonstrated to significantly improve BP levels [14], and 2 of the successful studies in academic settings cited by the authors also included a BP self-monitoring component [5,6]. In one of these studies [6], Bosworth et al conducted a 2 × 2 randomized trial to improve HTN control in which the arms consisted of (a) usual care, (b) bimonthly nurse administered telephone intervention only (this arm was highly similar to the intervention arm in this study), (c) BP monitoring 3 times a week only, and (d) a combination of the telephone intervention with the BP monitoring. Interestingly, the only arm that was successful relative to usual care was the combination of the telephone intervention and BP self-monitoring; the arm consisting only of bi-monthly telephone calls (very similar to this intervention) failed despite the study taking place in an academic setting (it was also less effective than BP monitoring only). Thus, the addition of self-monitoring to a nurse case management telephone intervention can achieve better results.

Applications for Clinical Practice

A telephone-based intervention delivered by a trained nurse for co-management of DM and HTN was not more effective than an attention control delivered by the same nurse in a community setting. This may have been due to several factors, including low intensity marked by less than 1 call per month, a lack of integration with other members of the primary care team, and lack of a BP self-monitoring component. Future studies are needed to determine the optimal type and duration of nurse case management interventions targeting glucose and BP control for diabetic patients in community settings.

—Sandeep Sikerwar, BA, and Melanie Jay, MD, MS

Study Overview

Objective. To determine the effectiveness of a nurse-led, telephone-delivered behavioral intervention for diabetes (DM) and hypertension (HTN) versus an attention control within primary care community practices.

Study design. A 9-site, 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited from 9 community practices within the Duke Primary Care Research Consortium. The practices were chosen because they traditionally operate outside of the academic context. Subjects were required to have both type 2 DM and HTN, as indicated by their medications and confirmed by administrative data as well as patient self-reporting. Participants had to have been seen at participating practices for at least 1 year and have poorly controlled DM (indicated by most recent A1c ≥ 7.5%), but they were not required to have poorly controlled HTN. Exclusion criteria included fewer than 1 primary care clinic visit during the previous year, serious comorbid illness, type 1 diabetes, inability to receive a telephone intervention in English, residence in a nursing home, and participation in another hypertension or diabetes study [1]. Participants were randomly assigned using a computer-generated randomization sequence [1] to either the intervention or control groups at a 1:1 ratio, stratified by clinic and baseline blood pressure (BP) control.

Intervention. A single nurse with extensive experience in case management delivered both the behavioral intervention and attention control by telephone. In both arms, calls were conducted once every 2 months over a 24-month period.

The calls in the intervention arm consisted of tailored behavior-modifying techniques according to patient barriers. This content was divided into a series of modules relevant to behaviors associated with improving control of BP or blood sugar, including physical activity, weight reduction, sodium intake, smoking cessation, medication adherence, and others. These modules were scheduled according to patient needs (based on certain parameters such as high body mass index or use of insulin) and preferences [1].

The calls in the attention control were not tailored but rather consisted of didactic health-related information unrelated to HTN or DM (eg, flu shots, skin cancer prevention). This content was also highly scripted and designed to limit the potential for interaction between the nurse and patient.

Main outcome measures. A1c and systolic blood pressure (SBP) were primary outcomes. Key secondary outcomes were diastolic blood pressure (DBP), overall BP control, weight, physical activity, self-efficacy, and medication adherence. Study staff obtained measurements at baseline and 6, 12, and 24 months [1].

Results. The researchers assessed 2601 patients for eligibility and excluded 2224. Most patients were excluded for not meeting inclusion criteria (n = 1156), in particular because of improved HbA1c control (n = 983), and 1064 declined to participate. They randomized 377 patients—193 to the intervention arm and 184 to the attention control arm. Participants had an average age of 58.7, 49.1% had an education level of high school or less, 50.1% were non-white, and 54.9% were unemployed/retired. Patient characteristics in the intervention and control arms were similar at baseline. Seventy-eight percent of patients completed the 12-month follow-up and 70% (263) reached the 24-month endpoint. Patients in the intervention arm completed 78% of scheduled calls while patients in the control group completed 81%.

After adjusting for stratification variables, the estimated mean A1c and SBP were similar between arms at 24 months (intervention 0.1% higher than control, 95% CI −0.3 % to 0.5 %, P = 0.50 for A1c; intervention 0.9 mm Hg lower than control, 95% CI −5.4 to 3.5, P = 0.69 for SBP). There were also no significant differences between arms in mean A1c or SBP at 6 or 12 months. However, A1c levels did improve within each arm at the end of the study, with the intervention group improving by approx-imately 0.5% and the control group improving by approximately 0.6%. In terms of secondary outcomes, there were no significant differences between arms in DBP, weight, physical activity, or BP control rates throughout the 2-year study period.

Conclusion. Overall, the intervention and control groups did not differ significantly in terms of A1c, SBP, or any of the secondary outcomes at any point during the 2-year study.

Commentary

The prevalence of type 2 diabetes and its comorbidities (such as hypertension and obesity) have increased due to a variety of factors including an aging population and an increasingly sedentary lifestyle. Several nurse management programs for DM and HTN have been shown to be efficacious in reducing blood sugar levels [2–4] and promoting BP control [5,6]. However, these interventions were conducted in tightly controlled academic settings, and it is unclear how well these programs may translate into community settings. The aim of this study was to test the effectiveness of a nurse-led behavioral telephone intervention for the comanagement of DM and HTN within non–academically affiliated community practices. Results indicated no significant differences between the intervention and control groups for A1c levels or SBP at any point during the 2-year study, but A1c levels did improve for both arms.

Despite this being a negative study, it is a unique and important contribution to the literature. It is the only trial as of yet that has tested the effectiveness of a nurse management intervention targeting both DM and HTN in a real-world, community setting. This novel approach is supported by data that suggests BP control is actually more cost-effective than intensive glycemic control in treating patients with type 2 diabetes [7]. There were several strengths to the study design, including the use of intention-to-treat analysis, stratified randomization, a diverse patient population, and blinding of the study staff who took BP and A1c measurements. Furthermore, a single nurse conducted all telephone calls, ensuring that differences in counseling skill levels would not affect the results of the study. The few weaknesses of the study included the fact that the nurse who delivered the intervention (as well as the patients) could not be blinded to treatment allocation, and the income of study participants was not reported.

The reasons for the negative outcomes of this study are unclear. The authors claim that similar interventions within academic settings have been shown to be effective and speculate that time and financial pressures of community practices may be reasons that the intervention was not successful. However, the “successful” interventions that they cite were quite different from and more intensive than this intervention. For instance, many of these studies used at least 1 call per month [3,4,8], and one even conducted several calls each week [3]. Furthermore, a DM study conducted by Blackberry et al in a community setting with less than 1 call per month (8 calls over 18 months) similarly failed to produce significant results [9], and therefore more frequent calls may be necessary in DM and HTN interventions. In a systematic review, Eakin et al demonstrated that 12 or more calls in a 6- to 12-month period were associated with better outcomes in physical activity and diet interventions [10], and this may also translate to closely related DM and HTN interventions.

In addition to the infrequent calls, this intervention also lacked communication and integration with patients’ primary care teams. Several studies have demonstrated that integration with primary care teams can improve outcomes in DM and HTN interventions [11,12], and nearly all of the successful studies cited by the authors also included at least some form of communication with patients’ primary care providers (PCPs) [2–4,5,8]. In many of these studies the nurse also had prescribing rights to alter medications [2,3,5]. The nurse in this study met monthly with an expert team of clinicians to discuss patient issues but did not communicate directly with any of the patients’ PCPs [1]. The authors acknowledge that this lack of integration may have contributed to their negative results and point to the fact that it is harder to integrate interventions within community practices that often lack internal integration. However, Walsh, Harris, and Roberts demonstrated that integration between primary and secondary care teams was both feasible and effective for a diabetes initiative within community practices [13].

An additional important feature not present in this intervention was self-monitoring of BP levels. Home self-monitoring of BP has been demonstrated to significantly improve BP levels [14], and 2 of the successful studies in academic settings cited by the authors also included a BP self-monitoring component [5,6]. In one of these studies [6], Bosworth et al conducted a 2 × 2 randomized trial to improve HTN control in which the arms consisted of (a) usual care, (b) bimonthly nurse administered telephone intervention only (this arm was highly similar to the intervention arm in this study), (c) BP monitoring 3 times a week only, and (d) a combination of the telephone intervention with the BP monitoring. Interestingly, the only arm that was successful relative to usual care was the combination of the telephone intervention and BP self-monitoring; the arm consisting only of bi-monthly telephone calls (very similar to this intervention) failed despite the study taking place in an academic setting (it was also less effective than BP monitoring only). Thus, the addition of self-monitoring to a nurse case management telephone intervention can achieve better results.

Applications for Clinical Practice

A telephone-based intervention delivered by a trained nurse for co-management of DM and HTN was not more effective than an attention control delivered by the same nurse in a community setting. This may have been due to several factors, including low intensity marked by less than 1 call per month, a lack of integration with other members of the primary care team, and lack of a BP self-monitoring component. Future studies are needed to determine the optimal type and duration of nurse case management interventions targeting glucose and BP control for diabetic patients in community settings.

—Sandeep Sikerwar, BA, and Melanie Jay, MD, MS