17-OHPC Blocks Preterm Cervical Ripening

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17-OHPC Blocks Preterm Cervical Ripening

SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in the prevention of preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks.

The study dose of 17-OHPC is substantially higher than that which is typically used to prevent preterm births in women with a history of premature delivery, which generally consists of a single weekly injection

“Our reasoning for the high dose was twofold,” said Dr. Facchinetti. “The cervical inflammatory processes in these women were already activated, so we needed to challenge them. Also, treatment was started later in pregnancy [compared with prophylactic treatment to prevent repeat preterm birth], thus there was less time for efficacy.”

All of the women in the study had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Patients with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intra-amniotic infection were excluded.

There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. Per hospital protocol, all of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, he said.

After randomization, which took place 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks. With respect to the cervical swab, “we collected [cervical] fluid beyond the external os to avoid shear stress and blood, and the samples were weighted and stored for immunoassays to measure inflammatory markers,” said Dr. Facchinetti.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (prior to week 37) compared with 54% in the observation group, representing a statistically significant reduction, according to Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group. There were no between-group differences in the number of women who delivered prior to week 35 or in infant birth weight or rate of low-birth-weight infants, he said.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” said Dr. Facchinetti.

The investigators also observed “important” within-group and between-group changes in the level of cervical secretion of interleukin 1 (IL-1), Dr. Facchinetti noted. “In the untreated group, there was a trend toward increased IL-1 secretion over 3 weeks, while the treatment group showed a significant decrease.” No statistically significant changes were observed in the other proinflammatory markers that were measured, including IL-6, IL-8, tumor necrosis factor-α, or nitrates/nitrites—a finding that suggests 17-OHPC selectively inhibits IL-1, he said.

Based on the results, “our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC],” said Dr. Facchinetti.

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SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in the prevention of preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks.

The study dose of 17-OHPC is substantially higher than that which is typically used to prevent preterm births in women with a history of premature delivery, which generally consists of a single weekly injection

“Our reasoning for the high dose was twofold,” said Dr. Facchinetti. “The cervical inflammatory processes in these women were already activated, so we needed to challenge them. Also, treatment was started later in pregnancy [compared with prophylactic treatment to prevent repeat preterm birth], thus there was less time for efficacy.”

All of the women in the study had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Patients with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intra-amniotic infection were excluded.

There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. Per hospital protocol, all of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, he said.

After randomization, which took place 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks. With respect to the cervical swab, “we collected [cervical] fluid beyond the external os to avoid shear stress and blood, and the samples were weighted and stored for immunoassays to measure inflammatory markers,” said Dr. Facchinetti.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (prior to week 37) compared with 54% in the observation group, representing a statistically significant reduction, according to Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group. There were no between-group differences in the number of women who delivered prior to week 35 or in infant birth weight or rate of low-birth-weight infants, he said.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” said Dr. Facchinetti.

The investigators also observed “important” within-group and between-group changes in the level of cervical secretion of interleukin 1 (IL-1), Dr. Facchinetti noted. “In the untreated group, there was a trend toward increased IL-1 secretion over 3 weeks, while the treatment group showed a significant decrease.” No statistically significant changes were observed in the other proinflammatory markers that were measured, including IL-6, IL-8, tumor necrosis factor-α, or nitrates/nitrites—a finding that suggests 17-OHPC selectively inhibits IL-1, he said.

Based on the results, “our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC],” said Dr. Facchinetti.

SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in the prevention of preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks.

The study dose of 17-OHPC is substantially higher than that which is typically used to prevent preterm births in women with a history of premature delivery, which generally consists of a single weekly injection

“Our reasoning for the high dose was twofold,” said Dr. Facchinetti. “The cervical inflammatory processes in these women were already activated, so we needed to challenge them. Also, treatment was started later in pregnancy [compared with prophylactic treatment to prevent repeat preterm birth], thus there was less time for efficacy.”

All of the women in the study had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Patients with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intra-amniotic infection were excluded.

There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. Per hospital protocol, all of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, he said.

After randomization, which took place 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks. With respect to the cervical swab, “we collected [cervical] fluid beyond the external os to avoid shear stress and blood, and the samples were weighted and stored for immunoassays to measure inflammatory markers,” said Dr. Facchinetti.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (prior to week 37) compared with 54% in the observation group, representing a statistically significant reduction, according to Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group. There were no between-group differences in the number of women who delivered prior to week 35 or in infant birth weight or rate of low-birth-weight infants, he said.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” said Dr. Facchinetti.

The investigators also observed “important” within-group and between-group changes in the level of cervical secretion of interleukin 1 (IL-1), Dr. Facchinetti noted. “In the untreated group, there was a trend toward increased IL-1 secretion over 3 weeks, while the treatment group showed a significant decrease.” No statistically significant changes were observed in the other proinflammatory markers that were measured, including IL-6, IL-8, tumor necrosis factor-α, or nitrates/nitrites—a finding that suggests 17-OHPC selectively inhibits IL-1, he said.

Based on the results, “our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC],” said Dr. Facchinetti.

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Juvenile Systemic Sclerosis Diagnosis Hinges on Skin Signs

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Juvenile Systemic Sclerosis Diagnosis Hinges on Skin Signs

Evidence of proximal cutaneous sclerosis and at least 2 of 20 predefined minor criteria are required for a diagnosis of juvenile systemic sclerosis, according to new provisional classification criteria.

Using clinical data from real patients in combination with a consensus-based methodology, Dr. Francesco Zulian of the University of Padua (Italy) and colleagues on the Ad Hoc Committee on Classification Criteria for Juvenile Systemic Sclerosis—a combined effort of the Pediatric Rheumatology European Society, the American College of Rheumatology, and the European League Against Rheumatism—developed the new classification criteria to help standardize the conduct of clinical, epidemiologic, and outcome research for this rare pediatric disease and may alter patient care by enabling earlier, more definitive diagnoses (Arthritis Rheum. 2007;57:203–12).

The lack of standard classification criteria until now “has posed a barrier to the initiation of trials,” according to Dr. Thomas J.A. Lehman of Cornell University, New York, who served on the classification committee. Clearly defined criteria are important for directing physicians who don't have much experience with the disease.

The much-needed juvenile criteria, which will supplant the adult criteria that have been used until now, “will help ensure that everyone included in a study has systemic sclerosis and not another condition or an overlap that may have a different long-term outcome,” Dr. Lehman said in an interview. “For patient management, the criteria will help in convincing physicians that a patient does, in fact, have systemic sclerosis.”

The criteria were developed in three phases, the first of which included the retrospective collection of information on demographic, clinical, and laboratory features of patients diagnosed with systemic sclerosis before age 16 from pediatric rheumatology centers worldwide. Investigators from the participating centers completed standardized case report forms to define organ involvement at the time of diagnosis. Forty-eight signs and symptoms, organized into nine categories were included for consideration.

In phase II, the committee developed questionnaires based on the data collected in phase I and sent them to 14 pediatric and adult rheumatologists with expertise in juvenile systemic sclerosis. The experts were asked to select the parameters essential for classification of the disease, based on their experience. Among the variables with the highest final scores, “those with a prevalence of at least 50% at the time of diagnosis, based on our patient population, were selected as provisional major criteria, and the remaining variables were listed as minor criteria,” the authors explained.

In the third phase, the provisional criteria were evaluated by the same 14 experts in a consensus conference, using the clinical profiles of 160 actual patients with a variety of diagnoses, including 100 from patients with definite juvenile systemic sclerosis collected in phase I. A consensus of at least 80% of the experts was achieved for 127 of 160 patients, 70 of whom were judged as having the disease (all from the phase I group) and 57 as not having it. The 127 patients were then used as the accepted standard for rating the provisional classification criteria with the best statistical performance and highest face validity.

Of 86 different provisional classification criteria tested on the case profiles of the 127 patients, the criterion with the highest ranking was that which required the presence of proximal skin sclerosis/induration and at least 2 minor criteria, which is more restrictive than the adult classification criteria, according to the authors.

Conversely, the minor criteria in the proposed classification are more numerous than those used for adults.

Although validated with actual patient data, the new classification criteria must still undergo validation in external prospective trials, they noted.

Provisional Classification Criteria

Major criterion (Required)

▸ Proximal skin sclerosis/induration of the skin

Minor criteria(At least two are required)

▸ Cutaneous

Sclerodactyly

▸ Peripheral vascular

Raynaud's phenomenon

Nailfold capillary abnormalities

Digital tip ulcers

▸ Gastrointestinal

Dysphagia

Gastroesophageal reflux

▸ Cardiac

Arrhythmias

Heart failure

▸ Renal

Renal crisis

New-onset arterial hypertension

Source: Arthritis Rheum. 2007;57:203–12

▸ Respiratory

Pulmonary fibrosis (high-resolution computed tomography/radiography)

Decreased diffusing capacity for carbon monoxide

Pulmonary arterial hypertension

▸ Neurologic

Neuropathy

Carpal tunnel syndrome

▸ Musculoskeletal

Tendon friction rubs

Arthritis

Myositis

▸ Serologic

Antinuclear antibodies

Systemic sclerosis-selective autoantibodies

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Evidence of proximal cutaneous sclerosis and at least 2 of 20 predefined minor criteria are required for a diagnosis of juvenile systemic sclerosis, according to new provisional classification criteria.

Using clinical data from real patients in combination with a consensus-based methodology, Dr. Francesco Zulian of the University of Padua (Italy) and colleagues on the Ad Hoc Committee on Classification Criteria for Juvenile Systemic Sclerosis—a combined effort of the Pediatric Rheumatology European Society, the American College of Rheumatology, and the European League Against Rheumatism—developed the new classification criteria to help standardize the conduct of clinical, epidemiologic, and outcome research for this rare pediatric disease and may alter patient care by enabling earlier, more definitive diagnoses (Arthritis Rheum. 2007;57:203–12).

The lack of standard classification criteria until now “has posed a barrier to the initiation of trials,” according to Dr. Thomas J.A. Lehman of Cornell University, New York, who served on the classification committee. Clearly defined criteria are important for directing physicians who don't have much experience with the disease.

The much-needed juvenile criteria, which will supplant the adult criteria that have been used until now, “will help ensure that everyone included in a study has systemic sclerosis and not another condition or an overlap that may have a different long-term outcome,” Dr. Lehman said in an interview. “For patient management, the criteria will help in convincing physicians that a patient does, in fact, have systemic sclerosis.”

The criteria were developed in three phases, the first of which included the retrospective collection of information on demographic, clinical, and laboratory features of patients diagnosed with systemic sclerosis before age 16 from pediatric rheumatology centers worldwide. Investigators from the participating centers completed standardized case report forms to define organ involvement at the time of diagnosis. Forty-eight signs and symptoms, organized into nine categories were included for consideration.

In phase II, the committee developed questionnaires based on the data collected in phase I and sent them to 14 pediatric and adult rheumatologists with expertise in juvenile systemic sclerosis. The experts were asked to select the parameters essential for classification of the disease, based on their experience. Among the variables with the highest final scores, “those with a prevalence of at least 50% at the time of diagnosis, based on our patient population, were selected as provisional major criteria, and the remaining variables were listed as minor criteria,” the authors explained.

In the third phase, the provisional criteria were evaluated by the same 14 experts in a consensus conference, using the clinical profiles of 160 actual patients with a variety of diagnoses, including 100 from patients with definite juvenile systemic sclerosis collected in phase I. A consensus of at least 80% of the experts was achieved for 127 of 160 patients, 70 of whom were judged as having the disease (all from the phase I group) and 57 as not having it. The 127 patients were then used as the accepted standard for rating the provisional classification criteria with the best statistical performance and highest face validity.

Of 86 different provisional classification criteria tested on the case profiles of the 127 patients, the criterion with the highest ranking was that which required the presence of proximal skin sclerosis/induration and at least 2 minor criteria, which is more restrictive than the adult classification criteria, according to the authors.

Conversely, the minor criteria in the proposed classification are more numerous than those used for adults.

Although validated with actual patient data, the new classification criteria must still undergo validation in external prospective trials, they noted.

Provisional Classification Criteria

Major criterion (Required)

▸ Proximal skin sclerosis/induration of the skin

Minor criteria(At least two are required)

▸ Cutaneous

Sclerodactyly

▸ Peripheral vascular

Raynaud's phenomenon

Nailfold capillary abnormalities

Digital tip ulcers

▸ Gastrointestinal

Dysphagia

Gastroesophageal reflux

▸ Cardiac

Arrhythmias

Heart failure

▸ Renal

Renal crisis

New-onset arterial hypertension

Source: Arthritis Rheum. 2007;57:203–12

▸ Respiratory

Pulmonary fibrosis (high-resolution computed tomography/radiography)

Decreased diffusing capacity for carbon monoxide

Pulmonary arterial hypertension

▸ Neurologic

Neuropathy

Carpal tunnel syndrome

▸ Musculoskeletal

Tendon friction rubs

Arthritis

Myositis

▸ Serologic

Antinuclear antibodies

Systemic sclerosis-selective autoantibodies

Evidence of proximal cutaneous sclerosis and at least 2 of 20 predefined minor criteria are required for a diagnosis of juvenile systemic sclerosis, according to new provisional classification criteria.

Using clinical data from real patients in combination with a consensus-based methodology, Dr. Francesco Zulian of the University of Padua (Italy) and colleagues on the Ad Hoc Committee on Classification Criteria for Juvenile Systemic Sclerosis—a combined effort of the Pediatric Rheumatology European Society, the American College of Rheumatology, and the European League Against Rheumatism—developed the new classification criteria to help standardize the conduct of clinical, epidemiologic, and outcome research for this rare pediatric disease and may alter patient care by enabling earlier, more definitive diagnoses (Arthritis Rheum. 2007;57:203–12).

The lack of standard classification criteria until now “has posed a barrier to the initiation of trials,” according to Dr. Thomas J.A. Lehman of Cornell University, New York, who served on the classification committee. Clearly defined criteria are important for directing physicians who don't have much experience with the disease.

The much-needed juvenile criteria, which will supplant the adult criteria that have been used until now, “will help ensure that everyone included in a study has systemic sclerosis and not another condition or an overlap that may have a different long-term outcome,” Dr. Lehman said in an interview. “For patient management, the criteria will help in convincing physicians that a patient does, in fact, have systemic sclerosis.”

The criteria were developed in three phases, the first of which included the retrospective collection of information on demographic, clinical, and laboratory features of patients diagnosed with systemic sclerosis before age 16 from pediatric rheumatology centers worldwide. Investigators from the participating centers completed standardized case report forms to define organ involvement at the time of diagnosis. Forty-eight signs and symptoms, organized into nine categories were included for consideration.

In phase II, the committee developed questionnaires based on the data collected in phase I and sent them to 14 pediatric and adult rheumatologists with expertise in juvenile systemic sclerosis. The experts were asked to select the parameters essential for classification of the disease, based on their experience. Among the variables with the highest final scores, “those with a prevalence of at least 50% at the time of diagnosis, based on our patient population, were selected as provisional major criteria, and the remaining variables were listed as minor criteria,” the authors explained.

In the third phase, the provisional criteria were evaluated by the same 14 experts in a consensus conference, using the clinical profiles of 160 actual patients with a variety of diagnoses, including 100 from patients with definite juvenile systemic sclerosis collected in phase I. A consensus of at least 80% of the experts was achieved for 127 of 160 patients, 70 of whom were judged as having the disease (all from the phase I group) and 57 as not having it. The 127 patients were then used as the accepted standard for rating the provisional classification criteria with the best statistical performance and highest face validity.

Of 86 different provisional classification criteria tested on the case profiles of the 127 patients, the criterion with the highest ranking was that which required the presence of proximal skin sclerosis/induration and at least 2 minor criteria, which is more restrictive than the adult classification criteria, according to the authors.

Conversely, the minor criteria in the proposed classification are more numerous than those used for adults.

Although validated with actual patient data, the new classification criteria must still undergo validation in external prospective trials, they noted.

Provisional Classification Criteria

Major criterion (Required)

▸ Proximal skin sclerosis/induration of the skin

Minor criteria(At least two are required)

▸ Cutaneous

Sclerodactyly

▸ Peripheral vascular

Raynaud's phenomenon

Nailfold capillary abnormalities

Digital tip ulcers

▸ Gastrointestinal

Dysphagia

Gastroesophageal reflux

▸ Cardiac

Arrhythmias

Heart failure

▸ Renal

Renal crisis

New-onset arterial hypertension

Source: Arthritis Rheum. 2007;57:203–12

▸ Respiratory

Pulmonary fibrosis (high-resolution computed tomography/radiography)

Decreased diffusing capacity for carbon monoxide

Pulmonary arterial hypertension

▸ Neurologic

Neuropathy

Carpal tunnel syndrome

▸ Musculoskeletal

Tendon friction rubs

Arthritis

Myositis

▸ Serologic

Antinuclear antibodies

Systemic sclerosis-selective autoantibodies

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Ultrasound Finds Early Jaw Changes in JIA Patients

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Ultrasound Finds Early Jaw Changes in JIA Patients

High-resolution ultrasound may be a useful diagnostic screening method for the evaluation of the temporomandibular joint in patients with juvenile arthritis, Dr. Siegfried Jank and colleagues reported.

Sonographic studies of the temporomandibular joints (TMJs) of 48 patients with juvenile idiopathic arthritis (JIA) demonstrated significant correlations between pathologic findings and both the duration of arthritis and the number of affected peripheral joints, reported Dr. Jank, of the Medical University of Innsbruck (Austria), and his colleagues.

Studies have shown that temporomandibular diseases/disorders (TMDs)—such as clicking, crepitation, and disk dislocation—in patients with JIA could lead to more severe symptoms, such as hypoplastic condyles, a convex facial morphology, and retrognathia. To prevent such outcomes, experts agree that therapeutic interventions should be implemented in the early states of a TMD; however, clinical symptoms typically appear late, after the onset of destructive changes, and may be masked by antirheumatic therapies, the authors wrote.

Although MRI is considered the clinical standard in the imaging diagnosis of the TMJ, its high cost and limited availability—as well as the need for anesthesia or conscious sedation, particularly in smaller children—preclude its use as a routine screening method in this population, reported the authors. Because high resolution ultrasound is a quick, inexpensive, and widely available option, the investigators sought to evaluate its potential usefulness in the diagnosis of TMD in JIA patients (Arthritis Rheum. 2007;57:213–8).

Each of the 48 patients with JIA who were enrolled in the prospective study underwent a sonographic investigation by an experienced oral and maxillofacial surgeon, who evaluated destructive changes and disk dislocation in both closed-mouth and maximum open-mouth positions. At the time of the ultrasound examination, the number of affected peripheral joints and the duration of JIA were obtained for each patient. A clinical investigation of the TMJ was also done, and was based on multiple parameters including clicking, crepitation, deviation of the mouth-opening movement, and pain on palpation of the TMJ and/or the mandibular muscles.

An analysis of the sonographic results showed destructive changes of the TMJ in 55% of the patients. From the full study population, 43% had evidence of disk dislocation in the closed-mouth position, including 24% who also had evidence of disk dislocation in the maximum open-mouth position. Only one of the patients diagnosed with disk dislocation in the maximum open-mouth position did not have evidence of dislocation in the closed-mouth position, the authors reported.

On clinical examination, the most common pathologic findings included history of TMJ lock in the closed-mouth position (12 patients), pain on palpation of the TMJ (11), and crepitation (11), they wrote.

When the sonographic and clinical data were correlated, there was a significant parallel between ultrasound evidence of destructive changes of the TMJ and patients with more than five peripheral affected joints, and between the number of affected peripheral joints and disk dislocation in the open-mouth position.

In addition, patients with JIA duration longer than 23 months had significantly higher rates of disk dislocation and destruction changes, compared with patients who had shorter disease durations. Similarly, disease duration longer than 60 months was significantly associated with a higher rate of destructive changes—but not with disk dislocation—than were shorter disease durations, they wrote.

The significant correlation between the number of affected peripheral joints and the sonographic evidence of destructive changes and disk dislocation suggests that the imaging method “is able to detect TMD earlier than clinical symptoms appear,” they wrote.

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High-resolution ultrasound may be a useful diagnostic screening method for the evaluation of the temporomandibular joint in patients with juvenile arthritis, Dr. Siegfried Jank and colleagues reported.

Sonographic studies of the temporomandibular joints (TMJs) of 48 patients with juvenile idiopathic arthritis (JIA) demonstrated significant correlations between pathologic findings and both the duration of arthritis and the number of affected peripheral joints, reported Dr. Jank, of the Medical University of Innsbruck (Austria), and his colleagues.

Studies have shown that temporomandibular diseases/disorders (TMDs)—such as clicking, crepitation, and disk dislocation—in patients with JIA could lead to more severe symptoms, such as hypoplastic condyles, a convex facial morphology, and retrognathia. To prevent such outcomes, experts agree that therapeutic interventions should be implemented in the early states of a TMD; however, clinical symptoms typically appear late, after the onset of destructive changes, and may be masked by antirheumatic therapies, the authors wrote.

Although MRI is considered the clinical standard in the imaging diagnosis of the TMJ, its high cost and limited availability—as well as the need for anesthesia or conscious sedation, particularly in smaller children—preclude its use as a routine screening method in this population, reported the authors. Because high resolution ultrasound is a quick, inexpensive, and widely available option, the investigators sought to evaluate its potential usefulness in the diagnosis of TMD in JIA patients (Arthritis Rheum. 2007;57:213–8).

Each of the 48 patients with JIA who were enrolled in the prospective study underwent a sonographic investigation by an experienced oral and maxillofacial surgeon, who evaluated destructive changes and disk dislocation in both closed-mouth and maximum open-mouth positions. At the time of the ultrasound examination, the number of affected peripheral joints and the duration of JIA were obtained for each patient. A clinical investigation of the TMJ was also done, and was based on multiple parameters including clicking, crepitation, deviation of the mouth-opening movement, and pain on palpation of the TMJ and/or the mandibular muscles.

An analysis of the sonographic results showed destructive changes of the TMJ in 55% of the patients. From the full study population, 43% had evidence of disk dislocation in the closed-mouth position, including 24% who also had evidence of disk dislocation in the maximum open-mouth position. Only one of the patients diagnosed with disk dislocation in the maximum open-mouth position did not have evidence of dislocation in the closed-mouth position, the authors reported.

On clinical examination, the most common pathologic findings included history of TMJ lock in the closed-mouth position (12 patients), pain on palpation of the TMJ (11), and crepitation (11), they wrote.

When the sonographic and clinical data were correlated, there was a significant parallel between ultrasound evidence of destructive changes of the TMJ and patients with more than five peripheral affected joints, and between the number of affected peripheral joints and disk dislocation in the open-mouth position.

In addition, patients with JIA duration longer than 23 months had significantly higher rates of disk dislocation and destruction changes, compared with patients who had shorter disease durations. Similarly, disease duration longer than 60 months was significantly associated with a higher rate of destructive changes—but not with disk dislocation—than were shorter disease durations, they wrote.

The significant correlation between the number of affected peripheral joints and the sonographic evidence of destructive changes and disk dislocation suggests that the imaging method “is able to detect TMD earlier than clinical symptoms appear,” they wrote.

High-resolution ultrasound may be a useful diagnostic screening method for the evaluation of the temporomandibular joint in patients with juvenile arthritis, Dr. Siegfried Jank and colleagues reported.

Sonographic studies of the temporomandibular joints (TMJs) of 48 patients with juvenile idiopathic arthritis (JIA) demonstrated significant correlations between pathologic findings and both the duration of arthritis and the number of affected peripheral joints, reported Dr. Jank, of the Medical University of Innsbruck (Austria), and his colleagues.

Studies have shown that temporomandibular diseases/disorders (TMDs)—such as clicking, crepitation, and disk dislocation—in patients with JIA could lead to more severe symptoms, such as hypoplastic condyles, a convex facial morphology, and retrognathia. To prevent such outcomes, experts agree that therapeutic interventions should be implemented in the early states of a TMD; however, clinical symptoms typically appear late, after the onset of destructive changes, and may be masked by antirheumatic therapies, the authors wrote.

Although MRI is considered the clinical standard in the imaging diagnosis of the TMJ, its high cost and limited availability—as well as the need for anesthesia or conscious sedation, particularly in smaller children—preclude its use as a routine screening method in this population, reported the authors. Because high resolution ultrasound is a quick, inexpensive, and widely available option, the investigators sought to evaluate its potential usefulness in the diagnosis of TMD in JIA patients (Arthritis Rheum. 2007;57:213–8).

Each of the 48 patients with JIA who were enrolled in the prospective study underwent a sonographic investigation by an experienced oral and maxillofacial surgeon, who evaluated destructive changes and disk dislocation in both closed-mouth and maximum open-mouth positions. At the time of the ultrasound examination, the number of affected peripheral joints and the duration of JIA were obtained for each patient. A clinical investigation of the TMJ was also done, and was based on multiple parameters including clicking, crepitation, deviation of the mouth-opening movement, and pain on palpation of the TMJ and/or the mandibular muscles.

An analysis of the sonographic results showed destructive changes of the TMJ in 55% of the patients. From the full study population, 43% had evidence of disk dislocation in the closed-mouth position, including 24% who also had evidence of disk dislocation in the maximum open-mouth position. Only one of the patients diagnosed with disk dislocation in the maximum open-mouth position did not have evidence of dislocation in the closed-mouth position, the authors reported.

On clinical examination, the most common pathologic findings included history of TMJ lock in the closed-mouth position (12 patients), pain on palpation of the TMJ (11), and crepitation (11), they wrote.

When the sonographic and clinical data were correlated, there was a significant parallel between ultrasound evidence of destructive changes of the TMJ and patients with more than five peripheral affected joints, and between the number of affected peripheral joints and disk dislocation in the open-mouth position.

In addition, patients with JIA duration longer than 23 months had significantly higher rates of disk dislocation and destruction changes, compared with patients who had shorter disease durations. Similarly, disease duration longer than 60 months was significantly associated with a higher rate of destructive changes—but not with disk dislocation—than were shorter disease durations, they wrote.

The significant correlation between the number of affected peripheral joints and the sonographic evidence of destructive changes and disk dislocation suggests that the imaging method “is able to detect TMD earlier than clinical symptoms appear,” they wrote.

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FACIT-Fatigue Scale Found Valid for Psoriatic Arthritis

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The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.

One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).

All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).

The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.

Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.

More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.

The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.

Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.

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The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.

One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).

All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).

The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.

Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.

More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.

The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.

Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.

The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.

One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).

All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).

The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.

Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.

More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.

The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.

Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.

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Earlier Is Better for Vaccine Delivery in Teens

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Adolescent immunization strategies should target youth in early to middle adolescence because primary health care visits decline substantially as adolescents age into their late teens, an analysis of adolescent health care utilization has shown.

To further optimize compliance with new adolescent immunization recommendations, all health care clinicians who provide preventive or acute care to this population should be trained to take advantage of every opportunity to provide immunizations, suggested Dr. Cynthia M. Rand of the University of Rochester (N.Y.) and her colleagues.

More than one-third of the overall health care visits by late-adolescent females (18–21 years) included in the analysis were to ob.gyns. As such, “education of obstetrician/gynecologists in the delivery of these vaccines [to older adolescents who missed the earlier vaccinations] is important,” they said.

The availability of newly licensed adolescent vaccines, including those for meningococcal conjugate, pertussis booster, and human papillomavirus (HPV), “heightens the need to rethink adolescent vaccination delivery in the context of comprehensive preventive care,” the authors wrote (Arch. Pediatr. Adolesc. Med. 2007;161:252–9).

To understand current patterns of adolescent health care visits and vaccinations, the investigators analyzed health care utilization data for 63,529 adolescents included in the 1994–2003 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. The types of health care professionals seen for all visits and for preventive visits were considered, as were the types of visits at which vaccination occurred. The variables were evaluated by adolescent stage (early, 11–14 years; middle, 15–17 years; and late, 18–21 years) and sex.

A review of the outpatient visits by age and sex showed a similar volume of visits in early adolescent boys and girls (3.7 million and 3.3 million for 11-year-olds, respectively) but substantially more visits among late adolescent girls than among boys (5 million and 1.8 million for 21-year-olds, respectively). There was an inverse relationship between health care visits and age among boys overall, with a sharp decline after the age of 16, while visits among girls increased in late adolescence, according to the authors.

When considering outpatient visits by physician type, 40% of outpatient visits for adolescents up to age 14 were to pediatricians, whereas older adolescent boys had more outpatient visits to family practice physicians (29%) than to pediatricians (7%), and older adolescent girls had more visits to ob.gyns. (36%). Internists in private offices provided a small number of adolescent visits, but they increased with age: 4% of early and 7% of late adolescent girls and 3% of early and 10% of late adolescent boys, Dr. Rand and her associates wrote.

Given this finding, it is incumbent on professional organizations such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists to provide “intensive, specialty-specific outreach and communication with their members to maximize delivery of new vaccines to their adolescent patients, particularly those populations that remain traditionally under-immunized,” the authors emphasized.

With respect to preventive care visits specifically, only 9% of all the adolescent visits considered were for preventive care, and early adolescents had three times as many such visits—primarily to pediatricians—than did late adolescents. “Preventive visits made by males declined somewhat after the age of 13 years and again more substantially after the age of 17 years,” according to the authors. Similarly, “preventive visits made by females declined moderately after the age of 14 years and declined further after the age of 17 years,” they said. For early adolescent boys and girls, preventive visits composed 13% of all visits; in late adolescence, girls had a greater proportion of visits, but only 3% were preventive, compared with 6% in teen boys.

This finding indicates that, to best deliver vaccines to adolescents within current health care visit patterns, vaccination before late adolescence is optimal, both because there are more preventive visits before the age of 15 years and because the visits tend to be to traditional immunization providers, such as pediatricians and family practice physicians, Dr. Rand and her associates wrote.

The data on immunization-related visits showed that adolescents generally received vaccinations during preventive visits, which is a concern with respect to vaccination-delivery strategies. “Preventive visits make up only a small percentage of outpatient visits by adolescents and occur less frequently among older adolescents, suggesting that vaccines targeted to late adolescents may be unlikely to reach most teens if vaccination remains coupled to preventive care,” according to the authors.

The study findings highlight the need for more robust strategies for increasing preventive care visits among adolescent patients. “Ensuring that adolescents receive annual preventive visits should be a priority of primary care physicians,” Dr. Rand and her associates stressed, noting that incorporating strategies such as patient reminder or recall to increase preventive visits and vaccinations is particularly important for this age group.

 

 

The practice of vaccinating at acute care visits also should be extended to adolescents “to take advantage of every opportunity to provide immunizations,” noted the authors.

This is especially relevant when considering vaccinations that are delivered in a series. For example, “the human papillomavirus vaccination will require multiple follow-up visits to complete the series, heightening the need to use all visits as vaccination opportunities,” they said.

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Adolescent immunization strategies should target youth in early to middle adolescence because primary health care visits decline substantially as adolescents age into their late teens, an analysis of adolescent health care utilization has shown.

To further optimize compliance with new adolescent immunization recommendations, all health care clinicians who provide preventive or acute care to this population should be trained to take advantage of every opportunity to provide immunizations, suggested Dr. Cynthia M. Rand of the University of Rochester (N.Y.) and her colleagues.

More than one-third of the overall health care visits by late-adolescent females (18–21 years) included in the analysis were to ob.gyns. As such, “education of obstetrician/gynecologists in the delivery of these vaccines [to older adolescents who missed the earlier vaccinations] is important,” they said.

The availability of newly licensed adolescent vaccines, including those for meningococcal conjugate, pertussis booster, and human papillomavirus (HPV), “heightens the need to rethink adolescent vaccination delivery in the context of comprehensive preventive care,” the authors wrote (Arch. Pediatr. Adolesc. Med. 2007;161:252–9).

To understand current patterns of adolescent health care visits and vaccinations, the investigators analyzed health care utilization data for 63,529 adolescents included in the 1994–2003 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. The types of health care professionals seen for all visits and for preventive visits were considered, as were the types of visits at which vaccination occurred. The variables were evaluated by adolescent stage (early, 11–14 years; middle, 15–17 years; and late, 18–21 years) and sex.

A review of the outpatient visits by age and sex showed a similar volume of visits in early adolescent boys and girls (3.7 million and 3.3 million for 11-year-olds, respectively) but substantially more visits among late adolescent girls than among boys (5 million and 1.8 million for 21-year-olds, respectively). There was an inverse relationship between health care visits and age among boys overall, with a sharp decline after the age of 16, while visits among girls increased in late adolescence, according to the authors.

When considering outpatient visits by physician type, 40% of outpatient visits for adolescents up to age 14 were to pediatricians, whereas older adolescent boys had more outpatient visits to family practice physicians (29%) than to pediatricians (7%), and older adolescent girls had more visits to ob.gyns. (36%). Internists in private offices provided a small number of adolescent visits, but they increased with age: 4% of early and 7% of late adolescent girls and 3% of early and 10% of late adolescent boys, Dr. Rand and her associates wrote.

Given this finding, it is incumbent on professional organizations such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists to provide “intensive, specialty-specific outreach and communication with their members to maximize delivery of new vaccines to their adolescent patients, particularly those populations that remain traditionally under-immunized,” the authors emphasized.

With respect to preventive care visits specifically, only 9% of all the adolescent visits considered were for preventive care, and early adolescents had three times as many such visits—primarily to pediatricians—than did late adolescents. “Preventive visits made by males declined somewhat after the age of 13 years and again more substantially after the age of 17 years,” according to the authors. Similarly, “preventive visits made by females declined moderately after the age of 14 years and declined further after the age of 17 years,” they said. For early adolescent boys and girls, preventive visits composed 13% of all visits; in late adolescence, girls had a greater proportion of visits, but only 3% were preventive, compared with 6% in teen boys.

This finding indicates that, to best deliver vaccines to adolescents within current health care visit patterns, vaccination before late adolescence is optimal, both because there are more preventive visits before the age of 15 years and because the visits tend to be to traditional immunization providers, such as pediatricians and family practice physicians, Dr. Rand and her associates wrote.

The data on immunization-related visits showed that adolescents generally received vaccinations during preventive visits, which is a concern with respect to vaccination-delivery strategies. “Preventive visits make up only a small percentage of outpatient visits by adolescents and occur less frequently among older adolescents, suggesting that vaccines targeted to late adolescents may be unlikely to reach most teens if vaccination remains coupled to preventive care,” according to the authors.

The study findings highlight the need for more robust strategies for increasing preventive care visits among adolescent patients. “Ensuring that adolescents receive annual preventive visits should be a priority of primary care physicians,” Dr. Rand and her associates stressed, noting that incorporating strategies such as patient reminder or recall to increase preventive visits and vaccinations is particularly important for this age group.

 

 

The practice of vaccinating at acute care visits also should be extended to adolescents “to take advantage of every opportunity to provide immunizations,” noted the authors.

This is especially relevant when considering vaccinations that are delivered in a series. For example, “the human papillomavirus vaccination will require multiple follow-up visits to complete the series, heightening the need to use all visits as vaccination opportunities,” they said.

Adolescent immunization strategies should target youth in early to middle adolescence because primary health care visits decline substantially as adolescents age into their late teens, an analysis of adolescent health care utilization has shown.

To further optimize compliance with new adolescent immunization recommendations, all health care clinicians who provide preventive or acute care to this population should be trained to take advantage of every opportunity to provide immunizations, suggested Dr. Cynthia M. Rand of the University of Rochester (N.Y.) and her colleagues.

More than one-third of the overall health care visits by late-adolescent females (18–21 years) included in the analysis were to ob.gyns. As such, “education of obstetrician/gynecologists in the delivery of these vaccines [to older adolescents who missed the earlier vaccinations] is important,” they said.

The availability of newly licensed adolescent vaccines, including those for meningococcal conjugate, pertussis booster, and human papillomavirus (HPV), “heightens the need to rethink adolescent vaccination delivery in the context of comprehensive preventive care,” the authors wrote (Arch. Pediatr. Adolesc. Med. 2007;161:252–9).

To understand current patterns of adolescent health care visits and vaccinations, the investigators analyzed health care utilization data for 63,529 adolescents included in the 1994–2003 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. The types of health care professionals seen for all visits and for preventive visits were considered, as were the types of visits at which vaccination occurred. The variables were evaluated by adolescent stage (early, 11–14 years; middle, 15–17 years; and late, 18–21 years) and sex.

A review of the outpatient visits by age and sex showed a similar volume of visits in early adolescent boys and girls (3.7 million and 3.3 million for 11-year-olds, respectively) but substantially more visits among late adolescent girls than among boys (5 million and 1.8 million for 21-year-olds, respectively). There was an inverse relationship between health care visits and age among boys overall, with a sharp decline after the age of 16, while visits among girls increased in late adolescence, according to the authors.

When considering outpatient visits by physician type, 40% of outpatient visits for adolescents up to age 14 were to pediatricians, whereas older adolescent boys had more outpatient visits to family practice physicians (29%) than to pediatricians (7%), and older adolescent girls had more visits to ob.gyns. (36%). Internists in private offices provided a small number of adolescent visits, but they increased with age: 4% of early and 7% of late adolescent girls and 3% of early and 10% of late adolescent boys, Dr. Rand and her associates wrote.

Given this finding, it is incumbent on professional organizations such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists to provide “intensive, specialty-specific outreach and communication with their members to maximize delivery of new vaccines to their adolescent patients, particularly those populations that remain traditionally under-immunized,” the authors emphasized.

With respect to preventive care visits specifically, only 9% of all the adolescent visits considered were for preventive care, and early adolescents had three times as many such visits—primarily to pediatricians—than did late adolescents. “Preventive visits made by males declined somewhat after the age of 13 years and again more substantially after the age of 17 years,” according to the authors. Similarly, “preventive visits made by females declined moderately after the age of 14 years and declined further after the age of 17 years,” they said. For early adolescent boys and girls, preventive visits composed 13% of all visits; in late adolescence, girls had a greater proportion of visits, but only 3% were preventive, compared with 6% in teen boys.

This finding indicates that, to best deliver vaccines to adolescents within current health care visit patterns, vaccination before late adolescence is optimal, both because there are more preventive visits before the age of 15 years and because the visits tend to be to traditional immunization providers, such as pediatricians and family practice physicians, Dr. Rand and her associates wrote.

The data on immunization-related visits showed that adolescents generally received vaccinations during preventive visits, which is a concern with respect to vaccination-delivery strategies. “Preventive visits make up only a small percentage of outpatient visits by adolescents and occur less frequently among older adolescents, suggesting that vaccines targeted to late adolescents may be unlikely to reach most teens if vaccination remains coupled to preventive care,” according to the authors.

The study findings highlight the need for more robust strategies for increasing preventive care visits among adolescent patients. “Ensuring that adolescents receive annual preventive visits should be a priority of primary care physicians,” Dr. Rand and her associates stressed, noting that incorporating strategies such as patient reminder or recall to increase preventive visits and vaccinations is particularly important for this age group.

 

 

The practice of vaccinating at acute care visits also should be extended to adolescents “to take advantage of every opportunity to provide immunizations,” noted the authors.

This is especially relevant when considering vaccinations that are delivered in a series. For example, “the human papillomavirus vaccination will require multiple follow-up visits to complete the series, heightening the need to use all visits as vaccination opportunities,” they said.

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Under a Third of Asthmatic Kids Got a Flu Vaccine in 2004–2005

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Less than one-third of children with asthma between the ages of 2 and 17 years received the influenza vaccine during the 2004–2005 influenza season, according to the first national estimate of influenza vaccine coverage in children with asthma by the Centers for Disease Control and Prevention.

While this rate is approximately three times higher than that reported for nonasthmatic children, the “inadequate” numbers indicate “that opportunities for vaccination during health-care provider visits likely are being missed,” according to Susan M. Brim of the CDC's National Center for Environmental Health and her colleagues (MMWR 2007;56:193–6).

With data from the 2005 National Health Interview Survey (NHIS)—a cross-sectional, household interview survey in the United States—the CDC investigators analyzed influenza vaccine coverage rates for the 5,124 youth aged 2–17 years represented in the database and determined that 29% of children with current asthma had received the influenza vaccine for the September 2004-February 2005 influenza season, compared with 10.3% of their nonasthmatic peers.

Of the children with current asthma, vaccine coverage was highest—at 32.9%—in the 2− to 4-year-old age group, compared with 28% in both the 5− to 12-year-old and 13− to 17-year-old age categories. Children who had experienced an asthma attack or episode within the 12 months prior to the survey (35.9% of those with asthma) were more likely to have been vaccinated than children with current asthma but no past-year history of an asthmatic episode (20%). Children aged 5–12 years with current asthma and no past year history of an asthmatic episode had the lowest vaccination coverage rate, at 16.4%, in the asthma group, the authors reported.

When the data were analyzed based on the number of health care visits per child during the 12 months preceding the survey, influenza vaccine coverage among children with asthma was directly related to the number of visits. “Approximately 10.8% of children with current asthma who had one health-care visit in the preceding year were vaccinated, whereas 42.0% of children with [10 or more] visits were vaccinated,” Ms. Brim and her associates wrote.

Because the 2005 NHIS was the first to include questions on influenza vaccination in the child portion of the survey, “the results of this analysis cannot be compared with previous years,” according to the authors. “Analysis of NHIS data from 2006 and future years will allow determination of trends in national influenza vaccination coverage in children with asthma.”

Such monitoring is essential for the design of public health strategies for increasing influenza vaccination coverage that targets all children with asthma, particularly those with the lowest coverage rates, the authors stressed. Continued monitoring also will be necessary to determine whether and to what extent changes, such as the 2006 revision to Advisory Committee on Immunization Practices (ACIP) influenza vaccination recommendations to include all children between the ages of 6 and 59 months, will impact actual coverage rates, they noted.

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Less than one-third of children with asthma between the ages of 2 and 17 years received the influenza vaccine during the 2004–2005 influenza season, according to the first national estimate of influenza vaccine coverage in children with asthma by the Centers for Disease Control and Prevention.

While this rate is approximately three times higher than that reported for nonasthmatic children, the “inadequate” numbers indicate “that opportunities for vaccination during health-care provider visits likely are being missed,” according to Susan M. Brim of the CDC's National Center for Environmental Health and her colleagues (MMWR 2007;56:193–6).

With data from the 2005 National Health Interview Survey (NHIS)—a cross-sectional, household interview survey in the United States—the CDC investigators analyzed influenza vaccine coverage rates for the 5,124 youth aged 2–17 years represented in the database and determined that 29% of children with current asthma had received the influenza vaccine for the September 2004-February 2005 influenza season, compared with 10.3% of their nonasthmatic peers.

Of the children with current asthma, vaccine coverage was highest—at 32.9%—in the 2− to 4-year-old age group, compared with 28% in both the 5− to 12-year-old and 13− to 17-year-old age categories. Children who had experienced an asthma attack or episode within the 12 months prior to the survey (35.9% of those with asthma) were more likely to have been vaccinated than children with current asthma but no past-year history of an asthmatic episode (20%). Children aged 5–12 years with current asthma and no past year history of an asthmatic episode had the lowest vaccination coverage rate, at 16.4%, in the asthma group, the authors reported.

When the data were analyzed based on the number of health care visits per child during the 12 months preceding the survey, influenza vaccine coverage among children with asthma was directly related to the number of visits. “Approximately 10.8% of children with current asthma who had one health-care visit in the preceding year were vaccinated, whereas 42.0% of children with [10 or more] visits were vaccinated,” Ms. Brim and her associates wrote.

Because the 2005 NHIS was the first to include questions on influenza vaccination in the child portion of the survey, “the results of this analysis cannot be compared with previous years,” according to the authors. “Analysis of NHIS data from 2006 and future years will allow determination of trends in national influenza vaccination coverage in children with asthma.”

Such monitoring is essential for the design of public health strategies for increasing influenza vaccination coverage that targets all children with asthma, particularly those with the lowest coverage rates, the authors stressed. Continued monitoring also will be necessary to determine whether and to what extent changes, such as the 2006 revision to Advisory Committee on Immunization Practices (ACIP) influenza vaccination recommendations to include all children between the ages of 6 and 59 months, will impact actual coverage rates, they noted.

Less than one-third of children with asthma between the ages of 2 and 17 years received the influenza vaccine during the 2004–2005 influenza season, according to the first national estimate of influenza vaccine coverage in children with asthma by the Centers for Disease Control and Prevention.

While this rate is approximately three times higher than that reported for nonasthmatic children, the “inadequate” numbers indicate “that opportunities for vaccination during health-care provider visits likely are being missed,” according to Susan M. Brim of the CDC's National Center for Environmental Health and her colleagues (MMWR 2007;56:193–6).

With data from the 2005 National Health Interview Survey (NHIS)—a cross-sectional, household interview survey in the United States—the CDC investigators analyzed influenza vaccine coverage rates for the 5,124 youth aged 2–17 years represented in the database and determined that 29% of children with current asthma had received the influenza vaccine for the September 2004-February 2005 influenza season, compared with 10.3% of their nonasthmatic peers.

Of the children with current asthma, vaccine coverage was highest—at 32.9%—in the 2− to 4-year-old age group, compared with 28% in both the 5− to 12-year-old and 13− to 17-year-old age categories. Children who had experienced an asthma attack or episode within the 12 months prior to the survey (35.9% of those with asthma) were more likely to have been vaccinated than children with current asthma but no past-year history of an asthmatic episode (20%). Children aged 5–12 years with current asthma and no past year history of an asthmatic episode had the lowest vaccination coverage rate, at 16.4%, in the asthma group, the authors reported.

When the data were analyzed based on the number of health care visits per child during the 12 months preceding the survey, influenza vaccine coverage among children with asthma was directly related to the number of visits. “Approximately 10.8% of children with current asthma who had one health-care visit in the preceding year were vaccinated, whereas 42.0% of children with [10 or more] visits were vaccinated,” Ms. Brim and her associates wrote.

Because the 2005 NHIS was the first to include questions on influenza vaccination in the child portion of the survey, “the results of this analysis cannot be compared with previous years,” according to the authors. “Analysis of NHIS data from 2006 and future years will allow determination of trends in national influenza vaccination coverage in children with asthma.”

Such monitoring is essential for the design of public health strategies for increasing influenza vaccination coverage that targets all children with asthma, particularly those with the lowest coverage rates, the authors stressed. Continued monitoring also will be necessary to determine whether and to what extent changes, such as the 2006 revision to Advisory Committee on Immunization Practices (ACIP) influenza vaccination recommendations to include all children between the ages of 6 and 59 months, will impact actual coverage rates, they noted.

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Progesterone Stalls Ripening of Cervix, Prevents Early Delivery

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SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in preventing preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks. The typical dose of 17-OHPC in these cases is usually a single weekly injection.

Dr. Facchinetti cited two reasons for the high dose: the cervical inflammatory processes were already underway and needed to be stalled; and the treatment was started later in pregnancy so there was less time for efficacy.

All of the women had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Those with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intraamniotic infection were excluded. There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. All of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, as per hospital policy.

After randomization 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (before week 37), compared with 54% in the observation group, representing a statistically significant reduction, said Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” he said. “Our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC].”

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SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in preventing preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks. The typical dose of 17-OHPC in these cases is usually a single weekly injection.

Dr. Facchinetti cited two reasons for the high dose: the cervical inflammatory processes were already underway and needed to be stalled; and the treatment was started later in pregnancy so there was less time for efficacy.

All of the women had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Those with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intraamniotic infection were excluded. There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. All of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, as per hospital policy.

After randomization 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (before week 37), compared with 54% in the observation group, representing a statistically significant reduction, said Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” he said. “Our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC].”

SAN FRANCISCO — The use of high-dose progesterone in women at risk for preterm delivery following premature labor slows the progression of cervical changes linked to early delivery, Dr. Fabio Facchinetti said at the annual meeting of the Society for Maternal-Fetal Medicine.

In a randomized controlled trial, the use of 17 α-hydroxyprogesterone caproate (17-OHPC) was associated with reduced cervical shortening and local inflammation, which led to a significantly reduced incidence of preterm deliveries, said Dr. Facchinetti of Universita di Modena e Reggio Emilia in Modena, Italy.

To investigate the mechanism of action of 17-OHPC in preventing preterm delivery, Dr. Facchinetti and colleagues randomized 45 hospitalized women who remained undelivered after an episode of preterm labor between 25 and 33 weeks to observation only or to treatment with twice weekly intramuscular injections of 341 mg of 17-OHPC until 36 weeks. The typical dose of 17-OHPC in these cases is usually a single weekly injection.

Dr. Facchinetti cited two reasons for the high dose: the cervical inflammatory processes were already underway and needed to be stalled; and the treatment was started later in pregnancy so there was less time for efficacy.

All of the women had singleton pregnancies, intact membranes, and cervical dilatation less than 2 cm. Those with chronic disease, gestational disease, large or multiple uterine myomas, or suspected intraamniotic infection were excluded. There were differences between the 23 women in the treatment group and the 22 controls in terms of maternal age or gestational age at time of preterm labor (mean 29 weeks), and the majority of patients had sonographic evidence of a short cervix at baseline, Dr. Facchinetti reported. All of the women received two doses of intramuscular betamethasone 24 hours apart to promote fetal lung development, as per hospital policy.

After randomization 4–6 days following hospital admission for preterm labor, each subject underwent a cervical swab and ultrasound measurement of cervical length at baseline, 1 week, and 3 weeks.

In terms of clinical outcome, 22% of the women in the treatment group had preterm delivery (before week 37), compared with 54% in the observation group, representing a statistically significant reduction, said Dr. Facchinetti. Among women in the treatment group, the mean length of pregnancy was 9 days longer than in the control group.

An analysis of the primary study outcome—change in cervical length—demonstrated significant differences between the treatment and observation groups. “After 3 weeks, women treated with 17-OHPC had a median 2-mm reduction in cervical length compared with 4 mm in untreated women,” he said. “Our speculation is that preterm cervical ripening is the real driver of preterm delivery and can be blocked by [17-OHPC].”

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Fish Intake Tied to Reduced Colorectal Ca Risk in Men

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BOSTON — Diets rich in fish may substantially reduce the risk of colorectal cancer in men, according to a new analysis of data from the U.S. Physicians' Health Study.

Of the 22,071 male physicians who participated in the randomized chemoprevention trial of aspirin and β-carotene initiated in 1982, those men who ate fish at least five times per week were 40% less likely to develop colorectal cancer, compared with men who ate fish less than once a week, Dr. Megan N. Phillips reported at the annual international conference of the American Association for Cancer Research.

In a previous case-control study nested within the Physicians' Health Study (PHS), Dr. Phillips of the Harvard School of Public Health in Boston and colleagues reported an inverse association between blood levels of long-chain n-3 fatty acids—which, in the diet, primarily come from fish—and colorectal cancer risk, as well as an interaction between n-3 fatty acids and aspirin.

In the current study, the investigators used data from the full PHS cohort to assess the associations between fish, n-3 fatty acid intake, and colorectal cancer risk, and to determine if fish consumption had a different effect on men who received aspirin for 5 years, compared with men who didn't use aspirin.

The information on fish intake was gleaned from a one-time abbreviated food questionnaire given to PHS participants 12 months after starting the study.

That questionnaire asked about average intake of four types of fish and shellfish, including a fatty “dark meat” category, in order to accurately estimate n-3 intake, said Dr. Phillips.

About 11% of the respondents reported eating fish 5 times or more per week, 48% ate fish 2–5 times per week, 31% ate it 1–2 times per week, and nearly 11% ate it less than once a week.

The investigators compared this information with rates of colorectal cancer that developed over a follow-up period that averaged 19.4 years.

By controlling for such factors as smoking, exercise, and multivitamin use, a Cox regression model showed relative reductions in risk of developing colon cancer, compared with men who ate fish less than once a week. In men who ate fish 1–2 times weekly, the reduction was 13%. Risk reduction was 20% for those who ate fish 2–5 times weekly, and 40% for those who ate it at least 5 times per week.

“The findings for n-3 fatty acids were similar to those for fish, with a statistically significant inverse trend with relative risks for increasing quartiles [of n-3 fatty acid] intake,” Dr. Phillips reported.

With respect to aspirin intake, “there was no significant additional risk-reduction advantage among men in the study who had been randomized to take aspirin for 5 years,” said Dr. Phillips, noting the possibility that “it may take more years of aspirin use to see an effect.”

Although the results appear robust, the findings of this study may be confounded by the fact that the patterns of fish consumption reported in the initial questionnaire might not have been maintained over time, Dr. Phillips noted.

Dr. Phillips had no financial disclosures related to her presentation.

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BOSTON — Diets rich in fish may substantially reduce the risk of colorectal cancer in men, according to a new analysis of data from the U.S. Physicians' Health Study.

Of the 22,071 male physicians who participated in the randomized chemoprevention trial of aspirin and β-carotene initiated in 1982, those men who ate fish at least five times per week were 40% less likely to develop colorectal cancer, compared with men who ate fish less than once a week, Dr. Megan N. Phillips reported at the annual international conference of the American Association for Cancer Research.

In a previous case-control study nested within the Physicians' Health Study (PHS), Dr. Phillips of the Harvard School of Public Health in Boston and colleagues reported an inverse association between blood levels of long-chain n-3 fatty acids—which, in the diet, primarily come from fish—and colorectal cancer risk, as well as an interaction between n-3 fatty acids and aspirin.

In the current study, the investigators used data from the full PHS cohort to assess the associations between fish, n-3 fatty acid intake, and colorectal cancer risk, and to determine if fish consumption had a different effect on men who received aspirin for 5 years, compared with men who didn't use aspirin.

The information on fish intake was gleaned from a one-time abbreviated food questionnaire given to PHS participants 12 months after starting the study.

That questionnaire asked about average intake of four types of fish and shellfish, including a fatty “dark meat” category, in order to accurately estimate n-3 intake, said Dr. Phillips.

About 11% of the respondents reported eating fish 5 times or more per week, 48% ate fish 2–5 times per week, 31% ate it 1–2 times per week, and nearly 11% ate it less than once a week.

The investigators compared this information with rates of colorectal cancer that developed over a follow-up period that averaged 19.4 years.

By controlling for such factors as smoking, exercise, and multivitamin use, a Cox regression model showed relative reductions in risk of developing colon cancer, compared with men who ate fish less than once a week. In men who ate fish 1–2 times weekly, the reduction was 13%. Risk reduction was 20% for those who ate fish 2–5 times weekly, and 40% for those who ate it at least 5 times per week.

“The findings for n-3 fatty acids were similar to those for fish, with a statistically significant inverse trend with relative risks for increasing quartiles [of n-3 fatty acid] intake,” Dr. Phillips reported.

With respect to aspirin intake, “there was no significant additional risk-reduction advantage among men in the study who had been randomized to take aspirin for 5 years,” said Dr. Phillips, noting the possibility that “it may take more years of aspirin use to see an effect.”

Although the results appear robust, the findings of this study may be confounded by the fact that the patterns of fish consumption reported in the initial questionnaire might not have been maintained over time, Dr. Phillips noted.

Dr. Phillips had no financial disclosures related to her presentation.

BOSTON — Diets rich in fish may substantially reduce the risk of colorectal cancer in men, according to a new analysis of data from the U.S. Physicians' Health Study.

Of the 22,071 male physicians who participated in the randomized chemoprevention trial of aspirin and β-carotene initiated in 1982, those men who ate fish at least five times per week were 40% less likely to develop colorectal cancer, compared with men who ate fish less than once a week, Dr. Megan N. Phillips reported at the annual international conference of the American Association for Cancer Research.

In a previous case-control study nested within the Physicians' Health Study (PHS), Dr. Phillips of the Harvard School of Public Health in Boston and colleagues reported an inverse association between blood levels of long-chain n-3 fatty acids—which, in the diet, primarily come from fish—and colorectal cancer risk, as well as an interaction between n-3 fatty acids and aspirin.

In the current study, the investigators used data from the full PHS cohort to assess the associations between fish, n-3 fatty acid intake, and colorectal cancer risk, and to determine if fish consumption had a different effect on men who received aspirin for 5 years, compared with men who didn't use aspirin.

The information on fish intake was gleaned from a one-time abbreviated food questionnaire given to PHS participants 12 months after starting the study.

That questionnaire asked about average intake of four types of fish and shellfish, including a fatty “dark meat” category, in order to accurately estimate n-3 intake, said Dr. Phillips.

About 11% of the respondents reported eating fish 5 times or more per week, 48% ate fish 2–5 times per week, 31% ate it 1–2 times per week, and nearly 11% ate it less than once a week.

The investigators compared this information with rates of colorectal cancer that developed over a follow-up period that averaged 19.4 years.

By controlling for such factors as smoking, exercise, and multivitamin use, a Cox regression model showed relative reductions in risk of developing colon cancer, compared with men who ate fish less than once a week. In men who ate fish 1–2 times weekly, the reduction was 13%. Risk reduction was 20% for those who ate fish 2–5 times weekly, and 40% for those who ate it at least 5 times per week.

“The findings for n-3 fatty acids were similar to those for fish, with a statistically significant inverse trend with relative risks for increasing quartiles [of n-3 fatty acid] intake,” Dr. Phillips reported.

With respect to aspirin intake, “there was no significant additional risk-reduction advantage among men in the study who had been randomized to take aspirin for 5 years,” said Dr. Phillips, noting the possibility that “it may take more years of aspirin use to see an effect.”

Although the results appear robust, the findings of this study may be confounded by the fact that the patterns of fish consumption reported in the initial questionnaire might not have been maintained over time, Dr. Phillips noted.

Dr. Phillips had no financial disclosures related to her presentation.

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Podocyturia May Signal Preeclampsia Risk Early

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Podocyturia May Signal Preeclampsia Risk Early

SAN FRANCISCO — Urinary excretion of podocytes appears to be a highly sensitive and specific marker for preeclampsia, Dr. Brian Brost said at the annual meeting of the Society for Maternal-Fetal Medicine.

Podocytes are highly differentiated epithelial cells that line the urinary surface of the glomerular capillary tuft. As part of the glomerular filtration barrier, “they play a central role in glomerular function,” according to Dr. Brost, an ob.gyn. at the Mayo Clinic in Rochester, Minn.

Because podocyturia is thought to occur earlier in the course of glomerular disease than does proteinuria, the detection of this marker may enable clinicians to identify women at risk for preeclampsia earlier than is currently possible, he said.

Preeclampsia has long been associated with pathologic renal changes, and recently published studies have linked the urinary shedding of podocytes with active glomerular disease.

“We hypothesized that viable podocytes would be present in urinary samples from women with clinically confirmed preeclampsia and would not be present in samples from normotensive pregnant women,” Dr. Brost said.

To test this hypothesis, the investigators analyzed clean-catch urine samples from 15 preeclamptic women and 16 normotensive women for podocyturia. Preeclampsia was diagnosed based on the American College of Obstetricians and Gynecologists' criteria for new-onset hypertension and proteinuria in previously normotensive pregnant women.

“We also evaluated serum concentrations of circulating angiogenic factors [thought to be predictive of preeclampsia] in order to compare the diagnostic accuracy of both tests,” Dr. Brost said.

In terms of patient characteristics, “maternal age in the preeclamptic group was higher than in the control group, as would be expected,” Dr. Brost said.

Additionally, by design, there was a statistically significant difference in gestational age at time of analysis.

“We had done some preliminary studies looking at the degree of podocyturia based on gestational age and there was no difference in those values, so for this investigation we picked term controls to try to ensure that these women would not develop preeclampsia along the way,” he commented.

For the podocyte assay, urine sediments were cultured on collagen-coated slides and incubated overnight. Urinary podocytes were identified and quantified based on their expression of the podocyte-specific protein, podocin. “Each sample was reviewed by a single renal pathologist, blinded to the diagnosis, to determine the number and percentage of cells that stained for podocin,” Dr. Brost said.

The assay results showed that podocytes were present in all of the samples collected from preeclamptic women and were not present in any of the control samples, indicating “the sensitivity and specificity of the assay were both 100%,” Dr. Brost reported.

Because the value of a diagnostic test depends on the pretest probability of the disease, “we estimated the diagnostic accuracy of both [the podocyte and the angiogenic factor] tests using pretest probabilities of 5% and 25%, which are the most commonly cited for low-risk and high-risk populations, respectively” Dr. Brost noted.

With use of the low pretest probability, “the negative predictive value did not differ between podocyturia and the angiogenic factor test,” he said. “For patients with a pretest probability of 25%, the negative predictive value was higher with podocyturia.”

In both the low and high pretest probability groups, the positive-predictive value was higher for podocyturia, he said.

Among the study's limitations is its small sample size, Dr. Brost said. “The numbers are low because this was meant to be a preliminary pilot study, but it has yielded exciting results. Our next step is to evaluate podocyturia in pregnancy with other renal processes to see what the effects would be.”

Future studies are needed both to confirm the study findings “and to test the hypothesis that podocyturia predates proteinuria and would thus provide a useful screening test for preeclampsia,” Dr. Brost concluded.

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SAN FRANCISCO — Urinary excretion of podocytes appears to be a highly sensitive and specific marker for preeclampsia, Dr. Brian Brost said at the annual meeting of the Society for Maternal-Fetal Medicine.

Podocytes are highly differentiated epithelial cells that line the urinary surface of the glomerular capillary tuft. As part of the glomerular filtration barrier, “they play a central role in glomerular function,” according to Dr. Brost, an ob.gyn. at the Mayo Clinic in Rochester, Minn.

Because podocyturia is thought to occur earlier in the course of glomerular disease than does proteinuria, the detection of this marker may enable clinicians to identify women at risk for preeclampsia earlier than is currently possible, he said.

Preeclampsia has long been associated with pathologic renal changes, and recently published studies have linked the urinary shedding of podocytes with active glomerular disease.

“We hypothesized that viable podocytes would be present in urinary samples from women with clinically confirmed preeclampsia and would not be present in samples from normotensive pregnant women,” Dr. Brost said.

To test this hypothesis, the investigators analyzed clean-catch urine samples from 15 preeclamptic women and 16 normotensive women for podocyturia. Preeclampsia was diagnosed based on the American College of Obstetricians and Gynecologists' criteria for new-onset hypertension and proteinuria in previously normotensive pregnant women.

“We also evaluated serum concentrations of circulating angiogenic factors [thought to be predictive of preeclampsia] in order to compare the diagnostic accuracy of both tests,” Dr. Brost said.

In terms of patient characteristics, “maternal age in the preeclamptic group was higher than in the control group, as would be expected,” Dr. Brost said.

Additionally, by design, there was a statistically significant difference in gestational age at time of analysis.

“We had done some preliminary studies looking at the degree of podocyturia based on gestational age and there was no difference in those values, so for this investigation we picked term controls to try to ensure that these women would not develop preeclampsia along the way,” he commented.

For the podocyte assay, urine sediments were cultured on collagen-coated slides and incubated overnight. Urinary podocytes were identified and quantified based on their expression of the podocyte-specific protein, podocin. “Each sample was reviewed by a single renal pathologist, blinded to the diagnosis, to determine the number and percentage of cells that stained for podocin,” Dr. Brost said.

The assay results showed that podocytes were present in all of the samples collected from preeclamptic women and were not present in any of the control samples, indicating “the sensitivity and specificity of the assay were both 100%,” Dr. Brost reported.

Because the value of a diagnostic test depends on the pretest probability of the disease, “we estimated the diagnostic accuracy of both [the podocyte and the angiogenic factor] tests using pretest probabilities of 5% and 25%, which are the most commonly cited for low-risk and high-risk populations, respectively” Dr. Brost noted.

With use of the low pretest probability, “the negative predictive value did not differ between podocyturia and the angiogenic factor test,” he said. “For patients with a pretest probability of 25%, the negative predictive value was higher with podocyturia.”

In both the low and high pretest probability groups, the positive-predictive value was higher for podocyturia, he said.

Among the study's limitations is its small sample size, Dr. Brost said. “The numbers are low because this was meant to be a preliminary pilot study, but it has yielded exciting results. Our next step is to evaluate podocyturia in pregnancy with other renal processes to see what the effects would be.”

Future studies are needed both to confirm the study findings “and to test the hypothesis that podocyturia predates proteinuria and would thus provide a useful screening test for preeclampsia,” Dr. Brost concluded.

SAN FRANCISCO — Urinary excretion of podocytes appears to be a highly sensitive and specific marker for preeclampsia, Dr. Brian Brost said at the annual meeting of the Society for Maternal-Fetal Medicine.

Podocytes are highly differentiated epithelial cells that line the urinary surface of the glomerular capillary tuft. As part of the glomerular filtration barrier, “they play a central role in glomerular function,” according to Dr. Brost, an ob.gyn. at the Mayo Clinic in Rochester, Minn.

Because podocyturia is thought to occur earlier in the course of glomerular disease than does proteinuria, the detection of this marker may enable clinicians to identify women at risk for preeclampsia earlier than is currently possible, he said.

Preeclampsia has long been associated with pathologic renal changes, and recently published studies have linked the urinary shedding of podocytes with active glomerular disease.

“We hypothesized that viable podocytes would be present in urinary samples from women with clinically confirmed preeclampsia and would not be present in samples from normotensive pregnant women,” Dr. Brost said.

To test this hypothesis, the investigators analyzed clean-catch urine samples from 15 preeclamptic women and 16 normotensive women for podocyturia. Preeclampsia was diagnosed based on the American College of Obstetricians and Gynecologists' criteria for new-onset hypertension and proteinuria in previously normotensive pregnant women.

“We also evaluated serum concentrations of circulating angiogenic factors [thought to be predictive of preeclampsia] in order to compare the diagnostic accuracy of both tests,” Dr. Brost said.

In terms of patient characteristics, “maternal age in the preeclamptic group was higher than in the control group, as would be expected,” Dr. Brost said.

Additionally, by design, there was a statistically significant difference in gestational age at time of analysis.

“We had done some preliminary studies looking at the degree of podocyturia based on gestational age and there was no difference in those values, so for this investigation we picked term controls to try to ensure that these women would not develop preeclampsia along the way,” he commented.

For the podocyte assay, urine sediments were cultured on collagen-coated slides and incubated overnight. Urinary podocytes were identified and quantified based on their expression of the podocyte-specific protein, podocin. “Each sample was reviewed by a single renal pathologist, blinded to the diagnosis, to determine the number and percentage of cells that stained for podocin,” Dr. Brost said.

The assay results showed that podocytes were present in all of the samples collected from preeclamptic women and were not present in any of the control samples, indicating “the sensitivity and specificity of the assay were both 100%,” Dr. Brost reported.

Because the value of a diagnostic test depends on the pretest probability of the disease, “we estimated the diagnostic accuracy of both [the podocyte and the angiogenic factor] tests using pretest probabilities of 5% and 25%, which are the most commonly cited for low-risk and high-risk populations, respectively” Dr. Brost noted.

With use of the low pretest probability, “the negative predictive value did not differ between podocyturia and the angiogenic factor test,” he said. “For patients with a pretest probability of 25%, the negative predictive value was higher with podocyturia.”

In both the low and high pretest probability groups, the positive-predictive value was higher for podocyturia, he said.

Among the study's limitations is its small sample size, Dr. Brost said. “The numbers are low because this was meant to be a preliminary pilot study, but it has yielded exciting results. Our next step is to evaluate podocyturia in pregnancy with other renal processes to see what the effects would be.”

Future studies are needed both to confirm the study findings “and to test the hypothesis that podocyturia predates proteinuria and would thus provide a useful screening test for preeclampsia,” Dr. Brost concluded.

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Prepregnancy BMI and Gestational Weight Predict Fetal Macrosomia

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Prepregnancy BMI and Gestational Weight Predict Fetal Macrosomia

SAN FRANCISCO — Prepregnancy body mass index and gestational weight gain are more predictive of fetal macrosomia than homeostasis model assessment and glucose load, a study has shown.

Because both of these are modifiable risk factors, “they should be emphasized in order to minimize the risk of macrosomia and associated adverse outcomes,” reported Dr. Chloe A. Zera in a poster presentation at the annual meeting of the Society for Maternal-Fetal Medicine.

In a prospective study designed to investigate whether either early or late gestational insulin resistance predicts infant birth weight and risk of macrosomia-related cesarean delivery, Dr. Zera of Boston's Brigham and Women's Hospital and colleagues collected homeostasis model assessment (HOMA) data, glucose load test (GLT) results, and clinical information including prepregnant body mass index (BMI), gestational weight gain, maternal age, delivery information, and infant birth weight for 439 pregnant women enrolled in the Massachusetts General Hospital Obstetrical Maternal Study.

All of the women had fasting blood samples drawn at 16–18 weeks gestation and all had GLT performed as part of routine care. Prepregnancy BMI was based on weight at first prenatal visit.

The investigators used multivariate analysis to predict infant birth weight as a function of the baseline characteristics of the study population and logistic regression to predict the odds of macrosomia and cesarean section, said Dr. Zera.

An analysis showed that 37% of the women in the study were overweight or obese prior to pregnancy, 17% of the infants in the cohort were macrosomic (more than 4,000 g), 27% of the deliveries were by cesarean section, and 30% of the cesarean deliveries were for macrosomia or failure to progress, Dr. Zera reported.

In the multivariate linear regression analysis, total gestational weight gain, prepregnancy BMI, and maternal age were significant predictors of birth weight, Dr. Zera said, noting that neither HOMA nor GLT were predictive. Both total weight gain and maternal BMI were significantly associated with risk of macrosomia in the logistical regression model, and maternal BMI alone was significantly associated with risk of cesarean section for macrosomia, she said.

Reducing prepregnancy BMI and decreasing gestational weight gain may reduce the risk of macrosomia and subsequent cesarean delivery, Dr. Zera noted.

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SAN FRANCISCO — Prepregnancy body mass index and gestational weight gain are more predictive of fetal macrosomia than homeostasis model assessment and glucose load, a study has shown.

Because both of these are modifiable risk factors, “they should be emphasized in order to minimize the risk of macrosomia and associated adverse outcomes,” reported Dr. Chloe A. Zera in a poster presentation at the annual meeting of the Society for Maternal-Fetal Medicine.

In a prospective study designed to investigate whether either early or late gestational insulin resistance predicts infant birth weight and risk of macrosomia-related cesarean delivery, Dr. Zera of Boston's Brigham and Women's Hospital and colleagues collected homeostasis model assessment (HOMA) data, glucose load test (GLT) results, and clinical information including prepregnant body mass index (BMI), gestational weight gain, maternal age, delivery information, and infant birth weight for 439 pregnant women enrolled in the Massachusetts General Hospital Obstetrical Maternal Study.

All of the women had fasting blood samples drawn at 16–18 weeks gestation and all had GLT performed as part of routine care. Prepregnancy BMI was based on weight at first prenatal visit.

The investigators used multivariate analysis to predict infant birth weight as a function of the baseline characteristics of the study population and logistic regression to predict the odds of macrosomia and cesarean section, said Dr. Zera.

An analysis showed that 37% of the women in the study were overweight or obese prior to pregnancy, 17% of the infants in the cohort were macrosomic (more than 4,000 g), 27% of the deliveries were by cesarean section, and 30% of the cesarean deliveries were for macrosomia or failure to progress, Dr. Zera reported.

In the multivariate linear regression analysis, total gestational weight gain, prepregnancy BMI, and maternal age were significant predictors of birth weight, Dr. Zera said, noting that neither HOMA nor GLT were predictive. Both total weight gain and maternal BMI were significantly associated with risk of macrosomia in the logistical regression model, and maternal BMI alone was significantly associated with risk of cesarean section for macrosomia, she said.

Reducing prepregnancy BMI and decreasing gestational weight gain may reduce the risk of macrosomia and subsequent cesarean delivery, Dr. Zera noted.

SAN FRANCISCO — Prepregnancy body mass index and gestational weight gain are more predictive of fetal macrosomia than homeostasis model assessment and glucose load, a study has shown.

Because both of these are modifiable risk factors, “they should be emphasized in order to minimize the risk of macrosomia and associated adverse outcomes,” reported Dr. Chloe A. Zera in a poster presentation at the annual meeting of the Society for Maternal-Fetal Medicine.

In a prospective study designed to investigate whether either early or late gestational insulin resistance predicts infant birth weight and risk of macrosomia-related cesarean delivery, Dr. Zera of Boston's Brigham and Women's Hospital and colleagues collected homeostasis model assessment (HOMA) data, glucose load test (GLT) results, and clinical information including prepregnant body mass index (BMI), gestational weight gain, maternal age, delivery information, and infant birth weight for 439 pregnant women enrolled in the Massachusetts General Hospital Obstetrical Maternal Study.

All of the women had fasting blood samples drawn at 16–18 weeks gestation and all had GLT performed as part of routine care. Prepregnancy BMI was based on weight at first prenatal visit.

The investigators used multivariate analysis to predict infant birth weight as a function of the baseline characteristics of the study population and logistic regression to predict the odds of macrosomia and cesarean section, said Dr. Zera.

An analysis showed that 37% of the women in the study were overweight or obese prior to pregnancy, 17% of the infants in the cohort were macrosomic (more than 4,000 g), 27% of the deliveries were by cesarean section, and 30% of the cesarean deliveries were for macrosomia or failure to progress, Dr. Zera reported.

In the multivariate linear regression analysis, total gestational weight gain, prepregnancy BMI, and maternal age were significant predictors of birth weight, Dr. Zera said, noting that neither HOMA nor GLT were predictive. Both total weight gain and maternal BMI were significantly associated with risk of macrosomia in the logistical regression model, and maternal BMI alone was significantly associated with risk of cesarean section for macrosomia, she said.

Reducing prepregnancy BMI and decreasing gestational weight gain may reduce the risk of macrosomia and subsequent cesarean delivery, Dr. Zera noted.

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Prepregnancy BMI and Gestational Weight Predict Fetal Macrosomia
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