Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.

In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.

It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.

“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”

Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).

[email protected]

Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.

In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.

It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.

“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”

Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).

[email protected]

Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.

In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.

It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.

“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”

Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).

[email protected]

Few patients who are initiated on second-line treatment for type 2 diabetes mellitus show evidence of recommended use of first-line treatment with metformin, according to research published online Sept. 13 in Diabetes Care.

A retrospective cross-sectional study examined Aetna member claims data from 52,544 individuals with type 2 diabetes. It showed that of the 22,956 individuals given second-line treatment, only 8.2% had claims evidence of recommended use of metformin in the previous 60 days.

Furthermore, 28% had no claims evidence at all of having taken metformin, and only a small number of these patients had evidence of contraindications to metformin, such as heart failure (2.9%), chronic obstructive pulmonary disease (3.1%), liver diseases (4.3%), or renal diseases (4.1%).

“Although gastrointestinal adverse effects related to metformin therapy might lead to guideline nonadherence and early second-line medication initiation, we did not find evidence for gastrointestinal upset in the claims data,” wrote Yi-Ju Tseng, PhD, of the Computational Health Informatics Program at Boston Children’s Hospital, and her coauthors.

Even at the top range of sensitivity, researchers argued that less than half of the patients on second-line treatment could have had prior recommended use of metformin as the first-line treatment, while at the lower end of sensitivity, that figure was less than 10% (Diabetes Care. 2017 Sep 13. doi: 10.2337/dc17-0213).

Wavebreakmedia Ltd

Few patients who are initiated on second-line treatment for type 2 diabetes mellitus show evidence of recommended use of first-line treatment with metformin, according to research published online Sept. 13 in Diabetes Care.

A retrospective cross-sectional study examined Aetna member claims data from 52,544 individuals with type 2 diabetes. It showed that of the 22,956 individuals given second-line treatment, only 8.2% had claims evidence of recommended use of metformin in the previous 60 days.

Furthermore, 28% had no claims evidence at all of having taken metformin, and only a small number of these patients had evidence of contraindications to metformin, such as heart failure (2.9%), chronic obstructive pulmonary disease (3.1%), liver diseases (4.3%), or renal diseases (4.1%).

“Although gastrointestinal adverse effects related to metformin therapy might lead to guideline nonadherence and early second-line medication initiation, we did not find evidence for gastrointestinal upset in the claims data,” wrote Yi-Ju Tseng, PhD, of the Computational Health Informatics Program at Boston Children’s Hospital, and her coauthors.

Even at the top range of sensitivity, researchers argued that less than half of the patients on second-line treatment could have had prior recommended use of metformin as the first-line treatment, while at the lower end of sensitivity, that figure was less than 10% (Diabetes Care. 2017 Sep 13. doi: 10.2337/dc17-0213).

Wavebreakmedia Ltd

Few patients who are initiated on second-line treatment for type 2 diabetes mellitus show evidence of recommended use of first-line treatment with metformin, according to research published online Sept. 13 in Diabetes Care.

A retrospective cross-sectional study examined Aetna member claims data from 52,544 individuals with type 2 diabetes. It showed that of the 22,956 individuals given second-line treatment, only 8.2% had claims evidence of recommended use of metformin in the previous 60 days.

Furthermore, 28% had no claims evidence at all of having taken metformin, and only a small number of these patients had evidence of contraindications to metformin, such as heart failure (2.9%), chronic obstructive pulmonary disease (3.1%), liver diseases (4.3%), or renal diseases (4.1%).

“Although gastrointestinal adverse effects related to metformin therapy might lead to guideline nonadherence and early second-line medication initiation, we did not find evidence for gastrointestinal upset in the claims data,” wrote Yi-Ju Tseng, PhD, of the Computational Health Informatics Program at Boston Children’s Hospital, and her coauthors.

Even at the top range of sensitivity, researchers argued that less than half of the patients on second-line treatment could have had prior recommended use of metformin as the first-line treatment, while at the lower end of sensitivity, that figure was less than 10% (Diabetes Care. 2017 Sep 13. doi: 10.2337/dc17-0213).

Wavebreakmedia Ltd

PARK CITY, UTAH – Systemic capillary leakage – which involves acute respiratory distress, ascites, pleural effusion, and abdominal distention – significantly increases the risk of hysterectomy in women with postpartum group A Streptococcus infection, according to findings from a single-site study.

The investigators at the University of Utah in Salt Lake City analyzed 71 cases of culture-proven infection at the university since 1991. They compared the 33 women who had hysterectomies, ICU admissions, pressor support, or mechanical ventilation with the 38 women who did not.

The goal was to identify predictors of poor outcomes and clarify when hysterectomy is the appropriate clinical decision. “These are young women, and it might have been their first pregnancy. You don’t want to remove their uterus if they don’t need it, but we know if women get really sick, they need that source control within 6-12 hours of presentation,” said Jennifer Kaiser, MD, the study’s lead investigator and an ob.gyn. fellow at the University of Utah.

[email protected]

PARK CITY, UTAH – Systemic capillary leakage – which involves acute respiratory distress, ascites, pleural effusion, and abdominal distention – significantly increases the risk of hysterectomy in women with postpartum group A Streptococcus infection, according to findings from a single-site study.

The investigators at the University of Utah in Salt Lake City analyzed 71 cases of culture-proven infection at the university since 1991. They compared the 33 women who had hysterectomies, ICU admissions, pressor support, or mechanical ventilation with the 38 women who did not.

The goal was to identify predictors of poor outcomes and clarify when hysterectomy is the appropriate clinical decision. “These are young women, and it might have been their first pregnancy. You don’t want to remove their uterus if they don’t need it, but we know if women get really sick, they need that source control within 6-12 hours of presentation,” said Jennifer Kaiser, MD, the study’s lead investigator and an ob.gyn. fellow at the University of Utah.

[email protected]

PARK CITY, UTAH – Systemic capillary leakage – which involves acute respiratory distress, ascites, pleural effusion, and abdominal distention – significantly increases the risk of hysterectomy in women with postpartum group A Streptococcus infection, according to findings from a single-site study.

The investigators at the University of Utah in Salt Lake City analyzed 71 cases of culture-proven infection at the university since 1991. They compared the 33 women who had hysterectomies, ICU admissions, pressor support, or mechanical ventilation with the 38 women who did not.

The goal was to identify predictors of poor outcomes and clarify when hysterectomy is the appropriate clinical decision. “These are young women, and it might have been their first pregnancy. You don’t want to remove their uterus if they don’t need it, but we know if women get really sick, they need that source control within 6-12 hours of presentation,” said Jennifer Kaiser, MD, the study’s lead investigator and an ob.gyn. fellow at the University of Utah.

[email protected]

Bortezomib and KW-2478, a novel nonansamycin heat shock protein 90 (Hsp90) inhibitor, had modest activity and was well tolerated in an open-label phase 1/2 study of patients with relapsed or refractory multiple myeloma.

The objective response rate in 79 evaluable patients treated with the combination was 39.2%, and the clinical benefit rate was 51.9%. Median progression-free survival was 6.7 months, and median duration of response was 5.5 months, according to a report by Jamie Cavenagh, MD, of St. Bartholomew’s Hospital, West Smithfield, London, and colleagues. The results were published online in the British Journal of Cancer.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

[email protected]

Bortezomib and KW-2478, a novel nonansamycin heat shock protein 90 (Hsp90) inhibitor, had modest activity and was well tolerated in an open-label phase 1/2 study of patients with relapsed or refractory multiple myeloma.

The objective response rate in 79 evaluable patients treated with the combination was 39.2%, and the clinical benefit rate was 51.9%. Median progression-free survival was 6.7 months, and median duration of response was 5.5 months, according to a report by Jamie Cavenagh, MD, of St. Bartholomew’s Hospital, West Smithfield, London, and colleagues. The results were published online in the British Journal of Cancer.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

[email protected]

Bortezomib and KW-2478, a novel nonansamycin heat shock protein 90 (Hsp90) inhibitor, had modest activity and was well tolerated in an open-label phase 1/2 study of patients with relapsed or refractory multiple myeloma.

The objective response rate in 79 evaluable patients treated with the combination was 39.2%, and the clinical benefit rate was 51.9%. Median progression-free survival was 6.7 months, and median duration of response was 5.5 months, according to a report by Jamie Cavenagh, MD, of St. Bartholomew’s Hospital, West Smithfield, London, and colleagues. The results were published online in the British Journal of Cancer.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

[email protected]

Can outreach improve the globally low rates of adherence to colorectal cancer screening? Yes, according to two recent studies in JAMA; the studies found that both patient-focused and physician-focused outreach approaches can result in significantly better patient participation in colorectal cancer (CRC) screening.

The first study (JAMA. 2017;318[9]:806-15) compared a colonoscopy outreach program and a fecal immunochemical test (FIT) outreach program both with each other and with usual care. The results of the pragmatic, single-site, randomized, clinical trial showed that completed screenings were higher for both outreach groups, compared with the usual care group.

The primary outcome measure of the study was completion of the screening process, wrote Amit Singal, MD, and his coauthors. This was defined as any adherence to colonoscopy completion, the completion of annual testing for patients who had a normal FIT test, or treatment evaluation if CRC was detected during the screening process. Screenings were considered complete even if, for example, a patient in the colonoscopy arm eventually went on to have three consecutive annual FIT tests rather than a colonoscopy.

A total of 5,999 patients eligible for screening were initially randomized to one of the three study arms. Across all study arms, approximately half were lost to follow-up. These patients were excluded from the primary analysis but were included in an additional intention-to-screen analysis. A total of 2,400 patients received a colonoscopy outreach mailing; 2,400 received FIT outreach, including a letter, the home FIT testing kit and instructions; 1,199 received usual care. Patients in both intervention arms also received up to two phone calls if they didn’t respond to the initial mailing within 2 weeks. Mailings and phone calls were conducted in English or Spanish, according to the patients’ stated language preferences (those whose spoke neither language were excluded from the study).

Of the patients in the colonoscopy outreach group, 922 (38.4%) completed the screening process, compared with 671 (28.0%) in the FIT outreach group and 128 (10.7%) in the usual care group.

Compared with the group receiving usual care, completion of the screening process was 27.7% higher in the colonoscopy outreach group and 17.3% higher in the FIT outreach group. Screening process completion was 10.4% higher for the colonoscopy outreach group, compared with the FIT outreach group (P less than .001 for all).

Dr. Singal, who is with the department of internal medicine at UT Southwestern Medical Center, Dallas, and his colleagues also performed several post-hoc secondary analyses. In one, they used a less-stringent definition of screening process completion in which biennial FIT testing was considered satisfactory. When this definition was applied, the colonoscopy outreach group had 0.5% lower screening process completion than the FIT outreach group. The chances of a patient receiving any screening during the study period was highest in the FIT group (65%), with 51.7% of those in the colonoscopy outreach group and 39% of those in the usual care group receiving any screening.

“FIT has lower barriers to one-time participation but requires annual screening and diagnostic evaluation of abnormal results,” wrote Dr. Singal and his colleagues.

Strengths of the study, said Dr. Singal and his colleagues, included the fact that the study took place at a “safety net” institution with a racially and socioeconomically diverse population. Also, the study design avoided volunteer bias, and offered a pragmatic head-to-head comparison of colonoscopy and FIT.

The second study took place in western France, and targeted outreach to physicians rather than patients (JAMA. 2017;318[9];816-84). When physicians were given a list of their own patients who were not up to date on CRC screening, investigators saw a small, but significant, uptick in patient participation in FIT screening.

One year after the reminders went out, FIT screening had been initiated in 24.8% of patients whose physicians had received the list, compared with 21.7% of patients of physicians who had received a more generic notice and 20.6% of patients whose physicians received no notification, according to first author Cedric Rat, MD, and his colleagues.

The study examined which notification approach was most effective in increasing FIT screening among the physicians’ patient panels: sending general practitioners (GPs) letters that included a list of their own patients who had not undergone CRC screening, or sending them generic letters describing CRC screening adherence rates specific to their region. A usual care group of practices received no notifications in this 3-group randomized cluster design.

Patients in the patient-specific reminders group had an odds ratio of 1.27 for participation in FIT screening (P less than .001) compared to the usual care group. The odds ratio for the generic reminders group was 1.09, a nonsignificant difference.

Between-group comparison showed statistical significance for both the 3.1% difference between the patient-specific and generic reminders groups, and for the 4.2% difference between the patient-specific and usual care groups (P less than .001 for both). There was no significant difference between the generic reminders group and the usual care group.

Dr. Rat, professor of medicine at the Faculty of Medicine, Nantes, France, and his colleagues enrolled GPs in a total of 801 practices that included patients aged 50participating GPs caring for 33,044 patients who met study criteria.

Physician characteristics that were associated with higher FIT participation included younger age and an initially smaller number of unscreened patients. Patients with low socioeconomic status and those with a higher chronic disease burden were less likely to participate in FIT screening.

Also, Dr. Rat and his colleagues noted that the busiest practices actually had higher CRC screening rates. The investigators hypothesized that a recent physician pay-for-performance grant for CRC completion might be more appealing for some busy physicians.

This was the largest study of CRC screening participation to date, according to Dr. Rat and his coauthors, and showed the small but detectable efficacy of an inexpensive intervention that, given complete patient records, is relatively easy to effect. Though the effect size was smaller than the 12% difference the investigators had anticipated seeing for the patient-specific reminders group, the study still showed that targeting physicians can be an effective public health intervention to increase CRC screening rates, said Dr. Rat and his colleagues.

None of the investigators in either study reported conflicts of interest.

[email protected]

Can outreach improve the globally low rates of adherence to colorectal cancer screening? Yes, according to two recent studies in JAMA; the studies found that both patient-focused and physician-focused outreach approaches can result in significantly better patient participation in colorectal cancer (CRC) screening.

The first study (JAMA. 2017;318[9]:806-15) compared a colonoscopy outreach program and a fecal immunochemical test (FIT) outreach program both with each other and with usual care. The results of the pragmatic, single-site, randomized, clinical trial showed that completed screenings were higher for both outreach groups, compared with the usual care group.

The primary outcome measure of the study was completion of the screening process, wrote Amit Singal, MD, and his coauthors. This was defined as any adherence to colonoscopy completion, the completion of annual testing for patients who had a normal FIT test, or treatment evaluation if CRC was detected during the screening process. Screenings were considered complete even if, for example, a patient in the colonoscopy arm eventually went on to have three consecutive annual FIT tests rather than a colonoscopy.

A total of 5,999 patients eligible for screening were initially randomized to one of the three study arms. Across all study arms, approximately half were lost to follow-up. These patients were excluded from the primary analysis but were included in an additional intention-to-screen analysis. A total of 2,400 patients received a colonoscopy outreach mailing; 2,400 received FIT outreach, including a letter, the home FIT testing kit and instructions; 1,199 received usual care. Patients in both intervention arms also received up to two phone calls if they didn’t respond to the initial mailing within 2 weeks. Mailings and phone calls were conducted in English or Spanish, according to the patients’ stated language preferences (those whose spoke neither language were excluded from the study).

Of the patients in the colonoscopy outreach group, 922 (38.4%) completed the screening process, compared with 671 (28.0%) in the FIT outreach group and 128 (10.7%) in the usual care group.

Compared with the group receiving usual care, completion of the screening process was 27.7% higher in the colonoscopy outreach group and 17.3% higher in the FIT outreach group. Screening process completion was 10.4% higher for the colonoscopy outreach group, compared with the FIT outreach group (P less than .001 for all).

Dr. Singal, who is with the department of internal medicine at UT Southwestern Medical Center, Dallas, and his colleagues also performed several post-hoc secondary analyses. In one, they used a less-stringent definition of screening process completion in which biennial FIT testing was considered satisfactory. When this definition was applied, the colonoscopy outreach group had 0.5% lower screening process completion than the FIT outreach group. The chances of a patient receiving any screening during the study period was highest in the FIT group (65%), with 51.7% of those in the colonoscopy outreach group and 39% of those in the usual care group receiving any screening.

“FIT has lower barriers to one-time participation but requires annual screening and diagnostic evaluation of abnormal results,” wrote Dr. Singal and his colleagues.

Strengths of the study, said Dr. Singal and his colleagues, included the fact that the study took place at a “safety net” institution with a racially and socioeconomically diverse population. Also, the study design avoided volunteer bias, and offered a pragmatic head-to-head comparison of colonoscopy and FIT.

The second study took place in western France, and targeted outreach to physicians rather than patients (JAMA. 2017;318[9];816-84). When physicians were given a list of their own patients who were not up to date on CRC screening, investigators saw a small, but significant, uptick in patient participation in FIT screening.

One year after the reminders went out, FIT screening had been initiated in 24.8% of patients whose physicians had received the list, compared with 21.7% of patients of physicians who had received a more generic notice and 20.6% of patients whose physicians received no notification, according to first author Cedric Rat, MD, and his colleagues.

The study examined which notification approach was most effective in increasing FIT screening among the physicians’ patient panels: sending general practitioners (GPs) letters that included a list of their own patients who had not undergone CRC screening, or sending them generic letters describing CRC screening adherence rates specific to their region. A usual care group of practices received no notifications in this 3-group randomized cluster design.

Patients in the patient-specific reminders group had an odds ratio of 1.27 for participation in FIT screening (P less than .001) compared to the usual care group. The odds ratio for the generic reminders group was 1.09, a nonsignificant difference.

Between-group comparison showed statistical significance for both the 3.1% difference between the patient-specific and generic reminders groups, and for the 4.2% difference between the patient-specific and usual care groups (P less than .001 for both). There was no significant difference between the generic reminders group and the usual care group.

Dr. Rat, professor of medicine at the Faculty of Medicine, Nantes, France, and his colleagues enrolled GPs in a total of 801 practices that included patients aged 50participating GPs caring for 33,044 patients who met study criteria.

Physician characteristics that were associated with higher FIT participation included younger age and an initially smaller number of unscreened patients. Patients with low socioeconomic status and those with a higher chronic disease burden were less likely to participate in FIT screening.

Also, Dr. Rat and his colleagues noted that the busiest practices actually had higher CRC screening rates. The investigators hypothesized that a recent physician pay-for-performance grant for CRC completion might be more appealing for some busy physicians.

This was the largest study of CRC screening participation to date, according to Dr. Rat and his coauthors, and showed the small but detectable efficacy of an inexpensive intervention that, given complete patient records, is relatively easy to effect. Though the effect size was smaller than the 12% difference the investigators had anticipated seeing for the patient-specific reminders group, the study still showed that targeting physicians can be an effective public health intervention to increase CRC screening rates, said Dr. Rat and his colleagues.

None of the investigators in either study reported conflicts of interest.

[email protected]

Can outreach improve the globally low rates of adherence to colorectal cancer screening? Yes, according to two recent studies in JAMA; the studies found that both patient-focused and physician-focused outreach approaches can result in significantly better patient participation in colorectal cancer (CRC) screening.

The first study (JAMA. 2017;318[9]:806-15) compared a colonoscopy outreach program and a fecal immunochemical test (FIT) outreach program both with each other and with usual care. The results of the pragmatic, single-site, randomized, clinical trial showed that completed screenings were higher for both outreach groups, compared with the usual care group.

The primary outcome measure of the study was completion of the screening process, wrote Amit Singal, MD, and his coauthors. This was defined as any adherence to colonoscopy completion, the completion of annual testing for patients who had a normal FIT test, or treatment evaluation if CRC was detected during the screening process. Screenings were considered complete even if, for example, a patient in the colonoscopy arm eventually went on to have three consecutive annual FIT tests rather than a colonoscopy.

A total of 5,999 patients eligible for screening were initially randomized to one of the three study arms. Across all study arms, approximately half were lost to follow-up. These patients were excluded from the primary analysis but were included in an additional intention-to-screen analysis. A total of 2,400 patients received a colonoscopy outreach mailing; 2,400 received FIT outreach, including a letter, the home FIT testing kit and instructions; 1,199 received usual care. Patients in both intervention arms also received up to two phone calls if they didn’t respond to the initial mailing within 2 weeks. Mailings and phone calls were conducted in English or Spanish, according to the patients’ stated language preferences (those whose spoke neither language were excluded from the study).

Of the patients in the colonoscopy outreach group, 922 (38.4%) completed the screening process, compared with 671 (28.0%) in the FIT outreach group and 128 (10.7%) in the usual care group.

Compared with the group receiving usual care, completion of the screening process was 27.7% higher in the colonoscopy outreach group and 17.3% higher in the FIT outreach group. Screening process completion was 10.4% higher for the colonoscopy outreach group, compared with the FIT outreach group (P less than .001 for all).

Dr. Singal, who is with the department of internal medicine at UT Southwestern Medical Center, Dallas, and his colleagues also performed several post-hoc secondary analyses. In one, they used a less-stringent definition of screening process completion in which biennial FIT testing was considered satisfactory. When this definition was applied, the colonoscopy outreach group had 0.5% lower screening process completion than the FIT outreach group. The chances of a patient receiving any screening during the study period was highest in the FIT group (65%), with 51.7% of those in the colonoscopy outreach group and 39% of those in the usual care group receiving any screening.

“FIT has lower barriers to one-time participation but requires annual screening and diagnostic evaluation of abnormal results,” wrote Dr. Singal and his colleagues.

Strengths of the study, said Dr. Singal and his colleagues, included the fact that the study took place at a “safety net” institution with a racially and socioeconomically diverse population. Also, the study design avoided volunteer bias, and offered a pragmatic head-to-head comparison of colonoscopy and FIT.

The second study took place in western France, and targeted outreach to physicians rather than patients (JAMA. 2017;318[9];816-84). When physicians were given a list of their own patients who were not up to date on CRC screening, investigators saw a small, but significant, uptick in patient participation in FIT screening.

One year after the reminders went out, FIT screening had been initiated in 24.8% of patients whose physicians had received the list, compared with 21.7% of patients of physicians who had received a more generic notice and 20.6% of patients whose physicians received no notification, according to first author Cedric Rat, MD, and his colleagues.

The study examined which notification approach was most effective in increasing FIT screening among the physicians’ patient panels: sending general practitioners (GPs) letters that included a list of their own patients who had not undergone CRC screening, or sending them generic letters describing CRC screening adherence rates specific to their region. A usual care group of practices received no notifications in this 3-group randomized cluster design.

Patients in the patient-specific reminders group had an odds ratio of 1.27 for participation in FIT screening (P less than .001) compared to the usual care group. The odds ratio for the generic reminders group was 1.09, a nonsignificant difference.

Between-group comparison showed statistical significance for both the 3.1% difference between the patient-specific and generic reminders groups, and for the 4.2% difference between the patient-specific and usual care groups (P less than .001 for both). There was no significant difference between the generic reminders group and the usual care group.

Dr. Rat, professor of medicine at the Faculty of Medicine, Nantes, France, and his colleagues enrolled GPs in a total of 801 practices that included patients aged 50participating GPs caring for 33,044 patients who met study criteria.

Physician characteristics that were associated with higher FIT participation included younger age and an initially smaller number of unscreened patients. Patients with low socioeconomic status and those with a higher chronic disease burden were less likely to participate in FIT screening.

Also, Dr. Rat and his colleagues noted that the busiest practices actually had higher CRC screening rates. The investigators hypothesized that a recent physician pay-for-performance grant for CRC completion might be more appealing for some busy physicians.

This was the largest study of CRC screening participation to date, according to Dr. Rat and his coauthors, and showed the small but detectable efficacy of an inexpensive intervention that, given complete patient records, is relatively easy to effect. Though the effect size was smaller than the 12% difference the investigators had anticipated seeing for the patient-specific reminders group, the study still showed that targeting physicians can be an effective public health intervention to increase CRC screening rates, said Dr. Rat and his colleagues.

None of the investigators in either study reported conflicts of interest.

[email protected]

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

The DATA2020 HealthyPeople.gov data search function just got more user friendly. The Office of Disease Prevention and Health Promotion, National Center for Health Statistics, and Office of Minority Health, partners in DATA2020, have released a shareable widget that gives users easy access to regularly updated information.

The health disparities tool at DATA2020 lets users sort and view health disparities by demographic groups, including race/ethnicity, age, disability status, and geographic location. Users also can easily navigate and visualize data and changes in disparities over time; compare data points for each population group; and see all rates, rate ratios, confidence intervals and other technical details about data collection.

The new widget is an easy way (by simply copying the provided code) to share health disparities information on individual websites. Users can browse by disparity type or by Leading Health Indicator. The widget needs no maintenance; content updates automatically.

Photo courtesy of the CDC

New research has provided an updated estimate of the spending needed to bring a cancer drug to the US market.

In analyzing data from 10 companies bringing a cancer drug to market, researchers found that sales revenue from these drugs was roughly 7 times higher than the research and development (R&D) costs.

The total sales revenue for the drugs—during a median follow-up of 4 years—was $67.0 billion, and the total R&D spending was $9.1 billion (including 7% opportunity costs).

Researchers reported these figures in JAMA Internal Medicine.

“[T]he price of cancer drugs is currently rising higher and higher each year,” said study author Vinay Prasad, MD, of Oregon Health and Science University in Portland.

“The cost of 1 drug for 1 year of treatment is now routinely in excess of $100,000 . . . . One of the often-cited reasons why cancer drugs cost so much—one of the justifications for the high price—is that the outlay by the biopharmaceutical industry to bring these drugs to market is sizable, and there have been a wide range of estimates for what that R&D outlay is.”

“The most-cited estimate is one that comes out of the Tufts Medical Group¹ that puts the cost to bring a cancer drug to market, when adjusted for 2017 dollars, at $2.7 billion. Another estimate is from the group Public Citizen.² And that is a much lower estimate, finding the cost to bring a drug to market of $320 million.”

“Both of these estimates have limitations in the methods for how they estimated the cost to bring a drug to market. Notably, the Tufts group is rather non-transparent. Because of confidentiality agreements, we don’t know what drugs and what companies they’re looking at, and we can’t independently verify their analysis.”

“The Public Citizen group, in contrast, is comparing expenditures over a period of time against the number of drugs in a different period of time to make an estimate of the cost to bring a drug to market, but this isn’t exactly the cost of bringing those particular drugs to market.”

These issues prompted Dr Prasad and Sham Mailankody, MBBS, of the Memorial Sloan Kettering Cancer Center in New York, to conduct the current study.

Analysis

The researchers analyzed US Securities and Exchange Commission filings for 10 drug companies that received approval from the US Food and Drug Administration for a cancer drug from 2006 through 2015.

Prior to this, none of the companies had any drugs approved for use in the US. However, the companies had a median of 3.5 (range, 2-11) drugs in development during the study period.

The researchers said the fact that these companies had no prior drug approvals eliminated biases that may be present when analyzing larger drug companies, such as redundancies in R&D development and tax incentives for listing different endeavors as R&D spending.

In addition, the fact that the 10 companies were developing other drugs during the study period means this study takes into account the cost of failure in bringing a drug to market.

Results

For the 10 companies and drugs analyzed, the median duration of drug development was 7.3 years (range, 5.8 to 15.2 years).

The median cost of drug development (in 2017 US dollars) was $648.0 million (range, $157.3 to $1950.8 million). For a 7% per annum cost of capital (or opportunity costs), the median cost was $757.4 million (range, $203.6 to $2601.7 million).

The median time from approval to analysis in December 2016 (or until the company sold or licensed the compound to another company) was 4.0 years (range, 0.8 years to 8.8 years).

The total revenue from sales of the 10 drugs during this time was $67.0 billion.

The total R&D spending was $7.2 billion, or $9.1 billion when including 7% opportunity costs.

The following table includes data broken down by drug.

*Received accelerated approval. (The other 5 drugs received regular approval.)

**Did not receive orphan designation. (Nine of the 10 drugs received orphan designation.)

“So I think what we’re showing is . . .  a transparent analysis of cancer drugs and companies, looking at the cost to bring a drug to market,” Dr Mailankody said. “And our estimate of $648 million is substantially lower than the often-cited number of $2.7 billion.”

“We’re also showing that, for these 10 drugs, revenue since approval is quite a bit higher than the R&D spending, almost 7-fold higher, and some of these companies have already had revenue of 10-fold or higher, compared to the R&D expenses.”

The researchers acknowledged that this study is limited by a small data set and the fact that the findings cannot be extrapolated to other types of drugs.

1. DiMasi JA et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20-33.

2. Young B et al. Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Card.” Washington, DC: Public Citizen’s Congress Watch; 2001. https://www.citizen.org/sites/default/files/rdmyths.pdf.

Photo courtesy of the CDC

New research has provided an updated estimate of the spending needed to bring a cancer drug to the US market.

In analyzing data from 10 companies bringing a cancer drug to market, researchers found that sales revenue from these drugs was roughly 7 times higher than the research and development (R&D) costs.

The total sales revenue for the drugs—during a median follow-up of 4 years—was $67.0 billion, and the total R&D spending was $9.1 billion (including 7% opportunity costs).

Researchers reported these figures in JAMA Internal Medicine.

“[T]he price of cancer drugs is currently rising higher and higher each year,” said study author Vinay Prasad, MD, of Oregon Health and Science University in Portland.

“The cost of 1 drug for 1 year of treatment is now routinely in excess of $100,000 . . . . One of the often-cited reasons why cancer drugs cost so much—one of the justifications for the high price—is that the outlay by the biopharmaceutical industry to bring these drugs to market is sizable, and there have been a wide range of estimates for what that R&D outlay is.”

“The most-cited estimate is one that comes out of the Tufts Medical Group¹ that puts the cost to bring a cancer drug to market, when adjusted for 2017 dollars, at $2.7 billion. Another estimate is from the group Public Citizen.² And that is a much lower estimate, finding the cost to bring a drug to market of $320 million.”

“Both of these estimates have limitations in the methods for how they estimated the cost to bring a drug to market. Notably, the Tufts group is rather non-transparent. Because of confidentiality agreements, we don’t know what drugs and what companies they’re looking at, and we can’t independently verify their analysis.”

“The Public Citizen group, in contrast, is comparing expenditures over a period of time against the number of drugs in a different period of time to make an estimate of the cost to bring a drug to market, but this isn’t exactly the cost of bringing those particular drugs to market.”

These issues prompted Dr Prasad and Sham Mailankody, MBBS, of the Memorial Sloan Kettering Cancer Center in New York, to conduct the current study.

Analysis

The researchers analyzed US Securities and Exchange Commission filings for 10 drug companies that received approval from the US Food and Drug Administration for a cancer drug from 2006 through 2015.

Prior to this, none of the companies had any drugs approved for use in the US. However, the companies had a median of 3.5 (range, 2-11) drugs in development during the study period.

The researchers said the fact that these companies had no prior drug approvals eliminated biases that may be present when analyzing larger drug companies, such as redundancies in R&D development and tax incentives for listing different endeavors as R&D spending.

In addition, the fact that the 10 companies were developing other drugs during the study period means this study takes into account the cost of failure in bringing a drug to market.

Results

For the 10 companies and drugs analyzed, the median duration of drug development was 7.3 years (range, 5.8 to 15.2 years).

The median cost of drug development (in 2017 US dollars) was $648.0 million (range, $157.3 to $1950.8 million). For a 7% per annum cost of capital (or opportunity costs), the median cost was $757.4 million (range, $203.6 to $2601.7 million).

The median time from approval to analysis in December 2016 (or until the company sold or licensed the compound to another company) was 4.0 years (range, 0.8 years to 8.8 years).

The total revenue from sales of the 10 drugs during this time was $67.0 billion.

The total R&D spending was $7.2 billion, or $9.1 billion when including 7% opportunity costs.

The following table includes data broken down by drug.

*Received accelerated approval. (The other 5 drugs received regular approval.)

**Did not receive orphan designation. (Nine of the 10 drugs received orphan designation.)

“So I think what we’re showing is . . .  a transparent analysis of cancer drugs and companies, looking at the cost to bring a drug to market,” Dr Mailankody said. “And our estimate of $648 million is substantially lower than the often-cited number of $2.7 billion.”

“We’re also showing that, for these 10 drugs, revenue since approval is quite a bit higher than the R&D spending, almost 7-fold higher, and some of these companies have already had revenue of 10-fold or higher, compared to the R&D expenses.”

The researchers acknowledged that this study is limited by a small data set and the fact that the findings cannot be extrapolated to other types of drugs.

1. DiMasi JA et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20-33.

2. Young B et al. Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Card.” Washington, DC: Public Citizen’s Congress Watch; 2001. https://www.citizen.org/sites/default/files/rdmyths.pdf.

Photo courtesy of the CDC

New research has provided an updated estimate of the spending needed to bring a cancer drug to the US market.

In analyzing data from 10 companies bringing a cancer drug to market, researchers found that sales revenue from these drugs was roughly 7 times higher than the research and development (R&D) costs.

The total sales revenue for the drugs—during a median follow-up of 4 years—was $67.0 billion, and the total R&D spending was $9.1 billion (including 7% opportunity costs).

Researchers reported these figures in JAMA Internal Medicine.

“[T]he price of cancer drugs is currently rising higher and higher each year,” said study author Vinay Prasad, MD, of Oregon Health and Science University in Portland.

“The cost of 1 drug for 1 year of treatment is now routinely in excess of $100,000 . . . . One of the often-cited reasons why cancer drugs cost so much—one of the justifications for the high price—is that the outlay by the biopharmaceutical industry to bring these drugs to market is sizable, and there have been a wide range of estimates for what that R&D outlay is.”

“The most-cited estimate is one that comes out of the Tufts Medical Group¹ that puts the cost to bring a cancer drug to market, when adjusted for 2017 dollars, at $2.7 billion. Another estimate is from the group Public Citizen.² And that is a much lower estimate, finding the cost to bring a drug to market of $320 million.”

“Both of these estimates have limitations in the methods for how they estimated the cost to bring a drug to market. Notably, the Tufts group is rather non-transparent. Because of confidentiality agreements, we don’t know what drugs and what companies they’re looking at, and we can’t independently verify their analysis.”

“The Public Citizen group, in contrast, is comparing expenditures over a period of time against the number of drugs in a different period of time to make an estimate of the cost to bring a drug to market, but this isn’t exactly the cost of bringing those particular drugs to market.”

These issues prompted Dr Prasad and Sham Mailankody, MBBS, of the Memorial Sloan Kettering Cancer Center in New York, to conduct the current study.

Analysis

The researchers analyzed US Securities and Exchange Commission filings for 10 drug companies that received approval from the US Food and Drug Administration for a cancer drug from 2006 through 2015.

Prior to this, none of the companies had any drugs approved for use in the US. However, the companies had a median of 3.5 (range, 2-11) drugs in development during the study period.

The researchers said the fact that these companies had no prior drug approvals eliminated biases that may be present when analyzing larger drug companies, such as redundancies in R&D development and tax incentives for listing different endeavors as R&D spending.

In addition, the fact that the 10 companies were developing other drugs during the study period means this study takes into account the cost of failure in bringing a drug to market.

Results

For the 10 companies and drugs analyzed, the median duration of drug development was 7.3 years (range, 5.8 to 15.2 years).

The median cost of drug development (in 2017 US dollars) was $648.0 million (range, $157.3 to $1950.8 million). For a 7% per annum cost of capital (or opportunity costs), the median cost was $757.4 million (range, $203.6 to $2601.7 million).

The median time from approval to analysis in December 2016 (or until the company sold or licensed the compound to another company) was 4.0 years (range, 0.8 years to 8.8 years).

The total revenue from sales of the 10 drugs during this time was $67.0 billion.

The total R&D spending was $7.2 billion, or $9.1 billion when including 7% opportunity costs.

The following table includes data broken down by drug.

*Received accelerated approval. (The other 5 drugs received regular approval.)

**Did not receive orphan designation. (Nine of the 10 drugs received orphan designation.)

“So I think what we’re showing is . . .  a transparent analysis of cancer drugs and companies, looking at the cost to bring a drug to market,” Dr Mailankody said. “And our estimate of $648 million is substantially lower than the often-cited number of $2.7 billion.”

“We’re also showing that, for these 10 drugs, revenue since approval is quite a bit higher than the R&D spending, almost 7-fold higher, and some of these companies have already had revenue of 10-fold or higher, compared to the R&D expenses.”

The researchers acknowledged that this study is limited by a small data set and the fact that the findings cannot be extrapolated to other types of drugs.

1. DiMasi JA et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20-33.

2. Young B et al. Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Card.” Washington, DC: Public Citizen’s Congress Watch; 2001. https://www.citizen.org/sites/default/files/rdmyths.pdf.

Paula Burch-Celentano

A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.

The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.

“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.

“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”

For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.

The researchers found that asexual parasites were cleared by day 7 in both treatment groups.

In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).

In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).

Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.

The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).

Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.

The researchers hope to expand testing of AQ-13 to more participants, including women and children.

Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.

“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”

Paula Burch-Celentano

A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.

The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.

“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.

“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”

For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.

The researchers found that asexual parasites were cleared by day 7 in both treatment groups.

In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).

In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).

Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.

The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).

Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.

The researchers hope to expand testing of AQ-13 to more participants, including women and children.

Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.

“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”

Paula Burch-Celentano

A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.

The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.

“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.

“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”

For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.

The researchers found that asexual parasites were cleared by day 7 in both treatment groups.

In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).

In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).

Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.

The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).

Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.

The researchers hope to expand testing of AQ-13 to more participants, including women and children.

Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.

“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”

Photo by Daniel Sone

A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.

However, this study is limited in that it only included 113 clinical trials approved in Finland.

An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.

The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.

The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.

The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.

Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.

Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.

Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).

In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).

The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:

• A new primary outcome being reported that was not specified as primary in the protocol
• A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.

The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.

Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).

Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials.

Photo by Daniel Sone

A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.

However, this study is limited in that it only included 113 clinical trials approved in Finland.

An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.

The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.

The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.

The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.

Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.

Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.

Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).

In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).

The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:

• A new primary outcome being reported that was not specified as primary in the protocol
• A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.

The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.

Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).

Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials.

Photo by Daniel Sone

A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.

However, this study is limited in that it only included 113 clinical trials approved in Finland.

An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.

The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.

The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.

The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.

Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.

Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.

Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).

In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).

The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:

• A new primary outcome being reported that was not specified as primary in the protocol
• A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.

The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.

Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).

Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials.

An assay testing the presence of three blood-borne host-proteins shows promise in accurately identifying viral and bacterial infections in febrile children, a validation study found.

The three proteins that the ImmunoXpert assay uses to differentiate between viral and bacterial infections are: viral-induced tumor necrosis factor-related apoptosis–inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and bacterial-induced C-reactive protein (CRP). TRAIL and IP-10 are novel identifiers, while CRP has been used in traditional bacterial detecting assays, Isaac Srugo, MD, and his colleagues reported.

Ralwel/Thinkstock.com

[email protected]

An assay testing the presence of three blood-borne host-proteins shows promise in accurately identifying viral and bacterial infections in febrile children, a validation study found.

The three proteins that the ImmunoXpert assay uses to differentiate between viral and bacterial infections are: viral-induced tumor necrosis factor-related apoptosis–inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and bacterial-induced C-reactive protein (CRP). TRAIL and IP-10 are novel identifiers, while CRP has been used in traditional bacterial detecting assays, Isaac Srugo, MD, and his colleagues reported.

Ralwel/Thinkstock.com

[email protected]

An assay testing the presence of three blood-borne host-proteins shows promise in accurately identifying viral and bacterial infections in febrile children, a validation study found.

The three proteins that the ImmunoXpert assay uses to differentiate between viral and bacterial infections are: viral-induced tumor necrosis factor-related apoptosis–inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and bacterial-induced C-reactive protein (CRP). TRAIL and IP-10 are novel identifiers, while CRP has been used in traditional bacterial detecting assays, Isaac Srugo, MD, and his colleagues reported.

Ralwel/Thinkstock.com

[email protected]